Pharmaceutical Liability News

FDA Panel Votes to Restrict Avandia
A federal medical advisory panel has recommended that Avandia, a controversial diabetes drug, should either be withdrawn from the market or have sales severely restricted because it increases the risk of heart attacks. The panel's votes were a blow to Avandia's manufacturer, GlaxoSmithKline, which argued that the drug is a safe and needed option in treating diabetes. However, panel members voiced great skepticism about the company's trustworthiness after questions were raised about its clinical trials. Internal company documents showed that GlaxoSmithKline kept crucial safety information about Avandia from the public for years. The panel took six votes on a variety of issues, but its most important came near the end of the meeting when asked what the Food and Drug Administration should do. Of the panel's 33 members, 12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug's label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, which was to weaken the label's present heart warnings. The FDA often takes the advice of its advisory panels, but in this case it was hard to predict what the agency would do, given the split nature of the vote.

Weight Loss Drug Works, But Faces Safety Worries
Vivus' potential weight loss drug Qnexa will likely draw scrutiny over nervous system and psychiatric side effects from a panel of Food and Drug Administration experts. The FDA acknowledges the potential blockbuster drug's effectiveness in cutting weight, but the agency has raised concerns about a range of side effects, advising reviewers to take into account rates of depression, memory and concentration lapses, and heart-related issues, among others. The drug met key goals in several studies, cutting between 13 and 15 percent of patients' body weight, but the FDA is concerned about five types of side effects, including heart risks, increased risk of suicide, metabolic issues and the potential impact on pregnant women. A panel of experts is scheduled to review the drug soon, and the FDA will make a regulatory decision later this year.

A University President's Outside Board Membership
The University of Michigan medical school recently became the first in the nation to say it would refuse any funding from drug companies for its continuing medical education classes. The decision could cost it as much as $1 million a year, but it was worth it, the medical school dean said, for education to be free from potential bias. At the same time, however, the president of the entire University of Michigan, sits on the board of directors for pharmaceutical giant Johnson & Johnson. Last year, the company paid her $229,978 for attending a limited number of meetings. Conflict of interest? Conflict of policies? If the medical school and mere professors could be tainted by drug money, what about the university president? She says no and claims she has never had to recuse herself from any discussion or action at the university because medical purchasing and investment decisions are so remote from her.

Makers of NuvaRing Sued Over Woman's Death
The estate of an Omaha woman who died while using the NuvaRing contraceptive is suing its makers, claiming the device caused a deadly blood clot. The lawsuit says the 43-year-old woman died in 2009, about five months after she began using NuvaRing. The lawsuit seeks damages from various pharmaceutical companies that currently or at one time manufactured and sold the contraceptive, including Merck & Co., which last year acquired former maker Schering-Plough. The lawsuit does not list the amount in damages being sought, but asks for actual damages related to such things as funeral costs and lost wages, as well as wrongful death and punitive damages. An autopsy showed the woman died from a blood clot in one of her lungs. Her family accuses the makers of NuvaRing, of, among other things, over-promoting the contraceptive while providing too little warnings of the risks of blood clots to users.

Diabetes Drug Maker Hid Test Data, Files Indicate
In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda. Avandia's success was crucial to SmithKline, whose labs were otherwise all but barren of new products; however, the study's results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart. Instead of publishing the results, the company spent the next 11 years trying to cover them up, according to internal documents. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law. "This was done for the U.S. business, way under the radar," wrote a SmithKline executive in an 2001 email about the study results. "Per senior management's request, these data should not see the light of day to anyone outside of GlaxoSmithKline," the corporate successor to SmithKline. The heart risks from Avandia first became public in 2007 with a study from a cardiologist who used data the company was forced by a lawsuit to post on its own Web site. In the ensuing months, GlaxoSmithKline officials conceded that they had known of the drug's potential heart attack risks since at least 2005. But the latest documents demonstrate that the company had data hinting at Avandia's extensive heart problems almost as soon as the drug was introduced in 1999, and sought intensively to keep those risks from becoming public. GlaxoSmithKline claims it had not provided the results of its study because they "did not contribute any significant new information."

Glucosamine's Benefits Disputed
Many people with chronic lower-back pain and osteoarthritis take glucosamine, a natural compound found in healthy cartilage, despite mixed evidence about whether it alleviates pain or disability. A study claiming to be one of the largest and longest trials of the supplement suggests that it does neither. Some 125 Norwegian patients with lower-back pain and osteoarthritis were given 1,500 milligrams of oral glucosamine for six months, while a similar group received dummy pills. Whether taking glucosamine or the placebo, their levels of pain, disability and quality of life were no different. "The most likely explanation for the outcome," researchers said, "is simply that glucosamine probably offers little benefit for chronic lower-back pain with osteoarthritis beyond whatever placebo effect it may provide."

U.S. Advisers Reject Vivus' Fat Pill
The first new prescription weight-loss pill in more than a decade failed to win backing from U.S. health advisers, who said safety concerns about the drug outweighed its ability to help obese patients shed pounds. Food and Drug Administration advisers expressed concern the once-a-day pill could cause depression, memory-loss and potential birth defects if used among millions of overweight or obese Americans. Approving the drug would be "a huge public health experiment," said one of the ten panelists who urged against FDA approval. Six others supported the drug. The FDA will weigh the vote before making its final decision and usually follows its panelists' advice. Though there is little doubt the drug works - helping many patients shed 35 to 40 pounds - potential side effects such as depression, memory loss, increased heart rate and birth defects were a top worry.

FDA to Review First of Three New Weight Loss Drugs
Dieters, doctors and investors will soon get their first extensive look at the first trio of new weight loss drugs, and the hope is that the new drugs can succeed where many others have failed: delivering significant weight loss without risky side effects. With obesity rates nearing 35 percent of the adult population, expectations are high for the first new prescription drug therapies to emerge in more than a decade. Even a modestly effective drug has blockbuster potential. None of the three medicines represents a breakthrough in research. Drugmakers have made little headway in understanding and treating the causes of overeating. Two of the drugs submitted for approval simply combine existing drugs - an anticonvulsant and an amphetamine - but have worrying side effects. The third is safer by less effective.  

Caustic Government Report Deals Blow to Diabetes Drug
A federal drug official has dealt a severe blow to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe. The reviewer found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study's tally of adverse events. Such repeated mistakes "should not be found even as single occurrences" and "suggest serious flaws with trial conduct." The detailed report will prove crucial when a panel of experts meet to consider whether to recommend to the FDA that the manufacturer, GlaxoSmithKline, withdraw Avandia from the market or restrict its sale. The panel's decision will have broad consequences for the company, the FDA and perhaps even the entire process by which medical products are approved. The agency almost never does clinical trials on its own, depending on drug companies to conduct them appropriately. Avandia, which helps patients get better control of blood sugar levels, has already come under intense criticism. It has been show to increase the risks of bone fractures and to cause swelling that can lead to heart failure and eye problems. A number of studies, including some by its manufacturers, suggest that it could increase the risks of heart attacks, strokes and death.

European Agency to Review Avandia Safety
The European Medicines Agency will review the safety of the diabetes drug Avandia following research suggesting it is linked to a higher risk of heart problems, strokes and deaths in older adults. The Committee for Medicinal Products for Human Use will conduct the review, and depending upon the outcome, marketing authorization for the drug in Europe could be revoked or changed. The drug's maker, GlaxoSmithKline, says it is confident that the drug "is an important treatment option for appropriate Type 2 diabetes patients."

FDA Expected to Weigh In On Avandia Risk
With the future of GlaxoSmithKline's Avandia diabetes drug hanging in the balance, the Food and Drug Administration is expected to release a key staff report on suspected health risks that will figure prominently in deciding whether the drug should remain on the market. Two recent studies concluded that patients taking Avandia faced an elevated risk of heart attacks and strokes, and the drug had long had critics demanding that it be withdrawn from the market. However, other research has found no health risk at all, and the company has asserted that the drug is safe. The FDA staff report and related documents will be made public as part of the agency's reconsideration of the drug's safety and efficacy. While important, the agency's findings are intended mainly to serve as guideposts for a panel of outside scientific experts who will meet to evaluate evidence suggesting that patients taking Avandia have a higher risk for heart attack, strokes and congestive heart failure. Typically, such advisory committees vote on whether a drug should remain on the market, sometimes with a new or revised warning label, or be withdrawn.

Glucosamine No Better Than Placebo for Back Pain
Taking glucosamine for six months did no more to ease chronic lower back pain than taking a dummy pill, Norwegian researchers have found. They said the widely used treatment appears to offer little benefit to patients whose aching back is caused by degenerative arthritis, and they said doctors should not recommend it for their patients. Studies of glucosamine, a dietary supplement, have been mixed, with some small studies showing a benefit in certain patients, such as those with osteoarthritis of the knee. Researchers did a randomized clinical trial to see what effect glucosamine had in 250 people over 25 with chronic lower back pain. They assessed people in the study at six months and against at one year using a pain and disability questionnaire and found no statistically significant difference in scores between the group that took the supplement and the group that took a dummy pill. Based on their results, it seems unwise to recommend glucosamine to all patients with chronic lumbar pain and degenerative lumbar osteoarthritis. Given the high quality of the study, the most likely explanation of the findings is that "glucosamine probably offers little benefit for chronic low back pain with osteoarthritis beyond whatever placebo effect it may provide."

Testosterone Gel Trial Ends After Heart Issue
A federally financed study to see if testosterone gel helps frail elderly men build muscle and strength was abruptly halted last year after participants taking it suffered a disproportionate number of heart attacks and other serious cardiac problems, and one died of what was apparently a heart attack. Ten men taking testosterone suffered serious cardiac problems, compared with only one in a control group of elderly men who were applying a fake placebo gel. Researchers were taken aback by the high rate of adverse heart problems. Some experts called it an anomaly and pointed to the fact that the trial's participants were sicker than patients in earlier testosterone studies and were treated with a relatively high dose of the hormone. Still, investigators about to begin a much larger set of testosterone trials immediately modified their study protocols, developing new inclusion criteria and agreeing to additional safety monitoring steps.

Federal Judge Rules for Merck in State Vioxx Suit
Drugmaker Merck & Co. has won the first trial over withdrawn painkiller Vioxx brought by Louisiana to recoup what it paid for residents to take the drug, arguing it wouldn't have been covered had its risks been better known. The state argued that it would have restricted sales of Viozz - a former blockbuster drug - through the state's Medicaid program if officials had known more about the drug's risks of heart attack and stroke. The state claimed Merck exaggerated how safe Vioxx was compared with other anti-inflammatory drugs in reducing the chances of potentially fatal stomach ulcers and gastrointestinal bleeding. IN his ruling, the judge noted that even though pain relievers in the same class as Vioxx were all required by the Food and Drug Administration to carry a warning about cardiovascular risks, Louisiana health officials never restricted payments for those drugs. The judge also ruled that "the weight of the evidence indicates that Vioxx has gastrointestinal benefits" and that Merck's marketing was consistent with that evidence. Louisiana was trying to recover more than $20 million for what it paid for Vioxx prescriptions, interest, attorney fees and litigation expenses.

When Is a Drug Too Risky to Stay On the Market?
The arthritis pill Vioxx was withdrawn but menopause hormones were not, even though both were tied to heart risks. A multiple sclerosis medicine was pulled and later allowed back on. Surprisingly, the Food and Drug Administration has no firm rules for deciding such cases - just a murky guideline of "when the risks exceed the benefits." The agency does not need better criteria for weighing drug safety, and it has asked a group of outside scientists to give advice. The FDA can order a drug off the market, but that can be challenged in court. A company will usually voluntarily withdraw the medicine at the FDA's request. The factors considered in establishing a drug's safety include: How serious is the illness being treated? Severe side effects are accepted for cancer drugs, however not for an allergy drug. How big the harm? How frequent are the risks versus the benefits? For example, a large federal study was stopped in 2002 after researchers saw more breast cancers and heart problems among women taking estrogen-progestin pills. Yet the absolute risk of suffering one of these problems was relatively small, and hormones remain the most effective treatment for menopause symptoms.

Diabetes Drug Linked to Higher Heart Risk
Two studies published in influential medical journals and using very different methods found that Avandia, a controversial diabetes medicine made by GlaxoSmithKline, substantially increased patients' heart risks. The studies were made public in hopes of influencing an expert panel that will convene to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market. An editorial in the Journal of the American Medical Association, accompanying one of the studies, concluded that there was little reason that patients should ever be given Avandia, since a similar medicine -Actos - works just as well but appears to involve fewer risks. In response to the studies, GlaxoSmithKline released a statement saying that better studies published in recent years had shown that Avandia was safe. Doubts about Avandia's safety have been growing since 2007 when a study found that it increased the risks of heart attacks by 43 percent. An investigation revealed that the company had known about the possible increased risks for nearly two years, and the FDA for at least a year, but neither had informed the public. Since then, a debate has raged inside the agency about what to do, with some officials arguing that the drug should be withdrawn and others saying that it remains an appropriate option for doctors and patients.

Combination Vaccine and Seizure Risk
Toddlers who get a vaccine that combines the measles-mumps-rubella and chickenpox immunizations are at twice the usual risk for fevers that lead to convulsions, a new study reports. The risk for a so-called febrile seizure after any measles vaccination is less than 1 seizure per 1,000 vaccinations; but among children who received the combined vaccine, there is 1 additional seizure for every 2,300 vaccinated. The reactions, which occur a week to 10 days after vaccination, are not life-threatening and usually resolve on their own. The fever-related convulsions can be frightening, but they are brief and not linked to any long-term complications or seizure disorders.

Merck Hit with $8 Million Fosamax Verdict
Merck & Co. has been hit with an $8 million jury verdict in the case of a Florida woman who says Merck's osteoporosis drug destroyed her jaw bone and caused significant pain. Merck plans to challenge the verdict, saying it doesn't match the evidence. Though the plaintiff took Fosamax for 10 years, Merck argued that her dental problems were due to heavy smoking and periodontal disease. The jury awarded her $8 million in compensatory damages after her first trial ended in a mistrial. Merck still faces more than 1,400 lawsuits alleging Fosamax harmed patients.

Paxil Litigation Over Birth Defects Shits to Settlement
Drugmaker GlaxoSmithKline has agreed to settle almost 200 cases in which plaintiffs allege the use of the antidepressant Paxil caused birth defects. The company has settled every other case scheduled for trial in the eight months since a Philadelphia jury awarded a $2.5 million plaintiffs verdict in the first Philadelphia Paxil test case to go to trial. The company began to appeal that verdict last year. The jury awarded only compensatory damages and no punitive damages. But the company then decided to settle another case along with 190 others. The cases have settled for confidential amounts, and up to another 100 cases, including cases that have not yet been filed, have settled. The litigation is two-thirds over. The company has said that 65 percent of all birth defects have no known cause and less than 1 percent of all birth defects are attributable to a mother's exposure to medication during pregnancy.

Botox Paralyzes Your Emotions, Too
A well-known side effect of Botox is the inability to fully express emotions. Research has now found another side effect: the inability to fully feel emotions. Botox, a popular cosmetic injection used to fight facial wrinkles, is made of an extremely toxic protein called Botulinum toxin. Botox works by temporarily paralyzing muscles that cause wrinkles. That means no unsightly wrinkles, but also no moving those muscles at all - which could have more significant consequences than simply looking frozen. Scientists think that facial expressions themselves may influence emotional experiences, so a person with a limited ability to make facial expressions may also have a limited ability to feel emotions. Researchers showed people emotionally-charged videos both before and after they were injected with Botox. Compared with a control group, the Botox participants "exhibited an overall significant decrease in the strength of emotional experience." In particular, the Botox group responded less strongly to mildly positive clips after they had the injections than before the Botox. 

FDA: Pfizer Will Pull Ineffective Leukemia Drug
Federal health regulators have announce that Pfizer has agreed to pull a leukemia drug off the market after a follow-up study showed it failed to slow the disease. The Food and Drug Administration cleared the drug Mylotarg in 2000 under its accelerated approval program, which grants speedy access to drugs that show early promise. The drug was cleared for patients older than 60 with relapsed acute myeloid leukemia, a bone marrow cancer. But the FDA said a follow-up study was halted last year after researchers reported more deaths among patients taking Mylotarg plus chemotherapy, compared with chemotherapy alone. The study was intended to show that adding Mylotarg to chemotherapy increased lifespan, which it failed to do. Mylotarg carries a warning label about a sometimes fatal liver condition called veno-occlusive disease. The FDA said the rate of reports of the disease associated with the drug increased during its time on the market.

Appeal Rejected in Hormone Case
The Supreme Court is allowing a new trial in the case of a woman who got breast cancer after taking hormone replacement therapy and is seeking punitive damages against Wyeth Pharmaceuticals. The justices rejected Wyeth's attempt to block the trial because it is to be limited to punitive damages. Wyeth also wanted the high court to throw out $2.75 million in compensatory damages that the woman won after suing Wyeth. A jury also awarded her $27 million in punitive damages after concluding that Wyeth inadequately warned her that its drugs Premarin and Prempro carried an increased risk of breast cancer. A federal judge struck down the punitive damages award, saying certain testimony from a former Food and Drug Administration official, who was the plaintiff's regulatory expert, shouldn't have been allowed at trial.

Concern Over Foreign Trials for Drugs Sold in U.S.
Medical ethicists have worried for years about the growing share of new drugs whose human trials took place in foreign countries where federal auditors could not make sure patients were protected, but no one knew how big the potential problem was. However, according to a report by the inspector general of the Department of Health and Human Services, 80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites. Ten medicines approved in 2008 were tested entirely abroad without a single test patient in the United States. The report found that Central and South America had the highest number of subjects per site and accounted for 26 percent of all subjects enrolled at foreign trial sites. In 2008, the Food and Drug Administration inspected 1.9 percent of domestic clinical trial sites, while just 0.7 percent of foreign clinical trial sites were similarly audited. The report also found that the FDA was 16 times more likely to audit a domestic site than a foreign one.

Emergencies Over Legal Drugs Increase
Emergency room visits for nonmedical use of prescription and over-the-counter drugs doubled during a recent five-year period, the Centers for Disease Control and Prevention are reporting. The increase puts the number of medical emergencies for abusing legal drugs on a par with those for illegal drugs. The most emergency room visits were for reactions to the opioid painkillers oxycodone, hydrocodone and methadone: 305,900 visits in 2008, up from 144,600 in 2004. The anti-anxiety drugs called benzodiazepines accounted for 271,700 visits in 2008, up from 143,500 in 2004.

FDA Warns of Fake Generic Tamiflu
The Food and Drug Administration is warning consumers that some online pharmacies are selling a fake version of the flu treatment Tamiflu that could be dangerous to people who are allergic to penicillin. The agency said the sites are selling a drug that purports to be generic Tamiflu. The drug is not FDA-approved and it contains a drug called cloxacillin, which is similar to penicillin and could cause a deadly allergic reaction, including difficulty breathing, rapid or weak pulse, and swelling of the throat of tongue, in people with penicillin allergies. The FDA said its investigators were able to buy the fake Tamiflu online without a prescription even though the drug is not legally available without a prescription. The investigators were sent 30 yellow and tan capsules that were marked as oseltamivir phosphate - the active ingredient in Tamiflu - but tests showed the capsules did not contain any oseltamivir and contained cloxacillin instead.

Drug for Sexual Desire Disorder Opposed by Panel
A federal advisory panel has unanimously voted against recommending approving a drug to treat female sexual desire disorder, but it encouraged the company to continue its research. The vote by the panel, which serves as an adviser to the Food and Drug Administration, followed an FDA staff report that also recommended against approval. The panel voted against a new drug application by Boehringer Ingelheim, a German pharmaceutical company. The panel's chairwoman said that the drug's impact was "not robust enough to justify the risks," which include dizziness, nausea and fatigue, especially with long-term daily use.

Female Viagra Falls Short, FDA Says
A pink pill designed to boost sex drive in women - the latest attempt by the drug industry to find a female equivalent to Viagra - fell short in two studies, federal health regulators announced. The Food and Drug Administration is considering Boehringer Ingelheim's drug flibanserin for premenopausal women who report a lack of sexual desire, a market that drugmakers have been targeting for more than a decade since the blockbuster success of Viagra in men. The search for so-called "female Viagra" has proved elusive though, with many drugs abandoned after showing lackluster results. The FDA will soon ask a panel of experts to weigh in on the safety and effectiveness of Boehringer's drug. In its review, the FDA said two studies failed to show a significant increase in sexual desire. Women taking the drug reported slightly more sexually satisfying experiences, but the FDA said that was not the primary measure of the study.

FDA to Post Safety Issues Online for New Drugs
Doctors and patients will be able to get more information about the risks of the latest drugs as federal health regulators begin posting their safety reviews online. Under a new policy, the Food and Drug Administration says it will begin publishing summaries of potential safety issues with recently approved drugs. The FDA is tasked with reviewing the safety and effectiveness of prescription drugs before they reach the market. But some drug side effects show up after they  are launched and taken by millions of patients across the country. The FDA's summaries will analyze side effect reports from doctors, patients and drug manufacturers. The agency plans to regularly publish summaries of those reviews for the public.

Insurer Sues Pfizer for Paying Kickbacks to Docs
A Texas health insurance company is suing Pfizer, saying the drug maker deceptively marketed three of its top-selling drugs, illegally encouraging doctors to prescribe them for non-approved uses and paying kickbacks to doctors. Pfizer has settled other similar lawsuits and agreed last year to pay $2.3 billion in civil and criminal penalties over its promotion of Bextra, Lyrica, Geodon and other drugs. The insurance company, which said it found out about Pfizer's actions because of that settlement, claims the New York drug maker gave doctors misleading information about the safety and effectiveness of the anti-inflammatory drug Bextra, about anti-psychotic Geodon and about nerve pain and epilepsy treatment Lyrica. The insurer claims that Pfizer encouraged doctors to use the drugs for conditions they had not been approved to treat, a practice known as prescribing off-label. Doctors can legally prescribe drugs off-label, but drug companies can't promote them to treat illnesses not listed on their federally approved labels. The insurer also claims Pfizer paid kickbacks to doctors who prescribed the drugs.

Popular Blood Pressure Pills Linked to Cancer
Some of the world's most popular blood pressure pills may slightly increase your risk of getting cancer, but doctors say it's too soon to ditch the drugs, according to new research. In an analysis of five previous studies following about 60,000 patients, experts found a link between people taking medicines known as angiotensin-receptor blockers, or ARBs, and cancer. The drugs are taken by millions of people worldwide for conditions like high blood pressure, heart problems and diabetic kidney disease. In the analysis, researchers found that people who took the drugs had about a 1 percent higher risk of getting cancer than people who weren't on the drugs. This included a whole range of cancers - prostate, breast and a noticeable spike in lung cancer. About 85 percent of those people were on telmisartan, sold as Micardis. There was no difference in the rate of cancer deaths in people on the drugs compared to those not on them.

Why Patients Aren't Getting the Shingles Vaccine
Shingles and its painful complication, called postherpetic neuralgia, result from reactivation of the chicken pox virus, which remains in the body after a childhood bout and is usually dormant in the adult. Up to a third of all adults who have had chicken pox will eventually develop one of both of these conditions, becoming debilitated for anywhere from a week to several years. That percentage translates into about one million Americans affected each year, with older adults, whose immune systems are less robust, being most vulnerable. Once the rash and its uncomfortable sequel appear, treatment options are limited at best and carry their own set of complications. While the search for relief costs Americans over $500 million each year, the worst news until recently has been that shingles could happen to any one of us. But in 2006, the Food and Drug Administration approved a new vaccine against shingles. Clinical trials on the vaccine revealed that it could, with relatively few side effects, reduce the risk of developing shingles by more than half and the risk of post-herpetic neuralgia by over two-thirds. However, in the two years since the vaccine became available, fewer than 10 percent of all eligible patients have received it. Despite the best intentions of patients and doctors, the shingles vaccine has failed to take hold, in large part because of the most modern of obstacles. What should have been a widely successful and simple wellness intervention between doctors and their patients became a nightmare. What doctors seem to be most concerned about - more so than safety - is cost. Although only one dose is required, the cost is $160 to $195 per dose, 10 times more than other commonly prescribed adult vaccines; and insurance carriers vary in the amount they will cover. 

Unreported Complaints Get Pfizer Warning
Federal regulators have warned Pfizer for failing to promptly report complaints with its drugs that may have involved serious injury. In a warning letter, the Food and Drug Administration cited a number of product complaints which were not reported to government regulators within the required 15 days. In some cases, Pfizer failed to report the adverse events all together, including reports of serious side effects with the cholesterol drug Lipitor and the antiseizure drug Lyrica. FDA inspectors found the unreported complaints during a routine inspection at the company's headquarters last year. The problems outlined in the warning letter are not new - inspectors cited the company for similar violations in 2004 and 2006.

FDA Warns Against Contaminated IV Antibiotics
The FDA has issued a public health alert warning healthcare professionals not to use certain brands of intravenous metronidazole, ondansetron and ciproflaxacin because of potential contamination. The agency alert applies to products sold under the Claris, Sagent Pharmaceuticals, Pfizer and West-Ward Pharmaceuticals labels. The agency received reports of floating matter in IV bags manufactured by an Indian company. The agency also received a complaint from a Claris customer who noted white matter - later identified as a type of mold - in a bag of antibiotic.

Teva Won't Make More of Powerful Sedative
The drugmaker Teva has announced it won't make any more of its sedative propofol, which could intensify a shortage of one of the most common anesthetics in the nation. The drug is hard to manufacture and the company gets little or no profit from it. The company had to halt production and recall some of the drug last year because of manufacturing issues, and it is facing a raft of propofol-related civil lawsuits. Propofol is by far the most common intravenous anesthetic in the U.S., used for general anesthesia and for sedation because when it's used properly, patients wake up quickly and side effects are rare.

FDA: Some Heartburn Meds Pose Long-Term Fracture Risk
Some heartburn medicines could increase the risk of hip, wrist and spine fractures in high doses or with long-term use, the Food and Drug Administration warned. Such so-called proton pump inhibitors are used for the treatment of gastroesophageal reflux disease, stomach and small intestine ulcers and inflammation of the esophagus, along with frequent heartburn. Product labeling will be changed to describe the possible increased risk. The warning and revised labeling stems from the FDA's review of several studies that reported an increased risk of hip, wrist and spine fractures in people using proton pump inhibitors. The warning and precaution sections of prescription labels and the drug facts label on over-the-counter medications will address the findings, the agency said.

Look-Alike, Sound-Alike Drugs Trigger Dangers
Whether its confusing the migraine drug Topamax with the blood pressure drug Toprol-XL, or the antihistamine Zyrtec with the antipsychotic Zyprexa, mistakes caused by drug name mix-ups continue to happen a decade after a groundbreaking Institute of Medicine report first declared that 7,000 people in the U.S. died from medication errors each year. Today, some 1,500 drugs have names so similar they've been confused with one or more other medications, according to a 2008 report by U.S. Pharmacopeia, the group that sets standards for medications in this country. Just last month, the international drugmaker Takeda agreed to change the name of its new heartburn drug Kapidex after reports of confusion with the prostate cancer drug Casodex. In some cases, women received a cancer drug intended only for men.

FDA Certification No Shield to Suit Against Generic Drug Makers
Generic drug manufacturers are not insulated from lawsuits by an FDA approval process that certifies such drugs as the "bioequivalent" of their brand-name predecessors, a federal judge has ruled. In a 29-page decision, the judge refused to dismiss a suit brought by consumers who were previously taking Wellbutrin, a brand-name antidepressant drug, and claim they experienced side effects upon switching to generic buproprion. The suit alleges that the two manufacturers - Teva Pharmaceuticals and Impax Laboratories - became aware of the problem, but failed to warn the public about differences that affected the release rate of the active ingredient. The judge applied the U.S. Supreme Court's recent decision in favor of Wyeth and concluded that generic drug manufacturers also have a continuing duty to issue warnings about any new hazards that arise after approval. Lawyers for Teva and Impax had argued that the suit should be dismissed because such claims are pre-empted by the FDA's determination that the generic products are "as safe and effective" as the brand-name drugs they imitate.

More Disclosure for Drug Research
Medical researchers receiving United States grants who have been paid more than $5,000 by drug companies like GlaxoSmithKline must publicly disclose the payments under rules proposed by regulators. Universities would have to list those "significant financial interests" on their Web sites once the rules take effect this year. While current rules require researchers on United States-financed projects to notify their universities of financial ties that exceed $10,000, institutions do not have to post that information online.

More Counterfeit Drugs Seen Around the Globe
Production and sale of counterfeit drugs is on the rise in rich and poor countries, with more unwary customers buying them over the Internet. Fake or substandard versions of medicines are often hidden in cargos taking circuitous routes to mask their country of origin as part of criminal activity worth billions. In wealthy countries, counterfeiting often involves "expensive hormones, steroids and anti-cancer medicines and pharmaceuticals related to lifestyle." But in developing countries, especially Africa, counterfeit medicines are commonly available to treat life-threatening conditions such as malaria, tuberculosis and HIV and AIDS.

Downside of Viagra? Possible Hearing Loss
Men who take Viagra could be at an increased risk for long-term hearing loss, a new study suggests. The results show that, among 11,525 men over age 40, those who took Viagra or other drugs that act in a similar manner were twice as likely to also report hearing loss as were men who had not used the drugs. The findings suggest that the current government warning regarding hearing loss and the use of erectile dysfunction medications is warranted. In 2007, the Food and Drug Administration announced labeling changes for the medications so that the risk of hearing problems was more prominently displayed. This action was taken after several case studies that linked the drugs and sudden hearing loss were reported.

FDA Clears Return of Rotarix Vaccine
The Food and Drug Administration has cleared the use of GlaxoSmithKline's Rotarix vaccine, which is designed to protect babies against a leading cause of diarrhea. Earlier this year, the FDA had urged pediatricians to temporarily stop using the rotavirus vaccine after discovering that doses of Rotarix were contaminated with bits of an apparently benign pig virus. They suggested doctors use Merck's RotaTeq vaccine instead. The agency recently reversed it decision, saying there is no evidence that porcine circovirus can infect or sicken humans.

FDA Urges Docs to Report Misleading Drug Ads
The Food and Drug Administration will begin asking doctors to keep an eye out for misleading drug advertisements as part of the agency's latest effort to police the pharmaceutical industry's multibillion-dollar marketing machine. The agency's "bad ad program" urges doctors to report ads and sales pitches that violate FDA rules. Drug companies are legally required to present a balanced picture of a drug's benefits and risks in promotions, though critics charge that many TV and magazine ads fail to do so. Currently, the FDA relies on a few dozen staffers to review hundreds of pharmaceutical ads, brochures and presentations voluntarily submitted by companies or reported to the agency by drug industry personnel. The agency issues warning letters to companies using misleading materials, but because of the volume of submissions those letters often aren't sent until months after the ad is released - and in some cases after the ad is no longer in circulation.

Birth Control Linked to Sexual Problems
Young women who rely on hormonal birth control like the pill are at significantly higher risk for sexual dysfunction than those who use nonhormonal methods, a German study suggests. Researchers found that one-third of 1,000 students experienced one of more forms of sexual problems associated with desire, arousal, lubrication, orgasm, satisfaction or pain. Students who used hormonal contraception had the lowest overall sexual function scores, and they had lower scores on desire and arousal compared with those not using any birth control or those using nonhormonal methods. Researchers suggested that contraceptive hormones might reduce circulating levels of testosterone, which is needed to stimulate sexual desire and regulate genital blood flow.

Teva Plans Appeals of Award in Hepatitis Case
Teva Pharmaceutical Industries plans to appeal a multimillion-dollar verdict in a civil case stemming from a hepatitis C outbreak two years ago. A Las Vegas jury ordered Teva to pay $356 million in punitive damages to a man and his wife. Another drug company, Baxter Healthcare, was ordered to pay the couple $144 million. Health officials have blamed reuse of vials of the anesthetic propofol for infecting patients with the incurable liver disease. The punitive damages come on top of more than $5 million already awarded to the couple by the same jury. It found the companies responsible for breach of implied warranty and failure to warn. The jury awarded the man $3.25 million and his wife $1.85 million from the companies. The drug manufacturer and distributor provided the propofol used by endoscopy clinics at the heart of the hepatitis C outbreak. At least 9 - and possibly as many as 114 - patients were infected with the disease.

Teva and Baxter Ordered to Pay $500 Million in Hepatitis C Case
A Las Vegas jury has ordered Teva to pay $356 million and Baxter to pay $144 million in the largest jury award in Nevada history. More than 100 people contracted the liver disease hepatitis C after the anesthetic propofol were reused for colonoscopy or endoscopy procedures. Teva made the drug and Baxter distributed it. Teva said it continues to believe that the evidence shows the company acted responsibly. The label for its product clearly states that it is for single patients use only and that aseptic procedures should be used at all times.

Merck Wins Federal Fosamax Trial
A federal jury in New York ruled that a woman who claimed she was harmed by Merck's osteoporosis drug Fosamax did not suffer from a serious jaw condition linked to the medicine, handing Merck a victory. The plaintiff used Fosamax for nearly eight years and claimed she suffered osteonecrosis of the jaw - a form of bone death associated with Fosamax and similar drugs - and dental problems as a result of long-term use of the medicine. The jury returned a unanimous verdict in Merck's favor, finding the plaintiff did not suffer from osteonecrosis of the jaw as of 2004. The jury found that the plaintiff had multiple medical conditions that can cause the development of similar jaw and dental problems. As of last year, about 978 Fosamax cases, which include some 1,356 plaintiff groups, were pending against the company in either federal or state court.

Wyeth Seeks New Trial in Nevada Prempro Case
Wyeth Pharmaceuticals has asked the Nevada Supreme Court for a new trial over its hormone replacement drugs, arguing that a Reno jury wasn't properly instructed on punitive damages before awarding three women a multimillion dollar judgment on claims the drugs caused their breast cancer. The pharmaceutical giant, since acquired by Pfizer, claims the jury's "premature" deliberation of punitive damages and comments about Wyeth executives' salaries made by the women's attorneys prejudiced jurors against the company. Jurors initially awarded the women a combined $134.5 million. However, a bailiff overheard that the jury was confused, and the judge ordered them to reconsider. The jury slashed $100 million from the compensatory judgment, awarding a combined $35 million to the women for past and future medical expenses and pain and suffering, and $99 million in punitive damages intended to punish the company. The judge finally reduced the overall judgment to $58 million - the largest personal injury award in Nevada history. The suit was one of thousands across the nation filed by women who claim the drugs Premarin and Prempro prescribed to ease menopause symptoms caused their breast cancer. One of the women in the Nevada case died eight months after the verdict was reached.

Novartis to Pay $72.5 Million to Settle False Claims Allegations
Drugmaker Novartis has agreed to pay $72.5 million in a settlement over false claims associated with its cystic fibrosis drug TOBI. The original lawsuit, filed by three whistleblowers, alleged the company submitted fraudulent bills to government health care programs for off-label uses of the drug. The settlement money will be divided among the federal government, various states and the three whistleblowers. Separately, the Food and Drug Administration sent a warning letter to Novartis for promoting off-label uses of one of its drugs, Gleevac, on two Web sites sponsored by the company.

FDA Rejects InterMune's Drug for Fatal Lung Disease
The Food and Drug Administration has declined to approve a drug from InterMune that would have been the first treatment for a fatal lung disease that afflicts about 100,000 Americans. The FDA requested another clinical trial to prove that the drug, called pirfenidone, was effective against the disease, known as idiopathic pulmonary fibrosis. The company said it would meet with the FDA as soon as possible to discuss the drug, which it had planned to sell under the brand name Esbriet. The data on the drug's effectiveness posed a dilemma for both the advisory committee and the FDA itself because the drug worked in one clinical trial but not in a second. The agency also questioned whether the benefit provided by the drug even in the successful trial was meaningful, as the drug cannot repair damage already done to the lungs and make patients better. However, the drug did seem, at least in one trial, to modestly slow the decline of lung function compared to a placebo.

Prostate Cancer Drugs May Pose Diabetes Risk
The Food and Drug Administration is looking into data suggesting a group of prostate cancer drugs increase the risk of diabetes and heart disease. The drugs are used to suppress the hormone testosterone, which fuels the growth of prostate cancer tumors. The FDA says it has not conclusively linked the drugs to health problems, but preliminary data from six studies showed slightly higher rates of diabetes and heart disease in patients taking the drugs.

Long Lashes Without Prescription, But with Risks
If women want to grow longer, fuller, darker eyelashes, Brooke Shields suggests on a ubiquitous television advertisement that they ask their doctors if Latisse is right for them; but in the case of Latisse, which has sold more than a million bottles to date and gained something of a cult following, it turns out to be easy to bypass a doctor's prescription or visit. Some salon workers dispense it to clients who go in for facials. Web sites in the United States and abroad sell it outright with few questions asked. Most people use Latisse, a topical solution, with few, if any, complaints. But the drug can cause redness, itchiness and irritation, which go away if use is discontinued. Less common is eyelid discoloration, which Allergan, the manufacturer, says "may be reversible." A rare side effect that has captured the most attention is the chance that one's hazel or blue eyes could turn brown - forever.

Drug Makers to Pay Fine of $81 Million
The Justice Department has announced that two subsidiaries of the pharmaceutical giant Johnson & Johnson had agreed to pay more than $81 million in a case accusing them of illegally promoting the epilepsy drug Topamax for psychiatric uses rather than the epilepsy and migraine headaches it was approved for. One Johnson & Johnson subsidiary will pay more than $75 million, which another has agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act and pay a $6.1 million criminal fine. The government says that both promoted Topamax for unapproved psychiatric uses under a program called Doctor-for-a-Day, which hired outside physicians to join sales representatives in visits to health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses.

High Court Rules with Investors in Lawsuit Against Merck
investors suing Merck over its handling of the pain medication Vioxx got a boost from the U.S. Supreme Court in a case that has hinged on when a two-year statute-of-limitations clock started ticking. The court backed the lawyers suing Merck & Co. Inc. in a class action securities fraud lawsuit. Merck pulled Vioxx from the market in 2004 because it increased heart problems. It expects to have completed $4.85 billion in payments to patients to resolve injury claims by the end of the year. The securities fraud case has been described as very large and likely to include "tens of thousands of investors and involve investing losses in the multiple billions." Merck shareholders have seen several setbacks in recent years, including a settlement for Medicare overbilling and a study that said Merck's cholesterol drug Vytorin was no more effective than a generic. In the case, Merck argued that the two-year limit had already passed when the lawsuit was filed in 2003, because the two-year time period should have started with "inquiry notice," the point when the facts would have led "reasonably diligent" plaintiffs to investigate further. The court rejected that argument and said the clock started when investors had actual knowledge of a violation or a reasonably diligent investor could have known. Shareholders argued that "Merck withheld from the investing public its inside knowledge" that Vioxx was causing heart problems. 

For $520 Million, AstraZeneca Settles Case Over Marketing of Drug
AstraZeneca has completed a deal to pay $520 million to settle federal investigations into marketing practices for its blockbuster schizophrenia drug, Seroquel. The government accused AstraZeneca of paying kickbacks to doctors as part of an illegal scheme to market drugs for unapproved uses, and that the company promoted drugs for unapproved uses by children, the elderly, veterans and prisoners. AstraZeneca released a statement that said, "It is in the best interest of AstraZeneca to resolve these matters to move forward with our business of discovering and developing important, life-changing medicines - while avoiding the delay, uncertainty and expense of protracted litigation." AstraZeneca is the fourth pharmaceutical giant in the last three years to pay to settle federal investigations into illegal marketing of antipsychotic drugs, a lucrative category of medications that have quickly risen to the top of the United States sales charts. The company was accused of misleading doctors and patients by playing up favorable research and not adequately disclosing studies that show Seroquel increases the risk of diabetes. AstraZeneca still faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug's risks.

Genzyme Expects a Fine of $175 Million
Genzyme, the beleaguered biotechnology company, expects to be fined at least $175 million by the Food and Drug Administration because of manufacturing problems that have caused severe shortages of two of its best-selling drugs. The company also announced another delay in restoring full supplies of the two drugs, Cerezyme, for Gaucher disease, and Fabrazyme, for Fabry disease. This time, it said, the culprit was a municipal power failure. Genzyme made the announcements in reporting that it had lost $114.9 million in the first quarter because it had set aside the money to pay the anticipated fine. At $175 million, the fine would be within the broad range that analysts had expected since Genzyme announced that the FDA wanted to enter into a consent decree and to take a greater role in overseeing its main factory. The factory was temporarily shut last year because of contamination from a virus, leading to a shortage of the two drugs that Genzyme initially estimated would last six to eight weeks. However, one setback has followed another, so the shortage now looks likely to last at least a year.

FDA: Pfizer Didn't Fix Issues Leading to Overdose
Federal regulators say the drugmaker Pfizer has failed to correct problems with its testing procedures that resulted in overdoses for more than two dozen patients during a company trial. The Food and Drug Administration issued a warning letter saying Pfizer is not properly monitoring physicians testing an experimental medication, which the agency did not name. Pfizer says the drug is Geodon, which the company is studying for children with bipolar disorder. The FDA warning follows up on problems first cited in 2006 when 26 patients in a company rial received overdoses of the psychiatric drug. Despite Pfizer retraining the physicians, FDA says three additional overdoses occurred in 2007. A 2009 inspection, which prompted the new warning, found Pfizer was still not following its own guidelines for safely conducting the study. Specifically, FDA inspectors said that the company was not alerting clinical investigators to new dosing problems as they occur.

Pills to Prevent Breast Cancer Bring Trade Offs
Older women at higher risk of breast cancer now have two good drug options for preventing the disease, but they will have to weight the trade offs, a major study shows. Tamoxifen, the longtime gold standard, is more effective and longer lasting, the results show. But a newer drug - reloxifene, sold as Evista - is safer. Tamoxifen is widely used to treat cancer once it's diagnosed, and Evista is used to treat osteoporosis. But the drugs have not found wide acceptance so far as cancer preventives. Doctors hope the findings will spur more high-risk women to consider taking one of the drugs. They're not recommended for women at average risk of breast cancer, but for the millions who are at higher risk because of gene mutations, family history or other factors, they can make a dramatic difference.

Unclear Tests for New Cancer Drug
Drugs aimed at disabling proteins that spur cancer are, many oncologists say, the future of cancer therapies. Only a few are available now but almost every new drug under study is designed to disable cancer-fueling proteins. But these so-called targeted therapies are only as good as tests to find their protein targets. And while most patients do not yet know it, those tests can be surprisingly unreliable. Acknowledging the problem, cancer specialists have announced new testing guidelines for one protein target, but as new targets are identified, the problem continues to grow. For example, HER2 tests can give false-positives up to 20 percent of the time, wrongly telling women they need the drug when they do not. Five percent to 10 percent of the time the tests can falsely tell a woman that she should not take the drug when she should. And Herceptin testing for breast cancer is easy compared with what is coming next. Genentech, Herceptin's maker, is about to apply to the FDA to sell the drug to treat stomach cancer. But it is much more difficult to tell whether a stomach tumor has high levels of HER2. Breast cancers usually are all positive or all negative. Not stomach cancers, which almost always have sections that are positive for HER2 and sections that are negative. The HER2 tests are the same, but the interpretation and scoring are different.

Genzyme Drug Shortage Leaves Users Feeling Betrayed
Thousands worldwide have been hit by a shortage of drugs made by the biotechnology company Genzyme to treat two rare inherited diseases. The supply problems, which have dragged on since last year, have frayed the close relationship - unusual in the pharmaceutical industry - that Genzyme had carefully built with the several thousand users of its high-price medicines over the last two decades. Some of those patients now say they feel betrayed by the company they once viewed as their savior, wondering why Genzyme did not have a sufficient reserve of such vital drugs and how the company could have stumbled so badly in trying to fix its production problems. Last year the company temporarily shut its main factory in Boston because of contamination from a virus. Such problems can arise in biotechnology factories, which use living cells to make drugs, and few faulted the company at the time. But Genzyme, which initially predicted that the drug shortages would last six to eight weeks, has repeatedly backtracked on when supplies would be fully restored, as it has run into further manufacturing problems. At one point, particles of steel, rubber or fiber were found in some vials of the drugs.

Cancer Drug Trials Program in Crisis
The system for conducting cancer clinical trials in the United States is "at a breaking point" and needs a major overhaul, a panel of experts says. The Institute of Medicine panel said inefficient management, complicated government oversight and inadequate funding hamper the ability of the National Cancer Institute's Clinical Trials Cooperative Group Program to design and run studies that answer important questions about new therapies. The Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year. For these trials to be successful, they require a significant investment of time by busy doctors and other healthcare workers to manage patients' care during the studies. But doctors are less willing to take part because they are not reimbursed adequately. Doctors and their clinics must pay for as much as half of the cost of clinical trials and nearly all must seek support from outside sources such as drug companies. And trials are getting more expensive as researchers develop more personalized cancer treatments, including the use of so-called biomarkers to see how a treatment is working.

Popular Anticonvulsant Drugs Raise Suicide Risk
Widely used anticonvulsant drugs, including Pfizer's Neurontin and Novartis' Trileptal, may increase the risk of suicide, attempted suicide and violent death in patients taking them for the first time, U.S. researchers have found. Compared with Johnson & Johnson's generic epilepsy drug topiramate or Topamax, the team found an increased risk for suicide in new users of Neurontin, sold generically as gabapentin, GlaxoSmithKline's Lamictal or lamotrigine, Novartis' Trileptal or oxcarbasepine and Cephalon's Gabitril or tiagabine. In one analysis, the team also found an increased risk of suicide with the drug calproate sold by Sanofi-Aventis as Epilim and as Depakine in the United States by Abbott Laboratories Inc. In 2008, the U.S. Food and Drug Administration required that all drugs in the anticonvulsant class carry a warning that they double the risk of suicidal thoughts and behaviors, based on a so-called meta-analysis of nearly 200 clinical trials - but the analysis was not large enough to show which drugs in the class were risky, and they are prescribed for a range of conditions. Anticonvulsant drugs are chiefly used for patients with epilepsy, but the drugs have been aggressively promoted, in some cases for conditions they are not approved to treat, such as bipolar disorder, pain and migraine headaches. While doctors are free to prescribe medicines as they see fit, drugmakers are only allowed to promote them for uses approved by the FDA. Recently, a Boston jury found Pfizer guilty of improperly marketing Neurontin, and Novartis plans to plead guilty to violating U.S. laws relating to potential off-label marketing and promotion of Trileptal.

Study Sees Slant in Articles On Drug
A new analysis of reviews and articles about the controversial diabetes drug Avandia has found that experts who were paid by its manufacturer have been significantly more likely than others to draw positive conclusions about the drug's safety and efficacy. Since 2007, scientists have published hundreds of studies, reviews and opinion articles about Avandia in scientific journals and elsewhere, arriving at a range of conclusions, some sharply opposed to one another. Avandia, or rosiglitazone, is prescribed, along with diet and exercise, to help control blood glucose levels in people with Type 2 diabetes. In 2007, the New England Journal of Medicine published a review of studies and concluded that its use was associated with a significant increase in the risk for heart attack. After a Congressional investigation, the Food and Drug Administration imposed a "black box" safety warning on the medicine. Earlier this year, confidential FDA reports recommending that Avandia be removed from the market were revealed. To explore possible links between authors' financial interests and opinions, researchers reviewed 202 articles by 180 authors who wrote about Avandia and the risk of heart attack. Then they had independent reviewers with no conflicts of interest grade each article as favorable, neutral or unfavorable, based on the authors' positions on an association between Avandia and heart attacks an on their recommendations for continuing or ending its use. Often, authors with favorable opinions of the drug were paid both by Avandia's maker, GlaxoSmithKline, and by its competitors. of those who offered favorable views, 87 percent had potential conflicts with Glaxo. Among authors who had unfavorable opinions, only 20 percent had received money from Glaxo.

Cancer Drug Often Used 'Off-Label' for Infertility
Three in 10 women being treated for infertility take the common breast cancer drug Femara, even though it could increase risks to the baby, researchers announced. They said the drug is often prescribed "off-label" to treat infertility, even though it is classified by the Food and Drug Administration as posing a pregnancy risk. A study of health claims also suggests policies by health insurers to only pay for the drug's approved uses could improve both the case and safety of the women who take it. Novartis' Femara or letrozole is approved to treat post-menopausal women who have hormone-receptor positive breast cancers, in which a hormone is driving the cancer. The drug, which is in a class of drugs known as aromatase inhibitors, works by blocking the production of estrogen in postmenopausal women. Femara has also been studied as a treatment for infertility, but so far there has not been enough evidence to show that it is safe and effective. In one Canadian study in 2005, a team found nearly a three-fold increase in the risk of birth defects in a group of 150 babies born after letrozole treatment, and the company has warned doctors against using the drug to treat infertility. Once drugs are approved by the FDA, doctors are free to prescribe them as they see fit.

Local Spa and Five Others Get FDA Warning
The Food and Drug Administration issued warning letters to six spa companies, including one based in King of Prussia, for making false and misleading statements about drugs they contended could eliminate fat. In a procedure known variously as lipodissolve, mesotherapy, lipozap, lipotherapy or injection lipolysis, patients receive a series of fat injections meant to "dissolve and permanently remove small pockets of fat from various parts of the body," the FDA said. The primary ingredients are phosphatidylcholine and deoxycholate, although vitamins and herbs may also be added. The FDA has not evaluated the drugs and says it knows of no "credible scientific evidence" that shows they eliminate fat. It also says that the injections' safety is "unknown." Adverse reactions include scarring, skin deformation and painful knots in treated areas. The spas and a Brazilian company that markets lipodissolve products have 15 days to respond to the FDA or face "legal action."

California Court Finds Antidepressant Manufacturers Could Have Warned of Suicide Risk
A generic manufacturer of the antidepressant Prozac could have warned about an increased risk of suicide associated with its prescription medication by changing its labels without approval from the Food and Drug Administration, according to a federal judge in California. The decision creates a split in the district courts within the 9th U.S. Circuit Court of Appeals on whether generic manufacturers of prescription drugs are allowed to change their own warning labels. The ruling aligned with at least three other circuit court decisions, as well as the U.S. Supreme Court's 2009 decision in a case which prevents drug companies in most cases from arguing that state tort claims are pre-empted by federal law because the FDA regulates their products. The case was brought on behalf of the mother of a 26-year-old man who committed suicide in 2004 after taking fluoxetine, a generic version of Prozac, for 36 days. The suit alleges that name brand maker Eli Lilly & Co. failed to adequately warn about the risks of suicide associated with the antidepressant. He said he added generic manufacturer Sandoz Inc. to the case after California's 1st District Court of Appeals ruled that brand-name manufacturers could be held liable in cases involving the equivalent generic medication. Both companies filed summary judgment motions claiming that they could not have warned about such risks because the FDA, which had been regulating antidepressants heavily at the time, would not have allowed an enhanced warning about suicide risks.

Painkiller Poisonings On the Rise
More and more Americans are landing in the hospital due to poisoning by powerful prescription painkillers, sedatives and tranquilizers. City-living middle-aged women seem particularly vulnerable. Between 1999 and 2006, U.S. hospitals admissions due to poisoning by prescription opioids, sedatives and tranquilizers rose from approximately 43,000 to about 71,000. That increase of 65 percent is about double the increase observed in hospitalizations for poisoning by other drugs and medicines. Accidental - or unintentional - poisoning by opioids, sedatives and tranquilizers rose by 37 percent during the seven-year period, while unintentional poisonings by other substances increased by just 21 percent. 

Win for Wyeth in Hormone Therapy Case Upheld After High Court Denies Review
The Pennsylvania Supreme Court has declined to hear the first hormone replacement therapy tort case to reach Pennsylvania's high court, leaving intact a judgment notwithstanding the verdict in favor of drugmaker Wyeth. The Supreme Court's decision to deny the plaintiff's petition for allowance of appeal in the case affirmed a trial court finding that the plaintiff failed to show proximate causation under the learned intermediary doctrine between her doctor's prescription of a Wyeth-made hormonal drug and her breast cancer. The female plaintiffs in the HRT litigation allege their breast cancer was caused by Wyeth's and other drugmakers' failure to warn adequately of the risks of breast cancer from hormonal drugs used to treat menopausal symptoms. The Superior Court's decision was a non-precedential decision, so the Supreme Court's decision to deny allocatur to the plaintiffs leaves the Superior Court's and the trial court's reasoning in the case as uncitable.

Harder-to-Break OxyContin Pill Wins Approval
The Food and Drug Administration has approved a new formulation of controlled-release OxyContin that makes the powerful pain drug harder to abuse. OxyContin, made by Purdue Pharma, is attractive to drug abusers because it contains large quantities of a potent opioid pain killer, oxycodone. The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication, thereby potentially decreasing the risk of overdose that could result from tampering. The new formulation will most likely result in less abuse by inhaling or injecting, but it still can be abused or misused by ingesting larger doses than are recommended.

Lithium Doesn't Slow Lou Gehrig's Disease
Lithium doesn't help patients with ALS, or Lou Gehrig's disease, contrary to previous study results, new research says. Results from a small study published two years ago suggested the drug, often used for depression, could slow the fatal neurological disorder. Many ALS sufferers and their families rushed to try it, spearheading a patient-led effort to test lithium without doctors. In the first trial to scientifically assess whether lithium works for Lou Gehrig's disease, doctors found it had no effect -  and stopped the study early because it seemed futile.

Nosebleeds Eased with Once-Maligned Drug
Thalidomide, a drug that caused birth defects when it was launched as a morning sickness pill a half a century ago, may be useful for treating a hereditary condition that affects blood vessels. Researchers have found that giving thalidomide to patients with a disorder called hereditary hemorrhagic telangiectasia reduced the severity and frequency of nosebleeds, one of the main symptoms. Experiments on mice with HHT showed thalidomide treatment was able to repair blood vessel wall defects through a mechanism involving proteins involved in cell growth. HHT affects about one in 5,000 people. Many patients develop recurrent, difficult-to-treat nosebleeds which can significantly harm their quality of life. Thalidomide was used to treat nausea during pregnancy in the late 1960s. The drug was taken off the market after severe congenital defects appeared in the newborns of mothers who had taken it.

Pfizer Gave Docs $35 Million in Last Half of 2009
Pfizer Inc. paid doctors and teaching hospitals a total of $35 million in the last half of 2009 for services ranging from speaking to other doctors about the company's products to running studies of its experimental drugs. The world's biggest drugmaker by revenue disclosed details of its payments to about 4,500 doctors and other health professionals. Unlike rivals who have made some disclosures, Pfizer included figures on the considerable payments made to doctors running human tests of its drugs. The information was released a little more than a year after Pfizer promised to do so. Patients can search the new database to see whether their doctor has received payments for consulting services, giving speeches or participating in drug testing, as well as free meals or travel reimbursement.

Pfizer Details Payments to Doctors and Researchers
Pfizer, the world's largest drug maker, said that it paid about $20 million to 4,500 doctors and other medical professionals for consulting and speaking on its behalf in the last six months of 2009, its first public accounting of payments to the people who decide which drugs to recommend. Pfizer also paid $15.3 million to 250 academic medical centers and other research groups for clinical trials in the same period. While other pharmaceutical companies have disclosed payments to doctors, Pfizer is the first to disclose payments for the clinical trials. Pfizer said most of the disclosures were required by an integrity agreement that the company signed last year to settle a federal investigation into the illegal promotion of drugs for off-label uses.

FTC's 'Pay to Delay' Case Against Cephalon Moves Forward
The Federal Trade Commission's crusade against "pay for delay" patent settlements between brand name and generic drug makers got a boost when a district court judge refused to dismiss a 2008 antitrust suit against Cephalon Inc. The case involves reverse payment settlements over the drug Provigil. The medicine, used to treat excessive sleepiness in people with sleep disorders, had sales of over $920 million in 2008. The FTC in court papers describes the case as "a straightforward story of anticompetitive conduct." In late 2002, four generic companies filed drug applications with the Food and Drug Administration to make generic versions of Provigil. Each claimed it could make the drug without infringing Cephalon's only remaining unexpired patent on Provigil - narrow coverage related to distribution of certain particle sizes. Cephalon sued the companies for patent infringement, but by 2005, generic competition seemed imminent. According to the FTC, "Cephalon therefore entered a series of settlement agreements under which it compensated each generic company - more than $200 million collectively - to abandon its patent challenge and forego entry until 2010." The FTC charged that this violates the Sherman Act and should be declared a per se antitrust violation.

Risks Seen in Cholesterol Drug Use in Healthy People
With the government's blessing, a drug giant is about to expand the market for its blockbuster cholesterol medication Crestor to a new category of customers: a preventive measure for millions of people who do not have cholesterol problems. Some medical experts question whether this is a healthy move. They point to mounting concern that cholesterol medications - known as statins and already the most widely prescribed drugs in the United States - may not be as safe a preventive medicine as previously believed for people who are at low risk of heart attacks or strokes. Statins have been credited with saving thousands of lives every year with relatively few side effects, and some medical experts endorse the drug's broader use. But for healthy people who would take statins largely as prevention - which would be the case for the new category of Crestor patients - other experts suggest the benefits may not outweigh any side effects. Among the risks raising new concerns, recently published evidence indicates that statins could raise a person's risk of developing Type 2 diabetes by 9 percent.

Pfizer Hit with $141 Million RICO Penalty Over Neurontin Promotion
Pfizer has been socked with an eye-popping $141 million penalty for unlawfully promoting its epilepsy drug Neurontin for unapproved uses for which, the plaintiffs said, it didn't even work. A federal jury in Boston concluded that the pharmaceutical giant had violated federal racketeering laws in promoting the drug for so-called off-label uses that were ineffective. The jury's verdict was actually $47 million, but the penalty was automatically tripled under the federal Racketeer Influenced and Corrupt Organizations Act. The plaintiffs, Kaiser Foundation Hospitals and Kaiser Foundation Health Plan, argued that Pfizer duped them into believing that Neurontin could effectively treat conditions such as migraines and bipolar disorder. Neurontin was approved to treat epilepsy in 1993 by the FDA.

Regulators Reject a Drug Maker's Plan to Use Its Alertness Pill to Overcome Jet Lag
Air travelers for now may have to rely on coffee instead of a wonder drug to help them function in new time zones. Cephalon said that the Food and Drug Administration had declined to approve use of its alertness drug, Nuvigil, to treat jet lag. Had the drug been approved, it would have been the first prescription drug specifically designated for jet lag. Nuvigil is a slightly longer-lasting form of Cephalon's biggest seller, Provigil. Both drugs are approved to treat the excessive sleepiness associated with narcolepsy, sleep apnea and shift work. Cephalon did not elaborate about why the FDA had rejected its application, other than to say that the agency had questioned the "robustness" of the results of questionnaires that asked participants in the company's clinical trial how sleepy they felt after taking the drug.

FDA Says Millions Got Unapproved Heart Pills
Doctors in the United States wrote more than four million prescriptions last year for nitroglycerin tablets, heart drugs placed under the tongue to reduce the chest pain angina or to stop a heart attack. However, the majority of the drugs sold had not been approved for sale, nor had their safety and effectiveness been vetted, by the Food and Drug Administration. Many doctors, who discovered only recently that pharmacies were giving their patients unproved heart tablets, now say they have no way of knowing whether patients have suffered unnecessarily as a result. The FDA, which in recent years has been cracking down on a decades-old backlog of unapproved drugs, sent warning letters to two drug makers ordering them to stop marketing unapproved nitroglycerin tablets - but the drugs are still being sold at pharmacies while the order takes effect. The FDA said that it had not examined the quality of the products it was ordering off the market but that it had recorded problems with other nonapproved nitroglycerin products in the past. The agency advised people who take unapproved nitroglycerin to continue taking their tablets but to consult their doctors about replacement prescriptions.

Charges in Scheme to Sell Fake Drugs
A Chinese national arrested in Hawaii faces charges that he manufactured and imported fake weight-loss medication with ingredients that could cause headaches, anxiety and chills. Federal prosecutors say a Chinese national traveled from China to Hawaii intending to meet with people interested in distributing his pills in the United States. his products included fake versions of Alli, a weight-loss drug. A man who had been taking Alli switched to a cheaper version sold online by the Chinese national, and he began to have heart palpitations, numbness in his left arm, severe anxiety, headaches and profuse sweating and chills.

Researchers Puzzled by Role of Osteoporosis Drug in Rare Thighbone Fractures
The case reports first surfaced about two years ago and they were frightening. A few orthopedists reported that women taking osteoporosis drugs to prevent broken bones were showing up with rare and serious fractures of their thighbones. The bone was snapping like a twig, sometimes splintering. Often there was no trauma, like a serious fall, to bring it on. Some of the women were younger, in their 50s, with pre-osteoporosis but without the extremely fragile bones of people with the full-blown degenerative condition. Case reports can be hard to interpret and may or may not indicate a real cause and effect. The FDA says it has not been able to find evidence of an increased risk of the unusual fractures in its analyses, including one of data from makers of bisphosphonates, the osteoporosis drugs. Now, a paper in the New England Journal of Medicine, also fails to find clear evidence that bisphosphonates are causing their fractures. The researchers report that the thighbone fractures are so rare, even in women taking bisphosphonates for up to 10 years, that it is not clear whether the drugs make them more likely. And, they report, if there is a risk, it is far outweighed by the drugs' clear benefit in preventing fractures of the hip and spine in people with osteoporosis.

U.S. Drug Move Said to Deprive Elderly
A Senate panel will hear complaints from nursing home operators, doctors, nurses and pharmacists that a Drug Enforcement Administration narcotics crackdown has left seriously ill patients crying for pain relief. The DEA says it is merely enforcing the law that requires pharmacies to wait for prescriptions that are signed by physicians before dispensing potent painkillers like Vicodin, Percocet and morphine. But the nursing home groups say the new enforcement rules upend many years of practice in which the government informally allowed nurses to speed the process by taking doctors' orders orally, or from medical charts, and passing them along to pharmacies, similar to the procedures used in hospitals. Now many of the nation's nursing homes report delays of a day or more in getting pain drugs to patients, leaving "vulnerable, frail patients to struggle through unimaginable pain for hours and even days, while physicians, nurses and pharmacists struggle to collect required DEA paperwork."

Top U.S. Psychiatrist Calls for Ethics Cleanup
American psychiatrists need to break away from a "culture of influence" created by their financial dealings with the drug industry, the head of the National Institute of Mental Health has said in a leading medical journal. He stops short of calling researchers corrupt or asking them to stop taking money from drug companies, but he highlights a "bias in prescribing practices" that favors brand name drugs over cheaper generics and non-drug treatments. He says the situation must change with new standards for transparency and full disclosure of psychiatry's collaborations with industry. His efforts also got a boost with the signing of the health care overhaul legislation which requires drugmakers and others to file annual reports to the government on their financial ties to doctors. The law requires reporting of gifts, entertainment, food, research money and other fees and grants. Consumer advocates applaud the "sunshine" provision because it also requires a database the public can search for their own doctors' ties to industry.

FDA Asks Pediatricians to Stop Using Diarrhea Vaccine for Now
Federal drug regulators have asked the nation's pediatricians to stop giving children a diarrhea vaccine until federal scientists can figure out why the product contains apparently harmless but extraneous pieces of a pig virus. The vaccine, called Rotarix, is manufactured by GlaxoSmithKline and is intended to prevent severe cases of rotavirus infections, a diarrheal illness that can cause dehydration in infants and young children. Neither doctors nor parents need worry about potential illnesses in children who were vaccinated with Rotarix, because the viral particles have been present in the vaccine from the earliest stages of its development. Extensive testing before and after approval has shown the vaccine to be safe.

FDA Warns of Muscle Risk from Statin Drug
The Food and Drug Administration says the highest available dose of the cholesterol drug Zocor can cause muscle damage as well as severe and potentially lethal kidney damage. The agency says statin drugs like Zocor are known to cause muscle damage in some patients, but the risk is more severe when patients are taking 80 milligram doses. The risks include rhabdomyolysis, a form of muscle damage that can lead to kidney damage or failure, and death. The FDA says the warning is based on clinical trials, studies, reports of side effects by users and prescription data.

Tougher Warning for Eczema Drugs?
Novartis AG and Astellas Pharma eczema drugs may need their warning labels expanded after dozens of new reported cases of cancer and infection in children, U.S. Food and Drug Administration staff said in documents recently released. Agency scientists said 46 cancer cases and 71 infection cases have been reported in patients aged 16 and younger from 2004 to 2008 with Novartis' Elidel and Astellas' Protopic. Both drugs - also known as pimecrolimus and tacrolimus respectively - already carry strong warnings about cancer and infection, but officials should consider expanding them to include the new post-marketing reports, they wrote. The documents were released ahead of an FDA advisory meeting to weigh potential safety concerns with a variety of drugs used in younger patients. Additionally, other FDA staffers said the warning label for GlaxoSmithKline's herpes drug Valtrex was "insufficient" for certain central nervous system side effects in children, although no other concerns were seen. Another scientists noted concerns about the use of Pfizer's antibiotic Zmax in pregnant women and the potential for it to cause stomach blockages in newborns. The FDA will weigh the recommendations from its panel of outside advisers before taking any action.

Report Says China Sold Bad Vaccines to Hospitals
A newspaper article by one of China's best-known investigative reporters has reawakened a controversy over whether provincial authorities improperly stored vaccines in rooms without air-conditioning, rendering them ineffective, and then let them be administered to children. While China's Health Ministry said it would look into the allegations, it also cautioned that it examined the evidence in late 2008 and did not find a widespread problem. A former chief spokesman at the Shanxi Province Disease Control and Prevention Center said a senior official was let go last year because of improprieties related to the vaccines and that the center required all hospitals in the province to buy vaccines at steep prices. To monitor compliance by the hospitals, the center put a sticker on each package of vaccine to show that it had been approved. However, the stickers would not adhere to the packages in air-conditioned rooms, so through 2006 and 2007, the center routinely had the vaccines transferred to a warm room where the stickers were attached. "I saw boxes and boxed of vaccines piled up high like a hill in a hot room without air-conditioning," he said. "Over the course of two years, I complained more than 30 times to the center's leaders that these vaccines were no longer effective."

Long-Term Safety of Drug-Coated Stents Doubled
New research shows more patients who got drug-coated stents right after suffering a heart attack later died from heart-related problems than those who received older, cheaper bare-metal stents. Stents are tiny tubular devices used to prop open diseased heart arteries and have been widely used for almost 20 years. Newer and more expensive versions of the devices are coated with anti-clotting drugs that keep treated arteries from reclogging. Seven years after the first drug-coated stent was approved in the United States, members of the American College of Cardiology debated the issue, saying more research is needed to understand the long-term effects. Danish researchers conducted a trial examining the effectiveness and risks of the two types of stents implants right after heart attack. They found that after three years, patients who got bare-metal stents were more likely to have problems, like requiring more intervention for blockages, while patients with the drug-coated variety were more likely to die from heart-related problems.

Finding Answers On How Thalidomide Caused Defects
The word "phocomelia" means seal limb, and it described an extremely rare condition in which babies are born with limbs that look like flippers. The long bones of the arms fail to develop, but fingers sometimes sprout from the shoulders. In some cases, the legs fail to develop. Fifty years ago, the team "phocomelia" became all to familiar as doctors began to see more and more cases. It turned out that a drug called thalidomide, which pregnant women were taking for morning sickness, was responsible. Magazines and newspapers ran shocking pictures of seal-limbed children, and the drug was banned in 1962. By then, 10,000 children, mostly in Europe, had been born with thalidomide-induced birth defects. Despite the notoriety, phocomelia remained scientifically mysterious for the next five decades. Only now are scientists finally starting to solve the puzzle by deciphering thalidomide's effects, and they are discovering surprise clues about how normal limbs develop.

Intense Treatment Hopes for Diabetics Dashed
Key results from a landmark federal study are in, and the results are disappointing for diabetics: Adding drugs to drive blood pressure and blood-fats lower than current targets did not prevent heart problems, and in some cases caused harmful side effects. A decade ago, the federal government launched the three-part study to see whether intensely lowering blood sugar, blood pressure, or fats in the blood would reduce heart attacks and strokes in diabetics. The first piece of the study - about blood sugar - was stopped two years ago when researchers saw more instead of less risk with that approach. Now, the other two parts of the study are in. What should diabetics do? Focus on health diets and lifestyles, and take tried-and-true medicines that doctors recommend now to control health risks. For the blood-fat study, researchers recruited more than 5,500 diabetics who also had another health risk, such as high blood pressure or cholesterol. All were given a statin - cholesterol-lowering pills sold as Lipitor and Zocor that have long been known to save lives. Half also were given Abbott Laboratories' blockbuster drug, TriCor; the rest got dummy pills. Nearly five years later, the groups had similar rates of heart attacks and strokes, although people with very high blood fats seemed to benefit from TriCor. There were also signs of a gender difference - TriCor seemed to help men but appeared to possibly harm women by raising the chance they would suffer a heart problem compared to women taking dummy pills.

FDA Warns Some Patients Cannot Process Plavix
The Food and Drug Administration is adding its strongest warning to the label for Plavix, cautioning that some patients do not respond to the blockbuster blood thinner. The FDA said in a statement that certain patients with a genetic variation cannot metabolize the drug, putting them at increased risk for heart attack and stroke. Patients can determine if they are "poor metabolizers" by taking a genetic test. The FDA recommends these patients use other blood thinners, such as aspirin. The FDA added similar language to Plavix's label last year, but the new warning appears within a black box, the FDA's most severe safety labeling. Plaxic is prescribed to heart disease patients to prevent dangerous blood clots, which can cause heart attack, stroke and death. With genetic tests costs around $500, experts say it's unlikely such testing will become standard for patients taking Plavix.

Avastin Fails Clinical Trial for Prostate Cancer
Roche Holding, the Swiss pharmaceutical giant, has announced that its cancer drug Avastin did not help men with late-stage prostate cancer live longer in a clinical trial, another setback as the company tries to extend use of the blockbuster drug into new areas. The miss in prostate cancer follows a similar disappointment with Avastin in gastric cancer but success in ovarian cancer. Avastin, which works by starving tumors of blood, is already used to treat colon, breast, lung and kidney cancers, and had 2009 global sales of about $5.8 million. The new uses of the drug, however, are seen as riskier than existing ones, and Roche had already warned that it was quite likely that not all of the three new trials for Avastin would be successful.

Court Rules Again Against Vaccine-Autism Claims
Vaccines that contain a mercury-based preservative called thimerosal cannot cause autism on their own, a special U.S. court has ruled, dealing one more blow to parents seeking to blame vaccines for their children's illness. The special U.S. Court of Federal Claims ruled that vaccines could not have caused the autism of an Oregon boy, ending his family's quest for reimbursement. The family had filed a civil lawsuit in Oregon state court against a number of pharmaceutical companies alleging that the thimerosal additive in many pediatric vaccines significantly contributed to the development of their son's autism. While the state court determined the autism was vaccine-related, the judge said overwhelming medical evidence showed otherwise. The theory presented by the family and experts who testified on their behalf "was biologically implausible and scientifically unsupported," he wrote. In 2009, the court ruled against three families who claimed vaccines caused their children's autism, saying they had been "misled by physicians who are guilty, in my view, of gross medical misjudgment." The families sought payment under the National Vaccine Injury Compensation Program, a no-fault system that has a $2.5 billion fund built up from a 75-cent-per-dose tax on vaccines. Instead of judges, three "special masters" heard the three test cases representing thousands of other petitioners. More than 5,300 cases were filed by parents who believed vaccines may have caused autism in their children. The no-fault payout system is meant to protect vaccine makers from costly lawsuits that drove many out of the vaccine-making business. In a separate matter, the U.S. Supreme Court said earlier this year that it would decide whether a federal law protects vaccine manufacturers from lawsuits in state court seeking damages for alleged design defects. The high court agreed to hear a Pennsylvania case involving a lawsuit by the parents of a child who suffered seizures after her third dose of a diptheria-tetanus-pertussis vaccine. They sued the vaccine manufacturers, Wyeth.

No Link Between Bone Drug and Fractures
U.S. regulators said they have found no link between oral bisphosphonate osteoporosis medications such as Merck's Fosamax and certain thigh bone fractures. The U.S. Food and Drug Administration issued its statement following the publication of case reports of atypical subtrochaenteric femur fractures - or fractures in the bone just below the hip joint - in women with osteoporosis using oral bisphosphonates. Bisphosphonates are a class of drug aimed at preventing bone fractures and offsetting bone loss associated with menopause and include Fosamax, Roche Holding AG's Boniva, Novartis' Reclast and Warner Chilcott's Actonel. In 2008, the FDA requested information from all bisphosphonate drug makers related to these type of fractures. The agency said a review of the data did not show an increased risk for women using the medications. The FDA said that, although its review of the data did not show a clear connection between bisphosphonates and atypical subtrochanteric femur fractures, the agency is working closely with outside experts to gain more insight into the issue. In 2008, the FDA said the drugs showed no overall risk of heart problems. However, recently, a judge refused to dismiss a lawsuit alleging that Fosamax caused jaw damage to a woman during the nearly eight years she took the pill. Merck faces a slew of lawsuits involving almost 900 cases by patients who say Fosamax caused osteonecrosis of the jaw, or death of jaw bone tissue.

Promising Alzheimer's Drug Fails in Study
A promising experimental Alzheimer's disease drug Pfizer and a partner are developing worked no better than a placebo in a late-stage study, an unexpected disappointment after the potential blockbuster stopped symptoms from worsening for a year in a prior test. Pfizer and its partner said that the drug, Dimebon, failed to meet its primary and secondary goals - improving thinking ability and overall daily function over six months in patients with milk to moderate Alzheimer's disease. Still, the results don't necessarily spell the end for the drug. The drugmakers are continuing three ongoing studies that could prove Dimebon helps patients in combination with other Alzheimer's drugs or when used for a longer period.

California County Sues GlaxoSmithKline Over Diabetes Drug
On the heels of a U.S. Senate report criticizing GlaxoSmithKline for health risks associated with its diabetes drug Avandia, a county has sued the drugmaker in federal court. The county wants the company to pay back money from all sales of Avandia in California since 1999, as well as pay restitution for medical treatment provided to Avandia users who suffered heart problems. The county itself, which runs a public hospital, spent $2 million buying Avandia between 1999 and 2007. The suit is the first governmental prosecution over Avandia in California.

Doctors Hastened Dying Kids' Death, Parents Say
A small but provocative study suggests that doctors may be giving fatal morphine doses to a few children dying of cancer to end their suffering at their parents' request. A handful of parents told researchers that they had asked doctors to hasten their children's deaths - and that doctors complied, using high doses of the powerful painkiller. Researchers doubt doctors are engaged in active mercy killings; instead, they speculate the parents interviewed for the study mistakenly believed that doctors had followed their wishes. A more likely scenario is that doctors increased morphine doses to ease pain, and that the children's subsequent deaths were only coincidental. Among parents studied, one in eight, or 13 percent, said they had considered asking about ending their child's life, and 9 percent said they had that discussion with caregivers. Parents of five children said they had explicitly requested euthanasia for their dying children, and parents of three said it had been carried out with morphine.

1 in 4 Parents Thinks Shots Cause Autism
One in four U.S. parents believes some vaccines cause autism in health children, but even many of those worried about vaccine risks think they children should be vaccinated. Most parents continue to follow the advice of their children's doctors, according to a study based on a survey of 1,552 parents. Extensive research has found no connection between autism and vaccines. In 2008, unvaccinated school-age children contributed to measles outbreaks in California, Illinois, Washington, Arizona and New York. Thirteen percent of the 140 who got sick that year were hospitalized. Fear of a vaccine-autism connection stems from a flawed and speculative 1998 study that recently was retracted by a British medical journal. The retraction came after a council that regulates Britain's doctors ruled the study's author acted dishonestly and unethically.

Judge Declines to Upset $22.5 Million Jury Award in Polio Case
A New York state judge has refused to throw out the $22.5 million verdict awarded by a Staten Island jury in a 28-year-old polio vaccine suit. Last year, the jury found Pfizer Inc. liable for negligent manufacture of the oral polio vaccine from which the plaintiff allegedly contracted polio while changing his infant daughter's diapers in 1979. The judge, in declining to set aside the verdict, said that the plaintiff "has sustained almost 30 years of past pain and suffering before having his day in court. He had physical and psychological injuries as a result of his contracting polio. It cost him his job, his marriage and the loss of enjoyment of life." With 30 years of past pain and suffering with polio, and another 20 years of future pain and suffering, as well as the prognosis of constant care due to the physical and mental conditions of post polio syndrome, the court did not find the jury awards to be excessive.

Court Finds Paxil Manufacturer Didn't Meet Burden to Pre-Empt
A lawsuit against SmithKline Beecham Corp. over the suicide of a 23-year-old woman, who ended her life two days after taking the antidepressant Paxil, can move forward, the 7th Circuit has ruled. In a unanimous decision reversing the lower court, the appeals court said that the drug manufacturer now known as GlaxoSmithKline didn't meet its burden of showing with "clear evidence" that the Food and Drug Administration would have rejected a change in the drug's labeling to warn about the enhanced possibility of suicide in young adults. In finding that the drug manufacturer did not meet its burden of clear evidence, the court pointed to the "extensive showing" required by previous cases. "Consequently, the plaintiff's claims are not preempted." The woman's death is not the only suicide to trigger a Paxil lawsuit. With regard to those suits and others related to drug labeling, previous cases have reversed earlier FDA assertions that federally approved drug labeling pre-empted state court lawsuits alleging a failure to warn.

Judge Dismisses FTC's Antitrust Claims Over Delay in Generic Drug's Rollout
An Atlanta federal judge's dismissal of the Federal Trade Commission's antitrust claims against several pharmaceutical companies that delayed a generic drug's market rollout through a settlement is a setback for the agency's opposition to such deals. The judge dismissed the FTC's lawsuit claims against the companies and the antitrust claims of consumers. He also dismissed some, but not all, of the antitrust claims made by direct purchasers, including retailers and wholesalers. The FTC brought antitrust claims against Solvay Pharmaceuticals and the companies it paid to delay the launch of generic competitors to its testosterone-replacement drug AndroGel. The FTC also sued generic drug companies which partnered with the company at the time. The FTC claimed the companies violated the Federal Trade Commission Act by illegally restraining trade and the company "willfully maintained" an illegal monopoly that violated the act.

Pfizer Wins Cancer Suit On Prempro
A Pfizer Inc. unit's menopause drug was not a cause of a woman's breast cancer, and the drugmaker is not liable for damages, a Philadelphia jury has found. In a similar case, a jury in the same city found against Pfizer and ordered nearly $10 million in damages. In the latest case, the Common Pleas jury said, after a day of deliberation, that Prempro, made by Pfizer's Wyeth unit, was not the cause of a woman's breast cancer. Jurors did find that Wyeth failed to adequately warn her prescribers about Prempro. The woman took Prempro for about four years before developing the disease in 2003 and died in 2005 at age 56. "There's overwhelming evidence the prescribers knew of the breast cancer risk," Wyeth's lawyer told the jury. "She made the decision that she needed to go on hormone therapy" and said in a 2005 bedside interview that she had been warned of the risk. The verdict is Wyeth's fourth victory in 11 cases over Prempro to have gone before juries. It lost a case recently when a jury awarded a retired school bus driver from Alabama $9.45 million for her cancer. Former users have filed more than 8,000 suits against Wyeth and another Pfizer unit, Pharmacia & Upjohn, over menopause drugs, according to a Wyeth regulatory filing last year.

Glaxo Defends Handling of Avandia Heart Risks
GlaxoSmithKline said a Senate report criticizing its handling of heart risks with its diabetes drug Avandia "mischaracterizes and distorts" the company's record. In a memo posted online, the British drugmaker takes aim at the highly critical Senate Finance Committee report that has reignited debate around its troubled diabetes treatment. The Food and Drug Administration added a warning about potential heart attacks to Avandia in 2007, but the scope of that risk is still not fully understood. The Senate report charged that Glaxo downplayed the drug's safety risks and withheld important data from the FDA. "That suggestion is fundamentally flawed and contradicted by the record of extensive, ongoing interactions between GSK and the FDA," states the company. According to the 30-page Glaxo document, the company voluntarily submitted data on Avandia's heart effects in 2005, and has steadily updated the government since then. The company also blasts Senate investigators for excluding results of several recent studies that appear to support Avandia's safety.

FDA Flags Heart Risk with HIV Drug Combo
The Food and Drug Administration issued a warning about potential heart risks when combining two HIV drugs. The agency said preliminary data suggests Roche's Invirase and Abbott Laboratories' Norvir can affect the electrical activity of the heart when used together. Changes to the heart's electrical activity can delay the signals that trigger heart beats. In some cases, the problem can cause irregular heart rhythms, leading to lightheadedness, fainting and even death. The FDA made its announcement after reviewing data submitted by Roche about the heart activity of patients using its drug with Abbott's Norvir. The agency said its review is ongoing and patients should not stop taking Invirase without talking to their doctor. Doctors should review patients' heart health and current medications to determine if they should continue taking Invirase.

Philadelphia Jury Awards $9.45 Million in Damages Over Prempro Drug
Another Philadelphia jury has decided that drugmaker Wyeth should be punished with punitive damages for the warnings provided to a plaintiff and her doctor over the risk of breast cancer from Wyeth's hormonal drug Prempro. The jury awarded $6 million in punitive damages and $3.45 million in compensatory damages in the country's first case involving a plaintiff diagnosed with breast cancer well after the 2002 release of the Women's Health Initiative, a randomized, controlled trial of the risks and benefits of hormone replacement. The jury's verdict was significant because the plaintiff was prescribed Prempro during a period in which the label had changed following the WHI, and the jury verdict showed the jury found that Wyeth didn't react appropriately to the WHI. After four hours of deliberation, the jury awarded $3.25 million in compensatory damages after finding that Wyeth failed to adequately warn the plaintiff's doctor about the risks of Prempro; that her doctor would have recommended a different treatment for her menopause if he had been adequately warned of the risks of Prempro; and that Prempro was a cause of her breast cancer. The jury also awarded $200,000 for the loss of consortium claim brought by her husband. The jury also said that Wyeth's conduct warrants punitive damages. The jury only deliberated seven minutes during the punitive damages phase before returning its verdict of $6 million.

Doctor Training Aided by Drug Industry Cash
More than half of the nation's medical residency programs to train doctors in internal medicine accepted financial support from the drug industry, even though three-fourths of the programs' directors said accepting the aid was "not desirable," a survey found. At issue are potential conflicts of interest as the residency programs accept drug company support to help train tens of thousands of new doctors at a point in their careers when they are beginning to prescribe drugs. The survey, conducted in 2006 and 2007, found that drug companies paid for educational materials like pocket guides in 83 percent of the programs that accepted support, meals in 90 percent, office supplies in 68 percent and drug samples in 57 percent. Medical residency programs in the southern United States were much more likely to accept the industry largess than those in the Northeast - 72 percent to 47 percent. The overall rate of accepting drug industry financing was 55 percent, but that was down from the 88 percent level reported in a 1990 survey.

A Face-Off On the Safety of a Drug for Diabetes
Three years ago, a cardiologist conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug's sales and a plunge in the share price of GlaxoSmithKline, Avandia's maker. The battle between the doctor and GlaxoSmithKline was waged from afar in news releases and published papers. But in 2007, 11 days before the cardiologist's study was published, he and four company executives met face to face in a private meeting whose details have not been disclosed until now. Fearing he would face pressure and criticism from executives, the cardiologist secretly recorded the meeting. A Congressional investigation has since concluded that GlaxoSmithKline had threatened scientists who tried to point out Avandia's risks, and internal memorandums from the Food and Drug Administration show that some government health officials want Avandia withdrawn. The drug is still being taken by hundreds of thousands of patients, and sales last year were $1.19 billion. So the battle over Avandia has begun anew, and issues raised in the meeting between the four executives and the cardiologist are likely to be raised again. For instance, during the meeting, company executives repeatedly promised to begin a crucial analysis of the safety of Avandia "within days." Nearly three years later, such a study has not been published in a medical journal, although the company has posted results on its Web site.

Deliberations Continue in Latest Hormone Replacement Therapy Trial
After an hour of deliberation and four weeks of trial, a Philadelphia jury will continue its work in a lawsuit over whether drugmaker Wyeth's hormonal drug caused an Alabama plaintiff's breast cancer. The verdict will either continue or disrupt the run of jury verdicts in favor of plaintiffs in Philadelphia hormone-replacement therapy cases. There are 1,500 HRT mass tort cases pending in Philadelphia Common Pleas Court. In the current case, a woman claims her breast cancer was caused by her use of Wyeth-made Prempro for six years before her diagnosis with breast cancer in 2004. Last year, a jury awarded $75 million in punitive damages and $3.7 million in compensatory damages to plaintiffs in a similar case. In another case, a jury awarded $28 million in punitive damages and $6 million in compensatory damages against Wyeth. Three other Philadelphia verdicts in favor of plaintiffs in the HRT litigation were overturned by trial judges and now are on appeal. During closing argument, the woman's lawyer said she was among the minority of women who become estrogen-deficient after menopause. Her cancer was estrogen-receptor-positive breast cancer that needed hormones in order to grow, and she got those hormones by taking Prempro. Wyeth's attorneys argued that woman who have never taken a Prempro pill get the same type of ductal, hormone-replacement-positive breast cancer that the plaintiff did.

Generics Face Longer Wait for Approval
American consumers are waiting nearly a year longer for government regulators to approve new lower-priced generic drugs than they did in 2005. The delays, caused by a growing backlog of applications at the Food and Drug Administration, may be costing consumers and the federal government millions of dollars a year as they continue in some cases to pay for name-brand drugs even after their patients expire, industry analysts said. Five years ago, the FDA typically approved a new generic drug within 16.3 months of the application's filing. However, by last year, with limited staff to review an increasing number of applications, approvals for new generic drugs were taking 26.7 months. The agency now has a backlog of nearly 2,000 pending generic applications - more than double the backlog in 2005.

FDA Seeks Restrictions On Asthma Medications
The Food and Drug Administration has called for putting new limits on powerful and long-lasting bronchial drugs that millions of Americans use to treat asthma - a move designed to lower the risk of complications that could lead to hospitalization or even death. Physicians should switch asthma patients away from medicines containing both long-acting beta agonists - commonly called LABAs - and inhaled corticosteroids, the FDA said. Patients, instead, should use products containing only the corticosteroids or other asthma-relieving medication whenever possible, according to the agency. In addition, patients who can't control asthma symptoms any other way should use LABAs for the shortest possible time. And LABAs never should be used alone in treating asthma in adults of children.

Placebos May Have Biological Effect On Body
When it comes to the placebo effect, it really may be mind over matter, a new analysis suggests. In a review of recent research, international experts say there is increasing evidence that fake treatments, or placebos, have an actual biological effect in the body. The doctor-patient relationship, plus the expectation of recovery, may sometimes be enough to change a patient's brain, body and behavior, experts write. Researchers cited studies where patients with Parkinson's disease were given dummy pills. That led their brains to release dopamine, a feel-good chemical, and also resulted in other changes in brain activity.

In Retrial, New Jersey Jury Awards $25 Million to Accutane User
Lawyers suing Roche Laboratories Inc. had reason to be dismayed 14 months ago when a New Jersey state appeals court threw out a $2.5 million jury verdict they had won for a man who blamed the acne drug Accutane for his bowel disease. However, the lawyers have recently won 10 times more at the retrial. A jury awarded $25.16 million to an Alabama man after finding that Roche knew or should have known that Accutane caused inflammatory bowel disease (IBD) and failed to warn prescribing physicians. It's the largest of five victories that Accutane users have won against the drugmaker, including a $13 million verdict last year for three plaintiffs. His claim was one of 791 on a list of Accutane cases assigned to a mass tort court in Atlantic City and dozens more are pending around the country. The man took Accutane 15 years ago and developed chronic ulcerative colitis, which led to removal of his colon, and he has suffered further bowel problems that required further surgeries. His lawyers presented evidence that Roche never published studies to the scientific and medical community that showed that Accutane's by-products damage the gastrointestinal tract and lead to degeneration and erosion of the intestinal lining - a trigger for IBD. The man's counsel also presented evidence that physicians prescribing Accutane noticed incidences of IBD in patients and reported them to the company. The jury found that Roche had failed to provide a warning and was the proximate cause of his IBD and awarded $25,159,530 in compensatory damages. No punitive damages were sought.

Pungent Pills
Some people with Type 2 diabetes say there's something fishy about their medication: its smell. The complaints have to do with metformin, a popular drug for Type 2 diabetes. A recent report says some patients have stopped using the medication because they think it smells like "dead fish," and pharmacists say they can identify it by its "old locker room sweat socks" odor. Patients have discussed the problem online, under postings titled "Should my metformin smell like rotting fish?" and "What does your metformin smell like?" Manufacturers have said that they are aware that the inherent characteristics of metformin have been associated with a mild odor upon opening the bottle, but there has been no correlation between an odor and the efficacy of metformin."

Paxil Interferes with Cancer Drug, Study Shows
The popular antidepressant drug Paxil may interfere with breast cancer treatments, making patients more likely to relapse and die, researchers in Canada have reported. Women who took GlaxoSmithKline's Paxil while taking tamoxifen at the same time were more likely to die of their breast cancer, the researchers found. The longer the overlap between Paxil and tamoxifen, the more likely the patients were to die. It is likely because Paxil, sold generically as paroxetine, interferes with the compound the body uses to process tamoxifen. Researchers looked at the healthcare records of more than 2,000 breast cancer patients 66 or older who took tamoxifen between 1993 and 2005. About 30 percent of the patients also took an antidepressant at some time during their treatment with tamoxifen, and paroxetine was the most common one. Fifteen percent of the patients died of breast cancer during the study.

A Warning On Mixing Herbs and Medicine
Researchers are warning that popular herbs and supplements, including St. John's wort and even garlic and ginger, do not mix well with common heart drugs and can also be dangerous for patients taking statins, blood thinners and blood pressure medications. St. John's wort raises blood pressure and heart rate, and garlic and ginger increase the risk of bleeding in patients on blood thinners, researchers found. Even grapefruit juice can be risky, increasing the effects of calcium-channel blockers and statins. Researchers found more than two dozen herbal products that patients should approach with caution, as well as a list of common drug-herb interactions.

Court Revives Accutane Suicide Suit
A New Jersey suit alleging Accutane caused a 19-year-old's suicide is back on track thanks to an appeals court ruling that gives the plaintiffs another shot at admitting expert testimony that the acne drug causes depression. The state's Appellate Division found that a flawed study, which led the trial court to dismiss the case, made up only a small part of the basis for the opinion. The panel remanded the case for the trial court "to consider whether the doctor should be allowed to testify on causation, without reference to the study." Since the anti-acne drug was introduced in 1982, it has been the subject of myriad suits alleging it caused birth defects, psychiatric problems and bowel disease. It was withdrawn from the U.S. market in 2009, though generic versions are still available. Hundreds of Accutane cases were consolidated on a mass tort docket in Atlantic County in 2005, but five were left in Essex County, which claimed psychiatric injury. One of them was a product liability and consumer fraud suit over the 1997 suicide of a woman's son shortly after he started taking Accutane. She alleges the label should have carried a suicide warning, which the Food and Drug Administration did not require until the year after the death. The doctor led the team that concluded a causation study, funded by Accutane plaintiffs and lawyer. Using positron emission tomography scans, the doctor found metabolic changes in the brains of acne patients treated with Accutane that were not present in those given antibiotics instead. The area affected was the frontal lobe which is associated with depression. Based on his study, he concluded that Accutane can cause depression and suicide. The defense challenged the report's admissibility, leading to judge to hold a hearing at which the study's defects came to light: missing data, inaccurate data and the doctor's failure to follow the methodology he claimed he used. The judge then ruled that he could not testify and granted summary judgment dismissing the case.

FDA Aims to Identify Risky Food and Drug Imports
U.S. border inspectors nationwide will soon start using a new computer system to identify risky food and medicine from abroad, the head of the U.S. Food and Drug Administration has announced. The project follows recalls of tainted toothpaste, pet food, seafood and other products from China, as well as a contaminated blood thinner blamed for dozens of deaths in 2008. About 20 million of shipments of food, medicine, medical devices and cosmetics are expected to arrive at U.S. ports this year, which is up from about 6 million a decade ago. With the growing flood of products, inspectors typically examine less than 1 percent. Under the new system, border staff can check products in a computer database that gives a score for the risk level. The score is calculated in part based on whether the maker has a history of recalls and how susceptible the product is to contamination.

Journal Retracts 1998 Paper Linking Autism to Vaccines
A prominent British medical journal retracted a 1998 research paper that set off a sharp decline in vaccinations in Britain after the paper's lead author suggested that vaccines could cause autism. The retraction is part of a reassessment that has lasted for years of the scientific methods and financial conflicts of a physician who contended that his research showed that the combined measles, mumps and rubella vaccine may be unsafe. However, the retraction may do little to tarnish the doctor's reputation among parents' groups in the United States. Despite a wealth of scientific studies that have failed to find any link between vaccines and autism, the parents fervently believe that their children's mental problems resulted from vaccinations. A British medical panel concluded that the doctor had been dishonest, violated basic research ethics rules and showed a "callous disregard" for the suffering of children involved in his research. That decision led to the journal to retract the paper.

FDA Aims at Doctors' Drug Pitches
The FDA recently sent a warning letter to a well-known dermatologist and clinical researcher, citing the doctor for expressing premature enthusiasm in the media about Dysport, an injectable antiwrinkle drug the agency had not yet approved. Her comments in the media in 2007 violated restrictions on drug promotion, and the agency asked the doctor to explain how she intended to prevent similar violations in the future. Under the Obama administration, the FDA has stepped up scrutiny of drug advertising, dispatching many warning letters about misleading commercials and online marketing efforts, but this is believed to be the first time the agency has warned an individual investigator - a medical researcher who oversees a clinical trial - for apparently promoting an unapproved drug. The doctor is far from the only cosmetic doctor to have jumped the gun. Some talk show hosts and beauty editors have often turned to clinical investigators for news of the latest cosmetic medical treatments. Now, some industry experts say the FDA warning may curb the media enthusiasm of certain cosmetic doctors who until now have provided scoops about coming medical products - or have talked up the latest unapproved cosmetic uses for drugs and devices that the agency had approved only for other purposes.

Rite Aid Will Not Appeal $2.5 Million Verdict in Wrong Prescription Case
Rite Aid will not appeal a $2.5 million verdict levied against it by an Alabama court in the case of a woman who received the wrong prescription. A woman who has rheumatoid arthritis received a steroid rather than her prescription pain medication in 2006. She took the incorrect pills and developed Cushing's syndrome, a disease of the adrenal glands that caused her to suffer from physical and psychological symptoms. Rite Aid said is had immediately responded in the aftermath of the incident and retained all its pharmacy staff. Rite Aid also said that while it will not appeal, the company "believes the size of the damages are disproportionate to the injuries that were caused by the prescription alone."

Fatal Botox Reaction Blamed for Girl's Death
The case of a mother who says her 7-year-old daughter died from a fatal reaction to Botox treatments for cerebral palsy is believed to be the first case alleging a fatal reaction to the drug to reach trial. The girl died in November 2007 of respiratory failure and pneumonia. Her mother alleges that an overdose of Botox weakened muscles controlling her breathing. Botox is known for cosmetic uses but it has also been prescribed at doctors' discretion to relax muscles in cerebral palsy patients. Federal authorities last year mandated "black box" labels that warn of potentially serious reactions to the drug.

Class Decertification in Pfizer Off-Label Marketing Case Upheld
A class of plaintiffs in a case against Pfizer over its alleged off-label marketing of an epilepsy drug was properly decertified when Pfizer presented new evidence that the class's main expert didn't prove class members' individual doctors relied on the marketing, the Pennsylvania Superior Court said. The court also ruled a class can be decertified after a decision on the merits if new evidence comes to light. The panel vacated a summary judgment motion in favor of Pfizer now that the class is decertified because leaving the judgment intact would preclude absent class members from bringing individual suit on the same issue.

Heart Patients Warned About Using Anti-Obesity Drug
European and American drug regulators had two starkly different reactions to data on an obesity drug. The raw data from the study indicated that people with certain health problems who took the prescription diet drug Meridia had more heart attacks, strokes and other cardiovascular problems than people getting a placebo. The European Medicines Agency advised doctors and pharmacists to stop prescribing and dispensing European equivalents of Meridia. The FDA, however, looking at the same study data, took a less forceful step and asked Meridia's maker to put a stronger warning on its label. The FDA said the new warning should indicate that the drug was not to be used by people who have a history of heart attacks or strokes, or who have uncontrolled high blood pressure.

Court Revives Plaintiff Verdict in State's First Precedential Hormone-Replacement Case
In Pennsylvania's first precedent-setting decision regarding hormone replacement therapy mass tort litigation, the Superior Court has revived a plaintiff's lawsuit by finding that the plaintiff was entitled to an exception to the two-year statute of limitations because she couldn't have reasonably known of an alleged link between her breast cancer and HRT drugs before the publication of a widely publicized study. Despite a $1.5 million verdict in favor of the plaintiff, her lawsuit was dismissed because of the judgment notwithstanding the verdict granted by the judge. However, the Superior Court said that the trial judge shouldn't have tossed the plaintiff's lawsuit because the suit was filed within two years of the publication of the National Institutes of Health's Women's Health Initiative study, which found that the use of hormone estrogen and progestin increase the risk of breast cancer. "Appellant had no reason even to suspect that there was a link between her use of HRT and breast cancer until the WHI report was released," the panel ruled. "Under the totality of circumstances, which included the facts that none of her prescribing physicians told her there was a causal link between her HRT and breast cancer, and the product information for Provera was entirely dismissive of any such connection. It defies logic, contrary to the trial court's suggestion, that appellant should have been aware of the risk of taking HRT through her own due diligence." The trial judge had found that the woman reasonably should have known that one of her HRT drugs was a cause of her cancer and that her statute of limitations expired two years after her breast cancer diagnosis.

FDA Cites Four Drugmakers for Inaccurate Claims
Federal health regulators have issued enforcement letters to Eli Lilly, Bayer, Amylin Pharmaceuticals and Cephalon for making inaccurate or incomplete statements while promoting their drugs. The FDA disclosed four letters issued to the companies by its marketing enforcement decision. The letter to Lilly cites a print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain and the pain ailment fibromyalgia. According to the FDA, Lilly's ad does not adequately display information about the drug's side effects, a requirement for all pharmaceutical promotions. The FDA's letter to Cephalon makes similar complaints about missing risk information in the company's promotional cards for Treanda, a lymphoma treatment. The FDA says the card is "false or misleading because it omits important risk information." The drug has been linked to serious infections, skin reactions and other side effects. In the letter to Amylin, regulators take issue with statements made by the company while promoting its diabetes drug Byetta at a conference last year. According to the letter, several statements promoted the drug for unapproved uses and "overstate the efficacy of Byetta." Similarly, FDA reviewers said Bayer's script for a presentation on its birth control implant Mirena "overstates the efficacy" and "presents unsubstantiated claims."

Deals to Restrain Generic Drugs Face a Ban
A group of House lawmakers and the head of the Federal Trade Commission want Congress to include a provision in the health care legislation that they say could save American consumers several billion dollars a year on prescription drugs. The group plans to ask Congress to block business deals in which they say makers of name-brand drugs directly or indirectly pay generic makers to delay competition from cheaper generic alternatives. In recent years, critics say, deals between name-brand makers and generic makers have delayed the introduction of a range of generics including cancer drugs, antidepressants and prescription-strength antacids. The F.T.C. has estimated that such deals currently cost American consumers $3.5 billion a year. Opponents of the general agreements - maligned as "pay for delay" deals - say they are standard industry practice and help prop up monopoly pricing. The Congressional Budget Office, considering only federal drug spending, has estimated that the House provision could save the government $1.8 billion in health costs over the next 10 years.

Health Facilities Settle with New York Over Drug Flushing
New York's attorney general announced a settlement with five health care facilities that flushed pharmaceutical waste into the New York City watersheds. Agreements were reached with the two hospitals and three nursing homes that disposed of painkillers, antibiotics, antidepressants, hormones and other pharmaceuticals through toilets and sinks and into the watersheds. The flushes potentially put about 9 million people's drinking water at risk. The three watersheds drain into reservoirs and lakes providing drinking water to New York City's roughly 8 million residents and another 1 million in several northern counties - nearly half the state's 19.4 million residents. Although such facilities are allowed to flush many - but not all - drugs through toilets and sinks, the nursing homes and hospitals nonetheless agreed to stop disposing of all drugs in that manner to protect the watersheds. Instead, the facilities will give the drugs to waste management facilities.

Withdrawal Warning On Parkinson's Drugs
Some people with Parkinson's disease develop severe withdrawal symptoms when they try to taper off a widely used type of Parkinson's drug, researchers are reporting. The drugs, called dopamine agonists, include Mirapex and Requip. They help control the movement problems caused by Parkinson's, but may cause other troubles in some patients - including impulse control disorders, in which people compulsively eat, gamble or shop. Some patients who have tried to stop taking the drugs because of the compulsions quickly developed other ills: withdrawal symptoms like anxiety, panic attacks, nausea, sweating, pain, fatigue, dizziness and drug cravings. Researchers studied 93 patients; 40 had taken dopamine agonists, and 26 had tapered off them, often because of compulsive behaviors. Five of those 26 had severe withdrawal. Two fully recovered, but three could not stop taking the drug.

In Antidepressant Study, More Questions Than Answers
The Journal of the American Medical Association published a study questioning the effectiveness of antidepressant drugs. The drugs are useful in cases of severe depression, but for most patients - those with mild to moderate cases - the most commonly used antidepressants are generally no better than a placebo. For the millions of people who take these drugs, and the doctors who prescribe them, this provocative claim had to be confusing, if not alarming. It contradicted literally hundreds of well-designed trials, not to mention considerable clinical experience, showing antidepressants to be effective for a wide array of depressed patients. But on close inspection, the new study does not stand up to that mountain of earlier evidence. To understand why, it helps to look at the way it was conducted. The study was a meta-analysis - a combined analysis of previous studies. Researchers identified 23 studies that met their criteria for inclusion. of those 23, they could only access data on 6 with a total of 719 subjects. Three of the studies tested Paxil and three used an older drug. If your goal is to answer a broad question about the efficacy of antidepressants as a class, six studies is not broad.

To Measure Medicine, Mind the Spoon
When the measuring cap that comes with the medicine bottle gets gooey and gummed up, the temptation is to grab a kitchen spoon to guesstimate a teaspoon's worth of liquid medicine - except it doesn't really work. Researchers asked 195 college students to measure a teaspoon of cold medicine using a variety of spoons. They found that the amount of liquid varied, depending on the size of the spoon: students underdosed when they used medium spoons and overdosed with larger ones. Yet they were quite confident that they were doling out the correct amount. Though the differences were small, they could add up.

FDA Plans Safety Check of Three Drugs for Anemia
The Food and Drug Administration will review the safety of the widely used anemia drugs sold by Amgen and Johnson & Johnson after another clinical trial suggested that high doses of one of the drugs might cause strokes. Agency officials found that the results of the new trial, as well as of previous trials, "raise major concerns" about the use of the drugs to treat the anemia caused by chronic kidney disease. Officials say the agency would convene an outside advisory committee to re-evaluate the use of the drugs in patients with kidney disease and to consider new ways to control doses of the products. Since 2007, studies have renewed concerns that the drugs might cause heart attacks and strokes and might also worsen the condition of patients with cancer. Since 2007, the FDA has held three advisory panel meetings on these drugs and has changed the labels of the drugs to warn of risks and lower the doses used. In the study, researchers found that there was no statistically significant difference in deaths and cardiovascular problems between patients who received Aranesp, one of the drugs in question, and those who received a placebo. While that represented a failure of the original goal of helping people, that the drug did not kill people was considered somewhat reassuring in light of the safety questions that had arisen between the time the trial started and when it ended. But those who took Aranesp had about double the rates of stroke.

Popular Drugs May Help Only Severe Depression
Some widely prescribed drugs for depression provide relief in extreme cases but are no more effective than placebo pills for most patients, according to new analysis. The findings could help settle a longstanding debate about antidepressants. While the study does not imply that the drugs are worthless for anyone with moderate to serious depression - many such people do seem to benefit - it does provide one likely explanation for the sharp disagreement among experts about the drugs' overall effectiveness. Taken together, previous studies have painted a confusing picture. On one hand, industry-supported trials have generally found that the drugs sharply reduce symptoms. On the other, many studies that were not initially published, or were buried, showed no significant benefits compared with placebos.

No Proof Vytorin Causes Cancer, FDA Says
Federal drug regulators say an extensive review shows there's no evidence that Merck's cholesterol drug Vytorin causes cancer, a suspicion raised last year by a patient study. Still, the Food and Drug Administration says it cannot definitively rule out whether Vytorin is linked to a higher risk of cancer or death from cancer. The FDA says it's examined all of the data from the study that first raised the alarm about a possible risk. It also has reviewed interim data from two very large studies that are still in progress. Merck & Co. sells Vytorin, which generates roughly $5 billion a year in sales.

Spray Flu Vaccine Recalled
Thirteen lots of nasal-spray vaccine for swine flu are being recalled for lack of potency, officials said. The lots, made by Medimmune, include more than 3,000 doses. There is no safety problem with the vaccine, and people who received doses from the affected lots do not need to be revaccinated. A lack of potency is slight, and the recall was a precaution and that most of the vaccine in affected lots had been used up when it was at full strength.

Not All Drugs are the Same After All
There is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts. The problem is not pervasive, but it's something consumers should be aware of - especially now that more insurers insist that patients take generic medications when they are available. Over the last eight or nine years, consumers have experienced "misadventures" when switched from a brand name drug to a generic. They experience side effects or find that their symptoms have returned - or even worsened. Some specialists, particularly cardiologists and neurologists, are concerned about generic formulations of drugs in which a slight variation could have a serious effect on a patient's health. The American Academy of Neurology has a position paper that says, in part, "The A.A.N. opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician's approval." But insurers tend to argue otherwise. Recently, ExpressScripts, which handles drug insurance for big employers, put out a news release announcing results of a study it sponsored that found no difference in hospitalizations or emergency room visits for people on brand-name epilepsy drugs compared with those taking generics. The Food and Drug Administration, meanwhile, says it stands behind generic medications and its methods for approving them.

Blood Pressure Drug Tainted with Bits of Metal
Federal health regulators are warning doctors about 11 recalled lots of an intravenous hypertension drug made by the Medicines Co. that are contaminated with bits of steel. The company recalled the affected lots of Cleviprex after detecting tiny particles of stainless steel during a routine inspection. The Food and Drug Administration said that the particles could potentially disrupt blood flow to the brain, kidney, liver, heart and lungs. Cleviprex is used to lower excessively high blood pressure in patients who cannot take pills. It is distributed to doctors for injection in patients who are undergoing surgery. Medicines Co. says it has not received any reports of health problems connected with the recall and advised doctors inspect vials of the drug for possible contamination before using them. The cause of the contamination is still unclear, and the company has not determined how many vials of the drug were affected.

Advisers On Vaccines Often Have Conflicts, Report Says
A new report finds that the Centers for Disease Control and Prevention did a poor job of screening medical experts for financial conflicts when it hired them to advise the agency on vaccine safety. Most of the experts who served on advisory panels in 2007 to evaluate vaccines for flu and cervical cancer had potential conflicts that were never resolved, the report said. Some were legally barred from considering the issues but did so anyway. The inspector general of the Department of Health and Human Services found that the centers failed nearly every time to ensure that the experts adequately filled out forms confirming they were not being paid by companies with an interest in their decisions. The report found that 64 percent of the advisers had potential conflicts of interest that were never identified or were left unresolved by the centers. Thirteen percent failed to have an appropriate conflicts form on file at the agency at all, which should have barred their participation in the meetings entirely. Three percent voted on matters that ethics officers had already barred them from considering. As numerous medicines have been pulled from the market in recent years, worries have grown that experts may be recommending medical products - even ones they know to be unsafe - in part because manufacturers are paying them. As a result, government agencies, medical societies and medical journals have become increasingly insistent that experts disclose potential conflicts. And while the experts invariably insist that they have done so, government audits routinely find large gaps between these disclosures and the experts' actual income from consulting.

800,000 Doses of Kids' H1N1 Vaccine Recalled
Hundreds of thousands of swine flu shots for children have been recalled because tests indicate the vaccine doses lost some strength, government health officials have announced. The shots, made by Sanofi Pasteur, were distributed across the country last month and most have already been used, according to the Centers for Disease Control and Prevention. The 800,000 prefilled syringes that were recalled are for young children, ages 6 months to nearly 3 years. A CDC flu expert stressed that parents don't need to do anything or to worry if their child got one - or even two - of the recalled shots. Though the vaccine is safe and effective, the issue is its strength. Tests done before the shots were shipped showed that the vaccines were strong enough. But tests done weeks later indicated the strength had fallen slightly below required levels. Why the potency dropped isn't clear. Young children are supposed to get two doses, spaced about a month apart. Health officials don't think children need to get vaccinated again, even if they got two doses from the recalled lots.

Infants' Swine Flu Vaccine Recalled as Less Potent
Nearly a million doses of swine flu vaccine for infants may have been slightly less potent than required but should work anyway, federal officials said while announcing a recall of the shots. The maker of the vaccine, Sanofi-Aventis, voluntarily recalled 800,000 doses of low-dose, thimerosal-free vaccine in prefilled syringes intended for infants ages 6 months to 35 months, the Centers for Disease Control and Prevention said. Since most of the vaccine was released a month ago, it presumably has already been used, but the recall is intended to alert doctors to return any supplies they have left. The vaccine was fully potent at release but dropped about 12 percent in follow-up tests. Officials believe children who got the vaccine are fully protected, assuming they got the two shots we recommend for that age.

Crestor Okay for Wider Use, FDA Panel Says
Federal health advisers say expanded use of AstraZeneca's cholesterol pill Crestor can benefit patients with healthy cholesterol levels by preventing heart attack, stroke and death. A Food and Drug Administration panel voted 12-4 with one abstention that Crestor's benefits outweigh its risks in patients with normal cholesterol and no history of heart disease, setting the stage for a dramatic expansion of a drug that is already a blockbuster seller. The FDA's panelists said the drug's lifesaving potential outweighed side effects, including a risk of diabetes. A positive FDA ruling would give Crestor the broadest indication of any cholesterol drug in the U.S.

Menopause as Brought to You by Big Pharma
Millions of American women in the 1990s were told they could help their bodies ward off major illnesses by taking menopausal hormone drugs. Medical associations, medical journals, gynecologists and physicians agreed. Many women began taking Prempro, a hormone drug made by Wyeth. At least 13,000 of those women have sued Wyeth over the past seven years, claiming in courts across the country that its menopause drugs caused breast cancer and other problems. The suits also assert that Wyeth oversold the benefits of menopausal hormones and failed to properly warn of the risks. Recently, a jury in Pennsylvania awarded a woman $75 million in punitive damages from Wyeth on top of compensatory damages of $3.75 million. The drug giant Pfizer, which absorbed Wyeth and its hormone drugs earlier this year, says that Prempro is a safe, federally approved drug that did not cause the woman's cancer. Pfizer claims that it acted responsibly by including a clear warning about a breast cancer risk on Prempro labels and by updating the warning as new evidence emerged. Pfizer also plans to appeal every product liability case on menopausal drugs it loses.

Poor Children Likelier to Get Antipsychotics
New federally financed drug research reveals a stark disparity: children covered by Medicaid are given powerful antipsychotic medicines at a rate four times higher than children whose parents have private insurance. Medicaid children are also more likely to receive the drugs for less severe conditions than their middle-class counterparts, the data shows. These findings are certain to add fuel to a long-running debate - do too many children from poor families receive powerful psychiatric drugs not because they actually need them, but because it is deemed the most efficient and cost-effective way to control problems that may be handled much differently for middle-class children? A pediatric advisory committee to the Food and Drug Administration recently met to discuss the health risks for all children who take antipsychotics. The panel considered whether or not to recommend new label warnings for the drugs, which are now used by an estimated 300,000 people under age 18 in this country, counting both Medicaid patients and those with private insurance. Antipsychotic drugs can have severe side effects, causing drastic weight gain and metabolic changes resulting in lifelong physical problems.

FDA Yet to Improve Safety After Vioxx Scandal
The Food and Drug Administration still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal. Congressional investigators found that the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans. Those recommendations came after the embarrassing and dangerous episode with Vioxx, a blockbuster pain drug the FDA approved in 1999, only to pull from the market in 2004 after linking it to heart attack and stroke. Agency officials have made some changes to drug oversight, but the FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market. "It is not yet clear if or when FDA's decision-making process will be substantially improved as a result of its efforts," according to the GAO report.

Little Evidence Tamiflu Works, Report Finds
British researchers say there is little evidence Tamiflu stops complications in healthy people who catch the flu, though public health officials contend the swine flu drug reduces flu hospitalizations and deaths. Researchers looked at previously published papers on Tamiflu as used for seasonal flu. They found insufficient data to prove whether the antiviral reduces complications like pneumonia in otherwise healthy people but concluded the drug shortens flu symptoms by about a day. The researchers said the benefits of Tamiflu were small and that authorities should consider its side effects before using the drug in healthy people. While the reviewed studies only looked at Tamiflu use for seasonal flu, the experts said their conclusions raised questions about the widespread use of the drug in people with any flu-like illness, including swine flu.

Questioning a $30,000-a-Month Cancer Drug
A newly approved chemotherapy drug will cost about $30,000 a month, a sign that the prices of cancer medicines are continuing to rise despite growing concern about health care costs. The price of the new drug, called Folotyn, is at least triple that of other drugs that critics have said are too expensive for the benefits they offer to patients. The colon cancer drug Erbitux, for instance, costs $10,000 a month and the drug Avasti about $8,800 when used to treat lung cancer. Drug makers in general have been raising prices sharply in advance of the possibly passage of health care overhaul legislation, according to various studies. But the price of cancer drugs has been an issue for several years. Critics, including many oncologists, say that patients and the health system cannot afford to pay huge prices for drugs that, on average, provide only a few extra months of life at best. Folotyn has not even been shown to prolong lives - only to shrink tumors.

Swine Flu Shot May Give Young Kids Fever
The European Medicines Agency warns that young children given GlaxoSmithKline's swine flu shot may get a fever after their second dose. The European drug regulator said data from GlaxoSmithKline showed a higher number of children aged six months to three years had a fever after their second dose of the Pandemrix vaccine, compared with the first. Kids were also more likely to have side effects like muscle pain, drowsiness and irritability. The European regulator recommends children get two doses of swine flu vaccine, though Glaxo says one dose is enough.

CDC Warns of Fake Swine Flu Emails
Health officials are warning the public about fake emails inviting people to sign up for swine flu vaccine registrations. U.S. Centers for Disease Control and Prevention officials put out an advisory about the emails, which call for adults to create a personal H1N1 vaccination profile on the CDC Web site. CDC officials say the emails appear to be spam messages designed by hackers to spread a computer virus.

Rising Pain Pill Use Taking Deadly Toll
In the past decade, drug deaths attributed to pain medicate have skyrocketed. Fatal overdoses involving opioid analgesics - typically prescribed drugs such as methadone, oxycodone of fentanyl - have more than tripled nationwide from 4,000 in 1999 to 13,800 in 2006. Such medications played a part in nearly 40 percent of all poisoning deaths in the United States in 2006, up from 20 percent in 1999. According to the Centers for Disease Control and Prevention, about 38,400 drug-induced deaths were recorded in 2006, rivaling the number of fatalities from vehicle accidents, about 45,000.

Merck Knocks Out Second Fosamax Test Case Before Trial
Wyeth and its new parent Pfizer may have been hit with jury awards totaling$103 million over hormone drugs, but a judge has dismissed the second of three bellwether cases facing Merck over its osteoporosis drug Fosamax just weeks before it was set for trial. The judge ruled that the plaintiff in the second test case, a 74-year-old Mississippian had failed to present admissible evidence of specific causation tying her jaw problems to Fosamax. The judge's opinion stated that, along with osteoporosis, the plaintiff "has a history of serious medical problems" including congestive heart failure, vascular disease and skin cancer. She has smoked cigarettes since age eight and continues to smoke despite suffering from chronic obstructive pulmonary disease and being dependent on an oxygen tank to breathe. Despite all that, the judge found that neither of the dentists who treated her injury and were offered as experts were able to credibly link her jaw damage to her use of Fosamax.

Public Database Urged to Monitor Drug Safety
What could be done to prevent another Vioxx? This pain medication for arthritis became a blockbuster after its introduction in 1999, only to be taken off the market in 2004 when a study linked the drug to an increased risk of heart attack and strokes. A new study offers an ambitious proposal to determine a drug's risks sooner than they might otherwise become evident. Researchers propose a system to examine widely prescribed drugs through safety analyses that would pool data as they emerge from various clinical trials of a medication and aggregate the information for a fuller picture of a drug's harms and benefits. The study proposes a broad model for monitoring drug safety that would consist of detailed publicly available data that independent researchers could freely analyze.

Court Mulls Class Decertification in Off-Label Drug Case
A class can't be decertified unless there are substantial changes to the facts of a case, nor can it be decertified once a partial ruling has been made as to the merits of the case, an attorney for a class suing over the off-label marketing of epilepsy and neuralgia drug Neurontin argued before the Pennsylvania Superior Court. He argued that a judge improperly decertified the class a month before trial. He also claimed that depositions of a sampling of Pennsylvania doctors who said they prescribed the drug for off-label uses but weren't influenced to do so by any Pfizer marketing campaign were not enough to overturn the class.

Rising Prices of Drugs Lead to Call for Inquiry
Democrats in Congress asked for two separate investigations of drug industry pricing as they continue working on legislation to overhaul the nation's health care system. Responding to news reports of unusually high wholesale price increases in brand-name prescription drugs, four House leaders and one senator asked for government reviews of the pricing practices. Although drug makers challenge the theory, some experts say the run-up in wholesale prices may be partly related to the industry's concerns about future cost containment under any healthcare legislation.

Vials of Genzyme Drugs Contaminated
Vials of five different Genzyme drugs for rare diseases may be contaminated with tiny particles of steel, rubber or fiber that could potentially harm patients, the FDA has warned. The particle contamination may be less of a threat to patients and the company than the viral problem. The FDA and Genzyme said that there had been no reports of patients being harmed by particles and that the problem affected less than 1 percent of the vials. The drugs affected by the FDA's notice were Cerezyme for the treatment of Gaucher disease; Fabrazyme for Fabry disease; Myozyme for Pompe disease; Aldurazyme for mucopolysaccharidosis; and Thyrogen for thyroid cancer. All by thyroid cancer are extremely rare inherited enzyme deficiencies that affect only a few thousand people in the world.

Case Tests Level of Proof for Excluding Coverage for Drug-Related Injuries
A son's wild party while his parents were out of town has presented the New Jersey Supreme Court with a novel insurance question: What proof of drug ingestion must there be for the homeowner's policy's exclusion for injuries arising out of illegal drug use to apply? A 21-year-old girl passed out at the 2003 party and was taken to the hospital, where a toxicology report found alcohol, cocaine, marijuana and various opiates in her system. She then sued the host of the party, alleging that his delay in calling for help exacerbated the consequences of her overdose. The family's homeowner's carrier asked to be released from providing a defense, saying the policy had explicit language saying injuries brought about as the result of illegal behavior would not be covered. A judge ruled for the family, saying there was no evidence to conclude that she overdosed because of her behavior at the party and not earlier. An appellate court, however, reversed the ruling, saying the insurance company provided enough facts to connect her drinking and drug use at the party to her overdose. Finally, the family's attorney has asked the court to reinstate the earlier ruling because of the uncertainty about whether the girl drank enough and took enough drugs before the party to account for the overdose.

Department of Justice Targets Pharmaceutical Industry's Interaction with Foreign Officials
The Justice Department is planning to focus more criminal enforcement on the pharmaceutical industry's interaction with foreign officials. Applying of the Foreign Corrupt Practices Act to the pharmaceutical industry will be pushed in the months and years ahead. Justice prosecutors "will be intensely focused on rooting out foreign bribery in the industry. That will mean investigation and, if warranted, prosecution of corporations. It will also involve investigation and prosecution of senior executives. Overall, the Justice Department is pursuing more than 120 FCPA investigations in cooperation with the FBI and the Securities and Exchange Commission.

New Cholesterol Study Puts Focus On Merck Drugs
Medical researchers are expected to present a study with potentially significant implications for multibillion-dollar cholesterol medications from the drug giant Merck. Analysts are paying rapt attention to the report because two previous studies reduced sales of the drugs after indicating that they may not work any better than cholesterol drugs known as statins that are widely available as inexpensive generics. Analysts are waiting to see whether the new study reinforces the earlier findings or makes matters even worse for Merck. At stake are sales of Vytorin and Zetia, two cholesterol-lowering drugs that are projected to bring in $4.5 billion in revenue for Merck in 2012.

Pfizer Drug Studies Fudged, Report Says
Analysis of a dozen published studies testing possible new uses for a Pfizer epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed. According to the report, when a company-funded study's primary finding wasn't favorable, that result was usually buried and something else positive was highlighted, without disclosing the switch. The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers. The lawyers, who are seeking class action status for the cases, claim Pfizer concealed evidence the epilepsy drug Neurontin didn't work for those unapproved uses, including nerve pain, migraines and bipolar disorder.

Pennsylvania Firm Named in Multistate Lawsuit
A Chester County drug distributor, Amerisource Bergen, and several of its business units have been named in a lawsuit that focuses on biotech giant Amgen for alleged Medicaid fraud. A suit filed in Massachusetts alleges that Amgen and two Amerisource Bergen companies offered kickbacks to medical providers to increase sales of Amgen's anemia drug, Aranesp. According to the multistate complaint, the companies would encourage medical providers to bill third-party payers such as Medicaid for free Aranesp that were provided at no cost. Amgen is further alleged to have conspired to offer illegal kickbacks to medical providers, such as sham consultancy agreement, weekend retreats, or other services to induce them to purchase and prescribe Aranesp. The goal was to increase sales of Aranesp and convert new providers from competitor drugs. The complaint asserts the companies caused medical providers to falsely certify to state Medicaid programs that the providers were in compliance with federal and state anti-kickback statutes, which prohibits bribes to medical providers.

On Drug Labels, Vital Facts May be Missing
Federal officials who approve drugs review an enormous amount of data about their effectiveness and harmful side effects, but critical information often fails to reach the doctors who prescribe them. In the case of sleeping pill Rozerem, for example, one review document from the FDA states that the drug made "no significant difference in time to fall asleep" and that patients "do not seem to recognize any benefit from treatment." But the reviewer's uncertainty about the drug's effectiveness is not reflected in Rozerem's label, which does not include efficacy data from a clinical trial of 848 young and middle-age adults; that trial found that the drug was no more effective that a placebo, and users actually took a minute longer to fall asleep than those on the dummy pill.

Gardasil Researcher Drops Bombshell
The lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, has said that the controversial drugs will do little to reduce cervical cancer rates and that there has been no efficacy trials in children under the age of 15. The researcher made these remarks during an address at the 4th International Public Conference on Vaccination. Although he talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received. She began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine. She went on to surprise the audience by stating that the incidence of cervical cancer in America is already so low that "even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the United States."

Stroke Risk Linked to Anemia Drug, Study Finds
A new study raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp nearly doubled the risk of stroke in people with diabetes and chronic kidney problems who are not yet sick enough to need dialysis. The study is the largest ever of these blood-boosting drugs and the only one that compared them to a dummy treatment. The medicines have become blockbuster sellers because they lessen the need for transfusions, but their ability to prevent heart attacks, kidney failure or other problems have not been proven. Over the last two years, the federal Food and Drug Administration has repeatedly strengthened warning labels on Aranesp, Epogen and Procrit as concerns rose that they may worsen survival in certain cancer patients, especially at higher doses.

Weight Gain Associated with Antipsychotic Drugs
Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs. The study found that 257 young children and adolescents in New York City and on Long Island added 8 to 15 percent to their weight after taking the pills for less than 12 weeks. The patients, ages 4 to 19, added an average of one to one-and-a-half pounds a week. Although the drugs' influence on weight and metabolism had been previously detected, the speed and magnitude of the effects found in the study were greater than previously reported - findings he said were made possible by looking exclusively at new patients.

Industry Years Behind On Testing Approved Drugs
Federal drug officials have long been criticized for failing to force drugmakers to complete studies proving that their drugs work as hoped, and congressional investigators released yet another report pointing out that some of these studies remain undone many years after being promised. The result is that doctors and patients remain unsure whether some critical medicines used to treat illnesses like cancer and heart disease are actually beneficial. Concerns about this situation reached such a pitch several years ago that Congress passed legislation in 2007 giving the FDA greater power to force drugmakers to complete their promised studies and to fine companies that fail to follow through. However, the Government Accountability Office said that from 1992 through 2008, the food and drug agency asked drug makers to complete 144 studies associated with 90 drug applications, and that drug makers had completed just two-thirds of the requested studies. Fifteen of the 52 uncompleted studies have been pending for more than five years, and several have been pending for more than eight years.

Menopause Remedies Contain Unknown Risks
Millions of women have tried custom-compounded hormones or herbal supplements since 2002, when a big federal study found risks from traditional hormone replacement therapy, or HRT. However, instead of a safer option, many women are getting products of unknown risk that still contain the estrogen many of them fear, women's health experts say. For years, medical groups have warned against custom-compounded hormones. The American College of Obstetricians and Gynecologists has denounced claims about their safety. The American Medical Association has urged more FDA oversight. The Federal Trade Commission has filed complaints against online sellers who made health claims for natural progesterone creams without supporting evidence.

Key Drug Facts Left Off Labels
Did you know that Lunesta will help you fall asleep just 15 minutes faster? Or that a higher dose of the osteoporosis drug Zometa could damage a cancer patient's kidneys and raise their risk of death? Much of what the FDA knows about a drug's safety and effectiveness is not included on the label, say two drug safety experts who are calling on the agency to make that information more accessible. In the New England Journal of Medicine, the researchers argue that drug labels don't reflect the nuanced decisions the FDA makes when deciding to approve a drug. If drug labels sometimes exaggerate benefits and play down drug risks, researchers say there's a very good reason: they are written by drugmakers. While the FDA must approve the final labeling, the actual language is drafted by the manufacturer, with input from FDA scientists.

Mylan to Pay $121 Million to Settle Medicaid Claims
Mylan Inc. and two other drugmakers will pay $124 million to settle claims they did not properly reimburse Medicaid for drugs, officials said. The New York attorney general said two Mylan subsidiaries violated the False Claims Act. Mylan will pay $121 million. Between 2000 and 2004, Medicaid bought drugs from the companies, and the drugmakers reimbursed Medicaid once per quarter. But the companies underpaid by pricing the drugs at a lower rate. Medicaid classifies some products as "innovator" drugs, which get higher rebates than "non-innovator" drugs. The government said Medicaid was paying innovator rates to the companies, and the drugmakers were reimbursing Medicaid at the lower non-innovator prices.

Drugmaker Reveals Which Docs it Paid to Speak
Merck & Co. paid doctors and nurses a total of $3.7 million this summer to give talks to colleagues about the drugmaker's products and other health topics, Merck has disclosed. Amid growing criticism of industry influence over which treatments doctors choose for their patients, the company posted a database on its Web site listing speaking fees paid to 1,078 doctors, researchers, nurses and other health professionals from July through September. The 1,078 speakers gave a total of 2,493 talks and were paid $1,548 on average. The top earner got $22,693, and dozens of doctors received more than $10,000.

In Blockbuster Ruling, Alabama Supreme Court Overturns Pricing Fraud Verdicts
The Supreme Court of Alabama has ruled that there was no basis for the state's fraud claims against three drug companies appealed adverse jury verdicts. The ruling wipes out verdicts of $33 million against Novartis, $81 million against GlaxoSmithKline and $215 million against Astra Zeneca. The court found that evidence presented by the pharmaceutical companies belied the state's fraud theory. "The sine qua non of the state's fraud claims in these appeals is its assertion that it did not know that the published average wholesale prices were merely suggested prices, exclusive of discounts or other incentives. This assertion is untenable in light of the correspondence and internal memoranda involved in the state's formulation of its reimbursement methodology." Because the state knew the AWP was not a true wholesale price average, the court found, it could not claim to have been defrauded by the drug companies. A long list of firms was involved in the state Supreme Court appeal.

European Court Sides with Drug Companies Over Pricing Matter
Europe's highest court handed the pharmaceutical industry a victory, saying that regulators should reconsider whether efforts by drug makers to prevent traders from exploiting price differences across Europe should be allowed. The decision, in a case involving GlaxoSmithKline, is a blow to governments in northern Europe that like the discount trade, which helps them cut the price of medicines they buy in bulk for their national health services. The case concerned discounters who buy bulk batches of medicines in southern European countries like Spain and sell surpluses in northern nations like Britain, where drugs generally command higher prices. To combat the discounters, Glaxo introduced a policy in the late 1990s to put higher prices on dozens of drugs sold in the Spanish market, but which it had determined were destined for export. Shortly after, the European Commission ruled that the company was restricting competition within the European Union. A lower court overturned the decision in 2006, saying that the commission had failed to consider Glaxo's evidence properly. The European Court of Justice upheld that ruling.

FDA: New OxyContin Would be Harder to Abuse
Federal health officials say a new version of the painkiller OxyContin that is designed to be harder to abuse offers some improvements over the original pill. Purdue Pharma has touted the new pill's plastic-like coating, which is designed to make the drug harder to crush and snort or inject. Food and Drug Administration scientists said that the drug's resistance to abuse is "limited," but "may provide an advantage over the currently available OxyContin." A panel of advisers to the FDA said last year that the company needed to do more testing to demonstrate the drug's tamper resistance. OxyContin, the nation's top-selling prescription painkiller last year with sales of more than $2 billion, was hailed as a breakthrough treatment for severe chronic pain when it was introduced in 1996. A time-release version of the narcotic oxycodone, it was designed for use over 12 hours to keep a steady state of the painkiller in the bodies of seriously ill patients. However, OxyContin and similar drugs were quickly adapted by drug abusers who discovered they could get a heroin-like high by crushing the pills and snorting or injecting the entire dose at once.

Rule On Eye Treatment Likely to Cost Millions
Medicare is putting in place a new policy that may sharply curtail the use of the cancer drug Avastin as a treatment for eye diseases. But the way the bureaucratic gears mesh in this case, the move could end up costing Medicare itself hundreds of millions of dollars a year and individual patients thousands of dollars. For several years, eye doctors have been using Avastin off-label as a treatment for retinal diseases, particularly age-related macular degeneration, the leading cause of blindness in the elderly. Avastin is similar in its mechanism of action to Lucentis, a drug approved to treat macular degeneration. Both drugs are made by Genentech. But Lucentis costs about $2,000 per injection - with an injection needed as often as every month. Although Avastin can cost thousands of dollars a month as a caner treatment, when used in the tiny portions required for eye-disease injections, it costs only about $30 to $50 per shot. But it was unclear how Medicare should reimburse eye doctors for that use of Avastin. Payment policies varied regionally, though ophthalmologists say their costs for the drug were essentially covered.

Bayer Labels' Cancer-Fighting Claim Draws Suit
A nonprofit group has filed a lawsuit against Bayer Healthcare charging that the company's labels and commercials falsely claimed its One A Day multivitamins for men may reduce the risk of prostate cancer. In the complaint, the Center for Science in the Public Interest charged that Bayer had deceived the group's membership of some 756,000 people who bought the pills under false pretenses. The group asked the court to permanently prohibit Bayer from making prostate claims about its dietary supplements. The lawsuit comes after a large federal study on prostate cancer and certain dietary supplements was halted last year after researchers reported that men taking vitamin E or the trace mineral selenium, or both, had similar rates of prostate cancer as men taking placebo pills.

Methadone Deaths Jump Sharply in Recent Years
A new federal report has underscored the potential danger of methadone, revealing that the number of deaths involving methadone jumped nearly sevenfold from 1999 to 2006. The rise in methadone-related fatalities was faster than increases in deaths from other opioid analgesics - drugs usually prescribed to relieve pain such as OxyContin and fentanyl - and from other narcotics. Overall, poisoning deaths involving all opioid analgesics more than tripled over the seven-year time frame, increasing among all age groups, said the report from the U.S. Centers for Disease Control and Prevention. Methadone is widely known for treatment of heroin addiction, but it has been increasingly prescribed to manage pain. The CDC statistics buttressed a March report by the U.S. Government Accountability Office, which said methadone's growing use for pain management has made more of the drug available, thus contributing to an increase in methadone-related overdose deaths.

Drug Deaths Outpace Car Crashes in More States
Drug-related deaths outnumber those from motor vehicle accidents in a growing number of states, according to new government data that highlight a shift in the top cause of deaths after disease and illness. Crashes still cost more lives nationwide, but state-by-state calculations show the rate of drug-induced deaths outpaced vehicle accidents in 16 states in 2006, up from about a dozen states the year before and eight in 2003. Drug overdoses make up the vast majority of the drug-related deaths, and there was a sharp increase in fatalities tied to cocaine and to drugs known as opioid analgesics - including methadone, fentanyl, sedatives and prescription painkillers like Vicodin and OxyContin. From 1999 to 2006, death rates for opioid analgesics increased for every age group. Deaths from methadone alone increased sevenfold, the U.S. Centers for Disease Control and Prevention said. Based on death certificate data, CDC researchers counted more than 45,000 U.S. deaths from motor vehicle crashes in 2006, and about 39,000 from drug-induced causes. The CDC does not have finalized data for 2007 or subsequent years.

Congress, Concerned About Steroids, Reviews Law On Dietary Supplements
In recent months, federal agents have raided several companies suspected of making bodybuilding products that illegally contain steroids and are sold as over-the-counter dietary supplements. The Food and Drug Administration, meanwhile, has warned consumers not to use products marketed for bodybuilding that contain steroids or steroidlike substances, or that claim to increase testosterone. The agency says users risk liver failure, kidney damage and other serious health problems. Now Congress is investigating whether laws, health agency resources and manufacturing guidelines are adequate to protect the public from products that illegally contain steroids but masquerade as dietary supplements. Under the law, dietary supplements are generally defined as products that contain or are derived from national foodstuffs like minerals or herbs and do not claim to prevent, mitigate or cure specific illnesses. But when products marketed as supplements are found to contain pharmaceutical ingredients like steroids, the federal government considers them misbranded - and unapproved illegal drugs.

Merck Paying More than 3,100 Death Claims in Vioxx Settlement
Merck & Co. is paying claims by the families of more than 3,100 users of its Vioxx painkiller who died of heart attacks or strokes blamed on the drug, according to a law firm administering a $4.85 billion settlement fund. The fund will pay about 3,000 claims for heart attack deaths and at least 122 strokes. Merck introduced Vioxx in 1999 and withdrew it in 2004 when a study showed the drug doubled the risk of heart attacks and strokes. Merck set up the fund, which covers claims of death and lesser injuries, in 2007 after reserving $1.9 billion to fight 26,600 Vioxx suits. "We don't know any drug right now with this number of deaths associated with it," said a Vioxx plaintiffs lawyer who is appealing the reversal of a $256 million verdict against Merck. Merck won 11 of 16 Vioxx suits at trial before agreeing to settle all claims. Under the accord, the facts of each case determine the extent of Merck's liability, which analysts once estimated to be as much as $20 billion overall. The law firm charged with administering settlements had reviewed 48,507 claims so far and has rejected 40 percent of them. Families of heart attack victims who died will get an average payment of about $374,000. Some will get as little as $5,000 and others more than $1.5 million depending on the user's age, how long they took the drug and whether they had health risks associated with obesity or hypertension.

Court Upholds $13 Million Drug Pricing Ruling Against AstraZeneca
A three-judge panel of the 1st U.S. Circuit Court of Appeals found "no material factual or legal infirmity in the district court's disposition of the case" and upheld a ruling ordering AstraZeneca to pay $13 million to a test-case class of Massachusetts third-party payers. The original ruling found that AstraZeneca acted "unfairly and deceptively" by causing the publication of false and inflated prices for its drug Zoladex, exceeding actual physician acquisition costs by as much as 169 percent. AstraZeneca then marketed these mega-spreads between the physician's acquisition costs and the amount they'd be reimbursed for the drug in order to induce doctors to buy and administer Zoladex. One appeal, AstraZeneca argued against the ruling on pre-emption grounds, contending that when Congress enacted the Medicare program, it pre-empted states from regulating drug companies. AstraZeneca also argued that the third-party payers knew about the price spread. The appeals court, however, didn't buy the arguments.

Health Concerns Over Popular Contraceptives
The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer Healthcare, largely as a result of marketing that presents them as much more than mere pregnancy prevention. Yaz, in particular, the top-selling birth control pill in the United States, owed much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a quality-of-life treatment to combat acne and severe premenstrual depression. Yaz, a newer sister to Yasmin, contains less estrogen. The franchise had worldwide sale of about $1.8 billion last year, based on Bayer's successful positioning of Yasmin and Yaz as the go-to drug brands for women under 35. But recently, the Yaz line's image has been clouded by concerns from some researchers, health advocates and plaintiffs' lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do. The FDA early this year asked Bayer to correct misleading television commercials. Last month, the agency cited the company for not following proper quality control procedures at a plant that makes hormone ingredients.

FDA Reveals It Fell to Push by Lawmakers
The FDA said that four congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting. The agency's scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation. But after receiving what an FDA report described as "extreme, unusual" and persistent pressure from four Democrats from New Jersey, agency managers overruled the scientists and approved the device for sale last year. All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey. The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

Wyeth Sues FDA Over Generic Drug
Drugmaker Wyeth sued regulators at the U.S. Food and Drug Administration in an attempt to block the sale of a recently approved generic version of its intravenous antibiotic Zosyn. In the complaint, the company alleges that the generic is not an equivalent product and could harm critically ill patients. Zosyn is an intravenous treatment for bacterial infections. Wyeth claims the drug version that the FDA approved recently for manufacture by India's Orchid Chemicals & Pharmaceuticals is based on an old formulation of Zosyn. The old version reacts with a standard IV solution when they are both administered through the same IV line. The reaction inactivates the antibiotic, limiting the dosage patients would get. Wyeth is seeking a temporary restraining order and a preliminary injunction to block Orchid from selling its version of Zosyn.

Defendant Asserting Zoloft Defense Found Guilty of Assault
A New York jury rejected a defendant's claim that withdrawal from the antidepressant Zoloft had driven him to beat his girlfriend. After deliberating for three hours, the jurors found him guilty of third-degree assault. The defendant claimed that his girlfriend had urged him to go off the prescription antidepressant before the 2006 altercation. An expert witness for the defense testified that a "small minority of individuals who take Zoloft could experience side effects that include violent acting out." The prosecution countered with an expert who testified that there was no scientific evidence linking Zoloft withdrawal with increased aggression.

In Lust for Lashes, Few Bat an Eye at Odd Risks
Latisse, Allergan's FDA-approved eyelash-enhancing treatment, was given the green light in 2008 as a treatment for hypotrichosis of the eyelashes, or sparse eyelashes. The prescription drug has inspired disbelief, devotion and at least one major lawsuit. Latisse was also recently sent a letter from the FDA stating that its promotional materials posted on the product's Web site were "misleading because they omit or minimize risks associated with Latisse." Among the risks, the FDA notes, is that the active ingredient can cause hair to grow in other places besides the lash area, cause inflammation of the cornea and can make lighter-colored eyes turn brown. Even before the FDA warning, the treatment provoked much discussion and debate. On one side of the aisle are those concerned about safety and the product's high price tag. On the other, Latisse-lovers who are willing to pay the price for long, lush lashes.

Jury Weighs Conflicting Opinions On Link of Zoloft Use to Violence
Jurors in the assault trial of a New York man will have to weigh the drastically different opinions of two Harvard-educated psychiatrists to determine whether the popular antidepressant Zoloft can trigger a violent episode. The man is facing misdemeanor assault charges for allegedly beating his girlfriend and preventing her from leaving his home in 2006 after she refused to have sex with him. He claims he was going through Zoloft withdrawal at the time and did not intend to assault the woman. The prosecution's expert repeated his opinion that no generally accepted scientific evidence supports the defendant's claims. He also testified that since Zoloft first entered the market in 1992, 9 million people have been prescribed the drug and only 50,000 adverse events have been reported. However, the defense expert testified that a "small minority of individuals who take Zoloft could experience certain side effects and that includes violent acting out." He told the jury that Zoloft could cause "the precursors to violence," including aggression and impulsivity. He also admitted that he had conducted no experimental research or scientific tests in reaching his opinion. Instead, he said he had interviewed the defendant and reviewed medical literature, "re-read the Zoloft label" and had done "a lot of online study."

Pfizer Lawyers Say Plaintiffs Guilty of Witness Intimidation in Neurontin Litigation
Just a month after Pfizer came under fire for allegedly using strong-arm tactics against a potential key witness in the multidistrict litigation over its Neurontin anti-seizure medication, the pharmaceutical giant lodged a similar complaint against a plaintiffs expert. In a 12-page brief, Pfizer accused a twice-sanctioned doctor-consultant of attempting to coerce favorable testimony from one of the physicians who treated the alleged victim in the case. The brief asserts that he sent a letter to a psychiatrist who treated the plaintiff, a Neurontin patient who killed himself in 2002, providing her with a confidential internal Pfizer e-mail and other documents intended to sway her testimony. The attorney who represents about 600 plaintiffs in the Neurontin litigation also lobbed witness intimidation allegations against a Pfizer investigator in the first Neurontin case to go to trial.

FDA Warns About Eyelash Thickener Claims
The Food and Drug Administration has warned Allergen Inc. that the Web site for its eyelash thickener Latisse is misleading because it avoids or downplays risks associated with the product. The agency says the site either doesn't mention potential side effects including bacterial eye infection, allergic reactions, excess hair growth outside the intended treatment area, and permanent changes in iris and eyelid pigmentation, or presents them in small text that is much less prominent than statements about the product's effectiveness. The drug is approved to make eyelashes thicker, fuller and darker. The FDA approved it for use last year. In some cases, pages on the Web site leave out information that is included in Latisse packaging.

FDA Warns Injectable Drug Can Cause Gangrene
The Food and Drug Administration said makers of the antihistamine and anti-nausea drug promethazine have to warn consumers over the potential risk of tissue injuries including gangrene if the injectable drug is administered incorrectly. The FDA is requiring companies to include a warning on the drug's label to state that it should not be administered into an artery or under the skin because of the risk. There is also a risk that they drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. The drug should be injected deep into a muscle. Also, a requested revision to the label process that if health care professional choose to administer promethazine intravenously, they should limit the drug's concentration and rate of administration.

Judge Likely to Accept Pfizer's Agreement in $2.3 Billion Case
At a hearing on Pfizer's $2.3 billion plea agreement with the Department of Justice, a Boston federal judge said he'll probably accept the company's sweeping compliance agreement with the U.S. Department of Health and Human Services in lieu of probation. The plea agreement is to settle charges that the company illegally promoted off-label drug use. Pfizer marketed the painkiller Bextra, which was approved only for specific uses such as arthritis pain, for acute pain following surgery. The company also illegally promoted off-label uses for the anti-psychotic drug Geodon, the antibiotic Zyvox and the anti-epileptic drug Lyrica. The judge grilled the attorneys on both sides about the corporate integrity agreement Pfizer and its lawyers signed with the HHS. He wanted more details about Pfizer's obligations under the agreement and the U.S. Attorney's Office's opinion about probation in the case.

Antidepressant Withdrawal Blamed for Assault
A New York man flew into a rage and beat his girlfriend when she refused sex. However, his attorneys argue that the attack was caused by his withdrawal from the prescription antidepressant Zoloft. His attorney claims he wasn't taking the drug any longer because his girlfriend asked him to stop. Prosecutors, meanwhile, argue that he repeatedly punched and kicked his girlfriend. Instead of taking her to a hospital, he tried to convince her to speak with his relatives and "make a plan" to avoid charges. The defense's expert witness is a graduate of Harvard Medical School who has testified that some people who take antidepressants like Zoloft may suffer "significant side effects," including agitation, excessive aggression and grandiosity.

Fines Unlikely to End Off-Label Drug Marketing
Pfizer was slapping with a record $2.3 billion in fines for illegally marketing some drugs, but critics say even that eye-popping total is unlikely to end the sometimes dangerous practice of promoting drugs for unapproved uses. The penalty pales compared to the billion dollars or more in annual revenue that blockbuster drugs generate, and new government guidelines stir worry that the marketing of medicines for unapproved uses will become easier. Off-label marketing is a tricky issue. Doctors say prescriptions for uses not noted on a drug's package label - the fine-print insert that comes with the prescription - play a crucial role in treating patients, especially those with deadly illnesses and few treatment options. However, the FDA prohibits companies from promoting their drugs for uses it has not approved.

Document Details Plan to Promote Costly Drug
The pharmaceutical industry has developed thousands of medicines that have saved millions of lives, but it has also used its marketing muscle to successfully peddle expensive pills that are no more effective than older drugs sold at a fraction of the cost. No drug better demonstrates the industry's salesmanship than Lexapro, an antidepressant sold by Forest Laboratories. A document quietly made public recently by the Senate's Special Committee on Aging demonstrates just how Forest managed to turn a medicinal afterthought into a best seller. The document, "Lexapro's Fiscal 2004 Marketing Plan," is an outline of the many steps Forest used to make Lexapro a success. The document makes clear that one of the principal means by which Forest hoped to persuade psychiatrists, primary care doctors and other medical specialists to prescribe Lexapro was by finding many ways to put money into doctors' pockets and food into their mouths. Earlier this year, federal prosecutors in Boston announced a civil lawsuit against Forest claiming that the company illegally marketed both Lexapro and a closely related antidepressant, Celexa, for use in children and paid kickbacks to doctors to induce them to prescribe the medicines to children. It is illegal to pay doctors to prescribe certain medicines to their patients. It is not illegal to pay doctors to educate their colleagues about a medicine. In recent years, federal prosecutors have accused many drug makers of deliberately crossing that line.

First Amendment Lawyer Says Drug Companies Also Have Speech Rights
A Miami Attorney says more industries are finding it worthwhile to their bottom line to sue the government, claiming their right to free speech has been compromised. The First Amendment lawyer is lead counsel in two cases that center on often-maligned industries looking to protect their First Amendment interests. He represents three data brokers suing Maine, Vermont and New Hampshire, which ban the sale of pharmacy information listing doctors and the medicines they prescribe. The trade group, PhRMA, was a party in Vermont and an amicus in Maine and New Hampshire. He also represents the Florida Association of Professional Lobbyists and others, arguing Florida's 2005 disclosure requirement on "indirect lobbying" - often referred to as grassroots lobbying - is unconstitutional. Whether a lobbyist or a pharmaceutical company, more businesses are pressing their constitutional claims than ever.

Stolen Insulin Poses Health Risks
The Food and Drug Administration is warning consumers to avoid certain vials of insulin made by Novo Nordisk that were stolen earlier this year and may not be safe for use. The agency said that the vials may not have been stored properly and could be dangerous to consumers. The FDA has received three reports of patients who suffered unsafe blood sugar levels after using the products. The FDA issued an alert earlier this year after three lots of Novo Nordisk's Levemir insulin were stolen during shipment through North Carolina. Regulators say only about 2 percent of the 129,000 vials have been returned.

Zoloft Experts to Debate Effect of Drug On Assault
A man claiming the antidepressant Zoloft caused him to beat up his ex-girlfriend may tap an expert witness to back up his defense, a state judge has ruled. But the judge also held that an expert witness for Pfizer, the maker of Zoloft, may take the stand in rebuttal. Prosecutors had moved to reargue a bench ruling made by the judge earlier this year, allowing defense experts to testify about possible behavioral side effects caused by taking mood-altering drugs like Zoloft. The defendant claims his actions were caused by "side effects or withdrawal" from Zoloft. Seeking to limit that defense, prosecutors had argued that theories about Zoloft's potential negative side effects had not gained "general acceptance in the scientific community" and should be excluded.

Rare Side Effect Seen from Breast Cancer Drug
A new report suggests that a drug widely used to prevent the recurrence of breast cancer may have a rare but dangerous side effect, increasing the odds that long-term users may develop an uncommon but aggressive new tumor. But medical experts were quick to question the significance and methodology of the study, saying clinical trials had repeatedly found that the drug, tamoxifen, reduced the recurrence and spread of common breast cancers and that its benefits exceeded any possible risks. Even the author of the report, which is based on an observational study and not the kind of randomized, controlled clinical trial considered the gold standard in medicine, said the findings should not affect practice because the drug's benefits were well established.

Study Finds Risk in Off-Label Prescribing
Physicians are allowed to use drugs in ways that are not specifically approved by the Food and Drug Administration, a practice called off-label prescribing. There is usually less scientific evidence to support nonapproved uses, and a new survey of physicians has found that many might not even know when they are prescribing off label. The average physician in the survey identified the FDA approval status correctly for only about half the drugs on a list provided by the researchers, according to a study. Confusion was greatest with psychiatric drugs, the survey of some 600 doctors found. Nearly one in five who prescribed Seroquel in the previous year thought it was approved for patients with dementia and agitation, even though it was never approved for this use and even carried a "black box" warning that it was dangerous for elderly patients with dementia. And one in three doctors who used lorazepam to treat chronic anxiety thought it had been approved for this use; in fact, the FDA warning advises against using it for this purpose.

ADHD Drug Abuse Calls Flood Poison Centers
Calls to poison control centers about teens abusing attention-deficit drugs soared 76 percent over eight years, sobering evidence about the dangerous consequences of prescription misuse. The calls were from worried parents, emergency room doctors and others seeking advice on how to deal with the problem, which can be deadly. Four deaths were among cases evaluated in a study. Kids taking ADHD drugs to get high or increase alertness may not realize that misuse of the drugs can cause serious, sometimes life-threatening symptoms, including agitation, rapid heart beat and extremely high blood pressure. In the study, researchers evaluated data from the American Association of Poison Control Centers from 1998 to 2005. During that time, nationwide calls related to teen abuse of ADHD drugs, specifically stimulants, increased from 330 to 581 yearly, and there were four deaths. Overall, 42 percent of teens involved had moderate to severe side effects and most ended up getting emergency room treatment.

Rare Pharmaceutical Fraud Trial Under Way in San Francisco
The former CEO of biotech firm InterMune concocted a press release that made false statements about the efficacy of his company's star drug, claimed the prosecutor in a rare pharmaceutical fraud case. She also contends that while the CEO had ample opportunity to correct his behavior, instead he concealed it. Yet his attorney maintained that everything his client asserted in the press release was true and that he never would have embarked on the clinical trial discussed in the press release if all he cared about were profits. The FDA approved InterMune's drug Actimmune to treat two rare childhood diseases, but InterMune also sought to market it to patients suffering from idiopathic pulmonary fibrosis, a lung disease that occurs far more frequently. In 2002, InterMune issued a press release trumpeting the clinical study that supposedly showed benefits for some IPF patients. However, the government contends the company grossly misstated the data and directly contradicted guidance CEO had just received from the FDA. The CEO left the company in 2003 and by 2006 the company had entered into a deferred prosecution agreement with the Justice Department. Because the government rarely prosecuted individual health care executives for fraud, attorneys involved in the case believed the company's deal would effectively end the probe. But the investigation continued and the CEO was indicted in 2008 on a count of wire fraud and felony misbranding of a drug each.

Study Weighs Risks of Vaccine for Cervical Cancer
The new vaccine designed to protect girls and young women from cervical cancer has a safety record that appears to be in line with that of other vaccines, but some serious complications have occurred, including at least 20 deaths and two cases of Lou Gehrig's disease. The most common serious complications after vaccination with Gardasil were fainting episodes and an increased risk for potentially fatal blood clots, possibly related to oral contraceptive use and obesity. The vaccine has been given to more than seven million girls and young women nationwide and there is no way to prove that complications came from the vaccine. But while the study was reassuring, the authors noted that the analysis was based on imperfect data drawn from reports made to a voluntary government surveillance database. The majority of adverse event reports were filed by Merck & Company, the vaccine's manufacturer, and most failed to provide enough information for further investigation.

Judge Upholds Merck Patent on Blockbuster Allergy Drug Singulair
The patent for Merck's blockbuster allergy and asthma drug is valid, a federal judge ruled, handing the drugmaker a crucial victory in its two-year legal battle to block a rival from selling a generic cheaper version. A judge upheld the patent for Singulair, which as Merck's top-selling drug provides about one-sixth of its annual revenue. The judge also issued an injunction that prevents Israel's Teva Pharmaceuticals from selling generic Singulair, a long-term drug to prevent asthma and allergy flare-ups, in the U.S. until the patent expires in August 2012.

Judge Says Medicare Did Not Misapply Rules Reimbursing Baxter's Drug Below Costs
A judge has ruled that Baxter International Inc. is not entitled to a higher Medicare reimbursement price for its hemophilia drug Advate. Baxter said Medicare and Medicaid reimbursement payments for Advate were less than the drug's sale price, which passed the cost on to physicians and discouraged them from using the product. It asked the Centers for Medicare and Medicaid Services to reclassify the drug so reimbursements would increase, and filed a lawsuit when those requests were turned down. Drugs are reimbursed at a higher rate if Medicare can get them from only one company, or if they are biotech drugs. Baxter said that described Advate because it is a biologic product, and at the time it was approved, it was the only hemophilia drug that had no added plasma proteins from humans or animals, meaning it cannot lead to accidental contamination with diseases like HIV or West Nile Virus. Baxter said that made the drug different from other hemophilia treatments. Medicare said Advate was grandfathered into the "multiple source drug" category because it reached the market in August 2003, only two months before a change in its reimbursement rules. Single-source and biologic drugs approved before October 2003 are reimbursed like multiple source drugs if there were similar products on the market at that time. The judge wrote that there is nothing legally wrong with Medicare's interpretation of its rules. He said the situation is unfair, but the complaint is with Congress, not Medicare.

Polio Vaccine Blamed for Outbreaks in Nigeria
Polio is spreading in Nigeria and health officials say in some cases it's caused by the vaccine used to fight the paralyzing disease. In July, the World Health Organization issued a warning that this particular virus might extend beyond Africa. So far, 124 Nigerian children have been paralyzed this year, about twice those afflicted in 2008. Nigeria and most other poor nations use an oral polio vaccine because it's cheaper, easier and protects entire communities. But it's made from a live polio virus which carries a small risk of causing polio. In even rarer instances, the virus in the vaccine can mutate into a deadlier version that ignites new outbreaks. A virologist with the U.S. Centers for Disease Control and Prevention says genetic analysis proves such mutated viruses have caused at least seven separate outbreaks in Nigeria.

No Mercury in Most Children's Vaccines
After hearing the warnings about the mercury we ingest when eating fish and how toxic heavy metals are, it might seem like a bad idea to use mercury in vaccines that are injected into the human body. But scientists say that the mercury used with some vaccines, known as ethyl mercury or thimerosal, is much different than the methyl mercury that comes from fish. Methyl mercury can accumulate in body tissue. At high levels it has been shown to cause such mercury poisoning symptoms as tremors, muscle weakness, memory loss and hypersensitivity to light. But researchers have found no evidence that ethyl mercury in vaccines causes such problems, and they have found no link between thimerosal and autism, despite persistent arguments by some parents of autistic children that there is a connection.

FDA Backs Drugmaker Mylan's Plant Probe
The FDA announced that its investigation into alleged problems at generic drugmaker Mylan's manufacturing plant in West Virginia found no deficiencies. "Our inspection found that the firm appears to have conducted an adequate investigation, and we did not find evidence that the lack of adherence to the standard operating procedures resulted in adverse impact to the affected product lots," the FDA said, adding that it had no evidence that data had been deleted and that audit trails were intact for each instance in which computer software was overridden by an operator. The investigation of Mylan was triggered by an internal report that said workers sidestepped computer-generated warnings about potential problems with medications being produced. Quality of medications, however, were never an issue.

Medications Pose High Poisoning Risk for Children
Parents may want to lock the medicine cabinet as well as the cabinet under the sink. A new study from the Centers for Disease Control and Prevention has found that more than twice as many children are accidentally poisoned with prescription or over-the-counter medicines as with household consumer products. The researchers estimate that more than 70,000 children under 18 visit emergency rooms yearly suffering from unintentional medication overdoses, compared with about 30,000 for poisonings and other products. Most of the affected children have ingested medicines without the parents' knowledge, but 8 percent of emergency room visits and 14 percent of hospitalizations were the result of parents accidentally overdosing their offspring. More than 75 percent of the medication overdoses were in children under 5.

Patients Reminded of Aspirin's Risk
Cheap, ubiquitous aspirin has long been known for health benefits from basic pain relief to heart attack prevention. But after a new study provided tantalizing evidence suggesting that aspirin might increase survival chances for colorectal cancer patients, experts were quick to warn that the drug, a medicine cabinet staple, also had its risks. Medical experts cautioned against starting a daily regimen of aspirin without consulting a physician, because of the risks of gastrointestinal bleeding and the potential risk for hemorrhagic strokes or bleeding in the brain. The study found that patients with colorectal cancer who were regular aspirin users had a much better chance of surviving than non-users, and were almost one-third less likely to die of the disease, while those who began using aspirin for the first time after the diagnosis cut their risk of dying by almost half.

Merck Readies for First Fosamax Trial
Merck & Co. is slated to fight the first numerous U.S. lawsuits brought by patients who claim they suffered jaw damage from the company's widely used Fosamax treatment for osteoporosis. Some 1,280 plaintiff groups, involving almost 900 cases, have alleged jaw problems due to Fosamax, a one-time blockbuster product that recently began facing competition in the United States. A judge will hear arguments from a 71-year-old Florida plaintiff who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006. Merck claims the plaintiff's medical problems were not caused by Fosamax.

Did Pfizer Intimidate Key Witness On Eve of Neurontin Trial?
Did Pfizer, the world's largest pharmaceutical company, cross the line on the eve of last month's crucial test trial involving its controversial anti-seizure medication Neurontin? Two weeks after the trial abruptly ended with the plaintiffs agreeing to dismiss their case with prejudice, questions linger about why Pfizer sent a former CIA agent and private investigator to the home of a whisteblowing scientist the day before he was scheduled to testify. The scientist told reporters that he and his family felt harassed and intimidated by the Pfizer investigator's appearance at their home and are still shaken by the event. The judge overseeing the Neurontin multidistrict litigation issued a restraining order instructing Pfizer and the investigator to stay away from the scientist and his family. Pfizer has apologized to the court for the incident, but maintains that the scientist exaggerated the facts "to attract negative media attention to Pfizer." Pfizer claims its investigator followed standard protocols and was not hostile or threatening to the scientist or his family.

With High-Profile Death, Focus on High-Risk Drug
Propofol is a high-risk that Michael Jackson was given before he died. While Jackson's apparent method of using the drug was unusual, researchers and addiction experts say propofol abuse is growing, particularly among those with medical access. Some experts say propofol abuse is spreading because unlike many prescription drugs, it is not a federally controlled substance. A 2007 survey of the country's 126 anesthesiology resident training programs found that 71 percent did not secure it in a pharmacy or track its dispensing. Two years ago, a petition urged the Drug Enforcement Administration to restrict it as a controlled substance. A spokesman for the agency said it was still evaluating whether potential abuse outweighs the benefits of easy accessibility for doctors.

Warning from FDA on Arthritis Drugs for Young Patients
Federal regulators added stronger warnings to a group of best-selling drugs used to treat arthritis and other inflammatory diseases, saying they can increase the risk of cancer in children and adolescents. After more than a year of review, FDA scientists said the drugs appeared to increase the risk of cancer after they were used for more than two and a half years. The agency studied several dozen reports of cancer, some fatal, in children taking the drugs. Half of the cases were lymphomas, a cancer that attacks the immune system. The FDA will bolster the "black box" warning on the five drugs sold in the United States.

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