Pharma Misbehaving

Media consumers, beware: that assertive, well-versed, trustworthy "expert" may in fact be an industry shill, Shannon Brownlee and Jeanne Lenzer write on Slate. Journalists across the board, and even some radio hosts, are failing to disclose financial ties to various industries—drug companies being a prime example—fudging the line between considered opinion and paid advocacy. More »

A congressional panel will examine three ad campaigns as part of a move to tighten regulations on drug companies' direct-to-consumer marketing, the Wall Street Journal reports. The committee will focus on ads for cholesterol drugs Vytorin and Lipitor, and anemia drug Procrit, which has been promoted as an anti-fatigue drug despite FDA demands not to do so. More »

The Food and Drug Administration repeatedly approved experiments using artificial blood despite data showing the products to be dangerous, the Washington Post reports. Investigators from the National Institutes of Health found heart attack risk tripled and death increased by 30% for subjects in 16 studies testing five kinds of artificial blood, which, it is hoped, will ultimately provide alternative transfusions. More »

The FDA has traced a contaminated blood thinner from a Chinese factory to 11 countries, the New York Times reports. Severe reactions to the contaminated heparin have been linked to the deaths of 81 Americans, but it wasn't immediately clear if the drug may have triggered fatalities in other countries. Chinese officials have denied that the contamination caused any deaths and have demanded to be allowed to inspect the US plant where the heparin was packaged. More »

Merck used its own ghostwriters to draft articles minimizing risks of its drug Vioxx, then found medical researchers to lend their names to the research, the Wall Street Journal reports. Merck, which pulled the painkiller from shelves four years ago over heart-attack risks, rejects the claims as "misleading." They appear in tomorrow's edition of the Journal of the American Medical Association . More »

Merck's "minutes" of a meeting of heart doctors discussing cholesterol drug Vytorin were created a month after the meeting and distorted the viewpoints of the experts, one panel member changes. The drug company submitted the document to congressional investigators probing its two-year delay in releasing a report saying the drug didn't work any better than a much cheaper generic one, Bloomberg reports. More »

Johnson & Johnson doctored data to get its birth control patch FDA-approved, according to a class action lawsuit that claims Ortho-Evra caused blood clots, heart attacks, and strokes. A J&J scientist allegedly doctored the data with a "correction factor" for the FDA, lowering estrogen-related risk by 60%: He "presented a truly misleading picture of the amount of estrogen delivered by the patch,'' the suit said. More »

A scientist hired by two drug companies to conduct trials of cholesterol-lowering drugs accused the firms of deliberately delaying release of the results, the New York Times reports. The results for the Vytorin and Zetia trials—which showed the drugs don't work to reduce plaque in arteries—were not released until almost two years after the medical trials wrapped up.  More »

The Food and Drug Administration has identified the extra ingredient found in samples of Baxter’s blood-thinning drug heparin, the Wall Street Journal reports today. Some batches of the drug—recalled in January after reports of allergic reactions—contained over-sulfated chondroitin sulfate, but it is not certain that was the cause of the hundreds of reactions or 19 deaths linked to Baxter’s product. More »

Despite rigorous testing, some drugs have side effects that only rear their ugly heads when introduced to the general population. Forbes catalogs some of the weirdest: Anti-smoking drug Chantix can cause insomnia and nightmares. Diet drug Alli can have unforeseen gastrointestinal side-effects; these can be counteracted by eating a low-fat diet , of all things. Mirapex, prescribed for Parkinson's and restless-leg-syndrome patients, can lead to compulsive-eating and gambling urges. More »

Baxter International has expanded its recall of heparin products as the FDA said the number of deaths possibly linked to the blood thinner rose from 4 to 21, the New York Times reports. The agency said it found "deficiencies" at a Chinese plant that supplied the active ingredient. Baxter, which produces about half of the nation's supply, has now recalled virtually all of its heparin products. More »

Big Pharma swallowed a bitter pill yesterday as Prozac and other antidepressants were found in a UK study to be largely ineffectual in all but the most extreme cases of depression. The meta-analysis of 47 clinical trials submitted to the FDA with licensing applications for six popular antidepressants concluded that they should be prescribed only when all other treatments fail to yield results, the Independent reports. More »

Pfizer said today it will drop its ads for cholesterol drug Lipitor due to criticisms of the TV spots, the New York Times reports. US lawmakers recently probed whether the campaign had inflated the credentials of artificial heart developer Dr. Robert Jarvik. "The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to mis-impressions and distractions," said Pfizer president Ian Read. More »

Drug companies have slapped a series of huge price hikes on some prescription drugs ahead of drug patent expirations, the Wall Street Journal reports. GlaxoSmithKline has raised the price of antidepressant Wellbutrin 44.5%, while Sanofi-Aventis hiked Ambien's price 70%. Wholesale prices for the top 50 drugs increased an average of nearly 8% last year. More »

The Chinese facility that supplied the active ingredient of the blood-thinner heparin, linked to hundreds of adverse reactions and four US deaths, was never inspected by the FDA because the agency confused it with another plant of the same name, the Washington Post reports. The company was given approval based on an earlier FDA inspection of the other factory. "The wrong firm was put into the database," said the FDA's deputy director. More »

A prominent researcher who revealed widespread fatalities associated with the heart surgery drug Trasylol says 22,000 people died because of the FDA's delay in blowing the whistle on the drug after his study was published. Drugmaker Bayer also failed to disclose negative results of its own study. In a 60 Minutes interview to air Sunday, Dr. Dennis Mangano says the FDA waited more than a year to pull Trasylol—until after it was banned in Germany. More »

The active ingredient in a drug linked to four deaths and hundreds of adverse reactions in the US has been traced to a Chinese factory which has never been inspected by the FDA, reports the Wall Street Journal . The drug is a blood-thinner made by Baxter International, a   version of the generic drug heparin, which is used in heart surgery and dialysis to prevent blood from clotting. Baxter has halted production of the drug. More »

Drug company Merck will dish out $650 million to resolve lawsuits and probes into marketing schemes, the Wall Street Journal reports. Central to the investigations is the company’s “nominal pricing,” which slashed some drug prices by 90% for hospitals but hid the discounts from Medicaid, even though federal law demands that drug companies offer the government program their lowest prices. More »

Taking epilepsy medication can double risk of suicidal behavior, the San Francisco Chronicle reports. Results of a government study showed the increased risk for 11 specific drugs, including Pfizer’s Neurontin and Lyrica, but the Food and Drug Administration warned that the findings probably apply to all epilepsy medications. Labels for the drugs will be changed to reflect the risks. More »

Drug-maker Eli Lilly could pay more than $1 billion to state and federal authorities to settle an investigation into how the company marketed an antipsychotic drug, the New York Times reports. In 2000-03, Lilly pushed doctors to prescribe Zyprexa as a treatment for age-related dementia—though the drug is approved to treat only schizophrenia and bipolar disorder. More »