The FDA Has Failed (Again) To Protect America

For decades, large corporations have repeatedly misled, lied, or unduly influenced the FDA. In so doing, the FDA betrayed the trust bestowed upon them by the American public.

Ghostwriters Used in Vioxx Studies

Vioxx was a best-selling drug before Merck pulled it from the market in 2004 over evidence linking it to heart attacks. Last fall the company agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.

The lead author of Wednesday’s article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry’s published research, because the ghostwriting practice appears to be widespread.

“It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” Dr. Ross said, whose article, written with colleagues, was published Wednesday in JAMA, the journal of the American Medical Assocation.

Merck Agrees to Pay $4.85 Billion in Vioxx Claims

Three years after withdrawing its pain medication Vioxx from the market, Merck announced today that it will pay $4.85 billion to settle 27,000 lawsuits by people who contend they or their family members suffered injury or died after taking the drug.

The settlement, one of the largest ever in civil litigation, comes after nearly 20 Vioxx civil trials over the last two years from New Jersey to California. After losing a $253 million verdict in the first case, Merck has won most of the rest of the cases that reached juries, giving plaintiffs little choice but to settle.

The settlement will help put Vioxx behind Merck, as well as sharply reduce its Vioxx-related legal defense fees, which are now running at more than $600 million annually.

Judges in Louisiana, New Jersey and California, who oversee nearly all the lawsuits, had pressed for a deal before a new wave of trials was scheduled to begin in January.

Plaintiffs will receive different settlement payments depending on the severity of their injuries and the length of time they took Vioxx. The deal becomes binding only if 85 percent of all plaintiffs agree to drop their cases and take the deal.

Based on the fact that the 27,000 suits cover about 47,000 sets of plaintiffs, the average plaintiff will receive just more than $100,000 before legal fees and expenses, which usually swallow 30 percent to 50 percent of payments to plaintiffs. Plaintiffs who do not want to accept the settlement can pursue their own claims, but with so many of the top trial lawyers in the United States agreeing to the deal, they may have difficulty doing so.

Merck Agrees to Settle Vioxx Suits for $4.85 Billion

Three years after withdrawing its pain medication Vioxx from the market, Merck has agreed to pay $4.85 billion to settle 27,000 lawsuits by people who claim they or their family members suffered injury or died after taking the drug, according to two lawyers with direct knowledge of the matter.

The settlement, one of the largest ever in civil litigation, comes after nearly 20 Vioxx civil trials over the last two years from New Jersey to California. After losing a $253 million verdict in the first case, Merck has won most of the rest of the cases that reached juries, giving plaintiffs little choice but to settle.

The settlement will help put Vioxx behind Merck, as well as sharply reduce its Vioxx-related legal defense fees, which are now running at more than $600 million annually.

Judges in Louisiana, New Jersey and California, who oversee nearly all the lawsuits, had pressed for a deal before a new wave of trials was scheduled to begin in January.

The agreement could still collapse, though lawyers with knowledge of the deal said that was unlikely. The deal becomes binding only if 85 percent of all plaintiffs agree to drop their cases and take the deal.

Plaintiffs will receive different settlement payments depending on the severity of their injuries and the length of time they took Vioxx.

Conflicted Safety Panel Let Vioxx Study Continue

In 2004, Merck pulled its painkiller Vioxx from the market. The drug was causing heart problems, strokes and deaths among patients in a large study that was under way at the time. Merck stopped the study early when those results became clear. Thousands of former Vioxx patients and their families are suing the company.

Now, documents obtained by NPR show that five years earlier, in 1999, during another large Vioxx study, patients had similar heart problems. But that study was not stopped.

Q&A: Monitoring Patient Safety

To learn more about data safety monitoring boards and their role in protecting patients who participate in drug studies, NPR turned to statistician David DeMets.

He says the current watchdog system is a good one, but that there are practical limits on the extent to which drug safety can be monitored.

Read the Q&A. June 8, 2006

During those five years, millions of Americans took Vioxx. And a Food and Drug Administration scientist has estimated that some 38,000 people who took the drug died.

Q&A: Vioxx Health Risks

Independent analysis of data sent to the FDA show that the cardiovascular risks from Vioxx begin shortly after a patient starts taking the drug. The data also indicate that the risks from Vioxx remain long after patients stop taking the drug.

NPR Health Editor discusses what’s known about Vioxx’s health risks. May 18, 2006

NPR’s Snigdha Prakash reports on why the earlier study wasn’t stopped and the public warned that Vioxx was unsafe.

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