Vioxx Case puts Spotlight on FDA Drug Approval Process

posted on:
March 23, 2007

author:
Staff

Drug maker Merck studied its blockbuster painkiller Vioxx well beyond the minimum federal requirements. At all times, the pharmaceutical giant says, it was in contact with the Food and Drug Administration.

During the last three weeks, court testimony from Merck scientists and a company vice president has painted a picture of a dutiful corporation that followed the letter of the law while trying to develop an arthritis remedy. Nonetheless, the recall of the drug in 2004 and warning flags raised by some scientists years earlier about the potential heart risks from Vioxx have led to more than 27,000 lawsuits against Merck.

The latest Vioxx trial, this one in Madison County, is over whether the drug contributed to the fatal heart attack of 52-year-old Granite City woman. Plaintiff lawyers have claimed Merck never adequately informed the public of risks and tried to quash dissension in the scientific community. The company insists it followed federal regulations and has vowed to fight each and every lawsuit.

Nationwide, litigation over Vioxx has essentially called the question on the FDA. Though the jury is expected this week to decide the Madison County case, the larger battle over the regulatory agency one that will be waged in Congress is just starting.

Multiple bills in the Senate and House could revamp the way the FDA does business from reorganizing offices to drastically beefing up studies of drugs after they’ve been approved for sale. Also Congress must deal with the agency’s funding plan which for 15 years has taken billions of dollars from the pharmaceutical industry to pay for negotiated approval procedures. That plan expires this year.

Activists who want major changes say this could be a pivotal year.

“The Vioxx story, the fact that there hasn’t been a long-term commissioner at the FDA in years, government studies criticizing the agency, the overall concern that the FDA has been inappropriately interfered with, all of this has raised serious questions about the capability of the FDA,” said Dr. Susan Wood, a research professor at George Washington University’s School of Public and Health Services. “It’s a perfect storm here.”

Agency history

The FDA is one the largest regulatory arms of the federal government. It has responsibility for the safety of food, dietary supplements, drugs, medical devices and even cosmetics. Yet the agency has routinely struggled with a budget that many consider woefully small.

In 1992, Congress came up with a new funding mechanism where the pharmaceutical industry negotiated fees now hundreds of millions of dollars annually in exchange for a quicker drug approval process. Corporations like Merck had been waiting an average of almost three years for drug approvals.

With the new funding plan, approval time was greatly reduced. It took the FDA roughly a year to approve Vioxx. Other drugs could be pushed through in six months.

But critics say a system where drug companies pay for and negotiate with the agency that regulates them tilts in favor of the corporations and against public safety. Reform advocates routinely note Vioxx’s history, detailed the in Madison County trial, as a case study in why the agency needs reform.

The drug went through more than 100 studies from its conception in the early 1990s until its approval by the FDA in 1999. It first faced trial in animals, then healthy humans, and then the people it was meant to treat.

Merck designed and paid for most studies, but prior to approval none of the studies tested effects longer than 18 months. The drug was recalled only after Merck halted a trial in 2004 that indicated Vioxx did sharply increase heart risks when compared to a placebo after long-term use.

Merck says the FDA was kept abreast of its Vioxx studies. The company at one point even needed a large truck to deliver volumes of data. But one clinical trial in particular is repeatedly referenced by critics as a disregarded warning sign.

In 2000, Merck received the results of a clinical trial of more than 8,000 patients comparing Vioxx to older painkiller Naproxen. The study showed that Vioxx’s heart risk was significantly higher than Naproxen’s, and the company quickly and repeatedly said that Vioxx wasn’t causing more problems, but that Naproxen was reducing heart risks.

‘Bastards,’ he said

Merck had the results in the spring of 2000, and they were detailed in an article in the New England Journal of Medicine later that year. Two years later, Vioxx’s label was updated to include the information.

The label changes were negotiated between the FDA and Merck. At one point, highlighted in court trials, outspoken senior Merck scientist Edward Scolnick called a proposed warning “ugly cubed” and denounced FDA regulators as “bastards.” When notice of the updated label was sent to doctors, it included the new study data as a precaution, but no concrete warning was given implying risk.

“The FDA messed around with the company for two years and only after that put some mild notice, not a warning, about the drug in the label,” said Dr. Sidney Wolfe, head of the Health Research Group for watchdog organization Public Citizen. “That’s just one example of how the FDA is increasingly beholden to the industry.”

Merck officials declined an interview request for this story, but in a statement, the corporation said, “We respect the FDA’s indispensable role in encouraging and regulating the development and marketing of pharmaceuticals.”

Reforms possible

This year, the arguments will likely jump from court to Congress, which must deal with the expiration of the fee system that has driven the FDA’s budget for drug research since 1992.

Possible reforms include reorganizing FDA offices to separate responsibilities for approving drugs and monitoring them after they’ve hit the market. Other legislative answers could be more and longer data reporting requirements, more scientific monitoring independent of the drug companies, and even a public database of clinical data.

The pharmaceutical lobby supports some reforms but worries about politics hampering companies abilities to create medicine, said Alan Goldhammer of The Pharmaceutical Research and Manufacturers of America. On the other hand, Wood said she worries that the debate over fee-based funding and the absolute need to at least come up with some money this year could lead to a hastily compromised reforms.

Both sides also readily admit that the debate is not likely to be permanently resolved this year. Though Vioxx is off the market, new drugs continue to be created.

“People want drugs that have the potential to do good. Vioxx was a part of that,” said Dr. Terry Moore, the head of rheumatology at St. Louis University, who continually monitored Vioxx’s saga. “The question about the FDA’s role, that’s one that probably isn’t going away,”

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