Healthy Skepticism Library item: 18590

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Meyer R
The FDA and drug companies: Too cozy a relationship ?
Pharma Marketer 2010 Aug 14
http://web.archive.org/web/20100817015752/http://www.pharma-marketer.com/the-fda-and-drug-companies-too-cozy-a-relationship/

Full text:

There is an interesting article in this weeks Time Magazine on Avandia and the FDA. At best it paints a picture of an agency too cozy with drug companies, at its worst it suggests that GSK knew the risks of Avandia and was more interested in sales than patient safety. Here are some excepts from the article:
The most recent studies of Avandia, the GSK officials told the FDA, had “yielded information that is inconsistent with an increased risk of myocardial ischemic events,” according to sealed court proceedings obtained by TIME.
What GSK didn’t tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK’s Global Safety Board had noted that a new assessment of Avandia studies “strengthens the cardiac-risk signal observed in the previous analysis.” Or that eight days earlier, the company’s head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an “increased risk of ischemic event ranging from 30% to 43%!” Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group.
After months of deliberation, the agency decided to keep the drug on the market – a move worth billions of dollars to GSK but that also may have put millions of patients at risk.
Such examples of the drug industry’s out maneuvering FDA regulators are disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring. More than 140 million Americans take at least one prescription drug in any given month, and they rely on the FDA to ensure those drugs are safe. That trust, the story of Avandia illustrates, is a gamble.
Over the past two decades, as drug after drug has been recalled after winning FDA approval, it has been hard not to wonder if FDA regulators have been captured by the drug industry.
It relies on drug companies to perform all premarket testing on drugs for safety and efficacy. And it relies on industry “user fees” for 65% of its budget for postmarket monitoring of the drugs it approves, thanks to a 1992 law designed to speed treatments to patients. “The FDA’s relationship with the drug industry is too cozy,” says Senator Chuck Grassley of Iowa.
Federal studies reveal that the FDA doesn’t have a complete or accurate list of prescription drugs on the market and is missing or has incomplete information on one- third of the drug-safety and efficacy trials under way
Over the past three years, the inspector general at the Department of Health and Human Services found that the FDA had inspected only 1% of clinical-trial sites from 2000 to 2005 and lacked financial disclosure data for clinical investigators in half of all industry drug reviews.
Instead of focusing on finding out if Avandia posed a heart risk, SmithKline Beecham was going to run a trial its sales representatives could use to promote the drug. “It was really a marketing study,” says Misbin now. But later that day, Dr. John Jenkins, the FDA’s director for new drugs, accepted SB’s proposal for testing the drug on the market and approved Avandia for sale. By agreeing to the company’s version of the postmarket trial, scientists say, the FDA abdicatedits responsibility to collect reliable data on Avandia’s safety.
At meetings with doctors in 2001, GSK sales representatives denied Avandia had cardiac side effects, prompting the FDA to issue a public letter of warning against the company.
GSK began a review of the drug’s heart risks, and in 2005 and 2006 thecompany produced internal analyses showing 29% and 31% jumps in negative heart events. On May 9, 2006, the company provided these results to the FDA. The agency didn’t immediately release those studies to the public, because its officials “didn’t necessarily agree with some of the methodology used,” says Dr. Janet Woodcock, head of the FDA Center for Drug Evaluation and Research.
“In virtually every trial, there were more cardiac events with Avandia than with the comparator,” Misbin says. He was convinced enough to call his uncle, who was on Avandia, and advise him to ask his doctor to switch him to another drug.
The Senate Finance Committee concluded in January 2010, after a two-year review, that GSK failed to promptly alert the FDA about Avandia’s drug risks. In response, FDA commissioner Dr. Margaret Hamburg initiated another review of whether to keep Avandia on the market. As part of that review, FDA investigator Dr. Thomas Marciniak presented a devastating report on RECORD’s shortcomings, detailing how the RECORD study minimized Avandia’s heart risks: one death among the drug takers, for example, was missing from the final tally, and discrepancies in some cardiovascular data favored Avandia by a ratio of 4 to 1. The congressional investigation also uncovered e-mails indicating that GSK executives had managed to persuade the trial’s supposedly independent steering committee to publish interim results that demonstrated how inconclusive the heart risk was. The trial’s design, Marciniak found, was “completely inappropriate and biased.”
The FDA ever more dependent on industry user fees, and with new drug- safety concerns emerging year after year, it will take more than faster data retrieval to restore the reputation of an agency that was once synonymous with trust in the public mind.
The FDA will have to start forcing companies to be transparent and call them out on it when they’re not
. Says the medical reviewer Misbin: “Companies are always going to present their best face. It’s our job to say no.” In that sense, the FDA just needs to perform the task it was charged with more than 100 years ago: protecting the public interest by keeping industry honest.
WOW ! This is quite a story and whomever you believe one thing is clear: the trust in both the FDA and the drug industry has been seriously violated and it may take decades to earn it back. I believe that all prescription drugs carry risks, there is no way around that but when companies know the risks and try and hide them using biased statistical analysis there is a huge problem. When there is conclusive proof that there was an effort to hide data the FDA needs to fine companies the equivalent of sales for that product to teach them a lesson. People who made the decision to hide, conceal or manipulate data should not only be fired they should be barred from ever working within the pharma industry again.
The question thus is: Would you take Avandia if you were a diabetic ? I sure would not.