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FDA Panel Votes to Keep Dangerous Drug on the Market

Call to action! There's still time to press the FDA to pull a dangerous and unneeded drug off the market—and let them know that their protection of Big Pharma must come to an end.

by Heidi Stevenson

15 July 2010

Evidence be damned! Diabetes drug Avandia offers no benefit over a rival drug, but causes significantly more deaths. In a panel vote that sees no reason to remove the drug from the market, the FDA reveals its true allegiance: Big Pharma.

Theheart.org's Shelley Wood has produced revealing reports from the site of the FDA's meeting addressing Avandia's safety.^(1,2) In spite of vocal and outraged comments by anti-Avandia doctors inside the FDA and no legitimate documentation to support its safety, only 12 of 33 panel members voted to remove Avandia from the market. A full 21 voted for a variety of other options. The most positive thing that can be said is that none of them voted to leave it on the market and remove label warnings.

Ten panel members voted to leave Avandia on the market with more label warnings and limitations on its use. (Keep in mind that doctors can prescribe without regard to such warnings.) Seven felt that only additional warnings are needed. Three said no changes should be made. One panelist abstained.

The vote on the TIDE trial, a GlaxoSmithKline (GSK) sponsored study that is currently in operation, was 20-10 in favor of its continuation. Two people abstained and one was absent.

At issue is the lack of good data on Avandia's safety. Those in favor of leaving it on the market claim that studies showing its dangers are flawed.

That, though, is the real issue. The safety of any drug can be determined only by knowing its dangers. Yet, though Avandia has been on the market since 2002, the first trial to determine its safety, TIDE, is just now being done. Worse, it's being reported that its manufacturer, GSK has hidden data documenting the dangers.

In fact, part of the documentation⁽³⁾ provided to the panelists includes an investigation by one of them, Dr. Thomas Marciniak, demonstrated that GSK had suppressed data showing the dangers. We shouldn't, of course, be terribly surprised at the panel's vote, since it appears that the FDA itself attempted to suppress the publication of these risks by Dr. David Graham.⁽⁴⁾

GSK has responded to negative commentary on its website.⁽⁵⁾ They stated, "Cherry-picking a handful of documents from more than 14 million pages of documents distorts the record and is misleading." However, they offer limited evidence to support that claim, and they fail to counter the arguments put forth by the FDA's Dr. Marciniak, which carefully delineated several instances of nonreporting of adverse events during a GSK study.

The question must be posed: Why did the FDA approve a drug without adequate safety studies? In fact, why did they approve Avandia without a single safety study? Why would any of the panelists opt to vote against market removal of a drug clearly documented to be on no extra benefit compared with an existing drug and with strong information to show that the drug is significantly more dangerous, likely costing thousands of lives, and that its manufacturer hid data showing that fact? Further, why would these panelists vote to continue a trial on that drug under these conditions?

The reason is, of course, obvious. Big Pharma has a stranglehold on the FDA.

Let's loosen that stranglehold. There may be a chance to get the FDA to make a final decision to pull Avandia from the market, but the only thing that could do so is awareness that the public insists on it—and the only way to get that message across is by contacting your congressperson and senators, so they will put pressure on the FDA.

We need to take a stand, and this is a perfect case. Avandia is a dangerous drug with no advantage over any other drug. There is absolutely no reason to leave it on the market, other than GSK's profits. How many thousands of people must die at the altar of Big Pharma Profits?

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