The New York Times reports (see here) that as far back as March 29, 2001, a SmithKline (precursor to GSK) executive held back clinical trial data that suggested Avandia was "no better than Actos, but ... also provided clear signs that it was riskier to the heart." In an e-mail that the NYT recently received, this executive said "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." In another email message, this executive said "These [data] put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm. It is a difficult story to tell and we would hope that these do not see the light of day."
"Hiding the results of negative clinical trials was once widespread in the drug industry," says the Times. That was supposed to change when Congress mandated such disclosures. "But the postings are often little more than cryptic references, so the issue is far from resolved," says the Times.
As I write this, GSK is presenting its case before an FDA advisory committee. You can follow this meeting on Twitter -- but don't look at GSKUS, GSK's official Twitter account. That account, so far, is silent about this unfolding story.
Here is GSK's Advisory Committee Briefing Document (pdf). It's 166 pages long and full of meta and other data purporting to prove the conclusion that "observational, and large controlled clinical studies continue to support the overall positive benefit risk profile of RSG as an important medicine for type 2 diabetes mellitus (T2DM) patients. Better durability of glycemic control with RSG compared to both SU and MET has been demonstrated in two long-term studies. This durability benefit has the potential, in real life conditions, to reduce microvascular complications of type 2 diabetes and to avoid the need for additional therapy, including insulin. Treatment with RSG does not demonstrate an increased risk in macrovascular complications compared to MET and SU. Therefore, the overall benefit risk profile for RSG remains positive."
Whatever the new data show, it is clear that GSK in the past conspired to hold back negative data from the public. And not only negative data about Avandia. "GlaxoSmithKline was found in 2004 to have hidden data that showed that its antidepressant, Paxil, led children and teenagers to have more suicidal thoughts and behaviors," noted the Times article. GSK settled a lawsuit by agreeing to publicly post data from all of its trials.
Given this kind of attitude, it's no wonder the public has a low opinion of drug companies. I myself started writing this blog when Merck was found to be hiding negative data about Vioxx, a drug that was eventually withdrawn from the market -- a fate that I believe awaits Avandia.
UPDATE: @GSKUS posted this: GSK responds to July 12 Senate Finance Committee letter to FDA #FDA http://tinyurl.com/25t3fvd
The first sentence of GSK's response: "The Senate Finance Committee (SFC) has released a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the product liability litigation."
14 million pages! Holy cow! I guess GSK learned from GM about how to swamp your opponents with tones of paper! I'm referring to the case that Nader brought against GM in "Unsafe at Any Speed." Remember the Gene Hackman movie "Class Action" that portrayed the story behind the case? When asked to supply relevant data, the auto company in the film sent a truckload of boxes of documents to bury the lawyers.
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ReplyDeleteAlexander Kisby, Online Editorial Manager at eyeforpharma, sent me a personal comment regarding this blog post:
ReplyDelete"[I]t is concerning that these clinical trial cover ups just seem to keep on coming to light. At eyeforpharma we have been pondering whether the industry has less people actually passionate about healthcare in these decision making positions. Would those passionate about healthcare still see the children with increased suicidal thoughts and acts as pesky numbers which could threaten their company profit or as human beings whose safety they could be putting at risk. It seems somewhere somehow many of these decision makers have lost sight of the people they are working to save. Is it because those people simply see it as a job plus benefits?"
Personally, I believe most people who work for pharmaceutical companies have good motives and truly believe they are helping people. After all, it must be much more satisfying work than working for a tobacco company, say.
Sorry to say, however, is that when your and your families livelihood depends on being a "team player" and touting the company line, you'll always find lieutenants who "just follow orders" and do as they are told.
Also keep in mind that whistleblowers go through a tough time and are universally viewed as "rats" whereas they should be viewed as heroes.