Healthy Skepticism Library item: 18412

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

Rich
Is the entire system corrupt to the extent that we can’t trust the data ?
World of DTC Marketing 2010 July 11
http://web.archive.org/web/20110219222123/http://worldofdtcmarketing.com/is-the-entire-system-corrupt-to-the-extent-that-we-can%E2%80%99t-trust-the-data/business-of-the-drug-industry/

Full text:

A “scathing” review of a drug trial that was used to approve GSK’s Avandia is how the Times reported the story. However what the story really tells is of a drug trial whose data may have been manipulated to hit certain end points. You wonder why consumers, patients and health care professionals have low trust in big pharma ?

In an interview on Friday, Dr. Jerome P. Kassirer, a former editor of The New England Journal, said the Record trial raised the question “whether the entire system is corrupt.” “To the extent that we can’t trust the data,” he added, “we are in jeopardy of giving patients the wrong drugs.” And how does GSK respond to this report ? spokeswoman for GlaxoSmithKline, said the study demonstrated that Avandia is safe and added, “The Record study was conducted according to good clinical practices and the data are reliable.”

That is a pretty powerful statement and you have to wonder how many health care professionals are now starting to doubt the “if the whole system is corrupt”. At the heart of this debate is:

Did GSK manipulate/leave out data when conducting clinical trials on Avandia ?
Did someone manage the clinical trials to highlight targeted outcomes ?
According to the article in today’s Times:

The agency’s initial review of the Record trial, in 2007, found no problems. But independent researchers who have examined the health records of thousands of patients taking Avandia have found strong hints that the drug is more dangerous than GlaxoSmithKline has claimed. So Dr. Marciniak took an unusually close look at the Record study, demanding to see records that the agency rarely examines.

I wanted to gain better insights into what this article said so I spoke to some “industry insiders” who quickly informed me that “GSK has a history of funky clinical trials”. They believe that the problem is a “systemic” problem within GSK and that you have to not only take into account what they are telling you but what they “aren’t telling you” when it comes to drug data.

Make no mistake about it. This is not about Avandia vs. Actos or other diabetes drugs on the market. This is about clinical trials data used to get approval on a new drug done with good medical and business standards. The FDA should hire independent medical and regulatory people to review the drug trial and the report on the data. If it turns out that in fact GSK manipulated data and put the drugs approval of patient safety than the fine needs to be equal to the sales from the drug during it’s time on the market. Maybe then the people who put drug approval ahead of patient safety will be a priority.

What is also sad about this piece is that it casts a giant shadow on the whole drug industry including the companies that play by the rules and get good data. It’s a shame that GSK had to throw mud on its industry and heads need to roll. It’s more of a shame that GSK has issues the same response as always.