need to hear more…

Posted on Thursday 11 October 2012

    Epimenides was a Cretan who made one immortal statement: "All Cretans are liars."
    Douglas Hofstadter, Gödel, Escher, Bach
    Beware of Greeks bearing gifts
    Virgil, the Aeneid
Glaxo Opens Door to Data on Research
New York Times
October 11, 2012

GlaxoSmithKline plans to open up much of its drug research in an apparent effort to deflect criticism that important information gathered in clinical trials often does not see the light of day. The move, a first for a major pharmaceutical company, is scheduled to be announced on Thursday by its chief executive, Andrew Witty, in London. Researchers contacted about the plan on Wednesday expressed a mix of enthusiasm and skepticism, citing the recent $3 billion settlement by GlaxoSmithKline with the federal government over charges that the company had misrepresented trial data for popular drugs like Avandia and Paxil…

The company intends to name an independent panel of experts to review requests submitted by researchers. If the requests are deemed to have scientific merit, the company’s data will be made available to scientists on a secure Web site. The new policy applies to global clinical trials since 2007 (notably, that excludes Avandia and some other drugs now on the market) and all clinical trials starting in 2013. “Making data available, particularly on the products that didn’t succeed, could avoid others having to learn the same lessons,” said Joshua M. Sharfstein, Maryland’s health secretary and the former principal deputy commissioner of the Food and Drug Administration. Critics have long called on drug companies to release the full results of clinical trials, arguing that public health would benefit from a better exchange of information about a drug’s benefits and risks. Although drug companies collect voluminous amounts of data during the trials, which involve thousands of patients in many countries and sometimes last for years, only a sliver of that information is typically made public, and often in formats — as in articles in medical journals — that can present the drugs in the best light. Some researchers said they would need to hear more before giving the plan their support…

“There is a deficit of trust,” said Dr. Steven Woloshin, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice, who frequently analyzes clinical trial results. “That’s why it’s totally essential that they publish not just results but also the protocol — the complete program.” Dr. Vallance of GlaxoSmithKline said the data would include the complete trial protocol. A company spokeswoman, Sarah G. Alspach, said in an e-mail that some other supporting documents would be provided to allow researchers to “understand and navigate the data so they can conduct their research.” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, wondered about the objectivity of the disclosure process, asking, “Would someone who wants to take a critical look at an existing drug on the market be granted access?” In the case of Avandia, the company acknowledged that it did not disclose details of clinical trials to the F.D.A. in some reports but said it did disclose it in others. It did not admit any wrongdoing related to reporting clinical trial data in Paxil. Dr. Vallance said that the panel would be composed of experts respected internationally, and researchers’ proposals would be accepted even if the release would cast the drugs in a negative light.“We’ve been caught by some things in the past — I think we want to be clear on this,” he said.

Were I not suspicious, one could legitimately suggest a competency hearing [or perhaps a therapeutic trial of Solanezumab®]. And so long as I’m into quotes, I’ll add the old saying, "the best predictor of future behavior is past behavior," to the mix. But I can see an on-the-other-hand in this because were I GSK, even if I had seen a white light on the road, I would still be reluctant to release full patient level data freely on the Internet – envisioning my competitors and lawyers poring over it for weaknesses to exploit. That’s not paranoia. It’s just what they do. So I worry that isn’t enough or that the Test Act won’t give adequate access to  really vet suspicious studies. See also Dr. Carrol’s comment on a previous shot at this topic.

If one were going to limit access to patient level data, I can think of two groups who should have that access. First, the editors and reviewers from a journal considering publication of a study should be able to look at the raw data if they think it’s necessary. Second, any legitimate critic should be able to look. If that were the case, I’m not sure that "The company intends to name an independent panel of experts to review requests submitted by researchers" will do. Given GSK’s track record, they might pick some version of Nemeroff, Schatzberg, and Keller. How about the FDA either becoming or appointing the "panel of experts"? That’s just off-the-cuff. The point is that I don’t get to pick the Grand Jury for my own legal case.

I don’t see this as PHARMA’s choice right now and I worry that GSK is trying to pre-empt government action. Maybe they had a $3 B white light experience, but it was really a flashing blue light event, and foxhole conversions rarely endure. "Some researchers said they would need to hear more before giving the plan their support." Me too…
hat tip to annonymous 

UPDATE: Pharmalot Report: Glaxo Peels Back Curtain On Drug Data
    October 11, 2012 | 3:36 PM

    Maybe their sudden need for transparency was part of the deal struck with the DOJ. They did the same with the Spitzer deal. They basically cover themselves in garlands, “Look at us, ain’t we the transparent ones” – in truth, they are forced to do it by litigation agreements signed backstage and away from the public eye.

    Just me being an old cynic, Mikey.

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