1 Boring Old Man

With Transparency Pledge, Glaxo Makes Promises No Other Drug Company Has
Forbes
by Matthew Herper
10/11/2012

In an unprecedented move that could signal dramatic changes in the drug industry, GlaxoSmithKline is promising to make detailed data from its clinical trials available to independent researchers so that scientists can draw their own conclusions about the safety and effectiveness of its new drugs. The change, which has yet to be implemented, is being announced at a speech in London at the Wellcome Trust, where Glaxo chief executive Andrew Witty is also detailing how the British drug giant has made its chemical libraries available to researchers working on drugs against tuberculosis and malaria. It could be a dramatic change for a company that has been dogged by scandal over lack of disclosure.

“Because of our unique role, we recognize that society holds us to higher standards than for other industries,” Witty says in his prepared remarks, which may change. “This is how it should be. Over the last four or so years we at GSK have been working hard to be more open and transparent. As I have shown these new approaches are helping to provide new solutions for serious global health issues. They will also help build society’s trust.” Right now, Glaxo publishes results from its clinical trials on its own Web site and on another site run by the National Institutes of Health, and it says it tries to publish scientific papers on every study in research journals. But doctors outside the company don’t have access to vast databases of how each patient in a clinical trial did. What Glaxo is promising to do is to create a process through which researchers can request this raw data and use it to do new analyses…

GlaxoSmithKline has in the past been at the center of scandals created in part by data on drugs that critics said was not made public in a timely manner, at the expense of patients who may have suffered dangerous side effects. In July Glaxo pled guilty to U.S. misdemeanor charges that it had marketed the anti-depressants Paxil and Wellbutrin for unapproved uses and had not disclosed clinical data related to the diabetes medicine Avandia, which eventually had its use severely restricted because it may increase the risk of heart attacks. As part of the settlement, which also included civil charges, it agreed to pay $3 billion. All these scandals had at their root the idea that patients were being endangered because data were not made public. New York Attorney General Eliot Spitzer sued Glaxo in 2004 for not disclosing negative data that linked Paxil to suicidal thoughts in children. As part of a settlement, GSK agreed to post all the results of its clinical trials on a company Web site. In 2007, Steven Nissen, chair of cardiology at the Cleveland Clinic, pooled studies found on that site to produce a New England Journal of Medicine article that started a firestorm of controversy around the pill, then the best-selling diabetes medicine in the world, that eventually resulted in its sales dropping to close to nothing. In the ensuing controversy, it was revealed that Glaxo had told the Food and Drug Administration about a study that mirrored Nissen’s own results, but had not made the results public except in a place on its website where they were particularly difficult to find.

Witty, who became Glaxo’s chief executive in 2008, has tried to distance the company from the Avandia controversy, focusing attention on the company’s efforts in the developing world, including research to create the first vaccine for malaria and now, announced today, new initiatives against tuberculosis and other emerging diseases. In Glaxo’s press release announcing the settlement with the feds, he said that the Avandia and Paxil controversies “originate in a different era for the company” and expressed his “regret” and said that his company had learned from its mistakes. What Witty is saying he will do now goes way beyond anything even Eliot Spitzer asked for. Glaxo would put in place a system by which independent researchers could request the data about what happened to individual patients in its clinical trials, and would be granted access if an independent group of experts thought the idea had scientific merit…

One obvious detail to worry about: the panel of experts, convened by Glaxo, who will decide which independent scientists get access to the company’s data. Will the panel allow critics, like Nissen, to look at this patient-level data, as the this information is known? “We’re not asking that panel to make judgements on the value of the questions being asked,” says Vallance. “We’re asking that panel to take a view on the scientific validity. So the answer to that question is yes, someone like Steve Nissen would be able to access patient-level data if he had a protocol that would answer a scientifically valid question robustly.” Vallance also warned, however, that it would be “anti-public health” for researchers to trawl the data for side effects without clear questions, because it would lead to unwarranted side-effect scares. But he said that even in the case of Glaxo’s best-selling asthma drugs, which some doctors warn can sometimes hurt patients, what he wants are the real answers. “We are not looking to hide something about our medicines,” says Vallance. “If it is a scientifically valid question, answered robustly and comes up with an answer, I think we need to know that answer.”

^{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.}

• "New York Attorney General Eliot Spitzer sued Glaxo in 2004 for not disclosing negative data that linked Paxil to suicidal thoughts in children. As part of a settlement, GSK agreed to post all the results of its clinical trials on a company Web site."
• GSK complied with a partial posing of the data in 2004, summary data rather than patient level data [a movement…].
• "In 2007, Steven Nissen, chair of cardiology at the Cleveland Clinic, pooled studies found on that site to produce a New England Journal of Medicine article that started a firestorm of controversy around the pill, then the best-selling diabetes medicine in the world, that eventually resulted in its sales dropping to close to nothing. In the ensuing controversy, it was revealed that Glaxo had told the Food and Drug Administration about a study that mirrored Nissen’s own results, but had not made the results public except in a place on its website where they were particularly difficult to find."
• July 2, 2012: "In the largest such deal to date, GlaxoSmithKline agreed to plead guilty and pay $3 billion to resolve criminal and civil charges in connection with off-label promotion of several drugs, failing to report safety data and reporting false prices. Two guilty counts involve introducing misbranded drugs, the Paxil and Wellbutrin antidepressants, into interstate commerce, and another count is for failing to report safety data about the Avandia diabetes pill to the FDA." [hope springs eternal…]
• August 2, 2012: "When I scrolled down, it had changed. There was Study 329, the famous one [Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial], but after all the narrative summaries, it had a list of Appendices [Appendix A through H]. I’d never seen them before and as I opened them, I realized that what I was seeing was the raw data – HAM-D scores/Subject/Item/Week and all the other various rating scales. The page said ‘Updated on Thursday 2 August 2012‘ down at the bottom." [a movement…]
• October 11, 2012: Today’s announcements…