GSK pledges transparency on drugs research data
GlaxoSmithKline has set out a new transparency policy that includes sharing information from its studies, as it moves to distance itself from recent multi-billion dollar US fines.
The Telegraph
By Jessica Winch
12 Oct 2012
Three months after GSK was fined $3bn [£1.9bn] for fraud related to concealing safety issues, chief executive Sir Andrew Witty said detailed data from its clinical trials would be made available to the scientific community. Britain’s biggest drugmaker will set up an independent panel of experts to review and approve requests from researchers to access the data. The move is a first for a pharmaceutical company and Sir Andrew said he hoped the initiative will “catalyse” other firms to follow suit. Sir Andrew said: “We need to take a different approach – one focused on partnership, collaboration and openness. By being more open with our clinical trial data, we also hope to help further scientific understanding.” The new system will start at the beginning of next year.Professor Stephen Curry, of Imperial College London, called the announcement a “positive development”. “Any form of openness and transparency in the pharmaceutical company is to be welcomed,” he said. However, he said the scientific community would reserve judgement until it became clear how the process worked in practice. “It’s nice to be optimistic but a drug company is not going to change its stripes overnight,” he said. “These are hard-headed business people. It’s very encouraging but I think we’ll wait to see what actually happens before passing any final judgment.”
In July this year, GSK reached a record $3bn settlement with the US government after pleading guilty to charges that it had provided misleading information on some drugs, including antidepressant Paxil and diabetes pill Avandia. GSK also announced on Thursday that it will make its library of compounds with potential activity against tuberculosis freely available to researchers. Investment in its Tres Cantos Lab, which allows independent researchers access to GSK facilities, will be doubled to £5m.
Were I Sir Andrew Witty, I might say, "How can I ever have a blockbuster drug again if I allow you to use my own data against me? Every drug is more toxic than the ads on the television say. You wouldn’t ask your blind date to show up without any make-up." That would be a legitimate retort if he made soap powder or a new disposable razor. I would respond, "But these are toxic chemicals I’m prescribing for depressed children. If I don’t know about the incidence of Akathisia or about the drug withdrawal syndrome, how can I warn the parents of those possibilities in their sad teenager? How will they know that worsening might not be the disease itself but rather an idiosyncratic reaction to the drug?" I don’t care if he doesn’t have a blockbuster [drug unless it’s a blockbuster drug that can standup under careful scrutiny]. He’s been Knighted because of his not-quite-really blockbusters. Think what will happen if he gets a real one.
1BOM,
I will come up with a less spam sounding name. Thanks.
In the interim would recommend listening to the “476: What Doesn’t Kill You” episode of This American Life. Specifically the story of the woman who swallowed objects. It is a reminder that there is something noble that the most interventionist of psychiatry can accomplish. This is NOT to excuse the behavior of those who would use such stories as a shield for the behaviors you are criticizing. Nor those who extrapolate from such cases to justify whatever they wish to promote.
Just that the story is a striking reminder of the complexity of some of the experiences of the people you and Dr. Carroll work with.
Funnily enough, since she received the treatment through MGH, the physicians who helped her are probably heavily connected to one industry or another.