Roche offers researchers access to all Tamiflu trials
by Deborah Cohen
British Medical Journal. 2013; 346:f2157 [Published 4 April 2013]More than three years after the Cochrane Collaboration first asked Roche for the full clinical study reports for its influenza drug oseltamivir [Tamiflu], the Swiss company has offered the collaboration access to “all 74 Roche sponsored trials.” Don MacLean, life cycle leader for Tamiflu at Roche, emailed the Cochrane researchers on 2 April to propose providing data in a staggered approach over the next few months. “In line with European Union law, each CSR [clinical study report] will be edited by Roche to ensure patient confidentiality and to protect legitimate commercial interests,” he wrote. A full phase III clinical study report typically consists of 2000 to 3000 pages, and redaction would be a “large undertaking,” he added.
The Cochrane group has cautiously welcomed the move, pointing out that Roche has previously promised access to data. MacLean’s email follows GlaxoSmithKline’s decision to release 30 clinical study reports on its influenza drug zanamivir [Relenza] to the same Cochrane group. The group is concerned, however, that data redaction and other problems may make analysis and interpretation impossible. Sile Lane, director of campaigns at Sense about Science, said that by acknowledging that there were 74 trials and agreeing to publish the results, Roche had recognised that arguments in favour of secrecy no longer held.
“This should be a good moment for them to sign up to the commitment set out at AllTrials for all trials relating to treatments in current use to be registered, and the results reported. It shouldn’t have taken the researchers years of persistence and publicity to get [access to] these Tamiflu results. Roche has an opportunity to tell the public and research community that it won’t happen like this again,” she said. The announcement comes after years of wrangling for access to what the Cochrane group believes to be the full dataset. Instead of offering access to 74 trials, in December 2009 Roche gave the researchers access to one part of 10 Tamiflu trials [each trial report comes in four to five parts]…hat-tip to Pharmagossip
Like most, I have something of an aversion to regulations and procedures. And the history of how all of this came to be is a study in the failure of years of attempted reform through various regulations designed to escape being outfoxed by the pharmaceutical industry. That hasn’t worked. The only way to insure honesty is to have complete data availability minus the subjects names. Dr. Healy brought up an excellent point last week [Not So Bad Pharma, April Fool in Harlow] in that subjects in clinical trials need to agree to that kind of data transparency up front in their consent forms. The pharmaceutical industry stands to lose a lot here. The truth about drugs will dissuade many from taking medications electively. Blockbusters will be a lot harder to come by and so there will be big changes in the industry as a result of these changes.
While “austerity” is being sold as necessary, wouldn’t it be great to look at all the worthless crap governments have paid for with enormous sums of money that would have been much better spent keeping people’s head above the water and taking care of infrastructure? Providing real medical care?
Tamiflu should be on a very special list with Cipro and other drugs that the government has pedaled because of the economic interests of one or more officials, and the chumpishness of our regulating bodies.
Sunlight as disinfectant.
The Tamiflu Saga (story) is embarrassing to many professionals, most of all those who took the pharma bait, hook, line and sinker, and on behalf of the government used billions to buy the ineffective drug in such great amounts that the surplus was in storage past expiry date.
DNL, Den Norske Legeforening, the association of Norwegian medical doctors has a journal that in issue 4, February 2013 discusses antidepressants critically, with an English translation, though the comments are in Norwegian only, the very first of them referencing the articles of dr Gibbons et al in the Archives of General Psychiatry which you and dr Carroll have most diligently dissected.
I can comment as a layperson in the NGO WSO, no gurantee of being printed, far stronger effect if dr Nardo and Carroll do. An open debate on antidepressants among doctors is, in my opinion, long overdue here. The medical journal is at
http://www.tidsskriftet.no/article/2975531
Having read all 6 comments to the article “Antidepressant drugs – Clinical practices must change” by drs Vaaler and Fasmer, I see that three point to Gibbons et al. One only, dr Bergsholm, references the critical articles in JAMA from dr Carroll and Spielmans, Jureidini, Healy, Purssey, sweeping them all off, thus:
“The study by Gibbons et al was criticized, but the critic was firmly “imötegaatt” ie “countered”. – Gibbons et al used like a mine field, protecting the business…
Next commenter is Ulrik Fredrik Malt, professor, head of psychiatry dep at Oslo University Hospital, Rikshospitalet, lecturer at Oslo university, editor of textbooks. His comment is long, reported conflicts of interests too short, as he is a leading KOL, has been on speakers bureaus, possibly first to publicly endorse use of SSRIs years ago, numbers of prescriptions rising ever since.
CEO of H Lundbeck A/S comments, a failed balancing act, as he uses the word “sludder” i e nonsense, and avoids mentioning any adverse effects, for instance 200 cardiac arrests among patients on Lundbeck’s Cipramax/Cipramil recently reported by cardiologists at Gentofte hospital.
There are two positive comments, a teacher, a patient, withdrawal-challenged after years on prescription drugs, not informed by doctors of the risks.
So if the good doctors Nardo and Carroll would comment in Tidsskriftet for den norske legeforeningen, on the mines laid out by Gibbons et al, it would be most welcome.
Justice Brandeis was on to somethin’
Duane
I’ve got a proposal for a project we could all contribute to — especially those who know a lot more than I do about neuroscience. It’s called BRINTELLIX WATCH.
Brintellix is the stage name for vortioxetine, the “novel” antidepressant being developed by Lundbeck and Takeda Pharm. They are calling it “multimodal” because it grabs ahold of a grab-bag of receptors:
Serotonin transporter (SERT) blocker (Ki = 1.6 nM) (or serotonin reuptake inhibitor (SRI)); 5-HT1A receptor high-efficacy partial agonist/near-full agonist (Ki = 15 nM; IA = 80%); 5-HT1B receptor partial agonist (Ki = 33 nM); 5-HT3A receptor antagonist (Ki = 3.7 nM)5-HT7 receptor antagonist (Ki = 19 nM); Vortioxetine also has affinity for the ?1-adrenergic receptor (Ki = 46 nM),
The above is pasted from the Wikipedia article which is written by someone with a skeptical bent. I don’t pretend to understand it except it sounds like Fifty Shades of Serotonin. All I know is a pill that hooks onto all those places is bound to do something.
No patients are taking it yet — but papers are being published in the journals. The FDA has accepted it for review. And although it hasn’t been cast for any roles, it already has an agent! The massive Ogilvy PR firm is taking it on in Europe; its US stage mom is TBD. I think it would be a real step forward if by the time this thingamabob is introduced to patients as the 8th wonder of the world, we could know as much as possible about it or at least have all the questions patients should ask. … sort of like counter-detailing before the big publicity blitz gets started. Anyone think it’s a good idea?