Release all Tamiflu data as promised, argue researchers
There can be no debate about Tamiflu whilst Roche does not keep its promise to release "full study reports" about the drug, argue senior researchers from the Cochrane group today.
The latest correspondence is posted online today as part of the BMJ's open data campaign, aimed at persuading Roche to honour the promise it made almost three years ago to make key Tamiflu trial data available for independent scrutiny.
Last week, Donald MacLean, Life Cycle Leader for Tamiflu, wrote to Professor Chris Del Mar in his capacity as coordinating editor of the Cochrane Acute Respiratory Infections Group, concerning "our debate on Tamiflu data."
The Cochrane researchers say they object to Roche's suggestion that there is a debate on Tamiflu data. "There is no debate nor can there be any debate about the data whilst you do not honour your promise," they say. "The only reason we keep asking Roche to keep its promise, rather than simply getting the data from the European Medicines Agency directly, is because Roche has not supplied all of the data to the European regulator."
Roche's letter also mentions "disagreements" over the type of analyses the Cochrane team wish to do, but the researchers point out that their methods and analyses have been public for nearly two years and "follow Cochrane procedure" and state that they are not aware of any specific concerns from Roche.
Roche's letter goes on to say that, in order to reach "an amicable resolution" Roche plans to set up "a multi-party advisory board to review the totality of Tamiflu data" …. which they believe is "a sensible, fair and transparent way of addressing this public debate."
But the Cochrane team argue that Roche's offer is merely a belated attempt at turning the clock back, and call on the company to expand its data sharing pledges "to become compatible with current regulatory norms."
They say: "The European Medicines Agency and the EU Ombudsman have made abundantly clear that there is no reason for anonymised clinical data to be withheld from public scrutiny once a marketing authorisation has been obtained for a pharmaceutical. Why should Roche not - at the minimum - meet this standard?"
In summary, they say, "we ask to you to honour your promise of three years ago and make public full clinical study reports in your possession."
Journal reference: British Medical Journal (BMJ)
Provided by British Medical Journal
- BMJ editor urges Roche to fulfil promise to release Tamiflu trial data Oct 30, 2012 | not rated yet | 0
- British medical journal slams Roche on Tamiflu (Update) Nov 12, 2012 | not rated yet | 0
- Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data Jan 18, 2012 | not rated yet | 0
- Tamiflu touted for child use Nov 16, 2007 | not rated yet | 0
- Roche probed for not reporting side effects Oct 23, 2012 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013 From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013 As an experiment, for the past few months I've been consuming at least one portion of Jell-O or unflavored Knox gelatin per day. I'm 64, in very...
Alcohol and acetaminophen
May 13, 2013 Edit: sorry for the typo in the title , can't edit I looked around on google quite a bit and it's very hard to find precise information on the...
Marie Curie's leukemia
May 13, 2013 Does anyone know what might be the cause of Marie Curie's cancer
- More from Physics Forums - Medical Sciences
More news stories
Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.
Medications May 17, 2013 | not rated yet | 0
Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial with their ...
Medications May 17, 2013 | 5 / 5 (1) | 0
(Medical Xpress)—An aspirin a day may not always keep heart disease away, say two University of Florida cardiologists. But a new algorithm they have developed outlines factors physicians should weigh as ...
Medications May 16, 2013 | 3.5 / 5 (2) | 0 |
(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...
Medications May 15, 2013 | not rated yet | 0
4 hours ago | not rated yet | 0 |
4 hours ago | 5 / 5 (1) | 0 |
5 hours ago | 5 / 5 (1) | 0 |
5 hours ago | 5 / 5 (2) | 0 |
Gourmands and foodies everywhere have long recognized ginger as a great way to add a little peppery zing to both sweet and savory dishes; now, a study from researchers at Columbia University shows purified components of the ...
4 hours ago | not rated yet | 0
9 hours ago | not rated yet | 0