Navigation Links
Release all Tamiflu data as promised, argue researchers
Date:11/26/2012

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."


'/>"/>

Contact: Emma Dickinson
edickinson@bmjgroup.com
44-020-738-36529
BMJ-British Medical Journal
Source:Eurekalert

Related medicine news :

1. Catch and release
2. CSHL Press releases new book on the biology of drug addiction
3. Institute for Population Health Improvement releases buyers guide for health information exchange
4. Premier global health journal, The Lancet, releases series on universal health coverage
5. Evidence that new biomimetic controlled-release capsules may help in gum disease
6. PMIC Announces Release of New CDT 2013 Dental Procedure Coding System
7. Muscular Development Store Releases the Optimum Performance Workout for High Intensity Training
8. MTSS-mba Membership Benefits Administration Software for Private and Taft-Hartley Employee Benefit Funds Releases New Pension Modules
9. Candeo Partners with Catholic Church Organization to Release New Sexual Addiction Recovery Program
10. GMC Denali Road Bike Review Released Today By GMCDenaliRoadBike.net
11. Waterpik Water Flosser Reviews Released Today By WaterpikReviews.net
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) will ... during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual ... F. Collen, a pioneer in the field of medical informatics, this prestigious award is ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, ... a medical article to the newly revamped Cosmetic Town journal section, ... hair transplant procedure known as Follicular Unit Extraction (FUE). , Dr. ...
(Date:10/12/2017)... Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... is holding a treadmill relay – Miles by Moonlight to raise money for the ... donating $300 or more. , Teams will work together to keep their treadmills ...
(Date:10/12/2017)... ... October 12, 2017 , ... In the United States, single-family ... some states—like New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the average ... extremely low property-tax rates, which contributes to the relatively lower cost of living ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... presents its enhanced Pepper Flow promotional review platform at the Promotional Review ... increased insight-driven capabilities help marketers streamline the medical, legal, and regulatory review ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... Oct. 2, 2017 Diplomat Pharmacy, Inc. (NYSE: ... Software and Consulting, LLC , and named its founder ... based in Tennessee , will operate ... expands EnvoyHealth,s service offerings for health care partners to ... "In an interoperable world, technology ...
(Date:9/28/2017)... -- Hill-Rom Holdings, Inc. (NYSE: HRC), will host its ... on Friday, November 3, 2017, beginning at 7:00 a.m. ... 8:30 a.m. (CDT) / 9:30 a.m. (EDT). ... and guidance for 2018, Hill-Rom executives will also highlight ... and long-range financial outlook through 2020. ...
(Date:9/25/2017)... Sept. 25, 2017  EpiVax, Inc., a leader ... and immune-engineering today announced the launch of EpiVax ... of personalized therapeutic cancer vaccines. EpiVax has provided ... access to enabling technologies to the new precision ... lead EpiVax Oncology as Chief Executive Officer. Gad ...
Breaking Medicine Technology: