Petition Closed
Petitioning Director, Division of Drug Safety Research Thomas Colatsky, Ph.D.

Food and Drug Administration: Drug Data Shouldn't Be Secret: Open the Books on Tamiflu

"Clinical trial data for the anti-influenza drug Tamiflu... were missing, unpublished and inaccessible to the research community... the country’s most widely used and heavily stockpiled influenza drug appeared no more effective than aspirin." Dr. Peter Doshi, Johns Hopkins University School of Medicine and Dr.Tom Jefferson,epidemiologist,Cochrane Collaboration. 

New York Times April 10, 2012

This petition is in support of The BMJ's  open data campaign  aims to achieve appropriate and necessary independent scrutiny of data from clinical trials  as it relates to  a public promise Roche made in 2009 to release full clinical trial reports in response to an investigation by the BMJ and Cochrane collaborators Peter Doshi and Tom Jefferson.

    The bottom line:
  • WHO recommends Tamiflu, but has not vetted the Tamiflu data.
  • EMA approved Tamiflu, but did not review the full Tamiflu dataset.
  • CDC and ECDC encourage the use and stockpiling of Tamiflu, but did not vet the Tamiflu data.
  • The majority of Roche's Phase III treatment trials remain unpublished over a decade after completion.
  • In Dec 2009, Roche publicly promised independent scientists access to "full study reports" for selected Tamiflu trials, but to date the company has not made even one full report available.

Releasing the trial reports would allow independent academics to answer questions about this globally stockpiled drug.

SOURCE: http://www.bmj.com/tamiflu

Tamiflu Timeline culminates in demand by British MP's to know whether $500 MILLION is going down the drain for a placebo

Letter to
Director, Division of Drug Safety Research Thomas Colatsky, Ph.D.
Drug Data Shouldn't Be Secret: Open the Books on Tamiflu

WHO recommends Tamiflu, but has not vetted the Tamiflu data because the data remain in private hands which hold tenaciously to the privatized data despite a growing clamor from scientists and thegeneral public..

CDC, like its British counterpart, encourages the use and stockpiling of Tamiflu, but either agency has had access to huge portions of the Tamiflu data.

The majority of Roche's Phase III treatment trials remain unpublished over a decade after completion and despite years of wrangling.

As far back as Dec 2009, Roche publicly promised independent scientists access to "full study reports" for selected Tamiflu trials, but to date the company has not made even one full report available. Their more recent proposals do not even come close to the full disclosure needed to determine whether or not Tamiflu works as well as they wish for us to believe.

Releasing the trial reports would allow independent academics to answer questions about this globally stockpiled drug.

The FDA has considerable power to pressure drug companies and if it needs enhanced powers then it would be appropriate to communicate with members of Congress to establish such powers as would be necessary to revoke drug approval retroactively should ROCHE continue to keep the data secret.

The FDA website indicates that your unit, CDER "evaluates
all new drugs before they are
sold, and serves as a consumer
watchdog for the more than
10,000 drugs on the market to be
sure they continue to meet the
highest standards. " Since it is not possible to evaluate the quality standard of Tamiflu without access to the data, it would appear that your unit has jurisdiction in the matter. We will appreciate information on what other sections of FDA mny also be able to assist in bringing the facts to light.