To:
Thomas Colatsky, Ph.D., Director, Division of Drug Safety Research

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The majority of Roche's Phase III treatment trials remain unpublished over a decade after completion and despite years of wrangling.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 may also be able to assist in bringing the facts to light.


Sincerely,

Geoffery Bard Portland,Santa Barbara
David Myers Portland,Oregon
Judith Lienhard Portland,Oregon
Janet Wolfman NYC,New York
Clare Tremper Renton,Washington
Laura Saxon Morriston, Florida