FDA officials conspired with Merck to defame Truth Teller–NEJM credibility

Alliance for Human Research Protection

June 2006

Two documented news reports provide evidence validating our charge that FDA officials and drug manufacturers. In this case, Merck and FDA officials colluded to deceive the public about the safety of widely prescribed drugs–in this case, Vioxx. Furthermore,  prestigious medical journals publish reports about drug trials whose lethal effects are concealed—in this case, The New England Journal of Medicine.

The drug’s hazards are shown to have been carefully hidden from the public and from prescribing doctors through a coordinated effort by Merck and FDA officials.  Bloomberg News reports that Merck has set aside $970 million to defend the Vioxx lawsuits and nothing to cover liability. The company has vowed to fight every case.

FDA officials have not only failed to protect the public from lethal or defective drugs, vaccines, and medical devices—documents show that FDA officials have conspired with industry to trash the reputation of scientists who blow the whistle.

Bloomberg News reports (below) that a transcript of the sealed videotaped testimony by Dr. David Graham, in a Vioxx litigation case (May 9), accused senior FDA officials of working “hand in glove” with Merck to tarnish his reputation.
“I experienced threats, intimidation and actually what, in my view, appears to have been a very organized and orchestrated campaign to smear and discredit me.”

Documents (mostly e-mail correspondence) also show that the very FDA reviewers who had recommended approval of Vioxx for marketing—and who clearly bear some responsibility for failing to detect the safety hazards—had the gall to accuse Dr. Graham of engaging in “simply bad science” when he blew the whistle on the mounting human casualties.

And documents show that top FDA officials colluded with Merck in an effort to prevent Dr. Graham from presenting his data analysis (1) before a professional meeting in France (2004); (2) to his peers in the prestigious scientific British journal, The Lancet; (3) to the Senate Finance Committee; and (4) in judicial proceedings.

Instead of protecting the public health, top FDA officials attempted to protect Merck’s reputation and financial interests by doing their utmost to conceal the truth from the public.  In the Lancet article, Dr. Graham estimated that Vioxx caused 88,000 to 140,000 cases of serious coronary heart disease.



Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.