"I was threatened with prison."
"One [FDA] manager threatened my children...I was afraid that I could be killed for talking to Congress and criminal investigators."
Kavanagh reviewed new drug applications made to the FDA by pharmaceutical companies. He was one of the holdouts at the Agency who insisted that the drugs had to be safe and effective before being released to the public.
But honest appraisal wasn't part of the FDA culture, and Kavanagh swam against the tide, until he realized his life and the life of his children was on the line.
What was his secret task at the FDA? "Drug reviewers were clearly told not to question drug companies and that our job was to approve drugs." In other words, rubber stamp them. Say the drugs were safe and effective when they were not.
Kavanagh's revelations are astonishing. He recalls a meeting where a drug-company representative flat-out stated that his company had paid the FDA for a new-drug approval. Paid for it. As in bribe.
He remarks that the drug pyridostigmine, given to US troops to prevent the later effects of nerve gas, "actually increased the lethality" of certain nerve agents.
Kavanagh recalls being given records of safety data on a drug -- and then his bosses told him which sections not to read. Obviously, they knew the drug was dangerous and they knew exactly where, in the reports, that fact would be revealed.
The situation at the FDA isn't correctable with a few firings. This is an ongoing criminal enterprise, and any government official, serving in any capacity, who has become aware of it and has not taken action, is an accessory to mass poisoning of the population.
Seventeen years ago, the cat was let out of the bag. Dr. Barbara Starfield, writing in the Journal of the American Medical Association, on July 26, 2000, in a review titled, "Is US health really the best in the world," exposed the fact that FDA-approved medical drugs kill 106,000 Americans per year. That's a MILLION deaths per decade.
Dr. Starfield was a revered public health expert at the Johns Hopkins School of Public Health. In interviewing her, I discovered she had never been approached by the FDA or any federal agency to help remedy this tragedy. Nor had the federal government taken any steps on its own to stop the dying.
The government has still done nothing.