Shut down the FDA, start over
Vera Sharav, at ahrp.org, has posted a piece about an investigation headed by NYU Professor Charles Seife.
Seife and his students probed the work of the FDA, the federal agency tasked with approving medical drugs for public use.
Sharav: “FDA documents obtained under the Freedom of Information Act, revealed that the FDA has been concealing from the medical community and the public serious research misconduct; including fraud, deception, avoidable risks for human subjects — even deaths — that occurred in clinical trials [of medical drugs].”
Professor Seife (from his article at Slate magazine): “Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wild video. It’s a seemingly endless stream of lurid vignettes—Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.”
“That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.”
“The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.”
There is much more, but that taste should be enough to convince any sane person that the FDA is a rogue agency, dedicated to protecting and forwarding the profits of pharmaceutical companies.
In past articles, I’ve revealed that, every year in the US, FDA-approved medical drugs kill 106,000 Americans. This conservative assessment was made by Dr. Barbara Starfield, in her landmark July 26, 2000, review in the Journal of the American Medical Association: “Is US Health Really the Best in the World?”
In my 2009 interview with Dr. Starfield, she emphatically stated that she was aware of no systematic federal effort to fix this horrendous ongoing disaster.
In fact, the FDA had (until they removed it) a page on their own site which stated: “Over 2 MILLION serious ADRs (adverse drug reactions yearly.” “100,000 DEATHS yearly.” The FDA was highlighting the catastrophic effects of medical drugs they themselves were certifying as safe and effective.
Of course, they took no responsibility.
This is on the order of a defendant saying, “Did I kill people? Well, if you look in that field over there, if you start digging, you’ll find a number of bodies. I know. I put them there. But I wasn’t really responsible. Why would you place me on trial?”
In a stunning interview with Truthout’s Martha Rosenberg (7/29/12), former FDA drug reviewer, Ronald Kavanagh, exposed the FDA as a relentless criminal mafia protecting its client, Big Pharma, with a host of mob strategies:
Kavanagh: “…widespread racketeering, including witness tampering and witness retaliation.”
“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 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.
Veterans of the Armed Forces, take note: Kavanagh remarked 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 recalled 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.
Getting the picture?
Anyone who believes the FDA can be fixed with a few adjustments to rules and a few personnel changes is whistling in the dark.
Talk about a swamp.
Nothing short of shutting down the Agency, fumigating the buildings, and starting over with actual humans in charge, humans who believe in human health, would work.
Scores of criminal prosecutions, convictions, and very long prison terms for current FDA employees would also be necessary.