Shut down the FDA, start over
By Jon Rappoport
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.
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