How the FDA is Recklessly Abandoning Drug Safety
Shocking Story Reveals FDA Not Concerned With Drug Safety
In the wake of shocking reports on how the FDA, terrified of being
outed for its questionable practices, spied on its own employees in the
hopes of rooting them out before they could become whistleblowers, a new
story has emerged on how deep the deceit goes. From marginalizing
safety reports to not reading them at all―and then going ahead and
approving the drugs in question―the FDA once more stands accused of
being little more than a rubber-stamping agency for Big Pharma.
Explosive revelations of an intensive spy operation by the FDA
on its own scientists emerged last month. Using sophisticated spy
software, the agency tracked and logged every move made by the targeted
individuals. The program even intercepted personal emails and copied
documents on their personal thumb drives.
The targeted scientists had expressed concern over the agency's
approval of dangerous medical imaging devices for mammograms and
colonoscopies, which they believe expose patients to dangerous levels of
radiation. Now, another whistleblower has stepped forward, and what he
has to say about the agency's drug safety reviews is shocking even to
the jaded...
Former FDA Reviewer Speaks Out About Systemic Suppression of Safety
Ronald Kavanagh was a drug reviewer for the FDA in the Center for
Drug Evaluation and Research from 1998 to 2008. In a recent interview he
reveals how the FDA bypassed or ignored safety issues on major drugs
approved during his employment. In an interview for the online
news magazine Truth-Out, he tells Martha Rosenberg1:
"In the Center for Drugs [Center for Drug Evaluation and Research
or CDER], as in the Center for Devices, the honest employee fears the
dishonest employee.
There is also irrefutable evidence that managers at CDER have
placed the nation at risk by corrupting the evaluation of drugs and by
interfering with our ability to ensure the safety and efficacy of drugs.
While I was at FDA, drug reviewers were clearly told not to question
drug companies and that our job was to approve drugs. We were prevented,
except in rare instances, from presenting findings at advisory
committees.
In 2007, formal policies were instituted so that speaking in any
way that could reflect poorly on the agency could result in termination.
If we asked questions that could delay or prevent a drug's approval -
which of course was our job as drug reviewers - management would
reprimand us, reassign us, hold secret meetings about us, and worse.
Obviously in such an environment, people will self-censor."
According to Kavanagh, people would be shocked if they knew just how
malleable safety data is. As examples, he points out that human studies
are typically too short and contain too few subjects to get a clear
picture of potential risks. In such a scenario, even a single case of a
serious adverse event must be taken very seriously, and data from other
longer term safety studies also need to be carefully analyzed. Kavanagh
claims he has seen drug reviews where the medical safety reviewer
completely failed to make such evaluations prior to the drug's approval.
How the FDA is Recklessly Abandoning Drug Safety
1 comment:
I can't say this surprises me one bit. I used to be involved in the "direct sales" industry. All I can think of is the old Ma Huang (ephedra) products. People were losing weight like crazy. One day I took my diet pill and went to play some tennis. After about an hour on the court my pulse had shot up to 145 or so and it did not come down for four hours. The FDA was turning a blind eye toward what may be considered an old school alternative to meth and no one can tell me that they did not know what was going on, whether the products were being sold in herb shops or not. It's all about money. Eventually a lot of people died and they had to step in and do something about it. But again, you can never convince me that they didn't know of the hazards. You can sell billions of dollars worth of ephedra without the FDA knowing about it. Dr. Crook, on a personal note I would love to invite you to post some articles on my site at http://www.dcclothesline.wordpress.com If you are interested I can set you up with an "author" account. Just drop me a line at dean.garrison.99@gmail.com It might help attract more readers to this site. I am very in favor of anyone who is not afraid to tell the behind the scenes stories, and this is the kind of stuff I want to see on my own blog. So if you want to write some guest pieces for us, just let me know. Of course I do prefer things like this article because it is what my blog is all about...government and business cover ups. Either way, thank you for a fine read. Keep educating the people my friend. Our whole nation is at stake.
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