Shocking Story Reveals How the FDA Is Recklessly Abandoning Drug Safety

By GabbyPA Latest Reply 2012-08-27 17:58:23 -0500
Started 2012-08-13 08:30:50 -0500

By Dr. Mercola
Read the entire article here:

This is a huge article and I hope you will look at it in it's entirety. We depend on this department to make sure what we are putting in our bodies is relatively safe to use. I have shared the book "Sweet Deception" and the DVD "Sweet Misery" that address a lot of similar things. What we need to do is find a way to make sure the FDA is doing what it is supposed to do. Protect the public.

Here is part of the article.

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.

FDA Actively Thwarts Serious Safety Investigations

There’s no telling how many ineffective and/or dangerous drugs and medical devices have been approved and ushered into market through sheer intimidation and bullying, either by pharmaceutical companies or FDA management. Perhaps even more shocking are the revelations that some of the internal rules and regulations of the FDA are clearly designed to thwart serious safety reviews from the get-go.

According to Kavanagh:

“[H]uman clinical pharmacology trials are typically done in Europe, yet clinical pharmacology reviewers at FDA have been barred from analyzing this information prior to studies being conducted in the US. Without being able to do this, we are unable to detect evidence of risks early and cannot provide guidance that would help with the development of the drug in terms not only of safety and proving efficacy, but also with the efficiency and cost effectiveness of the drug's development.”

Another loophole that can put your health in serious jeopardy is that drug companies are not required to include adverse events on the drug’s label if the adverse reaction is:

Below a certain percentage, and/or
Below double the rate of the adverse event found in a placebo

According to Kavanagh:

“By this rule, certain serious and potentially lethal adverse events that eventually resulted in a drug being withdrawn from the market would not have had any mention of the adverse events made in the labeling at all.”

Kavanagh also claims to have discovered another common loophole used by pharmaceutical companies to circumvent safety issues. They’d simply submit bits and pieces of data to different places, effectively preventing the reviewer to pull it all together. Then, because the safety issues falsely appeared to be negligible, it would be decided that no further evaluation would be necessary…

“On one occasion, the company even told me they were going to call upper management to get a clear requirement for approval that they did not want to fulfill eliminated, which I then saw happen. On another occasion a company clearly stated in a meeting that they had "paid for an approval,” Kavanagh says.

“Sometimes we were literally instructed to only read a 100-150 page summary and to accept drug company claims without examining the actual data, which on multiple occasions I found directly contradicted the summary document. Other times I was ordered not to review certain sections of the submission, but invariably that's where the safety issues would be. This could only occur if FDA management was told about issues in the submission before it had even been reviewed.

In addition, management would overload us with huge amounts of material that could not possibly be read by a given deadline and would withhold assistance. When you are able to dig in, if you found issues that would make you turn down a drug, you could be pressured to reverse your decision or the review would then be handed off to someone who would simply copy and paste whatever claims the company made in the summary document.”

Examples of Dangerous Drug Approvals:

read more

6 replies

Nana_anna 2012-08-27 17:58:23 -0500 Report

I can agree on the aspect of drugs being tested on animals. However, how can that be made in comparrison to humans? Still thinking on that issue.

MarkS 2012-08-13 15:23:28 -0500 Report

Also, about the mention of the drug pyridostigimine that Kavanugh mentions as approved by the 'animal rule' the following is from the FDA website:

Pyridostigmine bromide is the first drug approved under a recently issued FDA rule (frequently referred to as the "animal efficacy rule") that allows use of animal data for evidence of the drug's effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans.
The "animal efficacy rule," which became effective on June 30, 2002, is an important component of FDA's efforts to make medical countermeasures available to treat or prevent the effects of biological and chemical agents.

MarkS 2012-08-13 15:18:04 -0500 Report

This article is so biased its ridiculous. Do you know how many drugs never get approved as well as how many drugs are required to conduct additional clinical studies to assure the safety and efficacy prior to receiving approval? Also, clinical studies are done globally to assure a wide spectrum of patients as well as sufficient patients to meet ICH guidance for patient populations in a clinical study. Reagrding the data availability, pharmaceutical companies must report to the FDA any and all adverse events on a global basis in the annual Development Safety Update Report, if an IND is open; if the drug is not being submitted for a marketing application in the US then an IND will not be open and its not an issue. And I've never met an FDA reviewer who did not question a pharmaceutical company - its their job and they take it quite seriously. There are always digruntled employees in every career.

jayabee52 2012-08-13 11:23:24 -0500 Report

you would think a "Watchdog" Agency like the FDA would be immune from such practices. But unfortunately they don't seem to be!