Whistleblower Reveals How the FDA Is Recklessly Abandoning Drug Safety

Posted by clnews _Featured_, FDA Monday, August 13th, 2012

(By Dr. Mercola)

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.”

Read the rest of the article….