American corruption: the Food and Drug Administration

[barts]

Further to my Cassandra sooths about American corruption, an interesting (to me) story appears over at Alternet.org, Former FDA Reviewer Reveals Shocking Intimidation and Retaliation Within Agency.

People trust their lives to the FDA, but it is wholly in the thrall of the drug industry. Some "nuggets" from the interview with Ronald Kavanagh, B.S.Pharm., Pharm.D, Ph.D., an FDA drug reviewer in the Center for Drug Evaluation and Research.

As I assert, the US is the most corrupt nation on earth. The FDA is but one example of it--an example of an agency happy to kill people to serve drug companies.

In the Center for Drugs [Center for Drug Evaluation and Research or CDER] ... 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.

For example, human 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. New labeling policies can also mask risks as they exclude the labeling of adverse events if they are under a certain percentage and/or not double the rate found with a placebo. By this rule, certain serious and potentially lethal adverse events that eventually resulted in a drug being withdrawn from the market would not have had any mention of the adverse events made in the labeling at all. On top of that, I frequently found companies submitting certain data to one place and other data to another place and safety information elsewhere so it could not all be pulled together and then coming in for a meeting to obtain an agreement and proposing that the safety issue is negligible and does not need further evaluation.

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.

FDA's response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply add a watered down warning in the labeling. In fact, when patients exhibit drug toxicity it is usually attributed to an underlying condition which we know is likely to make the drug toxicity worse. This also allows the toxicity to be dismissed as being unrelated to the drug in any way. Consequently, toxicities are only attributed to the drug when the evidence is irrefutable. Thus the majority of cases where there is a contributing factor are simply dismissed. When you do raise potential safety issues the refrain that I heard repeatedly from upper management was‚"where are the dead bodies in the street?" Which I took to mean that we only do something if the press is making an issue of it.

Thanks to systemic and endemic American corruption, FDA approval can be (and often is) a death warrant for trusting Americans who think their government has integrity.

[Yarn]

I'd be interested to know, and would be more convinced if, there were evidence that FDA decisions frequently contradict those of foreign FDA equivalents.

Sometimes the FDA goes overboard, doing things like increasing the cost of drugs by requiring they contain less lead than the concentration found in a typical loaf of bread. And as a generalism, satisfying FDA requirements costs billions of dollars.

This doesn't deny the possibility of corruption, but it does call into question the claim that the process lacks any integrity. If corporations had complete control over it, why would they allow it to cost them so many billions of dollars?

And when it comes to medicine, too much caution kills as readily as too little.

FDA's response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply add a watered down warning in the labeling.

The warnings everyone sees in television ads are "watered down"?

European data ought be counted.

A better system would be for drug companies to have no discretion over who conducts the trials.

[barts]

A better system would be for drug companies to have no discretion over who conducts the trials.

Indeed. The testing should be done by disinterested third parties.

More damning evidence,

International Study Shows Drug Companies Hide Bad Clinical Trial Results

A new study conducted by Canada's Ottawa Hospital Research Institute found that pharmaceutical companies routinely hide bad clinical trial results – putting image, market share and profits over consumer safety.

Selective reporting

The study, conducted by the Ottawa Hospital Research Institute and in conjunction with researchers from Canada, France and England, found that major drug companies such as GlaxoSmithKline routinely hid negative clinical trial information on popular drugs such as Avandia and Paxil about 50 percent of the time.

According to a report in the Ottawa Citizen, the researchers said that drug companies generally use two methods to report positive drug trial results in medical journals, “The first method is to simply not mention tests which did not generate favorable results for a particular drug. The other method is to “cherry pick” data from a drug trial; playing up positive results and downplaying or simply not mentioning negative findings that were part of the same study.”

Unfortunately, this isn't the only study to expose selective reporting – and drug litigation lawyers say that consumers are the ones who ultimately suffer from these practices. Here are some other studies and articles addressing the issue:
New England Journal of Medicine. A study published in the New England Journal of Medicine (NEJM) also reported that drug companies are selective in what they report. Researchers responsible for the study reported that nearly 86% of negative antidepressant clinical drug trial information was never reported to the U.S. Food & Drug Administration (FDA), yet 94% of positive clinical trial information was reported.

Wall Street Journal. The Wall Street Journal's Health Blog reported that researchers evaluated 25 clinical cancer trials over a 10 year period which were terminated early as more and more negative results were discovered. Unfortunately, drug companies used nearly 75% of that “incomplete” data to obtain drug approval from the FDA and the EMA (the European Medicine's Agency – the FDA's European counterpart.

Annals of Oncology. A study published in the Annals of Oncology Journal reported that researchers reviewed over 10 years worth of clinical cancer trials which were terminated early and concluded that drug companies were more market driven than consumer safety oriented.

[NoJingoLingo]

Again I would have to go to monied interests fucking things up. Hey, if you can't comply with the regulations just by off the inspector, right?

[Apeman81]

Again I would have to go to monied interests fucking things up. Hey, if you can't comply with the regulations just by off the inspector, right?

And this cannot happen if the federal government controls things?

[Senor Hoint]

And this cannot happen if the federal government controls things?

Not if democracy is working properly. The federal government should be accountable to the people.

[Zel]

Sounds similar to the prelude of Bioshock 3. Great game.

[NoJingoLingo]

And this cannot happen if the federal government controls things?

Sure it can, but one is less likely to take a pay-off if they aren't over worked and underpaid. This is what republicans do, they defund the FDA causing more work for fewer people.

[Apeman81]

Not if democracy is working properly. The federal government should be accountable to the people.

The federal government is not a, nor is controlled by, democracy.

Our elected representatives to do not control the day to day workings of a federal government agency. But they can vote to de-fund such an agency should it become too unruly.

However, it has little incentive to do so.