Concerns about the Safety and Regulatory Safeguards of Medical Devices

[Time for change]

The prevalence of medical device use in the world is indicated by the fact that consumers spend more than $200 billion on them annually. A medical device is anything that is intended for the diagnosis, treatment, or prevention of disease that is not a drug or a biological (such as a vaccine). In the United States they are approved and regulated by the Food and Drug Administration (FDA) in a similar manner to how the FDA regulates foods and drugs.

A book that I co-edited and co-authored several chapters for (I receive no royalties from it because it was done as part of my government work), "Medical Device Epidemiology and Surveillance", was published a few days ago. That book discusses the many ways in which the safety and effectiveness of medical devices are monitored and evaluated after they are marketed. Most of the book is highly technical and probably of interest only to medical professionals. What I deal with in this post is an issue of broader public interest, the safety concerns that consumers have, or should have, about medical devices. I’ll start out with the chapter from the book which specifically deals with that issue:


A consumer advocate’s perspective on medical device epidemiology and surveillance

This chapter was written by Diana Zuckerman, president of the National Research Center for Women and Families. Keep in mind that the book had to be cleared for FDA approval before it could be published. Consequently, some of what was written was censored/deleted by the FDA prior to publication (more about that later). Dr. Zuckerman accurately notes several problems with the adequacy of the regulatory safeguards currently in place to ensure the safety of medical devices:

 The required monitoring period for implants is short (usually 1-5 years), and therefore cannot identify long term failure.
 The criteria for approval are not very stringent – “reasonable evidence” of safety and effectiveness.
 Mandated post-market studies are frequently not performed as required (or not performed at all).
 Racial and ethnic minorities and women are often not included in research, so the study results may not apply to them.
 Studies are often too small to identify serious problems.
 Advisory panels often include members with conflicts of interest with the device industry, and may act as rubber stamps for them.

The bottom line is that:

There is a clear conflict between consumer demand that products be proven safe and corporate demands that products be approved quickly and be allowed to change without the need for new approval applications.

Handling of whistleblowers by the FDA

How whistleblowers are handled says a lot about the integrity of a regulatory agency. A recent article in the Houston Chronicle discusses several concerns about the ethics of current FDA practices, especially involving the handling of whistleblowers. The Chronicle article reveals several disturbing patterns with the FDA:

As with everything else, Bush cronies always have the inside track:

Dr. Andrew von Eschenbach became friends with former President Bush and former first lady Barbara Bush… In September 2005, President Bush appointed von Eschenbach acting director of the FDA to replace Lester Crawford, who last week was sentenced to three years' probation and fined $90,000 for lying about stocks he owned in companies regulated by the FDA.

Fear of punishment for whistle-blowing is widespread:

Some FDA scientists have expressed concern that the agency has tried to suppress warnings about safety of new drugs and intimidate whistleblowers. A survey published last summer by the Union of Concerned Scientists of 997 FDA scientists found that 40 percent feared retaliation for airing concerns about drug safety in public.

Ketek is the drug that many FDA scientists believed caused cancer. The FDA ignored those warnings until public pressure forced them to withdraw Ketek from the market:

David Ross, a former FDA reviewer, told a House panel that von Eschenbach last summer summoned scientists who had reviewed Ketek after members of Congress had begun to question the drug approval. Ross said that Von Eschenbach, who was acting commissioner at the time, compared the FDA to a football team and told reviewers that if they told anyone outside the FDA about the problems with Ketek approval, they'd be "traded from the team." Ross testified that rather than be silenced, he left the agency.

The influence of industry on the FDA is shocking and totally inappropriate for a so-called democracy:

The drug industry has been a major player in the nation's capital. The Pharmaceutical Research & Manufacturers of America spent $8.8 million lobbying the executive and legislative branches on drug-related issues during the last six months of 2006, according to Political Moneyline.

My personal experiences with the influence of corporatism on the FDA

The corporate influence on the FDA is felt in many different ways: The FDA is forever arranging meeting with its corporate friends (an FDA building in even named “Corporate”), but actively avoids meeting with consumer groups. And groups of scientists sometimes spend several months reviewing applications for a drug or device approval, decide that the product is too dangerous to be approved, and then are over-ruled by upper management saying that the drug or device must be approved, but without providing a decent reason.

My own most egregious experience with FDA’s upper management involved a research manuscript I had written that discussed the risk of ruptured aortic aneurisms (a usually fatal event) associated with the use of a medical device intended to prevent those incidents. My manuscript was initially cleared by the FDA and accepted for publication by a vascular surgery journal. But then, the manufacturer found out about the article and complained about it to Lester Crawford, the FDA Commissioner, who pulled the article just prior to publication. Yes, this is the same Lester Crawford who was recently sentenced to three years’ probation and $90,000 for lying about his purchase of stocks in companies regulated by the FDA. Fortunately, someone leaked the story to the Wall Street Journal, which published it on their front page. Consequently, our records on the subject were subpoenaed by Senator Charles Grassley, former chairman of the committee that oversees FDA activities. However, I never heard back from him after submitting my records (I guess it’s possible that they never reached him, since I submitted them through the FDA). I am currently working on a follow-up (and probably more definitive) article, which I hope to submit for publication within the next year. Let’s see how Eschenbach handles this one.

Diana Zuckerman initially included this episode in her book chapter that I discussed above, “A consumer advocate’s perspective on medical device epidemiology and surveillance”. However, the FDA demanded that the story be omitted from the book. So her chapter does not fully express “a consumer advocate’s perspective” on the issue.


A final comment

Of all the things that irk me about this sorry state of affairs, Eschenbach’s speech where he compared the FDA to a football team ranks at the top. That is what it’s all about for these people. The FDA is like a football team, and the public, who is supposed to be served by the FDA, is instead regarded as the opposition. And of course the Bush/Cheney administration does nothing about this. It’s just like everything else run by these criminals – Instead of the idea of the purpose of government being to serve the public, everything is inverted, so that it is considered the purpose of the public to serve the Bush/Cheney regime. And those who don’t are either “dropped from the team” … or possibly worse.