Jewish World Review Feb 25, 2005/ 16 Adar I, 5765

Drs. Michael A. Glueck & Robert J. Cihak

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Consumer Reports


Wrong Way FDA


http://www.NewsAndOpinion.com | The FDA should stop hurting and killing patients.

Instead, last week Food and Drug Administration (FDA) press releases unveiled "a new independent Drug Safety Oversight Board to oversee the management of drug safety issues."

The FDA claims this Board "will enhance the independence of internal deliberations and decisions regarding risk/benefit analyses and consumer safety."

The Board is in response to some critics who say the FDA reacted too slowly to complications of new drugs, such as the arthritis drug Vioxx and the pain drug Celebrex. Some studies link these drugs to an increased risk for cardiovascular complications, such as heart attack and stroke, in some people.

But we view this self-righteous outrage as a convenient cover for the latest rush to power.

Opportunists in the media, Congress and pressure groups make a huge issue of the fact that certain FDA-approved drugs have adverse side effects in some people — while completely neglecting the relief many patients get from the same drugs.

So we decided to look at who will serve on this "independent" board. Will its members be free of dependence on the government? Or interference from politicians?

No.

Members will be "from the FDA and medical experts from other HHS agencies and government departments (e.g., Department of Veterans Affairs) who will be appointed by the FDA Commissioner."

A rare government employee dares to bite the political hand that feeds it.

These Drug Safety Oversight Board people will not be independent. They'll be recycled bureaucrats. And totally dependent on government.

When HHS Secretary Mike Leavitt said "The public has spoken and they want more oversight and openness," he got the openness right but the oversight wrong. Patients in pain and doctors behind bars are already victims of oversight overload.

Why do people in the media and Congress focus on a few people suffering complications from drugs and ignore the many suffering from lack of drugs?

Where was Congress when the FDA took six years longer than European drug regulators to approve the beta-blocker class of heart medicines? When finally approved, the FDA said these medicines would save 10,000 American lives every year. This implies that the FDA delays had caused 60,000 unnecessary deaths.

The Competitive Enterprise Institute, some doctors and some patients describe this suffering in policy reviews, books and newspaper stories, but very few others, especially in the big media and Congress, take any notice.

How is the Food and Drug Administration (FDA), a government agency that allows thousands of Americans to die every year because of its indolence and inaction, going to reduce this toll and increase safety by extending its sluggish ways with another bureaucratic committee?

It's absurd to pretend that any group of people or any person can draw a clear line between "safe" and "unsafe" drugs. Wherever the line is drawn, it is movable, like a line in the sand, depending on countless variables and variations.

Probably even more important, some people want drugs that have no side effects and are almost certain to have the desired effect. Others, such as patients with advanced cancer, are willing to try drugs that have a minimal chance of benefit, say less than 10 percent, and a high likelihood of bad side effects, say 90 percent.

And people change their minds, sometimes from day to day, about the degree of safety and risk that they want to accept.

The only way to be 100 percent safe all the time is very simple: no drugs, not ever. Of course, this also means no benefits, not ever.

Gualberto Ruano, M.D., Ph.D., and Robert Goldberg, Ph.D., write in "Personalized Medicine — The New Frontier for Drug Safety":

"Someday in the not so distant future, doctors will be able to offer patients medical treatments that are tailored to their own unique DNA profiles. This approach — known as personalized medicine — can keep valuable drugs that are safe and effective for the vast majority of patients on the market by pinpointing those at risk of side effects and underscoring the reality that no drug could possibly be safe for everyone."

In contrast, the FDA mandates impersonalized medicine by expanding centralized control over all aspects of drug development, prescription and use. This is utterly retrograde.

So, for starters, I recommend that Congress and the FDA consider this new Drug Safety Oversight Board idea a non-starter and quit wasting their time and our tax dollars on the idea.

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Second, I recommend that Congress tell the FDA to quit dictating to doctors and drug companies what they can tell each other about drugs and drug safety. For example, FDA policy prohibits drug companies from informing doctors and consumers about complications of drugs, if the complication occurs when the drug is used to treat conditions not approved by the FDA, an "off-label" use.

This is not safe.

Third, let's repeal the FDA's dictatorial powers over pharmaceutical drug use. FDA officials could issue their own "Seal of Approval" on the purity, safety and effectiveness of a drug, without having supreme authority to determine whether doctors can prescribe it or patients can use it.

In this arena, where are the liberals insisting on our right to "control our own bodies" or keep the government out of the medicine cabinet? Why do they want to maintain and extend FDA dictatorship?

Whose body is it anyway?

Editor's Note: Robert J. Cihak wrote this week's column.




Michael Arnold Glueck, M.D., is a multiple award winning writer who comments on medical-legal issues. Robert J. Cihak, M.D., is a Discovery Institute Senior Fellow and a past president of the Association of American Physicians and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists. Comment by clicking here.

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