The FDA’s Deadly Overcaution

In the past two months, there've been news accounts of two major diagnostic advances in medicine. One involves a far more efficient HIV detection test that FDA approved in late June. The other is a new prostate cancer test that may reduce the huge number of unnecessary biopsies and surgeries that are currently performed.

These breakthroughs appear to have significant life-saving potential. However, surprisingly, the new HIV test isn't all that new — it's been used in Europe since 2004 and is now the first line of testing in both the United Kingdom and France. As for the prostate cancer test, it's been available in Europe for over four years, but it still isn't approved here.

The problem isn't getting across the Atlantic. The problem is getting past FDA.

The new HIV test is novel because it detects both the antigens released by the AIDS virus and the antibodies that the immune system produces as it tries to fight the virus. Conventional tests detect only the antibodies, which often take much longer to appear. 

That promises to prevent the spread of the disease. "Since individuals are most infectious to others shortly after infection, detecting HIV earlier is critical and life saving," said Peter Leone, M.D., of the University of North Carolina's HIV/STD Prevention and Control Branch.

So why did it take the FDA six more years to approve it, a delay that presumably resulted in many needless HIV infections? The FDA's June 21 press release is silent on the matter.

At least the new HIV test is available here, which is more than can be said for the prostate cancer detection test. Current tests produce many false positives, and they also can't distinguish between aggressive cancers and those that are relatively harmless. A study last year estimated that more than 1 million men in the United States alone had been needlessly treated for prostate tumors that likely would never have killed them. 

The new test overcomes these disadvantages, but it's still stuck in the FDA's approval bureaucracy.

Why is the FDA slower than its European counterparts? After all, we're not talking about new drugs that can have serious or life-threatening side-effects. These are simply tests to detect potential illness. 

The reason for what can be called FDA's "deadly overcaution" is its fear of being thrust in the spotlight whenever there's an unanticipated adverse outcome from something that the agency approves. Our nation is cursed with a finely honed blame machine, consisting of politicians, reporters and trial lawyers, who are ready to turn every unexpected side effect into evidence of FDA wrongdoing. 

But the only way to guarantee no adverse medical outcomes is to have no new therapies, period. That would be a public health disaster far worse than any imperfect new drug or diagnostic test. 

In the past, the FDA has tried to speed up its approval process, usually after facing tremendous pressure from patient groups, only to slip back to its old habits when the pressure eases.

Now under the new administration, it's taken steps to make this problem even worse. Just weeks ago, for example, it announced that it was tightening its medical device approval process. 

Ideally, the FDA is supposed to be a safeguard for humans. In practice, as with these delayed tests, it often does just the opposite. Talk of FDA reform is fine, but one way out of this dilemma would be to take away the FDA's veto power over new therapies. Let the agency offer all the advice it wants on new tests and treatments, and put its stamp of approval on those it likes, but let the medical profession evaluate that advice on its merits, rather than under legal compulsion.

This may sound like heresy in this time of ever more centralized control over medicine, but why not leave the practice of medicine to doctors and patients?