Fire Those With Conflicts

Those with a conflict of interest should be given a quick heave-ho by the FDA, but this just isn’t happening. It demonstrates how far the FDA has strayed from its mandate to protect the public.

And where is the congressional oversight that would help put an end to this sorry FDA spectacle? Congress has been snoring on the issue of conflict of interest and there is little sign that Rip van Winkle will rise.

It was close to 40 years ago when the world was shocked by the thalidomide tragedy -- when regulatory agencies in many countries approved a drug that caused damage to the fetus in early pregnancy.

Thalidomide Is an Example

About 8,000 mothers worldwide who used the drug as a sleeping pill or as a remedy for morning sickness during the late 1950s and early 1960s gave birth to children with flipper-like arms and legs, missing fingers and toes and/or organs in the wrong places. The drug was ultimately banned in 1962.

The main reason why this nation did not approve thalidomide was because Frances Kelsey, a very strong-minded FDA reviewer, wasn’t swayed by the safety data on the drug and held her ground. Today, rather than rely on someone with Kelsey’s integrity, the FDA relies heavily on numerous outside medical advisors who often are on the pharmaceutical industry pad.

Thalidomide was a wake-up call for all regulatory agencies and prompted numerous progressive changes in safety review. Drug companies were forced to do a better job in proving that their products were safe and effective.

Congress Not Helping

Over the years, shortcuts in the safety review process began to occur when Congress, lobbied by the drug industry, began pressuring the FDA to get drugs out on the market more quickly. Some members of Congress swallowed the big lie that many of these drugs were medical breakthroughs.

That talk of breakthroughs is pure horse feathers. The vast majority of drugs the FDA reviews and then approves are knockoffs of drugs already available to consumers. In any given year, only a few new drugs are generally in the breakthrough category.

And now the chronic disease of conflict of interest is making it even more difficult for Americans to trust the FDA. The agency needs to clean house, and fast, before it becomes joke fodder on the late-night talk shows.

Next week’s column will review an even darker side of medical science, and revelations of a shocking new scandal will likely further damage our trust in scientists and government institutions.

Nicholas Regush produces medical features for ABCNEWS. In his weekly column, published Thursdays, he looks at medical trouble spots, heralds innovative achievements and analyzes health trends that may greatly influence our lives. His latest book is The Virus Within.

ABC News Second Opinion September 29, 2000.