Invisible victims of FDA drug policy

I’d call this quite the intellectual challenge. At what point do you stop testing and start distributing new drugs that will help people live healthier lives? Walter Williams points out an important issue influencing the drug approval process.People are physiologically unique, that’s why some drugs may work very well for an individual while others do not. The side effects can be all over the place too. Common side effects for Lisinopril, a popular drug to treat high blood pressure, include cough, diarrhea, dizziness, headache and tiredness, but there are many other side effects that preclude the user from taking the drug.

Prof. Walter Williams points out an article by Sam Kazman J.D. in the Journal of American Physicians and Surgeons titled Drug Approvals and Deadly Delays.

During the FDA’s drug approval process, it confronts the possibility of two errors. If the FDA approves a drug that turns out to have unanticipated, dangerous side effects, people will suffer. Similarly, if the FDA denies or delays the marketing of a perfectly safe and beneficial drug, people will also suffer. Both errors cause medical harm.

It comes down to this. One of the Food and Drug Administration’s (FDA) major business objectives seems to be “stay out of the media spotlight” and for goodness sakes, don’t approve any drug that can kill a few people. Of course, we all pray medications will do no harm, but how many lives could be helped by a medication that has yet to be approved by the FDA? And yes, how many die waiting for that new medication?

Kazman tells the story of one FDA employee who managed a division partly responsible for approving cardio-renal-pulmonary medications. Between 1968 and 1972, that unit had not approved even one new medication that was submitted by drug companies. Not one.

That kind of track record ensures your FDA department won’t be called into a Capital Hill committee room to explain why some people got sick or died after taking a drug you helped approve. Curiously though, there are no committee rooms booked for the victims who could now be living healthier lives if the FDA would have approved medications in a more timely manner.

By not approving any drugs in a four year period, this manager – known for following rules EXACTLY, was praised by activists including Ralph Nader who praised the unit for having “an unassailable record of protecting the public from harmful drugs”.

Nader had no concern for the FDA’s invisible victims, those who may well have been helped greatly by a drug or medical device not approved by the FDA in a timely manner.

What do physicians think?

On approval speed, 61 to 77 percent of physicians surveyed say the FDA approval process is too slow. Seventy-eight percent believe the FDA has hurt their ability to give patients the best care.

A possible solution?

One simple but apparently radical approach would be to leave the agency’s safety and effectiveness standards in place, while simply removing its veto power. In effect, FDA would become a certifying agency. Rather than being banned outright, as they are now, uncertified therapies would be available under medical supervision, with informed consent documentation of their uncertified status.

For those doctors and patients who trust FDA, nothing would change; they would simply continue to use FDA approved therapies. But patients who, in consultation with their doctors, wish to go beyond such therapies, would now have new options.

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