The FDA’s major problem is not laxity, but zealotry. Its current get-tough view on conflict of interest only aggravates the fundamental flaw in its institutional design. Transfixed on the harms drugs can cause, the FDA remains largely oblivious to the harms they can prevent. Any delay in the use of a successful drug is costly: The delay matters little to the FDA, but a great deal to the thousands who plea for compassionate exemptions to try a drug that has not met with FDA approval. Nor is the FDA sensitive, as individual physicians surely are, to the simple fact that a drug which cannot be tolerated by one person works wonders in another.
. . .
Right now, we all have a simple expedient to protect ourselves against dangerous drugs that make it to the market: Don’t take them. But we have no protection at all when the FDA denies us that choice in the first place. Right now the pace of drug approval is too slow. We don’t need the FDA to slow it up still further.
For the full commentary, see:
Richard A. Epstein. “Drug Crazy.” The Wall Street Journal (Mon., March 26, 2007): A12.
(Note: ellipsis added.)
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How to Protect Your Family From Bad Drugs
Twenty percent of drugs approved by the FDA are later withdrawn from the market or carry warnings that they may cause serious adverse effects. To identify bad drugs, ask these three questions:
1) Has the drug has been recalled or given a black box warning?
2) Has the drug been in litigation with numerous lawsuits against the drug company?
3) Has the drug has been banned in other countries?
To read more, see the complete article at:
Jeffrey Dach MD