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Opinion Piece in USA Today on the Promotion of Off-label Uses of Drugs

Sidney M. Wolfe

Many doctors have so little time to read articles in medical journals to keep up with advances in drug treatment – especially new uses for drugs not studied enough to be found safe and effective by the FDA – that they are dependent on drug company-selected articles for information about these off-label uses. Without these drug company handouts, it is reasoned, they would be lost. If aware of this, would you knowingly go to such a lost doctor?

The issue is not whether doctors are free to read articles about off-label uses of drugs in medical journals, often in the context of other articles, editorials and subsequent letters with opposing views. Nor is it whether they should be able to prescribe the drugs for these purposes. Both rights are uncontested. Rather, the issue is whether the distribution of favorable, out-of-context, hand-picked articles – paid for by the drug’s manufacturer – should be allowed to encourage potentially dangerous prescribing of drugs for purposes that lack evidence that benefits outweigh risks.

There is another danger in allowing promotion of off-label uses: It could halt much clinical testing of unapproved uses needed to ensure safety and effectiveness. What corporation would invest millions of dollars in testing that might detect serious problems with its product when promotion for unapproved uses offers a faster, cheaper route to increased sales?

The dangers of off-label use are illustrated by the recent fen-phen diet drug disaster. No large studies supporting long-term safety of the combination had been done. Had any company making fenfluramine or phentermine been allowed to send out published articles promoting the unapproved use of that combination -as the court would allow now – the number of women with heart valve damage might be over 100,000 instead of the 10,000 now believed to have been afflicted.

Since heart valve damage from fen-phen was not attributed to the combination, these adverse reactions were not reported until thousands of women already had been damaged, challenging the notion that after-the-fact adverse-reaction reports are an acceptable safeguard against off-label promotion. Back to promoting  potentially dangerous snake oil?