The government is investigating 16 more people whose heart valves may have been damaged by popular diet drugs - and critics are using the scare to fight Senate legislation that would spur wider sales of such unapproved medicines.
Although doctors haven’t proved that fen/ phen is to blame, the U.S. Food and Drug Administration is reviewing a total of 49 cases of heart damage linked to the diet drugs. Ten patients needed open-heart surgery.
The FDA has never approved taking both diet drugs fenfluramine and phentermine together. While drug salesmen may not advertise unapproved uses of drugs, it is legal for doctors to prescribe medicines in any way they choose - and some 6 million Americans are estimated to have tried fen/phen last year, before doctors spotted the possible heart side effect.
Now the Senate is preparing legislation to let drug salesmen get in on the act, allowing them to provide doctors with studies promoting unapproved uses of medicines.
Doctors “should have the ability to receive credible scientific information from reputable sources in order to make informed treatment decisions,” the bill’s author, Sen. Connie Mack, R-Fla., wrote senators last week.
But FDA allies say fen/phen shows that “off-label” drug promotion is dangerous, arguing that more Americans might be at risk for the heart damage had drug companies spurred even wider sales.
“Fen/phen is a prime example of the potential danger from off-label drug use,” said Jim Manley, spokesman for Sen. Edward Kennedy, D-Mass., who is leading the opposition.
“Problems like this would only be amplified by passage of this amendment.”
A drug goes on sale only after the FDA determines it is safe and effective against a particular disease. But doctors then can prescribe that drug for any disease, and some 40 percent to 60 percent of all prescriptions are for these off-label uses.
Doctors learn about new uses for old drugs from medical meetings or scientific journals. But the idea is that doctors are supposed to keep up with the latest science, not be swayed by a drug salesman.
Mack’s bill attempts to balance the issue by letting salesmen hand doctors copies of studies from what are considered the best medical journals.
The companies would have to admit whether they paid for the study, and provide a list of all related research so doctors could look up further information.
But the FDA cites concerns:
Time-pressed doctors aren’t likely to read further studies to ensure the company didn’t push only positive research.
A study on, say, 20 patients might be published in a top journal, but not big enough to catch side effects or prove how well the drug works in large-scale use.
The bill would remove a company’s incentive to do the more thorough research FDA demands for approval of the new use.