Now where have we heard Viagra compared to Phen-fen before?? I still think that the lawyers are going to have a field day with this drug.
If you just scan this article (sorry, it is long) be sure to read the last paragraph. Good summation...
Business Week: May 11, 1998
Cover Story
DANGER: READ THE LABEL
Doctors are prescribing drugs for unapproved uses--and patients are at risk
The thousands of men who are demanding Viagra from their doctors because they think it will enhance an already well-functioning libido might do well to think back on fen-phen. That's the combination of two obesity drugs, fenfluramine and phentermine, that diet clinics were prescribing to almost anyone who asked over the past few years, even though they had never been approved as a combination treatment. Nor were they O.K.'d as a diet aid for the slightly overweight. Then, last summer, researchers at the Mayo Clinic reported that some women taking the combination suffered serious damage to their heart valves--at least six required open-heart surgery--and fenfluramine was pulled off the market.
Like fen-phen, Viagra is also being widely prescribed for uses other than the male impotence it was approved for. No one knows, however, what might happen if millions of sexually healthy men start taking the drug over a long period. It's even more worrisome if women start taking it--the drug has never been rigorously tested for them.
The rush for Viagra highlights a troubling medical practice: Once the Food & Drug Administration approves a drug, doctors can prescribe it any way they see fit. It's called off-label prescribing, because the prescriptions are being written for diseases that aren't indicated on the label. The FDA has virtually no control over off-label prescriptions. In fact, 27 states have laws requiring that insurers pay for such prescriptions when given for life-threatening diseases.
It's true that off-label prescriptions are often beneficial. Because few clinical trials are conducted using children, many drugs are not approved for kids, but pediatricians still prescribe them on the assumption that they've been proven safe. Then there are the discoveries, often during large clinical trials, that an already approved drug is effective against another disease. The FDA usually expedites approval for such additional uses, but doctors need not wait.
Medical experts worry, however, that far too many off-label prescriptions are written without the science to back them up. Perhaps the most glaring example is the huge amount of antibiotics--up to one-fifth of all prescriptions, according to one study--that are uselessly handed out to cold sufferers. Colds are caused by viruses, and antibiotics simply do not work against viruses. By taking them, patients only contribute to the increase in antibiotic-resistant bacteria, a major health crisis. Still, doctors report that patients regularly demand antibiotics for colds--and they acquiesce.
Off-label prescribing is likely to increase, because of a federal law passed in December that lets drugmakers promote unapproved uses directly to doctors if they can back up their claims with a published study. ''We think being able to selectively pick out an article and send it to 300,000 doctors is a bad idea,'' says Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, a watchdog organization in Washington. ''For that matter, it's a bad idea to engage in massive use of any drug off-label in the absence of clear data.''
HALCION DAZE. Wolfe can back up his point with plenty of examples beyond fen-phen (table). Take Halcion, a sleeping pill that has been banned in Britain but not in the U.S. The drug has been shown to increase aggressive behavior and psychosis if taken for more than 7 to 10 days. But an FDA study in 1996 found that 85% of Halcion prescriptions were for longer periods.
The FDA does have some control over how an approved drug is promoted, and doctors are required to report any adverse effects to the agency. ''We have a provision that allows us to put in the label a warning about off-label use if that is causing a major health risk,'' says Dr. Murray M. Lumpkin, deputy director for the FDA's Center for Drug Evaluation & Research. But, he adds, ''it doesn't happen that frequently.''
In the case of Viagra, the FDA issued plenty of material on the drug's risks, which include headaches, blackouts, and vision problems. But it has no way of knowing how many doctors are passing on those warnings. Patients, though, might think back to fen-phen before reaching for a drug to spice up their sex lives. They may discover down the road that it was just not worth the risk.
By Catherine Arnst in New York |
