Feature Article

Danger of New Drugs

What do Yasmin and Vioxx have in common? While neither is available in Japan, Yasmin and Vioxx are prescription medicine trade names: an oral contraceptive and an anti-arthritis drug, respectively.

Yasmin was originally marketed as a “truly different” oral contraceptive with a claimed favourable effect on pre-menstrual tension, skin condition, and weight gain. However, a year later an independent review found that Yasmin had no advantages over much cheaper oral contraceptives. The Scottish Medicines Consortium, for example, advised in 2003 that Yasmin is not recommended — but it is still extensively prescribed.

Critics claim that 40,000 to 60,000 Americans suffered heart attacks while

taking Vioxx. When Vioxx was with-drawn, the manufacturer was hit with a deluge of lawsuits claiming it had withheld information about adverse effects on the heart in order to get the drug quickly approved and on the market.

But why blame the manufacturer? Why not sue the prescribing doctors instead, or as well?

Manufacturers’ representatives promote new drugs to doctors, many of whom immediately prescribe them. It was reported that nearly 107 million prescriptions for Vioxx were dispensed in the US between 1999 and September 2004.

It has been demonstrated many times that new drugs approved after limited trials are considered safe, but later turn out to be dangerous.

For me, the fact that a drug is new is a reason not to prescribe it immediately, but rather to be cautious and await independent confirmation of its possible benefits and that it has no harmful effects.

Naturally, if there were an effective and safe cure for cancer, I would use it straight away. However, many new drugs are simply variations on old themes and similar to existing drugs; their claimed benefits or improvements are often questionable or marginal at best.

So how should new drugs be tested? This is a big question and there is no simple answer, but I will discuss it in a future article.

Meanwhile, I would not mind being known as a NOMP doctor—not on my patients.