Not On My Patients, or Beware of New Drugs
What do Yasmin® and Vioxx® have in common?
The former is not, as you might think, a chocolate bar. As for the latter, I cannot help being reminded by the quirky spelling of the running ‘guru’ James Fixx, who unfortunately dropped dead at the age of 52 from a heart attack while running, in 1984.
They are both prescription medicine trade names: an oral contraceptive and an anti-arthritis drug, respectively.
The disease that killed James Fixx has also been claimed to have caused the deaths of 40,000 to 60,000 Americans who died of heart attacks while taking Vioxx®.
Yasmin® was promoted to doctors in 2002 as an oral contraceptive which was “truly different”, 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 existing, much cheaper, oral contraceptives. The Scottish Medicines Consortium advised in 2003 that Yasmin® is not recommended. In spite of this it was, and still is, extensively prescribed.
In the case of Vioxx®, when the drug was withdrawn, the manufacturer, Merck, was hit with a deluge of lawsuits from patients and their survivors on the charge that they withheld information about adverse effects on the heart in order to get the drug quickly approved and on the market. Quite right they should be sued, you might say.
But just a minute. It is the manufacturer who is being sued? What about the prescribing doctors? Why aren’t they being sued as well, or instead?
When a new drug comes out it is often heavily promoted, and the drug company representatives (‘reps’, salesmen, detail men) visit doctors with information about their new drug. And what do the doctors do? They immediately prescribe it. Like there is no tomorrow. It is reported that nearly 107 million prescriptions for Vioxx® were dispensed in the US between 1999 and September 2004.
Why, Oh why, do the doctors do it? Do they assume, because a drug has been approved for marketing and is available for prescription, it is safe? Apparently, yes. Are doctors so influenced by the blandishments of Big Pharma that their critical faculties fly out of the window? Are they bereft of judgment, of caution? Apparently, yes. Are they over-awed by a free ball-pen, or even a free dinner, so that they go right ahead and widely prescribe the new drug? Apparently, they do.
It has been demonstrated time and again that new drugs, approved after necessarily limited trials, are thought to be safe but later turn out not to be.
For me, the fact that a drug is new, is a reason not to prescribe it immediately, but to await independent confirmation of its possible benefits and freedom from harmful effects. Of course, if someone came up with an effective and safe cure for cancer, I would use it straight away, but many new drugs are ‘me too-ers’ which are similar to existing drugs; their claimed benefits or improvements are often questionable, or marginal.
How are new drugs to be tested, then? There is no simple answer, but I intend to discuss this matter in a future article.
In the meantime, just as there are so-called NIMBY people (‘Not in My Back Yard’ – nuclear power stations and waste disposal plants, for example, are necessary but I don’t want them near where I live), I would not mind, in relation to using new drugs, being known as a NOMP doctor: ‘Not On My Patients’.