Sloppy Reportage in Unapproved Drugs Story

The US media threw a needless scare into an already jumpy American population by reporting that “Doctors write 65 million prescriptions each year for unapproved drugs,” and “These drugs were never approved by the US Food and Drug Administration.” This is not entirely accurate, and the hype behind it follows the mantra, “If it bleeds, it leads.” Closer analysis, which a good editor should demand if a good reporter won’t do it independently, shows a much different situation.

The crux of the issue is the National Drug Code, a 10-digit number that the FDA uses to track a drug as it makes its way through pre-clinical, Phase I, II and III clinical trials. Pharmacies use the NDC number to order the drug whether it is approved or not. Some pharmaceutical companies are selling drugs that the FDA hasn’t blessed for certain therapies using the NDC. The message being, “Oh, dear lord, those unscrupulous drug companies are poisoning patients and the FDA is doing nothing.” And that isn’t so.

A simple solution would be to assign a new number to a drug once it has been approved. That way, a pharmacy couldn’t order something that hasn’t been approved. Like most simple solutions, this won’t work. And it won’t work because a great many of the drugs in question have been approved, just not for the prescribed purpose.

For example, quinine has been used in treating malaria for close to two centuries in western medicine – it works. However, it is also used to treat leg cramps. The FDA has approved quinine for malaria but not for leg cramps, and last year, it ordered firms to stop selling quinine-based drugs for leg cramps. The FDA says there were 665 “adverse events,” including 93 deaths linked to quinine treatment for leg cramps. Note, the FDA didn’t ban quinine for malaria, so is it approved or not? The media didn’t dig very deep into this (although CNN’s Audrey Gruber is a noble exception).

One of the keys to the success of the US pharmaceutical business is finding new ways to use old drugs, for which patents can be extended or newly awarded. Viagra was originally intended by Pfizer to treat angina, the benefits in treating erectile dysfunction were considered a side effect at first. When the patent for ED treatment lapses, Pfizer will need a new use for the drug, and it is looking at treatment of high blood pressure and stroke therapy. Currently, it is not approved for those, but Viagra is certainly approved for something, since it is one of the most prescribed pills in the country.

Rather than really explain the story, the media opted to scare the country by misreporting in effect that quinine is not an approved drug despite having saved millions of lives.

© Copyright 2007 by The Kensington Review, Jeff Myhre, PhD, Editor. No part of this publication may be reproduced without written consent. Produced using Fedora Linux.

Home