A Tale of Two Medicines - Vytorin and Lucentis

The world's pharmaceutical giants invent and market medicines that save, prolong and vastly improve the quality of our lives. In return, we give them more money than most people can imagine.

That's not entirely a bad trade, except that the highly complex nature of evaluating drugs, the ever-improving marketing savvy of the drug companies and the weakness of the Food and Drug Administration are clearly combining to tilt the deal too far on the side of profits and too little on the side of human health.

A small outburst of reports in recent days provides enough of a sample to build a scary theory about how drug makers are getting the better of the FDA, doctors and patients.

One case involves two different medicines made by the same company, Genentech Inc.
One drug, Avastin, is approved, marketed, prescribed and, apparently, effective as a cancer treatment. But some doctors who have been trying it out on their own patients believe it also shows great promise as a way to fight an eye disease known as age-related macular degeneration, or AMD. The other drug, Lucentis, is approved for AMD and, as far as modern science can tell, works.

But using Lucentis for AMD costs $2,000 per treatment, while using Avastin for the same malady would cost only $60 per treatment. Formally approving the cheaper drug for AMD treatments, and possibly preventing blindness in thousands of people a year, would require a new round of clinical trials to make sure it works without any unacceptable level of side-effects.

But Genentech, looking at a difference of $1,940 per dose -- or more than $1 billion a year nationally -- won't play along. And the FDA, which doesn't have the staff or the money to conduct such tests without drug companies' full cooperation, is stuck. And so are doctors who could prescribe, insurance companies that could pay less for, and patients who could benefit from the less expensive preparation.

Meanwhile, over in the heart and cholesterol aisle, the heavily marketed drug Vytorin is under suspicion by some experts as being a big, and potentially harmful, dud. Well, half of it is.

Vytorin is a mix of two medicines, a long-proven cholesterol- fighting statin and a newer medicine called Zetia. But the Zetia part has yet to establish that it actually helps people avoid heart attacks, live longer, healthier lives, or to do anything else but spend a lot more money on the new drug than it did on the old one. And one study in Norway has, very tentatively, linked Zetia to cancer.

In these cases, and many others, the FDA and the public are overly reliant on the good graces of drug companies to properly vet their medications to be as sure as possible that they not only help with disease but also don't cause any horrible problems along the way.

Such assurances require not only extensive premarket trials but also exhaustive monitoring and follow-up afterward, which is when the drugs are used by enough people over enough time to give a real indication of their benefits and risks. That's a moral responsibility -- but if corporations don't realize that, it should also be a mandated one.

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