Tuesday, July 12, 2011

The Drug Pipeline--Not So Dry?

Keeping up with today's theme, which is what's happening over in the pharmaceutical industry these days, an encouraging article comes from Jonathan Rockoff and Ron Winslow in the Wall Street Journal (subscription required). The article raises an interesting possibility--that despite all that I don't know about the science of drug discovery, I may actually have been right in HOOKED when I charged the industry with pursuing a dysfunctional model of R&D.

First the good news--20 medicines deemed truly innovative (though not necessarily shown yet to be better than existing medicines) have been approved by the FDA so far this year, compared to only 21 all last year. A Credit Suisse analyst predicts that in the next 3 years, more than 20 innovative drugs that will be good enough to earn blockbuster sums ($1B annually or more) are likely to see approval. Two recent breakthrough drugs for advanced melanoma, two new drugs for hepatitis C, and the first new drug for lupus in half a century are given as examples of recent advances.

Why? Rockoff and Winslow say that Pharma has wised up and realized you cannot make useful new drugs by a science assembly-line approach--the model I derided in HOOKED. You actually have to understand the mechanism of the disease. Hence a new era of partnering with university scientists and small biotech startups. (It also works financially because the big brand-name company can let the small firm assume all the risk, and then come in later and scoop up the drug if it seems promising. For one of the new melanoma drugs, ipilimumab, Bristol-Myers paid a biotech firm, Medarex, about $250M when doing the same drug discovery process totally in-house could have cost it $1B.)

The reporters also state that the more cost-conscious, generic-friendly environment works against the so-called drug discovery model that made profits in the past few decades--just tweak an existing molecule and make a me-too drug like The New Purple Pill. So companies are actually today trying to find diseases that don't already have a good treatment, and look for one. They count on the fact that while insurers in the future may not pay for the next Purple Pill, they will probably pay for the only drug that treats a deadly disease, even if it's priced very high. (Bristol-Myers intends to sock it to patients or their insurers to the tune of $120,000 for a full course of ipilimumab, which they will make pronouncible with the brand name Yervoy. How much they intend to make is shown by the fact that they purchased full control of Medarex for $2.1B.)

The news in this article, if accurate, is hardly the end of all that has been wrong with the drug industry that promotes a lack of professionalism on the side of medicine, and that hurts the public health in the name of profits. But it may be a sign that at least one aspect of the industry is moving in a direction that may actually help future patients, and that may gradually return the industry to an ethic of promoting health more than relying on slick marketing.

Rockoff JD, Winslow R. Drug makers refill parched pipelines. Wall Street Journal, July 11, 2011, A1.

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