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From the Editor: Mixed Signals


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-05-01-2006
Volume 0
Issue 0

Where is pharma going? Toward more science, and more political pressure on science. Toward greater patient responsibility-and more regulation-by-lawsuit. And forward. Let's not forget about forward.

You know what Wayne Gretzky used to say—skate to where the puck is going to be, not where it was. A lot of folks think it's good business advice, and it probably is. There's just that one little difference between business and hockey: In hockey, at any given moment, only two or three people are likely to change the direction of the puck, and you can see all of them. Business is more like hockey played with hundreds of players all slapping at the puck at once. What's worse, some of them have forgotten which side they're on, while others don't remember which way the goal is. Know what I'm talking about? If not, all you have to do is browse the news for any two-week period and ask yourself, "Where's this puck going."

Patrick Clinton

Here, for example, are just a few of the pharma headlines for the last few weeks:

See you in court A New Jersey appellate court gave its go-ahead to a nationwide class-action lawsuit on behalf of health plans that paid for Vioxx (rofecoxib). The state Supreme Court could overturn the decision, but either way, it's another example of a troubling tendency—payers using the courts when in retrospect, they don't like the way they spent their money.

Another agency heard from The Federal Trade Commission announced plans to subpoena close to 200 pharmaceutical companies to determine whether authorized generics diminish competition (that is, whether there is more competition when there are two drugs on the market instead of three). No word yet on when the Post Office, the Census, and Homeland Security will target pharma.

You bet your life A study by John Calfee of the American Enterprise Institute asked how much risk patients with multiple sclerosis were willing to take. The results were striking: Fifty-five percent said they'd "definitely" or "probably" take a drug with a one-in-a-thousand risk of death (about the risk they'll face if they take Tysabri) if it prevented relapse. Better yet, 80 percent said they were just as involved as their physician in making decisions about care. (See "Risks and Benefits".) That, of course, is how drug safety is supposed to work.

Scientific method Rep. Carolyn Maloney (D-NY) announced that she and Rep. Dave Weldon (R-FL) were introducing a bill calling for a study to determine whether there is a link between autism and the use of thimerosal in vaccines. It's true, a well-designed study might put the thimerosal controversy to rest—but don't count on it. Maloney and Weldon may not be trying to legislate results, but others in Congress certainly will be.

No pressure Senators Hillary Clinton and Patty Murray announced their intention to block Andrew von Eschenbach's appointment as commissioner of FDA, demonstrating that to some people, at least, the best way to get an agency to resist political pressure is...more political pressure.

I could go on, but you get the picture: more science, but more political pressure on the science. More attacks on the industry, but at the same time, signs that some patients and doctors use the system well.

And of course, more startling discoveries in healthcare. In the same two-week stretch, scientists announced they'd grown a urinary bladder from patient cells, transformed cells from human testes into stem cells, and reversed Type I diabetes in mice. These developments won't all bear fruit, but they're a powerful reminder: Healthcare, for all its wonders, is still in its infancy. We may not know where the puck will be next, but we know where it needs to go: forward.

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