Friday, March 17, 2006

It's the Money, Honey

Today the New York Times published an article citing a study of the Alzheimer's drug Aricept, which found an unusual number of cardiac related deaths.

Ever since FDA approval for mild or early stage Alzheimer's in 1996, Aricept, manufactured by Pfizer (the Viagra people) and the Eisai Company, has remained on the hot seat, primarily for being very expensive without being very effective. In 2004, a study conducted by Britain's National Health Service and reported in the medical journal The Lancet concluded that Aricept had "disappointingly little overall benefit" and was not cost-effective. A quick glance at drugstore.com today showed Aricept to be around $5 per daily dose.

In response to this British study, the Alzheimer's Association issued a statement--perhaps non-statement would be a better way to characterize it--carefully distancing itself from any opinion and urging for increased research funding. Yet in their treatment fact sheet available on the website they state plainly that only half of the people who take cholinesterase inhibitors (Aricept and friends) experience a modest improvement in cognitive symptoms.

What a pickle for the Association to find itself in. According to the NYT, they receive about 5% of their donations from the drug industry. In addition, members of the Alzheimer's Association Research Roundtable include Eisai Europe, Ltd, Elan Corporation, plc, Eli Lilly and Company, Forest Laboratories, Inc., Pfizer Inc, and Wyeth. Tricky. At the time of the Lancet study, it was the only study to have been conducted independent of the drug industry and as far as I can tell still the only one. Very tricky indeed.

I empathize with the plight of the Association folks who need to respond to these studies with drug industry dollars hanging over their heads and I want to help. I offer these lines, which they should feel free to crib:

In response to the Aricept study citing an unusually high rate of cardiac related death we say emphatically that we are against death in circumstances where death may possibly have been avoided, although it may have been unavoidable and not at all related to Aricept. We urge increased funding for and continued research on all causes of death, not simply deaths that may or may not be related to Aricept. Although we take a firm stand against death, we also feel this study should merely stimulate policy debate and not dictate individual treatment decisions*

*The last part of that sentence I actually cribbed from their statement in response to the Lancet article.

I'm not picking on the Alzheimer's Association. I'm sure their position is far from unique amongst disease advocacy and research groups. But where is the American study, independent of drug industry interests and unafraid to plainly interpret the data before them? Nothing can truly be bias free but surely we can do better than a study funded by a company that stands to make lots of money with one outcome and lose lots of money with another. We're so accustomed to seeing Philip Morris commercials that want to help us stop smoking that we think it's normal, but it isn't. It's just crazy.

I'll have to look back to get the citation but if you really want to bite your nails to the quick, there's a great article in The New Yorker from maybe a month back about President Bush and his "who needs science when I've got the Lord" attitude, which brings us back to what I'm really talking about here, and that's money--government funding for scientific research unencumbered by partisan influence. Scary stuff.

Love the FDA website by the way. While perusing the press releases to see if they had issued a statement about this latest Aricept study (not yet) I discovered that they recently approved a generic version of Flonase nasal spray. At last, I can afford to be allergic to my cat. Now if only they would fast track generic Norvasc (v. expensive blood pressure medication for my cat--catching a theme here?), then I wouldn't have to continue giving my business to those money grubbing Canadians.

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