Saturday, January 5, 2008

Lobbying Congress on Anemia Drugs: How Not to Take Care of Patients

Here's a recipe for taking rotten care of some especially needy and vulnerable patients.

The first thing you do is set crazy reimbursement rules for cancer centers and kidney dialysis clinics. You promise to reimburse the physicians based on a percentage of the costs of the drugs that they administer by injection.

I think back to my days as a practicing family physician and wince. Suppose the people in control had told me that if I saw a patient, diagnosed an ear infection, and prescribed a cheap but ideal antibiotic like amoxicillin, I'd get paid $40 for the office visit. If I prescribed two different antibiotics, I'd get $60. And if I prescribed some unnecessary but very expensive antibiotic like Zithromax, I'd get $80. How would that payment system have distorted my prescribing habits? I am glad I never had to find out.

But my colleagues in kidney and cancer care have gotten used to such a reimbursement system--to the extent that for some cancer clinics, these drug administration fees account for fully 1/3 of their revenue. How likely are those physicians to recommend a shorter rather than a longer course of chemotherapy, or a less expensive rather than a more expensive drug, even if the patient would benefit?

Now, into this crazy reimbursement formula you add an anemia drug like Epogen or Procrit. These are very expensive drugs, made by a fancy recombinant-DNA biotech system. The drugs make up for the fact that patients with cancer or with kidney failure fail to make enough of a substance that tells the bone marrow to make more red blood cells, leading to an anemia that can make the patients weaker.

The good news is that in moderate doses, these drugs restore the red cell count and make the patients feel stronger. The bad news is that in higher doses, these drugs, we now know, increase the risks of stroke significantly, and also, in some cases, create a risk for faster tumor growth.

How likely are the docs who are paid on a commission basis--that seems to be what it amounts to, call it what you will--to cut back on the doses they administer, when dispensing higher doses means higher revenues for their clinics?

Medicare, that pays for all of dialysis care and the lion's share of cancer care, finally realized it had a real problem on its hands. So in 2007 they proposed a new rule--they'd pay only for the moderate doses but not for the risky, high doses of these anemia drugs. Which, from a medical point of view, makes perfectly good sense, across the board and in general.

That meant a financial hit to the companies that make the drugs--Amgen and Johnson & Johnson. Both, but especially Amgen, responded with an over-the-top lobbying effort. They complained that some patients, who actually needed the higher doses because of individual treatment factors in order to feel strong enough, would be denied what their doctors recommended for them under the new Medicare rules. (Federal bureaucrats tell doctors how to practice medicine! Film at 11!) They cranked up the "astroturf" (so-called "grass roots" organizations that supposedly represent patients, but that are in fact heavily bankrolled by the drug companies).

As the Wall Street Journal recently reported, the effects have been stunning. Amgen topped all the drug firms in its lobbying expenses for the first half of 2007 ($9.1M). In exchange, both houses of Congress have introduced legislation to overturn the Medicare rules. (Of course, the American Society of Clinical Oncology that represents the cancer docs has joined in opposing the new rules.) Congress tells Federal bureaucrats how to tell doctors how to practice medicine! Film at 11! (Actually, the fate of this legislation is hard to predict, since if it does not pass, Medicare will continue to bleed red ink and Congress will have to find some way to increase tax support for the program. The costs for these anemia drugs is one of the single fastest-growing items in the Medicare budget.)

So what would a person say who actually cared about what happens to patients--as clearly neither Congress, nor Amgen, nor the physicians any longer give a hoot about? It may be that the new Medicare rules are really too burdensome and too awkward to determine which patient needs what dose of these drugs. So maybe the rules are in fact a bad idea and need to be modified.

But pardon me if I believe that the underlying problem that has to be fixed is paying docs a commission for prescribing more and more expensive drugs to certain categories of patients. And if the oncologists and dialysis physicians are offended because I just said that they don't care about their patients any more, I reply--fine; if you want us to believe that you really care about the patients, then join us in changing the way you get paid. If you continue to demand to be paid by a commission formula, unlike most other medical specialties, who in their right minds would ever believe you, that you are truly patient advocates?

Timiraos R. Amgen spends big protesting curbs on anemia drugs. Wall Street Journal, Nov. 13, 2007:B1-B2.

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