IAPAC proposes rationing HIV drugs in the US
Lotteries ethical’ but only as last resort
Universal access to health care isn’t coming to the United States any time soon. The prices of antiretrovirals aren’t expected to decline considerably. Evidence mounts that earlier treatment of HIV is good medicine but medicine that will have to be administered for years on end.
Those are some of the reasons why the International Association of Physicians in AIDS Care (IAPAC) in Chicago supports a policy to ration drugs for treating HIV/AIDS in this country. And in some ways rationing is already taking place in the form of governments’ decisions not to provide funding for life-saving treatments.
"As unpopular as it may be, we must use the R word," said Jose Zuniga, deputy director of IAPAC. "But we must call the consequences of a system that cannot provide adequate health care to those who will die without such care exactly what it is rationing."
IAPAC supports the extension of Medicaid eligibility and state-match requirements for AIDS Drugs Assistance Programs (ADAPs), but it considers them short-term solutions. Assuming that drug rationing is inevitable, IAPAC proposes that plans for explicit rationing be drawn up by a group that includes bioethicists, physicians, community leaders, health care officials, and HIV-positive patients. Such a panel would have to confront such difficult decisions as how a patient’s age, health, financial status, and ability to comply with drug regimens would determine eligibility for scarce drugs.
Lotteries used for scarce drugs
Using lotteries to distribute drugs that are in high demand is not unprecedented in the country, said Lawrence Gostin, JD, professor of law at Georgetown University and an expert on public health law. They have been used when new drugs for treating multiple sclerosis and Lou Gehrig’s disease first came out. Missouri’s ADAP has chosen to use a lottery for distribution of protease inhibitors.
"Many believe this is cruel. They believe they have contracted HIV from some chance event and why allow another chance event to exclude them from the possibility they have of living a better life," he said. "And yet most ethicists think that lotteries are a fine and good thing because from an ethical point of view this is random selection and prevents discrimination."
The most vexing problem with drug lotteries is the problem of scarcity, Gostin noted. Lotteries are fair if one assumes the scarcity is genuine (i.e., the drug can’t be manufactured fast enough), but often the idea of scarcity hides behind the fact that it is a social or economic decision society has agreed upon.
Without drug rationing or a national mandate to dramatically increase HIV treatment funding, the cost of the new therapies will remain prohibitive for many patients, public health officials warn. And drug prices are not expected to drop significantly any time soon. Indeed, the price of drugs is irrelevant in a discussion of the ethics of AIDS care, said John Collins Harvey, MD, PhD, professor of medicine at Georgetown University. Without the promise of high profits, the pharmaceutical industry would not have invested in the drugs to begin with and could not afford research costs to develop new ones.
As the most vivid example, the development cost of one of the four protease inhibitors on the market exceeded $1 billion dollars. For the small company Agouron Pharmaceuticals of La Jolla, CA, it took 10 years of losses and a $250 million investment before its protease inhibitor, nelfinavir, reached the market, said company President Peter Johnson. John Siegfried, MD, deputy vice president of the Pharmaceutical Research and Manufacturers of America in Washington, DC, said that he and many of his colleagues suffer from conflict over the need to make a profit and the needs of the ill and disadvantaged. The pharmaceutical industry ranks No. 1 in reinvesting its profits back into research (an average 21%) and in outright donations to organizations. He noted that 42 companies operated drug-assistance programs for the indigent and that 5% to 10% of patients using protease inhibitors have received the drugs free from manufacturers.
The most recent example of drug company largess is a grant program announced last month by Glaxo Wellcome Inc. of Research Triangle Park, NC. In efforts to overcome the dosing complexities of new combination drugs, the company is providing grants of $10,000 to $50,000 to programs that help patients adhere to the regimens.
While the importance of the profit motive in developing new drugs can’t be denied, Gostin argues that drug companies should be required to disclose more detailed information for public scrutiny. "We have little ability to look at figures to know whether we can trust they are making decisions that are clear and right and socially just," he added.
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