AIDS drug price hike prompts calls for intervention

Erika Check, Washington
Nature Vol. 429
May 6, 2004

The National Institutes of Health (NIH) has been asked to step in and halt the spiralling cost of AIDS medications in the United States. Under a 1980 technology-transfer law, the biomedical research agency can arrange for the generic production of pharmaceuticals whose invention was based on NIH-funded research, if the existing manufacturer will not provide the treatment on "reasonable terms". In January, Essential Inventions, a non-profit group based in Washington DC, asked the NIH to invoke these ‘march-in’ rights with regard to the AIDS drug Norvir, made by Abbott Laboratories of Abbott Park, Illinois. Last December,Abbott raised the US price of Norvir treatment from $1.71 to $8.57 per day.

The NIH will discuss the request at a public hearing at its headquarters in Bethesda, Maryland, on 25 May.Abbott says the price rise is necessary because the drug is used in low doses, resulting in lower sales. The request’s supporters include Sherrod Brown (Democrat, Ohio), the senior minority member of the House of Representatives subcommittee,which oversees the NIH."When a company raises the price of an essential medicine by 400%, it gets anybody’s attention,"Brown says. Taxpayers pay for biomedical research, he says,"but we never invoke the mechanism that would bring prices down for the public". The price increase angered AIDS activists because Norvir boosts other AIDS drugs called protease inhibitors - so all patients taking these are affected. The issue also coincides with a national argument over drug pricing in the run-up to November’s elections. That environment could make it hard for the NIH and its parent agency, the health department, to turn down the request.Health secretary Tommy Thompson "would have to say yes, it is reasonable for an invention to be ten times more expensive here than in other countries, even if US taxpayers funded it", says James Love, president of Essential Inventions. Abbott says the price increase will not affect uninsured patients,who get the drug free, or others who get it under government programmes.

The company’s supporters say that the Bayh-Dole Act,which contains the march-in clause, was not meant to control drug prices. Joseph Allen, president of the National Technology Transfer Center in Wheeling, West Virginia, and a former Senate staff member who worked on the act, says the phrase "reasonable terms" was not supposed to embrace price increases. Love agrees that the question of what constitutes "reasonable terms"will be crucial to the outcome of the request. But he argues that Abbott is trying to quash competition by charging more to patients who use Norvir to boost other protease inhibitors, rather than using Abbott’s own treatments,which incorporate the drug."This is designed to prevent people from buying non-Abbott protease inhibitors," he says."If this doesn’t trigger the march-in, nothing does."

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