Doctors rebellion against ritonavir price increase spreads in US

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Despite concessions announced last Friday by Abbott Laboratories, anger among US doctors over the company’s decision to quadruple the price of its protease inhibitor Norvir (ritonavir) in the United States appears to be growing, with an announcement at today’s Eleventh Conference on Retroviruses and Opportunistic Infections that a boycott of the company’s products and promotional activities is now supported by more than 200 leading HIV prescribers in the United States.

Physicians have pledged to boycott Abbott promotional events and advisory boards, will no longer permit Abbott sales representatives to visit their practices, and will seek to ensure that their practices or hospitals prescribe alternatives to Abbott products where those exist and it is not harmful to the care of a patient to do so.

At a press conference called by the AIDS Treatment Activists Coalition and the Organisation of HIV Health Care Providers (an ad hoc organisation established to mobilise physicians against the price rise), Dr Ben Young of the Rose Medical Center, Denver, told reporters that the clinicians who had signed on to protest Abbott’s actions represented the leading prescribers of HIV drugs in many US cities, and that Abbott’s actions in unilaterally raising the price of Norvir had now attracted the attention of state attorney generals in Illinois and New York. Both states have been active in looking at ways to curb drug prices, and the news that New York attorney general Elliot Spitzer has launched an investigation is likely to prove especially unwelcome to Abbott. Spitzer's previous targets include Microsoft, Merrill Lynch and Wall Street mutual funds. Last week he and Illinois state Attorney General Lisa Madison issued subpoenas to Abbott, requiring the company to disclose information for investigations into unfair pricing of Norvir.

Glossary

boosting agent

Booster drugs are used to ‘boost’ the effects of protease inhibitors and some other antiretrovirals. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

phase IV

Studies conducted after the effectiveness of a drug has been established and the drug marketed, typically to establish the frequency of uncommon or unanticipated toxic effects. May be described as a phase IV study or as postmarketing surveillance.

In a separate move, Essential Inventions, a not for profit company created by Consumer Project for Technology activist James Love, has filed a complaint with the Federal Trade Commission, alleging that Abbott has sought to price competitors out of the market and that this is a restraint of trade under US law. A second complaint from the same organisation has been filed with the Department of Health and Human Services, alleging abusive pricing of a medicine partially developed with government funds.

The Bayh-Dole Act, passed in 1980, gives the Secretary of Health and Human Services the power to “march-in” on each patent and license other producers to supply US consumers, to meet a health need or because the patent-holder has failed to make the invention available on reasonable terms.

Ritonavir is used overwhelmingly at low doses to boost the activity of other protease inhibitors manufactured by competitors to Abbott, whose own boosted protease inhibitor Kaletra is currently the market leader. Activists allege that Abbott’s action is designed to see off new entrants to the market such as Reyataz and Lexiva, both licensed in 2003. Abbott denies this charge, saying that the price increase was necessary in order to fund new drug development.

After two months of fierce criticism, Abbott announced a number of concessions last week. The company says that it will now provide ritonavir at the previous price to research studies of unlicensed products where it is needed for boosting, and will discuss with these companies options to make their therapies affordable when they are licensed. However this offer will not extend to phase IV (post licensing) studies of Lexiva or Reyataz that manufacturers have been mandated to conduct by the US Food and Drug Administration.

The company has also promised to make Norvir available in bottles of 30 capsules as well as 120 capsules in order to reduce the up-front payments required for those who must cover the entire cost of their medications.

Abbott had previously promised to freeze the price of Norvir at the old level for state AIDS Drug Assistance Programs until June 2005, when their funding is due for review. Last week the company promised to freeze the price at this level permanently.

The company also pledged to make Norvir available free of charge to anyone who does not have insurance coverage, or who exceeds their annual maximum budget for prescription drug costs, and to maintain this offer permanently.