Advocacy Group Plans to File for Permission to Produce and Sell ‘Low-Cost’ Stavudine in the United States

Reaction by U.S. advocacy groups to recent price cuts for AIDS drugs in Africa has signaled that "the debate on the high prices of AIDS drugs is moving to the United States," with one group yesterday announcing its plans to seek permission to produce and sell a generic version of a patented AIDS drug. The New York Times reports that members of the Consumer Project on Technology, a patient advocacy group, said yesterday that they had formed a not-for-profit company that would "soon" ask lawmakers for permission to produce and sell a "low-cost" version of the AIDS drug stavudine, or d4T. The patent for the drug is held by Yale University but licensed to Bristol-Myers Squibb, which sells the medicine under the brand name Zerit for about $10 per day in the United States. The Consumer Project, however, said it would sell its version of the drug for "10% or less" of Bristol-Myers' price. The group said that a provision in a 1980 law known as the Bayh-Dole Act allows the government to require a company selling a drug developed with government-funded research to grant a license to another party if "it is shown that the drug company is not making the invention available to the public on 'reasonable terms.'" The government has never approved a petition under the Bayh-Dole Act, but an NIH spokesperson said that if the government received the coalition's petition, it "will be taken seriously." The Consumer Project said that government grants funded "most" of the cost of discovering and developing Zerit, and that Bristol-Myers has received revenue from the drug that has well exceeded the company's expenditures on clinical trials. According to James Love, director of the Consumer Project, Bristol-Myers spent less than $15 million on clinical trials for Zerit, but has generated more than $2 billion in revenue from the drug. A spokesperson for Bristol-Myers said that Love's figures were "inaccurate," but "could not immediately provide the amount the company had invested to develop Zerit," the Times reports. A spokesperson from Yale said that university officials "could not comment" on the issue without seeing the group's proposal. The new company does not yet have a name and board members are currently being selected. Love said that the group expects to file the petition with HHS in mid-April. If the petition is successful, he said, the group may ask the government to allow it to sell other drugs, such as cancer medicines, whose discoveries were aided by government funding (Petersen, New York Times, 3/28).

Abbott Announcement Draws Reaction
In other drug pricing news, yesterday's announcement by Abbott Laboratories declaring that the company will sell "at cost" its two AIDS drugs Norvir and Kaletra and its HIV test Determine in sub-Saharan Africa has sparked praise and criticism from health officials and advocacy groups. A number of advocacy groups expressed "disappointment" that Abbott's offer did not include developing countries outside of sub-Saharan Africa. Love said that while Abbott's effort is "a step in the right direction," it is also "fairly limited." He added that Abbott has been "slow" in making its offer. ACT UP/New York called Abbott's announcement a "PR ploy," and group spokesperson Eric Sawyer added that Abbott's decision not to disclose its new prices is "a sign of 'bad faith'" (Gellene, Los Angeles Times, 3/28). Stefan Loren, an analyst for Legg Mason Wood Walker Inc., gave Abbott credit for stating that it will establish a system to distribute the drugs. "Abbott is the first company to imply that they're going to work on the distribution as well," he said. Abbott Chair and CEO Miles White added that the company had humanitarian interests in mind when making the offer. "Abbott has taken this action to give people most affected by this disease a better opportunity to access care. The next step in the global response is to develop the infrastructure necessary to deliver effective treatment" (AP/Philadelphia Inquirer, 3/28).