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AIDS drug's high cost spurs doctors' boycott

In an unusually combative display of physician anger, AIDS specialists in Boston and elsewhere across the nation are protesting a drug maker's steep price increase by boycotting that company's medicines, shunning its sales representatives, and severing research relationships.

Organizers say that 250 doctors and other health care workers in the United States are participating in the action that targets Abbott Laboratories, which in December boosted the wholesale price of a month's supply of the AIDS drug Norvir from about $50 for a daily 100-milligram pill to more than $250. The protest includes physicians from some of the best-known HIV practices in the country, including Fenway Community Health Center in Boston and AIDS Healthcare Foundation, based in Los Angeles. Doctors championing the boycott contend that Abbott increased the price of Norvir, among the first members of a class of drugs known as protease inhibitors, in part to persuade doctors to prescribe a newer AIDS pill made by the company. Abbott executives respond that they are attempting to derive a fair return on a medicine originally designed to be taken many times daily but now typically used only once or twice a day to enhance the effectiveness of other companies' drugs.The action comes amid intensifying opposition to high drug prices by patients and insurers and, industry analysts said, could signal a new brand of militancy among doctors who have been loath to use tools of protest more commonly associated with political and social activists. "If this is an effective mechanism, I suspect there's going to be a move of many more physicians across the country to use this kind of mechanism to attempt to control drug prices," said Kenneth Kaitin, director of the Tufts University Center for the Study of Drug Development. "To not carry Abbott drugs and not allow Abbott sales reps in, if that catches on, that's going to send shudders through the industry."

The protest is of sufficient concern to Abbott that the firm sent a vice president from its Illinois headquarters to Boston to meet with Fenway physicians after the protest began.

Dr. Stephen L. Boswell, Fenway's executive director, said he does not begrudge Abbott a reasonable profit. "But this is beyond any reasonable, justifiable increase," he said. "People depend on these drugs for their lives. We're going to object whenever we think what drug companies are doing is unreasonable and not in the best interest of the patients we're caring for." Physicians at Fenway and other clinics involved in the protest are refusing to prescribe Abbott's products whenever possible, so long as equally effective options exist from other companies. The impact, so far, of the drug boycott is unclear, with industry analysts saying that it is too early to assess.

Another part of the protest involves refusing to collaborate with Abbott on studies of new drugs, a decision that could potentially deprive the company of access to thousands of patients for clinical trials. The price increase has not been felt by most patients so far. Those with insurance generally are charged a set copayment, and AIDS patients who are uninsured typically get their medicines through state assistance programs. In some states, though not in Massachusetts, those programs have waiting lists.

Norvir has been on pharmacy shelves since 1996, and its arrival heralded a new era in the treatment of AIDS patients. Until then, AIDS medicines achieved only marginal success in arresting the virus. That changed dramatically with the development of protease inhibitors, with Norvir being the second from that class to become available. The protease drugs proved so effective that, in many AIDS patients, the virus was reduced to undetectable levels.

As originally designed, 12 pills of Norvir were to be taken by patients each day. But at such high dosages, the drug turned out to produce significant side effects, notably nausea and other gastrointestinal problems.

As the drug fell out of favor as a stand-alone treatment, researchers and doctors discovered that it could play a powerful role at a far lower dose in combination with other AIDS medicines. Norvir, it turned out, slowed the body from metabolizing those other drugs, an unexpected bonanza that allowed those drugs to stay in the bloodstream longer, making them more effective. In the language of the drug world, Norvir became a "booster" drug.

"It turned out to be a product that clogged up the molecular drain for lots of other drugs," said Dr. John Leonard, vice president of global pharmaceutical development for Abbott. At its zenith, Norvir produced $250 million in annual sales for Abbott. But as the use of the drug shifted, with patients taking just a pill or two a day, revenue fell sharply. Company figures show that 22,000 US patients now take Norvir.

"For us at Abbott Labs, this product that has become very important for propping up other drugs has declined to one-twelfth of its original dose," Leonard said. "From a revenue standpoint, Norvir dropped to $50 million a year.

"$50 million sounds like a big number but relative to research and development expenses, it is insignificant."

To more accurately reflect the value of Norvir, and to provide the money needed to discover new drugs, Abbott decided on the price increase late last year, Leonard said.

The development of AIDS drugs is among the hottest fields in the pharmaceutical business. The transformation of AIDS from an almost-certain death sentence to a chronic condition created a population of patients who will need expensive drugs for decades.

Competition for their business is intense. Along with the older-generation Norvir, Abbott makes a drug called Kaletra that combines Norvir with another medicine. In effect, Kaletra does in a single pill what Norvir had been doing in tandem with medicines made by Abbott's competitors.

Clinic doctors and attorneys involved with the protest said they believe that Abbott hiked the price on Norvir as a way of steering patients to Kaletra. "They're leveraging their market on Norvir to get a monopoly in the whole protease inhibitor booster market," said Tom Myers, general counsel for AIDS Healthcare Foundation, which has sued Abbott in federal court in Los Angeles, accusing it of antitrust violations.The drug company denies the antitrust allegations, and even as its executives pledged not to bow to pressure to reduce the price of Norvir, they said they have adopted a series of measures to ensure that the Norvir price increase causes as little pain as possible. Among those steps: The company said that it has permanently frozen at the earlier lower price what it charges government programs that provide Norvir to AIDS patients lacking health insurance. Not all AIDS physicians have joined the protest. Leading scientists such as Dr. Calvin Cohen, research director of Community Research Initiative of New England, continue to collaborate with Abbott. Cohen, whose Boston institute studies HIV drugs, said he believes the company will direct any increase in profits to the development of new drugs.

Still, even Cohen acknowledged that cynicism about the price hike is predictable. "There's good reason we should be skeptical of companies pleading poverty," he said. "I think the harder question is how do we tell real dedication from abuse."

Stephen Smith can be reached at stsmith@globe.com.

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