Healthy Skepticism Library item: 1442

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Vedantam S.
AIDS Plan Would Cut Drug Costs for Poor: WHO Would Provide 3-in-1 Pill to Nations
The Washington Post 2003 Oct 25
http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&node=&contentId=A14310-2003Oct24¬Found=true

Full text:

The World Health Organization will disclose next week the first details of a global AIDS strategy to bring low-cost drugs to 3 million people in poor countries, a plan that top officials said will eventually include endorsement of pills that combine three HIV drugs in a single tablet.

The endorsement of the three-in-one pills is expected to be controversial because they could violate a variety of patents. Only about 300,000 people are receiving AIDS medicine in the regions targeted by WHO.

The strategy is also expected to call for treating patients at the first sign of symptoms, rather than waiting for tests to confirm infection by HIV, the virus that causes AIDS, and to allow nurses and community organizations to dispense the medicines. As a first step, WHO will issue a list next week of the “first line” medicines to be used in poor countries.

One “fixed-dose” combination already is being sold by a generic-drug manufacturer in India, and several others are in the pipeline. Health experts here said the single-pill combinations would offer huge benefits by providing medication that would work for about 80 percent of patients in an easy-to-use and low-cost form.

If the pills proved popular and effective, the Bush administration could face a politically difficult choice between high-priced patented drugs and low-cost combination generics as it implements its own five-year program to fight AIDS in Africa and elsewhere.

Unlike generic AIDS medicines that copy a single drug’s formula, each of the new combination pills could infringe on several patents in one stroke, taking the conflict between providing lifesaving medicines and protecting intellectual property rights into uncharted waters.

“If we have this regimen in fixed-dose combinations, it will be the best,” Paulo Teixeira, director of WHO’s HIV/AIDS Department, said in an interview. “I hope very soon we will have more and more fixed-dose combinations.”

The combination pills are expected to be part of a broad strategy that the health agency will soon outline to reach its “3 by 5” target.

Teixeira and others said the effort could press ahead without the all-in-one pills, but such medicines would be the best way to rapidly increase the number of people receiving lifesaving therapies.

Of the 3 million patients targeted worldwide, nearly 2 million are in Africa; the rest are scattered across Asia and Latin America.

Activist groups have championed the “fixed-dose” approach. The International Federation of Pharmaceutical Manufacturers Associations opposes the approach, however, contending that combination pills have not been rigorously tested and would make it easier for counterfeit drugs to enter the market.

The pending WHO announcement will mark the second important development in days in the effort to increase access to AIDS medicines. On Thursday, the William J. Clinton Presidential Foundation, founded by former president Bill Clinton, announced agreements with three generic-drug manufacturers in India and one in South Africa to dramatically lower the price of AIDS drugs. Ira Magaziner, chairman of the foundation’s HIV/AIDS Initiative, said three fixed-dose combination pills were covered by the agreement, at an annual cost of $132 to $240 per patient.

Meeting WHO’s goal of providing treatment to an additional 2.7 million AIDS patients by the end of 2005 means 100,000 people would need to be started on medication every month. Several officials here privately conceded that the target is unrealistic, but all said it will spur a long-overdue international effort. More than 5 million people in poor countries need AIDS medication but are not receiving it, health specialists estimate.

Teixeira said the ultimate goal is to radically expand access to AIDS treatment in poor countries.

“We will say, you don’t need to get care only from doctors; let’s train nurses, community organizations and families,” he said. “We’re changing the paradigm of AIDS treatment.” Teixeira is credited for having rapidly increased access to HIV treatment in his native Brazil. Half of all patients in poor countries now being treated for AIDS are Brazilians.

The fixed-dose approach has several advantages, as well as a few drawbacks. Peter Graaff, an AIDS medicine policy expert at WHO, said the biggest advantage may be in getting people to take the medicine on the right schedule. Taking combinations of separate pills can be difficult, and supply problems with any one medicine can upset the entire regimen, he said. That could make it more likely that patients would develop and pass along resistant strains of the virus. However, some patients on fixed-dose medicines may experience side effects caused by just one of the medicines in the combination, Graaff said, and packaging the drugs in a combination tablet would limit the flexibility to switch patients to a different drug combination.

One combination medicine, called Triomune, developed by the Indian pharmaceutical company Cipla, is being used in Africa. It combines the medicines 3TC (lamivudine), d4T (stavudine) and nevirapine.

India is not part of the global system on intellectual property rights, but is expected to sign on by 2005. Under recently negotiated exceptions to the patent system, poor countries can allow local manufacturers to duplicate lifesaving generic medicines, and to export them after completing arrangements that carve out limited exceptions to patents.

Negotiating those “compulsory licensing” arrangements is expected to be much more complicated for the fixed-drug combinations.

Thomas Kanyok, who works in a WHO program that develops medicines for poor countries, said the threat of compulsory licensing could prompt multinational pharmaceutical companies to develop their own fixed-dose combination medicines or license other manufacturers to make them.

The other large variable in the equation is the U.S. government, which has pledged $15 billion to fight AIDS in Africa and the Caribbean over five years.

“Will that be used to buy generics, or will there be stipulations to buy from a U.S. manufacturer?” Kanyok asked.

Harvey Bale, director general of the international pharmaceutical federation, said that generic fixed-dose combination drugs have not being thoroughly tested and that WHO’s endorsement would encourage counterfeit drugs.

“We’re going to start treating 3 million by 2005,” he said. “The question is, are we going to help 3 million by 2005?”

But Ellen ‘t Hoen, spokeswoman for the Campaign for Access to Essential Medicines of the nonprofit group Doctors Without Borders, said combination pills are essential to fight AIDS in poor countries.

“WHO would have to say that this is the way to go,” she said. “That implicitly says that patents shouldn’t stand in the way.”