U.S. balks at generic medicines for AIDS
NEW YORK – The ongoing effort to get inexpensive AIDS drugs to impoverished countries around the world has hit a new stalemate – a debate over whether drugs approved by the World Health Organization are good enough for the Bush administration.
It’s a debate expected to be heard as the biannual International AIDS Conference convenes today in Bangkok, where issues surrounding the delivery of inexpensive generic drugs to developing countries are a likely topic.
In 2003, President Bush pledged, as part of his global AIDS initiative, to spend $15 billion on efforts to treat and prevent the disease in 14 African and Caribbean countries.
But until recently, the Bush administration has refused to buy generic drugs, approved by WHO, for use in the program. The U.N. agency has approved several combination generic medicines – cheaper copies of brand-name pharmaceuticals – which put three AIDS drugs in one pill, at a cost of as little as $132 for a year’s supply. The drugs are used internationally.
Instead, the government bought more expensive brand-name drug cocktails – usually, a collection of six different pills – which cost as much as $550 a person annually. The higher cost translates into fewer medications being delivered to the Third World.
Though various humanitarian groups and charities, such as Doctors Without Borders, use the list of generic drugs approved by WHO to purchase drugs to treat AIDS patients, the United States has refused to permit the Food and Drug Administration to join the effort.
And organizations that receive U.S. funds from the Bush AIDS initiative must buy the more expensive brand-name drugs – or use it for purposes other than medication.
In May, however, many AIDS activists rejoiced when U.S. Health and Human Services Secretary Tommy Thompson announced that the government, for the first time, would consider buying generic drugs with the $15 billion pledged by Bush.
But there was a catch: The administration would not automatically pay for AIDS drugs already approved by the WHO, even though they are being used in other countries.
Instead, any generic drugs not already approved by the FDA for use in the United States would have to be screened by the agency in an expedited two- to eight-week examination of documents supporting the drugs’ safety and effectiveness.
Dr. Mark Dybul, deputy chief medical officer in the Office of U.S. Global Aids Coordinator Randall Tobias, defends the decision to require FDA approval.
“We don’t know if they’re safe and effective,” Dybul said of the WHO-approved generic combination AIDS pills. “You can’t use drugs until you know. It’s medically irresponsible.” WHO develops the list of generic drugs after experts, appointed by drug regulatory agencies in various countries, approve them based on international standards for safety and effectiveness.
A recent study published in the Lancet, a British journal, found the generic combination pills to be as effective as the more expensive brand-name cocktail. Doctors Without Borders, an aid organization that wants to use the generic versions, was one of the groups that conducted the study.
Dybul said that though the article made interesting points, the existence of one study does not lead to drug approval.
Some AIDS activists have accused the government of stalling to give the brand-name companies time to develop their own AIDS drugs combinations. And some of the overseas generic companies have reservations about enduring an FDA approval process when their products have already been approved by the WHO.
“My personal feeling is that this is a farce,” said William Haddad, chairman of Biogenerics Inc., a U.S. company, who is also a consultant to Cipla Ltd., an Indian generics manufacturer that sells three-in-one AIDS combination pills approved by WHO.
“It is a continuation of the political process disguised as science.”
Haddad and others worry that the FDA might approve combination pills developed by U.S. companies and turn down the generic medications. Activists express concern that the brand-name companies’ combination pills could be priced higher than the generics.
David Rosen, a spokesman for Bristol-Myers Squibb, said recently the company is committed to producing an inexpensive combination AIDS pill. He said he did not know what the cost would be.
At Merck, spokeswoman Janet Skidmore said the combination pill “is not a done deal at this time.”
Two other companies – Boehringer and GlaxoSmith – are also considering putting pills they already make into one package, perhaps a blister pack. Prices have not been determined.
Dr. Jeffrey Murray, deputy director of the FDA’s Division of Antiviral Drug Products, said he expects the review process for the generic pills to go smoothly.
“We just need to make sure the strengths are the same” as the brand-name medications, he said, “and that when they are given … they achieve the same drug levels when they are combined in one pill as if they took the drugs separately.”
But many AIDS activists and doctors remain skeptical about the imposition of the approval process.
Dr. Paul Zeitz, director of the Washington-based Global AIDS Alliance, calls the requirement “a really dangerous precedent.”
“The notion that it (WHO-approved generics) is not good enough for U.S. funds to be used is completely ludicrous,” he said. “With 3 million people dying a year (from AIDS) and 8,000 dying a day, our vision is very clear and simple: There’s a life-saving product that’s available.”
Dr. Allan Rosenfield, dean of Columbia University’s Mailman School of Public Health, said, “The WHO system is a good one. It’s been verified by scientists at drug regulatory agencies in Europe. I do not believe that we need to say only America has quality.”
In the United States, an annual regimen of AIDS drugs can cost as much as $12,000 because doctors tailor prescriptions to individual patients and medications are not discounted here as they are for impoverished countries.
Amir Attaran, a population health professor at the University of Ottawa, said in an interview that the brand-name pharmaceutical industry’s failure to provide cheap combination drugs up till now is “inadequate, shameful and frankly disgusting.”
“For God’s sake, now we know that to simplify treatment by putting medications in a single pill or at least in a single blister pack, that would really help,” Attaran said.
In March, several U.S. senators, including Sen. Edward Kennedy, D-Mass., and Sen. John McCain, R-Ariz., sent a letter to Bush, urging the purchase of cheap generic AIDS drugs approved by the WHO.
Last year, the Clinton Foundation, started by former President Bill Clinton, managed to hammer down the cost of some generic AIDS drugs for use in developing countries.
Ira Magaziner, who heads Clinton’s AIDS effort, said they have agreements to buy the combination drugs from generic makers for between $132 and $149 annually for one person.
But Dybul, the physician in the U.S. Global AIDS Office, worries that the generic combination pills might not be as potent as they should be.
And he cited a recent WHO decision to remove two generic AIDS drugs made by Cipla, the Indian manufacturer, from its approved list.
WHO questioned documentation provided by Cipla and requested a resubmission.
Almost 40 million people are living with HIV worldwide and 20 million have died since AIDS was first diagnosed in 1981. UNAIDS, the United Nations program for the disease, said last week that more new infections were reported last year than in any year since the epidemic began.
Women are increasingly at risk and young people ages 15 to 24 account for half of all new HIV infections.
The pandemic is expanding rapidly in Asia, the UNAIDS report said, and only 7 percent of the people who need AIDS medications in developing countries have access to them.
It is time, Attaran said, to reach agreement on providing AIDS drugs as cheaply and efficiently as possible.
“I think the battle over generics or brand-name products has reached a pitch that is excessive and counterproductive,” he said.
“We are called upon as a global community to solve not just the scientific problem but the ethical, economic and distributive problem.”