Bangkok AIDS Conference

 

Another key conference theme is getting more generic copies of the main
AIDS drugs to the developing world.

The Belgium-based Medecins Sans Frontieres group warned that free trade
agreements such as the one Thailand is negotiating with the United States
could threaten that goal by imposing patent rules that block production of
those copies.





U.S. Rule on AIDS Drugs Criticized
Ban on Using Aid to Buy Foreign Generics Hinders Treatment, Experts Say

By Ellen Nakashima and David Brown
Washington Post Foreign Service
Wednesday, July 14, 2004; Page A12

BANGKOK, July 13 -- The Bush administration's prohibition against using money from its $15 billion global AIDS plan to buy foreign-produced generic drugs is complicating the delivery of medicine to some of the millions of poor people who badly need it, according to AIDS experts at an international conference here.

In an effort to sidestep the policy, some countries have been using U.S. money to train AIDS clinicians and buy lab equipment, while employing money from other sources to buy the medicines.

U.S. officials at the conference said Tuesday that they would go along with such an approach. They have also said a fast-track plan announced in May would allow some of the generics to receive rapid approval from the Food and Drug Administration, which would make them eligible for U.S. funding.

Specified in the giant President's Emergency Plan for AIDS Relief, the restrictions against unapproved generics, which for now include all foreign-made generics, have added to the already long list of obstacles to bringing antiretroviral (ARV) therapy to poor countries, experts attending the 15th International AIDS Conference here say.

"It was very confusing. You're trying to figure out who can buy what with what money," said Joia Mukherjee, medical director for Partners in Health, a Boston-based organization that has run an AIDS treatment program in Haiti for seven years and is developing others in Latin America.

The policy "slows the coordination" between the Bush plan and the people running treatment programs on the ground, Mukherjee said in an interview at the conference.

The U.S. Government Accountability Office reached similar conclusions in a report issued this week.

The GAO interviewed 28 U.S. government employees involved in the plan in the 15 countries where it is starting to operate. "Twenty-one respondents indicated that they had not received adequate guidance on the procurement of ARV drugs, which makes it difficult for the U.S. missions" to support country programs.

The State Department, which runs the plan, has not specified the activities that the program "can fund and support in national treatment programs that use ARV drugs not approved for purchase by the office," the authors wrote.

Partners in Health is expecting to receive at least $1 million in fiscal 2005 from the U.S. program. Mukherjee said she first began about nine months ago to inquire about whether it could be used to buy generic drugs. She -- and others -- were told no several months ago. But last week, she said, she was advised unofficially to use money from another source to buy generics and use the U.S. money for such things as salaries for health care workers, lab tests and a van.

That was "a compromise that wasn't acceptable before," said a person affiliated with one of the organizations that received a large Bush administration AIDS grant last winter. "We're still in the process of working out what drugs we will buy . . . in the countries we're in," said the official, who spoke on condition of anonymity.

Randall L. Tobias, the Bush administration's global AIDS coordinator, officially ratified that view in a statement Tuesday.

"We respect local governments' decisions as to how best to manage their HIV/AIDS programs. We will, however, not use U.S. tax dollars to purchase medications that have not passed the same consumer protection standards as those we use for our own patients in the United States," he said.

"In the event that a country elects to use non-U.S. funding to purchase 'copy' drugs that have not been approved for quality and safety by the U.S., the president's emergency plan will support non-pharmaceutical aspects of the country's care, treatment and prevention programs, and will do whatever is necessary to maintain integrated systems of care," he said.

AIDS treatment that uses generic pills containing three antiretroviral drugs in one tablet -- so-called fixed-dose combinations -- can cost as little as $200 for a year. That is less than half the cut rates at which major pharmaceutical companies are offering brand-name drugs in poor countries.

Most organizations that are providing money for AIDS drugs in those countries -- notably, the two-year-old Global Fund to Fight AIDS, Tuberculosis and Malaria -- require that generics they purchase go through a process called pre-qualification that is run by the World Health Organization and is similar to FDA approval.

The U.S. program does not recognize pre-qualification and instead has specified that all drugs it pays for must be approved by the FDA. In May, the agency established a fast-track system by which it will rule on applications from generics makers in two to six weeks.

Anthony S. Fauci, the physician and AIDS researcher who heads the National Institute of Allergy and Infectious Diseases, acknowledged the controversy over generics at a news conference Tuesday.

"I know there's been criticism about that, but I think we should give a chance to the FDA to prove if they're able to do it or not," he said. "The only way to do that . . . is to submit the application for the approval process."

Progress in the effort to put 3 million poor AIDS patients on treatment by the end of next year has been a major topic of discussion at the conference, whose theme is "Access for All."

In Haiti, where 280,000 people are living with HIV, the virus that causes AIDS, Partners in Health had about 50 patients on antiretroviral drugs in 2001. Today, largely with Global Fund money, it is treating 1,500 . The drugs are administered free through a community health clinic.

Cissy Kityo of the Joint Clinical Research Center in Uganda said that country's government cannot afford to pay for all the drugs it is providing patients, even with a price of about $300 per person per year for generics. Consequently, about 90 percent of the 20,000 people on treatment are paying for their drugs, she said.

Uganda's policy of making people pay for their drugs has allowed it to spend funds instead to hire and train health care workers, who are critical to prevention and treatment efforts, Kityo said. "We're just a small country trying to do our best," she said.

Chief among nongovernmental organizations providing antiretroviral is Medecins Sans Frontieres, whose name in English is Doctors Without Borders. Today it has 13,000 patients in 56 projects in 25 countries in Africa, Asia, Eastern Europe and Latin America. About half are on fixed-dose combinations, which spokeswoman Rachel Cohen termed a "radically simplified" treatment.

The organization is spending $200 per person per year. The best available price worldwide for brand-name equivalents is $562 per person per year. "If you have the option of spending $200 per person per year or $600 per person per year, and you're electing to spend $600, that means you're treating one person when you could be treating three," Cohen said.




Health GAP (Global Access Project)
PRESS RELEASE
13 July 2004


US GOVT. ACCOUNTING OFFICE TO WHITE HOUSE:
BUSH REQUIREMENTS FOR BIG PHARMA DRUGS OBSTRUCTS POOR COUNTRY
EFFORTS TO TREAT AIDS.

(Bangkok) - The non-partisan U.S. Congressional agency charged with maintaining the accountability of government programs delivered a simple message to President George Bush this week: the President's Emergency Plan for AIDS Relief (PEPFAR) is not delivering on its promises.

The release of the report of the Government Accountability Office (GAO), was timed to coincide with the XV International AIDS Conference in Bangkok and described a series of internal problems plaguing the $15 billion (US) program. The report on PEPFAR, the Bush program targeting 2 million people for ARhV treatment in 15 countries, described a program rife with administrative chaos and riddled with restrictions that have crippled service delivery.

The GAO interviewed 28 field staff from two government agencies responsible for on-the-ground implementation of the president's plan. The staffs from the U.S. Agency for International Development (USAID) and the Department of Health and Human Services (DHHS) were asked to identify the challenges they faced in getting help to people living with HIV/AIDS in the targeted areas. Of the 28 staff interviewed, 25 cited policy constraints imposed by PEPFAR in the procurement of affordable generic drugs as a major limitation on the treatment scale-up efforts in developing countries.

"Bush is selling compassion to American voters this election year, but the real agenda of the White House has been to create a slush-fund for US drug companies," said Paul Davis, domestic policy director for the U.S.-based advocacy group Health GAP (Global Access Project). "The Administration must immediately pledge $30 billion for global AIDS by 2008 and lift the ideological restrictions on the use of affordable generics and condom usage."

"A pattern is developing during this conference," continued Davis. "The U.S. government's own watchdog group says the Bush program is not working. United Nations Secretary General Kofi Annan says the program is not working. Scientists, fund recipients and activists say the program is not working. Its time for the President to admit what is clear to the world. PEPFAR is not working."

~  ~  ~  ~  ~  ~  ~  ~  ~  ~  ~


as the Wall Street Journal recently reported:

"As public-health groups urge wider use of generic drugs to lower the cost of treating AIDS and other diseases in developing countries, U.S. trade negotiators -- prodded by the drug industry -- are taking the opposite stance in new trade pacts, seeking to strengthen protections for costlier brand-name drugs.

In many countries, including the U.S., makers of generic drugs often can win approval simply by proving that their products are equivalent to the original drugs. But the key provision sought by the U.S. in new agreements restricts trading partners from approving for five years a generic-drug application if it relies on test data compiled by the original drug's manufacturer. In essence, that grants branded drug-makers temporary exclusivity, already available inside the U.S.

The goal is to shore up new global protections for U.S. drug makers in other countries.”



FIXED DOSE COMBINATIONS

Interview with Science reporter Jon Cohen Bangkok Notebook (excerpt)
from Kaisernetwork  7/15/04

JACKIE JUDD: Final question for today, and that has to
do with this research that came out from Doctors Without
Borders, and work they’ve done to see what kind of drug
regimens work. What were the results?

JON COHEN: Well it’s obvious to some people that if
you combine 3 AIDS drugs into 1 pill, that it ought to work.
It’s called a fixed dose combination. It vastly simplifies
getting people to stick with their treatment plan. If you got
to take 2 pills a day, it’s a whole lot easier than taking 6
pills a day, or 12 pills a day. You can cut these numbers down
greatly. And what they’ve shown is that it works. And that’s
good news because when there’s political resistance to do
things like fixed dose combination, they can now say, “Well
we’ve got evidence that it does work.”

And I visited these medicine - some frontier clinics.
I visited in Myanmar, I visited in Cambodia and I saw what they
were doing. And I also visited in China and I saw what they
were doing. And it was clear to me then, just meeting with the
patients that it was working. I mean when you meet somebody
who holds up a picture and says, “Look at me. This was me 6
month’s ago” and 6 month’s ago, they were skeletal and now they
are saying, “I’m chubby. You know I’m doing well,” it’s
obvious that it’s working.




    see also:  U.S. Ambassador Randall L. Tobias Zap






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