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Copyright 1999 The Chronicle Publishing Co.  
The San Francisco Chronicle

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MAY 24, 1999, MONDAY, FINAL EDITION

SECTION: NEWS; Pg. A1

LENGTH: 2140 words

HEADLINE: New Crusade To Lower AIDS Drug Costs;

Africa's needs at odds with firms' profit motive

BYLINE: Sabin Russell, Chronicle Staff Writer

BODY:
In the 18 years since he first showed symptoms of AIDS, Eric Sawyer has been a fighter, battling his own disease while agitating on the streets and in the halls of Congress for more research and better drugs.

The payoff is an array of costly new pills that since 1996 have helped slash the American AIDS death rate in half, and restored vigor and good health to Sawyer and tens of thousands like him.

Now a new cause is tapping the fresh energy and political instincts of American AIDS veterans, whose work succeeded in changing U.S. drug approval policy. They are helping in an international movement to let Third World nations make cut-rate copies of the life-saving drugs.

"When you are no longer burying your friends, you have the luxury of time to try to save people in more remote areas," said Sawyer, a co-founder of ACT UP/New York. "There is a tremendous sense of survivor guilt, which gives us inspiration to fight harder."

The problem is this: At Western market prices of $1,000 a month, the multidrug therapies are hopelessly out of reach in the very countries hit hardest by the epidemic -- in African and other developing nations where 90 percent of AIDS cases occur.

Activists such as Sawyer, director of a new group called the HIV/AIDS and Human Rights Project, think they have found a solution:

By declaring health emergencies, impoverished countries could sidestep patent laws and produce or import these drugs at a fraction of the cost, making them available to millions of destitute AIDS victims -- a market that big drug companies would never touch.

But the quest to flood Africa with cheap AIDS drugs has run headlong into conflict with American trade policy. High level Clinton administration officials are blocking attempts to tamper with AIDS drug patents, saying that they undermine the entire system of intellectual property protection that encourages businesses to find new drugs.

One of the best examples of this new front in the battle over AIDS drugs is South Africa, where a recently enacted law would override pharmaceutical company patents and allow "gray market" imports of cheap drugs from other countries.

Prescription drug prices vary dramatically from country to country, based on deals cut by the manufacturer. The antibiotic Amoxicillin, for example, costs 50 cents a pill in Johannesburg, 4 cents in Zimbabwe. The South African law would let the country pursue the lowest cost drugs on the world market.

But court challenges have delayed the law's being put into effect. Also, U.S. officials are threatening trade sanctions. One State Department memo to Congress boasted of a "full court press" involving the Vice President Al Gore, Commerce Secretary William Daley and four U.S. agencies to change the "offending" law.

"The U.S. government has . . . made it clear that it will defend the legitimate interests and rights of U.S. pharmaceutical firms," wrote State Department assistant secretary Barbara Larkin in her letter to Congress.

Veteran AIDS activists are angry. The Clinton administration, they charge, seems content to let multinational drug companies set American trade policy -- which is threatening access to life-saving medicines, not only in South Africa, but also in Thailand, India and poor countries around the world.

"Pharmacy companies are making U.S. government policy with essentially no other voices. That has to change," said John James, editor of the respected San Francisco newsletter AIDS Treatment News.

Drug companies have all but ignored markets in Africa. Less than 1 percent of AIDS drugs are sold in African nations south of the Sahara Desert, where 70 percent of new HIV infections and 90 percent of all AIDS deaths occur. Some 11.5 million people in sub-Saharan Africa have died of AIDS since the epidemic began.

Dr. Ian Roberts, special adviser to the South African Health Ministry, said the United States is showing little understanding of his country's public health catastrophe. "Medicines to treat HIV/AIDS are far too highly priced for the mass of our people," he said. "With up to 16 percent of our people already HIV positive, this can be seen as a national disaster."

Despite South Africa's gold and diamond mines, most of its people remain poor, with an average annual income of $2,600. "Clearly, we cannot afford retrovirals at a cost of $1,000 per month," said Roberts.

South Africa has emerged from the shadow of apartheid only to become a major center of the AIDS epidemic. An estimated 3.2 million South Africans are infected by the virus, including 45 percent of the nation's military personnel. Most of those infected are poor and black.

Consumer advocate Ralph Nader, who was drawn to the issue because of his long-standing interest in pharmaceutical regulation, called the Clinton position on South Africa "an affront to the sovereignty of Third World nations."

In a sharply worded letter to Gore, who chairs a commission on South African trade, Nader accused the United States of abusing its superpower status: "You have engaged in an astonishing array of bullying tactics to prevent South Africa from implementing policies . . . designed to expand access to HIV/AIDS drugs."

Nader's Consumer Project on Technology advocates two steps -- both of them legal under international law -- by which poor countries can slash the cost of AIDS drugs. The first is for poor countries to issue "compulsory licenses," granting rights to make copies of patented drugs without the approval of the patent holder. Compulsory licenses are permitted in health emergencies under international trade agreements.

The second step is to allow countries to shop around on the international market for AIDS drugs and import the cheapest available. Forbidden in the United States, such "parallel market" or "gray market" purchases are routinely permitted in Europe.

"Compulsory licensing will have huge effects on price, leading to decreases of 50 to 90 percent," said James Love, director of the Consumer Project on Technology.

But the pharmaceutical industry and the Clinton administration take the view that compulsory licenses and gray markets pose a threat to the entire system of intellectual property protection. Access to AIDS drugs, they say, can be solved without destroying the patent system.

"Patents are the lifeblood of our industry," said David Warr, associate director of tax and trade policy at Bristol-Myers Squibb, the New York-based maker of an array of drugs to treat AIDS and AIDS-related infections. "Compulsory licensing and parallel imports expropriate our patent rights."

The only beneficiary of an erosion of patent rights, said Warr, is the generic drug industry, which does not subsidize through its sales the costly process of research -- research that makes new top-of-the-line therapies available. "There is a need not to fight the firefighters," he said.

Drug makers stress that even if AIDS medications were magically made cheaper for the African market, the lack of an infrastructure to distribute the drugs and monitor patients means that few would benefit.

Tom Bombelles, a spokesman for the Pharmaceutical Research and Manufacturers Association, said patents are not the problem. Access to AIDS drugs remains a desperate problem in India, which does not recognize international drug patents and where manufacturers make low-cost generic versions of AIDS drugs.

Experts in the international AIDS crisis agree that merely lowering the price of AIDS drugs will not solve the problem, and potentially could make the epidemic worse.

"If you spread anti-HIV drugs in a population, but not in sufficient quantities, you are establishing a recipe for disaster. You could make people sicker, rather than better, and increase the possibility for development of drug-resistant HIV strains," said Tom Coates, executive director of the University of California at San Francisco AIDS Research Institute.

Coates said the limited money available to fight AIDS in Africa would save the most lives if it were directed at prevention first. Most African nations do not even have funds to pay for testing of the blood supply, and in 1997, only $650 million was spent on all African AIDS programs. "If, as UNAIDS (the Joint United Nations Programme on HIV/AIDS) has suggested, we raised spending to $2.5 billion, we could prevent half the HIV infections from occurring," Coates said.

By raising the patent issue, however, activists believe they are already nudging the international pharmaceutical industry to pay more attention to Africa. This month, Bristol-Myers Squibb announced a five-year, $100 million project to test AIDS drugs and improve physician training in five African nations, including South Africa.

But angry South African officials have dismissed the drug company program as misplaced. The country does not have doctors to spare for training in the United States, said Roberts, the adviser to the South African Health Ministry. And critics consider the offer a public relations ploy. "They are getting billions more than they should with their monopoly, so they send back a tip," sniffed Nader.

The size of the Bristol-Myers grant has nevertheless upped the ante in the international response to the AIDS catastrophe in Africa.

The controversies swirling around U.S. trade policies indicates that a new front has been opened in the global war on AIDS. Even as new AIDS medicines save lives in the United States, they serve to underscore the appalling medical gap between rich nations and poor.

Daniel Zingale, executive director of the AIDS Action Council, the nation's largest lobby on HIV issues, said the trade issues raised by Nader are looming larger. "In my view, on this issue, Ralph Nader is right," he said. "It's clear to us the pricing of AIDS drugs is not fair or serving the interests of most people infected by HIV."

The effect of American trade policy on the availability of AIDS drugs has already struck a chord on Capitol Hill. Representative Jesse Jackson Jr., D-Ill., has introduced an African trade bill that bars U.S. trade sanctions against countries that use compulsory licensing or parallel imports.

And Representative Marion Berry, an Arkansas Democrat and the only licensed pharmacist in Congress -- who has long been a thorn in the side of U.S. drugmakers -- is winning support with his criticism of the Clinton administration stand.

Last week, he introduced a bill, with Republican Jo Ann Emerson of Missouri as co-author, that would allow American wholesalers to import drugs sold in Mexico or Canada at lower prices than those set by pharmaceutical companies for the U.S. market.

"We're in favor of these companies making a profit," Berry said in a recent telephone interview. "We all want them to make as much money as possibly can. But when they make money at the expense of someone dying, because they can't afford to buy the medicine -- well, then it becomes a moral issue."

------------------------


CHART:
         THE WORLDWIDE TOLL OF THE AIDS
      EPIDEMIC CONTINUES TO RISE 
.
Here are the latest U.N. estimates of new cases of infection and disease       in 1998,  the numbers of people living with the disease or infected by 
the AIDS virus, and the cumulative totals since the epidemic 
was first detected. 
.
Global estimates of HIV/AIDS
Estimates as of end of 1998
.
People newly infected with HIV in 1998       5.8 million 
.
Number of people living with HIV/AIDS       33.5 million
AIDS deaths in 1998                          2.5 million
Number of AIDS deaths  since the beginning
of the epidemic                             13.9 million
.
          KEY
People living with AIDS       (a)
Newly infected with HIV
(infected during 1998)        (b)
.
EASTERN EUROPE AND CENTRAL ASIA
     270,000 (a)
      80,000 (b)
.
EAST ASIA AND PACIFIC
     560,000 (a)
     200,000 (b)
.
WESTERN EUROPE
     500,000 (a)
      30,000 (b)
.
 NORTH AMERICA
    890,000 (a)
     44,000 (b)
.
CARIBBEAN
    320,000 (a)
     45,000 (b)
.
NORTH AFRICA
AND MIDDLE EAST
    210,000 (a)
     19,000 (b)
.
SOUTH AND
SOUTHEAST ASIA
   6.7 Mil. (a)
   1.2 Mil. (b)
.
LATIN AMERICA
   1.4 Mil. (a)
    160,000 (b)
.
SUB-SAHARA AFRICA
   22.5 Mil. (a)
      4 Mil. (b)
.
AUSTRALIA AND
NEW ZEALAND
     12,000  (a)
        600  (b)
.
Source: UNAIDS
STEVE KEARSLEY/THE CHRONICLE




GRAPHIC: PHOTO, CHART: SEE END OF TEXT, John James, publisher of AIDS Treatment News, urged a change in U.S. policy away from protecting big drug makers and toward making medicines more available in poor countries., / Liz Hafalia/The Chronicle

LOAD-DATE: May 24, 1999




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