The Wall Street Journal - July 8, 1996

Canadian patients are driving to U.S. pharmacies, and Europeans are trickling into the U.S. for treatment. A South American airline is delivering AIDS drugs from the U.S. to Brazilian patients, while some people in Rio de Janeiro are buying supplies on the black market. In France, protesters won bigger supplies of the medicines in part by chaining themselves inside a U.S. firm's pharmaceutical factory outside Paris.

Many governments, meanwhile, have released the drugs ahead of schedule in emergency programs, in a rare display of bureaucratic flexibility. "That's something we've never seen before," says Stephen Hull, manager of public affairs for Merck & Co., one of the makers of the new drugs.

The object of this global pill chase is a class of drugs called protease inhibitors. A combination therapy that consists of the protease inhibitors plus two older AIDS drugs, AZT and 3TC, is proving effective at driving the AIDS virus into remission, which explains the rush to get the treatment. The new medicines are Merck's Crixivan; Invirase, from Roche Holding Ltd.'s Hoffmann-La Roche Inc. U.S. unit; and Abbott Laboratories' Norvir. Two other drugs are in advanced stages of human testing. Scientists will be discussing the drugs at the annual international AIDS conference in Vancouver, British Columbia, which started yesterday.

The U.S., which approved one protease inhibitor last December and two more in March, is ahead of most of the rest of the world in disseminating the drugs. Most of the patients, however, are outside the U.S.: The world has 21.8 million people infected with HIV, the AIDS virus, according to the United Nations' AIDS program, but just 3.7% of them are in North America.

Canada has approved only one of the protease blockers so far, and approval for the other two isn't expected until August. So in February, Jim Wakeford, a 51-year-old Toronto man who is HIV-positive, drove 90 minutes to Buffalo, N.Y. A Canadian doctor referred him to a U.S. physician, who wrote him a prescription for a protease inhibitor. Mr. Wakeford bought three months' worth for about $1,760. In May, a friend fetched him a two-month supply.

The trips were "all so clandestine," says Mr. Wakeford. "I call them my drug runs." U.S. law bars people with HIV and certain other communicable diseases from entering the country, though the ban is difficult to enforce. Mr. Wakeford hopes to get future supplies through a Canadian emergency drug-release program, which began in June.

Canadian doctors also have made the trips for their patients. Colin Kovacs of Toronto said he made about six trips to Buffalo this year, before Canada agreed in June to make a protease inhibitor available in the emergency program. He used money orders and credit cards supplied by his patients to buy the drug.

France, where 30,000 people have died of AIDS, is a front-line battleground for getting the drugs approved and distributed. Earlier this year, France's National AIDS Council suggested holding a lottery among patients to determine who would get the scarce protease drugs. The idea triggered outrage and protests.

In February, several dozen AIDS activists invaded an Abbott Laboratories facility outside Paris and chained themselves to drug-making equipment. They wanted the French government to approve a protease inhibitor made by Abbott in the U.S.

French Prime Minister Alain Juppe joined the criticism of the lottery idea, and urged health authorities to find another solution. After the approval in early March of Abbott's and Merck's protease drugs by the U.S., France provisionally approved the drugs, and the manufacturers came up with a plan to supply French patients with drugs made in the U.S. Now, some 10,000 people are being treated in France with the new drugs, the government says.

Getting the drugs remains difficult, though. In the U.S., one can buy them from pharmacies with a doctor's prescription. In France, they're rationed: The drugs won't be in French pharmacies until January, and in the meantime, hospital committees determine who gets them. In March, a group called Action-Traitements organized a well-publicized AIDS-treatment trip to New York to embarrass French authorities for moving so slowly. Twelve AIDS patients were treated by U.S. doctors and given prescriptions for the latest drugs.

On paper, Brazil is ahead of most countries at releasing the drugs, having approved some of them for general distribution. But the treatment's $12,000 annual cost dwarfs Brazil's average per-capita income of $4,400, so few can afford it.

Even for the elite patients who can pay, tracking down the drugs can be a full-time job. Varig, Brazil's major air carrier, has begun picking up AIDS drugs in the U.S. for patients who present a doctor's prescription. While interest in the service is growing, according to a Varig spokesman, its clients currently number only in the dozens. Other patients travel to Miami to obtain the drugs. Some patients say a black market for the protease inhibitors has already emerged.

Paulo, a university official with AIDS, spends half his $2,000 monthly salary and much of his time running down the drugs. He obtains 3TC from the Varig drug-delivery service. Crixivan is sold directly by Merck in Sao Paulo, and the Brazilian government distributes AZT for free. When the Varig drug flights were halted for a couple of weeks due to administrative problems, Paulo says he was forced to call a clandestine supplier of 3TC whose name has made the rounds of Brazil's AIDS patients. The supplier charged him a substantial premium.

Paulo says, however, that the effort has been worth it. He has gained 15 pounds since he started taking protease inhibitors early this year and is playing sports he had long ago given up.

Obtaining the drugs is hardest in developing countries, of course, which account for nine out of 10 of the world's HIV cases. Sub-Saharan Africa alone has 63% of all people with HIV. But public-health experts in Africa say that triple-combination therapy is so expensive and government budgets so minuscule that money should instead be spent on AIDS prevention and on treatment of other deadly diseases.

"There are a lot of drugs we don't have in Africa," says Jean Rigal, who works in Africa for the French group Doctors Without Borders. "These new drugs for AIDS aren't even on our radar screen."

Nor are they on China's. The country has a growing number of AIDS cases, mainly among intravenous drug users in Yunnan Province. Yet China hasn't approved the major Western AIDS drugs, including AZT. Instead, Beijing is encouraging research of treatments using traditional Chinese herbal medicine.

But two countries famous for their red tape, Germany and Japan, have shown uncharacteristic flexibility toward the new drugs. Germany hasn't approved the drugs for general use but is making them available under an unusual law that allows drugs approved elsewhere in the world to be prescribed to individual patients.

Japan normally doesn't make breakthrough drugs available until long after the U.S. does. This time, though, crusading Health Minister Naoto Kan has vowed to give Japanese the same AIDS treatment available to Americans. The Merck and Abbott protease inhibitors are available in clinical trials in Japan. Of Japan's small officially recognized HIV population of 3,600 people, 1,500 are expected to get protease drugs in clinical tests.

In some countries, it is local authorities who are rising to the occasion. David Capistrano, the mayor of Santos, a Brazilian port city of 450,000, started a program to furnish protease drugs free to 200 AIDS patients. (Merck is donating some medication.) One doctor in Santos has helped pay for protease inhibitors for eight patients.

The mayor's program is costing Santos nearly $100,000 a month, and critics say the money should be spent on other things. "We maintain that most of the attacks are based on prejudice," says Claudio Maierovitch Pessanha Henriques, municipal health secretary.

But even a big-hearted city like Santos has had to learn when to say no. "I'm receiving calls from patients and friends around the country who want to come here for treatment," says Mr. Maierovitch. Santos has set up a council of doctors and patients to determine who gets the precious new drugs.

As word of the new drugs spreads around the world, demand is certain to soar, raising questions about manufacturers' ability to supply patients. The makers of the three protease inhibitors say they are stepping up production.

Until governments finish approving the medicines and the factories reach expanded output, though, patients may have to continue improvising. One lifeline is mail-order pharmacies. The Komtur Apotheke pharmacy in Freiburg, Germany, says that each month, it is mailing about 6,000 packages of protease inhibitors to patients in other European countries.

Sourcing drugs through the mails is risky, however. French customs agents regularly stop drugs that are sent by post. The drugs they let through have at times been subject to 21% duties.

"It's kind of hit and miss," says Jean, a French AIDS patient who says he lost several hundred dollars' worth of drugs sent by mail from the U.S. Since March, he has been getting the drugs in France through his doctor.

For a fortunate few, an expensive option is to travel to the U.S. for treatment. Jerome Groopman, an AIDS researcher and physician at Harvard Medical School in Boston, says word of the new treatments has begun circulating widely among patients only in the past two weeks. But in the last month or so, Dr. Groopman has had two patients in from France looking for the drugs, and one from Brazil. Last week, a Greek patient said he wanted to obtain both 3TC and a protease inhibitor for a friend in Italy.

"I can't act as a pharmacy and ship drugs to people I haven't seen," says Dr. Groopman. "But if someone here wants to take it upon himself to send his own drugs, that's up to him."

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The Spread of HIV

21.8 million people have HIV, the AIDS virus. Here is a breakdown of where they live, as a percentage of total world-wide cases.

Sub-Saharan Africa 63.0% S. and S.E. Asia 23.0% Latin America 6.0% N. America 3.7% W. Europe 2.2% Caribbean 1.3% N. Africa and Middle East 0.9% E. Asia and Pacific 0.2% Australia 0.1% E. Europe and Central Asia 0.1%

Source: UNAIDS

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