Newsday - July 9, 2000
Laurie Garrett, Staff Writer

Late Friday, the German drug giant Boehringer Ingelheim announced that it will give its anti-HIV nevirapine absolutely free to poor countries that are hard-hit by HIV. The drug is being offered for use in a short course of treatment to block transmission of the virus from infected mothers to their newborn babies.

"We hope that our initiative for the prevention of mother-to- child transmission will help to make an impact on the HIV/AIDS epidemic," Rolf Krebs, vice chairman of the company's board, said at the donation announcement. He stipulated that the free drugs were to be given to countries that were defined by the United Nations AIDS Programme as being especially hard-hit by the epidemic, and would be offered only to nations whose governments indicate an "express need" for nevirapine for use on pregnant women and newborns.

With an estimated 80,000 HIV-positive babies born here annually, South Africa theoretically stands to benefit greatly from the German company's announcement. Yet South Africa's Minister of Health Manto Tshabalala-Msimang said this weekend that she was "worried" about the offer, hinting that she might not accept the free drugs.

"What's very strange is that we met with them last Friday and they did not even one minute indicate they were going to make such an announcement," Tshabalala-Msimang said on South African television, indicating the surprise announcement made her suspicious. Previously she had rejected nevirapine because of its cost.

In response, a spokesman for Boehringer Ingelheim, Paul Stewart, said, "I suppose I could understand her to some degree. But we've got 100 countries we're dealing with, and it's just not possible to talk to every minister of health. We're dealing with a real issue here, and we want to contribute, not to involve politics."

He said the company could afford to make the drug available for free because last year it yielded $225 million in profit from sales in the United States and Europe.

"What this announcement does is take out one factor-cost," Dr. James McIntyre, head of pediatric AIDS efforts at Chris Hani Baragwanath Hospital in Soweto, said yesterday. "I think it's a positive step. I would welcome anything that moves us further down the road."

And local activist Toby Kasper, of Mdcins Sans Frontires-a group that's been highly critical of drug pricings and companies-said the nevirapine announcement "may represent a significant step forward."

Taken alone to treat adult AIDS, nevirapine is worse than useless because viruses quickly become resistant to the drug. But studies in Uganda and South Africa show a few doses of the drug taken at the end of pregnancy and by the newborn can cut by half the chances of the baby's being infected. Even a single dose of nevirapine taken by the mother during labor followed by one dose given to the newborn radically reduce the risk of HIV transmission-by 47 percent. A computer analysis recently published in the British medical journal Lancet conservatively estimated that for South Africa alone, widespread use of nevirapine could prevent infection of 110,000 babies by 2005, or about a third of the total number otherwise projected to become infected in this country over the next five years.

Even prior to these findings, in February a World Health Organization panel concluded that nevirapine was a promising drug and ought to be rushed into pilot-project use in poor, AIDS-plagued countries. Yet South Africa has remained reluctant to approve use of the drug.

Dr. Helen Rees, chairwoman of the country's equivalent of the Food and Drug Administration (the Medicines Control Council), said her agency will review drug policies in light of encouraging research results expected to be presented here this week at the AIDS conference, noting that "the answer is pending."

Speaking on condition of anonymity, South African insiders who are privy to the discussions say the Medicines Control Council has had the new nevirapine data "for months," yet has been reluctant to approve the drug for political reasons. South Africa, which has an estimated 4 million HIV-positive adults, including about 23 percent of its pregnant women, is at pains to find finances to both create an infrastructure for dispersal of drugs, and for their purchase. Even if companies like Boehringer Ingelheim offer medicines for free, argued KwaZuluNatal Province's Minister of Health Dr. Zweli Mkhize, "We would have to consider the cost of conducting [HIV] tests ... and the allocation of additional budgets on the health side," for training doctors and nurses in proper use of the drug.

The timing of the Boehringer Ingelheim announcement also has angered Mkhize and top South African government officials. It looks suspiciously, they charge, like a publicity stunt aimed at salvaging the pharmaceutical industry's reputation in advance of expected demonstrations and attacks today against the drug giants at this AIDS conference. Indeed, Bristol-Myers Squibb recently announced it will donate $100 million to AIDS-related projects in South Africa, Botswana, Namibia, Lesotho and Swaziland. GlaxoWellcome lowered the price of its anti-HIV drug, AZT, which is also used to reduce mother- to-child transmission. The New York-based Pfizer Corp. just announced some improvement on its previous offer to lower costs for a drug used to treat some opportunistic infections common to AIDS patients. And the Merck Co. is expected to announce this week plans to invest heavily in development of the health infrastructure of Botswana.
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