TCS Daily

Don't Believe the Gripe

By Roger Bate - February 27, 2003 12:00 AM

The first AIDS vaccine to be tested on humans may protect blacks and Asians from the deadly disease, a U.S. biotech company announced this week. And according to doctor and patient groups, a new drug about to be approved is the biggest advance in combating AIDS in nearly a decade.

Well that's how one could look at it. But some activists and media outlets were in a tizzy about how the vaccine failed for most people in the trial and how the new drug is so expensive it will never be affordable in Africa.

Hope on Trial

Critics do have a small point to make about the vaccine. The company, VaxGen, has completed a three-year study involving more than 5,000 volunteers. Initial results show the vaccine only reduced the rate of HIV infection by 3.8% overall. But in a small subset, blacks and Asians who were given the vaccine had a 67% lower rate of infection than those who received a placebo.

This was the first major clinical trial for a human vaccine against HIV/AIDS, a disease that killed more than three million people last year. Currently there are over 40 million people worldwide with AIDS. There is no cure for the disease, and drugs that can keep it under control are only readily available in wealthy countries.

The 5,400 trial participants, selected for being at a high risk of contracting HIV (mainly gay men) received up to seven injections during the trial. Some received the vaccine and others the placebo shot.

Incidentally, there was no risk of the vaccine itself causing AIDS as it contains no genetic material from the HIV virus. Instead a synthetic copy of proteins found in HIV was used to try to sensitize the body's immune system to the virus so that it produces anti-bodies to fight it. The hepatitis B vaccine successfully uses the same approach.

All participants were monitored since 1998 to see if they became infected. Unfortunately the results were not great, but Dr. Peter Piot, executive director of UNAIDS, said the results were "promising". And he indicated in a press statement that the trial provides clear evidence that a vaccine can work.

Some skeptics doubt this, and claim that funding should be withdrawn from the project. But research is bound to continue, and it probably should - at least to investigate the significant success on blacks and Asians.

And for those in need of AIDS treatment, some good news emerged this week. Fuzeon is a new drug that promises to help patients who have failed to respond to other medications. It is probably the biggest advance in AIDS treatment since the advent of the protease inhibitors in the mid-1990s because of its ability to attack the most aggressive forms of the virus. Unlike existing AIDS drugs, which block replication of the virus after it infects a cell, Fuzeon stops it from entering a cell in the first place.

Roche Holding AG, the patent holder, said it will price Fuzeon in Europe at EUR18,980 ($20,424) for a year's supply (pricing in the U.S. will follow in a few weeks, but is expected to be similar). It is double the price of the next most expensive medicine mainly because it requires an extraordinarily difficult manufacturing process, involving 106 distinct chemical steps. Most drugs have 20 steps at most.

Many AIDS workers are excited that it can provide hope for the 50,000 patients in North America and Europe who are resistant to some of the existing AIDS therapies. Roche says it will be able to make enough of the drug for only 15,000 patients this year as it continues to ramp up production.

All state health departments will want the drug but they have to make decisions about allocating scare resources. A report in the Wall Street Journal said that California will not decide whether to put Fuzeon on its list of covered drugs until July, when it gets a better sense of what the state funding will be.

Nevertheless, as resistance to other drugs increases, demand for Fuzeon may well be met. Roche is likely to be able to deliver the drug to all European and American AIDS patients by the end of 2004.

Despite this good news, some activists are already complaining that the drug will never be marketed in developing countries because the cost is prohibitively high - further fueling the debate about patents and prices.

Roche invested over $600 million in developing the drug. It deserves to be able to reap the benefit from those who will want it in the West. At some stage the production process may be simplified to allow it to be sold in Africa. But it's the profit motive that developed this extraordinarily complicated drug, and no amount of protesting will ever develop a cheaper solution.

Dr. Roger Bate is a fellow of the International Policy Network and a columnist.

TCS Daily Archives