TCS Daily

A Different High-Tech War

By James K. Glassman - March 28, 2003 12:00 AM

The entire op-ed page of the New York Times on March 1 was consumed by six pieces under the general heading, "The New AIDS Fight." So far, so good. But take a look....

One op-ed groused that President Bush's unprecedented pledge to spend $15 billion to combat HIV/AIDS "falls far short." Another called for female condoms. A third urged fighting the disease by changing "negative sexual images" of African-American women. Another wasn't about AIDS at all, but hepatitis. A fifth urged changing patent rules to open the floodgates for generic, or knock-off, drugs. The final piece recommended the "ABC model": abstain, be faithful and use condoms.

What's wrong with this picture?

It's missing the single most important element in fighting a disease that currently afflicts more than 40 million people worldwide: medicines developed by pharmaceutical companies that devote tens of billions of dollars a year to research.

For too long, public discussion of AIDS has been dominated by the peripheral, the sanctimonious and the outrageous - with little regard to the principles of sound science and economics. Now that the Bush Administration has made AIDS its top health priority, we do indeed need a "new AIDS fight," but it is not the one that the scribblers on the Times op-ed page offer.

It is, instead, what I would call a "High-Tech Agenda for AIDS." The agenda would first focus on the swift development and dissemination of new drugs. The drug industry is already the world's most successful high-tech sector, but it is constrained by regulations that often prevent effective remedies from reaching the public - and, worse, it is under attack by self-styled populists and out-of-control lawyers.

The assault seeks to control prices and strip companies of property rights - even though free markets and patents have been absolutely essential to encouraging expensive, time-consuming research in the first place. It is no accident that nearly all drugs are developed in the United States, Switzerland and Britain -where governments intervene the least and where property rights are respected the most.

The attack could not come at a worse time. While AIDS cases in the U.S. have declined thanks to new drugs, the virus is mutating at frightening rates. As a result, scientists estimate that nearly all AIDS patients currently being treated with retrovirals will need new medications in the next five years. Stripped of incentives, drug companies simply will not be able to develop those treatments.

Currently, drug firms are testing 83 new medicines for AIDS, in addition to the 74 that have already been approved. The big breakthrough came in the mid-1990s (12 years after the first cases of Acquired Immunodeficiency Syndrome appeared), when the first protease inhibitors were introduced. Largely as a result, the number of AIDS-related deaths in the U.S. dropped from 51,670 in 1995 to 15,603 in 2001.

AIDS remains, however, the fifth-leading cause of death for Americans aged 25 to 44 and the number-one cause of death for black men. At the end of 2001, some 363,000 people in the U.S. had HIV/AIDS, and, while treatments are keeping them alive, a new study has found that at least half of these Americans carry viruses that are already resistant to some existing drugs, since the virus insidiously mutates to thwart the medicines.

Resistance to current drugs will only increase with time, and scientists know that a new generation of AIDS medicines is a necessity.

Now in clinical trials or awaiting approval by the Food and Drug Administration are 14 vaccines and 33 anti-viral drugs, many of which attack HIV in new ways. These medicines are being developed by companies as large as GlaxoSmithKline, Merck and AstraZeneca and as small as AuRx of Glen Burnie, Md., Therion Biologics of Cambridge, Mass., and Triangle Pharmaceuticals in the new hotbed of AIDS research, Raleigh-Durham, N.C.

A High-Tech Agenda for AIDS would encourage such firms to intensify their work and on getting others to join them - and it would do more. Here are the basic principles:

1. Free markets cure diseases, so governments should not set prices. Start with the understanding offered by the writer Andrew Sullivan, who himself is infected with the HIV virus. He says he owes his life to anti-AIDS drugs and the companies that developed them. "The reason we have a treatment for HIV," he wrote in the New Republic, "is not the angelic brilliance of anyone per se but the free-market system that rewards serious research with serious money."

2. Vigorously protect and extend the property rights of pharmaceutical firms, so they can be assured of receiving enough revenues during the time the drugs they invent have patent protection - before they are copied by competitors that spend little or nothing to invent new medicines. Without such protection, why would drug companies invest $802 million in bringing a drug to market?

3. Enlist other industries in the battle to defend intellectual property. From Silicon Valley to Hollywood to Research Triangle to Manhattan, all innovators need to line up with the drug companies to repel the assault on patents and copyrights. While pharmaceuticals are the primary target right now, entertainment assets, software, medical devices, and many others are in jeopardy if the drug defense fails.

4. Speed up the approval process. According to the Tufts University Center for the Study of Drug Development, it takes, on average, 10 to 15 years for an experimental drug to move to laboratory to market, and only one in 1,000 compounds that enter pre-clinical testing make it to human testing. On average, it costs a company $802 million to get a single drug from lab to patients.

5. Expand the federal role but recognize its limitations. Government does provide funding for basic research that helps develop drugs, just as money for space research has helped in bringing commercial products like alloys and aircraft guidance systems to market. But without the billions of dollars spent by pharmaceutical companies in the search for new medicines - and, of course, in the pursuit of profit - the U.S. would be no more effective in developing drugs than Albania.

Of the 64 AIDS and AIDS-related drugs on the market today, 57 (including all protease inhibitors -- were developed exclusively by private pharmaceutical companies. With 14,000 new HIV/AIDS infections occurring every day, the world relies on research by American drug companies, and a new agenda begins with that acknowledgement.

An important role for government - and one the Bush Administration has adopted - is to provide funding so that HIV/AIDS patients at home and around the world can afford treatment.

6. Drugs aren't the only high-tech weapon against AIDS. Nanotechnology, the science of using very tiny devices, so small that they can travel through the human bloodstream. A company called Evident Technologies in Troy, N.Y., for example, is developing nano-crystals that light up to "detect the presence and quantities of pathogens," like the AIDS virus. New York Gov. George Pataki recently announced an investment in the small firm through a state equity fund.

7. More charities need to follow the lead of the Bill and Melinda Gates Foundation, which has made AIDS its top health priority and has contributed more than $500 million already to disease-fighting programs, such as a joint comprehensive effort with Merck in Botswana, including anti-retroviral treatment, a $100 million project in India, and a deep commitment to finding effective vaccines.

8. Take on the counterproductive AIDS "activists." Unfortunately, many of these radicals continue to spread a message which, if successful, will lead to fewer new drugs and, thus, to more deaths. For example, Larry Kramer, co-founder of Gay Men's Health Crisis, recently wrote, "I believe it is evil for drug companies to possess a means of saving lives and then not providing it to the desperate people who need it. What kind of hideous people have we become? It is time to throw out the selfish notion that these companies have the right not to share their patents."

But, of course, drug companies would not "possess a means of saving lives" in the first place without the incentive of patents and profits. Developing drugs is a very risky business. Consider VaxGen, Inc., a tiny pharmaceutical company, based in Brisbane, Calif., with a market capitalization of just 54 million. The firm's AIDS vaccine, Aidsvax, reached Phase III clinical trials with considerable promise. But, in January, officials at the company said that the vaccine had, overall, failed to protect volunteers from HIV infection (though it may yet prove successful). The stock, which had been trading above $20 a share, quickly fell below $3.

If, as Kramer advocates, AIDS vaccines would be confiscated if they worked, why should investors in VaxGen and other companies put their money at risk? To the shareholders, the message is: Vaccine fails, you lose; vaccine works, you lose.

A High-Tech Agenda for AIDS cannot shrink from confronting the irrational assault of the radicals. Too many lives are at stake.

This is not to say that the question of how to distribute HIV/AIDS medicines to people who cannot afford them is unimportant. Drug companies themselves provided $1.9 billion in financial assistance and medical products to developing nations between 1998 and 2001 alone. Pfizer is distributing its medicine, Diflucan, free of charge and "without dollar or time limits" in nations in sub-Saharan African. Diflucan treats infections of the lining of the brain and the espophagus - a condition that affects an estimated 30 percent of AIDS patients.

The Pfizer Diflucan Program would not be bringing relief to AIDS patients in places like Rwanda and Namibia if patent protections had not encouraged Pfizer to develop the drug. Similarly, software patents were key to the success of Microsoft Corp. - and thus the Bill and Melinda Gates Foundation.

It is the development of innovative drugs and other high-tech therapies that will end the scourge of AIDS. As more drugs come to market, health-care costs will fall - and they already have. A study by the New England Journal of Medicine, for example, found that the advent of combination drug therapy for HIV/AIDS increased pharmaceutical spending by 33 percent but cut hospitalization costs by 43 percent. Meanwhile, charitable governments, corporations and foundations should more efficiently help those who cannot afford the medicines.

Such distribution issues are important - as are condoms, abstinence and social attitudes. But they should not distract policymakers from the main event: scientific innovation. That is where the New High-Tech Agenda for AIDS will concentrate.

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