- The Washington Times - Wednesday, June 8, 2011

ANALYSIS/OPINION:

A landmark study has just shown early therapy dramatically reduces the likelihood of HIV-infected people transmitting the virus to others. Left unstated: If people are on AIDS medications, aren’t they supposed to be taking steps to reduce infecting others anyway? With more than 1,000 Americans becoming infected with HIV each week, it appears prevention isn’t anyone’s priority. A decade ago, when the federal AIDS budget was $14 billion, the Centers for Disease Control (CDC) stated “[its] goal was reducing the number of new HIV infections in the U.S. from an estimated 40,000 to 20,000 per year by the year 2005.” Instead, annual infections increased to 60,000.

This year’s federal AIDS budget is a staggering $27 billion - yet less than $1 billion of that goes toward prevention. The best proven prevention method is testing. Testing has virtually eliminated transmission from blood transfusions, and testing pregnant women so that drug treatments can be administered has reduced transmission from women infected with HIV to newborns to less than 2 percent. Yet, the government has aggressively - and successfully - thwarted efforts to make HIV tests more widely available to the American people.

I fought for more than a decade to get an instant home test for AIDS - like a home pregnancy test - on the market. The Food and Drug Administration (FDA) banned them, so eventually I moved on. Yet home tests could be an important tool for AIDS prevention. Since the vast majority of AIDS is transmitted sexually, a home test could empower people to easily know before having sex if they or their partner is infected. If a test result shows one partner is infected and the other isn’t, they would be able to choose whether to risk having sex using a condom, or not to have sex at all. With some studies showing a 15 percent infection rate even when condoms are used and one partner is infected, the knowledge from testing could make a big difference.

FDA’s decision to ban home tests traces back to 1985 when I founded a company - later a Johnson & Johnson subsidiary - that was first to conceive the idea for an instant home AIDS test. But free-standing HIV testing clinics and laboratory associations - powerful opponents with a financial stake in the status quo - lobbied their allies in Congress and FDA. As a strategy to justify a ban, they self-righteously claimed there would be a significant risk of suicide if people tested themselves, and that the only way to avoid this was for all HIV testing to take place in a face-to-face setting, with pre- and post-test counseling.

The government now acknowledges there was never any basis for the suicide concern and studies show there’s no need for counseling with an HIV test. But in 1987, in an attempt to appease opponents, we decided to seek approval for a less desirable test - we called it a “direct access” test - in which consumers collected a specimen that was then mailed to a lab, with results and counseling provided by phone. The FDA responded to our application with a de facto ban, announcing they were absolutely open to home HIV tests - so long as they were “for professional use only within a comprehensive health care environment.”

After filing a series of lawsuits over several years we successfully forced FDA to review our application. Recognizing when it comes to AIDS, the government pays more attention to politics than science, we built a coalition of support from concerned interest groups like the National Association for the Advancement of Colored People and National Council of La Raza, and from leading AIDS activists and from influential members of Congress like Newt Gingrich. The FDA ultimately approved our direct access test in 1996. But the FDA still maintained its ban on instant home AIDS tests. Shortly thereafter, Johnson & Johnson responded to the government’s message and took the product off the market and closed the company. So I moved on to other things and nobody took up the fight for a home AIDS test.

Almost 700,000 Americans have died from AIDS since we first proposed a home test. Our country has the talent and resources to eradicate AIDS. Now that studies reinforce the value of early diagnosis, it’s time to give new approaches - like home testing - a chance. At the same time, there should be a congressional investigation into what exactly taxpayers are getting for our $27 billion annual expenditure on AIDS and how that spending - and more importantly, the infection rate - can be reduced. We can no longer afford to let AIDS spending and AIDS cases continue to grow exponentially.

Elliott J. Millenson was founder and CEO of Johnson & Johnson’s Direct Access Diagnostics subsidiary.

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