FDA Puts Politics over Saving Lives by Blocking HIV Test Kits

by Mark Flatten
December 7, 2018

AIDS was killing people and Elliott Millenson invented a way to stem the epidemic, a safe and effective home test kit that would let people know if they were infected with the deadly and incurable disease.

The U.S. Food and Drug Administration would not allow it.

The concern had nothing to do with the safety and effectiveness of the testing kit that Millenson developed. It worked and was safe. Rather, the FDA buckled to political pressure and intense lobbying.

For the agency that determines which medical tests and treatments Americans will have access to, the risk of people unknowingly spreading the HIV virus that causes AIDS was far outweighed by the risk of allowing them to find out for themselves whether they were infected.

The American people simply could not be trusted with life-and-death information about their own health.

Millenson recounted his 20-plus year battle with the FDA in an op-ed published Dec. 5 in the Washington Examiner.

His critique of the agency echoes the findings of a Goldwater Institute report published in November, Studied to Death: FDA Overcaution Brings Deadly Consequences. Most notable is that FDA bureaucrats have expanded their power far beyond the congressional mandate of approving safe and effective medications and medical devices as quickly and efficiently as possible. And that people are needlessly dying as a result.

The standard the FDA uses is supposed to be whether a product is safe for use in humans and effective in achieving the desired medical result. But the FDA has strayed well beyond that mission. It has taken upon itself the job of dictating how, when and whether a product should be used, effectively substituting the judgment of agency regulators for that of medical professionals.

Millenson’s history lesson is a good illustration.

Because of the public fears and social stigma associated with AIDS, about a third of the people who said they wanted to be tested would only do so if they could do it at home. After clinical trials that showed his device was both safe and effective, Millenson’s company submitted a new drug application to the FDA in 1987.

That triggered intense lobbying for a federal ban on home test kits. The way Millenson tells it, infected patients opposed them because of privacy concerns. Testing clinics and labs lobbied against approval because they feared the competition.

The new drug application was rejected and the FDA imposed a nationwide ban on home HIV test kits.

A series of legal battles ensued.

News accounts at the time said FDA regulators were concerned that home testing would not be the most efficient and effective way to screen for the disease, and believed specimens should only be collected by medical professionals. They also worried that as more people found out they were infected, it might “overburden the already overburdened healthcare system.”

The FDA ban was eventually lifted and the first home testing kit was approved by the agency in 2012. By then, almost two million Americans had been infected with HIV.

“Take as a given that knowing your status before having sex is a no-brainer,” Millenson wrote in the Examiner. “HIV is sexually transmitted, incurable and asymptomatic for a decade after infection. The story of why it took so long for governments to come to that conclusion — at a cost of millions of lives and trillions of dollars — is an untold scandal.

“The legacy of FDA’s politicization of home HIV testing is that a disease which could have been stopped decades ago is still with us.”

Mark Flatten is National Investigative Journalist at the Goldwater Institute.

Learn more about the Goldwater Institute’s work to make the FDA more patient-centric with Free Speech in Medicine and Right to Try.