“ Know your status,” the theme of this year’s World AIDS Day on Saturday, bears a sad irony and a witness to Washington’s toxic political system. It's a reminder of what happens when Washington cares less about right and wrong, or fact and fiction, than about money and power.

Take as a given that knowing your status before having sex is a no-brainer. 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. And I had a front-row seat.

At the dawn of the AIDS epidemic, I thought home HIV tests could help prevent new infections. So I founded a company to develop one. Research confirmed one-third of people who wanted to test would only do so using a home test. In 1987, after clinical trials demonstrated our product's safety and efficacy, we submitted an approval application to FDA.

I was stunned when FDA refused to accept our application and enacted a ban.

It was politics, and it came from many directions. Infected gay men, who’d organized seeking treatments, were fighting against expanding the use of testing, perceiving it as a threat to personal freedom. Testing clinics and labs, fearing competition, also lobbied aggressively against home tests.

FDA chose to ignore science. Opponents were so afraid of home HIV tests they lobbied state legislatures in California, New York, Texas, and Florida, which instituted state bans just in case FDA ever approved one. Nobody complained but me.

I sued the FDA in 1990. We settled, with FDA announcing they’d reversed their ban, would accept applications, and would hold an advisory committee meeting. Opponents got busy. At the meeting, FDA said their ban was still in place. I immediately sued again. In 1993, I settled. FDA kept its ban, but promised to expedite review of our application. So I sold my company to Johnson & Johnson.

With the legitimacy that J&J’s name conferred, I met with hundreds of people, gaining support from AIDS activists, members of Congress, and powerful interest groups. I also persuaded states to reverse their home test bans. In mid 1994 an FDA advisory committee voted unanimously to approve our test. After the meeting with CDC, which funded a network of testing centers, FDA began to claim that home testing would lead to more people testing and “overburden the already overburdened healthcare system.”

I provided an FDA memo documenting CDC’s opposition to CBS News, which aired a story. Two days later, agents from FDA’s Office of Criminal Investigations visited me at the request of FDA’s commissioner. The agents threatened me with criminal prosecution if I’d given the memo to CBS. I told them that I had, but that if they were really interested in criminal behavior, I had been complaining to the FDA commissioner for some time that our application’s chief reviewer was on the board of Whitman Walker Clinic, a strong opponent of home testing.

I was fired soon after. I sued J&J for wrongful termination and was awarded the business back, but settled, and J&J closed it down.

It took FDA until 2012 to finally lift its ban on rapid home HIV tests. Tragically, countries around the world had followed FDA’s 1988 ban, believing it was based on science, and also banned home HIV tests, resulting in countless additional people being exposed to or contracting HIV. Fortunately, following FDA’s 2012 home test approval, dozens of countries finally reversed their bans as well and approved home tests.

It’s impossible to say how many of the almost 700,000 American lives and 35 million worldwide could have been saved with home tests. Today, over a million Americans are living with HIV, 37 million worldwide, and roughly 40,000 Americans and 1.8 million worldwide are newly infected annually. That’s why almost 1 percent of Federal tax receipts are spent on AIDS, and treatment costs are rising every year.

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. Without a meaningful worldwide focus on HIV prevention, we’ll continue to observe World AIDS Day with slogans full of sound and fury, signifying nothing for decades to come.

Elliott Millenson founded the Johnson & Johnson subsidiary which developed the first home test for HIV.