The FDA, OraQuick and an Inveterate Scandal

scan-dal [skan-dl]
noun
     1. An offense caused by a fault or misdeed
       2. A 24-year ministerial act of governmental paternalism

In the midst of our country’s 236th celebration, it seemed as if independence was on everyone’s mind, including (and most especially) from those within the Food and Drug Administration (FDA). Independence, in this case, was from paternalistic policies.

The approval of the 20-minute, OraQuick Rapid HIV test—the over-the-counter home-use kit—doesn’t seem too terribly scandalous at first glance. In fact, if anything, it sounds like an unmitigated achievement, a holy grail for reducing HIV transmission. That is until you dig further into the initial FDA ruling, when that occurred and the cost of that decision.

According to statistics from an FDA Advisory Committee that presented its findings in May, the OraQuick technology holds the key to preventing more than 4,000 new HIV transmissions in its first year of use alone. Roughly translated, that’s about 8 percent of the 50,000 new U.S. infections that occur yearly.  In all, about 1.2 million people are now living with HIV, according to the Centers for Disease Control and Prevention (CDC); about 20 percent of those infected don't even realize they have it. Those 20% go on to the vast majority of all new infections.

And while July 3rd quietly marked the approval and announcement of this “new” test, the true scandal is that—minus the packaging and inserts—it’s the same one that’s already been in use for over eight years (April 2004) by AIDS Service Organizations and medical professionals nationwide. Eight years? Ouch!

A Timeline of Prevention and Care

This past June marked the 31st year since the first cases of AIDS were reported in the United States. For those first blindsided by AIDS in 1981, there was no treatment; in fact, for those diagnosed they were already in the later stages of AIDS, and no matter the medicine (or money), it was too late. Today, thank G*d, that’s not the case.

In thirty-one years, we’ve seen a rapid progression of treatment, from mono-therapy AZT to the “cocktail”—the panoply of antiviral medicines, taken in combination, which eases yesteryear’s suffering. But in order to be prescribed those lifesaving and life-prolonging treatments you need to know your HIV status. To do that, you have to get tested. But in order to get tested, you have to physically go somewhere, disclose your sexual history (or histories), wait for them to reveal your status, and hope they don’t secretly judge you. Couple that quandary with epidemiology—the HIV incidence and prevalence rates among gay and bi-sexual men and/or intravenous drug users—and you’ve got a recipe for instant discrimination. Even today, getting testing for HIV is often a dreaded day to mark a person’s passage from sexually-transmitted disease naiveté to potentially AIDS-ribboned man, woman or child. The beauty of the rapid home test is that it offers true confidentiality, privacy and convenience.

The Dirty Little Secret

In 1987, University Hospital Laboratories submitted an application seeking approval of a rapid in-home blood test for HIV. In March 1988, the FDA declined to accept it for filing—a ministerial act, that in the ordinary course of the regulatory process, holds up approval (or ultimate rejection). Rather than rule on it immediately or open future submissions to hearings, the FDA published a sequence of prerequisites for future applications. In essence, it stalled the possibility of rapid in-home tests. In fact, it went so far as to state that the only rapid test applications to be considered for approval were those performed in clinical settings.

The underlying rationale? So clients could receive the proper counseling from accredited professionals in order to: alleviate confidentiality concerns, social stigma and recrimination(s) from testing positive; reduce the likelihood of a false positive (or incorrectly interpreted negative result, especially for those in the “Window Period”); get people into medical treatment sooner (rather than later); reduce behaviors endangering; help facilitate disclosure to past partners; and offer psychological and emotional support to those infected. And so Counseling, Testing and Referral (CTR) organizations were borne (as was the big business of AIDS). But truth be told, it's easy to see the motivations behind  the FDA’s initial ruling in 1988.

Public-health concerns are as slow to maneuver in and around as are rulings by the FDA and the CDC. I get it. Public health officers want to get it right the first time. But their rulings (like lots of other governmental “intrusions” depending on how you view them) often overlook Occam’s razor—the ultimate law of parsimony; or, in laymen terms, “other things being equal, a simpler explanation is better than a more complex one.” To put it plainly, a quiet paternalistic moratorium on future in-home test kits was ill-advised initially and became even more so with each passing year. In fact, it only perpetuated stigma (in my humble opinion). What held true in 1987 and 1988 didn’t hold true for 1996, 2001, 2004, or any subsequent year thereafter.

By 2004, we learned even anecdotally that when people became aware of their positive HIV status, had access to, engaged in routine medical care and began treatment, the progression of HIV was dramatically reduced, bringing us all one step closer to our goal of ZERO transmissions. By 2011, in fact, meta-analysis studies statistically showed that when we’re adherent to our medications (antiretrovirals) and have an undetectable viral load, there is a significantly (2011, CDC pronounced) reduced likelihood of transmitting the virus to others. Some data says that it can reduce new infections by upwards of 96%. So why wasn’t there a new ruling during those years? What held up a  definitive ruling on a testing technology that had already been medically proven for eight years?

The potential human toll since the FDA’s first rapid, home-use HIV test application in 1987? While averting 4,000 infections (people, mind you) per year is a best guestimate from the advisory panel, anything greater than 1 was always too many. Thirty-one years into the epidemic, it all comes back to the basics of taking the first brave step to test. And for many of us, that would have happened much sooner if we could have tested in the privacy of home.