TESTIMONY OF ELLIOTT J. MILLENSON
FDA Blood Products Advisory Committee Meeting
November 3, 2005
Good afternoon. I’m Elliott Millenson. I was founder and CEO of Direct Access Diagnostics, the J&J companywhich developed the nation’s first home AIDS test. I no longer have any financial interest in AIDS testing. But, I do have an interest in public health. I’m here to offer some history on home AIDS testing, a perspective on how FDA’s actions have been perceived by industry – the folks who must commit the resources to bring a home test to market - and some thoughts on where to go from here.
I’m a businessperson – but I worked with the Public Health Service in the 1970s, helping educate Americans about the health consequences of smoking. I’ve seen firsthand what those in public health face. Strong science sometimes meets stronger politics. When I had the idea for a home AIDS test, I thought of developing a rapid test, since the technology was available. But, it was clearFDA would not approve such a test, so we developed a blood collection kit instead and sought FDA approval. We expected after approval, we would quickly transition to a rapid home AIDS test, which we always knew had much broader appeal.
But, even getting Confide approved turned into a nine year battle. It started with our 1987 application, to which FDA responded by placing a ban on all home AIDS tests. FDA announced in March 1988 they would only consider AIDS test applications “for professional use only in a health care environment”.
Industry believed FDA’s ban was politically motivated. FDA was pressured by AIDS activists who feared the social consequences of making AIDS tests too easily accessible, and clinics who feared the financial consequences– reduced government funding if home AIDS testing caught on. Opponents had lobbied aggressively against home AIDS testing at all levels of government, with particular focus on FDA.
Opponents conjured up the scare tactic that face-to-face counseling was essential to prevent suicides, a claim with no scientific basis. In fact, for well over a decade studies have revealed the overwhelming majority of people getting tested for AIDS haven’t received counseling anyway.
took two lawsuits from my company just to get FDA to consider our
application. Finally, in 1994 FDA
brought Confide before its Advisory Committee, which expressed support. But, in a subsequent private meeting
documented in a smoking-gun memo aired by CBS News, CDC opposed Confide,
arguing approval could
“ burden the already overburdened health care
system.” Two more years
passed - about 80,000 more Americans became infected - before FDA finally
approved Confide in 1996, nine years after FDA initially refused our
all history now. But, past actions
affect future decisions. AIDS is an
incurable sexually transmitted disease – which has already killed half a
100 more become infected with HIV – most from sex with an infected person. That’s a wake up call: some people don’t
abstain, aren’t faithful, and won’t use condoms. %. That’s worrisomes and reduce much
actual use data reveal a 10% failure rate for
only truly safe sex is sex between two uninfected partners. We teach our
children to put condoms on cucumbers.
We need to teachchildren the importance of AIDS
testing. In our sexually active
society, testing must be accessible in many places - especially the home -
because the majority of people are reluctant to go to a doctor or clinic for an
number of people who know they’re infected don’t tell their partners. So, we need to encourage people to know not just
their HIV status but that of their partner as well.
A rapid home AIDS test could quadruple the number of Americans getting tested according to CDC data. a good sign that here today. But, FDA needs to encourage many companies to develop and market home AIDS tests. Competition means less expensive, faster, more reliable, and more user-friendly home AIDS tests will be developed – quickly. Companies skilled in reaching consumers will educate Americans about the benefits of AIDS testing, and responsibly market their tests through a broad range of distribution channels, including, no doubt, public clinics who can give the test away to those with limited resources.
But, senior executives at major health care companiesbelieve FDA has had a strong bias against home AIDS testing for two decades. America’s most innovative companies will be slow to commit their R&D dollars to home AIDS testing– unless it is clear FDA’s longstanding opposition has truly softenedFor the good of all Americans, I urge you – the Advisors in this room –recommend FDA send a clear, credible, decisive message to industry that FDA is not just accepting applications, it’s aggressively encouraging them. The health of our great nation depends on your courage and conviction. Thank you.