Saturday, April 28, 2012

Demand FDA Approve Rapid Over-the-Counter HIV Test

[Action Alert! We have ONE WEEK to submit comments to the FDA - instructions below]

According to the Center for Disease Control in Atlanta, (the "CDC"):

- 1.2 million people in the United States (U.S.) are living with HIV infection.

- One in five (20%) of those people – or about one-quarter million people are unaware of their infection. That’s the equivalent of the entire population of Jersey City, New Jersey; Orlando, Florida; or Buffalo New York living with an infectious disease and not knowing it.

- 50,000 new cases of HIV infection every year in the United States since the epidemic began.

- An estimated 17,774 people with AIDS died in 2009, and nearly 619,400 people with AIDS in the U.S. have died since the epidemic began.

The scientific and medical communities are united in their belief that one of the most effective ways to control the spread of HIV is through early detection (testing) and early treatment (Anti retroviral drugs that reduce the viral load to undetectable levels).
And so, the fact that a rapid-test to detect HIV has been available for over a decade, but is still illegal to sell over-the-counter in drug stores, is nothing short of criminal.

On November 3, 2005, (six and a half years ago) the Blood Products Advisory Committee of the FDA wrote:

Over the past four years, FDA has approved a number of rapid HIV tests of low complexity, which are simple to use, require no special storage conditions and provide a highly accurate test result within 20 minutes for the detection of antibodies to HIV. Two of these tests were found to be simple enough to perform that they received a CLIA waiver, expanding the availability of testing.

But here’s the kicker. The FDA continued:

Since 2002, all rapid HIV tests were approved as restricted devices, with sales and use restrictions in place. Sale is restricted to clinical laboratories …and [t]he test is approved for use only by an agent of a clinical laboratory...[The] FDA has discussed HIV home-use test kits and home-use collection kits over the past 10 years in various forums…In the course of these discussions, appropriate regulatory criteria were identified for home-use specimen collection kits for HIV testing, but not for home-use HIV test kits. With improved test kit technology (ease of use, freedom from biohazards, and excellent performance characteristics), we believe it may be feasible to identify regulatory criteria for home-use HIV test kit.

Yesterday, while walking through my local pharmacy, I saw at-home pregnancy tests; tests to detect cocaine, marijuana, and a list of other drugs in one’s system; and of course, the blood glucose tests that many diabetics use on a daily basis. But in spite of the available technology, no home tests for HIV…even though the FDA itself concluded in 2005:

“Benefits of HIV home-use test kits include anonymous testing potentially leading to more people knowing their HIV status, empowerment of consumers in healthcare decisions, earlier diagnosis of HIV infection and therefore earlier intervention.”

And yet, in the decade that has passed since the rapid tests were denied for private home use, 500,000 new HIV cases have occurred. Of those, 100,000 people do not even realize they are infected.

Why does this continue?

The FDA is concerned that “Risks of HIV home-use test kits include inappropriate use of the test or test result, including misinterpretation,” “obtaining a test result without live counseling,” and “and use by minors.”

Yeah? And so what? Aren’t those the possibilities with any of the above mentioned at-home tests sold in a drug store? Would we rather that minors who are uncomfortable in a clinic simply walk around with HIV and infect others as their own health deteriorates for unknown reasons? Are they suggesting that pregnancy is a condition that does not require a support system?

Thousands of individuals would use a test at home rather than go to a clinic. People in rural communities who are reluctant to show their faces in a clinic where everybody-knows-everybody; men or women who have cheated on a partner; young people still ill-at-ease with discussing their activities; those for whom English is not a first language and for whom clinical translations are not readily available; those who are high-profile members of their communities; and those who were raised with a fear or stigma of HIV and AIDs - would all be more likely to test at home than walk into a clinic.

The reasons for denying the public access to these tests are entirely unacceptable.

In a perverse reversal of roles, it is the HIV clinics themselves who have been partly responsible for the delay in releasing these tests to the public. The very clinics and “AIDS Service Organizations” or “ASOs” who exist to help HIV positive persons navigate complex legal and medical support systems have a vested interest in keeping these tests out of public hands. Annually these agencies report the number of people to whom they provided services to private donors, government agencies who fund them on a ‘per-person-served’ basis, and to United Way Charities, which requires a “Number Served” figure as part of their funding formula. Thus, some of those agencies that are most vocal about “supporting” the HIV community are actually the very agencies that have given life to the idea that the FDA should prohibit private, at-home testing because it wouldn't be accompanied by “live counseling.”

A recent survey of over 1,500 people by "Who's Positive" revealed the gap in support between persons living with HIV and those with a clinic-based livelihood or agency role. The survey found:

"The survey gathered responses from 1,569 participants, 74% of which said that they would support an OTC rapid, oral swab HIV test that could be purchased in a retail store, if approved by the FDA. Other key findings include:

66% of the respondents who identify as a HIV-positive consumer support an OTC HIV test
80% of those aged to 30 support an OTC HIV test"

But then went on to show lower support by those with a vested interest in maintaining clinic control"

"A majority or nearly 52% of those who identified as a paid member of an HIV/AIDS organization support an OTC HIV test
47% of those who identify as one who performs HIV testing support an HIV OTC test"

It is hypocritical, self-serving, and dangerous.

On the other hand, the public often views medical technology companies with a critical eye…but in this case, it has been just such a company – OraSure Technologies – which has been fighting for a decade to obtain FDA approval to market it’s 20-minute, at-home anonymous test kit.

And once again, the issue is scheduled to be discussed before the FDA Blood Products Advisory Committee. OraSure has applied – again - for the approval of its OraQuick(R) Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter market at a meeting scheduled for May 15, 2012.

The Company will be presenting its findings from a study of 5,800 subjects who believed they were HIV negative. When enrolled in a test-phase using their at-home testing product across 20 sites nationwide, more than 100 of them tested HIV positive.

The FDA has issued the following public notice, permitting public comment in person or in writing. You know what to do:

On May 15, 2012, the FDA Blood Products Advisory Committee will meet from 8:30 a.m. to approximately 5:00 p.m. to discuss the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test.

The meeting will take place at the Hilton Washington DC/North, 620 Perry Pkwy., Gaithersburg, MD, Tel: 1-301-977-8900.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made on or before May 8, 2012 by submitting them to:

Bryan Emery or Rosanna Harvey
1401 Rockville Pike, HFM-71, Rockville, MD 20852
FAX: 301-827-0294
or via e-mail: or email:

Oral presentations at the meeting from the public will be scheduled between approximately 1:30 p.m. and 3:15 p.m. Those individuals interested in making formal oral presentations should notify Bryan Emery or Rosanna Harvey on or before April 30, 2012, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. Those making a request to speak will be notified regarding their request by May 1, 2012.
The notice and complete description of the May 15 and May 16 meetings (as well as the link to the webcast for the hearings) is available on the FDA Website

[pictures: thanks to Tom Donohue of "Who's Positive"]

No comments: