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FDA TO WEIGH AT- HOME TESTING FOR AIDS VIRUS at Public Hearing
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NY Times
October 13, 2005
By GARDINER HARRIS
Federal drug regulators have agreed to consider allowing a Pennsylvania company to sell the first rapid, at- home AIDS test that would make testing for the virus about as easy and accessible as a pregnancy screen. The move could put to rest 18 years of controversy.
Officials at the Food and Drug Administration and AIDS advocates long worried that people who got an AIDS diagnosis would panic and even consider suicide. So for years, the federal drug officials have insisted that counseling and professional support accompany AIDS tests. This requirement has complicated proposals for at- home tests.
But improved medicines now mean that AIDS is a chronic disease that can often be managed for years, so the fear that a diagnosis might lead to thoughts of suicide have subsided. Just as important, 40,000 people each year continue to be infected by HIV, the virus that causes AIDS. This rate has remained stubbornly high for years. Having tried many other strategies, federal health officials are now increasingly open to the idea that an at- home AIDS test could finally lead thousands to change their behaviors and stop infecting others.
"If we're going to win the war against AIDS, we need to make HIV testing as easy as pregnancy testing," said Dr. Freya Spielberg, a researcher in the Center for AIDS Research at the University of Washington.
A federal advisory board will discuss the proposal for an at- home AIDS test on Nov. 3. After that, the test's maker, OraSure Techologies, based in Bethlehem, Pa., said that it would likely apply formally to sell the device over- the- counter.
The test, called OraQuick Advance Rapid HIV- 1/2 Antibody Test, is presently sold only to doctors and clinics. It has already proven to be effective, safe and easy to use. So the remaining hurdles are decisions by the F.D.A. about whether approving such a device is a good idea and whether people can understand the product's label well enough to administer it to themselves.
A 1987 application for an at- home AIDS test kit led to years of controversy. At the time, AIDS advocates and public health officials predicted that such a test would cause widespread suicides, panic and a rush to public health clinics.
At hearings, AIDS advocates handed out copies of an obituary of a San Francisco man who jumped off the Golden Gate Bridge after discovering that he was infected with HIV. An official for the Centers for Disease Control and Prevention told the F.D.A. that such tests could lead to "a sudden increase in referrals to already overburdened health clinics," according to an F.D.A. document.
Federal regulators stalled the application for nine years, and at- home AIDS testing never caught on.
Some AIDS advocates are now warily supportive of at- home testing.
"For people who don't have access to a clinic or make a decision not to go to a clinic, this is better than nothing," said Gregg Gonsalves of Gay Men's Health Crisis in New York City, which opposed at- home AIDS testing 18 years ago and offers testing and counseling itself. "But it's not a magic bullet."
The switch by advocates is important. Politics have long played a crucial role in many F.D.A. decisions, according to longtime agency observers and previous agency officials. Recently, the agency decided to delay a decision on whether to allow over- the- counter sales of an emergency contraceptive. The decision was seen by some inside and outside of the agency as politically driven, and it led a top agency official to resign in protest.
Dr. Spielberg said that about a quarter of the nearly million people in the United States who have the HIV virus in their blood do not know that they are infected. And somewhere between 40 percent and 45 percent of those who test positive for HIV do so less than a year before they are diagnosed with AIDS.
Since an HIV infection often takes a decade to develop into full- blown AIDS, "this suggests that people are living with HIV, and spreading HIV for many years before they are aware of their infection," she said.
Many of these people avoid getting tested in clinics for a variety of reasons, including fear of discovery and convenience, studies show. And many hate having to wait more than a week for a lab result, surveys show.
Dr. Spielberg said that she surveyed 240 people infected with HIV and found that more than half said that they would have preferred to have found out about their infection with a rapid at- home test.
Having a rapid, over- the- counter test widely available, Dr. Spielberg said, "is the most powerful strategy we have to bring down HIV infections." People who find out that they are infected with HIV often change their sexual behavior to reduce further infections, she said.
By contrast, OraQuick requires a person to simply swab their gums and then place the swab in a holder. Twenty minutes later, a strip displays one line for a negative result and two lines for a positive one.
The argument against at- home tests has long been that they failed to ensure that patients would get adequate counseling. Activists now acknowledge that many people who get HIV tests in doctors' offices get little or no counseling anyway.
"The counseling that now occurs is very short or abrupt in many settings," said Gene Copello, executive director of The AIDS Institute, a Washington- based policy group.
Doug Michels, president and chief executive of OraSure, said he plans to include advice about counseling on OraQuick's label. "It could be a hotline number, a 24- hour manned counseling center, Web support or printed material that is included in the product," he said.
The company said it would include whatever the advisory committee and the F.D.A. deems is necessary, he said. The company now sells the device for between $12 and $17, although the price of an over- the- counter version has yet to be decided, Mr. Michels said.
FDA Public Hearing
The Food and Drug Administration (FDA) is announcing a meeting of its Blood Products Advisory Committee (BPAC) to discuss important issues that include an approach for home- use rapid HIV test kits. The Committee will hear a proposal by OraSure Technologies, Inc. for over- the- counter (OTC) availability of the OraQuick ADVANCE Rapid HIV- 1/2 Antibody Test for use with oral fluid specimens, including:
- Proposed studies to validate adequate performance in the hands of intended users
- The ability of informational materials to provide counseling and other information regarding accuracy of testing, correct test interpretation, management of psychological and social issues, and medical referral.
The BPAC will also hear presentations addressing the role of rapid HIV tests in CDC's Advancing HIV Prevention initiative and CDC's current HIV test counseling recommendations, the role of quality systems in diagnostic testing, psychological and social issues associated with HIV testing, and prior experience with approved home- use test kits.
In addition, the committee will hear updates on the following topics: (1) West Nile Virus; (2) draft guidance on nucleic acid testing (NAT) for human immunodeficiency virus (HIV)- 1 and hepatitis C virus (HCV): Testing, product disposition, and donor deferral and re- entry; (3) summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability held on September 19 and 20, 2005; and (4) re- entry of donors deferred based on hepatitis B core antigen (anti- HBc) test results.
The meeting is scheduled for November 3, 2005, from 8:00 a.m. to 5:30 p.m. at:
Holiday Inn Gaithersburg
2 Montgomery Village Ave.
Gaithersburg, MD
The meeting is open to the public, and no registration is required. Please contact the hotel directly at 301.948.8900 for directions or information about accommodations.
Background materials for this meeting are posted on the FDA website at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005- 4190b1.htm
A draft agenda is available at
http://www.fda.gov/ohrms/dockets/ac/05/agenda/2005- 4190A1_draft.htm
Interested persons may present data, information, or views - orally or in writing - on issues pending before the committee during the open public hearing. Written submissions may be made by October 25, 2005 to Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301- 827- 0314.
Those desiring to make formal oral presentations should, by October 25, 2005, 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 to Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301- 827- 0314.
Oral presentations from the public will be scheduled on November 3, 2005, between approximately 2 p.m. and 3:45 p.m. Time allotted for each presentation may be limited, depending on the number of requests to speak.
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Donald W. Jehn or Pearline K. Muckelvene at least 7 days in advance of the meeting.
Advisory Committee Telephone Information Line:
Please call the Information Line for up- to- date information on this meeting, 1- 800- 741- 8138 (301- 443- 0572 in the Washington, DC area), code 3014519516.
Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration
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