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CDC to Urge Routine HIV Tests
For a Broad Swath of Americans
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Wall St Journal
By MARILYN CHASE
May 8, 2006; Page A1
The U.S. Centers for Disease Control and Prevention is planning to recommend that doctors begin to offer voluntary HIV tests as a part of routine medical care for everyone in the U.S., ages 13 to 64, regardless of lifestyle or perceived risk for HIV.
In a sweeping revision of HIV guidelines, CDC officials say the agency also will recommend that patients no longer be required to sign separate informed-consent forms before submitting to an HIV test -- a current guideline that is law in New York and some other states. The CDC also plans to suggest eliminating or abbreviating requirements for often-lengthy pretest counseling.
The aim, CDC officials and doctors who support the changes say, is to broaden the scope and simplify the process of HIV testing to reach more infected people as early as possible. The CDC estimates that about 25% of the one million people now infected with HIV in the U.S. are unaware that they carry the virus, and may not find out until the infection progresses to the potentially lethal symptoms of AIDS. By that time, the patient could have unknowingly infected many other people.
"It's still very burdensome to test somebody 25 years into the epidemic, and that doesn't make sense," says Grant Colfax, co-director of AIDS statistics and epidemiology for the San Francisco Department of Public Health. He and nearly everyone agree, however, that there is no point in universal testing unless everyone who tests positive has adequate access to counseling and treatment.
While few people argue against broader testing, some patient advocates and others have already protested to the CDC that routine universal testing without strictly enforced informed consent could lead to coercion that drives people away from care and undermines HIV prevention. Others worry about breaches of privacy -- particularly since the CDC recommends that states switch to name-based reporting of HIV cases from alpha-numeric codes. Another concern is loss of insurance coverage or jobs.
Many doctors, as well as the CDC, favor widespread proactive testing because, they say, early diagnosis leads to treatment and longer life and reduces the spread of infection. Tim Mastro, the CDC's deputy director for science in the division of HIV/AIDS prevention, says "our greatest success story" in preventing AIDS has been the reduction of HIV in newborns due to routine testing and treatment of pregnant women.
Routine testing of pregnant women and treatment of those who are HIV positive have reduced the incidence of HIV in newborns from about 1,750 a year in the 1990s to about 300 a year since 2000. Because of this success, Dr. Mastro notes, routine testing draws "very strong support" from groups like the American Medical Association and the American Academy of Pediatrics.
CDC recommendations don't have the force of law, but they do signal to doctors and insurers a new standard for care and reimbursement. The CDC says details of the new guidelines are being finalized and are likely to be published this summer in the agency's Morbidity and Mortality Weekly Report, which 25 years ago first reported about a previously unknown, fatal disease that attacks the immune system. Back then, most cases were among sexually active homosexual men.
In the ensuing years, the human immunodeficiency virus and its clinical successor, acquired immune deficiency syndrome, or AIDS, have become a global pandemic affecting 40 million people, with five million new cases and three million deaths a year.
Laws requiring pretest counseling and separate informed consent were initiated in the 1980s and early '90s, when AIDS stigma led to torching of some patients' homes, treatments were few and a diagnosis was a death sentence.
Today, the CDC says, the development of rapid-result testing and more-effective treatments mean people have more to gain from knowing they are HIV positive. And Dr. Mastro contends that offering HIV tests to all patients -- uncoupled from a focus on risk groups -- could actually reduce any stigma still associated with taking the test.
Current testing guidelines focus on high-risk groups such as gay men and intravenous drug users and their partners, or on people in areas of high HIV prevalence. When a patient requests or a doctor recommends an HIV test, many places require up to 20 minutes of one-on-one counseling to explain the test and the implications of taking it. Then, in some states, a patient must sign a separate informed-consent document -- which lays out the risks and benefits of a procedure -- or provide specific oral consent, and the doctor must record that the patient was counseled and gave consent. Only then is the test performed.
The CDC plans to recommend that, pending revision of state and local laws requiring written informed consent -- a process that could take years -- HIV testing be offered to everyone ages 13 to 64. The test would be bundled with routine screening tests such as those for cholesterol and blood glucose as a normal part of care in doctors' offices, clinics, hospitals and emergency rooms.
A doctor would orally offer the test and a patient's oral consent -- or refusal -- would suffice. Then the test would be performed. If positive, the patient would be taken aside for private discussion of the results. Blood would be drawn for tests to confirm a positive result or rule out a false positive, and if still positive, the patient would, ideally, receive more detailed counseling about prevention, care and medical follow-up.
While the CDC stops short of recommending any specific test product, routine tests are enabled by the advent of rapid, inexpensive HIV tests such as OraSure Technologies Inc.'s OraQuick rapid HIV antibody test, which takes 20 minutes to determine if a person is infected with HIV. The test price ranges from $11 to $17 depending on the quantity ordered. Rapid tests yield false positives about two times per 1,000, which is why confirmation is required with more reliable tests. Confirmatory tests can take two days to two weeks to yield results and could add $50 to the cost, according to a physician-researcher who uses them.
The cost of populationwide proactive testing is far outweighed by the benefits to overall public health, says Thomas Frieden, commissioner of the New York City Department of Health and Mental Hygiene. More than half of new HIV infections are believed to be transmitted from people who are unaware they carry the virus, the CDC says.
A major fear among those who oppose broader testing with looser informed-consent requirements is that certain vulnerable groups -- women and minorities, for example -- won't be treated fairly. They may, these critics say, be offered the test in clinics or other settings where they feel coerced by harried health-care staffers to say yes, or where protection of privacy isn't uniformly maintained, or even where consent isn't specifically sought.
"Everyone has concerns about informed consent," says Catherine Christeller, executive director of the Chicago Women's AIDS Project, one of 54 groups that have written to the CDC to voice opposition to the end of informed consent. "Women -- particularly minority women -- have a concern about abuses."
Adds George Annas, chairman of health law, bioethics and human rights at Boston University: "You need permission to test. The default mode should be that patients have to say 'yes' to testing," not merely say no to refuse it.
Routine testing "is a double-edged sword," says Wendy Mariner, Boston University professor of health law. "It's valuable to alert people to availability of treatment. But critics worry routine testing could slide into testing without knowledge or consent. That's not what's intended, but it's a legitimate concern."
Prof. Mariner says fears among the general public that a positive test will result in a loss of insurance or employment are probably overdone. People now in Medicaid, Medicare, or group health policies "can't realistically be excluded" if they test positive, she says. Insurance plans can cap payouts, forcing patients to pay a larger proportion of their bills, but insurers can't legally exclude a specific disease like HIV.
Moreover, Prof. Mariner says, the U.S. Equal Employment Opportunity Commission has determined that under the Americans With Disabilities Act, HIV is a disability and employers thus can't discriminate against an employee infected with the virus.
However, HIV-positive people buying a new individual insurance policy could face higher premiums, or find that HIV is treated as a pre-existing condition much like cancer or heart disease, possibly excluding coverage of that condition for a period, Prof. Mariner says.
Supporters and opponents of broader testing agree that providing access to counseling and treatment is essential. When people are informed they're HIV positive, the CDC's Dr. Mastro says, counseling leads to a 68% reduction in risky behavior and fewer new infections.
Rochelle Walensky, assistant professor of medicine and an AIDS researcher at Harvard University, backs broader testing. "By not finding them," she says, "we're not doing them a favor." But, she warns, that if someone who tests positive "doesn't make it to care, then you've found the needle in the haystack only to throw it back."
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