Maybe, caring most for those with HIV/AIDS looks different than we believe

It’s easy to mean well and get behind popular preventive health programs that sound like they save lives and are in everyone’s best interests. But no matter how popular or intuitively correct an intervention may be, that doesn’t make it scientifically sound, mean its benefits outweigh the potential harms, or that it is the most ethical use of skyrocketing healthcare costs.

Yesterday, as part of World AIDS Day, the American College of Physicians issued a Clinical Practice Guidance Statement calling for HIV screening of every person over 13 years of age in the United States when they see a doctor for any medical care. Instinctively, routine testing sounds like it can only save lives by identifying more cases of HIV, but it comes with strings attached that few consumers realize. And those may prove costliest of all for the very people we most want to help.

The evidence — USPSTF

This clinical guideline was published in the current issue of Annals of Internal Medicine. In examining the evidence, the American College of Physicans (ACP) found only two guidelines on screening for HIV that have been developed in the United States. The primary one came from the U.S. Preventive Services Task Force, the federal agency tasked with performing rigorous systematic reviews of the evidence that are supposed to be used to guide our government health policies and programs. The latest 2005 USPSTF review of the evidence upheld its 1996 recommendations to counsel and screen people at increased risk for HIV infections*.

It found insufficient evidence to recommend routine screening of people without identified risk factors.

For those with advanced stages of HIV, the USPSTF found the evidence supports the use of highly active antiretroviral therapy for improving health outcomes and reducing mortality. While the use of HAART can be considered for people in earlier stages of the disease and at a high risk for progression (CD4 cell count below 350 cells/mm³ or viral load greater than 100,000 copies/mL), the evidence for use in those with these counts was lacking.

The USPSTF recommended screening of all pregnant women, stating that early identification of HIV-positive pregnant women can allow antiretroviral treatment to dramatically reduce transmission to the baby. It found the evidence showed good specificity and selectivity for FDA-approved HIV tests.

As the ACP noted, the USPSTF guidelines found limited evidence to know if, or how many, more HIV-positive cases might be diagnosed with universal screening and if it would result in a measurable drop in transmission as compared to just screening those at high risk. Nor is it known if routine HIV screening among low-risk populations would be accepted.

The ACP said that up to 25% of HIV/AIDS cases are missed if only those at high risk* are screened. This figure is often heard as support for universal screening. The source of this claim is a study cited in the USPSTF guidance, which has been reported as having found that 20% to 25% of people who test positive didn’t reveal high-risk behaviors to their physician.

What wasn’t revealed, was that the study referenced by the USPSTF was done 16 years ago, before HIV-awareness campaigns were as widespread. Researchers with the Division of STD/HIV Prevention at the CDC had reviewed patient records and patient histories at a family planning clinic from 1992-1993. It found that at clinics with less than 2% of positive HIV tests, “clients with no transmission risk by history were unlikely to be infected” (the highest was 0.8% for Black men). In high-risk sites with high rates of positive tests, clients without risk histories were more often infected (5.7% for Black men). Not only does this study fail to support vast numbers of cases of undiagnosed cases of HIV among people without risk histories, but it would appear to more accurately reflect less complete histories among clients less aware of the significance of the risks as compared to today.

Not reported by the ACP were the initial reports from 33 HIV screening programs at different health care settings that were presented by Dr. Bernard Branson, M.D., Associate Director of Laboratory Diagnostics, Division of HIV/AIDS Prevention at the CDC, and colleagues at the December 2007 National HIV Prevention Conference and the February 2008 Conference on Retroviruses and Opportunistic Infections. As published in the March 28 issue of Clinical Update, the percentages of positive HIV tests among those screened at different healthcare settings varied from 0.30% in primary care clinics, 0.98% in emergency departments, to 3.91% in mental health clinics. The percentage of positive HIV tests even at HIV/STD clinics was 2.13%. Overall, of those screened, with risk histories not evaluated, 1.15% new cases of HIV were identified. While these were among both high and low risk populations, it means that about 99% of people screened were HIV negative.

The ACP acknowledged that the scientific rigor in the development and examination of the evidence, the clarity, and freedom from conflicts of interest were superior in the USPSTF guideline compared to the one issued by the CDC. The CDC guideline may “place higher weight on evidence from observational studies than other guidelines and may extrapolate more from studies in high-risk patient populations and settings to low-risk patient populations and settings,” said the ACP.

CDC Guideline

The CDC’s 2006 guideline recommended all patients 13-64 years of age be routinely screened in all healthcare settings (voluntary screening only in settings with prevalence of undiagnosed HIV infection documented as less than 0.1%). All patients being treated for TB are to be routinely screened. All people seeking treatment for an STD or attending an STD clinic should be screened at every visit, regardless of risk history. And all pregnant women should be screened.

But there are two very important qualifiers to the CDC’s recommendations that aren’t widely reported in the media — nor were even mentioned in the new ACP Guidelines — and point out that universal screening can come with unexpected costs.

The strings

Per the CDC’s guidelines, universal HIV screening will be done without patients needing to be formally told or their informed consent given. It’s called “opt-out” testing. Consent is inferred as part of the routine consent for treatment that all patients are forced to sign to get care, unless the patient actively refuses testing. If they don’t specifically give notice in writing or orally of their objection, they will not be exempt from having an HIV test.

But there is no separate written consent form, patients don’t have to be counseled of the risks associated with screening, or told what will happen with their results, or given the opportunity to consent to screening. And few people will ever know that they’ve been tested.

Second, few people realize that the results of all positive HIV/AIDS lab tests must automatically be reported to the State Department of Health and to the federal government surveillance database, using patients full names and identities. Not only that, but all State Departments of Health must track all HIV-positive people individually, using their full names. Anonymous patient code identifiers are no longer allowed, nor do patients have any ability to opt-out of this mandatory government reporting. No longer is there any assurance of confidentiality.

To force all states to comply with the government’s HIV/AIDS surveillance, any health agency not using name-based surveillance records will have their federal funds for HIV/AIDS care cut off, according to new provisions in the Ryan White CARE Act. This issue was covered here.

Not only does this raise ethical issues surrounding invasions of individuals’ privacy by the federal government, it has raised concerns that it will deter patients from seeking medical care. Research consistently shows that mandatory reporting of names deters people at risk for HIV from seeking testing or treatment. A 1998 CDC study had found 19% of gay men had avoided testing for fear of their names being reported.

Security of databases and records have not proven reliable and inadvertent disclosures to insurance companies and employers of HIV results have already been reported. A Palm Beach health department even unintentionally sent out an email to 800 employees with a list of 6,500 HIV/AIDS patients. The fact it’s illegal to discriminate based on HIV status doesn’t mean it doesn’t happen and the consequences can mean the loss of jobs, housing, and health insurance, according to Robert Rybicki, assistant commissioner of HIV/AIDS Public Policy and Programs for the Chicago Department of Public Health

Privacy protections mean little when the Service Act, which governs how the government can use or release the data, says it can be used for public health purposes. That can mean whatever a state agency determines and state legal protections vary. Growing concerns are being raised that the government’s surveillance is the first step towards compulsory treatments.

It is one thing to counsel, educate and support HIV testing, it’s another thing for the government to mandate it and test patients whether or not they want it, understand the consequences or have given their consent.

And how will you feel if the government decides next to force HIV testing on people, as is done in many areas of Canada? Canadian news recently reported on the Conservative Party of Canada’s policy convention held on November 15-16, where delegates passed resolution P-110. The Tories resolution is similar to forced testing laws already in effect in Ontario, Manitoba, Alberta, Nova Scotia and Saskatchewan, according to Alison Symington, a senior policy analyst at the Canadian HIV/AIDA Legal Network. “It's a completely exaggerated response,” she said, “based in panic and fear.” Efforts to put forced testing in the Criminal Code have already been introduced.

As the newspaper reported: “In Manitoba, if a person does not submit to a forced blood test, they may be fined $10,000 or face a jail term of six months. If they refuse for more than one day, they can be charged with a separate offence for each day they refuse to get tested.”

Privacy commissioner, George Radwanski, told the justice committee: “Compulsory blood testing of ordinary law-abiding citizens is a privacy violation so enormous that I find it out of all proportion to a problem whose size hasn't even been demonstrated, and to its very questionable effectiveness as a solution in any event.” Instead, he advocated continued voluntary consent to testing and improved education**. [The full article and comments are here.]

The ACP guidance

The ACP went with the CDC and recommended routine screening for HIV for all patients.

Modeling was used to support routine screening for possibly reducing HIV transmission and as being cost-effective. “Modeling studies suggest that identification and successful treatment also probably reduce HIV transmission, both through changes in risk behavior and from suppression of viral load through treatment, although the magnitude of the risk reduction has not been assessed directly.”

The ACP guidance and media stories yesterday leave most consumers believing HIV/AIDS is near epidemic proportions in the United States and an urgent public health problem with everyone at risk. Having accurate facts can help lessen unwarranted fear of HIV/AIDS transmission and foster understanding of how to prevent the spread of the disease, increase education of those most at risk and in need of screening, and can lead to the soundest use of public healthcare resources.

The costs of screening every person in the country have been said by advocates to be cost effective, although as officials look for ways to reduce skyrocketing healthcare costs, earlier models of cost effectiveness may be viewed differently. According to Dr. Branson, implementing the CDC’s recommendations would cost from $36,000 to $113,000 per quality of life year, depending on the population tested, test used and frequency of testing. But identifying patients earlier and linking them to care would raise overall costs of screening for HIV to $98,000 over the lifetime of the patient. Increased funding will be crucial for both increased testing and interventions, he said. “Substantial increases in federal funding would be necessary to support routine testing in most public health facilities,” he said, “along with additional monies for HIV healthcare delivery in community clinics, state health departments” and other sources. Additional medical staff would be necessary to begin routine testing and would be challenging, given the already limited supply, he said.

In the latest Health United States 2007 report, the CDC estimated that 56,300 people are newly infected with HIV each year and that a total of about 40,000 people across the country have AIDS. Rates of HIV and AIDS have dropped four-fold since 1995, according to the CDC, and are the lowest in more than twenty years, largely due to the successes of health programs and education. Low incidences have been generally stable now for a decade. According to the CDC HIV Surveillance program, more than half of new HIV cases are in gay and bisexual men, and men make up about 75% of AIDS cases in this country.

To put these figures in context, the incidence of HIV in the United States is about the same as those afflicted each year with syphilis and TB (tuberculosis). The American Cancer Society estimates nearly 1.5 million new cases of cancer will be diagnosed this year; these cancer figures have also been dropping over the past decade. Compared to HIV/AIDS-related deaths, nearly 50 times more die from heart disease, 41 times more die from cancers, five times more Black men die in automobile accidents, nearly ten times more elderly die from chronic lower respiratory disease, and nearly three times as many women die in childbirth each year.

Certainly, this is not to lessen the tragedy of any lives affected with HIV/AIDS, but only to illustrate that the political popularity of causes and how much of a crisis we perceive them to be, can influence perceptions of the risks associated with illnesses, the over-reaching nature of government interventions we support, and the allocation of federal funding for research and treatment.

While there are about 28-fold more cases of cancers diagnosed each year in the United States than HIV, the National Institutes of Health spends a full 10% of its entire research budget on HIV ($2.8 billion) compared to $5.6 billion on all cancer research. The federal government spends more on HIV awareness, prevention and care than the entire FDA budget. Are the additional costs of screening every person in the country for HIV the best way to help HIV/AIDS patients? Is the cost to people’s rights of sovereignty and privacy over their bodies the price you are willing to pay to allow the government to make your healthcare decisions?

© 2008 Sandy Szwarc

* HIV Risk per the U.S. Preventive Services Task Force

A person is considered at increased risk for HIV infection if he or she reports one or more individual risk factors or receives health care in a high-prevalence or high-risk clinical setting. High-risk settings include STD clinics, correctional facilities, homeless shelters, tuberculosis clinics, clinics serving men who have sex with men, and adolescent health clinics with a high prevalence of STDs.

Those at increased risk include: men who have had sex with men after 1975; men and women having unprotected sex with multiple partners; past or present injection drug users; men and women who exchange sex for money or drugs or have sex partners who do; individuals whose past or present sex partners were HIV-infected, bisexual, or injection drug users; persons being treated for sexually transmitted diseases (STDs); and persons with a history of blood transfusion between 1978 and 1985. Persons who request an HIV test despite reporting no individual risk factors may also be considered at increased risk, since this group is likely to include individuals not willing to disclose high risk behaviors.

** Knowledge is Power

“What you should know about HIV/AIDS” by Dr. Robert C. Kalayjian of Case Western Reserve University in Cleveland, Ohio. In his column, he explains who is at risk, how HIV spreads (and doesn’t), how to avoid becoming infected, and how healthcare workers can minimize their risks.