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May 19, 2011 | Posted By David Lemberg, M.S., D.C.

Preliminary results from a large clinical trial demonstrate that persons with HIV are "96% less likely to pass on the infection" if they are taking antiretroviral medications.1 Based on the substantial protection afforded by early treatment, an independent safety review panel "recommended that the drug regimens be offered to all participants". The randomized clinical trial, known as HPTN 052, was scheduled to run until 2015, but is being ended early. Formulating public policy on the basis of these compelling findings would seem to be a slam dunk. But there are various stumbling blocks, both ethical and fiscal.

Physicians treating patients infected with HIV may face an ethical quandary. Initiating antiretroviral treatment as soon as a person becomes infected would substantially lower the risk of that person infecting others. But some patients are concerned about the potential side effects of AIDS drugs. Such persons avoid taking medication until they become obviously ill or until their CD4 count falls below 350 cells per cubic millimeter of blood (an accepted indicator of severity of infection).

Such a waiting game may satisfy the needs and desires of the infected person, but places the life of his sexual partner(s) at grave risk. Thus, the request to delay treatment poses an ethical dilemma for the doctor in the case. From the perspective of autonomy, it appears that the patient is exercising his right to make his own choice. But such a choice ongoingly threatens the lives of others.

If the doctor acquiesces, believing he is supporting the patient's right to an independent choice, he is necessarily violating the bioethical principle of nonmaleficence, i.e., do no harm. Beyond the direct, life-threatening harm that will be done to the HIV-infected person's sexual partners, serious burdens are placed on society in the form of increased utilization of costly services. Medical services, institutional facilities, health care workers, supplies, and medications, as well as social services and possibly hospice services, will all need to be funded and paid for by an ever-diminishing supply of available tax dollars. The physician who supports his patient's refusal to begin an early regime of antiretroviral medication fails to prevent an ongoing substantial drain of resources that could have been used elsewhere.

The response by concerned journalists to the breaking news was immediate. In an Op-Ed in The New York Times the following day,2 Charles Blow emphasized that federal and state governments have been "starving or restricting support, services and prevention efforts" for HIV-infected persons and those at risk of contracting HIV. He noted the vulnerability of those most dependent on AIDS Drug Assistance Programs (ADAP). Three-quarters of those enrolled in ADAPs have incomes less than 200% of the national poverty level. Fifty-five percent of those enrolled are black or Hispanic.

Blow doesn't hesitate or hold back his challenge, stating "it is morally reprehensible to restrict or deny life-saving drugs to those who need them". Such penny-wise budget cuts are "a colossal miscalculation of public health policy". Slashing funding for social welfare programs such as AIDS Drug Assistance may help squeeze dollars out of government budgets in the short term, but limiting or denying care to chronically ill persons will impose substantial financial costs in the long term.

The convincing evidence of HPTN 052 in supporting early treatment of HIV infection highlights another ethical issue with profound global implications. For many years HIV medications have been scarce or unavailable in the countries and regions that need them the most, including sub-Saharan Africa, South and Southeast Asia, and Central and South America. Of course, in the United States, too, many poor people without health insurance are on waiting lists to receive HIV medications.

The pharmaceutical corporations manufacturing these drugs can easily make them affordable to endemic communities. For example, GlaxoSmithKline's net profit in FY 2010 was almost $3 billion.

How much profit is enough? What if GSK's profit was capped at $1 billion annually? Does that seem draconian? One billion dollars is an unfathomable amount to the billions of persons on the planet who struggle to subsist on less than $2 per day. Surely $1 billion profit is sufficient for a corporation's executives and shareholders? The $2 billion left over (give or take) would go far toward providing HIV medication at cost to those who cannot afford such care on their own.

Such beneficence would have a meaningful impact in "winning the fight against AIDS".

1"Early H.I.V. Therapy Sharply Curbs Transmission", The New York Times, May 12, 2011

2"H.I.V. SOS", The New York Times, May 13, 2011

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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