Editor’s Note: On July 16, the FDA approved the use of the drug Truvada for the prevention of HIV. Previously, the antiretroviral drug had only been given to those tested positive for the virus. In May, The Doctor’s Tablet featured HIV/AIDS specialist Rodney Wright, M.D. who discussed the risks and potential benefits of using Truvada as a prophylactic. Today, we feature reaction to the FDA decision by Dr. Wright and Ruth Macklin, Ph.D. along with a post by Dr. Macklin examining the bioethical issues of using drugs such as Truvada for HIV prevention.
The FDA approval of Truvada for HIV prevention, while in theory good news, is of very little practical benefit to most of the close to 50,000 people in the U.S. who can be expected to contract HIV in the coming year. Most of those new infections are expected to occur in persons who access the healthcare system the least. Especially in the case of women and young African American men who will contract HIV in the coming year – it cannot be of benefit if there is no perception of being at risk, as most new infections in these groups are in persons who do not perceive themselves to be at risk for contracting HIV.
The Truvada approval is of nearly no benefit to the nearly 2.5 million people worldwide expected to contract HIV in the coming year. Despite spending billions of dollars to fight HIV, we are still only able to reach approximately half of the persons who currently need HIV medications to save their lives. In many parts of the world we are not yet able to provide condoms on a consistent basis, let alone any form of medication that has to be taken on a daily basis in order for it to be effective.
While I applaud efforts to bring the HIV epidemic under control and welcome this new weapon in our “tool box”, I’m afraid it is a tool that will go the way of the microlith for most patients. My hope is that this approval will spur further investigation into other prevention modalities that may be more “user friendly” and provide better protection to the population as a whole.
Rodney Wright, M.D.
Assistant Professor of Obstetrics & Gynecology and Women’s Health
Albert Einstein College of Medicine
Director of HIV Programs, Department of Obstetrics and Gynecology
Montefiore Medical Center
Drugs used for treatment (i.e. Truvada) should not be diverted from treatment to prevention. The task now that PrEP has been approved by the FDA is to ensure that there is a sufficient amount for both uses and that the manufacturing of the product needs to be scaled up. At present, only those individuals who have been tested for HIV and know that they are negative, as well as being in a high-risk category, would be eligible for PrEP. The problem of short supplies is likely to be much more serious in developing countries. There is where an urgent need for treatment exists among all those individuals who have not yet had access to medication.
Still, continued research is needed in the U.S. to monitor the use of PrEP by those individuals who are given the offer and accept to use it. A key issue is adherence to the regimen.
Ruth Macklin, Ph.D.
Professor, Department of Epidemiology & Population Health
Albert Einstein College of Medicine
This post is by Dr. Macklin on the ethics of using Truvada for prevention.
A little over a year ago, a breakthrough occurred in HIV/AIDS research.
Researchers showed that a medication used to treat people who are HIV-infected can prevent their uninfected partners from becoming infected. If the HIV-infected individuals are given the drug earlier than they would be treated for their own benefit, their sexual partners could have a 96 percent chance of avoiding HIV infection.
Termed “treatment as prevention,” this seemed like really good news for HIV prevention, and it is. Another study gave this same medication to healthy people at high risk of HIV infection, and the rate of infection in this population was also reduced, but not as dramatically.
Soon after the news broke, I received an email from a colleague in South Africa, a country with a very high burden of HIV disease. She wanted to consult me on an ethical issue raised by these scientific advances.
Since the same drug discovered to be effective in preventing HIV infection is one of the ingredients in medicine used to treat HIV-infected people, will there be enough to go around? Would it be ethical to divert resources from sick people in order to prevent others who are at risk from becoming infected?
From early on in the AIDS epidemic, policy makers have debated the choice between spending money for treatment versus prevention. Now, however, it is not only a financial choice but also a limited medical resource that is at stake.
A colleague from the CDC once told me “We can’t treat our way out of this disease.”
The consensus among experts has been that only a really effective preventive method—such as a vaccine—will make it possible to eradicate HIV, much in the way that smallpox was eradicated years ago. Some articles I read argued that prevention is the way to go, because ultimately putting resources into prevention would save more lives than continuing to put limited financial resources into treatment.
I decided to write about this for Health Affairs and invited Dr. Ethan Cowan, an Einstein colleague who works in the HIV field, to join me as a co-author. I spoke about our findings this week at a Capitol Hill briefing. At first we concluded that if it would save more lives, that could justify reserving for prevention some of the medicine used for treatment. “Save the most lives” was the ethical principle that led to this conclusion.
“Save the most lives” is the dominant principle in public health practice, and it seemed to apply to this situation. But then we pondered the consequences. Is it ethically acceptable to watch people sicken and die for lack of a medication while people who are still healthy or do not yet need to be treated are given that medicine? That seemed to us unconscionable. But in an ethical dilemma, one can’t simply use instincts or gut reactions.
In a controversy, one has to find an ethical principle that could justify a conclusion. Fortunately, there is no shortage of ethical principles. One that seems appropriate is the principle of “urgent need.” It is evident that people who are HIV-infected will develop symptoms of full-blown AIDS and die without receiving a life-saving medication. They have a more “urgent need” for medication than people who are still healthy, even if they are at high risk of infection, and those who are infected but who don’t yet need to be treated.
A variant of this principle is “the rule of rescue.” When doctors on an airplane are called to resuscitate passengers who have a cardiac arrest, they apply the “rule of rescue” in rushing to help. A different ethical principle calls for giving priority to “the worst off” in situations where resources are limited. Since HIV-infected people who need treatment are clearly “worse off” than those not in need of treatment, it would be ethically wrong to divert medicine in short supply for the purpose of prevention.
With the aid of these ethical principles, we were able to conclude that as long as drugs are in short supply and HIV-infected people need a life-preserving treatment, they should have priority for this limited medical resource.