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October / November 2010
From Mice Into Men
by Regan Hofmann with Tim Horn
Why should we cure AIDS? While every disease deserves to get adequate funding to be cured, there isn’t enough money to cure all ills. Since we have to make brutal choices anyway, one way to do it is to fund solutions that will save the most lives. HIV/AIDS is the No. 1 cause of disease and death among woman and girls ages 15 to 44 worldwide. Nothing kills more women in the prime of their lives. And given that nearly 50 percent of the 33.4 million people estimated to be living with HIV on the planet are men, the death rate for men isn’t far behind.
Also, unlike many fatal diseases that affect people at life’s end, HIV impacts young people, especially in the developing world. Which means HIV is drastically undermining the global workforce. And, when young people die, they often leave behind infants or young children and aging parents who, in turn, become a cost burden to society. And, by striking down millions in their prime, AIDS can greatly reduce nations’ gross national products.
There are those who argue that a cure isn’t needed because treatment has rendered HIV infection a manageable, chronic condition. It can be for those who can get, afford and tolerate care. ARV treatment has been so successful that public health officials and researchers are considering “treatment as prevention.” By lowering people’s viral levels to a point at which they become considerably less infectious, the thinking goes, treatment could help stop the spread of AIDS. The use of ARVs to protect HIV-negative people from the virus (an approach known as “PrEP” for “pre-exposure prophylaxis”) is also being studied. (It has already been proved that when HIV-negative people take a 28-day course of ARVs starting within 72-hours of potential exposure to HIV, their risk of infection is greatly reduced. This approach, known at “PEP” for “post-exposure prophylaxis,” was the grounds for PrEP.)
But for many reasons, lifelong treatment is far from the optimal solution for dealing with HIV. As we’ve already mentioned, it’s prohibitively expensive. The estimated lifetime cost of ARV medications can top more than $600,000 per person in the United States, according to a November 2006 study conducted by Cornell University researchers. And treatment doesn’t alleviate the many tough issues people living with HIV face. Pills don’t eliminate the threats of stigma, discrimination and criminalization. They don’t take away the fear that people will be unwilling to be your friend, to date or marry you or to take you home to their families. ARVs don’t remove the worry that you may inadvertently transmit the disease to someone else, including your baby. And given that we don’t know the long-term impact of the drugs themselves, compounded by the fact that people with HIV and on treatment are still at a higher risk than HIV-negative people for certain life-threatening diseases—like cardiovascular disease and cancer—ARVs are no guarantee against sickness and death.
Ideally, all people living with HIV should be aware of their status, be educated about treatment options and be given access to care should they choose to take it. But, the drugs aren’t the ultimate answer for those of us lucky to get our hands on them. And they’re certainly not the answer for the 5.5 million people who need drugs right now to stay alive and can’t get them.
Stopping AIDS with treatment may seem like a sound public health strategy, but at this point it’s purely academic theory. Universal access to treatment for all who require it has, to date, proved impossible. According to UNAIDS, less than half of the 33.4 million people with HIV who need ARVs are on them. Not only have we fallen short to meet current need, but we’re highly unlikely to play catch up considering that for every two people we put on treatment, three more become infected. And then there are the challenges associated with getting people tested and linking them to care. In the United States, one person in five living with HIV doesn’t know his or her status, and of the nearly 750,000 Americans who know they have HIV, an estimated 350,000 of them are not accessing care and treatment. If we can’t achieve universal access in the United States, our prospects for achieving it globally seem dim.
Ironically, the survival of more people with HIV makes it less likely, long term, that we will be able to care for them. And, because there are few new classes of treatment in the drug development pipeline, the number of people who exhaust the current set of treatment options will only grow. And more and more people contract HIV every day. The problem is getting exponentially worse on many fronts, daily.
Positioning treatment as prevention is a persuasive argument for justifying the cost of getting the drugs to everyone who needs them. Given that universal access is an integral part of one of the United Nations’ eight Millennium Development Goals, anything that supports that goal is likely to be embraced by global health leaders. But as noble as the goal of treating all who require it is, putting the entire global population of positive people on pills seems to be virtually impossible.
All roads, it seems, lead back to the necessity for a cure.
Which is why perhaps, after many years of the cure being viewed as a pipe dream, the word is increasingly on the tips of more people’s tongues today. Are we close? While we’re not likely to see a cure in the near future, what we do in the next year or two will impact whether the cure comes soon—or not soon enough. To fast track the cure, we’ve got to get more people talking about it.
As proof of how reticent people have been to say “cure,” consider that mainstream media barely covered the recent case of a man who has possibly been cured of HIV (albeit through impractical means). While speculation that combo-therapy could ring in the end of AIDS once appeared on the cover of Newsweek, data showing that HIV may have been eradicated for the first time in a person appeared on a small poster at the far end of the exhibit hall at the 2008 Conference on Retroviruses and Opportunistic Infections in Boston.
The poster told the story of an HIV-positive American, living in Berlin, who received a bone marrow transplant to cure his leukemia. The procedure, performed by Gero Hütter, MD, a German hemotologist at Berlin’s Charité Medical University, had a twist: The doctor re-introduced stem cells taken from a person with a certain genetic mutation that renders them (and theoretically the person to whom their cells are given) incapable of producing CCR5 receptors. Because HIV needs CCR5 to connect to and infect CD4 cells, not having it essentially renders a person immune to HIV.
Two-plus years after the procedure, “the Berlin patient” as the American is colloquially known, remains apparently HIV-free. Certainly many questions remain. Has the patient really been cured? The jury is still out. Doubters wonder whether the diagnostic tests that probed for latent HIV in places like the lining of his gut and his brain were effective, meaning that he could still harbor the virus. There is discussion about whether it was the high-dose chemotherapy, the CCR5-deficient stem cells or a combination of the two that seems to have chased HIV from his body.
No one knows whether the procedure can be successfully replicated, and the cost (up to $200,000 per patient) and health risks of such a procedure are high.
One thing’s for sure: Whether the Berlin patient proves that a “functional cure”—near-complete immune system control of HIV in the absence of HIV treatment—is possible or whether his body holds the grandest grail of them all—a “sterilizing cure” in which every scrap of HIV is eradicated from the body—he is proof of concept that HIV may be able to be controlled by something other than ARVs.
Few, including Hütter himself, are willing to say that AIDS has been cured, functionally or otherwise. But the findings of the Berlin patient and the research that contributed to Hütter’s gambit now inform current research. And they have helped invigorate the discussion around the cure.
The case of the Berlin patient also illuminates another key point: It’s not up to the NIH alone to find the cure for AIDS. And money does not necessarily force scientific discovery, and throwing cash against research projects with little promise is a waste. The high-stakes and high-cost responsibility should be spread between mighty giants like the NIH and other outfits like amfAR (of which Hofmann is a board member), ADARC, AVAC, IAVI, France’s Agence Nationale de Recherches sur le Sida, the Canadian HIV Trials Network and independent academic centers throughout the world. It will take the combined efforts and resources of multiple governments and a lot of public-private partnerships. Private funding of independent biotech companies has always been a critical link in the solution to any disease. In a recession-struck world, high-risk funding dries up quickly whether that’s on the part of individuals, venture capital firms or even the pharmaceutical companies themselves. It is unfortunate, to say the least, that at a time when we need to spend most aggressively, we face a dearth of resources and willingness.
Though we have long passed the tipping point at which it became clear that we needed to pour considerable funds into cure research, we haven’t invested the money. (Here’s where people cry, “Conspiracy!”) Indeed, the creation of a global market of tens of millions of patients who could live a full, healthy life as long as they took pills every day for the rest of their days does seem to be a pharmaceutical company’s dream. It is important to point out that the global HIV drug market is potentially becoming less profitable for the companies that make the drugs. If there were a way to pay for ARVs for 33.4 million people for the course of their lifetimes, it would pay to make the drugs. But given that the need for treatment expands as the resources to pay for the meds shrink, pharmaceutical companies are being forced to lower their prices (even abandoning patents earlier than before or, in some cases, coming straight out of the R&D pipeline to low-price-tag generic formulations). A Wall Street Journal opinion piece by Alec van Gelder suggested that “trampling over intellectual property rights removes drug companies’ incentives to invest billions of dollars in the development of the next generations of [ARVs].” And, as imperfect compliance leads to more drug resistance, there is an ever-increasing need for new compounds in general, and for getting a wide variety of drugs to the world at large. Historically, drugs with expired or nearly expired patents were offered to the developing world. Now, brand new formulations are required increasingly by nations and people who can’t pay for them. It’s another giant pink elephant in the room. Drug companies are for-profit. What will happen when it is no longer lucrative for them to make and distribute the meds? Already, we are seeing it happen. The pipeline for new treatments for HIV is nearly empty.
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