The new administration may threaten HIV care and cure research
by Jeannie Wraight
Our way of life in the U.S. has already drastically changed as I write this, barely weeks after Donald Trump’s election. As of yet (the time of this writing), HIV has not made the hit list, but most of us involved with or concerned about the HIV community are on the edge of our seats. With Trump staffing his cabinet and positions of power with people like his Chief of Staff Steve Bannon (a man often referred to as a White Supremacist), it’s far from alarmist to have concerns about the fate of a community with a disease known for mostly affecting people of color, gay people, and injection drug users.
A fear for PEPFAR’s future is already brewing, ignited by a questionnaire sent by Trump’s transitional team to the State Department. The questionnaire covered many aspects of our relationship with Africa, with two questions directly targeting PEPFAR:
• “Is PEPFAR worth the massive investment when there are so many security concerns in Africa?”
• “Is PEPFAR becoming a massive, international entitlement program?”
The tone and language of these questions is worrisome and we can only hope that we will not have a battle on our hands to retain George W. Bush’s President’s Emergency Plan for AIDS Relief that millions depend on for HIV treatment and care. Though, as of yet, the only other indication that PEPFAR will be under attack is Trumps “America first” mentality and actions.
Through the Obama administration, support for an HIV cure had grown, not quite flourished, but the political recognition of the importance of a cure was evident with NIH grants and support. This allowed for basic science on the HIV reservoir.
Conducting such basic research has been the most logical course with the many questions pertaining to the viral reservoir the most obvious priority. But in the wake of a political upheaval and dismantling of much of what we know in this country to be logical and sacred, it’s reasonable to consider that HIV cure research may not be “business as usual.” Even if the NIH continues its grants at the current rate, private donations to universities and organizations will certainly be on a major decline. With so many other battles that will need to be fought on immigration, climate change/the environment, human rights, etc., an HIV cure may not remain a top priority for some donors.
Curiously, Trump has stated that he wants to speed up the FDA drug approval process by reducing some of the regulations that may be considered red tape and which lengthen the amount of time it takes for a drug to make its way through the development pipeline. His logic here appears to be that the more drugs we have, the more competition there is, which will force lower drug prices.
One of Trump’s main contenders for FDA Commissioner, Jim O’Neill, managing Director of Mithril Capital Management, has also stated this this might be a course he would take. Although not an MD like the last four FDA Commissioners, this affiliation, at least offers hope that he may have some progressive intentions.
In a 2014 speech to biotechnology companies, O’Neil stated that he would like to “[l]et people start using them [unapproved drugs], at their own risk.” He suggests that the FDA should only require that drug companies “prove that a drug is safe,” before the public is allowed access to it. Data then would be generated through the use of these drugs and not clinical trials.
On the one hand, many lives could be saved with this approach. Countless numbers of adults and children have died waiting for a drug that had proved in clinical trials to work but didn’t receive FDA approval in time. If this were the case, need would likely end up dictating risk—how long a person would wait for a drug might depend and how sick they are. The more people who use it before them with good results, the more chance it would work.
On the other hand, it’s difficult to imagine that insurers would pay for drugs that are yet to be proven. Either way, regulations that could help HIV drugs move through the process quicker would likely be a good thing, as long as safety is paramount.
It remains to be seen the degree to which PLWHAs, HIV research, and the field of HIV will be affected by the Trump administration. Through this historic and chaotic time, the HIV community must and are doing what we do best—take action, not only to protect the lives of PLWHAs but all vulnerable populations. We cannot and will not sit back and hope that things, including PEPFAR and our research agenda, will be okay. As we have in the past, we must do everything in our power to ensure that we not only survive the Trump era, but that we continue to thrive.
Jeannie Wraight is the former editor-in-chief and co-founder of HIV and HCV Haven (www.hivhaven.com) and a blogger and writer for TheBody.com. She is a member of the Board of Directors of Health People, a community-based organization in the South Bronx and an advisor to TRW (Teach me to Read and Write), a community-based organization in Kampala, Uganda. She lives with her husband in New York City.