Author: Maegen Sincleair

First Ever Liver and Kidney Transplant Between an HIV Positive Donor and Recipient

On March 30th, doctors at Johns Hopkins announced that they have successfully completed the first liver and kidney transplant from an HIV positive donor. The surgeries were completed a couple of weeks ago and both patients are doing well, one has already gone home and the other is expected to go home soon. The liver and kidney came from the same HIV positive donor and each organ went to two separate HIV positive recipients. The transplant marks the first successful HIV-to-HIV transplant in the United States; similar transplants, however, have been performed in South Africa.

Johns Hopkins is the first U.S. hospital to gain approval from the United Network for Organ Sharing, a non-profit organization that manages the federal government’s organ transplant system. The approval is a big victory for the surgeons, infectious disease specialists, and the HIV advocates who spent years lobbying the federal government to allow the transplants. Since 1988, when Congress amended the National Organ Transplant Act, HIV positive individuals have been banned from becoming organ donors.  The amendment was a response to the AIDS crisis in the 1980s when HIV almost certainly led to AIDS and then death. However, HIV is now a manageable chronic disease and not the fatal public health crisis that it was in 1980s. It was not until the HIV Organ Policy Equality Act (HOPE Act) was passed in 2013 that medical professionals were allowed to begin researching the possibility of a HIV-to-HIV organ transplant.

The HOPE Act and the recent success at Johns Hopkins will give those who are HIV positive a better chance at getting an organ transplant. Prior to the HOPE Act, HIV positive individuals could be organ recipients, but viable organs were being wasted because they came from individuals who were HIV positive. A study conducted before the passage of the HOPE Act estimated that 500-600 individuals infected with HIV could donate organs annually, possibly saving 1,000 lives every year.

There is approximately 122,000 people on the transplant list at any given time and there is a consistent shortage of donors. Although many people who need organs die on the transplant list, individuals with HIV are particularly vulnerable and die even faster than their HIV negative counterparts. HIV-to-HIV organ transplants will benefit both people who are HIV negative and HIV positive. Allowing the transplants will enable HIV positive individuals to get much needed organs faster by utilizing good organs that had previously wasted. It will also benefit people who are HIV negative by shortening the transplant waiting list.

This has all been made possible by the passage of the HOPE Act and the work done at Johns Hopkins. Medical professionals at Johns Hopkins hope to share the protocols they developed with other transplant centers around the country, so that the procedure will benefit many more nationwide.

Three-parent Babies

On February 3, 2016, a panel consisting of elite scientists and bioethicists gave its approval to “go forward with caution” with a form of genetic engineering called Mitochondrial Replacement Therapy (“MRT”) as long as the process is carefully monitored and closely regulated.

The purpose of MRT is to prevent the passage or development of congenital diseases by using DNA from three parents. It would use a third party’s DNA to cut out the risk of certain disorders being passed on from parent to child by replacing the mother’s damaged mitochondrial DNA with healthy mitochondrial DNA of a donor. The ultimate goal is that parents can have healthy children that are genetically their own.

Although the panel did urge that the use of MRT be limited to male embryos because “the implications of a child growing up with donor mitochondrial DNA are not yet clear.” The panel argues that it is important to limit MRT’s use to males only, because males do not pass down mitochondrial DNA to their children. Since males do not pass mitochondrial DNA to their children it would prevent modified DNA from being passed down to multiple generations, which is incredibly important since the long term impact of modified DNA is still unknown. The Panel cautioned that the procedure should only be extended to female embryos once the long term effects are better understood. However, this decision differs from the United Kingdom’s approval of the technique in 2015 and its decision not to place any sex-based restrictions on the use of MRT.

The decision came from a committee that was created at the request of the Food and Drug Administration (“FDA”) to investigate the ethical implications of three-parent babies. First, there is a serious amount of concern that babies born as a result of MRT could have germline changes, which could be passed down for multiple generations. It also magnifies the slightest lab mistake into a problem that could be faced by people for decades to come. There is also a major concern about this technology being a tool to “play god,” which strengthens the argument for significant restrictions and regulations. Additionally, the technology poses several safety and regulation concerns.

However, this approval has hit the ultimate roadblock- the Congressional wall. The omnibus fiscal 2016 budget bill passed last year contained language that prohibits the government from using any federal funds to handle applications for experiments “in which a human embryo is intentionally created or modified to include a heritable genetic modification.” Therefore, the FDA is paralyzed and unable to move forward with MRT. As a result of this restriction families that could seriously benefit from MRT will not be able to take advantage of the technology anytime soon.

Fracking Creates Pregnancy Risk

This October the Johns Hopkins Bloomberg School of Public Health released a study linking fracking to adverse pregnancy outcomes, specifically premature births. Fracking, also known as hydraulic fracturing, is the “process of pumping chemical-laced water into shale to extract the oil or gas embedded within.” Fracking is a stimulation process used to access natural gas located 5,000-8,000 feet below the surface that was previously unavailable.

The study found that living within the most active area of fracking (most active quartile of drilling and production) activity was associated with a 40% increase in a woman giving birth prematurely (preterm is considered to be before 37 weeks gestation) and a 30% increase that an obstetrician had labeled their pregnancy high-risk. Of the pregnancies in the study 11% of those resulted in a premature birth with 79% of those preterm births taking place between 32 and 36 weeks.

Premature birth is a serious public health problem because it increases the risk of death and serious disability for children who are born prematurely. Children born prematurely may suffer from numerous health complications including breathing problems, feeding difficulties, cerebral palsy, developmental delay, vision problems, and hearing impairment. Preterm birth is the greatest contributor to infant death and the leading cause of long-term neurological disabilities in children. In 2010, preterm-related deaths accounted for 35% of all infant deaths and in 2005 preterm births cost the U.S. healthcare system 26 billion dollars.

The practice of fracking is a controversial topic for many reasons including other public health dangers fracking might be related to and the potential long-term environmental impact it might have. Preliminary studies conducted on births in Pennsylvania report an increased risk for low birth weight, which can be a sign of developmental problems. A Yale University study found that people living near natural gas wells are more than twice as likely to have respiratory illnesses and skin problems. There is also preliminary research suggesting that fracking is related to water pollution.

Additionally, fracking is a public health concern because its use and prevalence has rapidly expanded in the United States when much is still unknown about the dangers and long-term effects. The process of fracking dates back as early as the 1940s, while large scale use did not occur until 2003. It was around 2003 that “energy companies began actively expanding natural gas exploration with an emphasis in shale formations in Texas, Pennsylvania, West Virginia, Wyoming, Utah and Maryland.” Specifically, the expansion was supported by an EPA study released in 2004 announcing that fracturing posed no risk to the underground water supply. Shortly afterwards in 2005, fracking was exempted from the Safe Water Drinking Act in the Energy Policy Act of 2005 by the Bush administration. Fracking began in just a couple of states, but the practice has rapidly expanded and is now used in over fifteen states.

Although this study is not definitive, it shows that there are some public health risks associated with fracking and that more studies are needed. It is also a sign that the fracking industry should proceed with caution. Because fracking has relatively recently gained widespread usage, much is still unknown about the environmental consequences and the public health dangers fracking might cause.

Is Blood Discrimination Against the LGBT Community Really Over?

While June has undoubtedly been a groundbreaking month for the LGBT community with the Obergefell v. Hodges marriage equality decision, May was an important month as well. In May, the FDA followed through on its promise to reevaluate its current stance on blood donation from men who have sex with other men (MSM) by issuing a draft guidance proposing a 12 month deferral period. The draft guidance bars male donors who have “a history in the past 12 months of sex with another man.” The public will have 60 days to comment on the draft guidance and the FDA will ultimately issue a final guidance after reviewing the comments.

Currently, the FDA imposes a lifetime blood donation ban on “men who have had sex with other men (MSM), at any time since 1977.” he MSM rule was implemented in 1983 at the beginning of the AIDS crisis when the spread of the disease through transfusion was first recognized. The ban was initially created to be an outright ban on gay and bisexual men; however, in 1992 the FDA changed to its current policy to shift the focus from excluding whole populations it believes to be risky to excluding individuals engaging in risky behavior.

While it is FDA policy to limit donors based on risky behavior, the end result of the policy is an essential ban on gay and bisexual men.  If the risky behavior the MSM rule is trying to prevent is unprotected anal sex, then the guidance should not be directed exclusively at men who have sex with men. Women have anal sex, unprotected sex, and unprotected anal sex.

Both the current rule and the proposed guidance, perpetuate the stereotype that “gay sex, particularly anal sex, is deviant, disgusting, and diseased.” The rule also highlights the stereotype that if women engage in anal sex, it is an isolated, discreet, and accidental incident and also enforces the stereotype that heterosexual couples having unprotected sex are in a committed and monogamous relationship. But unprotected sex is seen as routine practice for those who identify as gay or bisexual because it is not possible for them to engage in a healthy, committed, and monogamous relationship since their sexual orientation by nature means they are sexually deviant.

Although a change from a lifetime ban to a 12 month deferral is progress, does it really go far enough? The new guidance will allow for a possibility of gay and bisexual men to donate, but the rule still stigmatizes them as a group. Many human rights and advocacy groups criticize the 12 month deferral for being too long because current tests can detect HIV as early as nine to eleven days after exposure.

The draft guidance also attempts to clarify the FDA’s policy on transgender donors. The note reads, “In the context of the donor history questionnaire, male or female gender is taken to be self-identified and self-reported. In instances where a donor has asserted a change in gender identification, medical directors may exercise discretion with regard to donor eligibility.” The FDA has been silent regarding transgender donors, as no official rule or draft guidance has been issued. As a result, blood donation and plasma centers have been left to create their own policy that has ultimately become a complete ban on transgender donors because blood banks and plasma centers view it as the simplest policy. Currently, there are multiple lawsuits around the country against blood and plasma donation centers for discrimination against transgender individuals. A transgender woman in Minnesota, Lisa Scott, is suing a CSL plasma center after being turned away. In Kent, Washington, Jasmine Kaiser is also pursuing legal action against CSL plasma center for being turned away because she was born biologically male.

Although the proposed guidance is a step in the right direction that will allow some gay and bisexual men to donate, the guidance is extremely lacking in its response to transgender donors.  The guidance is also only one step among many steps that should be taken to ensure equality in the way we screen blood donors. Until the FDA abolishes the MSM rule completely and creates proper policies to address transgender donors, discrimination against the LGBT community will continue.