FDA “Updates” Its Policy on Blood Donations from Gay and Bi-Sexual Men Engaging in Same-Sex Intercourse

Since 1983, FDA has banned men from donating blood for life if they have had sex with another man, even just once, at any point from 1977 and on, Despite lacking scientific significance, the lifetime ban has remained in effect until this past December. However, organizations like the Red Cross have been pushing for the ban to be revisited since 2006. On December 23, 2014, the FDA announced that it would alter the 31-year old national policy banning males who engage in same sex intercourse from donating blood. The new proposed policy would now allow males who are gay or bi-sexual to donate blood so long as the potential donor has abstained from same-sex intercourse for at least 12 months.

Politicians, gay rights activists, and public health officials have spoken out against FDA’s new policy and some are calling the ban “harmful and offensive.” According to Gay Men’s Health Crisis (GMHC), requiring gay and bi-sexual men to abstain from having sex with other men for a year ”is [still] a de facto lifetime ban.” GMHC went on to note that heterosexual men are not required to remain celibate for a year and therefore, the “step forward” that FDA is attempting to make is still overt discrimination.

Senator Tammy Baldwin (D-Wisc.), who led the charge for the government to end the lifetime ban, noted that although the new proposal was a step in the right direction, she “remain[s] concerned that [the new policy] does not achieve our goal of putting in place a policy that is based on sound science.” Baldwin noted, “[t]he Administration must continue to work toward implementing blood donation policies based on individual risk factors instead of singling out one group of people and turning away healthy, willing donors, even when we face serious blood shortages.”

Despite receiving criticism and concerns, the FDA’s new proposed policy garnered support as well. Steven W. Thrasher, for NPR’s Code Switch, a gay male who has written extensively about FDA’s lifetime blood ban, offered his support for the recently updated policy. Throughout Thrasher’s piece, he explained the technicalities and reasoning behind the ban, from his perspective, noting that because “the act of a man having sex with another man imposes a risk on his potential blood donation on the same level as taking IV drugs, having been incarcerated, or having had sex with someone who is an IV drug user or has been incarcerated, Thrasher is “okay” with the update on the ban.

Thrasher explained that there is a difference between “shaming gay men” and recognizing that the practice of homosexual male sex does have actual risks proven by various demographics. Thrasher cites statistics from the CDC, noting “the overall gay male population of the US is only 2%, according to the CDC, this group “accounted for three-fourths of all estimated new HIV infections annually from 2008 to 2010.” Thrasher said, “A one-year ban, however, would be based on the risk assessments of a practice — the practice of a man having sex with another man — and not unscientifically shaming gay men. This might sound like a fine difference. But it’s an important one.”

Others believe that the government should adopt the approach followed in Italy and Spain, where gay or bi-sexual men, engaging in sex with other men are allowed to donate blood so long as the donor is in a monogamous relationship and whose blood tests are safe. The “individualized risk assessment” approach appears to be successful in Italy, and according to a 2013 study, there is “no evidence of a significant impact on the human immunodeficiency virus epidemic in Italy.”

Whether you view the updated policy as a baby-step, a leap forward, or as no change at all, FDA’s recent announcement has undoubtedly reignited the conversation about blood donations polices and the still stigmatized health concerns of gay and bi-sexual men.

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ICE Detainee Facility Medical Treatment

The medical standard at Immigration and Customs Enforcement (ICE) detention facilities has become highly contested as more detainees are coming forward. In 1995, there were 6,785 immigrants being detained nationwide. As of 2013, this number rose to 34,000. Additionally, the annual cost to detain immigrants is above 2 billion according to the National Immigration Forum. However, the increasing number of detainees and the hefty cost of funding is not positively reflected in the medical treatment afforded this group. As the number of detainees continues to rise, concerns about medical treatment follow.  Because ICE detention facilities do not have effective or enforceable health standards, detainees are being denied necessary and sometimes emergency medical care.

Although ICE officials have agreed to provide immigration detainees with constitutionally adequate levels of medical care, they have fallen short of this goal. Instead, detainees are faced with issues such as waiting weeks or months to receive medical treatment and dealing with great distances between the facility and urban areas (making trips to hospitals or physician specialists difficult). The Detention Watch Network has noted that, out of the 250 detention centers none can guarantee basic medical care. Because of these standards, a detainee did not receive the proper medication or treatment for his type 2 diabetes.  As a result, his health quickly deteriorated and he suffered kidney damage, a heart attack, and he eventually went blind.

Currently, many cite the due process clause, the 2000 National Detention Standards (NDS), and the 2008 Performance Based National Standard as governing law for medical treatment standards within ICE detention facilities.

Under the due process clause, immigration detention is not a part of the criminal justice system. Therefore, detainees are not entitled to the full panoply of due process rights afforded criminal defendants. Also, detainees are not serving time; instead they are a part of the removal process to determine deportation. The aim of their placement in these facilities is to prevent immigrants from absconding during their immigration proceedings.

The 2000 (NDS) is the initial governing principle for the medical treatment of detainees. The NDS states, “immigrants in all facilities must have access to medical services that promote detainee health and general well-being, including initial medical screenings for mental illnesses within the local community”.

The standard was expanded in 2008 to include a performance-based format. This format would ensure access to medical treatment. Specifically, this would mean that detainees have the right to “access to emergent, urgent, or non-emergent medical care and access to mental healthcare within the Division of Immigration Health Services (DIHS).” The hope was that the expansion will ensure that detainee health care needs are met in a timely and efficient manner.

Unfortunately, the 2000 NDS was not very enforceable. Although it claimed to protect a detainee’s medical needs, in practice, it did very little. This standard prompted detainees to fill out medical attention slips; however, filling out the slip did not guarantee: (1) that the detainee would be seen by a physician, (2) that if care was received the medical issue would be solved, (3) that the detainee was guaranteed a follow up appointment, or (4) that the detainee may ask for a second opinion if he/she disagreed with the physician’s suggestions. Not only was the process to receive medical attention uncertain, but medical screenings were delayed as well. Medical screenings covered exams for determining potential mental problems and suicide risks. These screenings are done for imminent health problems that are.  However, under the 2000 NDS standard it could take up to two weeks before a detainee was confirmed to have a mental ailment or suicidal thoughts after being examined. This also applied to detainees who had been pre-diagnosed and who had received treatment prior to entering into the facility. In sum, the 2000 NDS resulted in unfavorable outcomes and delays.

These inefficiencies were addressed in the 2008 expansion. For example, the wait to hear back about a medical request once the medical attention slip was completed decreased from several weeks to 48 hours. However, this change was only implemented in facilities that choose to allow detainees to fill out medical attention slips. Additionally, medical exams for mental disorders and suicide risks were similarly enforced. A DHS report on five facilities found that only one complied with the health screening requirement and only three complied with the physical exam requirement. Therefore, these 2008 changes would only be effective in facilities that choose to enforce these new standards.

In sum, the conditions in ICE detention facilities in terms of medical treatment are far from feasible. The amount of deaths that arise from negligence and delays in medical care show how the healthcare system has failed some of the most vulnerable among us.

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Maine Ebola Quarantine Underscores Importance of Due Process during Public Health Emergencies

Although the fervor of domestic news coverage regarding the West Africa Ebola outbreaks has subsided, cases that were treated in the U.S. shed light on a public health infrastructure to which Americans rarely give much thought. Among the discussions of travel bans and increased surveillance, an issue arose of particular legal importance: the quarantine of Kaci Hickox.

Kaci Hickox entered the United States on October 24 after a month of work with Doctors Without Borders treating Ebola patients in Sierra Leone. Per protocols developed by the New Jersey Department of Health (NJDOH), Homeland Security officials detained Hickox upon her arrival at Newark Liberty International Airport. During her detention, her temperature appeared elevated, and, following the protocol, Homeland Security transferred her to a New Jersey hospital for quarantine under the watch of NJDOH. An Ebola test administered at the hospital came up negative. Despite the test results, the NJDOH detained Hickox until October 27, when she threatened legal action against the state. At that point, NJDOH released Hickox, who returned to her home in Maine. After Hickox’s arrival in Maine, the Maine Department of Health (MDOH) sought a court order to enforce a 21-day in-home quarantine against Hickox.

Although the MDOH action was rare, it is hardly unprecedented. Societies reaching back to the middle ages have long sought to isolate citizens in the interest of public health. In the United States, courts have upheld state government efforts to do so, even in certain extreme cases where, in the course of quarantine, citizens have been jailed or had treatment forced upon them.

MDOH moved to exercise its quarantine power over Hickox pursuant to the state’s public health emergency statute. Under that law, MDOH may exercise certain powers—such as supervision or monitoring of a citizens health—if a “public health threat” exists. Such a threat can include “behavior that can reasonably be expected to place others at significant risk of . . . infection with” a communicable disease that is reportable to MDOH.

MDOH grounded its argument for Hickox’s quarantine in the fact that she had been exposed to Ebola while treating patients while in Sierra Leone, that Ebola is a particularly virulent disease, and that, to minimize risk to the public, she needed to be isolated from the public for the balance of the 21-day incubation period during which she might develop symptoms. A day after issuing a temporary order on October 30 granting the MDOH petition, the Court altered its position.

In its October 31 order pending hearing, the Court struck down the quarantine. Citing information presented by MDOH in its petition, the Court noted that, despite her exposure to Ebola, Hickox was not symptomatic and, therefore, did not present a risk of infection to the public; only if she were contagious would the quarantine be justified. With that in mind, the Court permitted Hickox to move freely, but also upheld MDOH’s requests that she submit to direct monitoring for symptoms, coordinate her travel with MDOH, and immediately contact MDOH if symptoms develop. The MDOH monitoring of Hickox ended without fanfare on November 10, the end of the 21-day incubation period. Hickox did not develop symptoms at any point during her monitoring.

As fear about a domestic outbreak of Ebola fades, Hickox’s case serves as useful reminder of importance of providing due process to those whose freedom is restricted during public health crises. Aggressive state action may, at times, be informed by public sentiment and fear a threat to safety; judicial recourse must ensure that such action is properly checked and grounded in sound assessments of any risk to public health.

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Rising Pharmaceutical Costs Hit the Generic Market

In 1984, the 98th Congress passed the Drug Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Amendment, creating a statutory scheme wherein generic drug manufacturers will be able to put their products into the market using the pioneer (or branded) drug’s scientific safety and efficacy data. In return, the pioneer manufacturer is awarded five-years of market exclusivity before the generic may enter the market. Congress intended to allow the pioneers to recoup their capital spent on research and development as well as turn a profit, but then have prices decrease dramatically as generics enter the market. It worked as intended! The generic drug industry has been booming since its inception.

However, in recent years, drug prices have been increasing and increasing quickly. In 2013, Tetracycline, an extremely common generic antibiotic that most all of us have likely taken throughout our lives, cost only five cents per pill. In 2014, the very same antibiotic cost $8.59 per pill. This increase constitutes a 17,714 percent jump in just one year! The drastic jump in prices stands in the face of Congress’s intention with the Hatch-Waxman Amendment, but can the increase be explained by the market?

In the cases of Tetracycline, the price jump resulted from a drug shortage. Generic companies lacked the necessary raw materials to produce the drug in significant quantities. The shortage of Tetracycline continued for nearly two years. However, the Food and Drug Administration (FDA) announced that the producers now have adequate materials to produce the drug. There were also manufacturing issues associated with the shortage that have also been fixed.

The larger issue may be the market itself. When an all-star branded drug is on the market, the generic manufacturers line up to enter the market. When four or five generics enter the market, the prices drop significantly. However, without several generics of a single drug on the market, prices do not drop as dramatically. Supplies can drop for any number of reasons. Companies may simply leave the market. An FDA-inspection may lead to a temporary shutdown of a plant. Regardless, less competition means higher prices and, for the consumer, tough choices when it comes to medical care. For example, only three companies currently produce digoxin, a cheap and easy to make cardiac drug that has been around since at least 1785. At the beginning of the year, a month of digoxin cost approximately $50 (one consumer reported $1.15 for a three-month supply), but now customers are seeing prices nearing $1000 per month. Notably, the World Health Organization lists digoxin as an “essential medicine.”

Some voices, however, have expressed concerns about nefarious business practices. In 2013, the Supreme Court ruled that the Government and private parties may sue pioneer companies who pay competitors to stay off the market. The practice has caught the attention of the Federal Trade Commission (FTC) and state officials. An antitrust investigation of Lannett by the state of Connecticut found that the manufacturer had not violated any law or regulation. However, many of these price adjustments happen naturally, leaving the FTC without any options to combat the problem.

The problem has caught the attention of Congress, who requested explanation for drug price increases fourteen drug manufacturers (constituting ten of the nearly 12,000 generic drugs on the market). However, without any legal mechanism to act against the companies, Congress may have few options to deal with the issue. Sen. Bernie Sanders and Rep. Elijah Cummings have proposed a bill to require generic manufacturers to rebate Medicaid if drug costs increase faster than inflation. The CEO of Generic Pharmaceutical Association believes the legislation to be “misguided.” Whether the bill passes or not, it appears to do little to help consumers attain better access to their needed medication. Until action is taken or anticompetitive practices can be definitely proven, more and more patients will have to decide whether they can afford their medication this month.


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Virginia’s Controversial Certificate of Public Need (COPN) Law Withstands Legal Challenge

If you are a healthcare provider who wants to establish a new healthcare facility in a state like Virginia, you must first convince the state and your existing business competitors in the state that your healthcare facility is necessary. This is called obtaining a Certificate of Public Need (COPN), also known as Certificate of Need (CON). It is a process required by the state law of many states, including Virginia.

Virginia COPN Law

In Virginia, this process involves the State Health Commissioner approving the new venture based on: 1) the relationship of the project to the long term health care state plan; (2) the need for enhanced facilities to serve the population of an area; and, (3) the extent to which the project is accessible to all residents in the proposed area and the immediate economic impact and financial feasibility of the project on the immediate area.

In this process, healthcare facilities are required to prove that their business is necessary for that geographic area. But what is most difficult is that you must do so over the objections of your already established competitors in the area. Effectively, competitors who want to keep their share of the market have veto power over the new business venture.

Under Virginia Code § 32.1-102.3, a  COPN is required to establish any medical care facility, add beds or operating rooms to existing medical facilities, convert medical beds from one type to another, relocate medical beds from an existing facility, introduced a new nursing home service, introduce a specialty clinical service, add medical equipment to an existing medical facility, or make large capital expenditures for a existing medical facility, as determined by the State Health Commissioner.

Similar Laws in Other States

Virginia is not the only state in the nation to require this. There are 36 states that currently have similar CON laws. Most CON laws came about as a result of the federal Health Planning Resources Development Act of 1974. But the federal mandate was repealed in 1987. Some states discontinued CON procedures and repealed the CON laws. But many still enforce the CON process. CON laws were originally designed as a health planning tool to control access to care across a state but have become a battleground for providers to gain and keep market share.

Pros and Cons

Due to their restrictive nature, CON programs have been a subject of wide debate across the country. Supporters of CON programs believe that these programs allow states to distribute medical facilities across different areas in their state and help avoid the establishment of unnecessary medical facilities. The opponents of CON programs believe that these programs are monopolistic and contribute to higher prices because of reduced competition. Opponents also believe that these laws place unfair restrictions on new businesses and, as such, are against the free flow of interstate commerce.

Challenge to Virginia COPN Law

The Virginia COPN law recently withstood a federal challenge in the case of Colon Health Centers of America LLC et al. v. Hazel et al. in the U.S. District Court for the Eastern District of Virginia. A federal judge granted summary judgment in favor of Virginia and ruled that Virginia’s COPN law requiring new medical facilities to get a COPN before being allowed to open a medical facility in the state does not discriminate against interstate commerce. The Plaintiffs wanted to open a colonoscopy center and an MRI office in Virginia but were not allowed to do so because they were not able to get a COPN. The judge essentially deferred to the state.

It appears to be seen whether Virginia will ever repeal this law. It seems that this law is currently popular with the existing healthcare facilities in the state because it allows existing healthcare facilities to keep control of market share in a given geographic area.

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