HELP committee advances public health bills

Among a series of bills voted on by the Senate Health, Education, Labor and Pensions (HELP) committee on April 26, 2017 were bills focused on access to medications in emergency situations (Protecting Patient Access to Emergency Medications Act of 2017 (S. 916)) and hearing loss screening for children (Early Hearing Detection and Intervention Act (S. 652)). Also sent to the Senate floor were two other public health bills which would create a national commission on clinical care (S. 920) and better prepare the public health community for Zika and other mosquito-borne diseases (S. 849).

S. 916

The Protecting Patient Access to Emergency Medications Act seeks to amend the Controlled Substances Act to make it easier for first responders and those providing emergency medical services to have access to “time-sensitive and life-saving treatments.” The bill is sponsored by Sen. Bill Cassidy (R-La) and co-sponsored by Sens. Michael F. Bennet (D-Colo), Roy Blunt (R-Mo), and Al Franken (D-Minn).

S. 652

The Early Hearing Detection and Intervention Act is sponsored by Sen. Rob Portman (R-Ohio) and co-sponsored by Sens. Tim Kaine (D-Va), Sheldon Whitehouse (D-RI), John Cornyn (R-Texas, Sherrod Brown (D-Ohio), and Richard Blumenthal (D-Conn). The bill aims to improve state-based efforts to screen newborns, infants, and young children with hearing loss screening and link them to follow-up care if needed by amending sec. 399M of the Public Health Service Act. The Health Resources and Services Administration (HRSA), the Centers for Disease Control and Preventions, and the National Institutes of Health would need to coordinate and collaborate these efforts with those administering such programs as the Medicaid Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program, for example.

Largest mass shooting in U.S. history renews calls for changes to federal health policy

At 2:00 a.m. on Sunday, June 12, 2016, a man with an AR-15 assault rifle, a handgun, and another “device” walked into Pulse, a gay nightclub in Orlando, and carried out the deadliest mass shooting in American history. He killed 49 individuals, and wounded 53 others, before he was shot and killed by police.

According to Orange County Government Director of Health and Public Safety Dr. George Ralls, the nightclub’s location, approximately two blocks from Level 1 trauma center Orlando Regional Medical Center, where surgeons performed more than 30 surgeries on victims of the shooting, saved lives. Having a trauma center equipped to deal with the severe injuries inflicted, as well as resulting infections and other complications, is a “saving grace” for the tragedy, said Ralls.

Much of the public outcry following the attack is focused on whether the shooter was part of a terrorist organization or how the shooter was able to obtain the weapons. For public health advocacy groups, however, this tragedy is a reminder of federal laws and regulations which, they say, hinder their abilities to prevent similar massacres and properly treat patients in their aftermath.

Gun control research funding ban

In 1996, Rep. John Dickey (R-Ark) proposed an amendment to the omnibus consolidated appropriations act for fiscal year 1997 (P.L. 104-208) reading, “That none of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention [CDC] may be used to advocate or promote gun control.” That same language has been included in each successful appropriations act passed since then; in 2011, the appropriations act for fiscal year 2012 expanded the funding ban to the National Institutes of Health (NIH) (P.L. 112-74). The Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) includes an additional provision prohibiting HHS, health plans, and other databases from collecting information about firearm possession, use, or storage.

In a January 16, 2013, memorandum, President Barack Obama directed the HHS Secretary, through the Director of the CDC and other HHS scientific agencies to “conduct or sponsor research into the causes of gun violence and the ways to prevent it.” However, no funding has been appropriated to the research, and the CDC has not taken any action.

There have been multiple calls to end the research ban. In April 2016, a letter to the leaders of the Senate and House appropriations committees from 141 health care, public health, and scientific organizations asked Congress to provide the CDC with funding for research into the causes and prevention of gun violence. At the end of May 2016, Democrat members of the House of Representatives signed a letter asking House leadership to remove amendments freezing gun violence research from future appropriations bills.

Two days after the Pulse shooting, the American Medical Association (AMA) announced that the organization, the largest association of physicians and medical students in the United States and one of the signatories of the April 2016 letter, will actively lobby Congress to overturn the research ban. Calling gun violence a public health crisis, AMA President Steven J. Stack, M.D. said, “Even as America faces a crisis unrivaled in any other developed country, the Congress prohibits the CDC from conducting the very research that would help us understand the problems associated with gun violence and determine how to reduce the high rate of firearm-related deaths and injuries. An epidemiological analysis of gun violence is vital so physicians and other health providers, law enforcement, and society at large may be able to prevent injury, death and other harms to society resulting from firearms.”

FDA blood donor policy

When the HIV/AIDS epidemic began over 30 years ago, the FDA implemented a lifetime ban on blood donations from men who have sex with men (MSM), regardless of risk factors. Since at least 1997, the American Association of Blood Banks, the Red Cross, and America’s Blood Centers have advocated revising the policy and removing the lifetime ban because advances in blood screening technology and the scientific community’s increasing understanding of the HIV/AIDS virus rendered the ban medically and scientifically unwarranted. HHS convened a non-partisan group of scientific experts in 2010 for the Advisory Committee on Blood Safety and Availability. The Committee concluded that the lifetime ban should be changed because it prohibits low-risk donors from giving blood, but allows donations from high-risk individuals.

The FDA updated its policy in a December 23, 2014, announcement from then-Commissioner Margaret Hamburg, M.D. The change lifted the lifetime ban on blood donations from MSM, permitting donations if at least one year has elapsed since the donor’s last sexual contact with another man. The FDA noted  that the new policy, which went into effect in December 2015, would align blood centers’ treatment of MSM more closely to the treatment of other individuals who have engaged in behaviors that increase their risk of AIDS.

This change was met with mixed reactions. Responses to ending the lifetime ban have generally been positive, however, the 12-month deferral excludes many men who are in monogamous relationships and present no risk of HIV transmission while not deferring donations from women who have had many sexual partners, unless they are prostitutes.

In the wake of the Pulse shooting, people all over Florida, including many members of the LGBTQ community, rushed to donate blood to meet the needs of the injured victims. Due to the FDA policy, many would-be donors were turned away. Over 100 bipartisan members of the House and 24 bipartisan members of the Senate sent letters to FDA Commissioner Robert A. Califf, M.D., asking for an update on implementation of the 12-month deferral policy, and expressing their hopes that the agency will continue moving toward a less discriminatory and more science-based policy.