By Doron Dorfman
On May 11, the U.S. Food and Drug Administration (FDA) announced that it is lifting its highly contested blood deferral policy for men who have sex with men (MSM, i.e., gay and bisexual men), colloquially known as the blood ban.
While this decision should be applauded as a step toward equality, the policy remains flawed and needlessly stigmatizing, as it excludes potential donors who use pre-exposure prophylaxis (PrEP), an antiviral regimen that prevents HIV infection from sex.
By Barbara Pfeffer Billauer
Currently on appeal before the 11th Circuit is the question of whether a federal Administrative Agency (here, the U.S. Centers for Disease Control and Prevention) has the power to mandate masking on public transportation.
The case stems from the decision of a Florida judge, Kathryn Mizelle, in Health Freedom Def. Fund v. Biden, who ruled the agency overstepped its powers as enumerated under the Administrative Procedure Act (APA).
This excerpt from the new book titled “We Want Them Infected” is printed with permission from Jonathan Howard, MD and Redhawk Publications.
By Jonathan Howard
On June 29, 2021, Dr. Harriet Hall penned an essay on the website Science Based Medicine titled “A New COVID-19 Myth?” in which she wrote:
A correspondent suggested I should have known that the pandemic was over months ago. That’s obviously a myth. But where did that idea come from?1
I knew the answer. Even before the first wave peaked, doctors suggested the worst was over and that measures to control the virus were more dangerous than the virus itself. This message was repeated regularly throughout the pandemic.
By Jennifer S. Bard
The White House is preparing to shut down their COVID Task Force this May, in conjunction with ending the public health emergency — the latest in a series of astounding and shortsighted decisions that put individual Americans at as great a risk from serious harm as a result of catching COVID-19 as at any stage in the pandemic.
By declaring the pandemic over by fiat, the government is giving up the fight when they should be redoubling their efforts. Not only is COVID still very much with us, but all existing methods of preventing infection have either been severely weakened by the virus’ mutations, or simply abandoned. Additionally, more is known of the harm COVID causes past the initial infection.
There is nothing vague or subtle about the “end” of a disease outbreak. Either cases actually disappear, as with seasonal influenza, or they are dramatically reduced through a vaccine that prevents further transmission, as happened with measles and polio. Neither event has happened here. Instead, like HIV, which continues to be an ongoing public health emergency, the virus continues to infect and mutate.
By Jane Moriarty
One of the U.S. Centers for Disease Control and Prevention’s stated “essential public health services” is to “create, champion, and implement policies, plans, and laws that impact health.”
Yet, as the U.S. slogs through its third COVID winter, one thing is clear: personal responsibility and autonomy are at the heart of public health messaging. As CDC director Dr. Rochelle Walensky famously said, “your health is in your hands.”
In other words, CDC and other public health bodies now highlight personal responsibility and autonomy, and minimize the institutional ability to champion policies and laws that would improve the health and safety of the citizenry.
Given the comparatively poor results that the U.S. has had compared to other similarly-situated countries that focus more on the common good, it is time for our public health entities to reinvigorate their role as a force of legal and moral suasion to protect the public’s health.
The moral value of protecting the health of the public should be at the forefront of their messaging. Personal responsibility and autonomy are no match for the reality of commodified and unavailable health care, internet disinformation, health vulnerabilities, age-related vulnerabilities, the lack of paid sick leave, poverty, and the plight of the institutionalized.
By Matthew Chun
With its leadership in drug development, biotechnology, and computing technologies, the United States touts itself as being “the most innovative economy in the world.”
But when did the U.S. rise to its position as a global leader in these areas? Which regions of the country have led the charge? And what is the next frontier of American innovation?
To begin exploring these questions, I analyzed 45 years of publicly available patent data to map the growth of U.S. innovation in the life sciences and computing fields from 1976-2021. I also mapped the recent growth of patented “hybrid” inventions, which are closing the gap between these historically disparate fields. In particular, the hybrid inventions explored in this project represent interdisciplinary advances in areas including bioinformatics, cheminformatics, artificial intelligence, and quantum computing.
By Barbara Pfeffer Billauer
Throughout the COVID-19 pandemic, much air time and social media space has been allocated to the lab leak vs. natural spillover dispute regarding the origins of SARS-CoV-2.
To summarize briefly, the question is whether the pandemic was caused by a leak from a biosafety level (BSL) four lab in Wuhan, China, or whether it arose naturally as a consequence of a virus jumping from a bat to an animal and then to humans.
Given that the “truth” will likely never be known, and certainly not provable, the question becomes: is it important to seriously consider the lab leak theory?
The answer, I suggest, is an unabashed yes — but not for the reason you might think. The question is important prospectively, not retrospectively. Debating the origins of the COVID-19 pandemic is a fool’s errand. Considering laboratory accidents writ large, however, is important, as they remain a potent threat to international biosecurity.
By Ameet Sarpatwari, Alexander Egilman, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.
Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with skinny labels and their associated savings to Medicare, a discussion of the Philips Respironics recall and the need for reforms to medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.
By Sarah Gabriele
Filters on social media apps such as Instagram and TikTok are great to take silly pictures alone and with friends, and they often give us a good laugh. However, as Dr. Christine Stabler from Penn Medicine writes, they also create an illusion, a perfection that we struggle to live up to every day. This is the case even if almost everyone is well aware that pictures are filtered and carefully selected, and that pictures do not always represent reality.
By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson
This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 and Part 2.
EA is considered treatment, not research. EA was not established as a means to collect research data, even though certain safety data must be collected and shared with the FDA and the sponsor. But, once sponsors decide to capture/share EA-derived data above and beyond that needed to report SAEs, what should IRBs do when reviewing such plans: view this as research, and thus hold it to (higher) research standards, or continue to view this as treatment? This distinction is important for patients’ rights and welfare.