Scientific Evidence - Bill of Health

The Psychedelics Industry: Psychedelic Evangelism in Second Wave Research

January 31, 2024January 29, 2024 The Petrie-Flom Center Staff Leave a comment

By Patric Plesa

As interest in psychedelics research and popular psychedelics culture resurges, it is becoming progressively more difficult to discern facts from fantasy. As an academic with expertise in psychology, I too share in the growing enthusiasm for psychedelics research, especially toward therapeutic ends. But I believe a critical perspective, characterized by open science practices and critical theoretical lenses, is indispensable if this field is to avoid the errors of the past and the neoliberal pitfalls of the present.

Doctor asking patient to fill out survey before medical treatment.

Psychedelics in the Clinical Setting: The Potential for Harm and the Promise of Healing

January 30, 2024January 29, 2024 The Petrie-Flom Center Staff Leave a comment

By Caroline Hayes

The psychedelic renaissance is well underway, with hundreds of clinical trials currently looking into a plethora of different mental health conditions. I was a sub-investigator on a clinical trial researching a psychedelic study drug to treat depression, but I have since stepped back from psychedelic clinical trials due to personal ethical concerns about the way the field is evolving. Despite the seemingly boundless optimism for their potential as pharmacological treatments, there are a number of unique issues that psychedelics present in a clinical setting that are yet to be adequately addressed. I believe it is essential that these issues are rectified to minimize the potential harm to those desperately seeking relief from their mood symptoms.

Introductory Editorial — Critical Psychedelic Studies: Correcting the Hype

January 29, 2024January 29, 2024 The Petrie-Flom Center Staff Leave a comment

By Neşe Devenot

Since the 2022 publication of “Preparing for the Bursting of the Psychedelic Hype Bubble,” a JAMA Psychiatry Viewpoint by David Yaden and colleagues, a wave of scholarship and commentaries has emphasized the ethical importance of nuanced science communication about the still-nascent field of psychedelic medicine.

Torso of doctor in white coat with hands displaying in between them a rendering of an antibody.

The SCOTUS Antibody Ruling Has an Uncertain Impact for Drug Makers and Patients

December 20, 2023December 8, 2023 Timothy Bonis Leave a comment

How Amgen v. Sanofi will affect innovation and the pharmaceutical industry.

By Timothy Bonis

Millions of patients rely on monoclonal antibodies. The global market in 2022 was $210B with a compound annual growth rate of 11 percent. Monoclonal antibody patents are now some of the world’s most valuable intellectual property.

Monoclonal antibody patent law has been in turmoil for the past two decades. The Court of Appeals for the Federal Circuit (the “Federal Circuit”) has repeatedly raised the standards for antibody patents, forcing patentees to rethink how they protect their inventions. In April 2023, the increasingly stringent standards of the Federal Circuit were affirmed by the Supreme Court. In Amgen v. Sanofi, the justices unanimously upheld the invalidation of two antibody patents, potentially transforming patent law across biotech.

This post reviews the emerging post-Amgen literature, distilling the ruling’s likely impact on innovation and the pharmaceutical industry. A companion post addresses the ruling’s legal significance.

This post has three parts. Part I describes monoclonal antibodies and why Amgen is important. Parts II and III address innovation, first by discussing whether Amgen is reflective of modern antibody science and second by exploring how the ruling may affect the pharmaceutical industry.

When the Law of Scientific Evidence Collides with Medical Practice

December 13, 2023December 8, 2023 Barbara Pfeffer Billauer Leave a comment

By Barbara Pfeffer Billauer

Approaches to resolving scientific evidentiary issues continue to diverge throughout the country.[1] A prominent recent example includes the rejection of the medical diagnosis of Shaken Baby Syndrome (SBS) to reflect disparate views in the scientific, medical, and legal communities.

Under guise of making a scientific evidentiary ruling, a New Jersey court has just dismembered the medical diagnosis of SBS, with the judge disavowing the condition’s validity. The decision concerned two babies, both under one year old, who suffered devastating neurological injuries while under the care of their fathers.

City with trash in foreground and smokestacks producing smog in background.

The Privatization of Cancer

November 13, 2023November 13, 2023 Daniel G. Aaron 2 Comments

By Daniel G. Aaron

Cancer is fearsome, unstoppable even. So the story goes. Yes, you can secure some extra time with loved ones, and — if you are lucky — maybe your cancer is susceptible to drugs or surgery. But for most people, cancer sounds like a death sentence. The proper response is to throw drugs and radiation at it.

Cancer seems so unstoppable that many have started rifling through their cosmetic products and foods to eliminate all possible carcinogens. Despite the fact we have regulatory regimes to ensure our food, makeup, the air, and drinking water are free of carcinogens, people don’t trust them. There is an intuitive sense that products are not well regulated, leaving individuals to moderate their own cancer risk. In fact, the majority of Americans do not hold strong trust in our health agencies like FDA and CDC.

In my forthcoming article, I argue that our cancer regulatory regimes inadequately protect the public. I believe deregulation is one form of the “privatization of cancer.”

Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Organ Transplant Candidates Who Use Medical Cannabis Face Discrimination

October 20, 2023October 19, 2023 Hannah Rahim Leave a comment

By Hannah Rahim

Medical cannabis users in the U.S. face discrimination in seeking health care services, including restrictions against obtaining solid organ transplants.

Considering growing evidence that medical cannabis (which is legal in 38 states, 3 territories, and the District of Columbia) does not compromise post-transplant health outcomes, policymakers should rethink the use of cannabis consumption as a contraindicator to transplantation and should adopt legal protections to prevent undue discrimination towards medical cannabis users.

What the Law and Bioethics Tell Us About Synthetic Human Embryos

October 13, 2023October 13, 2023 Barbara Pfeffer Billauer Leave a comment

By Barbara Pfeffer Billauer

A synthetic embryo can now be constructed from very early pre-embryonic cells – without the need for an egg or sperm. These were initially created in mice. In April, researchers in China published about their creation of synthetic monkey embryos. In June, it was reported that the first synthetic human models were apparently created. This development throws a moral monkey-wrench into the current moratoria on embryonic research after 14 days. But there are more problems ahead.

Context Matters: Affirmative Action, Public Health, and the Use of Population-Level Data

October 4, 2023October 5, 2023 wparmet Leave a comment

By Wendy E. Parmet, Elaine Marshall & Alisa K. Lincoln

Last June, in Students for Fair Admissions (SFFA), the Supreme Court ruled that universities could not consider race in admitting students. In support of that decision, the Court dismissed the relevance of data about the varied experiences of racial groups, insisting that admissions decisions must be based solely on the experiences and merits of individual applicants. The Court’s rejection of group-level data evinces a critical misunderstanding about the uses and limits of such data that, if applied more broadly, portends troubling implications for health equity and health policy.

Siri, Apple's voice-activated digital assistant, tells iPhone user, "Go ahead, I'm listening," which also displays as text on the screen.

On Siri and Recognitive Violence

September 28, 2023September 28, 2023 The Petrie-Flom Center Staff Leave a comment

By Joshua A. Halstead

As a disabled person who relies on speech recognition software to complete a range of daily writing tasks (from emails to book chapters), I am no stranger to the universe of voice assistants, having cut my teeth on Dragon Dictate in the ’90s.

Though I’m used to the software knowing my voice, that it now knows my location is uncanny. This discovery occurred on a morning stroll when Siri spelled “Urth Caffé” correctly, rather than, as was expected, scribing “earth café.” This is when I realized that my assistant had turned into a stalker.

In this short article, I argue that Apple’s decision to integrate user location data into Siri’s speech recognition system created a product that contributes to gentrification and could further marginalize disabled people.

Category: Scientific Evidence