Pile of colorful pills in blister packs

The Age of Orphans

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By Sarah Rickwood

The 2020s are the age of orphan medicines.

Orphan medicines are available for a larger number of diseases and patients than ever before, a testament to the success of legislation established decades ago encouraging the development of these medicines in both the U.S. and European Union.

Orphan medicines were the majority of European Medicines Agency (EMA) approvals for the first time ever in 2016 (59%) and the majority of U.S. Food and Drug Administration (FDA) approvals for the first time ever in 2018 (58%).

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person cuts salami sausage on a wooden cutting board.

Tackling Salami Slicing and Indication Stacking in Orphan Drug Innovation Incentives

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By Sven Bostyn

The development of orphan drugs, so named for the rare diseases they treat, has been incentivized through regulation in the European Union. The primary reward is 10 years’ market protection (or exclusivity).

But are these incentive mechanisms working as they should? To date, only 131 orphan drugs have been brought to market. Findings from the European Commission’s long-awaited evaluation of the orphan drug system in Europe, 20 years after its inception, suggest there may be cause for concern.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

Mortal Sins of Orphan Drug Development: How to Save the Lost Souls

Join the authors on Friday, September 17, 2021 for the 2021 CeBIL Symposium. Register here!

By Jakob Wested and John Liddicoat

In a working paper from November 2020, the EU Commission finds a significant inefficiency in the EU orphan drug regulation (a pan-EU piece of legislation): that it does not contain a provision to safeguard the affordability and accessibility of orphan medicines.

The working paper then entertains the idea of inserting such a provision into the regulation. But, is the orphan drug regulation the right place for this type of law?

Diagnosing the problem behind orphan drug pricing is the key issue to address before jumping to consider ways to address excessive pricing.

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A range of contraceptive methods: DMPA, vaginal ring, IUD, emergency contraceptive, contraceptive pills.

Connecting the Dots: Reproductive Justice + Research Justice = Health Justice

By Monica R. McLemore

I believe that together, reproductive justice and research justice should result in health justice.

I am choosing to focus on research because it is the evidence base that is foundational to clinical care provision and because teaching is generated by research.

Thus, research serves as one root cause of harm associated with clinical care and teaching, and a potential barrier to realizing health justice, which has been outlined as a comprehensive approach to resolve the social determinants of health and develop jurisprudence toward health equity. Research justice is critical to the conceptualization, development and implementation of these measures.

However, the law cannot establish health justice without reproductive justice, at least not for pregnant-capable people. Reproductive health, rights, and justice have been the proverbial canaries in the coal mine when considering the loss of bodily autonomy and human rights.

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Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

How Long COVID Is Forcing a Reckoning with the Neglect of Post-Infectious Chronic Illnesses

By Colleen Campbell

While post-viral illnesses are not new, they have been considerably neglected by the public health, medical, and scientific communities. This invisibility has, in many ways, been constructed by institutional neglect and medical sexism.

The COVID-19 pandemic is now causing a reckoning with this institutional neglect. This is because COVID Long Haulers and patient advocates for the chronically ill are forcing an unprecedented recognition for these chronic complex diseases.

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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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DUQUE DE CAXIAS,(BRAZIL),MAY,20,2020: doctors take care of patients with covid-19.

The Future of Medicine Post-COVID: Not a Healthy Outlook for Women

By Laura Dean, Valerie Dobiesz, and Peter Chai

During the COVID-19 pandemic, women health care providers have not only put their health at risk, but also suffered disproportionate professional consequences.

Women comprise 70% of the global and 76% of the US health care workforce, and data from the U.S. Centers for Disease Control (CDC) suggest that nearly three-quarters of the COVID-19 cases among health care workers are women. Additionally, pregnant health care workers suffer greater morbidity and mortality from COVID-19, face uncertain risk from medications and vaccines due to exclusion from clinical trials, and experience significant psychological and medical risk managing pregnancy amidst an uncertain pandemic. Returning to work in an era where limited and ill-fitting personal protective equipment (PPE) is available and risk of infection is uncertain is especially challenging to new and lactating mothers seeking to advance their careers in academic medicine.

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Society or population, social diversity. Flat cartoon vector illustration.

The Cost of Exclusion in Psychedelic Research

By Xinyuan Chen, Mackenzie Bullard, Christy Duan, Jamilah R. George, Terence Ching, Stephanie Kilpatrick, Jordan Sloshower, and Monnica Williams

In the last two decades, researchers have started to reexamine psychedelics for their therapeutic potential. Though initial results seem promising, the research has a significant shortcoming: the lack of racial and ethnic diversity among research teams and study participants.

In the 1960s, psychedelic substances such as LSD, psilocybin, and mescaline were a major part of American counterculture. Less well-known is that, concurrently, researchers were studying potential therapeutic uses of these mind-altering substances. Unfortunately, psychedelics were classified as Schedule I drugs in 1970, halting research into their therapeutic benefits.

The recent renaissance of psychedelic research shows these substances have significant capabilities for treating anxiety, depression, posttraumatic stress disorder (PTSD), and substance use disorders. But these promising results are limited in their applicability: an analysis from 2018 showed that 82.3% of all study participants in psychedelic trials internationally were non-Hispanic Whites, and only 2.5% were African-American.

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