In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Iovance’s AMTAGVITM, the subject of the approval, is a personalized immunotherapy for advanced melanoma. To be treated, adult patients who are ineligible for surgery or have metastatic disease provide their tumor cells to their medical team. Tumor-attacking T-cells are isolated from the sample, grown and multiplied in-lab, and re-infused into the patients for a turbo-charged immune response that, according to clinical trial data, have shown promise in shrinking patients’ tumors. This drug joins a list of others that work something like this: Patients provide cell samples, which are then isolated and modified or expanded in-lab, and then eventually infused back into their bodies. This general patient experience, though, indicates a different model from what we have seen before. These “living drugs” use your own cells, but better, to fight these daunting battles.
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Insurance Coverage for Psychedelic Therapy
By Vincent Joralemon
As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. For example, experts estimate MDMA-assisted therapy for PTSD will cost upwards of $12,000 per patient.
These high costs highlight the need for comprehensive insurance coverage because many of those experiencing symptoms of conditions like PTSD also frequently lack the resources to pay for such treatments. Looking at how the current system works, including presently available psychedelic therapies, can help to inform coverage policies moving forward.
The FDA Backdoor to MDMA Rescheduling
By Vincent Joralemon
MDMA (also known as the club drug “molly” or “ecstasy”) is a Schedule I controlled substance — the most restrictive drug class with the most severe criminal consequences linked to it. But, perhaps not for long.
A recent effort to get MDMA approved by the U.S. Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. This provides a compelling model for efforts to decriminalize and destigmatize other substances moving forward.
Dr. Eunice Brookman-Amissah: A Pioneer in Safe Abortion Law Reform
By Joelle Boxer
Late last year, Dr. Eunice Brookman-Amissah won the Right Livelihood Award, also known as the “Alternative Nobel Prize,” for her pioneering efforts to improve safe abortion access in sub-Saharan Africa.
According to Dr. Brookman-Amissah, of the 36,000 deaths that occur globally due to unsafe abortion, almost 24,000 are in sub-Saharan Africa. “That was a totally unacceptable state of affairs,” she said, “given the fact that nobody, absolutely no woman has to die from a totally treatable and manageable cause.” Her advocacy work is credited with contributing to a 40% reduction in deaths from unsafe abortion in the region since 2000.
Sorry, You Probably Cannot Get MDMA Through Telehealth
By Vincent Joralemon
The U.S. Food and Drug Administration’s recent acceptance of an MDMA-assisted therapy New Drug Application has experts buzzing over expanded access to the infamous substance commonly known as “ecstasy” or “molly.”
Yet, once approved, FDA will put limits on the approved drug. If past psychedelics are any indication, this means that MDMA will probably need to be provided in a clinic under certain protocols. This means patients will need to wait for other MDMA products to complete clinical trials before we’ll see at-home, private use of the drug.
Designer Babies? The Ethical and Regulatory Implications of Polygenic Embryo Screening
By Hannah Rahim
New technologies are increasing the accessibility of polygenic embryo screening, which can assess the likelihood of an embryo developing polygenic diseases (e.g., diabetes, schizophrenia) or provide insight into certain polygenic traits (e.g., height, intelligence). This procedure has many complex clinical, social, and ethical implications, but is currently unregulated in the U.S.
Thank Ketamine for the Telehealth Extension
By Vincent Joralemon
In my last post, I discussed the rise of psychedelic lobbying — how companies with vested economic interests in psychedelics have applied pressure to shape regulations that favor their business models.
One such initiative — the ketamine therapy industry’s push to extend the COVID-era telemedicine flexibilities for prescriptions of controlled substances — highlights how sophisticated these campaigns can be, and how their impact stretches beyond the psychedelic industry.
Regulating Medical Assistance in Dying: A Comparison of the U.S. and Canada
By Hannah Rahim
The regulation of medical assistance in dying (MAID) is drastically different between the U.S. and Canada. Comparing the hasty liberalization of MAID in Canada with the more wary approach of the U.S. can yield important learnings for both countries.
Psychedelic Lobbying and Regulatory Capture
By Vincent Joralemon
Psychedelic companies and advocacy groups are spending substantial resources to influence regulatory policy, shaping what the blossoming field will ultimately cohere into.
Although regulations are designed to protect the public interest, the rulemaking process is often dominated by lobbying from those with special interests in the fields meant to be regulated. When that leads to undue influence, the result is known as “regulatory capture.”
Yet, not all lobbying campaigns are necessarily problematic — the goal instead should be for regulators to leverage industry insights while maintaining independence in their ultimate decision-making.
Food is Medicine Approaches to Address Diet-Related Health Conditions
By Hannah Rahim
Food is Medicine interventions aim to prevent and treat diet-related chronic health conditions and reduce food insecurity by providing food to individuals and communities, in connection with the health care system. While Food is Medicine has been gaining prominence in recent years, it has also received some criticism. This article will explore the development of Food is Medicine and its limitations, and briefly offer recommendations for successful Food is Medicine initiatives.