Yesterday, June 30, Petrie-Fromm Center Announced at Harvard Law School emission A three-year research project, the Psychedelic Drug Law and Regulation Project (poplar) Led by attorney Harris Bricken Mason Mark.
As we have covered extensively in this blog, the FDA has designated Ecstasy Breakthrough therapy for post-traumatic stress disorder, it has specified Psilocybin As a breakthrough in the treatment of refractory depression. These names indicate that psychedelics may represent a significant improvement in the treatment of existing mental health conditions. Many other psychedelic drugs, including ibogaine, KetamineAnd dimethyltryptamine is the focus of ongoing psychiatric research and commercialization efforts.This Research barriers are still high, But the momentum clearly benefits researchers.
The significance of psychedelics goes beyond their clinical significance: they can help researchers better understand consciousness and the human brain. In addition, their supervision highlights many shortcomings in current U.S. healthcare and public health policies. For example, their restricted status makes psychedelics difficult to research, and the commercialization of psychedelics by large companies highlights key issues in drug development, drug enforcement policies, research ethics, and intellectual property law.
In the following edited and condensed interview, Harris Bricken’s lawyer Mason Mark, MD, discussing POPLAR with Chloe Reichel, communications assistant at the Flom Center. Dr. Marks led this research project as a senior researcher at Harvard Law School.A longer version of this interview is available at the Petrie-Flom Center Health Act Blog.
Chloe Reichel: Can you describe the main goal of POPLAR?
Mason mark: The goal of the project is to promote the safety, innovation, fairness and accessibility of the emerging psychedelic industry. POPAR will publish original legal and policy research. We will also translate existing clinical research to make it easier to use by courts, legislators, federal agencies, and the public. Fundamentally, our goal is to correct misinformation and advance evidence-based psychedelic policies and regulations.
CR: Can you describe the current state of psychedelic drug research? What are the obstacles to conducting psychedelic research?
Mm: The Schedule I status of psychedelics is an important legal obstacle. It didn’t stop all psychedelic research until the beginning of the 21st century. The situation has changed a bit in the past two decades, when the DEA allowed some researchers to study a limited number of certain psychedelic drugs. Several experiments have been completed, promising results have been achieved, and there are many ongoing studies. But they are still relatively small, partly because DEA limits the amount of psilocybin and other psychedelics that can be produced each year. In addition, due to their Schedule I status, it is difficult to initiate research programs focused on psychedelics.
Because psychedelics are misunderstood and they are still severely stigmatized, federal funds are difficult to use for research. Therefore, many researchers are prevented from entering the field, and for similar reasons, universities are often hesitant to support such work. Almost all research is funded by private donors through corporate-sponsored research centers.
CR: Why is it important who funds and conducts psychedelic research?
Mm: Under current supervision, only well-capitalized private companies can fund psychedelic drug research, and to a large extent control the research agenda and influence drug policy. When wealthy private companies fund most psychedelic research, obtain special permission from the U.S. Drug Enforcement Administration to deal with them, and hold related patent rights, they will be protected by a multi-layered monopoly granted by the government. They can use this privileged position to shape the narrative surrounding psychedelics, influence government officials, buy the loyalty of scientists, and charge any price they want for psychedelics. The restricted Schedule I status of psychedelics is in their interest because it helps maintain their dominant position.
However, the public health problems that hallucinogens may solve, such as the deterioration of the drug overdose epidemic, are too large and important to be left to private companies that have a vested interest in the status quo. When it comes to such a serious issue, we don’t want the industry to influence the entire agenda. It is best to have a variety of scientists and other stakeholders to shape the narrative and guide public policy.
CR: Who might benefit from the legalization and commercialization of psychedelics? Who might be left behind?
Mm: Who can profit? Pharmaceutical companies, venture capitalists, and patent holders will definitely benefit from commercialization. In contrast, it is unclear to what extent the people who need psychedelic therapy most will benefit. If these treatments are too expensive, few people can afford it. The broad insurance coverage of psychedelics seems to have a long way to go, further restricting access and requiring patients to pay cash. Unless something changes, the company may experience the greatest benefits of psychedelic commercialization.
These problems are not unique to psychedelics. In recent years, we have seen drug prices rise, and even essential drugs such as insulin have existed for decades. Some life-saving drugs, such as biological drugs used to treat muscular dystrophy, can cost hundreds of thousands or millions of dollars per year or even each dose. These trends reflect the deep systemic problems of the healthcare system highlighted by the emerging psychedelic industry. However, certain characteristics of psychedelics also deserve special attention.
For example, the long history of anti-drug and punitive drug law enforcement has caused irreversible trauma, disproportionately affecting vulnerable groups, including communities of color and persons with disabilities. By preventing research for decades, the ban may also prevent people with mental illness from accessing more effective treatments, causing countless lives and billions of dollars in losses over the years.
There are other groups that may be left behind. Communities that have used psychedelics for hundreds of years may view patents and psychedelic commercialization as a form of exploitation and theft of their sacred knowledge and technology. In the process of promoting the commercialization of psychedelics, these groups may be marginalized.
CR: Xelosibin is a hallucinogen produced by mushrooms. Can you apply for a patent for mushrooms?
Mm: Mushrooms that appear in nature cannot be patented. There are several limitations to patentability, some of which are referred to as judicial exceptions to patent qualifications. These exceptions are formed by the precedents of the Federal and Supreme Court for more than 100 years. They prohibit patents on abstract ideas, natural products and natural phenomena. If something falls into one of these categories, it cannot be patented.
Therefore, if you go to the forest to pick mushrooms, you cannot obtain a patent because it is a natural product. You did not invent anything. However, if you modify the mushroom in some way to make it different from the version found in nature, for example through genetic manipulation, then you can apply for a patent for your creation. Regardless of whether you modify the mushroom or not, you can also apply for patents for various methods of growing and using it, because in these cases, you are not applying for a patent for the natural product itself, but for the method of producing or using it.
Compass Pathways can Patent for the crystalline form of psilocybin Because this form does not exist in nature. However, whether such a patent can withstand the challenge to its validity remains to be seen. For example, if a patent lacks novelty or is obvious to those skilled in the relevant technical field, the patent can be declared invalid in court.
CR: As interest in the therapeutic properties of natural substances has grown, so have concerns about bioprospecting and biopiracy. Can you explain these practices and related issues?
Mm: Bioprospecting is the practice of finding natural products that may have certain industrial or therapeutic applications. This is not necessarily a bad thing. Bioprospecting is very important because it allows humans to benefit from natural resources.
The more worrying term is biopiracy, which is defined as the theft of inventions or practices of indigenous communities, usually bringing them back to Western society, without adequate recognition, compensation, or permission from the communities that created them. Apply for patent or commercialization. Unfortunately, there are many examples—for example, in Peru, the psychedelic beer called ayahuasca has been commercialized by Western companies. There is growing concern that the endangered cacti used by Native American churches will be commercialized, over-harvested and eventually destroyed.
CR: What do you hope is the impact of this project?
Mm: At present, there are a few psychedelic drug research centers in major universities across the country. However, they are mainly focused on clinical research, mainly around MDMA and psilocybin trials. Surprisingly, there is almost no systematic analysis of the legal and policy issues caused by psychedelics, which is probably due to long-term stigma.
POPLAR will fill this gap in psychedelic research. If psychedelic laws and policies are not analyzed and modernized, this field will not progress. Researchers, businesses, and the public will continue to be constrained by social and legal barriers that have existed for 50 years.