The doctor is suing the DEA for the right to administer psilocybin to sick patients


Dr. Sunil Aggarwal

Research on the use of psychedelics to treat TEPT, depression, addictions and other conditions are gaining momentum quickly. At the forefront of this effort are several prestigious medical and educational institutions, including Johns Hopkins University, Langone Medical Center, New York University, i Mount Sinai School of Medicine in the USA, and the Imperial College London in the UK.

Laws related to psychedelics have also changed. Oregon decriminalized personal and non-commercial cultivation, possession, and consumption of magic mushrooms. Ditto for Denver, Oakland, Holy Cross, i Washington DC. And, more recently, Seattle City Council voted to decriminalize psychedelic mushrooms and LSD. But doctors still cannot use these drugs in their practice.

Dr. Sunil Aggarwal, co-founder of the TARGETS high school, an integrative medicine clinic in Seattle, wants to change that. Aggarwal has filed a lawsuit against the Drug Enforcement Administration for the right to administer psilocybin to dying patients. Naoko Miki de Japan green area, a project CBD affiliate, recently spoke with Dr. Sunil Aggarwal about the lawsuit.

Japan Green Zone (GZJ): I understand that you have filed a lawsuit against him to give.

Dr. Sunil Aggarwal: (A) Yes, two patients, the TARGETS Institute and I are the plaintiffs this lawsuit. We applied to the to give to obtain permission to purchase psilocybin from a company that manufactures it under a government license for research purposes. Patients have a right to get it, because there is a federal law to the WE called Right To Try. This is also enshrined in the state laws of Washington and 44 other states.

According to this law, people with serious life-threatening illnesses have the right to consume any drug that has completed at least the first phase of the FDAclinical trial process for the approval of new drugs and has been shown to be safe. People with serious illnesses cannot wait for a new drug to be approved. So this law is for those patients, and if the company that makes the drug says yes (and they have a right to say no), then you can get it from your doctor. There are no exceptions for these drugs, whether controlled substances or not.

Several hallucinogens are currently being tested in clinical trials. Psilocybin, in particular, is showing many positive results and is not only in phase 1 and phase 2, but is moving into phase 3. But the to give they rejected our request and said that they should not follow the law of the right to try and that they would never allow us to use psilocybin to treat patients more than for research. So we decided to sue to give.

My lawyer consulted with a law firm and, after reviewing the case, we concluded that the to give had misread the law of law and that the application had to be approved, so we filed a complaint with the U.S. Court of Appeals for the Ninth West Coast Circuit, which has an authority superior to that of the to give. The court took our case and asked us to prepare written arguments. The government also submitted written arguments. Then there was a friend’s writing, and then several people presented arguments in support of us. There was no one to present a letter of support to the government, they were all by our side.

GZJ: I understand that Dr. Did Johns Hopkins Griffiths also support you?

A: Yes, Dr. Roland Griffiths. He has been a supporter. And his partner, Dr. Matthew Johnson, both researchers at Johns Hopkins. Dr. Johnson is a clinical psychologist specializing in psychopharmacology and I met him a long time ago when he presented a study on the use of psilocybin to help people quit smoking. He recently announced who had received government funding for a clinical trial with psilocybin to treat tobacco addiction. Not only has he been given permission to conduct clinical trials, but he has been authorized to use taxpayers ’money to do so. So the government says this research is worth taxpayers ’money, but at the same time they say no, it’s too dangerous to prescribe this to patients. It is also unacceptable to use in patients with terminal cancer. It’s a mess, and the to give it is an island in itself. So we asked the court to intervene.

In fact, in addition to the leader of our legal team, there was another lawyer who spoke for us. The Attorney General of the State of Washington. The Attorney General represents the entire population of the state of Washington in these cases. For example, when Trump tried to impose a travel ban on Muslims, he opposed it and has repeatedly worked to protect the rights of Washington state residents. They supported us in our court case, saying that because the law of the right to probate is also a Washington state law and a law that was enacted unanimously by the state legislature, we support the right of physicians. to ask for what patients need on their behalf. . We have eight or nine more state judicial powers that have been incorporated.

So we have a coalition of judges from various states, experts like Dr. Matthew Johnson, prominent researchers, palliative care community leaders, hospitals, law professors, and many other allies. We hope the courts hear them and that they to give will approve the prescription of psilocybin so that it can be used by others also for the same purpose.

GZJ: What is the difference between the law of the right to judge and the law of compassionate use?

A: The Compassionate Use Act is a system managed by the FDA, and is basically an extension of clinical trials. If someone says they want to use a drug that is in clinical trials, the FDA he will say, well, write to us and we will take that into account. It is a good system in theory, but in practice it is not easy to get medication and it takes time. The Right to Trial Act eliminates this complexity and simplifies it. It is not in competition with compassionate use, but it provides a faster pathway for patients with life-threatening conditions. It is the same as an entry visa. The idea is to streamline a process that usually takes a long time when needed. Another difference is that the law of the right to use is not part of the drug development process: the FDA you can request data on this medicine, but you cannot use it to judge this medicine. Although some have expressed concern that this legislation violates the FDAthe authority of, this is not the case. This is only to facilitate access to medicines for dying patients.

GZJ: Are the two patients who are claimants terminal (terminal) patients?

A: If they are. But we don’t use the word “terminal” very often. We are an experimental clinic. The term assumes we know it all, however, standard care data say the five-year survival rate of this type of metastatic breast cancer is about that, so it’s terminal. Or even if there is no approved treatment. But do the data apply to integrated or complementary therapies? We don’t know, do we? When we say “terminal,” do we mean two years? Three years, a year or six months? We do not know. That’s why I prefer the term “life-threatening” or “serious” disease.

One of the plaintiffs has stage IV triple negative breast cancer difficult to treat. The other has ovarian cancer, stage III, which is now under observation, but has been repeated before, and is a very aggressive cancer with a mutation BRCA gen. Therefore, I believe that both meet the criteria for this law to apply to them. State law leaves that decision to the doctor. Doctors are already making decisions about who should receive hospital care. The same goes for It helps to die laws, which are now being enacted in many states. It gives the patient the right to make the decision to take a lethal drug and to decide when to do so. But only if the doctor decides that the patient is less than six months old. So the doctor is already making that kind of big decision.

GZJ: Was it the choice of the patients themselves to try psilocybin? Had they also tried ketamine before?

A: Yes. There are many patients who want to try psilocybin, but I chose these two patients because I was seeing them directly and because they both have a desire to help advance the field: cancer treatment and integrative medicine more broadly. None of this was possible without his willingness to make his private medical problems public. Yes, they had been looking for care with us that was associated with some kind of psycho-spiritual cancer care with ketamine and psychotherapy.

Don’t get me wrong, I’m not saying ketamine therapy isn’t helpful. Ketamine can be very helpful when there are no other options, but it seems that psilocybin has a more potent effect, and there are times when it is needed. Some people would choose ketamine even if both were an option, and historically people have used a combination of ketamine and psilocybin or other hallucinogens. This is what medicine is all about. There are times when you need more than one anesthetic, and there are times when you need more than one drug to improve a condition.

Naoko Miki is a book translator and co-founder of Green Zone Japan, a non-profit organization that provides up-to-date, evidence-based information about cannabis to Japanese medical professionals and the general public. She translates Project CBD articles for your site in Japanese as well.

Copyright, Project CBD. Cannot reprint without permission.

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