Looking ahead to the future of psychedelic medicines several thoughts come to mind. One is that these medicines will have a tremendous impact on psychiatry. Another is that some very useful psychedelics could end up being orphan drugs. How could it be that medicines that provide the best chance of cure of a psychological or psychiatric condition end up not being developed or being developed and then not marketed? It has to do with how many people need the medicine, how much profit the manufacturer makes per dose of the medicine, and now many doses are needed for a cure.
What Are Orphan Drugs?
There are many extremely rare medical conditions that are treatable but don’t end up being treated. A scientist sees the possibility of a cure for a rare form of disease. To get from that idea to a medicine approved by the Food and Drug Administration can easily take ten to fifteen years. Along the way the medicine has to be proven to be safe for human use and effective for its intended purpose. The total cost of taking a prospective medicine through this process easily runs into millions of dollars. A pharmaceutical company needs to make money in order to stay in business. If the drug in question does not offer the prospect of profits the company cannot afford to spend millions of dollars over a decade or more developing it. Thus the drug is an “orphan” without anyone to develop it and treat the handful of patients who need it.
Could Psychedelics End Up Being Orphaned?
In regard to psychedelic medicines there are lots of folks who could use help with their depression, PTSD, substance abuse disorders, and other problems. In that regard the situation is not like one with a rare genetic disease with only a hundred known cases in the world. However, psychedelics are extremely efficient. A psychiatrist can put a severely depressed person on a standard antidepressant and start psychotherapy for their PTSD, depression, or substance abuse disorder. The process can take weeks, months, or years. During that time the patient takes their antidepressant one, two, or even three times a day. If the process takes a couple of years the person could well end up taking (and their insurance paying for) more than a thousand pills.
In the case of a psychedelic medicine like psilocybin or MDMA the approach is to use the psychedelic as adjunctive therapy along with psychotherapy. This is similar to when antidepressants are used. The difference is that you only need one or two doses of psilocybin or MDMA for them to enhance the effectiveness of psychotherapy! Therapeutically this is a wonderful thing. For the person paying the bills this is also a great thing. For the company developing psychedelics with the expectation of making money (or at least not losing money in the process) this could be a problem.
? Which Psychedelics For Which Mental Health Issues
In the USA ketamine is available for treatment of depression. Two psychedelics, MDMA for PTSD and psilocybin for depression are in advanced FDA trials. The point is that not all psychedelics will be granted permission to treat all mental health issues. When a new drug is developed and given the OK to treat a given condition it receives protection against competitors for several years. As this happens other pharmaceutical companies seek to develop similar but not identical medicines. There are two goals. One is to have similar legal protection against competition and the second is to fine tune the effectiveness of the medicine in question.
One Effective Medicine Always Leads to Many
When scientists discovered a way to block stomach acid production with the drug Tagamet it was a multimillion dollar success. Then more and better medicines were developed and patients had many choices. The same has applied to types of medicines for blood pressure, heart disease, and more. There is no reason to doubt that the same will happen once the first psychedelics are approved for therapy outside of research settings in the USA.
As the psychedelic “treatment space” becomes more and more crowded it is likely that some new psychedelics may be the best choices for smaller and smaller treatment niches. This will get to the point where developing a very promising psychedelic will be cost prohibitive for pharmaceutical companies. Thus, we expect there eventually to be orphan drugs in the psychedelic space.