This Prize is part of a two-pronged attack on the unwillingness of the medical and regulatory establishments to listen to people with adverse events in general – not just the sexual dysfunctions mentioned here. The second front in the attack will be unveiled in a few weeks’ time.
The idea for a RxISK Prize began with our involvement with sufferers from Post-SSRI Sexual Dysfunction (PSSD) some years ago, and soon after people with comparable problems following Accutane and Finasteride. The motivation and endurance of those affected has been inspiring.
A complete and permanent wipe-out of your ability to make love is among the most debilitating side effects of a drug imaginable. In the case of all these drugs when it happens it affects men and women, young and old, can appear after a few days on the drug or only after treatment stops. It can last for decades, perhaps longer. It leads to suicides, the break-up of relationships and job losses. There is no upside to it.
PSSD shares many common features and looks like it is closely related to Post-Finasteride Syndrome (PFS), and Post-Retinoid Sexual Dysfunction (PRSD) triggered primarily by isotretinoin (Accutane). Isotretinoin is both a serotonin reuptake inhibitor and a 5-alpha reductase inhibitor (5ARI), so it could give rise to PSSD or PFS, or all three conditions may have something else in common.
We have recently submitted a paper for review describing 300 cases of PSSD, PFS and PRSD, and we are aware of many more cases and comparable phenomena happening on some other drugs. There may be tens of thousands affected as some evidence suggests that less than half of those who have been on SSRIs for months will regain full and normal function.
There are communities online and linked to universities researching these conditions as vigorously as the AIDS community once got involved in the search of a cure for AIDS. The most successful of these so far have been linked to PFS, with sufferers having created a Foundation to promote research on this condition. The research done by these groups have followed up all of the obvious treatment leads but nothing so far has worked.
The problems need more thinking out of the box. While serotonin and 5-alpha reductase may be where these problems start, they seem to go beyond this.
The fact that these conditions can appear after treatment stops and endure in the absence of any drug in the body for years is tremendously important to pharmacological science. This is not simple damage in that many sufferers report having temporary restorations to normal. It’s only temporary, but the fact that it happens is both a source of hope and something that in its own right needs explaining. These conditions are one of the central mysteries of pharmacology.
It is important to crack what’s going on because many doctors were inclined to dismiss PSSD, PRSD and to a lesser extent PFS, especially when it began after the person stopped treatment or when it persisted for so long in the absence of the drug. After an antidepressant, it’s very easy to claim that the problem is all in the mind. At the moment, psychiatrists seem to be the worst of all doctors, with urologists the best, and family doctors in the middle.
But PSSD, PFS and PRSD are not the only conditions in which there are enduring problems that may only appear after treatment stops. Tardive dyskinesia (TD) following antipsychotics has been recognized since 1959 and no-one thinks this is all in the mind or that it is impossible when it appears after treatment stops. But at the moment, TD has not been linked to PSSD, PFS or PRSD, and fifty years later we don’t know how it happens or how to cure it.
Another group of problems that share features in common are the withdrawal syndromes linked to antidepressants, antipsychotics and dopamine agonists. Like PSSD or TD, these appear on or after treatment and can last for years, even decades.
Now that we have a range of different drugs that can trigger these phenomena and can trigger them in different bodily systems, the chances of some pharmacologist or physiologist being able to explain what is going on should be much better.
Pinpointing the receptor systems or mechanisms involved could transform pharmacology. It would have implications for many drugs and drug development. There is probably a Nobel Prize for the person who can explain why TD or PSSD happens.
You don’t have to know a thing about receptors to be fascinated by this problem and to appreciate that the picture of a patient with PSSD is actually a window on human nature and identity.
Pretty well 100% of the people who take an SSRI will have some genital numbing within 30 minutes of taking their first pill. We don’t know what causes this. This is a problem right in front of the noses of millions of people. It’s astonishing that we don’t know how this happens. Answer this and we would be half way to finding out what happens to make it endure.
Another astonishing thing is that many of the withdrawal syndromes from drugs involve burning feet, loss of smell, disturbed balance or other odd sensations. These are features of a peripheral neuropathy. The peripheral neuropathies first appeared in medical textbooks 150 years ago before we knew we had brain cells, but we still know nothing more about how they happen than the day they were first described, even though we don’t have to look inside the body to research them.
There are good reasons to think there is a lot more of “us” in our skin and genitals and bodies than we are now inclined to think. We are in a brain dominated era and missing out on things that we may not need input from brain experts to solve.
It is not clear that specialist training is needed to solve these problems, anymore than John Harrison had specialist training when he won the Longitude Prize, 300 years ago.
Some background in biology may help, but even without this you may already have found something that makes a difference and just didn’t know there were so many people out there desperate to know what you know.
You might be a doctor or a data analyst who notices that some patients taking another drug just don’t seem to get the same problems.
For those entirely new to the issues, or those with a pharmacological or physiological background but no awareness of these issues before now, or someone who knows something about it but little about the full range of things that have been tried without success or noted to offer temporary benefits, RxISK has a portfolio of descriptions and leads that can be made available on request.
We are following in the footsteps of the method that led to a solution to the famous Longitude problem in instituting a Prize.
The first step is to raise $100,000 toward a Prize for a Cure. We would like as many people as possible who are affected or related to someone who is affected to make a donation of $200 towards a target fund of $100,000.
As mentioned, solving this problem will likely make a major contribution to solving the enduring withdrawal syndromes that affect anyone taking antidepressants and antipsychotics. Five per cent of the populations of North America and Europe, and anywhere else where antidepressants are used on the same scale, are unable to get off treatment because of withdrawal problems – that is 50 million people in North America and Europe alone. Fifty million cents would be $500,000 – so a target of $100,000 seems more than reachable.
The Prize will be offered to anyone who finds a cure for PSSD, PFS or PRSD. This could be a doctor, a scientist, a drug company, a member of the public – anyone. There are no restrictions.
RxISK has several sufferers from each of these syndromes who have convincing enduring conditions. The Prize will be given if someone can bring about a restoration to normal, or very close to it, that endures in our volunteers.
There are several reasons why we chose to make this initiative about sexual dysfunction rather than other problems such as antidepressant withdrawal. Mainly because the time is right, and there is already a strong basis to build upon. As more than one type of drug is involved, there is also potentially a larger group of people to approach the problem from different angles.
If no one claims the prize, we will use the money to support the most innovative research proposal or donate it to the PFS Foundation who are already undertaking some elegant research.
The difference between a prize and a research grant is this –
In the case of someone who has a cure, assuming it is not costly to administer it, they give it to our volunteers and if it works, they claim the money. Their overheads and costs will be minimal.
Research like that being undertaken for PFS has to recruit perhaps up to 100 subjects and get all to take a large battery of tests which have to be paid for. If the testing involves brain scans, this is costly. If it involves genes, this means recruiting thousands of subjects. A research grant even for $100,000 would not go very far toward helping this happen. And at the end of the day, research can end up with findings but no guarantee that these are the source of the problem rather than a consequence.
But in the absence of a Prize winner, the PFS Foundation already have a research infrastructure in place and research findings that can be built on, and so the money would go further there than anywhere else.
Anybody. We welcome donations from not just those affected by these conditions, but from anyone who wants to help. We have suggested a minimum of $200 in order to reach our target quickly, but we are aware that money is tight for a lot of people.
Obviously any donations over $200 are most welcome, as are monthly donations.
If anyone organizes a fundraising/sponsored activity, we will publish details on the website.
Donations can be made in one of three ways:
If anyone wishes to set up a linked fund that will support tax-deductible donations in another country, please contact us, and we will network into you.
While this initiative is focused on sexual dysfunction, we believe that it also draws attention to the more general fact that patients can be left with persistent side effects after the use of medications, some of which can be life-changing.
We hope that anyone interested in persistent side effects, either because they suffer from them or because they can see this is likely to be an important new frontier in medicine, will consider this Prize a cause worth supporting.
See our next post – How You Can Help.