Some months ago we had organised for 6 volunteers with PSSD to get tested for peripheral neuropathy, using a Sudoscan, made by Impeto Medical, who are based in Paris. By chance we found that there is a genital adaptor for the Sudoscan that has been in use for several years in Paris, leading to a publication over two years ago.
Through a colleague, we got in contact with Dr Jean-Henri Calvet, the medical director of Impeto – on the left of the picture, wondering if it was possible to get access to this adaptor. There was no response from Dr Calvet to us although he and Impeto have been busy responding to all sorts of other people telling them this was not possible. The letters seem full of concern and hope for future cooperation (dim and distant is left unsaid).
None of this made sense to us, leaving us wondering what the real story is. See Device Wrecks and Regulators. Turns out Impeto are embroiled in patent lawsuits and its impossible to find out whether there are problems with Sudoscan reported to regulators. Much of the digging on this has been done by Suzanne Stevens.
In terms of working out what is going on, even more interesting perhaps are the comments from Johanna Ryan following the Device Wrecks post. There is no money in testing a few hundred people with sexual dysfunction even though finding a test that worked might save lives. The money is in screening – for Diabetes.
This has a ring of truth to it – but the despair was followed by a sauce for the goose, sauce for the gander thought.
Someone reading this post has a chance to help set up a business – if you know an electrical engineer, either a jobbing one or one in a university department, or if you know anyone in a pharmaceutical or device company.
This post below can be transformed into a letter or email and anyone sending one can sign themselves as a RxISK researcher. You can also edit the letter to suit the audience.
RxISK is involved in trying to co-ordinate efforts to find a treatment for a debilitating disorder causing loss of sexual function that affects thousands, perhaps tens of thousands of people, triggered by drug treatment – SSRI antidepressants, finasteride used for hair loss in young men, and isotretinoin used for acne, which we will refer here to as Post-SSRI Sexual Dysfunction (PSSD).
PSSD has been known about for close on two decades and has recently been formally recognised by the European Medicines Agency and in the labels of antidepressants and finasteride.
Those affected end up with numb genitals and sexual dysfunction after exposure to an SSRI antidepressant – this condition can resolve but mostly persists for decades, leaving people profoundly distressed with some committing suicide. It can affect all age groups, both sexes, and all ethnic groups. There is at present no treatment.
The distress this devastating condition causes is aggravated by the response of health services where all too often those affected meet staff who refuse to believe a drug could be causing a problem months or years after it has left the body.
Having a test that demonstrated an abnormality is key to moving both research and treatment forward.
The basic condition likely involves a peripheral neuropathy. There is currently a lot or work going into devising tests for peripheral nerve function for other conditions but most of the attention at present is on efforts to count nerve endings in skin or brain responses to peripheral nerve stimulation. These tests do not pick up what is wrong in PSSD and they are also not the kind of tests that can be used for screening purposes and are much less likely to offer commercial opportunities.
In contrast, some PSSD sufferers have shown abnormalities in their hands and feet on instruments that essentially test galvanic skin responses (GSR) – lie detectors. But hand or feet abnormalities are not always present where genital changes are. What is needed is a GSR type machine with a genital adaptor – the kind that Impeto seem to have developed.
A possibly even more reliable test in the case of PSSD seems to be Quantitative Sensory Testing (QST) which detects sensation thresholds for cold and warm temperature and vibration. The testing in this case, as with GSR, is simple compared with biopsy or brain evoked potentials but it too needs a genital adaptor.
Fairly basic medical GSR machines sell at $30,000 each in the US. A QST machine could likely fetch similar prices.
The issue of sexual dysfunction or how sexually functional any of us are is a rapidly developing area. Way beyond the several thousand people affected with PSSD, close to 10% of the population of most Western countries is currently on an SSRI and will therefore have some degree of clitoral or penile numbing.
Many may be interested to test their degree of numbing.
There are an increasing number of drug companies making competing non-SSRI antidepressants, that do not cause genital numbing, who might be willing to provide machines to clinical practices to have genital state tested – both those on SSRIs or those not on an SSRI but contemplating treatment with an antidepressant.
One third of men suffer from premature ejaculation. Many take an SSRI to manage this or related problems. They want the drug to produce genital numbing and might be interested to avail of a test to establish the effects of treatment – were there a test available.
Many other drugs affect clitoral and penile sensitivity. A device that worked might make it possible to map out the sexual effects – good and bad – of many more drugs than the SSRI antidepressants, finasteride or isotretinoin, currently the drugs in the frame for causing problems. With the right device it might be possible to establish beneficial sexual effects for other treatments.
At RxISK, we know more than anyone else about PSSD and related conditions. We have access to a large bank of affected patients in most major countries who would be willing to be tested.
We can also advise on the possibilities of testing any prototype machine on healthy volunteers, before and after a single dose of an SSRI for instance – this would likely show effects sufficient to establish the credentials of the machine and perhaps point to the likely size of any market.
The RxISK interest in this is primarily to help those suffering from PSSD or Post Finasteride Syndrome or Post Retinoid Syndrome. We are not floating a commercial proposition for RxISK but it seems very clear that there might well be opportunities for others here that might help us help people with PSSD. The way to get people with PSSD or other sexual dysfunctions helped might lie in helping someone else to see that this is a potential market that is larger than the Diabetes market.