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.
Dear [….]
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.
The Market
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.
RxISK input
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.
annie says
This is such a brilliant proposition and entirely possible.
I worked for a guy who invented a machine for the financial market.
He had had a eureka moment and got himself a team of himself, the Inventor, a technical engineer and a financial director. They had a small factory in Cardiff Docks and an office in Notting Hill and they applied for the patent.
All this, but no sales team, no publicity, no brochures, no customers.
So, this was my job, all that..
After a year of graft, he sent me to the US to develop sales, and try and get independent agents. I had to be entirely self funding, my expenses were minimal and one or two sales had to pay for zooming from state to state.
There are people out there who get the vision, who can see the opportunities.
Impeto seem to have difficulties, but they could have developed a market with the add on, but, it looks like they are busy enough with their own Marketing Plan which doesn’t include veering off. But why develop the add on in the first place – stretched too thin?
Also, as they evidenced themselves in their Power Point Presentation, they could have stumbled in to a quite significant area of interest …
A doctor offloading his SudoScan, only 45 tests to break even, so around $183 per test..
Used IMPETOMEDICAL Sudoscan Unit Neurology General Um zu …
https://de.dotmed.com/listing/neurology-general/impetomedical/sudoscan/unit/2391990
Used IMPETOMEDICAL Sudoscan Unit Neurology General Um zu verkaufen – DOTmed Angebotseintrag #2391990: Used Sudoscan for sale. This device detects and measures peripheral neuropathy and has a strong reimbursement. $32,000 new. I’m asking $8250. Only 45 tests to break even. This device does have the renewable plates like the newer models
Sales Force Training
Power Point Presentation
https://www.powershow.com/viewht/80f081-MDhjN/Sales_20Force_20Training_20Sudoscan_powerpoint_ppt_presentation
Slide 43
Medication Confounders
Elevations and Decreases of scores with medications
‘Potential confounding factors to SudoScan results, not fully validated by research’ …
susanne says
I flagged up a research project being carried out on conductivity by a student in Bangor Electrical Engineering Dpt some months ago . It seemed to fall down a hole but if anybody knows anything about it there is an opportunity there – If not in Bangor other uni’s support student projects to set up businessesPontio Innovation
Pontio Innovation is a business development hub, which nurtures ideas and helps to make them a reality. We work with a network of members, from individuals to SMEs and larger enterprises. Our product design experts help our members to identify new thinking, methods and processes, which will help them to develop and succeed. Our purpose-built space is home to cutting-edge technology. That means we are able to facilitate the prototyping of commercial products and services and can bring viable ideas to market quickly.
Contact
School of Computer Science and Electronic Engineering
Bangor University, Dean Street, Bangor, Gwynedd, UK, LL57 1UT
Phone: 01248 351151
Email: csee@bangor.ac.uk
Anthony says
Getting your hands on the product is not the issue, it’s available only a matter of time. Say we get our hands on it l, Test pssd patients from severe to less severe, prove the condition exists, what then ? I get proving it exists is important and viable when it comes to health providers but will it take it a step closer to finding a cure? Or even a few more steps? Asking for hope sake only.
Dr. David Healy says
We hope to have a post next week or the week after on the experience people have going to doctors and being told this is all in your mind. The distress caused by the ridicule sufferers receive is part of what leads some of them to contemplate suicide. So having a test result to challenge them with would make a huge difference. Probably also to some of those affected who from time to time wonder if it isn’t in their own mind.
Beyond that, there is a challenge to medicine here. According to standard medical books PSSD is impossible. Sensory problems like this are supposed to happen to long nerves and show up in hands and feet – not in genitals. So PSSD upends a century of conventional medical wisdom. This conventional wisdom is trending towards expensive brain tests and skin biopsies to test for these problems. Having a simply test demonstrate what’s going again will be a challenge – who knows the end result might be they might start believing what people say.
David
susanne says
David
Can you give us some idea of how many have the diagnosis through Rxisk or elsewhere?(not considering how many may have without realising) If a test becomes available , being optimistic,how will they get it,?,will devices be spread around , ideally people will need to self refer or self test as most clinicians are still in denial that the condition exists. If the test becomes simple enough it would be good if people can test themselves – including for reasons of it being an intimate test -that would boost sales if manufactured – Not so long ago we could only get access to many devices/tests by discussion with a gatekeeper – usually GP These days there are many in stores or online.
Dr. David Healy says
Suzanne
No one is going to develop a test just for PSSDers – even though we have 500 on our books and there are likely several thousand at least.
The point behind the post is there is a market for checking out genital sensitivity way beyond PSSD. Do you or I know if we are as genitally sensitive as we should be, could be, would be?
D
Dr. David Healy says
Susanne
We have 500 PSSDers and there are likely thousands but no-one will want to make a device for such a small group even if it saves lives. The point behind the piece is to point out that there are millions of people out there who might be interested in testing for genital sensitivity. Are you or I as genitally sensitive as we should be, could be, would be?
David
susanne says
I would add , ‘or want to be’. I am uncertain about this now , I think a device should be available to anyone who wants it – yet there could be some negatives if people with variable sensitivities and sexual desires start to think there is some kind of thresh-hold for optimal satisfaction, especially when they have been happy enough before. Importantly though What would be the consequences for people not experiencing what is thought to be optimal sensitivity – my guess is potentially – drugs and more exploitation of insecurities than already in society by businesses offering ‘cures’. I do have a feeling that this kind of device will be snapped up though so maybe my thoughts are over-protective a bit over- maternalistic.
Dr. David Healy says
Suzanne
Developing a device may end up doing more harm than good. But given that people are simply not believed when they report what is wrong with them, having something supposedly objective may help get them listened to and depending on the device it may shed light on what is wrong
David
susanne says
Sparking off Johanna’s comments there is seemingly money to be made if someone can come up with a simple device . Witjh thanks again to pseudoscam :-
Ouistart tenant of the week – Impeto Medical
POSTED ON FEBRUARY 1, 2018 BY NICOLAS MENIER
“As a U.S. representative for the French company Impeto Medical, it is a treat working at the Ouistart San Diego based business center. Being surrounded by other small business owners and entrepreneurs makes for a very motivating environment to operate from.”
Herve Cote, U.S. Operations for Sudoscan medical device, Impeto Medical
Tenant of the week (with photo of very small office space and one desk being operated by the happy soon to be well off operator)
Company Name: Sudoscan Medical Device – Impeto Medical
Activity: The Sudoscan™ is an FDA approved medical device manufactured in France by Impeto Medical, designed to evaluate sweat gland function
Tenant since September 2017
Space rented: one private office, one storage office and one dedicated desk in our bright open space.
susanne says
PSSD Collaborative Research
A forum dedicated to collaborative research into PSSD (Post-SSRI Sexual Dysfunctio
Meeting- member of parliament (UK)
Moderators: Ghost, Sonny
Post a reply
First unread post • 9 posts • Page 1 of 1
Meeting- member of parliament (UK)
Unread postby Frog » Wed Aug 28, 2019 7:54 am
Hi all,
I’ve recently had a meeting with a caseworker who works my local member of parliament (UK) and spoke about PSSD and the symptoms linked to it including emotional and cognitive issues.
I today received a letter from my MP and he is raising the concern about support and treatment with the British health minister! He has been very helpful and I’m sure will continue to be!
I will update with any progress. I urge all of you in the UK to write to/email your MP and aks the same of them. There is power in numbers!
Frog
David says
I think it’s very important to recognise that pssd is much more than just sexual dysfunctions. There is damage done to emotional functioning and cognitive functions.
Dr. David Healy says
SSRIs also damage emotional and cognitive function but these are not part of PSSD. These injuries can happen without PSSD, just as 30 minutes after taking a first SSRI pill most people will be genitally numb to some extent without cognitive damage.
Some but not all people with PSSD can also have emotional and cognitive damage but these are separate injuries
D
David says
Is the mission of rxisk to also fix emotional and cognitive functions or only sexual dysfunctions? Or maybe you think one is related to another and fixing one thing will help with the other?
Dr. David Healy says
PSSD is a point of attack. It is very specific. Everything about it tears up most of what we understand about pharmacology and neurology. Finding an answer will not just help people with it but will change our understanding about a lot of things. The hope is that this will lead to a better understanding of lots of things.
RE emotional and cognitive changes, these also happen and RxISK insists on this and that the ultimate goal has to be getting health systems to believe people when they come and report what is happening to them.
D
Anthony says
I have a question regarding fertility, do pssd patients have to worry about that ? or even the slightest due to prolonged ssri use? I’m a male with pssd for 2.5 years and want to know if it’s something to worry about.
Dr. David Healy says
Being on an SSRI impairs fertility. But PSSD doesn’t. I would think if the PSSD resolves/gets cured, your fertility should be okay
D
Spruce says
I hadn’t though of it like this before.
I have emotional numbing as well as the sexual problems.
I always assumed the emotional and sexual numbing were both a part of PSSD and were connected.
Is this definitely not the case?
Dr. David Healy says
There is a very close link between emotional numbing and sexual numbing but the two are distinct. Anedonia is something different. Antipsychotics cause anhedonia but not genital numbing. Over time there can be a loss of libido but again, its distinct from anhedonia.
D
annie says
Impeto, have described their reasons for not developing Sudoscan in this region, hence the ‘Business Opportunity’ for ‘all-round’ sensitivity testing to potentially irrigate any ‘fixed boundaries’ …
https://forum.propeciahelp.com/t/genital-neuropathy-testing-possibility-project-from-dr-healy/37017
susanne says
Appealing To Impeto Medical Via Youtube
Moderators: Ghost, Sonny
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Appealing To Impeto Medical Via Youtube
Unread postby Kevin2017 » Tue Sep 10, 2019 2:00 am
There`s a new video on youtube appealing to Impeto Medical to cooperate with Professor Healy regarding the use of Sudoscan to test for PSSD. It would be helpful if people can add comments to the video referring to their own PSSD to add weight to the message.
Thank you.
https://www.youtube.com/watch?v=SS8uiys … e=youtu.be
Kevin2017
susanne says
Get the last reply from David – and it applies to so many of us who have been ridiculed and disbelieved in so many other cases when reporting to doctors. –
But re Sudoscan
Posted by ‘anonymous’ (as so often people get the truth out by having to post anonymously when the possibility of sueing by companies shows how unequal the power is in law as everywhere else)
As Guest (on Cafepharma message board – 2016 –
I do NOT work with the company (referring to another co. initially)but am familiar with the technology. The company sells different medical devices so there may be confusion that it is one device but the technology is real and has an FDA 510K Clearance. The problem is that the device it is too expensive ($40K-$50K) for most private FP, IM or Endocrinology doctors and is designed for patients living with diabetes. It tests for Autonomic Nervous System (ANS), Sudomotor Function Testing (SFT) and newer devices include Ankle Brachial Index (ABI) which are all real evidence-based assessments and have over 5-years of CPT reimbursement history
(also stay away from ANSAR and SudoScan devices that may be on sale because CMS has banned the products from use on federal patients). I would advise that you seek other company’s that sell newer and better technology. Best of luck! 🙂
Second hand devices (not adapters) are sold for For Sale IMPETOMEDICAL Sudoscan Unit
Condition :
Used – Excellent
maybe the business opps for doctors who buy them are not as promising after all. Have read somewhere a bit about complications of reimbursement by insurers private or medicare – will add if can find it again. CMS are the Codes used for reimbursement as far as I see but don’t now exactly the problem re sudoscan.
Quantity :
1
In Stock :
Yes
Date :
August 26, 2019
upwards of 32000dollars
Item Description
Seller assumes all responsibility for this listing.
Listing: #2814890
Condition: Used – Excellent
Brand: IMPETOMEDICAL
Type: Diagnostic Set
Model: Sudoscan
Multiple units from 2014 available and priced to sell. Each unit comes with plates. Buy multiple for a large discount.
SUDOSCAN is an a device for galvanic skin response that has been cleared for use by the FDA to test for Peripheral Neuropathies and Sudomotor function.
SUDOSCAN evaluates sweat gland function through a process called galvanic skin response. SUDOSCAN measures the ability of the sweat glands to release chloride ions in response to a small electrical stimulus on the palms of the hands and soles of the feet.
SUDOSCAN is a device that tests for small nerve peripheral neuropathy.
Reimbursable by most insurances including Medicare.
$200 average Medicare reimbursement
It is a 3 minute test that requires no patient preparation
No prior authorization needed
Scientifically proven for early detection of small nerve peripheral neuropathy
susanne says
Genital neuropathy Testing Possibility – Project from Dr Healy
Post-Drug Syndrome Survey: Help Raise Awareness and Aid Research
If you have experienced persistent symptoms for at least three months after cessation, please take part in this important project.
Learn more in the Survey FAQ Topic
Welcome to propeciahelp, a forum for both men and women suffering from persistent symptoms after use of 5alpha-reductase inhibitors such as finasteride, isotretinoin, saw palmetto extract, dutasteride as well as anti-androgens, antidepressants, and GnRH analogs. PLEASE NOTE: This is NOT a hair loss forum
Genital neuropathy Testing Possibility – Project from Dr Healy
Science
axolotl
Jul 5
Hi guys,
Bit of an unconventional one, but we’re writing to make you aware of the potential for a UK based test. Dr Healy wants to proceed with a test for genital neuropathy in a small group of PFS, PSSD and PRSD (Accutane) patients.
Professor Healy has reached out as he has had difficulty obtaining a necessary adapter from the company, and as such he is asking for interested patients to email the company requesting that this is provided owing to the importance of investigation into the condition
One of the UK’s leading experts in peripheral neuropathy already uses Sudoscan and has agreed to help us test PSSD, PFS and PRSD patients if Impeto Medical can supply us the special adaptors. Unfortunately, they seem unwilling to do this and have stopped responding to our messages.
We need your help. We would like you to add your name, city, country, and the date to Letter 1 and email it to jean-henri.calvet@impeto-medical.
CLICK HERE for a letter template
kan
Jul 23
He has answered the e-mail. Here’s his reply:
Thank you for your heartfelt letter.
As a medical doctor with strong moral values, I fully understand and share in the suffering that you or your loved ones feel. I also admire Professor Healy’s fight for the recognition of post-SSRI sexual dysfunction as a legitimate pathology.
We are a small French company that has developed a technology to evaluate the function of small nerve fibers of the autonomic nervous system which control the sweat glands. The measurements are taken on the palms of the hands and soles of the feet, the two areas of the body with the highest density of sweat glands. This method has been validated and is now widely recognized, as evidenced by the numerous international scientific publications devoted to it (> 150). Because of its simplicity, it is increasingly being used by specialists in the field of neurology.
Some time ago, a physician who has used the technology extensively, asked us to adapt the methodology to evaluate small nerve fiber function for erectile dysfunction. His aim was to complete a very preliminary study purely in a research context, looking to eventually replace the current standard of care diagnostic test (sympathetic skin response – SSR) which he considers to have limited performance. He wrote a first publication of 25 patients with diabetes who were suffering from erectile dysfunction. Prof. Healy came across this publication, and in the interest of providing optimal care to his patients, requested that we make the technology available for your benefit; this, of course, is a completely scientific and professional intention. However, the adaptation of our technology for this research study does not have the CE marking yet, and therefore cannot at this time be used on a larger clinical scale. We are currently working on filing for the application’s CE marking. In the meantime, your attending physician may use SSR for diagnostic purposes, being cognizant of its limitations. As a physician, as previously stated, I am aware of the struggles with your condition, and do not want under any circumstances to prevent you from benefitting from the latest medical technologies, as Professor Healy seems to imply; this would hardly be ethical. However, we must allow time for adequate research to be completed in order to achieve results that are reliable and usable by all.
Thank you for trusting me in working to help improve your care.
Sincerely yours.
Jean-Henri Calvet, MD, PhD
from ‘a small French company’ (!)
Pogo says
A genital adaptor is probably not needed to provide a proof of concept. Just standard electrode gel pads would suffice – I think. These could be the non adhesive type (for use on the scalp) and held in place with surgical tape.
Unfortunately, I doubt if it this would be useful.
Sudoscan and SudoPath™ (LD Technology) appear to come from the same stable. Reading though the paper it appears to measure the micro-circulation response only — as a way of ‘indicating’ — that neuropathy is ‘probably’ responsible for a reduced sweet gland response and thermoregulation, when compared to control subjects. In this respect it makes sense that they excluded from their study, anyone that was taking beta- blockers etc. The instrument does not appear (to me at least) as being able to measure nerve fibre conduction/signalling directly.
Spruce says
From this reply from Jean Henri it looks like he is asking us to play a waiting game, and that once the adapter has the CH marking, whatever that is, then he can provide us with the adapter.
I would like to believe and hope Jean Henri is being honest about this, and that he does indeed have the intention to file for the applications CE marking.
As a sufferer of PSSD, i don’t mind waiting a little while longer to try and get answers (i have been waiting 12 years already), but i just hope this doesn’t end up dragging on for years and years without us being able to get the genital adapter etc.
I was wondering if someone might be able to email and ask Jean Henri how long it might take for the genital adapter to get the CE marking. I would myself, but he hasn’t responded to my emails, so it might be better coming from someone who has had a reply.
Pogo says
It might be useful to look at the patent filing in case I have missed something.
https://patentimages.storage.googleapis.com/64/70/b8/4022409e8b83ba/US8934954.pdf
I read this as, the apparatus stresses the sweat glands to see ‘if’ and to ‘what degree’ they have atrophied. This could simply be the result, not of poor nerve inputs. Much is still not fully understood as to what is exactly happening. Some of the new current thinking is, that in diabetes the cells become so full of glycogen (which the cell can’t directly use as fuel), that there is no room left for glucose to enter. Whilst sweat may taste salty, the fluid comes from a salter plasma and so the cells require glucose to overcome the osmotic gradient and recycle as much sodium as possible. If this brakes down completely — the cells die. Therefore. Got this gut feeling that PSSD does not involve signalling beyond the reptilian part of the brain. If so, PSSD might also, exhibit subtler symptoms that go unreported, as they might not at first appear connected. This is a bit of a leading question: “Do people with PSSD find that they have lost “a lot” of their competitive spirit, only to have had it replaced, with a shadow of frustrations when trying to deal effectively with people?” It is a bad question in a way, as I’d guess that 98% of healthy people might instantly answer ‘yes’ without thinking. So I mean it from the point of view of anyone suddenly realising and thinking — Ah ha! Yes that too!
susanne says
Send a Release
Impeto Medical Responds to Published Allegations by LD Technology LLC (“LD”)
NEWS PROVIDED BY
Impeto Medical SAS
Mar 05, 2015, 03:00 ET
SHARE THIS ARTICLE
SAN DIEGO, March 5, 2015 /PRNewswire/ — In response to the incorrect assertions by LD, distributed by Marketwired in Miami, FL on February 12, 2015. Impeto Medical SAS and its U.S. company are both of strong financial health and their SUDOSCAN® devices have been proven to provide accurate results, as clinical research has indicated. Furthermore, Impeto prefers to have the courts decide this dispute rather than the press.
There are more than 40 articles written by Key Opinion Leaders, published by significant peer-reviewed scientific journals that scientifically demonstrate that Impeto’s SUDOSCAN® devices perform as advertised. These devices have been well accepted by Medical doctors in the U.S. and throughout the world. LD’s assertions to the contrary are simply incorrect.
Impeto’s SUDOSCAN® device was listed as a predicate device within LD’s first 510(k) application and subsequent clearance. For example, LD stated on its June 29, 2010 510(k) Premarket Notification Number K102166, that with regard to its EIS-GS device there is “Substantial equivalence [–] Predicate legally marketed device[:] SUDOSCAN 510(k) number 100223: Manufacturer Impeto Medical…. Similarities[:] Same intended use and same technology.” Thereafter, LD’s February 16, 2013 510(k) (2) Premarket Notification for its Sudopath device used the June 29, 2010 510(k) as the predicate. In other words, in its FDA documents, LD admits that its Sudopath device uses the same technology as the prior SUDOSCAN® device of Impeto.
Impeto’s D&B credit is in good standing. Additionally, Impeto has strong shareholders which support the company’s’ research for the past decade and to protect the R&D investments through strong worldwide patents and patent applications.
LD’s press release assertions are incorrect, especially regarding Non-Disclosure Agreements and allegedly improperly used information. The French courts have already ruled that Impeto and its engineers had acted properly and did not violate any rights of LD or its French predecessor.
Impeto has sued LD and its officer Albert Maarek in the U.S. District Court for the Southern District of Florida in civil action no. 1:15-cv-20109. The causes of action brought by Impeto Medical SAS against LD and Maarek assert infringement of three U.S. Impeto patents, infringement of Impeto’s SUDOSCAN® trademark, and false advertising. The Impeto patents and trademark registration were properly issued by the U.S. Patent and Trademark Office, and Impeto is confident in its position. Impeto prefers to have the courts decide this dispute rather than the press.
Impeto medical SAS was founded in 2005 in Paris. See website: http://www.impeto-medical.com.
Impeto medical Inc was created in 2011 as a full subsidiary of SAS. See website: http://www.sudoscan.com
SOURCE Impeto Medical SAS
susanne says
For Anybody with an interest in the technical side – loads of detailed material has been published by Hanna Ayoub including in a book all in the public domain.
susanne says
elcome to USA TODAY NETWORK’S EUROPEAN UNION EXPERIENCE
Prozac maker paid millions to secure favorable verdict in mass shooting lawsuit, victims say
Andrew Wolfson Louisville Courier Journal
Published 4:13 PM EDT Sep 12, 2019
LOUISVILLE, Ky. – The drugmaker that produces Prozac, the antidepressant that Joseph Wesbecker’s victims blamed for his deadly shooting rampage 30 years ago at Standard Gravure, secretly paid the victims $20 million to help ensure a verdict exonerating the drug company.
Indianapolis-based Eli Lilly vigorously shielded the payment for more than two decades, defying a Louisville judge who fought to reveal it because he said it swayed the jury’s verdict.
Wesbecker began taking Prozac about a month before his murderous spree that killed eight and wounded 12 in the print shop attached to the Courier Journal. All but one of the victims sued Eli Lilly, the company that manufactured the popular but controversial drug.
‘We need change’: El Paso mass shooting survivors file lawsuit against Walmart
On Sept. 14, 1989, Wesbecker, a pressman who had been placed on long-term disability leave for severe mental illness, entered Standard Gravure around 8:30 a.m., carrying a bag full of weapons, including a semiautomatic rifle.
Over the next 30 minutes, Wesbecker walked through the building, firing more than 40 rounds at those he encountered before shooting himself in the head with a handgun. It is the worst mass shooting in Kentucky’s history.
In 1994, a fiercely litigated, 11-week trial took place in Louisville in which Wesbecker’s victims and their families said the Prozac he took helped incite his murderous rampage.
On the eve of the jury’s verdict, which absolved Lilly of liability, the company made the secret payment without telling the judge overseeing the case.
In exchange for the payment, the plaintiffs – eight estates and 11 survivors – agreed to withhold damaging evidence about the arthritis drug Oraflex that Lilly withdrew from the market. Lilly pleaded guilty to 25 criminal misdemeanor counts for failing to report adverse reactions that patients suffered from the drug, and the drug company feared that the Prozac jury would be more inclined to rule against the drugmaker if it learned of it.
The plaintiffs agreed that if the jury found Lilly liable, they would not seek damages, nor would they appeal the verdict if they lost.
America’s first mass shooting: 70 years ago, a WWII veteran killed 13 of his neighbors
Jefferson Circuit Judge John Potter forced the disclosure of a secret deal between Prozac maker Eli Lilly and company and the plaintiffs
The Courier Journal
Jefferson Circuit Judge John Potter exposed the outlines of the deal decades ago, suspecting that money may have changed hands before the verdict. He fought the company for years to disclose the deal’s terms.
Lilly closely guarded the amount of the payment, and it remained a secret in Louisville.
Two of the victims recently told the Courier Journal that the payment totaled $20 million, worth about $41 million in today’s dollars, which the plaintiffs divided among themselves after paying their attorneys. The two victims told the Courier Journal they felt compelled to accept the money because they suffered egregious injuries that kept them from working again and they needed it to survive.
They asked not to be identified because the settlement required them to keep the amount secret, and they said they feared repercussions for revealing it.
The co-lead attorney for the plaintiffs, Illinois lawyer Nancy Zettler, told the Courier Journal she was not involved in the agreement but heard the same figure cited by the two plaintiffs.
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The Indianapolis Star reported the $20 million amount in 2000 and said the company paid an additional $5 million to cover workers’ compensation claims.
Under the deal, the plaintiffs could have received $15 million more if Prozac had been found 51%-100% liable for Wesbecker’s conduct.
Attorney Ed Stopher, who defended Lilly at trial, declined to comment and referred questions to the company, whose communication director, Mark Taylor, said it would not comment.
Lilly used the verdict to tout that Prozac had been proved a safe and effective antidepressant. In 1995, the company reaped a quarter of its $6.5 billion in revenue from Prozac – and faced 160 other suits nationwide over the drug.
Prozac is still prescribed across the USA and is considered safe if used as directed, although it does have some side effects, according to the College of Psychiatric and Neurologic Pharmacists.
The company and its lawyers acknowledged the agreement with plaintiffs (but not the amount of the payment), insisting it was legal and ethical.
They said it was not unusual for adversaries in civil trials to strike so-called high-low agreements, in which the plaintiffs and defense agree to minimum and maximum recoveries – regardless of the verdict – to reduce their respective risks.
Somerset lawyer Richard Hay said, “If parties use secret agreements to keep out evidence, it’s like taking a dive in a boxing match.”
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Lilly publicly trashed Potter and his investigation and won an order from the Kentucky Court of Appeals blocking it.
Potter appealed, and the state Supreme Court unanimously ruled in his favor in 1996, allowing him to press Lilly for details of the deal.
“In this case, there was a serious lack of candor with the trial court, and there may have been deception, bad-faith conduct, abuse of the judicial process or perhaps even fraud,” the court said. “We cannot tolerate even the possibility of such conduct.”
Potter set a hearing at which he intended to require attorneys for both sides to testify under oath. Lilly accused him of conducting a vendetta, and he recused himself.
The judge who inherited the case let the matter drop, and Potter’s questions were never answered.
Potter, 76, who retired in 2002 after 20 years on the bench, declined to comment for this story.
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Andrew Pointer and other shooting victims of Joseph Wesbecker hold hands as the verdict is read on Dec. 12, 1994, in their suit against Prozac maker Eli Lilly and Co. Pointer died in April.
The Courier Journal
Published 4:13 PM EDT Sep 12, 2019
susanne says
Hidden Injustice
A REUTERS SERIES
Court let Merck hide secrets about a popular drug’s risks
Lawsuits claim baldness drug Propecia
annie says
Linking-up
Court let Merck hide secrets about a popular drug’s risks
annie says:
September 12, 2019 at 10:19 am
A Reuters Series
https://www.reuters.com/investigates/special-report/usa-courts-secrecy-propecia/
Court let Merck hide secrets about a popular drug’s risks
Lawsuits claim baldness drug Propecia causes sexual side-effects
By Dan Levine
Filed Sept. 11, 2019, 1 p.m. GMT
susanne says
More Secrets and Lies by The by the disgaced Tavistock and Portman
Trans Care
Gender dysphoria in children: puberty blockers study draws further criticism
BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5647 (
Deborah Cohen, correspondent, Hannah Barnes, senior journalist
Author affiliations
Correspondence to: D Cohen deborah.cohen02@bbc.co.uk
An opportunity to strengthen the evidence base for these treatments in a particularly vulnerable group of patients may have been missed, say Deborah Cohen and Hannah Barnes, who catalogue new concerns about NHS research practices and decisions to lower the minimum age for treatment before results were published
The NHS Gender Identity Disorder Service (GIDS), based at London’s Tavistock and Portman NHS Foundation Trust, is England’s only provider of NHS specialist treatment for young people with gender dysphoria.
In 2010 GIDS and University College London’s Institute of Child Health applied for ethical approval to conduct a cohort study offering puberty blockers to a “carefully selected group of adolescents” with gender dysphoria in early puberty.
But questions continue to emerge about the researchers’ conduct of this early intervention study.
We reported in July that potentially crucial information may have been missing from the study’s protocol and patient information sheets, casting doubt as to whether participants gave informed consent.1 Critics had said that the researchers had downplayed interim findings that might suggest increased suicidality. And the researchers had not submitted the annual progress reports required by the NHS Health Research Authority (HRA), which promotes patients’ interests in health research. Also, despite the full study findings remaining unpublished, the NHS changed its policy to allow GIDS to prescribe these drugs to children under 12 in established puberty.
Here we present new allegations that the researchers might have broken rules when seeking ethical approval. They might also have misinterpreted another study’s findings about potentially worrying effects of the drugs on changing bone density.
Contested area of research
Gender dysphoria, a conflict between a person’s biological sex (or “assigned” gender) and the gender with which they identify, can cause distress.2
Puberty blockers are drugs that stop the rise in sex hormones that prompts development of secondary …
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