Device Wrecks & Regulators?
RxISK is powered by people working behind the scenes – picking at threads and sometimes finding something rather different to what they expected. One of those who can’t resist a loose thread is Suzanne Stevens, who has been interested in our Sudoscan problem.
Many of you suffering with PSSD or related PRS, PRSD and PGAD conditions have been emailing Impeto Medical in Paris to see what can be done about access to a genital adapter for their Sudoscan device. See Sudoscan Saga.
Impeto’s medical person , a Dr Jean-Henri Calvet, replied to some people with what seems like a genuine letter saying he is awfully sorry but they are a small company and they are trying to get a marketing seal of approval and can do nothing until they get this – even though there is an investigator in Paris using the adapter who has published results 2 years ago.
(There is no readily available photo of Dr Calvet. The image above shows Impeto’s CEO Philippe Brunswick making a pitch for their devices on US television. The featured blog image shows a bunch of investigators working with Impeto devices and image at the bottom is Impeto’s twitter image).
Despite a seemingly friendly, but very much pro-forma, letter, the situation looks fishy. Impeto have been told that people are committing suicide despairing that anything will ever be found to help them. They have been told that in the absence of evidence from a test that would confirm the existence of the condition, part of that despair stems from people with PSSD and related conditions being ridiculed by doctors and other “healthcare” staff – suggesting they need to go on an antidepressant or stop accessing google or they will remain ill for the rest of their lives.
It would have been very easy to bring 4-6 volunteers affected with PSSD over to Paris for testing there. Why not do it?
Impeto Medical
Well it seems Impeto Medical who make Sudoscan are embroiled in a patent dispute with another company and there have been published articles questioning whether their device works at all.
The device isn’t complex – its a modified version of a lie detector and likely could be build by someone reading this blog. For the record comparable devices (albeit ones with intravaginal probes) can sell for Euro 40K or USD 50K. There is a lot of money in these simple devices.
For the last century, Americans have been the device makers par excellence and Americans now have as many devices in their bodies as the rest of the world put together – as a compelling documentary on Netflix – The Bleeding Edge brought out – see Trailer.
A recent BBC Panorama program – The Great Implant Scandal – also brought out how lax the regulation surrounding devices is in Britain and Europe
Jeanne Lenzer has been writing extensively on this, and her recent book The Danger within us, has laid a basis for much of this coverage.
Against this background, Suzanne who had been writing to Impeto, getting nowhere, and increasingly getting a fishy smell figured on writing to MHRA who regulate both drugs and devices in the UK, or did before the European Medicines Agency took over, and of course will now do so again.
From: Susanne Stevens
Sent: 22 August 2019 17:41
To: Devices Regulatory <Devices.Regulatory@mhra.gov.uk>
Subject: Sudoscan device
Can you please tell me if MHRA has any information re Sudoscan and in particular the Sudoscan device with genital adapters.
Thank you
Susanne Stevens
On Mon, Sep 2, 2019 at 10:53 AM
Narramore, Michael <Michael.Narramore@mhra.gov.uk> wrote:
Dear Susanne,
Thank you for your query.
Please be aware that MHRA do not directly approve or certify medical devices; conformity is self-certified by the manufacturer or assessed by a notified body depending on the risk classification of the device. In addition the medical device regulations are based on mutual recognition throughout the EU and medical devices may be certified in any EU Member State. Because of this, MHRA do not hold information on individual medical devices and are not able therefore to respond to your questions regarding Sudoscan.
You have not explained what information you require regarding the device, however you may contact the manufacturer directly for information relating to the Sudoscan device and its certification as a medical device. If you have specific concerns regarding the device or the technology behind the device you may report these to MHRA for investigation.
Please note that we are happy to give general advice on the Medical Device Directives and new EU Medical Devices Regulations. Any views expressed by us on the interpretation of the legislation represent our best judgement at the time based on the information available; they are not intended to be a definitive statement of law, which can only be given by the courts. Accordingly, we would always advise you to seek the views of your own professional advisers.
Best regards,
Michael Narramore
Compliance Officer
Medical devices
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London, E14 4PU
From: Susanne Stevens
Sent: 02 September 2019 11:18
To: Narramore, Michael <Michael.Narramore@mhra.gov.uk>
Subject: Re: Sudoscan device [REF: E/2019/1574]
Thank you I must not have made it clear enough but what I am asking is have there been any adverse events about sudoscan referred to the MHRA
Regards
Susanne
From: Narramore, Michael <Michael.Narramore@mhra.gov.uk>
Date: Tue, Sep 3, 2019 at 11:57 AM
Subject: RE: Sudoscan device [REF: E/2019/1574]
Thank you for the clarification. Unfortunately, due to confidentiality requirements of the medical device regulations (Article 20 of the Medical Device Directive 93/42/EEC) and the Enterprise Act 2002 (section 237), we are not able to disclose information on adverse incidents relating to specific products or manufacturers.
Best regards,
Michael Narramore
Compliance Officer
Pulling Threads
We need some more of you out there to start pulling threads or commenting on this email sequence and helping us understand it.
First, it seems to suggest that Impeto could ship their device across the Channel and start using it tomorrow if they wanted to.
Second, what is the basis if any of MHRA withholding information on Device Wrecks where they make it available for Drug Wrecks?
(A note on terminology: adverse events and side effects is much too mild a term for what goes wrong on Drugs. When things get to the point where a doctor or patient reports a problem, they are usually reporting a Drug Wreck not a trivial event. This is even more likely to be the case for Devices which as the Netflix, Panorama and Lenzer work brings out destroy lives. Device Wreck seems a much more fitting term).
Is there no way to find out what might have happened with Impeto’s Sudoscan, and perhaps its genital adapter in particular, or maybe Impeto devices more generally?
A picture for Jean-Henri has turned up – he’s standing on the Left.
Follow Impeto on Twitter?
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The good old MHRA regulating, what appears to be, their own regulations. They often throw up these clauses. It’s rather like an 86-year-old making an insurance claim on an expensive rug that was damaged by water. The insurance company will deny the claim a few times because the liklihood is the claimant will get so frustrated they will just give up.
The MHRA use the same set of principles. They receive a query, they give a dumb answer then add a clause here and there.
Susanne is about to embark on a frustrating journey. Eventually, after emails that reach double figures, she will be told “we have answered your emails and consider the matter closed. Worse still they may label her vexatious.
Bob I’ve been on many frustrating journeys! I’m not wasting any more time on MHRA itself – myself. It’s a step along the way some times. Rarely has a straightforward response. But one pl0y is to fob off by saying the org is being rejigged , consultations consultations –
Another ploy is to wait right until the last legal moment they have to reply then claim the query is unclear – then it starts from the beginning again. But others have a right to a reply if they choose to enquire…adds to the evidence of how MHRA is allowed to act . They are obliged to give info which points in the ‘right’ direction, if they can avoid the question,as they have seemingly done, This is useful if anybody already knows something about that tangled web. Eventually some the ‘top dogs’ of these orgs. ‘retire’ when too much evidence piles up against them personally or as reps including of the MHRA – the CEO and one other is ‘retiring’ this month. Another job lined up no doubt.
The same run around goes on with other orgs such as NHS Trusts when making Freedom of Information requests. I have made one to Royal Free which has a few days to answer then the run around will start – the one I made to UCL has resulted in a request for more info. which gives them more time to play. It’s built in to the culture.But they don’t want an informed public.
It takes massive persitence to get anywhere but if we go through their nonsense we have the proof of how they mis-behave.
Yup.
I’ve liaised with them via email, even met them on three occasions. It took two years to set up a meeting with their then CEO, Kent Woods.
Nothing came of it.
” What we’ve got here is… failure to communicate. Some men you just can’t reach.” ~ ‘Captain’ – Cool Hand Luke
I had a similar experience when i tried to get answers and justice from the AWP organisation and the Parliamentary health service ombudsman regarding my PSSD. They tried to frustrate and block an open honest dialogue about the problem for years.
Many years of delays, pretending they didn’t understand the questions, answering questions with answers not relevant to the questions in my complaint, lies (which i was able to prove were written). All sorts of tactics meant to frustrate me, that went on for years.
The end result; My ex psychiatrist who prescribed me the citalopram which gave me PSSD was completely exonerated in writing, and was promptly promoted to a higher position in the local mental health trust.
My life was left in ruins, and i received a certain amount of ongoing nastiness from some of the staff who worked at the local mental health unit, who were aware of my complaint.
My final parting conversation from the woman from the PHSO included a taunt from her in the form of her saying “and those sexual problems” in a demeaning way, before she told me she was “bringing the conversation to an end”. So that was nice.
Years and years of my time and energy struggling to get some form of acknowledgement and/or justice, only to be rewarded with a massive kick in the teeth, and a parting insult.
This is probably the most excruciating part, is that they have the device and are told that people are taking their lives due to this condition and they still won’t proceed with testing. If you do or will do get in contact I am willing to try the machine because I am suffering with the condition. Please email me with the email I will provide I am willing to try anything.
Thanks
Just a small problem, with San Diego …
About us
Impeto Medical SAS is a privately owned medical device company formed in June 2005. Its corporate headquarters are located in Paris, France. Two subsidiaries have been created: Beijing Impeto Medical in China and Impeto Medical Inc. in San Diego, U.S. Please visit http://www.impeto-medical.com for more information
https://www.linkedin.com/company/impeto-medical-sas
SUDOSCAN Test (see June, 2018 PN News edition for more on this test) A nerve conduction test can confirm disease diagnosis. A small fiber PN attack is marked by burning and tingling; large fiber PN by numbness. A new test called Sudoscan (Sudo = sweat) has been successful in Europe, detecting small fiber disease through testing, via sweat glands, the tiny, sub-skin sebaceous nerves. These are among the first to react to the disease, leading to early, correct diagnosis. This is a 3-minute electrical test with a small current to hands and feet. Skin won’t conduct electricity. Since sweat glands have conductivity via electrolytes, the results can be measured. Of 100% results, 50% are normal; 25% are abnormal, unknown; and 25% test abnormal with diabetes. A side note is that skin conductivity decreases with age.
Unfortunately, the company went bankrupt in 2017 due to patent litigation by L. D. Technology.
https://pnhelp.org/application/files/5615/5076/9374/PN_News_Sepetember_2018.pdf
Impeto Medical Inc. in San Diego/Bankruptcy filings
https://www.inforuptcy.com/filings/casbke_423164-3-17-bk-05927-impeto-medical-inc
Hit the nail on the head, Bob!
Sadly, they do the dirty deed on you.
Then the one who does things to defend themselves, due to the dysfunctional games they play, is the ‘crazy one!’ ~They do everything to discredit you.
How long can they keep getting away with this vexatious behaviour?
You give up because there is no support and you feel you are all alone at sea!
The systems and the processes, are dysfunctional and if you have plenty of $$$$
you are always well represented.
logo Impeto Medical MENU
REGULATORY
Impeto Medical complies with State and Federal regulations regarding the manufacture and sale of EZSCAN and SUDOSCAN.
Updated: January 2019
EUROPE
Europe
EZSCAN and SUDOSCAN are in conformity with the European Medical device directive 93/42 (class IIa) and ISO 13485:2016. The certificates were delivered by SGS.
> CE certificate_SGS valid until 17 December 2023 and is subject to a yearly surveillance.
> ISO 13485:2016 Certificate Impeto Medical (Paris) valid until 17 december 2021 and is subject to a yearly surveillance.
CHINA
China
EZSCAN, EZSCAN2 and SUDOSCAN2 are cleared by the China FDA (State Food and Drug Administration) as medical devices.
> CFDA Certificate
> CFDA Certificate (Extension)
> CFDA Certificate (SUDOSCAN2 & EZSCAN2)
U.S.A.
SUDOSCAN is cleared by the US Food and Drug Administration (FDA).
FDA approval
SUDOSCAN is registered as a trademark in the US.
SUDOSCAN TM
The lattest letter of clearance for the 510(k)
AUSTRALIA
australia
EZSCAN is registered in Australia as a Medical device. The ARTG certificate has been delivered on 19 August 2009 by the Australian Department of Health and Ageing Therapeutic Goods Administration.
Australia certificate
CANADA
canada
EZSCAN and SUDOSCAN are licensed in Canada.
EZSCAN Canada licence
SUDOSCAN Canada licence
MEXICO
EZSCAN is cleared by the COFEPRIS.
Certificate SUDOSCAN (currently being renewed)
SOUTH KOREA
SUDOSCAN is cleared for sale by the Korean Food and Drug Administration.
Certificate SUDOSCAN (currently being renewed)
THAILAND
SUDOSCAN is cleared by the Thai Food and Drug Administration (TFDA).
Certificate SUDOSCAN
ARGENTINA
800px-Flag_of_Argentina.svg
Certificate EZSCAN
PERU
2000px-flag_of_peru_state-svg
Certificate SUDOSCAN
JAPAN
Flag_of_Japan.svg
Certificate SUDOSCAN
SAUDI ARABIA
750px-Flag_of_Saudi_Arabia.svg
Certificate EZSCAN & SUDOSCAN (currently being renewed)
MOROCCO
Kingdom of Morocco authorisation for EZSCAN2
Kingdom of Morocco authorisation for SUDOSCAN2
NEWSCAST: IMPETO MEDICAL NEWS
And they won’t test even a few of the volunteers who have spelt out how their lives have been ruined – stinks
If any body from diabetic orgs are going to their next conf in Barcelona – please ask them about this.
DIY Arduino Powered Lie Detector
This could be adapted? Great instructions as far as I understand or maybe if anybody want to have a go at making one – contact the guy for help?
OK, so I started Googling Sudoscan and Impeto. I didn’t find out any big secrets, but I did get a lead on a good-paying new job:
“This medical sales position is with Physician Focused Diagnostics … Representatives are responsible for educating physicians and other stakeholders on the clinical and business benefits of Sudoscan, a preventative screening device for diabetic peripheral neuropathy that will increase a clinic’s profit by at least $130K annually. Commissions are 10% of selling price of the device (up to $3,900 per sale, 2-4 expected per month), and can be 2-4x when upselling other preventative screening devices on our product line.”
That’s what Impeto is really interested in. It’s also what the clinics that consider buying their gadget will be thinking about. How many well-insured patients can I sign up for a Sudoscan test – and how much can I charge per patient?
The problem of PSSD is compelling for anyone who thinks about science, and for anyone who cares about people. But it’s definitely not where the money is. You know where the money is? DIABETES. Lots of people have it, friends – and lots more will. Which brings me to another key word: SCREENING. Why keep marketing to people who already have bad symptoms? The real money is in rounding up people whose hands and feet feel OK now, and selling them a test that can show them the terrible complications they’re “at risk” for later.
That’s probably why Impeto discarded their genital adapter. It likely wasn’t a dangerous device; it was just a real dog from a business point of view. Their French researchers were using it to detect erectile problems due to diabetic neuropathy. But if a guy already has “ED”, and you wonder if diabetes is the real problem, you can probably just test his hands and feet. And if he doesn’t have “ED” and you just want to screen him for Pre-Diabetes (or other profitable Risk Factors), then hands and feet are definitely the way to go. What sane patient wants an Electro-Diagnostic Penile Screening added to his annual physical? (And really, what doctor wants to do 12-15 of those a week?)
One idea occurs to my cynical little mind … if Impeto has mothballed their genital adapter, maybe they have a few dozen in a box in their warehouse. They can donate them to a nice non-profit working on PSSD, and value them for tax purposes at, oh gosh … fifty grand apiece? A nice little tax credit for something they were thinking of tossing in the dumpster – and they can count it as part of their charitable giving! It’s done all the time. Maybe they’ll throw in a Sudoscan machine with a scratched cover.
Seriously. We should look into this.
Johanna
Fascinating. Sounds right.
But following your logic, these machines look like they are pretty simple to make. If someone made a specific genital one, there is a fortune to be made – not just from PSSD, PFS or PRSD sufferers but from genital testing more generally – is your clitoris, penis, as sensitive as it should be, could be – whether you are on a drug or not.
If you are on an antidepressant, get tested to see what the effect is. If you have premature ejaculation – one third of men – get tested to see what difference an ssri might make.
Whatever drug you are taking, get tested to see what is happening – you might discover something that produces a beneficial effect on sex and be able to make a fortune from it
David
I am currently studying medicine and work at a pharmacy, have done countless research and came across a few things. Considering that most patients who suffer from pssd cannot feel pleasure it’s not so much in a numbness point of view but an excitement point of view. They simply cannot feel any sort of excitement or pleasure towards anything not just sex. Shifting our perspective on chemicals in the Brian rather than in the genitals is what should be done. Obviously surgery to repair damaged chemical receptors in the Brian hasn’t yet been conducted. Perhaps natural substances can show improvement or any sort of improvement such as a substance called iboga or other nerve repairing remedies. On the other hand I’ve found tests toward long term Gabapentin use to reduce serotonin in the brain Due to overexposure to ssris or using anticonvulsants in general, and adding a dopamine agonist as well. combo treatments to trick the Brian into thinking it’s in its natural state is crucial. But I find the best way to understand the Condition is using the 2by2 method. Bringing a non exposed patients and a pssd patient and comparing chemical responses when physically aroused then filling in the damaged areas to what’s been damaged.
Allen – Eric
The same person with the same email has submitted two versions of this point under two names. Anhedonia is something quite different to PSSD. Just like a cough can appear in lung cancer, tuberculosis, pneumonia, influenza etc and it makes no sense to investigate coughs rather than the clinical syndrome in which a cough appears, so too with PSSD. Its the genital numbness that’s distinctive – not anhedonia.
But more to the point, focusing on anhedonia is a sure fire recipe to getting doctors to tell affected people to just take antidepressants and to think no more about the issues.
The need is to find a test that people in healthcare can’t argue with. It seems a much better bet to get a test that would establish that genital numbness is not all in the mind than it would be to develop a test for anything related to anhedonia.
David
Although on the wrong track – respect for being persistent in getting the comment published – two tries and your labelled ‘vexacious’ in other circumstances. It would also be useful to read other sites such as Mad in America =there are many others publishing valuable learning material). People on the blog use pseudonyms with good reason but if someone sticks to one name (easy to forget the first one used maybe) it’s interesting to follow their thinking. Especially maybe if younger trainees challenge what they are being taught and don’t go on to perpetuate practices which can be harmful
Another factor which would scare Impeto off is if they have heard that the genital tests need to be investigated as to the posibility of links to prescribed drugs. Pharma companies together could close down or harm Impeto however massive their enterprise – especially as people with diabetes need medications.
A bit more research into Impeto and Sudoscan;- although it won’t help anybody who needs a scan…..
NEW DRUG+DEVELOPMENT+SUDOSCAN+is+involved+in+the+European+project+e-PREDICE+(Early+PRevention+of+DIabetes+Complications+in+people+with+hyperglycaemia+in+Europe).+e-PREDICE+aims+at+testing+the+long+term+efficacy+of+different+therapeutic+schemes+for+the+early+prevention+of+diabetic+complications+in+people+with+hyperglycaemia+currently+under+lifestyle+intervention.+This+project+involving+15+centers+in+Europe+was+developed+in+cooperation+with+Pr.+Jaakko+Tuomilehto.+Contact+Impeto+Medical+iNEW+DRUG+DEVELOPMENT+SUDOSCAN+is+involved+in+the+European+project+e+This+project+involving+15+centers+in+Europe+was+developed+in+cooperation+with+Pr.+Jaakko+Tuomilehto.
Contact+Impeto+Medical+if+you+have+a+drug+development+project
BMS
Why We Work with Healthcare Professionals
Working with and supporting the work of healthcare professionals
Sudoscan is Associated withBristol Myers Squid
Healthcare professionals and pharmaceutical companies regularly work together, from early scientific research and clinical trial programmes to the use of medicines in the patient pathway. As an integral part of the medicines development and ongoing clinical review process, it is entirely appropriate that fees are paid to healthcare professionals to reimburse them for their time and expertise
Bristol-Myers Squibb engages Consultants for services required to fill a legitimate business or scientific need of the company. They are used where requisite resources or expertise may not be available from other sources and have not otherwise been provide
Go to Wikipidia for further info Bristol-Myers Squibb admits $900m overstatement
Grants, Giving & Corporate Sponsorship Support
Bristol-Myers Squibb is committed to supporting appropriate independent requests for funding and in-kind support to non-profit third party Organisations which make a difference in people’s lives either directly or indirectly through healthcare related support, medical and scientific education, research and general community based charitable activities – such as
.usatoday.com/story/money/2015/10/05/bristol-myers-squibb-fined-14m-paying-bribes-chinese-hospitals/73381078/e)
Also we have -Astra Zenaka which manufatured
Seroquel (R) (quetiapine fumarate) Tablets – the only psych drug listed
Sudoscan is alsoinvolved with research into ADHD
And the current star of the show Johnsson and Johnson
CORDIS
Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe
Fingers also intheHIV/AIDS pie and many other health conditions.
There needs to be collaborations in health care but all this isn;t very healthy. Loads more info on google search if anybody is interested.
Guess who is or was WORLD WIDE CHAIRMAN OF THE Medical Devices and Diagnostics segment .
Gorsky began his Johnson & Johnson career as a sales representative with Janssen Pharmaceutica in 1988. Over the next 15 years, he advanced through positions of increasing responsibility in sales, marketing, and management. In 2001, he was appointed President of Janssen, and in 2003, he was named Company Group Chairman of Johnson & Johnson’s pharmaceuticals business in Europe, the Middle East and Africa.
Gorsky left Johnson & Johnson in 2004 to join the Novartis Pharmaceuticals Corporation, where he served as head of the company’s pharmaceuticals business in North America.
[3] He returned to Johnson & Johnson in 2008 as company group chairman for Ethicon, Inc. In September 2009,
he was appointed worldwide chairman of the Medical Devices & Diagnostics segment. In January 2011, he was named vice chairman of Johnson & Johnson’s Executive Committee. Alex became chief executive officer on April 26, 2012, and Chairman on December 28, 2012.[4]
A longtime advocate of diversity and inclusion, Alex has been named one of the “100 Most Inspiring Leaders” by Pharma Voice. He is the Executive Sponsor of two Johnson & Johnson employee resource groups, the Women’s Leadership Initiative and the Veteran’s Leadership Council.[5] Alex is also a member of the Business Council and the Business Roundtable.
Alex is a member of the Board of Directors of IBM, …blah blah…….another very splendid chap from Johnson and Johnson’s
References
Helfand, Carly (2019-03-15). “J&J chief Gorsky took a big pay hit in 2018 but still nabbed $20M”. FiercePharma. FierceBiotech. Retrieved 2019-06-26.
“Alex Gorsky – chairman and CEO of Johnson & Johnson”. zoominfo.com. Retrieved 13 September 2019.
Sellers, Patricia. “Why the guy got the CEO job at J&J”. Fortune. Retrieved 2018-05-11.
“Alex Gorsky”. Robert F. Kennedy Human Rights. Retrieved 2018-05-11.
“Johnson & Johnson tops the diversity board”. http://www.healthcareglobal.com. Retrieved 2018-05-11.
“Alex Gorsky at the 2013 Wharton Commencement”. whartonmagazine.com. Retrieved 2018-05-11.
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