This is the first part of a two part series on clinical trial fraud from Johanna Ryan, with part 2 next week. Jo is RxISK’s clinical trial and shoddy clinical practice sleuth – see The Maintenance Man.
Recently the U.S. Department of Justice called attention to a small but worrisome crime wave. Health care fraud is a familiar feature of American life that may account for up to $230 billion per year, or 10% of health-care spending.
In Florida, it’s been called the unofficial state sport.
This particular crime wave involved medical research fraud. In some cases the subjects never had the disease being studied or took the new drug to treat it. In others, those subjects didn’t exist at all.
I found out about this crime wave, not from the daily news, but from the law firm of King & Spaulding – attorneys for GlaxoSmithKline (GSK) and other major drug companies. K&S focused not so much on stopping the crime wave, as on advising its clients how to “position their companies as favorably as possible to prevent enforcement actions if the government comes knocking.” In other words, to make sure someone else, not GSK, takes the blame.
Here’s a brief roundup:
Miami pediatrician Yvelice Villaman-Bencosme founded Unlimited Medical Research and was the primary investigator for its clinical trials. In November 2020 her study coordinator, Lisett Raventos, pled guilty to health care fraud charges; in January, the doctor herself followed suit.
Dr. Bencosme was sentenced to 63 months, Raventos to thirty. Another employee, Jessica Palacio, was charged in May 2021.
Bencosme and her staff conducted fraudulent research on behalf of “an unnamed pharmaceutical company” by fabricating data in a clinical trial of an asthma medication in children ages 4-11.
The unnamed drug company was GSK and the product was its wildly profitable Advair Diskus inhaler. The study, dubbed VESTRI, aimed to test the safety of Advair Diskus in children.
Unlimited’s subjects were real children – mainly Dr. Bencosme’s own patients at her Sacred Heart family-medicine clinic. Most, however, were not real subjects. Dr. Bencosme simply used their names and identifying data to create fake records of study visits that never happened and meds that were never given.
In August 2020, eight people were arrested for research fraud at Clinical Research Solutions (CRS) outside Cleveland. They included Dr. John Panuto, an allergy and immunology specialist and CRS’ principal investigator; Amie Demming, the CEO; and three of Demming’s relatives in Tennessee and Las Vegas.
The charges involve completely imaginary patients enrolled in at least eight trials for major drug firms. “Roll up your sleeves and get to work” had a whole new meaning at CRS: Rather than recruiting patients who had the diseases being studied, employees allegedly used their own Social Security numbers and middle or maiden names to create fake patient records, backed up with their own blood and urine samples.
They’re also charged with spending the debit cards issued to compensate “subjects” for clinic visits.
Dr. Martin Valdes, 64, ran Tellus along with three non-physicians: Fidalgis Font, Julio Lopez and Duniel Tejada. In March 2021, all four were indicted on federal health-care fraud charges.
Like the Ohio defendants, Font and Lopez allegedly used data from family and friends to create profiles of fictional research subjects. Dr. Valdes, meanwhile, used data from patients at his Hialeah general-practice clinic, Healing Touch C&C, who were not actually enrolled in the trials.
Tellus took part in five trials through July 2016, including two that tested a new buprenorphine implant for opioid addiction and one large trial of a drug for diabetic kidney damage (CARMELINA).
An even more audacious fraud scheme, first uncovered in 2018, was not widely publicized by the DOJ or the media. We’re indebted to the Tri-City Herald in Washington’s Yakima Valley for most of what we do know.
Sami Anwar, 42, was convicted of multiple fraud charges in 2019 and was sentenced to 28 years in prison. Anwar, a medical-school graduate from Pakistan who lacked a U.S. license, operated an outpatient clinic called Zain Medical Center with a few local doctors. His first clinical-trials venture, “Zain Medical Research,” used the name of his partner, Dr. Cheta Nand, as principal investigator.
After gross irregularities were spotted in Zain’s work on two Pfizer studies, Dr. Nand was barred from future research contracts, and Zain Research shut down. Anwar simply re-incorporated as Mid-Columbia Research, borrowing the name of a second doctor, and worked on another half-dozen clinical trials before the racket was discovered.
Some Zain Medical Center patients had actually enlisted in studies and taken the drugs. The results could be scary: A teenaged girl taking Pfizer’s Chantix for smoking cessation was hospitalized for a suicide attempt. A three-year-old suffered permanent scars while testing an ointment for a skin disease she did not have. And several subjects were enrolled in two of Anwar’s drug studies at once, including one man whose death was not reported to study sponsors.
These were not criminal masterminds, or scientific ones either. The fraud schemes were crude, almost clownish. Anwar was perhaps the cleverest – but when the feds finally arrived at his Yakima Valley research center, they found him squeezing injectable drugs down the sink and stuffing his desk drawer with unused opioid painkillers.
Yet all these people were working for multinational drug companies, doing the kind of research that gets published in top peer-reviewed journals. The kind of research that your doctor and mine rely on when deciding what treatments we ought to have.
The frauds went undetected for years: CRS worked for seven companies before the eighth one noticed something wasn’t quite right. Tellus Research hummed along unnoticed until the CEO, Ms. Font, used the company account to buy herself a Range Rover.
When FDA inspections finally closed down Zain Research, Sami Anwar simply opened a new research center, in the same small town, at the same address, and was hired anew.
How the hell did that happen?
Find out next week.
Plus check out the overlaps between this and a post on the Politics of Care Forum this week – Medico-Chemical and Petro-Chemical Twins
This is a series to get the pulse-racing and wouldn’t you know – King and Spalding…
In conversation with Adam Heppinstall (Henderson Chambers) and Cécile Burgess (Managing Associate, AG) about how, for the first time, the English Court of Appeal endorsed the “holistic approach” to product safety.
WELCOME TO THE SEROXAT SERIES, WHERE AG AND HENDERSON CHAMBERS – WHO ACTED FOR GSK – DISCUSS THE KEY TAKEAWAYS FROM GSK’S VICTORY IN ITS DEFENCE OF THE LONG-RUNNING SEROXAT GROUP LITIGATION.
Tune in to hear from our experts on how the team successfully navigated the challenges of product group litigation, and third party litigation funding.
This is essential listening in 4 short videos as to why the Seroxat Litigation was short-changed by a legal process that reckoned that violence, homicide and suicide are far-and-away not considerations for a drug like Seroxat to be universally prescribed, with regulatory approvals, and how all the anecdotes in the world won’t change what could have been a landmark case where GSK was high on ghostwriting, lack of data transparency and the Study 329.
The structural misuse won’t bring back the bodies from the long-running and ever-lasting Seroxat Saga and how easily these people trip upon the light fantastic…
The $3 Billion – the UK refuse to Acknowledge
Ghostwriting and Fraud in GSK Clinical Trials
Study 329 quickly became controversial after it was discovered that Scientific Therapeutics Information (STI), a medical communications company hired by GSK, ghostwrote the manuscript, making inappropriate claims about the effectiveness of Paxil and downplaying the drug’s safety concerns, specifically with regard to Paxil-induced suicidal behavior.
The finding led to litigation, and in 2012, the U.S. Department of Justice (DOJ) fined GSK $3 billion (including a $1 billion criminal fine) to resolve civil and criminal charges arising from, among other things, the drug maker’s unlawful promotion of Paxil and other drugs and its failure to report certain safety data (the unlawful promotion of Paxil was only part of the $3 billion fine; two other GSK drugs were also implicated).
The allegations specific to Paxil include GSK’s participation in “preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18.” The DOJ further alleged that GSK did not make available data from two other studies that showed Paxil failed to demonstrate efficacy among patients under 18 and that GSK paid illegal remuneration to health care professionals to induce them to promote and prescribe Paxil.
More evidence of GSK’s scientific fraud in another Paxil clinical trial was exposed in court documents obtained in litigation conducted by our law firm. Study 352, which compared paroxetine to imipramine and placebo in people with bipolar (“manic depressive”) disorder, was published in the American Journal of Psychiatry in 2001 as “Double-Blind, Placebo-Controlled Comparison of Imipramine and Paroxetine in the Treatment of Bipolar Depression,” under the authorship of Charles Nemeroff and seven other authors.
The Study 352 article falsely reported that Paxil is an effective treatment for bipolar disorder and downplayed safety risks to patients, which caused harm to numerous people in the U.S. and around the world.
Much like Study 329, court documents show that GSK engaged STI to ghostwrite the Study 352 journal article; Sally Laden of STI was the ghostwriter for both of the medical journal publications regarding studies 329 and 352 that appeared in the names of academic research physicians. The first two drafts of the Study 352 article were written and reviewed by GSK before any of the named authors were contacted for their input. The documents show that Dr. Charles Nemeroff and other study authors with financial ties to GSK had little or no direct involvement in the trial results.
A U.S. Senate Finance Committee investigation revealed that Dr. Nemeroff, once a respected and award-winning researcher, had become one of the most prolific promoters of SSRI antidepressants while failing to disclose millions in payments from the pharmaceutical industry.
Dr. Nemeroff claims to be the author of over 1,100 medical journal articles.
Full details and Court Documents within – GSK Clinical Trials Paxil Fraud …
Yet another tale of how much regulation has failed to protect people . Part circus of clowns part Mafia. When only evidence rquired for licencing drugs is provided by those with self interests surely few in the medical world hardly were/are naive enough to accept that as adequate. The collusion is massive and includes regulators and ethics cttees.. The proof that fraud takes place was first revealed to me when doing work on consent . In particular accounts published by therapists was so obviously scewed to big up theories they had trained in or had personal reasons for supporting eg memberships of Institutes ; Cttees and training schemes and so on.
Thousands of people are still treated on what I would describe as fraudalent material There has been little reliable evidence to support the validity or credibility of much of what has been and is published. If there was a rigorous consent policy whereby clinicians. researchers and publishers were obliged to prove consent had been given to all levels pf participation Where people gave proof of having read accounts plus the right to add their comments – it could undermine the fraud to some extent although no doub loopholes would be explored. It might have been assumed that regulators protect citizens , that fraudalent theories and practices are a thing of the past whe ‘they’ could literally get away with murder But just as many vile psych treatments were enabled by corrupt bodies and organisations before regulation existed so now the loopholes which regulators surely must know exist – leave too many to crawl through. Too many people who move around the research world from one useful postion to another are extremely knowledge as to what they can be .
A type of fraud?
FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
Criticisms of the US Food and Drug Administration’s accelerated approval process have resurfaced after the recent approval of aducanumab (Aduhelm) for dementia.
If there are ghosts in the clinical trial machine, how can anyone TRUST what BIG PHARMA put in the medicines and vaccines?
If we allow this shemozzle to manifest, we have no comprehension of how far they will go!
Has biological warfare gone too far?
It is very sad to believe that people are way too trusting.
What is Big Pharma’s hidden agenda?
To diminish the growth of population, induce diseases in order to generate $$$$ for clinicians and lawyers or experiment on people. This corruption has been manifesting for way too long and people are not aware about what is really going on…………………!
The whole issue disgusts me. In fact, there are many things, at present in the UK that I find extremely troubling. Apparently, our schoolchildren are at the moment expected to learn and sing a song of praise for “our great country”. Meaning the UK, except that this has not been discussed with Scotland and Wales – nor Northern Ireland either I assume. So ill-thought-through is the “plan” that it hasn’t been realised that Scotland’s youth are already on their summer holidays! I hope that all schools have rejected the idea. The whole scenario takes us on a very slippery slope in my opinion.
To the issues in the post above. The same idea is true here. “Trust us for we know what’s best for you” is the mantra – and the trusting public believes it, or, rather, they are blind to the reality of what happens when you are too trusting.
You share the concerns of “hidden facts” within your community but most will dismiss your words or claim that you have “an agenda” concerning pharma companies etc. Very few will show more faith in YOUR words than the trust that they have that “doctors always have your best interest at heart”.
What has happened to our ability to question or to be questioned? Since when has our judgement become so hopeless that we constantly need to be told what’s good for us? Where will all this end?
We can already see the horrid effects of so many of us relying on ‘a pill for all ills’ – to us, our children, our grandchildren, our pets, our food, the water that we drink….the list is so long and disturbing but the majority continue regardless, no doubt putting their own perceived needs before the welfare of others.
And the song of praise? Who knows – but we DO know that having pride in your country is a personal choice and not something that happens because “those who should know better” send out a demand for it!
I agree with everything you have highlighted.
You bring up some very important points.
Therefore, those who don’t question, only reinforces my suspicion that people too readily believe what propaganda is programmed by doctors, Big Pharma, Educational institutions and Governments. They want us to believe everything they tell us!
Doctor Joseph Goebbels would indeed be most impressed with their manipulation of the nation. Never let the truth get in the way of a good story 😊
It is much easier to go with the flow than challenge such views.
I have always respected your insight and clear vision on this topic.
Once again, Mary, you have excelled in executing your mastery of the topic.
Isn’t it right that when something truly awful happens to you, that you investigate..
If the truly awful is because of an SSRI, or associated drug, cocktail or otherwise, leads you to questioning those responsible, do your efforts give you the response you were looking for?
How many of us have been back to our doctors, asking them to explain to us, why we had a truly awful experience.
When I had the beginnings of a successful communication with my village surgery who contacted the doctor in Canada, we had a series of emails, when the doctor put in writing that he would do everything he could to help with my Seroxat Case.
Because of this encouraging turn of events, I sent him all the details of what happened with the doctor and a psychiatrist which had led to two hospital stays and why I worked backwards from the appalling events and how it had happened. He completely changed his tune and said the practice had not received a formal complaint from me.
In goes the formal complaint and behind closed doors, a meeting took place with the practice manager, practice nurse and lady doctor. This lady, defied all probabilities by picking up the phone to call the Doctor Union. She made no mention of being familiar with me and did not address any of the facts I had painstakingly laid out.
The doctor in Canada telephoned me in my home at 7.00 am, Canada-time, to tell me he was far too busy to read the correspondence I had sent to him. He sounded curt, stressed, somewhat angry and dismissive.
Very unhappy with this turn of events, I contacted the Scottish Ombudsman. She telephoned the practice who spun the yarn and my case was closed.
The Clinical Director took it upon himself to telephone NHS Highland with the same result.
On each of the these occasions, not one of these individuals contacted me, about me.
We are not talking system error here, we are talking about my life in the country when most of these people were friends, people I had known, fellow parents of small children, fellow dog-lovers and fellow villagers.
The entire Seroxat episode was barbaric in the extreme.
You can’t sue Pharma, you can’t sue your doctors, and the recent RCP conference on Stopping Antidepressants was like reading stuff coming at us from the dark ages. What I have seen there was the death of progress…
Patrick D Hahn
Replying to @rcpsychand @wendyburn
You could have just read Chapter Six of my book:
It’s not just Ghosts in the Clinical Trial Machine, it’s Ghosts in the Medical Practice Machine…
Johanna has kicked off the Hornet’s Nest of Machines where it is unequivocally the case that even people behave like machines where compassion, humility and candour have completely gone out of the window – it all started with the Pharma Machine which the Medical Machine is at pains to copy with complete disregard to the Humanitarian Approach.
The Machine may plunder on, even Hancock has had his ‘half-hour’, but some of us do raise our heads above the parapet….
“…..but some of us do raise our heads above the parapet” – yes, Annie, and we’ll continue to do so won’t we, however many times we get pushed back!
As for Hancock – seems that saying “sorry” makes everything right if you belong to the right ‘set’. There it goes again – “We know what’s best for you and you must follow our rules – but WE can do as we like”. Some of us were, quite rightly, horrified when we read the story – but just listen to very many who have been interviewed by media regarding this, “it’s a private matter, leave the man alone”, “he’s apologised hasn’t he, what more do you want him to do?” etc. Want him to do? I don’t want him to DO anything – I merely EXPECTED HIM TO FOLLOW HIS OWN RULES! Too much to ask? It seems so – or is it just that once you reach the heights of your “profession” you are deemed to be above the rules of society? We could so easily come to that conclusion as we look and listen to all that worries us in “Health” today. How quick we’d ALL be to judge other countries if they displayed such disregard for their fellow man.
Annie – When I sent a letter to the GP and his cronies who were responsible for years of harm caused to me – he sent an article to thebmj complaining that people are researching doctors they have been registered with . I would advise every one to do the same. When I did What came up was astonishing ,If I put more details here it would identify them but I.m not ready – yet -to go public with names again. It was a horrible time in my life to be dealing with illness as well as the lies deceit and corruption of a network which widened the more I publicised what had happened.One of the GPs at the practice subsequently joined two ethics cttees, a rather marvellous way of covering up malpractice with the collusion obviously of her ‘colleagues’. She sent me a letter deregistered me from the practice – after I had already left .I had never met her, certainly never consulted her. She wouldn’t reply to my letter or meet or explain herself over the phone..The medical files got ‘lost’ they blamed admin. I have tried to find that bmj letter without success – if it comes up will send you a copy. If that hadn’t happened I would never have learned how corrupt they can be – or managed to get successful complaints against members of their group subsequently on behalf of others . That depended partly on knowing enough not to be fooled again plus finding that the group of them were not altogether admired in the area
I guess you will have heard on news today that Matt Hancock has broken the law again by ’embracing’someone identified as ‘mistress’ (how quaint, ) outside his ‘bubble’ Also by giving her a job in his dept. which is under investigation Who cares who he is screwing but he has constantly lectured us all to do our duty to the country Are they all having a laugh. Imagine having to kiss any of them for a job. Urrg.
Tired of hearing all the dramas, scandals and controversies regarding those work within the political infrastructure.
It is all about their rights and conquests to get promoted after they have screwed up! It is so ironic how they get rewarded for screwing up!
Yet, those who have suffered from their terrible policies, have to be kept silent and be mistreated.
Get rid of corrupt Governments and dodgy politicians.
The same should apply to other corrupt infrastructures.
What kind of a universe allows this corrupt culture to breed? ~ We, the people!
Yes Anon – they breed and interbreed producing more and more corruption. Including by being able to hide behind titles and positions until it gets buried out of sight unless some us keep exposing it here on the blogs and elsewhere. Here’s one I can name as it’s already in the public domain thanks to Freedom of Information. (I’ve used FOI loads of times when blocked by members of various institutions
Dr Gwen Adshead Fitness to Practice
Dr Helen Bright made this Freedom of Information request to General Medical Council
What they hadn’t admitted was that Gwen A was actually sitting on the FTP panel herself when a complaint was being investigated against her I was told she had removed herself after I had discovered this -ie not that she was obliged to resign
Gwen subsequently became a chair of ethics at coll of psychs. and author lecturer on – ethics amongst other things.
Official Complaint against Dr Linda Fleur FisherFullDocume–https://justiceforcarol.com › uploads › 2020/02
Fleur F was an ex chair of BMA ethics cttee
These just t;wo for now examples were a long time ago but the thread of underlying fear to some extent and also contempt they have for those who do speak out still runs on right through society We need only to look which groups are looked down on as dispensible – Survivors of Grenville; ‘working classes’ disabled people , mentally ill people locked up and abused et etc – you know what I mean…
“But some of us do raise our heads above the parapet – yes Annie, and we’ll continue to do so won’t we, however many times we get turned back”.
We need more prescribers to be able to raise their heads above the parapet and to be able to fulfil our professional Duty of Candour. This week, I believe I a heard brief radio reference (in ‘the wee small hours’) to what I understood to be an attempt from within The House of Lords to create a “Minister for Whistleblowers”. So very important. I don’t think I was dreaming. There are surely many prescribers who have listened to, and learned from the dreadful ADRs of their patients, but who are restrained from speaking truth to power by an awareness of the professional repercussions that must be expected to follow. There are indeed ‘Doctors of Conscience’, and I have been fortunate enough to meet such people on occasion.
I have also experienced what was perceived to be the painful rejection and disbelief that may follow attempts to discuss the devastation of misdiagnosed akathisia on my family.
Were physicians who may wish to be more vocal about what has happened to their patients as a result of serious adverse drug reactions, be afforded a safer professional environment for disclosure; then it is possible that those of us who write here may see more hope of acceptance, recognition and understanding from the doctors to whom we turn for our own health needs.
We must hope that these doctors read the brilliant and courageous publications from the inspiring Samizdat Health collection.
Tim – I would be more hopeful if the schemes were independant
A huge level of trust by those who have suffered already from whistleblowing is needed to use this scheme.This is this one run by NHS (,But also groups of doctors run closed support groups themselves )
WhistleblowingWhistleblowers’ support scheme
This scheme helps current and former NHS workers who are having difficulty finding suitable employment in the NHS as a result of raising a concern in the public interest.
The scheme is open for applications as we currently have places available. Submit your application form, equalities monitoring form, supporting evidence and documentation electronically to email@example.com.
The whistleblowers’ support scheme acts on the recommendations from the 2015 Freedom to Speak Up review and the learning from the 2017 pilot schemes. It offers tailored support to help participants develop the skills and confidence needed to remain in or get back into employment. This could include career coaching, advice, CV writing and interview skill practice and work shadowing and work placements.
We welcome applications from all NHS workers, past or current, who meet the eligibility criteria, including workers at all band levels and of all professional clinical and non-clinical backgrounds.
Is an NHS whistleblower – NHS whistleblowers may be workers or former workers (NHS employees, agency workers, bank workers, locums, trainees, students on placement) who have raised concerns about safety, risk, malpractice or wrongdoing at work in the NHS, which they thought was in the public interest.
Performance is sound prior to raising concerns — applicants need to demonstrate their performance, capability and conduct were sound prior to raising concerns. One criterion of the scheme is that there were no significant concerns in relation to your conduct and capability at work before you raised concerns.
Difficulty finding suitable employment since raising concerns in the public interest — applicants need to provide evidence they have applied for suitable employment but been unsuccessful. If you are currently employed, you will also need to provide evidence you need support finding alternative suitable employment, either inside or outside your existing organisation.
Eligible to work in the UK: The scheme is for NHS whistleblowers — it will not apply to those who aren’t eligible to work in the UK or have criminal investigations/convictions that prevent them from working.
Looking for work in England — this scheme is funded for those looking for suitable employment within the NHS or social care in England. If you are looking for work outside England please contact the NHS or social care organisations for your area.
A guide to the whistleblowers’ support scheme – Our brief guide outlines how the scheme works, who is involved and what will happen if you get a place.
How to apply
Whistleblowers’ support scheme application form
Equalities monitoring form
Please have a look at the eligibility criteria above before you complete the application form.
You will also need to provide evidence to enable us to assess whether you are eligible for the scheme.
Submit your application form, equalities monitoring form, supporting evidence and documentation electronically to firstname.lastname@example.org.
If you need the application form and criteria printed out, or cannot submit your form electronically, e-mail email@example.com.
We will accept hard copies by secure post to:
Whistleblowers’ Support Scheme, NHS England and NHS Improvement, 5th floor, Skipton House, 80 London Road, London SE1 6LH.
Once we have received your application, we will send an acknowledgement of receipt within five working days. Having checked the form is complete, and accompanied by the appropriate evidence, the scheme manager will review it. The scheme manager may contact you to discuss your application, and we may decide to approve it ourselves or refer it to a panel for a decision.
Throughout this process, your information and documentation will be treated in complete confidence.
Freedom to speak up website
Whistleblowers’ support scheme
Primary care review
Raising a concern with NHS England
Freedom to Speak Up: Guidance for NHS trust and NHS foundation trust boards
Freedom to speak up: whistleblowing policy for the NHS
Thank you for such a comprehensive and informative response Susanne. I agree that trust is a critical issue for those who have felt compelled by ethical and moral principles
to afford patient safety and duty of candour their highest priority.
Katinka Blackford Newman
I was interviewed for this podcast about antidepressants. Listen to “Episode 6 final cut” by Dr. Simon Adam https://anchor.fm/crazymaking/episodes/The-pill-that-steals-lives-e12pcdg/a-a5so6ve…
The pill that steals lives
In this episode, I speak with Katinka Blackford Newman about her experience with being on psychiatric medications, an
Prof Healy told a global health conference in Aberdeen that – in 29 paediatric clinical trials of antidepressants – every single one failed to produce an obvious benefit.
He said: “At the same time, in every single one of these trials it has produced more harms than benefits in the sense that it has made children become suicidal who wouldn’t have become suicidal if they hadn’t been put on these drugs.”
If the proof is in the pudding, why on earth do they give these drugs to people if it causes more harm than good?
Now, more than ever we need to band as brothers and do something about this.
Something does not seem right when children become suicidal ingesting these meds.
Why are children committing suicide whilst they are ingesting these meds?
We do not hear about how many adults commit suicide whilst ingesting these meds, do we? All conveniently swept under the carpet!
There is indeed, an elephant in the room.
This has been going on for way too long………………..,!
So, any updates? We’re they found guilty? Sentenced?