May Griffith innocent of misconduct, decide Montreal, Swedish Court and Ethics Board

You might recall the case of regenerative medicine researcher May Griffith, formerly at Linköping University in Sweden and now at University of Montreal in Canada. There was an Open letter by Linköping whistleblower Jaywant Phopase followed by Griffith’ retaliation campaign against him involving lawyers. In case you wondered why a Griffith paper Islam et al 2018 in a Nature-themed journal was not retracted despite findings of research misconduct: That is because the Linköping investigation results from 2015 were overruled, by the Swedish Central Ethics Review Board in March 2017 and even in a court of appeal in July 2018! Turned out, Griffith was a hapless victim of scheming Ukrainians, envious lab members in Sweden and a general confusion about the benefits of ethics dumping.

With the help of an expert from Karolinska Institutet (KI), the anaesthesiology professor Claes Frostell, Griffith was absolved of all previous misconduct findings by a CEPN verdict. Frostell educated CEPN that ethics dumping in countries with less oversight than Sweden are actually the way forward in clinical research, and CEPN agreed wholeheartedly. They even went as far as to say that some research grade “not for human use” reagent can very well be used on patients abroad when the researcher has an interesting scientific question to address. Now we know why KI had no problem with Paolo Macchiarini continuing his deadly plastic trachea experiments in Russia.

Phopase was attacked by Griffith lawyers primarily for writing to a journal regarding Griffith’ paper Jangamreddy et al Acta Biomaterialia 2018, accusing Griffith of having misappropriated his own research data to her private company Ferentis in Lituania, in a letter which has now been published on 6 June 2019. The original Jangamreddy et al 2018 article does not link anywhere to the Phopase letter, which is also behind paywall. Since Griffith provided me with a copy, I offer it in Green Open Access here, together with her email exchanges with the editors (here and here). The 2018 paper had to be corrected before because of image duplications and because of corneal performance measurements which biologically made no sense whatsoever (see criticism here).

The same Swedish lawyer Alexander Jute of MarLaw who harassed Phopase demanding that the Linköping researcher retracts his letter to editor and pays Griffith a financial compensation, has represented Griffith in the Stockholm courts, and won in full. The Swedish Research Council was ordered in the name of Swedish people to surrender all their money to Professor Griffith so she can continue experimenting on Ukrainian and Indian patients with corneal implants untested for safety and made from research-grade pig collagen. Or something like that. It is not clear if Griffith had her recovered Swedish funding money sent to Canada in a suitcase.

In the Canadian University of Montreal namely, Griffith was also reported for research misconduct by other whistleblowers than Phopase (her lawyer blamed Phopase anyway, because why not). The university acted swiftly: an internal investigation expressed in June 2017 their “full confidence in research integrity” of Griffith. They agreed with CEPN that Griffith was not responsible for her own papers and, as the letter by the University of Montreal Rector Guy Breton concluded:

“The Committee members would like you to be able to turn the page and give Quebec the benefit of your research”.

Funny that the Griffith lab in Montreal now consists of one single technician, and nobody else. The exonerated professor of regenerative ophthalmology seems to instead disperse the benefits of her research activities in India, with her old partners at LV Prasad Eye Institute in Hyderabad. Maybe Montreal did not beg Professor Griffith hard enough?

All that was possible thanks to an expert appointed by CEPN, after external experts (incidentally also from KI) found Griffith guilty of misconduct “by negligence” in Linköping. This is the report written by Frostell in January 2017, and this is how he opened it:

“As far as 1 have found, there is no patient that has been hurt by the procedure in question and no relative or patient who has expressed concern or complaint. Additionally, at least two early patients out of three operated upon had their vision at
least temporarily improved.”

No, Frostell did not meet any of these patients, nor did he see their medical files. Neither did he communicate with the doctors in Ukraine or India. Instead, he either used his KI professor superpowers to do distance diagnosis, or he uncritically followed Griffith’ own statements as the only trustworthy source.

Here is Frostell’s Summary:

“Serious charges of scientific misconduct have been brought forward against Professor May Griffith, active at the Laboratory of Regenerative Medicine (LRM) at Linköping University (LiU), by firstly an anonymous individual (-s?) in mid- 2015 and secondly by the final opinion pronounced 25 February 2016 by an external review committee (‘Granskningsgruppen’) of LiU, appointed by LiU in late May 2015 as a response to the initial allegations. The accused Professor May Griffith did finally challenge the verdict of the external review committee and LiU, and requested a second opinion from the CEPN (Stockholm). This body has in turn asked me to review the matter from the beginning; again responding to the question whether scientific miscoduct (‘vetenskaplig oredlighet’) indeed can be demonstrated in this case. 

In short, I have arrived at a divergent opinion and cannot find written evidence supporting beyond reasonable doubt neither the anonymous allegations, nor the verdict delivered by the external review committee. As detailed below, I have found signs of conflicts and divergent opinions within the research group at the laboratory of Professor May Griffith, that might explain how the matter initially was brought outside this laboratory to the attention of academic leadership at LiU. This case demonstrates a lack of good leadership of that laboratory and lack of skills in handling a difficult situation in an international network of researchers. Furthermore the case, in my opinion, throws light upon a complicated question about how to correctly interpret the legal framework governing clinical testing and development of implanted medical devices in Sweden and in situations in which Swedish-based researchers collaborate with a partner outside the European Union (EU). Some questions have been further pursued by requesting an expert opinion from the Swedish Medical Product Agency (SMPA— ‘Läkemedelsverket’-LMV).”

Frostell laments in several instances that his was not provided with the identities of the whistleblowers whom he accuses of anonymity. Obviously LiU knew their identity and chose to protect them from retaliations, but Frostell had apparently divergent views. Only fair, we know how his KI dealt with whistleblowers in case of Macchiarini, another regenerative medicine enthusiast who was also doing human experiments  outside of the EU, in Russia, with full approval of KI who banned him from continuing same in Stockholm. Incidently, soon after submitting his CEPN report, Frostell published a letter in The Lancet criticising the now retracted Macchiarini paper Jungebluth et al 2011 about the plastic trachea transplant.

Frostell lists this timeline of the events:

(a) Feb — March 2013. Visit to LiU by Dr Oleksiy Buznyk from the Filatov Institute of Eye Diseases and Tissue Therapy in Odessa (Ukraine).
(b) March 2013. Dr Buznyk returns to Odessa and brings synthetic corneas with him.
(c) Early 2013. Dr Buznyk and local colleagues secure an ethical permission and recuite [sic] 3 patients for corneal implants. These are not known facts for Professor May Griffith, until later that year (2013) when the implant surgical procedures already have been performed.
(d) 2014- Aug 2015. A paper is drafted and then published (ref 1, Buznyk et al, Clin Trans Sci 2015) on these 3 patients, with Professor May Griffith as last and corresponding author.
(e) 2015-05-08. A written anonymous allegation is sent to LiU (ref 2).

[…]

The KI expert later on accuses Buznyk of failure “to collaborate without secrets”. Actually, Buznyk was employed at LiU, in the Griffith group, even during the investigation of 2015. He was there, at LiU, he did not escape to Odessa after one month, leaving Griffith in the dark about his plans, like Frostell announced. Even now Buznyk is listed as “employee” in Linköping. Why was Frostell mistaken then? Why did nobody bother to check and correct his timeline?

This is what Frostell set off to debunk:

“The external review committee, headed by Professor Lars Terenius, concluded (both on 2015, December 11 and again on 2016, February 25) in summary that Professor May Griffith was guilty of scientific misconduct due to three actions/facts:
(1c-1) Appearing as corresponding author of the paper by Buznyk et al. (ref 1, Clin Trans Sci 2015), when she did not initiate the study in question and was unaware of the clinical implants until after the surgery had been performed;
(1c-2) Misrepresentation of conclusions issued by the company Adlego on animal work (that GLP level was achieved and confirmed), with the intent and consequence that official regulatory bodies outside Sweden were influenced to make favorable decisions on future projects involving implantations of synthetic corneas in patients;
(1c-3) Poor leadership of her laboratory at LiU to the extent that quality control of corneal implants was insufficient and that documentation of laboratory procedures deviated systematically to a degree that not even medical device legislation of 2013 was upheld to minimum (ISO) standards”.

On the issue of being corresponding author on an unethical paper, Frostell said this, and was fully supported by CEPN:

“a last author does not need to have participated in all aspects of the study but can assume a leading role in the publication of a paper and take upon himself or herself shared responsibility in all aspects of the scientific work. From this point of view,
Professor May Griffith did not transgress by accepting last authorship to the degree that scientific misconduct must be pronounced. […] However, it can be seen as “politically clumsy” on the part of Professor May Griffith to help the deviating Ukrainian partner to publish a “compassionate use” experience of three patients, when this foreign partner had rushed ahead and introduced implants designated for animal experimentation into humans.”

Basically, as long as your paper is a success, corresponding author shall take all the credit. Yet already in 2007, Griffith announced to be running clinical trials with her artificial corneas, it was always her project, not that of some Ukrainians or Indians as Frostell has uncovered. When faeces hit the ventilator, it was your foreign collaborator alone who did all behind your back and you as corresponding author who kept sending not-for-human-use reagents to Ukraine to be used in humans could of course not have known better.

On the matter that Griffith’ partners at the Swedish company Adlego fibbed everyone about animal data which did not yet exist when the clinical trials already began abroad, while being prepared in Sweden, Frostell said:

“neither the Ukraine nor the MPA of India required such data in order to approve the first non-commercial steps in the limited clinical trials planned at that point”

And anyway, Frostell somehow found out, without divulging his sources or references, that

“Animal testing of the medical device (synthetic corneas with type III collagen [RHCIII-MPC]) was conducted several years before initial human application occurred in Ukraine in 2013”.

This is exactly why the clinical trials were done in Ukraine and India, and not in Sweden or EU. Because nobody there asked for any preclinical results or proof-of-principle before experimenting on human Guinea pigs there. Exactly this is why Swedish scientists are perfectly right to go experiment on people abroad where your local ethics present a problem:

“A question was presented concerning territory: should research in Ukraine on a medical device manufactured in Sweden be viewed legally as partly performed in Sweden and, consequently, fall under a Swedish regulatory framework? The answer was “no.” I maintain that herein (6e-3 and 6e-4) lies the heart of this case.”

That Griffith was accused to have destroyed documentation, forged collagen purity analysis and had her electrical engineer husband issue clinical safety certificates for the corneal implants (read here)? Frostell asks to put in into perspective, vis-a-vis Macchiarini scandal:

“It is possible that a more thorough and uncompromising preclinical toxicity program would have to be carried further, and that process may uncover a lack of safety in the work described and examined. Unfortunately, we have recently experienced other examples in Sweden (e.g. the “Macchiarini scandal” at Karolinska Institutet and University Hospital), where systematic misrepresentation could be demonstrated as evidence of scientific misconduct. I consider it important to maintain the intent and
general understanding of this terminology and not allow for a broader application in a case such as this at LiU, in which staff conflicts combined with insufficient academic leadership at various levels and a lack of political skill are predominant.”

Frostell even goes so far as to declare that if LiU failed to provide proper facilities to Griffith as promised, she is perfectly in her right to manufacture corneal implants for human experiments from any material and in any conditions she chooses fit:

“When Professor May Griffith was employed in 2008 by LiU in collaboration with the County Council of Östergötland as a full Professor, it was written into the agreement that “in connection with tissue engineering, we will also secure laboratory facilities according to [principles] of Good Manufacturing (GMP).” Thus, a GMP-level laboratory was to be supported by the academic leadership of LiU. From my understanding, the failure to accomplish this appears due to some insufficiency within the leadership of LiU and lies outside the control of Professor May Griffith”.

In other words, Frostell commends Griffith for not having fabricated corneal implants in the mensa kitchen or a lavatory, but at least in some kind of a lab. Frostell concludes without prejudice:

“the academic leadership at LiU should take this legal process as a warning signal that deficiencies in the academic culture will continue to carry a high price. In this case, a wrong final decision on the question of scientific misconduct could delay a promising treatment for patients and may unnecessarily destroy the career of an established researcher in need of a supportive university”. 

CEPN did exactly as Frostell asked them to, this is their final report from March 2017, in Swedish and an English translation. On ethics dumping, CEPN had this view:

“the conclusion is drawn that the patients gave their informed consent to the surgical procedures. Now, whether the forms of information and consent have fully lived up to the declaration of Helsingki and the Swedish rules and regulations (e.g., regarding information about possible risks with the treatment), the Expert Group has not been able to determine. The Expert Group does, however, consider it proved that May Griffith followed national laws and regulations in Ukraine. The final conclusion of the Expert Group is that she is not guilty of research misconduct in this aspect.”

Many countries have no concept of inform consent, and in this case blind patients were recruited who were unlikely to profit from the corneal transplants even if those worked as the shaky data in Griffith papers claimed they did. Recruited on “compassionate use” grounds mind you, meaning the patients were promised a (very unlikely) cure to their type of blindness. This turns the concept of “compassionate use” on its head, but this is how clinical research sometimes happens even in Germany. And since CEPN is at it, in China it is legal to harvest organs from executed political prisoners. Maybe Swedish scientists would like to collaborate there? It gets better with CEPN decision:

“It is unquestioned in this case that the manufacturer of certain chemical raw material to the artificial corneas has stated that these cannot be used on humans and that they have been marked “Not for human use.” During certain circumstances it is, however, possible to use such products on humans; that is, when a well-described procedure exists, the laboratory lives up to certain quality demands, and the necessary documentation is provided.”

You read it right. The “certain circumstances” happen when a Swedish professor has a novel untested product to market and needs human guinea pigs in some poorer countries where ethics can be bought. And this was the conclusion:

“As a conclusion, the Expert Group does not consider that May Griffith acted wrongfully when she vested the role as corresponding author of the article in question, nor that she erred regarding the report from Adlego AB, or that satisfactory documentation regarding the studies in India or Ukraine has been missing. The decision of the Expert Group is thus that May Griffith is not guilty of research misconduct.”

With such a complete and utter exoneration from CEPN, Griffith asked her lawyer Alexander Jute of MarLaw to sue the Swedish Research Council (VR) for revoking her grant. The Appeal Court decided that VR is not qualified to analyse research misconduct reports or even to decide which scientist deserves public money and on which merit, and that such matters must be settled in court of law. The jurists, who are obviously the best experts for such things, decided that VR must give Griffith all the research funds she wants to have, and here is the court verdict, Swedish originals here and here, as well as translated English version.

If only judges were so powerful as to make abused patients being cured, by a court verdict. Oh wait, they did just that, when I was sentenced in Walles and in Macchiarini case.

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Update 10.03.2020

After some consideration, I decided to share following information. In July 2019, someone named “lila reid” tried to bribe me with €400 to remove some unspecified articles. Turned out that was initiated by May Griffith, as her lawyer confirmed. The lawyer in fact was tasked just weeks later to negotiate with me the removal of two articles about his client. I refused, obviously.

It does not speak of Professor Griffith’ intelligence, academic or otherwise, to have spent much more money on some lawyer’s letter than she was prepared to bribe me with. €200 per article???

In November 2019, the University of Montreal rejected all evidence and refused to investigate. In his letter to me, Rector Guy Breton insinuated that the intellectual property patented by Jaywant Phopase (here and here) legally belongs to University of Montreal and May Griffith, while warning me not to criticise his university, or else.

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