Industry Medicine Research integrity

Brexiting out of EU research and patient rights

Britain voted itself out of the European Union, and with this act UK research will soon be also out of EU funding and EU scientists (or any foreign scientists for that matter, given that the central point of the Brexit vote was immigration). Without freedom of movement, there cannot be any access to EU research funding, as Switzerland had to learn after their citizens also bravely voted in their own referendum against immigration in 2014. Thus, with the genie of racism and xenophobia out of the bottle in UK now, it is highly unlikely that the next Tory government will agree to allow foreign work-seekers onto their precious island. This Brexit out of Horizon 2020, ERC and other European research programmes will hurt, because, as the UK scientist and open science activist Stephen Curry mentioned in an interview: “The UK is a net contributor to the EU overall but ‘wins’ in terms of research funding”. While Scotland might find a way out through another vote on independence, England will be stuck where it is.

Maybe this is actually not that bad, given the interesting attitude British authorities and bureaucracy have to clinical research. Their prime concern goes out not towards the public interest or the patients’ wellbeing, but to the financial profits of biotech and pharma industry. All my inquiries about the most basic documentation or permits granted to the INSPIRE clinical trial on trachea-replacement were ignored or outright rejected, with the simple argument that sharing information with me would hurt the business interests of the commercial participants involved. The INSPIRE trial is about transplanting four patients with donor tracheas, which are prior to this to be decellurised and “regenerated” using a “stem cell” approach developed by Paolo Macchiarini (now accused of involuntary manslaughter for his trachea transplant experiments). Macchiarini’s former partner Martin Birchall, laryngology surgeon at the UCL and UCLH in London, is leading this trial (see my detailed analysis here and here), and the company whose interests need the most careful protection by British authorities is Videregen, which seems to imagine the trachea replacement in humans as similar to that of exchanging a car part. Only much more lucrative of course, Birchall himself put the revenue at up to the mouth-watering $740,000 per patient (Culme-Seymour et al, 2016).

With so much money at stake, British authorities felt compelled to protect Videregen’s investment from prying eyes, even if it means robbing potential patients of their right to informed concern and possibly even of their lives. This is apparently what Thatcherism did to that country, and without EU, the healthcare is bound to get worse and for-profit patient abuse and manslaughter may become tolerated as business collateral.

In this regard, one should really value the attitude of European states like Sweden and Germany where I was readily given information about clinical permits granted (or in fact, not granted) to doctors like Olausson and Sumitran-Holgersson in Gothenburg and the Heidelberg “stem cell” company TICEBA, respectively.

My original intent was to obtain the empty patient consent forms and information brochures for the INSPIRE trial, these documents contain no personal or proprietary information and must be released upon request. They are necessary by law to allow patients and their families to precisely understand what exactly the doctors propose to do to them, and how and why. A proper informal consent can only work under such conditions; otherwise dishonest doctors could trick patients into signing away to be sacrificed as human Guinea pigs for unscientific experiments.

Good morning!

The public university hospital UCLH ignored my freedom of information act (FOIA) inquiry, by treating me as a demented amnesiac. They simply pretended to have never received my FOIA inquiry in the first place, and left it there (details see here).

Meanwhile I found out that the INSPIRE trial is not even registered, the patient consent forms do not exist. At the same time, the EU continues forking out cash for the preparations of the follow-up clinical phase 2 trial “TETRA”, which was supposed to start recruiting and operating patients in UK, Austria, Italy and Poland from 2017 on, as Videregen announced. All this based on the imagined clinical outcomes of INSPIRE, which obviously do not exist even now and might never do. If this sounds schizophrenic to you, it certainly does not do so to British bureaucrats.

Innovate UK, the public funder which gave almost GBP 2 Million to Birchall and Videregen, rejected my FOIA for the INSPIRE documentation for commercial reasons (full document here, highlights mine):

Information on the INSPIRE project is available through our transparency data on the GOV site, found HERE.

Videregen Ltd, through a competitive process was successful in our 2013 “Supporting Regenerative Medicines and Cell Therapies“ competition. The organisation went through our competitions process in which experts assess the applications put forward and only those with the highest scores, past our quality threshold, are funded. A copy of the competition brief is attached. However, under Section 41 (Information provided in confidence) of the FOIA, we are exempting the release of the application form, performance reports and the grant offer letter. Applicants submit their grant proposal in confidence as it contains details which are commercially sensitive; if released we believe it would result in an actionable breach of confidence. As this exemption is absolute there is no requirement to conduct a public interest test. Further, we also hold the view that the project proposal, performance reports and grant award contains information which falls within the scope of the exemption of Section 43 of the FOIA, which relates to information considered to be “commercial in confidence”. To explain further, this is a qualified exemption, meaning that we have carried out a test to determine whether the public interest outweighs the requirement for commercial confidentiality. […]

We also considered the impact on Innovate UK if commercially sensitive information of companies we work and engage with were disclosed. We believe it would damage the trust in Innovate UK and likely to impact our ability to carry out our role and manage our current and future investments. […]”.

Just as UCLH, Innovate UK carefully overlooked that I also asked for the empty patient consent forms, as well as “information on how many patient have been treated already”. They simply ignored these FOIA inquiries of mine, to protect commercial interests of the businesses they invest public money into. Or maybe, deranged as I am, I only imagined asking for these, just as UCLH also diagnosed?

Never mind, next FOIA denial, this one by the NHS Blood and Transplant (NHSBT), “a Special Health Authority, dedicated to saving and improving lives through the wide range of services we provide to the NHS” (full document here):

The NHSBT’s Tissue and Eye Services gather consent, retrieve and prepare tissue for transplant. We provide the tissue, under our HTA licence, to UCL and Videregen. However NHS Blood and Transplant is not a partner in the Videregen and INSPIRE Consortium trial. Therefore we are unable to assist with your request as we do not hold the documents you require.

I pointed out to NHSBT that they are very much partner of the INSPIRE consortium, as listed elsewhere. They are also partner in EU’s TETRA Consortium, which is supposed to pay out to NHSBT over half a million Euro.  To this, the agency did not reply, but declared that they “do not hold” any “patient consent forms specifically relating to the Videregen and INSPIRE Consortium trial”.

The British Medicines and Healthcare products Regulatory Agency (MHRA), which task is to regulate “medicines, medical devices and blood components for transfusion in the UK”, wrote to me initially this, when asked for INSPIRE documentation (highlights again mine):

This information is exempted under Section 41 (Information provided in confidence), Section 43 (Commercial interests) and Section 22 (Information intended for future publication) of the Freedom of Information Act 2000 (FOIA). Section 41 is an absolute exemption and no consideration of the balance of public interest is required. Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any overriding argument for releasing the information that outweighs the commercial harm by providing potential competitors with an insight into the product development and design of this study. Section 22 is engaged, as the MHRA has been informed by the study sponsor that it intends to publish information on this study in the future”.

This is lack of concern for patients’ right of information is puzzling, given that MHRA declares that it “plays a leading role in protecting and improving public health and supports innovation through scientific research and development”. After some more emails exchanged, where I was told that MHRA keeps all information about their granting or non-granting of approvals secret, I asked them how they intent to “prevent any mad quack lobotomising people in his shed by writing “Got MHRA Approval” in big letters on the door”.  I also asked them to take “the patients’ side here for a change”. Afterwards, MHRA replied:

We have contacted the company concerned with this clinical trial [Videregen, obviously, -LS] and they have stated that they are happy for us to divulge the existence of the Clinical Trial Authorisation (CTA) and ethics opinion. The trial was authorised by the MHRA on 2nd October 2015. A positive ethics opinion was received on 7th  January 2016. The company have also confirmed that they will be registering the study on a public database before the study starts, in accordance with their standard operating procedures”.

Good that Videregen was so generous. Yet, if my hypothetical lobotomy quack should forbid MHRA to divulge the true status of his approval, his “patients” will never learn of its non-existence, happily on their way to his hypothetical lobotomy shed somewhere in the business-protective England.

Also the claim that INSPIRE really received an ethics approval following their MHRA licence is to be taken on blind trust alone. The British public agency which is said to have issued it, the South Central – Oxford A Research Ethics Committee, did not reply to my email asking for confirmation. And why should they? It could be bad for business.

So, let us sum up what I learned. The patient consent forms for INSPIRE apparently do not exist, the trial is not registered, no patients are being recruited, while meanwhile the follow-up phase 2 trial TETRA  on dozens or hundreds of patients is being eagerly prepared. This is what UCL and UCLH wanted so desperately to keep secret: that their INSPIRE trial has not moved anywhere for years now, its only progress was the award of €7 Million from the EU for the TETRA large-scale trial, which is likely not to go anywhere either, or even be terminated, as EU already announced to me. The bulk of the public money invested in INSPIRE and TETRA will certainly go somewhere, namely down the proverbial drain, unless the EU does not make up on their threat and stops TETRA.  But even then, will the patients will be safe from more Macchiarini-Birchall experimenting? Not sure.

Birchall’s other trial RegenVox is recruiting patients to have their voiceboxes replaced by “regenerated” ones, again with magic of bone marrow “stem” cells seeded on decellurised dead tissue. This trial Birchall designed originally together with Macchiarini, the latter “pathological liar” even claimed to be an active RegenVox participant in his not always entirely honest CV. The British public funder Medical Research Council (MRC) was more forthcoming in sharing information, probably to quell any unwelcome Macchiarini-association. The MRC Senior Information Officer, Anabel Raszpla, wrote to me:

I can confirm that Paulo Macchiarini was not involved in any way in the award (RegenVOX: phase I/II clinical trial of stem cell based tissue engineered laryngeal implants) that you point to in our strategic plan. This was awarded in 2013 through the Biomedical Catalyst, full details are available here.

The work highlighted in the case study built on an earlier award to Professor Martin Birchall (RegenVOX. Stem-cell based, tissue engineered laryngeal replacement) which was a preclinical research grant to evaluate different approaches to replacing the larynx carried out between 2011 and 2013. Paulo Macchiarini was listed as a co-investigator on the research grant application submitted in 2010, details available here. I can confirm that Paulo Macchiarini contributed to the design of animal studies for this earlier study but he did not participate in any experimental work that was funded by the MRC”.

So, while the concepts and design were devised by Macchiarini, the fact that he will not be operating himself, makes his “regenerative medicine” methodology utterly safe, both for larynxes and tracheas. Guess someone still did not get that the bad basic science and the bad clinical design were exactly the problem with his and Birchall’s human experimenting. Not just the hands of the surgeons.

Update 01.07.2016. An EU Spokesperson explained to me the general situation regarding Brexit and EU research funding in UK. My understanding is: the continued funding for phase 2 clinical trial TETRA is ensured by currently valid EU agreements with UK and can only be re-evaluated based on the objective performance (or, in fact, non-performance) of the phase 1 trial INSPIRE.

On the implications of the UK referendum:

EU law continues to apply to the full to the UK and in the UK until it is no longer a member. Until then, the UK remains a member of the EU with all rights and obligations of a Member State.

Article 50 of the Treaty is the only basis for the withdrawal of a Member State from the EU. It is for the UK to notify the European Council that it is triggering the Article 50 process.

Once the Article 50 process is set in motion, the two year deadline for concluding an agreement will become effective. If no agreement is in place by this date, and unless the deadline is extended by the European Council acting unanimously in agreement with the UK, the UK will cease automatically to be a member of the European Union.

The Commission will not engage in preparatory discussions with the UK authorities before such a notification is made to the European Council. There can be no negotiation without notification.

On the future impact on research funding:

It is far too early to speculate on this question. That will be addressed in due course, once negotiations with the UK begin on its withdrawal agreement as well as on the agreement concerning its future relationship with the EU. For the time being, nothing changes. EU law continues to apply to the full to the UK and in the UK until it is no longer a member“.

Update 2.06.2017. Looks like regenerative medicine is to be the future industry in the Brexited UK. This is what the Fifteenth Report of Session 2016–17 by the House of Commons Science and Technology Committee Regenerative medicine, published April 30th 2017, announces:

“It is important that the regulatory environment for regenerative medicine remains flexible to accommodate new and diverse approaches while also maintaining robust review processes to ensure that the most promising therapies are made available to patients. The next Government should review how regulatory ‘hospital exemptions’ are used for Advanced Therapy Medicinal Products (ATMPs) and how EU ATMP regulations might be adapted for the UK post-Brexit to reflect our own perspectives on the optimal balance between safety and accelerated access to cutting-edge technologies.

Having a universal NHS provides a receptive environment for the development and adoption of innovative and scientific advances in regenerative medicine, but the next Government should work with the NHS to: create the appropriate financial incentives to further stimulate regenerative medicine research and innovation; deliver a ‘fast track’ appraisal system for emerging therapies; and agree new reimbursement payment models which take greater account of the value of regenerative medicine therapies. The next Government should work with UK Research & Innovation (UKRI), industry and researchers to develop a strategy for advanced therapies that covers the entire regenerative medicine value-chain specifically—from academic research, to commercial development and clinical application—and the NHS’s Personalised Medicine strategy should explicitly include regenerative medicine and cell therapies. These strategies should be aligned to the Government’s response to the Accelerated Access Review and the strategic objectives outlined in the Government’s Industrial Strategy Green Paper”.

To me it reads that British patients are to be offered for medical experiments on the base of hospital exemptions (which do not require much on approval), paid by the tax-funded NHS, with the hope that it can turn into a profitable industry.

7 comments on “Brexiting out of EU research and patient rights

  1. I was worried that I exaggerated the British disregard for patients’ rights for the benefit of businesses, and probably some of my readers felt the same. Well, it proved worse than I thought. This from recent article in Science Insider, quoting UK Minister for Life Sciences (yes, they have such a governmental position in UK!):

    “But leaving the European Union could also offer some opportunities, for instance in regenerative medicine, Freeman said, where regulatory barriers have been growing in Europe and the United States. “Clearly there is an opportunity here for the U.K. to be a world leader,” he said”.

    So, in my view now it’s time to start really worrying about British patients.


    • Ana Pedro

      Unfortunately, often patients’ rights have been put in question for the benefit of business in many countries and in many circumstances, specially in those countries with a more developed pharmaceutical industry….it would be interesting to gather published data about this….it would be interesting a discussion about this in the context of EU/ Brexit… is a very up to date subject, very interesting and extremely important subject.


  2. Pingback: Paper Club week of July 29, 2016 – NEUROIMMUNOLOGY

  3. Pingback: How UCL throat surgeon Martin Birchall misleads patients and tricks public funders – For Better Science

  4. Pingback: Business interests trump patient safety in EU-funded trachea transplant trial – For Better Science

  5. Pingback: EU commemorates dead patients of Macchiarini & Birchall with a phase 2 trachea transplant trial TETRA – For Better Science

  6. Pingback: Murray vs Celixir: MHRA to sell British public for medical experiments? – For Better Science

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