Another legal loss for Moderna

forced to release trial protocol

Guest post from Dr Alan Black, retired pharmaceutical physician

GOOD NEWS: the important recent decision, by the First Tier Tribunal on information rights, overturns the decision by the NHS’s Heath Research Authority (HRA) [and supported by the Information Commissioner’s Office (ICO)] to deny public access to the study protocol and Investigators’ Brochure for Moderna’s NextCOVE covid vaccine study. Many congratulations and thanks must go to Dr Peter Selley whose admirable determination and perseverance are entirely responsible for this success. Whilst Dr Selley’s principal motivation for pursuing this case was more concerned with the balance of public versus commercial interests than the rights and wrongs of NextCOVE, his success will help to shine a light on the absence of ethical justification for this study. Read the full judgement here.

NextCOVE is the clinical trial which many of us believe was unethically recruiting healthy children in contravention of their rights as vulnerable non-consenting participants, as set out in various conventions and regulations such as the Declaration of Helsinki. The protocol and Investigators’ brochure should be made public so that there can be public scrutiny to see what possible ethical justification could have been provided by Moderna for testing this new mRNA booster vaccine in healthy children. These are children who are at a vanishingly small risk of suffering any serious consequences from covid. Their participation therefore exposed them to risk for no reasonable expectation of benefit. The release of these documents will allow the UK public to decide once and for all whether any ethical justification was actually provided by Moderna for the participation of healthy children. They can then judge whether the Research Ethics Committee properly discharged their statutory duty to fully consider the appropriate requirements of the Declaration of Helsinki, specifically those dealing with trial participants unable to give informed consent.

The reasons given by the HRA (and supported by the ICO) for non-disclosure were that the documents contained commercially sensitive information and that Moderna’s commercial interests supersede those of any public interest. These reasons are scathingly shredded here by Judge Watkin and colleagues:

“As the Tribunal has concluded that it is not satisfied that the commercial interests of Moderna would be prejudiced if the requested information was disclosed, the Tribunal is not required to consider the public interest test. However, it is worth noting that the Appellant contends that if Moderna succeeds in avoiding disclosure as a result of having included commercial information with the Trial Protocol (where it was not necessary for it to do so) and the Investigator's Brochure , this potentially creates a situation where any pharmaceutical company can avoid having to disclose otherwise disclosable documents simply by including unnecessary commercial information. It would not be in the public interest to allow such an approach to succeed and, if the Tribunal were to consider the public interest test, it would have regard to this potential outcome.”

The NHS’s HRA now has to make the protocol and Investigators’ Brochure available by 10^th July. The decision can be appealed so it’s not fully done and dusted yet unfortunately. However, in this Tribunal we appear to have found advocates for the important principle that the commercial interests of pharmaceutical companies do not automatically trump the public interest and the public’s “right to know”. Furthermore, the Tribunal makes it clear that if a company wishes to assert its rights to commercial confidentiality in the public sphere then they will need to provide a robust justification for doing so. The ICO and the HRA were clearly wrong to take such assertions by Moderna at face value.

“Whilst the Tribunal has been provided with an extensive closed bundle containing the withheld material which may contain commercial information relating to Moderna, it has not been directed to any part of the information that might cause prejudice if disclosed. Neither has any explanation been provided to set out how the commercial interests of Moderna would be damaged.”

Remember, NextCOVE is the study for which Moderna have already been found guilty by their industry’s self-regulatory body, the Prescription Medicines Code of Practice Authority (PMCPA) of:

• allowing children to be offered illegal financial inducements to participate and then misleading the PMCPA as to when they first knew about this illegal offer, and…

• allowing the use of inappropriate and unapproved advertisements, targeted at children and offering rewards such as teddy bears, to encourage participation.

These findings, and others, against Moderna have resulted in them being judged to have brought discredit on their industry. They have also resulted in the imposition of an audit of their compliance systems and have received some scathing press coverage.

As doubt has already been thrown on the ethical conduct of this study, it is even more important that questions relating to whether or not it should have been approved in the first place are answered as soon as possible. This is essential as lessons may need to be learned regarding the future ethical review of similar studies involving vulnerable participants unable to give informed consent. This judgement is therefore a very welcome contribution to enhanced transparency and accountability in clinical research.

HART Editor: HART has covered this topic for almost two years, starting with a letter to all participating centres here, with follow-up articles here, here and here. We are delighted to see our efforts and those of the UsForThem team now added to by this latest case brought by Dr Peter Selley.