GUEST BLOG: Ian Powell – Integrity and vaccine production: lessons for New Zealand

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Reputable medical journals such as the British Medical Journal (BMJ) are invaluable not just for doctors but for those that observe health systems and policies, both of which are intertwined with the practice of medicine and science.

Nowhere are these journals more important that in the understanding and experience of the production of antiviral drugs (medication used for treating viral infections by inhibit their development) and vaccines. This is more so because production is overwhelmingly dominated by large pharmaceutical companies (often referred to as ‘Big Pharma’).

These companies driven by profit-maximisation. not just profitability, are a risky fit for the provision of a public good such as vaccines. Until the current coronavirus pandemic this meant that their vaccine research and development was a lower priority. However, the pandemic generated a new lucrative market opportunity.

‘Big Pharma’ does not intentionally produce ineffective or dangerous vaccines. At the very least the reputational damage would be bad for business. Similarly, it is counter-intuitive for ‘Big Pharma’ to employ second-rate scientists.

But profit-maximisation creates opportunities for standards and carefulness to slide. On 2 November the BMJ (2021;375:n2635) published a timely reminder of this with lessons for New Zealand:

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Blowing the whistle on Pfizer in Texas

The article written by Paul Thacker is headed ‘Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial’. Thacker is an American journalist specialising in science, medicine, and environmental reporting. He is well published including with Science and the Journal of the American Medical Association.

Thacker reveals poor practices at Ventavia, a research company contracted to help to carry out Pfizer’s pivotal Covid-19 vaccine trial in Texas. Speed appears to have come at the cost of data integrity and patient safety.

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Brook Jackson, a regional director employed by Ventavia believed it had “…falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff conducting quality control checks were overwhelmed by the volume of problems they were finding.”

Former Ventavia employees have endorsed Jackson’s concerns. One described the work environment as “helter skelter”.

Jackson is a trained and experienced clinical trial auditor. During her short period of employment with Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Exasperated by non-responsiveness she documented several matters including taking photos.

After repeatedly notifying the company of these problems, Jackson emailed a complaint to the United States’ regulatory authority, the Food and Drug Administration (FDA). That same day she was dismissed by Ventavia.

Regulatory oversight failure

Especially in the context of ‘Big Pharma’ driven by profit-maximisation, independent regulatory oversight is critical. Unfortunately the FDA’s oversight capacity is severely under-resourced. When the FDA receives a complaint about a clinical trial, it “…rarely has the staff available to show up and inspect.” Oversight can and does occur too late.

The article records Dr Jill Fisher, a professor of social medicine in North Carolina, as advising that “There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities.”

Thacker notes that in 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.

Since then it has not got better. Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in 2020.

The complaint

Jackson was very specific in In her formal complaint to the FDA. She identified several serious concerns including:

  • participants placed in a hallway after injection and not being monitored by clinical staff;
  • lack of timely follow-up of patients who experienced adverse events;
  • protocol deviations not being reported;
  • vaccines not being stored at proper temperatures;
  • mislabelled laboratory specimens; and
  • targeting of Ventavia staff for reporting these types of problems.

Jackson’s complaint was emailed on 25 September. FDA acknowledged receipt within hours. A few days later she received a call from an FDA inspector to discuss her report but was told that no further information could be provided on what would happen next. She heard nothing further from FDA.

On 10 December Pfizer submitted a briefing document to an FDA advisory committee meeting to discuss its application for emergency use authorisation of its Covid-19 vaccine. No mention was made of problems at the Ventavia site. The next day FDA issued the authorisation of the vaccine.

In total Pfizer held clinical trials in 153 sites, three of which were run by Ventavia in Texas. In August 2021 the FDA published a summary of its inspections of the trials. Only nine of the 153 sites were inspected. Ventavia’s were not listed among them.

FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Lessons for New Zealand

Despite Pfizer proving to date to be a successful vaccine against Covid-19, the Texas experience is very concerning and offers New Zealand important lessons. One is that we can’t assume that ‘Big Pharma’ will provide the thorough, methodical and transparent rigour necessary to ensure the safety and integrity of vaccines.

Another lesson is the importance of well-resourced and vigilant independent regulatory authorities. This is particularly the case in countries like the United States where these authorities have to cope with a high level of corruption.

On 29 November Stuff published a scary article by Eric Crampton from the New Zealand Initiative: He argued that the pharmaceutical companies had sufficient motivation to give confidence over safety and that New Zealand’s regulatory authority MedSafe was unnecessary because we could leave it to similar authorities in other countries such as the United States.

Crampton could not be more wrong. MedSafe should take as long as is needed before approving a vaccine application. Relying on what the results of clinical trials reveal or what other regulatory authorities in a small number of ‘approved’ countries decide is insufficient.

MedSafe should also assess the performance of vaccines in those countries where they have been approved and rolled out, particularly those with big populations. This includes the extension of Pfizer to children between 5 and 12 Years.

A further lesson is that New Zealand should start planning to produce its own vaccines through a new ‘not-for-profit’ statutory entity. We already produce some animal vaccines. Why not extend the species scope? If a small country facing over 60 years of economic warfare like Cuba can do it, why not Aotearoa in a much more peaceful environment?

Ian Powell was Executive Director of the Association of Salaried Medical Specialists, the professional union representing senior doctors and dentists in New Zealand, for over 30 years, until December 2019. He is now a health systems, labour market, and political commentator living in the small river estuary community of Otaihanga (the place by the tide). First published at Otaihanga Second Opinion

10 COMMENTS

  1. I would recommend to read Rebecca Weisser’s article Are the kids OK in Australian Spectator as well as her article about prof. Nikolay Petrovsky and his vaccine. Dr. John Campbell, dr. Mobeen Syed talked about the above mentioned case immediately after it was first published.

  2. It was well docuented in the 1970’s that you can NOT trust Big Pharma to run it’s own trials and report it’s own data, but it was allowed to continue. Back then it was a ‘conspiracy theory’ to think badly of them, but since then BigPharma has been caught out so often, e.g. Thalidomide.
    Pfizer has just been caught doing so many things wrong that you basically just need to assume they’re lying until they can catagorically prove they are not.
    The latest 9of a BIG list of faults) they didn’t call people (who they have to legally) to double check how they feel after/during the trial.
    They then publish data that looks ‘good’, only 1,200 deaths in the first three months. BUT as they did NOT call people, these figures are RELIABLY about 100’s under reported. A WELL DOCUMENTED FACT, hence the legal need to actively call people.
    So what else are they lying about, or cheating?
    The truth will come out. It will be somewhere between the jabbed and unjabbed view point. So a mandate is immoral and I’d say illegal, as they realistically KNOW Pfizer (et al) are most probably lying, purposely or otherwise.

  3. Great article, thanks
    I would also suggest that we take seriously some of the more holistic medical practices. We need to focus on health from a wellness perspective, which includes diet, exercise, and mental and spiritual health.

    Not all medical solutions come in a pill or injectable form (though I don’t discount them)

  4. Big Pharma cannot be trusted, they are total rogues one and all. False claims about their products, insufficient and inadequate trials, false reporting, denying side affects, insisting on inaccountability , price rorting … the list goes on. Why we have any faith in any of them is crazy.

  5. Not to mention but will of course, Pfizer took 108 days to evaluate the safety of it’s vaccine but now says it will take the equivalent of 75 years to advise what data they have and what is in the vaccine. They need this time to read, manipulate and redact documents that took 108 days to collate.
    We live in crazy times but most people don’t know it (yet).
    Articles like this help people like me keep a modicum of sanity so thanks heaps!

    • I believe they’ve been DENIED the 75 years secrecy they sort. The fact they sort that is daming evidence enough on its own, in a SANE world.

  6. yup big pharma can’t be trusted, but that doesn’t mean the vaccines are neccesarly dangerous
    ….it’s an old canard but…correlation is not causation

    my aunty wore a blue hat and she got run over, let’s all stop wearing blue hats…isn’t gonna fly, is it?

    more dangerous is the US evangelican weight loss doctor flogging forged vaccine certificates.
    ..now that WILL actually kill people

  7. Well explained Ian. With many examples of ‘profit driven’ deceit and damage why do we continue to allow this modus operandi to continue?
    Totally agree on need for home grown development and production of vaccines.

  8. So what sounds like an independent (of Pfizer) third party clinical research organisation monitoring 3 out of 153 sites has cut corners, for reasons that may well be profit driven, and every single “big” pharma company” is culpable under the umbrella of Big Pharma. I guess we need to be clear on what we mean by Big Pharma

    While it’s not explicit this story implies the clinical sites themselves may be independent of the clinical research org (CRO). I would bet there will be contracts in place stipulating standards and responsibilities and Pfizer would have been paying both the CRO and the sites for their service. If those service providers have not delivered Pfizer should go after them.

    I don’t think you could name an industry, or faith-based institution where you could not find historical or present-day examples of bad or even shocking things happening. Somehow when it comes to pharmaceutical companies operating in the healthcare sector it is only the (big) pharma company that has profit motives. Its never the plethora of other companies, institutions and healthcare professionals operating in that sector.

    Unfortunately, money is a motivator for large amounts of the earth’s population but let’s pretend it’s only big bad pharma. That’s far less complicated.

    As for the role of Medsafe, they should absolutely undertake rigorous assessments. They charge NZ 100k (GST incl) for registering a new molecular entity so you would hope that pays for something! In terms of not relying on overseas assessments I think, Ian, you would be aware that companies can also provide abbreviated submissions. That’s half the fee (50K) and does rely on approvals in certain references countries (US being one), so it’s not like that does not happen already.

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