The Lights all went out in Massachusetts

The Pied Piper © Nina Otulakowski March 2022

Four weeks before Eric Rubin Boston Strangler and Fishy Business in the Rio de la Plata were posted, I wrote to Dr Carole Allen, the President of the Massachusetts Medical Society, who are notionally responsible for the New England Journal of Misinformation. My hope was to put her on notice that the journal was coming close to being party to a fraud on the court.

Open Letter

Dear Dr Allen

I was a participant at a November 2^nd Washington D.C. conference organized by a colleague, Dr Peter Doshi, a senior editor for BMJ, Professor Linda Wastila from the Dept of Pharmacy in the University of Maryland, Kim Witczak an FDA patient advocate, and Brianne Dressen – the founder of react19.org.  About Kim and Brianne, it could be said, “they practice and teach advocacy as a means to accomplish positive change”.

You are unlikely to have been able to become aware of this meeting, as it was focused on the harms suffered by some of those who have been vaccinated – all clearly pro-vaccine.  Any mention of harms now, however, is written off as misinformation. Besides things forced on them by doctors and patients (not regulators or journals) neither mainstream nor social media are willing to entertain the idea there might be any vaccine related harms and both went out of their way to make this meeting disappear.

On the day, without specifically mentioning NEJM, I argued that the effect of a lack of access to trial data and the ghostwriting of academic articles leads both Facebook and the New York Times to characterize any talk of harms as misinformation. Many clinicians blame these media for this problem, when, in the case of vaccines, we should be blaming the NEJM.

Imagine if, several decades ago, the tobacco companies had been able to ensure that any linkage of lung cancer or heart attacks to their products was deemed misinformation.

Three concerns have driven me to write this letter to you.

1. My research centers on the harms our treatments can cause. This should be, but is not, a thriving area of research given that to bring good out the use of agents the law regards as irremediably hazardous, both we and our patients need to know we are dealing with potential ‘poisons’, and harms might be a consequence of their use.

Linked to the November meeting, I set up a Cause-and-Effect Forum. This has begun laying out some cases, and I invite you, and anyone else who may be interested, to review these to see whether you can see a way to explain what has happened that, on a balance of probabilities, is as plausible as accepting the harm is likely to have been caused by a vaccine.

Brianne Dressen’s case was posted on this Forum on Tuesday and a colleague reviewing it and a prior post detailing her interaction with the New England Journal of Medicine suggested writing to you.

2. My interest in harms is not just a matter of recognizing when a patient has been harmed but also in exploring how we go about establishing harms.

There is a subtext to this. If doctors can no longer assess harms, which I believe they are losing the ability to do, treatments end up being viewed as sacraments – agents that can only do good – rather than potentially harmful. If this happens, those who manage health services are likely to think doctors are an expensive way to do a job that could be done by nurses and pharmacists. This is already happening. All things being equal, I’d prefer if we managed to hold on to a medical profession, rather than have doctors migrate into management.

3. One reason doctors are failing when it comes to harms is that the medical literature reporting clinical trials of drugs and vaccines is ghostwritten, with the harms eliminated. Against a background of lack of access to clinical trial data, with neither the ghostwriters, nor the apparent authors of NEJM articles, nor the journal or its reviewers, nor even FDA, able to access the clinical trial data, what NEJM publishes is not science.

Brianne Dressen was injured in the Astra-Zeneca vaccine trial. She was surprised to see the Falsey et al NEJM publication of this trial write her out of existence. She addressed Dr Rubin about her disappearance. You can read the correspondence here – New England Journal of Misinformation. How many people, or doctors, are likely to endorse NEJM’s position?

Peter Doshi has made public further correspondence with senior NEJM editors about access to the data for the Baden et al Moderna Trial published in the NEJM. Again, NEJM seems to concede it is publishing adverts rather than science. If there is no access to the data for an NEJM publication, it should not be called science.  It probably should not even be called decent media: the New York Times shows more concern for the integrity of its sources than NEJM.

I have two more cases involving Pfizer vaccine trials and NEJM in which harms have disappeared. These will feature in future posts.

My concern is to alert you to the risk that NEJM is or will be party to a perpetration of fraud on courts, on the media and on the wider public.

Several decades ago, the US Supreme Court took a view on a Hazel-Atlas Glass v Hartford Empire Co case. This case involved ghostwriting. It led the Court to a doctrine of fraud on the court, which involves conduct:

• on the part of an officer of the court; that
• is directed to the judicial machinery itself;
• is intentionally false, willfully blind to the truth, or is in reckless disregard for the truth;
• is a positive averment or a concealment when one is under a duty to disclose; and deceives the court.

It’s one thing to have a medical writer of an article, it’s quite another for that writer to portray a product as more efficacious and safer than it is and to do so deliberately.

In 2004, the combination of lack of access to the data and ghostwritten (as the NEJM trials are) claims for treatment efficacy and safety led the Attorney General for New York State to take a Fraud action against GlaxoSmithKline (GSK). The Department of Justice later took an action against GSK that was resolved with a payment of $3 billion.

Ironically, another more recent Supreme Court judgment, Matrixx Initiatives v Siracusano supported the rights of investors to access company data on harms. It is troubling that those of us investing our lives in treatments have less rights it seems than those investing money.

I am at present writing a paper with medical and legal colleagues exploring the ramifications of what I believe to be a fraud on both medical and legal practice. The NEJM vaccine trial articles will feature in that article.

I hope this statement doesn’t cause you to circle the wagons.  There are issues here to explore and resolve for the sake of patients, the journal, and the medical profession. It’s extraordinary to see the editor of NEJM so hamstrung in his ability to respond to the reasonable request of someone who participated in a clinical trial hoping to benefit us all.

The MMS must surely want to put this situation right. Perhaps re-reading Lysistrata is called for – the pharmaceutical industry needs the NEJM and other prestigious journals far more than the journals need pharma.

I also hope you don’t mind this letter being an open one. Like you, I believe passionately that:

“We must meet future encounters with COVID-19 and emerging variants by drawing on science and robust data to communicate accurate and trustworthy information”.

Yours

Update

A week ago, following the two posts above – Eric Rubin and Fishy Business – I sent an email to roughly 360 reviewers that NEJM had used in the first half of 2021, with the links and sharing the letter to Dr. Allen.

This email is being sent to all living reviewers listed by NEJM for the first half of 2021.  It will also be sent to 140 participants on a listserve interested in pharma-related matters, who are close in profile to the NEJM reviewers.

Attached is a letter I have sent to Dr Carol Allen, President of the Massachusetts Medical Society, who are responsible for the journal, outlining general concerns made more specific in the links below.

My general concerns center on a lack of access to clinical trial data for all drugs and the ghostwriting of the clinical trial literature.  The Pfizer vaccine has made many people aware that there is no access to the data from trials or that access might take decades. The published NEJM trials also make it clear that medical writers wrote the articles. 

The phrase fraud on the court in the letter to Dr Allen is used imprecisely. Strictly speaking it would refer to a lawyer commissioning a study known to be misleading in order to defend a case in court. We are not however far removed from this scenario.

Eric Rubin Boston Strangler

Fishy Business in the Rio de la Plata

I hope you will not be put off by the Lurid title and opening image in the first link. This is driven by the critical pass we have reached and the tone of some NEJM responses on these issues.

I try to ensure posts are fact-checked, but mistakes on issues as complex as these can slip through. I will correct anything pointed out that is obviously wrong.

I invite you to email any comments to me on any aspect of this material. You can also comment publicly on one or other of these postings and if indicated I can ensure your name and contact details do not appear.

Anonymous or not, no linkage will be made by me between your name and any comment you send unless you make it clear you are happy for a link to be made. 

I have no plans to publish any comments. At most I may offer an indication of the rate of response and offer an aggregate assessment of the tenor or tenors of comments.

You can also contact me independently of this exercise

Neither Dr Allen nor the reviewers have responded.

There have been responses from the 300 others or so the email has been since sent to.

Berkshire District

On March 29, Berkshire District in Massachusetts had an annual meeting at which, Eric Rubin gave a talk on: “Why do good clinical trials come up with conflicting results – the case of Covid-19”.

The message focused relentlessly on NEJM’s marvellous commitment to pushing the boundaries of science forward.

No mention here of harms on vaccines. No mention of what we now know about these trials.

As things stand, NEJM vaccine articles are written by a ghost in New Zealand, working for a company based in Dublin, with patients if they exist being entered into the trial in Argentina, Brazil, Turkey and South Africa, along with most of Nebraska, and some fine Texan operations, all of which helps Dr Rubin to a $750,000 per annum pay packet.

Time perhaps for the citizens of the Commonwealth of Massachusetts, at least those who have been injured and ‘left standing on her own‘, to embrace a new battle-cry:

No Publication without Representation 

All aimed at getting the NEJM to support the Mission Statement of the MMS –

We enhance and protect the physician-patient relationship
and preserve the physician’s ability to make clinical decisions
for the benefit of patients. 

Postscript comments suggest Stayin’ Alive as the appropriate Bee-Gee song.