President Joseph E Biden
The White House
September 28th 2021
Dear Dr Joe
We have a lot in common – Irish, Catholic backgrounds and perhaps one or two other bits mixed in, and a concern for those injured or killed in a War. Your addition of the role of doctor to your portfolio gives us one more thing.
I hope mentioning Dr. Joe doesn’t seem flippant. The point is that with Mandates for vaccines it appears that you or someone in the government are now filling a pharma CEO role, or that of a doctor at least in respect of their learned intermediary function, or both.
With Mandates, you have essentially become the license holder for the vaccine or market authorization holder, as regulators now term it.
Pharmaceutical companies are the MAH in the case of a drug. This means they undertake the marketing and are liable in the case of injuries if negligence or a design defect can be demonstrated. No one could ask for a more effective marketing program than a mandate, and the government is it seems now liable.
Companies have a loophole, though, in the role of a doctor as a learned intermediary. This role, linked to prescription-only status of drugs, was brought in to make the taking of these drugs safer but in practice companies exploit it to escape liability.
In the case of vaccines, especially where these are hard-mandated or soft-mandated, the government has become the marketer in chief as well as the person liable and finally as a learned intermediary who is supposed to know all about the treatment and the patient.
Legislation seems unlikely to have covered this unique situation. The negligence or design defect lies in the government not accessing trial data, in addition to the trial data itself (see below), and not functioning as a learned intermediary in establishing causality on our behalf in the case of injuries (see below).
Your de facto message at present to people – including children – is:
- We want you to take this vaccine.
- We are not going to tell you what the harms are.
- We couldn’t tell you what the harms are even if we were prepared to.
- We contracted out the provision of vaccines to third parties with a track record of fraud and we have no way to establish what happened in the studies they undertook.
- Our regulatory apparatus has a track record in approving products that kill more people than they save and in completely missing serious hazards
- But we want you to consent to being vaccinated
- If you don’t consent, many of your liberties will be removed.
- Once you consent you are liable for any injuries by virtue of your consent.
- The usual recourse to redress if you are harmed by a treatment doesn’t apply in this case for several reasons:
A/ The sums we make available for compensation are paltry – insufficient to pay the medical bills for many of the injuries likely to occur.
B/ It will be close to impossible for you to prove you have been injured by our product because we control the organs notionally supposed to assess causal links such as FDA/CDC and unlike pharmaceutical companies who are legally obliged to follow up adverse events and establish causality – and often link their drug to a problem when they do so – FDA/CDC (and other regulators) never do this and never establish causality (they may concede it when others, such as doctors, have established it, but will be unlikely to do so in this case other than in exceptional circumstances).
C/ We are legally immune.
D/ We will vilify you should you claim to have been harmed as will many doctors or others you may turn to.
Joe, you are telling us we are at War with the Virus, but you haven’t put a Red Cross in the field to pick up even our own troops who are wounded. You have created an atmosphere of joy when enemy troops (the unvaccinated) end up in the hands of our healthcare staff who openly sneer at them, and say they feel inclined to let them die. There are no convalescent hospitals or rehabilitation facilities for our troops to go to, no effort to sustain our morale by treating our troops decently.
You are drafting US citizens under terms and conditions that predate the American Civil War.
There is one difference between us. You are famous for being empathetic to troops but in this War, your empathy doesn’t extend to learning from your troops.
Let me explain. Three years ago, I (and others) sent a petition to FDA and the European Medicine’s Agency about Post SSRI Sexual Dysfunction, commonly called PSSD. This is one of many problems the SSRI drugs cause, including suicide, homicide, alcohol abuse, wiping out the ability to make love, abortions, miscarriages, birth defects – in all of which I’ve learnt more from the people with the condition that I was ever taught in medical school.
There is absolutely no question but that SSRI drugs cause suicide, homicide and other problems. Regulators and companies were however able to stall for nearly two decades before issuing any kind of warnings for these, and for three decades in the case of PSSD, using a system that is still in place and now helps conceal the effects of Covid vaccines, good and bad.
Within the year, the European regulator put a warning about PSSD on SSRI drugs in response to our petition. After three years FDA have done nothing – not even replied.
My engagement with these issues and the people affected has made several points clear that also apply to vaccines:
- There is no access to clinical trial data on medicines or vaccines.
- Close to all the medical literature reporting trial results for on-patent drugs and vaccines is ghostwritten, hyping the benefits and hiding the harms.
- Clinical trials of these treatments that are negative on their primary outcomes are often reported as positive.
- Clinical trials that have a significantly increased occurrence of harms have their harms airbrushed out of ghostwritten publications.
- Regulators (FDA, Health Canada, EMA) do not get to see the full trial data.
- Regulators approve treatments as working even when more people die on active treatment than on placebo.
- Regulators approve medicines on the basis of negative studies and agree not to let the wider world know about this.
- Regulators say nothing when companies publish negative studies as positive and make adverse effects of treatment, including death, vanish.
- For many trials there are more deaths on active treatment than on placebo, but for thirty years regulators have not warned about hazards as to do so would in their stated view deter people from seeking a benefit (that is a commercial benefit to companies rather than lives saved or a restoration of function).
- There are certainly a great number of deaths from Covid. These occur primarily in hospital settings and allow us to link many to Covid and to register these deaths and maintain figures that have some validity.
Deaths from the vaccine happen at home and in settings other than hospitals. No attempts are made to link the deaths to the vaccine (other than in Norway where 10% were likely linked to the vaccine and 26% possibly linked.) No register of deaths lets us know how common vaccine deaths are relative to Covid deaths.
Besides being Irish and Catholic and a doctor, there are other things you might note.
I am not depending on you to believe me, when I say there is Zero access to clinical trial data and all of the medical literature about on-patent products is ghostwritten, probably especially the studies that appear in the New England Journal of Medicine and other prestigious journals, so that the greatest concentration of Fake News on earth centers not on Donald Trump but on the drugs a doctor gives you.
I have testified before a House of Commons Select Committee in the UK about this, worked with Senator Grassley on this – was part of a group that kicked off the process that led to the Sunshine Act (an unfortunate outcome), written to all 5 Departments of Health in the Western European Archipelago (UK and Ireland), the NICE Guideline apparatus in the UK, medicine regulators in the US, Canada, the UK and Europe, Medical Associations in the UK, individual politicians, including party leaders, many of whom have checked out what I say and none have demurred on a single point. I’m happy to provide you with the correspondence but I’d invite you to check the claims out with your advisors and respond if you find disagreement.
I’ve lectured on all 5 continents about these issues to academic forums, as well as published these points in articles in major academic journals and university press books. I’ve communicated with major journals like BMJ, NEJM, Lancet, JAMA and none have disagreed.
I’ve testified in 50 odd US court cases usually bringing these issues into the frame. The response from lawyers for companies has generally been an attempt to persuade the judge that this is about whether person X killed themselves or others not about ghostwriting. Company lawyers have never argued that point.
My evidence has been at the heart of a fraud case New York State took against GlaxoSmithKline (GSK) and later in a Department of Justice case against GSK that led to a $3 billion resolution that in 2012 was the then greatest sum of money in a corporate case.
I am one of the very few people who has had access to trial data and can tell you more about what regulators are likely missing than anyone in FDA or CDC.
At present life expectancy is falling. It was falling in the United States before Covid and before we got vaccinations. The number of drugs someone is on – polypharmacy – is almost certainly a factor. A colleague, Joan-Ramon Laporte, and I wrote a short piece about the need to check out whether polypharmacy might be an issue with Covid deaths but the NEJM, Lancet, BMJ, and JAMA refused even to review it. As their responses came in, I noted publicly that at the time they’d have published a Dennis the Menace cartoon if it had the word Covid pasted onto it but not this. Three large studies have since supported our point and suggest the second greatest factor in death from Covid after age is polypharmacy.
Besides SSRI’s almost necessarily leading to more deaths than lives saved – this is what even the short-term clinical trials showed – they lead to an increased rate of abortions which should concern you and birth defects and kill both our interest in and ability to make love, in addition to wiping out sperm counts in men. Given 15% of the population are now on these drugs, it’s difficult to believe that this is not playing a part in reproduction rates falling below replacement levels both in the US and elsewhere.
This is likely to be much more pronounced in white populations than others, which could be viewed as evidence for a Great Replacement.
I mention this specifically to make clear that I don’t believe this. There is not a conspiratorial bone in my body. From 1997, in a Harvard University Press book, through to today, I have offered the view that we are seeing the unintended consequences of a system that we put in place with good intentions in 1962.
What we are seeing now is a case of bureaucratic insanity rather than a conspiracy. The best previous example of such an insanity was of course in Germany, who pioneered the bureaucratic art, and whose bureaucrats responsible for shipping people to the camps refused to release trains for the Eastern front as it would interfere with the operations of their system.
The current crisis has brought the mistakes in a system that appeals to bureaucrats to the fore, giving them check boxes that enable them to avoid making sensible judgements. This worked passably well up to about 1990 but has been coming off the rails ever since.
The outcome shows up in all sorts of strange ways. You are concerned about new laws in Texas which give private individuals an incentive to take initiatives in respect of abortions. In the US, and Canada private facilities, as well as public hospitals and universities are being encouraged to put divisive mandates in place after a nod and wink from you – a rather similar dynamic.
As a result, on my university campus I can pass by a restaurant that won’t let me in without a vaccine passport when the data suggests these students are likely at more risk from the vaccine than Covid. Standing waiting to get in, students pass by vaping, in addition to which 20% of them are likely taking prescription drugs that put me and others at a substantially greater risk of violence than of getting Covid from them and them at a substantially greater risk of suicide than death by Covid, without anyone freaking out and introducing mandates.
Up till this, many of us have applauded New Zealand in its efforts. But they are now in a peculiar position. They will almost certainly have by now more deaths from the vaccines than from Covid. The result? A wonderfully transparent and very impressive government now appears to be suppressing evidence of links between the vaccines and deaths in a tawdry and perhaps scandalous fashion.
Nobody it seems wants the branding to come unstuck.
My primary concern is with those who are harmed, and the gaslighting that stems from the need to save the brand. As regards benefits, the vaccines are interesting. I can see angles they point to that few have been considering up to now, but which companies are likely exploring.
Based on the clinical trials, the data of which it has not seen, the British regulator (MHRA) said there appeared to be no extra risk in populations of concern – those with asthma or other pulmonary disorders, diabetes or hypertension. Pfizer when applying to run trials of its vaccine mentioned a quite different population of concern.
It goes without saying that the vaccines will harm people. As it turned out, the risks that have featured most prominently in the media have been thromboses and myocarditis in largely healthy young people. There are genetic tests that could be done pre-vaccine to alert people that they might be at risk. But we don’t tell people. What people are told about the risks is hard to view as other than deliberately misleading.
There are close to 20,000 cases of cardiac problems reported to the UK regulator (100,000+ US equivalents), and over 5000 cases of thromboses perhaps heading toward 10,000 (50,000 US) if you want to throw in strokes. These hazards have been in the media, with your regulators dragged screaming and kicking to acknowledge them, but now able to use media reports to explain why the numbers of reports to them are high. These reports are mostly from doctors and cannot be dismissed as just self-reports.
The population that concerned Pfizer have not been in the media and MHRA’s report on the approval of this vaccine suggests the Pfizer clinical trials showed little or nothing in this population – perhaps the company were being over-concerned for you and me.
But MHRA have had over a quarter of million reports of these problems – heading toward 1.5 million US equivalents. Neurological problems. I’ve met several patients with significant neurological problems. I don’t dare tell their doctors about this as it will lead to me being cast out into outer darkness by simply making a link.
The problems include relapse of MS, as well as de novo onset of MS, aggravation of migraine, transverse myelitis and other problems that lead people to do their own research and worry a lot and then undergo expensive testing to check if they have MS or ALS. Warning people about these hazards however doesn’t fit the branding.
Meanwhile Peter Marks, FDA lead for these issues, tells everyone that CDC and FDA are working night and day to find a possible needle in the haystack of reports that come in to them. Missing, as a colleague has said, the haystack of needles in front of them.
You, if you talked to someone like Bri Dressen, a Utah preschool teacher, who was not just pro-vaccine but volunteered for a clinical trial, are as well placed to decide if the vaccine harmed her as the entire CDC and FDA apparatus put together. You wouldn’t be inhibited by the company strategies your bureaucrats borrow to deny that any problem has ever been linked to any vaccine – or hardly any to any drug.
We’re on religiously dangerous territory here. Something that can only do good and cannot harm is a sacrament. Our drugs and in particular vaccines are becoming de facto sacramental – which is possibly idolatrous. Even the Church now recognizes the Eucharist can harm and needs to be gluten-free.
Having just recently become a doctor, you will need Continuing Medical Education. When I said if you interviewed Bri Dressen from Utah you would be in a better place to work out what is going on in terms of vaccines and injuries than CDC/FDA, you, or someone reading this letter for you, likely dismissed the idea – Who Joe? To see why I say this, let me suggest you or one of your team watch the following lectures given three weeks ago to doctors in Sweden to get a better sense of the crisis medicine is now in.
There are print forms of these lectures here:
It is well-known you had a son in the military. I have a son who has been working treating the most severe infections in Africa, where at least one colleague was killed because of their efforts to introduce Ebola vaccines. He has also been promoting vaccines and other interventions on the Afghan-Pakistan border working for Doctors without Borders. He spends his spare time working in ICUs with unvaccinated Covid patients dying on ventilators.
I also have a son-in-law working in ICUs and a daughter working in neurology where they report post-vaccine problems to the regulator – believing naively that the regulator has more expertise in assessing cause and effect than they do. I haven’t tried to disabuse them of this crazy idea.
All have been vaccinated.
I wouldn’t be mentioning any of this to you but for the fact that, given no-one outside the companies actually knows what went on in the clinical trials of these treatments, and even then company processes mean that left hands don’t know what right hands are doing, and no-one in your or any other apparatus is making a genuine effort to recognize the harms these treatments are causing, your actions to mandate vaccines are arbitrary, unreasonable and divisive.
Earlier this year you made a pitch of wanting to unite a divided country, but you are deepening divisions. You could do a lot better, starting with listening to your troops, those who have been injured and the families of those who have died, in a War in which you are Physician-in-Chief.
Professor David Healy MD FRCPsych
 BMJ https://doi.org/10.1136/bmj.n1372 ; Norway study: https://doi.org/10.4045/tidsskr.21.0383; Norway regulator press release: https://legemiddelverket.no/nyheter/expert-group-has-assessed-deaths-amongst-the-frail-elderly-following-covid-19-vaccination