In 2008-2009, 7 young women died in a HPV vaccine trial in India. There was a backlash against the clinical trial industry. Quite apart from Pharma trials, the National Institutes of Health (NIH) had 70 ongoing trials that were abandoned.
It was clear, Indian investigators had to be taught how to assess awkward events properly.
Barbara Bierer, a Haematologist, and founder of MRCT travelled to India in 2014 to help the new Indian Society for Clinical Research (ISCR) with causality assessment. ISCR had been set up by Pfizer in 2010 and company support made the ISCR journal open access.
Causality assessment refers to the ways to assess possible links between a drug or vaccine and harms happening in company trials or other studies, or just clinical practice.
At this MRCT workshop investigators were encouraged to distinguish between adverse events and adverse reactions and to establish if:
- there were similar reports previously linking the drug or vaccine to an event
- there were similar reports in the label of related drugs or vaccines
- the event appeared in the investigator brochure
- the event was consistent with the pharmacological mode of action of the drug
- the event was consistent with the pharmacokinetic profile of the drug
- the event was consistent with peak plasma or overall concentration of the drug
- the event might be consistent with the first sign of a latent illness
- whether there were concomitant drugs
- whether there were concomitant conditions
- whether anything else was happening at the time of the event
- if none of the above consider that the event might have happened but be unrelated to the drug.
In the world of company trials, nothing ever steers an investigator toward linking a harm with a treatment. The entire trial process hinges on a mantra that trials rather than an assessment of individual cases by a clinician offer true cause and effect information. Unless an event has been demonstrated to happen to a statistically significant extent in a controlled trial there is no good evidence that the drug or vaccine has caused it.
WHO guidance on establishing causality for adverse events in vaccine trials now goes even further and states that every effort must be made to link an event following a vaccine to factors other than the vaccine. See Bellavita and Pulliyel.
The result – death after death from myocarditis, stroke or other cause, in Pfizer’s and other Covid vaccine trials that appear in the paperwork companies send to FDA and EMA feature as investigator codes as not-related. FDA reviewers close to universally agree with the ‘investigator’,
If anyone now rooting through any vaccine trials finds a death or serious injury that an investigator or regulator has linked to the vaccine, please send us news of where we can view this unicorn.
Wondering about Bierer, who had no background in adverse events or causality assessment, I texted a Haematology friend to ask if she had ever heard of BB. The predictive text on my phone converted Haem to Harm and a new science was born .
Circe Surrounded by Porkers © Nina Otulakowski June 2022
Harmatology is the science centered on making the harms of treatments disappear. It is key to transformating RCTs into a vehicle to provide a smooth assay system for drug licensing.
Harmatologists convert valid and criticial information about vaccines and drugs into anecdotes and misinformation. They transform the truth we need for our journey through life’s perils, the forced navigations between a Scylla and Charybdis, into ‘porkers’ or ‘porkies’- a porker is London slang for a lie – because it rhymes with the pie in pork-pie.
Porkers conjures up Circe, who famously magicked Odysseus’ men into pigs.
The precision of Harmatology 1.0 processes to ensure efficacy and eliminate harms developed steadily from the 1980s to the point where by 2000 companies could confidently claim that there is no evidence of any harms on any of their drugs.
We have moved on Harmatology 2.0, glimpses of which you can get below.
Embrace Randomized Controlled Trials (RCTs). Without much gaming, RCTs ensure company interests in seeing harms disappear are realized. RCTs necessarily focus on a primary endpoint and hypnotized by this the 99 other effects of a drug are gathered so haphazardly that they disappear even when these effects are immediate and all but universal like the sexual side effects of antidepressants. Mission Accomplished.
In the very first RCT of streptomycin in 1948, deafness and tolerance were missed. And in a 1960 RCT, run by Louis Lasagna, thalidomide showed up as effective and harmless. If only there had been more RCTs then to counter all that misinformation about that great drug. Lasagna was quite a visionary when he pushed to have RCTs incorporated into the 1962 Food and Drugs Act.
Healthy volunteer trials, or Phase one trials as they are called, offer the perfect opportunity to see the hazards your drug or vaccine causes, leaving you time to think, for example, about how to just not collect any information on sexual function in an antidepressant trial or any indications of dependence. These trials are never published so no-one will ever see what has disappeared. Mission ongoing.
Having eliminated anything occurring with any degree of frequency, insist that only effects occurring to a statistically significant extent in trials are viewed as having been established as linked to a treatment. Mission Accomplished.
Given that statistics strictly speaking should only be applied to a primary outcome, this gets rid of any possibility that any event other than the primary outcome can become statistically significant. Statistics can only be applied meaningfully to events that have been measured precisely. Nothing in a clinical trial, other than the primary outcome, is measured precisely.
Some people found it hard to believe when we said our drugs have no adverse events, as in Harmatology 1.0. Vatican 2 (Harmatology 2.0) has come to the rescue.
The vaccine trials have let us roll-out a development we’ve been working on – prepopulated lists of effects other than the primary outcome. These lists of immediate vaccine side effects like a sore arm are delivered on electronic devices for individuals in trials to complete in the comfort of their own homes – see Virtual Research.
The fact that they are collected on all individuals in the trial means that statistics can be applied to them. As a result, it can be claimed that vaccines give rise and only give rise to headaches, mild fevers, aches and pain – all the features of vaccine reactogenicity. The Apps have no space for the registration of other effects. If these are reported in letters or emails, they can be declared reported, they can be reported as expected reports, without conceding evidence for a linkage. Mission Accomplished.
Train investigators in both developing and developed world settings on the lines of the training offered by Bierer above. Mission Accomplished.
Introduce coding dictionnaries. These let us code suicides as nausea, emotional lability or burns. No one spots that they are the first line of authorship. Once the coding is in place, the paper writes itself. Mission Accomplished.
No paper appearing in any medical journal has ever in its methods section dealt with coding bar one – Study 329.
Brand careful analyses of cases that appear to establish that a drug or vaccine has on a balance of probabilities caused a harm as porkers (anecdotes, misinformation). Do this to the extent that journals like the BMJ or NEJM that used to publish case reports stop doing so. Do this with the stick of legal actions for publishing porkers harmful to your company’s interests and with the truffle of large amounts of money for reprints of published RCTs and meta-analyses of RCTs. Mission Accomplished.
Abolish Drugs Bulletins, which mention the harms of treatments, or make their lives harder by for instance requiring doctors to buy them, which the skinflints won’t rather than have them made available for free by health services. Mission Accomplished.
Get legal systems to accept that the only reliable information about drugs comes from clinical trials. When doctors report a harm, who knows how reliable that information is whereas with harms in RCTs we can tell the courts what the margin of error is. We can help courts to get away from prejudiced experts and offer information that every expert has to adopt. Mission still in the Balance.
Create Evidence-Based-Medicine. Mission Accomplished in 1991 by Eli Lilly and the BMJ working in conjunction. See Vampire Medicine.
Relentlessly exhort doctors to practice in accordance with the evidence. Begun in 1965 and continuing.
Outsource the running of Drug Trials to Contract Research Organizations (CROs) who shuttle between investigation centers and return the data from each site to a central repository linked to the CRO and probably offshore. Mission Accomplished.
Where before 1990, all of the assay data was in the lead investigator’s filling cabinet, after 1990 it was sequestered – goodness only knows where.
Embrace Guidelines. We don’t have to write them. The guidelines are based on the published literature, which is ghostwritten, and the bulk of which comes from our ‘trials’, with no access to the data. The guidelines write themselves and health services pay academics to convene and put their names to these standards that promote our drugs. Its a great business model and the greatest concentration of Fake literature on earth. Mission Accomplished.
Relentlessly exhort doctors to practice in accordance with Standards of Care, a.k.a. Guidelines.
Ensure medical trainees in all specialties learn the standards of care. Make it so that they need to parrot these to pass their exams and qualify in the specialty of their choosing. Mission Accomplished.
Even now few young doctors can imagine how a drug or vaccine could cause a problem. If a young aspiring medical student wants to engage with the ‘customer’ enourage them to think about something else – like hairdressing.
Ensure that Patients with Rare Diseases have a place in any forums where access to assay data is being discussed. None of these patient advocates will support access to assay data because the risks of people with a rare disease then being identified is too great. 6ission Accomplished.
One of our greatest weapons has been informed consent forms. They began as a way to inform people they were taking part in an experiment on one of our drugs. We turned them into something that tells people we will never let anyone see their data – not even regulators. Mission Accomplished.
This sounds good to those simple volunteers who think they are participating in a scientific exercise that will advance the health of their families, friends and communities but in fact will create a state of legal jeopardy for their family, friends and community who will not be able to get access to the evidence that our drug caused harms in the assays in which it was tested.
The data are the figures and the boxes ticked, right? Stick to that.
Never admit that people are the data. When we remove their names and contact details, we can invent figures and tick whatever boxes we want. No-one can ever find out that we have airbrushed problems out of existence or created non-existent trial participants
In our trials people come out apparently cured of severe illnesses like depression but commit suicide a few days later or have their sex lives wiped out forever and wish they had never had the drug or become dependent on the drug and are still on it a decade later. We do not want anyone to be able to contact these people. Mission still in the Balance.
Ensure people’s names figure nowhere. Named people willing to come into court and talk about their injuries and be cross-examined are like garlic or crucifixes to us. Mission Accomplished.
Fairly soon all trials will be Virtual. People will participate from their homes on electronic media and we will be able to monitor what is going on in the background and discontinue them from the trial before anything goes seriously wrong. See Virtual Research. Mission in Progess and looks unstoppable.
The Virtual Trial ‘data’ will feed straight through to Artificial Intelligence A.I. enabled medical writing systems who will report the results of the trials without a human hand going near anything. Pure objectivity. The finished article will appear in the New England J of Medicine two weeks after the trial has finished. See Albert Bourla’s Mooning. Mission in Progress – looks unstoppable.
In the meantime, we have Eric and a few others dotted about in all major journals. Every medical journal should have one. Eric rejects any request for access to the data, and all reports of an adverse event – New England Journal.
One of the worries is ensuring that doctors do not spot that if harms disappear they too will disappear – replaced by nurses with both soon replaced by robots – see Caught in the Firing Line. At the moment, with their snouts in the trough they show no signs of noticing what has happened.
American English rules. Make sure we keep spelling it Hematology.
Women-wash. Step up Barbara, Rebecca, Liz and others.
Circe is one of the more impressive women in Greek mythology. The way she dealt with smitten men and women rivals was impressive. One king was turned into a woodpecker and one rival was turned into Scylla who is mentioned above.
A 2020 book by Madeleine Miller that has had rave reviews seeks to rehabilitate Circe and make her a twenty-first century icon for women.
It will take a really strong woman or group of women to restore truth and dismantle Harmatology 1.0 and 2.0. But women mobilized by harms to their children, parents or friends (partners are a different matter) are perhaps the most powerful force on earth and capable of creating Harmatology 3.0 – the science needed to cut through all the misinformation and recognize harms.
This is wonderfully apposite; Alberta has been the Canadian province most concerned about Covid and Vaccine related porkers.