This is part two of Can Politicians Save US. Both are part of the Politics of Care forum. It would be great if you could print off these two posts and send to your local politician, asking what they figure on doing about some of these points.
Point Six in Can Politicians Save Us, mentions an Arms race and compared Drugs and Guns. But there are important differences between Drugs and Guns. With Guns, successive weapon systems trumped older ones because they were demonstrably more effective than what had gone before. This is not true of Drugs.
In the case of Drugs, it is the appearances of efficacy that trumps what has gone before. Unlike Guns, the latest Drug need not be better than the last Drug. Drugs are almost unique among modern technologies – Guns, Autos, Phones, Computers – in often being less effective and less safe than what has gone before.
A Drug is a Chemical plus Information that tells us how to use this chemical effectively and safely. The Chemicals were always dangerous and are not getting any safer.
Before the Fall of the Berlin Wall, the Information was largely accurate but now the greatest concentration of Fake Literature centres on the drugs our doctors give us.
In 1962, Pharmaceutical Companies were gifted a gadget that transforms poisons into sacraments and junk into life-saving remedies – the gadget is called a Randomized Controlled Trial (RCT).
RCTs are spun as offering Gold Standard Knowledge about Drugs but they are not knowledge. They are an algorithm put in place to help evaluate one, and one only, of the several thousand effects every drug has. To evaluate an effect in which some company has a commercial interest.
This money-tree effect may not be the commonest effect of a drug. In the case of SSRI antidepressants, numb genitals is the commonest effect. A mood benefit is pretty rare in comparison. But because RCTs hypnotize investigators to look at mood effects only, in SSRI trials they completely missed the numb genitals.
Now, as outlined in Can Politicians Save Us, point 6, we have falling Replacement Rates in most Western countries.
RCTs transform Poisons into Sacraments. Sacraments offer Efficacy without Safety issues – although even the Vatican now supports Gluten-free Eucharists.
RCTs Greenwash Chemicals.
Combining RCTs in the Guidelines of Evidence Based Medicine (EBM) locks everyone in healthcare into a cage the way GDP locks politicians into an economic cage. GDP reflects activity of a certain kind rather than activity we necessarily value. The activity includes cleaning up after the Exxon Valdez oil spill but doesn’t include pristine, plastic or oil free oceans.
In the same way the Drug Wrecks that come from administering Poisons with gay abandon, thinking they are Sacraments, has made treating the consequences of our treatments the leading form of health service activity.
If you are desperate for a metric – create one that flags up the proportion of health service activity that stems from treatment induced injury and death. This may now be as much as 50% of all activity, stemming especially from treatments supposed to be ‘preventive’ that companies market as reducing health costs.
Point Six in Can Politicians Save Us, and Nine above, mention an Arms race and compare Drugs and Guns. With Guns, successive weapon systems trumped older ones because they were demonstrably more effective than what had gone before. This is not true of Drugs.
In the case of drugs its the Propaganda Techniques not the Pharmaceutical Technologies that persuade people to buy. There is no access to the data on drugs that shows how efficacious they actually are or how safe. The claims about what they do and don’t do are written up by ghostwriters.
Biden has just been blaming Facebook and Social Media platforms for vaccine misinformation. While the New England Journal of Medicine and JAMA and other leading journals are stuffed full of ghostwritten articles about on-patent medicines, articles that in some cases have been proven outright fraudulent and perhaps are all to some extent fraudulent, with the journals saying its not their job to guarantee the integrity of the data, without Joe mentioning this, its difficult to know what to call him – naïve or hypocritical or what – part of the Deep State perhaps?
The greatest concentration of Fake News on earth centres on the drugs our doctors give us.
TBD in the slide above means To Be Determined. The document from which this slide comes was prepared in 1999. The articles on Zoloft studies for NEJM and JAMA had already been written by the ghostwriters – along with dozens of others. Zoloft was being sold for PTSD for which it was ineffective and unsafe, likely leading to the suicide of many US Veterans.
After the articles are written, pharmaceutical company marketing departments let the ghosts know which academic and clinical names are best suited to go on the authorship line. Best suited means who will be the best advocates for the drug.
Pfizer in this case had been advised by Paul Leber, ex-head of the CNS division of FDA, on how to get Zoloft which was ineffective, approved by FDA for PTSD, a condition Leber didn’t think was a real condition.
In response to a HealthCare rapidly deteriorating into health services, when things go wrong we are told that this is a problem of doctors not keeping to Guidelines. Its just the opposite. Doctors and increasingly nurses keep to the Guidelines more than ever before – because prescribers now get sacked if they stray from them.
Keeping to Guidelines cannot give us better Care if these are based on junk designed to sell the latest product with no regard as to whether the product is more effective or safer or better value for money. The Guidelines for PTSD endorsed the use of SSRIs like Zoloft.
Require universities to tackle their academics who let their names be put on ghostwritten medical articles without having access to and without being able to share the full study data with other doctors and academics and ideally the wider public.
At present Guideline Makers, Regulators, Journals, Politicians, Medical Associations all say it is not their business to police the medical literature. Facebook operates to a much higher publishing standard than Medical Journals.
Anyone who wants to know more should read Paul John Scott’s all too real account of exactly what goes on. Whichever country you are in you can substitute in the names of many of the most prominent medical academics such as Siegfried Kasper, Professor of Psychiatry in Vienna. We are told we can trust these academics because they have over 1000 articles to their names.
Behind this Fake Literature, there is an even deeper problem. There is no access to the data from clinical trials. No-one gets to see this. Remember drugs are not chemicals – they are chemicals that come with information about their use. Significant amounts of the information we get are fraudulent but in the absence of access to the data, this cannot be exposed.
The correspondence with regulators, Guideline Makers, Politicians, Medical Societies and others, supporting these claims is laid out in From Stephen O’Neill to the Crack of Doom.
When raising this problem with all these bodies I made it clear that it is not their job to police the medical literature. They now all parrot this response.
In honour of and Harvard/Boston where ghostwriting has been endemic and there is an understanding that no data will be asked for, a policy supported by successive Deans of Medicine like Jeff Flier, who presided over an orgy of shoddy links between a university and industry – see tweet in a series about ghostwriting and Harvard since deleted –
And the New England Journal of Medicine, who in 2009, made it clear they didn’t feel it was the journal’s responsibility to have check on the integrity of clinical trial data – see Philip Fine’s article HERE
Perhaps, its time for a Revolution or at least a Tea Party with the catchphrase:
No Prescription without Representation.
Change the consent forms for clinical trials.
Consent Forms began life in 1962 informing you that you were participating in research – you were often participating without knowing it before that.
Companies have since inserted phrasing telling us they will show our data to no-one. Reassured, we sign.
Companies now use these forms to block access to our data. There is no ethical, legal and in particular no scientific basis to refuse access – see Good Science or Good Business.
Our Signatures now put our families, friends and communities in a state of Legal Jeopardy – See Clinical Trials and Legal Jeopardy.
The data, which does not belong to companies, is being hidden for commercial reasons not out of any concern for the privacy of anyone who enters a trial.
There can be no argument about getting access to the data from premarketing healthy volunteer trials of drugs. These are run before drugs come on the market and in the case of the antidepressants revealed the suicidality, homicidality and permanent sexual dysfunction these drugs can cause. After marketing companies denied completely that these hazards exist and it took 15 years to get warnings about suicidality and we still don’t have the appropriate warnings about sexual function.
There are no issues of clinical confidentiality here. These are the trials that show what drugs are really causing – that allows pharmaceutical companies to game their later clinical trials in patients, where everything can be blamed on the illness being treated.
This is what an original consent form looked like.
It may take political support for Doctors to screw up the courage to ask companies for clinical trial data on a drug they are proposing to give you or your family. See Can Doctors Save Their Jobs and the World.
It may take political support for Doctors to screw up the courage to refuse to use guidelines – like the NICE Guidelines – that are not based on data – See The Nice Before Christmas.
If they are unwilling to do this, then doctors are like salt that have lost their saltiness – useless.
Like the Greek Women in Aristophanes drama Lysistrata, who stopped a war and the killing of Greeks by Greeks by refusing to make love to their men, so also pharmaceutical companies need doctors more than doctors need them.
Make it possible for doctors to refuse to tango with Pharma while they continue to kill and maim so many of your voters because they lack a backbone. Get them to do their job and your job will be done.
Remember No Prescription without Representation – or perhaps that should be We will not be Dicktated To.
Mobilise us, your voters, at risk of being killed or maimed when we visit our doctors, to ask if our doctor has access to the data on the drug they are proposing to prescribe to us. Empower us to declare a preference for being given medicines whose data is accessible -there will always be older, better and less expensive drugs that can be used.
Require doctors to report adverse events their patients suffer on treatment to pharmaceutical companies leaving the doctor’s name on these events and indicating a willingness to be cross-examined about the event. At present doctors only report 1 in 100 serious adverse events, primarily to regulators, and do not expect to be interrogated about these. This will call for medical courage.
Reporting to companies is important because companies are under a legal obligation to investigate the event and decide if their drug caused it. Companies are busy trying to get doctors and others to report to regulators who have no legal obligation to investigate and never link a drug to a problem.
Regulators never investigate because they strip away the names of doctors and patients and this immediately makes the reports worthless to us but gold-dust to industry.
Consider closing down the regulatory reporting systems run by FDA, EMA, MHRA and others – they are a waste of time. Some countries have pharmacovigilance systems that are independent of regulators and companies – strengthen these.
Companies are availing of an opportunity that opened up 420 years ago with the execution of Walter Raleigh. Raleigh was executed on the basis of testimony circulating about him outside of his trial. His detractors were not brought into court to be cross-examined. The injustice of this was recognized after his death and Hearsay was no longer accepted as evidence.
When regulators strip our names away – claiming confidentiality concerns – they transform our evidence into Hearsay or Anecdotes. But if our names remain on the reports and we and/or our doctors indicate a willingness to be cross-examined about what happened we may be able to help someone who is injured in the way we were or killed in the way one of our family was.
Encourage us, as the takers of a medicine, to report adverse events to companies and leave our names on the event. Remove our names and they are worthless to everyone except industry for whom this information is gold-dust – helping them to manage any debate about treatment hazards.
Without out names, we become Invisible and worse again add to the dangerous myth that RCTs give the best view of what drugs do – when even companies acknowledge that cross-examination does.
With our names present, we fracture a consensus that company propaganda aims at building about what drugs do and don’t do. Even Emperors can be put in their place by just one of us – even a young girl – speaking up.
Reform the coronial system, so coroners record in an accessible archive the drugs people are on at the time of death. This doesn’t happen now. After Age, when people die from Covid, vaccines or anything, the number of medicines they are is the greatest predictor of death but no one collects the details of the drugs they were on. Some are likely more dangerous with age or in medical emergencies than others.
Enable coroners to indicate that a prescription drug may have contributed materially to a death. They can’t at present. See Spotlight on the Suicides, The Coroner.
Advised by Medical Insurers, Doctors routinely betray us at Inquests. You will have to stop insurers advising doctors against stating that in their opinion a drug, prescribed in good faith, has killed their patient.
At inquests, at present, medical insurers de facto act in the interest of pharmaceutical companies rather than patients who have been killed by treatment.
You may have to limit the liability of doctors in order to embolden them to take a step that as a matter of honour they owe us but at present shirk. See Can Doctors Save Us.
The Access to Medicines campaign that secured access to Triple Therapy for HIV infections was one of our greatest ever moral and political triumphs within the health domain.
But current Access to Medicines campaigns increase polypharmacy and benefit industry rather than us. While reform of the patent system may help with this, it may not be the best option. An alternate approach would refuse to buy any new drug without access to the full trial data.
Universal HealthCare used to be a goal of progressive politics but it is rapidly coming to mean Universal Health Coverage, which for Pharma means that everyone has access to technical answers to health problems – as in the map above – and demand this as a right no matter what the cost. If Access to Medicine campaigns didn’t exist, Pharma would have had to invent them.
There is no meaningful Access to a Medicine without access to the data – a medicine is a chemical plus the information that informs its use. Having accessed the data on harms the public could be asked how much is this drug worth?
Industry pitch drug prices at what the market is prepared to pay for Sacraments – and we can be persuaded to build Cathedrals for Sacraments, while all around starve.
This would change if we are asked to weigh up How Much This Poison is Worth. Politicians are less likely to be viewed as rationing objects of desire to which we feel entitled if we are weighing up how much a Poison is worth.
In 1918, just after a Communist Revolution had been put down in Germany with Rosa Luxembourg shot, attempting to marry the Left and Right, Max Weber gave a lecture On Politics.
In it he said that government consists of political leaders and bureaucrats. The thing that distinguishes a Leader from a bureaucrat is that Leaders know there are times they have to act like Doctors and persuade their people to take their medicine. In Weber’s day this meant swallow a poison from which both the Leader and the People hope Good can be brought. He had no illusions that Leaders offer Sacraments.
For Weber a real Leader has a sophisticated mind in the sense that Scott Fitzgerald later defined this – a mind that has the ability to entertain two contradictory thoughts at the same time and still function. This is what doctors could once do – but not any longer. Entertaining two contradictory thoughts at the same time is likely to be something that focus groups can’t manage with quite the same reliability as they assess soundbites
Greta Thunberg’s generation stands as possibly the greatest symbol of the extent to which politicians, the media and many of us don’t get what is going wrong in healthcare. And if we don’t understand this, can we understand what is going wrong in the world?
Greta mobilized hundreds of thousands of her generation to come out and protest about the environment. A modern Joan of Arc.
But Greta’s generation is swallowing and demanding vastly more psychotropic and other drugs than any previous generation in history. Not for them any worry about becoming Stepford Wives or having their Revolutionary Consciousness dulled by Drugs.
They go to the Gym, eat their Veggie Burgers perhaps delivered by Uber, and see each other as empowered when they swallow Zoloft and Ritalin.
These drugs are now the second most commonly taken drugs by teenage girls after contraceptives. In the case of antidepressants like Zoloft, we have the greatest concentration of negative studies in human history – 45 out of 45 trials are negative – yet the consumption goes up and up.
In the case of these drugs, we also have the greatest known divide between what the academic literature says – the drugs work well and are safe – and what the data shows when accessed – the drugs don’t work and aren’t safe.
Any Leader who wants to save the World needs to do something about this. But this is not a moment for being seen to do things without understanding what is being done.
You have to avoid repeating JFK’s move on October 10 1962, which in response to the Thalidomide Crisis, effectively prioritized Efficacy over Safety, Technique over Judgment. Kennedy was a White Heat of Technology dude. Frances Kelsey kept Thalidomide – a drug proven to be Effective – off the US market on the basis of Safety. The judgment calls of people like Kelsey were undone that day in October.