It’s one of those classical images from the Wild Western Frontier. As white explorers and settlers moved out beyond the safe havens of established communities they were more and more living close to the edge and injury and illness claimed many lives.
Tending to these ailing populations there rose a population of rogues and charlatans travelling in the trail, offering patent remedies to cure any or all the ailments prevailing. Lotions and potions in brown, purple or green glass containers were sold from the back of the trailer to crowds of the desperate. Often, sadly, the results did not meet the expectations generated by the medicine men. I feel that there is a direct line connecting those rogue traders to today’s global pharmaceutical companies. I write in the context of my eighteen years of practical experience and written word researches.
My ongoing conclusion is that we should indeed be suspicious of today’s medicine men and their products. However they are no longer sole traders but partners in a vast construct of mutually dependent agencies, each one requiring the support of the others. This is the industrial-medical-governmental complex which is supported also by media, academia and governmental organisations like social services, the military and the police. Very complex but an unstructured mutual support service, integral to the very nature of their training.
This is where the cry of “conspiracy theory” is heard loudly. But there is no conspiracy – it’s more an understanding of purpose. Each member of the complex web of relationships plays a crucial but constrained role. The research directors work out where there is a need for the service. The RD is accountable to his board of directors and the like to have a stream of new products to maintain an influx of funds, to outflank opposing companies, eager to expand their portion of the market and to defend the use of current products and their image as an ever progressive organisation. The brief presented to research workers is, thus, to provide a specific product. “Develop a vaccine for chicken pox”, for example, and so the research team must deliver or give a very good reason for failure. And then try again as long as funds are available.
Success is not clearly defined except in terms of a positive balance sheet. The product must provide a demonstrable reaction titre in subsequent serological testing, to demonstrate that the recipients immune response mechanism has recognised the “jab” as foreign protein and developed a memory of it, that subsequent arrival of the antigen in the blood stream will be swiftly reacted to by the immune system. This is not the same thing as the vaccinated person fighting off [say] chicken pox, but it is taken as a measure of that capability.
Success is judged, however, by retrospective measurement at population level of the incidence of the disease. So it can only be assessed ten to fifteen years later with any sense of meaning. There is no ethical or, in fact, legal way in which the vaccine can be tested for effectiveness prior to its use in mainstream medicine. Of course, the practical safety of the vaccine has to be confirmed, as with all medicines, not to damage health in any way. This is difficult, too, as you cannot dose people with a substance which kills or damages them in any way. There are incidents – as recently when six students nearly died using vaccine product TGN1412 in a “guinea pig” trial.
Medical Doctor Marcia Angell has become a stern critic of U.S. health care in general and their pharmaceutical industry in particular. She is scathing on the topic of how clinical trials are conducted in America:
“Many drugs that are assumed to be effective are probably little better than placebos, but there is no way to know because negative results are hidden…. Because favourable results were published and unfavourable results buried … the public and the medical profession believed these drugs were potent…. Clinical trials are also biased through designs for research that are chosen to yield favourable results for sponsors. For example, the sponsor’s drug may be compared with another drug administered at a dose so low that the sponsor’s drug looks more powerful. Or a drug that is likely to be used by older people will be tested in young people, so that side effects are less likely to emerge.
“A common form of bias stems from the standard practice of comparing a new drug with a placebo, when the relevant question is how it compares with an existing drug.
“In short, it is often possible to make clinical trials come out pretty much any way you want, which is why it’s so important that investigators be truly disinterested in the outcome of their work…. It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of [previously] trusted physicians or [once] authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.”
[Contents of brackets are my contributions]
Angell believes that members of medical school faculties who conduct clinical trials should not accept any payments from drug companies except research support, and that support should have no strings attached, including control by the companies over the design, interpretation, and publication of research results. She has speculated that “perhaps most” of the clinical trials are viewed by critics as “excuses to pay doctors to put patients on a company’s already-approved drug”.
“Seeding trials” are particularly controversial. This designation is slightly unclear but seems to imply an understanding that the drug is both OK and will be used as a result of the trial. She’s also written a book about the Pharmaceutical companies, being very critical, saying the they’re not innovative and by taking politicians, regulators and medics under their wings have removed opposition. Thus they could grossly over profit from, and find undiminishing markets for, their products. Most research and development was simply rebranding and repricing older and maybe “Generic” drugs, out of patent.
Obviously a good book and researched from the standpoint of one in the core of the medical profession. As Editor of the New England Journal of Medicine Dr Marcia Angell is establishment and knows who she’s offending and so who can sling back any mistakes she might have made. As a medic she provides less of a critique of other medics who are duped by the Reps of Big Pharm – she should be far louder in that aspect. After all, they let themselves be convinced.
It boosts their status as those that preserve life, that they can provide these wonder chemicals to heal their patients. Having the paperwork provided by the Pharmaceutical companies helps and having appreciative regulators and politicians also boosts the medic’s psyche. For these others the reflected glory is also beneficial psychologically and reputationally and so all prosper from the success of any new medications – however unmerited the designation of success may be.
So why does Dr Angell’s reputation not carry through this message and precipitate revolution in the health care world?
Partly it may be because she is so soft on medics and does not regard the matter as a tripartite agreement. An implicit agreement based on what? Mutual respect, for sure, but also pharmaceuticals strongly underpin so much of modern medicine. Go to your GP and collect a prescription for your medicine nine times out of ten. Which is another link in the chain. Does the pharmacist say “No, you don’t need that drug”?
So Dr Angel believes the system to be warped solely due to the actions of the Pharmaceutical industry. Correct that and then medicine will be OK again. She even says as much: “Big pharm should get back to what it used to do in spending high budgets on developing ground breaking and revolutionary chemicals/drugs to tackle ailments we so clearly face in modern life.” [I paraphrase but get the essence of her thought, I’m sure.]
This leaves Dr Angel’s critique as in house infighting and so it lacks impact. She wants to correct the system from within whilst maintaining its outward strength and, indeed, not really to question the behaviour of those outside Big Pharm. As so much of the development work is based on medical research teams working within the hospital environment they are all profoundly part of the system she criticises. To be fair, she talks of the need to decouple the processes, but it is, of course, terribly difficult to achieve.
Where else can they find the patients to try the drugs on?
She still believes in the Health Industry and the centralised, top down structure that modern medicine so profoundly is. Well, this is what it used to be, of course – medics being the most successful guild ever [Putting stone masons to shame, eh! One ponders, ironically, how many of the General Medical Council, GMC, are, in fact, Masons!] But in those days the doctors were a single layer of health care. Medicine was largely management with simple lotions and potions prepared locally and cheaply, if used at all.
There was Jenner and his smallpox vaccinations two hundred years ago, and other lasting alchemical products but it was slow to become the multi layered process we see today, with suppliers, management, advice (National Institute for Clinical Excellence, NICE), repercussions (damages so lawyers and insurance agencies), computer records (“evidence based care”), politics and the public expectation of “Quickfit” repair services. Clearly this is absurd but where are lines to be drawn?
Doctor Angel makes many valid observations. In the UK the heroic Dr Jayne Donegan took on the GMC in their “Star Chamber” over these issues – objective assessment of published scientific data – and astonishingly won, so avoiding their removing her license to practice. Prof Michel Logeril, Grenoble, also tells of the gross distortion of published figures to mask detrimental outcomes of products companies want to market. There exists a mountain of such evidence.
To me, it seems that health care is best devolved back to the individual and not divided up into so many market sectors. In the UK, we could even launch a new organisation to help empower individuals and assist people in diet, nutrition and lifestyle development where they require this.
We could call it “The National Health Service”. Now that would be such a good idea…….