A medicine is a mix of a chemical that pharmaceutical companies produce and knowledge about how to use the chemical – that we produce.
Making even basic chemicals was beyond us for millennia. But once the process was cracked, discoveries and inventions came thick and fast. Making chemicals that could be used to treat diseases was beyond us for even longer but the pace of discovery began to pick up in the middle of the nineteenth century. The realization of what needed to be done to give a chemical a chance of becoming a medicine led to the hunt for a Magic Bullet. But even as the process became more rational the role of serendipity remained and remains enormous as the discovery of penicillin and so many other medicines demonstrates.
Huge amounts of knowledge are buried in the production of these chemicals that might be drugs. Some of that knowledge came from the pharmaceutical industry, especially the knowledge about how to mass produce the new chemicals to a quality standard. A lot came from university, institute or other research laboratories.
Patents or Prizes?
The emergence of these new medicines led to vigorous disputes as to how much an industry like the chemical industry needed to be incentivized to produce new drugs. Venice was the first economy to use patents and the English adopted the idea as a reward system in 1624 to stimulate commerce. At this point patenting seemed a better bet for something like building up a business that traded in goods rather than a means of fostering discovery. When there was a need for a radical breakthrough, Prizes looked like a better bet. The best illustration of this is the story behind the Prize offered for the discovery of how to determine Longitude won by John Harrison in the 1740s.
At a time when chemical companies could produce little of any value to medicine the French revolutionaries, ordinarily hostile to all things English, and with other things on their mind — like guillotining a King — figured it was a revolutionary thing to do to allow patents on medicines. The Germans initially frowned on this idea but later opted for process patents – I could get a patent on my way to make Prozac but not on Prozac itself. If you find a different way to make Prozac, you could make it. The Americans, who were much later to the game, from the get-go let companies have product patents – if I patent Prozac you can’t make it even by another method. I have a monopoly on it.
Process patents seem more the thing for the modern age with its emphasis on intellectual property rights than product patents that actively discourage innovation. And for a century the American pharmaceutical industry lagged behind all others, until political developments leveled the playing field and forced the Europeans in the 1960s to play by product patent rules and then the rest of the World to do so too through TRIPS in the 1980s, after which drug development slowed down.
Making a Medicine
But here’s the rub, whatever patent system or Prizes we offer them, companies just produce chemicals. It is we who produce medicines. A medicine is a chemical with information and the information comes from us.
In the 1950s, the information came from doctors giving us the new pill and both of us monitoring what happened. That was the ideal but some of them gave us a pill without telling us it was new, and some of the guys handing out these new drugs were people you probably wouldn’t want to take something new and potentially dangerous from. Whether we were fully on board or not though, this was a system where the knowledge was produced in a hands-on way by us and our doctors. If the drug didn’t obviously do something useful or clearly did something harmful it was either removed from the market or the knowledge of what could go wrong found its way pretty directly into clinical practice.
These new chemicals interfered with biology in a way that only poisons had done before. The need to get the information component right was brought home horrifically in 1961 when thalidomide stripped babies of their arms or legs and deformed them in multiple other ways.
Producing Health can never be just a matter of Consuming Chemicals.
The Wages of Fear
A wave of panic washed over the political establishment at the sight of armless babies. There was a reflex need to be seen to raise the bar for pharmaceutical companies bringing drugs to market. If these companies were going to make money out of people at their most vulnerable, they would have to pass through the eye of a needle. They would have to show in clinical trials that their drugs worked. And those of us who entered these trials would have to be informed that the drug was something not yet on the market so that we could make up our own mind whether to take the risks or not.
This sounds like and is portrayed as something good being drawn from an appalling tragedy, except that clinical trials had only just been invented and no-one realized they weren’t up to the task, except Louis Lasagna, one of their inventors and their main promoter – (See Marilyn’s Curse and related Lasagna series posts).
It took time for the problems to appear. In the 1960s, whether in trials or just by trial and error, the knowledge that made these new drugs into treatments that saved lives came from us. The doctors who gave the drugs were local – they knew us and our communities. In the first trials the doctors were treating patients they knew and when the trial was over and they broke the blind they were able to make sense of the findings in terms of the things they remembered seeing or hearing about directly from the patient.
And so in the decades just after the greatest cataclysm in human history, the risks we took in taking new drugs, whether in trials or just under the observation of our doctors, on behalf of people we knew, ushered in the most extraordinary period of medical advance in all of human history.
But it is exactly this space to mull over what you are seeing and hearing or experiencing that trials have now now left as road kill as they have become the fuel for Fast Medicine.
The Risks in Destroying Knowledge
The initial rationale for trials was that they would be run on drugs or in situations where it was just not obvious that the treatment was helping or that the risks were worth taking. For things that were evident, there was no need for further evidence.
When things aren’t evident and we decide to run a trial, we take a calculated gamble on something risky – and probably well over ninety percent of trials that get run involve risks not worth taking.
To test something out you first need to hypnotize doctors and patients. The blinding in a trial means more than the idea that neither the doctor nor the patient know what the drug is – they can often guess. It means you limit their vision. You get both to focus intensely on whether there is any sign of benefit – to the exclusion of all else. Drugs do a hundred different things but in a trial everyone is guided to ignore the ninety-nine other things and focus on just one thing – does this drug work for whatever it is the company is interested in.
In fact we have introduced another complication which is we ask does it work for depression or to stop heart attacks. Just as SSRIs do, a drug might so obviously blunt or numb reactions that you don’t need a trial to demonstrate this – or so obviously lower cholesterol levels that you don’t need a trial to show this. This blunting or lowering cholesterol can be helpful or not, but rather than call this working, we want to see if this helps depression or prevent heart attacks. When the trials finally squeeze out an answer that you can’t say these SSRIs are of no benefit, we in fact have no idea how the benefit has come about. Or if the trial finds that lowering cholesterol makes no difference, we have no idea why not.
Look at it this way. Alcohol can be very good for social anxiety. Everyone who takes it for this purpose knows what they are doing, and knows how it helps. If we ran a trial of alcohol for social anxiety, and on some rating scale could show some benefit, you would be asked to forget any ideas you had about how alcohol might be helping and just accept a company line that it “works” and therefore you should be taking it – for the rest of your life in all probability.
In the same way, our knowledge of how SSRIs help – they numb – is discarded in favor of the company or expert knowledge that these things work. Into this knowledge vacuum, companies were able to insert all kinds of baloney about serotonin and continue to offer up the hocus-pocus of chemical imbalances (See So Long and Thanks.)
The Great Hypnosis
The great hypnosis involves a post-hypnotic suggestion – that out of the trial will come gold standard knowledge of what drugs do.
We are being told forget our ability to produce knowledge – to produce medicines. They have put us through a machine that erases any inconvenient observations we may have. Our only role now is to consume the pills they give us and to swallow without question the information they provide with them. We have been made into consumers; we are no longer seen as producers.
The hypnosis is pretty dense. In SSRI trials, one hundred per cent of us had genital numbing and a change in sexual function but less than 5% of us apparently noticed this, or at least had it recorded by the doctor – many of these trialists are third raters you wouldn’t want to be treated by. To this day we don’t know how many of us return to normal sexually or emotionally after taking an SSRI even just for the 6 weeks of a trial.
So when your son or daughter rocks up to a doctor (visiting is too twentieth century) with the disturbing information that they have stopped functioning sexually, that they could smear chili paste on their genitals and they wouldn’t feel a thing so numb are they, he will check the product label and not finding anything like this there will tell them it’s all in the mind, or this is their depression speaking.
The more they protest, the firmer the noose of neurosis will tighten around their neck.
If you were in one of these trials where your attention was diverted away from the effects of these drugs on sexual functioning or when you tried to make an observation the doctor didn’t record it, the fact that you took risks in a trial for the benefit of your family and friends and community is now being used to skewer your family and friends, just as surely as your work in a lead smelter for most of the twentieth century poisoned any family or friends you had living nearby.
At least working in a smelter you were paid for the work you did.
Many of the trials on which our safety now depends have now moved to places like Bhopal in India or the townships of South Africa where the patients may not exist or if they are injured they can be disposed of without any trace of the problem appearing on the record. The “knowledge” that comes from these trials is deemed by the FDA, the MHRA, AllTrials, the Cochrane Collaboration and Barack Obama as the only real knowledge there is. Your experience by comparison is anecdotal – irrelevant.
If you’re a politician who hasn’t lobbied to make access to clinical trial data freely available, you’re a politician who would lobby to keep the lead smelter running in your district and the level at which lead in blood is regarded as dangerous as high as possible. Hey if kids poisoned by lead are hyperactive – well isn’t that what we have Ritalin for?
The Garden of Good and Evil
Earth teems with life. It’s difficult not to be productive amidst this abundance. It takes the degraded circumstances of a concentration camp to turn humans into just consumers and even there the human spirit can find meaning.
In the Garden, there were trees we could eat from that our parents and others had spent lots of time cultivating, whose fruit were Medicinal. But there was also a Tree, the Fruit of which Wisdom made clear we should avoid. Consuming this Fruit, which we hadn’t been involved in husbanding, we were told would lead to Exile.
The Fruit of the Clinical Trial Tree looks Medicinal – but it’s not life-giving.
It’s profoundly alienating because one more feature of the Clinical Trial process, at least within the current regulatory system, is that it locates the problem, the taint, the original sin in us. If trials show ADHD responds to Ritalin, it must mean the kid is defective.
Which lets politicians say or maybe nudge – “Why look at goddamned lead levels – you want to drive jobs out of this country? If you want to make this world a better place, just keep taking the pills. All of them”.
If Medicine is to be Safe, we need to reclaim our birthright as producers of Medicines.
To be continued.