Editorial Note. This post runs hand in hand with Vampire Medicine and Cisparency on David Healy.org. It is the second of three posts, following on from Reformation Day laying the basis for a RxISK Map which is linked to the RxISK Prize.
When you are facing down the barrel of a tank…
Pharmaceutical companies, medical academics, the government and the media will pitch their RCTs against your personal account, your anecdote, your hearsay. Their quantification gets set against your “meaning” whatever “meaning” means.
For the public this is a winning argument that will blow you away. This is objectivity set against subjectivity. An unbiased view set against your conflict of interest. The temptation for outsiders who don’t know you is to figure you may well have all sorts of perverse, neurotic, financial or other reasons to claim what you are claiming. Scientists don’t always get it right but if they all say the same thing, can they be wrong?
As part of the package, the establishment will also pitch their bureaucrats against your doctor. They don’t use the word bureaucrat, they say regulator, and doctors, not realising that when it comes to harms they are the regulator, lose their bearings.
But contrary to what everyone thinks, you have the data and the science on your side. Companies and bureaucrats and governments don’t. Science welcomes the unexpected and tries to explain it. The impulse to eliminate the unexpected and inconvenient has nothing to do with science.
What companies have and refuse to let anyone see are lots of figures. Some of these figures are entirely made up. Some come from people who never existed. Some are from bogus patients making a living from volunteering for trials.
But even where the bodies really exist companies only collect a small fraction of the figures that could be collected. This is because clinical trials are a microscope that focusses in on a limited set of figures in an attempt to decide if these support claims of a benefit or not.
A microscope can make one point clearer, but at a cost of blurring everything else. If you want to see what is in front of your nose a microscope or a telescope or a clinical trial are not good tools. Trials are designed to look at 1 of the 100 things a drug might do, and do so with such an intense focus that the investigators routinely miss all kinds of other things in front of their noses. Think hypnosis.
In addition, companies throw in a range of ruses to ensure that even the subset of data that is collected doesn’t reveal much of what might have happened in the trial, leaving ghost-writers able to present a picture that will maximise the sales of the drug. Maximising sales is what company trials are about – they are not about science.
The SSRI trials threw up a wonderful example of this. Close to 90% of people have sexual dysfunction on treatment and 100% have genital effects but companies claimed their trials only showed a less than 5% rate of sexual dysfunction.
Companies also ensure that no-one ever gets to see the full set of pieces of paper or electronic files in which the figures have been collected. Regulators don’t see them. Government ministers don’t see them. Academics and doctors and guideline makers don’t see them. The Ghosts who write the articles don’t see them. The original bits of paper look like they are kept as offshore as corporate or oligarchic money is.
This withholding breaches the norms of science. If you can’t see the data from an experiment, then it’s no more science than the pseudo-genetics that used to go on in the Soviet Union.
But an even more fundamental issue is that these figures are not data. The data is you and your medical record. Access to the data ultimately means access to you. The figures are meaningless without you. If you aren’t there to answer questions as to whether you did or didn’t have sexual dysfunction on an SSRI, the figures have no anchor in reality. They may as well have been entirely made up.
Pharma say your and your doctor’s relations with them are consensual. Informed consent began life as a means of ensuring you knew that you were about to be given a new product not yet approved.
Companies later slipped in words to consent forms about protecting your privacy. This sounds good to most of us. It doesn’t sound like companies trying to block any scientists who might add up their figures in way that wouldn’t suit their marketing, but this in fact is what it is.
Most of us figure that the point of a scientific exercise is to have independent experts look at the outcome and work out what it means. We take risks with new drugs in order to protect our families and friends and communities. We do not take risks in order to make it easier for companies to tell my family or friends to get lost when something happens to them on a treatment that also happened in the trials of that treatment years before.
RCTs are far from objective. Even when done by angels they are the Gold Standard way to hide Drug Wrecks. And the use of drugs based on company RCTs is as abusive as Harvey Weinstein’s relations with women in the movie industry. Most of the women concerned were in a better position to defend themselves than most patients injured by drugs are.
If you report a problem like PSSD or other problems to a doctor and they don’t believe you, the natural instinct is to turn to experts or tests for support but the key question is Why Does He Not Believe Me?
To be fair, if you have a lengthy history of all kinds of things wrong with you that change from week to week, a reasonable person might figure this explains why you are saying whatever it is.
There are also factors to do with both of you. Both of you operate in a culture where companies squirt a lot of ink in the water aimed at clouding the picture and making all doctors doubt you. This is most extreme when it comes to vaccines, statins and SSRIs where if a doctor accepts your story about being injured he is likely to be branded a scaremonger. He will in general come under informal pressure from at least some of his colleagues who will hint only the unsophisticated believe their patients.
If you’re a woman you are less likely to be believed, especially if you are a young woman – even though you are more likely to be an accurate observer than anyone else. If you are a woman and it has to do about sex you are less likely to be believed. And if you’ve had a label of mental illness, then it’d going to be difficult to be heard. This all stems from the culture around us.
There are factors to do with him as well. It may be he is being paid for getting you on or keeping you on meds or is at risk of losing his job if he pays too much heed to you.
But there are also benign factors to do with him. He probably wants to help. But to help he has to do what physicians have done for two millennia – fit what you are saying into a framework he understands. This might mean in the case of a woman with PSSD or PGAD referring you to Relate or suggesting pelvic floor physiotherapy – physio is a good suggestion for almost anything. If you are a man you will get Viagra.
And you too want him to have a hypothesis, a framework. You don’t want him to try things without having any idea what he is doing.
The trick for both of you is this. Sixty years ago women who complained their infants weren’t right were dismissed as neurotic without a test being done. Fifty years ago if tests came back normal, women complaining about something wrong with their infants were dismissed as neurotic. Forty years ago every medical student was being taught that, even if the tests are normal, you believe the mother. She will usually be right.
Just as the person best placed to know what is going on in her baby is the mother, so also the person best placed to know what is going on in you is you.
In one sense it’s not a matter of believing you or not, it’s a matter of him being open to you or not. He’s not hearing rather than not listening.
On the plus side the more open he is, the more interesting his job is likely to be. Recruiting you as a research assistant on your case is a much better bet than having you as a burden, maybe even a guilty burden.
On the plus plus side, if he doesn’t pay heed to you soon, he is going out of business to be replaced in the short term by cheaper prescribers – nurses and pharmacists – and soon afterwards by robots.
We have to find a way to help him see this.
Faced with patients bringing enduring sexual dysfunctions to them after SSRIs, finasteride or isotretinoin many doctors have responded that this is impossible – the drug is out of your body, there cannot be an enduring effect. But tardive dyskinesia proves this wrong.
There is at present no cure. And there will never be RCT data showing this happens. This unfortunately all gets in the way of him listening.
The company defence is these are anecdotes. No major journal has published anything on the problem. BMJ not surprisingly have turned down the chance.
If you took a case to Court and raised the hundreds of reports with regulators, the companies will call these anecdotes. If the judge didn’t immediately throw the case out the next step would be to label them hearsay. Hearsay is a circle of Hell below Anecdotes. They are hearsay because there are no names attached to them.
Companies have invested a huge amount of time and money recently into getting you to report to regulators rather than to them for this very reason. See American Woman and American Woman 2. Reports to companies have names attached and companies are obliged to follow them up and decide if there is a causal link.
If a company ever does try to get in touch with you or your doctor, they will usually ask for your medical records. You need to be very wary – the main object of the exercise is to find something, anything, in the records that they can use to cast doubt on a link to their drug.
If there is a convincing report of a problem being caused by a drug that cannot be explained away in any other way and the person is prepared to come to court and be cross-examined to back it up, this would no longer be hearsay or even anecdotal.
If your report is backed up by a report from your doctor who is also willing (in principle) to be cross-examined, the entire legal system falls apart if this can be dismissed as hearsay or even as anecdotal.
Your report and your doctor’s are much less hearsay and anecdotal than company RCTs which are ghost-written and where companies are refusing to let anyone come to court and testify that what the company says happened to them is in fact what happened.
This is what we are trying to do with the creation of a RxISK Map. RxISK reports filed by both you and your doctor are a declaration that: