The Shipwreck of the Singular

Crusoe’s first appearance was in The Creation of Psychopharmacology, where in recognition of the tensions inherent in medicine between the numerous who enter clinical trials and the single person being treated by a doctor, the book opened with a quote from George Oppen’s Of Being Numerous, in which he notes that: “Crusoe we say was rescued”.

Since Oppen wrote these lines, the idea of the perfect ultra-short story has caught the imagination of many. Competitions have been run in an attempt to equal or surpass Hemingway’s 6 words:  “For sale: baby shoes, never worn.”

“Crusoe we say was saved” is only 5 words and is not just a story but one with a perfect post-modern twist.

Crusoe deals in ambiguity – how apparent progress can give rise to new problems or even new evils. You will hate her if you are the kind of person who thinks good intentions the most important thing there is. She lives in a world in which as Gandhi put it: “He who would do a great evil must first of all persuade himself he is doing a great good”.

Sometimes its better to be less certain.  And here a mythic image can unite us in the way that holding hands in the dark can.  To check out who you’re holding hands with, Crusoe appears in Watch where you wave that wandThe Oedipus EffectThe Tree must go and Data Access Wars, but her spirit is also present in Randomized GodIf Pharma made cars, May Fools’ Day and One Script to rule them all .  She will appear again in a companion piece on January 1st – The girl who wasn’t heard when she cried wolf.

The Pharmageddon Three

Pharmageddon is about how three obviously good things we did to manage the pharmaceutical industry (for its own good of course) have given rise to the increasing threat that modern medicine poses to our safety and sanity.

1/         Making clinical trials mandatory for regulatory purposes. This was supposed to keep us safe in heavenly health by forcing the financial camel that is the pharmaceutical industry to squeeze through the eye of a scientific needle. But harnessing trials for this purpose has transformed their role from one of puncturing therapeutic bubbles into one of providing the fuel for therapeutic bandwagons, and has degraded them from scientific experiments to a mechanical exercise adapted to the convenience of bureaucrats.

2/         Prescription-only status for new drugs. This regulation aimed at bringing hazards to light and protecting vulnerable patients but is now a means whereby the major hazards of new drugs take 10-15 years to come to light and it is only after campaigns by injured patients that doctors ever concede there might be a problem. Doctors have become a risk-laundering system. Thalidomide might still be on the market if it had been prescription only.

3/         Rewarding companies with product rather than process patents for drugs. We have, possibly accidentally, over-rewarded pharma. Or product patents may have been a deliberate move by the United States to capture the European pharmaceutical industry. At a time when medicine has been captured by pharma, and doctors have been hypnotized to focus on clinical processes rather than clinical outcomes, patents might ironically be the one place in medicine where the process should be the outcome.

Crusoe’s other conundrums

1/         Eurordis. It sounds like a wonderful idea to form an organization for patients with rare diseases who would lobby Pharma to do something they didn’t want to do namely to focus on rare conditions for which the market returns might have seemed slim. But Eurordis and other rare disease organizations have now become one of Pharma’s most treasured conduits. These groups can be depended on to take Pharma’s side even though very little money changes hands – See Data Access Wars and Access to clinical trial data.

2/         Ownership of clinical trial data. It might seem like a good idea to have patients own their own data but ownership in this sense is a Trojan Horse. If you own something you can sell it and this will kill science. Imagine someone coming along to a scientific experiment who was only willing to let their piece of apparatus be used to find out what the universe is made of if an appropriate fee is paid beforehand.

It is not clear who owns clinical trial data. If pharmaceutical companies do not own it, the only proper course of action is, companies will say, to make the patient the owner. This sounds almost benevolent except it will transform patients into livestock at an auction.

3/         Eliminating chance through statistical significance testing – reliable analyses is what the pharmaceutical industry call this –  sounds like a good idea. But rather than producing reliable knowledge, claiming we only know something when the findings are statistically significant in fact induces a psychosis, causing both doctors and patients to discount the evidence of their own eyes. A reverse Macbeth problem – “I see no weight gain or muscle wasting or heart attack before me”.

4/         Quality improvement. We should monitor what doctors do – everyone can improve their performance. Having someone stand there with a tickbox to monitor what is happening in clinical care sounds like a good way to produce steady improvement.  In fact in close to 100% of cases the process becomes the outcome. And as the quality of the process improves the quality of the outcomes deteriorates.

There is no better way than this to transform doctors into factory doctors.  Set a target they should meet – screening 80% of patients who have asthma and pretty soon the relationship of doctor to patient will be changed from one in which you consult your doctor when you have a problem to one in which your doctor will summon you to be screened and tell you you have a problem even though you might feel perfectly well.

5/         Outcome data. Doctors should monitor what in fact happens when they do things. Mortality should be low and there should be little variation between centres. But if the treatment is one that shouldn’t be done, as in the case of hysterectomies or giving statins for primary prevention of cardiovascular disorders you can have perfect mortality statistics and almost no variation across centres but a disastrous outcome.

The best example of this are  recent approaches to mandatory vaccination for influenza and other disorders in which rather than count outcomes such as the number of living and dead in those vaccinated or not, quality services are determined by compliance with policy. If everyone is vaccinated the outcome is deemed good, whether or not there are more dead bodies.

6/         Reporting adverse events to regulators. Companies increasingly encourage people and doctors to report adverse events to FDA. This sounds marvelous and something like turkeys voting for Xmas. But in fact companies advocate this deliberately because they have a legal obligation to follow up reports to see what happens to patients whereas FDA don’t. This demonstration of corporate responsibility is in other words a way to transform drug induced injuries into anecdotes with no legal or policy implications. Unbelievable though it sounds this is the most devious and best way ever devised to hide the data – as the American Woman story demonstrates.

7/         Drawing up standards of care – guidelines – will help shield us from rogue doctors. In fact guidelines – especially the most independent guidelines – have become the greatest marketing tool for the pharmaceutical industry who have learnt how selective publication and creating new disease indications can capture a guideline completely. Guidelines then become a threat to the future employment of doctors practicing a medical care that is at odds with what pharmaceutical companies wish. In the United States at present, certainly within the mental health field, they have produced an extraordinary fear and paranoia with doctors unable to contemplate reducing medication in either number of different medications or dose.

There are two ways in which guidelines might work. One is a set of guidelines that outline treatments that should not be given. The other is a set of guidelines that outline where data is missing – that outline what we do not know rather than outline what it is pretended we do know. The Data Based Medicine Guidelines on dopamine agonists, antidepressants and mood stabilizers attempt to do this.

8/         In clinical trials, we should protect patient privacy and confidentiality. This sounds wonderful until placed in informed consent forms where it means, pharmaceutical companies will hide your data for ever.

9/         Medical staff should undertake ongoing educational assessment to remain up to date, and should demonstrate this openly to the public. The intention here is that doctors should have a real and continuing engagement with science.  But this is not measurable. The outcome will be a series of boxes to be ticked that get in the way of doctors asking real questions. Because industry do box ticking better than anyone else, this is guaranteed to hand healthcare professionals over to the marketing departments of pharmaceutical companies or their surrogates.

10/       Doctors should stick to what FDA approve and should not prescribe off-label.  If my roofer put an unapproved material on my roof I would be furious. But the so called approval process for drugs is about approving the wording of advertisements – it is not about setting standards for treatments that work nor is it about regulating the practice of medicine. The most effective treatments in medicine are off-label.  SRRIs are much more effective for premature ejaculation than for depression.

Forcing doctors to prescribe on-label would hand over medicine to the pharmaceutical industry. As it is doctors are increasingly scared to prescribe off-label – as they come more and more under the control of Sauron’s Eye. As Tom Laughren might have said but didn’t quite, doctors need to Man Up

11/        Everything would be okay if doctors just declared their conflicts of interest. The trouble here is we want doctors to be biased toward treatments that work and the best possible evidence. Someone with no conflicts of interest might be nice to go and talk to but if I need something done this kind of person is not going to be much use to me. The problem with doctors and conflicts is that they have lost sight of the fact that they can’t prescribe the best rather than the latest and the fashionable if they don’t have access to the data, and if they can’t stand up to pharmaceutical companies they have no brand value. They are like salt that has lost its bite. (Model doctorsScaremongers of the world uniteSo long and thanks for all the fish).

12/       The Mencken paradox. Most of these perversions arise from efforts to find solutions to problems – which suggests that the insoluble problem is our need to have solutions. Solutions end up being problems.

To adapt HL Mencken; “Every complex problem has many simple solutions – all of them wrong”.

Chuang Tzu

Or as Chuang Tzu put it in 323 BC;

“For security against robbers who snatch purses, rifle luggage, and crack safes, one must fasten all property with ropes, lock it up with locks, bolt it with bolts. This is elementary good sense. But when a strong thief comes along he picks up the whole lot, puts it on his back, and goes on his way with only one fear; that ropes, locks and bolts may give way.”

On Fridays

The unsolvable problem medicine faces is that each of us is shipwrecked in the singular. When on a Friday running from a threat to our life we seek refuge in Crusoe’s clinic, we have to hope that a basic humanity asserts itself. We have to hope that Crusoe has not been trussed in guidelines, and quality improvement programs, and that she is not being slowly cooked in a management pot. We have to hope that she is not part of a system in which cruelty has been normalized – as Ann Clwyd put it so devastatingly a few weeks ago.

We have to hope that Crusoe has not been saved. If snatched away, those of us who turn up on Friday will have to mount the mission to rescue her.