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 God, If 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.

Shipwrecked by the Cure. Created by Billiam James

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 doctors, Scaremongers of the world unite, So 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.

Illustration: Shipwrecked by the Cure, 2012 © Billiam James

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  1. Thalidomide has returned, after having been found to be effective for several conditions including multiple myeloma. Thalomid is the brand name sold by Celgene Corporation, and is now licensed in Canada In certain trials in recent years, “thalidomide demonstrated benefits in multiple myeloma patients and is being made available in Canada to treat those patients who are 65 years of age or older.”
    In 1998, thalidomide was approved by the US Food and Drug Administration (FDA) for the treatment of leprosy. In 2006, a new FDA approval was granted for thalidomide in combination with dexamethasone for the treatment of multiple myeloma. Thalidomide is also approved in other countries including Australia and the European Union.
    Health Canada has “carefully reviewed” data on thalidomide and the drug is only available through a controlled distribution program called RevAid. This means only doctors and pharmacists registered with RevAid can give out the product, and all patients must be registered in the program. Prescriptions only last for a limited number of days and women patients who may become pregnant must have regular checkups to make sure they are not pregnant while taking the drug, and must use two forms of contraception. Patients must also not donate semen or blood during, and four weeks after their thalidomide treatment. (Perhaps abstaining from sexual intercourse might be safer.)
    Never let it be said that BigPharma will miss any chance to use drugs that have been languishing in their warehouses.

  2. Many years ago, it was recommended that consent forms should be written at no higher than an 8th grade level since many patient did not actually understand them. I don’t believe that was ever done. Now we find, to no surprise that medication guides, provided to patients with certain prescription medications, “fall below the threshold of acceptable standards for patient print materials set by both professional societies and the federal government,” reported in the Journal of General Internal Medicine.
    The authors assessed 185 FDA-approved medication guides and rated only one as “suitable” overall for readability and ease of use. Only seven guides had an 8th grade reading level or less. None provided reviews or started with context. Roughly 30 of the guides had been assessed in 2006; some had improved readability, but others had declines.
    In addition, about 450 English-speaking adult primary care patients were asked to rate their comprehension of medication guides for Ritalin, morphine sulfate, and Aranesp. The mean comprehension score was low (53 out of 99).
    The authors recommend that a uniform standard for medication guides be developed.
    How, then, is informed consent to be given?
    Journal of General Internal Medicine article (Free)

  3. It was painful to read about the last hours of MP Ann Clwyd’s husband, who she charged was neglected and callously treated as he lay dying in a Cardiff hospital. She’s right; this shouldn’t happen to anyone. But is a culture of cruelty among nurses to blame? (It sounded too much like the scapegoating of schoolteachers over here, and for similar reasons.) I found a columnist in the Guardian who tried to give a nurse’s-eye view of the problem:

    “After I sent out a single tweet asking nurses to come forward with their opinions, my inbox was flooded within minutes. Nurses and their sympathetic colleagues were desperate, it seemed, for the public to understand that in many cases they are simply unable to fulfil their duties because the resources are not available.

    “One nurse told me that she worked a shift where there was no clean linen available in the entire hospital and patients had to lie in their beds naked: “I hated seeing my patients like that.”

    “A trainee midwife talked about a patient who went into labour when there were no available beds for 125 miles: “She ended up having an antepartum haemorrhage. She wouldn’t have made it if this had happened a few hours earlier in transit.”

    “A mental health nurse emphasised the effect on morale: “We are struggling and distressed because we know our patients are not getting the support they should, and feel we aren’t meeting our code of conduct as we can’t provide care to the standard that we should. Colleagues are regularly in tears.”

    “Doctors contacted me to support the nurses they work with. One explicitly blamed a perceived decline in compassion on cutbacks: “Compassion time is squeezed out of the day and sacrificed on the altar of efficiency.”

    That last quote is striking. It’s a bizarre world where we’d have to defend “compassion” in medical care, even purely for its own sake and as a value all its own. But what kind of “efficiency” can you have in the long run in a health care system where the individual patient is silenced and dealt with like a thing? At too many hospitals in the U.S. – and practically all the nursing homes – the labor of registered nurses is considered too expensive a commodity to “waste” on feeding the patient, talking to him or taking him to the toilet. That’s done by harried, poorly trained aides whose labor sells for less than that of grocery store cashiers. If our patient can’t get from the bed to the toilet, is it because he’s dizzy? Because his legs are weak? Because he’s losing the will to live? The aides may not know, and the nurse will have no idea, because she won’t be summoned until there’s a crisis.

    If your goal is simply hold down costs or “maximize billable hours” this may look like efficiency – but if your goal has something to do with healthier people, it’s the opposite of efficiency. It seems to me to be very like what’s happening in psychiatry and elsewhere, with medications being dispensed on an assembly-line basis as a substitute for care. Maybe we ought to say that a drug – a safe drug – is a chemical that comes with people attached. People who are allowed to give a damn.

  4. That is very, very good. A chemical that comes with people attached.

    It’s always the luck of the draw when forced to interact with anyone at all in the old fashioned ‘caring profession’. It has all gone pear shaped, not only with lonely old people who no-one cares about, but with someone who walks in the door of a surgery and says ‘I don’t feel very well on this drug.’ From then on the decisions are out of your hands. Once, again, Russian Roulette.

    No one contemplated Thalidomide. It was horrific and yet, nothing happened for over fifty years. An apology was granted not long ago. This week, these seriously disfigured people are to receive some money because they are old now, and it is difficult for them to chop vegetables, when they have no arms or legs and, which they did manage, but now they are old, they now cannot.

    I am hoping that we do not have to go through fifty years of blatant denial regarding ssri injuries, and although, we kept our arms and legs, something valuable and intrinsic to our life was taken from us. Taken from us, and worse, thrown back in our face.
    By this, I mean, us, watching the incredible twists and turns of an industry, designed to weaken the sufferers, not strengthen them……..and that is the curse of new ‘medicine’ today equipped with the ‘drug dealers’……….’modern’ doctoring……
    This is another Thalidomide and where are we now…………..
    We have gone back fifty years……….and who would have thought it??

  5. Merry Christmas Dr. Healy!
    Thank you for your work and dedication.

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