Making medicines safer for all of us

Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs. [Read more...]

Archive for December 2012

101 Uses for a Dead Journal

There used to be a wonderful cartoon series called 101 Uses for a Dead Cat, which led me 25 years ago to give a talk at a British Association for Psychopharmacology meeting entitled 101 Uses for a Dead Psychiatrist. That was back in the days when Psychopharmacology meetings were places of debate and the British Journal of Psychiatry was guaranteed to have something of real interest in every issue. Under a series of editors the Journal was so good that it still inspires affection in the likes of me and an older generation of psychiatrists – worldwide.

Perhaps as a legacy of those times, the British Journal of Psychiatry now runs an interesting little corner in which they invite authors to distill the essence of an issue into 100 words.

This isn’t as easy as it might sound. It’s like composing a haiku or limerick or tweet – if you’re not used to it, it takes time to get the balance right especially when they invite you to write 100 words on Psychiatry and the Pharmaceutical Industry, as they asked me 3 years ago.

After a lot of revisions, this is what I ended up with.

Little Pharma made profits by making novel compounds; Big Pharma does it by marketing. Doctors say they consume (prescribe) medication according to the evidence, so marketeers design and run trials to increase a drug’s use. They select the trials, data and authors that suit, publish in quality journals, facilitate incorporation in guidelines, then exhort doctors to practice evidence-based medicine. Because “they’re worth it”, doctors consume branded high cost but less effective “evidence-based” derivatives of older compounds making these drugs worth more than their weight in gold. Posted parcels meanwhile are tracked far more accurately than adverse treatment effects on patients.

As it turns out, here was a manifesto for RxISK before RxISK was a glint in anyone’s eye. The journal accepted it without demur.

But the climate had been slowly changing with the chill spreading from the heart out to the extremities as happens in the most serious conditions. The journal has been getting a lot less interesting. There are few people I know who confess to reading any of its seemingly evidence based pieces.

I had already had a problem when asked to do a book review – 300 words. Again difficult to distill the essence of an important and complex book like The Loss of Sadness into 300 words. I was pleased with the outcome but the journal wasn’t and approached someone else to provide a review. I thought about protesting but let it pass – this will be a future post.

I was then asked to review one of these in all probability ghostwritten evidence based pieces, an article comparing escitalopram and venlafaxine. This article had a heavy sprinkling of the flaws found in pharmaceutical company trials outlined in Ben Goldacre’s Bad Pharma. I pointed out a number of them and gave a view that the piece was close to worthless – but that the editor might try an interesting experiment. Why not ask the company to post the full dataset linked to this trial in exchange for the privilege of posting in the British Journal? He either never had the nerve to ask the company or else was rebuffed and nevertheless went ahead and published.

Then on September 20th came an invitation to write another 100 word piece – on Antidepressants. It took more than 6 weeks before something took shape. When it did after some polishing I finally felt happy.

Isoniazid, reserpine, imipramine, atropine, stimulants, benzodiazepines, antipsychotics, fluoxetine, ketamine – all have antidepressant credentials. The word coined by Max Lurie has lost meaning; it’s a basket for acronyms. Psychiatry was the first branch of medicine to have specialist hospitals and journals, the first to adopt controlled trials, rating scales, and guidelines. The antidepressants beckoned us toward clinical neuroscience but have led to myth, hidden data, ghostwriting, more lives taken than saved, womb to tomb consumption, and an increased incidence of “depression” from 1 per 1,000 to 1 in 5 of us. Knowing when not to prescribe is the greatest art in medicine.

The response was:

Dear David

Thank you, that’s excellent. I will show it to the Extras Editors for review and will get back to you with their decision.

A week later it was:

Dear David

The Extras Editor has reviewed your 100 words and is happy with it generally, but has some reservations concerning the phrase ‘more lives taken than saved’ – would it be possible to tone it down or omit it altogether? The Editor feels that 100 words is not a good place for a polemic and that we should present a consensus view held by the profession in general, which may not pertain to this particular phrase… One other thing is that all the drugs mentioned in the text but Prozac are referred to by their generic names, shall we call it fluoxetine for consistency?

I responded:


I can happily concede the switch from Prozac to fluoxetine but ‘more lives lost than saved’ is a completely evidence based position – I can provide all the data for this. It would simply not be possible to say the opposite. I didn’t think these pieces were aimed at giving a supposed consensus view – I had assumed they must inevitably be viewed as somewhat idiosyncratic.

[For the record the entirety of the placebo controlled trials database on antidepressants (over 100,000 subjects) shows an excess rate of deaths on antidepressants compared to placebo].

To which the reply on December 18th was:

Dear David

I hope you are well. I am afraid I don’t have good news regarding your 100 words on antidepressants. The Editors have deliberated further on whether to publish it and decided they could not, unfortunately, publish it in its current form. We are very sorry for this outcome and are grateful for your time and efforts.

Wishing you a Merry Christmas and a bountiful New Year.

Almost anyone I know who goes to the United States these days is astonished by the level of fear there among anyone working in the mental health field – fear to express any criticism about drug therapies, a fear to lower doses, or reduce treatment cocktails from 5 or 6 drugs to 1 or 2. The land of the free and home of the brave seems anything but these days.

Things feel better than this in Britain but there is all the same a marginalization of “dissent” and a greying of the landscape. The British Journal of Psychiatry has become exceedingly grey – although its current edition has an opinion piece by Pat Bracken and colleagues.

Twenty-five years ago friends from North America thought Britain was in decline. They remarked how the country couldn’t even afford to mow the grass that grew on the verges of or in the central reservations of motorways. The place was looking scruffy.

No, no I told them it’s a really clever idea. The country was being so intensively cultivated elsewhere that there was a real risk of a loss of biodiversity and letting strips of meadow flourish in the margins of motorways was a creative use of this land. Most of them I’m sure didn’t believe me – some of them I know didn’t.

Britain still has flourishing meadow grasses and plants along its motorways, but its academia it seems cannot allow anything slightly “wild” to grow in the interstices of their journals.

This is at a time when the editors of major British journals in particular see fit to use their journals as a pulpit to pontificate (offer their personal non-consensus views) on issues, while at the same time increasingly denying other voices.

Perhaps we should give up the pretense that this is a Collegial Journal, a journal for Fellows and Members. Where’s the collegiality in getting missives from nameless Editors relayed through someone even though she was quite delightful.

The current Editor in Chief started his term of office by saying he was proud that the British Journal of Psychiatry published articles like that by Healy and Cattell on Ghostwriting in Medical Journals. While the current edition has a call to action by Bracken and colleagues, it also has one by Arthur Kleinman that refers to the need for a Global Mental Health movement. This is certainly a well-intentioned piece but probably offers one of the best examples there is of the capture of evidence-based-medicine by the pharmaceutical industry of which more in the New Year.

It was the “Merry Christmas” what did it.

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 The Data Access Wars, but her spirit is also present in Randomized God, If Pharma made carsMay 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

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. SSRIs 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

RxISK Stories: If You’re Going To Look After Patients, Man Up

Man up!

This post also appears on and can be viewed here.

Pharmalot has just posted a piece – ‘Controversial FDA official, Tom Laughren, retires.’

This is a must read for anyone with anything to do with mental health – both the post and the comments afterwards where some have posted that they still believe the Black Box warnings on antidepressants arose because of pressure from the Church of Scientology rather than in response to the data.

Despite my billing as a must-read, the Pharmalot post will likely seem boring to many. But the comments won’t – they seethe with anger. This is one of those cases in which if you weren’t there its hard to appreciate the depth of feeling this man generated in many as he – and a few others including Paul Leber and Bob Temple – appeared to stand in the way of natural justice and patient safety. The most comprehensive cover is on the AHRP website where Vera Sharav dubs Laughren a double-agent.

He seemed a quiet man. He was grey. He behaved like a functionary. But he was the focus of one of  the most dramatic moments I have ever witnessed. This was at the FDA hearings about antidepressants and suicide in children, some 8 years ago now. Because of FDA procedures, the public get a chance to offer views. There were 73 three-minute slots. At this hearing a range of doctors and other men usually with affiliations to pharma spoke against the Black Box warnings and it was down to a series of mothers to plead for warnings.

Many of the pleas were aimed straight at the bureaucrats – Laughren and Temple. The moment is at the center of Pharmageddon, where I compared what happened then and happens over and over to the Greek Myth in which Demeter implores Zeus to restore her child to life. It is appropriate perhaps in that unlike the other Gods, who were dashing and colorful, Zeus often seems to have the character of the bureaucrat who ran Olympus rather an all-powerful Jehovah.

Demeter’s stories

Demeter was the Greek goddess of the Earth and of fertility whose daughter, Cora, was forcibly abducted and carried off to the underworld by Hades. Demeter protested to Zeus, who professed himself helpless, until Demeter threatened Earth with permanent Winter. Zeus intervened and restored Cora to her mother as Persephone. Because Persephone had eaten some pomegranate seeds while in the underworld, however, she must return to Hades each year, the several months of Winter each year.

Winter’s tale

Mary Ellen Winter confronted Laughren and the FDA about her 23-year-old daughter, Beth:

“Beth was looking forward to a career in communication and was experiencing some anxiety and having trouble sleeping when she consulted our family physician. He prescribed Paxil and said she would start feeling better in two weeks. Seven days later Beth took her own life.

We, like most of you in this room, grew up with confidence in the strides made in medicine and accepted with faith antibiotics and vaccinations prescribed. We believed the FDA would always act to protect our family’s well being. When my daughter went to our family GP last year, we trusted that our doctor was well educated and informed. We were wrong. We now know that pharmaceutical sales are a high stake business, driven to increase shareholder wealth. The consolidation of pharmaceutical companies like GlaxoSmithKline has resulted in increased sophistication in the quest to market and distribute pharmaceutical products. Priority has moved from health to profit. Not all doctors are equipped to understand the marketing targets they have become. The FDA has allowed our daughter to be the victim of a highly commercial enterprise that selectively releases clinical data to maximize sales efforts and seeks only to gain corporate profits…

As residents of the State of New York, we thank our Attorney General, Elliot Spitzer, for addressing issues that the FDA has been unwilling to address…”

[This action on the part of Ruth Firestein within Spitzer’s department in many ways triggered the Access to Data issues that have since engulfed GSK and gave rise to the recent EMA hearings and a debate within RxISK and its supporters about what to do with the data that arises from people reporting to RxISK].

Thy neighbour’s child

But Demeter came right into the room in the last but one slot when Mathy Downing singled out Tom Laughren:

“On January 10, 2004 our beautiful little girl, Candace, died by hanging four days after ingesting 100 mg of Zoloft. She was 12 years old. The autopsy report indicated that Zoloft was present in her system. We had no warning that this would happen. This was not a child who had ever been depressed or had suicidal ideation. She was a happy little girl and a friend to everyone. She had been prescribed Zoloft for generalized anxiety disorder, by a qualified child psychiatrist, which manifested in school anxiety… . She had the full support of a loving, caring, functional family and a nurturing school environment.

Her death not only affected us but rocked our community… When Candace died her school was closed for the day of her memorial service, a service that had to be held in the school gym in order to seat the thousand or so people who attended. How ironic, Dr. Laughren, that your family attended Candace’s memorial service. Our daughters had been in class together since kindergarten. How devastating to us that your daughter will graduate from the school that they both attended for the past eight years and that Candace will never have the opportunity to do so.

Candace’s death was entirely avoidable, had we been given appropriate warnings and implications of the possible effects of Zoloft. It should have been our choice to make and not yours. We are not comforted by the insensitive comments of a corrupt and uncaring FDA or pharmaceutical benefactors such as Pfizer who sit in their ivory towers, passing judgments on the lives and deaths of so many innocent children. The blood of these children is on your hands. To continue to blame the victim rather than the drug is wrong. To make such blatant statements that depressed children run the risk of becoming suicidal does not fit the profile of our little girl.” [1]

Laughren’s defence

I cannot remember seeing anything ever about or by Tom Laughren where I have thought you know the man’s right on that – except the bits where he has been dragged screaming to a table and been forced to agree. But in the Pharmalot obituary on his career there for the first time was something where I jumped and said “Yes, he’s right on that”.

In another setting, faced with a barrage of criticism of FDA, “Tom Laughren, director of the FDA’s division of psychiatry products, told the panel that the agency could do little to fix the problem and, instead, pointed the finger at medical specialty societies, which he insisted must do a better job educating doctors about side effects”.

He’s right. Doctors are failing patients far more than FDA. (See Professional SuicideModel DoctorsWe need to talk about DoctorsScaremongers of the world uniteSo Long and Thanks for all the Fish). Doctors have become infantilized for whatever reason and turn to a parental figure, a Zeus, to rescue them. If you take on the responsibility of looking after people the very least you can do is Man up – or better again Mother up.


The next two Crusoe posts will deal with these issues. It seems right to mark the end of one year and the start of the next by stepping back from the realm of real human drama and place these in their mythic context. Taking the issues out of the domain of data, science and real clinical histories into the realm of myth seems to confuse some readers – the hope is rather to engage with a wider readership and get artists or story-tellers or poets to engage with RxISK and its issues – as Bill James has done with his cartoons and images. We are dealing here with lives and in particular the fact that we each have one life only. The two Crusoe posts will attempt to capture the spirit of RxISK.

[1] Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Monday Sept 13th 2004, p 435.

[2] Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Monday Sept 13th 2004, p 332.

The Data Access Wars

This is the first of three Crusoe posts. For background on Crusoe, see Watch where you wave that wandThe Oedipus EffectThe Tree must go.

What does your doctor know about your medicines?

Beta Centauri was unquestionably a long way from Massachusetts. Somewhat to her surprise Crusoe found breathing no problem, and the temperature seemed just about right. The scenery as they’d come in was not unlike that of a temperate zone on earth.

Walking around, she had begun to wonder if there were clinics there when she spotted the entrance to what was unquestionably a medical facility. Going in, she found a procedure in progress. It seemed sophisticated – no anaesthesia. Wounds from battle or other encounters seemed to heal under the touch of a vibrating instrument passed slowly over them. In other cases apparently normal limbs turned out to be quite artificial, and repairing them was entirely bloodless. This was a new frontier.

But it was another building that ultimately drew her attention. Where only those in obvious need of care for something like a severed limb went to what she would have called a clinic, everyone came to this other building at some point. Here the staff administered a supply of some substance. The same for everyone. Crusoe took some. She noticed no effect.

What was it? She didn’t want to ask as who knew what would happen if the Centaurians realized she didn’t need what it seemed they did. It was only in one of the taverns in town, after a few drinks, that she was able without raising suspicions to get someone to tell her what went on in the building.

Some decades earlier, faced they were told with a looming pandemic, the entire population of the Economy was vaccinated. This was done compulsorily. The Corporation was the only body who held supplies of the right vaccine. While treatment may have saved them from something, there was a side effect.

This was not spotted at first – at least this was how Centaurian history recorded it. The vaccine knocked out a gene and all children borne after that were short of a protein – alpha-nucleositol, without which life was impossible. Fortunately very few children died, as when the problem declared itself in the first few children, the Corporation rushed out supplies of alpha-nucleositol and supplied it to everyone. Provided they took it, everything was okay. It came free of charge but with a requirement for annual screening.

No-one knew quite what was being screened for. But there were rumors. Some said that if the screening revealed that the subject held aberrant views on the Economy or the merits of the Corporation, the person’s supply of alpha-nucleositol was terminated. Everyone, including bioethicists and others with no links to the Economy or the Corporation, justified this on the basis that the Economy couldn’t be expected to support the continued existence of those who disagreed with its principles.

Every so often small groups it was rumored escaped with a supply of alpha-nucleositol, and headed it was said for some planet on the outer limits of galaxy, where it was rumored that someone had synthesized a gene for alpha-nucleositol.

What Crusoe needed she realized was information on where they were going and someone she could trust to get her there. Where’s Harrison Ford when you need him?


This take on Star Wars is not as remote as it seems. It’s happening on the planet right here beneath our feet.

Quite innocently some decades ago a network was set up by Silvio Garattini among others to investigate rare diseases. This later gave rise to Eurordis, an organization to speak on behalf of patients with rare diseases.

An organization of patients and by patients and for patients sounds like a wonderful thing but far from being a sanetocracy it has turned out to be an insanetocracy.

As it happens as of 2011 Eurordis took funds from 38 different pharmaceutical companies. These only amounted however to 22% of their income. Financial conflicts are not really the issue – they could survive without the money. It’s something else that keeps them tied to the Corporation. This is the patient group for whom pharmaceutical solutions are a lifeline. They are more committed to the interests of the pharmaceutical industry than are any of the employees of any of the pharmaceutical companies.

They can be absolutely depended upon to read the runes right and come out with a strong industry position, making it possible for industry representatives to sound relatively accommodating to others in contrast – as they did at the European Medicines’ Agency meeting on access to clinical trial data in November.

Eurordis don’t want anyone to know about any planet where you might get your gene transplant and they want us to ban anyone who is not a certified pilot or who might be flying some battered old jalopy. Han Solo and Indiana Jones not welcome.

Illustration: Data Wars, 2012 © Billiam James

Access To Clinical Trial Data: Privacy rights, property rights and phoney rights


At the European Medicines’ Agency meeting held on November 22nd convened to look at the issue of Access to Clinical Trial Data, the pharmaceutical companies came armed with an approach signaled a few weeks earlier by GSK’s Andrew Witty (see Won’t get Fooled Again). The industry panelists came from Lilly and UCB along with a representative from EurorDis Francois Houyez.

Possibly for the record, industry quietly raised their commercial interest in data secrecy in a jaw dropping argument that slipped quickly out of focus. Companies want to keep the data secret so that if for instance their drug gets rejected in Europe, they will still be able to submit the dossier for approval in Canada or Australia or India or wherever. Individual companies also want secrecy so that if they have wasted a lot of money finding out something doesn’t work, other companies won’t be able to save money through their experience.

But this was a footnote to the main show. Faced with a cogent and consistent case for access presented by Peter Gøtzsche, Ginny Barbour and Ben Goldacre, the response was that we in industry want to protect patient privacy and ensure good research governance – we can’t have wild men descending from the hills doing just anything they want with the data. These points were all made most clearly by Francois Houyez on more than one occasion. This was entirely predictable. See Won’t get fooled again and Access to RxISK Data.

Protecting vulnerable companies

The consent forms for industry trials do offer to protect your privacy. The data will be held by the company and only made available to regulators that a company might decide has an appropriate interest. No one who signs these forms realizes that this means we will be hiding your data potentially from everyone for ever while in some cases we will let regulators, who have proven singularly incompetent when it comes to detecting safety issues and whom we for the most part fund, see a part of the data. Even if they ask for all of it – we have a multitude of legal ways to frustrate such requests.

In months to come as the issue hots up expect to hear more from Eurordis. Eurordis will be covered in greater detail in a forthcoming post Access Wars. You will hear Eurordis or other rare diseases patients representatives telling you that as a professional patient group, one of the most influential in the field, with close links to regulators and companies, they are campaigning hard to protect your privacy. Most casual hearers of this message will likely be grateful their interests are being looked after – and who better to do it than a group speaking on behalf of patients.

Hiding the data

The problem here is that most people view the consent form as an invitation to participate in a scientific exercise. This invitation comes with an implicit understanding that the data that arises from the risks we take with medicines will be made available to the scientific community. Few of us would be likely to agree to have our data hidden. But this is what we are being asked to do in disguised form.

The disguise needs to be discarded. Now that the European Medicines’ Agency have agreed to make data publicly available, patients like Francois Houyez need to be able to opt out of scientific exercises if they wish. Heaven forbid that they get confused by the mixed messages being put in the public domain at the moment.

The disguise needs to be discarded so that you and I can be certain we are not putting our friends and families and communities in legal jeopardy. If we consent to have our data hidden we are putting them in a state of legal jeopardy. We in fact do worse than this – we threaten some of the fundamental rights of people we know and love by our participation in clinical trials where the hiding of our data by making it seem like the drug has no side effects in scientific studies makes it impossible for anyone injured by a drug ever to seek redress. Hiding our data makes it impossible for people we know in many cases even to achieve recognition that their treatment may have produced an adverse effect.

Only proper scientists should get to see the data

The second point industry tried to hammer home at the EMA meeting was that “we” need to ensure the right analyses are performed on the data. We need to make sure that patients don’t view the data and come to the naïve conclusion that an increased rate of adverse events on a drug means that there is an increased rate of adverse events on the drug. Even scientists are prone to making what industry call a Type 1 error – concluding that an increased rate of adverse events points to an increased rate of adverse events.

We go to great trouble to make sure any adverse events that crop up in our trials at an increased rate cannot be statistically significant and we don’t want all this work undone by someone saying something about new clothes.

Francois Houyez was very alarmed at the idea that a company or regulator might be saying one thing in public and someone like Ben Goldacre or Peter Gøtzsche might be saying another. This would confuse patients. It would dangerously add to the burden they already bear.

The supreme court v big pharma

But in fact the Supreme Court in the United States has ruled on just this issue. In January 2011 in the Matrixx Initiatives Case, Matrixx was accused of failing to declare anosmia (loss of the ability to smell) as a side effect of their cold remedy Zicam. The company claimed that as the data on anosmia was never shown to occur at a statistically significant rate, it was under no obligation to tell people. The Supreme Court disagreed it said people needed to see that data and needed to be able to make up their own mind whether an increase in the rate of anosmia was a risk worth taking.

They needed to be able to see the data and decide if the increased rate of anosmia was a risk worth taking if they were going to invest in Matrixx.

The rule therefore for you if you are an investor is you get to see the data and make up your own mind what it means. But if you are a patient, Francois Houyez, GSK, and other pharmaceutical companies are proposing a different set of rules for you. If you are taking risks with your life and health you can only have what the drug company decides you can have. The historical record shows that company perceptions of what information you should have are shaped more by their commercial interests than any concern for your wellbeing.

A medicine is…

A medicine is a chemical that comes with information. What is consumed is a combination of chemical and information. The information is what distinguishes a medicine from a chemical. If we are taking a medicine based on false information we are being duped into taking something other than what we might consent to take. Worse again we suspend the natural caution we would have about taking chemicals.

NEJM and JAMA as a source of spam

Its not clear there is any such thing as a right to privacy – governments and corporations snoop on us the whole time. But in so far as any of us have a “right” to a particular religious belief we have an equivalent right to make up our own minds or have a third party of our choosing make an assessment for us as to what the data on a medicine shows. If someone else in whom I do not have confidence makes the determination as to what the data shows, my rights to bodily integrity are at a risk of being violated in a manner that I have not consented to. My privacy rights are being at least as assailed as they are by spam-mailers and cold-callers. In this regard leading journals such as NEJM and JAMA have slipped into the position of being the greatest purveyors of  Spam today (Selective Publication and Academic Miscarriages).

Who owns your baby?

In the face of issues like this, many have been asking for years “who owns the data that arise in clinical trials”? It seems very clear that Industry don’t or don’t in all circumstances as in certain legal cases they have taken care to ship data off the US mainland. Ownership of the data is not as much an issue in Europe where there is almost no possibility of taking a successful legal action against a pharmaceutical company.

But the ice is very thin here. All right minded people – which for most of us means people who think like me – might instinctively feel that the people who take risks with medicines in clinical trials at the very least own their bit of the data. But if we do, we need to make sure we don’t mean something like ownership in the sense of property rights. This is a Trojan Horse moment – beware Pharma bearing gifts. It would suit Industry nicely to magnaminously offer patients like Francois Houyez ownership of their data if that meant property rights. Another wonderful press release for GSK. Except in this case we would all end up in a market where data gets sold to the highest bidder.

Ask not what GSK can do for you, but what you can do for GSK?

The paradox here is that almost all the advances in medicine and in science come from sharing rather than ownership. As Annemarie Mol makes clear in one of the greatest books written about medicine – The Logic of Care – it is a calamitous mistake to view patients as consumers. It is nearly as bad a mistake to view them as citizens – although it sounds far less problematic to ask what you can do for your country.

The idea of progress through sharing might sound like something close to socialism. It’s not intended to be. This is certainly not the usual social response to market aberrations which is to call for more regulation. Introducing concepts like ownership rights might sound like a good way forward but it risks being a recipe for handing over the latest rule book to the most powerful. The answer to unaccountable power is usually co-operation.

Aside from a belief that clinical trials are simply not the right way to investigate adverse events, RxISK is founded on the principle of co-operation. The model, if there is one, is more like the one that underpins the voluntary sector or better again the relationship between a mother and child or daughter and parents. This produces extraordinary economic benefits without a need for contracts or rights.