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...]

Author Archive for David Healy

Study329.org: The Panorama Files

science with a conscience 3

Study 329 is probably the most famous clinical trial ever. It is one of the few to attract a Fraud action and is certainly the only one with a $3 Billion fine linked to it. See A Milestone in Drug Safety.

The study began recruiting adolescents to Paxil, imipramine or placebo in 1994 and finished up in 1998. Later in 1998, SmithKline Beecham, the marketers of Paxil (they hadn’t discovered it), acknowledged in an internal document that the study had shown that Paxil didn’t work for children. This lack of benefit was something they were not inclined to share with the outside world. Instead they decided then they would pick the good bits out of the study and publish these.

The good bits led to a publication in 2001 – Keller and 21 others – in the Journal of the American Association of Child and Adolescent Psychiatry, which boasted that it was the journal with the highest impact factor in child psychiatry.

The authorship line was KoL-to-die-for-country.

At the time most of us were still innocent. Few would have guessed that no one on the authorship line might have had any meaningful input to the paper. Few would have guessed that none of the “authors” except perhaps the company personnel had seen the data.

The real author in the sense that most people in the street would recognize as authorship was Sally Laden. The study made Sally perhaps the most famous medical writer ever. But even she had not seen the data.

This is a woman who concedes that “There are some data that no spin can overcome”. Not having access to the data may make it easier in tricky cases.

The Keller and 21 others paper was published in July 2001. A month previously the Tobin trial in Cheyenne Wyoming returned a verdict against GSK (formerly SKB) and Paxil in a multiple homicide-suicide case.

The Tobin verdict and the facts that GSK was then the biggest pharmaceutical company in the world, and was notionally based in Britain, and that Paxil was the biggest selling antidepressant in the world, engaged BBC’s leading investigative program, Panorama.

Up till then, in 50 years, Panorama had never repeated a topic but they made four programs about Paxil – Seroxat,

  • The Secrets of Seroxat – or The Perils of Paxil – take your pick
  • Emails from the Edge
  • Taken on Trust
  • The Secrets of the Drug Trial

All the programs are available on Study329.org along with their transcripts.

At the heart of these programs was Shelley Jofre who showed that you don’t need medical expertise to sift the wheat from the chaff of most medical studies. She read the Keller paper within weeks of its publication and immediately smelt a rat.

The rest is a history that will reach a major landmark around September 14th when BMJ publish Restoring 329, a year after it was submitted to them and two years after work started on the Restoration.

The Panorama programs are now available on Study329.org.

As is The Famous Grouse lecture which covers the History of 329 and the Black Box Warnings.

Yet more will be added over the next few weeks.

The BMJ paper, when published, will sit there alongside the Keller and 21 others paper.

Mickey Nardo – 1boringoldman – one of the authors of the Restoration will be have a series of posts linked to the publication outlining how and why we cannot afford to glaze over when experts mention clinical trials – RCTs. We need to grab our chance for a Shelley Jofre moment with both hands. His posts will in addition be reproduced here.

The posts here and later on RxISK.org are available for comment and there is a contact us button on Study329.org.

Paroxetine names around the world

A Milestone in the Battle for Truth in Drug Safety

Study 329: The final chapter coming soon

Arguably the most controversial drug study ever, Study 329, published in July 2001:

  1. Concluded that paroxetine was a safe and effective medication for treating major depression in adolescents;
  2. Is still widely cited in the medical literature, providing physicians with assurance about the usefulness of paroxetine;
  3. Was criticized by a few alert and concerned journalists and academics. Their voices were buried by a tsunami of positive marketing and promotion by vested interests;
  4. Resulted in a successful New York state fraud lawsuit against GSK;
  5. Resulted in 2012 in the biggest fine in corporate history – $3 Billion; and
  6. Remains unretracted.

Paroxetine Names Around the World

ParoxetineWC

In June, 2013 Peter Doshi and colleagues published “Restoring invisible and abandoned trials: a call for people to publish the findings” in the British Journal of Medicine (BMJ).

They referred to this proposed protocol as RIAT, and described its purpose as follows:

Unpublished and misreported studies make it difficult to determine the true value of a treatment. Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond.

A team of researchers undertook to re-analyze the original data and publish a new analysis under the RIAT protocol.

In August, 2015, after a year and seven drafts, BMJ notified the team that their submission would be published in September, 2015. This will be the first ever trial with two completely different takes on the same data.

This new study, Restoring Study 329: Efficacy and harms of paroxetine and imipramine in the treatment of adolescent major depression: restoration of a randomised controlled trialshould shock all who care about integrity in drug safety. Find out the inside story when a new site, Restoring Study 329, goes live.

Shock, Mutilate and Poison: The Medical Mission

Changeling

Editorial Note: This post interrupts the Crusoe series.

The comments from Deirdre Oliver and “Truth” posted below assume Crusoe and I are one and in attacking me they risk derailing a position being laid out by Dr Crusoe. Dr Crusoe and I share some views or her posts would not feature here but while the issues about ECT have some relationship with the position she was staking out about drug regulation it seems better to separate out the attacks on me from the wider debate.

Anyone who wants to engage more fully should ideally read the attached chapters from the History of Shock Treatment – The Swinging Pendulum, A New Chapter? & Irrational Science. It is worth visiting Let Them Eat Prozac The Shock Controversy, where saving some items that might have been embarrassing to those attacking me, things that have come up before are posted. Also worth reading are Better to Die RxISKing it One and Two – the text of an address to ISEPP in Los Angeles last November. This talk was going to be posted by ISEPP – it is close in content to a talk given recently in Yale that has been posted.

So this post is responding to some of the comments that seem to come after it.

I am as constant as the Nothern Star

Caesar’s words that sealed his assassination – or words from Joni Mitchell. Take your pick.

The initial charge from Deirdre Oliver – see below – accused me of lacking consistency. She and many anti-ECT activists find it bewildering that I don’t call for ECT to be banned. It seems inconsistent to them to campaign against the toxic effects of drugs and not to call for ECT to be banned.

I have never called for a treatment to be banned – not SSRIs, not antipsychotics, not benzodiazepines, not psychosurgery and not any of the therapies that have been linked to a recovery of memories of abuse that never happened. My beef has been to get the hazards of treatment, whatever they are from whatever branch of medicine, put on the map so people can be better placed to decide whether or not to take the risks involved or to work out what has happened to them should treatment go wrong.

Getting to grips with the hazards should leave people better placed to decide if the primary problem was bad luck, a negligent therapist, or a systematic cover-up by an industry or other group promoting a treatment in a misleading way.

The cover up

Having gone into the background research, probably more than anyone else on earth, on what companies knew about the hazards of their drugs, and what those linked to ECT knew about the hazards of ECT, my view is that companies unquestionably engaged in and likely still engage in negligent and sometimes perhaps even fraudulent behavior when it comes to the hazards of drugs. Because drug treatments within mental health are used somewhere between 10,000 and 100,000 times more commonly than ECT, the consequences of this company behavior are far more devastating than any ECT cover-up could be – were there a cover-up.

I seem to be able to spot a cover up where others can’t. AllTrials for instance looks to me something that suits industry all too well. But there is no ECT cover-up that I can find.

Those who defend ECT can be wary and defensive. This is not surprising in the face of implacable hostility, and little support from the rest of medicine. Yet the person who most clearly put on the map the idea that ECT involves an organic insult was Max Fink, the person most excoriated by the critics of ECT. It has been very difficult to get clear-cut test evidence of enduring cognitive dysfunction on ECT; one of the few bits there is comes from Max Fink. D.O. below cites Charlie Kellner raising the possibility that the next generation of scanners may reveal harms on ECT. Kellner has been the editor of Convulsive Therapy, the lead investigator on the CORE ECT studies, and one of the major figures behind ECT. The fact that he thinks some scans might show something suggests an openness to the data here just not found among drug company apologists.

When I wrote a celebration of activist movements in ECT’s history (The Swinging Pendulum – above), and the efforts to use abuses linked to ECT to promote informed consent across all of medicine, I got a lot of my leads from Max Fink. When I supported the publication of Linda Andre’s Doctors of Deception (see comments), some of those concerned for the treatment weren’t enthusiastic because unlike D.O below they didn’t think it was meticulously researched, but no-one vilified me or ostracized me.

The research evidence

The critics cite evidence of brain damage in a paper by Hartelius and memory dysfunction in a paper by Janis – both dating back to the 1950s – or they invoke brain scans. The Hartelius’ study comes up again and again and came up a short while back in a set of exchanges on the Critical Psychiatry website between Barney Carroll and the CP network that more than fulfilled the English definition of fair play – at least 11 against 1 (as in cricket). Peter Breggin weighed in with the Hartelius paper. Carroll provided an analysis of this – attached here. This is a must read. Exchanges like this lead to silence on the CP site or to someone like Barney Carroll simply not having their contribution posted.

None of this is to say there isn’t brain damage on ECT. Poisons, poison. Mutilation, mutilates. And a convulsion is never a good thing. Some generation of scanner or other tests will reveal damage linked to ECT. But the same scanners will reveal as much or more damage linked to antipsychotics and antidepressants. What then?

In the meantime having worked with a variety of colleagues on scanning and cognitive testing protocols in an attempt to elucidate the harms ECT causes, I can report that with the best will in the world it isn’t easy to draw up a protocol that gets to where the critics seem to want to get. Their response is that the failure to come up with results that nails ECT points to a cover-up but what is being missed is that current scanners are pretty useless for anything fine-grained and cognitive function testing is little better.

ECT is linked to autobiographical memory problems – but so are the benzodiazepines. It’s easy to demonstrate this for the benzodiazepines but far more difficult in the case of ECT. There is nothing distinctive that ECT causes that drug treatments don’t cause in spades and no-one who gets ECT doesn’t get drugs also.

In terms of the severity of the conditions it treats, from resistant Parkinson’s disease, through Neuroleptic Malignant Syndrome and catatonia to psychotic depression, the benefit-risk ratio may be better for ECT than for anything else in psychiatry – when used for those conditions. This doesn’t mean it doesn’t cause problems. Unnecessary convulsions are never good.

Led the wrong way?

This brings us to legal actions. On the drug side, the actions that I have been involved in have never been against doctors. They have been directed at companies. These actions have brought a huge amount of material about the sequestration of trial data, ghostwriting of articles and public relations sponsored harassment of people trying to raise the hazards of treatment into the public domain. When juries have convicted in cases of birth defects, or suicide or dependence linked to antidepressants, it has been on the question of whether companies had good cause to warn and failed to do so. It has not been about getting treatments banned.

I have found it difficult to be party to legal actions against doctors in circumstances where drug treatments have been involved as it has seemed to me difficult to hold them responsible for the air they breathe. It is not unreasonable for them to depend on the literature that appears in respectable journals like BMJ and NEJM, although we may be nearing a point when juries decide otherwise.

A possibly even greater problem in medicine that RxISK.org seeks to address is the often abusive treatment that many of us receive that is made possible by a power-imbalance between doctors and the rest of us.

If not broken, the mental health system is wobbling badly, and there are an increasing number of people trapped within it, the learning disabled, the elderly and anyone who has an adverse response to a drug, who are at increasing risk of being treated for the consequences of prior treatment, and whose lives are being blighted and shortened as a result. I’ve been writing about this for nearly two decades – see Foreword: Dying for a Cure – and spent a good deal of the last two years working on a way to formulate the issues that might provide a platform for anyone having unnecessary treatment inflicted on them whether ECT or drugs, in community or inpatient settings, to escape from under the juggernaut.

How do we tackle being powered out? This happens across medicine – its not just a mental health issue but mental health activists are more aware of the issues than anyone else. Diverting them into calls for getting treatments banned is a great way to prevent them bringing a revolution in all of healthcare. Success in getting ECT banned might also be a good way to make a market for the next pro-convulsant treatment – Ketamine analogues.

Having at one point researched most of the major ECT legal cases for The Swinging Pendulum chapter above, the difference between ECT and pharmaceutical cases is striking. The ECT cases should be about medical negligence but time and again plaintiffs have ended up with experts on a mission to get ECT banned completely, when it might have been better to seek out an expert who concedes that ECT may be helpful but in their case was used abusively. And the plaintiffs have lost.

Romance

The call to ban ECT is linked to ideas that mental illness doesn’t exist – and indeed that disease doesn’t exist given the benefits ECT can produce in NMS and Parkinson’s disease. There is a romance to the idea that disease doesn’t exist but ninety-nine percent of the population just ain’t going to go there.

Romance might sound pejorative. I was going to say ethical nobility. When anesthesia was developed in the nineteenth century, it led some, who could not accept the idea of benefiting the many at the expense of the few, to agonies. There was an ethical nobility to such agonies in 1860, but most of us would regard their rehearsal now as romantic. Some of us split the difference and regard the bargain medicine has made as Faustian, but when it comes to the crunch of cancer or the maelstrom of melancholia we take the bargain and opt for anesthesia or ECT.

See Sherwin Nuland’s extraordinary TED talk on ECT. But for every Nuland who gets the call right, the Devil probably wins in having ECT inflicted on someone who shouldn’t have it – but s/he wins even more comfortably when it comes to drugs.

At the end of the day, I don’t see it as my role to decide for anyone what treatments they should or shouldn’t have. The message that the benefits you can get from me are linked to poisons, mutilations and shocks would reduce the use of all treatments across medicine, however anyone thinks they help, but they would still be given by some doctors to more than those who stand to benefit, or be demanded by some who don’t figure on meeting Dirty Harry.

The resistance to the message that medicines are poisons is not confined to mental health. Delivered at a recent event at the Hay-on-Wye HowTheLightGetsIn Festival, the message was not well received but it’s difficult in any other area of medicine to imagine hostility of the type that the critics of ECT mount, unless orchestrated by the pharmaceutical industry.

ECT is the most disputed treatment in all of medicine. This hostility was once actively fed by Pharma with adverts for chlorpromazine and other psychotropic drugs portraying a switch to their medicine as a way to eliminate Cuckoo Nest scenarios. Pharma have done some brilliant things in the mental health domain. One was their linking of concerns about the risks of suicide on SSRIs to Scientology. This was doctor Rope-a-Doping. The same has been done to ECT. From the 1960s onwards Pharma influence has made it steadily more difficult and its now close to impossible to get symposia on ECT into APA or other mainstream psychiatry meetings – this is activist Rope-a-Doping.

A true story

In one of the comments below, Johanna Ryan notes the mystique ECT has among some doctors. I’ve never really noticed it. It’s difficult to believe any doctors see ECT as anything other than Shocking. It would be great if they saw drugs as poisons in the same way. Some say they’d have ECT themselves if they ever became melancholic but an increasing number of them have never used it or seen it used. The only person recorded as seeing ECT as anything other than shocking was Ken Kesey, the author of One Flew over the Cuckoo’s Nest, who rigged an apparatus up in his garage thinking it might offer something similar to an LSD trip.

But ECT is iconic in other ways. Clint Eastwood’s movie The Changeling opens with the line – This is a True Story. Not based on a True Story but an actual True Story. The Changeling portrays the horrors of psychiatry as they have been since One Flew over the Cuckoo’s Nest – through involuntary ECT, The problem is the heroine’s incarceration happened 10 years before ECT was invented. There is something about ECT that all but compels people to use it as a symbol of the horrors of mental health systems. There is something about health which means we ignore where the real problems are coming from when ECT and anything else is used.

The people most likely to profit out of Dirty Harry turning into a pussycat or talking to an empty chair are Lilly, GSK and Pfizer. Sorting out the honchos who make the treatments that cause the most damage would take care of the problems linked to ECT en passant, but we’ll be a long time waiting for Harry to tell a drug company executive to make his day.

Meanwhile in another part of town….

Choosing ECT Rachel Perkins

Ad hominem

Lost in Medication: The Crusoe Report 3

Lost in Medication. Ask your doctor about the sexual side-effects of your meds. Based on Adam and Eve painting by Lucas Cranach the Elder in 1526

Lost in Medication. Ask your doctor about the sexual side-effects of your meds. Based on Adam and Eve painting by Lucas Cranach the Elder in 1526

Editorial Note: This follows Restoring Health part 1 and What’s Poisoning Health part 2 of the Crusoe Report in response to the Witty Magna Carta posts.

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 this Tree looks Medicinal – but it’s not life giving.

It’s profoundly alienating because of one more feature to the Clinical Trial process, at least within the current regulatory system, which 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.

 

See comments – J Rees’ article is Here.

What’s Poisoning Health: The Crusoe Report 2

Mother Bird

How did we get to the point where healthcare itself is sick – where we have as Annemarie Mol brings out become consumers of healthcare products rather than people whom doctors and nurses care for when we are at our most vulnerable?

The breach of trust in modern healthcare comes close to a mother poisoning her babies in their infancy.

From luxury to basic

Back in the 1950s or 1960s depending on where you lived many of our parents thought about buying a car. It was a time when people didn’t need cars. They could get to work easily by bus, train or bike. The local shops were close so you could walk to get all the bits and pieces you needed or send a child who would usually run.

A car was a luxury.

But when enough people bought them, cars began to become a necessity. Cars made it possible to live further out of town and living further out you needed a car. Work was now too far away for a bus. The local shops weren’t local in the way they had been before. You shopped at weekends for the week in supermarkets and to get there you needed a car. And pretty soon the range of things in local shops began to seem limited.

As the number of cars grew, cities changed and the city itself became a vehicle to sell cars. This is what marketing departments dream of – where everything conspires to sell the product. Once our way of living meant we needed cars, companies could market types of cars without having to persuade you that you needed a car.

Cars can be a great thing. If we get taken seriously ill having an ambulance to get us to hospital quickly may be life-saving. But cars are also inextricably linked to a climate change, a permanent change in the world in which we live, a change of the kind that most of us as individuals find hard to see how we could influence.

Most of us find it equally hard to see how we can resist the climate change taking place in healthcare – fabulously illustrated this week with all the hype surrounding Solanezumab, which seems all about bolstering the share price of Eli Lilly and creating an industry that will persuade people over the age of 50 to start taking it and similar drugs, and pays little heed to the agitation and despair that may be occasioned in many, and the almost Witch in Macbeth like “Keep the word of promise to our ears while breaking it to our Hope”.

Car, TV and dinner

In much the same way as they did with cars, many of our parents in the 1960s wondered if we needed a TV. You didn’t need to have a TV back then but it just looked like a good idea. A little luxury.

But soon afterwards, when Kennedy was shot, and the news ever more often began to break on TV, life without a TV  became inconceivable to many.

It was the same with computers. Lots of us got told by real computer geeks in the 1980s, we didn’t need computers – for what we did all we needed were electronic typewriters. But as TVs hooked up with computers to create the informational super highway we have entered a world now where you absolutely have to be hooked up or you’re not alive. There isn’t an option. Everything conspires to sell the product.

The informational super highway looked close to adverse effect free until Edward Snowden revealed there could be risks to all this that we weren’t aware of. And of course if you are not hooked up you might get a bunch of US SEALs breaking down your door one day and killing you because, well if you aren’t hooked up to the superhighway, you must be up to something bad. (Monty Python’s Spanish Inquisition in modern form).

There seems to be no way back. Nothing the individual can do.

Slow medicine

Except as mentioned in Crusoe Report – 1, we have found ways to resist the Fast Foods from Supermarkets that also began to come on stream in the 1960s. They were once a luxury but now are seen as second rate.

In just the same way as for food, cars and televisions, back in the 1960s drugs were not the only answer to health care problems. They were a necessity in some cases like an ambulance is a necessity but in many other cases an option or even a luxury.

Doctors were people you expected would know you and your family and community and would know when to tell a teenager that being lovesick was not an illness or parents that adolescence was not pre-psychosis, or pregnant women that having an occasional glass of wine was probably a lot safer than having most drugs during pregnancy. They were people who had the common sense to rarely have you on several different drugs at the same time.

When effective drugs came on stream for the first time, many of these doctors realized that they were dealing with poisons because they saw side effects they had never seen before – the deafness that came from streptomycin, the limbless babies following thalidomide. These new tools needed to be treated with respect. This was not a world in which statistical benefits on concocted indicators would have appeared on the front page of newspapers.

We have been swept into a world where as opposed to being regarded as poisons that could be tremendously useful if used wisely, drugs are seen as fertilizers – to be sprinkled as widely as possible and begun as early in life as possible – solanezumab from birth?

Why not? If at a time of growing evidence that antidepressants cause profound problems for the children born of women taking them in pregnancy, there can be serious proposals to stamp these drugs with the image of a pregnant woman to overcome the scruples women might have about taking antidepressants during pregnancy, some academic out there can be relied upon to propose solanezumab from birth and newspapers to frontpage it and governments to support it rather than take action against the corporations producing the heavy metals that are likely causing the problem to begin with.

Just as cars and climate change are inextricably linked to oil, Fast Medicine and the changing climate in healthcare are inextricably linked to the controlled trial. Why engage with the changing the world when statistical surgery and data suction can give you figures to die for?

To be continued…

Restoring Health: The Crusoe Report 1

Crusoe map

The diplomatic thing would be to say there is some agreement between the Witty Report and this one. There is certainly some overlap in suggested solutions.

We could perhaps even agree that the real problem is the failure of medicine rather than pharma malfeasance. But the fault-line runs deeper.

There are two or maybe three forces, depending on the way you look at it, that have created the whirlpool into which we are now being sucked. One set of forces lies in the push to consumption and the other lies in the nature of modern medicines.

A patch of ground

Lots of us used to have a small patch of ground where we grew vegetables or herbs – or maybe just flowers. Some of us still do. We produce our own food rather than buy it. Not so long ago most of us used to produce food or at least ate food produced by people we knew or were not far removed from.

Until very recently, after we bought food, we produced our own meals and usually did so for families or for a few people at the same time. Now when we buy food it’s often in the form of processed meals where all you need to do is hit a button on the microwave. There is no production. It’s all consumption. We might once have produced the fire that cooked our food, it’s now bought in in the form of a microwave.

Producing meals did more than provide food.  It helped produce children and families and communities. Now the children will often come in from school to an empty house and press a button on the microwave. Who knows what’s in the meals. It might look like food but the food processing industry is increasingly getting away from anything that would have been recognized as food a few years ago. And eating meals this way is not producing a community.

Consuming convenience foods isn’t all bad. If you’re Beethoven absorbed in producing The Ode to Joy, being able to hit a button on the microwave might be a blessing – provided when you go to the supermarket to pick up something you’re not paralyzed trying to pick between exotic looking food packages that promise so much to the eyes but which you know will break their promises to your hope when you dig a fork into them.

Choice is one of the problems that consumption brings with it.

Annemarie Mol brings this out dramatically in The Logic of Care – one of the greatest books ever written about medicine.

I am pregnant and 36. A national committee of experts in the Netherlands where I live, has looked at the statistics and suggested that pregnant women over 35 should have an amniocentesis in case of Down’s Syndrome…  I follow the advice. I take a day off and go to the hospital… I lie down on the examination table and feel the ultrasound probe moving over my belly. Still in my field work habits, or just to break the silence, I say to the nurse who is preparing the long needle that will be inserted into my womb: ‘I hope it all goes okay.’ We both know that a small percentage of women have a spontaneous abortion as a result of the procedure. The nurse snaps back: ‘Well, it is your own choice.’

This is no longer a system in which people are working together to produce health. This is an industry with products available for consumption or not. It has extraordinarily sophisticated ways to persuade your doctor to consume its products by putting them in your mouth. Often close to forcing you to take them, most of which you don’t need.

Infertile

Very few of us can justify consuming Fast Foods by appealing to the symphony we are working on. Most of us consume our burger while consuming the latest Infotainment from systems that make information and entertainment. While the world may now have become a Village – just like food, the Village News is divorced from the connections that villages and food once had.  Its global gossip.

Even the so-called scientific articles about the drugs you might consume are infotainment divorced from the things that actually happened when a drug was given in a controlled trial. The articles are almost always written by a ghost-writer who has never prescribed a drug in her life.

There is a balance we all need to find between producing and consuming. If part of our time is spent working for someone else who is producing stuff for others to consume and the rest of our time is spent consuming yet other stuff, without us actually producing anything, we end up infertile – alienated, men would say – and probably unhealthy or at greater risk of becoming unhealthy.

Recipe

For millennia, the production of food and health were entwined. The Rx symbol for a prescription is an abbreviation of Recipe. The implication of the saying that it takes a Village to produce a Child is that the child is healthy. The knowledge of how to bring up children, ward off infections, alleviate problems using certain foods or herbs has been something passed down in families and communities. The pharmaceutical industry knows all about this. Trying to market ADHD, they found that the greatest barrier to getting treatment accepted was the presence of a grandmother who might caution against the child being treated because he’s just the same as his father was and look her son has turned out just fine.

The Village we live in now is not one in which one woman will tell another who has just been told that the bone scanner shows some bone thinning that getting out and running or working the garden is the best way to avoid fractures. It is a Village in which women will be pressured through fear to take bisphosphonates – among the most horrific drugs ever pushed – and will end up living greatly restricted and non-productive lives as a result.

Slow medicine

Back in the 1950s pharmaceutical companies participated in the production of health. New antibiotics saved lives and got people off sick beds and back to work. This was a health that made us wealthier. It made sense for nations to think about providing treatments like this for free.

But now companies produce medical goods for consumption. These come tagged as health-giving. But where once you took the risk that went with drugs when you were in crisis, now your healthcare provider likely summons you in for checks and puts you on treatments you didn’t ask for. Where once the norm was a short course of a treatment like an antibiotic until you were well and except in the case of insulin it was extraordinarily rare to be on a treatment for life, now it’s unusual to find people not on anything and very unusual to find anyone over 50 not on several drugs for the rest of their lives. We are harming ourselves to make drug companies healthy, and even the United States is working as hard as it can to make sure that as many people as possible get as much access to drugs as possible.

How did we get to this point?

For anyone who thinks the only way to fight the alienating forces of the modern world is to join ISIS or some other fundamentalist movement or to drop out of the Euro, the food domain shows that it is possible to fight back against “a sterile modernity”. Fast Foods don’t have it all their own way. The Slow Food movement – a movement that began in Southern Europe – looks like its here to stay. We need to building a Slow Medicine movement.

To be continued.

Magna What? The Embarassing Side Effects of Drugs

Magna Farta

This post is designed to be read with the Drugs and Smell post on RxISK. Click on the image to read the small text.

Into the Matrixx

The second drug in the Anosmia Table in the Drugs and Smell post is Zinc Gluconate which was traded under the name Zicam. For anyone concerned about adverse events this is one of the most important drugs in History.

Zicam was marketed by Matrixx Pharmaceuticals. The company’s shareholders became concerned about reports it could produce anosmia and parosmia and asked to “look at the books”. The Board said no. The shareholders took them to court and ultimately to the Supreme Court. The company defense was that all it had were animal studies that were not statistically significant and some anecdotal reports of a problem, but as nothing had been properly linked to treatment there was no need to tell the shareholders. The Supreme Court disagreed.

If you are going to gamble with your money, the Supremes figure you are entitled to make up your own mind what the data means but not it seems if you are someone gambling with your life or your child’s life or perhaps the life of child yet to be born or a doctor gambling with your patient’s life.

Blind doctoring

The Supreme Court decision doesn’t stand quite alone though. There is an extraordinary legal case from 1981, Oksenholt vs. Lederle Laboratories, which no one seems to have picked up on.

Dr Oksenholt was sued by a patient whom he had put on a treatment for tuberculosis, Myambutol. This had caused her to go blind. He settled the case with her for $100,000 and then sued the drug company for withholding information from him that their drug could cause someone to go blind. He won the case. He also won $50,000 damages and an unspecified amount for future loss of earnings and $5 million punitive damages. See Oksenholt.

None of the doctors who gave medication to any of the Mass Shooters of recent years or Airline Pilots who have crashed – and there have been many on antidepressants – have interrogated companies legally about the with-holding of data. There is a precedent there for them.

Oksenholt v Lederle Laboratories

This is the third post in the Magna Carta series, a place-holder while we try to FOIA or otherwise find the missing Crusoe Report mentioned in the Witty Report last week. It’s the twenty-first post in the Persecution series.

Illustration: Magna Farta, 2015 created by Billiam James

Magna Pharma

Magna Carta

This post on the eight hundredth anniversary of the signing of Magna Carta is the second in a Magna Carta series, and the twentieth in the Persecution series.

Faced in 2012 with questions about the $3 Billion fine imposed on GSK – triggered by a sequence of events starting with Study 329, – is it just the cost of doing business? Andrew Witty snapped back:

“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors.

Witty A: Report to the President on changing the system

Accounts of what led to the 2022 Amendments to the Food and Drugs Act vary wildly. Some point to the new President’s first grandson being born with Tetralogy of Fallot linked to the mother’s antidepressant intake. Conspiracy theories invoked Marilyn’s Curse. They noted things like the coincidence of initials between the unknown American Woman whose baby had a Tetralogy of Fallot and Andrew Witty (See American Woman and American Woman 2). Others thought it was triggered by the increasing evidence of cognitive failure in more than one previous President linked by some to the fact both were on Statins.

Whatever the reason, Andrew Witty was recruited from GSK to rewrite the Charter between the people and Pharma. Here is a précis of his option appraisal.

1. Regulation & science

The licensing of drugs is a bureaucratic procedure that has nothing to do with science. As things stand, the way FDA goes about approving drugs has enough of the appearances of science so that most doctors and patients are fooled into thinking there has been a science based decision when there hasn’t.

To an extent the public can’t imagine, the bureaucrats are just interested in getting boxes ticked and to paraphrase Tom Lehrer, “When the drugs go up who cares where they come down, that’s not my department”.

Regulation is completely incompatible with science. Science seeks uncertainty, whereas regulation seeks to abolish uncertainty.

We in GSK thought it must be crystal clear that Pharma does regulation and not science when to support a legal action against the European Medicines’ Agency Data Access policies in 2013 that proposed to let doctors and others see our clinical trial data we argued that this “data” was simply the result of a regulatory exercise and regulators ordinarily maintain the confidentiality of submissions on products they regulate.

This was the winning option in the opinion of the Courts. Some of my colleagues had doubts about our ability to win using this argument while maintaining the illusion that companies do science. The argument was a blow to the self-esteem (amour propre) of FDA and EMA who, while asleep at the wheel, like to claim they base their actions on science.

But medicine predictably noticed nothing. As Thomas More said about the Nobles of England – they’d have slept through the Sermon on the Mount.  The only time they woke up was at Runnymede when there was something in it for them – (see Magna Carta).

2. The effectiveness fly in the 1962 ointment

Regulation needs to be disentangled from science. This cannot easily be done while the 1962 Amendments to the Food and Drugs Act contain an effectiveness criterion. The idea of forcing companies to show their drugs worked was a well-intentioned move but a disaster all round – a simple solution to a complex problem that has made things worse.

In the new regulations to mark the sixtieth anniversary of the 1962 regulations the word effectiveness needs to be replaced by safety.

For those who want companies to say what a drug is for, we can revert to the wording before 1962 by stating a drug should have a clear effect on a structure or function of the body.

Getting rid of the effectiveness criterion would do a lot of things. First it would make it a lot cheaper to develop new drugs. As a result, the cost of drugs would fall, more new drugs would be brought on the market and after marketing a lot of discoveries would be made. We could look forward to a new era of Wonder Drugs to rival the 1950s.

Second it would get rid of off-label marketing at a stroke.

Third it would mean that doctors and patients would have to be personally convinced a drug was actually helping them rather than depend on company claims that it was.

Fourth it there would be much less company clinical trial data and campaigns like BMJ and the Cochrane collaboration to access the data would likely wither on the vine. It would even be safe to appoint Peter Doshi and Tom Jefferson as data access Csars.

3. Evidence based medicine

Whether a drug works or not is not critical to companies but it is critical to medicine and patients. This is a question that cannot be left to industry. As with a lot of these things women have blazed the way as in trials like the Women’s Health Initiative study of HRT. There were earlier trials run by medicine like this during the 1960s but everyone has forgotten them – it’s so long since medicine ran a serious trial.

This would be real evidence based medicine.

One of the consequences of this is that it would likely mean that a full appreciation of the risks and benefits to be obtained from a treatment would only really be clear several years after the launch of a new compound when the proper clinical trials began reporting. What doctors do while waiting for these results to come in is the key issue. Our hunch is that hope is the most powerful incentive of all for most patients and most doctors. No regulatory system will ever change that.

4. Prescription-only arrangements

Quite simply these need to be dismantled. Anyone who doesn’t understand this doesn’t understand marketing – most doctors.

If prescription-only privileges are to be retained in some modified form, only those who do understand the need to abolish them should be involved in any modification.

There are a range of things that could be done such as:

  • Requiring doctors to have a training post in a company marketing department before qualification.
  • All editors of medical journals should have had a spell working in industry first – those without industry experience are too lilly-livered to take to the dance-floor with the amount of confidence needed to pull off any tricky steps.
  • Rewarding doctors for reporting adverse events
  • Penalizing doctors if they do not report them at a certain rate per year.
  • Maintain certain drugs on prescription-only such as cancer chemotherapies where patients are particularly vulnerable and the treatments particularly toxic.

5. Abolish medicine

Where alchemists, homeopaths, chiropractors and others, who have slavishly copied medicine, failed to make inroads, we have been able to walk in and leave with the Crown Jewels.

Using clinical trials and ghostwritten articles – the appearances of medicine – we have infected the body of medicine with an AIDs-like virus turning medicine’s defenses against itself. The insertion of these sophisticated adverts into the medical literature has triggered a Clinical Auto-Immune Deficiency (CID) reaction that leads most doctors and scientists to turn as viciously as they would turn on a quack on anyone who questions the results of these ghostwritten articles and trials that have no data and sometimes no patients. It’s been amazing to watch.

Physicians have had decades to find a way to get this cuckoo’s egg out of the nest of science. They could have based clinical practice only on investigations whose data is publicly available. They could have used the Human Rights of their patients as a lever – it is not for instance possible for any doctor to prescribe any branded medicine with informed consent as things stand at present.

But they haven’t done anything like this. The branches of medicine linked to the prescribing of branded products are finished as a profession. They have no brand value.

The market has now developed so that nurses, pharmacists, clinical psychologists and others can take over the role of prescribing drugs and are far less expensive than doctors.

If medicine has any value and we believe in market forces, abolishing it might lead to a solution. If people and governments come to think they need a set of experts who have brand value when it comes to good quality information on drugs, a new profession will be called into being.

Other physicians practicing in areas of medicine where branded products have little penetration could be allowed to continue.

One issue for others to consider is whether areas of medicine that are heavy users of medical devices are as badly affected as mainstream medicine.

A further option might be a promotion of patient co-operatives. Groups like ACOR.org are making a significant difference to healthcare. They might find it far easier to work with nurse and pharmacist prescribers than with doctors.

6. Boycott

One of the few things that might have influenced my behavior as CEO of GSK would have been a boycott. Record fines and even jail time are not deterrents. Almost everyone views these as a cost of doing business already. A jailed CEO might even boost share value.

We in GSK know that boycotts can hurt. In the crisis over making ARVs available to South Africa for AIDs the threat of a boycott was the only time our Board substantially altered its position.

The boycott would be aimed at getting companies to hand over Adverse Event data. Groups like AllTrials – which we did a lot to nurture – are campaigning for efficacy data. It’s been interesting to watch them punch themselves out on this issue which is tied to disease indications that don’t exist, and center on meaningless surrogate markers, and are produced for bureaucratic purposes only. These data are frankly close to worthless and are not what we have been trying to hide anyway.

What we have been hiding has always been the adverse event data.

7. Rewards

In 1962, in the frantic panic triggered by thalidomide all the wrong options were picked – the effectiveness criterion, prescription-only arrangements, and controlled trials. They all looked good at the time but companies are a bit like the dinosaurs in Jurassic Park, we are always going to find a way around the controls.

There was only one proposed change we really didn’t like and made sure we killed off – this was a proposed revision to the patent arrangements. Having US style product patents has been the key to the Pharma companies becoming Magna Pharma – the most profitable corporations on earth.

Companies need to be rewarded but the current product patents reward us beyond the dreams of avarice for delivering treatments that increasingly shorten life and increase disability.

There are other ways to cut this cake such as process patents, that would make blockbusters less valuable. Process patents would put a premium on diversifying the portfolio of compounds we hold rather than have us dependent on a small number of blockbusters.

At a stroke this would begin to turn us away from making everyone chronically diseased for life in order to make huge amounts of money out of them and away from just looking for drugs that millions will consume even though they don’t need them and turn us toward drugs that everyone will recognize are worth paying a lot of money for.

8. Access to data

The last decade has seen a huge fuss about access to Clinical Trial Data since we in GSK kicked open this door by posting the results of our trials on depressed children on the company website. We have been able to keep the lid on this and have fall back options such as the AllTrials proposals that if adopted will probably leave academics worse off vis-à-vis transparency than they are now.

We have taken some risks to win the argument so far by claiming that patients’ data is confidential – when pretty well everyone who volunteers for a company trial expects that independent experts will get to view the data at some point and would be horrified to find this is not the case. So far this has been a winning argument.

But the startling thing that everyone has missed so far and shows no signs of spotting is that there are thousands or hundreds of thousands of drug trials that remain completely unregistered, where there are no issues of clinical confidentiality. These are studies undertaken in healthy volunteers – normals. There is a compelling cases for ensuring these data are made fully available.

These contain the data we really want to hide – the adverse event data.

Companies will likely need an amnesty for some of the abuses of people that will come to light if the new regulations make these studies available to view.

9. Independent adverse event reporting

This is a key step.

We have taken astonishing steps to prevent decent reporting, or to denigrate reporting when it happens, and to manage the perception of risk rather than risks themselves. If the Nazis had access to our bag of tricks, there would be real and widespread doubt that the Holocaust ever happened.

For instance companies supported the development of an FDA MedWatcher App in 2013. This was widely applauded as we knew it would be. But it was in fact a way for companies to reduce the expense of maintaining a pharmacovigilance department, reduce their legal liabilities, and transform adverse events into anecdotes all in one go. Companies you see have a duty to follow up and decide if their drug caused the problem – FDA don’t have this duty.

But what was astonishing about all this was that pretty well everyone completely bought the idea that when it comes to working out whether a drug has caused a problem, a bureaucrat in FDA who is there because they don’t like meeting patients, has never treated the condition you have and never used the drug you are on, would be better placed than a good team of doctor, pharmacist and informed patient perhaps in touch with other good teams, to work out what’s going on.

If we’re good enough to get people to buy this, perhaps next April 1 we should see if we can persuade people the earth is flat.

Unless an independent patient organization gets involved in assembling real-time data and both doctors and patients combine to put risk mitigation programs in place, the other changes are less likely to work.

The bottom line is the average drug has at least 100 effects. Using clinical trials we have been hugely successful in hypnotizing doctors and patients to focus on one effect and to miss the other 99. This blind spot is the major driver of Pharmageddon (See Marilyn’s Curse).

If the climate change encroaching on healthcare is to be rolled back, we need someone to spit on some clay on the ground, make a paste, and rub it into the eyes of doctors or anyone who ends up prescribing.

10. Shareholding

Following the Supreme Court decision in the Matrixx case (note to self – check I am not confusing this with the movie), which said that while doctors and patients have no rights to access company adverse event data, shareholders have, one option is through Government to give everyone a shareholder stake or stakeholding in companies.

*****

There was a doctor on my panel who had a different point of view. Dr Crusoe. She produced a minority report which I will forward under separate cover.

A Magna Carta for Healthcare

Magna Carta

Editorial note: This is the first in a Magna Carta series, and the nineteenth in the Persecution series.

As the days lengthen and things warm up in England, historically it has been the time for the people to get restive.

Eight Hundred years ago, the people meant a group of us who counted – we called ourselves the Barons. There were other human beings – our serfs – who worked for us. Today, in theory even the serfs count.

Next Sunday, June 15, Eight Hundred years ago, we refused to accept King John’s right to rule in England as he had been doing, and confronted the king at Runnymede.

Today’s Barons are the Doctors. Doctors make a living out of the work done by the rest of the population – swallowing pills. These doctors are highly unlikely to confront Andrew Witty or any of the big beasts of the pharmacockracy – unless some of them do so as shareholders.

Eight Hundred years ago a charter was hammered out between us and the king that has since become known as Magna Carta. Today something similar is needed. The forthcoming publication of Study 329 will make clear why.

Up till June 15, John and other kings were absolute rulers, whose right to govern came directly from God rather than from the people. When this right was questioned the Pope weighed in on the side of the king, excommunicating anyone who questioned the authority of the monarch.

Magna Carta was based on two principles – the principle of No Taxation without Representation and the principle of Due Process. These principles are fundamental to most political systems today.

The area of politics that counts most for most of us is healthcare. Big Healthcare is now the biggest business in the United States and in the Western World. We desperately need a new compact between we the people and those who govern our healthcare – or at least a new compact between the doctors who make money for pharma by putting pills in our mouths and the Witty’s of this world.

No taxation without representation

No one bats an eyelid at the idea that the United States is pretty market oriented compared to the more communal or socialist systems found in Europe with Great Britain usually seen as sitting somewhere in the middle.

So it is surprising if you put UK PLC and US PLC into google and see what happens. Google recognizes UK PLC and Great Britain PLC but not US or United States PLC.

There was no google in the twentieth century. Had it been there, it would have started throwing up hits from the late 1960s when British Labour politicians (who used to be very socialist back then) started mooting the idea of UK PLC. The ex-Empire was now a company that had to make its way in the wider marketplace. The Government, we were told, was like the Board. It wasn’t quite clear if the rest of us were the shareholders. We had some notional control over the Board – we could vote them out. Election debates today still mention UK PLC –Scotland PLC hasn’t come on the radar yet.

It’s an odd way to see your country. Neither the US nor any European country views itself in this way. But then the Brits invented PLCs as well as Magna Carta and cricket.

The same idea lies behind the Magna Carta and a meeting of the shareholders of a company – there should be some trade-off between the financial input of the stakeholders in the company (country) and their ability to influence policy. It is worth paying money in the form of investments or taxes if the ship of state is being steered in a reasonable direction but not otherwise.

In health we pay either relatively directly or indirectly through insurance systems or government taxation for the benefits we receive. At present, our barons make money for pharma by putting pills in our mouths but pills that keep companies healthy rather than us healthy.

This happens because of a Flash Boy situation. The healthcare market (stock exchange) should produce better healthcare outcomes (channel money to genuinely productive ends). But neither the stock market nor healthcare support productive outcomes. Both have become a means to siphon money from the middle and working classes to a bunch of Flash Boys. This is possible because as with the stock market, in healthcare no-one gets to see the data behind the transactions. Drugs that are bad for us can be palmed off as life-saving without anyone being any the wiser and we are sold a costly bag of goods.

But we are not just being taxed in terms of the money we pay to consume drugs we don’t need. There is a tribute taken from our bodies also in terms of our participation in clinical trials. Companies need clinical trials to get their drugs on the market in order to make billions from them. These trials involve us taking risks with drugs that often prove too dangerous to market. We do so for free. Not only that but when some of us are killed or injured we collude with hiding the data of our injuries and deaths. We have no more status than serfs.

Or at least this was the way until the clinical trial operation was largely outsourced to India and Africa leaving UK PLC scrambling to persuade GSK, Roche and Pfizer that it is open for clinical trial business and willing to divert its NHS patients into company trials.

It’s this taxation drawn from our bodies that should fuel a demand for representation – we should have a say in deciding what we need medications for and we should have access to the data from trials to check on how it is being represented.

When trials run on our children lead to representations that paroxetine is effective and safe even though the actual data shows exactly the opposite – it’s time to intervene.

Due process

The other key element to Magna Carta was the idea that we are all equal before the law, kings and commoners, and that all have a right to a fair trial.

This principle established the rule of law and laid the basis for democracy. This is a basic Right that provides a basis for all other Rights.

Rather than assassinate the King or seethe with murderous fantasies (Anonymous) we can take him to Court. Rather than be executed at his whim, we have the right to a fair hearing by a Jury of our Peers (Just for the record Peers means other Noblemen).

The capacity of plaintiffs in the United States to take legal actions when they or their families are injured by treatments probably stands between the CEOs of pharmaceutical companies and an attempt to exact physical retribution (See Data Wars and Pharmaceutical Rape).

But even in the United States, there is a real problem. When we participate in clinical trials today, companies get to sequester the data from these trials in flagrant breach of the ethics and norms of science and yet parade their representations of those results as science. The participation of some of us in those trials puts all of us in a state of legal jeopardy. In the US, we may get our day in Court, but we will have the data from clinical trials in which our friends and families participated used against us.

We have entered a bizarre Wonderland where Queen John or Andrew can say off with our head if she wishes to or can say what happens on a drug is what I say happens – regardless of what in fact does happen.

It’s a world where increasingly we will be told by Sense about Science in the UK and related bodies in the US, Canada, Australia or wherever that to question the judgments of the scientific literature is to engage in an irrational War on Science itself. We may have a right to Due Process in the US (nowhere else) but even in the US Courts are no longer a place where rationality prevails.

Not a Peep from the Pope about the right to Due Process or Representation.

Meanwhile David Cameron on behalf of UK PLC has launched into an anti-corruption crusade – but there won’t be a word about this lack of due process or the extraordinary corruption of the scientific literature – on which hinges vastly more money than was ever dreamt of by Sepp Blatter and FIFA.

The Devil’s Disclaimer

Disclaimer rubber stamp

Editorial Note: The marketing of pharmaceuticals avails of something given to no other area of marketing – the product is made available on prescription-only. In this post Johanna Ryan, from RxISK’s Community Advisory Board, spells out the risks this gives rise to. This is a theme that has come up often and one we will return to.

Direct to consumers?

If you live in the USA, I don’t have to tell you about Direct-to-Consumer Advertising of prescription drugs. You’ve seen the TV spots all the time, introducing some disease that sounds awfully serious but whose symptoms are broad enough that you start wondering if you should “Ask Your Doctor.”

Then you hear about the wonder drug that is helping sufferers Get Their Lives Back. Happy couples stroll hand-in-hand through meadows or romp with their adorable children … while a polite voiceover tells you about vague but ominous side effects, from strokes and cancer to “certain fungal infections.” (And of course, those alarming “erections lasting more than four hours” which have become a staple of TV comedy thanks to DTC ads for Viagra and Cialis.)

Many of us suspect the drug’s advantages are being oversold and its risks artfully downplayed. But we also assume there must be at least one thing restraining all that hype: If patients run to the doctor asking for the drug, and suffer harm as a result, won’t that rosy TV ad be playing for a jury somewhere soon? Surely they can sue the drug company!

Cynthia DiBartolo

Actually, no, they can’t. An earlier column on this blog told the story of Cynthia DiBartolo, who developed head and neck cancer after treating her psoriasis with Humira, a widely advertised biologic drug made by AbbVie Corp. If you don’t live in the USA, you may be amazed by this sample ad for Humira aimed at women with psoriasis.

Ms. DiBartolo faces an uphill fight for justice because of something called the “Learned Intermediary Doctrine,” which holds that AbbVie’s only responsibility is to inform the doctor of all the relevant risks – not the patient. No matter how aggressively a drugmaker advertises, they can still leave the doctor holding the bag for their failure to warn the patient. In recent years the Texas Supreme Court upheld this doctrine even in the case of a woman who watched a drug-company video at the clinic where she got her first IV infusion of the drug (Centocor, Inc. v. Hamilton, 55 Tex. Sup. J. 774). And in Illinois, a man whose doctor sent him to a patient-education class taught by a drug-company nurse was not allowed to sue the company for its failure to warn him of the risk of blindness (Hernandez v. Schering Corp., 958 N.E.2d 447).

Given the odds consumers face, perhaps these ads ought to come with their own set of warnings. Here’s my proposal for a “Devil’s Disclaimer” to run with American DTC advertising: [1]

THE DEVIL’S DISCLAIMER FOR DIRECT-TO-CONSUMER ADVERTISEMENTS IN U.S.A.

If you should experience any adverse effects from this medication, please note the following legal disclaimer:

Don’t Come Crying To Us. Legally Speaking, It’s Not Our Problem.

It’s true, we have used this ad to approach you about your personal medical problems while you were innocently leafing through a movie-star magazine or surfing the Net. We seem quite warm and friendly. And we have supplied you with a long list of possible side effects and contraindications, via the small print or the mellifluous voice-over. (Not that you know what a contraindication is, you poor sucker.)

However, we do not and never will have a Relationship with you. So, it’s been nice getting to know you  – but no commitments, baby.

It’s not just us saying that either. The courts of just about every state in the nation are backing us up on this. So don’t go muttering about your father the police chief or your sister the lawyer. They can’t help.

Specifically, if you want to get all technical, we have no FIDUCIARY relationship with you. That’s the kind of relationship where we’d be expected to look out for your welfare, with the same degree of care that a reasonable person would devote to their own affairs. That’s up to your doctor.

All we’re obliged to do is give your doctor all the appropriate warnings, and let him sort it out for you. He’s the one that’s supposed to care, according to the courts. (Yeah, that guy – the one you just picked off the insurance company list. You can’t remember his name, and he can’t remember yours. But we’ve been snuggling up to him since he was in med school.) He’s in charge of digesting all that information, and thinking hard about how it applies to little ol’ you. And he’s the one we think you should sue if things go wrong. Let us know how that goes for you, okay?  LOL.

And what if we don’t tell him everything? What if we’re manipulating what he sees in his doctor journals and his continuing-ed seminars, just like we do with that celebrity magazine you were skimming? Oh, don’t worry. The FDA will make sure we do the right thing. (We know, because nowadays we pay the bulk of their salaries. Betcha didn’t know that.) And if the FDA doesn’t catch us, then we’ll definitely pay some kind of fine in nine or ten years. That’ll keep us in line for sure! ROFL.

So don’t come around whining that we promised you this, we promised you that. To quote that old country song, Here’s A Quarter, Call Someone Who Cares.

Or as we like to say: Ask Your Doctor.

LMAO,

<<Insert name of drug company>>


[1] Here is the actual disclaimer posted on one of AbbVie’s websites:

“The content on this site has been created solely for U.S. residents. It is intended for informational purposes only and should not be used to replace a discussion with a health care professional. All decisions regarding patient care must be handled by a health care professional, and be made based on the unique needs of each patient.”