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

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]:


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.


<<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.”

Psychiatry Gone Astray

Editorial note: We follow up the Guilty post last week with a piece written by Peter Gotzsche that has caused a stir in Denmark and provoked some of the Danish professors he critiques to respond.  

Peter C. Gøtzsche

At the Nordic Cochrane Centre, we have researched antidepressants for several years and I have long wondered why leading professors of psychiatry base their practice on a number of erroneous myths. These myths are harmful to patients. Many psychiatrists are well aware that the myths do not hold and have told me so, but they don’t dare deviate from the official positions because of career concerns.

Being a specialist in internal medicince, I don’t risk ruining my career by incurring the professors’ wrath and I shall try here to come to the rescue of the many conscientious but oppressed psychiatrists and patients by listing the worst myths and explain why they are harmful.

 Myth 1: Your disease is caused by a chemical imbalance in the brain

Most patients are told this but it is completely wrong. We have no idea about which interplay of psychosocial conditions, biochemical processes, receptors and neural pathways that lead to mental disorders and the theories that patients with depression lack serotonin and that patients with schizophrenia have too much dopamine have long been refuted. The truth is just the opposite. There is no chemical imbalance to begin with, but when treating mental illness with drugs, we create a chemical imbalance, an artificial condition that the brain tries to counteract.

This means that you get worse when you try to stop the medication. An alcoholic also gets worse when there is no more alcohol but this doesn’t mean that he lacked alcohol in the brain when he started drinking.

The vast majority of doctors harm their patients further by telling them that the withdrawal symptoms mean that they are still sick and still need the mediciation. In this way, the doctors turn people into chronic patients, including those who would have been fine even without any treatment at all. This is one of the main reasons that the number of patients with mental disorders is increasing, and that the number of patients who never come back into the labour market also increases. This is largely due to the drugs and not the disease.

Myth 2: It’s no problem to stop treatment with antidepressants

A Danish professor of psychiatry said this at a recent meeting for psychiatrists, just after I had explained that it was difficult for patients to quit. Fortunately, he was contradicted by two foreign professors also at the meeting. One of them had done a trial with patients suffering from panic disorder and agoraphobia and half of them found it difficult to stop even though they were slowly tapering off. It cannot be because the depression came back, as the patients were not depressed to begin with. The withdrawal symptoms are primarily due to the antidepressants and not the disease.

Myth 3: Psychotropic Drugs for Mental Illness are like Insulin for Diabetes

Most patients with depression or schizophrenia have heard this falsehood over and over again, almost like a mantra, in TV, radio and newspapers. When you give insulin to a patient with diabetes, you give something the patient lacks, namely insulin. Since we’ve never been able to demonstrate that a patient with a mental disorder lacks something that people who are not sick don’t lack, it is wrong to use this analogy.

Patients with depression don’t lack serotonin, and there are actually drugs that work for depression although they lower serotonin. Moreover, in contrast to insulin, which just replaces what the patient is short of, and does nothing else, psychotropic drugs have a very wide range of effects throughout the body, many of which are harmful. So, also for this reason, the insulin analogy is extremely misleading.

Myth 4: Psychotropic drugs reduce the number of chronically ill patients

This is probably the worst myth of them all. US science journalist Robert Whitaker demonstrates convincingly in “Anatomy of an Epidemic” that the increasing use of drugs not only keeps patients stuck in the sick role, but also turns many problems that would have been transient into chronic diseases.

If there had been any truth in the insulin myth, we would have expected to see fewer patients who could not fend for themselves. However, the reverse has happened. The clearest evidence of this is also the most tragic, namely the fate of our children after we started treating them with drugs. In the United States, psychiatrists collect more money from drug makers than doctors in any other specialty and those who take most money tend to prescribe antipsychotics to children most often. This raises a suspicion of corruption of the academic judgement.

The consequences are damning. In 1987, just before the newer antidepressants (SSRIs or happy pills) came on the market, very few children in the United States were mentally disabled. Twenty years later it was over 500,000, which represents a 35-fold increase. The number of disabled mentally ill has exploded in all Western countries. One of the worst consequences is that the treatment with ADHD medications and happy pills has created an entirely new disease in about 10% of those treated – namely bipolar disorder – which we previously called manic depressive illness.

Leading psychiatrist have claimed that it is “very rare” that patients on antidepressants become bipolar. That’s not true. The number of children with bipolar increased 35-fold in the United States, which is a serious development, as we use antipsychotic drugs for this disorder. Antipsychotic drugs are very dangerous and one of the main reasons why patients with schizophrenia live 20 years shorter than others. I have estimated in my book, ‘Deadly Medicine and Organized Crime’, that just one of the many preparations, Zyprexa (olanzapine), has killed 200,000 patients worldwide.

Myth 5: Happy pills do not cause suicide in children and adolescents

Some professors are willing to admit that happy pills increase the incidence of suicidal behavior while denying that this necessarily leads to more suicides, although it is well documented that the two are closely related. Lundbeck’s CEO, Ulf Wiinberg, went even further in a radio programme in 2011 where he claimed that happy pills reduce the rate of suicide in children and adolescents. When the stunned reporter asked him why there then was a warning against this in the package inserts, he replied that he expected the leaflets would be changed by the authorities!

Suicides in healthy people, triggered by happy pills, have also been reported. The companies and the psychiatrists have consistently blamed the disease when patients commit suicide. It is true that depression increases the risk of suicide, but happy pills increase it even more, at least up to about age 40, according to a meta-analysis of 100,000 patients in randomized trials performed by the US Food and Drug Administration.

Myth 6: Happy pills have no side effects

At an international meeting on psychiatry in 2008, I criticized psychiatrists for wanting to screen many healthy people for depression. The recommended screening tests are so poor that one in three healthy people will be wrongly diagnosed as depressed. A professor replied that it didn’t matter that healthy people were treated as happy pills have no side effects!

Happy pills have many side effects. They remove both the top and the bottom of the emotions, which, according to some patients, feels like living under a cheese-dish cover. Patients care less about the consequences of their actions, lose empathy towards others, and can become very aggressive. In school shootings in the United States and elsewhere a striking number of people have been on antidepressants.

The companies tell us that only 5% get sexual problems with happy pills, but that’s not true. In a study designed to look at this problem, sexual disturbances developed in 59% of 1,022 patients who all had a normal sex life before they started an antidepressant. The symptoms include decreased libido, delayed or no orgasm or ejaculation, and erectile dysfunction, all at a high rate, and with a low tolerance among 40% of the patients. Happy pills should therefore not have been marketed for depression where the effect is rather small, but as pills that destroy your sex life.

 Myth 7: Happy pills are not addictive

They surely are and it is no wonder because they are chemically related to and act like amphetamine. Happy pills are a kind of narcotic on prescription. The worst argument I have heard about the pills not causing dependency is that patients do not require higher doses. Shall we then also believe that cigarettes are not addictive? The vast majority of smokers consume the same number of cigarettes for years.

 Myth 8: The prevalence of depression has increased a lot

A professor argued in a TV debate that the large consumption of happy pills wasn’t a problem because the incidence of depression had increased greatly in the last 50 years. I replied it was impossible to say much about this because the criteria for making the diagnosis had been lowered markedly during this period. If you wish to count elephants in Africa, you don’t lower the criteria for what constitutes an elephant and count all the wildebeest, too.

Myth 9: The main problem is not overtreatment, but undertreatment

Again, leading psychiatrists are completely out of touch with reality. In a 2007 survey, 51% of the 108 psychiatrists said that they used too much medicine and only 4 % said they used too little. In 2001–2003, 20% of the US population aged 18–54 years received treatment for emotional problems, and sales of happy pills are so high in Denmark that every one of us could be in treatment for 6 years of our lives. That is sick.

 Myth 10: Antipsychotics prevent brain damage

Some professors say that schizophrenia causes brain damage and that it is therefore important to use antipsychotics. However, antipsychotics lead to shrinkage of the brain, and this effect is directly related to the dose and duration of the treatment. There is other good evidence to suggest that one should use antipsychotics as little as possible, as the patients then fare better in the long term. Indeed, one may completely avoid using antipsychotics in most patients with schizophrenia, which would significantly increase the chances that they will become healthy, and also increase life expectancy, as antipsychotics kill many patients.

How should we use psychotropic drugs?

I am not against using drugs, provided we know what we are doing and only use them in situations where they do more good than harm. Psychiatric drugs can be useful sometimes for some patients, especially in short-term treatment, in acute situations. But my studies in this area lead me to a very uncomfortable conclusion:

Our citizens would be far better off if we removed all the psychotropic drugs from the market, as doctors are unable to handle them. It is inescapable that their availability creates more harm than good. Psychiatrists should therefore do everything they can to treat as little as possible, in as short time as possible, or not at all, with psychotropic drugs.

Drug Traffic Accidents: ADHD

Editorial Note: In an End of Year post on RxISK, the concept of a Drug Traffic Accident was introduced. This can refer to being run over by a drug, sometimes called side effects, or adverse events, or adverse drug reactions or it can refer to the trafficking of drugs. This post covers both types. The first part is written by David Antonuccio and the second by the Editorial Board of the New York Times.

ADHD on a chalkboard

David Antonuccio:
Schopenhauer and ADHD

You are a decorated researcher, with multiple peer reviewed nationally funded research grants on the prevalence and treatment of ADHD. These have shown that the rate of diagnosis of ADHD seems to be rising inexorably. You have developed a model behavioral program that is relatively inexpensive and can be implemented in any classroom in America. 

Industry funded critics come out of the woodwork to call you a fringe scientist, an attempt to marginalize that appears to be standard operating procedure when new developments threaten industry profits and firmly entrenched beliefs. You are accused of inflating the prevalence of ADHD in order to further your “anti-medication agenda”, despite the fact that you are open to medication treatment for patients with severe problems who have been properly evaluated. 

You decide that you must stand up for the data, no matter whose ox is gored. You warn that there are at least some communities in the United States where the rate of ADHD and related drug treatment exceed all reasonable estimates of the disorder. You gladly participate in public debate with your critics because you see it as a way to advance the science and participate in important academic discourse. 

Then, out of nowhere, an anonymous typewritten complaint, that you are not permitted to see, launches a series of investigations into your research. Academics from all over the world rally to your defense by signing a petition supporting you. You are absolved of any wrongdoing in three subsequent investigations, recommended for promotion and granted the honor of a sabbatical. But ultimately your research is suspended and the data buried forever apparently because the university where you work is worried about the political fallout from the controversy. To make matters worse, since your position is not protected by tenure, your contract is not renewed the next year.  So much for academic freedom! 

About a decade later the data you produced are replicated and your work is essentially vindicated. In fact, new national studies suggest that ADHD is being diagnosed and medicated at rates that are higher than what your research indicated.

This may sound too far fetched to be true but it is what happened to Dr. Gretchen Lefever, a leading epidemiologist and ADHD researcher from Virginia. The details of her story are compelling and can be found in the peer reviewed journal article entitled “Shooting the Messenger”, published in Contemporary Psychotherapy.

Her story is reflected in the famous Arthur Schopenhauer quote, “All truth passes through three stages. First, it is ridiculed. Second, it is violently opposed. Third, it is accepted as being self-evident.”


An Epidemic of Attention Deficit Disorder

By THE EDITORIAL BOARD, New York Times, Dec 18th 

The hard-sell campaign by drug companies to drive up diagnoses of attention deficit hyperactivity disorder, or A.D.H.D., and sales of drugs to treat it is disturbing. The campaign focused initially on children but is now turning toward adults, who provide a potentially larger market.

There is no doubt that a small percentage of children, perhaps 5 percent, have the disorder and that medication can alleviate the symptoms, such as inability to concentrate, that can impede success in school or in life. Some studies have shown that medications helped elementary schoolchildren who had been carefully evaluated for A.D.H.D. improve their concentration and their scores on reading and math tests.

Recent data from the Centers for Disease Control and Prevention showed that 15 percent of high-school-age children had been diagnosed with the disorder and that the number of children taking medication for it had soared to 3.5 million, up from 600,000 in 1990. Many of these children, it appears, had been diagnosed by unskilled doctors based on dubious symptoms.

A two-decade campaign by pharmaceutical companies promoting the pills to doctors, educators and parents was described by Alan Schwarz in The Times on Sunday. The tactics were brazen, often misleading and sometimes deceitful. Shire, an Irish company that makes Adderall and other A.D.H.D. medications, recently subsidized 50,000 copies of a comic book in which superheroes tell children that “Medicines may make it easier to pay attention and control your behavior!” Advertising on television and in popular magazines has sought to persuade mothers that Adderall cannot only unleash a child’s innate intelligence but make the child more amenable to chores like taking out the garbage.

The potential dangers should not be ignored. The drugs can lead to addiction, and, in rare cases, psychosis, suicidal thoughts and hallucinations, as well as anxiety, difficulty sleeping and loss of appetite. On Tuesday, the Food and Drug Administration warned that some A.D.H.D. medications, including Ritalin, Concerta, and Strattera, may, in rare instances, cause prolonged and sometimes painful erections known as priapism in males of any age, including children, teens and adults.

So many medical professionals benefit from overprescribing that it is difficult to find a neutral source of information. Prominent doctors get paid by drug companies to deliver upbeat messages to their colleagues at forums where they typically exaggerate the effectiveness of the drugs and downplay their side effects. Organizations that advocate on behalf of patients often do so with money supplied by drug companies, including the makers of A.D.H.D. stimulants. Medical researchers paid by drug companies have published studies on the benefits of the drugs, and medical journals in a position to question their findings profit greatly from advertising of A.D.H.D. drugs.

The F.D.A. has cited every major A.D.H.D. drug, including the stimulants Adderall, Concerta, Focalin and Vyvanse, for false and misleading advertising since 2000, some of them multiple times. The companies, when challenged, typically stop those misleading claims, but the overall impact appears marginal. The number of prescriptions for A.D.H.D. drugs for adults ages 20 to 39 nearly tripled between 2007 and 2012, and sales of stimulant medications in 2012 were more than five times higher than a decade earlier.

Curbing the upsurge in diagnoses and unwarranted drug treatments will require more aggressive action by the F.D.A. and the Federal Trade Commission, which share duties in this area. It will also require that doctors and patients recognize that the pills have downsides and should not be prescribed or used routinely to alleviate every case of carelessness, poor grades in school or impulsive behavior.


Editorial Footnote:

  • The true rate of hyperactivity in children that could unequivocally benefit from ADHD medication is unlikely to be more than 1%.
  • Shire is not an Irish company any more than Forest Laboratories is.  Both have a base there for tax reasons.


The Snow Queen

Crusoe and Hans grew up together. Crusoe’s father encouraged her to believe she could do anything she put her mind to. Han’s father, Peter, was a story-teller who delighted both children with his stories, especially during the long evenings at the onset of Winter. He told them about the Microbe Hunters who discovered the causes of diseases and laid the basis for new cures.

But their favourite was the story of the Snow Queen. So scarily did Peter tell this that both children were certain that some Winter, the Snow Queen would sweep down and take one of them away leaving the other behind with a Mission to save whichever of them now had a sliver of ice in their heart.

Fairy Tales

The Heart of Medicine

But fairy tales are just that after all. Both went to University, and became doctors.

Medicine had just passed through a glorious Summer that had led to the greatest harvesting of the benefits of new treatments ever recorded in human history. Life expectancies increased dramatically. Where once almost every family was blighted by the death of a child, now almost no family had a child who died. In some countries the treatments conferred such obvious benefits that governments made them available for free. A tyranny of fear had been lifted.

After qualifying their paths diverged. Crusoe immersed herself in the problems patients brought to her. For her every patient was different.

Evidence Based Medicine

Hans gravitated toward the most exciting new discipline – evidence based medicine. What could be better than ensuring doctors stuck to treatments that had been proven to work and stopped doing things for which there was no evidence. Patients’ stories might be interesting, but the evidence allowed you to pull back the veil of stories and glimpse reality. Patient improvement might be only a placebo response. They and their doctors might think they knew what was happening but be wrong.

Even when there seemed to be cast iron proof that a drug did something useful in a laboratory or at a bedside, Hans insisted on the need to test it out in hundreds of patients. He was adept at reeling off instances when laboratory breakthroughs have proven to be a mirage. Hard-hearted though it might seem to dying patients, he insisted on a proper demonstration that treatments worked.

The Snow Queen

Unlike some of his colleagues, Hans was not a fundamentalist. There was a passion behind his approach born of a recognition that Medicine was up against the wiliest of adversaries – the pharmaceutical industry – who thought nothing of the deaths of children in pursuit of profits unless those deaths compromised a profit line.

Industry was truly villainous, and in an effort to contain its capacity to injure people Hans was to the forefront of ensuring that the latest evidence was built into guidelines to which doctors would have to adhere. Frustrated at the slow rate of progress, he was of the view this could only be explained by the fact that some doctors even those who were involved in writing the guidelines were on the take. He became a crusader for Sunlight – bringing all and any payments to doctors from industry into the chilly light of day.

His career took off. He moved to Boston. He hadn’t seen or heard from Crusoe for years. There was an ocean between them. He became dimly aware that she had become critical of guidelines. She seemed to have drifted into a position close to homeopathy quoting obscurantist nineteenth century philosophy about there being an Art to medicine in knowing when to give a drug but an even greater Art in knowing when not to treat.

Medicine clearly had to be one thing or the other – an Art or a Science. The idea that modern medicine could be an art he thought belonged to an era that believed in fairy tales.

The Clinic

Not having heard from Hans for over a decade, when she found a trip took her through Boston, Crusoe decided to surprise him. She found from his secretary that he had a clinic on Tuesday afternoons and joined the queue in the waiting room planning to walk in as his last patient.

She was early but had her iPad. The string of patients ahead of her after their appointments came back to the room to pick up waiting relatives, friends and belongings. She registered the low muttering of these returns. She could only catch snatches of the stories but there was no missing the disappointment.

“He told me there is no evidence that there is a dependence on these drugs – that my difficulties must just be the illness coming back”.

“He said I should stop worrying about the drugs. If I stopped the treatment and the illness came back that would be much more likely to cause harm to any baby we might have. If he had his way, pills would come stamped with an image of a pregnant mother precisely to stop people like me from misinterpreting what we find on the internet”.

“He told me that my hunch that my pills were causing me to drink were typical alcoholic denial and unless I got to grips with my alcoholism there was nothing he could do for me”.

“He told me that my idea that the medication he put me on to stop me smoking had caused me to have epilepsy was bizarre. Epilepsy is genetic not drug induced”.

“He told me that my conviction that the drugs had caused Shane to commit suicide was becoming close to delusional. I think we should leave before he detains me in a psychiatric unit”.

Crusoe walked in less jauntily than she had planned. Had she not known it was Hans she might not have recognized him. Flinty was the word that came to mind.

A Drink?

For a moment he had no idea who she was. Once he recognized her, he greeted her teasingly:

“What’s this I hear about you having gone over to the Dark Side?”

“Come out for a drink and a meal and I’ll tell you all about it”, she said.

He had a series of committee meetings he said but he could skip one and give her an hour – it was so good to see her. She really should have told him she was coming.

To Win Some, You Have to Lose Some

Quizzing him over a drink on how his patients responded to him, he told her that he suspected that time would show he was wrong in some cases but even on cases that once worried him he’d stopped feeling a long time ago. If the patients had been injured by treatment they would suffer less if he denied a link to treatment.

If someone who had been injured came to doubt the system and think that their injury could have been avoided, or that the system was going to acknowledge the injustice, it might lead to despair and who knows even suicide.

If patients on treatment or still to enter treatment came to doubt the system it would be too appalling a vista to contemplate.

Better leave it to people like him to negotiate with regulators and drug companies dispassionately. He was now in a position to do just this – a position he would never have been appointed to had he been too outspoken. And the companies were slowly coming round – they are registering their trials and making more data than ever before available.

Through the Looking Glass

There was even talk of nominating Andrew Witty for a special award – Nobel Prize might be a step too far for some people to take but even that artificial barrier would have to fall sometime.

 “You do know that you’re killing more people than you’re saving”, she said.

Don’t be silly”, he responded.

“Well life expectancies are falling, and drug induced death might even the leading cause of death now. That’s not because of the chemicals – the chemicals have always been risky. It’s because the information that makes it possible to use a chemical as a medicine has never been so toxic.

“Sorry”, she said, “that I didn’t get to Peter’s funeral. He was so pleased when you brought him over here to Boston. 

“He got the best possible treatment,” he said.

“Oh I’m sure, given the treating team knew who you are, that he was being treated perfectly according to every guideline for diabetes and hypertension. But you know if you wrote a guideline for treating a Peter the first thing you’d have to put in is to half the number of whatever medicines he is on.  I hear he was on twenty-one when he died”.

“So what do we do – do we go back to the day when some doctor arbitrarily decides what to keep in and what to leave out?”, he asked.

“Well  when it all comes down to dust, you believe in placebos. You call them RCTs but they are really placebos – mumbo-jumbo. You force people to believe in a system rather than to question it and make it better”.


said Crusoe’s partner afterwards.

“The Snow Queen is far more formidable and wilier than I ever suspected”,she said. “Maybe I should have dropped some anti-freeze in his glass of wine”.

Illustration: The Heart of Medicine, © 2013 created by Billiam James

The Medicine Maker

Editorial Note: This is based on the Finnish National Epic, the Kalevala. The image comes from the series painted by Axel Gallen to illustrate the Kalevala.

Crusoe spent years trying to make a Medicine Maker. She was finally successful at the end of a long Winter just as the first signs of growth appeared on the trees. Everyone for miles around came when they heard the news. People with oozing tubercular abscesses were given isoniazid and cured. Children with bacterial endocarditis were brought in on their deathbeds and after taking penicillin got up off their beds and walked. Epileptics in mid-convulsion were given diazepam and settled down and then stabilized on carbamazepine. There was no end to the wonders.

Everyone remembered it as the most glorious summer in the area about Turku.

News of these wonders came to Lilly in her Lapland fastness. She sent out messengers to confirm if this really was true – that there was such a wondrous Machine. Yes it was true each of her messengers told her. She must have it, she decided.

She summoned a trusty troupe and on Midsummer’s Night when everyone was busy partying but there was plenty of light for the raiding party to see what they were doing, she broke into Crusoe’s laboratory and stole the Machine.

The following day everyone woke late from the Midsummer festivities and it took time for them to realize the Medicine Maker was gone. There was consternation. No-one had any idea where it had gone. Summer turned into Autumn with still no clue.

But finally word leaked out from Lapland that Lilly had the Machine but could not make it work. Still she wouldn’t give it back.

Crusoe formed a plan. To ease the difficulties of travelling in mid-Winter, they would travel by boat up the Gulf of Bothnia to Lapland. After that they would travel overland to Lilly’s fortress and see whether they could retrieve the Medicine Maker.

Arriving in late December, they found the guards asleep at the fortress gate. Everyone inside was asleep. They found the Medicine Maker and made off with it.

When Lilly awoke some days later and found the Medicine Maker gone, she flew into a frightening rage. Summoning her Myrmidons she set off in pursuit. By this time Crusoe and her band had reached their boat on the shores of the Gulf of Bothnia. Placing the Medicine Maker in the bottom of the vessel, they set sail for the South.

They were gone three days, with home in sight, when the midday sky in the North behind them darkened ominously. The cloud approached rapidly dissolving into a flight of the most enormous vultures each with a warrior on its back. It swooped down on the boat and a tussle began between the Pharmers turned sailors and the vultures with Lilly’s troops on their backs.

In the struggle the Medicine Maker fell overboard into the Gulf.

Axel Gallén - the Kalevala

Lilly retreated.

Crusoe and her band who lived near the shore where the accident had happened sent repeated expeditions attempting to retrieve the Medicine Maker from the depths but to no avail. However they kept up the hunt because invariably each of these efforts led someone to come across a new medicine that had just popped to the surface liberated from the Machine beneath. There was not the plenty of before but there was enough to be grateful for.


Editorial Note: Crusoe has not been lying low since The Shipwreck of the Singular and The Girl who Wasn’t Heard When She Cried Wolf. Check these out for previous Crusoe posts. The AbbVie story calls for a decent myth. Here is a start.

Sink all Vaccines to the Bottom of the Sea?

Crusoe was listening to Oliver give out. “They called me yesterday evening”, he said, “to tell me about the vaccination clinic on Thursday. Did I know how bad shingles were for an older man like me? I could even go blind if it affected the nerve that led to my eye. Yes I told them I knew all this”.

“So are you going to come along to the Zostavax clinic?”  “No, I have a meeting”, I told them. “What time does your meeting start?”  “At nine o’clock”. “The clinic opens at 8 AM”. “Ah but I have to prepare things before the meeting”.

“What time does your meeting end at?” “At 5 PM”. “The clinic is open till 6.30, you can make it”. “Well possibly not. The meeting ends at 5 PM but it’s highly likely I will have to spend time in fringe activities afterwards”.

“What about the following week?” They weren’t giving up. What if I’d been taking Humira – taking a live vaccination might be dangerous – they didn’t ask.  

It’s getting to a stage where I think it might be better for mankind if all vaccines were sunk to the bottom of the sea, but worse for the fishes.

Looking Out To Sea…

Crusoe was day-dreaming at this point. She was in the Florida Keys looking out to sea.

“Out there are the leper colonies”, the boy said. “Really”, she asked. “Yes”, he said. “And what are lepers?” she asked. “Lepers are people who can’t take vaccines”, he said. “They can’t be let mix with normal people like us because they can contaminate us. So they have to spend their lives on those islands”.

“Do you know the name of the islands”, she asked. “Yes”, he said. “One is Cuba and the other is Haiti. And I know the names of their capital cities”, he said. “I know the names of every capital city on earth”. “Do you?, she asked. “Yes”, he said. “Port-au-Prince is Haiti and Humira is Cuba”.

“I think you’ve got Cuba wrong. Don’t you mean Havana?”

“No”, he said.


Puzzled she asked the barman later that evening – “Have they renamed Havana?”

“Yes”, he said, “several years ago. Humira. At first it was a joke, but it stuck. Everyone who is taking a Biologic drug now has to go there because as I’m sure you know they can’t take certain vaccines.

“There was a real fuss ten years ago when the vaccination program got into full swing. A hysteria developed about people who remained unvaccinated – they posed a threat to all the rest of us.

“It began in schools when some parents refused to let their children have the Flu Jab. The other children shunned them and made it impossible for a child to remain unvaccinated.

“The authorities couldn’t deny it because this was just what they had been saying to people in the first place to get them to accept the vaccines – it’s a duty you owe to others.

“Any way there was a big concern about all those taking Biologics. You don’t hear much about Humira now but it was the blockbuster then. The best-selling drug ever. And then it was finally decided that everyone taking a Biologic who couldn’t be vaccinated because their immune systems were compromised would have to relocate to Cuba.

“In the wake of the uprising that got rid of the last of the Castros, the Cubans were very keen to swap properties on the very generous terms the Federal Government offered – and that’s where people on Biologics went. They renamed Havana as a joke but it seems to have stuck. Humirastan didn’t”.


“And Haiti? Who’s on Haiti”, she asked.

“Oh that’s where they put people with HIV. They can’t take vaccines either. The rest of us have all had our vaccine against HIV and they figure that it will be eliminated completely from the US mainland within a matter of months. 

“People are taking bets on the President having a photo op on an Aircraft Carrier with a sign behind him – HIVictory – apparently it’s a tradition that stems from something called the Gulf War – you remember the War with Cuba back in the last Millenium”.

EMA v AbbVie

Editorial Note: Three months ago we launched an AbbVie campaign and followed it up with a petition calling on AbbVie ad InterMune to drop their action against EMA. The hope was to raise awareness of this critically important issue that had been sailing beneath the radar.

Over 6000 of you from more than 120 countries responded.

This interim judgement is not a victory. It may be more a stay of execution. See links here for how things are playing out in the press for example. But it does mean that for the moment EMA is open for business again – except for Humira trials –  so anyone who can should now access any trial data they can in case the window closes again.


———- Forwarded message ———-

From: Rasi Guido <>
Date: 5 December 2013 11:10
Subject: Update on EMA appeal of EU Court interim measures decision in AbbVie and InterMune court cases

Dear colleagues and friends,

I have written a number of times over the past months to keep you informed of developments in the AbbVie and Intermune cases.

There is an important news I would like to share with you concerning the appeal procedures lodged by the EMA in Cases C-389/13 (P) R and C-390/13 (P) R.

As you recall, early in July this year the EMA lodged appeals against the Orders of the President of the General Court suspending the decisions to disclose under Regulation (EC) No 1049/2001 documents contained in the dossier for marketing authorisation of the medicinal products Humira and Esbriet.

We have been recently notified of the two Orders of the Vice-President of the Court of Justice annulling the previous Orders and referring back the cases to the General Court for a new decision on the interim relief applications. The ordinary procedures will follow their normal course.

In the Orders, the Vice-President of the Court of Justice concludes that the President of the General Court erred in law in finding that the alleged infringement of the companies’ fundamental right to the protection of their business secrets and of their right to an effective remedy was sufficient in itself to establish the risk of serious and irreparable harm in the circumstances of the present cases.

Accordingly, the Vice-President of the Court of Justice asks the President of the General Court to examine one by one, the arguments and evidence put forward by the companies and intended to prove the serious and irreparable harm to those companies. In the event that the companies produce such proof with regard to certain information or certain documents, the Vice-President of the Court of Justice explicitly provides that the interim measure sought be granted to them, in respect of that information or those documents only.

The full text of the Orders will shortly be available on the website of the Court of Justice

Although we have not won the case yet, this is a first important result since the litigation started. We would like to share with you our positive feelings and would like to thank you again for your continuing support, contribution and inspiration for the achievement of our common transparency objectives.

Kind regards


Guido Rasi

Executive Director
European Medicines Agency
7 Westferry Circus | Canary Wharf | London E14 4HB | United Kingdom


The Church of GSKology 2

A century ago Freud and Jung made us aware of the biases underpinning what patients say. Not everything should be accepted at face value. In particular claims of abuse may not be based on reality. We needed experts – analysts – they claimed to tease out what is real from what is not.

The Catholic Church was once intensely hostile to Freud, but when it came to child abuse adopting a Freudian approach was very convenient. But while Freud essentially denied that real abuse was taking place and got away with it in his life-time, the Catholic Church has learnt to its cost that many claims of abuse are real.

The Pope

This intensely dramatic picture shows a former Pope convening the US cardinals in Rome. They were ostensibly there to put the problem of child abuse in the Church to right but it now seems that the meeting was about managing the consequences for the Church rather than for any of its victims.

Habemus Papam? 

There is no pope in medicine. The Presidents of National Associations perhaps once came close. Now someone like Andrew Witty comes closest to fitting the bill.

Whatever about a Pope, there are lots of Cardinals. These usually come with the title professor. Just as with the analysts, these professors have had a training that stresses that you cannot believe everything you are faced with. In this case it’s more a matter of not believing the evidence of our own eyes as it is doubt about what someone says. We see patients balloon in weight in front of us or voice suicidal thoughts that clear when the treatment is stopped but the Cardinals are the people who on behalf of the Pope tell us this is not happening.

How often eagerness to see a positive response can mislead

The primary training these Cardinals now get is in evidence based medicine (EBM). Psychoanalysis was once a significant advance, as was EBM. Both made us keenly aware of the biases that both doctors and patients bring to therapy – how often their eagerness to see a positive response to a treatment can mislead them as to what is going on.

Psychoanalysis made us more aware of the importance of fetishes – especially sexual fetishes. A fetish is a part that substitutes for a whole. Adherence to psychoanalysis ultimately itself became a fetish that impaired many doctors’ abilities to engage with the real complaints of their patients.

EBM has fetished RCTs in a way that endangers our ability to handle many of the real problems our patients have and our ability to tackle the abuse to which they are subject.

If the skepticism that underpins controlled trials were applied primarily to the claimed benefits of treatments – the original purpose of these trials – there would be little problem. But instead these trials have become a means to deny the harms that drugs cause. Your observation that your patient has been injured by treatment is an anecdote, we are told. There is no evidence here.

Our Cardinals feel sympathetic for your problems but advise you in the interests of the Church at large to keep quiet. You will be doing the Devil’s work if you speak out about things you know nothing about.

Remaining Quiet for How Long?

We have reached a critical juncture. On the one hand we have evidence from company run trials, up to half of which remain unpublished and over 80% of which are ghostwritten, and close to 100% of which the data are unavailable for independent scrutiny. On the other hand we often have evidence of a problem appearing on a drug, that clears when the drug is stopped and reappears when it is restarted.

This kind of evidence until recently was thought to be the strongest causal evidence there was in clinical practice. In over 80% of cases evidence like this turns out retrospectively to have been right. So which is the more dependable when treatments go wrong, the evidence from company trials or the evidence from doctors and patients own eyes?

When they hear Evidence Based Medicine most people think they are hearing Data Based Medicine. It is an irony that trials are used to drown out good observations from individual case studies when such case studies are often the one group of studies in modern medicine where we actually have the data – the person who was injured and their clinical record.

It seems, if only for rhetorical purposes, we need a way to demonstrate how unreasonable it is not to take such reports seriously. If the Church is to survive, we need some Cardinals to take up this cause.

Meanwhile back in the Church of GSKology …

In the Church of GSKology, the striking parallels between the way the Catholic Church is handling abuse cases in the Archdiocese of Minneapolis and GSK are handling access to clinical trial data were pointed out.

The legal system in Minneapolis though seems to be sorting the Catholic Church out. Judge van de North has just ordered the Archdiocese of St Paul and Minneapolis and the Diocese of Winona to release the names of 58 priests “credibly linked to episodes of child abuse”.  (Although the story seems to have vanished from the Star Tribune site – see

The legal system is not getting to grips with the Church of GSKology or with Astra-Zeneca in Minneapolis in anything like the same way.

In the case of Study 329, GSK got patients to sign consent forms saying they would not receive treatment that differed from standard clinical practice, when in fact the plan was to force titrate these children up to imipramine 300 mg per day.

At the end of the study there was a statistically significant increase in the rates of suicidality on Paxil compared to placebo.

Children have been abused. Whose duty is it to inform these now grown children. Pope Andrew?

Or the doctor involved in the trial or their institutions?

  • Marty Keller, or if not him, Brown University?
  • Barbara Geller from St Louis?
  • Rachel Klein from New York?
  • Neal Ryan from Pittsburgh?
  • George Papatheodorou or CAMH where he was working then?
  • Stan Kutcher from Dalhousie?
  • Gabrielle Carlsson from Stony Brook?
  • Graham Emslie from Dallas?
  • Karen Wagner from Dallas?
  • Michael Strober from UCLA?
  • Greg Clarke from Portland?
  • Elizabeth Weller from Columbus?

There were lots of others pulled in to the exercise, pleased perhaps to get their name on a paper. Boris Birmaher for instance.

Rumor has it there are a bunch of bioethicists and lawyers who have got greatly exercised about things going wrong in a St Paul and Minneapolis Astra-Zeneca clinical trial. Perhaps some of them could weigh in on the issue of what should happen next in the case of 329. GSK and A-Z are both British companies – perhaps this is a British thing.

What are the duties of companies, doctors, universities and clinical institutions in a situation like this?

Lives Touched by GSK


Notes of a Paxil Guinea Pig

What does GSK owe to the youngsters in its infamous Study 329 who became suicidal while taking the company’s paroxetine (Paxil/Seroxat)?

As someone who was briefly a GSK Guinea Pig, I’d say the most important thing they’re owed is the truth. It’s a highly delinquent debt – but it’s not too late for GSK to pay up.

I took part in a study of Paxil back in 1994. Like many U.S. subjects, I signed up mainly for the free medical care: I was tired of battling my employer’s HMO which doled out mental health treatment with an eyedropper. However, having already taken Prozac with little or no effect, I was also as curious as anyone to find out if these drugs “worked” or not, according to Big Science. I was willing to be a guinea pig if it would lead to some answers.

The protocol was that everyone was put on Paxil for a number of weeks, after which half of us would be switched cold-turkey to placebos, the other half would continue on Paxil.

Supposedly, this would determine whether people with “recurrent depression” should stay on long-term Paxil maintenance therapy. Looking back, however, what the study really did was to produce drug-withdrawal distress, then interpret that as the original depression coming back. And most likely, by 1994, GSK knew that.

Treatment Related Injury?

After the switch to either placebo or Paxil I fell asleep at the wheel of my car and had an auto accident with minor injuries. I didn’t want to drop out – I was pretty sure the cause of my accident wasn’t Paxil, but working a sixteen-hour shift. But I was told the study protocol demanded my removal. Not knowing the research design, I never found out whether they were being conscientious, or just the opposite – dropping my results to cover up problems.

The Paxil hadn’t helped me much. But after the switch, I quickly felt the ground under my feet get rockier, at least for awhile.

Well, I thought, it didn’t feel like the Paxil was doing me any good – but here I was feeling worse without it. It didn’t occur to me that this could be down to Paxil withdrawal, because I had never heard of it.

Once the blind was broken, the researchers confirmed I had indeed been switched to placebo.

I never found out if my study was published. When I finally saw a psychiatrist, his reaction was that this had been a “pretty stupid study,” because “everyone already knew” that people like me who’d had several depressive spells should be on medication for life. That makes me think there were already multiple published studies of this type – and possibly dozens more that the drug companies never bothered to publish.

GSK & Responsibility

I’m angry with GSK, not only for putting me through Paxil withdrawal, which, thank god, was not severe in my case, but also for what they later did to me and other patients by hiding the results. They and the other drug manufacturers led millions of us to believe we needed these drugs for life, “just like diabetics need insulin.”

At a minimum this deprived millions of people of a normal sex life, and may have numbed their ability to respond to life in other ways. Untold numbers of children have been exposed in utero. And I and millions of others became part of a twenty-year uncontrolled experiment on the long-term use of these drugs to control a “deficiency” that we may never have had.

Study 329

For the kids in Study 329 who became suicidal on Paxil, GSK’s deception may have done much worse. To this day, I’d bet some of them don’t know the role of the drug in their suicide attempt. Being “the kid who tried to hang himself at fourteen” affected how they saw themselves, to say nothing of how their families, schools and juvenile courts may have seen them. It’s long overdue – but not too late – to tell them that “what you did was not necessarily your own doing.”

Knowing the facts about the limited effectiveness of these drugs could also open doors for those who have not responded to them. For two decades we’ve been told we were a small minority whose condition, being Treatment Resistant, must be very grave indeed. That verdict led many to accept punishing multidrug treatments, ECT, or simply becoming resigned to a life of disability.

Like the kids in Study 329, we deserve the opportunity to rewrite the life story handed to us by well-meaning professionals acting under the influence of GSK.

GSK owes…

It’s not too late to learn something useful from the changes GSK put us all through. It might help us learn more about SSRI withdrawal and SSRI-induced agitation, including who suffers what effects and why. I have no idea what consent forms I signed 20 years ago, but I sure as hell never intended to give GSK the right to hide the results of the experiment they ran on me.

GSK owes me the truth. It owes at least as much to many others, like the kids in Study 329, who suffered far more than I did. To say nothing of the patients who never took part in research, but whose lives were altered by it nonetheless. It would have been infinitely better if they had owned up twenty years ago. But that’s no reason to write off the debt now.

The Church of GSKology

Editorial Note: This post is about midway through a series of posts that are broadly part of the AbbVie series. The series began with GSK’s Transparency and Access Journey, moved on to The House of GSK and will have at least two more posts after this. 

Reading the Minneapolis StarTribune, it was the reference to privacy that clinched it.

Facing a sexual abuse lawsuit, the archdiocese of St Paul and Minneapolis made a big deal of putting an independent panel in place to investigate.  They put the Reverend Reginald Whitt in charge of appointing the panel and receiving its reports on behalf of the archdiocese.

An Independent Panel that Sticks to the Rules

Rev. Whitt told priests and deacons that the task force may review specific files to determine whether the policies of the archdiocese concerning clergy sexual misconduct were properly followed. But, he wrote, “Access to these files will be within my control, and limited only to what is necessary for the task force.”

He also wrote that he recognized that many priests and deacons “may be anxious about your right to privacy and a good reputation.” He assured them that the archdiocese will proceed according to the principles of due process and uniform application of canon policy.

This sounds terribly like the approach Sir Andrew Witty is attempting to put in place for GSK, AbbVie and the rest of the branded pharmaceutical industry vis-a-vis abuses, including child abuse committed in their name.

Investigating Abuse

Is Abuse too strong a word? In Study 329, a controlled trial of Paxil given to children, there was a statistically significant increase in suicidality on Paxil compared to placebo. These children were unquestionably injured but it seems about as likely that GSK have contacted the children involved to tell them what happened as the Catholic Church have voluntarily got in touch with anyone who has been affected by their priests or nuns to inquire about their wellbeing.

In Study 329, the consent form tells parents and children that the child will not be exposed to any danger or risks beyond what would be found in normal clinical practice – but the protocol for the study involved an attempt to force titrate children up to a dose of 300 mg of imipramine. This is double the standard dose used for adults – at least in Europe. One reasonable hypothesis as to why this might have been done was that it was an effort to make Paxil look good. Pretty grim if it was.

Privacy Rights 

Just as the Church is insisting on the Privacy Rights of its priests, GSK, AbbVie and others have taken a legal action against the European Medicines Agency in an effort to claim Corporate Privacy Rights (See Let’s Do the AbbVie Again,  Avoiding Adverse Events).

Just as we respect an individual’s right to believe what they want – to be a Muslim, Hindu, Christian or Jew – and defend a pregnant woman’s right to control what happens to her body, GSK and AbbVie are claiming a comparable right to decide what the clinical trial data they hold means.

They are asserting their right to spin their version of what it is you put in your body even though this clashes fundamentally with your right to know what you are putting in your body.

Canon Law

Companies operate their own version of Canon Law. Canon law is the Church’s own internal legal system that the Church insists has primacy over national judicial systems. The Bishops and Cardinals adhere to this rather than the laws of the US or other countries. Whether intended or not, this is a system that favors the clerical abusers over abused children. It is this that has fueled the anger of those who have been abused. There would be little problem if the Church’s legal system were harder on the Clerics than on Children. But using a system that defies natural justice to safeguard Clerics not unsurprisingly causes anger.

GSK and other companies run something similar. They actively attempt to over-ride the legal systems of the United States and other countries with claims that unless findings are demonstrated in controlled trials to a statistically significant extent that they simply aren’t happening.

The US Federal Judicial Manual states that convincing evidence of challenge, dechallenge and rechallenge is the way to demonstrate that a drug has caused an adverse event. No place here for statistical significance.

With a flourish worthy of the best Jesuits, internally GSK and other companies apply exactly the approach advocated by the Federal Judicial Manual when assessing whether Paxil has caused a birth defect or suicide, but even after deciding in private their drug is guilty, in public they insist there is no absolutely no evidence that their drug has caused a problem.

This can even leave GSK personnel stating in public that they are not aware of a single side effect that is caused by Paxil or likely any of their drugs. See Burn in Hell.

The US Supreme Court has weighed in on this question and decided that GSK’s model is wrong. People have a right to make up their own minds as to what an adverse event profile means. The only people who have this right at the moment though are investors. Patients and doctors have no rights – at least not established.

Church of GSKology

GSK have applied to be treated as engaged in Science. They say that what they do has all the features of Science – clinical trials, peer reviewed publications.

Ideally the Courts would decide that rather than being a Science they are a Church – they operate a system that requires belief without evidence. There is less doubt that their publications are ghost-written than the Bible is.

While they have people with great public relations skills like James Shannon who say all the right things in public, like the Catholic Church GSK appear to operate an Opus Dei like arm which enables them to place their people close to heart of Britain’s regulator the MHRA and other bodies. They are close to being the Established Church in England.

In the face of abuse, GSK make a big deal about apparent reform but the Rev Whitt described the mechanism GSK have put in place perfectly: “Access to these files will be within my control, and limited only to what is necessary for a Responsible research proposal.”

Waiting for a Frances?

When it comes to reform it seems Andrew is a Ben not a Frankie.

We need some Martin Sixsmith or Dan Brown to write a book and make a movie on the lines of The Lost Child of Philomena Lee.

Don’t hold your breath. GSK are a lot scarier than the Catholic Church.