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

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 above 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.

Magna Carta

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.”

Psychiatry Gone Astray

Editorial note: We follow up the Guilty post last week with a piece written by Peter Gøtzsche 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 medicine, 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.”

New York Times

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”.

“And”?

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.

Medystopia

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.

Humirastan

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”.

HIVictory

“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 and InterMune to drop their action against EMA (European Medicines Agency). 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 <[email protected]>
Date: 5 December 2013 11:10
Subject: Update on EMA appeal of EU Court interim measures decision in AbbVie and InterMune court cases
To:

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 www.curia.europa.eu

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

Guido Rasi

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

[email protected] | www.ema.europa.eu

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