Making medicines safer for all of us

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

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

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

Archive for Blog

What’s Poisoning Health: The Crusoe Report 2

Mother Bird

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

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

From luxury to basic

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

A car was a luxury.

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

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

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

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

Car, TV and dinner

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

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

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

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

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

Slow medicine

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

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

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

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

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

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

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

To be continued…

Restoring Health: The Crusoe Report 1

Crusoe map

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

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

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

A patch of ground

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

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

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

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

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

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

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

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

Infertile

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

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

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

Recipe

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

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

Slow medicine

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

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

How did we get to this point?

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

To be continued.

Magna What? The Embarassing Side Effects of Drugs

Magna Farta

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

42 or Thereabouts

42 answer

See previous posts – Switch on Anti-Depression Today and So Long and Thanks for all the Serotonin.

In response to the recent BMJ editorial on Serotonin and Depression, there were seventeen letters of which three were published, along with my response. These are copied below along with the best letter – by Barney Carroll – which wasn’t published. Make your own mind up as to why.

Another piece of minor intrigue is that this editorial, originally entitled So Long and Thanks for all the Serotonin, a title BMJ felt uncomfortable with, registered well on Altmetric – an index that tracks how much Buzz an article is generating. When I started looking at this, the article was rated at 43 on Altmetric and then moved down to 40 passing through 42 en route. It will presumably pass back through 42 at some point as it gets displaced by Buzzier pieces. Amusing given the Hitch-Hiker link.

serotonin and depression

Healy states the obvious

As a matter of clinical science, the notion of a simple serotonin deficiency in depression ended 45 years ago, when the proposed therapeutic utility of monoamine neurotransmitter precursors was disconfirmed.1 There has been little incisive progress since then, owing to major missteps in the intervening years – for starters, the foolish introduction of generic major depression in lieu of clinically differentiated types of depression as the focus of investigations;2 the displacement of disinterested clinical science by corporate experimercials;3 the corruption of journals and of educational forums by key opinion leaders who promoted corporate marketing narratives;4 and the capture of research funding agencies and regulatory agencies by commercial forces. The discomfort that David Healy’s editorial has caused in some quarters reflects a general embarrassment at the emptiness of current research in mood disorders. The yield has not been commensurate with the billions of dollars thrown at the problem – to the point where most corporations have exited the field out of a healthy self-interest. Little wonder, then, that those who have reason to be embarrassed are now throwing the book at Dr. Healy for stating the obvious.

REFERENCES
1. Carroll B.J. Monoamine precursors in the treatment of depression, in «Clinical Pharmacology and Therapeutics» 12, 743-76 (1971).
2. Carroll B.J. Bringing back melancholia, in «Bipolar Disorders» 14, 1-5 (2012).
3. Carroll B.J. Sertraline and the Cheshire cat in geriatric depression, in «American Journal of Psychiatry» 161, 1145-1146 (2004).
4. Carroll B.J., Rubin R.T. The high cost of non-disclosure, in «Clinical Psychiatry News» 34(10), 27 (2006).

Bernard Carroll

Serotonin and depression – Healy does a disservice to psychiatrists

Alexander E Langford,  South London and the Maudsley NHS Foundation Trust

David Healy does a great disservice to jobbing psychiatrists with this editorial. By portraying them as ‘co-opted into a myth’ about low levels of serotonin being the sole cause of depression he paints them as gullible, and by stating that the same theory is ‘an easy shorthand for communication with patients’ he paints us as lazy and reductionist in our appraisal of the complex and diverse causes of depression.

In reality, good psychiatrists are and always have been only too ready to admit that they are unsure how antidepressants work. Serotonin does play an important role – likely via factors like neurogenesis and gene expression downstream from synapses – but modern psychiatry is way ahead of where Healy seems to think it is. The picture is far more complex. The fact that ketamine has been shown to be useful in depression does not ‘cast doubt on the link between serotonin and depression’, it rather confirms that the neurobiological underpinnings are as multifaceted as we think.

In any case, whatever their mode of action, SSRIs do work. Even the most stringent of analyses (i.e. Kirsch) support this. There is no good evidence that SSRIs work any less well than TCAs for depression , and the SSRIs have not become so commonplace in clinical practice due to some form of pharma-doctor conspiracy, as Healy would suggest, but because the older TCAs have a far less admirable side-effect profile and were also lethal in overdose. The safety of our patients should always come first, and they are far less safe without treatment for their depression.

Healy D. Serotonin and depression. BMJ 2015;350:h1771. (21 April.)

Serotonin and depression: myth or legend?

Philip J Cowen, Professor of Psychopharmacology, University of Oxford,

David Healy’s observations on serotonin and depression make interesting , if familiar, reading [1]. However, I was struck by the remarkable claim that the focus on serotonin has led to the ‘eclipse of cortisol’ in mood disorder research. A quick search in Scopus with ‘cortisol’ and ‘depression’ revealed a rapidly increasing number of published articles from the late 1990s, continuing unabated to the present time. Only last year saw the completion in the UK of a large placebo-controlled study which examined the effects of inhibiting cortisol synthesis in patients with depression refractory to SSRIs[2]. David also manages to suggest that ketamine has been shown superior to SSRIs in melancholic depression whereas no such comparison has been carried out. He further implies that the work of Andrews and colleagues is based on the intellectually paralysing notion that low serotonin causes depression whereas in fact these authors argue exactly the opposite [3].

Should one confront myths by constructing different ones? As an avid BMJ reader I find myself increasingly confused by this question. For if scientific narratives are manifestations of competing power claims and vested interests perhaps there isn’t really a ‘fact of the matter’- the important thing is to be on the right side. I agree with David.

  1. Lacasse JR, Leo J. Serotonin and depression: A disconnect between the advertisements and the scientific literature. PLoS Med 2005; 2: e392 DOI: 10.1371/journal.pmed.0020392 (http://medicine.plosjournals.org).
  2. Watson S, Anderson IM, Apekey TA, et al. Antiglucocorticoid augmentation of antidepressants in depression: The ADD study. J Psychopharmacology 2014; 28 (suppl): A38.
  3. Andrews PW, Bharwani A, Lee K R, et al. Is serotonin an upper or a downer? The evolution of the serotonergic system and its role in depression and the antidepressant response. Neurosci Biobehavior Rev 2015; 51: 164-188.

Serotonin and depression – personalized pharmacotherapy: an interim solution?

Adam M Chekroud. Yale University, USA

Prof. Healy offers an engaging historical perspective on the rise of serotonergic antidepressants that questions their efficacy and biological plausibility. However, this focus on low serotonin levels is a distraction that is basically irrelevant to whether serotonergic antidepressants are effective treatments for depression. It is important to note that response to serotonergic antidepressants appears to be heterogeneous rather than universally poor.  Unbiased trajectory-based analysis of over 2500 patients treated with SSRI antidepressants or placebo indicated that the majority of patients (over 75%) showed a superior response to patients treated with placebo.  However, nearly one quarter of patients treated with SSRIs showed a poorer response than patients treated with placebo. This suggests that in these patients, SSRI treatment actually interferes with their capacity to mount a placebo response, or perhaps even their capacity for resilience to depression [1]. This raises the critical issue of whether there are ways to identify those patients who would seem to be better off avoiding SSRIs and to divert these individuals to other treatments for their depression.

One factor reducing the effectiveness of antidepressants treatment is our inability to personalize pharmacotherapy, i.e., clinicians have no mechanism for predicting whether a particular patient will respond to a specific antidepressant. Instead, the process of matching patients and treatments requires a prolonged period of trial and error, delaying clinical improvement and increasing the risks and costs associated with treatment. Despite important progress in trying to identify depressed patients at high risk of treatment resistance [2], Psychiatry continues to lag behind other specialties like Cardiology and Oncology in which personalized treatment selection is far better established [3,4].

Developing more generally effective treatments and more rapidly effective treatments would be extremely important advances for public health.  However, in the absence of any such silver bullet, we advocate the development and implementation of innovative statistical methods to get the best available drug to each patient, as an interim solution. Personalized pharmacotherapy may still enable us to “save lives and restore function”. Giving up on these patients is not an option.

  1. Gueorguieva R, Mallinckrodt C, Krystal JH. Trajectories of Depression Severity in Clinical Trials of Duloxetine: Insights Into Antidepressant and Placebo Responses. Arch. Gen. Psychiatry. 2011;68:1227–37. doi:10.1001/archgenpsychiatry.2011.132
  2. Perlis RH. A clinical risk stratification tool for predicting treatment resistance in major depressive disorder. Biol Psychiatry 2013;74:7–14. doi:10.1016/j.biopsych.2012.12.007
  3. Kumbhani DJ, Wells BJ, Lincoff AM, et al. Predictive models for short- and long-term adverse outcomes following discharge in a contemporary population with acute coronary syndromes. Am J Cardiovasc Dis 2013;3:39–52.http://www.ncbi.nlm.nih.gov/pubmed/23467552
  4. Roobol MJ, Carlsson S V. Risk stratification in prostate cancer screening. Nat Rev Urol 2013;10:38–48. doi:10.1038/nrurol.2012.225

A pleasing look of truth

I wrote an almost identical editorial as this in 1991 (1). Covering the marketing of serotonin in 1997 (2), I cited Jerome Gaub’s 1767 opinion of Leibniz’ views on the relations of the mind to the body – it is a “fable whose novelty has recommended it, whose recommendation has spread it, whose spread has polished it, refined and adorned it with.. a pleasing look of truth” (3)

I use SSRIs.  Nevertheless I believe the SSRI era will soon stand as one of the most shameful in the history of medicine.  The shame does not stem from what pharmaceutical companies have done, which is just as might have been expected.  The shame will be seen to have arisen from the failure of doctors to know as much as they should have done about medicines they dish out so liberally.  A recent study showing how a dollop of neuroscience dressing can disguise otherwise meaningless material should be compulsory reading for doctors who are after all the true consumers of these drugs (4).

But perhaps an even greater shame will be seen to lie with the fact that this has been an era in which the bulk of publications on on-patent drugs in our best journals were ghostwritten, an era in which the journals refused to demand access to trial data as the price of publication – nowhere more clearly demonstrated than in the area of antidepressant studies on children.  It has been an era when industry has controlled journals, by spending money on some of them and by intimidating others into self-control.

  1. Healy D. The Marketing of 5HT.  British J of Psychiatry, 1991; 158, 737‑742.
  2. Healy D. The Antidepressant Era. Harvard University Press, Cambridge Ma 1997.
  3. Rather LJ. Mind and Body in 18th Century Medicine. Wellcome Historical Medical Library, London, P 17. 1965
  4. Weisberg DS, Keil FC, Goodstein J, Rawson E, Gray JR The Seductive Allure of Neuroscience Explanations. J Cogn Neurosci. 2008; 20, 470–477.

 

Meanwhile the patient information leaflets for pretty well all antidepressants and wannabe antidepressants like quetiapine as of today continue to promote versions of the Low Serotonin Hypothesis (thanks to Julie P for pointing this out).

Citalopram low serotonin

This should incense a lot of people.

Compulsory Vaccination and the Media – The Australian Experience

no vaccinations

Editorial Note: This is another post on the vaccination and censorship theme. Elizabeth Hart’s comments, over the past few weeks in response to some of the posts here, on efforts to stifle debate have been balanced and eloquent. Given the growing number of new journalism outlets, such as The Conversation, that portray themselves as tackling cutting edge issues fearlessly but in fact do no such thing it is a pleasure to help her get a message out that the editor of The Conversation has ignored.

Her interest in the issues began in an unusual way – after her dog died from a booster dose. Checking into it she became aware that pet vaccination is big business and one that has does more for the health of Vets than Pets. This is what radicalized her.

For the attention of:
Mr Andrew Jaspan
Executive Director and Editor
The Conversation

Mr Jaspan

I suggest there are serious problems of bias and censorship at The Conversation and I question whether you are fulfilling your charter.

The Conversation is very ‘pro-vaccination’, there is little in the way of critical analysis of vaccine products. For example The Conversation has helped promote HPV vaccination. I suggest HPV vaccination is controversial, see for example my summary which discusses the questionable way HPV vaccination was initiated in Australia when Tony Abbott was Health Minister in 2006.

The Conversation should be mindful that it has conflicts of interest in that it receives funding from universities that receive funding from the pharmaceutical industry for vaccine research. It seems to me that The Conversation is a marketing arm for the university and research sector.

Today comments were closed down on The Conversation article “Forget ‘no jab, no pay’ schemes, there are better ways to boost vaccination”.

Comments were also recently closed down on “Want to boost vaccination? Don’t punish parents, build their trust” and “’No jab, no pay’ policy has a serious ethical sting”.

I had posted detailed and referenced comments on these articles relevant to vaccine policy and practice, with some still awaiting a response. I had planned to post more comments, but I have now been thwarted in this regard, as ‘the conversation’ has been closed down. Opportunities for serious discussion on vaccination policy and practice are limited in the current hostile climate, and The Conversation does not help by curtailing debate.

Mr Jaspan, Prime Minister Tony Abbott’s announcement that vaccination will be compulsory to obtain family tax benefits is a very serious matter. We are on a slippery slope when governments mandate medical interventions such as vaccination.

There are serious problems with transparency and accountability for vaccination policy in Australia, and I have recently raised this matter with Prime Minister Abbott, see my letter dated 21 January 2015.  There is a serious problem of potential conflicts of interest and lack of disclosure by people influencing vaccination policy.

Tony Abbott, and Opposition Leader Bill Shorten, have reacted to the crude “No Jab, No Play” campaign by News Corp Australia media, e.g. The Sunday Telegraph.

It appears the vigilante pro-vaccination group SAVN (Stop the Australian (Anti) Vaccination Network) was also instrumental in this campaign. It also appears The Conversation is a supporter of SAVN, as evidenced by its publishing articles by self-avowed SAVN members, e.g. Rachael Dunlop and Patrick Stokes. It is notable that Patrick Stokes’ membership of SAVN is not included in the Disclosure Statement on his article “No, you’re not entitled to your opinion”.

I have tried to raise serious discussion about vaccination and individual vaccine products on The Conversation as my ‘activity’ illustrates, but I have often been impeded by followers of the SAVN who colonise comments threads on vaccination articles on The Conversation.

I was astonished today to discover that SAVN member Patrick Stokes has the ability to ‘hide’ (i.e. censor) comments on articles on vaccination on The Conversation, (see discussion between Patrick Stokes and Adam Bonner on “Forget ‘no jab, no pay’ schemes, there are better ways to boost vaccination”). Patrick Stokes is hardly an impartial arbiter, on what basis have you given him this power?

I also suggest there are serious problems at The Conversation in regards to proper disclosure of authors’ potential conflicts of interest. In this regard see my discussion with Professor C Raina MacIntyre on the “Want to boost vaccination? Don’t punish parents, build their trust” comments thread.

It is also ironic that experts on vaccination such as Professor MacIntyre and A/Professor Kristine Macartney do not appear to understand the difference between ‘vaccination’ and ‘immunisation’, and incorrectly use these words interchangeably, another point I raised on their articles. If ‘experts’ are so careless with the basics, what else are they getting wrong?

Mr Jaspan, compulsory vaccination is at odds with the requirement for ‘valid consent’ before vaccination, see Section 2.1.3 of The Australian Immunisation Handbook.

I suggest there should be an investigation into the aggressive campaign to make vaccination compulsory in Australia, and the tactics used by News Corp Australia, SAVN, and The Conversation.

Yours sincerely

Elizabeth Hart

http://over-vaccination.net/

Elizabeth Hart

The Couric Incident: HPV Vaccine & Mass Bullying

Katie Couric

Editorial Note: This post is by John Stone at my invitation. I am broadly speaking pro-Vaccination and reluctant to stray into the Vaccination Wars but the issues about free debate in recent posts seem most acute in this domain. Anyone who even thinks about questioning is vilified.

There are important public policy issues involved in MMR but less so with the HPV vaccine and the Flu Shot. For many working in healthcare, the Flu Shot is worrying. While in Britain it is not compulsory, there is a lot of pressure even though the case for having it seems weak. Elsewhere Flu Shots have been made compulsory. I’m sure many of us wonder what we would do if put on the spot like this.

Some of the strongest Vaccination advocates double up as Pro-Transparency campaigners. A Furor Vaxicanus just doesn’t seem to match up with transparency. John Stone is a Vaccine Safety Advocate who to my mind has also been one of the most reasonable voices commenting on some of the posts on this site over the last year. I don’t know John from a bar of soap (as we’d say in Dublin).

But I do know Rokuro Hama whose work John cites here. Rokuro and the group behind MedWatcher Japan are the most extraordinary courageous scientists and lawyers and all round safety advocates there are. Their MedCheck Bulletin is being made available in English for the first time this week and will be worth following – see MedCheck.

The point being raised by Rokuro goes to the heart of Evidence Based Medicine. When “girls” complain of serious problems after Gardasil or Cervarix, what weight do we put on what they say? What weight do we put on what we know about the biology of the HPV vaccine? What weight do we put on the fact that any effort to ask about this runs into media flak from SMC UK,  or SMC Australia, SMC Canada or SMC USA?      

Katie

In 2012 Katie Couric was the best paid media presenter in the United States, referred to as America’s Darling. Late in November 2013 it was announce that Couric was to give room in her ABC Television show Katie to the subject of vaccine injury from HPV vaccine. The result was an immediate furore.

Wiki recalls aspects of this historic episode:

In December 2013, Couric ran a segment on the HPV vaccine…which critics accused of being too sympathetic to the scientifically unsupported claims that this vaccine was dangerous…For example, Seth Mnookin accused her broadcast of employing false balance. In addition, Alexandra Sifferlin, of Time magazine, compared Couric to Jenny McCarthy, a well-known anti-vaccine celebrity…On December 10, 2013, a week after the original segment was aired, Couric posted an article on The Huffington Post responding to this criticism, in which she stated:

“I felt it was a subject well worth exploring. Following the show, and in fact before it even aired, there was criticism that the program was too anti-vaccine and anti-science, and in retrospect, some of that criticism was valid. We simply spent too much time on the serious adverse events that have been reported in very rare cases following the vaccine. More emphasis should have been given to the safety and efficacy of the HPV vaccines.”

The show which was falling in the ratings was due to be taken off the air the following summer was suddenly terminated 19 December, but not before a follow-up program had been screened giving all its room to the vaccine advocates. This was obviously a huge professional humiliation for Couric, but it was not the whole of the story: on Couric’s website a gigantic battle raged between families of injured people supporting the show and an angry mob of “skeptics” – many of them Australians – who ridiculed them. There were probably more than twelve thousand posted comments in all: more than a thousand apparently came from the keyboard of ubiquitous vaccine program advocate Prof Dorit Reiss, an academic (but not qualified lawyer) from Hastings law school in San Francisco, which is in partnership with Kaiser Permanente who were hired by Merck to study the post-marketing effects of their HPV vaccine Gardasil. Kaiser Permanente are also partners with Centers for Disease Control. While Reiss was more well-mannered than most of the vaccine advocates she dismissed any attempt to discuss vaccine injury as anecdotal, and her tactics were copied and deployed more brutally others. Many people, of course, speculated on how she could post so often while carrying out her professional duties at Hastings.

The episode also closely echoed a campaign earlier in the year to have Jenny McCarthy – widely labelled “anti-vaccinationist” – excluded from broadcasting, an episode which also involved Reiss and her colleagues at Voices for Vaccines. V4V also parades as not accepting pharma money but is in fact an off-shoot of Task Force for Global Health, which does accept pharma money, and is in partnership with the Centers for Disease Control. It is interesting to note that the chair of Task Force’s Board of Directors is leading Atlanta product liability lawyer Jane Fugate Thorpe.

The view from Japan

It should be evident, whatever the words of Couric after the event, that these are not stories about science asserting itself but of corporate leverage and internet bullying. The strategies and their effect say nothing about the quality of the science at all. They speak to the ethics of the proponents. It is particularly salutary to view these events against the background of a recent review of the evidence in the independent Japan Institute of Pharmacovigilance  bulletin Med Check – The Informed Prescriber (editor-in-chief Rokuro Hama). Hama is also a special advisor to the Cochrane Collaboration:

Harm of HPV

Abstract: Incidence of serious adverse reactions to HPV vaccine is 3.2% per year according to our  recalculation using the latest data (3,200 cases per 100,000 person years). This is almost equivalent to the incidence rate of serious adverse events within 1.2 years after the first vaccination (annual rate of 2.8%) reported in the randomized controlled trials (RCT) of Cervarix. In Cervarix RCTs, the excess incidence of serious reactions, autoimmune diseases and death after 3.4 years comparing with those during 1.2-3.4 years was calculated as 4,000 patients, 630 patients and over 100 deaths per 100,000 person-years respectively. These might also occur in Japan. As to the epidemiological surveys from Europe and North America that Japanese Ministry of Health, Labour and Welfare (MHLW) based on as the evidence for safety of the vaccine have flaws in their methodologies. One study confuses prevalence with incidence, and the other two have serious bias derived from “healthy vaccinee effect”. While there is no evidence confirming that HPV vaccination decreases incidence of and mortality from cervical cancer yet, supposing that the vaccine could halve the cervical cancer mortality, the expected maximum benefit would be two deaths per 100,000 person-years at the most. Hence, the harm experienced is overwhelmingly greater than the benefit expected.

The DisUnited Kingdom

In the United Kingdom media reporting of the harms of HPV vaccines has died out since 2009. An article in the Sunday Express by Lucy Johnston, much sneered at by Ben Goldacre in the Guardian, reported much the same thing as Med Check:

The cervical cancer vaccine may be riskier and more deadly than the cancer it is designed to prevent, a leading expert who developed the drug has warned. She also claimed the jab would do nothing to reduce the rates of cervical cancer in the UK. Speaking exclusively to the Sunday Express, Dr Diane Harper, who was involved in the clinical trials of the controversial drug Cervarix, said the jab was being ‘overmarketed’ and parents should be properly warned about the potential side effects.

It looks as if the article was withdrawn after a complaint by Dr Harper because she had alluded to the aggressive marketing of Gardasil by Merck in the US when the main topic was GSK’s Cervarix and this was not clear in the otherwise sound report. Be that as it may this is still a vaccine where the benefits are six years later still entirely theoretical and speculative and there are apparently many injured young women.

They and their families should be allowed to speak to the world without harassment. The public pay for these very expensive vaccines twice, first through the public purse, then through the harms they inflict. 

So Long and Thanks for all the Serotonin

Leunig depression cartoon

The BMJ article on Serotonin and Depression has stirred some interest. There are some highly technical comments on the BMJ site but of course the key point behind the piece is the rather obvious fact that twenty-five years ago many people were saying it was all a myth. The extraordinary Michael Leunig nailed it twenty years ago in the sketch above. (Leunig is wonderful across the board and razor sharp on medicine and mental health).

So did the BMJ know what they were doing when they sent the article to the Science Media Centre leading to the extraordinary new Switch on Anti-Depression (SAD) theory?

I thought they were making a mistake, but maybe not. The figures for impact from Altmetric show a lot of interest.

serotonin and depression

There are good grounds for a lot of people to be very angry.

The lawyers for several pharmaceutical companies for instance claim to be very angry and upset by recent posts mentioning that finding out about things such as the idea that lowered serotonin was a myth could provoke murderous fantasies in some people, most of whom would do nothing but simmer and seethe. They have been even more upset at the suggestion that while some of us can view all this as “academic” others might be radicalized and might storm the offices of pharmaceutical companies or journals.

See War on Civilization and Pharmaceutical Rape.

serotonin and depression

Our rulers are exquisitely aware of the potential for violence in those who are oppressed – those who are powered out. The violence inflicted on us – mostly by White Males – from Ferguson and Charleston to Baltimore playing out across television screens for the last year offers just one example. They expect Us to be as violent back as they are to US, and they tend to take pre-emptive action. At the first FDA Prozac and suicide hearings, the Chairman Daniel Casey wore a bullet-proof vest.

Clearly there has been no endorsement here for violent action but as one correspondent (MMC) put it, we sent Marlboro Man packing and something similar is needed here.

serotonin and depression

Better Die on your Feet than Live on your Knees sounds violent but was in fact the rallying cry of the Non-Violent Resistance movement that began in Ireland in the 1870s with Michael Davitt and later extended to Mahatma Gandhi and Martin Luther King.

If you want to see what is involved, fill a RxISK report on your behalf or someone close to you and take it to your/their doctor. There is a good chance you’ll find out just how violent the system is.

But keep knocking until you find a doctor who listens, let us know about them and we can build networks that can change medicine. It is only going to change from the Bottom Up.

Switch on Anti-Depression Today

5794416589_bb14397d5f_z

Science Media Centre roundup

Expert reaction to editorial on serotonin and depression as published in The BMJ (British Medical Journal)*

Dr Clare Stanford, Reader in Experimental Psychopharmacology, UCL, said:

“Prof David Healy’s article treads a path that is well-worn but out of date. He argues that selective serotonin re-uptake inhibitors (SSRI) antidepressants are used because of a pervasive myth that they boost serotonin levels, but this is something of a straw man. He makes the mistake of assuming that antidepressants reverse a functional abnormality in the brain that causes depression. Actually, the theory that low ‘levels’ of serotonin in the brain (whatever that means, functionally) causes depression died many years ago, in spite of the fact that a deficit in the synthesis of serotonin in the brain can trigger relapse of depression in some patients who are in remission: a fact which he also fails to mention.

“By contrast, the monoamine theory of ‘anti-depression’ is alive and kicking. There is plenty of evidence that SSRIs increase communication from neurones that release serotonin, as well as other monoamine transmitters, and that the ensuing downstream changes, such as creation of new neurons (neurogenesis) or modification of gene expression, can ameliorate depression.

“In short, SSRIs probably switch-on anti-depression, rather than switch-off depression (which could explain the rapid efficacy of ketamine).”

“I am sure that most clinicians and scientists will be dismayed that a flawed argument is used to underpin a suggestion that the use of older tricyclic antidepressants, which are so dangerous in overdose, is always preferable to the SSRIs.”

 So long and thanks for all the fish

The BMJ editorial that the Science Media Centre are referring to is Serotonin and Depression. It was originally called So Long and Thanks for all the Serotonin.

The first thing about the Science Media Centre comment is it’s wild. It completely misreads the editorial it’s commenting on – at no point does the editorial say I or any academic ever believed the serotonin hypothesis or changed our beliefs because it has now been debunked.

In an extraordinarily brief space Clare Stanford introduces a whole new concept Switching on Anti-Depression – that no one I know has ever heard of. And also manages to say that there was never any evidence for the serotonin hypothesis but that the serotonin hypothesis is right anyway.

It’s hard to believe Clare Stanford wrote something like this.

Which raises the question – who are the Science Media Centre? There were several posts last June about the Science Media Centre and Sense about Science – see Follow the RhetoricFirst Admit no HarmFollow the LawsuitFollow the Patient – cover aspects of what’s at stake. This is an organization that under the umbrella of taking a responsible approach to science ends up denigrating a lot of work or researchers that raise concerns about anything that might harm a corporation’s products.

Following the successful establishment of a UK SMC, comparable groups have been set up in Australia, New Zealand and Canada. See SMC Feasiblity Study for a document apparently stemming from a consultation exercise about what a Canadian SMC might look like.

Earlier this year a fuss blew up about coverage of HPV vaccines in the Toronto Star. The Star backtracked from its article, persuaded in part it would seem by input from SMC Canada that the Sixty cases of injured girls they had were just “anecdotes”.

The BMJ and other journals and media outlets divert a large amount of their content via the British SMC these days. They seem to think that this will increase coverage of their content – when the SMC is much more interested ordinarily to close down stories like this one rather than open them up. “We get our experts – who are usually media trained – to tell your journalists why you don’t want to bother with this story”.

Why do BMJ do this?

Who are the US equivalent of SMC?