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

Mickey Nardo: Tangled up in Life

Mickey and Sharon

Mickey Nardo died yesterday.

I got to visit with him and his wife Sharon on the phone a short while before he got involved with Jo Le Noury, Jon Jureidini, Melissa Raven, Catalin Tufanaru, Elia Abi-Jaoude and me Restoring Study 329 in 2013. It was one of those moments – I can still remember exactly where I was sitting when I made the phone-call. Sharon had just come back from Cuba. He and she felt like intensely private people. Until very recently, very few people knew who 1boringoldman was – not even Ben Carey of the New York Times. It was difficult getting a photograph of Mickey for the Restoring Study 329 website.

Its surprising the moment stands out so clearly, given several phone calls since – some of them fraught, and nearly 1500 emails between July 2013 and December 2016.

I was watching a program on Tom Waits last night and some combination of the gravelly voice of Tom Waits and my impression of what Philip Marlowe might have been like hints at what it was like talking to Mickey. The blogs certainly sang with a lyricism Tom Waits would have enjoyed and tracking things to their source felt like a metier designed by someone for Mickey.

Here is a brief account of his career chiseled out of him for the Restoring Study 329 site. What strikes me most is his interest in the tangles people end up in. This certainly is a theme that ran through his blog.

I can add one little bit of detail. He mentions being in the Air Force. He and Sharon were based in Britain for at least part of this. At one point when the RIAT struggle with BMJ over publication got very intense he was willing to come over to meet Fiona Godlee – in part because it would have given himself and Sharon a chance to revisit old memories.

First career

I went to medical school as a mathematician planning a research career. I did an Internal Medicine Residency and a NIH Immunologu Fellowship. My planned post-doc was interrupted by a three year required stint in the Air Force. To my great surprise, I loved being a practicing doctor. It wasn’t the diseases. It was the tangles that the patients struggled with that I found so compelling.

Second career

I changed gears and returned to a psychiatry residency at Emory University, and started psychoanalytic training. After training, I became the Residency Training Director. In the mid-1980s, a new chairman arrived and there was a major changeover to a biomedical department.

This time, I didn’t change gears, but psychiatry did. I resigned my tenured position and went into practice as a psychodynamic psychotherapist. I continued to teach in the psychoanalytic program and the college, but had little connection with the psychiatry department. In 2003, I retired, leaving Atlanta for the Georgia mountains, the end of a rewarding career.

Third career

After 5 years, I began to work some as a volunteer in a local charity clinic, and was absolutely horrified at the peculiar polypharmacy the patients were being given. About that time, Senator Grassley began to investigate a number of prominent psychiatrists for unreported industry income and other conflicts of interest – one being the chairman of the department I was affiliated with, Dr. Charles Nemeroff.

I began to read up on the psychopharmacology literature and couldn’t believe what I found. I had been oblivious to the gross invasion of academic psychiatry by the pharmaceutical industry, cloistered in my psychotherapy practice. I had already been a blogger, but the more I learned, the more the blog [1boringoldman.com] turned towards the dreadful state of affairs in psychiatry.

I started meeting others who were as alarmed as I was becoming. I polished up my old statistical skills from years before and I began to vet clinical trials and to read and write about all of the deceitful science. Along the way, I began to correspond with Allen Jones, the TMAP whistle-blower [Texas Medical Algorithm Program], and ultimately my wife and I spent a week in Austin Texas attending that trial. Sitting in the courtroom listening to the testimony, I realized how incredibly corrupt the whole scene had become. It made it all very real for me and I haven’t looked back since.

Along the way, I had looked into Paxil Study 329, but in August 2012, I happened onto the raw data that had finally been posted on the Internet, and I took a stab at analyzing it on the blog. I submitted my findings to the JAACAP [Journal of the American Academy of Child and Adolescent Psychiatry, publisher of the study] requesting a retraction [to no avail].

When a RIAT team [Restoring Abandoned and Invisible Trials] was being formed to reanalyze and republish that study, I jumped at the chance to be on the team.

Generalists and Partialists

An issue that crops up in comments on both this and the RxISK blog is the question of whether treatment would be safer if given by specialists (partialists) rather than general practitioners (generalists). We wouldn’t have the problems with antidepressants and antipsychotics for instance many people seem to think if prescribing was done by psychiatrists rather than GPs.

This could not be more wrong. There might at one point have been ways in which some partialists were better at making diagnoses than generalists – in dermatology for instance where clinical practice involves looking and touching and comparing this case to the last one. But in most other areas of medicine, nobody looks or listens anymore, least of all in psychiatry. People increasingly ask the questions on a rating scale or that present on an Electronic Medical Record (EMR), so much so that doctors are being replaced by nurses or pharmacists and all could soon be replaced by robots, and your problem on treatment likely doesn’t feature among the questions on the rating scale or programmed into the EMR.

Patient and doctor

Of if it does feature, perhaps you mention homicidal ideation, ticking the box is likely to lead to you being detained rather than any questioning of whether the management in the health service, or wherever you work is vindictive and bullying, as a BBC program on whistle blowing in the NHS recently suggested, in which case it might be more appropriate to detain the management. Ticking, in this case, and pretty well all cases, literally puts you in a box.

But even if dermatologists look at you and perhaps touch you, they rarely listen to you and when it comes to treatment they are as much boxologists as any other partialists. They put you on Ro-Accutane and doxycycline, and have begun to use Otezla and other new PDE-4 antagonists, and simply don’t hear you when you tell them you’ve become agitated or suicidal or you can no longer function sexually.

The only hope for medicine lies with generalists. They are still much more likely to see you when you walk into their office and notice differences from one visit to the next. Faced with the consequences of a bunch of partialists piling drug on top of drug so that people end up on 10 or 20 drugs per day, generalists are leading the push to de-prescribe. They have been the first doctors to rebel against guidelines, rating scales and EMRs.

So what goes wrong when a generalist gives drugs like antidepressants, Ro-Accutane or asthma drugs like Singulair and Accolate. The problem is they are likely to have been “educated” by a partialist who you might expect to know the truth about a new drug but who in fact is speaking from a text prepared for them by some pharmaceutical company, or have their names on an article written for them by pharma.

The image above is of a goat leading sheep. This is a recognized ph/farming maneuver. The sheep dutifully follow – to the slaughter house. If you google under the term Judas Goat, you can see many more images, some of them distressing. The Judas Goat gets his reward afterward.

The Judas idea applies well in this case, except those who end up slaughtered are those of us with skin or other problems – not the generalists who may have ended up doing the prescribing on the recommendations of a boxologist.

Campaigning to have us all seen by the right partialist, such as a shrink, in the case of an antidepressant, hoping this will lead to a better outcome is exactly the wrong answer to the problems we now have. If there was a choice between getting rid of partialists or generalists, at the very least the Goats would have to go, and if that didn’t solve the problem the partialists should be taken out, sparing only those who show some evidence of realizing their role is a semi-robotic one delegated to them by the generalist looking after the patient’s overall management.

Venomagnosia

 

 

 

Editorial Note:  I was asked to review Peter Kramer’s Ordinarily Well: The Case for Antidepressants for ISIS.  The in print review is HERE.  There is a sister post on RxISK – with a better cartoon and where the word Venomagnosia s explained – Come Back When you Have a Medical Degree.

This book was very difficult to review. In Ordinarily Well: The Case for Antidepressants, Dr. Peter Kramer makes two arguments that I agree with. One is that clinical observation—the interaction by which a medical professional learns about a patient—counts for something. The other is that clinical trials, or evidence-based medicine more generally, are not a replacement for clinical wisdom. He values antidepressants, in particular the selective serotonin reuptake inhibitor (SSRI) class of drugs, and so do I.

Applying support for clinical observation and skepticism about controlled trials to the question of whether antidepressants work, Kramer concludes that these treatments work very well. En route, he focuses on the claims of psychologist Irving Kirsch, among others, that based on clinical trial data, the benefits of antidepressants are all in the mind—a placebo effect. Kramer makes a straw man of Kirsch, but I agree with Kramer that antidepressants do things that are not all in the mind. I too reject Kirsch’s arguments that most of what antidepressants do stems from a placebo effect.

So where did my difficulties in reviewing the book come from? The trouble for me is that Kramer’s clinical vision seems strangely rose-tinted. He is an advocate of using antidepressants to treat depression, but he doesn’t seem to see any of the problems antidepressants cause. The fact that over half of the patients put on them don’t take them beyond a month should be telling. For those who do stay on treatment, he claims, no one has difficulties going off antidepressants with a gradual reduction in dosage. I, however, have patients suffering badly months or even a year later. In the case of any enduring problems, Kramer puts these down to the effects of the illness being treated rather than the medication.

There is no discussion in this book of significant problems that the use of antidepressants can cause. These include SSRI-induced alcoholism, SSRI-induced birth defects, including autism spectrum disorder, or permanent post-SSRI sexual dysfunction. In a 336-page book, the topic of SSRI-induced suicidality gets dealt with in one page. I think many surviving relatives would be astonished to hear that once the psychiatrist Martin Teicher had identified the problem of treatment-induced suicide, it became manageable. Kramer claims that “no case [he has had], not one, has looked like those Teicher has described, drug driven.”

Kramer asks us to believe in clinical observations—his observations. Not yours or mine or anyone’s that might cause the antidepressant bandwagon to wobble. He cites me at multiple points, so he is well aware of my work. But he doesn’t engage with the evidence that I and others have put forth, based on both clinical observations and other material, that SSRIs can unquestionably cause suicides and homicides, and do so to a greater extent than they prevent any of these events.

On the issue of children, suicide, and the black box warnings that antidepressants now carry, Kramer notes that “some of the data have trended the other way, although authoritative studies correlate increased prescribing with reduced adolescent suicide.” This fails to acknowledge that the drugs haven’t been shown to work in this age group. There is no mention that suicidal acts show a statistically significant increase in clinical trials in this age group. Kramer also does not indicate that among all ages, when all trials of antidepressants are analyzed together, they show increased rates of death (mainly from suicide) compared to non-treatment. He seems to have no feel for how compromised the “authorities” are that he uses to downplay the risks.

There are good grounds to be skeptical of the evidence-based medicine that Kramer uses to make his case. Quite aside from the fact that almost all the research literature produced by clinical trials is ghost written by pharmaceutical companies, and the data from them entirely inaccessible, controlled trials aren’t designed to show that drugs work. They work best when they debunk claims for efficacy, rather than the reverse. What’s more, the structure of clinical trials and their statistical analyses are the best method to hide a drug’s adverse effects. Ordinarily Well does not address these significant problems.

If a drug really works, then clinical observation should pick it up. We can tell antihypertensives lower blood pressure, hypoglycemics lower blood sugar, and antipsychotics tranquilize within the hour—all without trials. We can see right in front of us that antipsychotics badly agitate many people within the hour and that SSRIs can do so too. But we cannot see anyone get better on an antidepressant in a way that lets us as convincingly ascribe the effect to the drug. There is much to be said for clinical observation, but also a lot to wonder about when clinical trials suggest that drugs work but we can’t actually see it. For anyone keen to defend clinical observation, Kramer’s book poses real problems and would leave many figuring we need controlled trials instead.

I live and work in the United Kingdom and am acutely aware of some differences between America and Europe that also made it difficult to review this book. There is much more “bio-babble” in America than in Europe, from talk of lowered serotonin to chemical imbalances to neuroplasticity and early treatment preventing brain damage—all of which Kramer reproduces. I felt a John McEnroe “you cannot be serious” coming on at many points. The tone in which some of these points are made suggests that everyone reading them will find what is being said self-evident, when in fact it’s gobbledegook.

All medicines are poisons, and the clinical art is bringing good out of the use of a poison. It strikes me as un-American to even suggest that a drug might be a poison, and Kramer’s book gives no hint of this; the book is, in this sense, deeply non-clinical. He is giving an account of a mythical treatment, as far removed from real medicine as an inflatable sexual partner is from the real thing. It seems to me that he would not see or hear many of the patients I see, or at least would not credit their view of what is happening to them on treatment. This book will misinform anyone likely to take an antidepressant.

It will also cause problems for physicians. This book does not balance the risks and benefits that are intrinsic to medical wisdom. If antidepressants are as effective as Kramer claims, and are as free of problems as he suggests, there is no reason why nurses and pharmacists couldn’t prescribe them. Given that they are much less expensive prescribers, the surprise is that health insurers haven’t moved in this direction.

There is a way to bridge the gulf between Kramer and myself, which involves clinical observation. Most of the beneficial effects Kramer describes can be reframed in terms of an emotional blunting, or the numbing of all emotions, not simply the bad ones. Just like people on an SSRI will nearly universally report genital numbing within 30 minutes of taking their first SSRI—if they’re asked—people will also report some degree of emotional numbing—if asked. They don’t necessarily feel better; they simply feel less.

Unlike the somewhat mystical brain re-engineering Kramer invokes, this emotional blunting can be verified by clinical questioning. If clinical trials were designed to assess whether patients are numbed by these drugs, there would be little need for the fancy statistics that pharmaceutical companies use to claim the targeted benefits of their drugs, since emotional blunting would be evident through clinical questioning. And Irving Kirsch’s arguments about placebo would be irrelevant.

If SSRIs numb emotional experience, this would explain why they help some and not others, and explain the results we see in clinical trials, which are similar to the results that might be expected from a trial of alcohol versus placebo in the milder nervous states in which antidepressant trials have been run. This, then, would present us with a question: what do we think about emotional blunting as a therapeutic tool? Emotional blunting is not a romantic option. It’s a much more ordinary one. If that is the process by which antidepressants work, it does patients an enormous disservice to avoid discussing it entirely, which this book does.

 

Surrender

There has been a big delay between posts. This has been primarily about trying to find an image or images for this post – unsuccessfully so far.

The trigger to the post came from a piece on Surrendered Wives. The BBC website had the attached piece – strangely as part of their 100 Women series.

There are some articles around the place trying to imagine a Surrendered Husband, some humorous, but they go on at length and none are by men. No one lays out operational criteria for an SH a la DSM-5. Here then are some.

Surrendered husband

  1. Accept that my insights are likely to stem from something my partner mentioned a while before that I paid no heed to
  2. Accept that women are on average brighter than men and I should be tuning them in and men out more often
  3. Accept my partner has to manage in a world I would never survive in – the world of other women
  4. Accept that the only area men have a lead on women is in terms of strength but intimidation based on strength is unworthy
  5. Accept that women have more guts than men so if she’s standing up to me despite my strength advantage it’s probably something important
  6. Accept my position and status comes from society not my personal merits and that this leads to an over confidence in my abilities which risks being an Achilles Heel.
  7. Learn to focus on others

These criteria are up for grabs. They are drawn from the original surrendered wife criteria – with modifications. Part of the image problem was finding something that was humorous and at the same time conveyed a sense that it’s not surrender so much as a dawning insight that at least half and maybe more than half of the wisdom in the relationship lies in the other person.

But SHs were just a trial run for SDs.

Surrendered doctor

  1. Accept that when it comes to the side effects of treatment the patient (or the in-laws) are likely to know best.
  2. Accept that my job would be more interesting if I learned to co-ordinate the research efforts of my patients rather than continued to dictate to them.
  3. Accept that patients continue to come to me not because I am good at my job but because society has made it impossible to get medicines except through people like me.
  4. Accept that my actions are dictated by ghostwritten articles and inaccessible data mediated through guidelines that I haven’t the guts to stand up to.
  5. Recognize that far from being founts of wisdom and compassion my colleagues and I can get incredibly nasty if questioned. I am an obstacle to work around more often than a source of support.
  6. Medically Unexplained Symptoms point to limitations in current medical knowledge or perhaps my medical knowledge. The term is not a euphemism for hysteria.

These criteria are up for grabs. The best offers will be included in follow-up Surrender 2 post – along with an image if anyone can find one that works – one that is humorous and somehow conveys that at least half of the wisdom lies on the other side of the relationship.

The First Vaccine Wars

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Editorial: This is a final post in the current vaccine series.

In 1798 Edward Jenner in Britain demonstrated that vaccination with cowpox was a safer way to confer immunity to smallpox than variolation with smallpox. It quickly spread. In Britain, variolation was banned in favor of vaccination in 1840. In 1853, vaccinations were made compulsory with fines for refusal. Enforcement was in the hands of a new set of Welfare Officers.

The first vaccine wars broke out in Britain soon afterwards. Just as with variolation, there were ethical, religious and epidemiological doubters.

  • The vaccine came from cows – hence the name.
  • Vaccination sessions introduced pus from one person into a scarification produced on another. There were claims syphilis, tuberculosis and other diseases were transmitted in this way – with good evidence for syphilis.
  • Middle class mothers had difficulties when their babies were inoculated with pus from a working class child – in public sessions.
  • While vaccines could be got for free from the medical officers linked to workhouses, many felt this was pauperising.

Many of the Welfare Officers turned a blind eye to non-compliance. Resistance grew. It came from the ranks of Abolitionists (abolition of slavery) or supporters of the Temperance or Co-operative movements.

The visible scarification and link to cows were portrayed as the Mark of the Beast as foretold in the Book of Revelation. Links were made between food and blood adulteration.

  • Anti-vaccinators threw the full range of sanitarian arguments for the importance of hygiene and role of constitutions into the mix. Vaccinators deployed germ theory.
  • Anti-vaccinators saw germ theory being used to justify a Treaty with Dirt. Vaccinators talked about the feckless negligence of the labouring classes.
  • Anti-vaccinators claimed the upper classes didn’t contract smallpox because of their better food, and air.

Everyone viewed the problem in moral terms and as coming from below.

Anti-Vaccine League

An Anti-Compulsory Vaccination League (ACVL) was set up in 1866 followed by a National ACVL in 1874, after an 1871 Act made non-compliance impossible. Vaccinations were required for some employment. Refusing to have a child vaccinated led to a fine or jail in the event of being unable to pay. In jail, vaccine refusers found themselves yoked to felons and prostitutes. Some vaccination officers went to jail rather impose the Act.

There were mass demonstrations against government policy, with up to 100,000 at a demonstration in Leicester in 1885 at which an effigy of Edward Jenner was decapitated.

This was a replay of the English Civil War of the 1640s. The protesters were non-conformists. Compulsory vaccination they claimed was indistinguishable from compulsory baptism or circumcision. What was needed was tolerance of belief and a Medical Reformation to deliver Free Trade rather than a medical monopoly – although homeopathy saw vaccines as a vindication.

The Liberal Party (then the progressive party) was split down the middle between those who held to traditional beliefs and those who thought a party prepared to intervene to control child labour could also intervene to protect children with vaccines.

A review commission was convened in 1892. The government branded the anti-vaccine lobby as soft-headed, spiritualists, over-influenced by journalism and public opinion.

But by 1898, unlike for other infections no-one had identified a smallpox bug. The ideas of the later Nobel Prize winner Elie Metchnikoff were picked up by orthodox medicine and gave rise to talk about optimising immune responses with Opsonin – an idea lampooned in The Doctors Dilemma by George Bernard Shaw. Shaw, an anti-vaccinationist, portrayed medicine in Adam Smith’s terms as a conspiracy against the laity.

Between the lack of a bug, and clear lies about adverse effects such as syphilis, there were grounds to doubt medical and government bona fides.

Conscientious objection

A new Vaccination Act was adopted in 1898 that continued the policy of compulsion but allowed for conscientious objection provided a parent could Satisfy a magistrate they had grounds to opt out. But what is a conscience? There were no X-rays to demonstrate its existence. This provoked a Liberal crisis.

The idea of Conscientious Objection was also contagious. It became an even bigger issue a decade later when the Great War broke out.

The socialists were anti-vaccination and a founding principle of the Labour Party formed in 1900 was the abolition of compulsion – the socialists were against State Medicine.

In practice magistrates could issue a certificate of exemption but many had a conscientious objection to conscientious objectors.

The objectors didn’t like a law that made them licensed law-breakers rather than equal citizens. They invoked the 1689 Tolerance Act that brought the Civil War to an end by giving Dissenters the right to legally affirm allegiance.

Liberals were on both sides of the argument. The Liberal Party returned to power in 1906 and introduced a new act in 1907. This continued compulsory vaccination, and exemptions. But it removed the word Satisfy. This took discretion out of the hands of magistrates. Within two years, it was estimated that 25% of the children in Britain were unvaccinated, with 50% in some regions, and 90% in pockets. Smallpox never returned.

Smallpox fever

In 1930, the smallpox germ was detected – see image.

In 1936, the concept of herd immunity was born, but little was heard of it before the development of measles and rubella vaccines in the 1960s.

In the 1946 NHS Act, the Labour Party abolished compulsion for vaccinations.

The Torch of State Medicine passed to the American Centers for Disease Control (CDC) who chasing smallpox in South East Asia in 1975 conducted “an almost military style attack on infected villages”:

“In the hit-and-run excitement of such a campaign, women and children were often pulled out from under beds, from behind doors, from within latrines… People were chased, and when caught vaccinated… We considered the villagers to have an understandable though irrational fear of vaccination… We just couldn’t let people get smallpox and die needlessly. We went from door to door and vaccinated. When they ran we chased. When they locked their doors, we broke down their doors and vaccinated them”.

Religion?

There are times we prefer to take our chances with what the universe might have in store for us rather than run with the herd. This risks reprisals from the herd. Regardless of what name the community puts on the religion it believes in, community beliefs are conservative and favor civic duty, and loyalty. Having occasional animals stray from the herd is one thing, having the herd split is another, especially when a technical system appears to offer an efficient solution to a significant problem. In this case, splits can almost only be permitted on “religious” grounds.

Technical systems, especially in healthcare, do not tolerate pluralism. They reach for guidelines and standards. The vaccination controversies are emblematic of this. Today more than ever the System is working mightily to understand vaccine resistance – in order to “manage” it.

Despite the latest in consumerology and public relations, objectors in 2016 are dismissed in terms almost identical to those in use in 1906.

At the heart of this debate is the question – Who Chooses?

File under Phile: Anecdotes are not Science

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Editorial Note: The Post-Truth Rumorology post attracted a comment by Annie that deserves featuring.

She cites a really good Daily Mail article in which Melinda Messenger talks about intervening when her daughter is scheduled to have the HPV vaccine. The DM article drew this response from Dr. David Robert Grimes – a physicist at the University of Oxford – “Mothers should listen to the experts”.

Grimes: Mothers should listen to the experts not Dr Google

Cervical cancer is one of the few cancers we can prevent, which is why this vaccination program is so important and why all parents should ensure their daughters receive this potentially life-saving inoculation, writes Dr Robert Grimes, Science Writer and Cancer Researcher at the University of Oxford.

Gardasil, the form of the vaccine currently used in the UK, has been extensively tested for years and recipients constantly monitored for potential adverse effects.

More than 200 million doses have been administered over the past ten years, with research and trials dating back to 1991. The vaccine has proved to be a safe and effective intervention with an extremely low complication rate.

Only last year, a report based on data from more than a million recipients concluded the vaccine had a ‘favourable safety profile’. But still claims of ‘vaccine damage’ continue to circulate online, to be stumbled upon by the many who daily consult Dr Google, instead of turning to highly trained health professionals for advice.

Much of it comes from anti-vaccine campaigners, not content with the damage already done by the discredited, downright dangerous claims linking the MMR vaccine to autism. Among the groundless assertions are that the HPV vaccine causes thrombosis and chronic fatigue.

I cannot blame anyone whose child becomes ill or permanently exhausted for searching for an explanation and cause.

However, if you are giving a medical intervention to everyone at a certain age, as in this case, it is a medical certainty that some people get sick in the days, weeks or months afterwards. It would, of course, have happened whether or not they had received the treatment. It is merely coincidence.

Perhaps another issue with the vaccine, for some parents at least, is having to face up to the fact that their children will likely become sexually active in the not-too- distant future.

But, although pretty natural, such squeamishness doesn’t give you the right to deny your child, or the people they may become intimate with, the protection provided by this vaccine.

This most recent scaremongering, from the American College of Paediatricians concerning a risk of premature menopause, is equally without merit.

This is not some august medical body (in fact, that’s the American Academy of Paediatricians), but rather a group of conservative activists opposed to abortion rights, gay marriage and pre-marital sex.

Their claim is motivated more by ideology than by any evidence, and is simply not supported by the overwhelming weight of scientific evidence. There is no link between the HPV virus and premature ovarian failure, so it makes no sense to suggest that the vaccine may cause this condition.

Yet still, there have been a number of legal challenges mounted against the manufacturers of Gardasil, supported by the ‘Regret’ group in Ireland.

The case made it all the way to the Irish High Court, and although it was refused, the movement shows no signs of abating.

We need only cast our minds back to the damage done by scare stories about the MMR vaccine to be reminded how dangerous this can be.

Those who are not vaccinated against the HPV will have a much higher risk of contracting cancer than they would have of becoming ill as a result of having the jab, so, from a parenting perspective, it’s a no-brainer.

What we must avoid at all costs are these tales of personal misfortune, which are ultimately unrelated to the vaccine, getting in the way of an inoculation programme that could save many thousands of lives.

Editorial Note: Dr Grimes is not a doctor. He is closely linked to Sense about Science for whom vaccinations can do no harm.

Twittersphere

Annie also picked out some DRG Tweets. In response to Caron Ryalls

(a) No idea who you or your daughter are (b) Going to go out on a limb & say no medical records say HPV vaccine caused ill health

Caron Ryalls‏@caronryalls

U publicly claim my daughter’s ill health is unrelated 2 HPVvax but U hv no access 2 her medical records @drg1985!

Linked to the Daily Mail article: David Robert Grimes ‏@drg1985

The @DailyMailUK just ran page 3 model’s fears over HPV vaccine. Utter drivel. I was quoted in reply, w/ name mangled. Not linking.

..it’s utterly irresponsible of @DailyMailUK to run this crap, especially as I clearly stressed dangers of false balance to DM reporter.

And the sad thing is, the ramblings of a celebrity will garner far more press and panic than me or any scientist. Do better, @DailyMailUK

..it’s precisely this kind of thing that makes scientists weary about talking to the press; science is an afterthought. @DailyMailUK

Age of consent

The Messenger article was well done. Neither Motivation nor Expertise are always right, we ideally need both. But if forced to choose between them, and in particular when motivation is linked to a mother looking after her children, in our current post-truth world of which pharmaceutical companies are the masters – as Study 329 demonstrates, I personally would lean toward motivation.

What was a surprise for me in the article was that while Messenger was sent a consent form by her daughter’s school and made it clear she did not consent, on the day the vaccinators are there if a 12 or 13 girl consents the vaccinators can over-ride a parent’s objections.

The Victoria Derbyshire show last week also featured a pre-teen who figured they were in a mis-sexed body. They were looking forward to being 13 when they could essentially demand the alt-hormones.

But if a teenage girl walks into a beautician in Britain and wants her ears pierced, unless she is 16 nowhere will do it without parental consent, and in Scotland it would be illegal.

“Anecdotes are not science”

A common theme in comments like DRG’s is that anecdotes are not data or science.

The original phrase was the Plural of Anecdotes is Data. This was coined in 1969 by Raymond Wolfinger. It is at the heart of the Big Data industries. If this weren’t true Google and Facebook wouldn’t exist.

The idea that the Plural of Anecdotes is not Data appears to originate from the CEO of Nutrasweet after his company’s product became embroiled in a cancer scare. It has been the mantra of corporations defending products ever since. (Please let us know if you can find earlier uses).

The response “Anecdotes are not Science” to claims of harms came into existence earlier. It was being widely used by spokesmen for the Pedophile Information Exchange during the 1970s when they infiltrated the Gay Liberation Front and Britain’s National Council of Civil Liberties. The NCCL was then steered by figures like Patricia Hewitt and Harriet Harman, who feature in the photo above. Hewitt and Harman were later among the leadership of the Blair Government.

Statements that we haven’t proven harm to children offered the press a shooting-fish-in-a-barrel opportunity to go after the Loony Left.

The PIE also showed a mastery of the ability to split hairs and other tricks that are now part of the corporate armory – No pedophile ever harmed a child, they were busy telling us in the 1970s – it’s child-molesters that do things like that.

The upshot was caught in this constructed photo of Patricia Hewitt – a decent woman as far as I know – who probably never actually said this.  But she ended up years later being portrayed as taking the same position that all politicians on the Left or the Right take in response to drug induced injuries and occupational injuries or environmental toxicity – we can’t or haven’t proven harm.  In most of these cases, like environmental toxicities and drug induced injuries, it turns out the harms to children are even greater than to anyone else.

The Vaccine arguments portray children’s immune and other systems as still developing suggesting they are more able to overcome these challenges than older people.  This is Anecdotal.

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Post-Truth Rumorology?

The HPV Vaccination in Japan

Stopping the spread of Japan’s antivaccine panic

Following the post last week on MedWatcher Japan’s efforts to bring the issue of HPV vaccines to light, my attention was drawn to a recent Wall Street Journal article which stated:

“Japanese women’s health is increasingly at risk as public-health policy is driven by conspiracy theories, misguided political interference and bureaucratic caution. This is particularly evident in the government’s handling of the human papillomavirus (HPV) vaccine to protect against cervical cancer.

In June 2013, just two months after the HPV vaccine was included in the National Immunization Program, the Japanese government made the unusual and perplexing decision to keep the vaccine in the NIP but suspend “proactive” recommendations for it. This was evidently in response to highly publicized accounts of alleged adverse reactions.

The result was that girls in the target age group, from the 6th grade of primary school to the third grade of high school, stopped receiving the vaccine. Vaccination rates dropped to below 1% from about 70%….

The Vaccine Adverse Reactions Review Committee, a task force established by the Japanese Ministry of Health, Labor, and Welfare’s Health Science Council, has repeatedly concluded that no causal link exists between HPV vaccines and professed symptoms, and that most reported cases were likely psychosomatic. A study of 70,960 vaccinated and nonvaccinated adolescent girls from Nagoya also found no significant association between 24 alleged vaccine-induced symptoms and the HPV vaccines….

In Denmark, Kusuki Nishioka, the Japanese doctor who first suggested the HPV vaccine caused brain injuries, appeared on television. The vaccination rate there has since dropped to about 20% from 80%.

The antivaccination movement is gaining traction in Japan. On July 27, 63 young women filed lawsuits against the Japanese government and vaccine manufacturers in the district courts of Tokyo, Nagoya, Osaka and Fukuoka, demanding compensation for alleged side effects from HPV vaccines….

These events are reminiscent of the biggest vaccine scandal in history. In 1998, Andrew Wakefield published “scientific data” in the Lancet as evidence that the MMR vaccine for measles, mumps and rubella caused autism.

Mr. Wakefield’s data was later found to be manipulated, but it was not until 2010 that his paper was retracted and his medical license revoked. Earlier this year, Mr. Wakefield released a movie called “Vaxxed: From Cover-Up to Catastrophe.” Robert De Niro, whose son is autistic, tried to premiere this movie at the Tribeca Film Festival. This once again fueled antivaccine sentiment in the U.S.

We can’t afford to sit back and allow a similar situation to develop in which unscientific claims jeopardize lives around the world. The Japanese government should reinstate its proactive recommendation for the HPV vaccine and set a positive example before irrational fear of the vaccine gains further momentum in other countries”.

The vaccine business

Once upon a time it was public health doctors who decided what vaccines became part of national vaccination schedules. In Japan and elsewhere the introduction of HPV vaccines to the vaccination program was engineered by the makers of vaccines. Vaccination is a business as much as or even rather than a matter of public health. See HERE.

When concerns appeared in Japan and the government suspended the heavy promotion of the vaccine it triggered an international response with the Center for Strategic International Studies, a body set up in the Cold War “dedicated to finding ways to sustain American prominence and prosperity as a force for good in the world”, publishing a report on HPV Vaccination in Japan authored by Heidi Larson and others. HL and colleagues are based in the London School of Hygiene and Tropical Medicine, one of the institutions that spawned AllTrials – somewhere with close links to Sense about Science.

You’d never guess from this document that the HPV vaccine was adopted in most countries after intense corporate lobbying. Instead, we are told:

According to experts in rumor psychology, rumors help people make sense of the world and offer an initial explanation for anxiety-provoking information and events. The longer situations of uncertainty and anxiety persist, the easier it becomes for rumors to spread and the more difficult they become to counteract.

Governments need to get in there, we are told, and be the first to provide information; they need to tell people we feel your pain; when people raise concerns they need to be encouraged to “talk to your doctor”, (who of course has been briefed by our side only). Governments are told they need to avoid a vacuum that might be filled by “people who don’t have the public’s best interest at heart”. They need to be on board with Project Fear.

HPV or not HPV that is the question

In Europe, especially in Denmark, there has been work in parallel to the MedWatcher Japan efforts, undertaken by Peter Gotzsche and Tom Jefferson who have filed a complaint with the European Ombudsman centered on maladministration by the European Medicines Agency of the safety data for HPV aimed at getting access to the data. See HERE. Preliminary work on this material had shown real cause for concern – see Jefferson.

In response to the Wall Street Journal’s article above, Peter Gotzsche said:

Tom and a PHD student I employed two months ago are working with CRFs from the EMA on the HPV vaccines. To say that “most reported cases were likely psychosomatic” is an insult to these girls and their families. There are good data that make is pretty likely that most suffer from an autoimmune disease with antibodies against nerve tissue, but whether caused by the vaccine, a virus or something else needs to be found out.

We had a meeting about HPV vaccines on 24 Nov in Copenhagen. One of the presenters showed a slide that in Denmark, provided 100% of 12 year old girls get vaccinated, and that the vaccine is 70% effective, and protects against dying from cancer (which we don’t know but just think), then in the next 30 years, 10 will die if not vaccinated and 7 if vaccinated. Thus, even in the best of scenarios, the effect of the vaccine is likely to be very very small”.

What Gotzsche hasn’t said here is that company marketing of these vaccines has been full of rumors and scaremongering, portraying the vaccine as the last defense against a nasty and aggressive cancer, a defense that is close to completely successful and comes without problems.

In fact Pap Smears manage the problems very successfully, just as hand washing is our best defense against many other infections and both defenses come without a risk of neuropsychiatric adverse events. But we hear nothing about these approaches.

It’s not impossible that some of the Japanese cases are hysterical. The bigger problem we all have is that in the wake of the revelations about Tamiflu and Study 329 it is impossible to accept the bona fides of companies whose health depends on ensuring we get their treatments rather than rely on something else that is safer and costs almost nothing.

There is a certain sense in which the forces that fueled Brexit are fueling a Vaccinexit. If this happens the powers that be will have no one to blame but themselves. Peter Gotzsche and Tom Jefferson knew nothing about MedWatcher Japan before the post last week. The more people like this find each other, the more difficult it will be for the Heidi Larson’s of this world to manage the debate.

When the going gets tough, get a woman

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64 women to sue in 3 Japanese courts over health woes from cervical cancer vaccines

A group of lawyers for 64 women who are suffering health problems from cervical cancer vaccines said Tuesday the victims will file damages lawsuits against the government and two drug makers that produced the vaccines through four district courts on July 27.

Of the 64 women, 28 will lodge their suit with the Tokyo District Court, six with the Nagoya District Court, 16 with the Osaka District Court and 14 with the Fukuoka District Court, according to the lawyers.

Initially, the victims, mainly teenagers, will demand ¥15 million in damages each, for a total of ¥960 million, and increase the amount later depending on their symptoms. The victims’ health problems include pain all over the body.

The average age of the 28 planning to file their suit with the Tokyo court is 18. They received the vaccination when they were between 11 and 16 years old.

Noting that the cervical cancer vaccines have caused nerve disorders and other problems due to the excessive immune reactions they caused, the lawyers claimed that the government’s approval of the ineffective vaccines was illegal. The drug makers bear product liability, they added.

Masumi Minaguchi, one of the lawyers, said, “We aim to clarify the responsibilities of the government and the drug makers through the lawsuits so that the victims can live without anxiety:’

Cervical cancer vaccines were included in routine vaccination programs in April 2013. But the government stopped its recommendations for the use of the vaccines in June the same year after receiving reports on complaints of health damage.

Meanwhile, the Japan Pediatric Society and 16 other institutions in April recommended active use of the vaccines, saying it is clear they are effective in preventing cervical cancer.

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The organization behind this action is MedWatcher Japan, who have been one of the most effective organizations in the world at holding Pharma to account. Two of their key players Masumi Minaguchi and Hiro Bepu are seen here. Masumi Minaguchi is the lawyer taking this case.

In this case MedWatcher have capitalized on the fact the HPV Vaccine is given primarily to girls and women who are old enough to be able to complain when things go wrong afterwards.

The science behind the MedWatcher case is presented in their refutation of the Global Advisory Committee on Vaccine Safety position which can be accessed HERE.

The HPV vaccines look like being a problem for vaccine advocates in that they puncture the claim that vaccines are safe and the only risks stem from not giving them.

Earlier this year Merck admitted their Shingles vaccine could cause eye damage. Again the difference is that the people suffering the harm are old enough to make their voices heard.

The response from vaccine advocates in the case of HPV vaccines has been to push for giving these vaccines in infancy.

Vaccines are a conundrum. They can clearly be effective and most of us would want to avail of most of them. But where elsewhere in medicine, it is legitimate to be against over-medicalization, being against over-vaccination puts anyone who advocates it beyond the pale.

Why?

Go Figure: Where Does All the Pain Come From?

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Editorial Note: This anonymous comment featured toward the end of the Murder or Accident post. It seemed worth transforming into a post in its own right. In the week of the US vote, a key question facing voters is where does all the pain come from.

A colleague and I gave a talk to family docs this year and we discussed the opioid epidemic, including the 1% risk of addiction myth in Letters to the Editor at NEJM. One Key Opinion Leader (KOL) is now acknowledging that he may have overstated the safety of opioids but maintains that they still have a role in chronic pain, see Dr Russell Portenoy here: http://www.wsj.com/articles/SB10001424127887324478304578173342657044604

He strikes a controversial chord with others involved in treating the outcomes of chronic pain killer addictions, like Dr A. Kolodny, see here: http://www.medpagetoday.com/painmanagement/painmanagement/47855

Other KOLs like Dr Jane Ballantyne, have made 180 degree turns regarding opioid use in chronic pain, this article is well worth the read: http://www.nytimes.com/2012/04/09/health/opioid-painkiller-prescriptions-pose-danger-without-oversight.html?_r=0

Challenging myths that have so much resources poured into them to maintain is very difficult. We were all taught that pain was the “fifth vital sign” by the American Pain Society (around the same time OxyContin approval occurred). You can see the sordid history, including how patient satisfaction scores may have a role in this epidemic, here: http://www.kevinmd.com/blog/2016/04/the-opioid-epidemic-its-time-to-place-blame-where-it-belongs.html

The US Docs probably had some scare put into them by the successful legal case brought against a doctor (Dr Chin) in 1998 who was charged for not treating pain adequately. Incidentally, this was the same time as the heavy marketing machine was revving up for Purdue. http://articles.latimes.com/2001/jun/15/news/mn-10726

The appalling story about Purdue/Abbott’s role in this public health disaster is outlined nicely here:

https://www.statnews.com/2016/09/22/abbott-oxycontin-crusade/

There has been very vocal opposition from pain advocacy groups and physicians when British Columbia adopted the March 2016 CDC pain guidelines that discuss opioids and state they are not effective and should not be used for chronic pain and that doses should not exceed 50 mg equivalents of morphine.

Pain BC is encouraging patients who have been affected by these new regulations to complain to the College! https://www.painbc.ca/news/howdothesenewopioidguidelinesaffectyou. Nothing strikes fear into physicians quite like a good old College complaint!

Although the evidence of harm is abundantly clearly (lack of efficacy in chronic pain, massive overdose deaths, lives in ruin, 80% of heroin users report starting drug use with physician prescriptions), both people and doctors choose to ignore this and some doctors fear College investigators. Sounds a lot like Dr Chin all over again…

Big Pharma’s influence in Canada continues. See here for Purdue’s lobbying of the Federal Government: http://canadians.org/blog/who-behind-canadas-opioid-epidemic. A coalition of chronic pain and addiction specialists signed a letter earlier this year, requesting that Federal Health Minister Philpott consider making oxycodone only available as a tamper resistant formulation (of which Purdue holds the patent). Sixty percent of the signatories have ties to industry. http://www.theglobeandmail.com/news/national/ottawa-urged-to-reconsider-tamper-resistant-oxycodone/article29813367/?utm_source=twitter.com&utm_medium=Referrer:+Social+Network+/+Media&utm_campaign=Shared+Web+Article+Links

Dr David Juurlink may have said it best in the Globe and Mail piece referenced above:

“It’s time we stopped listening to pain specialists. Their messages, which were wrong, got us into this mess in the first place,” “Many of these physicians are deeply in the pockets of the companies that make opioids and that stand to profit immensely from the sale of these new products.”

Ontario released a new “Strategy to Prevent Opioid Addiction and Overdose” on October 12, 2016. This milquetoast framework to our public health crisis makes several vague recommendations, one of which is to make more substitution therapy available, specifically access to buprenorphine/naloxone (Suboxone). The document fails to provide suggestions for how to carry this out nor does it make mention of the potential public health risks. Studies have shown that Suboxone is ten times more likely to be diverted than methadone (i.e. not taken by the intended person and diverted to illicit market). We may want to ask Finland for some advice (buprenorphine, has been at the top of drugs misused in that country): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3154701/

The provision of methadone (the other substitution treatment available) in the province received well-deserved criticism from the “Methadone Treatment and Services Advisory Committee”. http://health.gov.on.ca/en/public/programs/drugs/ons/docs/methadone_advisory_committee_report.pdf. Page 11 details some of the most egregious concerns:

 Lack of access to comprehensive care in stand-alone fee for service clinics: Many of these clinics provide little more than urine drug screening and methadone prescribing and dispensing, leaving patients without access to primary care, mental health and addiction screening, brief intervention or counselling, and management of acute and chronic illnesses. Variation in the quality of clinical services: Some clinics require frequent attendance for urine drug screening and a brief office visit regardless of the state of recovery demonstrated by the patient. This is wasteful and can be harmful to patients’ recovery as attendance can be inconvenient and at times very challenging, particularly for those in rural and geographically isolated areas.”

Profit driven care has clearly moved the patient far way from being in the centre.
Some are sounding the clarion call of “another epidemic” happening where over 50,000 patients in Ontario are now on methadone https://substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-016-0055-4

Perhaps the most astonishing elephant in the room is “why are so many people in pain?” As a society we must look at the root drivers of this epidemic and that must also focus on prevention. We need to do some serious soul searching as a nation, as a community of peoples. We will need to address poverty, hopelessness, dislocation, safe housing, disintegration of community, lack of meaningful employment, adverse childhood experiences, resiliency, etc. if we have any hope of bringing this epidemic under control.

Comment

The links above are chilling. The video clip of Russell Pourtenoy is beyond belief.

It raises the question as to whether there is a growing amount of pain in the world as this US election suggests. The alternative is that doctors been adding to whatever pain and anxiety there is and to other dis-ease. While opioids and other pain-killers can give wonderful relief when given short term, as can benzodiazepines for anxiety, there is good evidence that given chronically opioids and benzos increase the amount of pain and anxiety we have – by altering physiological thresholds in the wrong direction.

Old style doctors, professionals, knew this. New style technocrats – we have the technology to fix your pain and anxiety – don’t know it.

It was and is an important part of caring for you to know the limits to what we can offer. But we now live in a world where choices like opioids are put on plate in front of you and your doctor and you are invited to choose. The right choice will supposedly deliver the jackpot – this is what marketing promises.

But somehow wisdom is never on the list of options – it can’t be – it’s not evidence based. It would be irrational to let you choose something that is not evidence based – like less medication or vaccines. That’s not a free choice.

Study 329 Trick, Treat or Treximet

treximet-wsj

The plan this morning was to continue coverage of the Opioid Epidemic but perhaps because it is Halloween a link to a Wall Street Journal story on how Drug Makers Turn Cheap Generics into Expensive Pills arrived by email. It was difficult to resist. Here’s why.

The article features Treximet, a combination of sumatriptan and naproxen, used for migraine. These two drugs are ancient. They come from the last millenium and should cost almost nothing. But Treximet is retailing at $750 for 9 pills. The two drugs as separate ingredients can be bought separately for next to nothing.

This hike in price is heading toward the 5000% hike in price Martin Shkrelli hit the headlines for when he jacked up the price of Daraprim a year ago. This was noted at the start of a series of posts on Pharmaceutical Rape by Laurie Oakley.

Pernication

Behind Treximet lies trials comparing the combination to sumatriptan alone and to naproxyn alone and to placebo showing some benefit it seems – if these trials can be believed. The trials were run by GlaxoSmithKline, for whom sumatriptan had been a flagship drug for decades, and Pozen Inc. Once concluded, in 2014 GSK transferred the rights to Pernix.

This smelt fishy to RxISK’s super-sleuth Johanna Ryan. What’s going on here? In related posts she also fingered the weight loss med Qsymia as egregious and both as indicators of something new this way coming and Qsymia features in the WSJ article also along with Duexis for pain, as price gougers extraordinaire. The new development seems to find new painkillers and new weight loss meds fertile ground. Regulators seem all too happy to license ever more dangerous variations or combinations of older drugs in these groups already on the market and causing serious problems.

This willingness has offered an opening for financial speculators to make a killing speculating on the likely profits these drugs could yield and getting out of the game before much happens. Pernix may be primarily an umbrella for some smart speculation of this sort. It certainly doesn’t look like a pharmaceutical company or anything to do with the actual delivery of healthcare.

Martin Shkrelli has since made it clear he’s been taking Efexor, and it made him feel so good, “invincible”, that he figured people will be more than willing to pay pretty well any price for these wonders of modern science.

Begs the question as to what the regulators in FDA are taking.

It’s more complex with Andrew Witty. You’d have to think GSK didn’t run the trials of Treximet just to hand it over to Pernix, no strings attached. What is the business model here. Is it Rape or is it Pernication? What drug do I have to be taking to make it work?

Mi Grain and Your Grain

When trying to get Study 329 published, we ran up against Liz Loder in the BMJ. She seemed completely resistant, stating on many occasions that we were biased – had conflicting interests. The article only got published after a conflict of interest duel. We wrote to the editor, Fiona Godlee, laying out Dr Loder’s possible conflicts. BMJ have never offered a satisfactory response to this letter.

The main conflict lay in Dr Loder’s husband working for a law firm, Ropes and Gray, who have worked on most of GSK’s recent difficulties including in relation to Study 329.

But in addition we pointed out that:

Dr Loder has made public statements favourable to GSK products, including: ‘For all of these reasons my mantra is that “You haven’t failed sumatriptan until you have failed to respond to a full dose of injectable sumatriptan given early in an attack!” There is also evidence that combining a triptan with an anti-inflammatory drug might improve the likelihood it will be effective’.

(http://live.washingtonpost.com/how-serious-are-migraines.html)

This article was published just before GSK’s Treximet (combination triptan and antiinflammatory) came on to the market – years after Dr Loder was supposed to have renounced all links to companies and their marketing.

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Trick or Treat or Treximet?