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Sunday 30 September 2012

Ben Goldacre's new book - "Bad Pharma" - Review - The drug industry - Pick your pill out of a hat. - Courtesy of the Economist website. + Observer Interview 7-10-12 Courtesy of Observer Online

The drug industry
"Pick your pill out of a hat!"
Sep 29th 2012 The Economist

They might do you some good, with luck
"Bad Pharma." By Ben Goldacre. Fourth Estate; 430 pages; £13.99. Also available as a Kindle book £8.99

DOCTORS like to project an air of authority when making their clinical decisions. Patients like it too, for it is reassuring to think that one’s health is in the hands of an expert. It would be unsettling if, upon prescribing you a drug, your doctor admitted that the scientific research about what exactly the drug did, and how effective it was at doing it, was patchy and distorted, sometimes to the point where nobody has any real idea of what effects the drugs they are prescribing are likely to have on their patients.

But that is the reality described in “Bad Pharma”, Ben Goldacre’s new book. A British doctor and science writer, he made his name in 2008 with “Bad Science”, in which he filleted the credulous coverage given in the popular press to the claims of homeopaths, reiki therapists, Hopi ear-candlers and other purveyors of ceremonious placebos. Now he has taken aim at a much bigger and more important target: the $600-billion pharmaceutical industry that develops and produces the drugs prescribed by real doctors the world over.

The book is slightly technical, eminently readable, consistently shocking, occasionally hectoring and unapologetically polemical. “Medicine is broken,” it declares on its first page, and “the people you should have been able to trust to fix [its] problems have failed you.” Dr Goldacre describes the routine corruption of what is supposed to be an objective scientific process designed to assess whether new drugs work, whether they are better than drugs already on the market and whether their side effects are a price worth paying for any benefits they might convey. The result is that doctors, and the patients they treat, are hobbled by needless ignorance.

So, for instance, pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a company’s drug.

The bad behaviour extends far beyond the industry itself. Drug regulators, who do get access to some of the hidden results, often guard them jealously, even from academic researchers, seeming to serve the interests of the firms whose products they are supposed to police. Medical journals frequently fail to perform basic checks on the papers they print, so all sorts of sharp practice goes uncorrected. Many published studies are not written by the academics whose names they bear, but by commercial ghostwriters paid by drug firms. Doctors are bombarded with advertising encouraging them to prescribe certain drugs.

The danger with a book like this is that it ends up lost in abstract discussion of difficult subjects. But Dr Goldacre illustrates his points with a plethora of real-world stories and examples. Some seem almost too breathtaking to be true—but every claim is referenced and backed up by links to research and primary documents. In scenes that could have come straight from a spy farce, the French journal Prescrire applied to Europe’s drug regulator for information on the diet drug rimonabant. The regulator sent back 68 pages in which virtually every sentence was blacked out.

And of course, the upshot of all this is anything but abstract: doctors are left ignorant about the drugs they are prescribing, and which will make their patients sick or get well, or even live or die. Statins, for instance, lower the risk of heart attacks, and are prescribed to millions of adults all over the world. But there are several different sorts of statin. Because there is little commercial advantage to be gained by comparing the efficacy of the different varieties, no studies have done so in a useful way.

Bereft of guidance, doctors must therefore prescribe specific statins on the basis of little more than hunches or personal prejudice. As Dr Goldacre points out, if one drug is even a shade more effective than its competitors, then thousands of people prescribed the inferior ones are dying needlessly every year for want of a bit of simple research. That is a scandal. Worse, the bias and distortions that brought it about are repeated across the entire medical industry. This is a book that deserves to be widely read, because anyone who does read it cannot help feeling both uncomfortable and angry.


Ben Goldacre: 'The world would be a better place if doctors were less enthusiastic about adopting very new drugs.' Photograph: Linda Nylind for the Guardian

The blindingly obvious inference of the extract from your book published in the Guardian– as of so many others you once commendably wrote in your Bad Science column – is that this is an industry totally unsuited to being run on profit-maximising lines by conventional shareholder companies. Given that, and the tremendous level of subsidy the industry already receives from governments around the world, why not spell out the vital necessity of locating it within publicly owned/non-profit organisations where there need be no obstacle to full transparency?

Harry Shutt, via email

I am a realist about this. I don't want a central-command state economy. In general, drug companies are reasonably good at developing new treatments and there's also a lot of good in the industry. The point of my book is that it's possible for good people in badly designed systems to perpetrate acts of great evil completely unthinkingly. I don't think any of the people I write about would punch an old lady in the face, but they would inflict the same level of harm when they are abstracted away from the outcomes of their actions.
This is made easier, I think, because in general, most drugs do work better than nothing: it's just that we may be misled into using, for example, an expensive new drug where an older, cheaper one is more effective.
Overall, the problem is we don't have a competent regulatory framework that prevents things from going horribly wrong. If companies are allowed to hide the results of clinical trials then they will, and that will distort clinical practice. Doctors and patients will be misled and make sub-optimal decisions about what treatment is best for them.
Similarly, if you can get on to the market by making a me-too copycat drug that represents little or no therapeutic advance and is even less effective than the drugs that it copies, then you will. And you can get such a drug to the market because regulators approve new treatments even when they've only been shown only to be better than placebo…

The Observer: Rather than the best current treatment available?
Exactly. When that happens, then there's less drive to innovate new medicines. So a lot of people think they know how you test a new drug, they think it's a placebo-controlled randomised trial, and that's kind of true. However, for most situations we already have some kind of treatment, so we're not interested in whether your treatment is better than nothing; we're interested in whether it's better than what we're already using. But you can get on to the market without ever comparing your drug against the best currently available treatment, and then you can bamboozle doctors and patients into using it by distorting the clinical evidence with all the tricks I describe, and then by giving a biased picture of that distorted evidence to doctors and patients through your marketing activity. All of that means, crucially, you can turn a profit by producing drugs that aren't very innovative.
So at the moment our regulatory frameworks do not represent a good set of incentives for innovation. When people say, "Oh my God, it's dreadful all these companies have had to pull out of developing new drugs for Alzheimer's", on the one hand Alzheimer's is a very difficult problem, on the other hand we haven't created a regulatory framework that sufficiently incentivises people to take serious risks, and research entirely new treatments.
I have been in healthcare marketing communications for more than 30 years (flogging drugs to doctors) and can confirm that much of the sharp practice you describe is caused by the pressure exerted on researchers by marketing departments. When a new drug entity makes it through Phase I, the pharmaceutical company's marketers carry out market research studies to find out what doctors expect and desire from such a product. The results of these studies are used to develop "guidance" for researchers designing Phase II and III trials. One issue is the speed with which some doctors ("innovators" in marketing speak) adopt new medicines. There is a drug surveillance system in this country that requires doctors to report all adverse events occurring in patients taking new drugs. So if doctors were a little less enthusiastic and prescribed new products to no more than a couple of patients at first, most problems would come to light before large numbers were affected.
arghbee, via web

I agree, the world would be a better place if doctors were less enthusiastic about adopting very new drugs. When I was taught how to prescribe by my clinical pharmacology professors, as an undergraduate in medicine, we were told: don't prescribe new drugs unless they are spectacularly superior to what you already have; let other doctors take the chance. And that's what I teach students myself. Regard the whole of the rest of humanity as unpaid stunt doubles. Because, when you prescribe a new drug, often you are prescribing something that has only been tested in a few thousand people for a very short period of time, perhaps only six months, and that's not long enough to know whether there are any medium- or long-term side-effects. It's also too few recipients of the drug to find out about rarer side-effects. On top of that, when drugs come to market they've only often been shown to be effective on short-term outcomes, and on surrogate outcomes, weak outcomes, theoretical outcomes. So a new drug might have shown to affect a blood test result, which we hope is theoretically associated with a real-world outcome, but not tested against real-world outcomes such as pain, suffering and death. On top of that, while doctors and patients sometimes fetishise the new, the evidence is that overall, new drugs are often no better than the older ones they replace.
If there is time for shared decision making, when we're prescribing a new drug, then I think first doctors could maybe say to their patients: "The drug I'm prescribing has only been tested in a few thousand people for less than six months, and it's only been shown to improve blood tests, not the real outcomes in your disease. If you prefer, we also have a tablet that has been around for 10 years, has been taken by millions of people, and that we know has a positive impact on real-world long-term outcomes – which would you prefer?" Because I think these are reasonable issues to factor in, when you're making a treatment decision.

Obs: And the point about marketing departments influencing trials?

This is a really interesting area and it's a good illustration of how there is good and bad in current marketing practices. I think it's really good that somebody out there listens to what doctors and patients want and need, in order to try to address those needs. There's a scandalously brief and interesting history of research on this question in academia. It was only very recently that people went out and formally asked patients: "What's the most important outcome to you?" The classic study was one in a rheumatology outpatients' clinic – they said: "What kind of trials do you think need to be done?" And the patients said: "We don't think you need any more trials comparing one pill against another, we want trials to tell us if physiotherapy improves outcomes, because doing physio is a massive drag and requires a lot of effort from us." The other thing they said, to everybody's complete astonishment, was: "We don't think that pain is the most important symptom, it's actually stiffness." And that amazed everyone. So good quality, systematic, mixed methods, qualitative and quantitative research, to find out this sort of stuff is really great and important.

Obs: Are pharma marketing departments doing that?

Well, they're probably doing some and a mix of other stuff. The real problems come when you look at the interplay between market research and the whole process of publication planning, which is something that many doctors and academics are completely unaware of. Certainly, I think, the public have very little knowledge of it. We all like to imagine that the academic literature is composed of worthy papers by independent academics exploring things on the basis of interest. We don't, for the most part, realise that there is often a hidden hand guiding this process. So when a new drug is being brought to market, especially one that addresses a problem that hasn't been addressed before, you will often get an elaborate sequence of covertly planned marketing activity in the academic literature, without any declaration that this is what's happening.
For example, companies will set about paying for and planning, and in some cases ghostwriting, papers saying that the disease their new drug treats is an underdiagnosed problem, it's much more prevalent than we thought. You might also start to produce lots of literature about how current interventions aren't very good, downplay your own side effects, promote off-label uses of your drug, and so on. That's all before you get anywhere stage-managing the literature about the actual benefits of your treatments.
So the interplay between marketing departments and research departments, I think, is inevitable. It's a mixture of good and bad, but the thing that's most striking is how ignorant most people are about these things, and how huffy and upset drug companies get when you start to talk about it. If people really think it's OK to have commercial medical writers writing papers instead of academics, then they should put their names clearly and proudly at the top of the papers. If people really think it's OK to stage-manage the whole programme of academic journal articles behind the scenes up to the launch of your drug, they should just mention that in the papers at the bottom: "This is part of the programme leading up to the launching of drug X. The idea for this paper came from the marketing department at Y." If they think all this activity is OK, then that's fine: they should be happy to declare that publicly, and we can decide for ourselves.

In your book you appear to be describing situations where companies knowingly suppress information that shows the products they are selling are ineffective or worse. My doctorate is in engineering and if we had done that we would have been liable to a prosecution for fraud. This is quite irrespective of the regulations pertaining to a specific industry, though we were required to report any significant deviation to the regulator as soon as we were aware of it. So, quite simply, why are these pharmaceutical companies not being prosecuted?
Joseph Cullen, via email

Well, it's a huge cultural blind spot. No one, with the exception of the Faculty of Pharmaceutical Medicine, which is a very small organisation, not one of the medical and academic bodies have stood up and said: "Selectively withholding unflattering trial data is research misconduct, and the ultimate end product is a biased picture of the effectiveness of your intervention."
If I deleted half the data points in one study to make my treatment look better than it really is, everybody would say that was research misconduct. But for some reason when I delete half of the trials from my clinical trials programme and only publish half of them, that is not regarded as research misconduct.
It's a cultural blind spot that comes about, I think, because the misconduct arises from a slightly diffused network of failure. So in some cases there will be obsessive, evil people at the centre, with full panoramic knowledge of everything that's happening, stage managing it. In other cases, you'll have individuals in organisations, maybe quite junior, they've got a trial with a negative result, nobody's enthusiastic about putting it out there, and to that one researcher, not publishing a paper intuitively doesn't feel the same as deleting some data points in a study, even if the end product is the same, in terms of the impact on doctors' and patients' knowledge of the risks and benefits.
That's why I think it's really disappointing that nobody, not the Royal Colleges, the Academy of Medical Sciences, the British Pharmacology Society, the British Medical Association, none of these organisations have stood up and said: selective non-publication of unflattering trial data is research misconduct, and if you do it you will be booted out. And I think they really urgently should.
I have to say, for a lot of the things I cover in the book, I honestly believe this stuff has been protected from public scrutiny for many years by a wall of tedium, or if you like, by a wall of modest scientific complexity. It's behind closed doors but not locked doors, it's all hiding in plain sight. I think it's very likely that this will turn out to be like MPs' expenses or phone hacking journalists. The people involved in these small communities have all convinced one another that what they do is completely normal and fine. But it's not. I think that when the public come to see what has been going on, they might be appalled.

I work for an institutional shareholder of many large pharmaceutical companies. Do you think there are any pharmaceutical companies that stand out in terms of transparency of trial results? And at the other end of the scale, are there any companies that consistently fail to publish negative trials?
Laura Foll, analyst, Henderson Global Investors

No. I have no reason to believe that any one is any better than the other. If you have bad regulations, incoherently enforced, then everybody does what they have to do, to succeed in the marketplace.

Considering we have to discuss and explain population-based risk to the individual we are treating, and the way we discuss risk biases the response, how do you discuss risk in simple terms, for example, in primary prevention?
Tariq Hussain, GP

This is an amazingly interesting area, and I think it is the next horizon in medicine. If you put me in charge of the medical research budget I would cancel all primary research, I would cancel all new trials, for just one year, and I would spend the money exclusively on making sure that we make the best possible use of the clinical evidence that we already have. This means first devising better ways of communicating risk to patients, and engaging in a process of shared decision-making wherever appropriate. Second, I would put the money into a better information architecture for evidence-based medicine. I would put the money into researching and implementing better systems to get the right information to the right doctor at the right time, to collate and then to disseminate the information that we have.

Obs: We had quite a few questions from readers who, faced with difficult decisions about changing drugs or trying a new drug, were reading trials and studies themselves…

That's a real mistake, actually. As I say in the book, I don't think it's a good idea for individuals to try to pick and choose their drugs, or stop their drugs. I think it's a very dangerous business. I don't say that because I want to protect any special status in the medical profession, I just think it takes a really long time to acquire the skills and knowledge to do that. People often say: "What do I do for me? For my treatment decision right here and now?" And the best advice I can ever give is to find a good doctor and talk to them about it, and anybody who tells you that they can give good advice about your medical problems in a newspaper article, or on the internet, or in some silly magazine, should be regarded with infinite suspicion, no matter how big a bouffant or how deep a perma-tan they have – I'm not thinking of anyone in particular, I don't really know that scene. I don't do readers' health advice and I think these things are best discussed with your doctor.
Patients often resort to saying: "Doctor, if it were you, what would you do?" Or "If it were your child…?"
I think that's a reasonable question to ask. Often decision making is a complicated business, weighing lots of risks and benefits against one another, often it can't be operationalised. But I think the important thing is that doctors have all of the information that they need in order to make informed decisions. First, because it's not hidden from them, and second because it is competently disseminated to them, and patients should have the choice to engage with that, but there's nothing compulsory about it. I think data on how good your local school is should be available to you, but equally I recognise that the overwhelming majority of parents never look at it, and that's normal. I wouldn't judge them. I just think the information needs to be available.

War costs U.S. a rocketing $2.7 billion per day. This could be invested in fair health-care and education systems instead of choosing for example 'quick fix' solutions such as 'social control' of the next generation by psychotropic drugs.

Every day the United States spends $2.7 billion on war. That's $2.7 billion tax dollars that we can't spend on health care, education, economic development, energy independence, or caring for our seniors. Also this thinking increases the likelihood of a 'quick fix' mentality which is invariably flawed.

Right now America is riddled with debate about how to pay for the basic services, like health care, that we all need. Last year alone we spent nearly $1 trillion dollars on wars past and present.  Next year, 57% of the discretionary budget is earmarked for military spending.   The debate surrounding the cost of health care reform could be largely resolved for a fraction of that amount.

Today you can tell your our leaders in Washington that you think the time has come to reduce our spending on war and instead fund the things we really need - like functioning schools, healthy communities, good jobs, and an end to the recession. All it would take is a slight shift in our priorities, and a slight change in our spending, to have a big impact.

Our leaders need to know that we don't want so many of our tax dollars being spent on violence and war every day and spend it on psychological therapies for kids rather than the 'Brave New World' of social control with psychotropics.

This apllies to the U.K. too:
The war in Afghanistan will cost £20 billion over the next four years -- exactly the amount that the government is trying to cut from the National Health Service through 'savings'.


Inside Psychiatry: Anxiety Over Antipsychotic Drugs

Writing in the New York Times, Richard A. Friedman, a professor of psychiatry at Weill Cornell Medical College in Manhattan, points out:
You will never guess what the fifth and sixth best-selling prescription drugs are in the United States, so I'll just tell you: Abilify and Seroquel, two powerful antipsychotics. In 2011 alone, they and other antipsychotic drugs were prescribed to 3.1 million Americans at a cost of $18.2 billion, a 13 percent increase over the previous year, according to the market research firm IMS Health.
Others drugs in this group of so-called atypical or second-generation antipsychotic drugs include Risperdal, Zyprexa, Geodon, Invega, and now Latuda.
Friedman goes on to observe:
It was also soon discovered that the second-generation antipsychotic drugs had serious side effects of their own, namely a risk of increased blood sugar, elevated lipids and cholesterol, and weight gain. They can also cause a potentially irreversible movement disorder called tardive dyskinesia, though the risk is thought to be significantly lower than with the older antipsychotic drugs.
Notice he says that the risk of tardive dyskinesia is "thought" to be significantly lower. In reality, the very study that he cites in his column, the National Institute of Mental Health (NIMH) sponsored CATIE study, did not find that the newer antipsychotics were safer in this regard.
Friedman correctly laments that these dangerous drugs, proven no more effective and no safer than the older ones, are being given off-label to individuals with much less severe psychiatric problems than psychosis: "But now, unbelievably, these powerful medications are prescribed for conditions as varied as very mild mood disorders, everyday anxiety, insomnia and even mild emotional discomfort."
How can an establishment psychiatrist dare to make such devastating criticisms? He covers himself at the end with this obligatory tag line: "Let's be clear: The new atypical antipsychotic drugs are effective and safe." Then he calls them lifesaving.

The reality is that all of these drugs are nonspecific lobotomizing agents that disrupt biochemical neurotransmission to the frontal lobes. I examine these effects in my book: Brain Disabling Treatments in Psychiatry, Second Edition. They achieve their effect by making people indifferent and apathetic toward their own suffering and toward life itself, in the extreme creating a grossly apparent zombie effect. A number of studies, summarized in my new book, Psychiatric Drug Withdrawal, also indicate that they may shorten the lifespan by many years in some patient populations.
Friedman is right that by any standards these drugs are overprescribed. But he leaves out two groups that are especially vulnerable to abuse by these chemical agents: the elderly and children.

In nursing homes throughout North America, antipsychotic drugs are given wholesale to patients in order to lower the costs of confining them, in particular by reducing the need for staff to meet the needs of these chemically-lobotomized individuals. Elders are placed at risk of many adverse effects and an early, hastened death due to the off-label prescription of antipsychotic drugs.

Children throughout America are being given these drugs for everything from insomnia to ADHD. Some of these children are developing horrific side adverse effects, including gynecomastia in preadolescent boys and girls who develop breasts indistinguishable from those of adult women. Sometimes these breasts grow back after surgical removal, despite stopping the medications. Steve Sheller, an attorney in Philadelphia, is pursuing numerous cases of gynecomastia and has described many cases to me. In addition, boys are developing premature puberty, like one of my patients is, at age 7.
The FDA has approved the use of some of these newer antipsychotics for a variety of purposes in children, including irritability associated with autism and bipolar disorder. It is time to stop this epidemic of pharmacological child abuse.
Attorney Sheller is circulating a petition that we endorse, asking the FDA to revoke approval of the prescribing of antipsychotic drugs to children. Mr. Sheller states in the petition:
We hereby petition the Food and Drug Administration (hereinafter "FDA"), pursuant to the Federal Food, Drug and Cosmetic Act ... to immediately revoke the pediatric indication for Risperdal®, all generic version of risperidone, and Invega (an extended release and injectable medication which includes the same primary active metabolite as Risperdal) unless and until the long-term safety of the drug can be demonstrated, or in the alternative to immediately require that labeling for Risperdal® and all generic versions of risperidone include a black box warning on the lack of sufficient safety data.
We urge concerned professionals and laypersons to sign the petition to the FDA. Each of us, as alarmed physicians, psychiatrists, therapists, counselors, educators, attorneys and citizens, needs to add our voice to this formal appeal to stop the wholesale over-drugging of one of the most vulnerable populations of our society -- our children. By supporting this petition and encouraging the FDA to take action, we also protect children every place in the world because as America goes with psychiatric drugs, so goes the world. You can go right now to the official government website to add your voice to protect children against the chemical assault of these powerful and dangerous chemical agents.

Peter R. Breggin, M.D. is a psychiatrist in private practice in Ithaca, New York, and the author of dozens of scientific articles and more than 20 books. His latest book is Psychiatric Drug Withdrawal: A Guide for Prescribers, Therapists, Patients and Their Families. The book describes the many hazards associated with taking psychiatric drugs for months and years, and then offers a safe and effective approach to drug withdrawal. It is written for both professionals and laypersons. His website is www.breggin.com.

For more by Dr. Peter Breggin, click here.
For more healthy living health news, click here.

Thursday 27 September 2012

Haim Ginot's famous poem for teachers reworked for pastoral care workers who have a 'DUTY OF CARE' TO BE AWARE about psychotropic drugs for children in their schools by Dave Traxson + 16 QUESTIONS FOR PASTORAL CARE WORKERS IN SCHOOLS

A Pastoral Care Worker's Revelation: a reworking of Haim Ginot's famous poem
 for teachers – by Dave Traxson


I've come to the empowering conclusion that I can be a decisive element in the child's life for care, safety, stability and growth.

It's my Humanity and warmth that creates the climate in our school.

It's my daily mood and expectations that nurtures the likelihood of growth in a young human being.

As a keyworker I possess a tremendous ability to utilise the power of Pastoral Care or Pastoral Scare for the benefit or not of a child.

I can be a tool of degradation or a tool for personal development of the child.

I can collude with or ignore the drugging children or take a lead in 'hugging' children and finding their inner 'rays of sunshine.'

I can humiliate and pathologise or humour and energise a child.

I can show human kindness or disinterest which is a lack of love.

In all situations, it is my response that decides whether a crisis is escalated or de-escalated, and a child feels normalised or pathologised.


 Key Questions For Pastoral Care Staff Relating to the Administration of  Psychotropic Drugs  on Children within the schools they work in.

I would like to pose some questions or dilemmas that educational professionals need to explore when working collaboratively with medical colleagues in an educational setting.  This applies when a child they are directly involved with is on or about to receive psychotropic medication that they have professional concerns about.

The purpose is to explore the remit of the "Duty of Care" of Educational Professionals in this sensitive area of multiprofessional collaboration

1)Are you following your own professional body's Code of Practice in relation to ethical practice and endeavouring to pursue the principles of beneficence ( promoting the well being of the child) and non-malifecence    (avoiding direct or indirect harm to the child)?

2)Is the GOLDEN RULE, "Would I want this approach for my own child" a criterion that helps in selecting an appropriate response for each case?

3)Does the headteacher and pastoral care team know how many children are on specific psychotropic drug treatments within their school / year group?

4)Do members of the pastoral care team get asked regularly to provide evidence and their opinions about the child's pattern of behaviour prior to the administration of psychotropic medication and whether they support the medication as partners in the delivery of services for the child concerned?

5)Is the headteacher or pastoral care staff part of the monitoring process regarding behaviour of particular children on psychotropic medication , especially the ones that they have clear  professional concerns about?

6)Do members of the pastoral care team regularly get updated by health professionals as to any changes in dosage and what possible side effects might be expected that result from these changes in regimen?

7)Have pastoral care staff had conversations with the child's parents or carers about any changes in behaviour or side effects that they have observed in school following any changes in medication?

8)Is it your responsibility as a caring professional to draw the parent's attention to any published information you are aware of in relation to this specific medical intervention e.g. NICE parent information sheets,factsheets and the ADHD Parent resource Pack (West Midlands Regional Partnership) etc.?

9)Do you as an educational professional feel comfortable about being  involved in administering medication on the advice of doctors and with parental permission so to do?

10)Do pastoral care staff in school have a means of challenging what they view as an intervention by medics that they are unhappy with, as they have an "In Loco Parentis" role for the children in their care in school? What process has been agreed for this within your setting?

11)Would you or a member of the pastoral care team trigger a Common Assessment Framework (CAF) meeting involving parents and other professionals to address any concerns you may have about levels of medication or speak to their school's nominated Safeguarding coordinator for advice about the best way forward?

12)How far should education professionals cooperate with medical professionals who are prescribing psychotropic medication for children the professionals know well? How can we best challenge this practice in cases we have clear ethical, practical, or professional concerns  about?

13)Should schools regularly administer these drugs when prescribed by the medical practitioner( with clear parental permission so to do)? Should staff be told of the rationale behind the recommended treatment and the possible Adverse Drug Reactions (A.D.R.s-side effects) prior to administration? Is this a legitimate "In loco parentis" role when many schools do  not give Paracetamol and yet are expected to administer Amphetamines?

14)Why are boys four times more likely to be identified than girls and prescribed drugs? Is this the case in your educational setting? How do you feel this may relate to young peoples later drug usage or dependence and to adult life outcomes e.g rates of  unemployment, criminality and imprisonment?

15)Are school governors regularly updated on the numbers of children on psychotropic medications and the benefits and difficulties experienced so they can also exercise their "Duty of care ",along with the Headteacher, as governors and have they seen the school guidelines on medication?

Do you think there could be a relationship between the use of prescribed stimulants with young children in your care and the later in life use of illegal stimulants such as cocaine,”speed”etc.                                 
 Collated by  Dave Traxson ,ASEP, Chartered Educational Psychologist in discussion with Headteacher colleagues, Pastoral staff and E.Ps

'“Pastoral Care Staff have a Duty of Care to be Aware.”



Sunday 23 September 2012

Medicalisation / pathologisation courtesy of Wikipedia

The Wikipedia article, MEDICALIZATION...
Jonathan Fishman 23 September 12:39
The Wikipedia article, MEDICALIZATION includes: "Medicalization is the process by which human conditions and problems come to be defined and treated as medical conditions, and thus become the subject of medical study, diagnosis, prevention, or treatment. Medicalization can be driven by new evidence or hypotheses about conditions; by changing social attitudes or economic considerations; or by the development of new medications or treatments.

Medicalization is studied from a sociologic perspective in terms of the role and power of professionals, patients, and corporations, and also for its implications for ordinary people whose self-identity and life decisions may depend on the prevailing concepts of health and illness. Once a condition is classified as medical, a medical model of disability tends to be used in place of a social model. Medicalization may also be termed "pathologization" or (pejoratively) "disease mongering"

DSM-5 - 'Father of the DSM' admits many children may not be ill when diagnosed with ADHD - Robert Spritzer says "that between 20 and 30 per cent of mental disorder diagnoses may be incorrect." Read and SIGN PETITION

The great ADHD myth

Last updated at 22:34 09 March 2007


kids playing in park
Have hyperactive kids been misdiagnosed with ADD?
The psychiatrist who identified attention deficit disorder - the condition blamed for the bad behaviour of hundreds of thousands of children - has admitted that many may not really be ill.
Dr Robert Spitzer said that up to 30 per cent of youngsters classified as suffering from disruptive and hyperactive conditions could have been misdiagnosed.
They may simply be showing perfectly normal signs of being happy or sad, he said.
'Many of these conditions might be normal reactions which are not really disorders,' he continued.
Dr Spitzer developed the bible of mental disorder classification in the 1970s and 1980s, which identified dozens of new conditions including ADD and obsessive-compulsive disorder.
Since then hundreds of thousands of children have been diagnosed with ADD, a behavioural disorder linked to poor attention span, and ADHD, which adds an element of hyperactivity.
The disorders describe disruptive and restless behaviour that results in children having difficulty focusing their attention on specific tasks. ADHD is most commonly noticed at the age of five, and as many as one in 30 British children is said to have it.
It is often treated with drugs, with Ritalin being the most commonly prescribed.
Some scientists say ADHD is a genetic disorder that does not disappear with adulthood.
But sceptics believe the diagnosis is a 'biobabble' label, which has evolved from a soundbite culture that is too prepared to medicalise anti-social human traits.
Dr Spitzer, professor of psychiatry at Columbia University in New York, now says the classification led to many people being diagnosed as medically disordered when their mood swings and behaviour were simply normal feelings of happiness and sadness.
In a BBC2 documentary series The Trap, which begins on Sunday, he says that between 20 and 30 per cent of mental disorder diagnoses may be incorrect.
His admission comes as figures show that the amount spent by the Health Service on drugs to treat ADHD and similar disorders in children trebled to £12 million in just five years, from 1999-2003.
Almost 400,000 British children aged between five and 19 are believed to be on the drugs - despite doctors' fears about side-effects.
That is the equivalent of every child in Britain each taking more than four doses of the drugs every year.
NHS guidelines recommend drug treatment for the most severely affected, although there have been reports of cardiovascular disorders, hallucinations and even suicidal thoughts.
There have been at least nine deaths reported to the UK's Medicinesand Healthcare products Regulatory Agency since Ritalin became available in the early 1990s.
But Dr Spitzer, who chaired the taskforce that compiled the international Diagnostic and Statistical Manual of Mental Disorders, said he is less concerned by wrong diagnoses and possible side-effects from drugs, than failing to prescribe them where needed.
'By and large the treatments for these disorders don't have serious side effects,' he told the Times Educational Supplement.
'I mean, some do, but they're not that serious, whereas the failure to treat can often be very hard on the child and on the family.'
He acknowledged that some parents put pressure on doctors to diagnose ADHD and obsessive-compulsive disorder, and prescribe drugs.
'We don't know to what extent that's been happening inappropriately,' he added.
Ian Graham, headmaster of Slindon College, an independent boys' boarding school near Arundel, West Sussex, has 20 out of 100 pupils diagnosed with attention deficit disorder and a few more with related diagnoses such as oppositional-defiant disorder.
About 17 of the boys are prescribed drugs including Ritalin, while the remainder have their condition controlled through diets that exclude chocolate, sweets or gluten.
The school also employs therapy techniques, and the old-fashioned tactic of getting pupils to run off their energy in outdoor activities.
Mr Graham said: 'I've never met a parent who is happy with the medication. They would all prefer not to use them, but to a man and woman, they all say they can't believe the change in their sons' ability to concentrate in lessons.'

Friday 21 September 2012

DSM-5 - The Association of Educational Psychologists warns of the risks of the new 'diagnostic bible,' from America to the Safeguarding of Children in the U.K. + PLEASE SIGN PETITION

New diagnostic guidance may lead to over-treatment of children
"Subjective and unscientific" new official guidance could lead to thousands more pupils being diagnosed with psychiatric conditions and prescribed unnecessary drugs, experts have cautioned.
The Association of Educational Psychologists (AEP) fears that a new manual, designed to help medical professionals diagnose mental health problems, is too vague and open to misinterpretation.
Kate Fallon, general secretary of the AEP, said that while teachers and parents are often relieved when young people in their care are diagnosed with a condition such as depression or attention deficit hyperactivity disorder (ADHD) and given medication, this can mask underlying problems in their home life.
The latest version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), drawn up by experts in the US and due to come into effect in the UK next May, could lead to "many, many more children and young people being diagnosed with psychiatric disorders", Ms Fallon said.
At its annual conference in Brighton last week, the Trades Union Congress (TUC) backed a motion calling on the National Institute for Health and Clinical Excellence (Nice) and the Department of Health to issue "clear guidance to all health practitioners about (DSM-5's) limitations".
"If we can't stop it coming out, we can at least advise people to be cautious about how they are using it," Ms Fallon told TES.
"There seems to be a growing motivation to have a medical diagnosis placed on a child. It can make the parent feel better or the teacher feel better. It doesn't find the underlying causes behind the issue, but it's easy to say, it's a label, and it sometimes helps the family get disability living allowance or the school be allocated extra educational resources."
The increasing diagnosis of children with psychiatric conditions is reflected in rising prescriptions of methylphenidate hydrochloride, the generic name for Ritalin. Prescriptions for the drug, commonly used to treat ADHD in children, increased from 158,000 in 1999 to 661,463 in 2010, according to NHS figures.
The manual is widely used by psychiatrists and GPs in reaching diagnoses on mental health problems. The AEP fears that the "broadened definitions" of psychiatric conditions in the new guidance could make children more likely to be diagnosed. "It means you wouldn't have to show as many symptoms or the same severity," Ms Fallon added.
Addressing the TUC conference, she told delegates that when children feel pressured, they demonstrate behaviours that tell the adults around them that "something is wrong", adding that this "may be too much pressure to achieve high grades in (their) exam, too much pressure to be very thin or very beautiful, to hang out with the cool kids or have all the latest gear".
This could lead, Ms Fallon said, to a shy child being "diagnosed with social anxiety. A sad, grieving or temporarily withdrawn child could be diagnosed with depression.
"We are worried that more children diagnosed with psychiatric disorders will lead to the increased use of drug therapy and long-term reliance on medication," she added.
Cathy Tattersfield, an executive member of the Association of Teachers and Lecturers and a teacher in a special school, told the conference that "quick-fix solutions ... don't provide long-term answers", and called for young people to be given "careful diagnosis and treatment".
The panel of experts that drew up DSM-5 for the American Psychiatric Association has also come under fire for its links to pharmaceutical companies, with 70 per cent of its members disclosing financial relationships with firms in the sector.
Both Nice and the Department of Health declined to comment.
A sad, grieving or temporarily withdrawn child could be diagnosed with depression
On medication
The prescription of Ritalin - widely used to treat ADHD - has soared in recent years:

Wednesday 19 September 2012

Antidepressants - The Proven Dangers of Antidepressants - Courtesy of Peter R. Breggin, M.D.

The Proven Dangers of Antidepressants
by Peter R. Breggin, M.D.

On March 22 the FDA issued an extraordinary “Public Health Advisory” that cautioned about the risks associated with the whole new generation of antidepressants including Prozac and its knock offs, Zoloft, Paxil, Luvox, Celexa, and Lexapro, as well as Wellbutrin, Effexor, Serzone, and Remeron. The warning followed a public hearing where dozens of family members and victims testified about suicide and violence
committed by individuals taking these medications.

While stopping short of concluding the antidepressants definitely cause suicide, the FDA warned that they might do so in a small percentage of children and adults. In the debate over drug-induced suicide, little attention has been given to the FDA’s additional warning that certain behaviors are “known to be associated with these drugs,” including “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity,
akathisia (severe restlessness), hypomania, and mania.”
From agitation and hostility to impulsivity and mania, the FDA’s litany of antidepressant-induced behaviors is identical to that of PCP, methamphetamine and cocaine—drugs known to cause aggression and violence. These older stimulants and
most of the newer antidepressants cause similar effects as a result of their impact on a neurotransmitter in the brain called serotonin.
For more than a decade, I have documented in books and scientific reports how this stimulation or activation profile can lead to out-of-control behavior, including violence. Indeed, the FDA’s conclusions seem drawn from my recent detailed review of Breggin Antidepressant Column, p. 2 studies pertaining to abnormal behavior produced by the newer antidepressants:
“Suicidality, violence and mania caused by selective serotonin reuptake inhibitors (SSRIs): A review and analysis” published in the International Journal of Risk and Safety in Medicine, 16: 31-49, 2003/2004 (The complete text of the peer-reviewed article
appears on this website). I made a similar analysis in my most recent book on the subject, The Antidepressant Fact Book (2002, Perseus Books).
As a psychiatrist and as a medical expert, I have examined dozens of cases of individuals who have committed suicide or violent crimes while under the influence of the newer antidepressants such as Prozac, Zoloft, Paxil, Luvox and Celexa. In June in South Carolina, Christopher Pittman will go on trial for shooting his grandparents to death while they slept. Chris was twelve when his family doctor started him on Zoloft.
Three weeks later the doctor doubled his dose and one week later Chris committed the violent acts. In other cases, a fourteen-year-old girl on Prozac fired a pistol pointblank at
a friend but the gun failed to go off, and a teenage boy on Zoloft beat to death an elderly woman who complained to him about his loud music. A greater number of cases involve adults who lost control of themselves while taking antidepressants. In at least two cases judges have found individuals not guilty on the basis of involuntary intoxication with psychiatric drugs and other cases have resulted in reduced charges, lesser convictions, or shortened sentences.
The FDA includes mania in its list of known antidepressant effects. Manic individuals can become violent, especially when they are thwarted, and they can also “crash” into depression and suicidal states. They can carry out elaborate but grandiose
and doomed plans. One clinical trial showed a rate of 6% manic reactions for depressed Breggin Antidepressant Column, p. 3 children on Prozac. None developed mania on a sugar pill. Even in short-term clinical trials, 1% or more of depressed adults develop mania compared to a small fraction on the
sugar pill.
Although it is difficult to determine the rate at which the antidepressants cause relatively uncommon tragedies such as suicide and violence, we do know that they cause stimulant effects such as irritability and agitation in a large percentage of patients, often a third or more. Doctors who fail to recognize these reactions as drug-induced may mistakenly increase the dose of the antidepressant with disastrous results.
Little will be lost by minimizing the use of the newer antidepressants. While there is strong evidence that they cause suicide, there is no convincing evidence that they can
prevent it. Many older antidepressants cause less stimulation and are equally or more effective in head-to-head clinical trials. Beyond that, a number of meta-analyses drawing data from multiple studies have shown that antidepressants are no better than a sugar pill.
People who are depressed often respond to placebo because it gives them hope. Severe depression is essentially a feeling of profound hopelessness and despair that can best be addressed by a variety of psychotherapeutic, educational, and spiritual or religious interventions.
Unfortunately, there are also risks involved with stopping antidepressants. Many can cause withdrawal reactions that last days and sometimes longer, causing some patients to feel depressed, suicidal or even violent. Stopping antidepressants should be done carefully and with experienced clinical supervision.
As a first step in responding to this public health threat, we should follow the example of Great Britain whose drug safety agency recently banned the use of many of Breggin Antidepressant Column, p. 4 these drugs in children. Beyond that, the FDA and the medical profession must forthrightly educate potential patients and the public about the sometimes life-threatening risks associated with the use of antidepressant medications.

Copyright 2004 by Peter R. Breggin, M.D. This column may be reproduced
without permission provided proper attribution is given to the author.