Monday, 16 November 2015

'Medication Mechanization: Microchip Sensors in Abilify to Increase Medication Compliance' #MichaelCornwall @Mad_In_America

Helping people in extreme states video
'Medication Mechanization: Microchip Sensors in Abilify to Increase Medication Compliance'
by Michael Cornwall on Mad in America

[Michael appeared on the Peter Breggin show today, November 11, 2015 to talk about digital monitoring of medication]

"I felt a chill go through my body when I read that the FDA has agreed to review for possible approval in early 2016 a new form of the drug Abilify that contains a microchip sensor capable of sending a message that indicates the exact time a tablet dissolves in the stomach. The message is recorded by a skin patch - along with data such as the person’s body angle and activity patterns - and, according to a press release from Proteus Digital Health, the developer of the device, “this information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and only with their consent, to their physician and/or their caregivers.”

The Japanese drug giant Otsuka teamed up with Proteus Digital Health in 2012 to create this potentially profitable new "chip in a pill” just as its patent on Abilify - at $6.9 billion the #1 most profitable drug in the U.S. in 2013 - was set to expire in 2014, leaving one of Otsuka’s most valuable markets vulnerable to generics. It is especially ominous to me that our government is teetering toward passing the Murphy Bill, which would make forced in-home treatment the law of the land, at the same time it is lurching toward putting such an Orwellian device in the hands of a pharmaceutical company, courts, and families.

According to the Washington Examiner:

”The new smart drug could be particularly useful for ensuring the mentally ill continue taking their medications, not just by giving doctors a way to monitor their behavior, but courts as well...all but five states have court-ordered programs where a judge can mandate that offenders with severe mental illness stick with a treatment program as a condition of remaining in the community."
As one Facebook commenter noted; putting a pill in your mouth and swallowing it, knowing it's going to transmit a message to prove one is submissive and compliant, is beyond Orwellian - it feels fascistic. I agree. The social contract draws an invisible line that must be guarded against forces in a society that, driven by fears, fantasies of benevolence, or by simple greed, and are blind and deaf to the cries of its citizens as their bodily and personal integrity are ground into powder along with the preparations they are compelled to take in the specious name of “health” and “safety.”

Sometimes, radicalizing people politically takes a really callous, stupid, and dangerous threat to people's liberty. This is one of those times.

The Washington Post article cites recent research that shows 74% of people who are started on antipsychotic medications stop taking them within 18 months. That's the justification offered for a psych drug that monitors its own use.
"These individuals already have a history of problems due to their unwillingness or inability to voluntarily comply with treatment … this could be an important advance for them that would help them maintain treatment compliance."
— D.J. Jaffe of the Mental Illness Policy Org.
Think about it: faced with the overwhelming 74% failure of a pharmaceutical intervention, why is the core issue deemed to be compliance rather than efficacy, and consumers' safety & satisfaction? And why are we "gearing up" to ensure compliance in particular for a drug that even the FDA admits has an unknown mechanism of action?

What other medical specialty would blame its patients for so overwhelmingly choosing not to take the medications that have been prescribed to them? For a field that has taken on the charge of controlling and regulating social deviance, the ethical boundaries that the FDA should be protecting are blurred by the growing perception that people who are DSM-diagnosed are potential risks to society, despite overwhelming risk to the contrary; that a DSM diagnoses should be a signal that a person needs and deserves our protection.

Only a worldview that embraces the disease and deviance model of human emotional suffering would dare to suggest putting a sensor in a psychoactive substance to monitor and enforce its ingestion by an otherwise free citizen.

I believe that at some very basic level empathy seems to have failed in a society that sees the need to develop a sensor-equipped psychoactive substance. The blasé emphasis on prioritizing prescription compliance, without considering the profound subjective experience - to anyone, let alone a person in crisis - of having a digitalized foreign object inserted deep inside, an object that is in turn sending messages to an invisible outside presence. This oversight amounts to a vertiginous stumble forward in our society’s failure to muster empathy and compassion for its members, instead delivering them, in the form of a now-literally captive market, to the drug makers.

I've been seeing clients in therapy for over 35 years, and at no point can I imagine sitting a few feet away from a person in distress and suggest to them that they should consider having a device inside them that would let me know every day at a distance their most intimate experiences - let alone when they digest something, lie down, or when they have taken their meds. I couldn't do it. It would feel ghoulish and perverse.

And I don’t want to be a part of a society that would do. Even - and perhaps especially - if it were being done “in my name.”

There is an aura of something shameful, a violation of a basic human right to privacy and bodily boundaries that is being ignored in the pursuit of this new digital monitoring of psychiatric medication. The shame is that, with a pill that records the moment of its absorption into our bodies, we are seeing the realization of a long-sought ideal of totalitarian governments; to cross the blood-brain barrier, gaining access to the very seat of our autonomy, and of our souls. With this, Otsuka could fairly revamp its marketing for Abilify by renaming it “Dis-Abilify,” without so much as risking - and potentially augmenting, in a society that seems to be exuberantly embracing an Orwellian ideal - its market share.

This is a time, if there ever was one, for citizens to act, and to act decisively; before the ability to make decisions, let alone act on them, is excised from our bodies completely by the next wave of pharma development.

Of course some will object to my characterization of those who developed this seeming well-meaning medical breakthrough as lacking a moral compass. But I have already heard the cries of outrage and fear from many of those for whom this Orwellian medicine is intended.

I'll end here with an ever-more apt quote from C.S. Lewis -
"Of all tyrannies, a tyranny sincerely exercised for the good of its victims, may be the most oppressive."


Wednesday, 7 October 2015

Lurasidone – financial conflicts of interest [reblog]

'Lurasidone – financial conflicts of interest' by Dr Peter J Gordon on Hole Ousia blog:

"The launch in the UK of Lurisidone began in August 2014.

My previous post on Lurasidone (Latuda) which is now been marketed in the UK followed the financial interests of one of the authors of the “Special article” in the British Journal of Psychiatry.

Leslie Citrome

It has now crossed my mind, and here I must be very clear that I am speculating, that the British Journal of Psychiatry may have been paid to publish this “Special article”?

I have now looked at the details provided on Lutada to medical professionals by the makers SUNOVION 

It is welcome that this new medication has fewer metabolic effects than currently available antipsychotics. It is worth reflecting that, when the “atypical” antipsychotics were first marketed, they were promoted as having fewer Extra-Pyramidal Side Effects (EPSEs) than existing antipsychotics. It later emerged that the atypical antipsychotics had considerable metabolic side-effects.

This is how Latuda is introduced:

lurasidone uk 3

Here are the “References” provided by its makers Sunovion. There are several key authors of studies cited along with “Latuda Summary of Product Characteristics”. I have previously covered Leslie Citrome. Another study author is well known as a Key Opinion Leader, Professor Stephen Stahl.

lurasidone references

I recently posted about Professor Stahl after he gave keynote addresses to this summer’s British Association of Psychopharmacology Conference.

Professor Stahl’s payments dwarf the $181000 dollars given to Dr Leslie Citrome by the makers of Lutada. Professor Stahl’s OVERALL payments by 15 Pharmaceutical companies amounts to $3.58 million.

Stephen Stahl
Evidence based medicine should include all evidence. This should include all financial conflicts of interest in those developing, researching and promoting new medications.

I do hope UK Psychiatrists are aware of all the evidence.


Sunday, 4 October 2015

Lurasidone – “Special Article” [reblog]

Lurasidone – “Special Article” on Hole Ousia website:

"I noticed this “Special Article” published in the October edition of the British Journal of Psychiatry. It details a novel antipsychotic medication called Lurasidone  (trade name Latuda):

Lurasidone, Oct 2015

I would anticipate that this is the start of a programme to educate psychiatrists in the UK on this new drug.

I note from the ProPublica Searchable database that one of the authors of this “Special Article” has received payments from the drug’s manufacturers as below:

Leslie Citrome


Thursday, 3 September 2015

Antipsychotic Maintenance Treatment: Time to Rethink? @JoannaMoncrieff #PLOS [reblog]

Citation: Moncrieff J (2015) Antipsychotic Maintenance Treatment: Time to Rethink? PLoS Med 12(8): e1001861. doi:10.1371/journal.pmed.1001861



"Summary Points
  • Existing studies of long-term antipsychotic treatment for people with schizophrenia and related conditions are too short and have ignored the impact of discontinuation-related adverse effects.
  • Recent evidence confirms that antipsychotics have a range of serious adverse effects, including reduction of brain volume.
  • The first really long-term follow-up of a randomised trial found that patients with first-episode psychosis who had been allocated to a gradual antipsychotic reduction and discontinuation programme had better functioning at seven-year follow-up than those allocated to maintenance treatment, with no increase in relapse.
  • Further studies with long-term follow-up and a range of outcomes should be conducted on alternatives to antipsychotic maintenance treatment for people with recurrent psychotic conditions.
Schizophrenia and psychotic disorders are estimated to affect 1% of the population and are one of the highest causes of global disability [1]. They place a considerable burden on individuals, families, and society, with costs amounting to US$62.7 billion in the United States in 2002, for example [2]. The highest costs are related to unemployment, and one long-term follow-up study found that more than 80% of people diagnosed with schizophrenia have some ongoing social disability [3].

Long-term antipsychotic treatment has been the norm for people diagnosed with schizophrenia and other recurrent psychotic disorders since the introduction of these drugs in the 1960s [4]. Recent data from the United Kingdom indicate that 97.5% of mental health service patients diagnosed with schizophrenia are prescribed at least one antipsychotic [5]. The practice is based on research believed to have established that continuous antipsychotic treatment reduces the risk of relapse. Interpreting the evidence is not straightforward, though, and other data are beginning to emerge that suggest that long-term treatment may have an adverse impact on levels of social functioning [6,7]. Is it time, therefore, to review the practice of antipsychotic maintenance treatment and question whether it should continue to be the default treatment strategy in people diagnosed with schizophrenia or similar psychotic disorders? ...." read complete essay

-----------------------------

blog post: 'More Harm Than Good: Confronting the Psychiatric Medication Epidemic' Conference 18 September 2015 London


Conference Programme 18 September 2015 London


Saturday, 22 August 2015

A Guide to Minimal Use of Neuroleptics: Why and How: Volkmar Aderhold, Peter Stastny @Mad_In_America

'A Guide to Minimal Use of Neuroleptics: Why and How' by Volkmar Aderhold MD & Peter Stastny MD, June 2015, on Mad in America:

"This new MIA publication, by German psychiatrist Volkmar Aderhold and American psychiatrist Peter Stastny, provides a thorough, evidence-based rationale for rethinking the prescribing of antipsychotics. The PDF may be downloaded for free."

[Authors’ affiliation: Volkmar Aderhold, Institute for Social Psychiatry at the University of
Greifswald, Germany. Peter Stastny: Department of Epidemiology, Columbia University, New
York]

"Preamble

In preparing this review, we are hoping that it will encourage people to become actively engaged with the use of neuroleptics in the treatment of individuals experiencing psychotic symptoms. Overall, it represents a critical discourse concerning the use of these medications and their indications, as well as any problems associated with them.  These perspectives are embedded in a scientific context to emphasize that this is not an ideological discussion, but rather an attempt to promote scientifically founded decisions on the behalf of clients. Consequently, a key portion of this contribution addresses the issue of “What to do?” Responding to patients’ needs means finding ways of utilizing these medications that offer the greatest benefits, with the fewest possible unwanted effects, for individuals experiencing psychoses. In addition, it deals with the ways in which neuroleptics can be most effectively and reasonably combined with other interventions. The aim of treatment is always to keep patients’ well being in mind.
 

Since we hope that the readership of this review will include lay readers as well as those considered “experts” or “methodologists,” we have chosen to define many technical terms in the text. We have provided references for the scientific material that is being citied, with a full listing of references at the end of the text. ..."

page 102
 Read full 135 page publication



Wednesday, 19 August 2015

'A Milestone in the Battle for Truth in Drug Safety' @DrDavidHealy Study 329

A Milestone in the Battle for Truth in Drug Safety: Dr David Healy, 17 August 2015:

Study 329: The final chapter coming soon
 
"Arguably the most controversial drug study ever, Study 329, published in July 2001:
  1. Concluded that paroxetine was a safe and effective medication for treating major depression in adolescents;
  2. Is still widely cited in the medical literature, providing physicians with assurance about the usefulness of paroxetine;
  3. Was criticized by a few alert and concerned journalists and academics. Their voices were buried by a tsunami of positive marketing and promotion by vested interests;
  4. Resulted in a successful New York state fraud lawsuit against GSK;
  5. Resulted in 2012 in the biggest fine in corporate history – $3 Billion; and
  6. Remains unretracted.

Paroxetine Names Around the World

In June, 2013 Peter Doshi and colleagues published “Restoring invisible and abandoned trials: a call for people to publish the findings” in the British Journal of Medicine (BMJ).

They referred to this proposed protocol as RIAT, and described its purpose as follows:

Unpublished and misreported studies make it difficult to determine the true value of a treatment. Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond.

A team of researchers undertook to re-analyze the original data and publish a new analysis under the RIAT protocol.

In August, 2015, after a year and seven drafts, BMJ notified the team that their submission would be published in September, 2015. This will be the first ever trial with two completely different takes on the same data.

This new study, Restoring Study 329: Efficacy and harms of paroxetine and imipramine in the treatment of adolescent major depression: restoration of a randomised controlled trialshould shock all who care about integrity in drug safety. Find out the inside story when a new site, Restoring Study 329, goes live."

Thursday, 30 July 2015

modern wisdom and spin: antipsychotic drugs


after a medical education event 2007

'Medical schools should prohibit financial ties between individual academics and industry' BMJ

Analysis: Web of industry, advocacy, and academia in the management of osteoporosis

'Medical schools should prohibit financial ties between individual academics and industry'
26 July 2015, BMJ 2015;351:h3170

Paolo Vercellini
Associate Professor of Obstetrics and Gynaecology
Department of Clinical Sciences and Community Health, Università degli Studi di Milano, and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy

The web of financial interests involving industry, advocacy and academia in the management of osteoporosis described by Grey and Bolland,1 is paradigmatic of a situation characterising many medical specialties.2 However, the ethical implications regarding each component of this web seem different. Industry is a private enterprise, its goal is profit, and its managers are accountable to shareholders. Advocacy organisations are morally accountable to patients, but are supported mainly with private funds.3 Conversely, most European academics are public employees paid with citizens' taxes and are accountable to society at large. Academics appears to have here by far the highest ethical liability, as without their compliance neither industry nor advocacy organisations could alone catch medicine so effectively in this web of interests.

Academics influence prescription practices and, hence, impact on citizens' health and healthcare resources. Therefore, citizens not only should have the right to know which academics are paid by whom and how much, but should also be allowed to decide whether these financial ties are permissible. Collaboration between industry and academics is necessary, but should not imply payments to individual investigators. Money deriving from industry-supported research could be centralised in anonymous institutional funds. Academics have the moral duty of educating young generations according to the highest ethical standards. The possibility that teachers do not enable their medical students to objectively appraise the evidence must be prevented, also because students are intellectually vulnerable. Thus, universities should prohibit the establishment of financial ties between academics and private enterprises, including medical communication companies.4

In his last published words, Arnold Relman warned: "now, more than ever, it is important that leaders in academic medical centers set an example for students and faculty by concentrating on advancing the non-for-profit social purposes of these institutions. They cannot do this if they also have ties to pharmaceutical businesses".

1.            Grey A, Bolland M. Web of industry, advocacy, and academia in the management of osteoporosis. BMJ 205;351:h3170.
2.            Kassirer JP. Professional societies and industry support: what is the quid pro quo? Perspect Biol Med 2007;50:7-17.
3.            Lenzer J. Many US medical associations and disease awareness groups depend heavily on funding by drug manufacturers. BMJ 2011;342:d2929.
4.            Schwartz LM, Woloshin S. Medical communication companies and continuing medical education: clouding the sunshine? JAMA 2013;310:2507-2508.
5.            Relman AS. Potential conflicts of interest for academic medical center leaders. JAMA 2014;312:558.



Tuesday, 21 July 2015

'Restoring Health: The Crusoe Report 1' @DrDavidHealy "We need to build a Slow Medicine movement"

'Restoring Health: The Crusoe Report 1' by Dr David Healy, 20 July 2015:

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

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

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

A patch of ground

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

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

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

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

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

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

I am pregnant and 36. A national committee of experts in the Netherlands where I live, has looked at the statistics and suggested that pregnant women over 35 should have an amniocentesis in case of Down’s Syndrome…  I follow the advice. I take a day off and go to the hospital… I lie down on the examination table and feel the ultrasound probe moving over my belly. Still in my field work habits, or just to break the silence, I say to the nurse who is preparing the long needle that will be inserted into my womb: ‘I hope it all goes okay.’ We both know that a small percentage of women have a spontaneous abortion as a result of the procedure. The nurse snaps back: ‘Well, it is your own choice.’
This is no longer a system in which people are working together to produce health. This is an industry with products available for consumption or not. It has extraordinarily sophisticated ways to persuade your doctor to consume its products by putting them in your mouth. Often close to forcing you to take them, most of which you don’t need. 

Infertile

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

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

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

Recipe

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

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

Slow medicine

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

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


How did we get to this point?

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

To be continued."


website link

Saturday, 18 July 2015

Rapid withdrawal & misprescribing of benzo leads to £1.35m settlement for Luke Montagu @CEP_UK co-founder

'Rapid withdrawal and misprescribing of a benzodiazepine leads to £1.35m settlement for Luke Montagu, CEP co-founder' on CEP (council for evidence-based psychiatry) UK

"The UK Times Magazine today publishes a long article describing CEP founder Luke Montagu’s terrible experience with antidepressants and sleeping pills."


Times Magazine 18 July 2015
intro from Times Magazine
























Excerpts:

"When he was first prescribed these drugs at 19, Montagu was not depressed and had never been diagnosed with depression. He was a student at New York University, and had recently undergone a general anaesthetic for a sinus operation that left him with headaches and feeling, as he puts it, “not myself”. Without carrying out any tests, a British GP announced that he had a “chemical imbalance of the limbic system” and prescribed Prozac. Montagu, “impressionable and in awe of doctors”, swallowed them unquestioningly. ..."

"At the end of 2008, however, Montagu, by then 38, resolved that enough was enough. He was on a new antidepressant, Effexor, that made him feel wired. To counteract this, he’d been prescribed sleeping pills, clonazepam, but they made him forgetful. He decided to start the new year clean. ..."

"On Collins’s advice, Montagu checked himself in to the Priory, where his clonazepam was taken away (he stayed on Effexor). “I thought I wouldn’t sleep for two or three nights, then I’d be so tired I’d crash out. Instead, it felt like my brain was torn into pieces. ...”

"Montagu eventually sued Dr Collins for the rapid withdrawal and long-term misprescribing of clonazepam, which led to a £1.35m out of court settlement."

The full article can be viewed at: http://cepuk.org/wp-content/uploads/2015/07/Times-Magazine-18-July-2015-pdf.pdf


'"Of course the money helped (£1.35million) - but it only covered loss of earnings .." says Viscount Hitchingbrooke"



Friday, 17 July 2015

'A dose of humility': @fgodlee BMJ Editor; "compassion and empathy an essential part of the therapeutic package"

A dose of humility: Fiona Godlee, editor, The BMJ, 16 July 2015;  fgodlee@bmj.com

BMJ 2015;351:h3857
 
"Paracetamol has come in for a bit of a kicking in recent months (doi:10.1136/bmj.h1186). So we asked James Dear and colleagues to comment (doi:10.1136/bmj.h3705). They confirm that important questions about this most commonly used drug remain unanswered. The evidence of effectiveness is patchy and depends on the condition: it’s good for postoperative dental pain; okay for headache, though not as good as other analgesics; of small and probably clinically irrelevant benefit for hip and knee pain; no better than placebo for back pain; and without enough evidence of benefit for the common cold. As for its safety, nearly 60 years of widespread use are reassuring. But there are simmering concerns about subclinical liver and cardiovascular effects and questions about whether or not to intervene in cases of small therapeutic overdose.

So, no clean bill of health for paracetamol, but it’s effective for some conditions, and like all drugs it should be used with care. What then of two other commonly prescribed types of drugs: antidepressants and non-steroidal anti-inflammatory drugs? Both types are associated with gastrointestinal bleeding but not, when used alone, with intracranial haemorrhage. However, Ju-Young Shin and colleagues have found that, when these two classes of drugs are used together, as they often are, there is an increased risk of intracranial haemorrhage (doi:10.1136/bmj.h3517). They base their conclusions on a retrospective population cohort study of more than four million people in Korea.

In a linked editorial Stewart Mercer and colleagues call the increased risk substantial: the absolute risk in the first 30 days of combined treatment is around 0.05% when compared with antidepressants alone (doi:10.1136/bmj.h3745). They also say that the risk in people treated for longer periods may be considerably higher. This clearly presents challenges for clinical practice. Pain and depression often go hand in hand, and guidelines are not good at dealing with multimorbidity and polypharmacy. Under these circumstances, they say, knowing patients and their wishes well and "taking an empathic, person centred approach may be as important as having better guidelines and a better evidence base."

Does homeopathy offer a harm free alternative for these common ailments? Yes, says Peter Fisher in a Head to Head article (doi:10.1136/bmj.h3735). Several large observational studies have concluded that doctors who use homeopathy in their practice have better patient outcomes at equivalent cost and use fewer antimicrobial drugs. Doctors should recommend it as part of integrated care, he says. His opponent, Edzard Ernst, is not impressed. He uses 134 of his 909 words on zeros, to press the point that one of the most commercially successful homeopathic remedies cannot contain a single active molecule. Agreeing with the findings of a recent "comprehensive, independent, and rigorous" evaluation, he finds no good evidence that homeopathy works other than through non-specific and placebo effects. Claims that homeopathic remedies are at worst harmless leave him equally cold. "Even a placebo can cause harm, if it replaces an effective therapy," he says.

I too am unconvinced by homeopathy. But the other stories in this week’s journal suggest the need for a good dose of humility about some conventional medicines too. And no harm will be done - indeed there is good evidence of benefit, says Ernst—if we make compassion and empathy an essential part of the therapeutic package."


Sunday, 5 July 2015

the luck's penny

Critical psychiatry post: 'Biopsychosocial formulation' by Dr Duncan Double, 4 July 2015

and my response:

"We propose a new model for formulation rooted in the idea that everything is biological, designed to guide the formation of hypotheses about cause."

Although the Lancet article is useful I don't think it goes far enough in terms of understanding the reasons for, or causes of, schizophrenia. Not everything is biological, from my perspective of 62 years in living on this earth in my body. Not everything can be explained by science or by the sum total of our body parts. That "otherness" of human beings whether we call it spiritual or existential has played a large part in my living. It's what has kept me alive and enjoying life, bouncing back from adversity and psychiatric drug treatment.

The problem with the biopsychosocial model is that the bio bit dominates the discourse. As far as I can see, from what I've read and been subject to. Plus the money for research is coming mostly from pharmaceutical companies. For example, I recently attended a seminar on the results from a schizophrenia survey in Scotland. At which Prof Lawrie, Scottish Mental Health Research Network, mentioned in his bio that he had got £1million from Pfizer to do genetic imaging studies and around £50K from Roche to study a new drug for schizophrenia. I saw no mention of monies to fund research of talking therapies or spiritual happenings.

He who pays the piper calls the tune. So how on earth are we going to divert the drug money into more therapeutic channels? It costs one million to develop a drug to the point of it being prescribed, so I hear from the Scottish Medicines Consortium. Drug companies will want to both recoup the development costs and make a profit. It's all about big business. The hard sell. And many psychiatrists are linked with the drug companies as consultants and KOLs. I might compare it to the cattle market (I used to sell hogs with lambs at foot, Lanark Market) where farmers selling beasts gave a "luck's penny" to those who bought their beast and in so doing bumped up the price" 


early 1970's on in-laws' farm, Lanarkshire

---------------------

17 June 2015: Dr Peter J Gordon: Public consultation on a Sunshine Act for Scotland [reblog]

23 April 2015: my #BMJ Response: 'Sunshine Act for Scotland: transparency, independence and accountability'



Scottish Parliament website


















Saturday, 4 July 2015

"I thought Prof David Taylor was in the pay of big pharma .." my comment on Critical Psychiatry post

Critical psychiatry: Do psychiatric medications correct a chemical abnormality in the brain? by Dr Duncan Double, 3 July 2015:

"I don't think David Taylor, Director of Pharmacy and Pathology, South London
Prof David Taylor
and Maudsley NHS Foundation Trust & Professor of Psychopharmacology, King's College, London can be a prescriber. This may be why, in his BJPsych Advances article, he suggests that psychiatrists don't infer that people with a diagnosis of schizophrenia need antipsychotics to block a surfeit of dopamine. If so, why is this what some psychiatrists tell patients? Medical students may even be taught to explain to patients that this is the reason they need antipsychotics. Perhaps Taylor needs to be more explicit that psychiatrists are wrong to tell people that medications correct a chemical imbalance and, if he does some medical student examining, mark students wrong when they suggest this.

I do agree with him that, "Rarely is there any certainty about [psychiatric] diagnosis". I think psychiatrists will still regard quetiapine as something to do with dopamine by calling it a dopamine multifunctional receptor antagonist (DAmF-RAn). They will just believe that they can use it for more conditions besides schizophrenia. I accept that the rationale for psychiatric prescribing is often not properly thought through (eg. see previous post).


Framing the model of drug action as drug-centre rather than disease-centred is primarily a critique of the biomedical model (eg. see my book review). It emphasises the non-specific effects of medication. I suspect that Taylor still thinks psychiatric medications correct a chemical abnormality in the brain. In that sense, he is not drug-centred, even disease-centred. What he means is that he doesn't accept simplistic hypotheses of biochemical imbalance. All well and good, but the critique of the biomedical model is more fundamental. There may be no difference between the chemical processes underlying mental illness and our "normal" behaviour." 


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And my comment:

"I thought Prof David Taylor was in the pay of big pharma, as in he receives payments as a consultant or key opinion leader by pharmaceutical companies. Please do correct me if I'm wrong? He may have seen the error of his ways, and the conflicts of interest, and cut the ties, making do on just his academic monies and generous pay from SLaM.

Mr Taylor's links with drug companies means, to my way of thinking, that he is compromised in what he says regarding the prescribing of psychotropic drugs. Despite his many titles before and after his name. Let him keep taking the handouts for he may have a habit to feed. As in, to bolster up his self esteem because he isn't able or qualified to write prescriptions.

Who knows the reason why some men, who appear to have a modicum of intelligence, have hidden their consciences behind the KOL name and kept on scapegoating the people for whom the drugs don't work, to silence the pain of life. I think that Taylor knows fine well that the biomedical model of mental illness is unproven (or pants). But the cash helps him in blinding the obvious"



Wednesday, 1 July 2015

Dr Joanna Moncrieff: 'Reasons Not to Believe in Lithium' on Mad in America, 30 June 2015

'Reasons Not to Believe in Lithium' by Dr Joanna Moncrieff on Mad in America, 30 June 2015:

"‘I Don’t Believe in God, But I Believe in Lithium’ is the title of Jamie Lowe’s moving account of her manic depression (now usually referred to as bipolar disorder) in the New York Times. The piece reminds us how devastating and frightening this condition can be, so it is understandable that the author put her faith in the miracle cure psychiatrists have been recommending since the 1950s: lithium.

Lowe took lithium from the age of 17 for 20 years, until at the age of 37 or thereabouts she was diagnosed with kidney failure, a direct result of this treatment. She will need dialysis, and a kidney transplant - a high price to pay for a really effective treatment. The sad thing is, we have little evidence that lithium is a really effective treatment, or even that it is effective at all.

Lithium is a neurotoxin. It inhibits the functioning of the nervous system so that people typically feel drowsy, lethargic and slowed up. These effects were observed in guinea pigs initially, and then in people with mania by the Australian doctor, John Cade, who first proposed that lithium might be a useful treatment for manic depression.1 In the 19th century lithium had been used for the treatment of gout, and became a popular ingredient of tonics and even beer, until it was shown that it did not dissolve the uric acid crystals that cause gout as had been claimed.2

The sedative and slowing effects of lithium, although usually described as side effects, account for why lithium can help reduce arousal and activity levels in people with acute manic symptoms. So there is nothing magic or specific about lithium’s action in manic depression. Lithium will exert its characteristic effects in anyone, whether or not they have mania or manic depression.  In theory, these effects might suppress the emergence of a manic episode, as well as reduce the severity of symptoms once an episode has started. The evidence that long-term lithium treatment reduces the occurrence of manic or depressive episodes is actually very weak, however.

The main problem with the evidence is that there is no study in which people who have been started on lithium have been compared with people who haven’t. Every randomised trial of lithium versus placebo starts with people who are already on drug treatment of one sort or another, often lithium itself. Now, there is good evidence — accepted by leading proponents of lithium3,4 — that withdrawing from lithium can precipitate a relapse of manic depression, especially a manic episode. Three studies have shown, for example, that people are more likely to have a relapse after stopping lithium than they were before they started it.5-7 No one knows the mechanism for this, but it is as if removing the neurological suppression produced by lithium causes the nervous system of a susceptible person to go into over-drive, precipitating a manic relapse.

So demonstrating that people who stop lithium and start a placebo have higher rates of relapse than people who continue on lithium does not demonstrate that going onto lithium in the first place prevents episodes.  But all the placebo-controlled trials of lithium are like this to at least some degree. The trial that established the idea of long-term lithium treatment, for example,  started with people who had already been on lithium for many years.8 In more recent studies, not all participants have been on lithium prior to enrolment, but those not taking lithium were likely to be taking other sorts of sedative medication. The first of these recent studies, the largest study up until that point involving 372 participants, found no difference between lithium, sodium valproate and placebo in terms of the rate of recurrence of any type of mood episode.9

The second found a higher rate of manic relapse in placebo-treated patients compared with those on lithium, but the pattern with which relapses occurred was strongly suggestive of a discontinuation effect. A large majority of relapses occurred in the first few weeks after allocation to placebo, and none occurred in the last few months of the study, suggesting that the point of discontinuation of previous medication was associated with subsequent relapses.10 In the final trial, rates of mania were higher in people on placebo by about 14% (14% vs 28%), but 20% of participants were taking lithium before randomisation, and still others were taking Depakote or antipsychotics, all of which were stopped relatively abruptly prior to the trial.11

The possibility that relapses in the placebo groups in these trials are induced by withdrawal of previous medication would make sense of the fact that it has proved impossible to demonstrate that people receiving modern drug treatment for manic depression do any better than those who don’t, or didn’t. In fact, overall, they seem to do slightly worse.

Two important studies have examined rates of relapse in people with classical manic depressive symptoms prior to the 1950s. American psychiatrist George Winokur found the records of 100 patients admitted to a psychiatric hospital between 1934 and 1944 with an episode of mania and then followed them up through their hospital records. He found that 48% had a relapse requiring hospitalisation over an average follow-up duration of 3.2 years. For comparison purposes this equates to a relapse rate of 15% per year.12 Margaret Harris, David Healy and colleagues did the same for patients admitted to the North Wales asylum in the 1890s. They found that on average patients had 4 relapses over the subsequent 10 years, equating to a relapse rate of 20% a year.  In comparison, during the 1990s, people with manic depression (most of whom we can assume were on drug treatment) were having an average of 6.3 admissions in 10 years, or 31% per year, for example.13 That’s over 10% higher than the rate of admission for people in the 1890s!

Relapse rates among patients taking lithium in randomised trials that have started with patients experiencing a manic episode (as the historical studies did) are uniformly higher too. In the comparison between lithium, Divalproex (Depakote) and placebo, for example, the lithium group relapsed at a rate of 31% a year (9). In the comparison between lithium, lamotrigine and placebo in people with mania it was 26% a year (10). Admittedly these figure include all relapses, and not just those severe enough to require hospitalisation. A large study conducted in the 1970s, however, found that rates of hospital admission for relapse were 21.5% per year in the lithium group.14

Several ‘naturalistic’ studies have tracked the progress of people taking lithium and other treatments. The vast majority of these studies also show high relapse rates among those on lithium, even though most studies highly compliant populations and we know that people who are compliant with any treatment (including placebo) have better outcomes than those who are not. One study of patients who were known to be compliant with their lithium treatment for at least a year, for example, found a rate of relapse of 40% a year over a 6 year follow-up.15

In my view the evidence that lithium helps prevent episodes of manic depression is far too weak to outweigh the harms it can cause (which commonly include thyroid damage, kidney damage, and acute neurological toxicity at doses very close to those used in practice, hence the need for blood monitoring). Manic depression is a highly variable condition. Some people have many episodes, some people few, and the pattern of episodes varies throughout life as well. Long periods of remaining well are not necessarily evidence of a treatment’s effectiveness.  What we would need to demonstrate the efficacy and value of lithium is a prospective randomised trial in which people who had not previously been on long-term drug treatment were randomly allocated to start lithium or placebo. At present, my view is that the evidence that lithium might be effective is not strong enough to justify such a trial, given the health risks associated with it.

As Jamie Lowe eloquently expresses, manic depression can be a terrifying condition, and I know that people will say therefore ‘if not lithium, then what?’ But the evidence that any long-term drug treatment is better than nothing is not strong.1 Many doctors and patients are very uncomfortable with that conclusion, and feel there just has to be something. And if people want to try some sort of drug treatment, like antipsychotics or anticonvulsants, then I feel that doctors should help them take it as safely as possible, at as low a dose as possible. But doctors should be honest about the state of the evidence and for lithium, I am not convinced there are any circumstances that justify the risks it entails.

In 1957 a pharmacologist bemoaned the fashion for treatment ‘by lithium poisoning’.16 One day, I believe, we will wake up and realise his concern was spot on!"

References:

(1)    Moncrieff J. The Myth of the Chemical Cure: a critique of psychiatric drug treatment. Basingstoke, Hampshire, UK: Palgrave Macmillan; 2008.
(2)    Johnson FN. The History of Lithium Therapy. London: Macmillan; 1984.
(3)    Franks MA, Macritchie KAN, Young AH. The consequences of suddenly stopping psychotropic medication in bipolar disorder. Bipolar Disorders 2005;4(1):11-7.
(4)    Goodwin GM. Recurrence of mania after lithium withdrawal. Implications for the use of lithium in the treatment of bipolar affective disorder. Br J Psychiatry 1994 Feb;164(2):149-52.
(5)    Baldessarini RJ, Tondo L, Viguera AC. Discontinuing lithium maintenance treatment in bipolar disorders: risks and implications. Bipolar Disord 1999 Sep;1(1):17-24.
(6)    Suppes T, Baldessarini RJ, Faedda GL, Tohen M. Risk of recurrence following discontinuation of lithium treatment in bipolar disorder. Arch Gen Psychiatry 1991 Dec;48(12):1082-8.
(7)    Cundall RL, Brooks PW, Murray LG. A controlled evaluation of lithium prophylaxis in affective disorders. Psychol Med 1972 Aug;2(3):308-11.
(8)    Baastrup PC, Poulsen JC, Schou M, Thomsen K, Amdisen A. Prophylactic lithium: double blind discontinuation in manic-depressive and recurrent-depressive disorders. Lancet 1970 Aug 15;2(7668):326-30.
(9)    Bowden CL, Calabrese JR, McElroy SL, Gyulai L, Wassef A, Petty F, et al. A randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Divalproex Maintenance Study Group. Arch Gen Psychiatry 2000 May;57(5):481-9.
(10)    Bowden CL, Calabrese JR, Sachs G, Yatham LN, Asghar SA, Hompland M, et al. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently manic or hypomanic patients with bipolar I disorder. Arch Gen Psychiatry 2003 Apr;60(4):392-400.
(11)    Calabrese JR, Bowden CL, Sachs G, Yatham LN, Behnke K, Mehtonen OP, et al. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder. J Clin Psychiatry 2003 Sep;64(9):1013-24.
(12)    Winokur G. The Iowa 500: heterogeneity and course in manic-depressive illness (bipolar). Compr Psychiatry 1975 Mar;16(2):125-31.
(13)    Harris M, Chandran S, Chakraborty N, Healy D. The impact of mood stabilizers on bipolar disorder: the 1890s and 1990s compared. Hist Psychiatry 2005 Dec;16(pt 4 (no 64)):423-34.
(14)    Prien RF, Caffey EM, Jr., Klett CJ. Prophylactic efficacy of lithium carbonate in manic-depressive illness. Report of the Veterans Administration and National Institute of Mental Health collaborative study group. Arch Gen Psychiatry 1973 Mar;28(3):337-41.
(15)    Tondo L, Baldessarini RJ, Floris G. Long-term clinical effectiveness of lithium maintenance treatment in types I and II bipolar disorders. Br J Psychiatry Suppl 2001 Jun;41:s184-s190.
(16)    Wikler A. The Relation of Psychiatry to Pharmacology. Baltimore: Williams & Wilkins Co; 1957.

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my post on Mad in America 19 July 2014: Psychiatric Interference:

Intro:
"In this post I want to make the case as to why I am "critical" and not "anti" psychiatry although at times I can feel very "anti", because of being a survivor of psychiatric treatment and mental illness labels three times over and because all of my family through 3 generations have been targeted by psychiatry. The biomedical model of mental illness has dogged our footsteps with "family history of" in psychiatric notes and disorder labels from hebephrenic schizophrenia to schizoaffective to bipolar.  A progression  depending on our "performance" or as I like to see it the "whim" of a psychiatrist.  For I've never believed any of it and left the labels behind when tapering the drugs and getting off them and getting back on with my life in the real world. ..."