This is how mental health professionals argue against informed consent

OF COURSE WE ARE WORTH THE TRUTH

I sometimes participate in conversations on Linked-in. It’s become a source of gratification at least some of the time as I see more and more people waking up to what is happening in the mental health system. That said, I’m also still often horrified at what I meet there out in the mainstream of mental health providers. I hang around, however, because I’ve also found that there are many folks who are really deeply grappling with issues that only a decade ago were simply widely avoided. It’s an exciting time and people are really opening up to the possibility of deeply humane ways of helping folks that at this time get labeled with psychiatric DSM diagnosis. Below I’m posting some slightly edited comments from one of the threads.

This sort of belief is tragically still rampant among mental health workers. It’s like a cancer and it needs to be called out and destroyed.

MHP is “mental health professional.” She is referring to Robert Whitaker’s talk at NAMI in the first comment. She feels that perhaps “patients” and family members should have been protected from the radical truth. OMFG. It’s like we live in the dark ages.

MHP: It can be questioned as to whether this was the best forum for such a speech as family members and patients were present. Would this be better served to have been presented only to professionals to prevent patients from grasping onto this view as a reason to stop their medications?

ME: yeah…lets keep on infantilizing everyone…they can’t handle the truth, right? Can’t make analytical choices or listen to debate? This is exactly what has been wrong with mental health treatment as currently practiced….the truth is routinely withheld and people cannot make informed choices. It’s nothing short of criminal when considered from that stand point. Some of us have been gravely harmed because we were not given choices. That’s why we’re motivated to share the whole truth…then people can decide what risks they want to take or not.

MHP: Monica, some people really can’t handle the truth, make analytical choices or listen to debate precisely because of their mental illness. On the other hand, many can despite any mental illness. That is what makes balance in this field so difficult to achieve.

ME: I was a social worker for many years in social services with the “seriously mentally ill.” The only people I routinely dealt with who couldn’t handle the truth were some of my colleagues and the administrators…that was my experience. And it continues to be my experience now. Mental health professionals are often terrified of the truth to the detriment of those they serve.

The truth is GREY, not black and white, those who understand this are very good at helping others understand it too. Withholding the facts about these treatments is LYING. Truth is nuanced — choosing which bits to share is dangerous and amounts to coercion in psychiatry because real choice cannot be made when only bits are given.

What is most frightening to me is that there are people who imagine they’re in a position to determine when and how what parts of the truth is communicated…and to whom.There are people who imagine they have the ability/right to determine who is fit for the facts and who is not fit for the facts…

This behavior is oppressive, repressive and ultimately brutally coercive. This is why a good number of people who’ve been harmed by psychiatry are so angry. I don’t know why that’s so hard to understand for so many people. It really only takes a modicum of empathy to imagine the indignity of such treatment.

Also in response to the first comment about this information being dangerous because “patients” might just up and stop their meds I wrote:

Robert Whitaker is always very careful to make clear that coming off medications precipitously is dangerous and ill advised. This is made clear in his books and in every talk I’ve heard him give.

Coming off medications must be done very carefully. And those of us who’ve come off them and help others do so are very explicit about how potentially dangerous it is and how careful and well-informed people need to be.

If anyone would like such information see here:

Psychiatric drug withdrawal and protracted withdrawal syndrome round-up

The sad reality is the medical establishment gets people on medications but doesn’t have a clue about how to safely help people off. Please do carefully educate yourselves and don’t expect psychiatrists to know how to do it in the safest ways. They are simply untrained in it and often cause much more severe withdrawal problems…it’s an absolute travesty.

More on INFORMED CONSENT

Links to posts:

The horrifying reality is that too often forced treatment is used: Coercion, subtle or otherwise, is the rule in psychiatric care…

and

See also: The Mental (Illness) system and thoughts on alternatives

In the below audio file from Non Duality Talk Radio I envision what a future with an infrastructure of care that supports meaningful alternatives might look like. Listen here: History in the system and my vision for mental health on Nonduality Talk

***

For a multitude of ideas about how to create a life filled with safer alternatives to psychiatric drugs visit the drop-down menus at the top of this page or scroll down the homepage for more recent postings.

Support Everything Matters: Beyond Meds. Make a donation with PayPal or Enter Amazon via a link from this blog and do the shopping you’d be doing anyway. No need to purchase the book the link takes you to. Thank you!

“The seriously mentally ill die, on average, 25 years earlier than the general population…”

(exploring the source of a statistic)

Are you familiar with this oft-quoted statistic: “people with serious mental illness served by the public mental health system die, on average, 25 years earlier than the general population”?  You see it everywhere – for example in TIME magazine, USA Today, and throughout the mental health blogosphere.

It comes from this 2006 report on mortality and morbidity in the seriously mentally ill population published by the National Association of State Mental Health Program Directors [NASMHPD].  The report also contains several other [less frequently quoted but no less powerful] statistics.  Consider:

  • suicide accounts for 30% of excess mortality [in the population suffering from “serious mental illness”], but 60% of premature deaths are due to other causes such as cardiovascular and pulmonary disease, obesity, and smoking – causes which are in some ways preventable.
  • people diagnosed with schizophrenia are 2.7X more likely to die of diabetes than the general population; 2.3X more likely to die of cardiovascular disease, 3.2X more likely to die of respiratory disease, and 3.4X more likely to die of infectious disease.  All of these causes of death are exacerbated by the following risk factors – obesity, smoking, diabetes, hypertension, and dyslipidemia [high blood cholesterol] – which are, again, significantly more prevalent amongst this population.

These are shocking things for science to say, surely a kind of gauntlet thrown at the feet of this population and those who serve/support/love them.

Methinks a champion is required; and this guy is probably NOT it.

What causes this shocking mortality/morbidity problem, and what can be done?

Are you thinking what I’m thinking?

In light of all that we’ve recently learned about psychotropic medications, antipsychotics in particular (causing brain shrinkage, diabetes, obesity, heart disease, et al): does the NASMHPD report have the guts to honestly own up to the fact that most of the abovementioned risk factors can often be traced back directly to the psychotropic medications so glibly prescribed to this population?  Actually, they do a pretty good job, acknowledging all of the following:

Residence in group care facilities and homeless shelters (exposure to TB [tuberculosis] and other infectious diseases as well as less opportunity to modify individual nutritional practices)… symptoms associated with serious mental illness [such as] feelings of hopelessness and powerlessness, learned helplessness…

Psychotropic medications may mask symptoms of medical illness and contribute to symptoms of medical illness and cause metabolic syndrome… [and] polypharmacy [is] identified as a risk factor for sudden death.

(from the 2006 NASMPHD report on mortality in the mental health population)

 

Seeing such promising signs – a willingness to acknowledge these usually unspoken-of risk/causative factors – I eagerly turned to the “Policy Recommendations” section…

Only to be severely disappointed.  Nothing addresses the risk factors listed above.  NOTHING.

[alright – they did briefly mention a tool used in New York State hospitals to insure folks weren’t prescribed 3 or more antipsychotic medications at the same time but that was just a subordinate clause in a very long sentence buried near the bottom of page 47… and I feel that’s just a tad inadequate, don’t you?]

Here’s what they do instead:

 

Policy Recommendations?  Change the language, of course…

The “Policy Recommendations for Providers and Clinicians” section starts out with some powerful and exciting language: mentally ill people must be assisted in finding “hope for tomorrow” and to “understand the hopeful message of recovery.”  They must be “enabled to engage as equal partners in care and treatment” and “empowered.”

But what is really meant is that the language must be changed so that these things are implied, while treatment remains largely the same.  Here is how NASMHPD recommends achieving a “partnership with the people we serve:”

Agree on a Treatment Plan

“Adherence” is the goal because it implies sticking to a collaboratively developed plan, as opposed to the more directive term “compliance.”  Six specific actions can increase the likelihood of adherence: keep the regimen simple, write out treatment details, give specifics about the expected benefits of treatment and the timetable, prepare the patient for side effects and optional courses of action, discuss obstacles to moving forward with the regimen, and get patient feedback.

(from the 2006 NASMHPD report)

So “partnership” between providers and “consumers” is to be achieved by a mere change of language (from “compliance” to “adherence”), which no longer implies the directive (ie use of force), power flowing from provider to patient.  Never mind that involuntary commitment and treatment of the mentally ill is as frequent a practice as ever, and that a patient’s supposed mental competence/ability to provide informed consent is often judged solely on the basis of the patient’s willingness to “adhere” to whatever lucrative treatment the doctor prescribes (take for example the strange case of Paul Henri Thomas, who was competent as long as he said “yes” to expensive ECT treatments, but was immediately “incompetent” upon refusing treatment).

What’s more, from the NASMHPD’s above use of the terms “regimen” and “side effects,” it’s clear they’re mainly talking abouttreatment centered on medication.

So in an almost incomprehensibly illogical turn of events, the NASMHPD first acknowledges that psychotropics and polypharmacy are causative factors for the increased mortality rate of the seriously mentally ill population, and then strongly emphasizes in the policy recommendations section the importance of compliance with/adherence to medication regimes!

What’s the big deal?

Ok. So the NASMHPD put out a lousy report in 2006 that, while acknowledging the mortality rate for the mentally ill population, failed to make good policy recommendations addressing its own listed causative/risk factors… so what?

What it boils down to is there’s a reason this statistic is quoted so often (a reason apart from its shocking nature).  The NASMHPD report forms the very foundation of some of the most important nationwide “official” mental health initiatives — and what I mean by that are SAMHSA [Substance Abuse and Mental Health Services Administration] and DHHS-funded [Department of Health and Human Services] initiatives.  These initiatives are meant to address the issue of mortality of the seriously mentally ill population; but they’re also taking their cues from the fatally flawed “Policy Recommendations” section… and that’s not a good thing.  In fact, it’s the most self-defeating setup imaginable.

[to make comments, visit the original post here]

You mean the study partcipant’s priorities are important, BY LAW?

The Short Answer: YES.  At the very least, a definite “maybe”…  Let me explain.

The Long Answer:

What I’m referring to is the World Medical Association’s Declaration of Helsinki, a list of ethical guidelines for medical human subjects research, itself not international law, but the international ethical standard.  The declaration has been codified into national law in many countries, including most of the European Union.  In the US, all foreign clinical trials of pharmaceuticals, medical devices, and procedures submitted to the FDA for approval must either abide by FDA standards or the 1989 Declaration of Helsinki (not the most recent draft; more on that here). 

The current Declaration of Helsinki (7th revision, from 2008) has a lot of great stuff in it – guidelines about informed consent, the physician’s duty to safeguard the health of the patient (far more important than the success or failure of a clinical trial), a stipulation that negative results must be reported publicly and registered in open-access databases—but what particularly caught my eye when I first read it last week was this:

Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research.

(Section B.17 of the 2008 Declaration of Helsinki; emphasis added)

What this means is that whatever the priorities of the population being treated are – those are by default the most important research questions.  Scientists/researchers are bound to investigate these stated priorities first.  They are more important than, as a totally random example, the needs or priorities of the pharmaceutical companies… 

Ok, but is the Declaration of Helsinki law in the United States?

As yet to be 100%, set in stone, decided.  However, there are some very interesting case precedents that point in a positive direction…

Kano, Nigeria; 1996: Pfizer conducted a clinical trial of an antibiotic, Trovan, on children suffering from an outbreak of meningitis.  11 of the children who participated died (5 of them taking Trovan), even though an FDA-approved non-experimental treatment regimewas available at the same clinic courtesy of Medicine Without Borders.  The parents of these children brought suit against Pfizer, first in Nigeria and later in the United States.  Among other things they charged that the experiments were done without informed consent, a violation of both the Nuremburg Code and the Declaration of Helsinki.

The case, Abdullahi vs. Pfizer, Inc., made it to the United States Court of Appeals, Second Circuit (covering New York, Conneticut, and Vermont; one step below the Supreme Court).  The court’s ruling was that the Abdullahi case could be tried under the Alien Tort Act because denying informed consent to the study participants (as guaranteed in the Nuremburg Code and Declaration of Helsinki) constituted a violation of “the law of nations” accepted by the “civilized world” as a norm of customary international law.  Pfizer appealed the decision to the Supreme Court, where it was it was denied certiorari; therefore the appellate court decision stands.

This ruling is now part of case law—meaning that unless the Supreme Court were to reverse the appellate court’s decision in a future case, the ruling is the law of the land (by US legal custom).[1]

  

IN A NUTSHELL: a study participant can sue a pharmaceutical company (or other researcher) for not respecting his rights as outlined in the Nuremberg Code and Declaration of Helsinki, which are considered international “laws of nations.”

    

To the Mental Health Community at large:

DID YOU HEAR THAT? 

The Declaration of Helsinki does represent your rights.  And it says:

WHAT THE (MENTAL HEALTH) COMMUNITY WANTS INVESTIGATED MUST BE INVESTIGATED. 

The priorities and health needs of the community are more important than anyone else’s — mainstream psychiatry, pharmaceutical companies, et al.

So now that you know the value of your opinions, WHAT DO YOU WANT RESEARCHED?  What are your priorities?  Health needs?  Research interests? 

Want to know more about Soteria and other social support treatments for schizophrenia?  How about the efficacy of peer-to-peer counseling?  Biofeedback training?  Holistic healing approaches?  Natural supplements?  Effectiveness of SSRIs, antipsychotics, and mood stabilizers?  The sky’s the limit!

Spell out your research interests, and perhaps we can put together a petition or letter informing our lawmakers and congressman of this community’s research priorities and the legal precedent for having those priorities respected. 

POWER TO THE PEOPLE!

[to make comment, visit the original post here]

[1] More on this here.

Overseas clinical trials of pharmaceuticals — the globalization of guinea pigs


(WARNING: this isn’t going to be pretty…)

In the 1940s, the US Government deliberately infected mentally ill and incarcerated Guatemalans with syphilis – almost 700 people in total.  The study design included arranging sexual encounters between prostitutes known to be infected and the male participants [you just can’t make stuff like this up].  After 2 years, the study was determined to be “useless” and was subsequently abandoned and forgotten in the Guatemalan rainforest.  As were the participants and their families.

Until last October, that is, when Wellesley College medical researcher Susan Reverby rediscovered it.   Against all odds, she managed to break the story.

It was kind of a big deal. 

Obama called the president of Guatemala on the phone, and Hillary gave a speech about it:

Although these events occurred more than 64 years ago, we are outraged that such reprehensible research could have occurred under the guise of public health…We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices.

(Hillary Rodham Clinton, Secretary of State; 10/1/2011)

Let me translate that for you:

Although these events occurred more than 64 years ago,

[something like this could never happen today]

we are outraged that such reprehensible research could have occurred under the guise of public health…

[However, under the guise of “stopping Latin American communist/socialist/populism” and “protecting American business interests”[1] loss of Guatemalan lives was totally cool by America in the past, so… why is this such a big deal?]

We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices.

[but in no way are we interested in offering support, reparations, monetary assistance, further treatment, etc. at this time.]. 

(Hillary, with a little help from ALT)

Thank you, and will you please SHUT UP ABOUT IT already?

 

The emphasis remained on “this could never happen today;” when Obama spoke with President Colon, he “reaffirmed the United States’ unwavering commitment to ensure that all human medical studies conducted today meet exacting U.S. and international legal and ethical standards,” a White House statement said.  Obama also charged the “Presidential Commission for the Study of Bioethical Issues” with researching the issue, particularly in the context of international clinical studies/trials. 

    

This just in: It could happen.

The Commission came back on Tuesday with its official report: despite 1000s of rules and regulations to prevent these human rights violations from happening, they could happen.

What they forgot to mention is that they do happen.  ALL THE TIME. 

A couple examples:

  • Grudziadz, Poland; 2007 – residents of a homeless shelter received as little as $2 to take part in a flu-vaccine experiment.  The subjects thought they were getting a regular flu shot (staff, of course, deny this).  Regardless, participants were getting a H5N1 bird-flu vaccine, not a typical flu vaccine.  At least 20 of them died. [more information here]
  • India and 11 countries; 2002-2004 – Ketek, FDA-approved only as an antibiotic for treating respiratory-tract infections, is tested on nearly 4000 infants and toddlers as a preventative measure for ear infections and tonsillitis.  At least 12 deaths and 93 “severe adverse events” occurred before the trial was halted and the medication given a black box warning. [more here]
  • Santiago del Estero, Argentina; 2008 – A vaccine, Synflorix, is tested on local children, toddlers, and infants by Glaxo-Smith-Klein.  14 infants enrolled died; their parents (some of them unable to read) did not understand that their children were in an experiment.  Local doctors received $350 for each child they enrolled in the study. [more here]

These are not anomalies, attributable to the rare cruel/evil researcher, a few “bad apples” in an otherwise ethically and scientifically rigorous community.  Nope; these kinds of research abuses are system-wide, and overseas clinical trials in countries where human research protections are easily overlooked are essential building blocks of the pharmaceutical industry’s business model.

This doesn’t come as a surprise to anyone familiar with the growing trend in overseas clinical trials (particularly for drugs with questionable – at best – efficacy). 

Frankly, I am most worried about the drug trials that get done elsewhere now, which we have little control over.

(Susan Reverby; researcher who broke the Guatemalan syphilis trial story, when asked to cite any ongoing experimental practices that gave her pause)

    

Like a tumor, so it grows…

Between 1990 and 2008 the number of clinical trials for pharmaceuticals being conducted overseas increased from 271 to 6485; that’s over 2000%!  In 2008 alone, 80% of the applications submitted to the FDA for new drugs contained data from foreign clinical trials.  While traditional clinical trial host countries – like the United States, Britain, Germany, and Australia – are hosting less and less per year, 24 of the 25 fastest growing countries are from the “developing world.”  Check out some of these average annual growth rates (from 2008):

  • 47% – China
  • 33% – Russia
  • 26.9% – Argentina
  • 24.6% – Czech Republic
  • 19.6% – India

This map also puts it in perspective:

[citation: Theirs, F.A., Sinskey, A.J., & Berndt, E.R. (2008).  Trends in the globalization of clinical trials.  Nature, 7; pp 13-15.]

What makes overseas trials so attractive to pharmaceutical companies?  Aside from the above-mentioned lack of human research subjects protections, there are a host of reasons.  Overseas clinical trials are cheaper; the contractor’s fee is cheaper, you can pay the participants and researchers pennies compared to the dollars of American trials, follow-up care and treatments are not required, etc.  In developing countries there are larger populations willing to participate because they have limited access to medical care.  Many more people are “drug naïve” (ie, they aren’t currently taking and have never taken medications) – and drug naïve populations typically yield better results than American test subjects whose systems have already been chemically manipulated.  It’s quicker to do a clinical trial overseas (again, because of the lack of regulation), and that means you don’t have to deal with long term side effects showing up in the results.

Another important factor is this interesting loophole: if American clinical trials show a drug has no benefit, the FDA will still accept overseas clinical trials as adequate proof during the approval process.  Certain countries have proven themselves invaluable when it comes to delivering positive results quickly for questionable drugs; they’re known as “rescue countries.”  Hungary, Morocco, Tunisia, Turkey, and Poland are a few notable examples  [more information on rescue countries in this book].

  

But Obama said…!

Yeah.  Didn’t Obama say that the United States has an “unwavering commitment to ensure that all human medical studies conducted today meet exacting U.S. and international legal and ethical standards?”  Yup.  He did.  On the phone with el presidente Colon de la RepĂşblica de Guatemala.  I hope he wasn’t bluffing, because Latin Americans take their machĂ­smo pretty seriously – decades of dictatorship will do that.

 
 
 
 
 
 
 

 

  

Do NOT mess with him.

 

 Let’s see:

When Obama said “US legal and ethical standards,” he could only have been referring to the FDA.  And on their website, they clearly state that overseas clinical trials will be accepted if they either a. comply with FDA regulations [insert complicated number here] or b. comply with the Declaration of Helsinki, which is essentially the international standard (though not international law) for human subjects research; medical trials in particular.

The first draft of the Declaration of Helsinki was released in 1969.  A few minor revisions brings us up to the 1989 version, which is the version the FDA officially acknowledges (read it here).

But here’s the thing: the Declaration has been revised several times since them (the most recent version is from 2008; read it here).  Some of those revisions were specifically made to address the movement of pharmaceutical trials overseas, and all of them are, presumably, rather inconvenient for the FDA and the pharmaceutical companies it partners with.  Here are a few of the key points from the 2008 version that are missing from the 1989 edition:

  • Investigators must disclose funding, sponsors, and other potential conflicts of interest to both research ethics committees and study participants
  • Study design must be disclosed publicly
  • Post-study, participants must be given access to treatment
  • Authors must report results accurately, and publish or make public negative findings
  • Research, notably that in developing countries must benefit and be responsive to health needs of populations in which it is done

Now the 1989 version still has some good stuff in it; the physician’s ultimate responsibility is the safety of the patient, NOT the success of the drug trial.  This is stated explicitly: even though the participant has given consent, it is the physician’s responsibility to make sure no harm comes to him.  Additionally, the declaration spells out pretty strict guidelines about informed consent: participants need to know study design, potential risks and benefits, and the ultimate purpose of the study.  They have the right to withdraw at any time, for any reason.  And if they are unable to give consent (ie, deemed incompetent) the only way they can be included in the study is if the study COULD NOT be done with competent individuals and the research entails only “minimal risk” and “minimal burden.”

Unfortunately, these conditions aren’t being met in the United States, let alone internationally. 

Are you feeling shocked, angry, outraged?  Is your heart aching for the children of Santiago del Estero, the homeless of Grudziadz, and for everyone who trusted that the data collected by pharmaceutical companies was a fair and accurate representation of a drug’s efficacy and potential risk?  Are you ready for something to CHANGE?

Good. 

Let’s do this.

[to make comments, visit the original post here]


[1] Think twice before you eat that Chiquita banana…

Psychiatry Residents don’t volunteer information for informed consent

We can easily assume that psychiatrists in general have the same habits as the residents talked about in the article below as many of our lived experiences suggest. When we are young, desperate and naive, how many of us think to ask the pertinent questions? And then when we are thoroughly brainwashed to believe meds are the only way, how many of us really want to know the risks? If we have no alternatives, as we are led to believe, doesn’t it feel safer to just not know? These “passive” doctors are taking the easy way out to our great expense.

That these doctors “meet the criteria of informed consent” by what they were willing to answer gives me no comfort. Unfortunately most of us still blindly trust our doctors and do not ask questions. Also in my experience even when I asked questions responses rarely covered all the bases. Doctors, in general don’t even know enough to give proper information as they get most of the information from the PDR and drug reps–both sources incomplete and often misleading. So meeting the current “criteria” for informed consent, whatever that might be, is unlikely to be sufficient anyway for real informed consent which should include alternatives.

Most doctors simply do not believe in alternatives and offering alternatives is not part of the generally accepted criteria among doctors for informed consent.

Of course when we come to learn by our own grave pharmaceutical injuries what informed consent might actually look like had we been given it and we start speaking up, the medical establishment denies our experience…so we really have a long way to go.

Below the article I am speaking about:

Reuters Health

Thursday, May 17, 2007

NEW YORK (Reuters Health) – Psychiatry residents tend to take a “passive approach to informed consent discussions” when presented with common clinical scenarios, according to a report in the Journal of Clinical Psychiatry.

“Since it appeared that residents in our study failed to actively bring up the topics necessary to obtain informed consent, educating them that they must do so may remedy the problem,” Dr. Bret R. Rutherford from Columbia University, New York told Reuters Health.

Informed consent refers to the communication between a physician and patient in which the physician discloses enough information so the patient understands the treatment or procedure he or she is agreeing to have – or not to have. The physician will typically provide the diagnosis, the purpose of treatment, the risks and benefits, and other relevant information. In turn, the patient should have the opportunity to ask questions.

Rutherford and colleagues investigated the informed consent practices of 108 psychiatry residents by assessing their responses to clinical vignettes describing three hypothetical patients with major depression, borderline personality, or neurotic character traits.

Only 8 of 324 completed vignette responses (3 percent) met the criteria for adequate informed consent, the authors report, and only 3 of 324 met criteria for optimal informed consent.

When revised criteria, which counted answering patients’ questions, were used, more than half the vignettes met the criteria for adequate informed consent, and one third of the residents met the revised criteria for all vignettes.

“Initially, we were surprised that so few residents met our criteria for informed consent,” Rutherford continued. However, when the data were reanalyzed to include what residents were willing to answer, the majority did meet criteria for informed consent.

“That told us the problem was not that the residents lacked knowledge about the elements of informed consent, but they failed to actively…bring up these issues with their patients.”

The results “suggest that changing residents’ passive approach to informed consent discussions might have a large impact,” the investigators write.

“Residents (and, apparently, all other physicians, given similar findings by other researchers) need to see it as incumbent upon them to proactively bring up informed consent issues with their patients and not simply answer the patients’ questions if they ask,” Rutherford concluded.

SOURCE: Journal of Clinical Psychiatry, April 2007.

More on INFORMED CONSENT

For a multitude of ideas about how to create a life filled with safer alternatives to psychiatric drugs visit the drop-down menus at the top of this page or scroll down the homepage for more recent postings.

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Highlight: Indispensable Book — Rethinking Psychiatric Drugs

By far the most informative, well-documented critique on psychiatric drugs that I’ve come across is Grace Jackson’s ” Rethinking Psychiatric Drugs: A Guide for Informed Consent.” It is appropriate for both professionals and lay-people, it is succinct and concise and loaded with information.

In 2004, an on-line medical newsletter posted an article with a captivating title: “All the Things They Taught Us That Were Wrong.” Penned by an academic psychiatrist who completed his post-graduate training nearly two decades before my own, the essay resonated with my own discoveries during residency and beyond. Probably, like him, my patient care and research experiences transformed me until I, too, developed the painful awareness of “all the things my teachers taught me” which proved to be untrue.This book is the culmination of many of those discoveries. It is the result of a five-year (and continuing) process of corrective self-education. It is the philosophically, epidemiologically, and scientifically supported revelation of how and why clinicians have often failed their mental health patients, partly because the information upon which they have relied (Evidence Based Medicine) has become increasingly unreliable. This development, along with many more, has compromised the ability of physicians and patients to participate in the construction of viable, informed consents to care:

“Informed consent…is about the right to make choices and the right to refuse consent; it is about the right of individuals to preserve their integrity and dignity whatever physical and mental deterioration they may suffer through ill health; it is about our duty always and in all circumstances to respect each other as fellow human beings and as persons.”

“The chapters which follow are intended to facilitate the shared decision making of consumers and health care providers. First, the public’s opinion about psychiatric drugs is explored through research conducted in several countries. Next, the sources of professional opinion are reviewed, beginning with the drug development process and the philosophy of Evidence Based Medicine. Chapter four explains the gold standard of medical research–the Randomized Controlled Trial–along with an emphasis upon the methodological deficiencies which commonly distort the value of drug treatments. Chapter five is an overview of the human brain. This is offered for the reader who desires a more detailed understanding of the targets of psychiatric drugs in terms of their chemical and structural effects. Chapter six introduces the concept of allostatic load–a phenomena of maladaptive changes made by the body in response to stimuli, such as medication. The chapter includes discussions of tolerance (an important mechanism of decreasing responsitivity to treatment over time) and drug discontinuation syndromes (withdrawal and rebound). It presents the concept of sensitization of a possible explanation for the phenomenon through which the pharmacological therapies may effect a progressive worsening or prolongation of initial symptoms.

At the heart of the book is a detailed examination of three major classes of psychiatric drugs: antidepressants, antipsychotics, and stimulants (the latter given for Attention Deficit Hyperactivity Disorder). The history of each drug class is reviewed. A neuroscience section explains contemporary hypothesis about presumed mechanisms of action. A special emphasis is placed upon the topics of drug effectiveness and safety, including long term effects, uncommonly acknowledged dangers, and alternatives to medication. The book closes with a discussion of the current crises in psychiatric research and practice, particularly as these problems continue to undermine the capacity of physicians and patients to collaborate in authentically informed decisions about health care.”

This book is accessible to both the professional and lay person. If you have any question about some of the undocumented assertions I make about psychiatric drugs on this blog, this book will back up what I say with science. Where I use personal experience, this book uses science and clinical experience.

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