Does long term use of psychiatric drugs cause more harm than good?
BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2435 (Published 12 May 2015) Cite this as: BMJ 2015;350:h2435
All rapid responses
1. Two extraordinary claims: (i) "psychiatric drugs are the third leading cause of death;"; and (ii) "we would have a healthier and more long-lived population if we only used 2% of the drugs we currently use." (1)
2. Ordinary evidence―at best―
I. Head to Head article: 898 words with 24 data values, no supplementary raw data disclosed by the author. (2,3)
A. 18/24 data values: overall results of cherry-picked studies, there is no evidence whatsoever that a systematic review with predefined selection criteria was used to reduce the risk of selection bias; all the opposite, the author presents evidence of cherry-picking:
“For antipsychotics, I used a meta-analysis … … receiving psychiatric drugs before randomisation.”
“A well conducted cohort study of patients … ... excess death rate was about 1% a year.”
“A cohort study of patients older than 65 … ... than when they did not take antidepressants.”
Some bad cherries were not picked by the author “The Finnish cohort study of mortality in patients with schizophrenia—and all other such studies that support the idea that antipsychotics lower mortality—is unreliable.” without a very good reason (e.g., systematic review with predefined selection criteria) to fully justify their disposal to the garbage can of useless evidence, a single study contradicting a single study (apologies for the previous redundancy) is not a compelling argument, it is in fact all the opposite: evidence of selection bias.
B. 6/24 data values: a study of danish prescription statistics published as a book (peer-reviewed or non peer-reviewed?) instead of a scientific paper published in a peer-review high impact biomedical journal - but that would not be enough: a full disclosure of the raw data used to estimate such a high number of deaths is necessary, otherwise: the results are simply unfalsifiable by any independent researcher eager to confirm or refute the following extraordinary statement: "The total number of deaths a year in Denmark (3693) when scaled up corresponded to 539 000 in the United States and European Union combined." which is simply a fallacious statement (non sequitur) resulting from an invalid and unsound deductive argument.(4,5)
II. Rapid responses by Professor Gøtzsche fail to provide the evidence required to ascertain the accuracy of the aforementioned extraordinary claims. Furthermore, it is full of fallacious arguments such as: (i) appeal to authority: “As they haven’t read my book, they cannot know whether my interpretation of the science is appropriate. My book is evidence-based and has hundreds of relevant references.”; (ii) appeal to emotions and wishful thinking: “My recommendations would lead to healthier and more long lived populations and would spare tens of millions of people from becoming mentally crippled.” and “My interpretation of the science is shared by the patients who disagree strongly with the psychiatrists about psychiatric drugs, which they intensely dislike“; (iii) many more other deceptively bad arguments (e.g., prosecutor fallacy, scapegoating, and stereotyping);(1,2,6) (iv) about: “ I believe that my impending book (4) will fully justify my assertions.” Re: a book in not a proof of anything related to the aforementioned extraordinary claims, the only proof here is a clear conflict of interest: book sales and marketing instead of providing raw data to support the statements - the burden of proof is on the side of Peter Gøtzsche not on anybody else to disprove him.
Why anybody have to buy and read a book about psychiatric drugs to fully understand the author’s claims? Re: no reason whatsoever, raw data would be enough.
3. I would like to conclude declaring that this was not an easy request of retraction because I have a great respect and admiration towards Professor Peter Gøtzsche―especially for the vehemence and courage of his criticism to the pharmaceutical industry and their dangerous liaisons with doctors and their organizations. Nonetheless, I’m also a pharmacological researcher: (i) I independently scrutinize human and animal studies involving any active pharmacological principle - approved or not into the drug market - in order to collect evidence (i.e., raw data about the safety and efficacy of drugs); (ii) I also scrutinize drug data if there is any statement about the efficacy and safety of drugs which I want to address independently: many times I agree with other critical voices of the pharmaceutical industry,(7-9) but this is clearly a disagreement that I cannot ignore, in fact (iii) I’m very disappointed after reading too many statements written by Gøtzsche “characterized by scarce numbers among lots of words” following the same style of big pharmaceutical companies: fallacious arguments and extraordinary statements inspired by their appeal to the masses (propaganda) instead of scientific literacy and extraordinary evidence (i.e., raw data).(10)
Finally, about the question: Does long term use of psychiatric drugs cause more harm than good?: (i) a barely defined outcome [overall ratio (harm:good)] as the key measurement unit of (ii) a dichotomy [Yes (harm:good > 1); No (harm:good < 1)] about (iii) “psychiatric drugs”: a poorly defined and simplistic unrepresentative generalization of active pharmacological principles acting on the central nervous system.
http://www.ncbi.nlm.nih.gov/pubmed/?term=nomenclature+psychiatric+drugs
There is no psychiatric drug debate after all: this is a request of retraction of the two extraordinary claims quoted above (first two lines of this letter) described by the author as his "two main messages".
References
1. Gøtzsche PC. Maudsley debate and guild interests. July 12, 2015. URL: http://www.bmj.com/content/350/bmj.h2435/rr-14
2. Gøtzsche PC, Young AH, Crace J. Does long term use of psychiatric drugs cause more harm than good? BMJ 2015; 350:h2435
3. Raw data: https://docs.google.com/document/d/1K9NKugN9jtLAWZxDaovdYGCI-nMaRv2cpPB0...
4. Partial list of fallacies. Internet encyclopedia of philosophy. URL: http://www.iep.utm.edu/fallacy/#H6
5. Hansen, Hans, "Fallacies", The Stanford Encyclopedia of Philosophy (Summer 2015 Edition), Edward N. Zalta (ed.), URL: http://plato.stanford.edu/archives/sum2015/entries/fallacies/
6. Gøtzsche PC. Re: Does long term use of psychiatric drugs cause more harm than good? May 17, 2015. URL:
http://www.bmj.com/content/350/bmj.h2435/rr-4
7. Ramírez JH. "Novo Nordisk replies to BMJ investigation on incretins and pancreatic damage" - Re: let's start this discussion again. URL: http://www.bmj.com/content/347/bmj.f4386/rr/763130
8. Ramírez JH. Re: Putting GlaxoSmithKline to the test over paroxetine. URL : http://www.bmj.com/content/347/bmj.f6754/rr/816737
9. Ramírez JH. Response to J. Castellani (PhRMA): An ounce of data (i.e., 64740 data values). URL: http://www.bmj.com/content/347/bmj.f1881/rr/762606
10. Ramírez JH. Concerns over data in key dabigatran trial. URL: http://www.bmj.com/content/349/bmj.g4747/rr/778288
Competing interests: https://chaoticpharmacology.com/disclaimer-coi/
It seems remarkable to me on the basis of a quick review of responses to this question, how little in the way of actually unbiased responses, helpful to patients and families, seem to be published here. Of course the question is far too broad--almost like asking, "Is living in the US bad for your health?" So much depends on the particulars (exact location, educational and financial status, gender, ethnicity and so on, that the differences greatly outweigh the similarities in struggling to provide a meaningful answer). However, having spent the majority of my life treating or supervising the treatment of thousands of patients with mostly severe mental/emotional disorders, there is no question in my mind that the answer would be along the lines of "Absolutely not and they can be life-saving when used properly." However for a variety of reasons they are often over-used: in terms of numbers of persons treated, average doses used, average numbers of medications prescribed per patient, that the skill of the treating practitioner can easily swing the answer considerably one way or the other [like the global question about living in the US vs. elsewhere].
My best advice to patients or families is if you or a loved one has serious symptoms and someone advises going on a medication or multiple medications: ask a lot of questions. Ask for some scientific literature supporting what they are proposing, in language you can understand. Talk to others about their experiences. In many locations, support groups are available. A doctor patient enough to listen to and answer your questions is an excellent start. If their answers sound as if they deeply understand this field, that's another good flag. Finally if you feel you do not have confidence in one provider, try finding someone in whom you feel you have more confidence.
Competing interests: No competing interests
It interests me very much how few clinicians are willing to take the risk of listening to their patients' experience and take what they hear seriously. This could threaten the slender beliefs they have to cling to that the poisons they push onto unwilling clients are helping not killing their clients, sometimes quickly sometimes slowly but always hastening death. this is proven, known widely in the medical profession and yet NOT ONCE in the ten years i was being pressured into taking highly toxic medicines did anyone explore the idea of INFORMED CONSENT- one of the key human rights which all people are entitled to explore with their health practitioner no matter what diagnosis is being applied.
Informed consent means trusting that there is a possibility of understanding and decision making from both sides of the discussion, something that most psychiatrists i have come across believe is unreasonable. in my experience it is possible to work with people in all states of mind to reach a genuine and real decision from almost every person. advocacy works on this basis and is a very important and happily growing part of the voluntary sectors contribution to the human rights of people with a diagnosis of mental ill health.
nowhere else in the legal system, nowhere other than with mental illness in the human rights act are people so robbed of all their basic human rights often explicitly but often implicitly and by coercion from within an institutionalised system which is completely incapable of allowing care specific to the individual, their wishes, aspirations and reality of each person who has come for help and finds themselves often subject to extreme abuse through a system which is institutionally abusive in its approach.
what is really needed is a reclassification of all 'mental ill health' into the inflammatory auto immune illness category which it rightly deserves to live.
i have cured my 'bipolar/manic depressives illness' by rigorous avoidance of inflammatory foods, increase in protein, fat and all the other nutrient dense foods which my body was starved of so unable to maintain basic replacement health. the poisons being administered do nothing but suppress emotions, hide physiological illness and malnutrition which is at the heart of many cases of severe and enduring ill health.
long term use of psychiatric drugs in my case have i believe left me with life long disabilities, many of which are around issues of trust and fear of people. these fears only compounded by abuse and harm perpetrated on me mentally and physically as well as sex abuse experienced on psychiatric wards during those 10 years of medications.
since coming off all medications i have not required acute inpatient care, since coming off medications i have been able to start addressing the underlying causes of my suffering.
i will now be able to live some kind of a life free from the numbing, toxic load the medications weigh people down with. this is not helping anyone other than drug companies and those who prefer silent suffering.
psychiatric drugs are not in any way helpful, there fore always do more harm than good.
Competing interests: No competing interests
Maudsley debate and guild interests
In the paper version of BMJ on 6 June, I replied to David Tovey, Cochrane’s Editor in Chief, and Rachel Churchill, Clive Adams and Geraldine Macdonald (Cochrane editors responsible for Cochrane Groups specialising in mental health topics) that journalists and others had interpreted their rapid response (1) to my Maudsley debate paper (2) as an attempt at protecting psychiatry’s guild interests, and that some had even suspected that they tried to protect the drug industry (3).
As I did not intend to question my four Cochrane colleagues’ integrity, I withdraw this statement to avoid any misunderstandings and I apologize for any hurt and confusion caused. The fact is that all of us in Cochrane do our best to keep industry influence out of our work, which we regard as essential for the trustworthiness of our reviews.
I had two main messages in my BMJ paper about the Maudsley debate, which are my personal views after having gone through the science: psychiatric drugs are the third leading cause of death; and we would have a healthier and more long-lived population if we only used 2% of the drugs we currently use. Tovey et al. felt I went too far with this recommendation. I believe that my impending book (4) will fully justify my assertions.
1 Tovey D, Churchill R, Adams CE, et al. Recommendations in debate are insufficiently justified. BMJ 2015;350:h2952.
2 Gøtzsche PC. Does long term use of psychiatric drugs cause more harm than good? BMJ 2015;349:h2435.
3 Gøtzsche PC. Author’s reply. BMJ 2015;350:h2955.
4 Gøtzsche PC. Deadly psychiatry and organised denial. Copenhagen: People’s Press; 2015 (in press).
Competing interests: No competing interests
Regarding Mr. Peter C. Gotzsche’s statement in the paper “Does long term use of psychiatric drugs cause more harm than good?” published 12 May 2015 in the BMJ, a few remarks are needed.
Statistics has the power to brighten or to darken the understanding of a phenomenon. There are differences in level between information, be it of any kind, and the meaning of that information. In the aforementioned paper it is stated that there are estimated to be 15 times more suicides among the people taking antidepressants. The number might be exact, but the understanding is incorrect. Any human being with a suicidal career, ending in suicide, experiences a depressive episode, regardless of the primary psychiatric illness diagnosed. This is treated with antidepressants. Detection and treatment of a depressive episode is the performance of present day psychiatry. Without this detection, the “15 times more” wouldn’t exist. Therefore, the correctness of psychiatric practice concentrates people having committed suicide under the umbrella of antidepressants. The anti-suicidal effect of antidepressants in comparison to natural evolution and other therapy methods is scientifically proven. The entire scientific literature regarding suicide states, using rigorously scientific data, that the variation of suicide incidence has completely different causes. Antidepressant drug therapy associated with other therapeutic methods has been proved to reduce suicide rates.
One must not seek but the well-being of sufferers. Dissemination of statements like “antidepressants kill” in general population will bring a lot of suffering to patients and their families. Any theoretical debate must have a maximum of decency in the face of death. Decency, in this case, is represented by covering the extensive scientific literature on suicide in its entirety.
Competing interests: No competing interests
Does long term use of any drug do more harm than good? Should a diabetic patient stop using insulin in case he/she develops hypoglycaemia? Psychiatrists fighting amongst themselves again! They really ought to get out more often.
Competing interests: No competing interests
In one of those curious co-incidences, an article appeared in the New York Times (NYT) the day after I responded to Bamrha's view that research ethics committees prevent research participants in psychiatric studies from being put in harms way. (1) The NYT article examines studies in the psychiatry department at an esteemed US research centre. (2) And it raises the question how well research ethics committee ( IRBs in the US) carry out their oversight mandate. The NYT article might interest BMJ readers.
1. http://www.bmj.com/content/350/bmj.h2435/rr-9
2. http://salsa4.salsalabs.com/dia/track.jsp?v=2&c=2xSqrI6KSQgGawGWluLJ%2B7...
Competing interests: No competing interests
Bamrah rightly notes that issues in the debate over psychiatric drugs deserve greater attention. One issue involves research ethics committees (RECs). According to Bamrah, Gotzsche exaggerates and is mistaken about the harms research participants face in research studies. In Bamrah's words "studies have to be subjected to the rigours of ethics approval, and clearly any such demonstrable harm would not get past an Ethics Committee." (1)
RECs are mandated to protect the rights and welfare of research participants. But there are concerns from within and outside the research community about how well this is done. Members of an REC noted in a medical journal that while their REC rejected an unethical study involving an angiotensin-converting enzyme (ACE) inhibitor versus an angiotensin-II blocker versus placebo in diabetics with proteinurea, seven Canadian university teaching hospital boards approved it and the study ran for two years. (2) In another multi-centered study, RECs at a dozen leading medical research centers in the US and Canada were reproached by the Office of Health Research Protection in the US. The RECs failed to inform vulnerable research participants with disabilities or their proxies that the experimental treatments being measured involved serious risks, including possible death, and that research participants were being withdrawn from the best current therapeutic treatment and randomly assigned to an experimental treatment that might increase their risk of dying.(3) Another study that raised concern because the design put participants in harms way was a lead paint trial conducted at an esteemed research centre (4) Trial participants did not know that their children were exposed and as it turned out being poisoned by lead paint that investigators were measuring.
Longstanding concerns about the death of a research participant in a drug trial conducted in the psychiatry department at the University of Minnesota recently resulted in two external reports. (5) Research was soon halted after one report highlighted "numerous conflicts of interest," concerns about coercion in recruiting vulnerable study participants, and an REC that payed "insufficient attention to harms and benefits" in the trial. Parts of the report resembled a national Canadian report on research governance. The Canadian report noted that RECs tend to focus narrowly on consent forms; pay too little attention to benefits and harms for research subjects; researchers consider ethics to be a matter of navigating through the REC; and institutions see ethics as little more than the efficient processing of research proposals (6)
Clearly, it is important not to paint all RECs with the same brush. But it is also important not to conflate - as Bamrah seems to do - what RECS are mandated to do on paper with actual practices. The above examples suggest that the public can ill afford to lose sight of the "rigours of ethical approval" in research oversight.
Mark Wilson
Bio-ethicist
Guelph On
Canada
1. http://www.bmj.com/content/350/bmj.h2435/rapid-responses
2.Corman J, Blajchman M, Knight A. Placebo tribulations. Canadian Medical Association Journal 2002;167:455-456.
3. Office of Health Protections. (2003, July). Determination letters. http://www .hhs.gov/ohrp/compliance/letters/2003.html#Jul
4.http://www.nybooks.com/articles/archives/2013/mar/21/lead-poisoning-igno...
5.http://news.sciencemag.org/education/2015/03/human-subjects-protections-...
http://www.auditor.leg.state.mn.us/sreview/markingson.pdf
6. M. Wilson, Getting a fix on good governance, J. Med. Ethics, April 1, 2004; 30(2): 232 - 232
Competing interests: No competing interests
Re: Does Long-Term Use of Psychiatric Drugs Do More Harm Than Good?
As this important question is debated, it is essential to note that the reporting of results from longer-term, government-funded studies of psychiatric drugs has often been done in a manner that has protected psychiatry’s guild interests, rather than in a manner consistent with the dictates of good science. This necessarily biases any public discussion and consideration of the “evidence” on this question.
Here are two examples of this corruption, (which we detail in our recently published book, Psychiatry Under the Influence.)
a) In the TADS study of depressed adolescents, an NIMH-funded trial that helped resurrect the prescribing of fluoxetine to pediatric patients, the researchers reported that “there were no differences between groups in rates of suicidal events” at the end of 36 weeks. In fact, if the data presented in a table in a 2009 report is carefully parsed, it can be seen that 17 of the 18 youth who attempted suicide during the 36 weeks were on fluoxetine at the time of their attempt. This finding was obscured in this way: if youth were randomized to placebo or cognitive behavioral therapy alone, and then switched to fluoxetine after the initial 12-week treatment period, with their suicide attempts occurring after that switch, their suicide attempt was still attributed to the placebo group, or the CBT-alone group.
b) In the NIMH-funded STAR*D study, which was touted as the “largest and longest study ever done to evaluate depression treatment,” the researchers announced that “the overall cumulative remission rate was 67%,” and, it appeared, based on the relapse rates reported in a 2006 article, that 50% to 66% of the remitted patients had remained well during the one-year follow-up. This was a pretty decent result. But then an independent researcher, Ed Pigott, used a Freedom of Information request to access the protocol and other study data, and he determined that only 38% of the 4,041 patients who entered the study remitted according to protocol criteria, and even more important, that only 108 of the 4,041 were still in the trial and well at the end of one-year, a documented stay well-rate of 3%. All of the other patients had either never remitted, relapsed, or dropped out of the study.
Based on the results presented by the investigators, these two NIMH studies have been said to provide evidence that support the longer-term use of psychiatric drugs. Unfortunately, the deconstruction of the two studies, which reveals quite different results, doesn’t regularly inform the debate about the merits of psychiatric drugs. There are many such examples of this corruption that can be detailed, and it is easy to see why this impairs any societal—or scientific—discussion about the longer-term merits of psychiatric drugs.
Robert Whitaker, former fellow at the Edmond J. Safra Center for Ethics, Harvard University.
Lisa Cosgrove, professor at the University of Massachusetts, Boston, and a fellow at the Edmond J. Safra Center for Ethics, Harvard University.
Kennard, B. “Assessment of safety and long-term outcomes of initial treatment with placebo in TADS.” Am J Psychiatry 2009; 166 (3):337-44.
Vitiello, B. “Suicidal events in the treatment for adolescents with depression study (TADS).” J Clin Psychiatry 2009; 70 (5): 741-7. See figure 1 for data showing drug exposure before suicidal event; see table 1 for assignment of suicidal events by randomization.
Rush, AJ. “Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: A STAR*D report.” Am J Psychiatry 2006; 163 (11):1905-17.
Pigott, H. “Efficacy and effectiveness of antidepressants.” Psychother Psychosom 2010; 79 (5):267-79. Also, Pigott, H. “Star*D: A tale and trail of bias.” Ethical Human Psychology and Psychiatry 2011; 13 (1):6-28.
Competing interests: No competing interests
Correction: "Long term use of psychiatric drugs: more harm than good? Re: The delusion of debate and unretractability"
Dear Editor,
There is a problem with this request of retraction,(1,2) I would like to correct the following lines in the text of my previous rapid response:
(...) "3. I would like to conclude declaring that this was not an easy request of retraction because I have " (...)
(...) "There is no psychiatric drug debate after all: this is a request of retraction of the two extraordinary claims " (...)
"request of retraction" in the two lines above is now corrected to "request of correction"
My apologies to Professor Gøtzsche for my honest mistake.
References
1. Erik C.W. Krabbe. The Problem of Retraction in Critical Discussion. [ version: 24 November 1999]
URL: http://www.phil.uu.nl/ozsl/articles/krabbe03.pdf (access date: Sep 28, 2016)
2. COPE. Retraction guidelines. URL: http://publicationethics.org/files/retraction%20guidelines.pdf (access date: Sep 28, 2016)
Competing interests: https://chaoticpharmacology.com/disclaimer-coi/