46 Elashoff M, Matveyenko AV, Gier B, et al. Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies. Gastroenterology. 2011; 141: 150–6.
47 Gøtzsche PC, Mæhlen J, Zahl PH. What is publication? Lancet. 2006; 368: 1854–6.
48 Public citizen to FDA: pull diabetes drug Victoza from market immediately. Public Citizen. 2012 April 19.
49 Lindeberg M. [Novo Nordisk has sent warnings about the cancer risk with its diabetes drug Victoza to US physicians]. Berlingske. 2011 June 14.
50 US Food and Drug Administration. FDA Approves New Treatment for Type 2 Diabetes. 2010 Jan 25.
51 Maxmen A. Debate on diabetes drugs gathers pace: petition unveils unnerving reports on potential carcinogenicity of GLP-1 mimics. Nature. 2012 April 30.
17
Psychiatry, the drug industry’s paradise
There is probably no other area of medicine in which the academic literature is so at odds with the raw data.
David Healy, psychiatrist1
Leaving the determination of whether mental illness exists strictly to the psychiatrists is like leaving the determination of the validity of astrology in the hands of professional astrologers … people are unlikely to question the underlying premises of their occupations, in which they often have a large financial and emotional stake.
Judi Chamberlin, former mental patient2
I have spent most of my professional life evaluating the quality of clinical research, and I believe it is especially poor in psychiatry. The industry-sponsored studies … are selectively published, tend to be short-term, designed to favor the drug, and show benefits so small that they are unlikely to outweigh the long-term harms.
Marcia Angell, former editor, New England Journal of Medicine3
Are we all crazy or what?
Psychiatry is the drug industry’s paradise as definitions of psychiatric disorders are vague and easy to manipulate.2,4 Leading psychiatrists are therefore at high risk of corruption and, indeed, psychiatrists collect more money from drug makers than doctors in any other specialty.5,6 Those who take most money tend to prescribe antipsychotics to children most often.5 Psychiatrists are also ‘educated’ with industry’s hospitality more often than any other specialty.7
This has dire consequences for the patients. The Diagnostic and Statistical Manual of Mental Disorders (DSM) from the American Psychiatric Association (APA) has become infamous. It is now so bad that Allen Frances, who chaired the task force for DSM-IV (which lists 374 different ways to be mentally ill; up from 297 in DSM-III)2 believes the responsibility for defining psychiatric conditions needs to be taken away from the APA.4 Frances has warned that DSM-V could unleash multiple new false positive epidemics, not only because of industry money but also because researchers push for greater recognition of their pet conditions. He noted that already the DSM-IV created three false epidemics because the diagnostic criteria were too wide: attention deficit hyperactivity disorder (ADHD), autism and childhood bipolar disorder.
According to Frances, new diagnoses are as dangerous as new drugs: ‘We have remarkably casual procedures for defining the nature of conditions, yet they can lead to tens of millions being treated with drugs they may not need, and that may harm them.’4 Drug regulatory agencies should therefore not only evaluate new drugs but should also oversee how new ‘diseases’ are being created. The confusion and incompetence is so great that the DSM-IV cannot even define what a mental disorder is.2 I have highlighted in italics some of the wishy-washy bits of the definition:
A clinically significant behavioral or psychological syndrome or pattern that occurs in an individual and that is associated with present distress (e.g., a painful symptom) or disability (i.e., impairment in one or more important areas of functioning) or with a significantly increased risk of suffering death, pain, disability, or an important loss of freedom. In addition, this syndrome or pattern must not be merely an expectable and culturally sanctioned response to a particular event, for example, the death of a loved one. Whatever its original cause, it must currently be considered a manifestation of a behavioral, psychological, or biological dysfunction in the individual. Neither deviant behavior … nor conflicts that are primarily between the individual and society are mental disorders unless the deviance or conflict is a symptom of a dysfunction in the individual.
It would be easy to improve on all this ambiguity and subjectivity and arrive at a more meaningful and robust definition. The DSM is a consensus document, which makes it unscientific. The Royal College of Physicians doesn’t seek website comments from the public on the diagnosis of breast cancer and ‘Real sciences do not decide on the existence and nature of the phenomena they are dealing with via a show of hands with a vested interest and pharmaceutical industry sponsorship.’8 Homosexuality was listed as a mental disorder till 1974 when 61% of the psychiatrists voted to have it removed, only to retain something called Ego Dystonic Homosexuality for those who felt uncomfortable about others’ condemnation of their sexual orientation!
Psychologist Paula Caplan was involved with updating the DSM to its fourth edition and she fought hard to get the silliest ideas out.2 In 1985, the APA decided to introduce Masochistic Personality Disorder to be used for women who were beaten up by their husbands. Caplan and her colleagues felt the proper response to this should be Macho Personality Disorder for the violent males, but they settled with Delusional Dominating Personality Disorder. They suggested to the APA committee that this would apply if a male fulfilled six of 14 criteria, of which the first was ‘Inability to establish and maintain meaningful interpersonal relationships’. The chairman, Allen Frances, asked what the empirical documentation was for this disorder and warned that it would be folly to open the floodgates to new and unsupported diagnoses. An interesting remark considering what was already included in DSM-III.
The people who develop DSM have heavy conflicts of interest and creating many diagnoses means big business in all sorts of ways and fame and power for those at the top.2 But does it help people to be labelled? Some of us still remember Minimal Brain Damage Dysfunction, which was thrown in the faces of millions of parents, and which could only be harmful, as there was nothing they could do whatever the problem was, if any. Other elastic diagnoses that could be used for most healthy people are Oppositional Defiant Disorder for children and Self-Defeating Personality Disorder for women.
Labelling women with Premenstrual Dysphoric Disorder might prevent them from getting a job or have custody of their children in case of a divorce.2 When the criteria for this diagnosis were tested, it turned out that they couldn’t distinguish between women with severe premenstrual symptoms and other women. Even men gave answers similar to those with severe symptoms. But who cares? The FDA obviously didn’t. It approved Eli Lilly’s antidepressant Prozac (fluoxetine) for this non-disease, which the US psychiatrists even had the gall to call depression!9 Lilly had the audacity to give the drug another name, Sarafem, which was a repainted Prozac with attractive lavender and pink colours.10 Pretty ironic to use pink as a symbol for a pill that ruins people’s sex lives (see below). Since men have the same symptoms, it would seem okay to treat them, too. In Europe, Lilly was forbidden to promote fluoxetine for something that wasn’t considered a disease, and the EMA fiercely criticised the company’s trials, which had major deficiencies. The Cochrane review of this non-disease included 40 trials and SSRIs were said to be highly effective.11 Of course. SSRIs have amphetamine-like effects, and some people feel better when they take speed.
Few psychiatrists are willing to admit that their specialty is out of control and they will continue to tell you that many patients are underdiagnosed. This is their standard defence, but under the glittering surface they know that they and their patients have a big problem. In a 2007 survey, 51% of 108 Danish psychiatrists said that they used too much medicine and only 4% that they used too little.12 In 2009, sales of drugs for the nervous system in Denmark were so high that one-quarter of the whole populatio
n could be in treatment every day,13 and yet Denmark comes out as the most happy nation on earth in poll after poll despite our terrible weather, which should make people depressed.
In the United States, it’s even worse. The most sold drugs in 2009 were antipsychotics, and antidepressants came fourth, after lipid-lowering drugs and proton pump inhibitors (used for stomach problems).14 It’s hard to imagine that so many Americans can be so mentally disturbed that these sales reflect genuine needs, but it gets worse all the time, with an alarming speed. In 1990–92, 12% of the US population aged 18–54 years received treatment for emotional problems, which went up to 20% in 2001–2003.15 Although there are hundreds of diagnoses in DSM-IV, only half of people who were in treatment met diagnostic criteria for a disorder. In 2012, the US Centers for Disease Control reported that 25% of Americans have a mental illness.16
Not even our children have avoided the disease mongering. In New Jersey, one in 30 boys is considered to have autistic spectrum disorder,16 and about a quarter of the children in American summer camps are medicated for ADHD, mood disorder or other psychiatric problems.17 One in four, and we are talking about children! As early as in the 1990s, a quarter of the children in an elementary school in Iowa were on drugs for ADHD,18 and in California, the diagnosis rates of ADHD increased sharply as school funding declined. About one-fifth of doctors didn’t follow the official protocol when making the diagnosis but rather their personal instinct.19
Psychiatry is really elastic and has replaced care with pills. Like SSRIs, drugs for ADHD have amphetamine-like effects.9 That the children can sit still at school cannot be taken as evidence that the diagnosis was correct; it merely shows that speed has this effect (and many others, including apathy, lack of humour and social isolation).
In 2011, an enterprise – evidently working on behalf of an anonymous drug company – sent a most bizarre invitation to Danish specialists treating children and adolescents for ADHD.20 The doctors would be divided into two groups for an exercise called Wargames where they should defend their product (two different ADHD medicines) with arguments and a visual presentation. Their efforts would be filmed and the company’s anonymous client might be watching from another room what went on. This ‘Big brother is watching you’ exercise was illegal. Danish doctors are not allowed to help companies market their products.
Drugs for ADHD are dangerous. We don’t know much about their long-term harms, but we do know that they can damage the heart in the same way as seen in long-term cocaine addicts and lead to death, even in children.18 We also know that the ADHD drugs cause bipolar disorder in about 10% of the children, which is a serious condition.21
In 2010, the US Centers for Disease Control and Prevention published a report stating that 9% of the interviewed adults met the criteria for current depression.22 The criteria were those listed in DSM-IV and very little was needed. You were depressed if you had had little interest or pleasure in doing things for more than half of the days over the past 2 weeks plus one additional ‘symptom’, which could be many things; for example:23
trouble falling asleep
poor appetite or overeating
being so fidgety or restless that you have been moving around a lot more than usual.
This is insane. How on earth did we get to the point of accepting a system that labels one-tenth of the US adult population as depressed at any one time? Are people who do this to us normal, or should we invent a diagnosis for them, e.g. Compulsive Disease Mongering Disorder? Little pleasure in doing things for eight days out of 14 will happen for most people, no matter how positive, active and outgoing they are. Trouble falling asleep is common; many people overeat (otherwise, we wouldn’t have an obesity epidemic); and people might move around more than usual if they succeed with something they badly wanted to achieve.
With such an approach to diagnosis, it’s easier to understand why the rate of depression in the population has increased a thousandfold since the days when we didn’t have antidepressant drugs.24 According to DSM-IV, I have been depressed many times in my life, but according to myself and those who know me I have never been anywhere near being depressed.
Allen Frances found it alarming that one-tenth of Americans were considered depressed and felt that the prescription of antidepressants is increasingly out of control because it is controlled by drug companies who profit from it being out of control.25 He also noted that DSM-V will further increase overtreatment with antidepressants, for example by medicalising grief, reducing the threshold for generalised anxiety disorder, and introducing new and highly questionable disorders for mixed anxiety/depression and binge eating. It is really perverse. All of us will experience the death of a close relative, but in DSM-V, bereavement is a depressive disorder if it has lasted more than 2 weeks.26 In DSM-III, that period of time was set at 1 year, and in DSM-IV it was 2 months. Why not 2 hours in DSM-VI? We should allow people to be unhappy at times – which is completely normal – without giving them a diagnosis of depression.
Over the years, many new disorders have been included and existing disorders exploded, e.g. in DSM-III, anxiety neurosis was split into seven new disorders.27 Another change was the introduction of a symptom-based approach for diagnosis, which has been criticised for creating diseases, and for classifying normal life distress and sadness as mental disease in need of drugs. The criteria for depression no longer distinguish between a disorder and expected reactions to a situational context, for example the loss of a beloved person or other life crises like divorce, serious disease or loss of job, which are no longer mentioned as exclusion criteria when making the diagnosis. These changes, which are so generous towards the drug industry, could be related to the fact that 100% of the DSM-IV panel members on ‘mood disorders’ had financial ties to the pharmaceutical industry.27
The psychiatrists are running amok. The DSM-V committee have had plans for lowering the diagnostic thresholds for many other conditions, e.g. for ADHD and attenuated psychosis syndrome, which describes experiences common in the general population, but the latter diagnosis was dropped.28 An international protest has been launched against DSM-V and even the chair of the DSM-III task force, Robert Spitzer, is critical towards the major revisions of personality disorders, which often lack any empirical basis.
After my depressing experience with the DSM-IV criteria for depression, I looked up Psych Central, a large website that has been highly praised by neutral observers and has won awards. It offers many tests, even including one for psychopaths, and its slogan is: ‘You’re going to be okay, we’re here to help.’ It’s comforting to know that if you break down under the weight of the diagnoses after having tried some of the tests, the website offers immediate access to a psychiatrist. You can read about psychotropic drugs and find out which codes in DSM-IV may be appropriate for you. A little experiment I did suggests that there is a diagnosis for each of us. We were eight perfectly normal and successful people that tried the tests for depression, ADHD and mania, and none of us survived all three tests. Two had depression and four had definite, likely or possibly ADHD. Seven of us suffered from mania; one needed immediate treatment (perhaps because she has written a book critical of the drug industry), three had moderate to severe mania, and three had milder degrees. It’s not the least surprising that when therapists have been asked to use DSM criteria, a quarter of healthy people also get a psychiatric diagnosis.2
One of the new epidemics is bipolar II.29 Unlike bipolar I, it has no mania or psychotic features, and the diagnostic criteria are very lenient. There only needs to be one episode of depression, and one episode of hypomania lasting more than 4 days. This opens up the floodgate for treating vast numbers of patients with antipsychotic drugs resulting in tremendous harm at a huge cost; even the very old drug quetiapine cost a staggering £2000 a year in the UK in 2011. The diagnosis of hypomania builds on simplistic questions, one of which is ‘I drink more coffee’. In trials, bipolar I and II are mixed together so that one cannot see whether antipsychotic
s have any effect in bipolar II, which is supposed to be milder. A smart marketing trick.
Bipolar illness in children rose 35-fold in 20 years in the United States.21 It’s not only the loose criteria that cause this disaster; both SSRIs and ADHD drugs cause bipolar illness, and both types of drugs may lead to conversion of a depression or ADHD, respectively, into bipolar disorder in one out of 10 young people.30 However, psychiatrists hail this as ‘better’ diagnosis, or they add insult to injury by saying that the drug unmasked the diagnosis!21
Even the characters in Winnie-the-Pooh have been found to suffer from psychiatric disorders. For example, little Piglet obviously suffers from generalised anxiety disorder and the donkey Eeyore from a dysthymic disorder.31
There is a substantial risk of circular evidence in all of this. If a new class of drugs affect mood, appetite and sleep patterns, depression may be defined by industry-supported psychiatrists as a disease that consists of just that; problems with mood, appetite and sleep patterns.32
UK general practitioner Des Spence has described eloquently how psychiatry has become so corrupted:33
Psychiatry has … become pharma’s goldmine, with a simple business plan. Seek a small group of specialists from a prestigious institution. Pharma becomes the professional kingmaker, funding research for these specialists. Research always reports underdiagnosis and undertreatment, never the opposite. Control all data and make the study duration short. Use the media, plant news stories, and bankroll patient support groups. Pay your specialists large advisory fees. Lobby government. Get your pharma sponsored specialists to advise the government. So now the world view is dominated by a tiny group of specialists with vested interests. Use celebrity endorsements to sprinkle on the marketing magic of emotion. Expand the market by promoting online questionnaires that loosen the diagnostic criteria further. Make the illegitimate legitimate.
Deadly Medicines and Organised Crime Page 34