Spence mentions that a small Harvard group of world specialists admitted undisclosed personal payments from drug companies totalling $4.2 million.
A review of 43 studies in ADHD, of which 34 were randomised, supports Spence’s kingmaker tale. Very few of the reported adverse drug reactions were called serious, although many children dropped out of the studies because of precisely that: serious adverse drug reactions.34 A large number of studies were conducted by the same groups of authors and sponsored by the companies manufacturing the drugs. Not a set-up that is likely to tell us the true occurrence of serious harms. Many of the studies are also rigged, either by dropping all children who improve on placebo before the trial starts, or the opposite, studying only children who have tolerated the drug before they are randomised to drug or placebo.18 Such manipulations are very common in trials of psychotropic drugs, also in trials of SSRIs,24 and they make people think the drugs are much better than they really are. Some trials even use both types of patient cleansing before they are randomised.21
Psychiatrists as drug pushers
Leading psychiatrists are often highly effective drug pushers. In 1999, Charles Nemeroff and Alan Schatzberg published a psychiatry textbook that was ghostwritten by GlaxoSmithKline.35 In 2006, Nemeroff was first author of a review on the effectiveness of a vagal nerve-stimulating device for treatment of severe depression,36 a truly weird idea. The paper was ghostwritten and published in the journal, Nemeroff edited,37 and all authors had financial ties to the device makers but none were revealed.36 The FDA approved the device based upon a senior manager overruling more than 20 FDA scientists as well as other managers who had reviewed the data and concluded that the device didn’t demonstrate a reasonable assurance of safety and effectiveness.
There was also corruption at Emory University where Nemeroff worked and at the closely affiliated hospital, Grady Hospital, but it was kept secret for more than a decade.38 In 2008, Senator Charles Grassley released a damning report about Nemeroff that showed that one reason why the scam could continue for so long was that the whistle-blowers (at least 15) were ordered psychiatric evaluations at Emory’s psychiatric department. Emory’s own chosen psychiatrists reportedly wrote up such exams without even examining the targeted doctors or gathering factual evidence, whereafter several of them were fired.39 (I wonder how these same psychiatrists conduct clinical trials for the drug companies.) At least four of the ‘evaluations’ were done by Nemeroff himself, which made the processes similar in nature to Stalin’s processes in the Soviet Union. The staunchest whistle-blower, who sat at the Conflicts of Interests committee at Emory University, refused to get an ‘evaluation’ after he had blown the whistle on alleged research-funding fraud and he became the victim of more than 12 years of continuing litigation, which he ultimately won.
In 2000, an antidepressant trial was published in the New England Journal of Medicine where the authors had so many conflicts of interest that there wasn’t room for them in the journal; instead, they were listed on a website.40 The conflicts of interest for three psychiatrists I comment on in this book were:
Dr. Nemeroff has been a consultant to or received honoraria from Abbott, AstraZeneca, Bristol-Myers Squibb, Forest Laboratories, Janssen, Eli Lilly, Merck, Mitsubishi, Neurocrine Biosciences, Organon, Otsuka, Pfizer, Pharmacia–Upjohn, Sanofi, SmithKline Beecham, Solvay, and Wyeth–Ayerst. He has received research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Forest Laboratories, Janssen, Eli Lilly, Organon, Pfizer, Pharmacia–Upjohn, SmithKline Beecham, Solvay, and Wyeth–Ayerst.
Dr. Schatzberg has served as a consultant to or received honoraria from Abbott, Bristol-Myers Squibb, Corcept Therapeutics, Forest Laboratories, Janssen, Eli Lilly, Merck, Mitsubishi Pharmaceuticals, Organon, Parke-Davis, Pfizer, Pharmacia–Upjohn, Sanofi, Scirex, SmithKline Beecham, Solvay, and Wyeth–Ayerst. He has received research support from Bristol-Myers Squibb, Pfizer, and SmithKline Beecham. He has equity ownership in Corcept, Merck, Pfizer, and Scirex.
Dr. Keller has served as a consultant to or received honoraria from Pfizer, Bristol-Myers Squibb, Forest Laboratories/Parke-Davis, Wyeth–Ayerst, Merck, Janssen, Eli Lilly, Organon, and Pharmacia–Upjohn. He has received research grants from Wyeth–Ayerst, SmithKline Beecham, Upjohn, Pfizer, Bristol-Myers Squibb, Merck, Forest Laboratories, Zeneca, and Organon. He has served on the advisory board of Wyeth–Ayerst, Pfizer, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories/Parke-Davis, Organon, SmithKline Beecham, Merck, Janssen, Mitsubishi Pharmaceuticals, Zeneca, Scirex, and Otsuka.
This trial gave rise to an editorial with the title: ‘Is academic medicine for sale?’41 One wonders when these people have time for seeing the patients. People who take money from many companies usually argue that they are not in the pocket of industry because they are not dependent on any particular company. Accepting this line of reasoning, it should be quite okay to be a prostitute as long as you make sure you have many customers every day so that you aren’t dependent on any particular one.
Psychiatry is in deep crisis. It has not only turned what were previously acute conditions chronic (see below), it has also medicalised normality. Psychotropic drugs are being used for the most bizarre ailments, e.g. a trial showed that escitalopram reduced the daily incidence of hot flushes in menopausal women from 10 to 9.42 This tiny effect might even be non-existing, as many women may have broken the blind as they can feel the difference between an SSRI and a placebo (see Chapter 4).
Considering the many effects psychotropic drugs have,21,24 their massive use is harmful. For example, a carefully controlled cohort study of depressed people over 65 years of age showed that SSRIs more often lead to falls than older antidepressants or if the depression was left untreated.43 For every 28 elderly people treated for 1 year with an SSRI, there was one additional death, compared to no treatment.
The chemical imbalance hoax
Instead of trying to understand the patients, psychiatry has developed into a checklist exercise,44 which one could ask a secretary or the patients themselves to do. Diagnoses are often made after brief consultations of 10–15 minutes, after which many patients are told that they need a drug for the rest of their life to fix a ‘chemical imbalance’ in the brain. Very often, they are also told that this is similar to being a patient with diabetes needing insulin.21 If this were true, the number of disabled mentally ill would have gone down after we introduced the antipsychotics and antidepressants, but instead, the number of people with psychiatric diagnoses and disability pension has skyrocketed. Worst of all, this has also affected our children. In 1987, just before the SSRIs came on the market, very few children were disabled mentally ill in the United States; 20 years later, it was more than 500 000, which was a 35-fold increase.21
WHO studies have shown that the patients fare much better in parts of the world where psychotropic drugs are little used, e.g. in poor countries where only 16% of patients with schizophrenia were regularly maintained on antipsychotics as compared with 61% in rich countries.21 These positive results have been confirmed in Finland where drug use was restricted so that only 20% of patients with schizophrenia took antipsychotics regularly and two-thirds were never exposed to drugs.21 In the United States, researchers who arrived at similar results experienced that their funding from the National Institute of Mental Health and elsewhere dried out.21 The news were not welcomed by the psychiatric leaders.
The chemical imbalance story, which is being told about all psychotropic drugs, even for benzodiazepines (‘nerve’ or sleeping pills),21 is a big lie. It has never been documented that any of the large psychiatric diseases is caused by a biochemical defect and there is no biological test that can tell us whether someone has a particular mental disorder.45 As an example, the idea that depressed patients lack serotonin has been convincingly rejected.24,46 In fact, some drugs that decrease serotonin also work for depression,24,47 e.g. tianeptine, and the Irish drug regulator banned GlaxoSmithKline from claiming that paroxetine corrects a chemical imbal
ance. There is a lot else that speaks against the chemical imbalance hoax, e.g. it takes weeks before the drugs work.48
Psychotropic drugs don’t fix a chemical imbalance, they cause it, which is why it is so difficult to come off the drugs again. If taken for more than a few weeks, these drugs create the disease they were intended to cure.21,24,49,50,51,52,53 We have turned schizophrenia, ADHD and depression, which were often self-limited diseases in the past, into chronic disorders because of the drugs we use.21
People may get terrible symptoms when they try to stop, both symptoms that resemble the disease and many others they have never experienced before. It is most unfortunate that almost all psychiatrists – and the patients themselves – interpret this as a sign that they still need the drug. They usually don’t. They have become dependent, just like a junkie is dependent on heroin or cocaine, and as ADHD drugs and SSRIs have amphetamine effects, we should view these drugs as narcotics on prescription and use them as little as possible.
Most psychiatric patients would be better off by not receiving drugs at all,21 (see also Chapter 4 and Chapter 18) and those that need treatment usually only need it for a short time or intermittently. Psychiatrists should consider that other medical specialists, unlike psychiatrists, would be very reluctant to offer long-term symptomatic treatment without knowing what lies behind the symptoms, e.g. if a patient suffers from nausea or headache.3 However, it requires strong determination, time, patience, and a tapering period to get patients off the drugs and minimise the withdrawal symptoms. If patients have been on drugs for years, the tapering period may go up to a full year. Most psychiatrists choose life-long treatment instead, which is a disaster for many reasons. It keeps the patients locked in the patient role and the drugs change their personality so that they don’t learn to cope with life’s challenges.21 It also seems likely that not only antipsychotics but all the drugs can cause permanent brain damage and permanent personality changes, e.g. with tardive dyskinesia, cognitive decline and emotional flatness.21
The brain damage has been shown to occur at receptor level and there is nothing strange about this, as this is how the brain works. Hashish, LSD and other brain-active substances may also lead to permanent brain damage and psychosis.
The fact that psychotropic drugs in the long run create the diseases they have a short-term effect on has been brought up again and again over the last 30–40 years, but every time, no matter how strong the new evidence, leading psychiatrists have brushed it under the carpet as quickly as possible.21 It is too painful and too difficult for them to handle. After they put psychoanalysis behind them – which was terribly unscientific, to the point of Sigmund Freud claiming we’re all homosexuals and that those of us who think otherwise are latent homosexuals – they embraced biological psychiatry, which made their specialty look as scientific as internal medicine, which it isn’t.
It is unhealthy to perturb normal brain functions with drugs whether they are legal or illegal. Psychotropic drugs can lead to violence, including murder. An analysis of adverse drug events submitted to the FDA between 2004 and 2009 identified 1937 cases of violence, 387 of which were homicide.54 The violence was particularly often reported for psychotropic drugs (antidepressants, sedatives/hypnotics, ADHD drugs and a smoking cessation drug that also affects brain functions). Antidepressants are being suspected of having a causal role in shootings, but when one of the teenage shooters in the Columbine High School massacre was found to have an antidepressant in his blood, the American Psychiatric Association immediately denounced the notion that there could be a causal relation and added that undiagnosed and untreated mental illness exacts a heavy toll on those who suffer from these disorders as well as those around them.55 This is sickening. It’s marketing speak and standard industry tactic to blame the disease and not the drug, but this is what psychiatrists routinely do, in particular when patients who try to stop experience withdrawal symptoms. Psychotropic drugs, including SSRIs, also increase the risk of traffic crashes.56
In the United States, people can be prescribed Nuvigil (armodafinil), which, as the name implies, makes you vigil again. It’s approved for shift work disorder. I am not joking, the drug exists. People who get tired at nightshifts now have a disorder. Like so many other psychotropic drugs, Nuvigil has effects like amphetamine and cocaine, so it’s yet another narcotic on prescription, and as always, the drug may kill you. It can lead to a life-threatening rash (Stevens-Johnson Syndrome), fatal multi-organ failure, mania, delusions, hallucinations, and suicidal ideation, hospitalisation, and a lot else.57 I’ll stick to my coffee, which won’t harm me.
Screening for psychiatric disorders
As indicated above, the sure way of making us all crazy is to screen for mental disorders. A notorious programme in the United States was TeenScreen, which came up with the result that one in five children suffered from a mental disorder, leading to a flurry of discussions about a ‘crisis’ in children’s mental health.18
The science related to screening for depression is of appallingly poor quality.58 For example, only in 5% of studies assessing the false positive and false negative results of screening for depression had the researchers excluded patients who were already diagnosed with depression. This flaw is inexcusable. If you want to know how good ultrasound is to pick up cancers in the stomach in people who look healthy, you don’t study people who have already been diagnosed with large cancers with ultrasound, the very technique you want to test.
Despite the fact that the authors of the Cochrane review on screening for depression recommended firmly against screening, after having examined 12 trials with 6000 participants,59 the Danish authorities – after dutifully quoting the Cochrane review – recommended screening for various poorly defined ‘risk’ groups. The test to be used has been recommended by the WHO, but it’s so poor that for every 100 000 healthy people screened, there will be 36 000 false positive.60 Many of these 36 000 will get a prescription for an SSRI.
Psychiatrists have already created raging epidemics of psychiatric diagnoses, but when I point out to them how harmful screening is, they won’t listen. What’s wrong with psychiatrists? Why aren’t they evidence-based? If I were to nominate a new psychiatric disorder, it would be ODUFD: Obsessive Denial of Unwelcome Facts Disorder. It’s very common among doctors, politicians and high-level administrators and there is no cure. University administrators are happy to accept enormous gifts from industry at the same time as they implement stringent conflict of interest policies for their faculty and their relationship with commercial sponsors.61
Unhappy pills
I don’t think fraud and lies in research and marketing, corruption of doctors, and the insufficiency of drug regulators have been worse than for the so-called happy pills.21,24,62 The deceptions start already with the name. The term selective serotonin reuptake inhibitors (SSRIs) was invented by SmithKline Beecham, which in 2000 merged into GlaxoSmithKline. Unfortunately, it’s the official scientific name of this class of drugs although there is nothing particularly selective about them. They are not particularly specific either. Most substances that affect the brain, including alcohol, are likely to have an effect on depression similar to that of SSRIs,24 and alprazolam, for example, an old benzodiazepine, is better than placebo and similarly effective as tricyclic antidepressants, although these drugs are better than SSRIs.63
Until 2003, the UK drug regulator propagated the hoax about lack of serotonin as the cause of depression in patient information leaflets.62 No one knows why SSRIs have the effects they have and there isn’t much happiness in the pills. Their most pronounced effect is to cause sexual disturbances. An FDA scientist found out that the companies had hidden sexual problems by blaming the patients rather than the drug, e.g. female anorgasmia was coded as ‘Female Genital Disorder’.62 The companies claimed that only 5% of the patients were sexually disturbed,24 which is one-tenth of the true occurrence. In a study designed to look at this problem, sexual disturbances developed in 59% of 1022 patients w
ho all had a normal sex life before they started using an antidepressant.64 The symptoms include decreased libido, delayed orgasm or ejaculation, no orgasm or ejaculation and erectile dysfunction, all at a high rate, and with a low tolerance among 40% of the patients. Some patients yawned during orgasm, which isn’t the most fantastic way of building up an intimate relationship. These problems have been overlooked because patients aren’t likely to discuss them with their doctor. The drugs should therefore have been marketed as a formidable disrupter of your sex life, but that wouldn’t have sold many pills.
In Denmark, sales of SSRIs are now so high that 7% of the entire population can be in treatment with an adult dose every day for their entire life.27 Or every one of us can be in treatment for 6 years of our lives! It’s clear that the drug companies are behind the overtreatment. The sales of SSRIs increased almost linearly by a factor of 18, while the number of products on the market (and therefore the marketing pressure) increased by a factor of 16 (r = 0.97, almost perfect correlation).27 In 2007, no less than 23 different drug companies marketed 47 different products. This enormous marketing pressure has also been important in the United States. Between 1989 and 2000, the use of SSRIs and similar drugs almost trebled in primary care, with each new agent adding to the aggregate use without a concomitant decrease in previously introduced newer agents.65
The patients aren’t too happy to take happy pills. In clinical trials, doctors have an incentive to persuade the patients to take the drugs, but in general practice, more than half of the patients stop them again within 2–3 months.62
Prozac, a terrible Eli Lilly drug turned into a blockbuster
Deadly Medicines and Organised Crime Page 35