SSRI ‘Indication Creep’ Relies on Negligent Doctors

Maria Bradshaw
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A report on antidepressant consumption released on 18 February 2014 by the Organisation for Economic Cooperation and Development (OECD)[1] shows huge increases in prescribing of the drugs across most countries. According to the report a key factor driving this increase is the expansion of the off-label use of the drugs for a vastly increased number of indications. While this may not seem like news, I think it warrants some analysis because I think what we are seeing is something more complex than simple market expansion.

In my view what we are seeing is a strategic rebranding of antidepressants as treatments for non-psychiatric conditions which could only occur in an environment where doctors have a criminal disregard for patient safety while knowing they will not be held accountable for patient harm. While the development of a new product often entails sacrificing sales from an existing product, the willingness of doctors to prescribe off label in the absence of any evidence of their effectiveness or safety allows pharmaceutical companies to maintain and even expand their revenues from SSRIs while replacing them with newer drugs and biologics.

After a very long period in which the development of psychiatric drugs involved little in the way of identification of novel agents, pharmaceutical companies and leading universities are now publishing large numbers of studies and issuing media releases telling us they are working on developing, or have developed, a range of new treatments for depression. In a delicate balancing act, big pharma are highlighting the lack of efficacy of antidepressants as a way of promoting their new treatments but remaining silent on their adverse effects so as not to undermine their prescription for non-psychiatric conditions.

Dr. Rao, from Chicago’s Loyola and on the speakers bureau for Forest Pharmaceuticals[2] tells us, for example, that drugs such as Prozac, Zoloft and Paxil that target neurotransmitters succeed in inducing the remission of depression in fewer than half of all patients and that “new insights are leading to  treatments beyond common antidepressants such as Prozac and Zoloft.”[3]

Similarly a Yale University/Astra-Zeneca partnership is questioning the value of SSRIs in favour of Ketamine-mimic Lanicemine[4],  a University of Pennsylvania/Takeda & Lundbeck partnership has developed and brought to market Brintellex, a new antidepressant with a markedly different  pharmacodynamic activity from that of SSRIS[5]. And Biohaven, which has a worldwide license from Yale University to use intellectual property relating to the use of certain glutamate modulating agents in the treatment of neuropsychiatric disorders has developed a candidate drug which targets the glutamatergic system.[6] All emphasise in their market communications the significant proportion of patients who experience no benefit from SSRIs, but do not promote the new drugs as having a superior adverse event profile.

The message is in both what they say – antidepressants don’t work effectively for depressed patients, so prescribe our new drugs – and what they don’t; keep prescribing antidepressants for other indications, as they are not harmful.

Recent studies show us this strategy appears to be working remarkably well.

A study published by Mercier at al in 2013 claims that between 25% and 60% of antidepressant prescriptions are issued for “health problems outside the field of psychiatry.”[7] An American analysis found that between 1996 and 2007, “the proportion of visits at which antidepressants were prescribed but no psychiatric diagnoses were noted increased from 59.5% to 72.7%.”[8]

The conditions for which Mercier et al found antidepressants were being prescribed included neuropathic pain, urinary stress incontinence, premature ejaculation, prevention of depression after stroke, emotionalism after stroke, smoking cessation, premenstrual syndrome, hot flashes, Irritable bowel syndrome, post herpetic neuralgia, trigeminal neuralgia, agitation in dementia, motor recovery after ischemic stroke, overactive bladder syndrome, tension-type headaches with drug abuse, sciatica, Parkinson’s disease, sleep disorders, pruritus, asthenia- fatigue-chronic fatigue syndrome, cancer-related fatigue, depression in physically ill people, unexplained complaints, somatoform disorders, treatment refusal, patient compliance, weight loss in adults with type 2 diabetes, HIV related neuropathy, phantom limb pain, burning mouth syndrome, non-specific low back pain, restless legs syndrome, other urinary incontinence conditions, erectile dysfunction, alcoholism, alcohol misuse, musculoskeletal symptoms, nocturnal enuresis, amphetamine withdrawal and cocaine dependence.[9]

Among the 44 conditions, ADs were found to be potentially beneficial with a high level of evidence in treating 15 conditions and potentially beneficial with a lower level of evidence in treating 5 others. No proof of benefit was found for 15 conditions and proof of no benefit for 9.9 In other words, 55% of the conditions for which antidepressants were being prescribed had either no evidence of benefit or evidence of no benefit for patients.

The FDA states that

Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.[10]

In another study conducted by Mercier et al a number of focus groups were convened to  “explore GPs’ viewpoints regarding their reasons for prescribing antidepressants and to determine what indications they reported using them for in daily practice.”[11]

The study showed that although the GPs stated that antidepressants were rarely prescribed for conditions other than those specified by the guidelines, they mentioned 24 unapproved “non-psychiatric” situations that might lead to a prescription.

The focus groups found that

ADs were seen as very useful, effective, safe and having few adverse effects, which gave the GPs a sense of self-confidence. The GPs were not afraid to prescribe antidepressants, which were seen as having little or no risk of addiction and as not harmful. Though antidepressants were sometimes assessed as useless, they were very rarely related to suicidal intentions.[11]

The researchers tell us that the GPs “harshly criticized the guideline criteria and agreed they were irrelevant in primary care settings” and had developed their own diagnostic tools including a ‘therapeutic test’ in which they gave a prescription for an antidepressant and assessed the patient a few days later as a way of reviewing their initial feelings about their diagnosis.

So much for evidence-based medicine.

In recent years there have been a constant stream of prosecutions and fines imposed on pharmaceutical companies for off-label promotion of drugs that have caused harm to consumers. And rightly so. In the end, though, these drugs are prescription only and it is doctors not pharmaceutical companies who supply them to patients. In all the stories we read of the harms arising from off-label promotion of drugs there is never a focus on the doctors who wrote the prescriptions. There is never a prosecution of a doctor for the kind of negligence described in the Mercier et al study.

Sometimes doctors are misled by members of their own profession who have sold out to the pharmaceutical industry. More often however, doctors are simply casual to the point of negligence when it comes to prescribing antidepressants. Pharmaceutical companies rely on doctors to ignore best practice and professional standards and evidence and the OECD data shows they don’t fail to deliver.

My son died as a result of off-label prescribing of an antidepressant and, while I recognize the role of the drug company who made the drug in his death, the fact is that no matter how hard Mylan Pharmaceuticals marketed their drugs, they would not have been in my son’s body had they not been prescribed by a doctor. Mylan did not sit with him and tell him he had a chemical imbalance that could be fixed by their drug. Mylan did not neglect to tell him of the adverse reactions he might suffer or that the drugs were being prescribed off-label. Mylan did not fail to report his death to the regulator. Those were the actions of his doctor, who since his death continues to prescribe the same drug off-label.

These drugs carry the FDA’s highest warning of lethality. They are potentially fatal. It’s time doctors started prescribing responsibly and were held to account when they don’t. My son’s case is currently being reviewed by the police who are assessing whether manslaughter charges should be laid. I have no doubt that they should be, not just for justice for my child but to provide a deterrent to the continued and casual expansion of off-label prescribing of antidepressants.

 


[1] OECD (2013), Health at a Glance 2013: OECD Indicators, OECD Publishing, November 21, 2013. DOI :10.1787/health_glance-2013-en

[2] Rao, M., A Mysterious Loss of Memory. Current Psychiatry, 8(4) April 2009
[3] New Depression Treatments Are on the Horizon. Loyola Medicine, February 14, 2014

[4] Fiddian, P., Antiepileptic is Effective Depression Treatment. Pharmaceutical International News. October 16, 2013

[7] Mercier, A.,  Auger-Aubin, I., Lebeau, J.,  Schuers, M., et al.; Evidence of prescription of antidepressants for non-psychiatric conditions in primary care: an analysis of guidelines and systematic reviews. BMC Family Practice. 14(15) May 14, 2013. doi:10.1186/1471-2296-14-55

[8] Mojtabai R, Olfson M: Proportion of antidepressants prescribed without a psychiatric diagnosis is growing.  Health Aff 2011, 30:1434-1442

[9] Mercier, A.,  Auger-Aubin, I., Lebeau, J.,  Schuers, M., et al.; Evidence of prescription of antidepressants for non-psychiatric conditions in primary care: an analysis of guidelines and systematic reviewsBMC Family Practice. 14(15) May 14, 2013. doi:10.1186/1471-2296-14-55

[11] Mercier, A., Auger-Aubin, I., Lebeau, J., Van Royen, P., Peremans, L.; Understanding the prescription of antidepressants: a Qualitative study among French GPsBMC Family Practice. 12(99) September 24, 2011. doi:10.1186/1471-2296-12-99

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Maria Bradshaw
DelusionNZ: Maria Bradshaw lost her only child to SSRI induced suicide in 2008. Co-founder and CEO of CASPER (Community Action on Suicide Prevention Education & Research), Maria promotes a social model of suicide prevention focused on strengthening community cohesion, addressing the social drivers of suicide and providing communities with the knowledge and tools required to reclaim suicide prevention from mental health professionals. Maria has an MBA from Auckland University and particular interests in sociological and indigenous models of suicide prevention, prescription drug induced suicide, pharmacovigilance and alternatives to psychiatric interventions for emotional distress. Maria has researched and written a number of papers challenging the medical model of suicide prevention.

11 COMMENTS

  1. Ms. Bradshaw,

    Thank you for a cogent and moving narrative. With your permission, may I cross-post this article with a short introduction to the Global Summit for Diagnostic Alternatives, sponsored by the US Society for Humanistic Psychology?

    There are many parallels in your article to points raised by several of the discussants at DxSummit.org . You may also find of interest, a paper which I published there on “Psychogenic Pain and Iatrogenic Suicide”. In that paper I offer evidence that the simple act of interjecting a psychosomatic diagnosis into the medical records of a chronic pain patient, is responsible for a 250% increase in suicide risk. See http://dxsummit.org/archives/1002

    Sincere best regards,
    Richard A. Lawhern, Ph.D.
    Resident Research Analyst and Moderator,
    Living With TN — An Online Community Within Ben’s Friends

  2. Thank you for your article, Maria. I hope the police do prosecute, we absolutely need the doctors to be held accountable for their harm, attempted murders, and murders of patients. And right now no one is policing the medical community. And the lawyers aren’t taking the cases either.

    And, Richard, I had “chronic pain” due to a “bad fix,” so was put on Wellbutrin (for smoking cessation), Ultram, and Voltaren. The adverse effects of this drug cocktail were then misdiagnosed. Then I was whacked out of my mind with many antipsychotics, and poisoned, anticholinergic intoxication poisoning. And I was eventually medically unnecessarily shipped to a doctor whose now been arrested by the FBI for having many patients unnecessarily shipped to him, “snowing” patients, then performing unneeded tracheotomies.

    Definately, Maria, there is a problem with lack of ethics within the mainstream medical community. I’m so sorry you lost your child.

  3. Thank you for this excellent article. Off-label prescribing is a huge issue in medicine generally, but the problem is particularly acute in psychiatry. I cannot understand the various regulators’ casual stance.

    Thank you also for drawing attention to the role of doctors in this whole mess. As you point out, Pharma is very powerful but it can only succeed if it has willing agents.

  4. Like you Maria it was many months after my daughter’s suicide that I discovered the facts around SSRIs. I too blamed myself for not being aware but I trusted our GP who had known us for many years to have my daughter’s best interest at heart. I could not believe that there was information available to our doctor that these drugs were not recommended for those under 18 years old because of the suicide risk which was not on the PIL at that time. My daughter was 17 and 2 weeks when she was first prescribed an SSRI. The doctor did mention that the drug was usually for adults but implied that my daughter’s height etc put her in this category. I could not do any research on the drug in 2004 with dial up internet at home. Besides I believed that the doctor was the expert and trusted her. When I realized that this trust was questionable and that the drugs were prescribed without any mention of side effects, without advising me as my daughter’s carer to be aware of this or that, that the recommended withdrawal procedure was highly dangerous and most likely the cause of her suicide – I wanted action taken. My solicitor advised me against lengthy and expensive legal action as all doctors in this area would follow the same prescribing/ withdrawal procedure and no negligence would be proven. I wish you well with your action and will hopefully be able to follow your example. Regardless of time elapsed a crime remains a crime.

  5. In a healthy and sane society a person with serious emotional problems could be treated with psychedelics in a good environment and with an experienced guide. But these virtually non-toxic drugs are illegal while the other most dangerous ones are handed out quite casually and without much reflection by of all people the doctors. So the doctors are the real drug dealers. The fact that this is true shows the degree to which civilization has distorted people’s ability to see clearly. It is not that they don’t have intuitions, they do; but these are over ruled by the experts and authorities who are usually supported by vast corporational networks. It would seem that almost everyone is working for the good of institutions and corporations whose goals are no longer human or humane. Death machines literally. Nations that can destroy whole countries (Iraq, Libya, Syria) are not going to hesitate to destroy their own people when it suit their purposes.
    All most all studies and research show that people taking the psychedelics experience a genuine enhance of their lives. Hardly true of the deadly psych meds. Hopefully people are catching on.