Glaxo denies “disease mongering”_Selling Bipolar questioned_PLoS

Since at least 2002, critics–including the director of the prestigious Cochrane Center, Dr. Peter C Gøtzsche–have been grappling with the notion that medicine has been derailed from its rightful mission of treating illness. http://bmj.bmjjournals.com/cgi/content/full/324/7342/886

“Disease-mongering turns healthy people into patients, wastes precious resources and causes iatrogenic (medically induced) harm. Like the marketing strategies that drive it, disease-mongering poses a global challenge to those interested in public health, demanding in turn a global response.” See, special issue of PLoS Medicine (Pubic Library of Science): http://collections.plos.org/diseasemongering-2006.php  

"Selling Sickness" by Ray Moynihan and Alan Cassels, followed by the Australian conference (April 11-13), "Disease Mongering," accompanied by a special issue of PLoS, have elevated the discussion. Three recent UK press reports address different aspects of the issue:

1. The Times World News: “Drugs companies ‘inventing diseases to boost their profits’ by Mark Henderson, April 11, 2006:
Richard Ley, of the Association of the British Pharmaceutical Industry, rejected the accusations, pointing out that Britain has firm safeguards against disease-mongering. Many of the authors’ criticisms, he said, were aimed squarely at countries such as the United States, where pharmaceuticals can be openly advertised directly to patients. “Drug companies are not allowed to communicate directly with patients, and we do not invent diseases,” he said.  http://www.timesonline.co.uk/article/0,,3-2128371,00.html

2. Guardian: “Glaxo Denies Pushing ‘Lifestyle’ Treatments” by Fiona Walsh Friday April 28, 2006.
“GlaxoSmithKline, Europe’s biggest drugs manufacturer, yesterday defended itself against accusations that it is turning healthy people into patients by "disease mongering" and pushing "lifestyle" treatments for little-known ailments.”  The head of GSK’s pharmaceutical operations, David Stout, denied the accusations, saying: " Things like restless leg syndrome can ruin people’s lives….”   http://business.guardian.co.uk/story/0,,1763199,00.html

3. Guardian: “Depression is UK’s Biggest Social Problem, Government Told” by Sara Boswell, April 18, 2006.
Lord Richard Layard, emeritus professor, London School of Economics, has an article in the BMJ in which he claims around 15% of the population suffers from depression or anxiety. He notes that the economic cost in terms of lost productivity is huge – around £17bn, or 1.5% of UK gross domestic product. "There are now more than 1 million mentally ill people receiving incapacity benefits – more than the total number of unemployed people receiving unemployment benefits."  http://society.guardian.co.uk/print/0,,329467273-106049,00.html

Richard Layard–as well as the National Institute for Clinical Excellence (Nice)–advises that drugs are not the best answer.  “He estimates that around 800,000 patients a year would require cognitive behaviour therapy. That means the country needs an extra 10,000 therapists.”
That should make psychotherapists ecstatic!

However, since the focus in mental health for the last several decades has been on drugs alone, there have been no controlled studies documenting the effectiveness of psychotherapy compared to the effect of a sympathetic listener.  Nevertheless, it is reasonable to assume that a even an incompetent therapist would do less harm than toxic drugs whose hazardous effects ARE documented.
The secret to the pharmaceutical industry’s staggering success until now may be found in the comment by GSK chief executive, Jean-Pierre Garnier: "Our eyes are open to all opportunities."

4. PLoS Medicine, like the BMJ online, has a commendable open commentary policy, and publishes responses to its articles almost the instant they are received. PLoS also is to be commended for requiring authors—including letter writers—to disclose funding sources for possible conflicts of interest.

Below is a critique of Dr. David Healy’s essay, “The Latest Mania: Selling Bipolar Disorder,”( See: PLoS Med 3(4): e185)  by Dr. Nassir Ghaemi who argues for the legitimacy of bipolar diagnosis citing  oft repeated misinformation about the ancient history and prevalence of bipolar disorder, and claiming the existence of “much larger empirical evidence that bipolar disorder has been highly underdiagnosed (rather than the minimal empirical evidence that it is overdiagnosed).”
 
Dr. Ghaemi’s critique is followed by Dr. Healy’s response corrects the historical facts, amplifying the points made in his original essay, pointing out:  “If bipolar disorder could be clearly traced back to the Greeks, the fact that American physicians so rarely made the diagnosis before 1970 and the introduction of lithium to the USA is hard to explain.”

Contact: Vera Hassner Sharav
veracare@ahrp.org
 
http://medicine.plosjournals.org/perlserv/?request=read-response&doi=10.1371/journal.pmed.0030185
 
The newest mania: seeing disease mongering everywhere
S. Nassir Ghaemi
, Director, Bipolar Disorder Research Program and Associate Professor of Psychiatry and Public Health, Emory University, Atlanta, GA, United States of America E-mail

Competing Interests: I wish to disclose the following current affiliations or involvement: research grants: GlaxoSmithKline, Pfizer; speakers bureaus: GlaxoSmithKline, Abbott Laboratories; advisory boards: GlaxoSmithKline, Pfizer.

Submitted Date: 26 April 2006 Published: 26 April 2006

I feel compelled to comment on your article on bipolar disorder by my friend and colleague David Healy. I respect Dr. Healy both as a historian of psychopharmacology and psychiatry, and as a psychopharmacology researcher. I have been impressed by his historical scholarship over the years in bringing out the economic and social aspects of the rise of psychopharmacology. I think his specific critiques about the likely overuse of antidepressants in the West in recent years, as well as the influence of the pharmaceutical industry, have been valid in many respects. I also find the special issue on disease mongering not unconvincing, especially as it relates to new potential diagnoses like adult ADHD. Yet I must take exception to the inclusion of bipolar disorder with such new-fangled entities.

Mania and melancholia have been well described since antiquity, and the current notions about the diagnosis of bipolar disorder (even the broader notions of the "bipolar spectrum") are fully present in the writings of Esquirol and Kraepelin. It seems highly unlikely that they were markedly influenced by the pharmaceutical industry. To accept the drift of this special issue, one would have to suppose that Arataeus of Cappadocia was heavily influenced by pharmaceutical marketing in the second century AD.

Of course, the possibility of overdiagnosis of bipolar disorder exists, often influenced by the pharmaceutical industry, but this in no way means that the diagnosis itself is invalid, nor does it counteract the much larger empirical evidence that bipolar disorder has been highly underdiagnosed (rather than the minimal empirical evidence that it is overdiagnosed) in the antidepressant era (1). Dr Healy seems to emphasize the issue in children, where indeed more uncertainty exists, but the overall impression of the article does not do justice to the reality that this illness has a long history of description and much more evidence of nosological validity (based on description, genetics, course and biological data) (2) than such newcomers as adult ADHD and restless legs syndrome. Perhaps we should be on the lookout for the newest mania: seeing disease mongering everywhere.

1. Ghaemi SN, Ko JY, Goodwin FK. "Cade’s disease" and beyond: misdiagnosis, antidepressant use, and a proposed definition for bipolar spectrum disorder. Can J Psychiatry. 2002 Mar;47(2):125-34.

2. E Robins, SB Guze. Establishment of diagnostic validity in psychiatric illness: its application to schizophrenia. Am J Psychiatry. 1970 Jan;126(7):983-7.

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The Best Hysterias: Author’s Response to Nassir Ghaemi
David Healy,
Director, North Wales Department of Psychological Medicine, Cardiff University, Cardiff, Wales, United Kingdom, E-mail

Competing Interests: DH has been a speaker, consultant, or clinical trialist for Lilly, Janssen, SmithKline Beecham, Pfizer, Astra-Zeneca, Lorex-Synthelabo, Lundbeck, Organon, Pierre-Fabre, Roche, and Sanofi. He has also been an expert witness in ten legal cases involving antidepressants and suicide or homicide and one case involving the patent on olanzapine (Zyprexa). None of these interests played any part in the submission or preparation of this paper.

Submitted Date: 27 April 2006 Published: 27 April 2006

Nassir Ghaemi has helped raise the profile of this truly debilitating disorder. This response trades on his respect for my historical scholarship. First mental disease entities are a recent construct. No disease resembling bipolar disorder was described before 1854 in Paris – and the links between folie circulaire described then and modern bipolar disorder are tenuous. Second, for the Greeks mania referred to any overactive insanity, and melancholia to any underactive state. The majority of manias were probably delirious states. The melancholias may have been anything from Parkinson’s disease to hypothyroidism. Third, Emil Kraepelin’s manic-depressive insanity (1899) was a very different disorder to bipolar disorder, which only appears in the late 1960s. If bipolar disorder could be clearly traced back to the Greeks, the fact that American physicians so rarely made the diagnosis before 1970 and the introduction of lithium to the USA is hard to explain. Kraepelin’s likely response to recent proposals that we recognize and distinguish between bipolar 1, 2, 2.5, 3, 3.5, 4, 5, 6 and bipolar spectrum disorders would probably not be printable.

Disease mongering is not the creation of diseases de novo – as in the restless leg syndrome Dr Ghaemi cites, descriptions of which go back to antiquity. Disease mongering is where the interests of the seller of a nostrum, who sells by emphasizing the existence of and risks of some condition, in fact outweigh the likely benefits from the proposed remedy to those affected by the putative condition (1). It shades into hucksterism and it was associated with Harley Street long before modern pharmaceutical companies. But companies now bring an industrial efficiency to this practice, and where physicians were once a bulwark of scepticism against any trading on credulousness, we are now the most cost-effective marketing tool companies have.

Mongering applies to conditions from mild elevations of blood pressure or lipids, or bone thinning. No one argues hypertension or hypercholesterolemia are not real or that in malignant cases these conditions do not constitute valid targets of treatment. But malignant cases are rare. In cases that are not malignant, when the likely intervention is with a toxic compound rather than a proposed alteration of lifestyle, there is or should be a boundary.

Psychiatry was once plagued by "boundary violations", where physicians exploited the dependence of their patients. All the indications are that we are now in a new era of drug-related boundary violations. There is perhaps nowhere in medicine where this is more obvious than in the case of bipolar disorders, with adults treated with bizarre cocktails and children put on some of the most lethal drugs in medicine.

Making it clear that the term mood-stabilizer is itself an advert and that the notion of bipolar disorder can be viewed as an instance of rebranding does not deny the reality of anything. The key concerns are not reality in this sense, but rather when to treat. As the history of hysteria shows, the best pseudo-convulsions come from patients with a convulsive disorder. The most realistic somatization from patients with other real disorders. Patients conform their presentations to the interests of their doctors. Drug companies know this. Patients deserve physicians alert to such possibilities. In the current welter of bipolar presentations, one worry is that patients with severe manic-depressive disorder will lose out. Another is that research on this most difficult of disorders will be invalidated by a dilution by patients with other problems. A final worry is that when the marketing caravan moves on, manic-depressive illness will be left once more under-resourced and researchers will have one less lever to pull as they have "had their chance".

References
1. David Menkes at Conference on Disease Mongering, Newcastle, Australia 2006.

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