Whistleblower in Coventry: Dr Yolande Lucire and Big Pharma

Australia lags well behind the US and Britain in facing up to the malfeasance of multinational drug companies pushing unsafe products. Very often Big Pharma itself has largely conjured up the booming markets in which its dubious drugs offer expensive treatment for dubious medical conditions.

The biggest and most lucrative scandals have been in two types of second-generation drugs: anti-depressants or SSRIs - Prozac, Paxil, Zoloft, etc, and "atypical" antipsychotics such as Zyprexa, Risperdal and Seroquel which were known from their licensing to be ineffective for the vast majority of clinical trial subjects and up to twice as bad for inducing suicide as antidepressants.

The corrupt drug trial and marketing practices of Big Pharma include imaginary science (the serotonin deficiency theory of depression), systematic suppression of lethal side effects (akathisia - cannot-sit-down restlessness - leading to suicidal ideation, suicide and murder) and a multi-billion dollar success over the past generation in medicalising the ordinary ups and downs of the human psyche.

Feeling sad? ("Moderate depression", worthy of a happy little Zoloft rock.) Diffident? ("Social anxiety disorder", try Aropax.) If antidepressants cured any significant number of people there would be significantly less cost and less demand for mental health services in Australia. Whether from inadequate or tendentious pharmacology training, laziness, busyness, greed driven by willed ignorance or even misplaced conviction, the medical profession has succumbed to the cynical marketing and the targeted blandishments of the pharmaceutical companies.

Medical and scientific journals from Nature to The New England Journal of Medicine allowed their columns to be infiltrated for years by blatantly dishonest research reporting and ghost written articles commissioned in Pharma-land but signed by distinguished professors frequently in receipt of seven-figure research and consultancy funding. Most of these journals do now take another tack, debunking Pharma claims and exposing fraudulence. But many medical professional bodies are still being subsidised beyond hope of objective dealing with the issue of mass iatrogenesis caused by dud drugs andmultiple drug prescribing ("polypharmacy"), and particularly with the lethal side effects of anti-depressants.

The key drug regulator in the US - and the planet - the United States Food and Drug Administration (US FDA) has failed to purge the Pharma-friendly experts who have dominated its rulings up to now. Our own Therapeutic Goods Administration obediently follows suit, also licensing drugs largely on information provided by their makers. But in America the going has been getting perceptibly harder for the drug companies.

Whistleblowers, class actions and litigious state governments confronting ballooning health costs have been taking a toll on profits. Pfizer was recently fined $US2.3 billion for fraudulently promoting four drugs including the "antipsychotic" Zeldox last year. This fine is seriously denting Pfizer's bottom (net income) line of $US8 billion, and whistleblowers, including former Pfizer employees, collected over $US100 million for their pains in this case - a big threat to Pharma for the future.

Although such a fine has been described in a recent British Medical Journal as"firing 22s into the arse of a rhino" and Pfizer has been called "too big to nail" (only a Pfizer subsidiary pleaded guilty to criminal charges), drug companies face a rising tide of multi-billion dollar class actions and the prospect of new laws which could put them out of business. The original whistleblowers who were listened to have made the key difference in the United States. Robert Whitaker traced the suicide epidemic and mental health cost blow-out following the launch of Prozac in 1988. The quiet Irishman, David Healy, exposed drug trial fakery and the vast, hidden collateral damage of pharma's SSRI bonanza in the 1990s and later.

These two and others have engineered a paradigm shift in public understanding, and professorial heads in receipt of undeclared consultancy riches have started to roll at research institutes and universities in the US, including even Harvard. According to the New York Times, Dr Joseph Biederman, the pioneer of "aggressive diagnosis and drug treatment of childhood bipolar disorder", failed to report most of the $1.6 million he received in pharma funding over several years while at Harvard.

The single person who has been trying hardest to fill the Whitaker/Healy whistleblower gap in Australia is Sydney psychiatrist, Dr Yolande Lucire. Thirteen years ago she began to notice alarmingly high hospital admission and suicide rates among patients treated with SSRIs and atypical antipsychotics in New South Wales's Greater Southern Area Health Service. Since then she has been fighting back against the Pharma-driven psychiatric consensus that treating with SSRIs is safe and effective, working hard to wean patient-victims as well as their prescribers off the drugs.

She has steadily accumulated damning statistics on suicide, homicide and hospitalisation rates among these patients in New South Wales. More recently it has become clear that a large percentage of people being treated with antidepressants can't metabolise them due to common genetic mutations. Dr Lucire has been campaigning to introduce systematic doctor education in order to minimise promiscuous and uninformed anti-depressant prescribing. With her complaints, findings and warnings about lack of action, Dr Lucire has been assiduously lobbying her colleagues, the Medical Board and the Health Care Complaints Commission of NSW, the Adverse Drug Reactions Advisory Committee (ADRAC) of the federal Therapeutic Goods Administration and a clutch of ministers, both state and federal, for many years. Most recently she has been providing redacted files on her own extensive sample of DNA swab-tested relapsing patients suffering from the side effects of SSRIs and polypharmacy.

And she has had one notable victory in the political arena. Under pressure from Dr Lucire, the secretary of Health and Ageing set up an inquiry early in 2009 into 90 of her serious adverse drug reaction reports, which occurred mainly in normal folk treated for stress and other vicissitudes of life and who had become suicidal and/or homicidal on antidepressants. The Psychiatric Drug Safety Expert Advisory Panel reported in December last year, confirming her concerns about the near-universality of ignorant polypharmacy and dangerous gene-based drug-drug interactions leading to akathisia, suicide and homicide and all the mental states preceding them.But its recommendations are still waiting to be noticed by the NSW Medical Board and Department of Health.

So far the Medical Board seems to have quite other ideas about Dr Lucire's contribution to public health than the Advisory Panel. In July 2007 one of the many patients she was trying to save from another bout of potentially lethal akathisia killed her own father and sister. In her view, this patient's akathisia was initially caused by the polypharmacy which had previously aggravated her mental condition. But this case led to Medical Board proceedings against her. She has concerns about the board's procedures and why she is being targeted.

At the core of her alleged delinquency are charges that she has failed to recognise that SSRI treatment is "standard practice" - also "best practice"; that she has "unusual beliefs (read: not good for the professional bottom line) about the side effects of psychotropic medication"; that she is "lacking in respect for colleagues' diagnoses", and has been "guilty of destroying patients" confidence in their treating doctor" (while saving their sanity and/or lives, could we add?).

Galileo would have been familiar with this kind of stuff. What Dr Lucire's hostile critics, like Galileo's, have not done is respond professionally to her criticisms in scientific terms. Could they be scared of the result? Dr Lucire continues to draw attention to the causes of the public mental health problem, albeit at times in a naive, didactic or exasperated manner, as she admits herself. She has good grounds for paranoia, but she is unwise to be forever saying that no-one takes any notice of her (fully justified) Cassandra-like warnings. The Expert Advisory Panel did; some fair-minded journalists do, and also a sprinkling of academics in science based disciplines.

She is appealing the latest tribunal decision in the Supreme Court of New South Wales backed with character references by a Who's Who of people wise to the ways of corporate money in the medical professions and familiar with the differences between majority views and what is scientifically established in psychiatry. Dr Lucire also persists in trying to stymie the campaign currently building around the country to drastically expand hospital and clinical services for the mentally ill.

Prominent in this campaign are Australian of the Year 2010, Professor Patrick McGorry of Melbourne University and headspace, and Professor Ian Hickie of the Brain and Mind Research Institute at Sydney University and the SPHERE national depression initiative. Patrick McGorry is a proponent of early drug intervention to combat youth depression. Ian Hickie is an outspoken and genuinely concerned intervener in a wide array of debates on the social health of Australia and Australians, most recently concerning the fate of badly accommodated university students.

But his Brain and Mind Institute was lately discovered by The Australian to be housing Lifeblood, a private company helping the pharmacy industry spend $75 million on "doctors' education". Lifeblood has boasted on its website that SPHERE, "a mental health program undertaken by 12,000 GPs since 1998", of which both Pfizer and the Brain and Mind Research Institute are commercial partners, has restored Pfizer's Zoloft to market leadership in the anti-depressant stakes. Hickie himself was the architect of the controversial (and Bristol Myers Squibb funded) "depression screening tool" (a checklist of questions for GPs) used in SPHERE.

How awkward this all must be for his institute - and for your (and my) Sydney University, which also boasts a Pfizer/PPF Chair of Pharmacy Management and a Pfizer Australian Chair in Clinical Pharmacy. Professor Hickie also co-authored the Royal Australian and New Zealand College of Psychiatrists' original (2003) recommended guidelines for treatment of depression, whose clarion call was: "Depression is common, serious and treatable. It affects 1 in 25 people in any 1 month." These RANZCP guidelines recommended that even "moderately severe" depression should be treated with Nefazadone, a drug which was withdrawn four months later because of fatal side effects. Very few specific side effects or drug-drug interactions were reported in these guidelines, which have been only cosmetically improved in their 2009 version for the “consumer and carer”.

The RANZCP guidelines (and near identical ones around the world) emerged from the Texas of Governor George W Bush where they became mandatory in the treatment of prisoners and public mental patients following a lavish lobbying campaign under the rubric of the Texas Medication Algorithm Project by Big Pharma. According to Dr Lucire, the notion of applying algorithms or "one size fits all" to a genetically diverse population in the days of personalised medicine borders on obscene.

What is first and most needed in Australia's so far depressing, big American, Pharma driven approach to depression is not more of the same but less. Antidepressants used for anything less then severe depression, and closely monitored, are an expensive, ineffective (less than three per cent more effective than placebo in clinical trials presented to the US Food and Drug Administration for their licensing) and dangerous family of drugs whose side effects and addictive qualities have triggered a serious crisis in public health - not least by an explosion of hospital beds for unrecognised side effect casualties.

The highway to massive cost savings - and effective redirection of public spending on mental health - is to break the addiction of psychiatrists, doctors, medical bureaucracies and patients to the notion that there is a pill for every ill. Dr Lucire's professional martyrdom may well continue short term. But developments in the US suggest that her brave and brilliant efforts in this direction, however casually and cynically denigrated, will eventually prevail here. There will be many and much to answer for if justice for her and the Australian victims of the SSRI scourge is long delayed.