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9 June 2005 Edition

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Pharmaceutical companies play down danger of neuroleptic drugs - BY SEAN FLEMING

Over the course of recent months I have, in a personal capacity, written to pharmaceutical companies in the 26-County state who manufacture what are known as atypical 'anti-psychotic' drugs in the 'treatment' of 'mental illness'. I was motivated to do this by what I believe is a failure on the part of these companies to fully inform psychiatric patients in relation to the dangers of such drugs.

I also raised these concerns with the Irish Medicines Board (IMB), the state's drug regulatory body, which I felt were entirely inadequately addressed.

It is accepted, for instance, within the medical profession that these drugs are associated with tardive dyskinesia (TD), a neurological disease characterised by abnormal involuntary movements of the facial muscles, mouth, neck or indeed any part of the body.

All the companies who manufacture these drugs fail to use the term tardive dyskinesia in the patient information leaflet (PIL) provided with the drugs. The PILs‚ provided by the companies and the psychiatric profession, falsely describe the symptoms of TD as 'side effects' of the 'medication'. This represents a serious distortion of the truth, as tardive dyskinesia is a disease of the nervous system caused by neurotoxic drugs. A high percentage of psychiatric patients develop TD, even after two to three months on these drugs.

Another serious health risk presented by these drugs is that of drug related diabetes. In 2003, in one of the most extensive reviews carried out by a drug regulatory authority, the Food and Drug Administration (FDA) in the US said that in relation to the older anti-psychotics, the new or atypical drugs olanzapine (Zyprexa), clozapine, quietiapine and risperidone (Risperdal) were all associated with a statistically significant increase in risk for diabetes.

The PIL though, in relation to these drugs for patients in Ireland, states that the risk is 'very rare' or 'rare'. Patients in the US who were prescribed Risperdal and Zyprexa and who subsequently developed diabetes have filed lawsuits against Janssen Pharmaceutica and Eli Lilly, respectively, and lawsuits been filed against AstraZeneca, manufacturers of Seroquel (quietiapine).

In September 2003, the FDA warned the American company Janssen Pharmaceutica about providing misleading information to healthcare professionals in relation to Risperdal and in an FDA report on Zyprexa, it was also noted that 29% of patients were gaining 7% or more of their baseline weight in under six months. Both drugs are notorious for massive weight gain and disfigurement.

Interestingly, in relation to Risperdal, the Irish Medicines Board (IMB) agreed late last year with Janssen the variation for the PIL in relation to diabetes. It is likely that the new and belated PIL for Irish patients will point out this increased risk. The present PIL still states, though, that it may occur in 'very rare cases'.

Given the real fears surrounding patient safety, the company Novartis, who make clozapine, have decided to monitor their drug by registering patients in Ireland to the Clozaril (clozapine) Patient Monitoring Service. Clozapine, it has been clearly established, can cause a drop in the white blood cell count.

It should also be noted that some companies don't make any reference at all to the risk of diabetes in their PILs, despite the fact that considerable medical literature makes it clear that all 'anti-psychotic' drugs present such a risk.

Bristol Myers Squibb, who make Abilify, and Pfizer, who make Geodon, simply fail to inform patients in Ireland about this.

The IMB, in its capacity as a member of the European Agency for the Evaluation of Medicinal Products, through which Abilify is licenced, could be calling for changes to be made in relation to this PIL. It could also make a call for an updated warning on Zyprexa's European licence. This though, to my knowledge, has not taken place.

Similarly, the IMB, through their participation in the World Health Organisation, could call on Pfizer to highlight the diabetes risk. In fact, the IMB's role within both bodies provides it with an opportunity to call for greater and more accurate patient information, irrespective of the various positions of drug regulatory authorities.

There must, therefore be a more proactive approach by the IMB on this issue. It may be reluctant to adopt such a stance, given that the pharmaceutical industry contributes approximately €3 billion a year to the Exchequer in tax payments. These figures come from the Irish Pharmaceutical Healthcare Association, representing the interests of the international research based pharmaceutical industry in Ireland, and with whom the IMB works closely.

The 26-County state is also the second biggest net exporter of pharmaceuticals in the world. It is also important to note that each of the drugs mentioned is worth abetween $2 billion and $4 billion a year globally to the companies involved. Outspoken criticism of these companies may, therefore, have real effects on investment in this country.

It is possible that in the future we may see legal action being taken by patients in Ireland against the companies concerned and even the psychiatric profession, if they have failed to monitor patients for signs of diabetes.

These drugs have not emerged as the psychopharmacological breakthrough for 'mental illness'. Psychiatry, it should be remembered, has a long history of discredited, torturous and dangerous 'treatments'.

It must be remembered that essentially, these drugs serve as chemical restraints in their mental and emotional numbing effects on the patient. Clearly, therefore, these drugs should only be prescribed for the shortest possible period of time. The psychiatric profession believe, though, that they help to redress some alleged brain chemical imbalance and that a patient must, therefore, remain on them for many years, if not a lifetime.

Patients being prescribed these drugs must be regularly monitored for signs of diabetes and other serious related medical complications. The patient must be informed in the PIL that diabetes can lead to blindness, kidney failure, hardening and narrowing of the arteries leading to strokes and heart disease. There must be a clear warning that liver disease, eye diseases, thyroid disorders and a potentially fatal blood disorder in which the body stops producing the white blood cells vital to its protection from infections, are also risk factors for these drugs. The patient must be informed that these drugs can, in the long term, cause brain damage and actual structural changes to the brain. There must be more awareness about the dangers of the drugs anticholinergic effects (severe constipation with bowel obstruction, difficulty urinating, dry mouth, blurred vision, etc).

The PIL should explicitly state that tardive dyskinesia is a neurological disease. The PIL must also explicitly mention other risks such as akathisia (compulsive restlessness) and neuroleptic malignant syndrome (similar to viral brain inflammation).

For these companies, though, profits come before psychiatric patients. If any other 'treatments' were causing even a small percentage of the problems that these drugs are causing, there would be a public outcry.

The rights and the dignity of psychiatric patients are not being upheld and the psychiatric profession has clearly sold its soul to the drug companies. It is to be hoped that successful litigation by patients in the US will bring radical change to the way these companies operate and that this will encourage others elsewhere to speak out. This failure to recognise the great harm caused by these drugs must be addressed once and for all.

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