This article on how pharmaceutical companies play down the dangers of neuroleptic drugs appeared in two Irish newspapers. One journalist who viewed it invited a psychiatrist friend of his to comment on it. Those comments by Siobhan Barry of the Irish Psychiatric Association as well as my counter response are included here.

Between November 2004 and April 2005, I in a personal capacity wrote to pharmaceutical companies in the Republic of Ireland 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 begin to 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 USA WHO WERE PRESCRIBED RISPERDAL AND ZYPREXA AND WHO SUBSEQUENTLY DEVELPED DIABETES HAVE FILED LAWSUITS against Janssen Pharmaceutica and Eli Lilly respectively, and lawsuits have also 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 IMB agreed late last year with Janssen the variation for the PIL in relation to diabetes. It is likely that the new PIL for Irish patients will point out this increased risk. The present PIL still states though that it may occur in 'very rare cases'. (17/7/05)

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 in Ireland contributes approximately €3 BILLION A YEAR TO THE EXCHEQUER IN TAX PAYMENTS. These figures come from the Irish Pharmaceutical Healthcare Association which represents 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 BETWEEN 2 BILLION AND 4 BILLION US$ A YEAR GLOBALLY TO THE COMPANIES INVOLVED. Outspoken criticism of these companies may therefore have real effects on investment in this country. Incidentally, use of tranquillisers and ‘anti-depressants’ in Ireland is also one of the highest in Europe.

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 in relation to the neuroleptics. 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 these drugs could only justifiably 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 remain on them for many years if not a lifetime.

PEOPLE BEING PRESCRIBED THESE DRUGS MUST BE REGULARLY MONITORED FOR SIGNS OF DIABETES AND OTHER SERIOUS RELATED MEDICAL COMPLICATIONS. The person 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 serious risks such as TARDIVE 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 serious health 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 USA 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.

RESPONSE FROM SIOBHAN BARRY OF THE IRISH PSYCHIATRIC ASSOCIATION TO ARTICLE:

In response to Sean Fleming, it should be understood at the outset that:

1. I am writing as the PRO of an organisation that was set up to work for those that are involved in the mental health services as service providers or users with view to improving what that service offers. I am not representing the pharmaceutical industry about whom much comment has been levelled in the correspondence.

2. All medications have the risk of causing side effects and this list includes over the counter preparations such as aspirin and paracetamol as well as dispensed drugs such as are used in the mental health field.

3. I can respond directly to two of the psychotropic medication related topics raised - firstly, reference is made to the involuntary movement disorder called Tardive Dyskinesia - There is evidence from the US, Morocco, India and our own studies carried out in Ireland which were not funded by the pharmaceutical industry that show that there is x6-fold increased rate of involuntary movements in people with schizophrenia, who have never taken neuroleptic medication, when compared to the general population. The finding of involuntary movements in schizophrenia is likely to be indicative of underlying brain pathology. In my view medications, particularly of the older type, are more likely to make this worse. Secondly, in the case of diabetes and the newer type of atypical neuroleptics was raised, and of course it is vital to monitor patients carefully - weight, blood pressure, random blood sugars and ECG for example when such medications are prescribed. However, there are also issues in relation to lifestyle and schizophrenia - in reduced levels of physical activity, increased smoking and an often poor attention to diet that undoubtedly may also play a part.

4. There is a reference to "a long history of discredited, torturous and dangerous treatments" perpetrated by psychiatry but the same could be said of governments, the media and humanity in general.

All patients, their families and doctors wish that there was a side effect-free one highly effective tablet for schizophrenia - regrettably there is not. The most comprehensive treatment for psychhotic illnesses of which schizophrenia is the most common comprises medication, psychological input, social & occupational recovery programmes and family/carer education. About 15% of people who develop psychosis have a single episode but the probablity of relapse within 6 months of stopping neuroleptic medication occurs for more than 80% of people so unfortunately, individuals need to persist with medication to stay mentally well in the majority of cases. There are a range of medication options to ensure that side effects for an individual are at a minimum.

What is needed in the mental health services is a reduction in stigma, a non threatening environment for assessment and phase-specific treatment from a multidisciplinary treating team involving medical, psychological, social and vocational care, where the individual plays a key decision making role in all aspects of their treatment plan.

Finally, on an allied note, one of the best predictors of outcome for people with schizophrenia is the delay between the onset of their illness and receiving effective treatment which includes neuroleptic medication. The longer this delay, the poorer the outcome. Elsewhere in the developed world, early intervention in psychosis programmes ensure that accessing effective treatment is available at an early stage in the development of psychotic illnesses with many consequent benefits in terms of recovery from illness and a reduction in the secondary handicaps of serious mental illness.

In closing, I would like to repeat that my remit and that of the organisation that I represent is to seek the best outcomes for those who use the mental health services.

Siobhan Barry,

PRO, Irish Psychiatric Association.

COUNTER RESPONSE from Seán Fleming:

To begin I take issue with Siobhan Barry describing the effects of neuroleptic drugs as ‘side-effects’. One of the REAL EFFECTS of such drugs is tardive dyskinesia which the psychiatric profession do not dispute is caused by such psychiatric drugs but which they play down as a side effect. The psychiatric profession also say that these drugs help to redress a chemical imbalance which ‘schizophrenics’, for example, are believed to suffer from. They say that an excess of dopamine, one of the brain’s neurotransmitters, causes the symptoms of such ‘illnesses’. They don’t tell people that there are no medical tests such as brain scans, blood tests or any other suitably objective medical tests which can measure such imbalances or prove that someone suffers from overactivity of dopamine in the brain.

In relation to my writing about tardive dyskinesia, a neurological disease, she says: "There is evidence from the US, Morocco, India and our own studies carried out in Ireland which were not funded by the pharmaceutical industry that show that there is x6-fold increased rate of INVOLUNTARY MOVEMENTS (capitals mine) in people with schizophrenia, who have never taken neuroleptic medication, when compared to the general population."

She does not give any references to such studies and I and others I have been in contact with have never heard of these studies.

It has to be stressed that she is talking about involuntary movements and not tardive dyskinesia which is an important distinction. It should come as no surprise that people who are deeply distressed may make involuntary movements. Thoughts that people find disturbing or intrusive may cause them to grimace or make such movements.

She also says in relation to this that: "The finding of involuntary movements in schizophrenia is LIKELY (capitals mine) to be indicative of underlying brain pathology".

She says ‘likely’ because there is absolutely no objective evidence through physically based medical testing of any brain pathology.

As Siobhan Barry herself will admit and what is indisputable is that WE DO KNOW THAT PSYCHIATRIC DRUGS SUCH AS THE NEUROLEPTICS whether of the older or newer variety DO CAUSE TARDIVE DYSKINESIA. THIS IS A NEUROLOGICAL DISEASE CHARACTERISED BY ABNORMAL INVOLUNTARY MOVEMENTS OF THE FACIAL MUSCLES, MOUTH, NECK OR INDEED ANY PART OF THE BODY. The psychiatric profession do not want attention drawn to the fact that they are causing SUCH A DISEASE with their drugs. Therefore it comes as no surprise to me that they are plugging these so-called studies. Psychiatric literature in relation to such ‘studies’ often uses terms such as ‘likely’ or ‘may’ or ‘seem to suggest’ when writing about them. Let us be clear though - Tardive dyskinesia is not a side effect of psychiatric drugs – IT IS A DISEASE CAUSED BY THE POISONING OF THE CENTRAL NERVOUS SYSTEM WITH NEUROLEPTIC DRUGS. Neuroleptic means nerve seizing.

I also would like to know though who funded these studies. Was it the Royal College of Psychiatrists in Ireland or some other psychiatric body which supports the disease or medical model of mental illness? If that is the case then people should not be surprised that these psychiatrists have brought their own biased views and their own wished for outcomes to these studies.

In relation to drug related diabetes she says we need to look at the role of lifestyle factors and how this may be responsible. She says that it is vital that patients are monitored for diabetes but does not say that psychiatrists ensure that this monitoring takes place. That is because it hardly ever does. The reality is that these drugs often do cause massive weight gain and the weight gain is the direct result of the drugs and the companies themselves admit the link. One can say with certainty that the weight gain is largely attributable to these drugs. I have seen people over the years who were quite literally disfigured by these drugs and who were not eating any more than they normally did. Also, considering the physical, mental and emotionally debilitating effects of these drugs people often do not have any energy and find themselves unable to do the things they normally did. Patients often complain of a ‘zombified’ feeling in relation to these drugs.

LET’S US NOT ALSO FORGET THAT AT LEAST 1 in 10 ‘schizophrenics’ COMMITS SUICIDE. I believe that these drugs are a major factor in this.

Siobhan Barry fails to mention the fact that the reason why psychiatric patients relapse when they stop taking psychiatric drugs is because of the fact that THESE DRUGS CAUSE DEPENDENCY. Many patients are deeply unhappy with the effects of these drugs and should have medical help and support in s-l-o-w-l-y withdrawing from them. They are denied such support.

A mention of other serious health risks caused by these drugs was not addressed by her (as pointed out in above article). In relation to her mentioning smoking psychiatric studies themselves indicate that the reason why these patients smoke may be due to the fact that nicotine helps to regulate psychiatric drug disrupted neurotransmitters.

She talks about the need to tackle the stigma of so-called mental illness. The reality is that psychiatry and the psychiatric profession create and perpetuate the stigma of ‘mental illness’. They tell people that they have ‘mental illnesses’ or psychiatric disorders related to brain chemical imbalances or genetic defects and yet they have never ever been able to establish a biological cause for even ONE of these ‘mental illnesses’.

They detain people against their will and forcibly drug people and administer brain-damaging ECT. No one seems to question this power that they have over vulnerable people and how it can often be abused. Psychiatrists pathologise aspects of a person’s thinking, feelings and behaviour given that there is NO OBJECTIVE PHYSICAL PATHOLOGY TO OBSERVE. The societal and environmental factors in severe mental distress or ‘mental illness’ are of secondary importance to them given that they believe that the causes of ‘mental illness’ are primarily biological.

In relation to her rather dismissive view of the long, tortuous and discredited history of psychiatry she also fails to see how these practices may well be continuing today. Many tens of thousands of poor souls suffered lobotomies by the psychiatric profession, a practice which continued up until recent times, a practice which the psychiatric profession now admit was totally wrong and barbaric. Today though we witness the continuation of this practice in many cases through chemical lobotomies. There is absolutely no justification for prescribing these drugs for many years or a lifetime given the very serious health risks presented. Psychiatry is inextricably linked with the drug companies who have distorted the findings of drug trials and who have lied about the real effects of their drugs. Psychiatry despite the great harm inflicted by it on their ‘patients’ will continue to protect its own professional power and prestige. Meanwhile many lives affected by their ‘treatments’ will continue to be ruined.