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, 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), which is 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 and 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 USA 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
developed diabetes have filed lawsuits against Janssen
Pharmaceutica and Eli Lilly respectively as have
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 though that some companies
don’t give any reference at all to the risk
of diabetes in the PIL 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 IBM’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 according to the
Irish Pharmaceutical Healthcare Association, representing
the interests of the international research based
pharmaceutical industry in this country and with
whom the IMB work closely, the pharmaceutical industry
contributes approximately €3 billion a year
to the Exchequer in tax payments. This 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 around $ 2-
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 out 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.
