He was a devoted father to our three beautiful children and a talented singer and musician as the sub-committee has heard. He was also a dedicated mental health professional. Niall died at around 11 a.m. on St. Stephen's Day 2003 of selective serotonin reuptake inhibitor, SSRI, induced suicide. He hung himself in the garden shed while our three children were alone in their pyjamas in the house. I was at work and not due to come home until around 8.30 p.m. that evening. The breakfast cereal was scattered around the table and no note was left. This was a spur of the moment action caused by drug-induced akathisia or mania; mental turmoil, inner restlessness, massive despair and unbearable turmoil where the only way out of such a black cloud is death. He lost control of his mind for the entire suicide event. He was a great thinker, level-headed, a highly intelligent sensitive man. His death by suicide was against his principles, beliefs and character — and against his important duties as a protective dedicated loving father, which he took very seriously.
His suicide was an explosive automatic reaction in which death must have been seen as a welcome relief from the rapid onset of depression, possibly caused by the SSRIs. He went around to his hospital duty office on 23 December 2003 to report back from sickness leave and return to work on 29 December 2003. That is not something a severely depressed person on the verge of suicide might be expected to do, three days before his death. It left me a widow at the age of 33, a single parent with three children under the age of five. I was told he had committed suicide by the Garda, in the accident and emergency department where I work and was left to explain to my children what had happened to Daddy.
My son, fatherless at the age of five, found his father hanging in the shed. He was left alone in the house, in his pyjamas, with his siblings and had to get help for his Daddy and his sisters — our little hero. My daughter, aged three, was left alone in the house in her pyjamas with her siblings while she was waiting for Daddy to come back — on the day of his death. She was the pearl of Daddy's eyes — our princess. My baby daughter was fatherless at the age of nine months. She was left in her pyjamas alone with her siblings in the house on the day of his death and found crying, by a neighbour, on the kitchen floor. She will never have memories of her father, my baby, Christa. That is our family today, one in five hundred.
The absence of appropriate mild drug treatment for mild depression in our community is contributing to a continuation of such deaths. These unnecessary deaths are very preventable if the required measures are put in place. Such experiences should never be repeated in Ireland, although the regime that gave rise to them continues. Our family's situation is incomprehensible, since it could have been prevented. My husband definitely was not lucky. The problem arises as serious conditions and common complaints are labelled as medical conditions requiring drug treatment. Runny noses are now serious allergies, PMS has become a psychiatric disorder and hyperactive children have ADD. Everyday sexual difficulties are seen to be sexual dysfunction, the natural change of life is a disease of hormone deficiency called menopause. Shyness has become a social anxiety disorder and distracted office workers now have adult ADD. It is not a conspiracy, simply daylight robbery and causes substantial harm. It is plain fraud costing human lives.
With all treatments there is a balance between benefits and harm. For someone who is very sick, the chances of marked improvement may easily outweigh the side effects from a drug. When drugs are being given to healthy people, there is a shift in the balance. If the patient is healthy the likelihood of benefit is smaller. The concern arises that what is being done in terms of the population through drug treatment is causing more harm than benefit.
To put matters into perspective, Dr. Ella Arensman, a member of the National Suicide Research Foundation, who gave evidence about suicide to this committee, said that most people who are depressed do not die by suicide. It is important to bear in mind that the majority who are depressed and who abuse alcohol, do not die by suicide. Mr. Paul Corcoran from the same foundation, said thoughts about suicide and death wishes are relatively common among young people. However, there is a large difference between that and those who go on to engage in suicidal behaviour or who die by suicide.
As regards SSRIs rectifying a chemical imbalance, independent evidence has not confirmed that there is such abnormality in depression. There are no specific anti-depressant drugs. Most of the short-term effects of anti-depressants are shared by many other drugs. Recent meta-analyses show SSRIs do not have clinically meaningful advantages over placebos. There is little evidence to support claims that anti-depressants are more effective in most conditions. Methodological artefacts may account for the small degree of superiority over placebos. Anti-depressants have not been convincingly shown to affect the long-term outcome of depression or suicide rates. Given the doubt about their benefits and concern about their risks, current recommendations for prescribing anti-depressants should be reconsidered.
The medical concept of depression obscures the diversity of problems and experiences that come to be so labelled, while social explanations and interventions have been undervalued. Anti-depressants have progressively become the automatic answer to patients' depressive symptoms. This automatism induces a passive attitude among general practitioners who see anti-depressants as their only therapeutic strategy and, therefore, do not take into consideration the possibility of developing more specific and individualised treatment plans such as watchful waiting or psychological psychosocial interventions based on scientific evidence. A passive attitude is inevitably induced in patients who receive a message suggesting modifications of thought, mood and conduct can be achieved by pharmacological means only.
Deceptive advertisements are dangerous and pervasive. The public's trust in doctors' prescribing decisions might plummet if it understood just how often drug marketers conceal risks from doctors, urge them to prescribe drugs for uses that have not been shown to be safe or effective, and make misleading claims to doctors about the drugs they promote. Deceptive pharmaceutical messages targeting doctors endanger patients by omitting, minimising or misrepresenting the risk associated with certain drugs. Teaching doctors that a drug is safer than it really is causes them to unintentionally endanger patients.
The industry's weapons of mass seduction are food, flattery and friendship, as well as lots of free samples and gifts. While contacts between companies and doctors tend to lead to less rational prescribing habits, many physicians deny they are being influenced. Human beings have a natural tendency to want to repay kindness. The best way a doctor can do this is by prescribing the drugs retailers are pushing. Doctors exposed to company representatives are more likely to favour drugs over non-drug therapy and to prescribe expensive medications when equally effective but less costly ones are available.
There is a clear gap between recommendations for prescribing and medical practice. Irresponsible prescribing is problematic. Long-term benzodiazepine prescribing is generally unlicensed, but substantial volumes of diazepam continue to be dispensed without charge in the GMS scheme. These drugs play a central role in the lives of Dublin's most disadvantaged people and may have become, especially for women, a standard means of coping with adversity. In my professional experience, while the dangers have been known for a long time, these drugs continue to be prescribed inappropriately, unnecessarily and irresponsibly. This causes people to become addicts by prescription.
The case of selective serotonin reuptake inhibitors suggests current regulatory practice overstates the benefits and underestimates the risks associated with drugs. Manufacturers' inappropriate inclusion of suicidal acts in the placebo group created a bias to estimates of the SSRI's suicide risk in the clinical trials. Regulators' rigid interpretation of confidence intervals may have delayed warnings of danger of suicidal acts. If the Irish Medicines Board had been rigid in the interpretation of efficacy, the SSRIs would have never been licensed. Regulatory approaches to data on safety and efficacy are asymmetric. For efficacy purposes, trials are seen as assay systems and any positive results outweigh what may be a majority of negative results. In the case of sertraline, although only one of the initial five and five of the first 16 trials showed clearly positive results, the regulatory bodies opted to be guided by indications of possible efficacy from a small subset of trials.
The routine acceptance of companies' summaries of the results of tests on their drugs as true reflections of the raw data on which they were based is troublesome. Trust is critical in the relationship between regulators and industry. Trust should be based on robust evidence; it should be earned rather than presupposed. Reliance on companies' summaries is neither sufficient nor appropriate in the absence of effective audit and verification of data that companies provide. The secrecy surrounding this information is also unacceptable.
Long-time FDA safety expert turned whistleblower, Dr. David Graham, told an astonished world in 2004 that the FDA, as currently configured, is incapable of protecting America. In Canada, Dr. Michelle Brill-Edwards, a former regulatory official, summed up a growing sentiment about the watchdogs, saying of Health Canada, "This dog won't hunt". The pattern of industry's influence seriously undermines the public watchdog's independence. I would say of the Irish Medicines Board watchdog that it does not hunt, bite or bark.
Regarding latrogenic deaths, drug reactions in hospitals only may constitute either the fourth or the sixth leading cause of death behind heart disease, cancer and stroke. No figures for the economic burden of drug-induced illness yet exist in Ireland but it is feared they could be vast amounts. We are going the wrong way.
The unhealthy influence of the pharmaceutical industry has become a global scandal. The full extent of that influence may even be undiscoverable. That influence is fundamentally distorting medical science, corrupting the way medicine is practised and corroding the public's trust in its doctors.
On the consequences of doing nothing, my family and I are a living example of the devastation caused unnecessarily and this will continue to be the case, day in and day out, for an increasing number of victims in the future. Other consequences are: pain, suffering and death for profit; an unsustainable bill for drug spending in Ireland; the creation of diseases for profit; an increase of dosages and uses of the same drug for profit; the genuinely ill people who need drugs will not be able to afford them and the healthy people who do not need them will be suffering and dying because of them at a bigger price; the unsafe use of drugs; loss of faith and trust in the medical profession; and the increasing medicalisation of society.
What can be done today? My executive report recommendations should be implemented. An independent ombudsman for health in Ireland should be appointed. Transparency, openness and informed consent are fundamental in health care and the pharmaceutical industry should not be exempted from those fundamental needs because of profits. There should be a call for an in-depth investigation into the influence of the pharmaceutical companies on our health service and the consequences of such an influence on our people's health should be measured.
Our lives begin to end the day we become silent about things that matter. Niall will always be in our hearts. I thank the members for their attention. My delegation will be delighted to answer any questions.