By Sarah Bosely

14 October 2009 (The Guardian) — A family has been awarded $2.5m (€1.7m) in damages after a jury in Philadelphia decided that the British-made antidepressant Seroxat was responsible for their three-year-old son's heart defects.
    GlaxoSmithKline, the British manufacturer of Seroxat, known as Paxil in the US, said it would appeal against the verdict. Although drug regulators in the US and UK warned in 2005 that Seroxat could be linked to heart defects, GSK does not accept its drug is the cause.
   

Drug regulators warned in 2005 that Seroxat could be linked to heart defects.

Thousands of women worldwide have taken antidepressants such as Seroxat in pregnancy, assured by manufacturers and doctors that they are safe. The case is one of a number in the US and the first to end in a verdict against the company.
    Michelle David, 24, was prescribed Paxil in the US after panic attacks. Around mid-February 2005, she discovered she was pregnant. According to her lawyer, Sean Tracey of Houston, Texas, her obstetrician gave her the standard advice at the time: that Paxil was safe. David later stopped taking it because of side-effects that might have been attributable to the pregnancy.
    Her son, Lyam Kilker, was born in October 2005. A couple of weeks later he stopped feeding and doctors found he had two holes in the heart and a very rare congenital defect called an interrupted aortic arch. "The hospital put in a stent to keep him alive," said Tracey. "He had acquired an infection — the heart condition made him more susceptible."
    Soon afterwards, Lyam had the first of two open heart operations and spent five months in hospital. He will need more major heart surgery in five to 10 years.
    A number of studies have suggested that rates of congenital heart defects are higher among women taking Paxil and other drugs of the SSRI (selective serotonin reuptake inhibitor) class. David Healy, professor of psychiatry in Bangor, Wales, who gave evidence in the Kilker case, said that at 4%, the rate of birth defects was double the normal rate, while the rate of major defects was 2% compared with 1%. The general rate of miscarriages is 8%, but 16% of women on Seroxat miscarry.
    GSK denied that its drug was responsible for harm to babies in the womb. "While we sympathise with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition," said the company in a statement. "Very unfortunately, birth defects occur in 3-5% of all live births, whether or not the mother was taking medication during pregnancy.
    "GlaxoSmithKline acted properly and responsibly in conducting its clinical trial programme for Paxil, including sharing documentation and submitting results from studies on Paxil to regulators. Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicine's labelling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public."
    Lawyers for women in the US allege that GSK knew of the problem earlier than it admits. Internal documents produced at the Kilker trial suggest that it was investigating complaints as early as 2001, when a woman emailed GSK to ask whether Paxil could be the reason for her baby developing severe heart defects in the womb. The pregnancy was terminated.
    GSK replied with a formal letter telling her to consult her doctor. But an internal report recorded that the link between her baby's defects and Paxil was "almost certain". In court, GSK officials said the report was a mistake and that somebody had filled in the form wrongly.

© The Guardian 2009

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Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems. In short, it is not only dangerous to start taking psychiatric drugs, it can also be dangerous to stop them.
Withdrawal from psychiatric drugs should only be done carefully under experienced clinical supervision.

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The adverse effects of widely-prescribed drugs are often overlooked because there is so little truly independent academic evidence, says Professor David Healy, who gave evidence in the Lyam Kilker case and has been warning of the dangers to pregnant women for years.

15 September 2009 (Bloomberg) — An executive of GlaxoSmithKline Plc, the world's second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil/Seroxat to birth defects, according to a company memo introduced at a trial.
    "If neg, results can bury," Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.
    The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil/Seroxat caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo's total revenue.
    The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil/Seroxat. Kilker's mother, Michelle David, blames Paxil/Seroxat for causing life-threatening heart defects in her 3-year-old son.
    Glaxo officials urged scientists to withhold information about Paxil/Seroxat's risks from a paper laying out the company's "core safety philosophy" for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.
    "They said if there's any doubt, take it out," Tracey told jurors. "They do not want to scare anybody. It's a very competitive marketplace. It's a multibillion-dollar industry."

'Rare Thing'

Glaxo executives contend that the boy's heart defect wasn't caused by Paxil/Seroxat, Chilton Varner, one of the company's lawyers, told jurors today in her opening statement. In court filings, Glaxo has said it appropriately tested and marketed the antidepressant drug.
    "When Lyam Kilker was born in 2005, GSK had not received notice" of his specific type of heart defect in connection with Paxil/Seroxat use, Varner said. "The numbers will tell you the defect is a rare thing."
    The Paxil/Seroxat label at that time reported about animal studies, "including the rate of deaths," she said.
    Glaxo didn't target pregnant women and its sales force didn't use strong-arm tactics to push prescriptions, Varner said. "Whatever the marketing was, it played no role in Ms. David's doctors' decision to prescribe Paxil/Seroxat or Ms. David's decision" to take the drug, she said.

Rat Studies

Glaxo officials purchased the compound sold as Paxil/Seroxat from a Danish company that had done animal studies showing young rats died after taking low doses of the drug, Tracey said in his opening statement.
    One of the company's scientists noted in internal documents in 1980 that information in the rat studies suggested Paxil/Seroxat "could be" a cause of birth defects, Tracey said. Still, the drugmaker refused for almost 20 years to do studies on why the young rats died, he added.
    Tracey told jurors they would see documents in the trial that the company hadn't turned over to regulators or congressional investigators. "You are going to see docs that have never seen light of day before," he said.
    For example, Tracey pointed to a 1998 internal review by Glaxo of all reports of side effects tied to Paxil/Seroxat and officials found "an alarmingly high number" of birth-defect reports. Even with those concerns, the report was never turned over to the U.S. Food and Drug Administration and "the alarming language" was deleted from it, the lawyer said.
    In 2001, the company received a letter from a woman who used Paxil/Seroxat during her pregnancy and decided to abort her fetus after tests showed it had birth defects, Tracey said.

Internal Report

In analyzing the woman's case, Glaxo officials concluded in an internal report that it was "almost certain" the fetus's birth defects were caused by his mother's Paxil/Seroxat use, the family's lawyer added. Still, the company didn't turn over its analysis to the FDA or beef up the drug's warning label, Tracey said.
    It wasn't until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil/Seroxat increased the risk of birth defects, Tracey said.
    The lawyer for David, a college nursing student who was a former cheerleader for the National Basketball Association's Philadelphia 76ers, told jurors that Glaxo hid Paxil/Seroxat's problems to protect its profits. Paxil/Seroxat is "the No. 1 asset to this day this company has ever owned," the attorney said.

"˜Quite Different'

Varner said she will present "quite different" evidence on animal tests tied to Paxil/Seroxat. "The animal testing did not suggest Paxil/Seroxat caused birth defects," Varner said. The FDA considered the tests when it approved the drug for use by U.S. consumers in 1992, she said.
    When Glaxo officials considered offering Paxil/Seroxat for sale in Japan, internal records show executives worried in 1994 they might have to do more safety testing on the antidepressant, said Dr. David Healy, an Irish psychiatrist testifying as an expert for Kilker's family in the case.
    It may be the "type of study we wish to avoid," Jenny Greenhorn, an official in Glaxo's international regulatory affairs unit, said in a memo.
    Glaxo also is fighting suits in the U.S., Canada and the U.K. over claims that Paxil/Seroxat, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven't been released.

New York Settlement

    In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil/Seroxat/Seroxat may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.
    The company's provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn't mention the Paxil/Seroxat/Seroxat litigation.
    "We do not disclose our legal reserves for any specific litigation matter," Glaxo spokesman Kevin Colgan said.
    Glaxo American depositary receipts, each representing two ordinary shares, fell 68 cents, or 1.7 percent, to $38.76 in New York Stock Exchange composite trading today. Glaxo fell 14 pence, or 1.2 percent, to 1,175.5 pence in London.
    The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

Original story © Bloomberg. Read it here

Secret e-mails show that one of the world's biggest drug companies distorted results from trials of their anti-depressant Seroxat, covering up a link with suicide in teenagers. The BBC TV programme Panorama has shown shocking footage demonstrating how GlaxoSmithKline's PR people 'spun' the results of trials on children which showed risk of suicide, self-harm and violence, and which also indicated it was no more effective than a sugar pill. Instead they claimed to doctors that the drug was 'remarkably safe' and effective for under-18s, with the support of an 'independent' professor of psychiatry who earned over $500,000 in fees from the drug giant.
Read our story here

9 October 2007 — Taking SSRIs with painkillers can increase the risk of bleeding from the stomach, research shows.
    People using antidepressant drugs in the selective serotonin re-uptake inhibitors (SSRIs) category have double the risk of bleeding from the stomach. But researchers from the University of East Anglia have found that combined with painkillers, the risk increases by a factor of six.
    The researchers said that while SSRIs on their own carry only a small risk of bleeding, this risk becomes much more serious when they are taken in combination with painkillers.
    The findings were based on analysis of four studies covering more than 153,000 patients. The study found that over a period of one year, one in every 106 patients taking SSRIs together with painkillers required hospital admission due to bleeding in the stomach.
    The researchers said SSRIs are not the best choice for treating depression in people with a history of stomach ulcers or indigestion.

On Monday 19 October the Irish Times published a letter from eight psychiatrists, professors of psychiatry who lead the teaching departments in this subject at UCD, UCC, TCD, UCG, University of Limerick and at St James's and St Patrick's Hospitals, Dublin. The eight professors denied that antidepressant use is connected to homicidal acts, though they were careful to use the word 'cause' rather than 'link' when all eight accused Dr Michael Corry of stating 'definitively' that "antidepressants cause homicide".
    Ignorance of the scientific literature on the dangers of antidepressants, up to and including provoking acts of murder, and of the warnings by regulators, is deplorable in any health professional.
    Ignorance at the highest levels of the teaching of psychiatry in Ireland, ignorance among the eight professors who control the teaching of psychiatry in this country, is not just deplorable, it is inexcusable, it is appalling, it is dangerous.
    To demonstrate just how dangerous SSRIs are, and to educate the ignorant, as a public service we publish here just two from a very extensive selection of the scientific literature on this matter, a literature the eight leading psychiatrists should immediately familiarise themselves with.
    1: 'Antidepressants and Violence: Problems at the Interface of Medicine and Law'. By Professsor David Healy et al. PLoS Medicine, here or download here
    2. 'Suicidality, Violence and Mania Caused by SSRIs: A Review and Analysis'. By Dr Peter R Breggin. International Journal of Risk & Safety in Medicine, here (download)
    Incidentally, one of the eight is the gentleman who has laid a complaint with the Medical Council against Dr Michael Corry, UCC Professor Timothy 'Ted' Dinan.
    Even GlaxoSmithKline, maker of Seroxat, states in its own Product Monograph of 12 September 2008, page 6, that 'There are clinical trial and post-marketing reports with SSRIs and other newer anti-depressants, in both paediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others. The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, depersonalization. In some cases, the events occurred within several weeks of starting treatment.'
    And the Food and Drug Administration, the US regulator, includes in its prescribed patient information leaflet for all SSRIs this statement, which is placed below the Black Box warning on suicidal thoughts and acts: 'The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and paediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.'
    The patient leaflet continues: 'Families and caregivers of paediatric patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behaviour, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for [Insert drug name] should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
    'Families and caregivers of adults being treated for depression should be similarly advised.'
    Is it not astonishing and disturbing that Ireland's eight leading professors of psychiatry are ignorant of this?

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Dr Orla O'Donovan, a sociologist who specialises in the politics and sociology of health and medicine, with a focus on 'the cultural and economic power of the globalised pharmaceutical industry', has a letter in the Irish Times castigating both the eight professors and Times writer Kate Holmquist for misrepresenting the known facts about the dangers of antidepressants.
    O'Donovan is a lecturer in the Department of Applied Social Studies at University College Cork. Among her works is the study Power, Politics and Pharmaceuticals, co-edited with Kathy Glavanis-Grantham, which was published by Cork University Press last year.
    Dr Michael Corry has written to the Irish Times to defend himself against the eight and challenge their misrepresentation of the facts. You can read the text of his letter here.

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On the night of August 15/16, Shane Clancy stabbed a friend to death in Bray, Co Wicklow, seriously injured his ex-girlfriend and almost killed his victim's brother. He then stabbed himself to death.
    He had been taking SSRI antidepressants. Police said he may have been 'overdosing'. The young man had presented to a general practitioner  (GP) with feelings of deep sadness and heartbreak after splitting up with his girlfriend; the doctor prescribed a course of SSRIs.
    Since then, controversy has raged. Dr Michael Corry of The Wellbeing Foundation told Crime Correspondent Ali Bracken of the Sunday Tribune: "If he was not on medication, he would not have done what he did. I would stake my career on that. His behaviour was out of character. He went from homicidal to suicidal. It's a Jekyll and Hyde situation."
    Clancy (22) started taking medication a week before he murdered Sebastian Creane and stabbed his former girlfriend Jennifer Hannigan before committing suicide. Clancy had told friends that he did not like the way the drugs made him feel and gardaí believe that he may have been misusing the medication by taking more than the recommended dosage.
    Dr Corry, who has a private practice in Dublin, said that the side affects of antidepressants can be severe when people initially take them.
    "In the first three to seven days [on antidepressants], people can feel totally out of character and worse than before. Side effects can be patients wanting to self-harm, commit suicide and harm others," he added.
    "Antidepressants inhibit oxytocin, which is basically the self-love hormone. It results in an emotional numbing. People can be feeling no pain but not alive either."
    This would not be the first case of homicide under the influence of SSRIs or SSRNIs, the modern classes of antidepressants which cost the Irish taxpayer €54 million in 2008. The shooters in the infamous Columbine High School massacre in the USA were taking SSRIs, and there are many other documented examples of of 'out of character' violence and  murder, often of close family or loved ones, sometimes of work colleagues, often followed by the suicide of the perpetrator.
    Nonetheless, following Dr Corry's statement and Ali Bracken's exposure of how easy it is to persuade doctors to prescribe SSRIs, the usual crew of defenders of these drugs took to the airwaves and print media to decry the notion that they are implicated in this tragedy.

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Tribune coverage lays bare the role of dangerous drugs

The Sunday Tribune has done a great service by taking this tragedy so seriously and investigating the role of antidepressants in the double deaths of murder victim Sebastian Creane and his killer, Shane  Clancy.
    Crime reporter Ali Bracken went undercover, detailing symptoms of mild depression to five doctors. Four prescribed her SSRIs, though she was a new patient and clinical guidelines state that these drugs should not be prescribed as a first resort for mild depression, where counselling is the appropriate first step.
    And on the front page of the Sunday Tribune on 4 October, Bracken reported that Shane Clancy was given a three-week supply of antidepressant medication by a pharmacy on the day before the tragic events, despite his doctor instructing he should only be supplied one week's dosage at a time because of a previous overdose.
    She conducted an extensive interview with Shane's father, Patrick, who expressed his horror at what had happened and his unease at the role of doctors and pharmacists in prescribing and distributing antidepressants:
    "I think every parent should ask their GP where they stand on antidepressants and in what circumstances they would prescribe them to their children. We all need to look at the relationship between doctors and pharmaceutical companies. Shane put a high dosage of chemicals into his body and I've no doubt he reacted to that. Some people take antidepressants and they don't agree with them. The consequences of that can be horrific."
 
Read the Tribune's full coverage here
Find Letters to the Editor here 

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Ali Bracken, ST Crime Correspondent

The HSE spent almost €54m on antidepressants for medical card holders in 2008, up 35% on the previous year, despite an Oireacthas report recommending an increase in counselling services as psychiatric drugs "tend to be prescribed for want of an alternative" and can lead to "severe adverse reactions".
    A report by the Joint Committee on Health and Children in 2006, The Adverse Side Effects of Pharmaceuticals, found that the prescription of antidepressants by medical practitioners for "minor symptoms" was "leading in some cases to severe adverse reactions".
    The report continues: "The patient presenting with symptoms expects some tangible form of treatment and the practitioner feels under pressure to respond so as to, at the minimum, send the patient away in a more confident frame of mind. It is in the absence of a full range of counselling and psychotherapy services that many medicines, intended for moderate to severe psychiatric disorders, are prescribed for minor symptoms leading in some cases to severe adverse reactions."
    I visited five doctors in August for the Sunday Tribune and reported feeling depressed. Four out of the five prescribed antidepressant medication, despite the fact it was a first-time visit to each surgery and no counselling had been undertaken. Three of the GPs were asked about the waiting time to see a counsellor/psychiatrist in the public health service and all reported there would be a wait of at least several weeks, possibly several months.
    Since 2006, there has been a large increase in psychiatrists, counsellors and psychologists employed by HSE.
    The number of psychiatrists increased by 52 to 299 between 2006 and 2009; counsellors increased by 23 to 180; psychologists increased by 60 to 367 in the same time period.
    In 2007, the HSE spent €40m on antidepressants for medical card holders, compared with just under €54m last year. The joint committee report also recommended that there be an increase in the number of psychologists and counsellors in the community health service. "This would provide practitioners with an alternative to drug therapy in minor cases and would complement drug treatment in more serious case," it added.
    The family of a young man who carried out a murder-suicide in Bray in August are concerned about his use of antidepressants and intend to raise the issue at the inquest into his death.
    In a letter to the Gerry Ryan Show last week, Shane Clancy's mother Leonie wrote: "What lessons can be learned? If it can happen to Shane it can happen to anyone. Was it because he didn't drink or do drugs that his system just couldn't cope with the antidepressants or can depression melt your brain if it gets that bad? Will we ever know?
    "I drove him to the doctor and made him get some antidepressants which he didn't want to take but I insisted. It's very hard to watch your six-foot son with tears dripping down his face."
    Clancy murdered Sebastian Creane (22), at his home in Bray in Co Wicklow, before turning the knife on himself.
 
September 20, 2009 © The Sunday Tribune

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September 6, 2009 — by Ali Bracken

The family of a young man who carried out a murder-suicide in Bray three weeks ago are understood to be concerned about his use of antidepressants and intend to raise the issue at the inquest into his death.
    The Sunday Tribune has learned that members of Shane Clancy's family, from Dalkey in south Dublin, want to explore whether antidepressants could have in any way influenced his behaviour on the night he murdered Sebastian Creane (22), at his home in Bray in Co Wicklow, before turning the knife on himself.
    The Trinity College Dublin student also stabbed his former girlfriend Jennifer Hannigan and Creane's older brother Dylan in the attack. Both have recovered from their injuries.
    A source close to the family said some members of the family plan to research antidepressants and speak to the appropriate experts about the medication as they are anxious to explore whether the pills could have influenced his behaviour. Family members believe the best place to raise these concerns will be at an inquest into the 22-year-old's death, which will be held at Wicklow Coroner's Court in several months' time.
    The two men's inquests will be dealt with at the same hearing by Wicklow east coroner Cathal Louth. If permitted by the coroner, expert witnesses could be called to give evidence about the impact antidepressants can have on a patient's behaviour.
    Clancy started taking antidepressant medication a week before the murder-suicide and had told friends that he did not like the way the drugs made him feel.
    Last week, a psychiatrist claimed that the murder-suicide in Bray would not have happened if Clancy had not been taking antidepressants.
    Dr Michael Corry, who is an outspoken critic of antidepressants, said: "If he was not on medication, he would not have done what he did. I would stake my career on that.
    "His behaviour was out of character. He went from homicidal to suicidal. It's a Jekyll and Hyde situation." Corry was not involved in the medical treatment of the 22-year-old.
    Other psychiatrists and GPs have since disagreed with Dr Corry's assessment.

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