Reply from the Irish Medicines Board.

16/03/2011

F.A.O. Pat O’mahony.

Hello again,

I am sending this e-mail to you despite the fact that I’m not sure you have taken much notice of my previous numerous e-mails. I have been asked…”Are you sure the I.M.B. are aware of all the information out there?” and “surely if they know, they will have to do something about this drug?” So just to pacify everyone, I will do it again!

As you already know I have serious issues with citalopram and what I believe are the very flimsy warnings that are attached to these types of drugs (ssri’s) in the patient information leaflets. The reason I have such issues is very simple, I know my son and what he was capable of, or not capable of in this instance.  I believe that “Failure to warn” is a major flaw on your part considering the facts of the numerous warnings from the E.M.A. and the F.D.A. and of which I have already brought your attention to.

I believe an investigation should be instigated with citalopram but I also realise you don’t have to take my word for it, that’s why I’m drawing your attention to some coroners reports around the world particularly as the coroner at Shane’s inquest reported his findings as “of medical Importance”. As you may be aware the jury at my son’s inquest refused to return “a suicide verdict” and instead chose the only other option open to them…an open verdict.

The jury was obviously strongly influenced by the evidence of Professor David Healy and that of assistant state pathologist Dr Declan Gilsenan, who testified to “toxic” levels of citalopram in my son’s blood. Both doctors also stressed that the high levels of the drug were not necessarily due to an overdose, but could have resulted from a build-up of citalopram resulting from it being slower to metabolise in Shane’s body.

Prof Healy stated categorically that “it is the drug that causes the problem”, at least in susceptible patients who can form a small but significant minority. He added that the higher the dose taken, the greater the likelihood of serious adverse effects and behaviours. In my son’s case, the post mortem had shown levels of citalopram which lay between ‘toxic’ and ‘lethal’.

Professor Healy also stated “My view is that there should be compulsory monitoring of patients in the initial period after starting to take the drug,” he said. He explained that the danger period is generally within the first two weeks and usually within the first days of taking the drug. “As many as 50% of patients prescribed citalopram [the active ingredient in Cipramil and other brands] could find it is the wrong drug for them,” he said. “If they react to it, if there is any kind of oddity, they should go back to their doctor and … have the drug changed.”

There were a few of the usual psychiatrists who tried to refute his claims namely Patricia Casey and Timothy Dinan. As Patricia Casey has a long association with lundbeck and Timothy Dinan is also associated with lundbeck and has an advisory position with yourselves, you can take from that anything you want to! Also very interestingly both psychiatrists took separate actions against Dr.Michael Corry , the latter to the Irish Medical Council against Dr.corry for remarks that he made in association with my son. He said he would stake his reputation on the fact that Shane would not have done what he did if he wasn’t on anti-depressants. 

As I have previously referred to, I would like to draw your attention to some coroner’s around the world that have serious issues with citalopram and its close relationship with suicide and homicide. 

1. Recommendations of Magistrate Jacqueline M. Milledge Australia… (Senior Deputy State Coroner)

Inquest of Roxanne, Luke, Grace and Michael Richardson.

To the Minister for Health and the Therapeutic Goods Administration:

That the use of Citalopram in the treatment of depression be monitored and further studied to determine its effectiveness in the treatment of depressive illness and to guard against any side effects that may exacerbate a predisposition to violent behaviour.

2. Coroner Dr.Andrew Reid, St Pancras Coroner’s Court. U.K.

Inquest of Ian Fox.

“At his inquest on Thursday, Mr Fox’s wife, Maria Fox, blamed her husband’s sudden death on the drug, and a coroner ruled the ‘adverse effects’ of Citalopram had played a part.

 “Coroner Dr Andrew Reid said he accepted that Mr Fox had jumped in front of the train, adding: ‘I’m satisfied he did so while the balance of his mind was disturbed while suffering the adverse effects of Citalopram.’”

3. Coroner Ian Smith Cumbria, U.K.

Inquest of Nigel Woodburn.

The retired bank manager, of Bardsea Green, south Cumbria, was killed at the wheel of his car on June 16, minutes after confessing to his wife he’d had suicidal thoughts. He had been prescribed Citalopram after becoming depressed through ill health.

Coroner Ian Smith is to write to the committee on the safety of medicines – an independent advisory body – following the inquest into the death of Nigel Woodburn. He said: “I have to say this is probably the fifth, if not sixth inquest I’ve heard within a period of three years when somebody either just going on to Citalopram or Seroxat, or coming off it, have killed themselves one way or another, totally out of the blue, totally without expectation, without a history of suicidal thoughts in the past. “Mr Smith returned a narrative verdict that Mr Woodburn died in a road vehicle collision.

4. Birmingham coroner Aiden Cotter U.K.

Inquest of Yvonne Woodley.

Birmingham coroner Aiden Cotter, called for more research into the drug after experts raised concerns over its side-effects.

 A coroner has ordered an urgent investigation into an anti-depressant after it turned a mother-of-two into a ‘zombie’ before she was found hanged in her attic. Housewife Yvonne Woodley, 42, visited six GPs who increased her dosage of Citalopram in the months before her death.

5. Brecon coroner Geraint Williams.

Inquest of Stephen Leggett.

The FDA warning came too late for Stephen Leggett, according to his family. On March 15, 2004, just five days after he’d taken his first dose of citalopram for stress over work, the 53-year-old Taunton teacher killed himself by dousing himself in petrol and setting himself on fire.

 Brecon coroner Geraint Williams said he was “profoundly disturbed” by the effect the drug had on Mr Whitfield. He took the first dose on Thursday and he killed himself on Monday.”

 In March last year the US Food and Drug Ad- ministration issued a public health alert about a type of antidepressant which it said could lead to deeper depression and even suicide in some people.

 It seems to fit a pattern seen in other deaths linked to this type of drug. CITALOPRAM (marketed by the brand name Cipramil in the UK) belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

I have attached Professor Healy’s report for your consideration. (Again)

Looking forward to hearing from you,

Leonie Fennell

REPLY FROM THE IRISH MEDICINES BOARD…

 

SENT BY E-MAIL

 1 April 2011

RE:     Citalopram – IMB Case Ref 043226

 

Dear Mrs. Fennell,

Thank you for your most recent e-mail, dated 16 March 2011. We have studied the points you have raised and take this opportunity to respond.

As described in previous correspondence, the role of the Irish Medicines Board in respect of medicines licensing is to assess all available data on the safety, quality and efficacy of  medicines and if authorised, to approve the product information for the doctor and for the patient. This information is subsequently updated following the evaluation of new data, as required. The product information is considered by the doctor in the context of their assessment of their individual patient’s clinical condition at the time of treatment and any particular risks identified.

We have previously outlined the specific product information currently in place for the class of medicines to which citalopram belongs (known as the SSRIs) and would like to clarify that this information reflects the outcome of a number of EU reviews and evaluations of the data, at which the IMB has participated within the European Medicines Agency. These reviews took account of the US data and resulted in a common wording, applicable across all EU member states. The specific warnings are included in section 4.4 of the summary of product characteristics (the information for the doctor) and in section 2 of the package leaflet for the patient.

As mentioned too, following the last review, the IMB required the relevant companies to update the product information for the doctor and the patient. We also highlighted this information to all doctors and pharmacists via our Drug Safety Newsletter (edition 28, previously provided and available at 20September2008.pdf) which is sent to healthcare professionals.

All medicines are subject to ongoing monitoring following authorisation through various methods, including the spontaneous adverse reaction reporting system, regular review of cumulative safety data, evaluation of additional clinical trial and other study data and worldwide published literature. Through such monitoring, reports including those provided by coroners in other jurisdictions are reviewed and evaluated, following notification to the relevant national competent authority. This system of monitoring supports ongoing review and assessment of medicines to determine whether their benefits continue to outweigh the risks for the populations of patients treated according to the approved conditions for use.

You have mentioned in your e-mail a member of an advisory committee of the IMB. As previously indicated, under the Irish Medicines Board Act, all experts who are members of advisory committees are required to declare their interests in any industry regulated by the IMB, including the pharmaceutical industry. At all advisory committee meetings, committee members must again declare any potential conflicts in relation to any item on the agenda. They are not permitted to participate in any discussions or decisions relating to a potential conflict and must absent themselves from that part of the meeting.

I hope this information is helpful and clarifies your outstanding queries.

Yours sincerely,

____________________________

Dr Caitriona M. Fisher (on behalf of Pat O’Mahony, Chief Executive)

Manager, Chief Executive’s Office

Irish Medicines Board

6 thoughts on “Reply from the Irish Medicines Board.

  1. Did they even read your letter?

    It’s a bog-standard reply Leonie, one that I and others are all to familiar with when dealing with the UK Medicines regulator, the MHRA.

    To put ex-pharmaceutical employees in charge of regulating pharmaceutical drugs is like putting Billy Smart in charge of the RSPCA.

    You deserve so much better…so does Shane.

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  2. Hi Fid,
    I have no intentions of giving up until self-harm and harm to others (suicide/homicide) are admitted to be a possible side effect of these drugs as they are in other countries!
    In that IMB drug safety newsletter that they are referring to it states…
    Suicide/suicidal thoughts or clinical
    worsening
    Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. (This gives patients the impression that that suicidal thoughts are a symptom of depression and not the drug)
    It’s only when you get a lot further down that it says the drugs can be the cause and not your illness!

    If you are a young adult.
    Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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  3. The IMB response is utter bollox.
    Typical stuff from an inept and corrupted drug regulatory authority.

    Drug regulator ‘risks conflict of interest’

    http://www.timesonline.co.uk/tol/news/world/ireland/article6907930.ece

    From The Sunday Times
    November 8, 2009
    Drug regulator ‘risks conflict of interest’
    Gabrielle Monaghan
    Ireland’s drug regulator has been accused of being too close to the pharmaceutical industry. An academic report has concluded that more than one-in-four senior personnel at the Irish Medicines Board (IMB) had “potential conflicts of interest”.

    Orla O’Donovan, one of its authors, said public concern about the safety of drugs, such as swine-flu vaccines, could be alleviated if the IMB was more open about the relationship between its decision-makers and advisers and the drugs industry.

    The report, published in Social Science & Medicine, showed a chairperson of one of the IMB’s advisory committees had taken part in research sponsored by the pharmaceutical industry and received industry honoraria and consultancy fees.

    A former chief executive worked for a drug company before joining the IMB and left to work for another one.

    Between 1996, when the agency was set up, and 2005, four members of the IMB’s senior management team had a background in the pharmaceutical industry and one of those also participated in research funded by drug companies, the research found. In total, five out of 19 senior people had links with the drug industry.

    The IMB, a state body that charges pharmaceutical and medical devices companies for inspections of drugs, says no staff members have any drug company connections. It said advisory committees, which it does not regard as staff, do not make decisions.

    The IMB said employees are not allowed to have any interest in the drug industry and are prohibited from working on products they have been involved with. “Products are licensed purely on the basis of their potential benefit to health,” an IMB spokeswoman said.

    The study says the Irish Medicines Board Act of 1995, which set up the agency, is unclear about the “beneficial interest” committee members must declare, such as receiving honoraria from companies or serving on an advisory committee.

    The study compares policies at the IMB with those of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency. It found all three operate on the assumption that potential conflicts of interest can be managed and are therefore not a problem.

    O’Donovan gave the example of a 2002 IMB newsletter which announced that Professor Frank Hallinan, a former Schering-Plough employee, had resigned as chief executive and would be joining Wyeth Biopharma as director of quality. Pat O’Mahony, his successor, worked as a technical manager in the veterinary pharmaceutical industry in Ireland and the UK.

    O’Donovan’s study showed that public access to information about potential conflicts of interest of senior IMB personnel and advisers is restricted.

    Like

  4. European Regulators And Their Conflicts Of Interest

    http://www.pharmalot.com/2009/11/european-regulators-and-their-conflicts-of-interest/

    Given the ongoing controversy over conflicts of interest involving the pharmaceutical industry, a group of researchers sought to gauge the extent to which this may be a problem among European regulators – specifically, the Irish Medicines Board, the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency in the European Union.
    And so they examined three issues – What are the policies and procedures within each agency for dealing with conflicts of interest? Is there COI between senior people employed by these agencies and people in their key advisory committees and the pharmaceutical industry? Is information about employees’ and advisers’ COI made public? Their findings, which were published in Social Science & Medicine, suggests there is reason for concern.
    They concluded that, “notwithstanding significant variations in policy and procedure, the approach to COI in the IMB, MHRA and EMEA is one of management rather than prohibition. In all three agencies, close interaction between experts and the pharmaceutical industry is taken-for-granted and therefore allowable…
    “Even accepting a narrow interpretation of COI, our research found evidence of widespread potential COI amongst experts involved in the three agencies, more than one in every four in all three contexts…Our review suggests that within the increasingly commercialised IMB, MHRA and EMEA, COIs are constructed as inevitable, manageable and relatively free from pejorative connotations…”
    For instance, the IMB and MHRA require not only disclosure of interests of scientific experts but also of members of their households, but the EMEA makes no such requirement. The thresholds for declarable financial interests in the pharmaceutical industry also differ. EMEA experts are asked to indicate if the value of financial interests exceeds $75,000, but the IMB wants to know if the value exceeds $30,000.
    Between 1996 and 2005, four of 12 IMS senior managers had a pharma background and one also participated in research funded by drugmakers. A former CEO was an employee of a drugmaker immediately prior to his IMS appointment and took a job with another drugmaker directly after leaving the agency. In addition, an advisory committee head had participated in industry-sponsored research and had been in receipt of industry honoraria and consultant fees. In total, five of 19, or 26 percent, had connections with industry.
    A look at the MHRA executive board since 2004 found that five people had industry backgrounds before joining the agency, one went on to an industry job after leaving and one participated in research funded by a drugmaker before joining the MHRA. In total, seven of 25, or 28 percent of MHRA personnel had a relationship with drugmakers.
    “We found that of the 26 chairs of various Working Groups, Panels and Expert Advisory Groups 15 had personal interests, 12 had non-personal interests, 6 had both personal and non-personal interests and 10 had neither type of interest,” wrote the researchers. “Our review of the publicly available declarations of interests of the EMEA Management Board found that 25 percent of members declared interests in the pharmaceutical industry…
    “Searching for non-conflicted people would place additional strains on regulatory agencies and make it more difficult to recruit staff, thus possibly undermining their economic competitiveness, but we believe that the threats of serious or irreversible damage to people’s health are too high to continue in the current direction.”
    [Full disclosure, Social Science & Medicine is published by Elsevier, which also publishes The Pink Sheet, where Ed Silverman works as an editor].

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    1. Hi Truthman,
      This was in the Irish Times march 2010 but strangely enough hasn’t been implemented yet!

      Drugs regulator to publish declarations of interest
      PAUL CULLEN
      Tue, Mar 23, 2010
      THE STATE’S drugs regulator is planning to provide public access for the first time to the declarations of interest of its staff, board and committee members in pharmaceutical companies.
      The Irish Medicines Board, which licenses new drugs and medical devices, plans to bring its practices into line with the European Medicines Agency, which publishes such declarations online, The Irish Times understands.
      The agency yesterday rejected claims in an academic journal that senior people working in or with the IMB face potential conflicts of interest as a result of past links to the pharmaceutical industry.
      Orla O’Donovan of UCC’s department of applied social studies, writing in the journal Social Science Medicine, claimed the agency “manages” rather than prohibits potential conflicts of interest and restricts public access to information on the issue.
      Writing in the same journal, Prof John Abraham of the University of Sussex described the lack of public access to the declaration of interests by committee members as “shocking” and “an unacceptable democratic deficit in modern Europe”.
      IMB rules prohibit staff or their families from having any financial interest in the pharmaceutical industry and from working on products that they may have had an involvement with in previous employment. Members of advisory committees are asked to confirm at each meeting that they have no conflict with matters under discussion.
      However, declarations of interest have not been publicly available up to now because they are deemed to contain personal information which is exempt from release under freedom of information legislation.
      © 2010 The Irish Times

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  5. It might be worth contacting Orla O’Donovan…

    Orla O’Donovan of UCC’s department of applied social studies, writing in the journal Social Science Medicine, claimed the agency “manages” rather than prohibits potential conflicts of interest and restricts public access to information on the issue.

    Like

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