Healthy Skepticism Library item: 2711

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: media release

Jones S, Jones C.
Email To The MHRA re Strattera and Suicidality
Stuart Jones 2005 Sep 30
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=402

Keywords:
SSRI SNRI Strattera ADHD anti-depressant Atomoxetine tomoxetine suicidality

Notes:

Ralph Faggotter’s Comments:

In the UK the ‘Medicines and Healthcare products Regulatory Agency’ has a facility on its website for the public to be able to provide input via email. This is a great idea, but of course, you never know how much notice is taken of your suggestions.

Here is is one such well-written letter sent to the MHRA regarding the drug Strattera and SSRIs/SNRIs, from Stuart and Claudette Jones.

You can register your own opinions on the MHRA website at http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=401

Full text:

From Stuart and Claudette Jones.
F.A.O. Dr Raine,
June.Raine@mhra.gsi.gov.uk

Dear Dr Raine,

We make no apology for using the blunt instrument of an open letter to you, in your capacity as an officer of the MHRA.

Historically, the MCA/MHRA have been less than prompt, in replying to our correspondence and we still await the reply to one letter of 2003.

In 1990 a physician named Martin Teicher wrote about a strange phenomena, several of the patients he was treating with Prozac, one of the newer type of Selective Serotonin Reuptake Inhibitor SSRI antidepressants, had complained to him of an overwhelming preoccupation with thoughts of suicide after being administered the medicine.

These patients were adults suffering from severe chronic depression and as everyone knows, major depressive disorder (MDD) can cause it’s victims to become suicidal, but the thing Teicher found disturbing about Prozac was, his patients and he, were convinced the suicidal thoughts only occurred, or became obsessively overwhelming, after being treated with the SSRI.

The nineties saw an increasing number of health professionals complaining that the newer type of SSRI and their close cousins, the Selective Norepinephrine Reuptake Inhibitors SNRI antidepressants were causing people to become suicidal. It is also true that many ordinary people had complained that they, or people they cared for, had become suicidal on these drugs. As a result many court actions were brought against the companies who manufactured them.

One such action in the United States saw the manufacturer of the SSRI Seroxat being held responsible for a man slaughtering his family and then turning the gun he used on himself to commit suicide.

Around this time the pharmaceutical giant Eli Lilly developed a defence to protect themselves against such actions. The Eli Lilly defence went like this … Some people who are depressed also feel suicidal, so when we’re taken to court for drug induced suicide we always prove it was depression not Prozac that caused the death. (The disease not the drug defence)

Despite this massive evidence the regulatory agencies and the drug companies insisted that the benefits of the drugs outweighed the risks and in any case depression caused people to feel suicidal.

Most of the worlds medicines regulatory agencies, including for the United Kingdom’s MCA, now the MHRA, and the United States FDA either did not pick up on, or disbelieved these signals of drug induced suicidality, with the exception of the German Agency, the Germans insisted that Prozac carry a warning to doctors and patients that the drug caused suicidality before granting a licence for it’s people to be prescribed the drug.

Professor David Healy, an eminent psychiatrist and expert in psychopharmacology , who practices in the UK, also became concerned that these drugs were causing some people to become suicidal and addressed the matter to the MCA in a agonisingly prolonged sequence of correspondence.

By the year 2000, Professor Healy had convinced Dr Keith Jones, MCAs head of drug safety that people needed a warning, and Dr Jones agreed that a warning of emergent suicidality should be made, not just to the profession, but more importantly, to the people who might be prescribed the drug and their families.

The MCA didn’t issue that warning. It was to take another three years for a warning that drug emergent suicidality was a possible consequence of taking these antidepressants. Three years of pressure from concerned professionals, high profile media condemnation and patients rights activists.

That warning was not to be given until after the dissolution of the MCA as such, and the ad hoc expert working group (EWG) set up by the MCA to investigate the safety and efficacy of all SSRIs, some of who’s members were discovered to have pecuniary vested interests in the pharmaceutical companies who made the families of drugs they were supposed to be investigating.

A fact that was not generally known , but became public as a result of the SSRI scandal is, the MCA was, and the MHRA phoenix which rose from the ashes of the MCA, is, wholly funded by the very pharmaceutical companies who make and market the drugs which they are authorised to regulate.

• The Select Committee on Health, during it’s exhaustive investigation into The Influence of The Pharmaceutical Industry, held between 2003 and 2005, addressed whether the MHRA as is, could effectively regulate the safety and efficacy of medicines and came to the conclusion it could not, the committee made a recommendation to Parliament that the way the MHRA regulated and licensed medicines for public use should be changed.

During the committee’s investigation, evidence was presented to them that The SSRI/SNRI family of medicines had been increasingly prescribed for children and adolescents for the treatment of depression, despite the fact that they didn’t work and caused some children to become suicidal.

The committee closely questioned Sir Alisdair Breckonridge and Dr Raine, who were representing the MHRA, on these matters. The committee members were not satisfied with their responses, and Sir Alisdair was requested to give further evidence in written form on the work of the new EWG’s progress on SSRI safety and efficacy.

In Sir Alisdair’s written submission to the Select Committee, he admits that these families of drugs are not effective for the treatment of depression in children and adolescents, and can cause suicidality.

The Select Committee also addressed the charitable status of some patients interest groups who received funding from pharmaceutical companies. They had grave concerns that such funding might affect the way in which such funded charitable groups might inappropriately, if sometimes inadvertently, recommend, or otherwise support the use of some drugs. The pharmaceutical companies have historically given financial support to people who support the use of their drugs.

This week, after a long and wide-ranging inquiry on the treatment of childhood depression, Andrew Dillon, Chief Executive of NICE (The National Institute for Health and Clinical Excellence) and Executive Lead for this guideline says “This guideline makes it clear that psychological treatments are the most effective way to treat depression in children and young people. It’s important that children and young people taking anti-depressants do not stop taking them abruptly, but we would advise people to talk to their GP at their next regular review about whether a psychological treatment may be a more effective treatment option.”
NICE Guidance for the treatment of childhood depression includes for:
Children and young people with moderate to severe depression should be offered, a first-line treatment, a specific psychological therapy (such as cognitive behavioural therapy, interpersonal therapy or family therapy of at least 3 months’ duration).
Antidepressant medication should not be offered to children or young people with
moderate to severe depression except in combination with a concurrent psychological therapy and should not be offered at all to children with mild depression.

Now we have a new drug which has gained a licence for a different disease. The drug is called Strattera, the disease is ADHD, but is it a new drug?

In it’s data sheet submitted to the FDA for it’s original licence application, it is stated as being an SNRI, a medicine whose close family members, are effectively banned for under 18 years for the treatment of depression in most of Europe.
Depression is one of the factors found in some children diagnosed as suffering from ADHD.

Strattera’s maker Eli Lilly developed this drug as an antidepressant SNRI, it failed as such, they subsequently applied to the FDA, and got, a licence for the drug to treat ADHD.

The MHRA may feel, as do we, it’s an anomaly that Dr Andrew Mossholder, the FDA expert drug reviewer did not have the necessary information about Strattera to include in his review of antidepressants and suicidality

Never the less, since gaining it’s licence, it’s been found to cause liver disease and Tuesday, under duress from the FDA, Lilly admitted the drug causes suicidality.

What must now urgently be addressed by the MHRA and NICE is whether it’s good clinical practice to administer a drug which has a risk of causing suicidality to already disturbed children?

The first of the SSRIs gained licences in 1988, it took 15 years and the death of people, for the UK’s drug regulators to reluctantly insist on a suicide warning to be given to patients/customers.

It took 17 years for NICE to give a warning that these drugs did not work as well as cognitive behaviour therapy, and that they shouldn’t be used in first instance by any physician for the treatment of depression in children, but rather, only as a means of last resort, alongside concomitant therapy given by an expert in the field of child psychiatry.

On the third of February in a response to the BBC at the time of the emergence of the Strattera causing liver failure alert, Professor Gordon Duff, chairman of the Committee on Safety of Medicines, said: “This is an important drug in the treatment of ADHD in children, and it has been widely and effectively used in the US and increasingly in the UK.
Which, is the same response the regulators gave to the people who voiced concerns over the safety and efficasy of SSRIs and they also caused other side effects than those which affect the mind.

Yesterday, in a response to the BBC the MHRA pronounced that: Updated warnings will be put on the drug’s patient information leaflet.
The news follows recent reports of concerns about potential suicidal side effects of commonly used antidepressants among children and teenagers.

Dr June Raine of the MHRA said: “We are advising healthcare professionals that patients should be carefully monitored for signs of depression, suicidal thoughts or suicidal behaviour and referred for alternative treatment if necessary.
Dr Jones stated the same thing about the SSRIs in the year 2000.

In the interest of patient safety, the FDA has mandated that Strattera should carry the most severe warning, in the form of the Black Box.

Our question to the MHRA is; How long before the suicide warning is mandated as necessary on the UK,s Stattera. patient information leaflets this time Dr Raine?

Yours Sincerely, S A Jones and C F Jones.
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