Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Friday, May 26, 2006


ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, FullDisclosure, and Accountability

In the wake of the extraordinary acknowledgement this month by Glaxo SmithKline that the clinical trial evidence shows that not only children and adolescents are at increased risk of suicidal behavior if they take its antidepressant, Paroxetine/Paxil (or any other "new generation"antidepressant). Adults too are at increased risk of suicide if they take Paxil and that risk is six-fold compared to those given a placebo.

Our colleague in the UK, Charles Medawar, of Social Audit, has been closely monitoring British public officials, drug company executives and leading academic psychiatrists, almost all of who have a financial/professional stake in protecting the reputation of SSRI antidepressants. His primary focus has centered on the British cast of characters in this tedious and insidious shadow play. GSK's acknowledgement confirms that the"authorities"- academic, government regulators and industry - have denied, deceived, and concealed evidence of drug harm. GSK's acknowledgement refutes the recent claims made in the official organ of the American Psychiatric Association, The American Journal of Psychiatry.

The claimed findings reported by Dr. Gregory Simon and colleagues about their epidemiological study, Suicide Risk During Antidepressant Treatment, in The American Journal of Psychiatry 163:41-47, January 2006, vol.163.1.41 are unsupported by the data. Dr. Simon reported that there was no increased suicide risk during the first week of treatment with an SSRI. This claimed finding from a methodologically flawed, uncontrolled study was widely disseminated in the major press. "Depression Drugs Safe, Beneficial, Studies Say" (Washington Post). Uncritical reporters transcribed the investigators' claims without understanding that these were scientifically invalid. However, Charles Medawar found egregious inconsistencies in that published report. He inquired, ever so politely, of Dr. Simon, the lead author to explain the inconsistencies. The one sided correspondence reveals that academic psychiatrists have misrepresented what the data actually shows. "In agreement with Jick and colleagues (15), we found a significantly higher risk of suicide attempts in the first week of antidepressant treatment than in subsequent weeks". In Dr. Simon's initial response, he conceded: "Risk in week 1 was not higher than in weeks 2, 3, and 4. But risk in week 1 was higher than in subsequentweeks (from week 5 onward)." Uncorrected, inconsistent statements of findings confuse many readers: they serve to deflect from the very troubling evidence that these widely prescribed drugs pose a serious threat to those who take them, especially throughout the first month. Such misleading reports served industry's interests.

The release simultaneously of two "positive" SSRI studies, both financed by the National Institute of Mental Health, seems suspiciously calculated. Our suspicions are validated by the accompanying editorial in the Amer. J of Psychiatry which questioned the need for the black box label warnings! It is especially troubling that that most of the uncritical media had accepted the claimed "positive" results on faith. But the report, like most of the scientific literature about SSRI antidepressant safety and efficacy provides false and misleading information tailored to conceal that these drugs induce suicides. Since SSRIs have failed to demonstrate an antidepressant effect, given that in controlled clinical trials placebo has matched and even outperformed SSRIs, critics are beginning to wonder on what basis the FDA approved these drugs as "antidepressants"? This may be a case of misbranding. Simon G, et al

See also:; Contact: Vera Hassner Sharav212-595-8974

Thursday, May 25, 2006

Bowled over by Gisela Stuart MP

Bowled over by Gisela Stuart MP

Is it not surprising that in spite of overwhelming evidence that the drug manufacturers, GlaxoSmithKline, suppressed evidence during the adult trials for their best selling anti-depressant drug, Seroxat, Gisela Stuart MP, has not signed an Early Day Motion for a debate in the House of Commons proposed by her fellow MP, Mr. Paul Flynn

Meantime, Seroxat is still being prescribed to her constituents some of whom will undoubtedly experience suicidal thoughts and may even attempt suicide because of the anti-depressant prescribed. It has been established that Seroxat can cause suicide in both adults and children and last week the regulatory authority issued a warning to GPs and prescribers about the link between Seroxat and suicide.

A 38 page legal document from Dr. P. Breggin clearly indicates that GlaxoSmithKline have known for 15 years that Seroxat can induce suicide and aggression. This document has been sent to Gisela Stuart MP on four separate occasions yet she still has not signed the Early Day Motion for debate. This is particularly vexing in the light of her signing an Early Day Motion regarding coverage of televised cricket!

Email Gisela Stuart to voice your concerns at:

Bob Fiddaman

Friday, May 19, 2006

Sir Alasdair Breckenridge - Playing the Stock Market?

Social Audit Ltd
P.O. Box 111 London NW1 8XE
Telephone/Fax: 020 7586 7771

Professor Sir Alasdair Breckenridge CBE, Chairman
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ
26 April 2005

Dear Sir Alasdair,

Following my letter of 14 April, I am writing to make an FOIA request to try to clarify the position you outlined in your letter of 12 April:

1. Did you disclose in writing your recreational interest in the stockmarket, and the steps you took to avoid possible conflicts of interest, to colleagues on the Sub-Committee on Pharmacovigilance, Committee on Safety of Medicines, Medicines Commission, Department of Health, European Medicines Evaluation Agency and the MCA and MHRA, and was your interest made clear to those centrally involved in your appointment as Chairman of [a] the CSM; and [b] the MHRA? If so, please provide a copy of any declaration(s), indicating the dates on which they were made.

2. Whether or not your interest was declared in any written statement, please would you indicate whether and how you communicated your interest to any or all of the above-mentioned colleagues in any other way.

3. What steps, if any, had the MHRA taken, prior to my initial enquiry, to satisfy itself of the adequacy of the arrangements you made to avoid possible conflicts of interest and, in particular: [a] whether you gave instructions to your stockbroker in writing and, if so, what they were? [b] whether instructions to your stockbroker made clear what "associated industries" were prohibited as investments, and specifically which companies associated with the pharmaceutical sector were excluded? [c] whether the instructions you gave to your stockbroker were in any way modified following your appointment as [i] Chairman of the CSM; and [ii] Chairman of the MHRA? [d] whether and to what extent your investment portfolio reflected your own recommendations to your stockbroker about investments in specific companies that should be bought or sold? [e] whether and to what extent members of your family held, bought or sold stock in their own name(s)? and [f] whether any family investments were held through nominees?

I have already made clear that the issue here is not to do with personal probity; it is about Agency and Departmental policies and perceived fitness for position, the man for the job. These questions arise mainly because I��m trying to understand more about the culture and organisation of drug regulation, and the legitimacy of the Agency��s claim to deserve public confidence. I am particularly anxious to know if your colleagues knew of your interest and regarded it as unexceptional. I have also wondered what standards might apply to other people centrally involved in drug regulation:

4. Would the Agency consider it appropriate for other MHRA staff, with similar interests in stockmarket investment, to disclose this and explain the steps taken to avoid possible conflicts?

5. Would such disclosure be considered appropriate for anyone now applying for appointment to the new Commission on Human Medicines, given that "the new appointees will be required to sign a form declaring their interest" and that the guiding principle on appointments is that, "there are robust arrangements in place to manage any interests that are declared"?
These issues seem all the more relevant, given the Parliamentary Health Committee��s recent conclusions on the MHRA (para 376 refers), also the circumstances in which the abortive November 2003 ��Intensive Review�� of the safety of SSRI antidepressants was set up, at the time you were chairman of the CSM. Given the steps you took to avoid investment in pharmaceutical and associated companies, it seems that much harder to understand the appointment to that review of two CSM members who were shareholders in the main company under investigation.

I look forward to hearing from you.

Yours sincerely,
Charles Medawar

The reply:

Medicines and Healthcare products Regulatory Agency
Market Towers1 Nine Elms Lane, London SW8 5NQ

Mr Charles MedawarSocial Audit LtdP.O. Box 111London NW1 8XG
General enquiriesTelephone 020 7273 0000 Fax 020 7273 0353E-mail
Direct line: 020 7084 2600Direct fax: 020 7084 2737

20th May 2005

Dear Mr Medawar,

I am writing on behalf of the Agency in reply to your FOIA request of 25 April 2005, addressed to Sir Alasdair Breckenridge.

You ask whether Sir Alasdair made known his recreational interest in the stockmarket on his appointment to the Chairmanship of the CSM and then the MHRA. The former appointment was subject to the then Code of Practice for Ministerial Appointments to Public Bodies, and while serving as Chairman on the CSM Sir Alasdair was subject to the rules relating to declarations of interest set out in the Code of Practice for Members of the Medicines Commission and Section 4 Committees and Sub-Committees. In his appointment as the Chairman of the MHRA, Sir Alasdair is subject to the Civil Service Management Code.
To take your points in turn:

1 and 2: There was no disclosure in writing by Sir Alasdair of his recreational interest in the stockmarket in relation to his appointments to the Chair of the CSM and of the MHRA. Recreational interests are not required to be disclosed unless the person believed that it could be regarded as influencing his advice.

3 and 4: MHRA took no steps to extract details on any of the areas you cite. Under the relevant Codes, the onus is on the individual Committee Chair or member, or staff member to disclose interests which he or she considers relevant. Once interests are disclosed, the Agency will advise that individual of any Agency requirements concerning the retention, disposal or management of those interests. The Agency is not required, under the relevant Codes, to investigate proactively the possibility of any interests other than those that have been declared:

5. The Code of Practice for applicants for the new Commission on Human Medicines is currently being finalised. But it is likely to specify that the Chairs and members of the CHM, the Homoeopathics Board and the new Herbal Medicines Committee must hold no direct personal interests in the pharmaceutical industry. This will apply also to the Chairs of Expert Advisory Groups. All Chairs and members of the advisory committees must declare any financial interest or other matters that could affect their impartiality, or that could reasonably be perceived as affecting their impartiality.

Yours sincerely,
Roy AlderDirector, Executive Support

Tuesday, May 16, 2006


Gentlemen - it seems, as you know, that GSK has looked at some of its Seroxat data again... and I'm sure it has nothing to do with Dr Breggin's report becoming public several weeks ago - nothing at all..........

I notice that the MHRA continues to support the use of the drug in the UK - when even GSK itself is backing off:

"GSK added warnings acknowledging that patients on the drug may experience persistently worse depression, or may experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality and these symptoms may be severe, abrupt in onset, or were not part of the patient's presenting symptoms."

The company advises doctors: "Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication."It seems that this data is anything between 10 and 15 years old (perhaps Dr Hudson, you could tell us EXACTLY how long GSK have been sitting on this data)

Anyway - who's to blame for this terrible situation....

GSK for not analysing the data properly in the first place?

GSK for analysing the data and then HIDING the results for so long?

GSK for lying to the MHRA and the public?

The MHRA for ignoring the huge amount of anecdotal evidence about the lack of safety of seroxat?

The MHRA for dragging its feet while 'investigating' GSK?

The MHRA for not wanting to stir up any trouble for its paymasters?

Ian Hudson for appearing to be complicit in what can only be described as a cover up?

Kent Woods for being as much use to the public as chocolate fireguard?

The Government for allowing the MHRA to continue to function in its present form?

So many questions - so few answers.

You see, the problem is, that I don't know the answers - but I'm sure that someone out there does....


Roger Cleghorn

Saturday, May 13, 2006


Sarah Boseley, health editor
Saturday May 13, 2006
The Guardian

Britain's bestselling antidepressant, Seroxat, can cause adults as well as children to become suicidal, according to the manufacturer, GlaxoSmithKline.GSK, which for years denied there was a problem with the drug, has sent a letter to all doctors in Britain warning of the potential risk in some adult patients. The company has reanalysed data from the clinical trials of the drug and found that significantly more adults who were given Seroxat became suicidal than those given a placebo. Seroxat has been banned from use in children by the UK drug regulator for the same reason. The revelation came as the health secretary, Patricia Hewitt, declared the end of the "Prozac nation" yesterday, launching a programme to cut the numbers of patients on drugs such as Prozac and Seroxat and extend counselling to the thousands of people with mild to moderate depression and anxiety.

"Millions of people suffer from mild to moderate mental health problems and treating them takes up about a third of GPs' time," she said in a speech to the National Mental Health Partnership's conference. "Too many people are prescribed medication as a quick-fix solution."Talking therapies worked just as well as drugs and people preferred them, she said. Two centres dedicated to counselling and psychotherapy will open in Doncaster and Newham as "demonstration sites" with the intention of extending access to talking therapies across the UK.

Seroxat is the biggest-selling SSRI (selective serotonin reuptake inhibitor) in Britain. In 2003 doctors wrote 19m prescriptions for the drug for patients with anxiety and depression. But concerns about the drug and others in its class have been growing.

GSK's letter to doctors is the result of a reanalysis of its trials requested by the US drug regulator, the food and drug administration, which is reviewing SSRIs. Seroxat is given to patients not only for depression and anxiety but, for a range of other problems defined by psychiatrists as separate conditions, such as panic disorder, generalised anxiety disorder and obsessive compulsive disorder.

The analysis has found that patients taking the drug for those conditions may also have an increased risk of suicidal thinking and behaviour. But the clearest findings come from trials of the drug in people who were depressed. In those, says the letter, the frequency of suicidal behaviour was higher in patients on Seroxat than those who, without knowing it, were on a placebo.

The numbers were small - 11 out of 3,455 on Seroxat and one out of 1,978 on placebo - but the difference was statistically significant, meaning it was unlikely to have occurred by chance.

Because of the small numbers, GSK says the findings should be interpreted with caution.
It adds that "all of the reported events of suicidal behaviour in the adult patients ... were non-fatal suicide attempts, and the majority of those attempts were in younger adults aged 18 to 30". But the data does suggest "that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24".

GSK says in the letter that it "continues to believe that the overall risk:benefit of paroxetine (Seroxat) in the treatment of adult patients" with depression and other disorders "remains positive", but it warns that young adults particularly should be carefully monitored on the drug.

David Healy, professor of psychiatry and director of the north Wales department of psychological medicine, who has for years called for warnings about the suicide risk of SSRIs, said yesterday that GSK had been in possession of the statistics it was now making public for at least 15 years."Seroxat has a severe withdrawal syndrome, which seems to me to be worse than for other drugs in the group, and the withdrawal syndrome in its own right is linked to people becoming suicidal," he said.

GSK yesterday rejected any accusation of dragging its feet on the data on suicidal behaviour in depressed adults. It had taken advice from experts who had suggested new ways of looking at the information, a spokeswoman said.

The analysis, completed recently, had been forwarded to US and UK authorities.

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