E-DRUG: UK Drug Regulatory Agency Accused of Cover-Up
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[This might become as important as the Softenon case, which started drug
regulation in most European countries. Long story but very important for the
way how we handle drug regulation and safety. WB]
Dear Members of E-Drug,
On Saturday, the UK Guardian published an article on the controversy
following the resignation of a member of one of the UK drug regulatory
agency's expert committees. The consumer representative resigned after a
behind-the-scenes struggle on SSRI antidepressant safety and efficacy
data from clinical trials and reports by physicians and patients.
The themes involved in the controversy echo those taken up and expanded
upon in a new book by Charles Medawar and Prof. Anita Hardon to be
released next week. The book "Medicines out of control? Antidepressants
and the conspiracy of goodwill" warns about how public health suffers
from many regulatory systems' secrecy, conflicts of interest and flawed
decisions about benefit and risk.
More information about the book will follow this coming week. Below an
article from the Alliance for Human Research Protection and the article
in the Guardian from Saturday. Reprinted here under fair use.
Best wishes,
Lisa Hayes
On behalf of Health Action International Europe
Amsterdam
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3-13-04
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting openness and full disclosure
http://www.ahrp.org
When push came to shove, the British Medicines and Healthcare Products
Regulatory Agency (MHRA, equivalent to the FDA) put the interests of a drug
company ahead of the public health interest. Following a
behind-the-scenes-struggle, Mr. Richard Brook, Executive Director of
MIND, resigned from an expert workgroup of the Committee on Safety in
Medicine reviewing SSRI antidepressant safety and efficacy data from
clinical trials and reports by physicians and patients. Brook, the panel's
only consumer advocate, charged the committee and the MHRA with a cover-up
in its efforts to conceal the severity of the drug-related problems.
The panel's review of the original Paxil / Seroxat data found that
regulators have known since 1990 that higher than recommended doses
20mg) caused severe adverse side effects leading many patients testing the
drug to drop out. Yet, neither physicians prescribing Paxil nor the public
was informed about the potential hazards posed by higher doses. Regulators
in Britain, Canada, and the US failed to protect the public health by
requiring GlaxoSmithKline to put prominent warnings on the drug's label. As
a result, ill-informed doctors prescribe Paxil / Seroxat and other
antidepressants at unsafe higher doses than recommended, leading to
preventable harm and deaths.
The evidence shows that regulators in the UK and the US have known about the
risks for patients, but have tacitly aided and abetted manufacturers who
concealed vital safety information from prescribing physicians and the
public for over a decade.
When it became apparent that the UK committee would cover-up the evidence of
dose related harmful drug effects, Brook warned the CSM and MHRA that "he
felt he had no choice but to go public [with the evidence] because of the
risks to patients." The Guardian reports that Brook "was warned in a letter
last Monday from the MHRA that he could risk prosecution under the Medicines
Act 1968, which protects the commercial confidentiality of information from
drug trials."
The unraveling antidepressant saga both in the UK and the US provides a
window into the secret world in which drug manufacturers and
government regulators interact behind closed doors. This secret
intermingling is undermining the safety of patients who take prescribed
drugs because physicians who prescribe the drugs are kept uninformed about
the known and potential dangers posed by these and probably other drugs. For
some patients SSRIs can trigger violent and suicidal behavior.
The Guardian reports: "Key figures not only on the CSM but also in the
Medicines and Healthcare Products Regulatory Agency - the drug
licensing body which it advises - have a history of consultancy, research or
even employment by pharmaceutical companies. Ian Hudson, for instance, the
worldwide safety director of GlaxoSmithKline (GSK) until 2001, is now
director of licensing at the MHRA."
Cozy relationships between FDA officials and drug company officials are even
more pervasive at the FDA because the financial stakes are so much greater.
For example, the chief counsel for the FDA, Daniel Troy, filed an Amicus
Curiae brief in 2003 with a US court siding with Pfizer, the manufacturer of
the SSRI antidepressant, Zoloft. The issue was the company's failure to warn
about suicidal risks of Zoloft. Troy argued that FDA would not permit Pfizer
to put a warning on the Zoloft label about evidence suggesting a link
between the drug and increased suicide risk, because that would be
"misbranding the drug."
That Amicus Curiae brief is part of Congressional testimony submitted by the
Alliance for Human Research Protection to the Senate Health,
Education, Labor & Pension Committee hearing on Suicide Prevention and
Youth: Saving Lives, March 2, 2004, and will be posted on the committee's
website.
The Guardian reports that failure to warn physicians about prescribing a
higher than 20mg recommended dose of Paxil / Seroxat, has resulted in about
17,000 patients [in the UK]- out of an estimated 500,000 on the drug - to be
started on higher doses than recommended last year. Experts informed AHRP
that the equivalent estimates for the US would be between 250,000 and
500,000 (out of 3 million) Americans who would have been prescribed too high
a dose. For estimates of US consumption of SSRI antidepressants, see a
letter submitted by Dr. David Healy, foremost expert on the effects of
antidepressants to the FDA at the request of Dr. Robert Temple, FDA
Director of the Office of Drug Evaluation I at:
http://www.ahrp.org/risks/healy/FDA0204.html
On Thursday, March 11, a mildly phrased alert issued to UK physicians by the
CSM appears to be a direct result of Mr. Brook's warning to the committee.
The CSM alert informs physicians that higher doses of Paxil / Seroxat were
no more effective than the recommended 20mg dose, but that higher doses
cause more adverse effects. See:
http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/parox
etine_11304.htm
MIND, the largest nonprofit mental health agency in the UK, is calling for
an independent review of the workings of drug regulation with patient
representation at its heart. They were backed by Charles Medawar of the
consumer group Social Audit.
The following links lead to additional Guardian reports Saturday March 13,
2004:
Drug safety agency accused of cover-up Sarah Boseley, health editor
http://politics.guardian.co.uk/publicservices/story/0,11032,1168613,00.html
http://politics.guardian.co.uk/publicservices/story/0,11032,1168584,00.html
A secretive system Editorial
Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org