E-DRUG: New book released: Medicines out of control?
Dear E-Drug Readers,
Today the book "Medicines out of Control? Antidepressants and the
Conspiracy of Goodwill" was launched in London and Amsterdam. Below is
the press release outlining the book?s themes and its recommendations to
improve transparency about drug safety and make consumers more aware of
the risks and sometimes limited benefits of drugs.
For more information, or to order a copy of the book, go to the Social
Audit website: www.socialaudit.org.uk <http://www.socialaudit.org.uk/> .
On behalf of Health Action International Europe
Health Action International
DRUG BENEFITS, ?PARTLY A MYTH SUSTAINED BY SECRECY,
LACK OF PUBLIC ACCOUNTABILITY,? CLAIMS NEW BOOK
Calls for an overhaul of the ?secretive and profoundly inadequate system
of medicines control?, are made in a penetrating new book launched on
Tuesday, 16 March. The book focuses on the issues surrounding increased
antidepressant use in Europe and a UK government inquiry into the
?looming antidepressant drug crisis?, due to report in May.
Medicines out of Control? is a provocative, evidence-based case history
on the safety of medicines. The book charts the promotion, regulation,
prescribing and use of mood-regulating drugs, especially antidepressants
? ?blockbuster? drugs such as Prozac and Seroxat/Paxil. It warns how the
unfolding crisis of dependency on antidepressants may prove to be a
watershed in drug control. In questioning the adequacy of the UK
government?s current drugs inquiry, this book raises basic questions
about the competency of drug regulators and the lack of transparency in
tackling user dependency and complaints in many countries.
It also raises strong concerns about the enormous growth of
antidepressant use in countries including The Netherlands, when there is
little evidence of health benefit among many users. Dutch health
insurers have reported a surge in the number of people using
antidepressants in recent years. In fact, between 1996 and 2001, the
number of Dutch consumers using antidepressant drugs (Selective
Serotonin Reuptake Inhibitors (SSRIs)) jumped by 150%. In 2001 alone,
the Dutch spent Euro 104 million on antidepressants, 5% of the total
drug budget (see note below).
?The antidepressant crisis illustrates how drug benefit-risk assessments
are increasingly made on the strength of evidence that is hugely
incomplete and highly partial, using evaluation procedures that are
often chaotic and misconceived,? said Charles Medawar, principal author
and executive director of Social Audit. ?Drug safety and effectiveness
is, in part, a myth sustained by entrenched secrecy, the dominance of
vested interests, misplaced optimism and an overwhelming lack of public
The book highlights concerns including:
* How the antidepressant crisis exposes the limitations of drug
regulatory systems, based on scrutiny that is often badly flawed, mainly
of company-sponsored clinical trials conducted before drugs come to
* That the medicines control authorities continue not to
officially recognize the risks of dependency on antidepressants when
user evidence suggests the contrary.
* The refusal of drug regulators to take account of valuable
evidence from users.
* Failure to take stock of the extent of iatrogenic illness (harm
from medical intervention), including substantial risks from the
medicalisation of daily life.
?The book emphasizes the urgent need to confront the disease awareness
campaigns and under-the-counter, direct-to-consumer advertising [DTCA]
now taking place in Europe despite the European Union consensus not to
allow DTCA,? said Anita Hardon, co-author and scientific director of the
Amsterdam School for Social Science Research. ?This kind of promotion
leads to an unsustainable demand for medicines, and overuse of drugs
such as antidepressants. The EU and European governments are not
sufficiently acknowledging how this huge demand for, and optimistic
belief in drugs? benefits undermine the sustainability of public health
Medicines out of Control? states that current systems are ?fatally
flawed? in their routine and ?gross overestimation? of the benefits of
medicines over risk and harm.
Ivan Wolffers, professor of international health at the Free University
in Amsterdam, has also drawn attention to the overuse of SSRIs including
Seroxat and Prozac in The Netherlands. ?For more than ten years we?ve
been told that antidepressants are safe,? he said. ?The image is quickly
Medicines out of Control? suggests that all of the actors involved in
the healthcare system have been too trusting about the proclaimed
positive effects of medicines. In fact, the authors argue, the results
of much scientific research on medicines is tainted as most are financed
by the pharmaceutical industry which is searching for products that will
reap huge sales.
Secrecy about drugs? benefits and risks is another pressing problem. The
authors point out that when medicines are registered by the government,
much of the clinical research results remain secret. The book argues
that additional post-marketing surveillance is needed to guarantee the
safety of medicines once they are on the market and being used daily. In
fact, to support the argument, the book reveals that based on new
research results the recently revised estimated number of users affected
by drug withdrawal reactions from paroxetine (Seroxat/Paxil) is not one
in 500 users, but one in every four.
Consumers should demand more transparency about the details of clinical
research, the authors agree. ?In The Netherlands there are many
commercial research organizations that carry out research for the
pharmaceutical industry,? said Anita Hardon. ?We believe patients should
only take part in clinical trials if the results are made public. We are
now working on an informed consent procedure that would demand greater
openness about this clinical data.?
A number of key recommendations are made in Medicines out of Control?
* Overhauling the secretive and inadequate system of medicines
* Establishing a post-marketing drug surveillance system that
operates independently of the licensing authorities, run by and on
behalf of medicines? users.
* Obtaining a commitment from regulators to encourage transparency
in drug regulation, subject only to the protection of personal privacy
and commercial manufacturing knowledge.
* Moving European medicines policy under the umbrella of DG Health
and Consumer Protection instead of DG Enterprise.
* Improving Europe-wide regulation of ?under-the-counter? disease
* Increasing the amount of independent drug information available
* Improving patient information so it is focused on health, not
Note: Dutch antidepressant use figures drawn from Achmea Health website,
J. van Lennepkade 334 ? T
1053 NJ Amsterdam
Tel: + 31 ? (0)20 683 3684
Fax: + 31 ? (0)20 685 5002
- end -
NOTE TO EDITORS
Medicines Out of Control? Antidepressants and the Conspiracy of Goodwill
by Charles Medawar and Anita Hardon, was largely funded by the Joseph
Rowntree Charitable Trust, with additional support from the Allen Lane
Foundation and the 1970 Trust, and is published by Aksant Academic Press
(Amsterdam). Price: £19.25 (Euro 27.50).
Principal author Charles Medawar is executive director of Social Audit,
and a leading specialist writer and lecturer on medicines policy, drug
safety and corporate, governmental and professional accountability.
Medawar has held several appointments with leading international health
agencies including the World Health Organization where he is currently a
member of its Expert Advisory Panel on Drug Policies and Management. His
previous book, Power and Dependence: Social Audit on the Safety of
Medicines (1992) was widely acclaimed and, in 2002, BBC1?s Panorama
?Emails from the Edge? programme, was based in part on his work.
Co-author Anita Hardon is Professor in Anthropology of Care and Health
at the University of Amsterdam, and Scientific Director of the Amsterdam
School for Social Science Research. She is a leading expert on social
and cultural aspects of consumer drug use, based on more than 20 years
of research in Asia, Africa and Europe. Widely published on medicine use
and women's health issues, she has been involved in evaluations for
agencies such as the European Union. Hardon currently chairs the Health
Action International (Europe) Foundation Board. Previous publications as
co-author include The Social Lives of Medicines (2003), and Drugs Policy
in Developing Countries (1992).
For more information on Social Audit, established by Charles Medawar in
1971, visit the website ( <http://www.socialaudit.org.uk/>
www.socialaudit.org.uk), which attracts 500,000 visitors a year.
UK Government?s Drugs Inquiry
In May 2003, the Medicines and Healthcare Products Regulatory Agency set
up an expert group of the Committee on Safety of Medicines to review the
safety of widely prescribed antidepressant drugs (Selective Serotonin
Reuptake Inhibitors - SSRIs) including Seroxat, Prozac and related drugs
in the UK. Particular emphasis is on withdrawal reactions and reported
suicidal behaviour. The committee is expected to report its findings in
May this year.
Media queries (UK)
Contact: Joy Francis 020 8558 6100 or 0771 382 7372 email:
Media queries (for Anita Hardon/The Netherlands)
Contact: Lisa Hayes (+31-6) 547 16694 email: firstname.lastname@example.org
MEDICINES OUT OF CONTROL? - HOW TO ORDER
This title can be ordered through bookshops or obtained by mail order,
1. Contact Health Action International (Europe) at Jacob van Lennepkade
334-T, 1053 NJ Amsterdam, The Netherlands. Tel: (+31-20) 683 3684 / Fax:
(+31-20) 685 5002 / E-mail: email@example.com and www.haiweb.org
<http://www.haiweb.org/> . The book price is Euro 27.50 plus shipping.
Payments can be made in Euros using credit cards (MasterCard or VISA).
2. Medicines out of Control? can be ordered directly from the
publishers, Aksant Academic Press
(http://www.iisg.nl/publications/aksant.html#aksant) and its
distributors, Transaction Publishers:
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