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 to be 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 accountability.”

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 market.
• 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 systems.”

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 changing now.”

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. 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? including:

• Overhauling the secretive and inadequate system of medicines control.
• 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 awareness campaigns.
• Increasing the amount of independent drug information available to physicians.
• Improving patient information so it is focused on health, not just medicines.

Note: Dutch antidepressant use figures drawn from Achmea Health website, http://www.achmeahealth.nl/mednet/mednet.php?type=showdoc&id=10704.

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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).

Authors
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).