Calls for an overhaul of the "secretive and profoundly inadequate system of medicines control", are made in a new book 'Medicines out of Control?' launched in March 2004. This 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. 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 (SSRIs) jumped by 150%. In 2001 alone, the Dutch spent Euro 104 million on antidepressants, 5% of the total drug budget.

"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, 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."

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.

Medicines Out of Control? Antidepressants and the Conspiracy of Goodwill by Charles Medawar and Anita Hardon, is published by Aksant Academic Press (Amsterdam). Can be ordered from http://www.socialaudit.org.uk/

Source: HAI-Europe Press release

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