8 June 2005

The widespread panic that follows the withdrawal of over-promoted high profile drugs could be prevented if both the adverse effects and the extent of the benefits were made completely clear to general practitioners and specialists, according to Professor Gillian Shenfield from the Department of Clinical Pharmacology at Royal North Shore Hospital in Sydney.

The much-publicised withdrawal of rofecoxib and subsequent queries about the safety of celecoxib, as well as the withdrawal of cerivastatin and mibefradil, are all cases in point. They led to widespread panic and created a lot of work for health professionals.

In the latest issue of Australian Prescriber, Professor Shenfield, expresses her concerns that genuine patient-centred care is at risk because safety advice is suppressed or goes unheeded.

“There seems to be a glamour about anything new, despite the absence of long-term safety information when a drug is first approved”, says Professor Shenfield.

In the case of celecoxib, which became available on prescription in 1999 and listed on the Pharmaceutical Benefits Scheme (PBS) in 2000, the cost of enthusiastic prescribing to the PBS in its first year was $200 million. The drug was heavily promoted by both industry and the media, and key opinion leaders - who are invited by pharmaceutical companies to talk to groups of prescribers.

Consumers were persuaded that the new ‘wonder’ drugs were more efficacious than older medications, despite the limited knowledge of the extent of the benefit of the drug.

“There is a perception that anyone criticising a new drug is only concerned about cost, whereas the caution often relates to the paucity of safety data and limited experience with the drug,” says Professor Shenfield.

Professor Shenfield points out that it is essential that both prescribers and consumers grasp the fundamental fact that confidence about safety can only be provisional for all newly-licensed drugs.

National Prescribing Service, an independent organisation providing evidence-based information and services to health professionals and the community on Quality Use of Medicines (QUM), says emphasis should be on what is not known rather than what is known about new drugs.

"There is no merit in being among the first to prescribe a new drug, whatever the pressures from patients and drug companies", says Professor Shenfield.

For the full article visit the Australian Prescriber website www.australianprescriber.com.

ENDS

Australian Prescriber is an independent peer reviewed journal providing critical commentary on therapeutic topics for health professionals. It is published by National Prescribing Service Limited (NPS), an independent, non-profit organisation funded by the Australian Government Department of Health and Ageing.

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