Some of the recent corporate collapses show that the relentless pursuit of profit can have disastrous consequences. Although the pharmaceutical industry aims to help patients it may not be immune from questionable corporate practices.
The New York Times has reported an accusation that rules were broken in the promotion of gabapentin.1'Worst Pills, Best Pills', an American drug bulletin, has been keeping its readers and other members of the International Society of Drug Bulletins (including Australian Prescriber) informed of the case.2
Allegedly, the manufacturer concocted uses for gabapentin to boost profits. Despite a lack of independent supporting evidence, the company is said to have aggressively promoted these 'off-label' indications to doctors. The promotional strategy is alleged to have involved payments to opinion leaders and the placement of ghost-written articles in medical journals.
These strategies appear to have worked well as sales of gabapentin reached US$1.3 billion in 2000. 'Worst Pills, Best Pills' reports that as much as 78% of these sales were for uses without evidence that gabapentin was safe and effective.2
Although these allegations are yet to be tested in court, and the manufacturer involved has now been taken over by another company, the Editorial Executive Committee of Australian Prescriber believes readers will be interested in how big business might influence prescribing. As gabapentin is an extraordinary case, the Editorial Executive Committee has asked well-known medical journalist Melissa Sweet to provide more details.
Could it happen here? The code of conduct for the Australian pharmaceutical industry prohibits claims which are not consistent with the product information approved by the Therapeutic Goods Administration. Although the code offers some protection, similar rules in the USA did not prevent the gabapentin controversy. To strengthen the code it is important that health professionals contact Medicines Australia if they have evidence of drugs being promoted for unapproved indications.
- Petersen M. Whistle-blower says marketers broke the rules to push a drug. New York Times 2002 March 14; Section C, Page 1 (col. 5).
- Neurontin (Gabapentin) - The illegal corporate creation of a blockbuster drug. Worst Pills, Best Pills 2002;8:36-8.