Protection of the public or protection of the pharmaceutical industry?

Editor, -The article 'Should consumers be warned about aspirin, alcohol and gastric bleeding?' (Aust Prescr 2005;28:18-19) contains some peculiar logic. It suggests there is evidence that the risk of upper gastrointestinal bleeding is increased in patients consuming at least three to five drinks daily. However, it appears that commercial considerations dissuaded the Therapeutic Goods Administration (TGA) from adding an appropriate warning label to aspirin and non-steroidal anti-inflammatory drugs (NSAIDs). The primary concern of the TGA should be the health and protection of the public, not the commercial interests of the pharmaceutical industry. Why should marketing considerations enter into the TGA's deliberations at all? Have we not learned from the rofecoxib debacle?

If, as the US Food and Drug Administration (FDA) concluded, there is a problem with moderate-high alcohol intake in combination with the use of aspirin/NSAIDs, then a warning statement for consumers is required. Equally, a similar warning should be required for paracetamol if there is good evidence of an increased risk of hepatotoxicity with alcohol consumption.

It may have been acceptable to conclude that a warning label is not currently warranted because the literature is not clear on alcohol increasing the risk of gastrointestinal bleeding due to aspirin/NSAIDs. However, it is bizarre to conclude that there is a real problem with moderate-high alcohol intake yet not warn consumers because of a need to maintain commercial parity in the analgesic market.

Clinicians are recommended to identify 'at-risk' patients. Would not this be easier if there was an appropriate warning label on analgesic packages, particularly as health professionals may have no knowledge of their patients' consumption of analgesics purchased at supermarkets and other retail outlets?

Gregory Peterson
Professor

Luke Bereznicki
PhD Scholar, National Institute of Clinical Studies

Unit for Medication Outcomes Research and Education
School of Pharmacy
University of Tasmania
Hobart

Dr J. McEwen, Principal Medical Adviser, Therapeutic Goods Administration, and Dr R. Whiting, Chairman, Medicines Evaluation Committee, comment:

Professor Peterson and Mr Bereznicki express concern that commercial considerations dissuaded the TGA from adding warning labels about alcohol consumption to aspirin and non-steroidal anti-inflammatory drugs. While that implication might be drawn from the article, they can be assured that such was not the case.

The TGA is advised on these matters by the independent Medicines Evaluation Committee (MEC).¹ This committee includes some of Australia's foremost academics and practising clinicians with expertise relevant to over-the-counter medicines. The most recent consideration of the need for warnings about alcohol intake on analgesic products was in February 2003. At that meeting, the MEC considered a review on non-prescription analgesics.² That review includes at page 36 a speculative question about the reasons for warning statements in the USA, viz: 'Or is there an unstated commercial reason; namely, that if an alcohol warning has to go on paracetamol, it must be placed on aspirin and the NSAIDs so that none of these analgesics is perceived as having a marketing advantage over others in a highly competitive environment?'

It can be stated unequivocally that medical and scientific considerations were the sole determinants of the advice of the MEC to the TGA. Commercial matters were not taken into account.