Introduction

During a randomised controlled trial (RCT) of a medication review clinic it was discovered that an industry-sponsored audit of H. pylori eradication was being carried out and it was decided to investigate the effect, if any, on the RCT. Investigation of the sponsored audit revealed serious shortcomings in the methodology and it was decided to conduct an observational study to explore this aspect further.

Methods

Case notes, for 81 of the 85 patients who attended the sponsored H. pylori eradication treatment clinic, were reviewed in order to determine the extent of compliance with the audit protocol with particular regard to both inclusion and exclusion criteria. Case notes and computer records were compared to confirm the accuracy of recording of gastrointestinal drugs, consultations and investigations recorded on the audit sheets for the six months before and after H. pylori eradication treatment. In addition the associated costs of all gastrointestinal drugs, related consultations and investigations for the six months before and after H. pylori eradication treatment were calculated using gross NHS prices which applied during the audit period. These were compared with the costs recorded in the sponsored audit sheets.

Results

Only half (56%) of the patients receiving eradication therapy met the relevant inclusion criteria and only 24% received first line therapy as stated in the sponsored clinic protocol. Of major concern were inaccuracies in drug costs, which were overestimated by 52% prior to eradication and underestimated by 19% after eradication. As a result of these systematic errors, the sponsors made claims of a net saving of £98 to the practice. In reality, the true costs incurred by the practice were £3,839 excluding both practice staff and GP time. The net increase in sales of the sponsor's gastrointestinal drugs was £1,390, a 56% increase over baseline for the 80 patients reviewed.

Discussion

These findings, if generally applicable, call into question the wisdom of industry involvement in the direct provision of healthcare via sponsored clinics. In an analysis of self- regulation, Herxheimer and Collier¹ were critical of the Association of the British Pharmaceutical Industry's lack of effective sanctions to secure compliance with its code of practice² and concluded,

" its self-regulation seems to be a service to itself rather than to the public".

Conclusion

In order to establish the practice of industry involvement with such clinics as credible, independent regulation is required to ensure that the therapy proposed is appropriate and cost-effective for the health service rather than the sponsoring company.

References

1. Herxheimer, A. and Collier, J. 1990. "Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation." British Medical Journal 300(6720):307-311.

2. Association of the British Pharmaceutical Industry. 1999. "Code of practice for the pharmaceutical industry." The Association.