Healthy Skepticism Library item: 19886

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Randall H
Drug Promotional Problem Dec 1989
MJA 1989 Dec; 151:(532):653

Full text:

The Australian Pharmaceutical Manufacturers Association (APMA) received 28 evaluable complaints of violations of the APMA Code of Conduct during the period January to June 1989. The complaints were received from independent medical practitioners (seven complaints), the Department of Community Services and Health (one complaint), the Australasian Society of Clinical and Experimental Pharmacologists (six complaints) and from sources within the pharmaceutical industry (14 complaints). Of the 28 complaints, seven complaints were found not to be in breach of the Code in whole or in part and one complaint is still to be finalized. Of the five complaints that were carried over from the previous six-month period, four complaints were found to be in breach of the Code of Conduct.

Corrective actions of the 24 cases that were found to be in breach of the code included a requirement for modification (10 complaints) or withdrawl (10 complaints) of the promotional material, the mailing of a corrective letter (five complaints) and a severe reprimand (one complaint). The breaches refer to:

A promotional aid by Cyanamid Australia Pty Ltd for Pipril (PIP001 07/88). The committee ruled that a statement concerned the potential for ß-lactamase induction of ceftazidime and piperacillin was unbalanced, and that graph that compared the incidence of resistance between monotherapy and combination therapy was not representative of the general literature. Action taken: the promotional aid was to be modified before future use and now has been withdrawn.

A promotional aid by Glaxo Australia Pty Ltd for Zantac (GLA 094). The Committee ruled that the promotional claim “For all these reasons, Zantac is now the No. 1 choice for Gastroenterologists in Australia” has been based on incomplete data and overstated the case. Also, the recommended changing the heading of a table showing interactions among ranitidine, cimetidine and nine other drugs from “Clinical Significance” to “Potential Clinical Significance”, as some interactions were of questionable clinical significance. Action taken: the promotional aid was to be modified before future use.

The promotion of Naprosyn in booklets that were sponsored by Syntex Australia Ltd for distribution by the Australian Sports Medicine Federation (ASMF) to the lay public and sports medicine professionals. The Committee ruled that the booklets contained promotional material and encouraged the public to ask doctors to prescribe a specific product. Action taken: Syntex was required to ask the ASMF to cease the distribution of the booklets on their current form to non-health-care professionals.

An advertisement by Rhone-Poulenc Australia Pty Ltd for Orudis SR (JHA 10487). The Committee noted that the thrust of the advertisement was 200mg “once daily therapy”, and ruled that even though this was the most commonly used dose, it was contrary to the dosage recommendation of “100-200 mg nocte” as stated in the Approved Product Information. Action taken: the advertisement was not be used again in the same form.

An advertisement by Reckitt & Colman Pharmaceuticals for Epilim (EPI 7402PDA). The Committee ruled that the claim that “Epilim often is better than other anticonvulsants” required, but it has been discontinued.

A brochure for Daonil that was distributed by Hoechst at an international diabetes conference in Sydney. The Committee ruled that the literature could be interpreted as demonstrating unacceptable bioequivalence of the Australian generic brand of glibenclamide to Daonil. Action taken: Hoescht AG (West Germany) sent a corrective letter to all the registered Australian delegates at the conference and Hoescht Australia was required to undertake not to reissue the brochure in Australia.

A press release for the vaccine Enegrix-B by Smith Kline & French Laboratories. The Committee ruled that the press release encouraged the public to ask doctors to prescribe a specific product. Action taken: Smith Kline & French were admonished for a serious breach of the Code. The Committee decided that any attempt at a corrective publication would just exacerbate the breach.

An advertisement by Syntex Australia Ltd for Naprosyn 500 (SYN 733). The Committee ruled that the comparative statement that Naprosyn 500 was more effective than Feldene and Voltaren had not been substantiated. Action taken: the advertisement has been discontinued.

An advertisement by Syntex Australia Ltd for Naprosyn (SYN 737). The Committee ruled that the advertisement implied that there was no need to take special precautions when treating elderly patients, and this conflicted with the Approved Product Information which states “Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients”. Action taken: the advertisement was withdrawn.

A booklet by Smith Kline & French Laboratories for Tagamet. The Committee ruled that two statements that concerned acid supression were contrary to medical opinion and two statements that concerned adverse reactions were out of date and speculative. Action taken: the booklet has been withdrawn and was not to be used again in its current form.

An advertisement by Smith Kline & French Laboratories for Tagamet (S&H SKTTA 503/496). The Committee ruled that the advertisement implied that cases of simple reflux could be treated under the Pharmaceutical Benefits Scheme that long-term treatment was encouraged which is contrary to the approved indications. Action taken: the advertisement was withdrawn and was not to be used again in its current form.

An advertisement by Smith Kline & French Laboratories for Engerix (S&H SKTEN 487). The Committee ruled that the advertisement implied that all adult members of the general community required hepatitis B vaccination and that this implication was not supported by the indications in the Approved Product Information or current medical opinion. Action taken: the advertisement was withdrawn.

A promotional aid for Feldene by Pfizer Pty Ltd (PFX 1954). The Committee had made a previous ruling about this promotional but found subsequently that the amended copy did not include one of the required amendments. Action taken: this was rectified promptly and it was acknowledged that timing of the reports had contributed to the problem.

An advertisement by Smith Kline & French Laboratories for Engerix (SKTEN 449). The Committee ruled that the advertisement implied that all children in the general community required hepatitis B vaccination and that this implication was not supported by the the indications in the Approved Product Information or current medical opinion. Action taken: the advertisement was withdrawn.

A patient education leaflet in Chinese by Smith Kline & French Laboratories for the vaccine Engerix-B. The Committee ruled that the leaflet was in breach and thereby constituted a promotion to the general public of a product that was available only on a prescription. Action taken: Smith Kline & French acknowledged the error and withdrew the leaflet from circulation before the Committee’s decision.

Advertisements and accompanying abridged Product Information by Pfizer Pty Ltd about a new indication for Minipress (PF1002/CJB). A previous ruling had been made about one of these advertisements, but the Committee ruled that it subsequently was published without all the required amendments. Action taken: the advertisements were withdrawn immediately and a corrective letter was required to be mailed to all doctors.

A poster and leaflet by Smith Kline & French Laboratories concerning “Hepatitis-B Awareness Week” in support of the product Engerix-B. The Committee ruled that the poster and leaflet represented promotion of a prescription product to the general public and that they presented an unbalanced medical claim about the need to vaccinate members of the general community against hepatitis B. Action taken: the posters and leaflets were withdrawn and a corrective letter was required to be mailed to all doctors who received the original materials.

A promotional aid for Voltaren by CIBA-GEIGY Australia Ltd (C-G 633/CJB). The Committee ruled that the phrase “twice as often” breached the Code as it could not be substantiated, and the phrase “first choice” breached the Code as it implied special merit. Action taken: the promotional aid was to be amended before further use.

A promotional aid by Searle Australia Pty Ltd for Cytotec (SRL1022). The Committee ruled that the aid promoted a non-approved indication. Action taken: the promotional aid was to be amended before further use.

An advertisement by Bayer Australia Ltd for Adalat 20 (Bay 267). The Committee ruled that the statement “no other antihypertensive offers greater cardiovascular protection than Adalat 20” could not be substantiated. Action taken: the advertisement was to be withdrawn.

A mailing by Searle Australia Pty Ltd in regard to new literature about Cytotec. The Committe ruled that the mailing promoted a non-approved indication. Action taken: a corrective letter was required to be sent to all recipients of the mailing.

A mailing by Searle Australia Pty Ltd in regard to the Pharmaceutical Benefits Scheme availability of Cytotec. The Committee ruled that the mailing promoted a non-approved indication. Action taken: a corrective letter was required to be sent to all recipients of the mailing. (see previous complaint).

A promotional aid for Endone by The Boots Company Australia Pty Ltd. The Committee ruled that a statement concerning adverse reactions contained a “hanging” comparative and incorrectly reflected the Product Information. Action taken: the promotional aid was required to be modified.

A hepatitis B vaccination campaign in schools by Smith Kline & French for Enegrix-B. The Committee ruled that the campaigned represented the promotion of a prescription product to the general public. Action taken: the campaign was ceased before the review and a retraction letter was required to be mailed to all the involved schools and doctors.

It is expected that further reports will be released at six-monthly intervals.