Healthy Skepticism Library item: 19885

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 Promotion Problems
MJA 1989 Apr 17; 150:(531):463

Full text:

The Australian Pharmaceutical Manufacturers Association (APMA) received 27 complaints of violations of the APMA Code of Conduct that appeared in various promotional materials from the months of July to December, 1988. The APMA received these complaints from independent practitioners, the Department of Community Services and Health and from sources within the pharmaceutical industry. No breach was found in 11 of the complaints, 11 of the complaints were upheld in whole or in part and five of the complaints still are to be finalized. Five complaints which were carried over from the previous six month period were found to be in breach of the code. The breaches refer to:

An advertisement by Pfizer Pty Limited for Feldene (PFX 1590). The Committee ruled that the statement “Feldene provides the unique benefits of good tolerability and superior relief of pain, stiffness and inflammation, with the compliance-building convenience of single daily dosage” was not substantiated. Action taken: the advertisement was withdrawn.

An advertisement by Pfizer Pty Limited for Minipress (PFX 1445). The Committee ruled that the phrase “single-agent therapy” implied that a second antihypertensive agent was unnecessary and this claim was not substantiated. Action taken: the advertisement was withdrawn.

An advertisement by Schering Pty Limited for Isoptin (SCHISI245/L & B). The Committee ruled that the phrase “it offers a range of long-term benefits unmatched by other drugs in this field” was an unqualified superlative. Action taken: the advertisement was withdrawn.

Promotional material by Upjohn Pty Limited for Provera. The Committee ruled that the weight of clinical evidence that was presented did not substantiate the claims of improved clinical efficacy as a result of a micronized formulation change. Action taken: a clarification statement was issued to recipients of the original promotional material.

A ‘Dear Doctor’ letter, journal advertisement and promotional aid by Smith Kline & French Ltd for the vaccine Engerix-B 20 μg. The Committee ruled that the material implied special merit for a “full strength 20 mcg dose” which was misleading; statements that referred to prolonged protection and more security in the case of the inappropriate storage of the vaccine were not supported by the product information; and the statement that the vaccine “compensates for individual variations in immune response” was not substantiated. Action taken: the promotional materials were withdrawn and a letter was issued which clarified the storage conditions of vaccines.

A journal advertisement by Wellcome Australia Limited for Septrin (WEL 130). The Committee found the statement “the unique two-stage action of Septrin on bacterial folic acid metabolism actually multiplies the odds against mutant bacteria surviving to evolve into resistant strains” to be misleading in its use of the terms “unique” and “multiplies”. Action taken: the advertisement was withdrawn and Wellcome undertook not to repeat the statement in the same manner.

An advertisement by Janssen-Cilag Pty Ltd for Hismanal (JANJ193/CJB). The Committee ruled that the claim “shown to be superior” was not substantiated and that the word “superior” is a “hanging” comparative. Action taken: the advertisement was withdrawn.

An advertisement and accompanying abridged product information by Pfizer Pty Limited in respect of a new indication for Minipress (PFI002/CJB). The Committee ruled that, contrary to Australian Drug Evaluation Committee’s recommendations, the advertisement implied safety, not only for those awaiting prostatic surgery, but also for the indefinite use of Minipress for all with benign prostatic hypertrophy; and the statement that “no effect on blood pressure in normotensive patients has been noted” was not supported by the approved product information. Action taken: the advertisement was withdrawn and a clarification letter was mailed to doctors.

An advertisement by Eli Lilly Pty Ltd for Keflex (ECS 3354). The Committee ruled that the advertisement implied that Keflex was the first drug of choice for tonsillitis, even though this was negated by a warning in small print at the bottom of the advertisement. Action taken: the advertisement was not to be used again in the same form.

A booklet entitled Cotrimoxazole in perspective released by Roche Products Pty Ltd’s Medical Information Service. The Committee ruled that the booklet had been assembled carelessly and was misleading. Action taken: the booklet was withdrawn from circulation.

An advertisement by Glaxo Australia Pty Ltd for Ceporex in MIMS June-July 1988. The Committee ruled that the advertisement’s claim of the drugs high success rates for the treatment of respiratory (87%-98%) and urinary-tract (100%) infections was not substantiated. Action taken: the advertisement was withdrawn.

An advertisement by Beecham Research Laboratories for Augmentin (BRL/FINESSE-253 9/87) in MIMS June-July 1988. The Committee ruled that the advertisement was misleading by not specifying that Augmentin was the only broad-spectrum antibiotic which can be administered by mouth that inactivates antibiotic destroying enzymes. Action taken: the advertisement was to be modified before future use.

An advertisement by Beecham Research Laboratories for Floxapen (BRL/FINESSE-323 3/88) in MIMS June-July 1988. The Committee ruled that the statement “skin and sift tissue infections expelled with extraordinary expediency: used unqualified superlatives. Action taken: the advertisement was withdrawn.

A promotional aid (PFX 1889) by Pfizer Pty Ltd for Feldene. The Committee ruled that some claims that referred to the mode of action of the drug in osteoarthritis were referenced inadequately; and a chart heading differed from the which was used in the original publication and was misleading because it implied significantly better results in a range of parameters, rather than in only one parameter, when Feldene was used. Action taken: the promotional materials were withdrawn and modified before further use.

An advertisement by Wellcome Australia Limited for Septrin (WEL 308B). The Committee ruled a minor breach as there was no reference to caution in the prescribing of the drug for elderly persons (as will in due course be included in the amended product information). Action taken: the advertisement was discontinued.

An advertisement by Roche Products Pty Limited for Bactrim (BAC 881). The Committee ruled that the statement “Bactrim – indications are unchanged” was misleading by implication and omission in view of the Australian Drug Evaluation Committee’s recommendation to include a caution in the prescribing of the drug to elderly persons.

The advertising campaign by Roche Products Pty Limited for Bactrim (BAC 881, 882). The Committee ruled that the campaign was in breach of the Code because it was unbalanced and misleading by implication and omission. Action taken: Roche was required to suspend the whole campaign and issue a corrective letter to all doctors.

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