GlaxoSmithKline takes legal action to block new controls on its smoking cessation drug
Leading researchers have attacked the pharmaceutical giant GlaxoSmithKline for trying to block proposed new controls on the smoking cessation treatment bupropion (Zyban) in Australia.
The plan, which requires that patients have a second GP consultation to get a full prescription, was developed in response to concerns about costly waste of the treatment.
But the company has taken legal action, arguing that the Pharmaceutical Benefits Advisory Committee does not have the authority to make changes once drugs have been listed for subsidy. The company also claims that the committee's procedures denied it natural justice.
Prominent researchers, including Professor Simon Chapman, editor of Tobacco Control, resigned from a research group funded by the company, the Australian Smoking Cessation Consortium, in protest at the company's legal action.
Almost 500000 prescriptions have been filled since bupropion was listed on the pharmaceutical benefits scheme in February 2001, costing the federal government $A106m (Â£41m; $66m; a60m).
But a study, based on interviews with 151 patients who were prescribed the drug in 2001, found that less than 20% of patients completed the full course of treatment (Medical Journal of Australia 2002;177:277-8). Less than half had any counselling or support, despite this being integral to the treatment's success.
"We regard the legal action being taken by your company as being not in the best interests of the prudent use of public money," Professor Chapman and colleagues wrote in their resignation letter.
The action, they added, "has almost certainly caused widespread damage to your company's reputation within the smoking cessation expert culture in Australia."
The researchers said bupropion had been prescribed to about 10% of Australian smokers, but this had had no obvious effect on the prevalence of smoking.
They noted that the company's consumer division recently hosted a dinner examining an apparent halt in the decline in the prevalence of smoking: "This stalling has occurred during the time when Zyban was listed by the pharmaceutical benefits scheme."
Concern about apparent wastage of the drug comes at a time of frustration among antitobacco activists over lack of funding for other tobacco control measures, such as mass media campaigns.
Tobacco control in Australia had stalled because of complacency and "ludicrous" levels of funding, Californian experts warned in a recent editorial in the Medical Journal of Australia (2003;178:313-4)[Medline].
Meanwhile, the Australian Consumers Association has said that GlaxoSmithKline's action should remind doctors and researchers of the perils of involvement in industry funded groups.
The researchers involved in the consortium were furious that the company had not told them about the action in advance or sought their advice. Instead, they first learned of it at a conference several days after the hearing at the federal court.
Martyn Goddard, spokesman for the association and a former member of the Pharmaceutical Benefits Advisory Committee, said: "I'm very glad those people have resigned, but now they must be asking themselves whether they should have joined in the first place."
A judgment is not expected for some months.