But does Glaxo "create" its markets?
Glaxo has built up one of the world's biggest 1 sales-forces for drugs, 9,500-strong and growing; the firm is still recruiting in Europe in the expectation that several new products will be approved there. These days its marketing machinery goes into action far 1 earlier in a product's life. While a new drug is being developed, Glaxo holds costly symposiums to which it invites experts — many of them doctors — who know about the disease the drug is designed to treat. Critics say the aim is to build a market while the drug is more an idea than a reality. Mr Mario says the drug companies use such symposiums to gauge market potential.
Once a drug is presented to regulators for approval, the marketing men get to work. After Imigran, an anti-migraine drug, was submitted to regulators for approval in mid-1990, Glaxo used public-relations firms to work out how to create demand. Doctors are to be blitzed with medical literature as well as being given guidelines on how to diagnose the disease. Medical authorities are to be persuaded of the economic savings derived from treating migraine. Fair enough, so long as such claims are true: developing brands and educating consumers matter as much to drugs firms as to others. 1
• Might such heavy investment in development and marketing distort expectations inside and outside the firm?Some doctors believe that these practices raise the stakes in a new product to such an 1 extent that a company's scientific judgement might become clouded: that too little could be made of a drug's side-effects, and too much of its benefits. Mr Mario says that this is not possible. Any adverse information1 must be reported to regulators, he says, who are the industry's final arbiters. The claims made by drug firms about their products are also regulated.
Recently there have been complaints that Glaxo is confusing doctors in its promotion of Salmeterol, an anti-asthma drug that was launched in Britain last November, through claims about it potency. Although Glaxo has changed its promotional material for Salmeterol, Mr Mario believes that discussions about products should take place only with regulators. After all, drug firms do not have to publish data to get products approved, so even medical journals provide an incomplete view. Mr Mario believes that Glaxo should not be responsible for telling doctors about unfavourable reports on its drugs. It is the regulators who must decide.
• But what about post-marketing studies? Don't they put an unreasonable burden on doctors?Dr Bill Inman of the Drug Safety Research Unit, a charitable organisation based in Britain's Southampton, is opposed to another common pharmaceutical practice. Almost immediately after a drug has been launched, Glaxo and others establish small studies ostensibly to monitor the performance of their drugs in a normal population, rather than the one carefully selected for clinical trials. The idea is to spot any new adverse effects. But because doctors are paid for the exercise, Dr Inman regards it as a covert form of promotion, particularly as recruited patients often stick to the drugs after the study is complete.
Mr Mario does not think post-marketing studies are unethical: regulators have not yet managed to arrange a consistent system to handle later adverse reports, so the studies do the job.
He may be placing too much faith in regulators. America's Food and Drug Administration is in turmoil, overburdened and charged with corruption. In Britain critics believe that the relationship between drug firms and the Medicines Agency is too cosy. All information that passes between them about the approval of a drug is confidential. The agency is soon to be spun off from the Department of Health, financed solely by drug companies' licence fees. Moreover, recent surveys have shown that doctors are highly dependent on the industry's marketing men for information, which means that an appropriate debate on potential side-effects can never really take place. This may be why the World Health Organisation has gone so far as to suggest that sales-forces for drugs should be financed by the state.
© The Economist
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