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Theme: Conflicts of interest

Healthcare is big business. As the stakes grow ever larger, so do the pressures on healthcare professionals and consumers. Those who inform, educate and regulate are also prey to an array of influences. For Prescrire, the response is "Non merci…"

Themes

Experts and conflicts of interest

When will European policy makers and regulators realise that their primary responsibility is to promote citizens' well-being, and not the profitability of the pharmaceutical industry? "Conflicted" experts must be excluded from drug approval procedures.

Roche is seeking to expand the market for its cancer drug, erlotinib. This is only to be expected from a company that relies on maximising its drug sales and stock value. After all, treatment with this drug costs about 2000 euros a month.

After obtaining marketing authorisation in some forms of lung cancer, Roche saw the licensing committee of the European Medicines Agency (EMEA) reject an application for the use of erlotinib in advanced-stage and metastatic pancreatic cancer in July 2006. The committee considered that the adverse effects of erlotinib in this setting outweighed its limited efficacy.

When Roche appealed this decision, EMEA convened a special session including a panel of four experts to examine the application in late 2006. The expert panel issued a favourable opinion and the drug was finally approved for use in metastatic pancreatic cancer (1).

However, other than the addition of a retrospective subgroup analysis with a low level of evidence that favoured the product, the same application was submitted.

Smelling a rat, Prescrire asked EMEA for copies of the four experts’ conflict of interest statements. Unsurprisingly, all four experts had links to pharmaceutical companies, and two of them had dealings with Roche. A third expert’s statement dated back to 2004 and had not been updated since (2).

Sadly, conflict of interest statements do not guarantee scientific integrity. When will European policy makers and regulators realise that their primary responsibility is to promote citizens’ well-being, and not the profitability of the pharmaceutical industry? ‘Conflicted’ experts must be excluded from drug approval procedures.

Prescrire Int 2007; 16 (93): 2.

References:
1- European Medicines Agency “Questions and answers on the change to the marketing authorisation for Tarceva” 14 December 2006: 2 pages. 2- European Medicines Agency “Lettre à la revue Prescrire” 29 June 2007: 12 pages.