Researchers involved in drug trials will now have to reveal whether they have any financial interest in the drug company, when it is submitting licensing applications to the US Food and Drug Administration (FDA). The new rule will not be law until February 1999, but aims to eliminate data bias from financial considerations.

Companies will have to disclose whether clinicians have received stock and patent options, payments in the form of grants, gifts or further work. A recent article in the New England Journal of Medicine (1998; 338: 101-6) found that doctors who had a financial relationship with manufacturers of calcium channel blockers were more likely to consider them safe than other doctors investigating the same product (BMJ, 1998; 316: 493).

In another ruling, the FDA has implemented new rules on food labelling in the US. Labels on a range of foods containing psyllium a plant with a soluble fibre from its seed husk can now claim that the product may reduce the risk of coronary heart disease as part of a diet low in saturated fat and cholesterol. Last year a ruling allowed the same claim for foods containing soluble fibre found in whole oats.

The FDA has substantiated other claims as part of the Nutrition Labelling and Education Act 1990, including calcium and the reduction in risk of osteoporosis (see p 12) and folic acid and the reduction in birth risks. (The Lancet, 1998; 351: 609).

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Written by What Doctors Don't Tell You

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