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BMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b4389 (Published 27 October 2009) Cite this as: BMJ 2009;339:b4389

Package inserts are a poor source of information about drugs

Doctors and patients often rely on drug labels and package inserts for information about the benefits and harms of prescription drugs. In the US, labels and inserts are written by drug companies and often lack important details, write two observers. It can be hard or even impossible to find out how well a drug works, or how likely patients are to experience side effects. The manufacturers are not required to give numerical data or to pass on to consumers any doubts expressed by the Food and Drug Administration (FDA) at the time of approval. Some drugs have an easier passage through the approval process than others, they write. Doctors and patients need to know if reviewers were sceptical about marginal benefits, if approval was a “close call,” and if so, why.

Improvements to labels and inserts may be on the way in the US. In the meantime, the regulatory authority should make the review process more accessible to outsiders. A standardised executive summary would help, preferably one that contains tables of results from phase III trials, the reasoning behind reviewers’ decisions, and any strings attached to approval. FDA reviews are a rich source of information, say the observers, but the important bits often get lost. Earlier this year, the federal government pledged $1.1bn (£0.6bn; €0.74bn) for research comparing existing medical treatments. Better dissemination of what we already know would be cheaper and quicker, they conclude.

Sperm donor gives genetic heart disease to multiple biological children

When a 23 year old man donated sperm repeatedly to a commercial sperm bank in the US, he had no idea he was carrying a gene mutation that causes hypertrophic cardiomyopathy. Neither did the couples that used his sperm to conceive 22 children. The mutation eventually surfaced when one of his biological children died at the age of 2 while waiting for a heart transplant. …

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