Drug Study Volunteers Misled?

Volunteers in drug studies often choose to participate based on misleading information, say medical ethicists in the latest issue of the British Medical Journal. They argue that drug companies conduct a certain type of skewed study merely for marketing purposes.

The type of study addressed is called open label extension studies. In these, participants in an earlier trial of a particular drug are invited to take the drug while it awaits regulatory approval so that the company can assess long-term safety of the drug.

According to a press release about the article,

"Many of the patients who volunteer to take part in [drug] studies have previously been involved in clinical trials of the product and are often recruited on the basis that they are helping scientific research.

"But researchers investigating OLES estimate that less than four per cent of these studies were published in scientific journals and found that many of the trials they looked at were of dubious scientific integrity."

This is only one side of the story, of course, but it’s one I’ll consider if I decide to participate in a drug study. Although, I don’t know how much regulation of open label extension studies varies between the UK and other countries. Such studies are conducted in many other countries, including the US and Canada.

The full text of the journal article, not just the press release, is also available.

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