Healthy Skepticism Library item: 13419

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Publication type: news

Aldhous P.
US wasted billions on ineffective cholesterol drugs
New Scientist 2008 Mar 31
http://www.newscientist.com/channel/health/dn13557-us-wasted-billions-on-ineffective-cholesterol-drugs.html

Full text:

Spiralling health care costs are sure to be a big issue in the coming US presidential election. So here’s a number for the candidates to debate: $1.5 billion.

That is the unnecessary sum spent on cholesterol-lowering pharmaceuticals in the US in 2006 alone, thanks to the marketing of a drug that doesn’t actually seem to reduce the risk of cardiovascular disease.

This sobering figure comes from researchers led by Cynthia Jackevicius of the Western University of Health Sciences in Pomona, California, US, who have analysed prescriptions of ezetimibe, a drug that inhibits the uptake of cholesterol, in the US and Canada.

Ezetimibe was launched in the US, as Zetia, in October 2002, and in Canada, branded as Ezetrol, in May 2003. The drug was intended as an addition to treatment with statins, and prescriptions in the US accelerated after July 2004, after it was marketed as a combination pill, along with the statin Vytorin. This was backed by a large advertising campaign.

Negative results
While ezetimibe does reduce levels of LDL, or “bad” cholesterol, manufacturers Merck and Schering-Plough announced in January that the combination of ezetimibe and a statin had failed to produce a greater reduction in the thickening of artery walls in a clinical trial, compared to treatment with a statin alone.

The Vytorin ads were pulled soon afterwards, and a US congressional committee is now investigating allegations that Merck and Schering-Plough were aware of the results for some time before making their announcement. The companies have denied that claim.

Full results of the negative trial were published on 30 March, along with an analysis of prescriptions and costs from Jackevicius’ team. The researchers found that in 2006, more than $19.5 billion was spent on cholesterol-lowering drugs in the US.

But if US prescriptions had followed the pattern observed in Canada – where the Vytorin combination was not approved and direct-to-consumer drug advertising is banned – the cost would have been about $18 billion, with more patients continuing to take a statin alone.

Shifting focus
“This very much supports the hypothesis that direct-to-consumer drug advertising is a major influence on the difference in costs between the two countries,” says Barbara Mintzes, a prominent opponent of drug advertising at the University of British Columbia in Vancouver, Canada.

Harlan Krumholz, a member of Jackevicius’s team at Yale University in New Haven, Connecticut, US, hopes the ezetimibe controversy will shift the focus for drug approval onto whether a drug actually reduces the risk of cardiovascular disease, rather than its effect on blood cholesterol.

Krumholz notes that in December 2006, Pfizer abruptly halted development of a drug called torcetrapib, which increased “good” HDL cholesterol and decreased LDL, after it was found to increase deaths in a clinical trial.

“Knowing what a drug does to LDL is insufficient to know what it does to people,” Krumholz argues.

Journal refs: The New England Journal of Medicine (DOI: 10.1056/NEJMoa0800742 and 10.1056/NEJMsa0801461)