US wasted billions on ineffective drugs
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).