he UK Government's decision to off-load the responsibility to patients
is a BAD decision. It not only increases the inequity, it also creates
the situation where the patient-physician relation is disconnected.
While it is clearly recognized that statins are essential drugs for
management of cardiovascular risk and its prevention, the UK government
failed to acknowledge that not one dose fits all. Depending upon the
level of serum cholesterol, the dose must be titrated to have effective
control of cholesterol. In the absence of periodic monitoring for
effectiveness and to deal with side effects the OTC solution is ill
conceived. The studies in the past few decades have shown that if
there
are side effects patients stop taking their medications.
This leads to
poor compliance. In the end, it might cost the tax payers even more
with additional hospitalization and increased morbidity and mortality.
The very purpose of prevention will be defeated.
It is time for the UK Government to reconsider its decision and for the
other countries to weigh the long term implications of OTC statins.
Arun Chockalingam, MS, PhD, FACC
Assistant Director
Institute of Circulatory and Respiratory Health
Canadian Institutes of Health Research
-----------------------------------------
The UK government recently decided to make the cholesterol-lowering
drug
simvastatin available over the counter (OTC) from July this year for
people at moderate risk of cardiovascular disease. The Lancet just
published an editorial entitled "OTC Statins: A Bad Decision for Public
Health," which illuminates the emerging issue of making drugs available
over the counter (OTC). This often precludes insurance coverage for
the
drug, placing the burden on the patient.
The push has also begun to bring cholesterol-lowering drugs to the mass
market in the United States. The Associated Press reported this week
that several American pharmaceutical firms who make the drugs known as
statins have begun behind-the-scenes efforts to convince officials at
the U.S. Food and Drug Administration to follow the UK's lead in
allowing the drugs to be sold over the counter.
We at ProCOR are interested in your comments.
Brian Bilchik MD
Director, ProCOR
OTC Statins: A Bad Decision for Public Health
(Lancet 2004; 363: 1659)
The editorial comments: "There are no trials of OTC statins for
primary
prevention of heart disease. There are no data on compliance with OTC
statins, which for products that need to be taken daily longterm is a
concern. Will those who buy simvastatin also stop smoking, lose weight,
and do more exercise, or will they substitute drug use for lifestyle
modification? Will pharmacists have the time to determine the
individual's risk of coronary heart disease before selling the drug
and
also to give lifestyle advice? All these are unknowns, which is
unfortunate for the UK public, who will be the guinea pigs in this
large-scale OTC experiment.
Americans have escaped this role, with two applications for OTC
statins
(pravastatin 10 mg and lovastatin 10 mg) being rejected in 2000 because
of
insufficient evidence that either drug could be used safely and
effectively in an OTC setting."
"In the absence of evidence of the overall mortality benefits of OTC
simvastatin, it is difficult to avoid concluding that the motive behind
the Government's decision is saving money. Statins are currently
prescribed to about 1.8 million people in the UK, costing the NHS 700
million pounds a year. With the NHS bill for statins predicted to be
more than 2 billion pounds a year by 2010, transferring costs to
patients might seem timely. But privatising the prevention of heart
disease will increase inequalities, with many unable to afford the
likely 10-15 pounds per month long-term. For the manufacturer, of
course, the motive is clear. With simvastatin now off patent, creation
of a new market (perhaps 8 million more people in the UK) will please
shareholders."
"What is now needed is a surveillance system for OTC simvastatin.
Evidence of benefit and risk must be collated in this
primary-prevention
setting, and used to decide on applications for increased doses of
simvastatin or other statins to be available OTC. In the meantime the
planned National Institute for Clinical Excellence appraisal of statins
for prevention of coronary events due to be published in June, 2005,
should be fast-tracked to provide updated guidance on statin
prescribing. If the Government is serious about preventing heart
disease, then privatisation of that prevention is not the answer. And
if
the UK public is to be used in an OTC
experiment, then the evidence must be collected and used for the
benefit
of all."
©2004 The Lancet
_____________________________________________________________________
To reply or contribute to ProCOR's Global Dialogue:
ProCOR (www.procor.org) is a program of the Lown Cardiovascular
Research Foundation. ProCOR's email discussion is administered by
SATELLIFE (www.healthnet.org), The Global Health Information Network.
Dr.Alejandro Wajner
(Buenos Aires, Argentina).
Junio 5, 2004.
E-mail: [email protected]
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