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fresh~horses wrote:
'New' drugs too often offer little new
Breakthrough drugs are rare. Most newcomers driving up costs are just
me-too marketing darlings
By ANDRE PICARD
Thursday, September 8, 2005 Page A25
In 2004, prescription-drug spending in Canada rose to a staggering
$18-billion a year (not including the $1.3-billion in prescription
drugs dispensed in hospitals). In 1985, prescription drug spending was
only $2.6-billion annually.
In the past decade alone, drug spending has doubled, to the point where
Canadians now spend more money on prescription drugs than on physician
services.
While the vertiginous rise in costs is worrisome, we can at least take
comfort that all this new spending is a sign of scientific progress, a
reflection of dramatic breakthroughs that are providing innovative new
lifesaving treatments. But is that true?
New research, published in the most recent edition of the British
Medical Journal, suggests otherwise
Dr. Steven Morgan and his colleagues at the Centre for Health Services
and Policy Research at the University of British Columbia decided to
examine the data and figure out exactly what is driving expenditure
growth.
The Canadian Patented Medicines Prices Review Board, which regulates
drug prices in the country (the principal reason our drugs costs are
far lower than in the U.S.), reviews all drugs before they get to the
market.
Between 1990 and 2003, the board reviewed 1,147 newly patented drugs.
As part of its procedure, the board distinguishes "breakthrough" drugs
from other medicines. It found that 68 drugs (a mere 5.9 per cent) met
the regulatory criterion of being a breakthrough drug -- defined as the
"first drug to treat effectively a particular illness or which provides
substantial improvement over existing drug products."
These breakthrough drugs include: filgrastim (sold under the brand name
Neupogen), used to treat a common side effect of chemotherapy;
donepezil hydrochloride (Aricept), used in Alzheimer's; infliximab
(Remicade), used in rheumatoid arthritis and Crohn's disease.
The board also classifies variants on the breakthroughs as innovative,
bringing the total to 142. If only 142 of the 1,147 new drugs actually
provide a substantial improvement, that means the other 1,005 don't --
they are merely variations of drugs that already exist.
"We called them 'me-too' drugs," Dr. Morgan said. The "me-too" drugs
are knock-off drugs by brand-name manufacturers (as opposed to copycat
drugs made by generic companies after patents expire) of their
competitors' successful products, and sometimes variations on their own
drugs.
The "me-too" drugs usually feature a small molecular variation but do
essentially the same thing. Still, they can be very profitable.
Take the cholesterol drug Lipitor, the world's best-selling drug, with
$10.8-billion (U.S.) in sales last year alone. It was actually the
fourth drug in its class out of the gate -- after Mevacor, Pravachol
and Zocor -- but slick and aggressive marketing made it the market
ruler....
There is a great deal of individual variation in response to a drug. A
different drug in the same class may work or be tolerated better than
another. So it's desirable to have a number available.
Having a number of different drugs in the same class provides
competition even when the drugs are under patent.
Later drugs, even in the same class, often work significantly better
than the original drug. The article mentions Lipitor, which was
something like the 4th or 5th statin marketed. But Lipitor is probably
the most effective statin. And the earliest one was not very effective.
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