me too drugs marketing darlings and little else

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fresh~horses - 08 Sep 2005 20:42 GMT

'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.

Another classic example is the best-selling heartburn and ulcer
medication Nexium, which is a derivative of the older drug Prilosec.
While the two drugs do essentially the same thing, the reformulation
and repackaging allowed the manufacturer, AstraZeneca PLC, to prolong
its patent and hence its profits.

In research published in the BMJ, Dr. Morgan and his team focused on
prescription-drug spending in British Columbia -- which they were able
to do because of B.C. PharmaNet, a database into which all filled
prescriptions must, by law, be entered.

The researchers found that breakthrough drugs accounted for only 2 per
cent of use and 10 per cent of expenditures.

By contrast, "me too" drugs accounted for 44 per cent of use and 63 per
cent of expenditures in 2003. The balance, 54 per cent of use and 27
per cent of expenditures, was on so-called "vintage" drugs -- brand
name and generic drugs that entered the market before 1990, when the
board started classifying drugs on an annual basis.

The bottom line, according to Dr. Morgan, is that 80 per cent of the
increase in drug expenditures in B.C. between 1996 and 2003 was
"explained by the use of new, patented drug products that did not offer
substantial improvements on less expensive alternatives available
before 1990." There is no reason to believe the pattern is any
different elsewhere in Canada, or in the developed world for that
matter.

That the prescription and cost of "me too" drugs is rising far faster
than time-tested competitors should give us all pause. This tremendous
waste of money should also lead policy-makers to consider whether the
current method of regulating prescription drug prices and of
determining which drugs are placed on provincial formularies is
adequate.

Canada provides generous patent protection to brand-name drug
manufacturers, and some provinces (notably Quebec) provide generous tax
breaks to these companies. They do so on the understanding that these
companies not only create jobs, but that they innovate and ultimately
produce drugs that will save the health system money.

What we're getting now is a lot of the same-old, same-old, with
ever-increasing sticker prices. We're not getting a lot of
breakthroughs and innovation, let alone miracles and cures, for our
drug dollars.

http://www.globeandmail.ca

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