Healthy Skepticism Library item: 2431

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Picard A.
'New' drugs too often offer little new
The Globe and Mail ( Canada) 2005 Sep 8
http://www.theglobeandmail.com/servlet/ArticleNews/TPStory/LAC/20050908/HPICARD08/TPNational/Canada

Keywords:
research development

Notes:

Ralph Faggotters Comments: One of the key collective delusions which permeates the modern world is the notion of ‘constant progress through science’.
We are exposed to this mantra in one form or another almost daily to the point that nearly everyone takes it as a self-evident truth.
However reality , if we care to observe it, tells a very different story.
One example of this is the idea that medical science is going ahead in leaps and bounds and that if we keep pouring billions of dollars into R&D we will reap the rewards with brilliant new cures for diseases.
But where are the ‘brilliant new cures’ of the last 20 years?
The truth is that they are almost non-existant.
Medicinal cures for diseases are in fact rare.
Most bacterial, malarial and fungal conditions can be cured with medicines but diminishingly so.
Some cancers can be cured with medicines some of the time, but over-all, technology has given us much more cancer than it has taken away.
Apart from the above, cures are rare.
Most medications ‘treat’ disease but do not cure.
While you are taking your blood pressure, heart failure, HIV, erection, oesophageal reflux or diabetes pills you are being HELPED but not cured.
For a pharmaceutical company to find a cure for these conditions would be economic suicide for the industry.
Imagine if you just had to take ONE pill ONCE and your high blood pressure was cured forever!
This would be a disaster for an industry which relies on the fact that you will need to take your BP pills for decades and hence pay them a dividend every month till you die.
Even then, less than 6% of new medications are GENUINELY NEW according to the generous criteria set by Dr. Steven Morgan and his colleagues at the Centre for Health Services and Policy Research at the University of British Columbia who decided to study this matter.

Has medical science has run out of puff?

Full text:

‘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