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Global Drug Discovery: Europe Is Ahead
Health Affairs
Published online August 25, 2009
Global Drug Discovery: Europe Is Ahead
Donald W. Light
Abstract
It is widely believed that the United States has eclipsed Europe in
pharmaceutical research productivity. Some leading analysts claim that
although fewer drugs have been discovered worldwide over the past decade,
most are therapeutically important. Yet a comprehensive data set of all new
chemical entities approved between 1982 and 2003 shows that the United
States never overtook Europe in research productivity, and that Europe in
fact is pulling ahead of U.S. productivity. Other large studies show that
most new drugs add few if any clinical benefits over previously discovered
drugs. I discuss ways in which Congress, employers, and insurers can
increase the value of drugs and revitalize the U.S. pharmaceutical industry.
[Health Affairs 28, no. 5 (2009):w969- w977 (published online 25 August 2009;
10.1377/hlthaff. 28.5.w969) ]
Donald Light is the Lorry Lokey Visiting Professor at Stanford University,
in Stanford, California, and a professor of social medicine in the
Department of Psychiatry at the University of Medicine and Dentistry of New
Jersey.
~~~~~~~~~~~~ ~~
PhRMA's Statement blasting Dr. Light's article:
www.phrma. org/news_ room/press_ releases/ phrma_statement_ regarding_ bene
fits_of_u.s. _innovation/
Dr. Light's response to PhRMA
August 27, 2009
PhRMA, the American pharmaceutical trade association, issued a strong
rebuttal to an article in the August 25th issue of Health Affairs-web
exclusive that documented the superior research productivity of Europeans to
Americans in developing global drugs since 1982. (See article at
http://content. healthaffairs. org/cgi/content/ abstract/ hlthaff.28. 5.w969v1 ).
"Global Drug Discovery: Europe in Ahead" apparently touched a raw nerve at
PhRMA because the article took a prominent study that is used to show
American superiority and demonstrated it was due to companies investing much
more money in the United States than Europe, especially in recent years.
By correcting for this bias and comparing innovativeness on a level playing
field, however, Europe came out ahead. Written by Donald Light, the Lokey
visiting professor at Stanford University and a professor at the University
of Medicine and Dentistry of New Jersey, the article otherwise used the same
data and methods as the original study proclaiming U.S. research dominance.
Light also cited evidence over the past 25 years that most new drugs offer
few or no benefits over existing drugs.
PhRMA charges that Light "paints a distorted picture that gives short shrift
to the medical advances made possible by America's pharmaceutical research
and biotechnology companies." In fact, all the new chemical entities
credited to the United States in the original study claiming American
superiority were included.
The PhRMA statement also charges that the article "ignores the chilling
effect of government price controls on such innovation." In fact, Light
notes that European research productivity has increased despite countries
negotiating lower prices on many drugs that reflect their added value. He
cites evidence that UK prices on patented drugs are high enough to pay for
all research and related costs and make a reasonable profit. Several other
countries and Canada have comparable prices. But companies can make more
profit faster in the United States, where they can charge about twice as
much; so they usually launch new drugs first in the U.S. Companies also
frequently raise prices on older drugs, which most countries do not allow.
The industry trade association claims that cancer patients are living on
average three years longer due to new treatments, and heart attacks fell by
nearly half from 1999 to 2005. Evidence for such claims needs careful
assessment, especially studies supported by industry. For example, earlier
diagnosis of cancer results in higher 5-year survival rates regardless of
treatment effects, just because the cancers have not advanced as far. Heart
attacks have declined for a number of reasons, including the benefit of
drugs.
As proof of clinical benefit, PhRMA points to the high percent of new drugs
that receive a priority rating from the FDA while being tested. Many of
these drugs, however, do not prove to have much clinical advantage. Only 1
in 7 new drugs offers significant clinical benefits over good drugs
discovered before. The FDA used to rate even fewer as notable until the
industry pressured it to abandon its rating system and replace it with the
looser one used now. The FDA is under constant pressure from the companies
that now pay for its review of new drugs to give them a priority rating.
PhRMA claims that Light used "misguided" ways of attributing new drugs to
Europe and the U.S. Those methods, however, were developed in order to
demonstrate how completely the U.S. has dominated Europe in drug research
productivity by Henry Grabowski, a distinguished economist whose studies the
industry widely cites to claim that research costs are staggering and
profits are modest. By correcting for investment size, Light found that
dollar-for-dollar, European research productivity has increased to surpass
the U.S. in global and first-in-class new drugs. In biotech and orphan drug
innovation, the U.S. still leads.
For all four kinds of drugs, the data from IMS and Grabowski show that U.S.
research productivity has been declining. Other methods for attributing new
drugs might come to different conclusions. More helpful than giving the
impression that nearly all new drugs are developed in the United States when
the data show this is not the case would be to seriously consider reasons
why US research productivity has been declining on a level playing field.
Contact: Donald W. Light dlight@princeton. edu or dwlight@stanford. edu
FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which
has not always been specifically authorized by the copyright owner. Such
material is made available for educational purposes, to advance
understanding of human rights, democracy, scientific, moral, ethical, and
social justice issues, etc. It is believed that this constitutes a 'fair
use' of any such copyrighted material as provided for in Title 17 U.S.C.
section 107 of the US Copyright Law. This material is distributed without
profit.
Health Affairs
Published online August 25, 2009
Global Drug Discovery: Europe Is Ahead
Donald W. Light
Abstract
It is widely believed that the United States has eclipsed Europe in
pharmaceutical research productivity. Some leading analysts claim that
although fewer drugs have been discovered worldwide over the past decade,
most are therapeutically important. Yet a comprehensive data set of all new
chemical entities approved between 1982 and 2003 shows that the United
States never overtook Europe in research productivity, and that Europe in
fact is pulling ahead of U.S. productivity. Other large studies show that
most new drugs add few if any clinical benefits over previously discovered
drugs. I discuss ways in which Congress, employers, and insurers can
increase the value of drugs and revitalize the U.S. pharmaceutical industry.
[Health Affairs 28, no. 5 (2009):w969- w977 (published online 25 August 2009;
10.1377/hlthaff. 28.5.w969) ]
Donald Light is the Lorry Lokey Visiting Professor at Stanford University,
in Stanford, California, and a professor of social medicine in the
Department of Psychiatry at the University of Medicine and Dentistry of New
Jersey.
~~~~~~~~~~~~ ~~
PhRMA's Statement blasting Dr. Light's article:
www.phrma. org/news_ room/press_ releases/ phrma_statement_ regarding_ bene
fits_of_u.s. _innovation/
Dr. Light's response to PhRMA
August 27, 2009
PhRMA, the American pharmaceutical trade association, issued a strong
rebuttal to an article in the August 25th issue of Health Affairs-web
exclusive that documented the superior research productivity of Europeans to
Americans in developing global drugs since 1982. (See article at
http://content. healthaffairs. org/cgi/content/ abstract/ hlthaff.28. 5.w969v1 ).
"Global Drug Discovery: Europe in Ahead" apparently touched a raw nerve at
PhRMA because the article took a prominent study that is used to show
American superiority and demonstrated it was due to companies investing much
more money in the United States than Europe, especially in recent years.
By correcting for this bias and comparing innovativeness on a level playing
field, however, Europe came out ahead. Written by Donald Light, the Lokey
visiting professor at Stanford University and a professor at the University
of Medicine and Dentistry of New Jersey, the article otherwise used the same
data and methods as the original study proclaiming U.S. research dominance.
Light also cited evidence over the past 25 years that most new drugs offer
few or no benefits over existing drugs.
PhRMA charges that Light "paints a distorted picture that gives short shrift
to the medical advances made possible by America's pharmaceutical research
and biotechnology companies." In fact, all the new chemical entities
credited to the United States in the original study claiming American
superiority were included.
The PhRMA statement also charges that the article "ignores the chilling
effect of government price controls on such innovation." In fact, Light
notes that European research productivity has increased despite countries
negotiating lower prices on many drugs that reflect their added value. He
cites evidence that UK prices on patented drugs are high enough to pay for
all research and related costs and make a reasonable profit. Several other
countries and Canada have comparable prices. But companies can make more
profit faster in the United States, where they can charge about twice as
much; so they usually launch new drugs first in the U.S. Companies also
frequently raise prices on older drugs, which most countries do not allow.
The industry trade association claims that cancer patients are living on
average three years longer due to new treatments, and heart attacks fell by
nearly half from 1999 to 2005. Evidence for such claims needs careful
assessment, especially studies supported by industry. For example, earlier
diagnosis of cancer results in higher 5-year survival rates regardless of
treatment effects, just because the cancers have not advanced as far. Heart
attacks have declined for a number of reasons, including the benefit of
drugs.
As proof of clinical benefit, PhRMA points to the high percent of new drugs
that receive a priority rating from the FDA while being tested. Many of
these drugs, however, do not prove to have much clinical advantage. Only 1
in 7 new drugs offers significant clinical benefits over good drugs
discovered before. The FDA used to rate even fewer as notable until the
industry pressured it to abandon its rating system and replace it with the
looser one used now. The FDA is under constant pressure from the companies
that now pay for its review of new drugs to give them a priority rating.
PhRMA claims that Light used "misguided" ways of attributing new drugs to
Europe and the U.S. Those methods, however, were developed in order to
demonstrate how completely the U.S. has dominated Europe in drug research
productivity by Henry Grabowski, a distinguished economist whose studies the
industry widely cites to claim that research costs are staggering and
profits are modest. By correcting for investment size, Light found that
dollar-for-dollar, European research productivity has increased to surpass
the U.S. in global and first-in-class new drugs. In biotech and orphan drug
innovation, the U.S. still leads.
For all four kinds of drugs, the data from IMS and Grabowski show that U.S.
research productivity has been declining. Other methods for attributing new
drugs might come to different conclusions. More helpful than giving the
impression that nearly all new drugs are developed in the United States when
the data show this is not the case would be to seriously consider reasons
why US research productivity has been declining on a level playing field.
Contact: Donald W. Light dlight@princeton. edu or dwlight@stanford. edu
FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which
has not always been specifically authorized by the copyright owner. Such
material is made available for educational purposes, to advance
understanding of human rights, democracy, scientific, moral, ethical, and
social justice issues, etc. It is believed that this constitutes a 'fair
use' of any such copyrighted material as provided for in Title 17 U.S.C.
section 107 of the US Copyright Law. This material is distributed without
profit.
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