[Ip-health] Reuters - New Drugs Are Barely An Improvement Over Decades-Old Standbys, Study Finds
Riaz K Tayob
riaz.tayob at gmail.com
Mon Jun 3 22:44:42 PDT 2013
[With the rise of the financial rentiers in the US, perhaps this sheds
some light on the IPR rentiers...]
New Drugs Are Barely An Improvement Over Decades-Old Standbys, Study
*Reuters* | Posted: 06/03/2013 4:00 pm EDT
By Sharon Begley
NEW YORK, June 3 (Reuters) - Despite the more than $50 billion that U.S.
pharmaceutical companies have spent every year since the mid-2000s to
discover new medications, drugmakers have barely improved on old
standbys developed decades ago.
Research published on Monday showed that the effectiveness of new drugs,
as measured by comparing the response of patients on those treatments to
those taking a placebo, has plummeted since the 1970s.
While that is already unwelcome news to drug and biotech companies, the
consequences for the pharmaceutical industry could get worse under
President Barack Obama's healthcare law.
The law established an independent research institute to compare the
effectiveness of different treatments for the same condition. That way,
patients as well as private insurers and government programs such as
Medicare can stop paying for less effective therapies. If the new
analysis is correct, then "comparative effectiveness research" could
conclude that older drugs, which are more likely to be generics, are
better than pricey new brand names that deliver the most profits for
Fears of a crisis in drug innovation have grown over the years. When the
healthcare journal Prescrire in 2011 ranked new drugs, only 17 of the
984 developed since 2001 were deemed "a real advance" or better. And a
survey of 184 expert physicians in 15 specialties published last month
in Nature Reviews Drug Discovery showed the doctors were more likely to
rate drugs more than a decade old as "transformative."
To be sure, drugs that completely change outcomes for patients continue
to emerge. Gleevec, from Novartis, greatly extends life for leukemia
patients, for instance. New antivirals such as Incivek from Vertex
Pharmaceuticals have doubled the cure rate in hepatitis C, and Eylea
from Regeneron Pharmaceuticals is better than anything previously
developed for macular degeneration.
Because of those and other examples, "we believe that a lot continues to
be accomplished in terms of yielding very, very positive results for
patients, so there seems to be a disconnect between that and this
paper," said Randy Burkholder, deputy vice president of policy at the
Pharmaceutical Research and Manufacturers of America (PhRMA) trade group.
CANCER TO MENTAL ILLNESS
The new study in the journal Health Affairs examined 315 clinical trials
that compared a drug to a placebo and were published in four of the
world's top medical journals (BMJ, Journal of the American Medical
Association, Lancet and New England Journal of Medicine) from 1966 to
2010. The drugs targeted the full range of human ills, from
cardiovascular disease and infections to cancer, mental disorders and
In the early years, drugs easily beat the placebo: They were, on
average, 4.5 times as effective, where effectiveness means how well they
lowered blood pressure, vanquished tumors, lifted depression or did
whatever else they were intended to.
But the trend line was inexorably downhill, found Dr Mark Olfson of
Columbia University and statistician Steven Marcus of the University of
Pennsylvania. By the 1980s drugs were less than four times better; by
the 1990s, twice as good, and by the 2000s just 36 percent better than a
placebo. Since older drugs were much superior to placebo and newer ones
only slightly so, that means older drugs were generally more effective
than newer ones.
"Their results are pretty compelling," said Dr Aaron Kesselheim of
Harvard Medical School, who helped conduct the survey of physicians on
"transformative" drugs but was not involved in this study. "It does
appear that things are headed in the same direction, with newer drugs
having relatively less efficacy."
Experts disagree on why that should be, but suspicions range from the
U.S. regulatory process to basic biology.
"It may be that the drug discoveries based on low-hanging fruit were
made long ago," said Olfson, as with discoveries based on the most basic
or easily targeted causes of high blood pressure. In that case, older
drugs based on those targets would pack a bigger punch than newer ones
that target less-central causes of disease.
Or, it could be that the patients who volunteer for clinical trials have
gotten harder to treat. In many cases, people volunteer because existing
drugs are not helping their cancer, schizophrenia or other condition,
Olfson said, "and may have forms of the disease where it's harder for a
drug to demonstrate a benefit."
Another explanation could be that the scientific quality of clinical
trials has improved over the decades, as the Health Affairs analysis
found. Human studies in the 2000s were more likely than those in the
1960s to enroll hundreds of patients rather than dozens.
"It may be that the compounds aren't getting less effective but that
they're getting looked at more carefully," said Dr Harold Sox of the
Dartmouth Institute for Health Policy and Clinical Practice and former
editor of the Annals of Internal Medicine.
'SOMETHING REAL IS GOING ON'
While experts agree that tougher trials and similar factors explain some
of the decline in drugs' reported effectiveness, "something real is
going on here," said Olfson. "Physicians keep saying that many of the
new things just aren't working as well," and therefore prescribe
antidepressant drugs called tricyclics (developed in the 1950s) instead
of SSRIs (from the 1980s), or diuretics (invented in the 1920s) for high
blood pressure instead of newer anti-hypertensives.
Whatever the reason for many new drugs packing less punch than old ones,
that will not keep them from reaching patients.
"The way the drug regulatory system is set up, even if you have just a
small advance, if you market it right it can be very profitable," said
Critics of the high prices of drugs that are only marginally (if at all)
more effective than older, cheaper, often generic medications hope that
head-to-head studies will persuade more physicians to stop prescribing
expensive but less effective drugs. The Affordable Care Act of 2010 -
"Obamacare" - established the Patient Centered Outcomes Research
Institute (PCORI) to conduct such comparative effectiveness research.
The drug industry says it isn't worried. "Our sector is not concerned
about objective, high-quality patient-centered comparative effectiveness
research," said PhRMA's Burkholder. "We believe the substantial value of
our products will continue to be demonstrated."
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