of new drugs 'offer few benefits'
companies were accused today of conning the public by hyping up patented
medicines with little new to offer while downplaying their side-effects.
85% of new drugs offer few if any new benefits while having the potential
to cause serious harm due to toxicity or misuse, a study has concluded.
The author of
the research delivered a damning attack on "Big Pharma" at a meeting
of sociology experts in the US. Professor
Donald Light described the pharmaceutical industry as a "market for
lemons" - one in which the seller knows much more than the buyer about
the product, and takes advantage of this fact.
drug companies hide or downplay information about serious side-effects of
new drugs and overstate the drugs' benefits," said Prof Light, a professor
of comparative health policy at the University of Medicine and Dentistry
in New Jersey, US.
they spend two to three times more on marketing than on research to persuade
doctors to prescribe these new drugs. Doctors may get misleading information
and then misinform patients about the risks of a new drug. It's really a
two-tier market for lemons." He
alleged that the pharmaceutical industry owned companies in charge of drug
testing and provided "firewalls" of legal protection behind which
information about dangers or lack of effectiveness could be be hidden. Companies
were assisted by the "relatively low bar" for effectiveness that
had to be crossed to get a new drug approved, he claimed.
Light presented his paper, entitled "Pharmaceuticals: A Two-Tier Market
for Producing 'Lemons' and Serious Harm" today at the American Sociological
Association's annual meeting in Atlanta, Georgia. The study includes data
gathered from independent reviewers which suggest that 85% of new drugs
provide few, if any, new benefits. Yet toxic side effects and misuse of
prescription drugs had made medicines a significant cause of death, said
Prof Light. The
professor makes the same claims in a new book, The Risk of Prescription
Drugs due to be published this autumn by Columbia University Press.
his paper and the book, he describes the "risk proliferation syndrome"
involved in drug marketing. This is said to arise from maximising the number
of patients exposed to the side effects of new drugs of dubious efficacy.
a drug began with clinical trials designed to minimise evidence of harm
and published literature that emphasised its advantages, said Prof Light.
on this foundation, pharmaceutical companies staged massive campaigns to
sell the product, when a controlled limited launch would allow evidence
of its effects to be gathered, he argued. Leading clinicians were recruited
to try using the drug for conditions other than those for which it was approved,
and to promote "off-label" or unapproved uses, Prof Light maintained.
Physicians inadvertently became "double agents" - promoters of
the new drug, yet trusted stewards of patients' health. When patients complain
of adverse reactions, studies show that doctors are likely to discount or
dismiss them, according to Prof Light. He accused companies of conducting
a "swamp the regulator" policy - bombarding the bodies that award
drug licences with large numbers of "incomplete, partial, sub-standard
study of 111 final applications for approval found that 42% were missing
data from adequately randomised trials, 40% were supported by flawed testing
of dosages, 39% lacked evidence of clinical efficacy, and 49% raised concerns
about serious adverse side-effects, he said.
major reports had focused on "biased, poor trials" involving the
diabetes drug Avandia and the antibody cancer drug Avastin. Avandia has
been linked to an increased risk of heart attacks, while controversy surrounds
Avastin's effectiveness as a breast cancer treatment. A US Food and Drink
Administration expert panel has called on the agency to withdraw its licence
allowing Avastin to be used for this purpose. Companies
control the generation of scientific knowledge and which findings will go
to licensing authorities such as the FDA or be published, Prof Light argued.
result is that drugs get approved without anyone being able to know how
effective they really are or how much serious harm they will cause,"
few basic changes could improve the quality of trials and evidence about
the real risks and benefits of new drugs. We could also increase the percentage
of new drugs that are really better for patients."
Light highlighted the marketing of statin cholesterol-lowering drugs as
a good example of pharma hype. Company-supported clinical researchers and
medical writers created a global market for controlling cholesterol with
statins, he argued.
set of relationships between heart disease and saturated fats and cholesterol
had been converted into the simple message that "cholesterol kills".
Yet two major
trials of statins found little evidence that the drugs reduce the risk of
heart attacks. In contrast, they showed an increased total risk of harm
to health and death from the drugs despite the lowering of cholesterol levels.
major meta-analysis, which pooled the findings of a number of studies, found
that "statins were not associated with reduction in the risk of all-cause
trial led by a statin manufacturer was stopped early so that adverse side-effects
were not recorded. Mental illness and diabetes were other areas where questionable
use of drugs occurred, said Prof Light.
serotonin reuptake inhibitor (SSRI) antidepressants became immensely popular
despite evidence that they are little better than "dummy" placebos
for most patients.
paper, Prof Light concluded: "The evidence here indicates that the
two-tier market for prescription drugs is the largest and most dangerous
market for lemons in modern society. Neither wars nor used car injuries
incentives for research produce a few that substantially improve patients'
chances of getting better or avoiding death but a large number of barely
innovative drugs each year. These new drugs of little benefit consume about
four-fifths of all drug costs.
incentives and institutional practices around testing and regulatory review
predictably result in approvals being based on trials so biased and poorly
run that no one knows how much better or worse new drugs are."
von Radowitz, PA
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