Drug Firms'
Control of Data Troubling: Lancet Report
By Doug Macron
NEW YORK (Reuters Health) -
Drug firms have become
the largest sponsors of medical research, generating
vast amounts of valuable information through their
efforts--but the companies' enormous control over
when, where and how that data is reported may not
serve patients' best interests, according to the
authors of a report in the latest issue of The
Lancet.
The
pharmaceutical industry dedicates more time and
resources to creating, gathering and disseminating
information than to actually producing medicines,
the authors write in the report. In part, drugmakers
do so in order to satisfy licensing requirements,
protect patents and obtain regulatory approvals. But
companies also use the data to promote sales and
educate patients and physicians about their
medicines, in the process influencing prescribing
practices and the direction of medical research.
In
addition, only select data is made publicly
available through papers in medical journals,
presentations at medical conferences or product
labeling, the authors write in their report, which
focuses specifically on multinational drug firms.
Much of the data that drug companies produce is
protected by intellectual-property laws, they note.
The
fact that the information is often selectively
released or kept secret raises concerns about
whether patients' and the public's best interests
are being adequately addressed, they maintain.
"When
things go well in terms of a product, there's no
lack of information about what a product does or how
well it functions," Dr. Ike Iheanacho, deputy editor
of Drug and Therapeutics Bulletin and co-author of
the Lancet report, told Reuters Health during a
telephone interview. "What we're talking about is
lack of openness when a product doesn't perform so
well or it doesn't perform as well as a competitor."
The
authors note that companies view publication of
clinical data in medical journals as key in raising
awareness about a drug. "However, to improve sales,
it is also crucial that the published report shows
the company's product in a favorable light," they
point out.
"Publication is especially helpful if the article is
published around the time of the product's launch,"
the Lancet report reads. "Echoing these aspirations,
trials with negative results tend to be published
much later than those with more positive
conclusions."
Moreover, the authors note, "conclusions of trials
sponsored by drug companies, rather than by other
sources, tend to be more favorable to the sponsor's
product." It is unclear why company-sponsored
studies are so often favorable, the authors write,
although an inherent bias in trial design is
possible.
The
Lancet report also notes that by being responsible
for so much of the medical research that is
conducted, transnational pharmaceutical companies
can influence the direction of medicine toward drug
treatment, rather than non-drug intervention.
The
sheer quantity of drug-industry research might
inappropriately impact healthcare policies, leading
them away from "tried, familiar and usually cheaper
approaches, to novel, unfamiliar, and generally more
expensive alternatives that offer no real clinical
advantage," the authors write.
"Moreover, as increasing numbers of medical
researchers are drawn to the industry, alternative
voices and opinions can become muted, and novel
avenues of research might be overlooked," the
article states.
The authors worry about the dearth
of "independent, non-commercial sources of
information" in many countries, which they say
leaves prescribers "heavily reliant on drug-company
representatives for their information."
Independent medical research with
support from non-industry sources, such as
governments, should be encouraged, Iheanacho told
Reuters Health. However, he conceded that funding
for such research can be very hard to come by.
The situation is made worse by
"weak" regulations controlling drug firms'
promotions, the Lancet article suggests. "In many
countries, regulatory authorities are either absent
or ineffective, and in industrialized countries,
they typically devolve much of the policing to the
industry itself," the report states.
While transnational drugmakers'
promotions to physicians and consumers are valuable
for raising awareness, they also have the potential
to do damage, the authors believe.
"Rational prescribing is inevitably
threatened when, for example, opinion-leaders are
briefed, promoted, cultured, and supported by
manufacturers," the authors write. They cite as
troublesome drug firms' funding of patient-advocacy
groups, noting that Viagra manufacturer Pfizer Inc.
supports the Impotence Association and the Men's
Health Forum in the UK. Similarly, the authors are
concerned about the effect that drug-company gifts
might have on doctors' prescribing patterns.
In the end, the Lancet report
concludes, pharmaceutical companies' investment in
information is "time and money well spent. However,
the huge scale of work involved, lack of openness,
accompanying duplication, and distortion of the
overall research effort and resulting messages make
the business of information-generation inefficient
and threaten patients' interests."
"There's nothing in our article that
says the pharmaceutical industry shouldn't conduct
research," Iheanacho told Reuters Health. "One just
has to be aware of what the consequences of having
an industry-dominated research agenda are."
The Lancet article is the first in a
planned series of four focusing on the role of the
pharmaceutical industry in medicine.
SOURCE: The Lancet 2002;360:1346,
1405.
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