Drug Firms' Control Over Data Raises Concerns -- Lancet Article

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Drug Firms' Control Over Data Raises Concerns -- Lancet Article

By Doug Macron

NEW YORK (Reuters Health) Oct 31 - 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 publically 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 towards 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 reads.

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, Dr. 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, " Dr. Iheanacho said during the interview. " 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.

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