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Drug Firms' Control Over Data Raises Concerns - Lancet Article

http://www.medscape.com/viewarticle/443862

Oct 31, 2002
By Doug Macron
Reuters Health
NEW YORK

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.
 

© 2002 Reuters Ltd