July 2005 AJPH Supplement Cover -----
Two laws recently passed by Congress with strong industry backing have had a chilling effect on government efforts to protect public health, according to a UCSF study.
The laws make all raw data produced by federally funded research available for public review, and require that any data disseminated by the government adhere to definitions of quality set by the law - definitions that industry interests helped develop. The new laws allow industry advocates to more easily challenge or stall government scientific research and weaken proposed regulations that affect them, the UCSF researchers assert.
Yet at the same time, research by industry faces no such high standard, and as a result, pharmaceutical, tobacco and other industries can make claims that are harder to challenge than the government’s research-based standards, says Lisa Bero, senior author of the study and professor of clinical pharmacy and health policy at UCSF.
Bero and her colleagues urge passage of new laws to increase public access to industry-sponsored science - at least to the same level as government-funded research.
“If we are going to have laws that force greater scrutiny on research related to public health, they should apply to industry-funded research at least as much as to government-funded research,” Bero says.
The potential harm of the current imbalance can be seen in the increasing scrutiny bearing down on the FDA, Bero points out. FDA critics - and media attention—have largely focused on the quality of the agency’s drug safety research, yet the FDA relies on information supplied by drug manufacturers - research that remains fairly inaccessible to government review.
In many cases, the information provided to the FDA by drug manufacturers has turned out to be inaccurate, and evidence of potentially dangerous side-effects appears to have been suppressed by the industry at times, she says. Meanwhile, media reporting on FDA drug safety oversight has largely focused on “bad government science.” More focus is needed on “bad industry science,” she suggests.
The UCSF study is published in a special issue of American Journal of Public Health, online July 20, which draws on once-secret internal tobacco industry documents to show this particular industry’s role in establishing these laws that now cripple regulation of many industries. The documents show motives, strategies and tactics used by the tobacco industry working with other corporate interests to challenge the scientific basis for public health policies.
This article is part of the entire issue devoted to “How Challenges from Industry Undermine Scientific Evidence and Public Health Protections.”
The two laws in question are the Data Access Act, passed in 1998, requiring for the first time that all raw data produced under federally funded research studies be publicly available, and the Data Quality Act of 2001, requiring that government-disseminated data adheres to standards established by the law.
“The Data Quality Act has implications for all corporate interests,” Bero says. “The tobacco industry documents give us insight into how different companies worked together to produce legislation that makes it harder to regulate industry. It basically allows corporate interests to challenge laws—existing or proposed—that do not meet the industry-developed data quality standards for government-sponsored research.
“What is really ironic is that the data quality law applies only to government-sponsored research (such as NIH research), but not industry-funded research. So, industry-funded research does not have to adhere to the standards. This is particularly relevant with all the transgressions we’ve seen lately related to the quality or failure to publish industry science. The public health community cannot use the data quality law to challenge industry science.”
Co-authors with Bero are Annamaria Baba MPH, formerly a research associate in clinical pharmacy; Daniel M. Cook, PhD, postdoctoral fellow at the Center for Tobacco Control Research, both at UCSF; and Thomas O. McGarity, JD, professor of law at the University of Texas School of Law.
The study was supported by the California Tobacco-Related Disease Research Program.