Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Unprecedented industry-backed laws limit public safety,

22.07.2005


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."

Wallace Ravven | EurekAlert!
Further information:
http://www.pubaff.ucsf.edu

More articles from Studies and Analyses:

nachricht The personality factor: How to foster the sharing of research data
06.09.2017 | ZBW – Leibniz-Informationszentrum Wirtschaft

nachricht Europe’s Demographic Future. Where the Regions Are Heading after a Decade of Crises
10.08.2017 | Berlin-Institut für Bevölkerung und Entwicklung

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Highly precise wiring in the Cerebral Cortex

Our brains house extremely complex neuronal circuits, whose detailed structures are still largely unknown. This is especially true for the so-called cerebral cortex of mammals, where among other things vision, thoughts or spatial orientation are being computed. Here the rules by which nerve cells are connected to each other are only partly understood. A team of scientists around Moritz Helmstaedter at the Frankfiurt Max Planck Institute for Brain Research and Helene Schmidt (Humboldt University in Berlin) have now discovered a surprisingly precise nerve cell connectivity pattern in the part of the cerebral cortex that is responsible for orienting the individual animal or human in space.

The researchers report online in Nature (Schmidt et al., 2017. Axonal synapse sorting in medial entorhinal cortex, DOI: 10.1038/nature24005) that synapses in...

Im Focus: Tiny lasers from a gallery of whispers

New technique promises tunable laser devices

Whispering gallery mode (WGM) resonators are used to make tiny micro-lasers, sensors, switches, routers and other devices. These tiny structures rely on a...

Im Focus: Ultrafast snapshots of relaxing electrons in solids

Using ultrafast flashes of laser and x-ray radiation, scientists at the Max Planck Institute of Quantum Optics (Garching, Germany) took snapshots of the briefest electron motion inside a solid material to date. The electron motion lasted only 750 billionths of the billionth of a second before it fainted, setting a new record of human capability to capture ultrafast processes inside solids!

When x-rays shine onto solid materials or large molecules, an electron is pushed away from its original place near the nucleus of the atom, leaving a hole...

Im Focus: Quantum Sensors Decipher Magnetic Ordering in a New Semiconducting Material

For the first time, physicists have successfully imaged spiral magnetic ordering in a multiferroic material. These materials are considered highly promising candidates for future data storage media. The researchers were able to prove their findings using unique quantum sensors that were developed at Basel University and that can analyze electromagnetic fields on the nanometer scale. The results – obtained by scientists from the University of Basel’s Department of Physics, the Swiss Nanoscience Institute, the University of Montpellier and several laboratories from University Paris-Saclay – were recently published in the journal Nature.

Multiferroics are materials that simultaneously react to electric and magnetic fields. These two properties are rarely found together, and their combined...

Im Focus: Fast, convenient & standardized: New lab innovation for automated tissue engineering & drug

MBM ScienceBridge GmbH successfully negotiated a license agreement between University Medical Center Göttingen (UMG) and the biotech company Tissue Systems Holding GmbH about commercial use of a multi-well tissue plate for automated and reliable tissue engineering & drug testing.

MBM ScienceBridge GmbH successfully negotiated a license agreement between University Medical Center Göttingen (UMG) and the biotech company Tissue Systems...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

“Lasers in Composites Symposium” in Aachen – from Science to Application

19.09.2017 | Event News

I-ESA 2018 – Call for Papers

12.09.2017 | Event News

EMBO at Basel Life, a new conference on current and emerging life science research

06.09.2017 | Event News

 
Latest News

Comet or asteroid? Hubble discovers that a unique object is a binary

21.09.2017 | Physics and Astronomy

Cnidarians remotely control bacteria

21.09.2017 | Life Sciences

Monitoring the heart's mitochondria to predict cardiac arrest?

21.09.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>