Is Industry-Funded Science Killing You?

The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest"

(Page 4 of 4)

All the Data That Are Fit to Post
Private initiatives are also achieving the goal that Sens. Dodd and Kennedy want to legislate: registration of all clinical trials. In 2004 the International Committee of Medical Journal Editors (ICMJE) adopted a policy that requires, as a condition of consideration for publication in their journals, registration of clinical trials in a public registry. Trials beginning after July 1, 2005, must be registered at or before the onset of patient enrollment. The ICMJE established criteria that each trial must meet to insure transparency and required that the registry be accessible to the public free of charge. At the time, the only website that qualified was ClinicalTrials.gov, run by the United States National Library of Medicine.

The ICMJE policy has had an effect. After the policy was announced, the number of clinical trial registrations increased by 73 percent—from 13,153 to 22,714. As of April 2007, the registry contained over 40,000 trials, with more than 200 new trial registrations occurring weekly. Now four other clinical trials registries meet the ICMJE criteria, and many more journals have adopted the ICMJE clinical trials registration policy.

Also in 2004, the Pharmaceutical Research and Manufacturers Association announced that it was launching an online registry of clinical trial results. The association’s members, which include the world’s leading drug companies, will provide the results of all clinical trials completed after October 1, 2002, at clinicalstudyresults.org.

And since May 2006, researchers no longer can complain that journal editors will not publish negative or inconclusive results. PLoS’s journal PLoS Clinical Trials explicitly addresses the problem of publication bias: It will publish the results of randomized trials from all medical and public health disciplines. Publication does not depend on the trial’s outcome, size, or implied importance. Even negative results provide useful information about the effectiveness of treatments, alerting other researchers not to waste their time and resources on therapeutic dead ends. Indeed, researchers arguably have a moral obligation to publish their results, whether positive or negative, since subjects undertake risks to generate the data.

Collaboration Celebration
Collaboration between academia and industry should be encouraged, not attacked. In most areas of research, including computer science, geology, and chemistry, such ties are correctly seen as a source of innovation that has dramatically improved the quality of our lives during the last half-century.

Given the potential life-or-death consequences for patients, collaboration between the pharmaceutical industry and medical researchers needs to be monitored, and adjustments should be made whenever abuses come to light. But through such private efforts as financial disclosure requirements, registration of clinical trials, and peer-reviewed publication of all clinical trial results, the scientific research enterprise has shown itself capable of protecting the validity of research results without new government regulations.

“In a transparent atmosphere, misconduct can be detected, challenged, and if necessary, purged and punished,” Stossel noted in his 2005 New England Journal of Medicine article. “The intense energy currently dedicated to demonizing academic-industrial research relationships should be redirected toward developing better ways to identify and facilitate the type of partnerships that have brought more good, by far, than harm.” He added, “The public wants trustworthy science, and it can get that without new ethical rules. Even more it wants results—real lives saved—and it can’t get those if commercial sponsorship of research is made difficult, or impossible.”

Science Correspondent Ronald Bailey (rbailey@reason.com) is the author of Liberation Biology: The Scientific and Moral Case for the Biotech Revolution (Prometheus Books). This article derives in part from research commissioned for a white paper on scientific conflicts of interest by the non-profit consumer education consortium the American Council on Science and Health. ACSH receives no-strings-attached funding from individuals, foundations, associations, and corporations. Bailey would also like to note that he owns various fairly speculative biomedical stocks that he really hopes will benefit a lot from industry-academic collaborations. The number of shares he holds in any one company amounts to a few hundred at most.

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  • ||

    Like my writing teacher always told me, "Write what you know."

    :-)

  • ||

    I haven't read the article yet but my guess is that Mr. Balko's answer will be "no".

    Let's see...

  • ||

    Er...Mr. Bailey's answer.

    I really need to get some coffee before I start my daily trolling.

  • George Tenet Fangirl||

    faculty advancement, obtaining sponsored research funding, winning the acclaim of one's professional peers, competing for prestigious research prizes, and yes, desiring to alleviate human pain and suffering, all may be more powerful in influencing faculty behavior than the prospect of material enrichment.

    So we don't need government regulation because profit isn't the pharmaceutical industry's primary motive? Fascinating!

  • ||

    In other loosely health related news, This is a parody, right?
    I hope to god it is.

  • thoreau||

    I have to take issue with the discussion of peer reivew:
    Peer review has been the traditional means of assuring a study's validity.

    Not quite true. Peer review is simply a first hurdle to cross, a minimal quality check. We look to see whether the work described is thorough and testable. The ultimate check of a study's results is replication by multiple independent investigators. Independence is important because the original investigation may be marred by any number of errors in execution and interpretation, be those errors the result of carelessness, bias, unstated assumptions, peculiar equipment, etc.

    Which brings us to this:

    By requiring disclosure, journal editors are in effect admitting peer review's failure. Since their reviewers are not competent to evaluate findings based solely on the data, warning labels need to be slapped onto industry-funded studies.

    Wrong. Like I said above, the goal is to have a study reported so it can be examined and then replicated by independent investigators. Reporting of financial interests is about finding out whether various investigators are independent of one another. We wouldn't accept a replication as particularly meaningful if it came from somebody in the same lab as the original investigator, and we might have some questions if the only people replicating the result were all tied to the same interests. It wouldn't necessarily mean that they were deliberately sloppy, but it could be that people with common interests are making the same unwitting errors.

    And peer review overlooks honest errors as well as deliberate fraud. "Peer review doesn't necessarily say that a paper is right," said Martin Blume, editor-in-chief of the American Physical Society's nine journals, in a January 2006 interview with Science. "It says it's worth publishing."

    This part is true. Hence peer review is simply a first step before the report is put out there for the wider community to evaluate.

  • thoreau||

    I really need to get some coffee before I start my daily trolling.

    I need to know whether you are an employee of Starbucks before I can conclude that this is an honest, unbiased assessment of your optimal trolling condition. :)

  • undergroundman||

    Check this out: http://0-biology.plosjournals.org.ilsprod.lib.neu.edu/perlserv/?SESSID=becebecc868c315d7a120cf45b188abe&request=get-document&doi=10.1371/journal.pbio.0050193

    "In a 2005 commentary, vom Saal and Claude Hughes, a reproductive endocrinologist who had served on the HCRA panel, argued that the report was already obsolete when it came out [16]. By the end of 2004, they had identified 115 published studies on low doses of bisphenol A. They also found a troubling trend. Ninety percent of government studies found significant effects of bisphenol A at doses below the EPA's lowest adverse effect level, but not a single industry study found any effect. Many of the industry studies, they pointed out, either used a rat strain with very low sensitivity to estrogen or misinterpreted failure to find effects with positive controls. Vom Saal and Hughes urged the EPA to conduct a new risk assessment on bisphenol A."

  • ||

    Dr. T's points are VERY important to keep in mind. Nicely put.

  • thoreau||

    I wish there was more traffic in this thread, but I recognize that lampooning Ahmadinejad is important.

  • VM||

    Hi Doktor T!

    You're probably correct, but this is one where I'm taking Bronwyn's advice from the "germs in space" (above)... :)

    cheerio!

  • ||

    thoreau: Thanks very for the comments. In fact, I agree with your point on replication about which I said in a different context:

    Of course peer review, like democracy and economic institutions such as corporations, is not perfect. The process by which scientific publications are reviewed can doubtless be improved. One proposal is that scientists place pre-prints of their articles online, where their colleagues and competitors can critique them before they are submitted to journals for publication. Others have even argued that peer review doesn't actually improve scientific reports and that it could be eliminated. Peer review is only one, though important, part of the larger system of liberal science that eventually enables us to determine what is true. The gold standard for what is true is not peer review, but experimental replication and the extension of scientific results. The last 200 years of technological progress is powerful evidence that scientific fraud is rare, and the Enlightenment institutions of free speech and mutual criticism that form the basis of liberal science remain strong.

    "Validity" means that reviewers find the study "well grounded" not that it represents transcendental truth.

    I'm not sure that you disagree that disclosure constitutes a "warning label" which you may well think is a good idea when one is worried about the independence of researchers. Please note that I am in fact in favor of reasonable financial disclosures which I discuss in the article.

    Again, thanks for the comments.

  • nfl jerseys||

    ngfd

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