Tuesday, February 02, 2016

More on Failed Disclosures: Even Former Tobacco Industry-Funded Scientists Disclose their Past History of Financial Conflicts

In 2014, Dr. Roger Jenkins was co-author of an article published in the European Journal of Applied Physiology on acute cardiovascular reactions to inhaled particles. The study tested exposures to a variety of pollutants, including tobacco smoke. This journal uses the ICJME conflict of interest disclosure form (similar to that used by JAMA).

Background Information: Dr. Jenkins officially retired in 2004 from the Oak Ridge National Laboratory, where he conducted research that was funded, in part, by tobacco companies. Until 2008, he served as an expert witness to the tobacco industry. However, during the five years prior to publication of this article, he did not testify in litigation and was no longer employed at Oak Ridge. Thus, he had no personal conflicts of interest for the past five years.

Question: Should Dr. Jenkins have disclosed his history of past conflicts, dating back to 2008, in this 2014 article?

As I revealed over the past two days, in a similar situation, a number of smoking cessation drug researchers who had a history of funding from pharmaceutical companies failed to disclose those relationships, presumably because they were not active for the past 36 months, and item 3 of the ICJME form asks for a disclosure of conflicts within the past 36 months.

So according to this reasoning, there was no requirement for Dr. Jenkins to disclose his past history of tobacco industry funding and his having served as an expert witness for the industry in litigation.

To be sure, failure to disclose these past financial interests would be deceptive to journal readers, and without a doubt, anti-smoking groups would attack Dr. Jenkins for hiding this important information from the public. We certainly expect that past relationships with tobacco companies should be disclosed, even if they are no longer in place and have not been in place for several years.

The Rest of the Story

In contrast to the anti-smoking researchers, who failed to disclose their extensive history of funding from pharmaceutical companies, Dr. Jenkins did disclose the potential conflicts that were present more than five years earlier, but were not currently active, since he had retired 10 years earlier and had not testified for the past five years. Nevertheless, he disclosed that he "acted as an expert witness in tobacco industry-related litigation from 1997 to 2008."

Contrast this with the disclosures of several of the co-authors of articles published in 2016 in Addiction and JAMA:

1. In a recent set of two articles on treatment for smoking cessation published in the Annals of Behavioral Medicine in April 2011 (article 1; article 2), the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Michael C. Fiore served as an investigator on research studies at the University of Wisconsin that were funded by Nabi Biopharmaceuticals."

However, in the recently published JAMA article, Dr. Fiore states that he has no conflicts of interest to disclose. And in the Addiction articles, he states that he has "received no direct or indirect funding from ... the tobacco, alcohol, pharmaceutical or gaming industries."

2. In a 2010 paper, Dr. Baker acknowledged "research grants from Pfizer, GlaxoSmithKline, Nabi Biopharmaceuticals, and Sanofi." That paper itself involved research with financial support from GlaxoSmithKline in the form of free study medication.

However, in the recently published JAMA article, Dr. Baker states that he has no conflicts of interest to disclose. And in the Addiction articles, he states that he has "received no direct or indirect funding from ... the tobacco, alcohol, pharmaceutical or gaming industries."

3. As recently as 2012, Dr. Jorenby disclosed in an article that his research involved financial support from GlaxoSmithKline in the form of free medication provided to study participants, and in a 2011 publication, Dr. Jorenby disclosed that the study was funded by Nabi Biopharmaceuticals.

However, in the recently published Addiction articles, Dr. Jorenby states that he has "received no direct or indirect funding from ... the tobacco, alcohol, pharmaceutical or gaming industries."

Why This is So Important

For decades, we in tobacco control have attacked tobacco industry-funded researchers for failing to disclose their relationships with tobacco companies. But it goes much further than that. The tobacco companies were found guilty of violating the RICO statute in large part because of industry-funded scientists failing to disclose these relationships.

In fact, in her final opinion in the DOJ lawsuit against the tobacco companies, Judge Kessler included an entire section entitled: "The Industry's ETS Consultants Cited and/or Published Without Disclosure of Tobacco Industry Ties." Judge Kessler wrote a 43-page section on scientists' failed disclosures of conflicts of interest.

In the case of the tobacco industry, these failed disclosures seriously undermined the public's health. They led to many policy makers believing that secondhand smoke was not harmful, which delayed or prevented the adoption of smoke-free policies to protect the public from exposure to secondhand smoke.

In large part, the reason why virtually all scientific journals have conflict of interest policies now is this past history of failed disclosures of scientists' ties to the tobacco companies.

It is for this reason that it becomes so imperative for us, as scientists in the tobacco control movement, to disclose our own conflicts of interest. It would seem highly hypocritical for us to demand that past relationships with tobacco companies need to be disclosed but that past relationships with pharmaceutical companies can remain hidden. No one is suggesting that the public health implications are the same; however, the principle is.

Ultimately, if we want the public to take seriously our efforts to protect the integrity of science from influence by corporations which have a vested interest in influencing the public's opinion about the safety of their products, then it becomes critical that we set the example by being transparent about our own conflicts of interest.

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