Researchers Fail to Disclose Conflicts of Interest with Big Pharma and Appear to Hide their Financial Relationships

In an article published in the current issue of the journal Addiction regarding effective treatment for smoking cessation, all co-authors except one denied having received any funding from pharmaceutical companies. Their declaration of interests statement reads: "The authors have received no direct or indirect funding from, nor do they have a connection with, the tobacco, alcohol, pharmaceutical or gaming industries or anybody substantially funded by one of these organizations."

In a related article also published in the journal Addiction regarding effective treatment for smoking cessation, the same authors (again except one) again denied having received any funding from pharmaceutical companies. That declaration of interests statements reads: "The authors have received no direct or indirect funding from, nor do they have a connection with the tobacco, alcohol, pharmaceutical or gaming industries or anybody substantially funded by one of these organizations."

In two additional related articles published in the same January issue of Addiction, the same authors make the identical declaration, claiming that they "have received no direct or indirect funding from, nor do they have a connection with the tobacco, alcohol, pharmaceutical or gaming industries or anybody substantially funded by one of these organizations." 

Two of the authors of the Addiction articles also published an article in the current issue of JAMA regarding the effectiveness of smoking cessation drugs. In that article, co-authors Dr. Michael Fiore and Dr. Timothy Baker have apparently declared that they have no conflicts of interest to disclose.

The Rest of the Story

Unless I am mistaken, it appears that the above disclosure statements are false and that several of the co-authors have indeed received funding from the pharmaceutical industry.

Dr. Fiore

The truth is that Dr. Fiore actually has a long history of significant financial relationships with pharmaceutical companies that manufacture smoking cessation drugs, none of which are acknowledged in his disclosure. Here is what is being hidden from readers:

1. According to his own 2008 JAMA article: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

2. According to his own sworn testimony, at the time of his chairing in 2008 of an expert NIH panel to make recommendations about the recommended clinical strategies for promoting smoking cessation, Dr. Fiore received up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

3. In 2006, Dr. Fiore acknowledged that "I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

4. In 1998, the University of Wisconsin appointed him to a named chair, made possible by an unrestricted gift to the University from GlaxoWellcome.

5. In the past, "Dr. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."

6. Dr. Fiore directs a tobacco research center that received nearly $1 million in funding from makers of quit-smoking medicine in 2004 and $400,000 in 2005.

7. 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."

8. In a December 2010 article on treatment for smoking cessation published in the Wisconsin Medical Journal, the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Dr Fiore has served as an investigator in research studies at the University of Wisconsin that were funded by Pfizer and Nabi Biopharmaceuticals."

Amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma. I imagine that most readers would be shocked to find out about this intense and long history of financial conflict with Big Pharma, given that Dr. Fiore reported no conflicts of interest and that he specifically stated that he has received no funding from pharmaceutical companies.

Specifically, Dr. Fiore stated that he has "received no direct or indirect funding from ... the ... pharmaceutical ... industr[y]...". This seems to be inaccurate, as Dr. Fiore acknowledges that he has received funding from GlaxoSmithKline, Nabi, Pfizer, sanofi-aventis, Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, and Pharmacia.

Thus, the disclosure statement appears to be quite false, as Dr. Fiore states that he has not received funding from any pharmaceutical companies, but the truth is that he appears to have received funding from a minimum of 10 pharmaceutical companies.

Dr. Baker

The truth is that Dr. Baker also has a long and significant history of financial relationships with pharmaceutical companies that manufacture smoking cessation drugs. Here is what is being hidden from readers:

1. In 2008, Dr. Baker reported that: "he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

2. In 2000, Dr. Baker disclosed as follows: "Timothy Baker has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, and Lederle."

3. As recently as 2012, Dr. Baker disclosed in an article that his research involved financial support from GlaxoSmithKline in the form of free medication provided to study participants.

4. In another 2012 paper, Dr. Baker also acknowledged that GlaxoSmithKline provided financial support in the form of free study medication. The same disclosure was made in another 2012 paper. And in another paper as well.

5. According to a 2011 paper: "Timothy B. Baker has served as a consultant, given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline, Nabi Biopharmaceuticals, Pfizer, and Sanofi-Synthelabo."

6. 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.

Again, amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma. I imagine that most readers would be shocked to find out about this intense and long history of financial conflict with Big Pharma, given that Dr. Baker reported no conflicts of interest and that he specifically stated that he has received no funding from pharmaceutical companies.

Specifically, Dr. Baker stated that he has "received no direct or indirect funding from ... the ... pharmaceutical ... industr[y]...". This seems to be inaccurate, as Dr. Baker acknowledges that he has received funding from Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, Lederle, Nabi Biopharmaceuticals, Pfizer, GlaxoSmithKline, and Sanofi-Synthelabo. Thus, the disclosure statement appears to be quite false, as Dr. Baker states that he has not received funding from any pharmaceutical companies, but the truth is that he appears to have received funding from a minimum of 8 pharmaceutical companies.

Dr. Douglas Jorenby

The truth is that despite claiming that he has not received funding from pharmaceutical companies, Dr. Jorenby has received "research support from Pfizer, Nabi Biopharmaceutical, Sanofi-Aventis and consulting fees from Nabi Biopharmaceutical." In addition, 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. In a 2011 publication, Dr. Jorenby disclosed that the study was funded by Nabi Biopharmaceuticals.

Dr. Megan Piper

According to her disclosure in a 2012 paper, Dr. Piper participated in a research study in which a research agreement was entered into with GlaxoSmithKline in which the company provided free study medications in a clinical trial of one of its smoking cessation drugs.

Dr. Tanya Schlam
According to her disclosure in a 2012 paper, Dr. Piper participated in a research study in which a research agreement was entered into with GlaxoSmithKline in which the company provided free study medications in a clinical trial of one of its smoking cessation drugs.

Summary

In summary, although all of these co-authors declared in multiple recent publications that they "have received no direct or indirect funding" from pharmaceutical companies, five of these co-authors appear to have received either direct or indirect funding, or both, from pharmaceutical companies.

The only possible argument for why this funding should not have been disclosed would be that the funding occurred in the past. However, this argument does not work because that's not what the disclosure states. It states that the authors "have received no indirect or direct funding." There is no time limitation on this disclosure. It clearly implies that the authors have never received funding from pharmaceutical companies.

Certainly, readers of these articles are being led to believe that these authors have not received funding from pharmaceutical companies. But this is not true. Thus, readers are being greatly deceived by these failed disclosures.

Moreover, as I have argued previously, I do not believe that conflicts of interest end the moment a grant from a pharmaceutical company terminates. Certainly, if a researcher had received tobacco industry funding in the past, we would demand that he or she disclose such funding, even if it occurred in the past. And if that researcher failed to make the disclosure, we would certainly criticize him or her for deceiving journal readers. And I have no doubt that if the disclosure stated that he or she has received no funding from tobacco companies, it would be uniformly be viewed in the tobacco control movement as a false disclosure. I pity the researcher who would find himself in that situation. The attacks from Stan Glantz alone would be devastating. And for good reason.

This is why journals have conflict of interest policies in the first place. The point is that readers need to be aware of potential conflicts of interest in order to appropriately evaluate the study validity. A past conflict does not alter the underlying point that the existence of that relationship could be perceived as to have influenced the conduct, interpretation, or reporting of the study.

As the instructions to authors of Addiction state: "Declarations of interest do not indicate wrongdoing but they must be declared in the interests of full transparency. ... Declaring a conflict of interest is the responsibility of authors and authors should err on the side of inclusiveness."

There are two important points here. First, there is absolutely nothing wrong with having a conflict of interest. If pharmaceutical companies did not fund research, the drug development process would be greatly hindered, and it would be devastating to the public's health. So there is nothing wrong with pharmaceutical companies funding university research, nor is there anything wrong with university researchers accepting pharmaceutical company funding. The key is that the funding needs to be disclosed. And furthermore, the interest being served is not some technical definition of what needs to be disclosed, but instead, it is the interest of full transparency. It hardly seems that readers of these articles in Addiction would agree that full transparency has been achieved if they found out about the extensive list of pharmaceutical funding of many of the co-authors of these articles as I have outlined above.

Second, authors should err on the side of inclusiveness. The guidelines to authors do not specify any particular date by which a conflict of interest becomes null and void. They do not state, for example, that authors should declare any funding from pharmaceutical companies that occurred in the past X number of years. Erring on the side of inclusiveness would seem to indicate that any past funding relationships should be disclosed. Moreover, the plain language of the disclosure statement (i.e., authors have not received funding from...) would seem to indicate that there is no history of funding, not simply no current funding. If what was meant is that there is no current funding, then that is what should have been stated. It would still have been an incomplete disclosure, but at least it would not have deceived readers into believing that there was no past funding either.

While the failed disclosures in this case serve mainly to deceive readers, in some cases, conflicts of interest can have important ramifications for the protection of the public's health. Just yesterday, Senator Bernie Sanders blocked the Senate confirmation of President Obama's nominee for FDA commissioner because he has a long history of financial relationships with pharmaceutical companies. Sanders stated: "Dr. Califf's extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies."

My point is not that Dr. Califf is inappropriate to serve as FDA commissioner (although that may well be the case), but simply that if these conflicts of interest were not disclosed to the Senate, then our policy makers would not have even had the opportunity to consider whether this nominee is best positioned to protect the public's health.

The purpose of conflict of interest disclosures is not to suggest that there is any wrongdoing, but to provide full transparency to journal readers, and ultimately, to the public.