A recent study in the Journal of Oncology titled “Relationships Between Authorship Contributions and Authors’ Industry Financial Ties Among Oncology
Clinical Trials”, tried to determine whether authors who play ‘key’ scientific roles in oncology clinical trials, are more likely than those who do not play such roles to have financial ties to industry. The finding was simple, the most productive authors (those who wrote the most papers, did the most studies) benefited from industry support.
In other words, the study tried to determine whether doctors who do work get paid for their work.
Research Findings
Of the 235 articles reviewed, 52% reported industry funding, 42% reported government funding, and 24% reported foundation funding.
Only twenty-nine percent of authors reported at least one financial tie to industry. The most common areas of funding were (12%), honoraria (11%), and consulting (10%).
Among industry-sponsored trials, 669 (44%) of 1,518 authors reported at least one tie to a commercial entity. Of these, 94% reported at least one tie to the study sponsor. Among authors of non–industry-sponsored trials, 173 (12%) of 1,409 reported ties to a commercial entity.
The research found that sixty-four percent of the authors — 1,881 of 2,927 — said they performed at least one key role in the study.
The study found that such researchers “who design clinical trials, analyze or interpret the data, or play other key scientific roles are four times more likely to have financial ties to industry than their counterparts who have lesser roles in these studies, such as recruiting study subjects or collecting the data.”
Limitations
The study was limited because the data were derived from articles published in a single oncology journal during a limited time between January 1, 2006, and June 30, 2007.
The data on financial ties and on authorship contributions from the study were also limited because they were self-reported, which could lead under- or over-reporting of financial ties, or of inaccurate reporting of authorship contributions.
Another limitation included the possibility that multiple instances of authorship by an individual author could have influenced the results.
In addition, the authors acknowledged that “the data do not directly address the causal mechanisms underlying the observed association between authorship contributions and financial relationships.”
Discussion
The problem with this type of investigation is that it can be misconstrued despite the fact that the collaboration provides benefits to patients. The paper assert that “cancer researchers who have the greatest ability to influence research are also the researchers with the greatest financial ties to the pharmaceutical and biotechnology industries.”
Instead, the recent JCO article suggests that these financial relationships have the potential to bias the outcome of such clinical research, even though patients are improving.
Such a suggestion harms patients, physicians and researchers because it stigmatizes important research and clinical testing on cancer drugs bases on the “potential for bias.”
But even Dr. Harlan Krumholz of Yale University, noted that "In some cases, industry-physician relationships may represent high integrity interactions between industry and academic scientists seeking knowledge about the effect of a treatment on patients.
Another reason why the media and the authors of this article need to reconsider their claims for potential bias is because “not all types of relationships between researchers and companies are of equal concern,” according to Dr. Bernard Lo, director of the program in medical ethics at the University of California at San Francisco.
For example, speaker’s bureaus, consultation, and clinical trials play totally different roles in the type of experience and value physicians and researchers gain, and the amount paid is also different.
Journals accommodating this kind of survey non-research as scholarship, downplay the value of industry association, and allow the authors to cite only the alarmist background is extremely problematic. Moreover, the recent JCO article only displays how “disclosure” is heavily abused.
Editorial
In response to the study, an editorial “Authorship and Industry Financial Relationships: The Tie That Binds” was also published in JACO, which noted that “collaborations between physicians and drug companies clearly benefit society, as evidenced by the remarkable advances we have witnessed in cancer research in just the past few years.”
The authors of this editorial however try to downplay such collaborations by citing an Institute of Medicine (IOM) report that “concluded that such conflicts present the risk of undue influence on professional judgments and thereby may jeopardize the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in medicine.”
The evidence for this ‘risk of undue influence’ is minimal at best because as the editorial states, “all authors must now report their contribution to a study’s conception and design; financial support; administrative support,” and other factors. Moreover, the editorial itself states that what Dr. Steven Joffe and other authors found “is perhaps not at all surprising given that most physicians in the United States have a financial relationship with industry.”
This relationship with industry is crucial for cancer research, patients and physicians because the vast majority of the clinical trials are pharma sponsored because the universities cannot afford to do investigator initiated trials.
In addition, phase III and registration trials are overwhelmingly carried out by private companies, and more than 80% of medical oncology is private practice. With numbers like that, where do these authors suggest getting funding for trials on new cancer drugs, resources to recruit patients, and physicians who are willing to dedicate there valuable time for free?
Conclusion
The JCO study on relationships with industry stated clearly that:
“There is a lack of solid empirical data to determine if, on balance, relationships between physicians and industry ultimately harm or benefit society.”
Accordingly, the idea suggested by authors in the editorial and article that disclosure is not enough, must realize that “there are a number of ways to minimize conflicts of interests including removal, recusal, third-party evaluation, codes of ethics, and disclosure.” In fact, the American Society of Clinical Oncology guidelines, published in 2003, rely heavily on disclosure as the principal method of dealing with perceived COI.
The fact that “author disclosures are becoming increasingly complex and there is not a uniform system for the disclosure of financial information,” does not translate into a conflict for doctors who work with industry. Specifically, the article noted that although researchers are associated with industry sponsorship:
“little is known about the relationship between investigators’ personal financial ties and study outcomes.”
Moreover, the article “states that the data does not prove that authors’ financial ties are problematic, nor do they necessarily reflect efforts by sponsors to influence investigators’ work."
Without such data, cancer research in collaboration with industry should be continued and strengthened, especially when the JCO article stated that “most patients in cancer-research trials were not worried about financial ties between researchers or medical centers and drug companies and would still have enrolled in the trial if they had known about such financial ties.”
In the end everyone may benefit one day from improved cancer care, even the authors.