May 12, 2009 — Nearly 1 in 5 oncology research articles published in prestigious journals was funded by industry, raising questions about the "industrialization of clinical research," write the authors of a review published online May 11 in Cancer.
But industry is needed to translate research into products, argues a critic of the review, who says that "bioethics" discussions detract from the main aim of seeking a cure for cancer.
The review authors looked at 1534 cancer clinical-research studies published in 2006 in 8 prestigious medical journals, including the New England Journal of Medicine, the Journal of the American Medical Association, and the Journal of Clinical Oncology, and found that 17% were funded by industry and 29% had some kind of conflict of interest. These studies also tended to have positive outcomes.
They also found that 50% of the studies were government funded and 29% had philanthropic grant funding.
The studies covered oncology drugs, diagnostic tests, technologies, and surgical interventions.
This mix of funding in published cancer studies is not optimal and is a sign of the industrialization of clinical research, suggested lead author of the review, Reshma Jagsi, MD, DPhil, assistant professor of radiation oncology at the University of Michigan Medical School in Ann Arbor.
"We need to direct concerted effort to disentangle research endeavors from industry ties," Dr. Jagsi said in an interview with Medscape Oncology.
Industry involvement in oncology research, or any medical research, always has the "potential" to influence the research, Dr. Jagsi said.
"It would be wonderful if the vast majority of cancer research published in high-impact publications was publicly funded," she said, adding that more public funding of research is needed.
However, a critic of the review called it another example of a bioethics study that is "cluttering" the medical literature. "We are not going to cure cancer by ethics but by work," Thomas P. Stossel, MD, told
Medscape Oncology. Dr. Stossel is American Cancer Society Professor of Medicine at Harvard Medical School in Boston, Massachusetts.
"Industry translates research into products," he said, adding that academic–industry research relationships have "overwhelmingly" done more good than harm but have been "demonized" by commentators, many of whom have conflicts of interest of their own, namely their careers as bioethicists.
Point and Counterpoint
In effect, Dr. Jagsi and Dr. Stossel represent 2 nearly polar opposite viewpoints about academic–industry research relationships.
On the one hand, Dr. Jagsi wants to minimize industry-funded research. "If we wish to have truly unbiased research, then we need more publicly funded research. Disclosure of industry relationships or conflicts of interest is probably insufficient," she said.
On the other hand, Dr. Stossel believes the collaboration between academia and industry is integral to the creation of therapeutic products. "Innovation will come from partnership between curious entrepreneurial researchers and industry. We need to promote that partnership," he said, adding that the biotechnology industry is the epitome of this dynamic
Interestingly, both Dr. Jagsi and Dr. Stossel both believe that conflict of interest is inevitable in medicine. "There is only 1 state of freedom from conflict of interest — death," said Dr. Stossel. "It's very hard to eliminate conflict of interest. I'm a radiation oncologist, and I'm biased in favor of radiation as treatment," said Dr. Jagsi.
Both also are in favor of disclosure of academic–industry ties. "Disclosure and oversight of academic collaboration with industry are reasonable policy," Dr. Stossel wrote in an essay (New Engl J Med 2005;353:1060-1065). For her part, Dr. Jagsi called for heightened standards of disclosure and higher standards of editorial scrutiny, such as requiring journal submissions with conflicts of interest to have more peer review than those without it.
However, in the end, the 2 oncologists disagree about the degree to which focus is needed on conflict of interest in research. "We need voices that are writing extensively about conflict of interest and related concerns. We need to be continually reminded of the potential influence of industry ties on research. Everyone thinks they are the one who will not be influenced by industry ties," said Dr. Jagsi.
Dr. Stossel believes that bioethicists have overblown the importance of conflict of interest in research, and questions the relative absence of academic voices defending their collaborations with business. "Why aren't there more proindustry commentators?" he wondered.
Writing last month in an essay in the Wall Street Journal, Dr. Stossel and a coauthor commented that "when challenged by reporters, most academic consultants to industry refuse to comment or offer a meek explanation, instead of retorting that industry pays them because they add critically important value."
Dr. Stossel believes that a historical "squeamishness" about money and the public discussion of money among doctors are among the reasons for the quietude among academic researchers who work with industry.
Ramping Up on Conflict of Interest
The new review is published at a time when conflict of interest is a hot topic of debate, with academic institutions, drug companies, and government all having an active interest.
As reported on Medscape's sibling website, theheart.org, several institutions and companies have recently announced new rules. Johns Hopkins said that it will no longer allow staff to accept drug samples or participate in consulting work, whereas the Duke Clinical Research Institute and the Cleveland Clinic have adopted public conflict-of-interest disclosure websites. Eli Lilly, Merck, and Pfizer have said they will start publicly disclosing payments made to physicians. Meanwhile, Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wisconsin) introduced the Physician Payment Sunshine Act in January. Beginning in 2010 — if passed — the bill would require drug and device companies to disclose all payments to physicians over $100 in any calendar year; that information will be available to the public beginning in 2011.
Positive Outcome More Likely
In the review by Dr. Jagsi and colleagues at the University of Michigan, the medical journals used to tabulate conflict of interest included the above-mentioned, as well as the Lancet, the Journal of the National Cancer Institute, Lancet Oncology, Clinical Cancer Research, and Cancer.
Conflict of interest was identified if it was explicitly declared by the authors (including declared industry ties not related to the published research); if an author was an employee of industry at the time of publication; or if the study had industry funding.
Of the 1534 studies, the researchers found that conflict of interest was most likely to be found in studies in which the corresponding author was a member of a department of medical oncology (45%), and least likely if he or she was in the department of diagnostic radiology (4%). Conflict of interest was observed in 33% of North American studies, 27% of European studies, 4% of Asian studies, and 40% of studies from other locations.
The review also showed that, in a subset of 124 randomized trials assessing overall survival, studies with industry funding were more likely to report positive outcomes when a conflict of interest was present (P = .04)
"Our study shows quite powerfully that when a conflict of interest was identified, there was a significant increase in the likelihood that a randomized trial would show a positive outcome," said Dr. Jagsi.
However, the authors of the studies were not more likely to give the results an unwarranted positive spin, the reviewers noted. "There was no observed difference in the likelihood that the author interpretation was positive, or in the likelihood that the author interpretation was more positive than the objective assessment of effect on overall survival," they write.
