NcXHF

INDUSTRY AND ONCOLOGY
by (covered) recipient principal investigators. As such, amounts
being attributed to principal investigators in connection with
research can appear very high in total value transfer (especially
across multiple companies) but be misleading about actual
value received and provide no relevant information
about influence. This disconnect is especially egregious in the
oncology research space, where patient care, concomitant therapies,
required diagnostic equipment, etc., is that much more
costly.
Assumptions, Interpretations, and Lack of Context
Because AMs are left to make individual interpretations and assumptions
about Open Payments reporting, the data being reported
are not amenable to apples-to-apples comparisons. For
example, some AMs may report payment activity at the level of
the study principal investigator and stop there if no physician is
in that position. Others may go further to attribute funds to site
principal investigators, while others may go still further to attribute
funds to all physicians (including sub-investigators) actually
working with patients. Each approach provides a different
view of the same payment data. However, without knowledge of
the underlying assumptions made, third parties could reach different
and sometimes incorrect conclusions. Context to the
public about the potential differences in application and interpretation
of Open Payments is still needed.
Effect on Clinical Oncology Practice
As our understanding of oncology deepens to reveal that
what was once believed to be a single disease (or a collection
of diseases differentiated on where a tumor primarily presents)
is, in fact, more than 200 disparate diseases whose nature
depends more on an individual patient’s specifıc
molecular constitution than where the primary tumor fırst
presented in that patient clinically, we will need to design and
implement smaller, smarter, more nimble clinical trials to
develop the suite of tailored medicines (and combinations
thereof) that have the greatest potential to treat an individual
patient’s unique disease. This democratization of clinical trial
design is likely to require an even greater absolute number of
these smarter, nimbler trials, requiring industry to have even
more relationships, with attendant fınancial ties, to individual
physician investigators who either design and sponsor the
trials themselves or partner with industry to manage and implement
this important clinical trial work.
At the same time, the parallel global trend of increased
transparency threatens to cast a pall over this necessary work,
as some—concerned by a recent history replete with highly
publicized allegations of industry marketing abuses—question
the legitimacy of industry’s continued fınancial ties with
physicians who stand in the position to prescribe their medicines.
Certain physicians, or their institutions, might react
(or already have) by curtailing their ties to industry-sponsored research
and development work, just when the pursuit of good
science requires more partnership. We, as a society, need policies
and practices that foster better collaboration across industry,
private practice, academia, and government to pursue
this good science for society’s benefıt. Meanwhile, and for
some time to come, the burden will likely be placed on industry
and physicians to explain how these legitimate relationships
foster the greater societal good in an effort to win back
our skeptics’ trust.
CONCLUSION
Oncology research and practice in the modern era require
collaborations between academic physicians and industry.
These collaborations provide challenges and opportunities
that the entire oncology community must understand and
address—especially the complexities that result from these
relationships. These relationships which are necessary to
continue advancing the fıeld of oncology influence decisions
from the level of the individual patient and provider, academic
institutions, professional societies, and, most recently,
national health policy. As we strive to provide the best and
most promising therapies to our patients, we must acknowledge
the issues surrounding relationships with industry and
learn to navigate and overcome these challenges.
Disclosures of Potential Conflicts of Interest
Relationships are considered self-held and compensated unless otherwise noted. Relationships marked “L” indicate leadership positions. Relationships marked “I” are those held by an immediate
family member; those marked “B” are held by the author and an immediate family member. Institutional relationships are marked “Inst.” Relationships marked “U” are uncompensated.
Employment: Richard B. Gaynor, Eli Lilly and Company. Reshma Jagsi, University of Michigan. Leadership Position: Richard B. Gaynor, Eli Lilly and Company.
Stock or Other Ownership Interests: Richard B. Gaynor, Eli Lilly and Company. Mark J. Ratain, AspenBio Pharma, Biscayne Pharmaceuticals. Honoraria:
Reshma Jagsi, International Journal of Radiation Oncology Biology Physics. Consulting or Advisory Role: Reshma Jagsi, Eviti. Beverly Moy, MOTUS (I),
Olympus (I). Mark J. Ratain, AbbVie, Agios Pharmaceuticals, Biscayne Pharmaceuticals, Cantex Pharmaceuticals, Cerulean Pharma, Cyclacel, Daiichi Sankyo,
EMD Serono, Genentech/Roche, Kinex, Onconova Therapeutics, Sanofi, Shionogi, XSpray. Speakers’ Bureau: None. Research Funding: Reshma Jagsi, AbbVie
(Inst). Mark J. Ratain, Bristol-Myers Squibb (Inst), Dicerna (Inst), OncoTherapy Science (Inst), PharmaMar (Inst). Patents, Royalties, or Other Intellectual
Property: Mark J. Ratain, pending patent related to a genomic prescribing system, pending patent related to a genomic prescribing system (Inst), royalties
related to UGT1A1 genotyping for irinotecan, royalties related to UGT1A1 genotyping for irinotecan (Inst). Expert Testimony: Mark J. Ratain, Apotex,
Fresenius Kabi, Mylan, Teva. Travel, Accommodations, Expenses: Richard B. Gaynor, Eli Lilly and Company. Other Relationships: None.
asco.org/edbook | 2015 ASCO EDUCATIONAL BOOK 135