1169Journal Reports / The Spine Journal 13 (2013) 1167–1169

BMP formulation demonstrated that its use may be associated with an in-

creased risk of cancer.

OBJECTIVE: To evaluate whether BMP, as commonly used today, is as-

sociated with an increased risk of cancer or benign tumors.

METHODS: We performed a retrospective study using Thomson Reuter’s

MarketScan database. We retained all patients who had no previous diag-

nosis of cancer or benign tumor and who had at least two years of uninter-

rupted enrollment in the database before and after their operations. A

propensity score-matched cohort was created to ensure greater covariate

balance between treatment groups.

RESULTS: Within the propensity score matched cohort (N 5 4,698),

BMP-exposed patients had a non-significant increase in the rate of cancer

diagnosis (9.37% vs 7.92%; p5 0.08). After adjusting for covariates, BMP

exposure was associated with a 31% increased risk of benign tumor diag-

nosis (OR: 1.31; 95% CI, 1.02-1.68; p! 0.05). When the benign tumor

diagnoses were stratified by organ type, BMP patients had significantly

more diagnoses of benign nervous system tumors (0.81% vs 0.34%; p 5

0.03), and within this group benign tumors of the spinal meninges were

much more common in the BMP-treated group (0.13% vs. 0.02%; p 5

0.002).

CONCLUSION: The results of this large, independent, propensity-

matched study suggest that the use of BMP in lumbar fusions is associated

with a significantly higher rate of benign neoplasms, but not malignancies.

PMID: 23756740 [PubMed - in process. Available at: http://www.ncbi.

nlm.nih.gov/pubmed/?term523756740].

Reprinted with permission from: Lad SP, Bagley JH, Karikari IO, Babu R,

Ugiliweneza B, Kong M, Isaacs RE, Bagley CA, Gottfried ON, Patil CG,

Boakye M. Cancer after spinal fusion: the role of bone morphogenetic pro-

tein (BMP). Neurosurgery 2013 Jun 14 [Epub ahead of print].

http://dx.doi.org/10.1016/j.spinee.2013.07.018

Staff report on Medtronic’s influence on INFUSE clinical studies.

United States Senate Finance Committee. Int J Occup Environ

Health 2013;19(2):67-76.

BACKGROUND: On June 21, 2011, the US Senate Finance Committee

staff initiated an inquiry into whether Medtronic, Inc improperly influ-

enced peer-reviewed studies of Medtronic’s bone-growth product InFuse,

also known as bone morphogenetic protein 2 (BMP-2).

METHODS: In response to the June 21, 2011 request by Chairman Bau-

cus and Senator Grassley, Medtronic produced more than 5000 documents

pertaining to 13 studies sponsored by Medtronic where there was abso-

lutely no reporting of adverse events associated with InFuse. Committee

staff conducted a review of the documents submitted by Medtronic and

other materials.

FINDINGS: Staff found that Medtronic was heavily involved in drafting,

editing, and shaping the content of medical journal articles authored by its

physician consultants; that Medtronic paid a total of approximately $210

million to physician authors; and that a Medtronic employee recommended

against publishing a complete list of adverse events possibly associated

with InFuse; among other findings.

CONCLUSION: The Committee’s investigation discovered troubling

evidence that Medtronic officials influenced the content of articles in

peer-reviewed scientific publications to present InFuse in the best possible

light. In order to address the problem of biased research in medical liter-

ature, drug and device manufacturers and journal editors need to imple-

ment stringent disclosure policies that detail industry funding to

physician authors. Medical journals should critically examine past studies

that may exhibit industry bias that harms patients and misleads physicians.

A company employee involved in the drafting of a scientific article should

be listed as an author.

PMID: 23684264 [PubMed - in process. Available at: http://www.ncbi.

nlm.nih.gov/pubmed/23684264].

Reprinted from: Staff Report on Medtronic’s Influence on INFUSE Clini-

cal Studies. United States Senate Finance Committee. Int J Occup Environ

Health 2013;19(2):67-76. Creative Commons Attribution License.

http://dx.doi.org/10.1016/j.spinee.2013.07.019

Taking financial relationships into account when assessing research.

Resnik DB, Elliott KC. Account Res 2013;20(3):184-205.

Many scientific journals, government agencies, and universities require

disclosure of sources of funding and financial interests related to research,

such as stock ownership, consulting arrangements with companies, and

patents. Although disclosure has become one of the central approaches

for responding to financial conflicts of interest (COIs) in research, critics

contend that information about financial COIs does not serve as a reliable

indicator of research credibility, and therefore, studies should be evaluated

solely based on their scientific merits. We argue that, while it is indeed im-

portant to evaluate studies on their scientific merits, it is often difficult to

detect significant influences of financial relationships that affect research

credibility. Moreover, at least five factors can be examined to determine

whether financial relationships are likely to enhance, undermine, or have

no impact on the credibility of research. These include as follows: whether

sponsors, institutions, or researchers have a significant financial stake in

the outcome of a study; whether the financial interests of the sponsors, in-

stitutions, or researchers coincide with the goal of conducting research that

is objective and reliable; whether the sponsor, institution, or researchers

have a history of biasing research in order to promote their financial goals;

how easy it is to manipulate the research in order to achieve financial

goals; and whether oversight mechanisms are in place which are designed

to minimize bias. Since these factors vary from case to case, evaluating the

impact of financial relationships depends on the circumstances. In some

situations, one may decide that the financial relationships significantly un-

dermine the study’s credibility; in others, one may decide that they have no

impact on credibility or even enhance it.

PMID: 23672544 [PubMed - in process. Available at: http://www.ncbi.

nlm.nih.gov/pubmed/?term523672544].

Reprinted with permission from: Resnick DB, Elliott KC. Taking financial

relationships into account when assessing research. Account Res

2013;20(3):184-205. Available at: http://www.tandfonline.com/doi/full/

10.1080/08989621.2013.788383#.Ue2Q3G1fdmk.

http://dx.doi.org/10.1016/j.spinee.2013.07.020