- Department of Neurosurgery, Cedars Sinai-Medical Center, Los Angeles, USA
- Department of Orthopedics, Cedars Sinai-Medical Center, Los Angeles, USA
- Department of Neurosurgery, University of California Davis Medical Center, Sacramento California, USA
Department of Neurosurgery, Cedars Sinai-Medical Center, Los Angeles, USA
Department of Neurosurgery, University of California Davis Medical Center, Sacramento California, USA
DOI:10.4103/2152-7806.148025Copyright: © 2014 Drazin D. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
How to cite this article: Drazin D, Shweikeh F, Wieshofer E, Kim TT, Johnson JP. Public awareness of the bone morphogenic protein controversy: Evidence from news publications. Surg Neurol Int 30-Dec-2014;5:
How to cite this URL: Drazin D, Shweikeh F, Wieshofer E, Kim TT, Johnson JP. Public awareness of the bone morphogenic protein controversy: Evidence from news publications. Surg Neurol Int 30-Dec-2014;5:. Available from: http://sni.wpengine.com/surgicalint_articles/public-awareness-bone-morphogenic-protein-controversy-evidence-news-publications/
Background:Use of recombinant human bone morphogenic protein-2 (rhBMP-2) in spinal fusion has seen a tremendous increase. Public awareness of rhBMP-2 and its complications has not been assessed. The authors studied published news media articles to analyze information provided to the public on this bone graft substitute.
Methods:We utilized the academic database, LexisNexis, to locate newspaper articles published between January 2001 and July 2013. All articles were coded by a coder and reviewed by the principal investigator.
Results:The search identified 87 national and 99 local newspaper articles. Complications mentioned in national newspapers included cancer (24%), retrograde ejaculation (24%), and abnormal bone growth (14%). Local newspapers cited cancer (14%), inflammation (14%), and retrograde ejaculation (9.2%) most frequently. Fifty national (59%) and 35 local (54%) articles had no mention of complications. Sources of evidence cited by articles were (in order of frequency): Governmental agencies, medical research or published studies, healthcare personnel or patients, and companies or corporations.
Conclusions:Only a small percentage of newspaper articles presented potential complications. Despite lack of clear scientific causal relationship between rhBMP-2 and cancer, this risk was disproportionately reported. Additionally, many did not cite scientific sources. Lack of reliable information available to the public reiterates the role of physicians in discussing risks and benefits BMP use in spinal surgery, assuring that patients are making informed decisions. Future news media articles should present risks in an impartial and evidence-based manner. Collaboration between advocacy groups, medical institutions, and media outlets would be beneficial in achieving this goal.
Keywords: Bone morphogenic protein, BMP, news media, public, rhBMP-2, spine fusion surgery
Bone morphogenic proteins (BMPs) were discovered almost 50 years ago by Marshall R. Urist.[
In 2002, the Food and Drug Administration (FDA) approved the use of rhBMP-2 products for single-level ALIF spinal fusion. Soon after its introduction, it was being utilized by surgeons off-label for other spinal fusion operations.[
Today, medical products, procedures, and medications are often advertised on the internet, television and in printed media. Public response to this marketing system has shaped the future of numerous pharmaceutical companies and their products. This paper examines BMP, a bone growth adjuvant increasingly used in on-label spinal operations as well as off-label operations by spine surgeons. The federal government has questioned its complications and safety profile.[
We utilized the guided news search function in LexisNexis, an academic database that locates news articles in all major newspapers and news magazines in the United States. On June 30, 2013, we searched for articles with the terms “bone morphogenic protein,” “Infuse®,” and “Medtronic.” All articles were coded by a coder (EW) and reviewed by a principal investigator (DD). The coding structure included the identification of: (i) headline topic (legal, medical, financial, no topic specified); (ii) year of publication; (iii) complication mentioned (sterility, cancer; infection, etc.); (iv) area where Infuse® was used (lumbar, cervical spine); (v) topic of the article, if complication was not reported (FDA approval, sales reports); (vi) type of circulation (national versus local). Each of the above characteristics was noted, and the frequency with which each item appeared in the pool of articles was recorded.
The database search yielded a total of 186 articles from U.S. newspapers published from the time period between January 2001 and June 2013. Eighty-seven were national newspaper articles and 99 were local newspaper articles. There were 9 duplicate national articles and 11 duplicate local articles; no article was coded twice. Headline topics were medical or product-related (35%), financial (investing and stocks) (28%), and legal (lawsuits and bribery charges) (26%). Eleven percent had no particular headline.
Initial articles containing reports on BMP were published in 2001, coinciding with the release of the bone substitute. The frequency of articles then steadily decreased until 2005-2006, when negative reports and complications with BMP began to be increasingly reported [
There were a total of 87 articles from national newspapers: 42 from the Star Tribune, 33 from New York Times, and 12 from the Wall Street Journal. A few of these were feature articles (13), many were short, concise pieces (43), and others had an actual extensive description of the topic of BMP (31). Fifty articles had BMP as their main focus, while the other 37 discussed it as part of another main medical topic. Most articles from national newspapers were published in 2008 or after, and almost all articles communicating complications were published post-2008. Opinions expressed in national publications on major complications included mention of cancer (24%), retrograde ejaculation (RE) (24%), and abnormal bone growth (14%).
There were a total of 99 articles from local newspapers, most commonly from the St. Paul Pioneer Press (51), Investor's Business Daily (11), and Finance and Commerce (5). Most articles were brief and short news items (57), 29 were features, and only 13 provided an extensive description of the BMP topic. Additionally, the majority (67) discussed BMP as part of articles on various medical issues, while only 32 had BMP as their central focus. Unlike national newspapers, local newspaper articles began to surface earlier in 2006 with reports of Medtronic bribing physicians to fabricate studies and under-report its risks. The first articles on complications were in 2008. Local newspapers and news magazines that reported complications cited cancer (14%), inflammation (14%), and RE (9.2%) most commonly.
Public perception of medical drugs in general is largely influenced by news media publications and reports. The importance of reporting medical news accurately and scientifically is paramount to the public having an educated view on medical drugs and devices. In our current report, we identified notable trends among the news publications with regard to rhBMP-2. In our study, we found that from 2001 to 2005, news publications highlighted the release of BMP and its subsequent FDA approval with over half of these articles not mentioning adverse complications. After 2005, scientific reports of possible adverse events announced by the FDA and other independent researchers were cited by newspapers and by 2008, we found that the over-representation of complications from rhBMP-2 was significantly increased and seen in 100% of national and local news media. Additionally, descriptions of previously unrecognized complications were also increased in their presentations to the public.[
RhBMP-2 has only been approved by the FDA for use in anterior lumbar spine fusion procedures using a very specific interbody spacer. News articles most often cited the lumbar spine (32%) as the area where BMP was used but other articles reported its off-label use in the cervical spine. Although it is at the physician's discretion to use a given drug for indications not approved by the FDA, it was reported that spine surgeons had allegedly used BMP in an off-label manner as a result of financial reimbursement by manufacturing companies.[
In 2011, amid the controversy of the effectiveness of BMP, Medtronic initiated and contracted with the Yale Open Data Access (YODA) group, and provided funds for an independent analysis of data published by Medtronic and its researchers.[
Abnormal and unwanted bone growth
It has been suggested that BMPs may be toxic to neural tissue and may incite a vigorous inflammatory response in some patients.[
Sexual and urological complications
RE was a prevalent complication reported with the use of BMP bone graft. RE is a condition in men where the internal vesical sphincter muscle at the base of the bladder fails to contract during ejaculation.[
Risk for cancer
Our analysis found that the risk of cancer was commonly mentioned in 24% of major newspapers (1st highest, tied with RE) and 14% (1st highest, tied with inflammation) of local newspaper articles. Not all of the articles listed recognized research publications as cited evidence (<78%). The issue of cancer risk is an especially important one and multiple studies have reported conflicting evidence for this controversial risk.
Carragee et al. demonstrated that patients who were treated with rhBMP-2 were 4-5 times more likely to develop a new malignancy.[
Two recent population-based studies, however, presented the issue of cancer and BMP in a different light. Lad et al.[
Cooper et al.[
Although in vivo and in vitro studies have shown evidence that BMP can cause neoplastic progression, there is no clear biological basis for how its administration can influence cancer risk.[
Significance of our analysis for physicians
Evidence from contradictory studies suggests that cancer risk with BMP use may have been exaggerated in newspaper and news magazine articles. Lack of reliable information has not been made to the public and may, in fact, have created unnecessary patient anxiety. Since the risk of cancer is the most common complication publicized by the news media, surgeons utilizing BMP must be prepared to: (i) explain the controversial nature of the cancer risk claim, (ii) provide patients with as much verbal and/or written information as is necessary to answer their questions, (iii) ensure full patient awareness of all potential benefits and risks, (iv) counsel patients, (v) assist patients in making an informed decision about whether to include or not include BMP in an upcoming surgery, and (vi) support the patient's choice.
It might be prudent to involve medical advocacy groups or medical institutions with media outlets to issue more frequent public statements regarding new medical research findings. These articles could present and discuss risks and complications in a more impartial and evidence-based manner than those authored by newspaper and news magazine reporters. These articles would then add to the print media and internet searches used by the public.
It is important that there be transparency in the dissemination of medical information. The harms and risks associated with BMP and all medications, products and procedures need to be presented without bias and without the potential impact of a conflict of interest. Only with reliable information and all the pertinent facts can a patient intelligently participate in decision-making and make informed choices.
Limitations in our study
The LexisNexis database does not represent all printed material and the search may miss articles on the topic. As such, findings may represent a skewed view of the topic. Besides printed sources like newspapers, patients may get their information online. The internet is commonly used by the public for personal research about a diagnosis, available treatments, risks, and complications. Articles that have been published in newspapers and news magazines may be referenced and read (or re-read) during this search. Although scientific articles (research studies, clinical trials, case reports, etc.) may have been published in professional medical journals, these articles may not be as readily available or as easily understood by the public. Therefore, it is important for physicians to inform their patients of the most recent medical research and to explain any relevant evidence that will help them make an informed choice.
Our analysis of published national and local newspaper and magazine articles on rhBMP-2 indicated that only a small percentage of printed media presented accurate and responsible information on the numerous potential complications. The risk for cancer was disproportionately reported and of specific concern because only a small fraction of articles cited scientific publications. Based on our study, the lack of reliable information publically available makes it even more important for physicians to discuss both the risks and benefits of using BMP in spinal surgery. More news media articles are needed that present and discuss risks and complications in an impartial and evidence-based manner; advocacy groups and medical institutions with media outlets may be able to help facilitate this goal.
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