Editor's Note: Part 1 of this article appeared in the May 1, 2013 issue.
Not only has Medtronic made billions selling expensive screws and hardware for highly controversial spine fusions, but a Senate investigation also found Medtronic felt compelled to write and edit medical journal articles attributed to outside physicians that downplayed the risks of the company's best-selling bone graft, Infuse.26
Instead of using bone from a patient's own body to insert in the disc space, Infuse is a powerful biological agent that stimulates the growth of new bone and can sell for more than $5,000 a pack, depending on the size.27 The Senate Finance Committee said that the world's largest medical device-maker did not disclose its role in shaping 13 key studies of Infuse, which helped turn the bone graft into an $800-million-a-year product.
Infuse has been used to treat more than 500,000 patients, but one huge problem appears to be that it cannot control the growth of new bone. One clinical trial of Infuse was halted because of excessive bone growth in the spinal canals of 70 percent of patients.28 This complication was the subject of a 2004 paper written by doctors who had received millions of dollars from Medtronic. However, the studies failed to mention serious risks of Infuse including male sterility, infection, bone growth, and increased back and leg pain.
Inexplicably, the surgeons who wrote the article said that patients weren't harmed by the excess bone growth. But that claim was refuted by another surgeon who admitted he had patients who developed pain from excessive bone growth that required additional surgeries.
Senate investigators also reported over the course of 15 years, Medtronic paid $210 million to a group of 13 doctors who co-authored the series of now-repudiated papers about the product. Between 1997 and 2003, two of the "independent" authors received $8.5 million from Medtronic.29
Another example is Dr. Thomas A. Zdeblick of the University of Wisconsin, who claimed he did not have a "direct financial interest in the success of Infuse or Medtronic." Over the years, however, Dr. Zdeblick has received over $20 million in royalty payments from Medtronic in connection with patents on devices, including one that is used with Infuse.30
Such "ghostwriting" has been condemned as a breach of integrity because doctors rely on information in those articles to make medical decisions, not knowing that the papers may contain biased, inaccurate or potentially harmful information.
"This sounds eerily familiar to many of the transgressions we've read about from the pharmaceutical industry," said Harlan Krumholz, MD, a professor of medicine at Yale University, when told of the Senate report. "It paints a picture of a company very heavily involved in the science, marketing contaminating the science, and the medical profession and researchers being complicit."31
"Medtronic's actions violate the trust patients have in their medical care," said Sen. Max Baucus (D-Mont.), in a statement. "Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has."32
Medtronic's payola is not new, nor is Medtronic the only device company doing this. What made this case unique was the "massive corruption and the towering sums" paid out to greedy MDs who put their profit above their patients or their own integrity.
Zombie Science: Putting Medical Spine Care Before Chiropractic
"The incentives are all out of whack," said Justin W. Timbie, a health policy researcher at the RAND Corporation. "The current system favors treatments that are well paid, not necessarily those that are most effective."33
Not only have Big Pharma and Big Device Manufacturers paid doctors millions to compromise their ethics, but their refusal to follow new research guidelines also has been rampant in the medical profession, especially in regard to spine care.
This pattern resembles "zombie science," according to Bruce Charlton, MD, who defines it as "a sinister consequence of evaluating scientific theories purely on the basis of enlightened self-interest ... In the real world, it looks more like most scientists are quite willing to pursue wrong ideas so long as they are rewarded with a better chance of achieving more grants, publications and status," or making great livelihoods.34
No doubt the best example of zombie science rests with medical spine care. But after a century of the AMA libeling chiropractic as an "unscientific cult,"35 the present era of evidence-based health care has been a blessing to chiropractors. More than 20 years ago, research showed that the medical treatments for low back pain – drugs, shots and surgery – were ineffective and inappropriate in many cases. Indeed, this cat was first let out of the medical black bag in 1989 when orthopedist / author, Gordon Waddell, admitted, "Low back pain has been a 20th century health care disaster ... back surgery has been accused of leaving more tragic human wreckage in its wake than any other operation in history."36
The paradigm shift in spine care essentially began in 1990 when research by Scott Boden, MD, now-director of the Spine Center at Emory University, found no clear correlation between disc abnormalities and back pain.37 Richard Deyo, MD, MPH, noted this misleading disc theory has led to "false positive" misdiagnosis, suggesting that "many of these abnormalities are trivial, harmless, and irrelevant, so they have been dubbed incidentalomas," and "are likely to lead to more tests and perhaps even unnecessary surgery."38
The BACKLETTER, a newsletter from the Department of Orthopedic Surgery at Georgetown Medical Center in Washington, D.C., spoke of the "growing frustration" with the medical approach. "The world of spinal medicine, unfortunately, is producing patients with failed back surgery syndrome at an alarming rate ... there is little evidence that patient outcomes have improved.39-40
The turning point, of course, occurred following an extensive, two-year seminal study released in 1994 by the U.S. Public Health Services' Agency for Health Care Policy and Research (AHCPR)41 that listed spinal manipulation as a "proven treatment," as did studies from Canada42 and the U.K.43 that also recommended hands-on conservative care over medical care for this problem.
What angered spine medicine the most about the AHCPR study was its finding that confirmed the rare need – estimated to be only one in 100 cases – for back surgery except in the most severe cases of cancer, fractures, infections, cauda equina, or cases that did not respond after four weeks of conservative care.44
Another study in 1994 compared international rates of back surgeries and found the rate of back surgery in the United States was at least 40 percent higher than in any other country, and was more than five times the rates in England and Scotland. Back surgery rates increased almost linearly with the per-capita supply of orthopedic and neurosurgeons.45
Today, there are more randomized, controlled trials on spinal manipulative therapy for low back pain than any other treatment.46 Researchers now vindicate chiropractic treatments over medical care for the majority of "mechanical" back pain cases that comprise the majority ( approximately 85 percent) of all back pain cases, a fascinating, yet untold story never revealed by medical journalists on cable news.47
By 2006, the Dartmouth Institute of Health Policy also admitted 30-40 percent of spinal fusion surgeries were unnecessary.48 This is a low-ball figure, but still alarming.
Finally, this research has led to substantial changes. Both the North American Spine Society and American Society of Spine Radiology now admit the term bulging disc should only be used as a descriptive term, not a diagnostic term.49 In 2010, the North American Spine Society also admitted spine fusion should be a last resort and recommended spinal manipulation – five to 10 sessions over two to four weeks – should be considered before surgery.50 In 2011, North Carolina Blue Cross / Blue Shield announced it will no longer pay for spine fusion if the sole criterion is an abnormal disc.51(Ironically, many spine experts now suggest chiropractors should be considered America's primary spine care providers by virtue of their superior educational training and clinical effectiveness.)52
This is a growing concern since 80-90 percent of all adults will suffer from acute low back pain in their lifetime, and many mistakenly seek initial help from their medical primary care providers, who are untrained in this area of musculoskeletal disorders.
Dr. Scott Boden admitted this inadequacy: "Many, if not most, primary medical care providers have little training in how to manage musculoskeletal disorders."53 Many other researchers also confess medical primary care physicians are typically inept in their training on musculoskeletal disorders,54 prone to ignore recent guidelines,55 and more likely to suggest spine surgery than surgeons themselves.56
Dr. Deyo has noted the frustration in medical spine care: "People say, 'I'm not going to put up with it,' and we in the medical profession have turned to ever more aggressive medication, narcotic medication, and more invasive surgery."57
Not only is payola an unethical motivator; the medical profession is also steeped in stubbornness. Researchers have found that today it takes 15 years for a new treatment to be incorporated into mainstream medical practice; more shocking, it takes 44 years for a method that has been proven to be ineffective, dangerous or outmoded to be removed from practice.58
Considering the initial discogenic theory was debunked 22 years ago, in 1990, perhaps this foretells that it may take another 22 years before the paradigm shift from drugs, shots and spine surgery to the chiropractic model takes place.
This growing denunciation of the medical spine care treatments has led researchers to the chiropractic model, but this shift has gone unnoticed by the media and the naïve public who continue to believe in the "bad disc" concept kept alive by unscrupulous spine surgeons and a medical media that refuses to tell the truth about this paradigm shift in spine care.
Obviously the medical model has had its day, and with less than stellar results. According to Mark Schoene, editor of The BACKLETTER, "Given the unsustainable growth in medical spending, there is a need to cut back on unnecessary, ineffective, and costly treatment services."59
Now that the tide has turned due to the plethora of evidence, a judgment day may be at hand, according to Christopher Bono, MD, in his keynote address to the International Society for the Study of the Lumbar Spine:
"In the U.S., we have decreasing reimbursement for everything we do in spine. Why? It is the years of overbilling and overtreatment that have led to the current situation. In the end, I hope we can come up with a better solution ourselves before the government or some other entity solves this situation for us."60
That "better solution" has been clear on this issue, but now we find a bigger problem – corruption that keeps this medical approach alive despite the critics, cost, and ineffectiveness. Imagine the millions of patients harmed financially and physically by "the years of overbilling and overtreatment," as well as the billions of dollars wasted on "zombie science" methods with this abuse of drugs, epidural shots, MRIs looking for incidentalomas, and spine surgery based on an outdated discogenic theory.
"It's no wonder the public has lost confidence in the drug and device industries," noted Harlan Krumholz, MD.61 He might have added the lost trust in the entire medical spine field. With the many skeletons in the medical closet – from tobacco to pharmapayola to surgical corruption – it's hard to understand how anyone can trust their MD knowing the bias, bribery and greed that permeate the medical profession.
Perhaps the answer is patients simply do not know the history of these events because the medical professionals and the medical media are not telling them. Medical payola is so ubiquitous it will require more than merely a few lawsuits to fix this problem that is certainly bad to the bone in medicine.
26. "Report: Medtronic Influenced Studies on InFuse Bone Grafts." Associated Press, Oct. 25, 2012.
27. Carreyrou J, Mcginty T. "Top Spine Surgeons Reap Royalties, Medicare Bounty." Wall Street Journal, Dec. 20, 2010.
28. Fauber J. "Medtronic Helped Write, Edit Positive 'Infuse' Spine Studies." Milwaukee Journal Sentinel, Oct. 25, 2012.
32. Meier B, Wilson D. "Spine Experts Repudiate Medtronic Studies." New York Times, June 28, 2011.
33. Chen PW. "Why Studies That Compare Treatments Lack Impact." New York Times, Nov. 8, 2012.
34. Charlton BG. Replacing education with psychometrics. Medical Hypotheses, 2008;71:327-9.
35. Memo from Robert Youngerman to Robert Throckmorton, Sept. 24, 1963, plaintiff's exhibit 173. Wilk, et al., v AMA, et al.
36. Waddell G, Allan OB. A historical perspective on low back pain and disability. Acta Orthop Scand, 1989;60(suppl 234).
37. Boden SD, Davis DO, Dina TS, et al. Abnormal magnetic resonance scans of the lumbar spine in asymptomatic subjects: a prospective investigation. J Bone Joint Surg (U.S.), 1990;72:403-408.
38. Deyo RA, Patrick DL. Hope or Hype: The Obsession With Medical Advances and the High Cost of False Promises. AMACOM, 2005.
39. The BACKLETTER, July 2004:79.
40. The BACKLETTER, March 2005:84.
41. Bigos SJ, Bowyer O, Braea G, et al. Acute Low Back Pain Problems in Adults: Clinical Practice Guideline No. 14. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, 1992. AHCPR publication No. 95-0642.
42. Manga P, Angus D, Papadopoulos C, Swan W. The Effectiveness and Cost-Effectiveness of Chiropractic Management of Low Back Pain. Ontario Ministry of Health - Kenilworth Publishing, 1993.
43. Meade TW, et al. Randomised comparison of chiropractic and hospital outpatient treatment. British Medical Journal, 1990;300(6737):1431-1437.
44. Bigos SJ, Op Cit, page 8.
45. Cherkin DC, Deyo RA, et al. An international comparison of back surgery rates. Spine, June 2004;19(11):1201-1206.
46. Rubinstein SM, Terwee CB, de Boer MR, van Tulder MW. Is the methodological quality of trials on spinal manipulative therapy for low-back pain improving? International Journal of Osteopathic Medicine, 2012;15(2):37-52.
47. Deyo RA. Conservative therapy for low back pain: distinguishing useful from useless therapy. Journal of American Medical Association, 1983;250:1057-62.
48. Elliott Fisher, MD, on the CBS Evening News: "Attacking Rising Health Costs," June 9, 2006.
49. Description of bulging disc. American Spinal Decompression Association: www.americanspinal.com/bulging-disc.html
50. Freeman MD, Mayer JM. NASS contemporary concepts in spine care: spinal manipulation therapy for acute low back pain. The Spine Journal, October 2010;10(10):918-940..
51. Blue Cross / Blue Shield of North Carolina: corporate medical policy on lumbar spine fusion surgery, September 2010.
52. Murphy DR, et al. The establishment of a primary spine care practitioner and its benefits to health care reform in the United States. Chiropractic & Manual Therapies, 201;19:17.
53. Boden S, et al. Emerging techniques for treatment of degenerative lumbar disc disease. Spine, 2003;28:524-525.
54. Joy EA, Van Hala S. Musculoskeletal curricula in medical education - filling in the missing pieces. The Physician and Sports Medicine, November 2004;32(11).
55. Bishop PB, et al. "The C.H.I.R.O. (Chiropractic Hospital-Based Interventions Research Outcomes) Part I: A Randomized Controlled Trial on the Effectiveness of Clinical Practice Guidelines in the Medical and chiropractic management of Patients With Acute Mechanical Low Back Pain." Presented at the annual meeting of the International Society for the Study of the Lumbar Spine, Hong Kong, 2007; presented at the annual meeting of the North American Spine Society, Austin, Texas, 2007
56. Bederman SS, Mahomed NN, Kreder HJ, et al. In the eye of the beholder: preferences of patients, family physicians, and surgeons for lumbar spinal surgery. Spine, 2010;135(1):108-115.
57. Kolata G. "With Costs Rising, Treating Back Pain Often Seems Futile." New York Times, Feb. 9, 2004.
58. "Refuting Ineffective Treatments Takes Years." The BACKLETTER, 2008;23(9).
59. The BACKPage editorial. The BACKLETTER, November 2012;27(11).
61. Fauber J, Op Cit.
Read Dr. Smith's four-part series, "Back Surgery: Too Many, Too Costly, Too Ineffective," beginning with part 1 in the March 26, 2011 issue.
Dr. J.C. Smith, 1978 graduate of Life Chiropractic College, is the author of The Medical War Against Chiropractors: The Untold Story From Persecution to Vindication. Contact Dr. Smith via his website, www.chiropractorsforfairjournalism.com.