Change comes painfully, as we are ruefully told; sometimes, it comes one funeral at a time. This agonizing state of affairs could not more appropriately describe the challenges to conventional health care that we are facing at this moment - complete with backlash, soap opera, and deceit that would dwarf the goings-on in such classics as The Phantom of the Opera.And only with the very recent revelations challenging the safety of the widely used COX-1 and COX-2 NSAID painkillers, we seem to be witnessing another painful upheaval.
In a wonderful review of the upheavals of our thinking in health care involving paradigm shifts, Alternative Therapies in Health and Medicine has recently suggested that the history of medicine is replete with examples of resistance to change and discarded therapies that now appear ludicrous, even at the risk of the patient's health.1 In my last column, I reviewed in detail how the groundbreaking investigations of Edward Jenner in smallpox; Ignaz Semmelweis and Oliver Wendell Holmes in simple sanitation procedures (hand washing, to be exact); and Kilmer McCully in suggesting that folate deficiency and homocysteine elevation played a role in cardiovascular disease; were all met by hostility and persecution. The conventional medical wisdom also held pellagra to be caused by foreign invaders, rather than a nutritional deficiency; and that peptic ulcers were more likely to be caused by matrimonial passivity, rather than a bacterium, which could be treated with antibiotics.2
Closer to home and in my very first FCER Forum column, I chronicled the many examples of resistance to alternative medicine,3 which became more barefaced after the publication in 1994 of the 14th edition of medical guidelines from the Agency for Health Care Policy and Research (now the Agency for Health Research and Quality) on low-back pain,4 which promptly led to efforts not only to suppress the guidelines (incredibly misrepresented by the AMA immediately afterward5), but also to shut down the entire agency. This was simply because spinal manipulation was represented as being one of the two means to treat acute back pain, supported by the best evidence at that time - while such medical "standard" treatments as chymopapain injections or surgery for spinal stenosis or spinal fusion received weaker ratings. The history of anti-chiropractic invectives labeling the profession as "unscientific" unfortunately fills volumes, from the days of Morris Fischbein's crusades against chiropractic as editor of the Journal of the American Medical Association,6 to a mind-numbing invective published in 2002 by Timothy Mirtz7 which I have rebutted in considerable detail elsewhere.8
More recently, of course, we are witnessing the fall of another icon in medical treatment: the COX inhibitors. When you consider some of the machinations of how rofecoxib (Vioxx) was handled, for example, you begin to realize how resistant to change so many parties have been to its distribution and consumption. The story begins five years ago when The New England Journal of Medicine published an article which demonstrated that this COX-2 inhibitor had lower GI toxicity than naproxen,9 arguably the primary representative of the class of COX-1 inhibitors, believed not only to cause 16,000 deaths annually in the U.S. due to GI bleeding,10 but also leading to reduced glomerular filtration rates,11 miscarriage,12 persistent pulmonary hypertension in newborns,13 congestive heart failure in the elderly,14 and cartilage destruction in osteoarthritis.15
But the FDA had actually approved rofecoxib one and a half years before the article was published in a peer-reviewed journal. The cardiovascular data were considered to be incomplete, as the design of the original randomized trial had not anticipated this deleterious side-effect. It was only by happenstance - in another randomized trial which examined 2,600 patients with colonic polyps - that the new problem surfaced. Despite the fact that patients with cardiovascular disease were excluded from this particular study, the rate of patients who experienced a myocardial infarction or stroke on Vioxx (3.5%) was nearly twice that of the population given a placebo (1.9%).16 How did the manufacturer of Vioxx (Merck) react? By issuing a stream of publications, beginning with a press release dated May 22, 2001, titled, "Merck Reconfirms Favorable Cardiovascular Safety of Vioxx" and then complemented by numerous papers in peer-reviewed journals by Merck employees and their consultants.17
And the FDA? We know the rest, beginning with the fact that David Graham, the FDA whistleblower and safety expert, told Congress in August 2004 that Vioxx alone may have caused more than 30,000 deaths.18 And now we know that the COX-2 cardiovascular risk party has been joined by both Celebrex [celecoxib]19 and Bextra (valdecoxib),20 both products of the pharmaceutical giant Pfizer, which as of the middle of December 2004, actually said that it had no plans to pull the products off the market.19 Almost as if to demonstrate that it is really on top of things, and to complete this bizarre game, set and match, the beleaguered FDA seems to have taken some initiative by announcing in December that a controlled trial of 2,400 healthy participants demonstrated that a COX-1 inhibitor, Bayer's product naproxen (Aleve), displayed a 50 percent elevation of the rates of heart attacks and strokes.21
Does all this amount to a clean sweep of the NSAIDs? In just two months, all these recent findings would appear to have put a severe dent into the safety record of one of the AHCPR's leading treatments for back pain as I had indicated earlier. Admittedly, it is most likely that any or all of these trials concerning the risks of NSAIDs contain flaws that can be addressed in the debates and investigations to come. But it should be immediately clear that the actual numbers of potential deaths involved in the use of these widely used medications far outweigh, by several orders of magnitude, any that could possibly be attributed to cervical manipulation - which is experienced by a far smaller segment of the population and has undoubtedly received its share of slings and arrows in numerous and often excessive attacks upon its safety.22,23
Where is this NSAID gotterdammerung taking us? As if on cue in a movie that you might label, "The Revenge of the Alternative Meds," a box (formerly referred to in newspaper journalism as a "southwest kicker") appeared on the front page of the Boston Globe and other news services, proclaiming that a two-year clinical trial funded by the National Center for Complementary and Alternative Medicine at the NIH had found that a substitute for NSAIDs - acupuncture - significantly reduced pain and increased movement in patients afflicted with osteoarthritis of the knee.19,24 What if "chiropractic" had so proudly occupied that space in the front-page southwest kicker in prominent national newspapers? (You could say that this is one time I'm trying to think inside rather than outside of the box.)
In no uncertain terms, this tells of the enormous window of opportunity that is now open to chiropractic research as it seeks to take its place in today's health care choices for the patient. It goes without saying that interest and support of the profession in such research, and both recognizing and using the auspices of the Foundation for Chiropractic Education and Research in this regard, is crucial. To back away from this calling at this time would be an incalculable loss, primarily for the patient.
And what about change? It is inevitable that, with the flow of discovery and time, what will truly mark the outstanding individual is his or her accommodation rather than the suppression or distortion of new information. So, rather than produce an "exit, pursued by a bear," as Shakespeare notes in The Winter's Tale, we would do best to heed the predominant message from that play, which was actually best expressed by Spenser over 400 years ago:25
| All things steadfastness do hate |
And changed be: yet being rightly weighed
They are not changed from their first estate,
But by their change their being do dilate,
And turning to themselves at length again,
Do work their own perfection so by fate.
And so, change needs to be accepted by health practitioners, policy-makers, the public, the media, bears - whatever. The only realistic key for making change both feasible and palatable is research.
- Hyman M. Paradigm shift: the end of "normal science" in medicine: understanding function in nutrition, health, and disease. Alternative Therapies in Health and Medicine 2004;10(5):10-15;90-94.
- Rosner A. Toward a new epistemology through an accessible language. Dynamic Chiropractic, Feb. 12, 2005;23(4).
- Rosner A. The backlash against alternative medicine. Dynamic Chiropractic, Nov. 2, 1998;16(23).
- Bigos S, Bowyer O, Braen G, et al. Acute low back pain in adults. Clinical Practice Guideline No. 14. AHCPR Publication No. 95-0642. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services, December 1994.
- AMA Editorial Board. AMA's Pocket Guide to Back Pain. New York, NY: Random House, 1995.
- Wardell W. Chiropractic: History and Evolution of a New Profession. St. Louis, MO: Mosby Year-Book, 1992, p. 82.
- Mirtz TA, Long P, Dinehart A. Slaughter RL, DuVall Jr., CE, Bryson R, Kourmadas F. Campo J. NACM and its argument with mainstream chiropractic health care. Journal of Controversial Medical Claims 2002;9(1):11-25.
- Rosner A. NACM's interpretation of "mainstream" chiropractic care: a critique of Mirtz' article. Submitted to the American Chiropractic Association, Nov. 4, 2002.
- Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. The New England Journal of Medicine 2000;343:1520-1528.
- Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. The New England Journal of Medicine 1999;340(24):1888-1899.
- Hamill RJ, Rowlingson JC. Handbook of Critical Case Management. New York, NY: McGraw-Hill, Inc., 1994, pp. 106-113.
- Nielsen GL, Sorensen HT, Larsen H, Pedersen L. Risk of adverse birth outcome and miscarriage in pregnant users of non-steroidal anti-inflammatory drugs: population based observational study and case-control study. British Medical Journal 2001;322:266-270.
- Alano MA, Ngougmna E, Ostrea EM Jr, Konduri GG. Analysis of nonsteroidal antiinflammatory drugs in meconium and its relation to persistent pulmonary hypertension of the newborn. Pediatrics 2001;107(3):519-523.
- Page J, Henry D. Consumption of NSAIDs and the development of congestive heart failure in elderly patients. Archives of Internal Medicine 2000;160:777-784.
- Rainford KD. Profile and mechanisms of gastrointestinal and other side effects of nonsteroidal anti-inflammatory drugs [NSAIDS]. American Journal of Medicine 1999;107:27s-33s.
- Mukherjee DM, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. Journal of the American Medical Association 2001;286:954-959.
- Topol EJ. Failing the public health: Rofecoxib, Merck, and the FDA. The New England Journal of Medicine 2004;351(17):1707-1709.
- USA Today, Dec. 20, 2004, p. 14A.
- FDA: Consider "alternative" to Celebrex: Pfizer examining data that show higher risk of heart attack. Dec. 24, 2004: www.cnn.com/HEALTH/conditions/12.17/
- BEXTRA: Valdecoxib tablets. Dec. 4, 2004: www.pfizer.com/download/uspi.bextra.pdf.
- Henderson D, Dembner A. Another painkiller tied to heart attack risk. Boston Globe, Dec. 1, 2004.
- Smith WS, Johnston SC, Skalabrin EJ, et al. Spinal manipulative therapy is an independent risk factor for vertebral artery dissection. Neurology 2003;60:1424-1428.
- Ernst E, Assendelft WJJ. Chiropractic for low back pain: we don't know whether it does more good than harm. British Medical Journal 1998;317:160.
- Boston Globe, Dec. 21, 2004, p. 1.
- Spenser E. The Faerie Queene. London, United Kingdom: Ponsobie, 1596.
Anthony Rosner, PhD
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