Dangerous Cargo


Dangerous Cargo

The Lancet Viewpoint commentary, Low back pain: a call for action,[i] came to a sobering conclusion about the “widespread use of ineffective and harmful care” in the pandemic of LBP:

“Other barriers to optimal evidence-based management include widespread misconceptions of the general public and health professionals about the causes and prognosis of low back pain and the effectiveness of different treatments, fragmented and outdated models of care, and the widespread use of ineffective and harmful care, particularly in countries regarded as models of high quality care.”

Instead of resonating loudly among all worldwide spine care professionals, the Lancet warnings seemed to have fallen on deaf ears. Similar to the AHCPR, ACP, JAMA, FDA, and Joint Commission guidelines, the Lancet review made the news one day and now is long forgotten.

“Belay those warnings; full steam ahead” orders the captain onboard the Medical Titanic. No matter what dangers may lay ahead for its passengers or how far off-course this medical transport may be to safer passage, its backwash continues to drown people in “widespread misconceptions” about the “outdated models of care.”

Deadly Cargo

Certainly opioid painkillers have gotten the most attention lately with 35,000 deaths in 2015. According to the National Institute on Drug Abuse, more than 115 people daily in the United States die after overdosing on opioids.1 The misuse of and addiction to opioids—including prescription pain relieversheroin, and synthetic opioids such as fentanyl—is a serious national crisis that affects public health as well as social and economic welfare.

Not only more deadly than illicit street drugs, this medical cargo of prescription painkillers is more profitable. Who needs El Chapo when people have Dr. Chapo to give them narcotics in this era of Pharmageddon?

The Centers for Disease Control and Prevention estimates that the total economic burden of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.2

The NIH explained “How did this happen?”

In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive.3,4 

Despite the obvious blame, we have never heard a mea culpa from the AMA or pharmaceutical industry for hijacking Americans in pain on the Medical Titanic; instead, this ship of medical pirates continues on its deadly course by refusing to follow the new guidelines calling for nondrug, noninvasive treatments offered by chiropractors and other CAM providers.

Shot in the Back

Although the opioid scandal is well known, overlooked in the cargo of “ineffective treatments” are epidural steroid injections, now the most commonly performed procedure in the US and worldwide for managing chronic low back pain.

The recent growth in ‘pain management’ clinics featuring epidural steroid injections (ESI) has received growing criticism from medical experts such as Robert J. Barth, a neuropsychologist, who believes these ESI treatments “reliably fail, the treatments seems to lead to a progressive worsening of the claimant’s presentation, the ineffective treatment never ends, and the original treating doctors refer the claimants into pain management simple as a means of escaping from or ‘dumping’ a problematic patient.”[ii]

Barth believes “pain management does not accomplish anything but getting the patient addicted.” He concludes that the “pain management situation in the U.S. is, indeed, horrific.”[iii] Nonetheless, it is among the fastest growing segments in medicine today.

Although not approved by the Food and Drug Administration (FDA) for spinal pain, 11 million injections are still performed by medical pirates in the US and worldwide epidural procedures are estimated over 30 million per year; they are typically short-acting and ineffective over the longer-term while exposing patients to major risks/complications.[iv]

Not only are ESI underwhelming, they can be dangerous with serious complication rates as high as 16.8% for cervical epidural/transforaminal injections[v]:

  • Specific risks of inadvertent intravascular injections leading to brain/cord injury
  • Risk of quadriplegia with intramedullary cervical injection
  • Risk of cardiopulmonary arrest and pneumocephalus with cervical ESI
  • Risk of Adhesive Arachnoiditis

Neurosurgeon Nancy E. Epstein wrote a revealing commentary, The Risks of Epidural and Transforaminal Steroid Injections in the Spine: Commentary and a comprehensive review of the literature, that included other adverse reactions, such as hydrocephalus, air embolism, urinary retention, allergic reactions, stroke, blindness, neurological deficits/paralysis, hematomas, seizures, and death.

She concluded:

“Although the benefits for epidural steroid injections may include transient pain relief for those with/without surgical disease, the multitude of risks attributed to these injections outweighs the benefits… For many patients with spinal pain alone and no surgical lesions, the ‘success’ of epidural injections may simply reflect the self-limited course of the disease.”

Epidural steroid injections are not always effective – it is estimated that they help relieve the patient’s pain only about 50% of the time.

“Have they been overused? Yes. And I’ve seen the complications. They happen when people have done far too many. I’ve seen people who’ve had two to three dozen epidurals in a given year,” said Forest Tennant, MD, a prominent pain management specialist in an interview with Pain News Network

“Let’s face it. The money motive is there. And this money motive is not just the anesthesiologists. It’s the surgery centers, it’s the hospitals, and it has caused problems.”

Despite such warnings and transient benefits at best, ESI are a lucrative procedure costing from a few hundred dollars to over $2,000 per injection.

In recent years a gigantic industry has grown up around invasive but nonsurgical treatments for back problems. It is split across several larger non-surgical disciplines: radiology, anesthesiology, physiatry, and neurology, that often fall under the guise of “pain management.”

These physicians generally refer to themselves as “spinal interventionalists,” but most of them are simply known as “needle jockeys,” who do other expensive procedures as well:

  • Epidural Steroid Injections (ESI)
  • Selective Nerve Root Blocks
  • Facet Joint Injections
  • Medial Branch Blocks
  • Facet Joint Radiofrequency Ablation Neurotomy
  • Sacroiliac Joint Injections
  • Sacroiliac Joint Radiofrequency Ablation Neurotomy
  • Hip Joint Injections
  • Piriformis Injections
  • Provocation Discography
  • Analgesic Discography
  • Percutaneous Discectomy
  • Intradiscal Heating Procedures
  • Intradiscal Reparative Injections
  • Vertebroplasty
  • Kyphoplasty
  • Spineoplasty
  • Sacroplasty
  • Ramoplasty
  • Ilioplasty
  • Spinal Cord Stimulator
  • Electrodiagnostic Evaluations

Nothing on this list is under $600 in private insurance. And many of these procedures are repeated every month or two, and sometimes every week or two. At this point it simply becomes ‘throwin’ good money in after bad,’ but as long as it’s thrown money at MDs, ‘So what?’ is their answer with no apologies.

Bad Discs Ahead

Perhaps the most lucrative deception onboard the Medical Titanic is the disc fusion scam — a closely held secret among surgeons that “bad discs” appear in pain-free people.

Today the “bad disc” ruse has led to the largest scam in American spine medicine, but remains the mortar to the prosperous island where many spine surgeons live in wealth and leisure off the backs of unsuspecting passengers in pain.

A recent paper, Failed Back Surgery Syndrome: A Review Article, by James Daniell and Orso Osti of the University of Adelaide in Australia found fusion surgery has a substantial failure rate, which they estimated as high as 46%. Moreover, many patients opt for repeat surgery, but that often leads to “diminishing returns.”

According to the authors, “Although more than 50% of primary spinal surgeries are successful, no more than 30%, 15%, and 5% of the patients experience a successful outcome after the second, third, and fourth surgeries, respectively.”[vi]

Here is a list of previous news articles  debunking the ‘bad disc’ diagnosis and describing some of the poor outcomes of spine surgery:

The article by Gina Kolata was particularly interesting in regards to FDA non-regulations on advertising for surgery unlike for medications:

Before a drug can be marketed, it has to go through rigorous testing to show it is safe and effective. Surgery, though, is different. The Food and Drug Administration does not regulate surgical procedures. So what happens when an operation is subjected to and fails the ultimate test — a clinical trial in which patients are randomly assigned to have it or not?

The expectation is that medical practice will change if an operation turns out not to help.

If only.

It looks as if the onus is on patients to ask what evidence, if any, shows that surgery is better than other options.

Take what happened with spinal fusion, an operation that welds together adjacent vertebrae to relieve back pain from worn-out discs. Unlike most operations, it actually was tested in four clinical trials. The conclusion: Surgery was no better than alternative nonsurgical treatments, like supervised exercise and therapy to help patients deal with their fear of back pain. In both groups, the pain usually diminished or went away.

The studies were completed by the early 2000s and should have been enough to greatly limit or stop the surgery, says Dr. Richard Deyo, professor of evidence-based medicine at the Oregon Health and Sciences University. But that did not happen, according to a recent report. Instead, spinal fusion rates increased — the clinical trials had little effect.

Spinal fusion rates continued to soar in the United States until 2012, shortly after Blue Cross of North Carolina said it would no longer pay and some other insurers followed suit.

“It may be that financial disincentives accomplished something that scientific evidence alone didn’t,” Dr. Deyo said.

Obviously this is the first time the pirates’ treasure chest was found empty. Not only did NCBCBS change the course of the Medical Titanic, so has CMS, if only for a short time, that is.

In 2013, an update from Palmetto Government Benefits Administrators (GBA), a regional Medicare Accounting Contractor, revealed the results of their pre-payment service review of “Medicare-severity” diagnosis related groups (MS-DRG).

 Palmetto’s findings for MS-DRG 460 (spine fusions) in North Carolina, Virginia, and West Virginia exposed high error rates regarding lack of medical necessity documentation, no doubt causing a panic among spine surgeons and hospitals when this Palmetto MAC refused to pay them.

According to data published on the Palmetto GBA website, a pre-payment review of 251 claims in North Carolina, Virginia, and West Virginia led to 168 claims either completely or partially denied. The total reviewed was $6,356,890 and $4,141,771 was denied, resulting in a charge denial rate of 65%.[vii]

Imagine the shock wave when payment for 65% of fusions were denied! Finally, there appears to be some sanity in the medical spine industry, at least by the payors at CMS.

The criticism of spine fusions is not new by any means. In 2004 noted spine researchers Rick Deyo, Alf Nachemson, and SK Mirza also mentioned the need for restraint in their article, “Spinal-Fusion Surgery — The Case for Restraint”, published in the New England Journal of Medicine:

“The use of spinal-fusion surgery is increasing rapidly in the United States. Most of these expensive, complex procedures are now being done for back pain and degenerative disease. Spinal fusions require long operations and are associated with an increase in the rate of complications, particularly in older patients. The benefits of surgery may be only modest, and pain relief is affected by many factors besides the anatomy. The authors of this article argue for restraint in the use of spinal-fusion surgery and for controlled trials to define more clearly the associated benefits and the indications.”

In 2006, Ms. Reed Abelson wrote The Spine as Profit Center in the New York Times revealing spine fusion surgery is among the most profitable areas for two reasons: very costly surgery and accessory hardware:

Spinal-fusion surgery is one of the most lucrative areas of medicine. An estimated half-million Americans had the operation this year, generating billions of dollars for hospitals and doctors.

But there have been serious questions about how much the surgery actually helps patients with back pain and whether surgeons’ generous fees might motivate them to overuse the procedure. Those concerns are now heightened by a growing trend among some surgeons to profit in yet another way — by investing in companies that make screws and other hardware they install. The parts can be highly profitable. A single screw that goes into the spine, for example, sells for about $1,000 — at least 10 times the cost of making it.

Such doctors face “an awfully pernicious conflict of interest,” said Dr. Richard A. Deyo.

Let me be clear no one is suggesting all spine fusions are unnecessary, just most of them. Disc surgery is an effective and reasonably safe procedure if there is a simple straightforward clinical picture such as an obvious disc fragment sitting on a nerve root, pain in a clear radicular pattern, destabilizing spine problems, severe trauma, fracture, cancer or neurological catastrophe that comprise only 10-15 percent of cases.

But most spine surgery is most often done in murky situations such as DDD, disc bulge only, combination of radicular and back pain, long-term symptoms, simple spinal stenosis, sacroiliac pain, etc. These are the mechanical (pathophysiologic) problems chiropractors’ nondrug, noninvasive treatments help so well.

Just as the crew of the RMS Titanic ignored warnings to change course, so has the Medical Titanic been warned multiple times but has chosen to ignore every guideline. This medical myopia continues to mistreat doomed passengers leading to the current worldwide opioid addiction, the tsunami of failed back surgery, and lives drowned in disability and despair in this Quiet Epidemic.

The medical spine professionals are unwilling to give up these cash cows no matter what recommendations any group of EBM researchers, ethical healthcare professionals, or investigative journalists might have to say.

Like spittin’ in the wind onboard, asking the medical crew to change risky habits is a futile gesture especially when there is so much money in its cargo. Like illicit street drugs, there is simply too much money and too much greed to change course for the Medical Titanic despite the impending doom from their dangerous but profitable cargo.

As examples of living on the prosperous island, Becker’s Spine Review recently posted these articles:

Despite these pirates smuggling this dangerous cargo of spine care, the Medical Titanic sails on with no end in sight with its hazardous medical contraband to contaminate the worldwide population of 540 million LBP sufferers.

When Will We Begin to Fight?

Captain John Paul Jones proclaimed while looking in the eye of defeat by a British armada, “I have not yet begun to fight!” As legend has it, he rallied his crew in a stunning and unexpected victory of a much bigger foe.

I’m still waiting for our chiropractic leaders to begin the fight, but I’m not holding my breath any longer. The chiropractic flotilla seems unwilling to fight for what is right. We waited for decades for the research to prove our superior results, but still this armamentarium has been unused to fight our foes.

The question now begs to be asked: why hasn’t the chiropractic profession taken this plethora of SOS warnings on LBP treatments to the public? This silence speaks volumes.

“Man the chiropractic lifeboats” should have been the response to the SOS signal from the sinking Medical Titanic. Instead, we hear nothing.

If it had not been for the art of spinal manipulation and the good results gained by thousands of DCs over the years helping millions of patients, there would have been millions more victims on this Medical Titanic washed overboard into the sea of pain, disability and death.

Instead of recommending a fleet of chiropractors manning the lifeboats ready to rescue these ailing passengers, the Lancet panel threw a small life preserver with its confusing explanation about ‘nonspecific’ causes of LBP with just as vague alternative treatments — not much hope for the passengers to grasp onto for help in the freezing waters of pain.

Inexplicably the Lancet panel never mentioned chiropractors are the logical rescuers as the 3rd largest physician-level health profession in the world and the primary profession that deals exclusively with spine-related problems with nondrug and noninvasive treatments.

I am still stunned the Lancet panel did not give credit to the chiropractic professionals who fought for over a century in the medical war against the AMA trying to eliminate our treatments that now have proven to be best for the majority of ‘nonspecific’ LBP cases.

Where is our acknowledgement for a job well done persevering to keep alive the art of spinal manipulation while the medical foes branded us a dangerous “unscientific cult”?

Without one classic chiropractor on board, it came as no surprise our profession was given short shrift and chiropractic was not enthusiastically heralded by the panel as a safe haven.

The evidence is clear—the tyranny of medical spine care has been a disaster for 90% of people with nonspecific LBP, yet the chiropractic profession seems afraid to attack these medical pirates. Sadly, our associations have been strangely quiet storming the media with the plethora of EBM anti-medical and pro-chiropractic spine care evidence.

Today the case can easily be made, but as far as I can determine, our present chiropractic leadership seems afraid to fight, instead hiding trying not to make waves with the Medical Titanic and appears stymied with no attack plan in mind.

“We have not yet begun to fight” is their cry of cowardness rather than a rallying cry to the troops.

Who will be our John Paul Jones?

[i] Rachelle Buchbinder, Maurits van Tulder, Birgitta Öberg, Lucíola Menezes Costa, Anthony Woolf, Mark Schoene, Peter Croft, on behalf of the Lancet Low Back Pain Series Working Group

[ii] Barth RJ. “Saying No!–Unjustified Surgeries, Pain Management and Tests.” For the Defense, March 2006;48(3):33-39. Washington & Lee Law School Current Law Journal Content.

[iii] Ibid.

[iv] https://www.lumoptik.com/market-opportunities

[v] Abbasi A, Malhotra G, Malanga G, Elovic EP, Kahn S. Complications of interlaminar cervical epidural steroid injections: A review of the literature. Spine (Phila Pa 1976) 2007;32:2144–51.

[vi] Failed Back Surgery, The BACKLetter, Vol. 33, No. 7, July 2018

[vii] Todd Schuck,  The Future of Spine Surgery: Pervasive Scrutiny & Shifting Trends Create Uncertainty for Inpatient Spine Procedures, Senior Director-Business Development, Specialty Healthcare Advisers | Monday, 13 January 2014