Articles by JCS

Laser Spine Closes


LASER SPINE INSTITUTE CLOSES

Numerous studies in recent years suggest US physicians most often don’t follow evidence-based guidelines recommending minimal diagnostic and conservative treatments. There is simply too much money involved to follow guidelines.

According to investigative journalist and editor Mark Schoene of the BACKLetter, it’s painfully obvious back care in the United States has been heavily oriented around opioids, excessive imaging, and early referrals to surgeons. There has been broad overuse of numerous, heavily marketed back pain treatments, from passive physical modalities to invasive pain interventions such as laser and open-spine fusion surgery, a lucrative enticement that averages an estimated $77,500 at the Mayo Clinic, despite critics stating fusion surgery has been abused, often unnecessary, ineffective, and disabling.

“So, in this area of medicine, patients would be well advised to take their doctors’ diagnostic and treatment recommendations with a large grain of salt,” according to Mr. Schoene who wrote about the inaccurate and aggressive marketing in “Massive Wave of Unregulated Medical Marketing Putting Patients and Providers in Peril”:[1]

“Regulators have not caught up with this tidal wave of marketing. And much of the information that goes out to physicians and patients in these marketing efforts is unregulated—and of questionable accuracy...

Anyone familiar with the history of the spine field knows that there have been a series of controversies and scandals over the past few decades, in which inaccurate information and aggressive marketing have played major roles.

Some of these scandals and controversies include the Vioxx debacle, the overuse of the bone grafting agent INFUSE (BMP-2), the excessive utilization of spinal fusion for “discogenic” pain and other unvalidated indications—and the promotion of stem cell therapy for disc degeneration, to name a few.”

I might add the most pervasive example of scandal and aggressive marketing was the Laser Spine Institute that promoted the “bad disk” diagnosis as a legitimate reason for surgery when, in fact, it is well established that “bad disks” appear in pain-free people.

Finally, this mass misinformation will cease harming people according to an article in Becker’s Spine Review, “Laser Spine Institute shuts its doors.” I almost fell out of my chair upon reading this report, but I wasn’t totally surprised considering the LSI had lost its BBB accreditation last year.


Tampa, Fla.-based Laser Spine Institute was unable to secure financing to continue operations and closed March 1.

Five things to know:

1. Over the past six months, the company closed three surgical centers and reduced its operating cost structure, but it was unable to develop a sustainable cost structure. As a result, Laser Spine Institute ceased operations and is transferring patients to local competitors.

2. The centers that remained open until last week included facilities in Tampa, Cincinnati, Scottsdale, Ariz., and St. Louis. Laser Spine Institute has reached out to other surgical providers in those communities to potentially send patients who were scheduled for procedures at the closed centers. The company also reached out to patients slated to have surgery after the centers closed and referred them to other in-market options.

3. The company reported it was unable to "attract the necessary financing to undertake a Chapter 11 process and continue operations." In 2016, it opened a new $56 million headquarters in Tampa.

4. Laser Spine Institute employs around 1,000 people at its four locations, including more than 500 in Tampa, according to ABC Action News.

5. Originally launched as a single operating room facility in Tampa in 2005, the organization has provided around 100,000 surgical procedures for patients with back pain and neck pain.

How can this huge spinal surgery mill go broke considering its massive PR program promoting the widespread “bad disk” fallacy? Perhaps because the majority of its patients were dissatisfied as I wrote in my exposé, Marketing Pain: Part 2.

As well, according to newspaper accounts, a group of doctors from a competing surgical center sued the founders of the company for breach of fiduciary duty, conspiracy, defamation, slander and intentional interference. They won, and the award amount falls at more than $264 million.

In 2018, the institute was also ordered by a Pennsylvania court to pay $20 million in compensation to the estate of an Ohio woman who died after undergoing surgery at the company’s Philadelphia center in 2014, according to multiple reports.

The institute made headlines back in 2013 when professional wrestler Terry “Hulk Hogan” Boella sued it for performing a series of ineffective procedures costing hundreds of thousands of dollars, according to their 2013 lawsuit.

Despite the fact the “bad disk” scam for spine fusion remains alive among the public as the cause of LBP, in fact, research has debunked this theory for the majority of nonspecific cases, which may explain why these fusions fail considering 'bad disks' appear in pain free people as this Mayo Clinic chart shows:

A few ethical spine surgeons now are speaking up to discredit these expensive, unnecessary, and often disabling surgeries, such as Dr. Ian Harris from Australia.

Why this orthopaedic specialist no longer performs spinal fusion surgery

6th March 2018

Q&A

The latest Choosing Wisely list warning against spinal fusion surgery for low back pain is supported by Professor Ian Harris. We talk to him about the issue.


What has contributed to the rising popularity of spinal fusion surgery?

One of the reasons is the introduction of spinal instrumentation such as screws, plates, rods and wires to hold the spine together, allowing the patient to move freely after the surgery yet still stabilising the spine enough to ensure fusion occurs. We now have quite strong devices that are relatively easy to insert accurately, sometimes in a minimally invasive way. The technology around spinal fusion has improved, yet all the while we haven’t addressed the fundamental evidence of its effectiveness. We still haven’t looked to see whether the patient is actually better off or not from having the fusion. 

Are there any indications where it would be used?

Professor Harris: There are areas where it’s less commonly used but thought to be of benefit, such as acute fracture following an accident, but even then there are grey areas and controversies. At the Whitlam Orthopaedic Research Centre in Sydney, we published a review for spinal fusion for the most common traumatic accident — burst fractures between the thoracic and lumbar spine. It’s commonly treated with instrumentation and fusion, but the evidence isn’t very good. Several studies show treating burst fractures without any surgery is just as good, and decompressing and fusing the spine is probably not necessary. I am a surgeon myself and I see spinal patients and did, until recently, perform spinal fusion surgery. I know many surgeons who say they’re proud to not perform spinal surgery for back pain. But there are also many surgeons who regularly do — so somebody in there is wrong

How much does spinal fusion surgery cost?

Well, it’s broken down into a lot of different things, but the implants alone can cost between $10,000 and $20,000. Surgeons’ fees vary a lot depending on the setting but could be anywhere up to $50,000.

Should GPs even bother referring to these surgeons — and should the surgeons be saying no?

Professor Harris: It’s a very good question. There are increasing high-level practice guidelines being produced and the guidelines on back pain are now very hands off. It’s about not over-medicalising or complicating the condition. Once the Pandora’s box of the MRI report has been opened it’s difficult to put the lid back on.

What are the adverse outcomes?

It is major surgery, even if it’s done less invasively than it used to be, and carries all of the risks associated with that: blood loss, risk of infection, nerve damage close to where the surgery is being performed, as well as technical failures from the implanted device. But the biggest complication of spinal fusion surgery is that it doesn’t work, and the patient still complains of pain afterwards and the patient has not had their function restored.

What happens if that is the case?

It often leads to further surgery. For example, when we look at the rate of revision surgery compared to primary surgery in hip replacements and knee replacements we find that sure, there is a certain percentage of revision, but the rate of revision surgery after spinal surgery is much higher. In fact, we’re in the middle of conducting an audit under NSW workers’ compensation and found for lumbar spine surgery, roughly half of the operations done are actually revision operations. 

Why does it take so long for the message to filter through that treatments don’t work?

I think the message has gotten through but it’s not always believed. Most people know there are question marks over the value of spinal fusion surgery — so it’s not a matter of it filtering through. What we should be doing is putting our efforts into finding out whether it works or not, but we’re not doing that. On one side of the fence, we’re continuing to operate, on the other we’re refusing to operate and nobody is putting the effort into finding out where the truth lies.

Criticism of “usual medical care” has increased recently due to the opioid crisis and the pandemic of unnecessary spine surgery, evident from a March 1, 2019, article in Becker’s Spine Review, The spine surgery devices, techniques that won't stand the test of time:

Mitchell Levine, MD. Lenox Hill Hospital (New York City): 

“Interventions for focal back pain and neck pain without neurological involvement are going to trend down. Insurance companies are tightening their criteria for approving fusion surgeries and evidence-based care will be standard. This increased scrutiny on efficacy will be brought to bear on all aspects of spine care, including pain management and physical therapy as well. The overuse of epidural steroids and ablative procedures in spinal stenosis treatment is already being evaluated.”

Hopefully Dr. Levine’s assessment is accurate to stem this tide of unnecessary surgery and “usual medical care” methods such as narcotic painkillers, epidural steroid injections and spinal cord stimulation, have proven to be just as ineffective.

MEDICAL MISINFORMERS

Certainly Dr. Harris is not alone in his criticism, however, just as other critics found, he is mostly ignored by the medical media misinforms such as Sanjay Gupta at CNN and medical-industrial complex because there is just too much money to be made by lying to the public.

According to an article, The Ultimate Target in the Back Pain Misinformation Crisis Is the General Public:

However, the ultimate solution to this crisis—as well as the back pain crisis—will come through inoculating ordinary people against the ill-effects of misinformation (i.e. helping them recognize poor reporting, inadequate analysis of scientific studies, and pure hype)—and poor advice from their healthcare providers, which is all too common in the back pain field.[2]

“Poor advice from their healthcare providers” is an understatement.

Not only are people lied to daily about their “bad backs,” they are also told a bigger lie, “whatever you do, never go to a chiropractor.” Nor do these primary care provides admit they are untrained in musculoskeletal disorders—less than 10 hours of education according to many experts, including FOX News reporter Dr. Marc Siegel.

In 2017, Dr. Siegel on FOX News admitted primary care providers have only 9 hours of education on the “back” and he blamed the opioid epidemic on his colleagues and pharmacists. “We’re getting a growing awareness of two things: the abuse of back surgery and the abuse of opioids.”[3] Both of these stem from medical spine care, not chiropractic care.

The recent Lancet review, Low back pain: a call for action - The Lancet, was prophetic when the panelists addressed such misconceptions about usual medical care:

Millions of people across the world are getting the wrong care for low back pain,” according to lead author of The Lancet review, Professor Jan Hartvigsen from the University of Southern Denmark.

A subsequent Lancet review, Low Back Pain: A Major Global Challenge, the editors acknowledged the “barriers to optimal evidence-based management” were due to the medical community that remains stuck in “widespread misconceptions…outdated models of care…and the widespread use of ineffective and harmful care.”

Without question, these MISS laser ads perpetuate “widespread misconceptions” of the debunked ‘bad disk’ concept by luring naïve patients with the bait-and-hook offer to “Call for Your No-Cost MRI Review.” (BTW: if you look closely at this LSI ad, in the top row of images are not MRIs but radiographs.)

 

https://chiropractorsforfairjournalism.com/images/7b994c961b24ef98e0d332c34bd61f98.png

As LSI patients’ complaints online revealed, when they called for a “no-cost MRI review” they were screened by a “bird dog” telemarketer who first checks for insurance coverage and reportedly quoted prices before the patient was consulted or examined by an MD. If they don’t fall for this sales pitch, they can expect strong-arm follow-up calls from these surgery mills.

The idea of immediately leaving a surgery center pain-free with only a small bandage on your back certainly sounds appealing but, in reality, this quick fix with laser spine surgery constitutes the newest “widespread misconception” in LBP.

ACA EMBARRASSED

I’m glad to see the LSI go out of business, but it left an indelible misconception in the public’s mind. Plus, the ACA has a lot of explaining to do why it ever hooked up with them in the first place.

Paradoxically, despite the horrible reviews and the loss of BBB accreditation, the Laser Spine Institute was a sponsor of the American Chiropractic Association. I am stunned that the ‘new’ ACA was willing to throw its own profession under the medical bus if it can make some easy money while sleeping with the enemy.

Despite the growing chorus of strong criticisms about spine surgery and usual medical care in general, but we’ve not heard one iota of criticism by the ACA. Will it renounce its association with Laser Spine Institute or will it turn a blind eye  hoping this embarrassment goes away on its own?

I daresay if the mainstay of chiropractic care—SMT-- were under similar attack by journalists and The Lancet review, you know damn well the AMA would go on the attack to destroy our profession.

Yet when the chiropractic profession has the same legitimate opportunity to hammer its opposition’s failures, it goes belly-up.

In effect, it seems the ‘new’ ACA has acquiesced to the medical model with its new pro-medicine posture, its anti-VSC, anti-SMT, pro-instrument, and anti-classic chiropractic philosophy. Indeed, classic chiropractic may die a slow death in the hands of the ‘new’ ACA.

Despite the emphasis on evidence-based healthcare as the ‘new’ ACA’s main propagandist, Stephen Perle, and its pro-medical minions tout, they seem to ignore the plethora of evidence against the medical model of usual spine care; instead they only harp not to take xrays by chiropractors to detect locations of vertebral subluxations or to detect pathoanatomical disorders that might exclude SMT. The 'new' ACA makes no call for a moratorium on spine surgeries as the Australians already have.

FOLLOW THE MONEY

Instead of attacking this laser surgery misinformation in the beginning with its “band-aid” quick-fix solution, the ACA jumped into bed for a sponsorship fee with the Laser Spine Institute without questioning the veracity of laser spine surgery as I wrote in Marketing Pain: Part 2.

Incredulously, I recall attending a class a few years ago at the NCLC listening to the LSI spokesman giving his sales pitch to gullible DCs, many mesmerized by the high-tech notion of laser surgery. No one was allowed to question the laser technique nor the ‘bad disk’ fallacy. The message was clear, “Just refer patients to LSI, thank you very much.”

We all know Big Pharma and device manufacturers taint physicians with gifts and kick-backs, so why is it any different when chiropractic associations do the same with sponsorship such as we witnessed when the Laser Spine Institute jumped in bed with the ‘new’ ACA?

Unfortunately, most physicians in the spine area have often proven to be blind to the implications of commercial financial relationships. Many are convinced, despite abundant evidence to the contrary, that their medical judgments and advice are not influenced by these relationships and sources of revenue. Yet there is compelling evidence that even small gifts can bias decision-making and choice of diagnostic and treatment interventions.[4]

It is no secret that Big Pharma seduces most every MD with gifts, and for good reasons. Aside from the proliferation of unnecessary spine surgeries, the opioid epidemic had the same origins—bribery and misinformation by Purdue Pharma that created the present Pharmageddon we now suffer that kills nearly 70,000 Americans annually.

A recent study by Manvi Sharma, PhD, et al. found that physicians who received payments from drug companies were more likely to prescribe costly, brand name medications—and new formulations of older drugs—than their peers. Excessive spending on brand-name drugs is a significant contributor to skyrocketing medical costs in the United States and leading to more deaths than ever before.[5]

So, how is it any different for DCs since chiropractors don’t prescribe drugs (at least not yet); as we’ve witnessed the only inducement is via donations at conventions or association sponsorship.

Another example is a curious  situation recently with the Georgia Chiropractic Association (GCA) in my adopted state that arranged a “meet and greet” event with the Pain Institute of Georgia, a local needle jockey clinic in Macon. There was no mention of a sponsorship, but it seems strange the GCA would heavily market DCs to attend this medical mixer unless there was a financial inducement.

This clinic bills itself:

“Pain Institute of Georgia is a multi-disciplinary practice offering Interventional injection procedures, medication management, physical & aquatic therapy.”

A “multi-disciplinary practice” that makes no mention of chiropractic care, yet the GCA is canoodling with them for inexplicable reasons—possibly another sponsorship so gullible DCs will refer to them? Indeed, this begs not only the conflict of interest issue, it also makes me wonder why the GCA is making friends with medical doctors using “outdated models of care” who rarely refer to DCs as the guidelines recommend?

It will be interesting to see how the ‘new’ ACA responds to its fallen sponsor, the Laser Spine Institute. Just as the NFL Commissioner’s office has to deal with the New England Patriots’ owner, Robert Kraft, who was arrested for canoodling with Chinese prostitutes in Jupiter Beach, the ACA has a lot of explaining to do why it was in bed with these surgical prostitutes.

 



[1] The BACKLetter Vol. 34, No. 3, March 2019

[2] The Ultimate Target in the Back Pain Misinformation Crisis Is the General Public, The BACKLetter, Volume 34, Number 3, 2019

[4] Paul DP, III, The inherently flawed relationship between physicians and pharmaceutical companies’ gifts: TANSTAAFL, Atlantic Marketing Journal, 2018; 7(1):89–102.

[5] Sharma M et al., Association between industry payments and prescribing costly medications: An observational study using open payments and Medicare part D data, BMC Health Services, 2018; 178(6):861–3.

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