DC Medical Malpractice & Patient Safety Blog

Few health problems are as frustrating as back pain. Americans spend an estimated $73 billion every year seeking relief from their aching backs, and any disorder as common and intractable as that is ripe for abuse.

We’ve written about the less-is-more approach to back surgery, a notion recently reinforced by a study published in the Archives of Internal Medicine.

As part of an initiative of the National Physicians Alliance, a project called “Promoting Good Stewardship in Clinical Practice” compiled the top 5 activities in primary care for which changes in clinical practice could lead to higher-quality care and better use of resources. Included in those five recommendations was “Don't do imaging for low back pain within the first six weeks unless red flags are present.”

According to the American Academy of Family Physicians, those flags include a history of trauma, fever, incontinence, unexplained weight loss, cancer, long-term steroid use, and intense localized pain. And even then, the first treatment usually consists of nonsteroidal anti-inflammatory agents or acetaminophen and a gradual return to usual activities.

The stewardship project reviewed medical literature, guidelines and commentaries about the benefits and risks of routine imaging, such as MRI and CT scan, in low back pain. It also assessed the cost of spine imaging using data from the National Ambulatory Medical Care Survey. One high-quality review focused on outcomes in patients with low back pain and found no significant difference in pain or function between patients who got immediate lumbar spine imaging versus less aggressive care.

Plus, the data documented certain harms from such early imaging, including patient “labeling.” Anyone can have an anatomical abnormality that shows up on a screening test but that, in fact, has nothing to do with the reason the person went to the doctor in the first place. That’s labeling, and it prejudices future diagnoses and care, prompting unneeded follow-up tests for minor findings, exposure to radiation, unnecessary surgery and significant cost.

“Routine imaging should not be pursued in acute low back pain,” was the project’s categoric conclusion. “Not imaging patients with acute low back pain will reduce harms and costs, without affecting clinical outcomes.”

Writing in the September newsletter of his Patient Safety America movement, John James, a Ph.D. scientist, applauds this conclusion. He advises anyone who shares his back-pain experience to question any medical provider who advises an imaging test as a first-response to diagnosing and alleviating pain. It’s difficult to do nothing, but sometimes that’s the best medicine. And the best use of health-care resources.

One-third of Medicare patients with low back pain receive diagnostic imaging within a month of the initial complaint, James reports. The use of MRI imaging for low back pain in Medicare patients increased more than 300 percent in the decade from 1994 to 2005. That doesn’t signify too many people lifting boxes improperly as much as it does inflated treatment for a common malady.

James notes that, according to the stewardship project, if no scanning were done because medical recommendations were being followed, $140 million would be saved. And if unnecessary MRI and CT scanning were eliminated, the additional savings would be $160 million. And that doesn’t even include the additional costs associated with unnecessary surgery.

“As a patient,” James writes, “you have a critical role in helping physicians with good stewardship. If a physician suggests that you wait for your acute back pain to resolve before he makes images of your back, then go along with that recommendation. In the process, you might be avoiding some potentially harmful treatments.”

And be careful, he adds, about the potential for overusing pain medication.

To learn more about the risks of back and spine surgery, read our backgrounder.

It’s a widely, if grumpily, accepted fact that primary care physicians spend less time with patients than either would like. There are only so many minutes in the day, and there’s always more paperwork than time to address it.

No medical practitioner is more overburdened than a primary care physician, because in many health plans, he or she is the so-called “gatekeeper” to specialized care. Patients must see one in order to warrant a referral to someone else – a dermatologist, a cardiologist, a psychiatrist, a surgeon.

So no wonder that the American Medical Association recently asked the Centers for Medicare & Medicaid Services (CMS) to reimburse network physicians in fee-for-services health plans for phone calls, counseling and other efforts they expend to coordinate care for chronically ill patients.

No question that the labyrinthian nature of the U.S. health-care system demands much of people obliged to navigate it on behalf of others, and these professionals deserve to be compensated, according to independent health-care journalist Merrill Goozner.

But with shrinking coverage, strained budgets and the inexorable increase in the cost of health care, how will these merit pay raises be funded? How about, Goozner suggests, by the medical establishment reassessing and realigning its priorities? How about by embracing a rational sense of proportion?

There’s an ocean of difference in what providers are paid. Specialists often receive two or three times the fees paid to a primary care doc. Goozner says it’s difficult to justify that the “relative value” of back surgery or angioplasty is so much more than other kinds of treatment involved in gate-keeping. These two specialties, he says, are exemplary of “the most expensive and overused procedures in medicine, incentivized by the extraordinarily high fees earned by the surgeons who do them.”

Whether or not you agree with the politically driven Congressional mandate that any new spending must be offset by federal budget cuts – known as the “pay-for” rule – maybe Medicare should adopt the same policy. If Congressional Republicans find it acceptable to charge emergency flood relief with a pay-for, if President Obama is OK with sending the bill for his jobs package to the nation’s millionaires, maybe medicine should cover the coordination of care pay-for with a reduction in the inflated fees for specialist care.

“Congress needs to come up with nearly $300 billion over the next decade simply to hold physician salaries where they are,” Goozner writes. “The permanent fix would set a cap for total physician pay; and allow it to rise over time for inflation. But why not require that CMS adjust payments to the various specialties to meet that cap? Otherwise, in a few years we’ll be right back where we are today: a permanent fix that wasn’t permanent at all, with new services inflating the total tab beyond the cap.”

That's the sellout price for a spine surgeon. Give or take a few million.

Like police officers, whose thin blue line separates them from “the other,” medical researchers and doctors are loath to diss their fellow professionals. But this week, the code of omerta was breached with a series of critical reports in The Spine Journal about industry-sponsored research in general and the use of a bone growth product in particular.

As noted in the New York Times, “It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.”

At the center of attention is Infuse, a product manufactured by Medtronic that’s used in more than 100,000 spinal fusion surgeries in the U.S. each year to encourage growth of new bone so the spine fusion "takes." The Spine Journal articles claimed that researchers subsidized by Medtronic exaggerated the benefits of Infuse and minimized the risks.

All surgical procedures and all medical products carry some element of risk, large or small. Dumbfoundingly, some of Infuse’s defenders claimed it had no risk. None. Zip. Nil. Uh-huh, and I’m vacationing next month on Jupiter.

In a joint editorial, five doctors wrote, “It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research.”

Objective research and the “do no harm” vow apparently have their price, and for some of the so-called “scientists” championing Infuse, it is $12 million to $16 million—the median amount collected by researchers from Medtronic. Median. That means half got more. Clearly, for Medtronic, corrupting science is a good investment: In the most recent fiscal year, Medtronic earned an estimated $900 million from Infuse.

Infuse was approved by the FDA in 2002 for one type of spinal fusion, and as required, Medtronic reported complications in its use that the agency considered sufficiently significant to require the company to list them on the product label. But, as the New York Times explained, “in reporting on such studies in 13 medical journal articles published during the last decade, researchers whose studies were paid for by Medtronic maintained that Infuse’s use was not tied to any complications.”

In addition to its approved use, Infuse is used for other spinal procedures. The Justice Department, however, has been conducting a criminal investigation to determine whether Medtronic illegally promoted such off-label uses, which the company denies.

At this point, Medtronic's credibility, and that of the people who speak for its scientific authority, is thin.

It's a new story but an old story too: For-profit spine surgery centers recruit patients with promises of relieving their long-standing back pain with tiny cuts and high-tech lasers. Then comes a string of malpractice lawsuits from patients crippled by the surgery. Then the journalists mount the evidence: Big profits, many operations, little scrutiny from state or federal health regulators, and no evidence the high-tech stuff even works.

Bloomberg News just published this expose of malpractice issues at the Laser Spine Institute, which has surgery centers in Philadelphia, Tampa, Scottsdale and Oklahoma City.

One problem for patients is that there's no FDA for surgeons. Unlike drug companies which have to show scientific evidence that their products work, surgeons can make promises to patients about minimally invasive surgery and show testimonials from satisfied customers that make it all sound irresistible, even with no real scientific proof that their high-tech stuff works any better than what other surgeons offer.

The laser part of the surgery merely substitutes the laser beam for what other surgeons would accomplish with an electrical current. In both cases, the idea is to burn off sensitive nerve endings between the vertebrae. The problem is that no matter what device does the burning, the pain relief tends to be short-lived as the nerve endings grow back.

The other part of the typical surgery at Laser Spine Institute involves removing some of the bones surrounding the spinal cord when those bones have become overgrown and the spinal canal is narrowed and painful. That is standard back surgery. It's different at the Laser Spine Institute only in the doctors operating through smaller holes and viewing the operative site through telescopes (endoscopes) rather than direct vision.

Since the surgery is done at a same-day surgery center, patients are sent home or to hotel rooms afterward, and that can be a huge issue if something goes awry. For example, it's not uncommon that patients start bleeding near the spinal cord after back surgery. This can create a collection of blood near the spine that compresses the nerves and can cause paralysis and damage to nerves controlling bowel and bladder function -- known as cauda equina syndrome.

The Bloomberg article also documents malpractice issues with other for-profit spine surgery outfits that compete with Laser Spine for patients. Those include the Bonati Institute in Hudson, Florida and North American Spine of Dallas.

Another big problem with the business model of these spine outfits, which are competing for an estimated $73 billion that Americans spend annually seeking relief from back pain, is that surgeons are offered a "piece of the action" as investors in the profitability of the surgery center. That means that the more patients they send to surgery, and the bigger and more elaborate the operations they do, the more profit they make.

Sure enough, University of Michigan researchers found that surgeons increased their recommendations for back surgery by 87 percent after they became part owners of surgery centers. Their findings were published in the journal Health Affairs last year.