Friday, October 21, 2011

Medical website rebuts Wall Street Journal story about Dr. Adam Lewis

Orthopedics This Week recently took the Wall Street Journal to task for publishing an article on the front page that raised questions about local neurosurgeon Dr. Adam Lewis and his stake in Spinal USA:

"Gary Moore died at St. Dominic's Hospital in Jackson, Mississippi on April 7, 2011 after undergoing a 360-degree spinal fusion procedure performed by his neurosurgeon, Adam Lewis, M.D.

This tragic event was then compounded by the Wall Street Journal article on October 8, 2011, titled, "Taking Double Cut, Surgeons Implant Their Own Devices."
Rosen: Unnecessary Surgery

The Journal article implied that Moore died because Dr. Lewis performed unnecessary surgery due his undisclosed ownership in Spinal USA, LLC., the company that supplied some of the devices used for the procedure.

As evidence of Moore’s unnecessary surgery, John Carreyrou and Tom McGinty, the writers of the WSJ story, cite two spine surgeons, "who later reviewed [Moore's] medical records," and said Moore's history of heart disease and bowel obstruction "made him a poor candidate for a 360-degree spinal fusion." One of those reviewing surgeons was none other than Charles Rosen, M.D., the founder of the Association for Medical Ethics. The Association is an advocacy organization that has been hyperbolically critical of surgeon/industry relationships. The other reviewer was not named.

Rosen, according to the story said, "No operation of any kind could be justified." The other surgeon said a less aggressive procedure might have been warranted, although the patient's records don't suggest it was needed. Rosen reviewed Moore's medical records and films for the Journal.

Dr. Lewis's lawyer said in the story that his client's financial interest in Spinal USA had nothing to do with his decision to operate on Moore. He said Dr. Lewis used the implants because he helped design them and believed they were the best on the market for the procedure.
Surgeon Quotes in “Bad Context”

Another surgeon interviewed by the writers was California neurosurgeon Scott Lederhaus, a member of Rosen’s Association.

Carreyrou and McGinty write that rather than use spinal implants from third-party manufacturers, "scores" of surgeons have started their own device makers to "churn out similar products, putting themselves in a position to benefit financially from the hardware they insert into patients." They write that "critics" of such arrangements say surgeon ownership gives surgeons an incentive to perform more operations, and that the conflict of interest has led to a "spate of unnecessary back surgeries that waste health-care dollars and often do patients more harm than good."

They quote Dr. Lederhaus as telling them that, "Patients are having huge operations that are un-indicated because of conflicts of interest."

We called Dr. Lederhaus to ask him if he thought that Moore's surgery was "un-indicated" and whether he thought Dr. Lewis operated on Moore because of his ownership in Spinal USA.

Dr. Lederhaus told us that he did not review Moore's medical records, nor was he speaking specifically about Dr. Lewis. He told us that his comments in the article could have been put in better context and that the writers did not tell him that his general comments would be attributed to a specific situation.
The Journal’s Failure

And there we have the critical journalistic dishonesty of the Journal article. The writers have taken a specific case and linked it, without direct evidence, to a general proposition that has been pursued by the Journal. That being, that physician ownership in the business of healthcare leads to medical decisions being made for the physician's own financial interests at the expense of the patients and payers.

That's a fair public policy question and debate. But that debate must be held with facts, data and honest reporting. The Journal failed here.
Confuses Distributors for Manufacturers

The writers also failed to get basic information correct regarding the supplier of the implants, Spinal USA, the company in which Dr. Lewis has a minority ownership stake.

The Wall Street Journal’s Carreyrou and McGinty erroneously describe Spinal USA as a POD (physician-owned distributor) and link a request by some U.S. Senators to the Office of Inspector General to look into the expansion of PODs and getting additional guidance for their legal structures.

Write the reporters, "The inherent conflict of interest is fueling concern. In June, five U.S. senators asked the Inspector General of the Department of Health and Human Services to open an investigation into physician-owned device companies, citing concerns that the surgeons involved have a financial incentive to 'perform more procedures than are medically necessary.'"

They go on to write that a report provided to the agency by Utah Sen. Orrin Hatch, the senior Republican on the Senate Finance Committee, "identified at least 20 states where surgeon-owned implant companies are present, and warned that they were spreading from spine surgery to other areas of medicine such as hip, knee and cardiac surgery."

Just one problem here, Hatch was writing about physician-owned distributors, not "surgeon-owned implant companies" as Carreyrou and McGinty report.

In an interview with OTW on October 10, Jim Pastena, the president and CEO of Spinal USA since July 2011, told us:

"In some respects, the article is sensationalized, in that it mixes different issues and statistics that are general in nature, but made to look like they are Spinal USA’s numbers. An example of this is that we are not a POD, but a small manufacturer that designs, manufactures, and sells our own products, very similar to a number of other fine companies like K2M, Kyphon, and Globus. When those companies were small, they had a large percentage of doctor ownership, and as they matured, that ownership became less dominant.

"Overall, the article focused on the potential conflict of interest that can arise when a doctor has ownership in a company that makes medical device products that he or she may use in surgery. We understand this issue and we have done everything possible to ensure that Spinal USA is structured in a way to prevent any possible conflict of interest.

“Our doctor investors are kept at arm’s length—we don't get involved in their medical practice and we don't advise them on any product usage. They provide technical expertise to us and help us develop new products that give hope for better surgical results.”
Wrong City?!

Another insinuation of the Journal story is that the number of spinal fusion surgeries performed in the area served by Spinal USA has increased because of the surgeon owners.

Carreyrou and McGinty write that at Huntsville Hospital (Alabama), one of the city's two hospitals, “351 spinal-fusion surgeries were performed on Medicare patients in 2009, up from 333 in 2006, before Spinal USA came to town, a Wall Street Journal analysis of Medicare claims data shows. At Crestwood Medical Center, the city's other hospital, there were 187 such operations on Medicare patients in 2009, up from 107 in 2006, the analysis shows. Huntsville Hospital says it spent $5.6 million on Spinal USA products in its most recent fiscal year.”

Again, we have a bait and switch scenario. The hospital where Dr. Lewis performed the surgery on Moore was St. Dominic's Hospital in Jackson, Mississippi, not in Huntsville, Alabama.

We asked Spinal USA about the alleged overutilization of spinal surgery in the area.

A written response from the company stated, “All market data in the spine market historically show an increasing growth in spine surgery procedures projected to continue for years to come. This is primarily related to the aging of the population. As such, surgery will increase from a procedural standpoint necessitating by default, an increase in products used to do these procedures.”

The company told us that an internal analysis of shareholder procedural volume at one of their accounts “interestingly revealed that within the last four years, there was a 22% decline in surgeries dropping from 435 procedures in 2007 (January – June) to 341 procedures on 2011 (January-June)

According to the UCLA Anderson School of Management, The Wall Street Journal’s John Carreyrou was part of a team of Journal reporters who won the Pulitzer Prize in Explanatory Reporting for their coverage of corporate scandals in 2003. He has also won the German Marshall Fund's Peter R. Weitz junior prize for excellence in European reporting. In 2007, he was part of a team of Journal reporters who won the New York Press Club's consumer award for its coverage of health care. In 2008, he was named a Gerald Loeb Award finalist in the feature writing category for a series on the broken U.S. healthcare system. In 2009, Carreyrou and a team of reporters won the award for distinguished investigative reporting from the New York Newspaper Publishers Association for a series of articles on nonprofit hospitals.
Shifting Surgeon Roles and Responsibilities

As more surgeons become employees of hospitals and healthcare systems, their ability to select the implants or instruments to use in surgery is declining.

The rules and laws governing how physicians will be compensated for their intellectual property contributions to improve medical devices and their rights to own hospitals, manufacturing companies and distributors will continue to evolve.

Spinal USA’s Pastena says as a manufacturing company that has investors who are doctors who serve on the board the company is in full compliance with all the laws and guidelines that are part of the everyday operation of a medical device company. “We know the laws, we know the regulations, and we know what we need to do to compete in this market. Whatever changes are made in Washington, we will work within that framework.”

No doubt, changes will come. Let’s hope the changes are based on integrity, honesty and accurate data. This story by The Wall Street Journal meets none of those criteria. It is demonstrably wrong, misleading and the sensationalized tabloid type of reporting that other Rupert Murdoch owned publications are famous for


Ironghost said...

It is demonstrably wrong, misleading and the sensationalized tabloid type of reporting that other Rupert Murdoch owned publications are famous for."

That's all you need to know right there. Of course Orthopedics Daily will defend the practice the WSJ described. Throwing that bit of sour-grapes on the end throws the whole article into the dumpster, professionally.

Anonymous said...

Your blog Kingfish is the most balanced source for journalism in our area. Thanks for that.

Anonymous said...

conflicts of interest are as common as long waits in doctors' offices in the medical profession. doctors can't be satisfied with all the money they make as a doctor so they invest in equipment, hospitals, etc. so they can double dip.

Anonymous said...

Ironghost, are you suggesting that Murdoch's reputation and other publications are irrelevant?

Anonymous said...

I wonder who has, historically, donated more to congressional campaigns; Dr. Lewis or his former patient? (and I guess we can't forget that Spinal USA, LLC has free speech rights, too).

Why do you suppose it is that we can't get a simple law re: conflicts of interest passed, but sweeping tort reform legislation is no problem?

Anonymous said...

Why should a service provider of any type be prohibited from investing in the tools he/she uses to provide their respective service? If my (insert service provider)is good, I don't give a rip who invests in the tools they use. If outcomes or professional reputation is the issue with (insert service provider), do your research and get another opinion, estimate, etc. I doubt any of the doctor's patients were forced at gunpoint to undergo surgery.

bill said...

As I've said here before, it's overreaching for the government at any level to tell a physician he can't have ownership in a company that makes something he uses. There are ample mechanisms in any hospital committee structure to stop a surgeon from performing unnecessary procedures, and the same system can identify and expel poor practitioners. Bill Billingsley

Anonymous said...

Did his patients know he was putting his own hardware in? Do you think knowing that information would have been a factor in their determining whether to get a second opinion?

The insurance companies are the only ones with the power to stop this practice. The don't like paying for necessary surgeries, much less unnecessary ones.

Anonymous said...

But Bill, doesn't "the system" you speak of also have a conflict of interest? Don't they have the very same conflict of interest that Dr. Lewis does? That is, they get paid the same regardless of whether the procedure was necessary? But make more, the more procedures that are performed?

Anonymous said...

4:12, Absolutely it would have been a factor but not the only factor by any means. I would be curious to know what chance of success these patients with bad outcomes were given by the doctor or what expectation they had from the procedure itself. In other words, who has financial interest in the hardware itself would seem irrelevant to those who have had successful outcomes-- assuming there have been successful outcomes. The people who seem to have the issue with who owns the hardware are those who had bad outcomes.

Ironghost said...

Ironghost, are you suggesting that Murdoch's reputation and other publications are irrelevant?

This is the Wall Street Journal, and they do still have a reputation for good research. I wouldn't compare Murdoch's Brit Tabloids (which are nearly fiction) to this. Smearing everything with a broad brush is sloppy. I expected them to defend the practice, but throwing in personal attacks ruins the message.

Anonymous said...

Medicine is no longer a profession, it's a business. The Hippocratic Oath be damned.

Anonymous said...

Senate Investigation:

PODs to be probed by US Senate:

Spinal USA AL/MS Doctors:

June 9, 2011 WSJ article:

Lumbergh said...

I have worked as a surgical device rep for 10+ years. While it easy for some people to claim that doctors are only out for themselves and do not care about their patient, the vast majority of doctors have the very best of intentions.

That said, how do you think medical device companies come up with new innovations? The same way any other invention happens...people who see and do something everyday figure out a new and better way to do it. I would not expect a banker to come up with the next great pacemaker design, just like I wouldn't expect a cardiologist to come up with the next great financial product. Nor would you want them to.

The fact that some doctors love what they do enough to create an innovative or lower cost product, finance it's development, and undertake the multi year beuracratic
nightmare that is an FDA approval should be celebrated, not vilified.

Unscrupulous doctors are the exception, not the rule. The question the WSJ should be asking is if a doctor didn't
design it and invest in it, who would have?

Anonymous said...

Lewis used his power as a doctor to convince patients they needed his procedures. It is no different than someone going to the GI doc, they always wind up with a scope up there ass and some pretty colon pics, but they don't get there problem solved. Seen a cardiologist lately? You will get a nuclear scan and treadmill, or some damn MRI or CT that is so new that they don't know what to do with the results. My point is that subspecialists are procedure intensive, and if you go to one, expect a procedure. If you want a doctor, see an internist. The problem is that the general public won't take "lets wait and see or do nothing" as a possibility. Something, even if it kill you, has to be done. Such is life, Lewis is a cut happy and sloppy Neurosurgeon. He offers "hope" to the hopeless by making promises that he can't keep. The great secret that they don't want you to know is that most "spinal" surgery does little if any good for pain, decent for pending nerve loss however. Just ask a few folks who have hardware in their backs just how satisfied they really are.

Anonymous said...

11:21 It's fine for doctors to be innovative. But, I think you, like some of the doctors, are rationalizing and miss the crucial ethical point.
The PATIENT should be FULLY INFORMED or else they are not truly a willing participant. And, throwing jargon at a patient and omitting inconvenient facts that won't get the desired decision is not acceptable.
The idea that a patient might actually be an important partner in his or her own health and might know their own body, circumstances and tolerances seems to escape doctors these days.
I think you, like many doctors, are finding rationalizations to justify your self interest.
And, frankly, as a patient, I've gone from being a individual with knowledge of MY medical history to being just another body on an assembly line. Quantity over quality is lucrative for my doctors but bad for my health and expensive for taxpayers!
I have lots of tests now but it's been quite a long time since my doctors have used their EYES and EARS. A good diagnostician knows what his patient LOOKS like and SOUNDS like can observe changes so they can test appropriately.

Anonymous said...

The WSJ article tried to combine the facts the Lewis operates a lot more than other neurosurgeons, is sued more than other neurosurgeons and implants his own devices into one giant article. The article might have had more impact (at least in Jackson) if it had focused on the number of surgeries, their outcomes and the the malpractice...with a side that he also implants his own devices.

Interesting that Sister Dorothea announced her retirement yesterday. Coincidence?

Anonymous said...

11:21 - Sure, innovation. That's why implant companies employ doctors as CONSULTANTS in which the DISCLOSE their payments on their WEBSITES.

Where else can an individual invest a little over 100k and bring home $26,000+ a month. Now that's innovation. Got ethics? Of course you need my implants!

Let's hope the OIG, FBI and DOJ are taking a close look at Saint Dominics, Spinal USA and its owners. When insturmentation is installed on medicare patients, YOU taxpayers are footing the bill. Now, back to the $26,000+ a month in the surgeon's pocket... Talk about innovation... What conflict of interest? Of course they are the best implants on the market. Why would patients want hardware installed that saves the hospital money?

11:21, I assume you read the entire WSJ article

"The Food and Drug Administration has a less stringent approval process for medical devices nearly identical to ones on the market. Surgeons only have to submit mechanical-testing data attesting that their implants are "substantially equivalent" to existing ones. The FDA usually gives its green light within 90 days."

Lumbergh said...

@8:39: I completely agree your point that the patient should be informed if there is a financial interest. I think the vast majority of doctors would agree as well.

@9:18: I know several people (not in the medical industry) that have made investments far less than $100k and make the kind of money you are talking about. That happens because the idea the person is financing is more valuable than the cash investment that finances it. If you truly don't believe intellectual property has value, there is no point in can't fix stupid. How much startup capitol did facebook need to become a billion dollar company?

While the approval from the FDA may take 90 days for a substantially equivalent product, I hope you don't think they woke up one morning, had the idea, and 3 months later were implanting these devices. The company I work for just moved our manufacturing plant from it's original building to our new corporate head quarters a few miles away. To get approval from the FDA to begin assembling the device at the new site took over 2 years. We didn't change the device at all, just the address where it is made. I know details like this do not mean much to an expert like yourself, but clearance from the FDA on the product design is just one aspect of pretty complicated process.

bill said...

4:23 yesterday, that's technically not the case. The medical staff committee structure is not run by the hospital - it's run by the doctors. The only time a conflict of interest would be present is when the doctor being reviewed is in a financial relationship with the doctors reviewing him. In other words, if someone on the committee is also making money off the sale of the devices to Dr. Lewis, that person has a conflict of interest. The hospital has no role in the policing of the medical staff, other than collecting the records and making sure the doctors understand the rules. BB

Anonymous said...

Most everyone in the healthcare community knows the reputation of this physician and would never let him lay a hand on them!

Anonymous said...

The smell of rotting grapes here is nauseating.

Anonymous said...

Bill, that might not "technically" be the case, but it is "realistically." The bottom line is that "the system" you are saying we can rely on (to stop the performance of unnecessary procedures or expel bad practitioners) makes money off of each procedure that is performed - directly or indirectly, whether necessary or not - and is not going to run off a cash cow like Lewis. One would become very unpopular with some very important people at St. D (and elsewhere) if one did so.

As far as outcomes are concerned, let me just say that the best outcomes are generally seen in patients that didn't need surgery in the first place, and the doctors who run "procedure mills" aren't usually put out of business because of bad outcomes because their ratio to procedure/bad outcome is normal (or even good), and they're making a ton of money for their hospital.

And, to be clear, I'm not making any comment on Dr. Lewis or St. D., because I don't know all the facts. However, if his (or any doctor's) product is that great, let them make money off of selling it to everyone else - not themselves. What happened to all my "let the market decide" cheerleaders?

Anonymous said...

Anyone in the implant business knows these entities are scams set up to make the surgeons money by incentivizing them to implant more to make more money. I've been in this industry a long time and I can identify the docs that would go for an arrangement like this. Its the same ones, every time. Docs use what they are comfortable with and whose reps they trust. In situations like Spinal USA, when a doc buys in, they convert ALL of their business overnight. That never happens when a doc isn't making money on the implants. And the OIG has now proven that hospitals that purchase from PODs (because their surgeons own them), spend more on the products and perform more surgeries than hospitals who don't buy from POD's so the incentive is not theoretical, it affects surgeons' decision making. Add to that the fact that Spinal USA and similar companies products could never compete in market without financial kickbacks, it is low grade product. Not to say it will fail, but it is not as sophisticated as other products.

Anonymous said...

Jan 22, 2014 replied to Otc 24, 2011.

So, why suddenly now?

Anonymous said...

someone is concealing the information or research showing spinal USA medical implant device failure and faulty hardware. just try to look it up----you can find everybody else but not spinal USA my friend died due to removing the faulty hardware where the screw latches broke off and the screw backed out. died few weeks later of blood clots.

Anonymous said...

Dr. Adam Lewis ruined my quality of life by insisting that since injections and physical therapy on multiple occasions didn't work so he said that he needed to do a 360 fusion of my L5/S1 and told me that my MRI also showed that I had Spina Bifida Occulta. He performed the surgery by going through my abdomen to place a titanium cage between the L5-S1 and then I was turned over and cut on each side of my lower back to place pins and screws and rods to brace my spine where the fusion was performed. Something went wrong because I was told before having the surgery that on the 1st night they would be making me get out of bed and sit in a chair and that I woild only be in tje hospital 3 days at the most! The first night they didnt get me up and I habe never felt that kind of pain in my entire life, and they came and got me the first night and rushed me to have a CTscan and on day 2 they sent me for another CTscan and an ultrasound on my legs and then on day 3 they finallu had someone jelp get me out.of bed to sit in a chair and i did that many times for the next couple of days and then finally afyer 5 days in the hospital I was sent home and i never got an answer about what had happened during my surgery that caused them to rush me 2 times for CTscans and why I was in the hospital for 5 days instead of the mac of 2 to 3 days i was told. And then a year later my back was worse so they removed all of the rods, screws, and pins and my back has still gotten worse and i dont think there is a thing i can do about it last surgery was in October of 2008 and now my life has been ruined bevause of Dr.Adam Lewis!

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