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.
Charles RosenRosen, 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)
Who Are These Reporters?
We don’t know why the Journal is conducting this investigation with a suspect methodology that wouldn’t pass muster in a freshman journalism class. By all measures, these appear to be qualified reporters.
John Carreyrou/ucla.eduAccording 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.
The mean-spirited fellow doctors who did this remind me of The Pharises who were willing to kill to gain or retain power. The guys who damaged Dr. Adam Lewis should have to pay a huge price and lose their licenses to practice Medicine!
Disgusting!