A Surgeon Stands Up to His Peers and Fights for the Physician Payment Sunshine Act

Maggie Mahar

Summary: In part 1 of this post I discussed how the mainstream media has begun the work of health care reform by making the public aware of the amount of waste and hype in the system. There, I focused on two recent stories about back surgery: the first appeared in the Wall Street Journal, the second on Bloomberg. Both tell the tale of patients injured and billions of health care dollars squandered when patients suffering from back pain caused by “degenerative” (aging) spinal discs undergo a very pricey procedure called “spinal fusion.”

As I explain in part 1, medical research shows that when back pain is caused by aging discs, fusion is not as effective as other, less lucrative, treatments. And, with fusion, the rate of serious complications is much higher. Nevertheless, from 2002 to 2008, the number of fusions done in U.S. hospitals doubled to 413,000, generating $34 billion in health care bills. In 2008, Medicare alone laid out $2.24 billion for the procedure.

Meanwhile both Bloomberg and the WSJ reported that device-makers such as Medtronic, which makes products used in spinal fusion, have been handing out millions in royalties and “consulting fees” to surgeons who promote the procedure. Congressional critics charge that in many cases, these payments are nothing more than “kickbacks."

In part 2 of this post I focus on Dr. Charles Rosen, a spine surgeon at the University of California at Irvine who has had the courage to speak out about the use of surgical devices that are not helping patients. In part 1, Bloomberg quoted Rosen questioning fusion; in part 2 I explain that he gained notoriety within his profession a few years earlier, when he publicly expressed his concerns that a very popular artificial spinal disc, Charite, was hurting patients.

Rosen also is concerned about the consulting fees that device-makers lavish on some surgeons. He believes that when companies pay physicians who write about new devices and procedures, the transactions should be made public. “I don’t care if someone is making $1 million or $2 million," he told me. "I don’t want to restrict payments—I just think they should be transparent.”

Today, Rosen is no longer a lone voice in the wilderness. In 2006, he founded the Association for Medical Ethics, a group of 300 physicians dedicated to highlighting the repercussions of the for-profit health care industry’s influence on health care. Most of them are spine surgeons.

Meanwhile, he has helped win a major battle for transparency. In 2010, Congress passed the Physician Payment Sunshine Act as part of the health reform package.

Some call Dr. Charles Rosen a traitor to his profession. Others view him as a patient-centered physician who is not afraid to break ranks with fellow surgeons in order to protect patients.

For years, Rosen, who is a spine surgeon at the University of California at Irvine, has questioned the hype surrounding some of the costly devices used in very lucrative spine surgeries. In too many cases, says Rosen, patients who undergo these procedures find no relief from pain—and on some occasions, they wind up worse off than they were before being wheeled into the OR.

J&J’s Spinal Disc-“Big Money Riding On This”

I first interviewed Charles Rosen back in 2004 when he raised questions about a new artificial spinal disc called “Charite,” a product made by Johnson & Johnson subsidiary DePuy Orthopaedics. (The first half of the Charite story that I tell below can be found in my book, Money-Driven Medicine. I discovered how the story ended only last week, when I caught up with Rosen.)

Initially, Rosen, who founded the Spine Center at UC Irvine, was interested in using the new Charite disc in his own practice, but before experimenting on his patients, he told me, he wanted to do “due diligence.” So he sat down to read the 300- page transcript of the 2004 meeting when an FDA panel considered Charite for pre-market approval.

Rosen was stunned. It turned out that in the clinical trial needed for approval, Charite had been compared to an outdated procedure that was no longer in use. Two years later, TheStreet.com noted that even the medical journal Spine acknowledged that J&J “simply set out to prove that Charite worked at least as well as a competing procedure that—because of its high failure rate—has been abandoned by most surgeons. [The company] also excluded pain relief, a primary goal of back surgery, from its definition of success.”

But Rosen was most startled to discover that the results for the first 71 patients in the trial were not counted when deciding whether or not to approve the device—even though they represented 25% of the patients enrolled in the trial. Their outcomes were reported separately on the grounds that these early subjects were “training patients.”

The physicians were “just getting their feet wet,” with those first 71 patients, the project manager of the FDA’s orthopedic branch would later tell Rosen.

“‘Just getting their feet wet?’ Rosen asked when I interviewed him. “How do you tell the child of a man who is now disabled that the doctor operating on his father was ‘just getting his feet wet?’ The arrogance of that . . .”

At the FDA panel meeting, J&J representatives admitted that the rate of “adverse events” was higher among the first 71 patients—who were not included in the final count. Moreover, the benefits of Charite seemed ambiguous—even among the later patients. Thirteen percent reported “no change or an increase in pain” while 12 percent reported only “some relief.”

Nevertheless, the FDA approved Charite.

Based on his research, Rosen decided that he would not use it on his own patients. Docotors in Europe had been implanting the device in their patients for nearly 17 years, he discovered, but with mixed results. A 2003 article in the European Spine Journal summed up the outcomes, concluding that: “total replacements should be considered experimental procedures and used only in clinical trials.” After reviewing the data from the continent, Rosen feared what might happen in this country: "thousands of patients could wind up prisoners of their own bodies—in chronic pain, with no solution." Indeed, following the FDA approval, Rosen himself would see disc implant patients who came to him after a failed operation left them in excruciating pain.

The next year, when a Wall Street Journal reporter asked him about the controversial $11,500 device, Rosen was forthright, saying that the FDA’s approval of the device “puts the American people potentially at great risk for receiving operations that could fail at a high rate and result in untreatable pain and disability.”
The front-page story, published on June 7, 2005, was headlined:
"J&J’s New Device For Spine Surgery Raises Questions: Artificial Disc Aims to Help Body’s Natural Movement Some See Risk if it Slips ‘Big Money Riding On This’"

“Our Dirty Laundry Should Not Be Aired In Public”

Two months later, Rosen attended the North American Spine Society’s (NASS) annual meeting, and soon discovered that the controversy was turning ugly—and personal.
At the conference, he attended a presentation about disc replacement. As he entered the large room, he noticed two huge projector screens on either side of the stage. But it didn’t occur to him that he was about to see his own name blown up on both of them.

Toward the end of the session, one of the speakers acknowledged that there was disagreement among surgeons as to how well the implants worked. “He was bringing up pertinent questions, I was surprised,” Rosen recalled. But, abruptly, the tone of the presentation changed.

The physician giving the presentation suddenly put up a slide on the projector screens. Rosen expected a diagram of the spinal disc. Instead, he was stunned to see the front page story from the Wall Street Journal where he had been quoted.

The presenter pointed to the screen and said “Our dirty laundry should not be aired in public.”

“It was clear that he was very angry” Rosen later recalled. “Then he told us, ‘if you do that’—and he stabbed his finger at the Journal story—‘this will happen”—and a second slide popped up on the screen.”

The new slide displayed a page from a class action lawyer’s website. Rosen didn’t recognize the attorney’s name, but he did recognize his own name. There it was—big enough for everyone in the room to read—quoting him saying that he couldn’t imagine using Charite. The quote had been taken from a story on TheStreet.Com.

Rosen groaned. As he later told a friend, he realized that a smear campaign had begun: “Someone … is implying that I am a shill for a plaintiff’s firm, and that my criticism of the disc can be written off as unethical and financially motivated.” Rosen had attended the very first meeting of the NAAS. Now, some in his professional society considered him a pariah.

Before long, Rosen discovered just how acrimonious the debate over the disc had become. On the Web, a rumor claimed that he was “in cahoots” with Jim Cramer, the former hedge-fund-manager turned TV host, suggesting that Cramer was “shorting” J&J (betting that the stock would go down), and paying Rosen to talk down the device. Rosen had never spoken to Cramer and didn’t even watch the show.

Rosen had no financial interest in what devices surgeons used; he had never taken consulting fees from any company or bought device-maker’s stock. “This leaves me free and clear to decide what is best for my patients,” the 50-year-old physician told me. “As a surgeon, I make a fair living; I don’t need to compromise my objectivity. The majority of doctors aren’t willing to be bought,” he added.

But Rosen knew that a key group of surgeons did have a financial interest in the device industry, and that J&J had been pushing hard to offer incentives. “At the NAAS conference, one surgeon told me, in confidence, that a J&J rep in her town offered her $1,000 for every disc she implanted,” he confided. “She refused—she’s not going to touch the disc—but she was scared.” J&J denied the allegation that one of its reps offered a bounty.

Stories of industry kickbacks had become commonplace in the world of surgical devices. As Dr. Nortin Hadler, author of Worried Sick, observes in his newest book, Stabbed in the Back: Confronting Back Pain In An Overtreated Society : “Entrepreneurial relationships that might compromise the choice of what’s best for one’s patients walk a very fine line between the sanctioned and the illegal. In July of 2006, device-maker Medtronic [one of J&UJ’s rivals] paid $40 million to settle a whistle-blower suit in federal court for allegedly paying kickbacks to induce surgeons to use its spinal implants.”

Surgeons Fear Losing Business, or Being “Left Behind”

By the fall of 2005, 3000 of J&J’s discs had been implanted—despite concerns about slippage combined with fears that many discs would wear out during the patient’s life time. The consensus was that replacement could be wickedly difficult. As a result, only two of the nation’s largest insurers had agreed to pay for the operation. But some hospitals were willing to absorb the cost of the device, because, as Dr. John Boockvar, chief of neurology at Wyckoff Heights hospital in Brooklyn told Dow Jones newswire, “It is important be on the leading edge.”

Patients who read favorable reports about Charite began to ask for the operation. “Some doctors say they’re worried they will lose business if they don’t offer the Charite option,” the Wall Street Journal reported, quoting the director of the spine program at the University of South Florida. “There’s a feeling that it isn’t adequately proven, but there’s an anxiety about being left behind.”

In the year after Charite won FDA approval, it began drawing criticism from medical researchers—and lawsuits from patients. In a column headlined “Hope Slips for Disc Implants,” The Street.Com's Melissa Davis reported that, at the end of 2005, “Medicare has delayed covering Charite discs because it wants more evidence and less controversy about their value. Some big insurers, including Cigna and Blue Cross/Blue Shield of California have done the same.

“Critics believe that Johnson & Johnson carried out a flawed study,” she explained, using guidelines that better suited the company than the patients themselves—and has since plowed forward with Charite despite clear evidence of poor outcomes. For its part, Johnson & Johnson has readily portrayed Charite operations as complex, but has also launched an extensive surgeon training program to help make sure that the procedures ultimately succeed.”

“The medical journal Spine has published an editorial citing multiple concerns about the clinical trial that led to the disc's approval,” Davis added. “In the end, the editorial concludes, Johnson & Johnson simply managed to show that just 57% of Charite recipients—carefully chosen and treated by highly trained surgeons—met ‘modest’ measures for success.”

"If well informed, how many patients will accept an improvement chance no better than a coin toss?" back surgeon Sohail Mirza asked in the editorial. "Contrary to optimistic marketing, the data provided to the FDA and published in this issue of Spine argue for caution by patients and surgeons. Hopes for a cure of back pain and a marketing bonanza must be held in check by principles of fairness and responsibility, and by the end results."

By May of 2006, Medicare had decided to stop paying for the device in patients over 60, noting that the $30,000 to $50,000 surgery had not been sufficiently tested for long-term effects. (Under health care reform, we can expect that Medicare will make similar decisions about other products and procedures if long-term clinical evidence suggests that risks outweigh benefits.) In recent years, private sector insurers have followed Medicare’ s lead, and sure enough, Blue Cross and Blue Shield also determined that more research was needed over a longer period of time.

In the summer of 2006, the Online Journal reported: “As of July there have been more than 130 serious adverse events associated with use of the Charite disc reported to the FDA,” and “lawsuits multiply.”

That year Rosen operated on a Charite victim, 45- year old Dane Titsworth, who described the pain he experienced with the disc “like [someone] driving a big rig over your legs." After the surgery, Mr Titsworth said the pain became unbearable and cost him his job with State Farm Insurance, and nearly his marriage.

Rosen fused the part of his spine where another surgeon had implanted the disc. “The Charite does not absorb shock like a healthy disc, or mimic natural motion” Rosen explained to USA Today on July 25, 2006, “and a dislocation or fracture of the disc can also cause problems.”

In March 2006, eight more patients like Titsworth contacted Rosen, all suffering more pain in their back with the Charite disc than without it.

“R.I.P. Charite”

In the spring of 2010, J&J finally stopped producing Charite, an event which received little publicity. Most of the public is far more interested in a success story than a tale of a product that has disappointed. Editors and TV producers know that Hope Sells. (Though as I pointed out in part 1, the mainstream press has begun to do a far better job of digging into the facts about “medical breakthroughs” in a way that should encourage patients to ask some skeptical questions. Often, the financial press does some of the best reporting in this area: investors want the truth about whether a new product is as good as the company’s touts claim—otherwise, they will lose money. To them, money is more important than Hope. )

According to J&J, it halted production because it had a new, improved product, the “In Motion” disc, which a company spokesperson explained “retains the Charite's essential features and incorporates several minor modifications designed to facilitate insertion.” At the time, lawsuits brought by Charite patients were still pending.

In truth, artificial discs are no longer considered the breakthrough answer to back pain. As Medical Devices Today, a blog aimed at investors, reported at the end of 2009: “The fairy tales in the artificial disc market seem to be over . . . Five years ago, the promise of artificial disc replacement in spine seemed emblematic of the enormous enthusiasm about spine more broadly …Today, how different things seem . . . uncertainty and caution have replaced the enthusiasm of a couple of years ago . . . The disappointing commercial in-roads made by the first discs to come to market have raised questions about what was once seen as the blockbuster potential of this novel technology.”

When I read Melissa Davis’ reports describing the attacks on Charite at the end of 2005, I was finishing Money-Driven Medicine. At the time, I wondered how the story would end—and whether Rosen would be vindicated. Little did I know that his battle with device-makers and their influence over how physicians practice medicine had just begun.

In 2006, Rosen formed the Association for Medical Ethics (AME), an organization that represents physicians who are dismayed by how device-makers and drug makers influence physicians. The Association is now 300-doctors strong; most members are surgeons. But any doctor can join at long as he or she passes the Association’s litmus tests—no industry ties.

The Association is not trying to limit payments to physicians. “I really don’t care how much anyone makes, as long as it’s in the open,” Rosen told me in a phone conversation last week. “We’re not trying to limit the payments. And we’re not trying to stop collaboration between physicians and industry. We’re merely asking for transparency so people can judge on their own as to whether there is bias.

He went on to explain that the whole premise behind AME is purely about disclosure: “When doctors are reading about a new procedure in a medical journal, and they see a vague disclosure that the author did some consulting work for a company it doesn’t mean much. But when it is clear that the author got a million dollars last year, that will give a reader pause. Medical journal articles and scientific endorsements help manufacturers sell products; their impact is greatly diminished when doctors read that an author received an enormous amount of money.

“Compare the effect of reading, hypothetically, that one author received $5,000 last year from Medtronic vs. reading he received $1 million,” Rosen said. “The amount makes a difference.”

Rosen’s Boss Threatens to Fire Him

Forming the Association for Medical Ethics did not help Rosen’s standing within his profession. “When I started AME, the chairman of my department at UC Irvine told me that he was going to have to fire me,” Rosen recalled in our conversation last week. “He came me into my office and said, “here are some evaluations from three residents who said you aren’t doing a good job.”

“I asked him when three residents out of sixteen can decide that an associate professor should be fired. I also pointed out that I had all 16 evaluations, and asked to see the three he had. They turned out to be ‘addendum’ [additions] to the original evaluations—and they were unsigned.”

Rosen refused to back down. Ultimately his department chair “got into trouble with the university” for unrelated reasons, and left UCI. “My current chairman has no industry ties, and there are no problems,” he told me last week.

Why Do Surgeons Ignore the Medical Evidence?

It’s important to realize that, privately, the majority of orthopedic surgeons question the number of back surgeries done each year. Most just don’t speak out about it. But last summer the Atlantic Monthly reported that “at a 2009 national orthopedics conference in Bonita Springs, Florida, the usefulness of surgery for back pain was debated. Those arguing against surgery pointed out that while 85 percent of adults experience lower back pain at some point in their lives, for all but 10 percent, the pain goes away within three months, regardless of what doctors do. In a poll that followed the debate, only one member in attendance volunteered that if she had ‘discogenic’ back pain, she would choose surgery.”

As for fusions, the Wall Street Journal sums up the consensus among “Conservative spine surgeons” who argue that “a spinal fusion is appropriate only for a small number of conditions, such as spinal instability, spinal fracture or a severe curvature of the spine known as scoliosis.”

The most recent evidence suggests that unnecessary fusions are taking a terrible toll on patients: “A study of workers' compensation cases published this year in the online edition of the journal Spine showed that patients who had a spinal fusion were much less likely to return to work within two years after their surgery than a group of patients with similar conditions who didn't have surgery, and that 27% of them had to be re-operated on,” the Journal reports. “Their rate of permanent disability was more than five times as high as the patients whose spines weren't fused, and their daily intake of powerful narcotic painkillers increased by 41% after surgery.”

“It’s amazing how much evidence there is that fusions don’t work [for patients suffering from aging discs], but surgeons do them anyway,” Sohail Mirza, a spine surgeon who heads the Department of Orthopaedics at Dartmouth Medical School in Hanover, New Hampshire told Bloomberg. “The only one who isn’t benefiting from the equation is the patient.”

“Payments by medical-device makers pose an ‘irresistible’ temptation to tailor treatment to more-lucrative procedures,” Eugene Carragee, chief of spine surgery at Stanford University in Palo Alto, California confided. “There is precious little in human nature to suggest this proposition is unlikely.”

Indeed, for surgeons, the financial incentives to perform spine fusions can be compelling. Though hospitals often lose money on the procedure when it's performed on Medicare patients due to the high cost of the implants, the surgeons themselves can get paid as much as $12,000 per surgery.

Yet, in truth, very few doctors who persist in ignoring clinical evidence are consciously trying to boost their incomes. Most remain committed to a procedure because this is how they always have addressed a particular medical problem. Habit, combined with a belief that if “I have always done it this way, it must be a good treatment,” can blind a doctor to medical evidence. No physician wants to believe that he has been giving his patients anything less than the very best advice. It can be extremely difficult to acknowledge that what you learned in medical school was simply wrong.

Still, the Journal confirms that a big part of many surgeons' income lies in their consulting and royalty arrangements with device makers. At the North American Spine Society's annual conference in Orlando, Fla., in October, more than 250 spine surgeons self-disclosed financial relationships with spine-device manufacturers under a policy adopted by the professional group. Many reported receiving hundreds of thousands of dollars or more from multiple device makers, in addition to having private investments in numerous companies.

Back Surgeons Don’t Take Criticism Lightly

When Rosen stood up to his peers knew he was taking a serious risk. Back surgeons are known to be quite thin-skinned when anyone questions the efficacy of their procedures. In 1995, when the Agency for Healthcare Research and Quality (AHRQ) released a set of guidelines that discouraged surgery in the management of lower back pain, “a number of politically active surgeons took offense,” Dr. George Lundberg, explained when I was writing Money-Driven Medicine. In 1995 Lundberg was editor of the Journal of the American Medical Association (JAMA) and he recalled how the back surgeons “aggressively lobbied Congress, demanding that the AHRQ back off. At the time there was talk of eliminating AHRQ altogether; but Congress finally settled the matter by slashing its budget.”

“It was a tragedy—the whole program was knocked out,” Dartmouth’s Dr. Jack Wennberg told me. “Congress gives them $300 million—that’s a laugh. They were out of the business of determining the scientific basis of clinical practice.”

Rosen on the Short List to Become Surgeon General

So perhaps it should come as no surprise that when Dr. Rosen landed on the short list to become the Obama administration’s Surgeon General in 2009 two powerful fellow surgeons set out to organize a campaign to make sure that he did not get the appointment.

Talk of Rosen becoming Surgeon General began after he testified before the Senate Special Committee on Aging in 2008, urging that legislators vote for the Physician Payment Sunshine Act. By then, Washington had become increasingly interested in potential conflicts of interest when physicians consulted for device-makers.

Late in 2008 the chairman of his department at UCI, Dr. Ranjan Gupta, learned of the possibility.

"We are all very proud of Dr. Rosen and the work he's doing," Gupta said. "It's very exciting for him to be on the list for surgeon general." But when talking to the Orange County Register, Gupta acknowledged that physicians at UCI, and nationally, were threatened by Rosen's work in medical ethics. "Chuck was ahead of his time. He was met with a lot of resistance. People were not thrilled.”

Among those “not thrilled” was Dr. Stephen Ondra, a spine surgeon who had recently been appointed senior policy adviser for health affairs at the Veterans’ Administration. When Ondra heard the news, he fired off an email to Dr. David Polly, a nationally known back surgeon calling Rosen “toxic and dangerous.” “I would leave nothing to chance,” Ondra added. “This moment in history is too important to our country to let such a disreputable and dangerous person continue his self-promotion crusade.” He encouraged Polly "and other physicians" to "weigh in" with the U.S. Department of Health and Human Services with their concerns.

Not only were Ondra and Polly both back surgeons, they had one other thing in common: both were consultants for Medtronic.

Over four years, “Polly collected more than $1 million from Medtronic” reports Dr. Roy Poses, at Health Care Renewal: “The services he provided were many, but among them, Polly was paid to write articles for medical journals; write a chapter in a book and a book outline; recruit patients for publicity efforts; attend Medtronic national sales meetings; travel to conferences in Japan, Paris and elsewhere; lead training and educational sessions for physicians; and lobby Congress.

As for Ondra, Bloomberg reports that he landed his job at the VA only after Medtronic Chief Executive Officer William Hawkins told a subordinate to write a letter recommending Ondra for a position in the administration.

Before he went to the VA, Ondra had received some $4 million in payments from Medtronic. (To be fair, Dr. Ondra disclosed his relationship with Medtronic when he was tapped for the job at the VA in 2009, and his work for Medtronic stopped in June 2008. At the VA, he is not involved in purchasing medical devices.)

On Pharmalot, Ed Silverman offers this link to e-mails exchanged by Medtronic executives, discussing how best to promote Ondra for the positions. (These messages offer a fascinating behind-the-scenes look at how corporations campaign to place allies inside an administration. Scroll down to read the message from Medtronic CEO William Hawkins.)

In part 3 of this post, I will discuss Charles Rosen’s testimony urging the Senate to pass the Physician Payment Sunshine Act. At the time, he was the only U.S. physician willing to publicly testify in favor of the legislation. The Act passed, along with the reform package. In the final part of this post I’ll discuss why the new law is likely to have a chilling effect on fees that both device-makers and drug-maker pay physicians—and how this could help lower health care costs