Two top UC Irvine surgeons have spent a decade working with a California company to promote a $2 million surgical robot despite a lack of reliable scientific evidence showing that it is safe or gives patients better results.
Professors Ralph Clayman and Thomas Ahlering and manufacturer Intuitive Surgical Inc. say the robot is a state-of-the-art surgical tool that allows for less-invasive and more-precise surgeries, resulting in better outcomes.
The professors have written scientific papers praising the robot, which Intuitive spotlighted in its sales presentations. Each has traveled the world, touting the machine’s benefits to thousands of physicians. And they’ve repeatedly downplayed the device’s risks, maintaining that doctors can quickly learn to use it safely.
“I could see this was the future and that this was giving us super-human powers,” Clayman said in an interview in June. “To change things for the better is a rare and wonderful privilege.”
But now, after the company has sold the da Vinci robot to hundreds of hospitals – including at least seven in Orange County – there are mounting concerns about its safety.
Federal regulators are looking into a sharp rise in injury and death reports in da Vinci surgeries. At least 71 people have died since 2000, according to a recent study. The reports include severe burns to internal tissue, pierced arteries and organs, and internal bleeding that is not discovered for days. Intuitive faces lawsuits from dozens of patients who say they were harmed.
Intuitive executives say the rise in injury reports is not out of line with the increasing use of the device.
“The da Vinci Surgical System has an excellent safety record with more than 1.5 million surgeries performed in major clinical centers around the world,” said Angela Wonson, the company’s vice president of communications. “Through the adoption of da Vinci surgery, surgeons have made significant progress in reducing the number of patients receiving open incisions for conditions found in gynecologic, urologic, general, cardiac and thoracic surgery.”
The story of how the two doctors campaigned for the device before there was good scientific evidence to support its use raises questions about whether UCI officials are doing enough to monitor the faculty’s financial relationships with companies. The professors appear to have sidestepped state law and university rules aimed at limiting inappropriate corporate influence on academic science and patient care.
Their enthusiasm for the robot conflicts with a growing chorus from academics independent from the company who question whether the device is worth its high price. A surgery performed with the robot can double an operation’s cost. For instance, prostate surgery costs $9,400 with the robot, according to one report, compared with $4,400 when done by hand.
“The company that makes the robot has been very clever at marketing,” said Dr. Philipp Dahm, a University of Florida professor who recently published a paper questioning the quality of the studies used to back the machine’s use. “It’s remarkable that there have been no checks and balances to confirm this is a good thing.”
For the professors, their work in robotic surgery has boosted their worldwide academic prestige as well as their personal finances.
Intuitive says it has paid Ahlering or his foundation at least $107,000 since 2002. The company says it has paid Clayman $5,000, the last payment in 2005. He’s continued to lecture on robotic surgery, receiving honorariums and travel totaling between $4,500 and $30,000 since 2009, according to his disclosures, at events where the company was a sponsor. Intuitive has also been a top financial supporter of an academic society that Clayman co-founded and that pays him $30,000 a year to edit a journal.
The company has also given UCI’s medical school, where Clayman serves as dean, nearly $1.5 million in grants and reimbursements for training surgeons from across the country.
Clayman and Ahlering say they have only done what is expected of academic surgeons: researching methods to make surgery safer and sharing their findings with other doctors. The university strongly supports them.
“Their work embodies the way academic medicine is supposed to be practiced,” said John Murray, a UCI spokesman.
In interviews, both professors said they had few concerns about the device’s safety. They said that any injuries in robotic surgeries were caused by the surgeon operating it, not by the machine – a point disputed by other doctors.
“The robot can’t hurt the patient,” Clayman said.
He added that he did not believe doctors had moved too fast to adopt a machine.
“To the people who started it,” he said, the progress “seems really slow.”
FINDING ‘SURGICAL CHAMPIONS’
As Intuitive began selling the da Vinci in 2000, executives told investors they planned to use some of the nation’s leading surgeons “to drive rapid and broad adoption” of the machine, according to company documents.
Getting those surgeons – “key opinion leaders” or “surgical champions” in the company’s parlance – to endorse the da Vinci could encourage other physicians to ask their hospitals to buy one.
Pharmaceutical and medical device companies routinely recruit academics to help their sales efforts. Executives know that a product recommendation from a professor means far more than a pitch from a sales rep.
The company needed the help of the surgeons, in part, because the da Vinci isn’t a robot in the true sense. It can’t do surgeries alone. Instead surgeons sit several feet away from the patient at a console, where they use joystick-like hand controls and foot pedals to operate surgical instruments attached to the robot’s arms.
The advantages of the robot, the company says, are smaller incisions, 3D vision at the surgical site and tiny instruments that bend and rotate more effectively than the human wrist.
Intuitive’s plan went beyond using surgeons to develop techniques for operating with the da Vinci. The company made them part of its sales machine.
Clayman said he was first paid by Intuitive in 2002, when he received $500 for moderating a panel at a company-paid dinner for physicians. That same year, he lobbied UCI officials to buy the medical center’s first robot. The university became the first academic center to buy the machine west of the Mississippi.
At that time, Clayman, who had been a pioneering surgeon in minimally invasive surgery, had just been hired as chair of UCI’s urology department. He later was promoted to dean of the university’s medical school, where he received $490,000 in 2012, state records show.
“Dr. Clayman saw it for what it could be,” Ahlering said in June. “He is a visionary guy.”
Ahlering was then performing conventional open-prostate surgeries at UCI Medical Center. Clayman asked him to learn to use the robot.
“I knew it was going to be a game-changer,” Ahlering recounted. “I said, ‘My life has changed forever.’”
Within months, Ahlering had performed the first robotic prostatectomy in Southern California. The company then flew him to Denmark, Australia and Canada to demonstrate the procedure to doctors from each nation.
According to his curriculum vitae, Ahlering gave more than 60 lectures about robotic surgery from 2002 to 2010. The talks took him to France, Italy, India, China, the Czech Republic and Venezuela.
Ahlering now heads UCI’s Robotic Oncology Center, where he performs about 10 da Vinci surgeries each month. The university paid him $491,000 in 2012, state records show.
Clayman gave talks about robotic surgery in Cancun, Mexico; Munich; Mumbai, India; Atlanta; Orlando, Fla.; and Philadelphia, according to agendas.
Intuitive executives were so pleased with the professors’ work that in 2005 they flew them to a corporate meeting in Tucson, Ariz., where they were given a Lucite trophy. Clayman was paid $2,000 and Ahlering $1,500 to speak before a crowd of sales representatives.
“You spend a million dollars. Does it make you a better surgeon? The answer appears to be yes,” Clayman told a crowd of doctors in Las Vegas in 2004, according to Urology Times.
‘BRUSHING UP’ AGAINST ETHICS RULES
UCI’s School of Medicine has written rules governing professors’ relationships with companies, intended to keep academics independent and patients safe. The rules warn professors not to give talks promoting products and require them to disclose payments received for outside work.
But the rules are vague and aren’t always enforced.
For example, in May, Clayman gave a talk in San Diego at an Intuitive-paid event that the Register attended. Despite warnings that faculty should not let companies review their planned presentations, Clayman presented slides prepared by Intuitive and stamped with the company’s name.
Murray explained that the conflict of interest rule was just “recommended guidelines for the faculty and not strict university policy.”
In university-required disclosure forms, Ahlering disclosed just $7,000 of the $107,000 he received from Intuitive.
He said that he placed the rest of the money – consisting of honorariums and travel reimbursements – into a nonprofit foundation that he created. He explained that he had felt at one point that he was “brushing up” against the university’s rules. “But if I don’t put it into my income taxes then they don’t really care,” he said.
He is the sole employee of the foundation, the University Surgeons of Orange, but he doesn’t receive a salary. He said he uses money deposited in the foundation – about $300,000 in the last seven years – for research and to travel to conferences.
State law bans any university employee with financial ties to a company from being involved in decisions to buy that firm’s products. In 2010, as the medical school’s new dean, Clayman put Ahlering in charge of an internal committee that he directed to work on purchasing the university’s third da Vinci machine and promoting it to patients.
Murray said the university is reviewing whether Ahlering’s involvement with that purchase violated the law. The university didn’t know about Ahlering’s foundation until the Register inquired about it.
But UCI’s Murray characterized these discrepancies as minor. He said that the professors’ work wasn’t influenced or directed by Intuitive. Their lectures were educational in nature, Murray said, and not promotional.
“The fact is, if these two surgeons were motivated by money, they could double or quadruple their income in private practice,” Murray said. “Instead, they remain committed to academic medicine.”
‘SUPERIOR OUTCOMES’ IN PROSTATE SURGERY
As part of their strategy, company documents show, Intuitive sales executives decided to focus on the robot’s use in prostate surgery, a procedure that is dreaded by men because it can leave them impotent and incontinent for the rest of their lives.
They planned to promote the “da Vinci prostatectomy” like a pharmaceutical company would sell a new drug.
But to do that, executives needed published data showing the robot could be safely used in prostate surgeries. More than that, they wanted reports showing that patients opting for a da Vinci surgery had a lower risk of the complications they feared.
Executives turned to a tactic used by marketers throughout the medical industry. Known as “publication planning,” it involves getting academic physicians to publish papers in scientific journals that support a product’s use.
Jonathan Conta, the company’s senior marketing manager, boasts on his résumé that he worked with the company’s “key opinion leaders” – that is, academic surgeons – to “drive a 125 percent increase in peer-reviewed journal publications.”
Dr. Myriam Curet, Intuitive’s chief medical adviser, said that it was the company’s medical staff – not the salespeople – who determined what papers they would like published. “We look for gaps in the literature,” she explained, “and we talk to surgeons to see if they are interested in doing a sponsored study.”
In such studies, which are common in the medical industry, companies give academics a financial grant for work leading to a published paper.
Soon after UCI purchased a robot, Clayman and Ahlering began publishing reports that Intuitive salespeople added to their presentations.
A sales brochure from 2004 is devoted to Ahlering’s results in 120 patients. His results, it said, demonstrated that the robot could “deliver improved clinical outcomes without compromising cancer control.”
But a look at the detailed outcomes for those patients shows only modest, if any, improvements.
For example, 17 percent of robotic surgery patients were found to have a “positive margin” – where the surgeon nicks the prostate as it is being removed, which can leave cancer cells in the body – compared with 20 percent of those having conventional surgery. The robotic surgery patients also had longer operating times, requiring more anesthesia.
There were two clear improvements: blood loss and hours spent in the hospital were lower for robotic surgery patients because their incisions were smaller.
Ahlering explains on his website that his dozens of papers have shown that the procedure “produces superior outcomes” and “validate the wisdom” of using the robot.
Intuitive also used the studies by Ahlering and a small group of other surgeons in advertisements directed at patients.
In a radio ad, for example, the announcer states that recent studies suggest that the da Vinci prostatectomy offers “improved cancer control and a lower incidence of impotence and urinary incontinence.”
Ahlering goes even further in a taped presentation on an Intuitive website that promotes the procedure to patients. “My patients have not just an earlier return to sexual function,” he says, “but a more complete return to sexual function.”
“Compare the benefits,” he says, “and decide what is best for you.”
Intuitive executives say their ads are intended to educate patients. “Surgeons, in consultation with their patients, make the ultimate decision as to whether or not surgery is an appropriate treatment,” said Wonson, the company vice president.
By the end of 2006, Intuitive revenues were rising by more than 60 percent a year, and the company was sitting on $240 million in cash. The company was promoting the robot for use in hysterectomies, gastric bypasses, heart revascularizations and other procedures. But a key to the rising revenues, Intuitive said in its annual report that year, was the da Vinci prostatectomy.
Intuitive doesn’t just profit from the initial sale. Like manufacturers of office printers who profit from sales of ink, Intuitive raked in millions by selling parts for the robot, which quickly wear out. Hospitals must also pay the company $150,000 for an annual service contract. The company can charge high prices because no other firm sells a similar device.
Because the machine and its upkeep are so costly, most hospitals have struggled to cover their expenses. Ahlering told United Press International in 2006 that UCI was losing thousands of dollars on every robotic surgery, because most insurance plans wouldn’t pay for the higher costs. He explained that the university had started to charge for each da Vinci prostatectomy as an outpatient procedure rather than an inpatient surgery, which had boosted billings and covered more of the cost. “Now we’re losing $3,000 instead of $6,000 per case,” he told the reporter.
Morris Frieling, the chief financial officer of UCI’s medical center, told a crowd of doctors in May that hospitals need to do a great number of surgeries with the robot, in a wide variety of specialties, to avoid losses.
“You need to have enough volume to support this,” he said.
Today, more than 80 percent of prostatectomies are performed with the robot.
The sales push has been so successful that researchers are finding that more men are having surgeries they don’t need. A study in June by University of Michigan doctors found that 44 percent of men diagnosed with low-risk prostate cancer chose to have robotic surgeries or another advanced treatment in 2009. That was up from 32 percent of such patients in 2004.
That shift happened even as more experts were warning men not to have the prostate-specific antigen, or PSA, test, which has been found to lead to unneeded surgeries.
Underlying those warnings is the fact that most prostate cancer grows so slowly that it poses no lethal threat. In 2011, a federal task force recommended that healthy men no longer take the blood test.
But Ahlering and other UCI doctors continue to recommend the test to men as young as 45. On his website, Ahlering says the test has led to “earlier and more accurate detection” of prostate cancer. He then includes a link to “new advances in prostate treatment” that takes readers to a page praising the da Vinci prostatectomy.
It’s far from clear, however, that the robotic procedure saves more patients from lifelong complications.
Last year, a research group led by Dr. Michael Barry at Massachusetts General Hospital published the results of a survey of more than 600 men. They found that the patients reported high levels of incontinence and impotence whether they had a prostatectomy with the robot or not. For example, 89 percent had a big or moderate problem with sexual function after conventional surgery; 87.5 percent did after a da Vinci prostatectomy.
Most patients lose less blood and recover faster from a da Vinci prostatectomy because their incisions are smaller. But in another study, more men choosing the robotic procedure later said they regretted their decision. The researchers attributed the patients’ dissatisfaction to the higher expectations they had for full recovery.
There have never been definitive clinical trials to test the safety and effectiveness of the robot. While the Food and Drug Administration requires such trials to test the safety of prescription drugs, it demands far less before approving a medical device.
Dahm and his University of Florida colleagues reviewed the da Vinci prostatectomy studies that have been published so far, including those by Ahlering and Clayman. They found that most were simple patient case reports that provided little reliable scientific evidence.
Intuitive’s Curet pointed to other recent papers, including some by doctors she said were independent from the company, that continue to show better results. A study this month, for example, found fewer complications and deaths among robotic surgery patients in the first 30 days after the procedure.
Curet said it is not unusual to have a new device initially supported by patient case reports. “Slowly the level of evidence will improve as more surgeons use the technology,” she said.
Ahlering said he continues to recommend the PSA test because he believes it saves lives. He said he counsels each patient on the risks and benefits of the test.
Asked about Barry’s study that found nearly identical levels of side effects in both open and robotic prostatectomies, Ahlering said, “He’s wrong.”
In a recent lawsuit, Ahlering and UCI were sued by the family of a patient who say the professor was so focused on performing a robotic prostatectomy that he ignored CT scans showing an unexplained density in the man’s kidney. Fourteen months later, another doctor diagnosed the patient, Thomas Perry, with advanced kidney cancer, and he soon died, the lawsuit says.
The university said it could not discuss the case because of the ongoing litigation.
RISE IN REPORTED DEATHS
As the number of robotic surgeries increases at hospitals across the country, injury and death reports are rising faster.
A search of the FDA’s database shows that there were 282 injury reports in 2012, including 28 deaths. That was up 34 percent from 2011 when there were 211 reports, including nine deaths.
During that same time, the number of da Vinci surgeries in the United States increased by 26 percent, to 367,000.
Intuitive executives say the rise in injury reports is due to a change in how they document device malfunctions. The numbers, they say, are “in line with historical trends.” A report of an injury, they note, does not mean it was caused by the device.
But FDA officials are now talking to surgeons in an attempt to understand what’s behind the increase in reports of injuries, which have occurred even in procedures considered routine, such as hysterectomies. The agency removes the names of hospitals and doctors from the reports, making it impossible to know where the injuries occurred.
Many injuries are never reported to the FDA, according to Dr. Marty Makary, a Johns Hopkins professor. Makary recently published a paper detailing how he found da Vinci injury cases in lawsuits and media reports that were missing from the federal database.
Many of the reported deaths involve unintended cuts to blood vessels, bowels or other organs. The patient goes home, not knowing something is wrong, but dies days later from infection or internal bleeding.
There are also reports that the equipment caused sparks or burned internal tissue. One woman suffered 10 days of intense pain after a hysterectomy. After she died, an autopsy showed that her external iliac artery had been burned.
In another case, the surgeon reported that a patient’s bowel was perforated when the instrument activated by itself, without the doctor pressing the foot pedal.
Two of this year’s deaths happened when doctors pierced organs as they inserted the sharply pointed instrument known as a trocar into the patient’s abdomen to make way for the robot’s arms.
Murray said there had been no serious injuries, unexpected deaths, surgical errors or equipment failures during robotic surgeries at UCI Medical Center. The Register found only two malpractice lawsuits against Ahlering, who has performed more than 1,200 da Vinci prostatectomies, and none against Clayman, in court files.
Many of the reported injuries at other hospitals appear as if they could have been caused by surgeons’ inexperience.
For years, Clayman and Ahlering have pushed the idea that surgeons can swiftly learn to use the robot. In 2003, they published a paper called “Robotic Revelation,” where they described how Ahlering had quickly mastered the machine.
They wrote that his experience was proof that a surgeon – after brief training that included practice on the carcass of a pig and a human cadaver – could “progress immediately to the successful performance of both simple and highly complex” surgeries. They wrote that they hoped the case “might empower many more urologists” to offer the procedures.
In another paper that year, they wrote that a doctor could become skilled with the device after operating on just 8 to 12 patients.
Intuitive widely promoted both papers.
But other doctors say it takes much more time and effort to become skilled.
Vanderbilt’s Dr. Joseph Smith reported that it took him 150 surgeries before he got results as good as when he performed open prostatectomies. He said it took him 250 surgeries before he was comfortable and confident using the machine.
Complications can occur in any type of surgery, and it’s not clear if they are more or less common with the da Vinci.
But the increase has worried some doctors.
Makary, the Johns Hopkins professor, wrote about the robot in his book, “Unaccountable,” which exposes hidden dangers inside hospitals. He points out that surgeons have no sense of touch when using the robot. Surgeons can accidently sever the aorta, he said, because they can’t feel its firmness.
“We’re all dazzled by technology, but the problem is we don’t have good ways of evaluating it,” Makary said. “We want doctors involved with new technology and its adoption, but we want good ethics to govern how that is done.”
Contact the writer: mpetersen@ocregister.com
