Who watches the surgeons?
Patients have little protection when new procedures introduced, critics say
You’re lying on a surgical table about to undergo an innovative new medical procedure that you have been told is safe, reliable, life-changing.
You assume those claims are supported by independent oversight and intensely scrutinized evidence from the medical establishment or some government regulatory body.
“Somebody has to go first. But there is always a certain risk.” THOMAS SCHLICH MCGILL HISTORY OF MEDICINE PROFESSOR
You could be wrong. Brent Jesperson was. And the former dentist believes it cost him his vision, and his career.
In a $12-million lawsuit filed this week, Jesperson blames a “breakthrough” — and now abandoned — eye surgery widely performed during the 1980s and ’90s for nearly destroying his life.
The claims haven’t been proven in court, and the target of that lawsuit, Toronto ophthalmologist Dr. Yair Karas, says he will address the allegations before a judge. In a Star interview, Karas said he has done 10,000 RK procedures in his 36-year career and has “no regrets.”
How heavily should new surgical techniques be policed by the authorities? Who do patients turn to when these procedures go wrong?
“I think it’s the best thing I’ve ever done,” Karas said. “There’s 1,000 police officers in Toronto that got into the police because of what I did, there’s 50 pilots in Air Canada that are flying with my surgery otherwise they wouldn’t get in and there is at least 1,000 firefighters in Canada . . . clergymen, like bishops, judges in the Supreme Court, most of the important families in this country . . . Most of the doctors in the U.S. know my name.”
But Jesperson’s experience raises important questions. Who is looking out for the public when a new procedure is introduced? How heavily should new surgical techniques — which can be groundbreaking and life-saving — be policed by the authorities? And who do patients turn to when these procedures go wrong?
In 1994, Jesperson paid nearly $4,000 for a procedure called radial keratotomy, or RK, to address his nearsightedness.
Tired of a lifetime of wearing glasses, he says, he figured it was safe. If it wasn’t, he reasoned, certainly someone would stop it.
“At the time I had it done, I thought, ‘If it were bad, wouldn’t they (the Ontario College of Physicians and Surgeons) shut him down,” Jesperson, 51, said in a recent interview.
While Karas is the only target of the lawsuit, Jesperson — and many of the dozen other RK patients interviewed by the Star — say they lay equal blame for vision problems that compromised their careers and personal lives at the feet of a regulatory system they believe failed to protect them.
Unlike drugs or medical devices, which undergo government testing and face approval processes that can last for years, surgical techniques tend to spread much more quickly as doctors experiment and exchange information at medical conferences and in journals.
Their decisions on whether to practise an experimental procedure are sometimes guided by personal ethics rather than independent oversight.
“Surgery is one of the few areas of medical innovation that is not very well regulated,” says Thomas Schlich, a professor of the history of medicine at McGill University in Montreal. “That tension has been around forever: if you want to try something new, you have to try it out. Somebody has to go first. But there is always a certain risk.”
So is there a way to better monitor medical innovations that hold the risk of harming patients?
While the provincial colleges of physicians are responsible for regulating the practice of medicine, they aren’t proactive about assessing the safety of new procedures.
Instead, they typically take action only after the fact, when medical harm has already been committed and victims file formal complaints that lead to disciplinary hearings — far too late to prevent tragedy.
“The colleges don’t go in and check on anybody in their private clinic to see if they’re being a good doctor,” says Dr. Martin McKneally, a surgeon and professor emeritus at the University of Toronto’s Joint Centre for Bioethics. “I think that the colleges could do more, but that is not in their current mandate — their mission is to protect the public, but not in a policing function.”
Ontario’s College of Physicians and Surgeons has no policy of issuing statements about medical procedures, a spokesperson confirmed.
Millions of Canadians every year undergo elective, unregulated procedures — such as cosmetic surgery and in vitro fertilization — in private clinics without vig- orous oversight. And sometimes, it goes terribly wrong. In 2004, Micheline Charest, one of Quebec’s most famous TV and film producers, died at age 51 after complications from plastic surgery at a clinic in Montreal. In 2007, a 32-year-old mother named Krista Stryland died after undergoing li- posuction at a Toronto cosmetic clinic. A year later, a Calgary woman named Ashish Toews died following a tummy tuck procedure in an independent clinic.
“There is so little oversight in some of the details of what goes on in private clinics, there can be times when there are adverse consequences,” says Dr. Keith
“The need for innovation never outweighs the responsibility to ensure patient safety” JULIA HALLISY EMPOWERED PATIENT COALITION
Barrington, chief of newborn medicine at Ste-Justine University Hospital Centre and professor of pediatrics at the Université de Montréal.
His 2011 study published in the Journal of Pediatrics concluded that close to 100 babies could die or suffer severe brain injury every year in Canada because of the lack of control in the unregulated in-vitro fertilization business, which has led to an “epidemic” of multiple births and dangerously premature babies.
Some doctors and ethicists argue for stronger oversight of new procedures by hospitals and medical colleges, along with better-informed patients. But they also warn that over regulation would stifle the kind of innovation that has resulted in life-saving techniques.
“The problem in medicine is that you are living now and not10 years from now,” says Dr. Steve Arshinoff, a leading ophthalmologist who practises at Humber River Regional Hospital.
“So when you go for any operation, you unfortunately get the knowledge and the standards of the time and not the knowledge and procedures that we’ll have 10 years from now.”
That was the dilemma for a generation of nearsighted people in the ’80s and ’90s who were assured RK would safely correct their vision.
As the first mainstream medical procedure to correct myopia, RK — a precursor to modern laser eye operations — was swiftly embraced as a leap forward. Many ophthalmologists began practising it on patients after simply taking a weekend course advertised in ophthalmology magazines.
But most experts now agree the widespread adoption of RK surgery has led to thousands of permanently damaged corneas, resulting in ruined careers, limited lifestyles and, in some cases, depression and suicidal thoughts.
Ottawa ophthalmologist Dr. David Edmison, a former board member of the Canadian Ophthalmology Society, says many like him shared concerns about RK’s long-term implications at the time.
“I felt that the risk-benefit ratio was skewed toward potential risk,” says Edmison, who never performed the procedure. “As soon as you get your licence to practise medicine, you are licensed to pick up a scalpel and do whatever you wish with it. So it escaped the umbrella of regulatory approval.”
But while regulatory bodies remained silent, so did the ophthalmology community, which was quietly raising concerns internally.
“They didn’t feel it was either up to them, or they didn’t feel it was important to them to step in and try and sanction the few that did take it up,” Edmison says. “Anybody in medicine was quite reluctant to point fingers at colleagues and say, ‘Thou shalt not do this.’ There wasn’t the same feeling for the patients’ best interests that they were willing to risk censure.”
In retrospect, he says “there’s no question I wish there had been more evaluation of this procedure.”
RK’s path — from a Russian-developed experimental technology in the 1970s to widespread adoption in North America — is a case study in unchecked medical innovation that many now view as reckless.
A review of medical publications and literature revealed there were concerns about the procedure as early as 1985.
An article in Ocular Surgery News warned of “an ongoing concern” among RK surgeons about incisions that “weaken the cornea, do not heal adequately, and leave patients susceptible to traumatic wound rupture.”
Among those raising issues was Dr. Maurice John, one of the first North American ophthalmologists to begin practising RK. He travelled to Moscow in 1980 to learn the technique in a two-day seminar with its innovator, Dr. Svyatoslav Fyodorov.
Twenty-eight years later, John says that while many patients experienced good results from RK for many years, cataracts and farsightedness have proven a chronic long-term outcome.
“There’s an evolution of all of this stuff, and this was part of the evolution of (eye) surgery,” says John, now 69 and semiretired after performing RK on as many as 8,000 eyes between 1980 and 1997 in Louisville, Ky.
“We didn’t fully understand what was going on,” he says in hindsight. “Was there over-promising? Sure.”
Those who questioned it at the time were ostracized.
A Texas ophthalmologist named Dr. John J. Alpar, who publicly questioned the ethics behind his industry’s widespread adoption of an unregulated, untested procedure, says he was “hated” by his colleagues at the time.
In a 1985 medical journal article, Alpar argued that despite its infancy and mysterious long-term outcomes, RK was promoted by many ophthalmologists in newspaper and magazine advertisements “with claims that at the present time are not completely justified.”
His explanation for their collective conduct: “A great amount of cash income, uncontrolled and unregulated by the government, can be collected with relatively little work.”
Today Alpar, 87 and still practising in Amarillo, says his instincts were tragically prescient.
“It was never a safe operation. (RK patients) should never have been subjected to this unnecessary suffering. I still see patients whose eyes are screwed up considerably because of RK.”
Morris Waxler, a former U.S. Food and Drug Administration chief scientist in the late 1990s, has witnessed the emergence of new eye procedures first-hand.
RK, he says, was easily adopted by ophthalmologists because it required no unique devices subject to regulatory government approval.
“It was ophthalmologists and refractive surgeons in control of themselves,” Waxler says. “They have a long tradition of doing what they think is best.”
At its core, any system of heightened patient protection has to be open and transparent, he argues.
His solution: eye surgery patients sign a declaration ensuring their outcome will become public through an independent body.
“(Eye) surgeries have traditionally operated under a cloak,” he says. “It’s the Wizard of Oz behind the curtain doing his magic. He doesn’t tell you how many were injured. There’s no reason for keeping patient outcomes secret. They keep it secret because it’s to their own economic benefit.”
Coming clean with patients on longterm outcomes of new procedures is at the heart of balancing patient rights with innovation, says Julia Hallisy, founder and president of the California non-profit group the Empowered Patient Coalition.
“We must use a robust informed-consent process in which patients clearly understand that they are test cases for some of these new procedures. The need for innovation never outweighs the responsi- bility to ensure patient safety in our medical treatments.”
As the pace of medical breakthroughs accelerates, some hospitals have moved to exert more control over them.
Several of the teaching hospitals at the University of Toronto have instituted an “enabling innovation” protocol for new surgical procedures, says the U of T’s McKneally.
The measures include detailed reviews by the surgeon-in-chief, endorsement by at least two other “informed colleagues” and rigorous follow-up of the outcomes for the first patients.
Part of the protocol for new procedures at U of T teaching hospitals requires surgeons to insert what he calls the “Columbus Clause” — a reference to the explorer Christopher Columbus — into standard consent forms to explicitly warn patients about the risks of innovative medicine. WHILE HEADING INTO uncharted medical waters is always uncertain, it’s made all the more treacherous with the growing number of potentially risky procedures taking place in private clinics outside the control and surveillance of hospital review committees.
“There is oversight in the hospital setting,” says McKneally. “It’s a little less clear in the private clinics.”
He, like others, suggests the various professional colleges that are supposed to oversee doctors and specialists might have to step in to play a bigger role.
But can college regulators reasonably be expected to monitor innovative techniques?
“What happens if you are the innovator, if you’re the guy who invented something?” asks Arshinoff.
“There will be a very limited number of people who are in any position to comment on whether what you are proposing to do is better or worse than was historically done.”
And stifling innovation with red tape has its own implications, he says.
He notes that while a lot of patients eventually developed problems with RK eye surgery, the procedure also helped advance newer techniques now widely used in cataract surgery.
“You have to balance those two things: where do you say the doctor was too slow to learn something new or too fast to try it?” That’s cold comfort for RK’s victims. In the aftermath of permanently damaged corneas, uncorrectable vision, a lost career and subsequent depression, Jesperson sought help from every medical authority in Ontario he could think of.
Health Canada, in a 2011 written response to his inquiries, directed him to the province, which is responsible for the “administration and delivery of healthcare services.”
The Ministry of Health and Long-Term Care sent him to the College of Physicians and Surgeons.
His complaints to the college, which is charged with oversight of the medical profession, have been dismissed, along with those of two other former RK patients interviewed by the Star.
“For patients like me,” Jesperson says, “there’s really nowhere to turn.”