CT Center for Patient Safety Newsletter
August update  August 20 2009
In This Issue
Dead by Mistake
PR - not science
Neuontin and the courts
Doctors Reap Benefits

Six months ago, Hilke Schellmann, a Hearst reporter,
called and tole me Hearst was beginning  a national
and state specific report on the 10th anniversary of the misnamed Institute of Medicine report "To Err is Human."
We think it should have been named "98,000"
preventable deaths.
The CT Center for Patient Safety was a contributor to the
articles and I urge you to read them and distribute them to
 your legislators.  These articles have reopened the important discussion about transparency and accountability of our
Connecticut Hospitals.  Links to these articles appear in a
right hand column. 
Thank you Jeanne Hamilton,  Not only does she serve as
Chair of our Board of Directors, Jeanne courageously spoke
with a reporter about the death of her father,
T. Stewart Hamilton.
Not even a Hospital President is immune to MRSA
July 30, 2009, 5:22PM
When Hartford Hospital in Connecticut marked the death of former president Dr. T. Stewart Hamilton in a 2002 employee newsletter, the obituary stated Hamilton "died peacefully on July 29, with his family at his side."
Left unsaid was that Hamilton died at Hartford Hospital from complications brought about by MRSA, a form of bacteria spread through skin contact or an infected open wound, which he may have contracted after being admitted for treatment of a minor head laceration.
"I thought it was stitches and then we go home," said his daughter Jeanne Hamilton of Mystic, recalling what turned into a 12-day ordeal for her father that resulted in the family's decision to take him off life support.
The experience led Jeanne Hamilton to become involved a few years later with the Connecticut Center for Patient Safety, a group dedicated to improving hospital care and preventing the spread of hospital-borne illnesses such as MRSA, methicillin-resistant Staphylococcus aureus.
She is now the organization's president and uses her father's death as a cautionary tale of how any patient can be vulnerable to MRSA.
"If you think you're safe because you've got an 'in' with the hospital, forget it," Jeanne Hamilton said of her father. "He had a pretty big 'in' with the hospital."
A native of Detroit, T. Stewart Hamilton took over administration of Hartford Hospital in 1954, remaining in charge until retiring in 1976.
He helped the hospital recover from a disastrous 1961 trash-chute fire, which killed 16, and was also at the forefront of efforts to pass federal Medicare legislation in the 1960s. The country's first Medicare reimbursement check was issued in 1966 to Hartford Hospital in his honor.
During that same period, he also served terms as president of the Connecticut Hospital Association and the American Hospital Association.
Although her father had turned 91 in June 2002, Jeanne Hamilton said he was living an active life out of his apartment at Duncaster, a continuing-care community for the elderly in Bloomfield, Conn.
In fact, the two were planning a cruise on the Great Lakes when, on July 17, 2002, T. Stewart Hamilton fell at home.
Hospital records state the fall was likely "orthostatic in nature," meaning he may have suffered a dizzy spell.
"He hit the back of his head on the dishwasher and got a 2-inch cut," Jeanne Hamilton said.
The wound was initially treated by nurses at Duncaster, who suggested he visit the hospital for stitches.
An ambulance took him to Hartford Hospital's emergency room, and he was given a private room, where, his daughter said, five hours passed before he received staples for the wound.
"The doctor came in. He said, 'Well, Stewart, we can either give you Novocain (for stitches) or the staples and it will be really quick and over with," Jeanne Hamilton recalled.
She said the hospital decided it would be better to keep her father overnight.
"I thought they were doing us a big favor because of who he was, to rule out strokes and so forth," she said.
Overnight turned into four days, during which time Jeanne Hamilton said her father seemed to be deteriorating. She asked that he be discharged back to the clinic at Duncaster, which she hoped would improve his spirits and recovery.
"I didn't see the reason for him staying any longer and thought being in the hospital wasn't helping," she said.
Her father's July 21, 2002, discharge papers described him as "a pleasant ... white male physician who was president of Hartford Hospital" and stated he was getting "weak and confused." His blood count had dropped, but there was no evidence of gastrointestinal bleeding, according to the paperwork.
There was no mention of a MRSA infection.
Jeanne Hamilton said her father arrived back at Duncaster around 7 p.m. She drove home to feed her dogs and then returned and spent the night at her father's side.
About 12 hours after his discharge, T. Stewart Hamilton was readmitted to Hartford Hospital the morning of July 22 because he needed an oxygen tube inserted into his throat.
It was at this point, according to a hospital summary of his second stay, that MRSA was discovered in cultures taken of his blood upon readmission.
"They said the source of the infection was at the wound," Jeanne Hamilton said.
On July 28, she was approached by Dr. John McArdle, then of Hartford Hospital's intensive care unit, she said.
"On the 28th, the ICU doctor said to me, 'We should talk.' I looked at him and said, 'Should we let him go?'" Jeanne Hamilton recalled. "He just wasn't responding to antibiotics. The doctor said, 'We've thrown at him every antibiotic known and several that are brand-new.' He was getting everything they could do for him."
T. Stewart Hamilton's oxygen tube was removed, and he died about four hours later.
"I knew my dad so well and knew he wouldn't have wanted to go on fighting that and come back and go through months of recovery," Jeanne Hamilton said. "We said, 'You know, he just might surprise us and pull out of this on his own,' but he didn't."
She believes her father likely contracted the MRSA infection while waiting to be treated in Hartford Hospital's emergency room, although she readily acknowledges it would have been hard to prove.
"I suppose he could have gotten it when they were dressing his wounds (at Duncaster) before they sent him off to the hospital in the first place. I don't think so. He could have gotten it in the ambulance, but I doubt it," she said.
Jeanne Hamilton also said her father's cut was freshly bandaged by hospital staff before his brief return to Duncaster and was never touched by anyone at that medical facility before he was readmitted to the hospital July 22.
"I have no definitive proof it was ... in the emergency room. But that's pretty much what I think happened because that's where his wound was open and unattended the longest," she said.
McArdle, who worked at Hartford Hospital from 2001 to 2003 and currently practices at Connecticut's Yale-New Haven Hospital, in a recent interview recalled treating T. Stewart Hamilton.
McArdle said he was not initially familiar with who the man was, but it was made clear he was an important patient.
"All the higher-ups in the hospital knew he was in the hospital, so folks would occasionally come by to talk to the family or check up and so on," McArdle said. "He devoted his life to the hospital. He was a huge force."
McArdle said although he does not remember all the details of the case, the MRSA infection "absolutely" led to the death.
"It's conceivable he got it in the community, but probably much more likely he got it in the health care environment," McArdle said, adding T. Stewart Hamilton's age would have made him more vulnerable.
"Even if you're a healthy 91, you're still not a young person who is healthy," he said.
Jeanne Hamilton said she never pursued any investigation of her father's death. "It didn't occur to me. I've learned so much in the last six years," she said. Filing a lawsuit against Hartford Hospital was never an option.
"I knew we couldn't sue. I knew we shouldn't sue," Jeanne Hamilton said. "He believed in that hospital. He was totally devoted to that hospital and its quality of care."
She added she is not angry with Hartford Hospital, specifically, but is angry at the prevalence of MRSA in health care settings.
"I think it could have happened at any hospital, and that's scary," she said.
McArdle said a lawsuit likely would not have gone anywhere because of the difficulty in proving where and how T. Stewart Hamilton contracted the bacteria.
"MRSA has become such a common infection," McArdle said, adding he did not recall T. Stewart Hamilton's contracting MRSA making any waves within Hartford Hospital, despite who he was.
"(Unless) there was a clear path where MRSA got from 'Patient X' to 'Patient Y,' it's not the kind of thing that would in and of itself prompt an investigation," he said.
Asked for comment, Lee Monroe, a Hartford Hospital spokesman, in an e-mail said T. Stewart Hamilton "was for many years a beloved leader of Hartford Hospital and his loss continues to be mourned among us."
"At the time of his death and continuing into the present the country has been experiencing a dramatic increase in the prevalence of drug-resistant bacteria both in community settings and in healthcare facilities," Monroe wrote. "These organisms can be acquired almost anywhere, even at home."
Monroe said Hartford Hospital recognizes the significant impact MRSA has on the health and quality of life of patients, families and the community and the significant role hospitals play in combating it.
She said Hartford Hospital is "committed to winning the battle against healthcare-associated infections" through a comprehensive program of hand hygiene, contact precautions, attention to the environment and education.
"Our plan for the reduction of MRSA, regardless of its acquisition from the community or healthcare acquired, is thorough and rigorously adhered to," Monroe said.
Asked if her father would be happy with her health care advocacy, Jeanne Hamilton said, "Yes. No doubt. No doubt."
"His whole life was dedicated to making health care better for the patient," she said. "If his death can help ... that may be the final piece of his legacy."

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Ten years - a million preventable deaths

 Wyeth paid ghostwriters to pen journal articles on hormone replacement therapy
By Anne Zieger
In a practice that is proving to be sadly common, it appears that drugmaker Wyeth paid ghostwriters to prepare dozens of articles on hormone replacement therapy that were published in journals under physicians' names, according to reports appearing in The New York Times.

This practice, in which drug companies pump up their reputation by paying for journal coverage favorable to them, has been under investigation for some time by various regulatory bodies, and Sen. Chuck Grassley asked Wyeth about the practice in December.

Wyeth's public policy on the subject of such articles, adopted in 2006, specified that listed authors must get involved early in the publication process, and that any financial assistance by Wyeth, or contributions by medical writers, must be spelled out in the published text.

But that doesn't seem to have happened here. Many articles cited by The Times were review articles, which examine existing studies to look at their substance. In one case, a company was paid $25,000 to write an article, listing the author as "TBD," or to be decided. (There's no way to be more straight about its being a marketing puff piece than that.)

The articles in question were published between 1998 and 2005. Wyeth's role in paying ghostwriters was discovered by lawyers suing the company, the Times piece says. 

Pfizer Investigator Stalked Neurontin Witness
                 Who Paid Off the Plaintiffs?
Tuesday August 18th, 2009
Jim Edwards
The first of Pfizer's Neurontin mass tort cases could not have been stranger: The plaintiffs dropped the case after a mystery donor paid them $50,000; a Pfizer investigator was accused by a witness of blocking his driveway and scaring his family; and CEO Jeff Kindler made it personal between him and the lead plaintiffs' lawyer, Mark Lanier.
Lanier said the donation came from another plaintiffs' attorney who had been watching the case in the courtroom. He told the AP:
"Isn't that wild?" Lanier said. "I've never had anything like that happen before."
Wild, and also convenient. As BNET noted July 24, the case was described as "very tough" by the judge. The plaintiff's family claimed Neurontin was prescribed off-label for their daughter, Susan Bulger, who killed herself. The anti-seizure drug was not indicated for depression. But the dead woman had attempted suicide before and had a history of mental problems. The case was probably a loser for Lanier. The real mystery is why he decided to bring it in the first place.
Pfizer can breathe a sigh of relief, too. The first witness, former Pfizer drug sales rep David Franklin, told the court he was stalked by a Pfizer pflunky. AmLaw: 
He told the courtroom that the day before trial, a private investigator hired by Pfizer came to his house, blocked the driveway, and would not leave until his wife called the police. After Franklin's testimony - during which he said that the private investigator had yelled at his wife and frightened his young daughter - Judge Saris told [Pfizer lawyer William Ohlemeyer of Boies, Schiller & Flexner] that "no one should be going after Dr. David Franklin anymore."
Ohlmeyer confirmed the incident to the AP:
"It sounds like this didn't happen the way it should have happened," Ohlemeyer said. "We apologized to (Franklin) for what happened."
Having performed The Great Escape - the settlement truncates any more entertaining testimony about what else Pfizer's spies might have gotten up to in the case -  Kindler then decided to open his mouth. Bloomberg:
"We are pleased to have been vindicated in this case," Jeffrey Kindler, chief executive officer of New York-based Pfizer, said in a phone interview on Bloomberg Television today. Neurontin has been "prescribed to treat millions of patients safely and effectively for many, many years and it's been widely studied for more than two decades," he said.
"Vindicated?" Lanier didn't like that:
Kindler's comments are "outrageous," Lanier said. "All Pfizer got today was a six-month stay of execution. We have 1,200 more of these cases to go."
In a media battle, the freewheeling Lanier will beat Kindler every day of the week. The company had made a great case that Neurontin was the least of Bulger's problems. The plaintiff was so unsympathetic that the judge even had to warn the jury that she was not related to Boston gangster Whitey Bulger. Kindler should stick to winning these things on the facts. The "vindication" here only sets the company up for more difficult cases to come.

Doctors Reap Benefits By Doing Own Tests
By Shankar Vedantam
Washington Post Staff Writer
Friday, July 31, 2009 

In August 2005, doctors at Urological Associates, a medical practice on the Iowa-Illinois border, ordered nine CT scans for patients covered by Wellmark Blue Cross and Blue Shield insurance. In September that year, they ordered eight. But then the numbers rose steeply. The urologists ordered 35 scans in October, 41 in November and 55 in December. Within seven months, they were ordering scans at a rate that had climbed more than 700 percent.
The increase came in the months after the urologists bought their own CT scanner, according to documents obtained by The Washington Post. Instead of referring patients to radiologists, the doctors started conducting their own imaging -- and drawing insurance reimbursements for each of those patients.
In focusing on health-care reform this year, President Obama pledged that a revamped system would hold down exploding costs. But none of the players -- Congress, the administration or the array of interests involved in the process -- has offered a clear path to that goal. And efforts to control medical practices that have driven up expenses, including physician "self-referrals," underscore how difficult it is to alter entrenched patterns.
A host of studies and reports by academics and the federal government shows that physicians who own scanners order many more scans than those who do not. As a result, Americans pay billions of dollars in extra taxes and insurance premiums.
Government panels have found that, across several areas of medicine, ordering more procedures does not improve health outcomes. In the case of medical scans, unnecessary imaging also creates a health risk -- as many as 1 percent of all cancers in the United States appear to be caused by radiation from medical imaging, according to Amy Berrington de Gonzalez, a radiation epidemiologist at the National Cancer Institute.
A lawyer for the Iowa urology practice defended its medical decisions. "The standard of care for a certain category of patients may require a CT scan and the practice may have decided to purchase a CT scan as a result," Victor Moldovan said in an e-mail. "Any assertion that there is some wrongdoing simply because of an increase in scans is unfounded." The urology practice, he added, "understands its obligations very well and complies with all applicable standards."
He noted that in many cases scans must be pre-approved by insurers, "which effectively limits any over-utilization." The Wellmark data compared how often the urologists and equivalent physicians in the region ordered scans. Before their scanner was installed, the urologists ordered fewer CT scans than the other doctors. Afterward, the urologists ordered more than three times as many as the other doctors.
Critics of self-referral say that, just as doctors are not allowed to write prescriptions and then sell medications, they should not profit from imaging. Congress, as part of health-care-reform efforts, is considering a proposal, championed by Reps. Jackie Speier (D-Calif.), Anthony Weiner (D-N.Y.) and Bruce Braley (D-Iowa), to prohibit the practice. Maryland is the only state that bans self-referrals, but the law is rarely enforced.
Physicians, medical associations and imaging-device manufacturers argue that allowing doctors to own and operate scanners increases patient convenience and allows quicker diagnoses.
"It is important for legislators not to take tools out of the hands of doctors," said Jim York, an orthopedic surgeon and president of the Maryland Patient Care and Access Coalition, a group fighting to allow physicians to operate their own scanners.
Detailed analyses by several peer-reviewed researchers, the Government Accountability Office and an independent congressional agency known as the Medicare Payment Advisory Commission, or MedPAC, show that, while self-referrals might improve care and convenience in some cases, that is not the case nationally.
The issue was ostensibly settled in 1992 when the Stark Law was enacted. The legislation prohibited physicians from referring patients to the doctors' own scanning devices. The law offered an exception, however, for physicians whose scanners were in the same office building as their practice. The exception was designed to allow doctors to keep small X-ray machines to quickly figure out, for example, whether a limping patient had a sprain or a fracture.
But since the law was passed, high-tech MRI and CT scanners have become smaller, making it possible for many more physicians to use the "in-office" exception.
A dramatic increase in imaging has followed for the most expensive scans -- MRI, CT and certain cardiac stress tests. According to a GAO report last year, Medicare reimbursed $28 for the most commonly prescribed X-ray in 2006, compared with $1,118 for the most commonly prescribed MRI.
Nationwide, a growing share of physician income came from imaging fees: In 2000, scans in the offices of cardiologists earned the doctors 23 percent of their total Medicare revenue, according to the GAO. In 2006, the figure was 36 percent.
In a report last year, Laurence Baker, a health research professor at Stanford University, found that each new MRI scanner is associated with 733 additional procedures in a region and that each new CT scanner is associated with 2,224 additional scans. That is among only Medicare patients age 65 and older, Baker said, meaning the overall use of the machines probably is much higher.
"Physicians who purchase machines for their offices have a financial incentive to refer patients for additional services, as long as those services are profitable," MedPAC noted in a report last month. "Although physicians are usually motivated by professional ethics and concern for their patients' best interests, physician ownership could influence the clinical judgment of some physicians, particularly when there is not strong evidence to guide their decisions."
On the Web site of medical imaging device manufacturer GE Healthcare, several physicians offer testimonials about how quickly an expensive new scanner could pay for itself: "We're already beating our pro forma [earnings] in terms of the return on investment," one West Virginia physician boasted.
"We were looking for ways to improve our bottom line while also improving patient care," wrote Sanford J. Siegel, a urologist who practices in the Washington area. "The results have been very satisfactory, and I can say absolutely that we are providing better care because we have an in-office CT scanner."
In an interview, Siegel said that he wrote the comment a few years ago, but that since then, insurers have reduced reimbursement rates and imaging is no longer the moneymaker it once was. Siegel, the president of Chesapeake Urology Associates, said he was certain his practice did not order more imaging after purchasing an in-house CT scanner five years ago.
He cited the example of Alvin Crawford, 53, of Reisterstown, Md., who recently came to the office in pain. In an account confirmed by Crawford, Siegel ordered a CT scan using the in-house device. Within minutes, the urologist said, he had identified a kidney stone and scheduled Crawford for a procedure to remove it. If he had sent Crawford to an independent radiology center, Siegel argued, the diagnosis would have taken much longer.
"Just because doctors have CT scanners in their office does not mean they are abusing the system," Siegel said. "Is everyone a Bernie Madoff or a crooked politician? Most doctors are dedicated to providing outstanding patient care. They don't think, 'A CT scan is coming and I am going to make money.' They think, 'A patient needs a blood test or a scan, and I am doing it for him.' "
Jean M. Mitchell, a professor of public policy and a health economist at Georgetown University, estimated that eliminating incentives for needless care could reduce the nation's health-care bill by as much as a quarter. If self-referrals are not barred, she said, physicians ought to be paid through bundled fees, rather than for individual procedures.
"Fee-for-service medicine is like a la carte dining," she said. "Bundling is like a fixed-price dinner. You can get a fixed-price dinner at a restaurant across from my office in Georgetown for $40, which includes salad, soup, entr´┐Że and dessert. Your choices are limited, but if you ordered a la carte, the same things would cost $75. If patients want unlimited choice, they should be willing to pay for it themselves."

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Op-Ed Contributors
10 Steps to Better Health Care
Published: August 12, 2009
WE have reached a sobering point in our national health-reform debate. Americans have recognized that our health system is bankrupting us and that we have dealt with this by letting the system price more and more people out of health care. So we are trying to decide if we are willing to change - willing to ensure that everyone can have coverage. That means banishing the phrase "pre-existing condition." It also means finding ways to pay for coverage for those who can't afford it without help.
Both of these steps stir heated argument, not to mention lobbyists' hearts. But what creates the deepest unease is considering what we will have to do about the system's exploding costs if pushing more people out is no longer an option. We have really discussed only two options: raising taxes or rationing care. The public is understandably alarmed.
There is a far more desirable alternative: to change how care is delivered so that it is both less expensive and more effective. But there is widespread skepticism about whether that is possible.
Yes, many European health systems have done it, but we are not Europe. And evidence that places like the Mayo Clinic in Minnesota or the Cleveland Clinic are doing it is likewise dismissed because their unique structures (for example, their physicians work on salary rather than being paid for each service) make them seem as far from Middle America as Sweden is.
Yet in studying communities all over America, not just a few unusual corners, we have found evidence that more effective, lower-cost care is possible.
To find models of success, we searched among our country's 306 Hospital Referral Regions, as defined by the Dartmouth Atlas of Health Care, for "positive outliers." Our criteria were simple: find regions with per capita Medicare costs that are low or markedly declining in rank and where federal measures of quality are above average. In the end, 74 regions passed our test.
So we invited physicians, hospital executives and local leaders from 10 of these regions to a meeting in Washington so they could explain how they do what they do. They came from towns big and small, urban and rural, North and South, East and West. Here's the list: Asheville, N.C.; Cedar Rapids, Iowa; Everett, Wash.; La Crosse, Wis.; Portland, Me.; Richmond, Va.; Sacramento; Sayre, Pa.; Temple, Tex.; and Tallahassee, Fla., which, despite not ranking above the 50th percentile in terms of quality, has made such great recent strides in both costs and quality that we thought it had something to teach us.
If the rest of America could achieve the performances of regions like these, our health care cost crisis would be over. Their quality scores are well above average. Yet they spend more than $1,500 (16 percent) less per Medicare patient than the national average and have a slower real annual growth rate (3 percent versus 3.5 percent nationwide).
Caveat: Because we relied on Medicare data for our selections, it is possible that some of these regions are not so low-cost from the viewpoint of non-Medicare patients. But overall data strongly suggest that most of these regions are providing excellent care for all patients while being far more successful than others at not overusing or misusing health care resources.
So how do they do that? Some have followed the Mayo model, with salaried doctors employed by a unified local system focused on quality of care: these include Temple, where the Scott and White clinic dominates the market, and Sayre, where the Guthrie Clinic does. Other regions, including Richmond and Everett, look more like most American communities, with several medical groups whose physicians are paid on a traditional fee-for-service basis. But they, too, have found ways to protect patients against the damaging incentives of a system that encourages fragmentation of care and the pursuit of revenues over patient needs.
The physicians and hospital leaders from Cedar Rapids told us how they have adopted electronic systems to improve communication among physicians and quality of care. Last year, they decided to investigate the overuse of CAT scans. They examined the data and found that in just one year 52,000 scans were done in a community of 300,000 people. A large portion of them were almost certainly unnecessary, not to mention possibly harmful, as CAT scans have about 1,000 times as much radiation exposure as a chest X-ray.
"I was embarrassed for us," said Jim Levett, a cardiac surgeon and the head of a large physician group. More important, the area's doctors and clinics are turning that embarrassment into change by seeking out solutions to reduce the expense and harm of unnecessary scans.
That number of scans in Cedar Rapids may seem shocking, but there is nothing surprising about it. Nationwide, we do 62 million CAT scans a year for 300 million people. So Cedar Rapids's rate was actually better than average. But all medicine is local. And until a community confronts what goes on in its own population - to the point of actually seeking the data and engaging those who can solve the problem - nothing will change.
The team from Portland told us of a collaboration of doctors, state officials, insurers and community leaders to improve care. For more than four years, physicians have been tracking some 60 measures of quality, like medication error rates for their patients, and meeting voluntary cost-reduction goals.
Asheville, after gaining state support to avoid antitrust concerns, merged two underutilized hospitals. In Sacramento, a decade of fierce competition among four rival health systems brought about elimination of unneeded beds, adoption of new electronic systems for patient data and a race to raise quality. Sacramento also went from being one of America's high-cost areas for health care to being among the low-cost elite.
In their own ways, each of these successful communities tells the same simple story: better, safer, lower-cost care is within reach. Many high-cost regions are just a few hours' drive from a lower-cost, higher-quality region. And in the more efficient areas, neither the physicians nor the citizens reported feeling that care is "rationed." Indeed, it's rational.
Many in Congress and the Obama administration seem to recognize this. The various reform bills making their way through the process have included provisions to protect successful medical communities by incorporating payment approaches that reward those that slow spending growth while improving patient outcomes. This is the right direction for reform.
There is a lot of troubling rhetoric being thrown around in the health care debate. But we don't need to be trapped between charges that reforms will ration care and doing nothing about costs and coverage. We must instead look at the communities that are already redesigning American health care for the better, and pursue ways for the nation to follow their lead.
Atul Gawande directs the Center for Surgery and Public Health at Brigham and Women's Hospital in Boston and is a staff writer at The New Yorker; Donald Berwick is the president of the Institute for Healthcare Improvement in Cambridge, Mass.; Elliott Fisher directs policy-reform efforts at the Dartmouth Institute for Health Policy and Clinical Practice; and Mark McClellan is the director of health care reform policy at the Brookings Institution. All are physicians.
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