After the death of a healthy research volunteer, administrators vow to improve safety standards.
Speaking deliberately and in a voice trembling with emotion, Dean/CEO Ed Miller took the stage at the Johns Hopkins Medicine town meeting at the end of July and pondered the tragedy that had rocked Hopkins and the nation. "Eight weeks ago tomorrow," Miller said, "Ellen Roche died at our institution...Each day I feel more the reality that this young woman who had her life ahead of her died in a human experimentation here at Johns Hopkins."
Few members of the faculty and staff had ever before seen Miller, a reserved and businesslike anesthesiologist, show emotion. But nothing about daily discourse on Hopkins’ medical campuses had been as usual since the death of Ellen Roche. "And it did happen on my watch," Miller said, "We have taken institutional responsibility for that."
Roche, a healthy 24-year-old employed at the Asthma and Allergy Center on the Johns Hopkins Bayview campus, had volunteered for what was thought to be a routine study conducted by Alkis Togias, a respected asthma expert. To understand what goes awry in the lungs of asthmatics during an attack, Togias wanted to observe how normal lungs respond to irritants and asked healthy volunteers to inhale a drug called hexamethonium. Within days, Roche was coughing, running a fever and had to be hospitalized for lung problems. Soon, she had to be put on a ventilator, and on June 2, she died.
The cause, a special Hopkins internal review committee found, probably had been the hexamethonium Roche inhaled. Togias hadn’t known enough about the drug before administering it, the committee said, and the Bayview Institutional Review Board (IRB) never should have approved the study.
In the aftermath of the tragedy, the federal Office for Human Research Protections (OHRP) came to campus to conduct its own review of the University’s guidelines for assessing research proposals involving human volunteers. Finding those methods not up to its standards, OHRP shut down all of Hopkins’ federally funded human-subject protocols, some 2,800 studies. Although many ongoing studies were quickly reinstated, about 1,700 will need to be re-reviewed over the next several months before they can begin again. The monthlong series of blows starting with Roche’s death drew worldwide attention to the School of Medicine.
"The result," Miller said, "is that we are going to have to raise the bar even higher to assure that patients and others who come for a study have the ultimate protection we can humanly give." He and Vice Dean for Research Chi Dang laid out a plan that will increase the number of permanent IRBs from three to fourthe third was added shortly after Roche’s deathrequire additional training for researchers who work with human subjects, tighten rules governing participation by students and employees as research volunteers and require that investigators work with a librarian and a pharmacist in reviewing non-FDA-approved substances to be administered to volunteers.
"Our goal,” Miller stated, "is to put in place a review process that will serve as a national model. We are a mature enough institution to look at ourselves critically, and if we have faults, to fix them. And there can’t be any slippagenoneno excuses whatsoever."
To read more of Miller’s thoughts on these events, see "Post-op."
Medicare must change, Bush asserts.
For the first time since taking office, President Bush came to Baltimore on July 13 and chose The Johns Hopkins Hospital as the place to kick off his plans for reforming Medicare. Accompanying him was Tommy Thompson, secretary of health and human services. Dean/CEO Edward D. Miller welcomed the president, noting that his visit topped off a day in which Hopkins once again had been named "America’s Best Hospital."
"Medicine changes, and Medicare has not," Bush told a Hurd Hall audience of about 120 that included doctors, nurses, two Maryland congressmen and the mayor of Baltimore (scores of employees, patients and staff watched on closed circuit TV). "Even though a lot of people think the 1965 Mustang was the best car ever made, it wasn’t very modern," Bush said, recalling that Medicare was established by Lyndon Johnson in that year. "And even though Medicare may be the best invention of man, it’s not very modern today."
The president called for competition for service to reduce premiums, stop-loss insurance for patients, and for seniors, like federal employees, the right to pick a plan that meets individual needs. "We need to take care of low-income seniors," he said, adding that Medicare Part A and B should be combined into one unified trust and that prescription drug benefits should be an integral part of Medicare. With the proper reforms, Bush concluded, doctors could actually spend more time practicing medicine and less on paperworkor in the courtroom.
Prior to the president’s speech, Wilmer Eye Institute Director Morton Goldberg invited Bush to sit for a few moments in the "president’s chair"the black leather perch used by the Institute’s first director, William Holland Wilmer, to examine eight United States presidents, from William McKinley to Franklin D. Roosevelt, as well as Charles Lindbergh.
Bush also visited the laboratory of Professor Ran Zeimer, where Goldberg demonstrated the DigiScope, a device that simplifies photographing the retina, and met with Bob McEwan, administrator of the transplant center.
Anne Bennett Swingle
Like the New York Yankees of the 1950s, The Johns Hopkins Hospital keeps coming out on top. For the 11th straight year, it garnered the No. 1 ranking among the nation’s elite hospitals according to U.S. News & World Report. The Mayo Clinic, Massachusetts General, Cleveland Clinic, UCLA Medical Center and Duke University Medical Center rounded out the top six.
Among the departmental rankings, Ear, Nose and Throat, Gynecology, Urology and Ophthalmology stayed at #1. Digestive Disorders moved to #2 (up from #3 last year), while Geriatrics and Rheumatology remained #2. Cancer, Pediatrics, Respiratory Disorders and Hormonal all remained#3, Heart and Orthopedics stayed at #4, Psychiatry remained #5, Kidney listed as #6 (up from #10), and Physical Medicine and Rehabilitation came in at #15 (up from #19).
Meanwhile, in ranking medical schools, the same magazine placed the School of Medicine second only to Harvard, also for the 11th consecutive year. That gap is closing. Of the nation’s 125 accredited medical schools, Harvard came in with an overall score of 100. We were a close second with 94, up dramatically from 73 points last year.
Back in 1992, when members of the Hospital’s Women’s Board were opening a coffee shop in the glitzy new Outpatient Center and convincing Tommy Schweizer to sign on as a volunteer, they told him he’d be able to cheer up the customers. Schweizer, a semiretired builder and longtime member of the board at the respected Rouse Company, started coming in every Wednesday morning. The Coffee Bar was just a two-pot shop in those days, so he had plenty of time to dole out his special brand of drollery along with coffee to patients, doctors and anyone else who wandered in.
Today, serving up at the compact eatery has grown more complicated. A long line presses against the counter, 12 pots are a-brewing, and 66,000 cups of coffee, along with 85,000 bagels and muffins, are dispensed each year. The Coffee Bar rakes in a profit of nearly $100,000, all of which the Women’s Board hands over to the Hospital.
Schweizer, meanwhile, has rarely missed a Wednesday in nine years, despite the increasing busyness and his advancing age (79 last summer). "It’s a real workout," he says. "When it really gets going, it’s a madhouse." Still nothing has deterred his tendency to kid around ("See the cranberries in that muffin? They’re just down from Nantucket.") because he knows that many of his customers have just received bad news from their doctor. He can see it in their eyes. Every once in a while his unflagging jocularity pays off. "Not long ago I heard a woman say, ‘Is that guy for real? That’s the only smile I’ve had today.’ A comment like that makes all those years worthwhile."
Like the three or four other stalwart male retirees who help staff the coffee shopalong with a cadre of Women’s Board volunteersSchweizer keeps coming back week after week. His old friend Ed Halle, a former Hospital senior vice president, explains his perseverance this way: "Tommy was in the Marine Corps, and he’s a marine at heart. He sticks at a job until it’s done. He’ll probably stick with the Coffee Bar until it’s doneor he’s done."
Instead of making huge incisions, surgeons these days can get to damaged parts deep in the body with a few tiny cuts and then work with unheard-of precision to make repairs. Such triumphs result not from newfound dexterity but a flood of technological developments that have hit the operating room in the last few years. Tiny, astonishingly sophisticated cameras now offer clear views of hidden-away organs; high-frequency instruments cut and cauterize tissue with almost no bleeding and with incredible exactness. So quickly, in fact, is new technology modernizing standard operations that surgeons often find themselves hard-pressed to learn the skills necessary for using the equipment. As of last spring, a futuristic lab here is set up to help them.
Covering almost the entire 12th floor of the building named for the preeminent 1940s surgeon-in-chief Alfred Blalock, the Johns Hopkins/United States Minimally Invasive Surgical Training Center lab, or MISTC, offers instruction in the latest endoscopic techniques. The lab includes two large surgical suites with nine stations, two of which are equipped with cameras that feed into a small lecture hall. With the touch of a computer keypad, an instructor can display digital images on a big screen of what’s going on at the station, including endoscopic views. Lectures can be broadcast anywhere in the world.
MISTC offers specialists from all over a chance to practice the latest minimally invasive techniques on animals, cadavers and mannequins before heading for the OR. It also provides a stage for using CT or MRI imaging as guides in placing instruments, and a place for representatives from medical supply companies to test new instruments.
Launched with $5 million from US Surgical Supply and Stryker Communications, and directed by surgeons Paul Flint and Greg Bulkley, the self-supporting facility serves as home base for Hopkins continuing medical education courses in the burgeoning field. Day-to-day operations are handled by Director of Education Randy Brown, an associate professor in comparative medicine and surgery.
An unusual new center offers all sorts of possibilities to patients who want to avoid transfusions.
For years, some patients have refused transfusions. Most are Jehovah’s Witnesses whose religion forbids accepting donor blood, but a scattering simply don’t want to take any chance of contracting an infection through someone else’s blood. (Scientists say such risks now are minuscule thanks to sensitive screening tests, but memories of HIV acquired through transfusions remain fresh.) For such reasons, finding ways to reduce the need for human blood in medical care makes good sense, says hematologist Thomas Kickler, director of the Eugene and Mary B. Meyer Center for Advanced Transfusion Practices and Blood Research.
Funded by a trust set up by the late faculty psychiatrist Eugene Meyer, the unusual center makes it possible for specialists like anesthesiologists and surgeons to perform major operations that normally require an abundance of blood—think hip replacements and organ transplantsfree of transfusions. To carry out these “bloodless” surgeries, ATP physicians use an array of techniques to conserve the patient’s blood. Drugs like erythropoietin expand the number of oxygen-carrying red cells before the operation begins. Hemodilution—removing blood immediately prior to surgery and reinfusing it when bleeding occursavoids the need for donor blood. And taking only a fraction of the usual quantity of blood for post-operative testingmicrosamplingdoesn’t deplete the blood count.
Meanwhile, the search is on to find alternatives for human bloodoxygen carrier substitutes, as Kickler prefers to call them. A handful of companies are locked in the race, and the winner could make a financial killing. Substitutes, which perform the job of only the red blood cells, have shelf lives of one to three years (stored human blood is good for only 42 days), require no refrigeration and are compatible with all blood types. They would go a long way toward boosting the blood supply. Restrictions on who can donate are broadening, and since the mid-1990s, the cost of blood has roughly doubled to $130 a unit. In July the American Red Cross, which furnishes about half the nation’s supply, raised its prices by $30 to $50 a unit.
ATP Center clinical investigators from both Anesthesia and Transfusion Medicine have played a lead role in evaluating blood substitutes made from human or animal hemoglobin, the oxygen-carrying part of blood, and using them with hemodilution in complex surgeries. And in the only university-based effort in the nation, these scientists also have been making a genetically engineered blood substitute to try to produce a recombinant substitutea molecule so close to human hemoglobin that patients will have no negative reactions.
Spearheading the search for this recombinant substitute is Clara Fronticelli, a lifelong hemoglobin researcher who came out of retirement in 1998 to take on the quest. Since then, working in a cramped lab with just one fellow, a technician and no links to industry, she has been able to obtain and purify a hemoglobin molecule and use a process called polymerization to link a chain of the molecules together so they will not be swept out of the body before delivering oxygen to the blood. These totally synthetic molecules are being tested on animals with stroke, hemorrhagic hypotension and blood infections in the labs of Richard Traystman, director of research for Anesthesiology and Critical Care Medicine, and his colleague Raymond Koehler.
Kickler says that until recently, patients who wanted to avoid blood products had limited options. “With the advances now available at the ATP Center, they’ve gained an array of possibilities."
If the word bug arises on an ordinary day in the Children’s Center, it’s probably in reference to some minor infection. But last spring bugs took on a new meaning when a crowd gathered to cheer on Pediatrics Chairman George Dover as he downed a mid-morning snack of mealworms, crickets and beetle larvae.
The event, held in the Center’s Zoo Lobby, was part of the grand finale to the annual Radiothon for the Children’s Center. The nonstop, 106-hour broadcast features interviews with patients and their families and a culminating stunt to help boost donations. This year, the show’s two local radio personalities vowed to eat one bug for every $100,000 pledged by listeners, and Dover joined thempledges eventually totaled $745,426. The stunt was dubbed the "Wheel of Ick" because a roulette-like wheel determined the type of insect that would be ingested. A farm in Ohio specializing in edible insects supplied the delectables.
Moments before the event began, a Children’s Center staffer offered Dover some candy GummiWorms in case he wanted to fake his way through the insect-eating ordeal. Dover declined, although he did return later to see if the GummiWorms could help him get rid of the buggy taste in his mouth.
A mini museum emerges in the room under the dome where the great physician penned his masterpiece.
In 1891,William Osler, The Johns Hopkins Hospital’s first physician in chief, took over a narrow room on the Hospital’s second floor belonging to Hunter Robb, chief resident in gynecology, and sat down to write. Over the summer and into the fall, Osler worked almost non-stop laying out ideas for teaching physicians to care for the sick. The postgraduate medical education he proposed would go on to become the standard for the nation. When Osler had finished, he tossed the manuscript for The Principles and Practice of Medicine into the lap of his fiancee, Grace Revere. "Here is the book," he said. "Now you can have the man."
Over the years, the room where Osler penned his renowned textbook gained an ugly false ceiling and a few pieces of battered metal furniture and became simply one more office. Few people had any idea of the place it held in American medicine. Two longtime members of the Hopkins medical faculty, however, Stephen Achuff and Victor McKusick, couldn’t forget.
Two years ago, Achuff and McKusick set out to set the picture right. They raised $150,000 from fellow faculty and friends to fund a restoration of the room. Then, to assure historical accuracy, they worked with Hopkins’ Alan Mason Chesney Medical Archives and hired Peg Walsh, a respected interior designer who’s handled other restorations for the Hospital. Last May, the Textbook Room, full of Osleriana, opened.
Among the items on display are the silver bowl that Osler and his new bride received as a wedding gift when they married shortly after the book was finished, Osler’s stethoscope and the latchkey to his home on Franklin Street. The desk, though not the one at which Osler penned his famous treatise, is a Franklin Street original.
Achuff and McKusick see the room as a "living memorial," a place where scholars can read about Osler and small groups can discuss the history of medicine or see videotaped interviews and talks. They are still in search of Osleriana, particularly the first-edition copy of Principles and Practice inscribed by Osler to Robb, whose room he commandeered for all those months.
"So much of what makes Hopkins unique is its traditions," Achuff says. "Today, when medicine is changingand so much of that change is badit helps to look back and balance those pernicious trends by honoring Osler for the ideals he instilled in us."
For nine years, Ed McCarthy’s cello sat in its case. McCarthy, a professor of pathology and orthopedic surgery, found it a vexing state of affairs. He’d been a cellist long before he was a doctor, studied the instrument in elementary school, played all through his undergraduate years at Columbia University. Even after arriving in Baltimore in the 1970s, he’d taken lessons from renowned teachers at the Peabody Institute and Baltimore Symphony Orchestra and given recitals all over town.
Mary King, a conservatory-educated violist and first-year medical student, finally put an end to McCarthy’s dry spell. The popular med school teacher had first met King when he was on the admissions committee. "I thought about asking her to play when she interviewed, but I didn’t want her to think I was looking over her shoulder," McCarthy remembers.
Imagine his delight then when, last winter, King called him to ask if he’d be interested in forming a string quartet. The two didn’t have to look far to recruit two violinists, first-year student Ingrid Burger, an accomplished musician from Arizona, and M.D./Ph.D. candidate Rowena McBeath from Alaska who had played with a full orchestra when she was just 14. When the four finally sat down to play one night in February, "we realized from the first minute that we had something special," McCarthy says.
Late last spring, the Vesalius Quartet, named after the 16th-century Belgian anatomist whose elegant drawings of the human body dispelled ancient misconceptions, burst upon the Hopkins scene with a stirring performance of Beethoven’s String Quartet, Op. 18, No. 1, a piece that McCarthy describes as "of intermediate difficultynot as easy as Haydn or Mozart nor as hard as late Beethoven or Dvorak." It’s quite long and can test sheer stamina, but the quartet executed all four movements with grace and a finely tuned sensibility. The performance, which took place in the soaring atrium of the Weinberg Building, was part of a music and lecture series called "The Art of Healing."
The mystifying connection between music and medicine has long been a source of fascination for McCarthy, who is working on a book about the therapeutic value of music. As for Vesalius, McCarthy says he’s in it for the duration, for at least as long as the students are here, so happy is he to be making music again. "I’ve gone through periods before when I didn’t touch my cello for years. Of course, I always listened to music. I couldn’t live without it."
After decades in residence in the Park Building, last spring the Johns Hopkins Children’s Center primary care clinics moved across campus to the ground floor of the recently vacated Jefferson Building (former Oncology Center). There, the Harriet Lane Primary Care Clinic, the Teen and Adolescent Clinic and the Intensive Primary Care Clinic have consolidated into a single new unit known as the Harriet Lane Primary Care Center for Children and Adolescents.
Among the benefits of consolidating the three clinics is convenience for families with children of different ages, who will no longer have to visit doctors in different areas of the hospital. The move also frees up space for expanding and renovating the Pediatric Emergency Department on Park 1.