FDA Device Panels: Undisclosed Conflicts and Loss of Public Trust

FDA Advisers’ Financial Ties Not Disclosed

Many Doctors Who Sit on Food and Drug Administration Panels Reviewing Medical Devices Have Links to Device Makers Undisclosed by the FDA

The FDA, which operates from these headquarters offices in Silver Spring, Md., seeks advice on medical-device approvals from a number of doctors and scientists with financial ties to device makers that the agency doesn’t publicly disclose. REUTERS

By JOSEPH WALKER

Dec. 8, 2014 10:33 p.m. ET

David Kandzari, an Atlanta cardiologist, also has worked as a consultant to makers of medical devices. He received at least $100,000 from them in five years, according to corporate and government data.

Another organization he works with, the Food and Drug Administration, doesn’t appear to mind. In October, the FDA put Dr. Kandzari on a panel reviewing a medical device made by Boston Scientific Corp. , one of the companies he has advised.The FDA didn’t disclose the connection. It was among numerous financial ties the FDA hasn’t disclosed between medical-device makers and the doctors and other experts who review devices for it, a Wall Street Journal analysis of corporate, state and federal data shows.

In panels evaluating devices involved in cardiology, orthopedics and gynecology from 2012 through 2014, a third of 122 members had received compensation—such as money, research grants or travel and food—from medical-device companies, an examination of databases shows.

Nearly 10% of the FDA advisers received something of value from the specific company whose product they were evaluating.

The FDA disclosed roughly 1% of these corporate connections.

The situation concerns critics. “Undisclosed conflicts raise questions about the decision-making capacity of the committees and whether the public can have confidence in their recommendations,” said Joseph Ross, an associate professor at Yale School of Medicine.

The FDA follows the committees’ advice in a large majority of instances, on prescription drugs as well as on medical devices. On devices, it has convened more than 20 meetings this year for recommendations on whether to approve novel products or put new regulations on older ones.

The issue arose most recently in July regarding a panel evaluating surgical tools called power morcellators that cut up uterine fibroid growths. A gynecologist stepped down from the panel not long after the Journal inquired about payments he had received from a maker of the devices, a connection the FDA hadn’t disclosed.

The FDA said under current law and policy, it discloses advisers’ financial interests only when it has determined the experts need a waiver in order to serve.

In making this determination, it has discretion. Having done paid work for a medical-device company doesn’t disqualify a doctor or scientist from sitting on an advisory panel, nor require public disclosure, as long as the work wasn’t related to the specific topic or product the panel focuses on, FDA officials said.

Current consulting work that is directly related to a panel topic is typically a disqualifying conflict, as is ownership of a large amount of the device maker’s stock, said FDA Associate Commissioner Jill Hartzler Warner. Still, if the FDA believes the individual’s expertise can’t be found elsewhere, it can issue a waiver.

It posts such waivers on its website. The agency said it can’t reveal any other financial ties or potential conflicts because what its scientific advisers tell it is confidential.

“Our challenge and our goal is to retain public confidence in the advisory-committee process and at the same time to obtain the very best advice,” Ms. Hartzler Warner said.

“If you have a financial interest with a sponsor or a related firm, but it’s not related to the product at the meeting, it’s not disqualifying,” she said. “The firms are often large and diverse, and whatever position the FDA takes, it won’t affect the relationship between the firm and the” expert adviser.

Doctors said their consulting work doesn’t affect their panel decisions. “I’ve never sat there on a panel and thought, ‘I wonder what my friends at companies X, Y and Z would say.’ I just don’t view it that way,” Dr. Kandzari said.

In the panel in October, he voted to approve a heart device from Boston Scientific, a firm that has paid him between $5,700 and $8,190 in consulting fees and expenses for food, travel and lodging since 2011, according to company data. The consulting didn’t concern the kind of device the October panel evaluated, so it posed no conflict, he said.

Dr. Kandzari confirmed he has consulted for various device makers. He questioned the accuracy of payment data posted by companies, saying, among other things, that some payments were actually made to his employer.

As for Boston Scientific, it said that device makers “are not consulted, or engaged in any way in the selection of panel members.”

The FDA said broader disclosure could discourage people from sitting on advisory panels. The agency already has a challenge getting highly qualified experts to sign on, Ms. Hartzler Warner said. Edward Y. Cheng, an orthopedic surgeon at the University of Minnesota Medical School and Cancer Center, said doctors have a strong financial disincentive to serve because they must take time away from their practices.

Among ties not disclosed by the FDA were $6,666 in consulting fees Dr. Cheng received from a maker of all-metal hip implants a year before he sat on a panel evaluating the safety of that type of hip. Dr. Cheng said the work was unrelated to all-metal hips.

Dr. Cheng said it is the FDA’s job to gauge whether a conflict exists but added: “if I personally thought a conflict existed that would affect my ability to remain unbiased, I would decline to participate.” The FDA said it doesn’t comment on individual panel advisers or their finances.

There is no central way for the public to learn of ties between panel members and makers of medical devices or drugs, which pay hundreds of millions of dollars a year to physicians in consulting, speaking and other fees, according to data from the Centers for Medicare and Medicaid Services. Concerns that such ties could affect doctors’ medical decisions have led to calls for greater transparency.

Many large drug and device companies post their payments to doctors online, often as part of legal settlements over fraud allegations. Some states, including Massachusetts and Vermont, post payments to physicians in their areas.

Doctors often must disclose potential conflicts when writing for scientific journals or giving presentations at medical meetings. The federal government this year launched a database called Open Payments, which so far has five months of 2013 data on company payments to doctors and teaching hospitals. The Journal used all these sources as well as archives maintained by PharmaShine, a service of Obsidian Healthcare Disclosure Services LLC.

No database reveals doctors’ and medical scientists’ stockholdings, so any search can give only a partial picture of financial ties.

The Journal’s tally of payments to members of panels on cardiology, orthopedic and gynecology devices in 2014 found that 64% received no value from device makers in the past five years. The rest did, varying from less than $15 for food and beverage to more than $500,000 in research funding.

Of doctors who received something from companies, 32% got less than $500 in value and 26% received $10,000 of value or greater.

Before advisory-panel meetings, the FDA asks potential members to report all financial ties, including consulting fees, research grants and stock, in companies with business before the panel and their competitors. In general, if the value of current interests exceeds $50,000, a person will be excluded, said an FDA guidance document.

If the agency decides a payment isn’t truly a conflict, it can issue what is called a “502 authorization” letting the person serve, said Ms. Hartzler Warner.

The 502 authorizations, unlike waivers, aren’t publicly disclosed.

The FDA declined to say how many 502 authorizations it issues annually.

“The problem with the FDA’s policy is you don’t know how they use their discretion,” said Celia Wexler, a lobbyist for the Union of Concerned Scientists, a group that opposes political interference in scientific and regulatory matters.

“It’s very difficult for us to know to what extent the FDA probes, and the extent to which panel members take the disclosure requirements seriously.”

Shortly before the July panel on morcellator surgical devices—which reviewed concerns they could spread hidden uterine cancers—the Journal discovered that panel member Andrew Brill had received nearly $100,000 in consulting fees in 2013 from Johnson & Johnson , then the largest maker of morcellators. The information was on a J&J-run public database, which also shows that another J&J unit paid $6,000 to Dr. Brill in 2013.

Dr. Brill resigned from the panel just before it met. The FDA said he recused himself because of his financial interests with companies. It declined to discuss why it initially appointed him to the panel. Dr. Brill declined to comment.

Documents posted on the website of the American Association of Gynecologic Laparoscopists show Dr. Brill also had ties to another morcellator maker, Karl Storz GmbH of Germany, for which he was a consultant and speaker in 2012.

Another corporate connection the FDA didn’t disclose: Dr. Brill sat on a panel examining risks of surgical mesh products, which are used to support internal organs and treat urinary incontinence, in 2011—a year when he received $82,600 from J&J subsidiaries, including one that makes surgical mesh. The information is on J&J’s website.

J&J declined to comment. It pulled its morcellators from the market earlier this year. Karl Storz didn’t respond to requests for comment.

Keith Isaacson, a doctor who served on the morcellator panel, had received nearly $12,000 in consulting fees from a J&J subsidiary in 2013, the Journal reported in July. Further review of databases shows that Dr. Isaacson also got $9,500 from J&J from 2010 through 2012 for consulting, food and education and training; and that he received $148,400 in consulting fees and other compensation from Karl Storz from 2009 through 2013. The information came from websites of J&J, a Massachusetts health agency and Open Payments.

At the panel’s meeting, Dr. Isaacson expressed doubt about data showing that women getting surgery for fibroids have a 1 in 350 chance of having malignant tumors that morcellators could spread, a panel transcript shows. He noted a recent study that found the risk was closer to 1 in 7,450.

Dr. Isaacson declined to comment. The FDA wouldn’t discuss the payments or why it placed Dr. Isaacson on the panel in view of these corporate ties.

Dr. Kandzari, the cardiologist who served on an October FDA panel evaluating a heart device, is the director of interventional cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta. He has published many medical-journal articles. He said his consulting for device companies is aimed at helping firms design more-efficient clinical trials.

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One FDA panel Dr. Kandzari sat on last year considered a pacemaker and a defibrillator made by Medtronic Inc. That is a company from which Dr. Kandzari received between $76,600 and $130,600 for consulting work, teaching, travel, lodging and meals from 2010 through 2013, according to company and federal databases. A panel transcript shows he abstained from voting on whether to approve expanded use of the devices because he wasn’t sure whether the benefits outweighed the risks.

Dr. Kandzari said his past consulting for Boston Scientific, the maker of the device that was being evaluated at the October panel, had concerned an arterial stent. The October panel focused on a different Boston Scientific product: a plug that seals a heart appendage to cut the risk of strokes caused by clots.

That plug, called the Watchman, had been backed by previous FDA panels but was being reviewed again because a study showed patients receiving it had more strokes caused by blood clots than patients getting the blood thinner warfarin.

While the panel in October deemed the device safe, a narrow majority that included Dr. Kandzari judged it not as effective as warfarin. Still, he voted yes in a 6-5 panel vote concluding its benefits outweighed its risks, tantamount to a recommendation of marketing approval.

Dr. Kandzari said despite his concerns that “stroke was not necessarily reduced with this technology,” he believed it should be available for patients who are at high risk of complications from warfarin.

Following the advisers’ vote, Boston Scientific told analysts it expected the Watchman to win FDA approval in the first half of 2015 and eventually reach $500 million in yearly sales.

—Andrea Fuller contributed to this article.

Write to Joseph Walker at joseph.walker@wsj.com

J&J Morcellation Surgery Device May Unleash Deadly Cancer

 Morcellation Surgery: When CuttingEdge Kills

How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?

By Harriet Brown  Photograph by Jamie Young  FiDA Highlight

On good mornings, Hooman Noorchashm wakes early, a relic of the days when he rose at 4:30 am for surgical rounds at Brigham and Women's Hospital. He pads through the quiet house to pop a coffee pod into the machine, then heads for his home office, where, over the course of the day, he will calmly, deliberately compose and send dozens of emails.

Doctor. Mother of six. Stage 4 cancer patient. Amy Reed may not have much time to live, but she's making sure her death won't be in vain.

His wife, Amy Reed, sleeps till 6:30 am, when she slips on a red Phillies T-shirt, snugs a maroon jersey cap over her stubbled head, and begins the work of getting six children under 12 ready for the day. An anesthesiologist at Beth Israel Deaconess Medical Center, Reed was on the team that treated both the Boston Marathon bomber and his victims. She is by nature even-keeled. You'd want her as your anesthesiologist. You'd want her sharp intelligence and steady presence with you in the OR. She and her husband aren't people who "do drama," as they put it. They're experienced doctors who argue logically rather than raise their voices or yell or cry.

On good mornings, then, in the face of events that have devastated their family, this composure seems both a gift and a burden. Last fall, a routine hysterectomy seeded cancer throughout Reed's abdomen. The hysterectomy didn't cause the cancer, but it very likely transformed it from stage 1 disease, with a 60% 5-year survival rate, to stage 4 disease, with a grim prognosis. About 85% of women like Reed are dead 5 years after diagnosis.

Reed's surgeon, one of the best in the country, wasn't to blame for the catastrophe. Nor was this a random disaster, the kind of bad-luck bolt from the blue that can strike anyone—the brick falling off the building, the truck spinning on the icy highway. The cancer upstaging was a preventable consequence of a surgical technique, one that is still being used in operating rooms around the country.

And this is what Noorchashm and Reed can't bear. This is what keeps him doggedly online, in the research, on the phone, whether he's home or sitting by Reed's hospital bed or driving her to and from chemo. The effort has led to international attention, much of it critical. Noorchashm's incendiary question: When new technology makes medicine cheaper and more convenient, how many patients have to die to prove it's not worth it?

"People have faulted my husband's enthusiasm," Reed says of Noorchashm. "But women are having this surgery right now." 

On good mornings, his arguments land as powerfully as his wife's even gaze. "People have faulted my husband's enthusiasm," Reed says on one of those mornings. "But women are having this surgery right now. Today. And they're going to have their lives destroyed, just like ours."

This year, more than half a million women in the United States will undergo hysterectomies. The majority will be between 40 and 55 years old, and, like Reed, most will have the surgery for fibroids, benign growths in the uterus that can cause pain, bleeding, and other symptoms. Five years ago, only about 12% of these surgeries were performed laparoscopically, done through incisions just big enough to fit a scope and tiny camera. Last year, nearly 30% were done that way, and the numbers were considered likely to rise.

Compared with traditional open abdominal procedures, laparoscopic surgeries were said to result in shorter hospital stays (and, therefore, lower costs for insurers), faster healing, less pain, fewer infections, and smaller scars. Still, when Reed first discussed hysterectomy with her surgeon, she asked for an open operation, despite the larger incision and longer recovery time. "I said, ‘I'm an anesthesiologist. I know how they operate. I'd rather have them see what they're dealing with and not mess around with little holes,' " she recalls. "Laparoscopic surgery's not all it's touted to be sometimes."

She'd known about her fibroids for a while, but the bleeding and pain had ramped up dramatically during her last pregnancy. Her husband arranged a consult with a colleague, Michael Muto, who directs the gynecological oncology fellowship at Brigham and Women's, which is Harvard's teaching hospital and an industry standard-bearer. As Reed remembers, Muto reassured her that the problem was "a no-brainer"; she'd have her uterus removed, and that would be that. "He told me, ‘This is not cancer, it's not anything terrible, this is what fibroids do.' " She says this quietly, matter-of-factly, 3 months later, sitting in the sun-splashed living room of a white clapboard house on a narrow street in the Boston suburb of Needham. From time to time she reaches under her cap to rub at a spot where her hair is starting to grow back, white fuzz now laced through the dark.

Muto said no surgeon would do what she wanted. You're young and healthy, Reed remembers being told; there's no reason in the world to have this done as an open surgery. "Dr. Muto wears a nice white coat with the Harvard emblem on it," says Noorchashm, sitting across from Reed. "He's my colleague, and we trust our own establishment." He pauses, and then corrects himself. "I trusted the establishment."

So Reed had MRIs and biopsies to check for cancer, as is standard before a fibroid operation, and went ahead with the laparoscopic hysterectomy. She went home that afternoon, and everything was fine until the surgeon called 8 days later to say that the pathology report showed leiomyosarcoma, a cancer in her uterus. And nothing has been fine since then.

Imagine a hive filled with angry bees flying this way and that, buzzing, darting, stingers at the ready. Now picture that hive inside a woman's belly, where at any moment the bees could explode through the body, wreaking the deadliest kind of havoc. The hive, says Noorchashm, is a good metaphor for a sarcoma, a kind of cancer that can grow anywhere in the body. He's operated on sarcomas and knows that the way to handle them is to carefully remove them in one piece. Now imagine inserting a long spinning saw—something like a handheld blender—into the hive while it's still inside the woman's body and cutting it up into tiny pieces. "What's going to happen," says Noorchashm, "is a million bees are going to come out and you're dead."

That saw is called a morcellator, and over the past 10 years or so, it's become standard procedure in laparoscopic surgeries to remove fibroids, the uterus, or both. "Morcellation prevents you from having to make a larger incision," says Larry Kaiser, dean of the Temple University School of Medicine. "You couldn't take the uterus with fibroids out through these small ports used for the camera and instruments."

The trouble is, some cancers—like leiomyosarcoma—don't show up on biopsies or MRIs done before surgery. If a woman's uterus is morcellated inside her body, cancer cells are spewed around the abdomen, where they cling to internal organs and, inevitably, grow. Even benign tissue that's morcellated can implant in the abdomen and trigger pain, bowel obstructions, and other problems.

Morcellation is what Reed and Noorchashm want to stop, arguing that it's unacceptable if there's any chance of hidden cancer—and there's pretty much always a chance. "It's flawed surgical procedure," says Noorchashm. Some ob-gyn surgeons say morcellation is safe if it's done in a containment bag, something like the bag inside a vacuum cleaner. Noorchashm disagrees. Bags can break, he says, especially when you're using a rotating power saw. Instead, he and Reed want surgeons to remove the whole, unmorcellated uterus vaginally when they can, and do the old-fashioned open surgery when they can't.

On the day Reed got the bad news, Noorchashm was down at Duke, preparing for surgery. After he got the call, he scrubbed out, booked a ticket home, and left. In the cab on the way to the airport, he called Muto, who told him what he'd already told Reed: Leiomyosarcoma is so rare there are no protocols for treating it, no best practices, no good survival statistics. Some doctors do nothing, waiting to see if it comes back; some start chemotherapy to try to stave it off; some schedule surgery to clean out anything that's already growing.

Noorchashm was horrified, both by the stark reality of the facts and by the offhand way he felt they were being delivered. "In my mind, when I hear sarcoma, and the sarcoma has been broken up inside, that's a five-alarm fire," he says. "And here's a surgeon thinking, We have three options, including watching and waiting. That's like taking a water gun and shooting at a five-alarm fire."

That day in the Raleigh-Durham airport, an advocate was born. Noorchashm began researching, making phone calls, and sending hundreds of emails to anyone he thought might make a difference—family, friends, colleagues, doctors, researchers, journalists, editors of medical journals. He and Reed (who at the time felt physically fine despite the cancer inside her) created a petition on Change.org calling for a ban on the practice.

Doctors and administrators maintained that what happened to Reed was unfortunate but incredibly rare and that it didn't make sense to abandon morcellation—a convenient and widely usable technique—because of such an unusual occurrence. The largest professional organization for ob-gyn surgeons, the American Association of Gynecologic Laparoscopists, issued an official statement disagreeing with putting limits on the procedure.

Some ob-gyns pointed out that the alternative laparoscopic techniques (removing tissue vaginally or morcellating in a bag) aren't an option for women with large fibroids—and worried that restrictions would lead to thousands of unnecessarily invasive open surgeries. These can cause more blood clots and infections, both of which can be lethal, says Joseph Ramieri, an ob-gyn surgeon and professor at Mount Sinai School of Medicine. "I'm not defending morcellation—as a technique, it leaves an awful lot to be desired," he says. "But it needs further study before we put limitations on it."

Noorchashm and Reed were asking for a huge shift in medical practice, and physicians, especially surgeons, can be slow to change, says Brian Van Tine, a physician who heads the Sarcoma Program at Barnes-Jewish Hospital in St. Louis. Part of the resistance was likely financial. If, say, half of the women who have hysterectomies have abdominal surgery rather than laparoscopy and must spend an extra day or two in the hospital, that's a lot of extra costs for insurance companies to cover. "Morcellation saves money," Van Tine says, "and these surgeries are a huge moneymaker."

As a result of the couple's efforts, new information emerged about just how uncommon leiomyosarcoma really was. Reed says that Muto, who refused to comment for this story, told her the cancer affects 1 in 10,000 women, but that statistic was based on the population at large. Among women with symptomatic fibroids, the number may be closer to 1 in 415, Noorchashm discovered—incredibly, from a paper listing Muto himself as a coauthor. In fact, Reed was the second woman within a year whose cancer was upstaged by morcellation at Brigham and Women's Hospital alone. The first woman has since died. Since Reed's surgery, at least five other women around the country whose cancers were upstaged by morcellation have come forth. And there are certainly others out there.

Though Reed's odds of living to see her youngest son graduate from high school are slim, she chooses not to focus on the numbers. 

As the winter progressed, Reed committed herself to doctors' visits and weighing treatment options—and remaining an upbeat, present mom to her children. Noorchashm stayed up nights writing strongly worded letters, posting comments on every website remotely relevant to the cause, and having strategic conversations with anyone who would talk to him. The only resulting change he saw was in his own reputation. He'd gone from star surgeon to social leper, shut out of the operating room at his own hospital (though he can't prove it was because of the campaign) and avoided by colleagues and former friends. "They closed ranks on me," he says now, with sadness in his voice. "I broke the white code of silence; I hung out our dirty laundry."

But he pushed on. He contacted hospital executives, the FDA, legislators. In return, his bosses at Brigham emailed faculty and staff warning them not to talk to Noorchashm and to speak to the hospital's chief medical officer if contacted by Noorchashm. Gerald Joseph, vice president of the American Congress of Obstetricians and Gynecologists, wrote to a colleague about Noorchashm: "Nothing is going to create any peace in this man."

And then, in February, something shifted. Kaiser (the dean at Temple) passed Noorchashm's materials to the head of gynecology, who responded by making the institution the first to ban open morcellation, requiring surgeons to use an isolation bag or not morcellate at all. Within weeks, another hospital got on board: Rochester General Health System declared that its surgeons wouldn't morcellate without a bag. Noorchashm wasn't satisfied—the bags could break, he said. He carried on with his campaign.

At the end of March, 5 months after the surgery that spread Reed's cancer, Brigham and Women's—Noorchashm's own employer—did the thing no one expected. The same administrators who had shaken their heads at this angry, disenfranchised surgeon finally acknowledged his case. They banned fibroid morcellation without a bag. Then, in mid-April, the FDA came out with a new analysis: A shocking 1 in 350 women seeking the removal of symptomatic fibroids has a hidden cancer, it said. The FDA issued an advisory strongly discouraging the use of morcellation, crediting Noorchashm with bringing the issue to its attention. More institutions, including the University of Pennsylvania Health System and Cleveland Clinic, changed policies. And Johnson & Johnson, the biggest morcellator maker in the United States, suspended production and sale of the tool. Noorchashm's life was shattered, but he had achieved much of his goal. "We have the privilege of being able to give meaning to what's happened to us," he says. "That gives us strength."

But he and Reed aren't finished. The FDA will hold a hearing in July, and Noorchashm expects it to be contentious. "That's when the likes of Gerald Joseph"—the man who said that Noorchashm would never find peace—"will come in with their suits and their lawyers and make arguments about the 'benefit of the majority,' " he says. "But medicine is not a popularity contest. You have to practice in a way that every single person matters."

Reed knows her chances of living to see her youngest son graduate from high school are slim. She copes, in part, by resisting the urge to focus on probabilities. The first time she Googled leiomyosarcoma—the day the surgeon called her—was also the last. "If your chance of living is 30% versus 70%—I don't even know what to do with that," she says. "You don't live 30%. You live or die. And either way, today I could be hit by a car."

She certainly wasn't the type to wait around for her cancer to spread. She opted instead for a radical procedure, performed by only a few surgeons in the country. The Sugarbaker operation, named for its inventor, Paul Sugarbaker, is a brutal 9-hour surgery that removes all visible evidence of sarcoma, as well as the patient's appendix, gallbladder, omentum (the fatty covering of the intestines), and peritoneum. Once the organs are gone, surgeons pour heated chemotherapy into the abdominal cavity and let it sit for 90 minutes. Sugarbaker told Reed that if the surgery went well, she'd have an 80% chance of having no recurrence in her belly in 10 years. In other words, she'd be back to baseline, back to where she would have been if the cancer had not been upstaged. "That was the best number I'd heard," she says, her eyes a little teary for the first time. So in November, she and Noorchashm flew to Washington, DC, for the surgery. Before getting on the plane, she nursed her youngest son, then 14 months old, for the last time and handed him to her mother.

Reed's recovery was more grueling than she'd anticipated. She couldn't eat for 10 days and lost 20 pounds. The incision, which runs from her sternum to her pubic bone, was so taut she couldn't stand up straight for weeks; even now she sometimes hunches to minimize the pain. Once that healed, she started on a course of chemotherapy, which just finished. And now comes the hardest part. "I'm afraid to be done with chemo," she says one afternoon, her youngest son curled on her lap under a blanket. "At least I was poisoning the cancer. Now what happens? Now I wait?"

Her son sits up suddenly and grabs a plastic hippo, making it clomp across the kitchen table. Reed holds the boy loosely, one arm across his legs, and when he slides off her lap to chase a squirrel from one window to another, she lets him go without hesitation. She's started making plans for the near future, for the time when they can get back to some semblance of normal life. She's maintained a research lab over the past 10 years, and she and Noorchashm are talking about working together to study, and ultimately defeat, leiomyosarcoma. "We have the know-how, and we certainly have the drive," she says.

At 2 am the house is quiet. Reed and the children sleep upstairs, but Noorchashm is still awake downstairs. He sits alone in a small pool of light, staring at a bronze statue on the mantel: St. George on his horse, his magical spear poised to slay the dragon. In the story, George kills the dragon to save not just the princess but also the rest of the town's children, who were being fed to the dragon one by one to appease it.

It's a metaphor, Noorchashm thinks. No, it's more than a metaphor; it's the new story of their lives, a fight to the death with the powerful creature that has changed their world forever. The horse is the media and doctors he's rallying to the cause; the shield represents the status of being a cardiac surgeon at Harvard. In some versions of the myth, the princess lives but George winds up dead; in others they get a happily-ever-after ending.

Noorchashm is a realist; he knows that odds are he will lose his wife sooner rather than later. He may also lose his career, but he's not worried about that just now. He's focused on the moment, the here and now. This fight he and his wife are immersed in, a fight not of their choosing.

He taps his long surgeon's fingers against the metal, sets the statue down on the desk, pulls the laptop closer, and opens a new email. He is not just George but the spear itself, aimed at the dark and bitter heart of the monster.