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On Oct. 22, some 5,000 physicians will convene in Washington for five days of discussions about high-tech heart treatments. Representatives of more than 160 medical- device companies also will be there to promote their valves, catheters, and stents. This annual confluence of medicine and commerce is carefully choreographed, but still, things don't always go as planned.
In September, 2004, with thousands of doctors at the conference watching live by satellite on giant screens, a cardiologist in Milan inserted an experimental heart valve into a gravely ill patient. Suddenly the patient's heart began to fail. For 45 minutes the stunned audience watched a series of desperate life-saving attempts, until finally the satellite transmission was cut. The patient died later that day. "It was harrowing," says Dr. Martin B. Leon, the New York heart specialist who started the influential conference 18 years ago. "That was a very difficult thing for us."
Leon's anguish over the incident remains palpable, but he also had a financial interest in seeing the valve work. He co-founded the small company that invented the device. That company was sold to Edwards Lifesciences (EW) just a few months before the device was used in the televised procedure. The deal netted Leon $6 million in cash, plus the chance to earn an additional $1.5 million if the product achieved certain milestones, one of which related to the number of patients successfully treated.
Did Leon's financial stake in the experimental device play a role in its being promoted at an important conference where he is the most prominent figure? "Absolutely not," Leon says. The question, he adds, "borders on being offensive." Nevertheless, he now wonders whether the technology was refined enough to be ready for prime time.
As Leon prepares for this year's conference, he does so amid renewed anxiety over the mixing of medical and corporate interests. Spurred by widespread concern that industry money has too much influence on patient care, the nation's leading medical institutions are reining in doctors. In May, the Cleveland Clinic tightened its conflict-of- interest procedures after ties between device companies and prominent doctors there came to light. Several top academic medical centers have ordered physicians not to accept even trivial company giveaways. "We don't think about whose pen we're holding or who bought us that last pizza, but it creates influence," says Dr. P.J. Brennan, chief medical officer of the University of Pennsylvania Health System.
Leon's career illustrates the potential conflicts that have become commonplace and are prompting the new rules. The doctor, who traces his choice of profession to the day his grandmother died in his arms after a heart attack, is chairman of the Cardiovascular Research Foundation in New York. The foundation uses donations and fees from medical device companies to stage Leon's annual conference, called Transcatheter Cardiovascular Therapeutics (TCT). A professor of medicine at Columbia University, he has helped start a handful of cardiac device companies through a corporate "incubator" he co-founded. He also has served as a paid scientific adviser for several other startups. Over the years, companies to which he has had close ties have been featured prominently at TCT, creating at minimum a perception that the companies' products are favored for reasons other than medical merit.
"Things that Marty is part of get exaggerated attention" at the conference, gripes the CEO of one device startup. The CEO declined to be identified out of fear he would offend Leon and imperil his company's treatment at TCT.
Mostly undisclosed until six years ago, the tangle of physicians' financial interests at TCT is now acknowledged in a booklet distributed to participants. In 2005 no fewer than 345, or 44%, of the more than 750 doctors and researchers who made presentations at TCT had received compensation from companies, some of whose products they evaluated at the conference.
Beyond the danger that conflicts may distort individual clinical decisions, some TCT observers worry that the event engenders a general excess of enthusiasm for complicated device-based procedures. From 1986 to 2003 the number of nonsurgical cardiac procedures, such as propping open arteries with wire-mesh stents, rose twelvefold, according to the American Heart Assn. Such procedures "are uncomfortable, relatively expensive, and might be taking the focus away" from less invasive, equally effective treatments, such as taking medicine, says Dr. David D. Waters, chief of cardiology at San Francisco General Hospital.
TCT undeniably stirs excitement about devices. When new products perform well in the live cases--real-time procedures beamed in from hospitals all over the world and viewed at the conference--a crowd of animated doctors and investors typically gathers around the booths of the relevant manufacturers. "Marty turned the medical meeting into the auto show," says Dr. Stuart F. Seides, associate director for cardiology at the Washington Hospital Center.
Leon, 55, says his conference keeps doctors abreast of new techniques, and he notes he has toned things down in recent years. Product names, for example, are no longer displayed prominently on-screen during live cases. His main answer to questions about conflicts echoes that of most other branches of medicine: more disclosure. "If you're a faculty person at TCT," he says, "you cannot do anything unless you disclose your conflicts." The heart association and other medical groups have recently issued detailed new disclosure guidelines, and medical journals have followed suit.
But as the volume of disclosure rises, some fear the ritual will become a mere formality, attracting only cursory attention. Dr. Ezekiel J. Emanuel, chair of the department of clinical bioethics at the National Institutes of Health, observes: "If everyone is disclosing, it's as if no one is disclosing."
Born in Brooklyn, N.Y., into a close-knit family, Leon was only 17 when his grandmother died. He endured a second loss as he was finishing medical training at Yale University in 1982: His mother had a fatal heart attack after bypass surgery. Convinced that traditional surgery isn't always best for heart patients, he chose to enter a new subspecialty, interventional cardiology. Interventional cardiologists clear plaque-laden arteries and fix irregular heartbeats without invasive surgery. Leon became a researcher in the young field, joining the National Institutes of Health in 1983.
Back then it was still unusual for practicing physicians or academic researchers to double as entrepreneurs. Two developments helped erode the wall. The Bayh-Dole Act, enacted in 1980, sped up the commercialization of discoveries at university labs by allowing them to hold patents. Named for its sponsors, Senators Birch Bayh (D-Ind.) and Robert Dole (R-Kan.), the law turned academic research into a revenue center, as universities licensed findings to companies and shared royalties with the M.D. and PhD staffers responsible for the discoveries. Doctors learned they could go into business while continuing to practice medicine.
Meanwhile, health maintenance organizations began to clamp down on physician pay. That prompted some doctors to turn to device and drug companies eager to hire them to consult or give speeches. Few rules existed to restrict such activities. The growing partnership between doctors and industry created an expanding constituency for TCT, which Leon and an NIH colleague had decided to start over a six-pack of beer in 1988. Their goal, Leon says, "was to see if we could develop better techniques that would be more durable, safer, more predictable than what we had."
Leon's first consulting arrangement with a company grew out of the inaugural TCT in Washington. Marvin Woodall, who headed Johnson & Johnson (JNJ)'s new cardiac-devices division, asked Leon to serve as the unit's paid ex-officio medical director. As an adviser, Leon was prescient and blunt, Woodall recalls. The cardiologist once dissuaded him from paying $93 million for a company trying to use lasers to open clogged arteries. "Laser angioplasty never did work that well," says Woodall, who is now retired from J&J and serves as CEO of Leon's research foundation.
By 1990, Leon, then 39, with a wife and two children, felt confined intellectually and financially by his government job. "I was making $52,000 a year, and it was important for me to be able to do other things," he says. He left the NIH, joined the medical faculty of Georgetown University, and became a staff cardiologist at the Washington Hospital Center, where he led clinical trials for startup device companies.
Leon and TCT have provided a launching pad for many small companies. "It is the premier forum for the introduction of new technology," says Howard Leonhardt, CEO of Bioheart Inc., which is developing several cardiac devices. Leon agreed to serve on the company's scientific advisory board in 2000. "He introduces us to the right people," Leonhardt says. "He's a prominent leader at the cutting edge." Bioheart is testing a cell-based therapy for repairing damaged hearts using a catheter designed with Leon's input.
At TCT, Leon makes speeches, presents data, and comments on some live cases. He is "a mixture of teacher and showman," says Dr. Patrick W. Serruys, chief of interventional cardiology at the Thoraxcenter-Erasmus University in Rotterdam and a longtime TCT participant. Once, after losing his voice, Leon sought out President Bill Clinton's throat doctors, who suggested swallowing a large dose of steroids. He did, and went on speaking. At the 1997 conference, Italian cardiologist Antonio Colombo (the same doctor whose patient died during the 2004 event) transmitted a live procedure during which he used a tiny motorized device to clear plaque from a professional singer's artery. On camera the patient began singing O Sole Mio to the accompaniment of a guitarist sitting by his side.
Through the 1990s, Leon and other interventional cardiologists had links with companies they didn't routinely acknowledge at the conference. "There were conflicts for all of us," says Dr. Richard Schatz, a cardiologist at Scripps Clinic in San Diego and the co-inventor of the Palmaz-Schatz stent, the J&J product that launched the stent industry. "Those were naive days. Those days are over."
To comply with guidelines issued by health-care associations, Leon has become more of a stickler about disclosure by all TCT faculty members. But a look at some of Leon's own acknowledgments reveals that they sometimes don't tell the whole story.
In 1999 he co-founded a company called Percutaneous Valve Technologies Ltd. (PVT), which developed a cardiac valve that could be implanted by a catheter snaked through an artery, rather than open-heart surgery. When Edwards, based in Irvine, Calif., bought PVT for $125 million in early 2004, Leon collected his roughly $6 million. In addition, he and other PVT shareholders were promised a total of three $10 million payments upon the achievement of three milestones: the successful treatment of 50 patients, regulatory approval in Europe, and limited approval in the U.S.
At TCT later in 2004, Leon disclosed the relationship simply as "PVT-Edwards," one entry in a list of 26 companies from which he received equity, consulting fees, or research grants. He didn't spell out the potential milestone payments in the TCT materials. Doctors who watched the live procedure that ended with the death of the patient in Milan might not have known that the conference's leading figure had an intricate and continuing relationship with the manufacturer of the device being implanted.
Edwards CEO Michael Mussallem says the presentation at the event was appropriate, stressing that Leon disclosed a relationship with the company. The demonstration "gave the technology a lot of visibility, no doubt about it," he says, but he argues that this will have little effect on whether the milestones are ultimately achieved. Leon says the disclosure conformed with TCT policies and those of medical associations.
Since the mid-1990s, he says, large committees of doctors have made decisions about what material will be presented at the conference. "We're trying very hard to not allow commercial interests to be promoted by TCT," he says. But he concedes he retains veto power over who takes the stage and what appears on the video screens. Others in the industry say the perception lingers that Leon influences many aspects of the conference. Asked about this, he says: "I'm extremely sensitive to potential conflicts of interest, and I tend to be overprotective and careful about making sure there is no undue bias." For the first time this year, he adds, two doctors who are not affiliated with Leon's foundation will review all presentations planned for the conference, along with the disclosures provided by the selection-committee members, to ensure that industry money has no sway.
To comply with Columbia's policies, Leon has recently simplified his web of financial relationships. Earlier this year, he says, he donated his rights to the Edwards milestone payments to a school in Manhattan, which he declines to identify. That is so he can participate in current clinical trials for the PVT valve, which has been refined since the 2004 live case. And in 2005 he gave up the $257,679 annual salary he had been drawing from his foundation. But he makes no apologies for accepting payments from manufacturers. "If you expend a significant amount of time and effort" helping a company develop a new device, he says, "there will be financial remuneration."
Another complicated Leon relationship concerns Abiomed, a company in Danvers, Mass. In 2005, Leon's incubator, Accelerated Technologies Inc., sold a small company called Impella to Abiomed for $42.2 million in stock. Impella had invented a tiny pump that helps the heart do its job and can be implanted in minutes. Three versions of it are on sale in Europe, and the company is conducting clinical trials in the U.S. Leon received stock then worth nearly $1 million, plus the opportunity to receive a small share of up to $16.75 million in milestone payments, based in part on Abiomed's regulatory approvals and units sold. Six months later, Impella was featured in two live cases at TCT. At the same conference, Abiomed co-sponsored an evening event featuring doctors talking about heart pumps. Leon, who was the keynote speaker, noted briefly in the disclosure booklet and on a slide that preceded the presentation that he was a "major shareholder" of Impella-Abiomed. He retains the opportunity to collect milestone payments from the company.
Abiomed CEO Michael Minogue says Leon's involvement isn't problematic. "He doesn't own that high a percentage of the company, and he's not involved in the trials," Minogue says. "What he has brought to the company is that he helped make the product more user-friendly."
This year's TCT promises the event's first-ever panel on conflicts of interest. Eminent authorities on medical ethics are scheduled to participate. The conference overall offers 704 hours of presentations; the time allotted for the conflicts panel is 30 minutes.
By Arlene Weintraub and Amy Barrett