Robert Jarvik returns

From: Red Herring
Oct. 11, 2002

Robert Jarvik, the flamboyant designer of the artificial heart, is trying to restore his reputation with a new, simple cardiac pump.
By Steve Ditlea
October 11, 2002

In the '80s, Robert Jarvik gained worldwide attention for his Jarvik 7 artificial heart. Unfortunately, it wasn't the kind of attention most scientists would like: he was cast by the media as a Faustian figure, prolonging the lives of a handful of patients, but with ghastly consequences. Tethered to cumbersome air pumps, his patients were subject to infections and strokes before eventually dying. The title of a May 16, 1988, editorial in the New York Times against government funding for artificial-heart research soon became a media catchphrase for Dr. Jarvik's work: "The Dracula of Medical Technology."

It was an agonizing fall from grace. At the peak of his career, Dr. Jarvik was hailed as humanity's great medical hope for conquering heart disease. He was also a bit arrogant and a publicity hound. According to sociologists Renée Fox and Judith Swazey, who chronicled the early history of the artificial heart in their book Spare Parts (Oxford University Press, 1992), he was "flamboyant" and an "intelligent young playboy" who even went so far as to talk about his sex life in a Playboy article. Then, after several highly visible patient deaths and being ousted as CEO of his Utah-based medical device company, Symbion, Dr. Jarvik withdrew from the limelight in 1988.

He has maintained a low profile ever since, seldom talking to the media and only occasionally making appearances at medical conferences. He has not, however, stopped trying to develop breakthrough mechanical technology for the human heart. Dr. Jarvik is no longer the dashing dark-haired figure who appeared on the cover of L'Uomo Vogue holding his "miracle" heart to his chest. Instead, the reserved 56-year-old, his thinning gray hair combed back, toils away at the headquarters of Jarvik Heart, a deliberately modest, closely held enterprise that, rather than developing another artificial heart, is working on a more modest and practical device--a cardiac pump to aid a failing heart.

"The main thing I learned over all these years is how hard it is to do this with something complicated," says Dr. Jarvik, who is the company's CEO. "I feel that the only real chance for success is with simple systems." Such a statement is a far cry from what he advocated early on--that natural organs could and should be completely replaced by artificial devices.

In the past decade, he also has learned the importance of keeping close control of his enterprise, which he does with the help of his wife and chief financial officer, Marilyn vos Savant, the "smartest woman in the world," according to the Guinness Book of World Records. With a small group of investors and his product--the Jarvik 2000 Flowmaker--which has gone through initial human trials, Dr. Jarvik is attempting to restore his public reputation as one of modern medicine's most distinguished technological innovators and entrepreneurs. Though still viewed askance by those who remember his '80s public persona and by cardiac-device competitors that dispute the validity of his current approach, he is a figure who commands respect in his rarified research circles. "Rob is unique in this field," says O.H. Frazier, chief of cardiopulmonary transplantation at the Texas Heart Institute, who has performed more heart transplants than any other surgeon and also has implanted most of Dr. Jarvik's pumps--more than 20 to date. "Others are engineers or medical doctors, but he's both. He can make these devices himself, and he's there in the operating room with you. He's the only person like that."

New York Jet
It's an unlikely locale for a state-of-the-art medical device company: an art deco building with a ground-floor piano showroom on Manhattan's West Side. In his 16th-floor office, adorned with splashy magazine covers from before his fall from grace, Dr. Jarvik demonstrates a shiny metal device that looks like a miniature nozzle for a garden hose. He plunges the titanium pump, the size of his thumb, into a bowl of water. A stream of water jets out, splashing the polished conference table and his expensive black suit, direct from Paris tailor Francesco Smalto. But Dr. Jarvik couldn't care less about such collateral damage. He's relishing the demonstration too much--visibly proud of his pump, which has taken almost 15 years to develop.

The Jarvik 2000, of course, isn't designed to pump water, but rather to enhance the flow of oxygenated blood throughout an ailing body. Its purpose is to treat a medical condition with a greater mortality rate than cancer or AIDS: congestive heart failure. In the United States alone, close to 5 million people are living with congestive heart failure, and another 400,000 are diagnosed every year. Many of these individuals would be eligible for heart transplants but will never get one because of a critical donor shortage. In their final months, patients are often bedridden, kept barely alive by heart-stimulating drugs that can cost as much as $20,000 a month.

Last year, a multicenter study published in the New England Journal of Medicine found that the implantation of a heart-assist pump may be better than drug therapy. The specific model tested, the HeartMate, from medical device manufacturer Thoratec, was a first-generation device the size of a portable CD player. It was subject to mechanical failure and uses a power line that pierces the skin, at times leading t0 infection. Dr. Jarvik's device is one-tenth the size of the HeartMate and, unlike competitors' second-generation products, is meant to fit comfortably inside the patient's otherwise intact heart.

Currently, pumps used to sustain transplant candidates constitute a $150 million market in North America and Europe. When such devices, priced at $60,000 or more, are widely used for permanent implant in nontransplant patients, the market could top $6 billion.

Initial tests on humans, 35 so far in the United States and abroad, have shown the Jarvik 2000 to be safe and effective. The next step will be clinical trials for lifetime use, which Dr. Jarvik will soon propose to the U.S. Food and Drug Administration. Such trials will take at least two years, possibly resulting in FDA approval of the commercial use of the pump within four or five years. While the device has proven mechanically reliable so far, a successful outcome is by no means assured, since clinical trials can reveal all sorts of unforeseen problems.

Nonetheless, working in Dr. Jarvik's favor is a technology track record far better than many assume. Largely unreported by the press, a smaller version of his original Jarvik 7 artificial heart has been used successfully to sustain hundreds of patients until they could receive a heart transplant. The device survived the dissolution of Symbion in 1991, when the University of Arizona Medical Center was assigned the rights to it. In March 2002, SynCardia, a medical device company, was organized to secure the necessary funding to submit the descendant of the Jarvik 7 for final FDA approval to market it in the United States.

Lifeline
Dr. Jarvik showed his technical prowess early, developing medical instruments, including a surgical stapler, in his teens. "I licensed the patents to companies and was interested in the commercial follow-up," he says. "I made a modest amount from patent royalties, which paid for my expenses later in school." He studied architecture in college, until his father was diagnosed with an aneurysm and was operated on by the heart surgeon Michael DeBakey, creator of the mobile army surgical hospital (MASH) and many now-standard cardiac procedures. Dr. DeBakey inspired the younger Jarvik to switch to premed in 1965. Dr. Jarvik studied medicine for two years in Italy (he didn't get accepted to a U.S. medical school), then completed a master's degree in biomechanics at New York University. He returned to medicine at the University of Utah, and after graduating, went to work with Willem Kolff, a university professor, inventor of the artificial kidney, and a developer of an artificial heart tested in animals.

When Dr. Kolff turned his university research into a business, Kolff Medical Associates, Dr. Jarvik got involved in all aspects of the enterprise, writing business plans and meeting with potential investors, as well as working on design and manufacturing. Eventually, after a dispute over the materials to be used in an artificial heart, Dr. Jarvik wrested control of the company from his mentor and changed the company's name to Symbion. Others in the company, including cardiologist Clifford Kwan-Gett and designer Tom Kessler, have insisted that Dr. Jarvik, perhaps enamored by his own rising fame, never properly acknowledged their contribution to the artificial heart.

In any event, Dr. Jarvik broadened Symbion's production to include cochlear implants for the hearing impaired. In all, he raised $6 million from investors, including Humana, Johnson & Johnson, Southwest Venture Partners, and Warburg Pincus, before going public in 1983 with a $19 million IPO--a sizable offering for a startup at the time. In the wake of the human trials of the Jarvik 7 and subsequent media coverage, the firm grew to 75 employees.

As patients' misery from painful infections and dangerous complications became more widely known, Dr. Jarvik seemed at times to be insensitive to their concerns. When he testified before the U.S. Congress and was asked about possible undue pressures put on patients by their families and doctors to try his artificial heart, he said, "I absolutely have never thought of that before." Today, Dr. Jarvik says, he just wanted to help people while also making a "reasonable" amount of money.

Even with the bad press and patient deaths, Symbion was close to making its first profit after ten years, when, in 1987, Warburg Pincus led a hostile takeover offer, because, says Dr. Jarvik, the company was a tempting target. He tried to fight the takeover but, with only 8 percent ownership, failed. "After the takeover went through, they fired me as the first order of business and locked me out of my office. It was a very unpleasant experience," Dr. Jarvik recalls.

The following year the New York Times published its often-quoted "Dracula" editorial. By then Dr. Jarvik had left Utah to start over and was working on his new heart pump. When the device was in its early development, he incorporated his company as Jarvik Research, and a decade later, when the pump was ready for human trials, he changed the name to Jarvik Heart. Today he is backed by a limited core of investors led by Leon Hirsch, a partner in JHK Investments, a private investment firm. Mr. Hirsch serves as company chairman.

Jarvik Heart has raised $12 million to $16 million, according to Alexander Arrow, senior medical technology analyst at Ladenburg Thalmann, an investment bank in New York. Dr. Jarvik acknowledges that larger investments or even an IPO might make development of his device easier, but he's learned his lesson. "I'm not interested in getting into a situation where I have to deal with the wrong kind of compromises and pressure from investors who are looking at their short-term situation," he explains.

With just 15 employees and limited resources, his firm has been able to manufacture the devices and conduct pilot studies at the Cleveland Clinic and the Texas Heart Institute in the United States and at hospitals in Germany, Sweden, Switzerland, and the United Kingdom. Dr. Jarvik keeps the financials of his firm confidential. Holding a tight rein on expenditures is Ms. vos Savant, who earned the title of "smartest woman in the world" after taking an IQ test at the age of 10 and scoring in the top percentile for a 23-year-old. Since 1986, she has been writing a column for Parade magazine called "Ask Marilyn" and has inspired a Web site called "Marilyn is Wrong!" According to Dr. Jarvik, she provides business expertise gained while managing a variety of small retail and real estate businesses owned by her family in St. Louis.

Because his company is modestly run, Dr. Jarvik sounds unusually restrained for the often hype-laden medical device field. When discussing the future, he uses conservative numbers instead of the six-figure patient projections many cardiac-device makers cite. "If we're highly successful, the Jarvik 2000 will be used in the tens of thousands a year, and it doesn't make a lot of sense to project much more than that," he says. "We don't need to make huge claims, because we're not in the same promotional position as others in this market."

Dr. Jarvik sees his business approach as straightforward. "The No. 1 priority is patient results. If our patients do well, we will grow," he says. In addition to drawing key employees from major medical firms, including Baxter Healthcare, BD, and Wyeth BioPharma, the company is exploring the possibility of increasing production. Still, the questions remain: Can Dr. Jarvik grow the firm to, say, an $800 million company? Will he surrender control to an industrial-scale management team?

Patients & Patience
One of the highlights of the annual meeting of the American Society for Artificial Internal Organs in June was a former clinical psychologist named Peter Houghton. The 63-year-old Englishman was about to celebrate his second anniversary with a Jarvik 2000 implant, the longest of any patient. Since a bout of flu attacked his heart at age 55, Mr. Houghton's organ had weakened to less than 10 percent of its pumping capacity, leaving him barely able to walk across a room. Recently, thanks to the Jarvik pump, he completed an 81-mile walk. And with its load lightened, his heart has recovered 25 percent of its capacity--a margin that kept him alive when the heart device briefly stopped after a thief in London ran off with its battery pack.

Mr. Houghton has become well-known in England. The tabloid press calls him "Torchy" (his heart pump is powered by batteries like a torch, or flashlight) and "Plughead" (the device's power connection is behind his ear). In a brief interview, he expressed his admiration for Dr. Jarvik: "Human society owes a debt to its innovators. Robert has put his career at stake to push medical treatment further, hasn't he?"

In turn, Dr. Jarvik says patients like Mr. Houghton are what his decades of perseverance are all about. "When we talk about improving patients' lives," he says, "alleviating the misery they endure now, then we've done something very good for people."

Steve Ditlea is a freelance technology journalist based in Spuyten Duyvil, New York. Write to letters@redherring.com.

Copyright 2002 Red Herring Magazine