The University of Utah's artificial heart program, once in the vanguard of research to prolong life, is beating feebly nowadays.
At the end of September, it lost its major funding support: more than $1 million yearly in federal contract money. In another blow, the technology that it developed is being marketed largely by the University of Arizona.Dr. John Watson, chief of the devices and technology branch of the National Heart, Lung and Blood Institute - part of the National Institutes of Health in Bethesda, Md. - said that three months ago the NIH passed over the U.'s program, choosing not to renew a research contract there.
At the time, U. officials made no public announcement of this loss, but they commented on it this week when contacted by the Deseret News.
The NIH is empowered by Congress to funnel medical research grants and contracts. It had supported the U.'s artificial heart program to the tune of an estimated $20 million over the past 20 years.
This time around in the federal funding cycle, instead of renewing the U.'s research contract request, the NIH chose three other institutions, which will receive contracts worth $5 million to $6 million apiece, over the contracts' three-year lifetime.
Asked if the U.'s artificial heart program has any other NIH grants, Watson said, "Right now, everything has come to a halt in terms of federal funding.
"They submitted grant applications, and they were again peer-reviewed. While they were scored well, they weren't at a high enough priority compared with other grants to be funded."
John K. Morris, counsel to U. President Arthur K. Smith, said, "The program is not going to be completely shut down. It will be scaled back.
"Of course, the continuation of the program, the scope of it, is going to depend on the success of Dr. (Don B.) Olsen and others in generating new grant applications and additional funding sources."
Olsen, director of the U.'s Institute for Biomedical Engineering, which includes the artificial heart laboratory, is vacationing out of state. He was unavailable for comment Thursday.
Richard K. Koehn, U. vice president for research, said the heart program had about50 employees until the NIH refused to renew the contract. Now, "we're looking at somewhere between 15 and 20 people," he said.
"We're not pleased, obviously. But we have projects that are funded and not funded all the time. It's a constant worry."
Individual research grants and the shifting of some other university resources allow a scaled-back program to continue while major funding is sought elsewhere. But the NIH loss jeopardizes the program's future.
"You're talking about a fairly large, organized, research operation that requires a fairly substantial infrastructure to keep it going," Koehn said.
The project needs engineers, materials specialists and other experts. "It's really impossible to support that kind of infrastructure on the basis of individual contracts and grants," he said.
"You really need major funds to support that kind of unit. So it's going to be a struggle," Koehn said.
Meanwhile, CardioWest Technologies Inc. is now owned almost entirely by the University of Arizona Medical Center. CardioWest was formed to market the artificial heart developed at the U.
Originally, CardioWest was to be a 50-50 partnership between the Arizona center and Medforte Research Foundation of Salt Lake City, a nonprofit group spun off from the U.'s artificial heart program.
But Richard Smith, a biomedical engineer at the University of Arizona Medical Center, Tucson, said the joint effort turned out to be much more expensive than expected. So as the Arizonans put in more money, "based on the charter of our company, we really just took over most of the ownership."
Arizona now owns approximately 75 percent or 80 percent of CardioWest, which supplies artificial hearts almost identical to the U.'s Jarvik 7 heart.
In a new trial recently approved by the U.S. Food and Drug Administration, about 50 artificial hearts supplied by CardioWest are expected to be implanted next year at several medical centers across the country. Sixteen of them were implanted this year.
The hearts are expected to keep patients alive while awaiting transplants. They are not considered suitable for long-term heart replacement because they are powered by compressed air. The opening for the compressed air tube could allow infections to enter the body.
Research is continuing elsewhere on developing the next step in the technology, a totally implantable artificial heart.
The NIH's Watson said the recent contract awards were for designing such a device.
In a second phase, the best concepts among competing designs will be chosen "for testing of reliability . . . and bench testing and performance testing in animals, prior to use in clinical trials."
The U. was among several institutions responding to the call for contract proposals, Watson added.
The proposals were peer-reviewed. "In the overall ranking, and within the funds that were available, we weren't able to continue support at the University of Utah," he said.
Organizations that were funded were the Abiomed/Texas Heart Institute, with Abiomed based in Boston and the institute at Houston; Penn State University/3-M Corp., a consortium based at the Hershey Medical Center, Hershey, Pa., and Ann Arbor, Mich.; and NIMBUS/Cleveland Clinic Foundation, in Sacramento and Cleveland, respectively.
"Please put in your article that a lot of the research that led up to work on the implantable artificial heart came from the University of Utah over the years, and they're a recognized leader in this field.
"So it wasn't that they had an awful proposal. It was that they had a lot of competition," Watson said.
Stewart Grow, president of Medforte Research Foundation, said the group sponsors medical research.
CardioWest "just got approval from the FDA to open four additional centers around the country," he said.
It has a manufacturing center in Vancouver, British Columbia, he said. "We've been shipping hearts to Toronto and also to Paris," he said. Sixteen of the artificial hearts were implanted last year - two in Toronto, two in Arizona and the rest in Paris.
"This technology is really late 1970s technology," Grow said. "But for certain types of needs, it is still the best type of technology and probably will be for the next five years."
He credited Medforte with helping to keep the artificial heart alive after the FDA canceled the permit that Symbion Inc. had. Symbion was formed to market the U.'s Jarvik 7 heart after the heart was implanted in Dr. Barney Clark more than 10 years ago.
When the Symbion program ended, legal rights to the technology reverted to the university.
Grow said Medforte probably put $150,000 into reviving the technology. This was matched with some money from Symbion "and some inventory from the defunct company." The University of Arizona Medical Center added the same amount.
"It was not ever envisioned to be a profit-making venture. It was envisioned to move the technology of the heart further along," Grow said.