Lobbying Blitz Seen Behind Restoring of Funds for Artificial Heart Research

An extraordinary flip-flop by federal officials last week over continued financing for research into a total artificial heart was prompted by an unusual lobbying blitz by aggrieved scientists and an act of senatorial hardball, participants said this week.

The National Heart, Lung and Blood Institute agreed to reinstate funds for the fully implantable heart after members of the U.S. Senate threatened to retaliate with new limits on how federal institutes spend medical research money.

The senators’ successful maneuver followed an intensive campaign by scientists from four artificial-heart research groups who converged on Washington and underwent what several said was a crash course in politics whose effectiveness surprised even them.

“It wasn’t just the fact that a lot of fairly powerful senators got involved,” said Sen. Orrin Hatch, the Utah Republican who played a central role. “I think it unnerved (federal health officials) that so many people came out of the woodwork.”

The episode has left officials and scientists pleased but baffled.

Most remain unsure why the funding was revoked in the first place--and how it could be reinstated so easily. Some observed that the initial decision to cut the money happened to coincide with congressional budget negotiations.

Most expressed satisfaction with the outcome--continued financing for research into both the artificial heart and other circulatory assistance devices. But a few voiced concern about the intrusion of politics into a scientific matter.

A member of the staff of Sen. Lowell Weicker (R-Conn.) said Weicker “was very concerned about the Senate forcing the National Institutes of Health to make certain decisions about scientific grants and contracts. He . . . believes that science and politics should be kept separate and the Senate should not be directing or influencing those kinds of decisions at the NIH.”

Officials at the institute, meanwhile, have remained silent.

Dr. Claude Lenfant, the director, did not return repeated calls. Nor could the official in charge of technical devices be reached. Blair Gately, an institute spokeswoman, said simply, “They reinstituted the funding and they don’t have any other comment.”

At issue were four $5.6-million contracts to develop a battery-powered replacement heart. The five-year contracts to develop the device--an alternative to the earlier Jarvik-7 artificial heart--were awarded last December.

But in early May, Lenfant decided to halt the financing effective in October. Instead, the money would be spent on development of the so-called left ventricular assist device (LVAD)--a device that offers partial support for, rather than replaces, an ailing heart.

According to Lenfant, new data convinced him that the LVAD would be ready for use in humans much sooner than the artificial heart. However, critics counter that the two devices address different conditions and that both deserve federal support.

Word of Lenfant’s decision to cut the funds reached the scientific community May 3 in Reno at a conference of the American Society of Artificial Internal Organs. Immediately, the contractors began conferring on a strategy for getting the decision reversed.

“Not being very astute in matters of politics, we sort of groped around as to how best to do it,” said Dr. Don Olsen of the University of Utah. “But we came to the conclusion it would take a very concerted effort in terms of who we contacted and the timing.”

The group also enlisted the help of a Boston law firm that had done work for one of the contractors and “who knew how to do these sorts of things,” Olsen said. “I’ll tell you frankly, I didn’t have the slightest idea how government worked.”

The following Monday, the blitz began.

Olsen, head of artificial heart research at the university, called Lenfant and the office of Sen. Hatch. Other contractors contacted senators and representatives from every state affected, including California, Pennsylvania, Texas, Ohio, and Massachusetts.

As it turned out, those included ranking members from both parties on key committees that oversee the heart, lung and blood institute, an arm of the giant National Institutes of Health, which has a hand in much of the medical research done in the United States.

The next week, the scientists flew to Washington. Early Tuesday, they mapped a strategy in a conference room in a Senate office building. Then they divided into groups and spent the day meeting with members of Congress and their staffs.

The scientists’ strategy was two-fold.

If Lenfant’s decision was budgetary, they would try to win congressional support for additional funding. If the decision was scientific, they would try to persuade the scientific advisory council to the institute to back their project.

So that Thursday, when the advisory council met in Washington, Olsen and other contractors attended. Among them was Dr. O.H. Frazier, director of cardiac transplantation at the Texas Heart Institute and a member of both the council and a contracting group.

At that meeting, the contractors got what they wanted--confirmation of the scientific validity of their program. The council passed a resolution calling the research “technically feasible, clinically important and timely” and urged that additional funds be found.

Armed with that endorsement, Hatch summoned Lenfant to a meeting in his office on June 8. Also present were three other senators and their staff members. Not persuaded by Lenfant’s arguments, the senators dispatched their staffers to analyze the institute’s budget.

According to one staffer, they found the budget was about to be increased by $75 million to more than $1 billion. They also found that while Lenfant claimed he could not fund the existing contracts, he intended to spend money on new grants.

“There was certainly the appearance of the ‘Washington Monument syndrome,’ ” said one Senate staff member. The phrase refers to a perhaps apocryphal proposal by the U.S. Parks Service, faced with threatened budget cuts, to embarrass proponents of the cuts by shutting down its most visible monument.

So Senate staffers began drafting amendments to pending legislation reauthorizing the institute for the next three years. The amendments would have required all of the institutes at NIH to honor existing contracts before embarking on new grants.

Nearly a dozen senators also wrote to the chairman of the subcommittee that has jurisdiction over health matters urging that it mandate the program. And Sen. Ted Kennedy (D-Mass.) wrote the Senate Appropriations Committee suggesting that additional money be made available.

Last Wednesday, on the eve of a second scheduled meeting with Hatch, Lenfant telephoned the senator’s office, according to Hatch. If the senators would drop the amendment, Lenfant would reinstate the funding of the artificial heart program.

Contractors and other scientists hailed the decision--which was announced by members of Congress while institute officials said nothing. However, a few congressional staffers acknowledged some reluctance about the manner in which the issue was resolved.

“We would prefer that these decisions not be made on a political basis,” said an aide to Kennedy. “They should be made on the basis of peer review and good health policy. You sort of have to separate the outcome from the process. The process is not the way we would have wanted these things to have worked.”

Hatch, however, said he had “absolutely no qualms.”

“We’re the ones that fund them and set up the programs and make the decisions which way to go,” he said in a telephone interview this week. “When we set up the programs and provide the funding, we don’t expect them to second-guess the whole thing.”