Plague Of Mismanagement Infects Federal Agency's Malaria Project

WASHINGTON—Malaria, a wily scourge that kills from one to three million human beings each year, now finds itself associated with a victim of another sort: a 15-year-old, $100 million federally funded program to develop a vaccine against this ancient threat. Wracked by internal bickering, distracted by lawsuits and investigations, and stymied by a lack of progress, the Agency for International Development’s (AID) malaria project has fallen years behind in its’ search for an effective vaccine. With its future under a cloud, the project offers an unfortunate example of what can happen when a government agency outside the scientific mainstream embarks on a major research project. The scientific challenges of developing such a vaccine are daunting. But they have taken a back seat in the last few years to a siring of administrative problems. Among the most notable are: The prospect of a criminal indict ment of some AID program officials suspected of misappropriating government funds. A report soon due out from the General Accounting Office that is said to highlight “significant fiscal irregularities” in the agency’s handling of the program, including excessive storage costs for 1.200 monkeys acquired to test a nonexistent vaccine. Charges of fraud filed by the Justice Department in U.S. District Court in the District of Columbia against one of the South American project managers. In addition, some $250,000 in U.S. government equipment has been illegally appropriated by the government of Colombia. " An internal revolt by some of the principal scientific investigators, who have complained publicly of unprofessional conduct by middle managers of the project. " A tangled thicket of lawsuits and countersuits, including a sexual harassment charge (since dropped) against the principal contract officer. That official now devotes most of his energies to exposing faults in the program. " A suit in U.S. District Court in Northern Virginia against the agency’s principal contractor that claims fraud against the U.S. If allowed to proceed, the action could become a precedent for other federal whistle-blowers to seek prompt judicial remedies for their complaints rather than pursuing lengthy administrative cures. These problems have cast doubt on the project’s chances of discovering, testing, and producing a widely available and effective vaccine. As Terri Sutton, a former secretary at AID, noted in a deposition taken for one of the many suits filed, “The whole issue is a sad management experience.... It has turned a curable disease into a noncurable one.” It wasn’t always so. Officials who launched the program in the late 1960.. had in mind an effort similar to the one that produced the successful polio vaccine a decade earlier. Prevention was seen as the key after the failure of earlier attempts to eradicate the carrier, the Anopheles mosquito, or to treat the victims once they had been infected. “Lives were being lost, and they wanted to shorten the usual gap of 10 to 15 years between research and field delivery of a major vaccine,” says Charles Chambers, executive director of the Americas institute of Biological Sciences (AIBS). The institute, which operates more than a dozen other science projects for federal agencies, has coordinated the malaria research program for AID since 1982. Chambers believes that some of the problems facing the malaria program reflect the fundamental tensions that arise when a government agency interested in results tackles a difficult scientific problem. “It is very difficult to get constant funding in a world where only short-term results count,” says Chambers, a biochemist. “‘The funding goes away when the enthusiasm, wanes and that is no 'magic bullet’” But the malaria project also faces problems unique to AID. Says Lee Howard, director of AID’s Office of Health from 1967 to 1980, “Although AID had done some applied research—in hardy strains of wheat, for example—it had never done basic biology. That’s a different world.” For one thing, the project has never had an independent, scientific oversight body to review ongoing results. Such a body was finally appointed this year after an internal agency assessment criticized its absence. Kenneth Bart, of AID’s Office of Health, agrees that die omission of an outside advisory board was a mistake, but says that it didn’t hinder progress on a potential vaccine. In addition, some observers contend that the agency did not employ the type of people needed to run such a research project. “AID found itself involved in a scientific project without a scientific infrastructure,” says Chambers. “Big organizations don’t prevent research—look at [the successes achieved by] NIH and NASA, for example. But when the chief technical officer left, there wasn’t an anchor to keep the AID ship from drifting. To this day they [AID officials] don’t realize it.” That key technical officer, entomologist James Erickson, was suspended with pay in April 1987 after AIBS filed charges of sexual harassment against, him. Punished for unprofessional conduct and with his government scientific career in ruins, Erickson now wages war against the program to which he devoted six years of his life. “The malaria program has been horribly run by AID for the last three years, due both to a lack of competent people and because the individuals in charge have been carrying out their own agendas,” says Erickson. “AID is a political organization, without a ‘history of the tribe.' You can’t make the right scientific decisions until you know what the basic policies are, and those were never made clear.” Erickson is not alone in his criticism. In a draft report for the agency written last year, as outside review team concluded that “AID can no longer provide the needed level of day-to-day supervision” for the vaccine project. They recommended that it turn the job over to a university, while retaining overall control. One example of the sizable gap between political promises and scientific reality occurred in August 1985, when AID convened a news conference to announce “a breakthrough” at New York University. The event highlighted the work of microbiologist Ruth Nussenzweig, who was said to have achieved a process that identified, isolated, and duplicated a protein that surrounds the form of the malarial parasite as it passes nto the human organism. The process suggested a way of controlling the complex parasite when it was uniquely vulnerable. AID, under congressional budget pressure, added $1 million to the $2.6 million the agency had already contributed to Nussenzweig’s work at NYU. And its press release declared that “it is not unreasonable to expect clinical trials to begin within the next two years and to have a vaccine ready for widespread use by 1989.” Four years later, agency officials say that they don’t expect to come up with a vaccine for anywhere from one to three years. Any worthy candidate, they add, would require at least two years of field trials. What went wrong? Notes Chambers, “They announced that a vaccine is at hand. It wasn’t.” Nussenzweig declined to comment on the status of her work. It wasn’t the only time that AID officials tried to pump up the program. Later that same year a prototype malaria vaccine based on the earlier discovery underwent human field trials against Plasmodium vivax, a common, but not the most deadly, form of malaria. But once again, the breakthrough didn’t live up to its billing.. “The results came back flat,” recalls Chambers. “It didn’t prove the level of protection that would be needed.” Needless to say, those negative results were not served up at press conferences. As far as as the public knew, the program was making steady, if not dramatic, progress. But good scientific judgment isn’t the only thing that has been lacking in the quest for a vaccine. The project has also had to weather a romance gone bed between Buckson and a contractor manager at AIBS, Dorothy Jordan. A 1988 AID document deJicately describes it as a “volatile interpersonal relationship with considerable conflict” Jordan maintains that Erickson tried to pressure her to continue the affair after she sought to end it, a charge he has denied. A government panel acquitted him of that charge but found him guilty of unprofessional conduct and suspended his pay for one week. Although the punishment was seen as relatively mild, a longer suspension would have been subject to an appeal, a prospect that AID officials could hardly have relished. Now sitting at home while he draws his government paycheck. Erickson has brought suit in federal court under a little-used statute that permits private citizens to sue contractors for defrauding the federal government. At the same time, AID’s inspector general continues an investigation that involves possible criminal charges against various agency officials for misappropriation and forgery. Although the allegations and countercharges involving Erickson and ABS may be unusual, the malaria vaccine project has also been buffeted by more routine storms. A thick sheaf of letters from scientific investigators in the All) malaria network reveals numerous problems. One of the network’s principal investigators, microbiologist Wasim Siddiqi of the University of Hawaii, has described ABS as “unprofessional and irresponsible.” He has complained that the contractor was not adequately prepared to conduct a site visit and that, as a result, its report jeopardized funding for his project Another letter, from veterinary medicine dean R.E. Dierks of the University of Illinois, complains that “manipulation” of funds by the middle managers “will destroy the malaria research network and terminate a very productive program.” The U.S. Office of Personnel Management, in its investigation of the charges against Erickson, found that ABS’s performance was “not adequate.” But it also concluded that Erickson, who it said should have been incharge,d id not begin to complain about the project’s shortcomings until after the end of his romance with the ABS employee. One AID action that triggered vigorous internal debate was its decision last year to build a human field-testing station in Papua New Guinea. The $23 million project, which involves collecting and analyzing baseline data on the native population as well as constructing a suitable testing station, was authorized at a time when there was neither a vaccine nor any viable candidates. “Field stations to test vaccines would be established even though no clinical successes are in hand and no candidate vaccines have been tagged for development,” wrote Nancy Pielemeyer, of AID’s policy and planning office, in an assessment of the project last fall. “This is not a reasonable foundation for a $23 million project,” an amount equal to nearly one-quarter of the entire 17-year malaria vaccine programmed budget. She suggested that the same work could be checked, if and when a vaccine was produced, at existing test stations in Africa. Urgent Message Indeed, some officials worry that the expensive preparations will siphon off precious research funds. The upcoming GAO report, for example, is sharply critical of the $2 million that AID has spent to house and feed 1,200 Bolivian and Peruvian monkeys purchased a year ago to test the nonexistent vaccine. Last month AID sent out an urgent message to the labs holding the animals that asked them to transfer the primates to other agencies that could make better use of them. One indirect outcome of the decision to build a field station in Papua New Guinea was the elimination of AID support for about half of the 17 projects in the basic research network. “Some of it was very interesting basic science,” explains AID’s Bart. “But it was not directed science, and that’s what we needed.” The researchers in the malaria network, although they do not question AID’s right to shift the program’s direction, are bitter at the way in which the decisions were carried out. “One day, without warning, my grant was cut by 60%,” says one microbiologist from a Washington-area research institution. “You can’t conduct science under conditions like that.” The scientist, whose AID contract has been terminated, fears repercussions from other potential funding sources if he speaks publicly. Ironically, the opposite situation—tco much money—has also been a problem for AID. An expert panel convened by AID after the purported NYU breakthrough concluded that the “lmutmg factor [in developing a vaccine] will be money, not technology.” In response, AID hiked its spending from $7.9 million in 1984 to $ 13.5 million in 1985. The annual budget of a Colombia-based project, for example, went up in one year from $100,000 to $350,000. Over a four-year period, $147,000 of the money allegedly turned up in a Swiss bank account listed in the name of one of the Colombian scientists, Carlos Espinal. The Justice Department has filed suit against Espinal in U.S. District Court in the District of Columbia, charging him with fraud. Even the shadowy world of undercover drug interdiction has played a part in crippling this once-promising scientific venture. Erickson has claimed that the former U.S. ambassador to Colombia, Lewis Tambs, once asked him to use the agency’s malaria mosquito eradication program as a cover for an Agent Orange defoliation project to destroy coca plants. Erickson said he told Tambs that the scheme was impractical and irrational, whereupon the ambassador became “somewhat irritated with me and I was rather quickly sent home.” Erickson, who traveled to South America to oversee a local contract proposal involving Colombian monkeys, has also battled the Colombian government. Documents from the Colombian government show that it appropriated some of the AID equipment used in the malarial vacce research, in direct violation of U.S. law. But the case was not pursued because the Reagan administration, lcoking for positive results to sell its floundering antidrug program to Congress, needed the cooperation of that government to control drug production and trafficking in the region. The uneven funding patterns over the past several years led AID consultant Caryn Miller to conclude that “members of the research community are (being] used as pawns, to provepoints that in many cases are already well-documented. Not only will the credibility of AID vis-á-vis the scientific community plummet further, but speculation of a cover-up will heighten.” The agency’s credibility couldn’t be much lower in the eyes of some scientists. One principal investigator has complained bitterly about the inclusion of a on the site review team —as well as $6 million in outside investments. A scientist who “was pursuing precisely identical research” and, in effect, competing for the same grant money. The scientist claims that the outcome reflects the bias of the reviewer. “Given this type of treatment,” he says, “what scientist will be willing to put his career on the line, knowing that contractual agreements may be reversed at any moment? In the long run, the credibility of not only this program but of the other programs of the other U.S. AID network members is at stake.” Jim Anderson is diplomatic correspondent for United Press International.

Plague Of Mismanagement Infects Federal Agency's Malaria Project

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July 1989

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