Biotech Industry Gearing Up For More Science, Less Hype

But it's still unclear which new approaches in human therapeutics will pay off big; cancer and neuroscience are among the contenders Despite the enormous amount of money invested in research and development of biotechnology-derived human therapeutics in the past two decades or so, biotech industry participants and observers say the future is still unclear. Only 21 biotech drugs have been released so far, and many of those are bioengineered versions of substances that have been known and used for a long time, such as insulin and human growth hormone. During this time the industry has experienced spectacular rises and falls, both scientifically and financially, often fueled by hype and unrealistic expectations. Currently in the pipeline, however, is the next generation of biotech drugs. And these drugs will take advantage of the latest discoveries of how cells work, targeting previously uncharacterized receptors on the surface of cells or moving directly into the nucleus to turn specific genes off or on. But much of this next generation is either still in the laboratory or just beginning clinical trials. And considerable debate emerges among biotech observers in government and industry concerning which areas of research will, from an entrepreneurial standpoint, be most profitably pursued. Research activities in the biotech sector are currently feverish. In the United States, there are more than 22,000 people involved in the development of biotech-spawned human therapeutics, with almost $3.9 billion spent annually on research and development, according to the North Carolina Biotechnology Center. These workers are dispersed throughout 186 biotechnology firms and 87 sites or subsidiaries of pharmaceutical companies. At least 145 biotech drugs are in various stages of clinical trials, and about 1,100 Administration. The uncertainty prevails, however, with observers citing, for example, the recent drastic downturn in the market for biotech stocks, investors, resulting in a 30 percent to 50 -------------------------------------------------------TI : NAS Scientific Misconduct Report Draws Harsh Criticism AU : FRANKLIN HOKE TY : NEWS PG : 3 A long-awaited report on scientific misconduct issued in April by a National Academy of Sciences panel is being assailed by critics in Congress and the research community as wrongheaded in some of its findings and short on concrete suggestions. But the report is being praised by many of the same people for the degree of prominence it gives to an issue of importance to the scientific community. The report grew out of a series of high-profile scientific misconduct scandals involving National Cancer Institute researcher Robert Gallo, former Rockefeller University president David Baltimore, and others. In 1989, NAS launched a major panel study of the problem and its potential remedies. The National Academy of Engineering and the Institute of Medicine joined in support of the project. The resulting 22-member Panel on Scientific Responsibility and the Conduct of Research met seven times between May 1990 and June 1991, with broad financial support from government agencies and private foundations, to produce "Responsible Science: Ensuring the Integrity of the Research Process." Most critics of the report take aim at two major targets. They object to the definition of scientific misconduct arrived at by the panel. Also under attack is the panel's conclusion that scientists and their research institutions, rather than the government, should retain primary responsibility for investigations into scientific misconduct. "I do think the report itself represents a victory," says Margot O'Toole, a researcher with Genetics Institute Inc. in Cambridge, Mass. "But the things they're calling scientific misconduct are, for the most part, already illegal. You can go to prison for these things." In 1986, O'Toole, then a postdoctoral researcher at the Massachusetts Institute of Technology, alleged that central data in an immunological study published in the prestigious journal Cell had been fabricated by Thereza Imanishi-Kari, then chief of the MIT lab where O'Toole worked. Imanishi-Kari is now an assistant professor of pathology at Tufts University. Among the paper's coauthors was Nobel laureate David Baltimore, then director of MIT's Whitehead Institute, who strongly defended it. The resulting controversy led to congressional hearings, and, eventually, Baltimore's resignation last year as president of Rockefeller University. The NAS panel sought a concise and reliable definition of scientific misconduct, settling on "fabrication, falsification, or plagiarism in proposing, performing, or reporting research" for the first and most serious, actionable form of misconduct, with two additional lesser categories. The second category of misconduct is "questionable research practices." These practices, as defined by the panel, include: failing to retain data for a reasonable period, inadequate recordkeeping, conferring or requesting authorship for inappropriate reasons, restricting reasonable peer access to data, using inappropriate statistical methods to enhance findings, inadequately supervising subordinates, and "misrepresenting speculations as fact." "Misrepresentation of speculation as fact is not illegal," comments O'Toole on this point, "but it's not science." The third category, "other misconduct," includes not only such behaviors as sexual harassment and misuse of funds, but also cover-ups of misconduct in science, reprisals against whistleblowers, and malicious allegations of misconduct in science. A minority view written by two panel members and published in the report takes exception to this classification of misconduct. "The `other misconduct' category introduces ambiguities into the definition, and blurs the boundaries between misconduct in science and questionable practice," write the two dissenters. They are Howard K. Schachman, a professor in the department of biochemistry and molecular biology at the University of California, Berkeley, and Keith R. Yamamoto, a professor and vice chairman of the department of biochemistry and biophysics at the University of California, San Francisco. "The absence of consensus on the definition," they add, "undermines a primary goal of the report to achieve clear boundaries for the definition of misconduct in science." "The report tried to define scientific misconduct in crystal-clear terms," says Frank Press, NAS president. "Then there is a spectrum of inappropriate behavior, some of which is just as bad, but some of which is a matter of style. For instance, some professors will give authorship to a graduate student, saying, `Go on, you did the work,' but others won't. I know which I'd prefer, but this isn't misconduct. With lab notebooks, I'd keep mine forever, but if someone discards them after 15 years, is that misconduct? If someone gets rid of them after two years, that might be inappropriate." In addition to their effort to define scientific misconduct, the panel sought to judge who--among scientists, their institutions, and the government--is primarily responsible for policing science. "We think the existing self-regulatory system in science is sound," said panel chairman Edward E. David, Jr., an electrical engineer and consultant, and former White House science adviser, at the April 22 news conference called to release the report. "Individual scientists," the report says, "in cooperation with officials of research institutions should accept formal responsibility for ensuring the integrity of the research process." The report also warns, "The inability or refusal of research institutions to address misconduct-in-science cases can undermine both the integrity of the research process and self-governance by the research community." At the news conference, David added, "Research institutions may want to adopt formal guidelines for the conduct of research.... However, these kinds of guidelines should be an option rather than a requirement." Rep. Ted Weiss (D-N.Y.) objects to removing government--the major funder of science--from the process. Weiss chairs the House Human Resources and Intergovernmental Relations Subcommittee, which has conducted hearings on scientific misconduct. "The report does not acknowledge that the federal government needs to provide standards and oversight for investigations involving federal research funds," says Weiss. "I had hoped ... that the report would provide practical advice to Congress as it considers legislation on misconduct investigations, whistleblower protection, and conflicts of interest." "The recommendation that the institutions have a primary role in investigating misconduct is flawed," says Eugene Dong, an associate professor of cardiothoracic surgery at the Stanford University School of Medicine and a lawyer who has prosecuted cases on behalf of whistle-blowers. "They should not stand in the shoes of the government." Dong contends: "It's not for the academy to lump the interests of the institutions and the government together. The government gives money and the institutions receive money, so their interests are different." On the issue of who should be responsible for investigating misconduct, O'Toole is mixed. "I don't really think the institutions are going to do the job properly," she says, "but on the other hand I don't see any other way." Dong also worries that whistle-blowers will not be protected if investigations are to be conducted by institutions. "The risks whistleblowers run are at the hands of their own institutions," Dong says. "The academy misses this point when they say the government should delegate authority for investigations to the institutions." While panel members do not see the government as the primary policeman in science, they do suggest the creation of an independent Scientific Integrity Advisory Board (SIAB) as a kind of information clearinghouse on misconduct. They see the congressionally chartered National Academy of Public Administration as a possible host for SIAB. According to the report, this body would "exercise leadership in addressing ethical issues in research conduct," but "would not replace or interfere with the principal responsibility of research institutions to deal with specific cases." "The report hopes institutions will set up their own procedures where both sides can be heard," says academy president Press. "If institutions need help doing this, SIAB will help." Observers assess the overall value and importance of the report differently. "I'm pleased that they've come out calling this a serious issue," says O'Toole. "But the scientific community is much too focused on defining misconduct. Instead, what they should do is define proper conduct. There's a great lack of consensus on this." Echoing other observers, Weiss notes, "The report is important because it represents the research community's recognition that scientific misconduct is a serious problem which cannot be swept under the rug." But he adds that "the academy would have provided an important service by recommending standards and oversight mechanisms." Frank Press sounds a positive note, emphasizing the contributions of the report, two years in the making at a cost of $888,000: "The report is an important statement from an important scientific body saying that scientific misconduct is a serious issue."

Biotech Industry Gearing Up For More Science, Less Hype

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