Notebook

Table of Contents Priviledged Information The Appeal of Creation Hungry for Life Petit Moues Model Women in Trials Keep on Smiling New-Look FDA? The United States Securities and Exchange Commission (SEC) filed an insider trading complaint against a Columbia University professor on September 28. The complaint names Dale J. Lange, a professor of neurology at Columbia's College of Physicians and Surgeons, and six others for trading in Cephalon Inc. securities prior to the West Chester, Pa.-based company's public announcement of favorable research results. Lange served as an investigator for Cephalon's clinical trials of Myotrophin, a drug developed to treat Lou Gehrig's disease. SEC alleges that Lange made a profit of $26,496 from shares of Cephalon purchased prior to the June 12, 1995, public announcement that Myotrophin slowed the progression of the disease. Cephalon stock, which is traded on NASDAQ, climbed more than seven points to close at $18.375 on the day of the announcement. Lange, who consented to surrender profits and pay a penalty, becomes just the second researcher to be accused of insider trading by SEC. In April, SEC filed insider trading claims against Milton Mutchnick, head of gastroenterology at Harper Hospital and a faculty member at Wayne State University in Detroit, and his former assistant Rangarao Panguluri, now in private practice in Anaheim, Calif. (T.W. Durso, The Scientist, June 9, 1997, page 1). DISCLAIMER DEFENSE: Barry Ashe argues that a disclaimer from the endorsement of evolution can have a secular purpose. The Tangipahoa Parish School Board of Louisiana will appeal the ruling of a judge against a disclaimer from the endorsement of evolution drafted by the board in 1994. In his August judgment, United States District Judge Marcel Livaudais wrote, "While encouraging students to maintain their belief in the Bible, or in God, may be a noble aim, it cannot be one in which the public schools participate." According to constitutional tests, a government practice honors the separation of church and state if it has a secular purpose, neither advances nor inhibits religion, and does not entangle the government with religion. American Civil Liberties Union attorneys successfully argued that the disclaimer could not pass this test. The disclaimer advises students that the teaching of evolution is not intended to "influence or dissuade the Biblical version of creation or any concept." Barry W. Ashe, the school board's attorney, maintains that the resolution was adopted for the secular purpose of addressing "concerns that a pluralistic and diverse school constituency might have about teaching only evolution." Ashe, an attorney at the law firm of Stone, Pigman, Walther, Wittmann, and Hutchinson in New Orleans, was scheduled to file an appellate brief by October 26. MONKEYING WITH AGING: In two experiments conducted by the National Institute on Aging, monkeys receiving 30 percent fewer calories than controls exhibited biological indicators associated with longevity. Monkeys denied the calories of their fully fed counterparts in two separate studies showed signs that less food could lead to a longer, leaner life (P. McCarthy, The Scientist, May 26, 1997, page 11). "These results may someday serve as models for human studies," says George S. Roth, acting chief of the National Institute on Aging's (NIA's) Laboratory of Cellular and Molecular Biology. In one study, 30 monkeys receiving 30 percent fewer calories than the control monkeys had higher levels of HDL2B, the good cholesterol linked with lower risks for cardiovascular disease (R.B. Verdery et al., American Journal of Physiology, 273 :E714-9, 1997). In an earlier study, monkeys with the same caloric restrictions exhibited a slower decrease of the steroid hormone dehydroepiandrosterone sulfate (DHEAS), a biomarker of the aging process (M.A. Lane et al., Journal of Clinical Endocrinology and Metabolism, 82 :2093-6, 1997). The lower level shouldn't be taken as a cause-and-effect mechanism, cautions Mark A. Lane of NIA's Gerontology Research Center. "DHEA levels are of great interest to us, not because we believe that DHEA is the fountain of youth, but rather because it gives us a very good marker to measure the rates of control vs. categorically restricted monkeys." The monkeys in both studies have been followed for 11 years and will be followed until the population dies out. A defective mouse gene may provide scientists with a better way of understanding petit mal seizures, or absence epilepsy, in humans. "The mouse model resembles humans because the abnormal brain waves have the same frequency and form as in humans, and the mice also have tonic-clonic seizures," says Wayne N. Frankel, a staff scientist at Jackson Laboratory in Bar Harbor, Maine. The scientists also found a gene associated with the seizures in mice, Nhe1, which remained intact but was rendered nonfunctional through mutation (G.A. Cox et al., Cell, 91 :139-48, 1997). Nhe1 encodes a cell membrane ion transporter that regulates pH and cell volume. The gene plays a surprising role in the mouse epilepsy because it is expressed commonly, but its mutation seems to affect only the brain. Frankel hypothesizes that the mutation led to subtle changes in pH levels of some brain cells, leading to the seizures, which the mice eventually outgrew. Although no similar mutations have been discovered in human cases of epilepsy, only a few human epilepsy genes have been identified. Frankel says the mouse model will help scientists study the disease because of the similarities in brain wave patterns. "This is a unique mouse, with more essential elements of human absence epilepsy than any existing mouse models," he explains. Pharmaceutical companies are grappling with ways to include more women in clinical drug trials in order to comply with a proposed rule from the Food and Drug Administration (FDA). The proposed regulation, published in the September 24 Federal Register, would allow the agency to shut trials down if women aren't sufficiently represented. In 1993, FDA told drug companies to include more women in trials, but 25 percent of the trials the agency examined since then excluded women on the basis that they could have gotten pregnant during the research, according to Mary Pendergast, FDA deputy commissioner. "Our concern is the potential risk to women," says Jeff Trewhitt, a spokesperson for the Washington, D.C.-based Pharmaceutical Researchers and Manufacturers of America. "How do you avoid undo risk to women who may be pregnant and not know it?" Pharmaceutical companies are examining their research protocols and looking for ways to comply without putting women in danger, according to Trewhitt. Drug companies have until December 23 to comment on the policy. FDA will then decide whether to finalize the decision. In order to transfer science from the laboratory to the bedside, the National Institutes of Health should focus on funding more young clinicians, several witnesses told the Subcommittee on Public Health and Safety, a Senate committee that oversees NIH, at an October 9 hearing. "I do most of my research at nights and on weekends," said Katrina A. Gwinn, a Mayo Clinic neurologist in Scottsdale, Ariz., who is entering her second year of practice. "The people doing patient care are being squeezed out of research." Young practitioners are less likely to do patient-oriented research because of lack of federal grants and because they can make more money in private practice, according to Gordon H. Williams, a professor of medicine at Harvard Medical School and chairman of NIH's clinical research granting group. They also often lack training in grant writing and don't receive enough mentoring during their early years, he said. At the hearing, Williams suggested establishing more fellowships and expanding loan-repayment programs for clinicians who also do research. Even though getting old is no joke, humor (of both the intentional and unintentional kinds) lightened a mini-symposium on relationships of estrogen, memory, and Alzheimer's disease October 7 at the New York Academy of Sciences. Rockefeller University neuroendocrinologist Bruce McEwan drew a predictable chortle in his keynote speech on the neurobiology of estrogen, when he projected a Gary Larson cartoon to illustrate that the brain's amygdala can preserve fearful memories. The drawing showed animals in the forest reminiscing about where they were-in their burrows, chasing frogs in the swamp-when they first heard the news that Bambi's mother had been shot. Hunter College neuroendocrinologist Victoria Luine started her talk on estrogen enhancements of memory with a wry definition of short-term memory as "remembering who the last speaker was." Describing her tests of the memories of rats in a maze, she noted that the young females did much better than old females; however, administration of estrogen is promising for the old females. "In time," she said, unintentionally drawing a laugh, "we hope to at least get them up to the level of the old males." In his closing address on estrogen as a possible modulator of Alzheimer's disease, Columbia University neurology professor Richard Mayeux observed that female Alzheimer's patients usually forget whether they had hormone replacement therapy and their husbands tend to offer little help recalling the fact. "Men are notoriously bad informants," he complained. "Any clinician will tell you it's true." The symposium was cosponsored by the academy and the American Federation for Aging Research. NEVER THE SAME: FDA's Gary Dykstra predicts that budget cutbacks and international considerations will keep the agency in constant flux. Hard fiscal times and continuing efforts to harmonize the pharmacopoeias of the world may make the Food and Drug Administration (FDA) of the future a much different animal from what it is today, attendees were told at the September 15-17 joint Pharm Tech and BioPharm Conferences in Philadelphia, sponsored by trade publishers Advanstar Communications of Eugene, Ore. "You are going to see a changing, perhaps ever-changing, FDA," warned Gary Dykstra, the agency's deputy associate commissioner for regulatory affairs. Lamenting a $66 million shortfall in the preliminary 1998 FDA budget compared with the 1997 figure, he said, "If the curve keeps going in that direction, by the year 2000 we won't have enough operating dollars to support the people we have out in the field." FDA's labs will shrink from 17 to nine within 15 years, Dykstra revealed. Five of the remaining labs will be multipurpose facilities and only two of the other four labs will concentrate entirely on drug work-one in Philadelphia and another in San Juan, Puerto Rico. Meetings have been held with private laboratories about contracting more work to them. Certification of private labs and accreditation of the certification bodies also are being discussed. He said the latter proposals are mindful of a long-term goal to establish international standards for pharmaceuticals; a step toward this goal was taken with the recent signing of a "mutual recognition agreement" between United States and European Union trade officials regarding pharmaceutical plant inspections. Dykstra even suggested that FDA's food- and drug-related operations eventually might be separated. "Stay tuned," he counseled. "Things are changing almost on a daily basis."

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October 1997

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