An Update on the Head Injury Laboratory

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An Update on the Head Injury Laboratory An ad hoc committee set up in the spring to review the Head Injury Research Laboratory ofthe School of Medicine completed its report on August 2; it is published in this section ofAlmanac starting on page III. Below and onpage!! is the text ofa separate report summarizing recent events surrounding the Laboratory. It was prepared by the Secretary of the University, Dr. Mary Ann Meyers, on August 23. An Update on the Head Injury Laboratory The Head Injury Clinical Research Labora- and training of laboratory personnel, steriliza- declared their belief that the Head Injury Lab tory in the School of Medicine remained in the tion experiments, and the occupational health "has made significant changes and improve- headlines this summer as the federal govern- program in the Head Injury Laboratory. The ments... and that current protocols and facili- ment suspended its funding and President report also stated that the deficiencies in the ties are in compliance"with the NIH guidelines. Sheldon Hackney halted its use of animals in project can be corrected because they are not Upon receiving the report, Dr. Hackney said experiments designed to determine the best part of the research's basic concept or protocal that he was reassured by the committee's find- treatment for human victims oftrauma-caused or its experimental approaches. ings that the treatment ofresearch animals met brain damage. The president's action was taken A University ad hoc committee subsequently NIH standards. But he has also noted that "the in late July in response to concerns raised in a concurred with the NIH reviewers about the lack of cleanliness in the lab, the sub-standard preliminary report bythe National Institutes of scientific merit of the head injury reserch. In a recovery room, the lack of adequate supervi- Health (NIH). A week earlier Secretary of report issued in early August, the Penn investi- sion by a veterinarian, the smoking, the inap- Health and Human Services Margaret M. gators described the study as being of "great propriate comments ... are not acceptable at Heckler cited the same report in ordering sus- importance to human welfare," but they also this University." According to the president, the pension of an annual SI-million NIH grant for found practices that were not in compliance administration "will not permit the lab to support of the baboon research project. with NIH guidelines. The infractions included resume experiments with animals" unless both Secretary Heckler's order followed fourdays smoking the in the operating suite, lack ofasep- Penn and NI H officials "are fully satisfied that of sit-ins by animal rights activists at institute tic surgical techniques, casual dress, a sub- the use of animals in the research project is in headquarters in Bethesda, Md. and was given standard recovery room, incomplete post-oper- complete compliance with all relevant guide- on the basis of evidence from the laboratory ative records, and inadequate supervision of lines and that there will be no deviations, no gathered in a 1984 raid by the Animal Libera- the animals by a qualified veterinarian. matter how slight, from those guidelines." tion Front (A.L.F.). The activists stole video- Unlike the NIH reviewers, who questioned The research activities of the Head Injury tapes made by researchers to document more the effectiveness of drugs used to anesthesize Lab were suspended for three months during than60 hoursof experiments in which baboons' the laboratory baboons on the basis of video- the winter of 1982-83 by Dean Edward J. heads were subjected to sudden acceleration to tape records of the animals' movements and Stemmleron the advice ofthe Medical School's induce brain injuries. A 24-minute edited ver- researchers' statements about alleged wakeful- Animal Care Committee. Subsequently the sion has been exhibited around the country by ness, the Penn committee was satisfied that the committee reviewed a tape ofa procedure and People for Ethical Treatment of Animals, and doses ofanesthesia were always fully adequate. interviewed investigators involved with the the organization claimed Secretary Heckler's The internal review team reached its conclusion study. It then unanimously approved continua- decision as a major victory while scientists crit- on the basis of the stability of recorded physio- tion of the project, and in March of 1983 the icized it as an apparent capitulation to extrem- logical parameters as well as the nature of the dean released the lab from research restrictions. ists. baboon's movement, which were much slower NIH has been supporting the head injury The NIH preliminary report, which has not than is characteristic of an unanesthesized project at the rate of about $1 million annually been publicly released, stressed that the exper- state. for the past 13 years. Since the 1984 break-in iments were bothjustified and appropriate but Furthermore, the University committee focused national attention on the Medical concluded that there had been material failure noted that while it does not condone "instances School lab, favorable assessments of the to comply with health policy for the care and of apparent inappropriatejocularity and offen- research have been made by four distinguished use of laboratory animals. It raised questions sive comments" visible on the videotapes, it felt reviewgroups. The current NI H and University about the management of anesthesia and anal- certain that the seemingly callous remarks of investigations were delayed by the refusal of gesia, according to NIH director James B. the young researchers "do not reflect the animal activists to provide officials with copies Wyngaarden, a former member ofthe Medical general... manner in which experiments were of the stolen videotapes until one year after the School faculty, as well as about the supervision carried out." In conclusion, the Penn reviewers A.L.F. raid. ALMANAC SUPPLEMENT September3. 1985 I Within a week after receiving the NIH'S pre- liminary report, on which the suspension of funding was based, the University submitted an interim response. It contained a report to Pro- vost Thomas Ehrlich and Dean Stemmler from Vice President for Health Affairs Thomas W. Langfitt and Associate Professor of Neuro- surgery Thomas A. Gennarelli. Dr. Langfitt is principal investigator for the Head Injury Clin- Report of ical Research Center, agovernment-supported The Committee to Review enterprise, which is primarily focused on The Head Injury research involving human victims of severe Clinical Research head injury. Over the past dozen years, a por- tion of the Center's budget has funded the Laboratory laboratory project using primate models. It is Of the School of Medicine directed by Dr. Gennarelli. In their report, the Penn scientists make clear that whatever the past deficiencies in the lab, TABLE general supervision and operation of the OF CONTENTS research facility will in the future fully conform I. Introduction III to Public Health Service guidelines. Further- II. Committee III more, all of they deny allegations inhumane Ill. Pre-Meeting Activities IV treatment of animals and provide a compre- IV. The Review IV hensive account of the anesthetic and V analgesic . History which site visitors and agents, expert consul- VI. General Findings VI tants to the Medical School's Animal Care a. Compliance with the Guide Committee have found suitable for the preven- VII. Specific Findings 1tion and relief of pain. Scientific Merit Meanwhile, members of the biomed- many a. The Magnitude and Importance ical research community have expressed dis- of Head Injuries that the decision to may government's suspend b. The Experimental Design support for Penn's head injury research project c. The Results seemed to come in direct response to pressure d. Adjuncts to the Baboon Model from animal In a letter rights protestors. to e. Peer Judgment Secretary Heckler, the Association of Ameri- 2. State of the Animals, Their Aware- can Medical Colleges and threeother academic ness to Pain and Their Care in organizations wrote that appearing to capitu- Acute and Chronic Studies late "to the demands of an irresponsible advo- a. Pre-Injury increases the of cacy group ... vulnerability b. At the Time of Injury academic institutions to further break-ins, c. During the Post-Injury Period destruction of property, and loss of research d. At the Time of Sacrifice data of incalculable value." 3. Placement and Removal of the But the government's focus on the Head Helmet Lab continues, and in late the Injury August 4. Review and Monitoring of Studies Department of Agriculture is expected to file a 5. Facilities complaint against the University charging vio- 6. Conduct and Demeanor of the Lab- lations of the Animals Welfare Act. The Sub- oratory Personnel committee on Oversight and Investigations of VIII. Conclusions VIII the House Science and Technology Committee IX. Recommendations VIII has requested information on the baboon pro- ject from NIH and may hold hearings when Congress returns after Labor Day. Reportedly, more thanadozen congressmen are sponsoring an amendment to the NIH'S annual appropria- tions bill that would permanently cut off fed- eral funding for the lab even if the final NIH report gives it a clean bill of health. Washinton-based trustee John H. Porter, chairman of the public relations firm of Need- ham, Porter & Novelli, has been advising the administration on public relations aspects of the challenge from animal rights activists. Sur- veying the summer's developments, hesuggests that continued focus ofthe media spotlight on the Head Injury Lab will make Penn the stand- ard bearer for the cause of animal research- highly visible and, therefore, an easy mark for snipers. II ALMANAC SUPPLEMENT September3,198-5 Report of the Committee to Review The Head Injury Clinical Research Laboratory Of the School of Medicine August 2, 1985 II. Committee The Committee consisted of three members of the School of Medi- cine faculty: Dr.
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