Tobacco Documents Online

William W. Shinn, Esquire } V j .... ..,. . . . _ .. t ~ • 3)ARVARD MEDICAL SeOOL ~ E-. -, , , BETCRAEL HOSPITAL ~, .. DLPARTMENT,OF MEDICINE brairing:Add.ess: . DIVISION'DF RESPIRATORYDISEASE9BETM ISRAEU HOSPITAL GARY Ll MUBER; M.D., CHIEF , 3 30 9MDONLINE AVE'NUE Shook, Hardy $ Bacon Mercantile Bank Tower 1101 Walnut Kansas City, Missouri 4104 Dear Bill, October 27, 1977 lOSTON: MLS9ACNUSETT9 02215 f61i1 735-2391 We are proceeding with our evaluation of the animal facilities at Charlesgate West, and the development of a plan that will reopen these facilities. As we have communicated, we have on the advice of consultants voluntarily closed the facility to all research directly related to the Tobacco and Health Research Programi. This means that all'' studies related to experimental tobacco smoke inhalation in conjunc- tion withithis program have ceased. We have consulted essentially all available resources within the Harvard complex to help solve the problem. Dr. Bernar&F. Trum, D.V.biI. is the head of a team of individuals responsible for animal care throughout the medical school area. Dr. Trum has visited the Charlesgate West facilities, as have two of his assistants, Dr. Arthur Lage and Dr. EdwinIM'cNeen, both of whom are veterinarians. A preliminary report was filed by Dr. Trum on October 13, 1977 (enclosed). These three veterinarians are in the process of developing a definitive report so that we can meet all of the guide- lines of the Animal Welfare Act of 1970, and the Department of Health, Educationiand Welfare recommendations contained in the "Guide for the Care and Use of Laboratory Animals." We have delegated Dr. Melvin First, of our group, to be responsible for developing recommendations to me, which I will forward'to our industry sponsors through you, for reasonable solutions. He will be assisted in this task by Dr. David Drath, a biochemist in our group who is a member of the West Quadrangle Animal Users Committee of the Harvard Medical School, and by htr. Val Pochay, who for the past two years has been the Director of the Charlesgate West Animali Inhalation Facility. We at this time have a three-step plan for the solution of these problems. First, we are proceeding with the funds in hand, allocated from both the industry- sponsored Tobacco and Health Research Program and from the National Cancer Insti- tute, to renovate a portion of Charlesoate West for the study of experimental atherogenesis and'tobaceo smoke inhalation, in accord with our plans for the NCI funded program and the independent research in this area sponsored by the industry. , The upgraded cost of this portion of the renovation is somewhat less than $40,000, and we will be able to'accompliish that with an allocation of our existing resources. That work is underway, and1wil'1 be completediin early December. This will allow us to continue with the pigeon program, which has been now fully awarded by the NIH, contingent oniour development of an adequate facility. Gb 16--a

r • . liilliiam W. Shinn, Esquire Page 2 October 27, 1977 Second, that we are proceeding immediately with the recommendations enclosed in the memorandum from Dr. Trum on October 13, 1977. These will allow us to under- take rather short term (30 day) exposures of rodents to tobacco smoke, and proceed with the work of the industry-sponsore&Tobaceo and Health Research Program. We will not be able to undertake, under these conditions, the long term inhalation studies that are curcial to our answering the questions that we have raised'relia- tive to our observations of the effect of tobacco smoke on the lung parenchyma. We will be able to answer certainispecific questions about mechanisms of tobacco aid lung interaction, as well as specific questions that we wish to pursue on analyzing the effect of some components (gas phase only, particulate phase only, etc.) on the lung. Third, we willi develop through Dr. First and Dr. Trum recommendations for upgrading,the facility to a level that will meet the standards of the "Good'Labor- atory Practice Act." We hope to accomplish this within the next month or so, and in so doing provide the guidelines that will give us a facility that will be beyond question to any external criticism. We have an estimatedicost from the contractors that we have worked with closely in the past two years of $250,000~$a00s000 to re- novate the facility to the standards. We do not have that magnitude of funding in hand, however, as you know, and would require additional' supplimentary support fromm the industry if we are to proceed. I believe Iimade the right decision in voluntarily shutting doim the facility untili these recommendations could be implemented. As the site visitors from the NCI communicated to use recently, no "dollar value" can be placed on a reputation, and they urged us to maintain all aspects of our program at the highest level of accreditation. I do not want, and I woul&hope our industry sponsors do not want, any "embarrassment" on what is otherwise excellent science in an industry-sponsored program because the animal quarters could not pass accreditation. The questions we have now raised in our recent research completed on the interaction of tobacco smoke and'the lung parenchyma need critical answers. I'hope our industry-sponsors will help us meet the responsibility of developing those answers. Sincerely yours, Gary L. Huber, M.D., Chief Division of Respiratory Diseases GLH/mks Enclosure