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C M FM 0 R A N D U M RE: HARVARD PROJECT: MEADOW' PROPOSAL FROai : LEE E. STAIvFORD DATE: JANUARY 4, 1979 The purpose of this memorandum is to document some areas of concern which developed from my review of Dean Meadow's proposal. The following are listed in random fashion, without regard to their relative importance: 1. Where is the renovation money coming from? The letter does not state directly that it is to come from the tobacco companies. In my view, this is clearly implied and II am certain it is Dean Meadow's intent. However, we may wish to preserve this question for our meeting with him. 2. Who is expected to pay construction "add-ons" and cost overruns? We have a copy of a letter d'ated~December 11 1978, to Dean Meadow from Sophie Koch-Weiser, Harvard architect, in which she expresses concern that changes are already being requested in the drawings submitted'. Of course, if the drawings are not fixed, the costs are not fixed. Ms. Koch-Weiser also notes that construction costs will increase at the rate of 1% per month. 3. The proposal assumes that Dr. Huber's non- industry funding will remain at 35% of total. He has told me that the NCI nicotine titration grant may not materialize. Secretary Califano is concerned about Dr. Huber's research credibility because he receives industry support. This atti- tude may affect Dr. Huber's participation in future NIH grants. Since most of his other funding comes from this source, there is reason to wonder if non-industry support will diminish. 4. Dean Meadow's proposal makes no provision for interest costs on the renovation money. Interest at 12% would approximate $300,000 over five years. 03'748594 5. The proposal does not mention the current eviction problems at Charlesgate. I understand that Dean Meadow is negotiating with the owners of that property in the event there is a continuation of the program. A rent f igure is shown for Charlesgate, so I assume that Dean Meadow intends that Harvard lease the property for use by the project.

Memorand= re Farvarc3 Fr cj.e=t Januar_- 4, 1979 Page Two 6. The proposal provides that Mount Auburn will reimburse the industry over five years from overhead recovered cn non-ind,,:stry research. The proNosal makes no mentionof Harvard likewise reimbursing the industry for non-industry research at Charlesgate. This is an area which should be explored in negctiation. 7. All reimhursement to the industry should be applied as a credit to re :uce industry pa1,,nents for Project costs. This will simplify accounting procedures. 8. The hospital agrees to repay the industry $184,000 for labs and offices of other hospital researchers over five years. This amount should be paid directly by the hospital. (See Dr. Huber's letter of 12/25 in which he implies that the hospital can and will pay up front.) 9. The proposal to the industry is based upon Dr. Huber's attracting 35% of his funding from other sources. If he is unable to attract such funding (see point 3), a question regarding the future of his program arises. I can foresee a possibility of non-industry support drying up which would' leave the program 65g funded. In such circumstances, could the industry research projects be continued? 10. A recent letter from Dr. Huber, dated December 25, mentions new underground animal facilities at Harvard which should be ready by late 1979 or early 1980. This projection has been changed to 1980 or 1981. Dr. Huber has assured me that he does not want to consider these facilities and that Charlesgate is the best option for his program at this time. Dr. Huber will ask Dr. Bernard Trum, retired head of animal care f acilities at Harvard, to provide an opinion that the plans for Charlesgate meet the applicable standards for animal faci lities . 11. In his proposal, Dean Meadow asserts the neces- sity of satisfactorily conclud'ing the present agreement which will include settlement of obligations assumedby Beth Israel and Harvard. He mentions an estimated amount of $700,000 outstanding as of December 31, 1978. This is slightly more than the budgeted amount for the period for which funds have been withheld (approximately $635,000). 03"748595 12. Beth Israel has told Dr. Huber that it thinks the industry should pay all expenses incident to the breach of lease at Charlesgate, including the Hospital's attorney fees. That is absurd. I think the best approach at this time is to see what Dean Meadow suggests regarding Beth Israel. Our

C. Memorandum re Farvard Project Januarv 4, 19r~_- Page Three position~ should be: (1) the industry has no agreement with the Hospital and no obligations toit; (2) the prcuiems at Charles- gate were created by the Hospital's breach of its lE:_e and were in no way occasioned by the industry or Dr. Hul :c,-; and (3) in general, the project has suffered a myriad of problems at Beth Israel. According. to Dr. Huber, Dean P'Iead'ow has stated, on several occasions, that Beth Israel is responsible for its own expenses regarding Charlesgate and, further, that the equipment is the property of the industry and should be return- ed'to the industry. It will be important to have Dean Meadow's support in severing the relationship with Beth Israel and obtaining our eq,uipment. Dr. Huber believes the Dean will support the industry in this regard. Dr. Huber has just advised that the industry's pulmonary function lab equipment has been removed fromithe hospital. This solves part of the concern. 13. The visa of Dr. Paul Davies, Project stereolo- gist, will expire on February 1, 1979. Dr. Huber advises, how- ever, that he can probably be kept in the country by Harvard for at least several months. If a decisioniis reached~ to continue the Project, he will be able to obtainia permanent visa. 14. The following is a summary of research which Dr. Huber has advised us is presently underway or is contem- plated: I. Animal studies - (a) Pigeon inhalation bioassay for atherosclerosis study. NIH grant with the purpose of determin- ing the effect of high and low intake of CO on development of atherosclerosis. (b) Study of pathophysiologic mechanisms of athero- genesis and their relationship to smoking. Study is financed by industry. It utilizes the same pigeons as in (a). (c) Experimental effect of tobacco smoke on rodent host defenses. 03'748'596 (d) Macrophage studies. A Huber-published study indicated that there may be an initial toxic (adverse) ) effect of smoke on the macrophage,

4 iwiem.ora~du..^~ re :Harvard Project Januai;- 4, 1979 Page Four e followed in 60 days by adaptation. Further studies are needed to answer questions of long-term effects on the macrophage. Follow-up study of effect of tobacco smoke on animal lung parenchyma. Study is prcgressing very slowly at this time and no results will be known before Summer, 1979. (f) Comparison study of the effect of whole smoke and gas phase-only on rodents. II. Chemistry - Dr. Melvin First's group is studying the chemistry and aerosol physics of tobacco smoke. III. Human studies (located at Mount Auburn) - (a): Study to determine the amount of smoke retained in lungs by measurement of puff volumes, inhala- tion volumes and exhalation volumes, i.e., how much smoke goes in and out of the lungs. Simul- ataneously, nicotine, cotinine and CO in the blood are measured. This study will utilize a smoke dosimeter recently received from NIH'. (b) Dr. Jack Roe is engaged~in studies on mediators of hypertension. (c) Dr. Walter Abelmann is studying myocardial function in smokers. (d) Dr. Huber and Dr. Panos Voukykis intend to study cardiovascular function in humans. They contemplate various studies, including a possible repeat of the Aronow work. 0 The NCI nicotine titration~award is still undecided. Dr. Huber does not favor the highly restrictive protocol specified by NCI. LES:ccw