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~ss-¢mm~ • "~ THE NEW ENGLAND INSTITUTE , /~ ^~~" - February 12, 1975 ~-- 2 /2:/ /" Mr. Joe E. Bdens, President Brown & W~Ifamson Tobacco Corp. 1600OOW./~IW. Ill Street .- Loui~ille. Kentucky 40210 /D~r Mr. Edens: ./ There probably has been very little new in the field of scientific discovery that ha~ been of any particular comfort ~o the tobacco industry in quite some :ime, I believe this letter is an exception. .,.., -. . - One ~f the major areas of study of the doctorate staff members of this Institute is the hosK ~efense system. Very simply defined, that is the body's way of defendfng itself against disease, including cancer. Firs~t as evidence of our staffls authority and achievements in sclencej I enclose a llst of this [nstitute's publications, including those on the subject of the body'~ defense system. This covers a period of the last ten years, " A year ago, • scientist colleague of mine wrote, "Cancer research remains a topic of intense interest ~o almost everyone if for no other reason than thac statisticallyp each of us has a one-in-four chance of dying of the disease." Some time hack in the 16th Century, Francis Bacon said, "Hen fear death as children fear tc go in the Jark; and as Kna~ natural fear in children is increased with tales, so is the other." My eolleague's statement is true today, and after fouz centuries Francis Baconrs staKemenr also remains true. Men do fear death and Zhus men do fear cancer. Tales of cancer can and do increase this fear. There Is always a proliferation of these tales -- new ideas as KO its cause~ new ideas as ~o its zure. People are often shocked with the concep~ that they might have had cancer and not have k~o~rn i~. B~= i~ you think about i£ iogically~ you realize that every day eachof us is ex~)sed co carcinogenic agents that are alway~ present in our envlror~menK. These agents are several. One, lonizing radiation, made up of diagnostic X-rays, l~inous dials, fallout, eke., will cause shout lO,O0O cancer cells per person annually. This is am estimate~ but it is close enough. The idea of thousands of cancerous cells being formed in our bodies during a single year from ~ust one causative sourc~ is mind- boggling for mos~ people, we tend to blank i~ out. °

If so many cancer cells are formed in each of us every year~ why don'~ more people have cllnlea] cancer? The answer lies in the individual's ability to reslst invasive disease. That Is~ it is dependent u~)n the effieipncy of the body's "host defense system~" Most people's defense systems are adequate but one in four is not The body has a system containlng elements suc| as antibodies which normally pr0~eets l~ from invaslon by disease-producing agents. These agents include vdruses~ bacteria, fungi, blood-borne parasltes (malaria) and cancer cells. This host defense system recognizes alien materials. Whe~ challenged, it mobilizes its varlous highly effective defense mechanisms, attempting to eliminate and destroy the invader. )~arvelous though the defense system may be, its efficiency varies from one individual ~o the next, snd from time to time in the same indl- vldual What zould be done to enhance it? The New England Institutels research on the host defense system began in 1954. It was predicted on the hypothesis that it might be pos- sible to stimulate the host defense system, enabling a person to cope far more effectively wlch an alien challenge. Our long search covering more than 1,000materials, was directed at finding a chemical of knovra s~rueture, which had no side effects and which, in physiologic amounts, could stlmulate the host defense. This search was long enough in time, broad enough in geographi- cal scope~ and i~volved enough investigators and funds to qualify as a saga in itself. The first s~age mu]~ninateg when it wHs found that an extract from the livers of a certain species o~ sharks contained a mate- rlal which met all criteria. In order ~o procure enough of this material to eontlnue the research~ we needed msny sharks. U~fsrft[nately, ore canRo~ fill ouK a~ order foz~ for a shark. One has Ko catch them. And when it turned ou~ that the active ma~erlal In the liver began to degrade within abou~ 20 minutes of ~he shark's death, it became necessary no bring them ashore alive (We must add that we are delighted tlla~ this phase of the work ms behind us!) Our studies with sharks showed that the substance which controls the host defense system in man is a uhiquinone -- specifically, Coenzy~Re Q-10. Its chemical structure ms completely kno~r~. It is normally presen~ in virtually all ~he cells of man bu~ in varying 8~nounts. Q-IO does no[

Mr Joe E Edens February 12, 1975 Page 3 attack or fight an invader. It stimulates the dndividual'~ uost defense system. PHASE I CLINICAL TRIAl With Food & Drug Adminis~ratlon approval, a Phase I clinical trial was undertaken ahout 18 months ago at Tale. Such a trial is designed only to evaluaEe toxicity. Is Q-10 toxic? Does it have any side effec=s? If so. what are they? The Professor of Surgery who directed the zllnical trial at Yale was one of the eoun=ry's foremost authorities £n breast cancer. Patients chosen by him had received all possible surgery -- mastectomy, castration and. [n some cases, removal of the pituitary. They had received every appropriate type of radiation and chemical and endocrine therapy -- all to no avail. The~ had a life expectancy of gut a few weeks. Under these =ondltions~ we did no= expecE any positfve effects. We were only testing for toxleity in accordance with F&DA Phase I requlre- meats. We assumed these patients would dfe within two to uaree weeks and on autopsyI we would obtadn iRfor~atlo~ on possible ~oxleity. gigs- teen patlents were involved in the trial. Q-10 was administered hy in- jection once a week over a period of ap;roximately Ii months, Half of them died, ss expected. But 50% of them began uo improve. First there was a lessening of paiRp and medieatlo~ was reduced, in some cases, IK wee eliminated• These patients began to lose their "look of death" and began Eo feel bet=or. They began to ge~ up and about Though they still had Eumor, there were defdniKe subjective and objective signs of improve- men=. Some of Esem re=urned home and resumed normal lives. That phase of the clinical trial was an unqualified success• Those patients who died and, indeed, those who lived, showed no signs of toxicity nor side effects. Data from Chat trial brought about F&DA clear- ance for a Phase II trial• PHASE II -- to test the effectiveness of ~-i0 Should we "shou=" these results in headlines? T¢ quo=e Dr. ~orrls Fisbhein i~ an editorial ~rom MEDICAL WORLD NEWS concernin~ in par[, the work of this Institute and Q-1O, "Such results though hopeful, ~ust be viewed with caution, . ,banner headlines muse still wait until many more years of work have been completed, gut already~ cancer research has produced

Mr, Joe E. Edens February 12, 1975 Page 4 many front-page stories. The development of Q-IO may prove =o be the next," We are now ready to begin Phase II, agaln a= Yale. In Phase II, unlike Phase I, we do look for proof of effectiveness. Q-TO will be given at the first sign of any recurrence of cancer after removal of the primary =~or. We hope to find out much new data• For instance: What is the normal O-10 level in blood? DO people with a low Q-10 level contract cancer more readily than those with a normal Q-IO level? How will Q-10 work when glven in combination with vaccines and other therapeutic trpatments, such as radiation which markedly reduces the host ~efense system? By using Q-IO, can we reverse that depression oz the host defense system and thus be able to use mo~e radla~lon with less sid~ ~ffects? There is so much we still don't know, and so much work still undone. Q-10 wa~ extracted from beef heart. It takes about 2,000 ibs. of beef heart to make 2{ or 30 grams of highly purified Q-10, One haJf gram is used per injection and each in~ectlon costs about $500. NO patient has had to pay the cost of Q-10 therapy because 6unding came from gifts and grants from foundations, corporations and individuals. Because we felt we could no= s~op this therapy for those patients who did well, al- though rney still had cumors, we provided this additional therapy in an amo~t of abou~ $280.000, Though plans are eonerete for Phase li~ we need approximately ~285~O00 to begin. This amount hardly seems like much when we stop and think what an intriguing hope ~-i0 is for cancer ~oncrol. Proposals for this research have nwlce been approved by tnp American Cancer Society i~ the past two years but have remained unfunded because )f their lack of adequate funds

Hr. Joe E. Edens February 12, 1975 Page 5 J r We ~urn to you for help at this critical time in our research, slnce we fe~l you have a particular interest and Concern in the problem. We respectfully requesu your partial support. If you have interest in what I have tried to ~xplain~ several years of technical backup materla] can be made available to you, and I would he glad to forward any of the scientific publications to you that are shown on the attached list. We would welcome you here to visit our laboratories Please le~ me hear from yo.-- i ncere~ John H. Heller,'NM. D. Preslden~ JHH:amk Enclosure .J