Tobacco Documents Online

.. r The Cancer Letter Vol. 4, No..33, Aug. 18, 1978 tablishments, including consulting laboratories, in which certain drugs and devices are processed or held, an may examine research data that would be subject to reporting and inspection pursuant to (certain provisions of the law).... Thus, most sponsors and many investigators under INDs, INADs, IDEs and those institutions in which such studies are conducted would be subject to FDA inspection whether or not they consented." The proposals acknowledged that confidentiality of records with names of patients is a problem, and attempt to deal with it. "The commissioner finds it necessary to state clearly and publicly when FDA will request access to such records, and if such access is requested, how the agency will safeguard the privacy of subjects.... Agency personnel must invite the investigator to be present with them throughout FDA's records review, and they must inform the investigator that he or she may see the records which they may wish to copy and may review any records-that are copied. Agency personnel may not copy medical records containing the names of research subjects, and the investigator is to be given the right to delete any information that could identify an individual subject, except when: (1) A more detailed study of the records regarding particular subjects is indicated; or (2) there is reason to believe that the records do not represent actual studies, or do not represent actual results obtained. The exceptions to the prohibition against the copy- ing of individually identifiable medical records by FDA personnel rest primarily on the need to deter- mine whether a given research subject in fact exists and whether the research subject in fact participated in the investigation. Where an individually identifi- able medical record is copied and reviewed by the agency, the record is properly safeguarded within FDA and is used or disseminated under conditions that protect the privacy of the individual to the fullest possible extent consistent with laws relating to public disclosure of information (Freedom of In- formation and Privacy Act regulations) and the law enforcement responsibilities of the agency.... "The commissioner recognizes the highly sensitive nature of this provision. He welcomes reasoned dis- cussions of the issues involved and specific proposals under which patient confidentiality could be further protected without compromising the ability of FDA to verify clinical data submitted in support of appli- cations for research or marketing permits." . A limited number of reprints of the proposed rules is available from FDA and will be sent on request on a first come first served basis. Write to Bureau of Drugs. Advisory Opinions Branch, HFD-35, FDA, 5600 Fishers Ln., Rockville, Md. 20857. Ask for the reprint from the Aug. 8, 1978 Federal Rc~gister of "Obligations of Clinical Investigators ot' Regulated Articles." TIMN 0142772 ~~S: GORI GETS INTO ANOTHER CONTROVERSY AT A TIME WHEN HE DID NOT NEED ONE Gio Gori, deputy director of NCI's Div. of Cancer Cause & Prevention, has said he is not one to go looking for controversy and does not regard himself as a controversial figure. Nevertheless, controversy has a way of finding him. Gori's latest flap has not only brought down on his head the wrath of NCI Director Arthur Upton but also that of HEW Secretary Joseph Califano. The storm was touched off last week when the Associated Press sent out a story based on a report that Gori and Cornelius Lynch of Environ Control Inc. prepared for publication in the Journal of the American Medical Assn. Gori has headed NCI's Smoking & Health Program since its inception in 1970, and Enviro Control is the program's prime contractor, with Lynch as manager. The report for JAMA essentially summarizes what has been known about the Smoking & Health Pro- gram's efforts to develop less hazardous cigarettes since the tobacco industry started marketing the various new brands of low tar and nicotine cigarettes more than two years ago (The Cancer Letter, January 1976). The new brands, some with tar and nicot"ine levels as low as' 1 mg and .1 mg, respectively, ob- viously are not as dangerous to health as those with 20 or 30 times those levels. Gori and Lynch presented it in a somewhat differ- ent and more explicit way: They compared the present low t & n brands to the average pre-1960 cigarettes. Gori told AP that studies showed persons who smoked no more than two of the pre-1960 cigarettes per day had no higher death rate than non- smokers. There are among present day cigarettes brands with levels of toxins a fraction of the pre- 1960 brands. One brand-Carlton Menthols-is so low in tar and nicotinq that most persons could smoke 23 a day with no more risk than incurred by those who smoked two a day before 1960. God and Lynch compiled a list of these "tolerable" cigarettes, showing how many of each could be smoked to equal two pre-1960 cigarettes. "I am not calling any cigarette safe," Gori em- phasized. "The only cigarette that. is safe is the ciga- rette that is not lit. I am not talking about what might happen to any individual. I am talking about averages. There may be a risk that still may be there even though we might not see it in overall, large population studies. But we can now begin to talk about tolerable levels of smoking from an overall, public health standpoint. I think we will begin to see some beneficial effects in this country in tive or six years." Since 1970, NCI has spent about S 18 million on the effort to develop less hazardous cicyarettes--that is, remove or reduce tars. nicotine, carbon monoxide, nitrogen oxide,, and acrolein. The tobacco industry Page 5 / Vol. 4 No. 33 The Cancer Let te t- lst of 3 pages

, participated in the program, as contractors and as advisors, and some companies carried on their own independent research. In 1975, using some of the methods that came from NCI's program, the industry began introducing one new brand after another of low tar and nicotine content. One of the problems with such brands in the past had been that smokers considered them tasteless. Most of the new ones contain flavor additives de- veloped by the firms. Most are closely guarded secrets. Despite Gori's careful disclaimer, critics reacted to the report as if he had endorsed smoking. Sidney Wolfe, who heads the Ralph Nader Health Research Group, reacted in typical Nader fashion, saying that Gori should be fired for making "the most damaging statement about smoking in the last 10 years." Gori couldn't care less what Wolfe says, but the criticism from Upton and Califano carried consider- ably more weight. Upton responded as he had to, to make it clear that NCI was not endorsing any of the new cigarettes or taking the position that any smok- ing could be considered safe. "It is the firm position of the National Cancer In- stitute, the National Heart, Lung & Blood Institute and the Public Health Service that no cigarette now on the market can be considered wholly without risk to health," Upton said. Gori's use of the word "tolerable" was "unfortunate" and his statements have "set back our cause, and even if we can correct the misinterpretation, we will have lost valuable momentum," Upton said. Califano, who earlier this year announced his own program to halt cigarette smoking, said, "There is no such thing as a safe cigarette or anything like it." He said government scientists "are very disturbed that millions of people might think so." Gori received some support from the American Cancer Society. "There is no such thing as a proven safe cigarette," said Arthur Holleb, senior vice presi- dent for medical affairs. But Holleb acknowledged that the low tar/nicotine cigarettes do impose less serious risk of lung cancer and other disease than the more hazardous brands. Holleb called upon the tobacco industry to per- form a service to consumers and public by stopping manufacture of the more hazardous brands. "Given the industry's own research findings as reported over the weekend by the American Medical Assn. together with research reports of the National Cancer Institute and the National Heart & Lung Institute and epi- demiology studies of the American Cancer Society, there can no longer be any question about the toxi- city of high tar/nicotine cigarettes," Holleb said. "The tobacco industry now must decide how much responsibility it feels toward the American public and its health. The industry must ask itself what good is being done for consumers by its continuous pro- motion of hazardous high tar/nicotine products The Cance" Letter-, Aug. 18, 1978 / Page 6 when it has the demonstrated ability to concentrate on products of lesser risk." The Naderites, some members of Congress and even some within NCI have been critical of the Smoking & Health Program. Including the $18 million spent on developing less hazardous cigarettes, the program has received about $25 million since 1970-an insignificant amount considering the contribution even the critics say that smoking makes to the incidence of cancer. But the critics argue that NCI is in the position of funding research for the tobacco industry and that the money should be going into antismoking campaigns. The pragmatists, for whom Gori seems to be the leading spokesman, contend that antismoking efforts have been dismally unsuccessful and that the only way to make an impact on incidence of smoking re- lated disease is to produce less hazardous cigarettes. The Smoking & Health Program is in the midst of the reorganization being carried on in the Div. of Cancer Cause & Prevention since Gregory O'Conor became director of the division earlier this year. The program has been moved into the extramural Car- cinogenesis Branch, headed by Thadeus Domanski. Gori no longer is head of the program, although O'Conor said he expects Gori to provide "advice, consultation and assistance." The controversy over the smoking program came at a time when Gori least needed it. Since O'Conor became director, it was obvious that Gori's days as deputy were numbered. "We get along fine, our relationship is excellent," O'Conor told The Cancer Letter. "But when I took this job, in view of the visibility, the fact that the division was being reorganized with a new director, it would be good for all of us to have a new deputy." Upton was quoted by the IUashington Post as saying that he had been talking to Gori for several months about changing jobs because he and O'Conor "simply haven't found a comfortable working re- lationship." Gori insisted that "Greg and I are good friends. In fact, he has been my strongest supporter in this fracas (on cigarettes). It is true that he would prefer someone else as his deputy. We do have different philosophical approaches on some things, but I have tremendous respect for him." O'Conor said he was trying to find a position for Gori within DCCP "commensurate with his experi- ence and grade." The Cancer Letter learned that another possibility -at least until last week's furor-was O'Conor's old job as head of NCI's Office of International Affairs. O'Conor said existing contracts in the Smoking & I-Iealth Program would be continued, includin,- studies on the long range effects of nicotine. The pro-gram recently undcrwent an internal review, and O'Conor has recommended that it he exhancled to TIMN 0142773

include more work on basic carcinogenesis related to smoking, and new research on education and be- havioral factors. Both grants and contracts will be used to fund extramural projects. O'Conor said the program would be coordinated with Califano's office. Gori denied that he told a Post reporter that Cali- fano was putting pressure on Upton to fire him (which Upton denied). Gori admitted that he did say Califano probably was unhappy in that he might consider the report on less hazardous cigarettes would undercut the secretary's antismoking initia- tives. Gori fell into considerable disfavor with some NCI and NIH brass about 18 months ago when he partici- pated in an effort to go over their heads directly to Congress` in an appeal for more money for nutrition research. When the Diet, Nutrition & Cancer Program was established following a mandate by Congress in re- newal of the National Cancer Act three years ago, Gori was given the job of heading it (along with his other duties). Working with an advisory committee of nongovernment experts in that field, Gori got the program started and contracts were awarded. NCI's budget levelled off about that time, and when the nutrition program was given a no-growth budget, the advisory committee drafted a strong letter criticizing the decision, NCI policymakers and other NCI programs. Copies were sent to the White House, members of Congress and other key individu- als. The letter brought on a tirade by Cancer Panel Chairman Benno Schmidt at a meeting of the Na- tional Cancer Advisory Board, who objected to the criticism of other cancer programs. It also earned the disfavor, according to some observers, of NIH Director Donald Fredrickson, who they say blamed it all on Gori. Others felt that Gori and his commit- tee had gone too far and had unfairly and unneces- sarily embarraased NCI's leadership. It was not long after that NCI Deputy Director Guy Newell, who was then acting director of the institute, was required by HEW to immediately reduce the number of advisory committees. Among those Newell elected to eliminate was the Diet, Nu- trition & Cancer Program Advisory Committee. Newell denied he was exacting revenge, but com- mittee members wondered. A few months ago, Sen. George McGovern sicced his Nutrition Committee onto NCI. The Cancer Pro- gram was severely criticized for not making a greater effort on nutrition research, and Upton was required to explain, defend and promise to do better. Gio Gori could not be blamed if he had com- mented, "It wouldn't have happened if they had listened to me." ' As part of the response to Congress. Up.ton agreed to provide more coordination of nutrition research TIMN 0142774 with other agencies, along with giving it more money and attention. He also relieved Gori from responsi- bilities with the program, and turned it over to, ironically, Guy Newell. SENATE APPROPRIATIONS COMMITTEE SLASHES $25 MILLION FROM NCI TOTAL The Senate Appropriations Committee this week cut $25 million from the 1979 fiscal year allocation for NCI that had been approved last June by the HEW Appropriations Subcommittee. It was the first time the full committee has cut any money from the amounts recommended for NCI by the subcommit- tee since the National Cancer Program's inception in 1971. The subcommittee, with Sens. Edward Brooke, Birch Bayh and Richard Schweiker supporting in- creased cancer funding, had approved $950 million, not including training funds which will have to be included in a separate bill after authorization legis- lation has been passed. Training funds are expected to be about $20 million, which would have brought the total NCI appropriation to S970 million-S 100 million more than NCI is getting this year and also S 100 million more than requested by the Admini- stration. - The House• has voted $888 million, plus training. A cut of S50 million by the full committee was asked by Sen. Henry Bellmon (R.-Okla.). In arguing for the cut, Bellmon quoted from a letter published in the Congressional Record which charged that NCI has mismanaged its funds and that there has been no progress in cancer research since the 1971 Cancer Act. Bellmon commented that the letter was written by Sidney Wolfe. Appropriations Committee Chairman Warren~Mag- nuson said, "Well, I'm as well versed on the Cancer Program as anyone, and I never heard of Sidney Wolfe. Who is he?" (Wolfe is head of Health Research Group, a Ralph Nader affiliate.) Sen. Lawton Chiles (D: Fla.) pointed out that Mag- nuson had first requested $925 million (plus training) from the subcommittee. "Why not compromise at that?" Chiles asked. The committee agreed without any formal vote being taken. Neither Brooke nor Bayh was present when the decision on cancer funding was made. Brooke ap- peared later to make a futile effort to add $25 million to the amount approved by the subcommittee for the National Heart, Lung & Blood Disease Institute. RFPs AVf,.LABLE Requests for proposal described here pertain to contracts planned for award by the National Cancer Institute, unless otherwise noted. Write to the Contracting Officer or Contract Specialist for copies of the RFP, citing the RFP number. Some listings will show the phone number of the, Contract Specialist, who will respond to questions. Listings identify the respective sections of the Research Contracts Branch which Page 7/ Vol. 4 No. 33 The Cancer Let t e r

Y a{e issuing the RFPs. Their addresses, all followed by NIH, B d es a, Biol y& Viral co Con trol Carcinogen M d. 20014, are: Diagnosis Section - Landow Building logy & Field Studies Section - Landow Building Rehabilitation Section - Blair Building is Section - Blair Building Treatment Sktion - Blair Building Office of the D~ir~ector Section - Blair Building Deadline date shown for each listing is the final day for receipt of the completed proposa/ unless otherwise indicated. SOURCES SOUG ~T R FP N01-CP-85646-58 Title: Resource effort fQr microscopic and auto- radiographic technblogy Deadline: Sept. 7 NCI is interested in enteringto a basic ordering agreement for a two year period with an organiza- tion(s) to obtain assistance in prepar,4tion and exami- nation of tissues by high resolution li t microscopy, transmission and scanning electron mic scopy and quantitative light and electron microscopir•~auto- radiography. Respondents should have experience and Ape tise in use of these methodologies and expertise interpreting the results. Specific tasks will be ideri tified. Pick up and delivery of specimen from the NIH reservation is required. Respondents should have proven abilities and equipment to perform the above described ultrastructural techniques to provide data on (1) the pathogenesis of tumors of vario target organs and (2) the localization of labele,d and unlabeled compounds, including chemical physical carcinogens into cellular organe by auto- radiographic and x-ray defraction tech ues. For information purposes, the incu bent per- formers of tasks under this basic or g agreement for the past two years have been Li on Bionetics Inc. and Experimental,Pathology~Iraboratories Inc. Contract Specialist: Mary Ar,ehstead Carcinagenesis 301-.4°27-7957 R FP N f H-ES-78-1 Title: Development offomatic cell mutation sys- tems in human Deadline: Appro Proposals solicit the capability to somatic cell m access to and different he lation; mu specific must b and r inately Oct. S from_qualified sources having evelop methods for study of ations in vivo. Offerors must have 'e able to purify several (at least 10) oglobin variants from the human popu- be able to produce and purify mono- tibodies against these hemoglobin variants; able to deliver purified monospecific FTCT amin-labelled antibodies to the government; must be able to develop methods to prove that t1A/ detected variants are mutant cells; and when th above techniques are sufficiently developed, ust be able to screen a number of humans expose to chemi- cal mutagens and compare them to mat ~ ed controls. National Institute of Environmental Health Sciences Procurement Office, OAM / PO Box 12233, Building 1,1r; Room 1101 Research Triangle Park,NC 27709 NCI CONTRACT AWAR Title: Biologic, biochefiical and immunologic characteristic,Af "premalignant" human mammary e.Ifithelial hyperplasias Contractor: D e/Univ., $223,500. `s Title: Relatiq hip of thyroid function to growth of m mary tumors, continuation Contracto . Albany Medical College, $37,000. Title: strogen/progestin effects on breast in ned- natal period, continuation Co1~tfactor: Univ. of California (Santa Cruz), $92,400. itle: Data management system and statistical sup- port for NCI Serum Panel - CQntractor: U.S. Small Business Administration, $57,362. TitIe:Ven alteration/renovation/upgrading projects d provision for additional support at Fr enck Cancer Research Center Contractor: \Litton Bionetics, $410,670. Title: Develoent of an assay for genetic damage to mamm {y gland cells Contractor: Ohio ~ate Univ., $382,300. Title: Resources mo lling and analysis, renewal Contractor: JRB Assoc~tes, $24,666. Title: Isolation and tissuqculture of human tumor cell ~s Contractor: Sloan-Kettering'nstitute, $9 1,035. Title: Cervical Cancer Screening Program Contractor: Maryland Dept. of Health & Mental Hygiene, $233,042. ~ Title: Diagnostic use of leukemia-a ociated antigens ~ Contractor: Health Research Inc. RoOipll Park Div., $67,376. Title: Development and validation of an irl vitro mammalian cell mutagenesis system f,or car- cinogenesis screening, continuation Contractor: Litton Bionetics, $478,262. %he Cancer Letter -Fditor JERRY D. BOYD Published fifty times a year by The Cancer Letter, Inc., P.O. Box 2370, Reston, Virginia 22090. All rights reserved. None of the content of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording or otherwise) without the prior written permission of the publisher. TIMN 0142775 . ~