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I have never had this happen to me. I've never heard of it happening to any other scientist that I've ever talked to. This is very, very unusual. Paul? I don't know if Paul has. But I don't know if anyone else has tested the waters and gone against an agreement like this, like we signed. I mean, that was clearly

Mr. SYNAR. Well, let's talk about that agreement, because you obviously have a confidentiality agreement. The last 10 years you haven't been free to talk publicly about your work. There have got to be other researchers in that same situation. How do these agreements work in practice? Are they, in effect, a complete bar to getting information to the very people that the information is supposed to serve?

Mr. DENOBLE. I've never had an agreement-I've never had an agreement with anybody else like this. This is the only agreement that I've ever had.

Mr. SYNAR. This is unique to the tobacco industry?

Mr. DENOBLE. No, sir, it's not. Industry has agreements that you will not divulge proprietary information, that you will not take data with you when you leave. Those every company has. This agreement was probably similar to those agreements, but it was being enforced in quite a different way.

This was used to prevent us from publishing information that did not relate to a product, did not relate to a marketing issue. It just didn't relate to anything like that. It was just the science. And what we found wasn't liked.

Mr. SYNAR. Let me conclude with just this general question, Dr. DeNoble, if I could. You are presently employed where?

Mr. DENOBLE. I work with the Department of Mental Retardation with the State of Delaware, servicing folks who have--or citizens who are mentally retarded.

Mr. SYNAR. And Dr. Mele, you are where?

Mr. MELE. I work with the Defense Department.

Mr. SYNAR. OK. What has this experience over the years told you about the tobacco industry? What does it tell you about the character and the trustworthiness of this industry?

More importantly, what did it feel like on April 14, 1994, as you watched as the rest of America did, the testimony of the seven chief tobacco executives of this country on the issue of whether or not, one, tobacco is deadly; and second, that nicotine is not addictive. What did you feel like at the moment when you saw that?

Mr. DENOBLE. That's a very difficult question to answer. You know, when I first agreed to appear before this committee, I promised that I probably would not go out and make public policy. It's difficult to watch those hearings and to feel good about what happened to us.

I would very much like to stick with the issues surrounding the laboratory, and would very much like to stick to the issues in the data, and would very much not like to personalize this. That's the best answer I can give you, sir.

Mr. SYNAR. Dr. Mele?

Mr. MELE. It just brought back to me the amount of data and type of data that we had collected and that was going nowhere. And in a very limited sense, that data should be out. I don't know

about broader public policy issues, but we put a lot of effort into collecting that data.

They asked us to collect it, they suppressed it, and it remains suppressed right now. It may be of use to the world, it may not. That should be put out and let the scientific community judge. Mr. SYNAR. Thank you both.

Mr. WAXMAN. Mr. Synar, if you'll just yield to me. Not only did they suppress the data, but due to these agreements they had with you as researchers, and I assume they have this with all their researchers, they have been able to keep people who work for them from coming forward to talk about what they know and what they've done even as employees of the tobacco industry.

I want to tell you that I think you have come to us in good conscience, concern, and with a great deal of courage to make this presentation. And I hope others will be coming forward as well. Mr. Wyden?

Mr. WYDEN. Mr. Chairman, thank you. I'm going to go back to the laboratory in just a second, Dr. DeNoble.

But, Mr. Chairman, I would like to enter into the record at this point a Wall Street Journal article, February 11, 1993.

Mr. WAXMAN. Without objection, it will be put into the record. [The article follows:]

THE WALL STREET JOURNAL

VOL CCXXI NO 29 ✰✰✰ EASTERN EDITION

1993 Dow Jones & Company, Inc All Rights Reserved.
THURSDAY, FEBRUARY 11, 1993

Smoke and Mirrors

How Cigarette Makers Keep Health Question 'Open' Year After Year

Council for Tobacco Research Is Billed as Independent But Guided by Lawyers

An Industry Insurance Policy

By ALIX M. FREEDMAN
And LAURIE P. COHEN
Staff Reporters of THE WALL STREET JOURNAL

This is the story of the longest-running misinformation campaign in U.S. business history, and how it may ultimately backfire on its corporate sponsors.

The tale opens in 1954. Cigarette smoking, like tail fins and the new music called rock-and-roll, was fun and glamorous. But a warning had just been sounded that smoking might not be good for you. A scientist at Memorial Sloan-Kettering Cancer Center had painted tobacco tars on the backs of mice and produced tumors. The tobacco industry met this sudden threat head-on.

In full-page newspaper ads headlined "A Frank Statement to Cigarette Smokers," tobacco companies announced that a new research group, funded by the industry but independent, would examine all phases of tobacco use and health." Its solemn pledge: "We accept an interest in people's health as a basic responsibility, paramount to every other consideration in our business.

The tobacco industry's main vehicle for damage control was up and running.

Sowing Doubt

For almost four decades, the Council for Tobacco Research in New York has been the hub of a massive effort to cast doubt on the links between smoking and disease. Sponsored by U.S. tobacco companies and long run behind the scenes by tobacco-industry lawyers, the ostensibly independent council has spent millions of dollars advancing sympathetic science. At the same time, it has sometimes disregarded, or even cut off, studies of its own that implicated smoking as a health hazard.

"When CTR researchers found out that cigarettes were bad and it was better not to smoke, we didn't publicize that" in press releases, says Dorothea Cohen, who for 24 years until her retirement in 1989 wrote summaries of grantee research for the Council's annual report. "The CTR is just a lobbying thing. We were lobbying for cigarettes."

Many companies under attack for their products have underwritten research to buttress safety claims. What sets the tobacco industry apart is the scope, aggressiveness and persistence of its under

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taking. For decades rival tobacco companies have acted in concert to combat the growing body of evidence linking their products to cancer, heart disease and emphysema.

Cheap Insurance

The U.S. Centers for Disease Control today links 434,000 deaths a year to smoking. The surgeon general has declared smoking "the single largest preventable cause of death and disability," citing "overwhelming" evidence from no less than 50,000 studies. Yet the wisp of uncertainty supplied by the Council has always been enough to protect the $50 billion industry in Congress and especially in court, and tobacco companies have never paid a dime in product liability claims.

Addison Yeaman, a former Brown & Williamson Co. lawyer and ex-chairman of the Council, says the passage of time hasn't altered his faith in this view expressed at a Council meeting in 1975: The “CTR is (the) best and cheapest insurance the tobacco industry can buy, and without it, the industry would have to invent CTR or would be dead.'

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Michael Pertschuk, a former chairman of the Federal Trade Commission, finds the industry's defense extraordinary: "There never has been a health hazard so perfectly proven as smoking, and it is a measure of the Council's success that it is able to create the illusion of controversy in what is so elegantly a closed scientific case."

A Legal Peril

But now the device the industry has so long used to deflect attack has become its biggest vulnerability. That is because the Supreme Court last year said smokers can sue, accusing the industry of deliberately hiding or disorting smoking's dangers. And the U.S. attorney's office in Brooklyn, NY.. is conducting a criminal investigation into whether the industry used the Council to defraud the public.

Whether anything will come of the criminal inquiry - and whether plaintiffs can convince juries that the industry did in fact misrepresent health hazards - are very much open questions; just last month, one jury rejected allegations of a conspiracy. But if plaintiffs should begin to succeed, perhaps by gaining access to now-secret Council documents, they could turn on its head what up to now has been an almost totally winning industry strategy.

The Council for Tobacco Research declined to respond to questions about its activities, as did all of the Big Six tobacco companies Phillip Morris Cos., RJR Nabisco Holdings Corp., American Brands Inc., B.A.T. Industries PLC (parent of Brown & Williamson), Loews Corp. (parent of Lorillard) and Brooke Group Ltd. (parent of Liggett Group).

At the outset, many in the industry thought the late-1953 crisis posed by the Sloan-Kettering mouse research was entirely manageable. With the Council, "the industry was told that in the best of worlds, we'd do a great service to mankind," says James Bowling, a former Philip Morris director. "Our product either would be exonerated or, if involved (in causing cancer), they'd identify the ingredients and we'd take them out. We thought this was marvelous."

So apparently did some scientists. The Counal snagged a noted figure, Clarence Cook Little, as its scientific director. Thanks to his renown as a former University of Michigan presi

dent and director of a prestigious laboratory, the Council was able to attract an illustrious scientific advisory board, which culled through proposals from a who's who of American scientists who sought its research grants. Over the years, it has doled out more than $200 million.

But the Council's role was never just research. It was largely a creature of Hill & Knowlton, the public relations firm, which cigarette merchants retained when the mouse research came out. Hill & Knowlton installed the Council in the Empire State Building in New York, one floor beneath its own offices, with one of the PR firm's staffers as the supposedly independent research council's executive director. Hill & Knowlton also began publishing a newsletter that reported such news items as "Lung Cancer Found in Non-Smoking Nuns," and it helped authors generate books with titles like "Smoke Without Fear" and "Go Ahead and Smoke."

Some people, including many in the news media, were skeptical of the Council. "To reporters, the Council was never independent," says Earl Ubell, a veteran science reporter at WCBS-TV in New York. "It was a wholly owned subsidiary of the tobacco industry." But in the interest of balance, journalists writing on smoking and health routinely included the Council's views.

And many smokers lacked the professional skepticism of reporters. "You would have to have lived in that era to understand they kept providing false reassurances, so I had no idea that smoking was so very dangerous," says Janet Sackman, who once appeared in ads as Miss Lucky Strike and who now has throat cancer.

As early as 1958, however, the Council had strong intimations from studies it financed that smoking could be dangerous. "Cigarette smoke condensate is a weak mouse skin carcinogen,' said a Council-financed study completed in that year.

Ensuing Council-financed research found more links to disease. In 1961, a study of 140 autopsies at a Veterans hospital in Iowa City, Iowa, said "a history of cigarette smoking is significantly related to the incidence of carcinoma." In 1963, researchers at Philadelphia General Hospital and the University of Pennsylvania linked chronic smoking to earlier coronary artery disease and a higher incidence of coronary occlusion.

The Council summarized such results in its annual reports, but it often chose other research to stress to the public. Ms. Cohen, who wrote the summaries, cites a 1965 study that said pregnant women who smoked had smaller babies and were more likely to give birth prematurely. But the industry in 1982 submitted to Congress a study the Council hadn't financed, saying that smokers had no greater risk of premature babies and that low birth weight wasn't a problem.

"In the '60s," says Ms. Cohen, "there was so much bad news about smoking that there really wasn't much the CTR could put out, but anything they could find they would use." THE LAWYERS STEP IN

By 1964, keeping the case open was no longer just shrewd public relations; it had become a legal imperative. As more Americans came to believe smoking could kill, the number of tobacco liability suits jumped to 17 from seven the year before. And in that year, the Surgeon General labeled smoking a health hazard.

It was a serious, stunning shock," says Mr. Bowling, the former Phillip Morris director. "That's the stage at which the lawyers became a lot more involved."

Needing a defense from science as never before, yet dreading the legal exposure that adverse research would bring, the industry created within the Council a Special Projects division - with lawyers, not scientists, at the helm. Much of what it did was shrouded in mystery. "Everything was cloak-and

dagger," recalls John Kreisher, a former associate scientific director of the Council. "We weren't allowed on their floor."

The core of the lawyers' operation was a vast database, storing the world's literature on tobacco and health, data on foes and strategy documents. The lawyers began shuttling the globe, looking for research and expert witnesses. They sought out studies supporting causation of lung cancer by factors other than smoking and research suggesting the complex origin of all diseases linked to tobacco.

Overtures to scientists usually were handled by outside law firms, especially Jacob, Medinger, Finnegan & Hart in New York. It also served as counsel to the Council, and its Edwin Jacob took the lead role at the Special Projects unit. This arrangement offered crucial advantages. Notes Roy Morse, a former research chief at R.J. Reynolds: "As soon as Mr. Jacob funded" a scientific study, "it was a privileged relationship and it couldn't come into court" because of legal rules protecting attorney-client communications. "So they could do projects that they could bury if they chose."

How often they may have done that is unclear, because 1,500 Council documents are under seal in a federal suit in New Jersey, withheld under the attorney-client privilege. In any case, the industry had other options, such as halting funding after an initial phase. Mr. Jacob and the firm of Jacob Medinger declined to comment.

SCIENTISTS SIGN UP

In 1972, the Special Projects unit gave Hugh Fudenberg. an immunologist, funding to determine whether some people are genetically predisposed to emphysema. Early results indicated up to 10% might be. Dr. Fudenberg planned "to warn high-risk people not to smoke," he says, but before he could his funding was discontinued without explanation. "They may have cut me off because it would have been negative for them," he speculates.

A researcher named Geoffrey Ashton learned the limits of the Council's independence in 1976. He was invited by Mr. Jacob to study whether there might be some genetic factor underlying both smoking and certain diseases. But the study never got funded. Dr. Ashton says the lawyer told him "the presi dents of the tobacco companies had turned down the proposal because they didn't think the outcome would be useful to them."

This case, like several others, points up the sometimesperplexing relationship between scientists and the tobacco Council. Dr. Ashton says he was "very apprehensive" about casting his lot with the industry. What finally won him over? **Not to shock you, but scientists are always looking for money to further their research," Dr. Ashton says.

Likewise, a pharmacologist, Charles Puglia, did a special project for the Council's lawyers from 1979 to 1981, although he believed smoking to be dangerous. He explains: "It was early on in my career and it got me started with a laboratory."

While these scientists hesitated to accept tobacco funding but finally said yes, others, such as Theodore Finley, hesitated and finally said no. Dr. Finley, encouraged by Jacob Medinger lawyers to apply for cigarette research funding, decided to examine whether emphysema can result from a reduction that smokers face in a protective lining of the lung. He soon backed out. "If my theory was correct, it would have discredited cigarettes," he says. "But it would be hard to talk about the evils of tobacco while being supported by them at the same time. This was dirty money I felt like a prostitute."

The researchers the Council cultivated most assiduously were those of a different breed: contrarians whose work disputed the perils of tobacco. For instance, James F. Smith did two controversial studies in the 1960s and 1970s saying smoke

ss tobacco did not cause cancer. (The surgeon general in 1986 said it raised the risk of oral cancer.)

Although Dr. Smith all but repudiated his own conclusions on CBS's '60 Minutes" in 1985 — urging the public to avoid smokeless tobacco a short time later he acknowledged he accepted an offer of several thousand dollars from Jacob Medinger lawyers to review scientific literature in preparation for a tobacco liability suit. The plaintiff was the mother of an Oklahoma youth who had died of oral cancer after using smokeless tobacco for seven years.

The Jacob Medinger firm and other defense lawyers won the suit, invoking Dr. Smith's studies as independent research. But there are indications he had longstanding ties to the Council; one court document shows his first study was earmarked a "priority" for funding by Council lawyers 20 years earlier. Dr. Smith says the Council paid for equipment at his department's lab at the University of Tennessee when he was doing his smokeless tobacco studies, though it didn't finance the studies.

REWARDING RESEARCH

Two other favorite scientists of the Council were Carl Seltzer and Theodore Sterling. Dr. Seltzer, a biological anthropologist, believes smoking has no role in heart disease and has alleged in print that data in the huge 45-year, 10,000-person Framingham Heart Study which found otherwise have been distorted by antitobacco researchers. Framingham Director William Castelli scoffs at Dr. Seltzer's critique but says it "has had some impact in keeping the debate alive."

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Dr. Sterling, a statistician, disputes the validity of population studies linking smoking to illness, arguing that their narrow focus on smoking obscures the more likely disease cause -occupational exposure to toxic fumes.

For both men, defying conventional wisdom has been rewarding. Dr. Seltzer says he has received "well over $1 million" from the Council for research. Dr. Sterling got $1.1 million for his Special Projects work in 1977-82, court records show.

In relying on such research, the tobacco industry is "exploiting the margins of science," contends Anthony Colucci, a former top researcher and later director of scientific litigation support at R.J. Reynolds. He offers an analogy: "There's a forest full of data that says tobacco kills people, and sitting on one tree is a lizard with a different biochemical and physiological makeup. The industry focuses on that lizard — that tiny bit of marginal evidence."

R.J. Reynolds is suing Dr. Colucci, an outspoken critic, to keep him from testifying in a trial or talking to the media about tobacco liability, and accuses him of demanding a big consulting contract to keep quiet. Dr. Colucci says Reynolds "manipulated the negotiations" so it can now portray them as an extortion attempt. He adds: "This is a clear demonstration of the extent to which a tobacco company will go to silence someone who is telling the truth."

The Special Projects unit worked in a variety of ways to protect tobacco companies. Lobbying in Congress against advertising curbs, the industry in 1982 submitted to Congress a researcher's statement that peer pressure, not advertising, induced young people to smoke. Congress wasn't told that the research had been funded by Council attorneys. This was no accident. At a meeting of tobacco-company lawyers the year before, Mr. Jacob explained that the reason for funding that particular research as a Special Project was to conceal the researcher's ties to the industry. "We did not want it out in the open," Mr. Jacob said, according to the meeting transcript as cited in a Newark, N.J., federal judge's opinion.

The Council's lawyers weren't content for long to confine

their activities to the Special Projects division. By the late 1960s, they had begun to encroach on the smoking research emanating from the putatively independent Council itself. Often, the Council and its lawyers shared or swapped projects and

scientists.

By 1968, the Council had begun putting researchers under contract for many studies. This gave it the right to control both a study's design and publication of the results. However, as a contractor, the Council could be held responsible for withholding negative findings. So its operatives would do their utmost to ensure that ugly surprises didn't arise.

This contributed to a parting of the ways with Hill & Knowlton. "The lawyers had this thing under control," recalls Loet Velmans, a former chief executive of the PR firm. It quit the account in the late 1960s, he says, out of frustration that the industry "for legal reasons felt it couldn't admit to anything (on tobacco and health) because then it would be sued out of existence."

Says Robert Kersey, a former head of tobacco research at Liggett: "Almost everything that transpired had to be done under the advice of counsel so that nothing... would incur a potential liability."

SMOKING RODENTS

In 1968, the Council contracted with Mason Research Institute in Worcester, Mass., to evaluate "smoking machines" for animal inhalation studies and do toxicity tests on rodents. As the study drew to a close in 1972, Mason researcher Miasnig Hagopian was astonished when scientists from the Council and from R.J. Reynolds began turning up weekly at his lab, where he says they sat for hours taking notes. They made sure that only the most genetically vigorous (that is, cancer-resistant) rodents were going to be used, he says, and dictated which cigarettes and how many puffs were administered to them.

"It got to the point where they were directing the course of the study," says Dr. Hagopian. "It was nowhere near as objective as if it had been funded by" the governinent.

Although he did complain to Mason's president. Dr. Hagoplan concedes he and other researchers mainly "looked the other way." They wanted to make sure the contract was renewed so they could do the critical experiments on whether smoke affects rodents' lung tissues. However, the Council canceled funding before Mason began the animal study.

The Council pulled out the big guns after another study, at Bio-Research Institute in Cambridge, Mass. When Syrian hamsters were exposed to smoke twice a day for 59 to 80 weeks, 40% of those of a cancer-susceptible strain and 4% of a resis tant strain developed malignant tumors. Before publishing the study in 1974, the institute's founder, Freddy Homberger, sent a manuscript to Robert Hockett, then scientific director of the Council. Dr. Homberger says he had to do so because halfway through his study, the Council had changed it from a grant to a contract "so they could control publication they were quite open about that."

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Soon thereafter, Dr. Hockett and Mr. Jacob, the lawyer, hastened to Dr. Homberger's summer home in Maine. Their mission? "They didn't want us to call anything cancer," Dr. Homberger testified years later at the Rose Cipollone tobacco liability trial in federal court in Newark, N.J. "They wanted it to be pseudo-epitheliomatous hyperplasia, and that is a euphemism for lesions preceding cancer. And we said no, this isn't right. It is a cancer." Today, Dr. Homberger adds that Mr. Jacob told him he would "never get a penny more" if the paper was published without making the changes.

He compromised. At the last minute, he changed the final proofs to read "micro-invasive" cancer, meaning a microscopic

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