Defense Remedies Witnesses: Testimonies and Expert Reports

May 30, 2005 9:37 pm by Gene Borio

WRITTEN DIRECT EXAMINATION OF DONALD B. RUBIN, Ph.D.

WRITTEN DIRECT EXAMINATION OF DANIEL R. FISCHEL

WRITTEN DIRECT EXAMINATION OF ROMAN L. WEIL, Ph.D.

Expert Report of ROMAN L. WEIL, Ph.D.

DEFENDANTS’ WRITTEN DIRECT EXAMINATION OF JANET WITTES, PH.D.

Expert Report of JANET WITTES, Ph.D.

WRITTEN DIRECT EXAMINATION OF DENNIS W. CARLTON, Ph.D.

Expert Report of DENNIS W. CARLTON, Ph.D.

10 Responses to “Defense Remedies Witnesses: Testimonies and Expert Reports”

  1. Kerry Scott Lane MD Says:

    A forward looking remedy in need of implementation is the monitoring of aflatoxin and mycotoxin levels in tobacco products. My patents to this end have been public knowledge since May 2000, and PM was made aware of them in 1998. Only PM has made weak overtures towards implemenation of An FDA regulatory framework to minimize these carcinogenic toxins on tobacco. Aflatoxins are heat stable and mutate the p53 tumor suppressor gene, found in 60%+ of all human cancers. No other toxins known carry these profiles as toxic agents and cause cancer in the below Part-per-billion range. This means individual cigarettes can carry millions of aflatoxin molecules. Aflatoxins are profoundly immunosuppressive and have been shown to raise HIV viral levels 500% in smokers. In the event of a viral epidemic, smokers will be particulary immunocompromised and therefore more infectious. Similar examples include aflatoxin and Hepatitis C, aflatoxin in food and AIDS in Africa. Google “tobacco aflatoxin”.
    This is the time for judicial-legislative activism, for public health and security as FDA authority has been repeatedly thwarted by Tobacco Congressman. Doctors Townsend and Appleton in their cross examination failed to disclose ammoniation neutralizes aflatoxin, which is ommission of a material fact under oath. We were told ammoniation was for taste….Who knew they were using ammonia to neutralize the aflatoxin in the tar fraction, (or are they, and in what percentage of the products?).Forty per cent in 1994.
    We will need Dr. Bazerman’s monitors to keep this industry honest for quite some time as they have been far less than forthcoming on this and other issues…

  2. tobacco observer Says:

    I see this personal advertisement has a lot to do with the ongoing trial. . .

    >>A forward looking remedy in need of implementation is the monitoring of aflatoxin and mycotoxin levels in tobacco products.

    Really? Which RICO violation would that remedy?

    I must have missed the part of this trial where the gov’t accused tobacco of violating the RICO act by not monitoring aflatoxin levels in cigarettes.

    >>Aflatoxins are heat stable and mutate the p53 tumor suppressor gene, found in 60%+ of all human cancers. No other toxins known carry these profiles as toxic agents and cause cancer in the below Part-per-billion range. This means individual cigarettes can carry millions of aflatoxin molecules.

    Gosh. . .millions of molecules, huh? You forgot to mention where that number came from, but lets say its right.

    I’m told that every teaspoon of Jiffy peanut butter *DOES* carry millions of aflatoxin molecules since the stuff is ubiquitous in peanuts and other legumes and grains, including corn.

    In fact at the legal limit of 15 ppb, with an Aflatoxin molecular weight of 328 g/mol, every yummy teaspoon of peanut butter “can” contain up to 75 trillion aflatoxin molecules. So by your “data” is it safe to assume that one teaspoon of peanut butter is over one million times as toxic as a corresponding dose of cigarette smoke?

    >>In the event of a viral epidemic, smokers will be particulary immunocompromised and therefore more infectious.

    Last I checked, “viral epidemics” occur many times per year in this country. Have you any data to support this supposition that smokers are more infectious? Or are you merely spitting out alarmist-sounding pseudoscience to sell your patent?

    >>This is the time for judicial-legislative activism, for public health and security as FDA authority has been repeatedly thwarted by Tobacco Congressman.

    So you want the judge in this trial to write the law now? That’s interesting. Curiously, at least one of the major tobacco companies actually does support FDA regulation of cigarettes, though apparently that “conspiracy” isnt supported by the others.

    >>Doctors Townsend and Appleton in their cross examination failed to disclose ammoniation neutralizes aflatoxin, which is ommission of a material fact under oath.

    I suppose that might be true if a discussion of aflatoxins were in any way “material” to any of the alleged RICO violations that make up the heart of this case.

    But hey, if as you claim ammoniation neuralizes aflatoxins, that means your little problem is solved without further intervention, right?

  3. Laurie Comstock Says:

    I have never heard of peanut butter killing 400,000 plus people a year. I am sure some people who are allergic to peanut butter may have died but certainly not 400,000. If peanut butter killed that many people I am sure there would be a ban on it.

    I have personally lost 13 family members and a number of friends to tobacco-caused diseases. I have not lost one family member to peanut butter.

  4. tobacco observer Says:

    >>I have never heard of peanut butter killing 400,000 plus people a year.

    Right. But peanut butter has *lots* of aflatoxins in it, undoubtedly many times more than cigarettes do.

    The point is, worrying about trace amounts of aflatoxins present in cigarette smoke is probably akin to worrying about someday getting lead poisoning from the bullet that just hit you in the chest.

    >>If peanut butter killed that many people I am sure there would be a ban on it.

    Just like motor vehicles, guns, and alcohol are banned, right?

    >>I have personally lost 13 family members and a number of friends to tobacco-caused diseases. I have not lost one family member to peanut butter.

    I presume you mean tobacco-related diseases. That’s the term the Surgeon General likes, mainly because the etiology of all of them is multifactorial.

    But how do you know that peanut butter wasn’t a contributing factor?

    The point is, its easy to link things, and its particularly easy to make emotional arguments or alarmist statements. . .but its quite another thing to achieve a reasonable standard of proof for anything. . .including claims about aflatoxins made by individuals with strong personal vested financial interest in making them.

  5. Laurie Comstock Says:

    Just because tobacco-related diseases is a common term used by both the Surgeon General and the general public, I prefer the term “tobacco-caused” diseases because it calls attention to the fact that tobacco is to blame.

    I understand that the tobacco industry does not like that term and that’s probably why you are objecting to it. I will continue to use that term.

  6. krueger Says:

    “But peanut butter has *lots* of aflatoxins in it, undoubtedly many times more than cigarettes do”

    Inhaled versus ingested sometimes makes a difference. If you’re confused about the difference, ask anyone who’s been exposed to anthrax:

    http://www.cnn.com/HEALTH/9802/19/anthrax.explainer/

    http://www.swmedicalcenter.com/114319.cfm

    Thanks for your medical and epidemiological analysis.

    I think I’ll stick with medical doctors and epidemiologists, thanks all the same.

  7. krueger Says:

    “tobacco-related diseases”

    Ah, the soft words favored by Big Tobacco. In public.

    In private, the tobacco industry is not so soft. Hasn’t been for years.

    In 1958, BAT scientists visited the US for a study tour that included visits to Philip Morris, American Tobacco, Liggett and several research institutions. They found a consensus: “With one exception the individuals with whom we met believed that smoking causes lung cancer; if by ‘causation’ we mean any chain of events which leads finally to lung cancer and which involves smoking as an indispensable link.”

    Report on Visit to USA and Canada by H R. Bentley, DGI Felton and WW Reid of BAT, 1958, 17 April – 12 May {Minn. Trial Exhibit 11,028}

    That was clear enough for industry scientists to say “cause” disease. In private.

    In public, for almost half a century Big Tobacco continued to use soft words. “Associated”. “Related”. Not proven! Merely a statistical association. Controversial. Scientists disagree. Don’t you see. It’s all so very complex. That was the public story.

    In private, Big Tobacco was clear that its product caused disease, was causing disease, was giving the customers horrible diseases. It had no problem with “cause”. It had no problem defining exactly what “cause” meant here. Decades ago.

    But for decades Big Tobacco’s PR carefully avoided mentioning what its own scientists were telling it.

    Interestingly, if Big Tobacco had simply told the truth, had simply said the same thing in public that it said in private, had simply disclosed what it knew, it wouldn’t be on trial right now.

    It was its decades of lies, coverup, and massive public smokescreen that got the industry in trouble here.

  8. tobacco observer Says:

    >>Just because tobacco-related diseases is a common term used by both the Surgeon General and the general public, I prefer the term “tobacco-caused” diseases because it calls attention to the fact that tobacco is to blame.

    I don’t really think one can assign “blame” (ie culpability) to inanimate plant material, like tobacco. To me, that would be akin to blaming a knife for a murder. If you want to draw that kind of connection, I think the more appropriate term is “etiology” (see below).

    >>I understand that the tobacco industry does not like that term and that’s probably why you are objecting to it. I will continue to use that term.

    Feel free to use whatever terminology you like.

    I don’t speak for them, but I would assume the Surgeon General, the World Health Organization, and (I guess) tobacco would all object to your terminology for the same reason I do; it’s simply inaccurate. The etiologies of the overwhelming number of diseases attributed to tobacco are multifactorial. Tobacco may be a significant contributing factor to many of these diseases, but it is generally not a necessary or sufficient “cause”. The overwhelming majority of *non*-smokers also die of heart attacks, strokes, and cancer, you see.

    >>“tobacco-related diseases”
    >>Ah, the soft words favored by Big Tobacco. In public.

    Yes, Big Tobacco is very devious that way. Somehow they’ve managed to trick the Surgeon General of the United States, the World Health Organization, the Center for Disease Control, the Mayo clinic, and by the medical community at large, all to favor that very term in public discourse!

    http://mayoresearch.mayo.edu/mayo/research/nicotine_research_center/diseases.cfm
    http://www.trdrp.org/

    >>Inhaled versus ingested sometimes makes a difference. If you’re confused about the difference, ask anyone who’s been exposed to anthrax:
    >>I think I’ll stick with medical doctors and epidemiologists, thanks all the same.

    I think you’re the one who is a bit confused here. Perhaps you should ask your favorite doctor (or anthrax victim) to explain to you the difference between an infectious disease like anthrax and a carcinogen like aflatoxin.

    I’d suggest speaking to a doctor who doesn’t spam message boards out of a vested personal financial interest in selling their proprietary (and clinically unproven) technology, but that’s just me.

    If you’re still confused, you might wish to speak to a toxicologist (not an epidemiologist) about the mantra of modern toxicology “the dose makes the poision”.

    http://www.wiley.com/WileyCDA/WileyTitle/productCd-0471288373.html

    That might segue into a nice discussion about how she feels about the “threat” posed by picograms of aflatoxins in burning cigarette smoke (say compared to the million-fold amounts of the same stuff in peanut butter, or compared to the tons of carcinogenic polycyclic aromatic hydrocarbons in the same cigarette smoke).

    But if you are too lazy to do any of that, you could simply read the following article from the Journal of Oncology addressing the very item in question:

    *****
    Oncology. 1991;48(3):194-5.

    Aflatoxins in sera from patients with lung cancer.

    Cusumano V.

    Microbiology Institute, Faculty of Medicine, Messina, Italy.

    Sera from patients with lung cancer and from healthy donors were screened for the presence of aflatoxins. Significant differences in levels of aflatoxins between the two groups were found. Only 1 of the neoplastic patients with aflatoxins in the serum was a smoker. However the percentage of sera from lung cancer containing aflatoxins is not significant enough to provide evidence for a casual relationship between aflatoxins exposure and development of lung cancer in humans.
    *****

  9. krueger Says:

    “I don’t really think one can assign “blame” (ie culpability) to inanimate plant material, like tobacco.”

    I agree.

    The plant and its leaves don’t cause death by themselves. And in fact there were few tobacco deaths until Big Tobacco created mass manufacture, mass marketing, and mass consumption of its tobacco product.

    Before the invention of the Bonsack machine, before the creation of the Marlboro man, tobacco existed, yet lung cancer was a rare disease. A physician might see one case in his lifetime.

    30 years after mass manufacture, mass promotion, and mass consumption of tobacco product started, the epidemic of lung cancer started. It has not yet stopped.

    No, the plant didn’t make Big Tobacco do that.

    Big Tobacco did that.

    And Big Tobacco kept right on doing that after it became clear the product was making the customers sick and killing them.

    The plant didn’t make Big Tobacco do that either.

    And Big Tobacco engineered the product for addiction, pushed it with billions of advertising, marketing, and promotion, made it attractive to kids, and got generations addicted to it.

    The plant didn’t make Big Tobacco do any of that.

    No, I wouldn’t blame the plant here.

    “The overwhelming majority of *non*-smokers also die of heart attacks, strokes, and cancer, you see.”

    Thanks for the epidemiology. Likewise, the majority of anthrax deaths don’t result from terrorism. Clearly, the etiology is complex here. Mailed anthrax spores don’t “cause” deaths. Gosh no. It’s just an “association”; “multifactorial”; not “a necessary or sufficient cause.” You can’t just say that anthrax spores cause anthrax. Can you?

    “Big Tobacco is very devious that way. Somehow they’ve managed to trick the Surgeon General of the United States, the World Health Organization, the Center for Disease Control, the Mayo clinic, and by the medical community at large, all to favor that very term in public discourse!”

    Oh, it’s no trick; it’s the simplest thing in the world; it’s called intimidation.

    Big Tobacco has the best organized PR machine in the world, and one of ways it uses it is to attack scientific evidence that shows what its product does to the customer, and to the people nearest to the customer. This slows down and waters down the wording of science announcements until they’re ready to withstand all attack. This has been a very effective strategy for the industry, as it keeps the public discourse on tobacco soft and vague.

    Here’s an example: does secondhand smoke cause breast cancer? Well, the evidence grows stronger with each new study that it does; if it were any other carcinogen, we would have long ago heard yes, it does, the evidence is sufficient to say “cause” — but:

    “Mainstream health organizations are intentionally cautious in making claims about tobacco, reserving final judgment until the evidence cannot be dismissed by the tobacco industry” observes Dr. Michael Thun, vice president of epidemiology and surveillance research at the American Cancer Society.

    http://health.yahoo.com/news/59725

    This is a recent example, and just one example. Big Tobacco has a long history of intimidating scientists, health groups, government officials, and reporters who speak the truth about it and its product.

    As Philip Hilts said:

    “I’ve been reporting for about 25 years, a lot of it about health, a lot of it about big companies - I’ve never encountered anything like the aggression and hostility from the tobacco companies….they have a lot of money to push their point of view - in PR, they swarm you with PR people, with paper, in court, every way they can. So there’s nothing to compare to it.”

    http://www.pbs.org/wgbh/pages/frontline/smoke/interviews/hilts.html

    Big Tobacco uses similar different methods for the same result in Washington:

    “The industry hired one lobbyist for every two members of Congress. The major manufacturers spent over $30 million in lobbying fees last year alone, a number that does not include the millions in campaign contributions or the billions spent on advertising grass roots and front organizations. The number of tobacco lobbyists on the Hill was obscene.”

    Dr. C. Everett Koop

    http://www.no-smoking.org/sept98/09-14-98-1.html

    A nice overview of the scene is at:

    http://leda.law.harvard.edu/leda/data/413/Solet.html

    So if you’re a government official, and you’re minded to speak the plain truth about the number one preventable killer in America, what you know is your boss, his boss, all the people who have influence in government, are powerfullyinfluenced by Big Tobacco. You think twice. Maybe you say “associated with” instead of cause.

    If radon had the same PR muscle, we’d seldom hear it causes lung cancer today. We’d hear about an “association”. It’s just “related”. The soft language. It’s all so complex.

    Poor radon, it doesn’t have a massive well funded PR operation that intimidates science and science reporting. Poor radon, no soft language for it; we just hear radon causes cancer. Causes. Period. Because it does. Because no one ever lost their job for speaking the plain truth that radon causes lung cancer.

  10. krueger Says:

    “you might wish to speak to a toxicologist (not an epidemiologist) about the mantra of modern toxicology ‘the dose makes the poision’”

    Why thank you; I did. He told me that’s the mantra of traditional toxicology. It works well for acute exposures. It doesn’t work so well for chronic low level exposures. For that, modern toxicology gets help from epidemiology.

    Tobacco product generates chronic low level exposure to carcinogens, lung and heart pathogens, and toxins. That’s what causes the death.

    Please feel free to debate a particular carcinogen in tobacco smoke, whether it’s present in sufficient amounts to (be proven to) cause cancer, and so on and on.

    The truth is, the product exposes the customer, and the people closest to the customer, to over 4000 chemicals which include the following known carcinogens:

    Benz(a)anthracene, Benzo(b)fluoranthene, Benzo(j)fluoranthene, Benzo(k)fluoranthene, Benzo(a)pyrene, Chrysene, Dibenz(a,h)anthracene, Dibenzo(a,i)pyrene, Dibenzo(a,l)pyrene, Indeno(1,2,3-c,d)pyrene, S-Methylchrysene, Quinoline, Dibenz(a,h)acridine, Dibenz(a,j)acridine, 7H-Dibenzo(c,g)carbazole, N-Nitrosodimethylamine, N-Nitrosoethylmethylamine, N-Nitrosodiethylamine, N-Nitrosopytrolidine, N-Nitrosodiethanolamine, N’-Nitrosonomicotine, 4-(Methylnitrosamino)- 1-(3-pyridyl)-1-butanone, N’-Nitrosoanabasine, N-Nitrosomorpholine, 2-Toluidine, 2-Naphthylamine, 4-Aminobiphenyl, Formaldehyde, Acetaldehyde, Crotonaldehyde, Benzene, Acrylonitrile, 1, 1 -Dimethylhydrazine, 2,Nitropropane, Ethylcarbamate, Vinyl chloride, Hydrazine, Arsenic, Nickel, Chromium, Cadmium, Lead, Polonium-210.

    Please feel free to explain which of them is or is not present in sufficient concentration to convince you, based on your medical and epidemological and tox expertise, that chronic low level exposure is or is not safe. Consider their effect in pyrolysis. You can then move on to combinations, synergistic effects; which combinations are safe? Take your time.

    I won’t be spending any time on it myself. Why? Because this debate is over. Despite the best efforts of Big Tobacco to prolong the debate, to create the appearance of controversy long after any real scientific controversy had ended, it’s now clear that Big Tobacco’s product, used as intended, gives horrible diseases to the customer, and to the people closest to the customer.

    At this point, only the tobacco industry still denies this. For instance, in this trial we still hear denial from Big Tobacco:

    http://democrats.reform.house.gov/Documents/20040827162948-44223.pdf

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