[Congressional Record Volume 142, Number 135 (Thursday, September 26, 1996)]
[Senate]
[Pages S11443-S11446]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                       AD HOC HEARING ON TOBACCO

 Mr. LAUTENBERG. Mr. President, on September 11, I cochaired 
with Senator Kennedy an ad hoc hearing on the problem of teen smoking. 
We were joined by Senators Harkin,

[[Page S11444]]

Wellstone, Bingaman, and Simon. Regrettably, we were forced to hold an 
ad hoc hearing on this pressing public health issue because the 
Republican leadership refused to hold a regular hearing, despite our 
many pleas.
  Yesterday I entered into the Record the testimony of the witnesses 
from the first panel. Today I am entering the testimony of the 
witnesses from the second panel which included Minnesota Attorney 
General Hubert Humphrey III and Dr. Ian Uydess, a former research 
scientist for Philip Morris.
  Mr. President, I ask that the testimony from the second panel of this 
ad hoc hearing be printed in the Record.
  The material follows:

  Testimony at the Ad Hoc Hearing on Proposed Legislation to Halt FDA 
Regulations, and Grant Tobacco Industry Special Immunity From State Law 
                    Enforcement Actions, U.S. Senate


     statement of minnesota attorney general hubert h. humphrey iii

       Thank you, Senator. I appreciate you holding these 
     discussions today on the issue of proposed federal 
     legislation to resolve all litigation and regulation 
     affecting the tobacco industry.
       Publicly airing these issues before any action is taken is 
     absolutely critical. Clearly, any legislation to terminate 
     state tobacco lawsuits and to half FDA's controls on 
     marketing to kids will have a sweeping effect on the whole 
     nation, and in fact would raise insurmountable constitutional 
     concerns.
       I would also encourage you to get direct input from health 
     advocates. Clearly, their views must guide us in approaching 
     this issue, because ultimately the public health issues at 
     stake are monumental.
       It's no secret that I am personally very skeptical about 
     the legislation being discussed in news reports. While I 
     cannot comment on the litigation discussions I have had with 
     my colleagues from other states on this issue or specific 
     terms of an acceptable resolution, I can reiterate the 
     general concerns I have raised about this approach.
       Specifically, these are a few of my major concerns.
       Concern number one: As a general proposition, I am very 
     skeptical about forcing these law enforcement matters out of 
     state courts and into Congress. First, I do not believe that 
     an attempt to preempt the pending legislation of sovereign 
     states would be constitutional. Beyond the constitutional 
     issue, reports this week indicating that the largest 
     cigarette maker, Philip Morris, spent more money to influence 
     Congress last year than did any other corporation or special 
     interest group does not make me feel any more comfortable. 
     Obviously, we would not feel comfortable presenting our case 
     before any jury that had been the recipient of $15 million 
     worth of ``persuasion.'' This is the bottom line: The tobacco 
     industry believes it will never find a more favorable jury 
     than the U.S. Congress.
       Concern number two: I am very skeptical about any 
     legislative deal to let the tobacco industry have special 
     immunity from obeying the same state laws that every other 
     industry must obey. Just last week, I enforced Minnesota 
     antitrust laws against a pharmaceutical giant. A few weeks 
     before, I enforced Minnesota consumer fraud laws against a 
     small local auto dealer. These businesses, big and small, 
     were held responsible for their lawbreaking. If these 
     businesses--and hundreds of others--are held accountable for 
     their lawbreaking, I ask you to consider whether it is fair 
     and honorable to cut a backroom political deal that would 
     grant the politically powerful tobacco industry blanket 
     immunity from obeying the same consumer fraud and antitrust 
     laws that every other business must obey.
       At a minimum, it is essential that this deadly product, 
     like every other product Americans eat or drink or ingest, be 
     placed under the on-going jurisdiction of an appropriate 
     federal agency, such as the FDA. Issues such as the 
     addictiveness of nicotine, the hazards of tobacco's secret 
     chemical additives, and possible technologies for making 
     safer cigarettes must be considered.
       My final concern: I am very skeptical about any legislation 
     whose terms don't meet the three bottom line principles I 
     have insisted on since we launched our case over two years 
     ago.
       (1) The first principle we have insisted on from the 
     beginning is an ironclad guarantee that the tobacco industry 
     stop marketing tobacco to kids. The legislative proposal's 
     insistence that the FDA be cut out of the regulatory picture 
     clearly is a major setback to attaining that all-important 
     principle.
       (2) Our second principle we have insisted all along is to 
     recover taxpayer damages commensurate with the harm done by 
     the tobacco industry's lawbreaking. Considering that we are 
     talking about decades of lawbreaking and that the costs of 
     tobacco-related health problems is estimated by the CDC to be 
     about $50 billion per year, I have serious questions about 
     whether the proposal is consistent with this important 
     principle.
       (3) The final principle we have insisted on from the very 
     beginning is that the tobacco industry tell the whole truth 
     about health and smoking. The public demands to know what the 
     tobacco industry knew and when they knew it. But the proposal 
     being discussed does not require the tobacco industry to open 
     up its documents so that we learn things such as how to make 
     safer cigarettes that can save lives. Allowing the tobacco 
     industry to continue to cover-up this information from those 
     who could benefit from it would be a huge step backward from 
     this third important principle.
       Senator Lautenberg and members of the Committee, in 
     Minnesota we are two years and over 10 million documents down 
     the road. We have spent tremendous time, energy, and 
     resources preparing to go to trial with the strongest case 
     the tobacco industry has ever seen. We still have far to go, 
     but we have now come more than half the distance toward our 
     goal. We ask Congress not to undercut us, but instead to 
     support us.
       Despite our unflagging determination to build our case and 
     proceed to trial, we are always ready to talk settlement--
     with the defendants, that is. Settlement talks between the 
     plaintiffs and defendants are one thing. We always are open 
     to that. But federally-mandated global termination of all 
     state law enforcement actions against the single industry--
     simply because that industry is politically powerful--is 
     quite another.
       Let me leave you with this final thought. Over 30 years 
     ago, some in Congress undoubtedly thought they were doing the 
     right thing when they passed legislation to require labeling 
     of cigarettes. We now know, however, that the tobacco 
     industry actually participated in the writing of the labeling 
     legislation. As a Lorillard Tobacco company attorney now 
     explains, the industry understood all along that the labeling 
     law provided the industry with an argument against smoker's 
     liability suits. The book Ashes to Ashes documents that, 
     quote ``even the tobacco spokesman kept saying for the record 
     that they opposed the warning label, `privately'--the 
     Lorillard attorney is quoted as saying--`we desperately 
     needed it.' I suggest that this is an important lesson for us 
     to keep in mind in 1996 as Congress contemplates its 
     appropriate role in this matter.
       I appreciate your invitation to share my concerns with you 
     today. You are doing the country a great service by airing 
     these issues. I would be pleased to answer any questions you 
     might have.


                        statement of i.l. uydess

       Introduction & Background: My name is Ian Uydess and I 
     worked as a Research Scientist at Philip Morris USA for more 
     than 10 years (Dec. 1977 to Sept. 1989). During that time I 
     headed-up a number of basic and applied research projects, 
     developed a patented bioengineering process designed to 
     produce a `safer' cigarette, and conducted a variety of lab 
     and field experiments on tobacco. I also learned a fair 
     amount about what Philip Morris knew about its products and 
     possibly a bit too much about some of the experimental work 
     that it was conducting on cigarette smoke and nicotine both 
     in the United States and in Europe. I also began to 
     understand the basis for some of the company's fears. A 
     rather extensive account of my work at Philip Morris is 
     already on record in my February 1996 statement to the Food 
     and Drug Administration and for that reason, is not discussed 
     in great detail here.
       While I was provided with a variety of opportunities an 
     challenges at Philip Morris, I decided to leave the 
     employment of that company in September 1989 as a result of a 
     number of factors including my disillusionment and great 
     disappointment with the decisions and direction of that 
     company, my deep concern regarding the adverse consequences 
     of smoking, and my conviction that the public had the right 
     to know what the cigarette industry has known about tobacco 
     and its products for a great many years.
       I sincerely believe that there are many people who are 
     either still working at Philip Morris or who have left that 
     company over the past several years, who could be sitting 
     beside me right now if only they had the formal support and 
     protection of this Congress. Like myself, I think they would 
     be willing to come forward with the hope that their testimony 
     would in some small measure help this Congress to take a more 
     formal and united stance on this critically important issue.
       The apparent unwillingness of some of our congressional 
     leaders to openly and effectively support an official hearing 
     on these matters only makes it that much more difficult for 
     other concerned individuals from within the cigarette 
     companies to come forward to share their knowledge and 
     information with us.
       I sincerely hope that with your help, we can remedy this 
     situation.
       My concern regarding the adverse consequences of smoking is 
     not new, but dates back to when I was a graduate student at 
     Roswell Park in Buffalo, NY. This was when I first began to 
     understand the magnitude of the real-world consequences of 
     smoking since many of the patients at Roswell Park were 
     victims of smoking-related cancers. It was no secret, even 
     then, that Roswell Park had a position on this topic. Dr. 
     George Moore, the director of the institute at that time 
     (circa 1969), frequently voiced his concerns regarding the 
     adverse consequences of smoking.
       And he was not alone. Years before the institute had 
     established a `Rogues Gallery' that featured portraits of 
     famous individuals who had lost their lives to smoking. 
     Roswell Park was, and still is, one of the nation's most 
     innovative centers for the study and treatment of neoplastic 
     disease. Smoking is one of the principal reasons why many 
     patients have gone there.
       I think we all recognize that cancer is a frightening, 
     unpredictable and devastating

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     disease that in one form or another can strike anyone, at 
     anytime, even when all the recommended health precautions are 
     taken. That is why it is still so hard for me to understand 
     why anyone would knowingly subject themselves to such a known 
     hazard that could increase their risk of contracting this 
     terrible and debilitating disease (although the answer to 
     this is one of the reasons why we are gathered here today).
       The truth of the matter is that I am still haunted by the 
     memories that I associate with my days at Roswell Park, 
     although it is these very memories which, coupled to my 
     recent experiences within the tobacco industry, that have 
     compelled me to appear before you today.
       What I didn't fully appreciate or understand at that time, 
     were the varied and interwoven reasons why so many people 
     continue to smoke even in the face of the known dangers of 
     smoking. However, after working in the tobacco industry for 
     more than a decade I have now come to understand this 
     situation better.
       To a large extent, smoking is a result of a complex system 
     of events which first attract and then `hook' the smoker. We 
     now know that this includes a variety of physical, 
     psychological and chemical factors and is perpetuated by the 
     cigarette manufacturer's targeted advertising practices 
     toward children and their historic lack of truthfulness and 
     candor about what they have known about the adverse effects 
     and addictive qualities of smoking for many years.
       I, too, was once unsure of my position on many of these 
     issues until I had a chance to work within, and learn about 
     this industry. My education about tobacco was provided to me 
     by Philip Morris. They taught me how tobacco was cultivated, 
     purchased, blended and processed and how cigarettes are 
     manufactured. I also learned about the extensive knowledge 
     that Philip Morris had about tobacco, smoke and cigarette 
     design and how it used its knowledge, experience and 
     technical capabilities to formulate and manufacture its 
     products. Over the years, Philip Morris invested a 
     substantial amount of time and effort to make sure that I 
     understood and could apply this knowledge to my job, and 
     that's exactly what I did.
       As my career at Philip Morris developed, I was asked to 
     take on increased responsibilities and given broader access 
     to the various departments and operating units of the company 
     (both in the U.S. and Europe). I communicated regularly with 
     the senior management and scientific staff of R&D and 
     collaborated on numerous occasions with the engineers, 
     chemists and product development scientists in Richmond. 
     Between 1978 and 1989 my responsibilities included basic and 
     applied research on the structure, biochemistry and 
     microbiology of tobacco, as well as a number of efforts in 
     support of process and/or product development. I was also 
     responsible for setting up and conducting field experiments 
     on tobacco using local Virginia tobacco farms contracted by 
     Philip Morris.
       During the 1980's, some of my highest priority efforts were 
     targeted at developing new or improved methods to remove 
     `biologically-active' (toxic and/or mutagenic) materials from 
     tobacco. This included developing a microbiological process 
     to remove nitrate and nitrite from `SEL' (the `strong extract 
     liquor' used by Philip Morris to manufacture its 
     reconstituted tobacco sheet, `RL', at Park 500), as well as 
     conducting experiments to learn how to limit the uptake and 
     distribution by the tobacco plant of toxic chemicals like 
     cadmium. Although substantial progress was made in each of 
     these areas (the denitrification process was successfully 
     scaled-up to pilot plant/production levels, and the cadmium 
     experiments were beginning to yield valuable information 
     about the uptake and distribution of cadmium in lab-grown 
     tobacco plants), both programs were unexpectedly and 
     summarily shut down by PM management--the denitrification 
     program because of what were alleged to be `product quality' 
     problems, and the cadmium program because PM management 
     decided that it wanted this work to be continued `outside' of 
     the company.
       My concern and disappointment over these decisions was 
     largely due to the fact that both of these projects could 
     have led to safer products for both the company and its 
     customers. Instead, they became lost opportunities for 
     everyone.
       There have been other lost opportunities as well. Safer 
     products could also have been produced by Philip Morris years 
     ago, if it had only used the wealth of information that it 
     had generated regarding the removal of other dangerous 
     compounds from tobacco like the `nitrosamines'. It may well 
     have taken some additional work to get it into production, 
     but wouldn't it have been worth it? A similar situation was 
     encountered in the reduced alkaloid (reduced nicotine) 
     program, `ART', which like denitrification, was exhaustively 
     researched in the lab, successfully scaled-up to pilot plant 
     levels and then shut down for `product quality' reasons.
       It is interesting to note, however, that at least two of 
     these `failed' programs (denitrification and reduced 
     alkaloids) are frequently cited by Philip Morris as 
     legitimate attempts to improve their products (``We tried''). 
     I've been told that one-ranking scientist at PM was even 
     credited with saying that the reduced alkaloid (lowered 
     nicotine) program was, the best $350 million dollars the 
     company had ever spent! I'd hate to believe that this 
     statement meant that Philip Morris was sometimes happy to 
     spend millions of dollars on a successful technology which 
     could have led to safer or less addictive products, with no 
     real intent on using those technologies (unless it had to) 
     just so that it could say `it tried'.
       The truth of the matter is, that some of these efforts both 
     within Philip Morris as well as within some of its 
     competitors (RJR and B&W) could well have led to the 
     development of `safer' and/or less addictive products that 
     ultimately could have saved lives. But that didn't happen at 
     least in part, because of the lack of responsibility and 
     commitment of the cigarette industry to do something 
     substantial to safeguard the health and well being of their 
     customers.
       But then again, why should they? They are still not 
     regulated and therefore, are neither accountable nor liable 
     for their actions (or lack of the same). So why should they 
     spend their hard-earned cash just to safeguard the health and 
     well being of the public when by doing so, they might lose a 
     bit of their market share, particularly if they remove the 
     very thing that keeps their smokers `hooked'? Who'd want to 
     explain that to their board of directors? It would be far 
     better to do nothing, deny everything, and to keep on doing 
     that for as long as they can. After all, what can anyone 
     really do about it today? The lack of law means that the 
     law is on their side.
       We are very fortunate to live in a free and democratic 
     society in which we each have the right to make our own, 
     informed decisions about the products that we make and use. 
     I, for one, do not want to change that. But the manufacturers 
     of cigarettes should, like the manufacturers of other 
     ingestible products, be accountable for the quality of what 
     they make and market to the public, especially when it comes 
     to safety.
       We could, as the cigarette manufacturers have suggested, 
     leave it up to them to police themselves in this matter. 
     However, considering the cigarette manufacturers history up 
     to this point, it seems unlikely that they would now do this 
     responsibly. When it comes to the health and safety of the 
     public, voluntary self-regulation by the cigarette industry 
     is clearly unacceptable.
       That's why our elected representatives created the FDA 
     years ago to help set the standards by which the public would 
     be protected from the accidental, negligent or irresponsible 
     acts of the manufacturers of our foods, drugs and cosmetics. 
     This wasn't a partisan effort or some sort of devious plot, 
     but rather the result of our nation working together to 
     create a new agency to help formulate, monitor and enforce 
     regulations to protect the citizens of this country from 
     unsafe products and the injury they may cause. And how did we 
     do this? By working together to make sure that the 
     manufacturers these products were accountable, by law, for 
     their actions.
       But somehow along the way, we left out tobacco. It was one 
     of those `historic' agricultural industries that escaped FDA 
     regulation, even though their products were ingested like so 
     many of the other goods that we wanted to have regulated by 
     that agency. Allowing tobacco to go unregulated may have 
     seemed reasonable back then given our cursory knowledge of 
     nicotine's role in addition and our limited understanding of 
     the cause-and-effect relationship between smoking and cancer. 
     But that was then. Today we know much more. And as a research 
     scientist who spent more than 10 years of his career working 
     within Philip Morris, I can attest to the fact that at least 
     this company knew more than it was willing to tell.
       We can't change the fact that cigarettes weren't 
     specifically addressed in the FDA guidelines of 1938 or, in 
     the various amendments that have been enacted since then. But 
     what is of concern to me today is the fact that until just 
     recently, we haven't taken any formal action to correct this 
     situation.
       Don't we have enough scientific data regarding the adverse 
     consequences of smoking? Aren't more than 400,000 of our 
     family, friends, coworkers and neighbors dying each year from 
     smoking-related diseases?
       Haven't we seen and read enough to convince us that 
     nicotine is additive and that the manufacturers of cigarettes 
     are carefully controlling the design of these products to 
     ensure that effect?
       Haven't some of the cigarette industry's own internal 
     documents, executives and research scientists attested to 
     these very facts?
       Can we think of any other industry in this nation that we 
     allow to go so totally unchecked with regard to the safety 
     and/or contents of its products?
       And don't we, the public, deserve to be fully informed 
     about, and protected from, the known hazards of inhaled 
     tobacco smoke?
       And yet it is only recently that the FDA with the support 
     of the President, has begun to address this problem by 
     mandating that the sale and marketing of cigarettes to 
     children be regulated by that agency. But even that has been 
     a battle.
       So how as a society do we explain this? Is it all simply a 
     matter of semantics, rhetoric and fruitless, circular 
     discussions? Can we afford to have the final decision about 
     regulation and compliance be left in the hands of the tobacco 
     industry?
       The cigarette manufacturers would like us to believe that 
     they are unfairly and unjustly under attack by those whose 
     specific intent it is to deprive them of their rights and to 
     destroy their industry. They would also like us to believe 
     that any attempt to

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     regulate them would result in the total collapse of state and 
     local economies, the loss of countless jobs and the 
     irrevocable loss of business to all those companies that are 
     in any way dependent upon this industry. Maybe that's why the 
     cigarette manufacturers find it advantageous to keep this 
     topic partisan and adversarial (`us' against `them') when the 
     truth of the matter is, that it is not.
       This is a `we' issue that in all probability has, in one 
     form or another, already touched the lives of each of us. How 
     many of us have lost a parent, relative, friend or neighbor 
     to a smoking-related illness like cancer or emphysema? How 
     many of us know someone who has tried to quit smoking but has 
     failed? Is smoking really `an adult choice', or are there 
     other factors involved in this `habit' that make smoking less 
     of a `free choice' than the industry would like us to know?
       I often wonder what the tobacco company CEOs, their board 
     of directors and attorneys say to their families and 
     especially to their children when they're asked about what 
     they know about nicotine, addition or smoking and health?
       Who is really being fooled by this, and why are we still 
     arguing about it?
       The only conclusion that I can reach, is that we are in the 
     midst of a national tragedy; a crisis of indecision and lack 
     of appropriate action that has crippled our nation for far 
     too many years, although one hopes that the recent 
     initiatives taken by President Clinton, Dr. Kessler and the 
     FDA will mark the beginning of a new and more responsible 
     era.
       We cannot continue to allow ourselves to be repeatedly 
     engaged in the fruitless, repetitive and transparent rhetoric 
     of the tobacco industry given the extraordinary numbers of 
     smoking-related deaths and illnesses that we know occur each 
     year. Where else in the history of our society have we failed 
     so thoroughly to act on such a critical and immediate topic 
     of public health even when the data were far more scarce, the 
     impact of the situation a mere fraction of what we see today, 
     and the cause-and-effect relationships much more obscure? 
     We've taken faster, more affirmative action in the past when 
     we just thought that a red dye in our food might adversely 
     affect our health or, when an artificial sweetener that was 
     already on the market was suddenly suspected of being a big 
     less safe than we had originally believed.
       The bottom line is that we have allowed ourselves to be 
     lulled into complacency and manipulated by the politics, 
     semantics and financial wealth of this industry in much the 
     same manner that it has manipulated information about smoking 
     and the content of its products these past 20-30 years.
       We've appealed to the cigarette manufacturers to become 
     proactive partners to help implement solutions, but they have 
     only further tightened their circle of resistance.
       On top of that, the cigarette industry would like us to 
     continue to believe that any attempt to regulate them would 
     be illegal and if implemented, would result in certain ruin 
     for tobacco workers, tobacco farmers, the tobacco states, the 
     industry itself, its advertisers, the grocery store next 
     door, the nation as a whole, everyone!
       But once again, that is not true.
       Regulation of tobacco products will be a difficult at 
     first, but not impossible. It will also not be anywhere near 
     as injurious to the nation as the tobacco manufacturers and 
     their allies would have us believe. There are even those who 
     think that it can be beneficial. To be successful, however, 
     it will take a concerted effort on the part of each and every 
     one of us and possibly for some, temporary sacrifices. It is 
     not a personal agenda item or political issue, but one of the 
     safety and well being of the public for generations to come.
       Regulation of the tobacco industry by the FDA is totally 
     consistent with what our country originally intended this 
     agency to do--to protect us--and it is clearly in the best 
     interests of this nation, its businesses and most 
     importantly, its people.
       The sad fact is, that much of the misery, frustration and 
     fear that we are witnessing today could have been avoided if 
     we had only acted earlier. I sincerely hope that the members 
     of this congress can put aside their differences and join 
     together if for no other reason than to save the lives of the 
     children who have not yet begun to smoke.
       Thank you.

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