WASHINGTON-He was the man the tobacco industry loved to hate-and for good reason. While serving as Commissioner of the US Food and Drug Administration (FDA) from 1990 to 1997, David Kessler, MD, led a long investigation of the tobacco companies.
WASHINGTONHe was the man the tobacco industry loved to hateand for good reason. While serving as Commissioner of the US Food and Drug Administration (FDA) from 1990 to 1997, David Kessler, MD, led a long investigation of the tobacco companies.
In his book, A Question of Intent (Public Affairs, 2001), Dr. Kessler, both a physician and an attorney, describes in fascinating detail his years spent battling cigarette makers. Dr. Kessler, who now serves as dean of the Yale University School of Medicine, spoke with ONI’s Washington Bureau Chief Patrick Young about his battles with the tobacco industry and the war that’s still smoldering.
Oncology News International: Your book contains a quote about retribution: "The guilty have a head start, and retribution is always slow of foot, but it catches up." Are we catching up with the tobacco industry?
Dr. Kessler: We are chipping away. We now know what they have known for 50 years. We know that they knew they were selling an addictive drug and that they have been manipulating nicotine levels to sustain smokers’ addiction. That’s 50 years during which they put the nation’s health at risk. We’ll never catch up entirely, but we have made some progress.
ONI: But the industry seems as healthy as everprofits are up and there’s an increase in domestic demand. Did your efforts fail?
Dr. Kessler: No. The one measure more than any other that the tobacco industry has tracked over the past 100 years is social acceptability. All their advertising, all their promotionit was not aimed at getting any individual to pick up a cigarette; it was aimed at maintaining the public perception of smoking as something that ordinary people did for pleasure and satisfaction, something that was socially acceptable. They don’t have that any more.
ONI: What was the defining moment when you knew you had to take on the tobacco industry?
Dr. Kessler: When I became FDA commissioner, tobacco was the farthest thing from my mind. There was a young man at the agencyJeff Nesbit, the associate commissioner for public affairs. After watching me for a while, he said, "Mr. Commissioner, I think you should take on tobacco. FDA regulates everything else that comes into contact with the body, everything we eat and all our drugs. Why doesn’t FDA regulate tobacco?"
I thought he was crazy, but not because I thought tobacco was too big or too powerful. I fell into the trap that a lot of people fall intojournalists, editors, public officials who say: "This is an industry that doesn’t have a lot of credibility. Who believes them, anyway?"
ONI: So what got you focused on tobacco?
Dr. Kessler: Nesbit persisted, and I agreed to have a meeting. I went around the room and asked people to give their opinions. There was a lot of concernnot that it was the wrong thing to do, but that the problem would take all our resources and all of our efforts.
Then I came to a young woman lawyer. She looked at me and said, "If you’re willing to take on tobacco, I’m willing to spend the rest of my career working on it." She understood this was not going to be an easy win.
We set up a group and started asking the question, "Why doesn’t FDA regulate tobacco?" It took us 2 years before we reframed it to, "Is nicotine in tobacco a drug?" The change may seem subtle, but it’s a very big difference.
The next turning point was when one of the young lawyers came into my office and said, "You know, the industry knows how to take nicotine out of tobacco, but they leave nicotine in. And that may mean they intend nicotine’s effect."
This was critical because the definition of a drug is something that’s intended to affect the structure or the function of the body. Does nicotine do that? Of course it does.
ONI: I take it that "intended" is the key word in the FDA code.
Dr. Kessler: It is, but whose intent? For decades the courts have interpreted it as the manufacturer’s intent. Where we had to go was where no one else had gone before. We had to go inside the industry. We had to determine what the companies knew, what they intended. In our wildest imaginations, we never thought we would get our hands on the evidence they had all along about nicotine’s addictive properties.
ONI: But you did uncover that evidence.
Dr. Kessler: I remember reading the documents. The general counsel of a major American tobacco company wrote: "We are, then, in the business of selling nicotine, an addictive drug." That was written in the 1960s, but I didn’t see it until the mid-1990s.
ONI: Did you have a strategy after that first meeting, or did the investigation just evolve?
Dr. Kessler: It evolved. We started seeing pieces. First, we saw they added nicotine to the paper wrapper, which is porous in cigarettes. We then saw that some of the lowest-tar cigarettes had a higher nicotine concentration than regular cigarettes. So we had evidence of manipulation of nicotine. This went to the issue of intent.
I remember the day we received a tip. It came from an informant that I only knew at the time as "Research." He insisted on talking only to me. Research said, "Check patents filed in foreign countries." And that led us to a genetically engineered, high-nicotine tobacco plant that was grown in Brazil and used in American cigarettes to boost the nicotine content.
We started gathering all these pieces. An envelope came in anonymously that talked about the use of ammonia and showed that the industry was, in essence, doing free-basing.
So we had all these pieces of evidence, but the industry said that was all circumstantial. It was only when we got our hands on documents that showed the companies indeed knew that nicotine was an addictive substanceand had acted on that information for decadesthat I understood there was no turning back.
For decades, in front of judges and juries and the American public, the industry argued that smoking was about freedom and about choice. But once we established that the industry knew all along this was an addictive product, and that it was children who were becoming addicted, it undermined the industry’s defense. It’s not about freedom of choice. Addicts have no choice.
ONI: Did the sophistication of the industry in influencing public opinion about smoking surprise you at all?
Dr. Kessler: I completely misjudged it. I thought this was an industry that no one believed. Little did I know they had everyone on the payroll from former British Prime Minister Margaret Thatcher to former Senate Majority Leader Howard Baker.
They got Congress to investigate us and cut our budget. They got firefighters to support them and claim that cigarettes were not a significant cause of house fires. They got women legislators to walk away from the issue of women and cancer, even though lung cancer has surpassed breast cancer as the number one cause of cancer deaths in women. They even went after members of our investigative team and brought them up on charges of perjury and harassment.
ONI: What do you make of the tobacco industry’s campaign to keep cigarettes out of the hands of kids, including their recent TV ads in which a store clerk says Philip Morris backs him in not selling tobacco to minors?
Dr. Kessler: Look at the ads that they run when they want to sell cigarettes. Those ads have an edge that appeals to people who want to push the envelope.
But look at the ads they run to convince other people, "You can now trust us." There’s no edge to those ads. Those ads are aimed at you or me, not at the child or teenager or young adult who may try smoking.
The industry is running those "trust us" ads to affect jury pools. They face billions of dollars in potential verdicts, and they want to convince future jurors that they’ve turned over a new leaf.
ONI: So they are still trying to manipulate public opinion.
Dr. Kessler: Of course. And today, Philip Morris says that it wants FDA regulation of tobacco products. We fought for regulation for a decade and then lost in the Supreme Court by one vote. We couldn’t get Congress to pass legislation, and we still have not.
I never thought that we would get Philip Morris to agree to regulation and not get the courts or Congress to agree. And that raises certain concerns. Do we give them their regulation? By doing so, we give them a stamp of social acceptability, the government’s imprimatur. It says, "It’s okay to continue selling this product, regardless of the consequences." So it certainly raises real concerns. The type of regulation Philip Morris wants and the type of regulation I would favor are still very different. I favor strong regulation that would give FDA control over tobacco products for decades to come.
ONI: Much of what you proposed as your initial concept of regulation was incorporated into the tobacco settlement agreement between 46 states and the tobacco companies. Has it actually helped reduce youth smoking?
Dr. Kessler: The big difference is that the FDA still does not have jurisdiction over tobacco products. With jurisdiction, we could put into place measures to reduce smoking.
But we now know how to reduce smoking in young people and even adults, even without regulation. We know the elements and the programs that work. We know that counter-advertising works. Messages aimed at industry manipulation and social acceptability work. What we need to do is take those measures and move them toward a national campaign.
ONI: How do you see the smoking situation being resolved?
Dr. Kessler: In the short term, we need strong FDA regulation, a strong national counter-advertising campaign, and price increases to deter young people from buying cigarettes.
In the long term, this industry is very vulnerable and at risk legally, and will be for decades. Multimillion-dollar verdicts are becoming commonplace. Every cigarette they sell only serves to increase their liability. So one day, major American tobacco companies are going to need to get out of the business. And at that timeand it is not going to happen in the short termthey may be forced to seek accommodations that are currently beyond our imagination.