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A Question Of Intent: A Great American Battle With A Deadly Industry

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Tobacco companies had been protecting their turf for decades. They had congressmen in their pocket. They had corrupt scientists who made excuses about nicotine, cancer and addiction. They had hordes of lawyers to threaten anyone -- inside the industry or out -- who posed a problem. They had a whole lot of money to spend. And they were good at getting people to do what they wanted them to do. After all, they had already convinced millions of Americans to take up an addictive, unhealthy, and potentially deadly habit.

David Kessler didn't care about all that. In this book he tells for the first time the thrilling detective story of how the underdog FDA -- while safeguarding the nation's food, drugs, and blood supply -- finally decided to take on one of the world's most powerful opponents, and how it won. Like A Civil Action or And the Band Played On, A Question of Intent weaves together science, law, and fascinating characters to tell an important and often unexpectedly moving story. We follow Kessler's team of investigators as they race to find the clues that will allow the FDA to assert jurisdiction over cigarettes, while the tobacco companies and their lawyers fight back -- hard. Full of insider information and drama, told with wit, and animated by its author's moral passion, A Question of Intent reads like a Grisham thriller, with one exception -- everything in it is true.

492 pages, Paperback

First published January 1, 2000

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About the author

David A. Kessler

15 books76 followers
(David Kessler is also the name of another author, a hospice expert who worked with Elisabeth Kübler-Ross, although David A. Kessler did co-author a book on elder care.)

David Aaron Kessler is an American pediatrician, lawyer, author, and administrator (both academic and governmental). He was the Commissioner of the Food and Drug Administration (FDA) from November 8, 1990 to February 28, 1997, and has subsequently held administrative and academic posts at Yale and the University of California at San Francisco.

More information is available at Wikipedia.

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Displaying 1 - 30 of 35 reviews
Profile Image for Will.
303 reviews5 followers
May 11, 2019
4.5 / 5.0

For the past 2.5 years, I've worked on federal tobacco regulatory law, helping the FDA in its implementation and enforcement of the Tobacco Control Act (TCA). The TCA, which was signed into law in 2009, represents the federal government's first successful foray into tobacco regulation. But, it certainly wasn't the first attempt at tobacco regulation. Nearly fifteen years earlier, in 1995, the FDA issued a proposed rule (finalized in 1996), wherein it asserted jurisdiction over cigarettes and smokeless tobacco products, and set out sales and promotion restrictions (aimed at curbing youth use) on such products. Industry ultimately challenged that rule and, in 2000, the US Supreme Court--in a 5-4 decision--struck the rule, as outside the Agency's authority. But, the FDA's regulatory efforts nonetheless remained an important milestone in public health--the Agency had uncovered the malevolent acts of industry and demonstrated its resolve to tackle the greatest cause of preventable death in the nation.

In my time at FDA, I've been cognizant of the Agency's tobacco regulatory efforts from the 1990s (indeed, the TCA directed the Agency to repromulgate and finalize the very rule that the US Supreme Court had thrown out) and the industry's behavior during and through the time preceding those efforts. Still, I found former FDA Commissioner David Kessler's "A Question of Intent," which details his time at the Agency, investigating industry and issuing the 1996 rule, to be both eye-opening and inspiring. It left me with a greater sense of conviction and pride over the work that I do, and a heightened wariness over the conduct of industry (although, admittedly, that wariness had always been present).

A lot of things stood out for me from "A Question of Intent." First and foremost, I was very disappointed to read about the seeming complicity between industry and their counsel in hiding the former's misdeeds. Zealous advocacy is integral to legal representation; but, the conduct of industry counsel, at times, certainly seemed to go beyond that, advising industry to create the Council for Tobacco Research (which falsely sowed public uncertainty as to the health consequences of smoking) and generally attacking facts rather than relying on legal argument. Kessler devotes a whole chapter (ch. 47) at the end of the book to--in a somewhat academic fashion--considering the role of industry attorneys in the misdeeds of industry, and ultimately labels them "co-conspirators." It's hard not to agree with him on that point. Relatedly, the apparent revolving door between industry and the FDA's Office of Chief Counsel was likewise distressing. Kessler mentions persons with whom I currently work as having previously counseled industry; and, more alarmingly, he notes that three former FDA Chief Counsels as representing Brown & Williamson at the US Supreme Court-level. What an embarrassment.

Second, I was surprised (and kind of confused) by how active a role Kessler presents himself as playing in the investigation and attempted regulation of tobacco industry. Kessler repeatedly mentions taking home boxes of tobacco documents, going to the library to conduct legal research, and pouring over the minutia of data and research. Is this an accurate description of his time? If so, it seems bizarre for the head of a large agency (filled with very qualified persons) to spend his time in such manner, although I guess it speaks to his curiosity of mind and strength of conviction (or, perhaps, just to his written dramatization of the past). That aside, I was sincerely impressed by the political work Kessler did to get the 1996 rule issued. Kessler intelligently (from both a political and public health perspective) characterized tobacco use as a pediatric disease, and tirelessly worked on skeptical HHS officials and wary White House staff to make sure the Agency's investigation ultimately led to meaningful regulation. I found his description of the backroom lobbying to get the rule out to be very interesting.

Third, Kessler does a remarkable job at detailing the misdeeds and secrecy of industry, and the protection afforded to industry by members of Congress. Kessler seems to spare no one, in discussing those who stood in the way of the Agency's investigation and regulation efforts. Political villains that emerge from this telling include Denny Hastert, Mike Bilirakis, and Tom Bliley. The behavior of the recently retired Joe Barton surprised me the most, as the now-former representative goes as far as submitting a criminal referral of Mitch Zeller to DOJ, on the basis of his testimony to Congress. It's tough not to finish "A Question of Intent," without a somewhat cynical view of Congress, and industry's capture of (many of) its members. That said, the conviction with which certain members work to support Kessler in the Agency's efforts is somewhat heartening (VP Gore, Rep. Synar, Rep. Waxman, and--at least at the end--Pres. Clinton come out well). The behavior of industry is, as you'd expect, pretty damning; and, Kessler spends a good part of the book discussion that. But, almost three decades later, it's not very surprising to read about industry consistently lying about its knowing marketing of cigarettes for their (nicotine-caused) addictiveness; and, so, I don't have a lot to say about that here.

Fourth and finally, I was surprised by the deliberation that went into the Agency's investigation and regulation of industry. As Kessler presents it, when he joined FDA, he hadn't planned on regulating tobacco (indeed, he seems to have not considered the issue beforehand): "I had not come to FDA intending to take on tobacco. My only goals back then had been to run the agency well and to enforce the law." 359. But, things slowly built to the point where he felt the need to do so--a close staff member encouraged him to do so; the Agency issued a measured response to the long pending Coalition on Smoking or Health petition; the Agency began investigating; those investigations uncovered substantial evidence; etc. Still, even then, Kessler was unsure whether and how to act--the legal theory behind the 1996 rule (under which the Agency found that nicotine met the FDCA definition of "drug," and cigarettes and smokeless tobacco met the FDCA definition of medical devices (for their delivery of such drug)) was put forth by a coworker at a summer BBQ, and Kessler--at least before the Agency finished its investigation--repeatedly expressed uncertainty over the Agency's ability to regulate tobacco absent new legislation. It's fascinating to hear that such a significant event was largely the result of a series of small steps and seemingly short-term deliberation.

Kessler ends the book by calling for a complete dismantling of tobacco industry; his time investigating and seeking to regulate tobacco had, understandably, left him cynical of its very existence and wary of industry's potential to, perhaps, gain power and stability through regulation. It's an arguably prescient call though--the threat of regulatory capture is ever-present and, to many advocates, a reality. Coupled with the compelling enumeration of the misdeeds of industry, it's a warning that I hope to remember in my own work.
Profile Image for Rachel.
245 reviews7 followers
November 4, 2012
Holy Moly!

After 10 years of working in tobacco control, I really thought I knew the ins and outs of the evils of the tobacco industry. My knowledge had only scratched the surface.

The level of murder, manipulation, cover-ups is truly mindblowing.

I rarely read nonfiction, and I almost never read things that are work related. This was recommended by someone who is a pumonlogist, a lawyer and a former NJ Commissioner of Health. When he said it reads like a novel, I thought, "Yeah, sure, to YOU - uber-intellectual-brilliant guy".

But in fact, even regular folk like me couldn't put it down.

My only critique is that Kessler struck me as a self-proclaimed perfectly-intended faultless superhero. I'm on his side 100%, but even when he tried to not seem cocky, he seemed a little cocky. I guess he earned it.

Once you've read it, email me and I'll tell you how to lobby your NJ legislator for more tobacco-control funding.
Profile Image for Josh Horn.
9 reviews2 followers
March 26, 2013
As both a lawyer and doctor Kessler was well qualified, though young (only 37), to head the FDA, and the impact his administration had on public health is a testament to his effort and leadership abilities. Not only has Kessler intimately detailed the FDA's course of exploring tobacco regulation, but his writing imparts the gravity of those decisions, making the book both rich in detail and intoxicating narrative. As someone who was in elementary school during Kessler's administration, the substantial changes he brought to the FDA have been considered "background" to the events in my life, but this book illustrates the tremendous effort and intellect it required to obtain those protections which I took for granted. No doubt the book is biased, as any autobiographical work is, though Kessler presents the truth, or nearest thing to it, as he discovered through his team's thorough investigation of the tobacco industry.
Profile Image for David Blankenship.
607 reviews6 followers
February 9, 2025
Nicotine is an addictive drug. It has enriched tobacco companies through the ages, and that wealth has been used to fight against regulation even as tobacco has caused pain and misery to almost every family by the damage smoking does to one's health.

This memoir of David Kessler, former head of the Food and Drug Administration, was an eye-opening look at the lengths to which an industry will go to achieve self-preservation. Throughout the 1990s, as more evidence continued to be compiled about how tobacco companies had sought to deny any responsibility, the FDA (as well as other entities) compiled data about the dangers of this product. No matter how much truth was compiled, however, legaleese and (more often) and the compromising of political entities through financial support of influential congressmen, judges, and other well-placed influencers, as well as scare tactics played out in the PR industry, made it almost impossible to fight this battle.

This book is now almost a quarter-century old, and it would be interesting to see how much has changed in that time. The development of various kinds of e-cigarettes and other nicotine transferral systems has changed the industry and the debate, as well as a recognition of how bad such things really are for people.

Having picked this up for cheap at a used bookstore, I read this during the first few weeks of the second Trump administration, as he and his minions have decided to destroy any and every government agency that won't kiss his ring. I'm guessing a story like the one told in this book would have been read by MAGA fans as the story of government overreach, where unelected bureaucrats tried to destroy our freedom, or something like that. But a book like this shows the tremendous difficulty of a government agency in getting anything done, especially one that has to fight against an interest lobby as influential and wealthy as tobacco. The lengths the FDA had to go to get anything off the ground, as they dealt with infighting within their own agency (not to mention the many special interests both the executive and legislative branches), shows that government regulation is almost impossible, and that it ever happens at all is minor miracle.
67 reviews
August 21, 2018
Gripping, well organized and written. An accessible but comprehensive account of Commissioner Kessler's and FDA's effort to establish regulation of the tobacco industry. Gives the reader a good feel for how agency rule making tends to be driven far more by political pragmatism than a case's merits. The description of the court appeal process was unfortunate and revealing. Particularly interesting to me was the discussion of attorney ethics in Chapter 47. Tobacco industry legal counsel were not only advising, but in many cases had completely taken over research and other industry functions, destroying and hiding adverse findings. This sort of thing has been, in my experience, a common practice in many industries, and has prevented the public, and agencies empowered to protect it, from learning about health-impacting product hazards. Although usually cited as the required standard of legal care in an adversarial legal system, Kessler raises and briefly discusses the ethics of this legal practice. Worth the price of admission, and lots of references for further mining the topic.
Profile Image for Matthew.
32 reviews
June 19, 2023
This book manages to make an incredibly dense topic not only readable, but truly riveting. Kessler distills an incredible amount of information spanning nearly a decade into just 393 pages that read more like a thriller than a case study in politics or policy. My main takeaway from this book has to do with corporate power and the extent to which wealthy corporations are able to influence not only their own regulation, but also the facts that the public uses to evaluate proposed regulation. It is a cautionary story that draws to mind industries like pharmaceuticals, tech, and oil & gas—all of which have clear negative costs to society and public health, but which also have the money and power to fend off any substantial regulation that threatens their profitability. Highly recommend for anyone who wants to learn more about the relationship between the public and private sectors in U.S. policymaking.
Profile Image for Hannah.
565 reviews10 followers
July 22, 2019
Favorite book of the year (so far, at least). It is an interesting read about the duties and obligations of the FDA and the steps taken to limit the control of big tobacco. There are a lot of similarities that can be drawn between the powerful tobacco industry of the past and current multi-billion-dollar corporations. A great mix of science, policy, and law.
Profile Image for Sara.
710 reviews
January 14, 2021
I rarely quit books, but I had to quit this one about halfway through. The ethical component to this issue is interesting to me, but the details of public policy-making are too tedious to plow through.
Profile Image for Kira Swidzinski.
114 reviews
July 25, 2022
Wow. Very informative, interesting, and intriguing. I enjoyed the way Kessler wrote, incorporating personal story with fact. It wasn’t overwhelming and I felt that I could properly understand and take away a lot of information.
Profile Image for Bob Schmitz.
694 reviews11 followers
February 9, 2021
Wow, what a book! My friend, Sally Herndon, who is the Head of Tobacco Prevention and Control Branch at NC Division of Public Health in Raleigh recommended this book. It reads like a murder mystery or a spy novel with good guys and evil people, twists and turns of the plot, defeats and climaxes. But this gripping detective story is true. It is the story of the evil machinations of the tobacco industry and the fight by the author, David Kessler, the Commissioner of the FDA, to regulate cigarettes as the delivery method of nicotine an addictive drug. In fact, the tobacco industry knew for years that nicotine was addicting was carefully regulating the levels of nicotine in cigarettes to keep customers addicted. They lied about this in court for years. The one question I had at the end of the book was why didn’t the heads of these tobacco companies go to jail like any other lying drug dealer. They did essentially what Perdue Pharma did with Oxycontin and got away with it.
The tobacco companies specifically targeted children. They realized “whoever gets them started wins the game.” They greatly feared regulation by the FDA and poured money at politicians willing to do their bidding, specifically towards the deregulation by Reagan and the Republicans. The tobacco companies funded “grassroots” action groups to target taxes in general but with the specific goal of getting rid of the cigarette excise tax. They attacked the FDA and Kessler in specific, demonizing him as taking away people’s freedom to decide. It sounds familiar to the Republicans mantras of today. They hid and lied about scientific evidence. They threatened current and past employees with destruction for telling the truth. They acted like Mafia dons. The worked to gut the funding of the FDA. Their lawyers engaged in endless sophistry just as our recent president and his minions have done. The tobacco industry seemed to be unencumbered with a conscience.

The author takes the reader through each twist and turn of the battle, week by week, sometimes day by day, person by person, document by document peeling back the layers of deceit. It is a heroic story well told. I highly recommend.
Profile Image for Vicki.
857 reviews63 followers
July 2, 2007
Okay, I told myself I would only review books I'd read in the last 9 months or so (don't want to fake a literary lifestyle that I'm not actually living), but even though I read this years ago I'm going to review it because it's still on my bookshelf, and because it was AWESOME.
I read it for a graduate poli sci class, and even though it was 400 fairly dense pages, I was sucked in. Staying up until 3:30 sucked in. It's a policy/thriller; the true story of the battle to regulate cigarettes as drugs, as told by then-Commissioner of the FDA. I'd try to explain why it's fantastic, but just read it if you care at all about this kind of stuff.
32 reviews1 follower
August 25, 2008
If you are interested in learning about the power of the tobacco industry and the questionable ethics of the men (and women) we elect to write laws and protect our interests, I would encourage you to read this book. It is difficult to avoid anger when reading about the complicity of congressmen, in protecting a dangerous and harmful practice. Concern for public health and safety took a back seat to profits and power. The author was head of the FDA for a number of years. He played an instrumental role (along with many others) in changing the face of the industry and revealing the corruption throughout.
5 reviews
September 4, 2016
Insightful and thought-provoking

This book on the FDA journey to regulate tobacco provides great insight into the challenges faced by those in our government committed to following their conscience. The bravery to follow through on a politically-charged topic is inspiring, as is David Kessler and those who worked on this mission.
Profile Image for Janna.
32 reviews1 follower
September 9, 2008
I read this book in my media studies class in college. It's giant and amazing. David Kessler was the former FDA commissioner, and this book is his retelling of the battle against big tobacco. This book came out the same year as the film The Insider and makes a great companion to the missing pieces of the movie. If you like American history, scandal, whistle blowing, and the legal system -- you'll like this book.
3 reviews
March 20, 2007
This is a great book, providing an in-the-trenches look of the efforts of David Kessler & the FDA to combat the tobacco industry. Very impressive read for anyone who is against said industry, and probably good background reading for anyone who works for it.

I'm personally glad I read this book, it elevated my distaste for the tobacco industry to an even higher level.
Profile Image for Brooke.
25 reviews
March 31, 2008
This is an incredibly interesting book that reads like fiction but is totally fact. It's all about the FDA's quest to regulate tobacco and the war that the cigarette companies wage. It's just really informative and very fun to read... especially if you like reading about government policy but often find it very dry!
109 reviews3 followers
December 15, 2008
I read this book shortly after seeing the film "The Insider." It proved to be a great compliment and somehow, I found myself more compelled with the investigative spirit and rich details of Kessler's book. He provided such thorough evidence and a compelling case for the wrongs perpetuated by the tobacco industry and the fight to make them atone for their sins.
Profile Image for Elizabeth.
25 reviews
September 15, 2011
I enjoyed this book a lot. It was pretty entertaining and informative and really highlighted how politics at all levels affect policy. I particularly enjoyed all the random facts about the tobacco industry and how they conceptualized and manipulated their product and was pretty appalled (but not entirely shocked) at how the industry was able to dodge regulation for so many years.
Profile Image for Daniel Ginsburg.
14 reviews
October 14, 2013
This book is a bit dated, but it's still a good read. I read it as part of an MBA class on business ethics. It's kind of like a combination of a detective novel, a chapter from a history book, and a legal thriller all rapped up in one. As one chapter ends the book grabs you in and gives you no other option but to keep reading - be careful!!
Profile Image for Sarah.
34 reviews1 follower
October 11, 2015
One of my favorite books. Not only about tobacco but also tells a great story on how the recommended daily calories on nutrition labels were selected (spoiler alert: the meat and sugar lobby had a big influence - shocker). Written in an engaging style, Kessler illustrates how the FDA is pushed around by the political and corporate interests.
Profile Image for Eric.
14 reviews6 followers
June 15, 2010
Reading this book in my Ethics class. Fascinating autobiography on how Kessler (head of FDA at the time) took on the tobacco companies - still reading it, but it has caught my attention much like a good fiction book would.
Profile Image for Heather G.
116 reviews
May 12, 2013
David Kessler is my public health hero. Book reads like a thriller in some spots and is quite entertaining. Scary look at the influence of industry and politics on public health issues. Shows how manipulation of public opinion is orchestrated. Take away point: don't smoke!
Profile Image for Anthony Faber.
1,579 reviews4 followers
November 18, 2014
Interesting real life mystery of how the FDA (the author was the head of FDA) managed to find out what the tobacco industry is really doing with nicotine levels in cigarettes, by surmounting a great wall of non-disclosure agreements.
10 reviews1 follower
August 12, 2007
Great book. I already loved David Kessler, and now I love him even more :)
180 reviews4 followers
September 13, 2007
I suppose this is a tell-all by a Washington insider. I knew a lot about the subject matter going into it, but I think it's fairly readable for others.
Profile Image for Suzanne.
364 reviews
June 5, 2008
I read this for a school course, and really enjoyed it. It reads like a thriller novel but with enough details and evidence to please the nerdiest of book nerds.
104 reviews3 followers
April 29, 2010
Author is a lawyer and a doctor. (He must hate himself...) Anyway, it's probably the only true story ever written that is both entertaining and an excellent example of mens rea.
Profile Image for Patti.
309 reviews
September 14, 2011
Had to read for class..it had it's interesting moments.definitely got you riled up..
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