Wednesday, October 12, 2005

IN MY VIEW: Why the Campaign for Tobacco-Free Kids' Campaign of Deception on the FDA Bill is So Unethical

Given the controversy of the past two days over what I feel is the misuse of the Ignite youth anti-smoking group by the Campaign for Tobacco-Free Kids (TFK) and over what I feel is an unethical campaign of deception being run by TFK (and Ignite - although I have been hesitant to blame the young people for this), I think it may be useful and important at this point to try to summarize the reasons why I think TFK's campaign of deception for the FDA legislation is indeed a campaign of deception and why I think the campaign is so unethical.

First, we need to establish three core ethical principles of public health and tobacco control. Two of these have been spelled out in a recent Tobacco Control article (see Fox BJ. Framing tobacco control efforts within an ethical context. Tobacco Control 2005;14[Suppl II[:ii38-ii44). One is spelled out in the APHA Code of Ethics.

1. Truthfulness

While it may seem obvious, I think it is worth being explicit about the fact that truthfulness is an important aspect of ethical behavior, not only by individual practitioners but by public health organizations. As Brion Fox points out in his outstanding review of ethical principles in tobacco control practice, if organizations fail to be truthful, they will actually be doing a disservice to the public: "Hence the tobacco control community must hold this principle sacrosanct and strive for disclosing the whole truth, otherwise it may lose its credibility."

2. Transparency

This is similar to truthfulness, but it entails something more. Not only must public health organizations be truthful about the facts that are relevant to judging a public health intervention or policy, but they must also be forthright about the relationships and process by which these interventions or policies came about. As Fox argues: "The tobacco control community should strive for transparency in its dealings. If the tobacco control community fails to explain its dealings within an appropriate framework, it may be perceived as biased or hiding relationships, and it could lose its reputation for independence."

3. The Community-Level Equivalent of the Principle of Informed Consent

Just as public health organizations must provide individuals with full and accurate information before enrolling these individuals in research studies, public health organizations must also provide the public with full and accurate information that is necessary to make decisions on policies that affect them. This is what the APHA Public Health Code of Ethics calls the "community-level" equivalent of the individual-level ethical principle of informed consent:

"Public health institutions should provide communities with the information they have that is needed for decisions on policies or programs and should obtain the community'’s consent for their implementation. ... there is a moral obligation in some instances to share what is known. For example, active and informed participation in policy-making processes requires access to relevant information. ...Such processes depend upon an informed community. The information obtained by public health institutions is to be considered public property and made available to the public."

The Rest of the Story

There are a number of elements to what I view to be a campaign of deception being conducted by the Campaign for Tobacco-Free Kids to promote the FDA legislation, but here are some specific examples of what I consider to be deceptive, misleading, or non-transparent aspects of the campaign:

1. Lack of Truthfulness and/or Forthrightness about Philip Morris' Support for the Legislation

A. Direct Claim that Big Tobacco was Trying to Kill the FDA Legislation

The Campaign for Tobacco-Free Kids sent out a 2004 communication to its constituents stating that Big Tobacco was opposing the FDA legislation and was mounting a huge campaign to defeat it. This was, in my opinion, quite clearly an intentional failure to disclose that the largest member of Big Tobacco by far - Philip Morris - was in fact supporting the legislation and using its massive lobbying and public relations resources to promote the bill's passage.

By neglecting to mention this critical fact, and by not being forthright about Philip Morris' support for the bill, I believe that TFK misled its constituents into believing that this was simply an issue of public health vs. Big Tobacco: that everyone in public health supported the bill and that everyone in Big Tobacco opposed it. But this was not the truth. In fact, the Campaign was well aware that Philip Morris supported the bill and that many tobacco control advocates believed that it represented a huge bailout for Big Tobacco that would harm the public's health. This "nuance" was not revealed to TFK's constituents in the above communication.

There is no question that Philip Morris - by far the dominant company of Big Tobacco - with approximately half of domestic cigarette market share, was and remains a vehement supporter of the legislation.

In contrast to the impression that TFK gave its constituents, Philip Morris expressed significant disappointment that the 2004 FDA tobacco legislation failed, and has made the re-introduced bills its key legislative priority for the 2005 Congressional session: "Although PM USA has been increasingly successful in pursuing its societal alignment initiatives, regrettably, Congressional legislation providing for regulation of the tobacco industry by the U.S. Food and Drug Administration (FDA) was not passed in 2004. Although this was a significant disappointment, obtaining FDA regulation of the tobacco industry remains a key priority."

So the Campaign for Tobacco-Free Kids' communication to hundreds of tobacco control advocates stating that Big Tobacco was fighting vigorously to kill the FDA legislation in 2004 was, in my view, quite clearly a distortion of the truth, a hiding of the truth, and it resulted, I supect, in hundreds of advocates being misled about the truth of "Big Tobacco's" position on the legislation.

B. Continued Implication that Big Tobacco is Fighting the FDA Legislation

The TFK web site still implies that Big Tobacco is fighting the FDA's efforts to regulate tobacco, even though the largest company of Big Tobacco is actually pushing vigorously for such legislation. A special report, entitled "Tobacco vs. the FDA" is described as outlining "the Food and Drug Administration'’s tireless efforts to regulate tobacco as a drug and the industry'’s escalating legal challenges, which continue to block the federal government from protecting American children."

I think it is misleading to state that the tobacco industry is continuing to block the federal government from regulating tobacco, since Philip Morris is pushing the federal government to do so. By calling the report "Tobacco vs. the FDA," I think TFK is implying to the public that Big Tobacco is against FDA regulation. This is misleading and can probably be considered to be inaccurate as well.

Not only is the largest component of Big Tobacco pushing vigorously for FDA legislation, but by no means is the industry escalating its attempts to derail FDA legislation. Certainly, the truth is that Big Tobacco, overall, is decreasing its attempts to derail the legislation, as Philip Morris, the company with the greatest lobbying power, is now using that power to support the legislation.

C. Implication that Tobacco Interests are Trying to Buy Congress' Opposition to the FDA Legislation

As I discussed in a previous post, TFK has publicly attacked Philip Morris, among other companies, for contributing money to Congressmembers to try to get them to vote against legislation that TFK thinks will support the public health and which TFK claims are not in the interests of the tobacco companies. A recent press release claims that: "With over $600,000 already donated to candidates this year, the tobacco interests are hoping to continue to see federal policies that favor their bottom line over the public's health."

Unless TFK is also misrepresenting its position on the FDA legislation (which is that this legislation will favor the public's health over the interests of the tobacco companies), then it cannot be accurate for TFK to claim that the money that Philip Morris is donating to Congressional candidates is being contributed in order to promote federal policies that "favor their bottom line over the public's health." Clearly, TFK believes that the FDA legislation will favor the public's health over Philip Morris' bottom line. Thus, by logical inference, TFK must believe that Philip Morris' donations to influence Congress are actually being given in the hopes of enacting a federal policy that will favor the public's health (after all, the FDA legislation is the primary, if not only, major federal tobacco policy issue that will be considered by the current Congress).

D. Public Statement that Defeat of FDA Legislation was a Win for the Tobacco Industry

This statement, made in a press release, communicates to the public and the media, I believe, that the tobacco industry was against the FDA legislation. In the release, TFK stated: "Tobacco Industry Wins, Kids Lose As Conference Committee Votes Down FDA Authority Over Tobacco." If the tobacco industry won by the defeat of this legislation, then I think the public and media would naturally assume that the tobacco industry must have been against the legislation.

But in no way was the defeat of the FDA legislation a win for Philip Morris. In fact, as revealed above, the company expressed its extreme disappointment over the bill's defeat. While this particular example might be explained by suggesting that TFK was interpreting a loss for the tobacco industry in its own opinion as opposed to that of the industry itself, I still find this to be a misleading statement that implies to probably the bulk of readers that the tobacco industry was opposed to the legislation.

E. Failure to Disclose Philip Morris' Support for FDA Legislation on the TFK Web Site


Despite a voluminous amount of public information and public statements about the FDA legislation on its web site, a thorough search of the site failed to reveal any mention of the critical and relevant fact that Philip Morris supports this legislation. The Campaign had any number of opportunities to disclose this information (it's not like they just have one web page devoted to this bill), yet decided not to disclose it each and every time (unless I'm missing something, but I don't think I am because I did a quite thorough search).

Among the web pages that provide public information and public statements about the legislation but fail to disclose the fact that Philip Morris supports the legislation are the following:

Report on the FDA Legislation

Press Release in Support of the FDA Legislation

Statement on FDA Legislation

Fact Sheet on FDA Legislation

Information Sheet on FDA Legislation

Support for FDA Legislation

What FDA Legislation Really Means

Another Press Release on FDA Legislation

Yet Another Press Release on FDA Legislation

And Yet Another Press Release on FDA Legislation

One More Press Release on FDA Legislation

Another Press Release

And Another

One More Press Release on FDA Legislation

Press Release on FDA Legislation

Another

Additional Press Release on FDA Legislation

Another One

Second to Last Press Release Example

Final Press Release Example

2. Lack of Truthfulness and Forthrightness About What the FDA Legislation Does and Does Not Do

In a letter to members of Congress which purports to inform policy makers about the FDA tobacco legislation, the Campaign for Tobacco-Free Kids (and other health groups) compared the authority that FDA would be given to regulate tobacco products with existing authority that the Agency has to ensure the safety of other products. The Campaign stated that the legislation provides "FDA with authority over tobacco products similar to the authority it has over other products. FDA would have the authority to stop tobacco marketing and sales to our children and to subject tobacco products to the same consumer protections, such as ingredient disclosure, product regulation and truthful packaging and advertising, applied to other products. Just as we entrust FDA with the authority to approve every ingredient in food to ensure safety, we should give FDA the same authority to regulate tobacco products."

The problem is that in no way is the authority provided to FDA in this legislation similar to that provided to the Agency for the regulation of other products, such as food and drugs. In fact, it is fundamentally different, as I have discussed in detail.

I believe that this letter is misleading and deceptive and likely had the effect of providing members of Congress with an inaccurate understanding of the nature of the proposed legislation. I think the letter misrepresents the nature of the legislation in a profound way.

3. Lack of Transparency and Forthrightness About the Process that Led to the Legislation

This legislation was the result of a negotiation process - a back-and-forth process - mediated by certain members of Congress. The major (and I think only) public health group at the table was the Campaign for Tobacco-Free Kids and the major (perhaps only) tobacco company at the table was Philip Morris, since it was the only company that desired FDA regulation.

Clearly, this legislation resulted not from a simple request by the Campaign for Tobacco-Free Kids to adopt it, but instead, from a process of compromise (what I would call negotiation) between the two major parties with a stake in the legislation - the Campaign for Tobacco-Free Kids (representing the public health community) and Philip Morris.

While I am not claiming that any direct negotiation took place between TFK and Philip Morris, I think that the accurate way to depict the nature of the process by which this bill arose is to explain that it resulted from a negotiation process that involved TFK and Philip Morris. And because the only significant party opposed to the legislation was Philip Morris, I think it is safe to describe the process as a negotiation between TFK and Philip Morris.

Again, I am not suggesting that the two parties ever communicated directly, but since presumably they had to let the Congressional mediators know whether they were willing to accept certain provisions in the bill, the process does essentially represent a negotiation between the two parties (TFK and Philip Morris).

If TFK had simply provided the text that they favored and left it at that, then I would not characterize the process as a negotiation. But because it is quite clear that TFK had to let the Congressional mediators know what they considered to be acceptable and unacceptable compromises to what they really would have desired (a bill with no loopholes), what took place was indeed a negotiation. The Campaign has itself admitted that compromises were made in the process of developing this bill. But who were the compromises made to appease if not for Philip Morris, the major tobacco interest being represented in the negotiations?

I think this is absolutely critical information that must be disclosed publicly in order to provide "the information ... needed for decisions on policies or programs." I simply do not think that any member of the public or any public health practitioner or any young person thinking about joining an organization to fight Big Tobacco can possibly be considered to be adequately informed about this proposed public health intervention without understanding that it was the result of a negotiation between TFK and Philip Morris.

So far as I know, such a disclosure has never been made by the Campaign. In fact, the Campaign has publicly denied that any negotiation with Philip Morris took place. While the Campaign can certainly argue that it is technically correct (since it could claim that it is interpreting the word "negotiate" in a very narrow way), the denial is, I think, misleading to the American public and to public health practitioners who I think deserve to have this critical information before making a decision on what position to take on this proposed public health policy. At very least, a full and honest disclosure about the nature of the process that led to the formation of this public policy proposal is warranted.

Conclusion

For all of these reasons
, I believe that the Campaign for Tobacco-Free Kids' campaign to promote the FDA tobacco legislation is, and has been, a campaign of deception.

And because TFK's actions violate the core ethical principles of truthfulness, transparency, and the community-level equivalent of the principle of informed consent, I believe its campaign to be unethical.

In his Tobacco Control article, Brion Fox makes the point that "There are many reasons to better integrate ethics into tobacco control, not least of which is that it is morally appropriate to act ethically as professionals. This is true even if acting ethically may have short term costs." He also argues that "by consistently framing ourselves and actions in accord with sound ethical principles, we can seize the high ground from the tobacco industry and provide a common language to communicate with the public and among ourselves."

The Campaign for Tobacco-Free Kids has, I think, failed to do this. Instead of seizing the high ground from the tobacco industry, it has seized the low ground right next to the industry. And that is not going to bode well for the reputation, credibility, and perceived character of the tobacco control movement.

Fox argues that acting ethically is not only important in its own right, but because it is necessary to preserve the perceived character and credibility of the tobacco control movement. Once the public's trust is lost, he argues, the movement is pretty much shot: "if the public health community cannot shape the moral argument and resonate with the public, there is a very real risk that consumers and policymakers, whether they are smokers, potential smokers, or ardent nonsmokers, will be less receptive to tobacco control efforts. Moreover, by the time we observe that the tobacco control community has lost the public'’s trust, perceptions will be so entrenched they will be difficult to change, so it is best that we proactively consider our ethical goals and how to best portray ourselves before observing dramatic problems."

The rest of the story reveals, I think, that it is too late. We are already observing dramatic problems, and none is so dramatic as the Campaign for Tobacco-Free Kids' campaign of deception.

2 comments:

penhappy said...

Just in case my passion for youth advocacy comes out in this post, I am very passionate about what the youth and the volunteer force of tobacco advocates in this country does.

Now for this post, I have emails where TFK sent out about Philip Morris' support of the bill and that it was a negotiation. I also remember emails about this negotiation weakening the FDA regulation to where alot of the different tobacco control advocates decided that this 2004 version of the FDA legislation should not be passed. I am looking into my thousands of emails from last year because I thought you were one of those against it's passage because PHilip Morris was involved and had weakened the language of the bill, in fact I think it was you who explained this to me in a very long email. The only thing that did survive in this legislation was the pork belly bills. The tobacco buyout also survived.

I am sorry but I cannot see how any tobacco company coming to the table to make a regulation benefit them and hurt their competition as being honest, trustworthy or on the same side of the fence. Michael Meyers was called to the negotiation table and yes Philip Morris also joined that table, but it wasn't like they were friends or that the mission statement of TFK changed or that Mr. Meyers was misleading and deceptive. I believe he was working to protect kids and lives and knew coming in that the powerful tobacco lobby would substancially weaken the bill in the first place if it was passed, to set at a table with one of the players was a means to an end.

I work on committees to pass smoke free laws, I sit at the table with smokers, restuarants, bars, and even some of the companies that sell products to these companies and people. Doesn't put me in bed with them. It is a means to an end to accomplish a goal and to hear the concerns from all sides. It is a way to make it work, because when it comes to FDA regulation, common sense would say they would just pull it from the shelves as hazardous, but you and I both know the problem that would create considering it is the most addictive natural drug known to man, and so many more people are addicted to it then to any illegal drug.

So it becomes a process where we need all sides at the table to solve this very complicated problem. Still doesn't mean I am going to trust the other side, I will scrutinize what they do, and what they say. Their past tells me I should not trust them. They could be working against me. Taking my own words and twisting them against me. Hmmmm sounds famililar?

John R. Polito said...

Yes the FDA is a mess but is tobacco control any less a mess? We have the American Legacy Foundation's web site listing its #1 corporate parter as Time-Warner, the tobacco industry's leading media partner in helping enslave yet another generation of youth.

If that isn't bad enough our leading youth smoking prevention organization is in agreement with the U.S. tobacco company holding a 49% market share in recommending that the smoking and chewing of a natural insecticide should be regulated by the U.S. agency responsible for overseeing the safety of medicines. Medicine?

We have the pharmaceutical industry's "New Definitions Division" to thank for that. And we thought Big Tobacco was good. These guys were bold enough to label an extremely addictive teratogen that’s more lethal than strychnine and three times deadlier than arsenic as "medicine," term it's use "therapy," and redefine "quitting" to mean quitting smoking but not necessarily quitting nicotine.

Is nicotine replacement therapy (NRT) a bad hoax upon smokers? I believe it is. The core foundation of all NRT claims are double-blind odds ratio victories over placebos. But nicotine is a psychoactive chemical producing an alert dopamine adrenaline intoxication. If a smoker has any prior quitting history at all they know what it feels like to both be deprived of nicotine and to have it present.

What motivation would a quitter have to stay in the study when their expectations of receiving weeks or months of free pharmaceutical grade nicotine were frustrated? We don’t know as most dropped out in the first two weeks and their beliefs and motivations were either never assessed or in the few cases where they were NRT researchers waited months (and in the case of the nicotine spray and inhaler an entire year) before conducing an assessment. Why wouldn't a greater percentage of satisfied users have remain in the study longer and then reaped the benefit of ongoing motivation, education and support study protocols that each have their own independent effectiveness?

A June 2004 a study by Mooney found that only 17 of 73 double-blind placebo controlled NRT studies conducted assessments to determine if they were in fact truly blind. Twelve of the 17 (or 71%) failed their own blinding assessment. This link is to a full text copy of Mooney’s blinding assessment - http://whyquit.com/studies/NRT_Blinding_Failures.pdf

It is thus false for anyone, including Tobacco Free Kids, to suggest that NRT studies were blind. Why is this important? It's important because Tobacco Free Kids and most other health advocates perceive the FDA as already regulating nicotine as "medicine" and in their minds they know that the key chemical in nicotine laden smoke is exactly the same.

I predict that detailed blinding data will someday soon be available and NRT’s house of cessation cards will come tumbling down. Contrary to the garbage being peddled by the pharmaceutical industry, with a 93% six month failure rate OTC NRT is not an effective aid to smoking cessation (see http://tc.bmjjournals.com/cgi/content/full/12/1/21?ijkey=5.ko5/Oz4yutI ).

Picture an "honest" FDA at last deciding that NRT is not effective for cessation and pulling its authorization. How much sense would it then make for Tobacco Free Kids to continue its half-baked plan to have the FDA forever legitimize, institutionalize, and forever normalize corporate profiting from intentionally addicting immature minds to a lifetime of chemical dependency upon nicotine?

How hard would it be for Tobacco Free Kids to support a substitute bill such as the following?

"In that nicotine is extremely addictive, the states and their political subdivisions shall have full authority to regulate the marketing and sale of nicotine delivery vehicles including tobacco. This full and complete federal preemption waiver expressly includes but is not limited to authority to require additional health or dependency warnings, to establish the legal age of use, to regulate or ban all exterior or point of sale marketing, to fully regulate or ban advertising, to require that minors be excluded from all sales locations, to mandate physician prescribed prescriptions, to impose appropriate fines and punishment for violations, and authority to impose a partial or complete ban on the sale of any or all nicotine delivery vehicles."

John R. Polito
john@whyquit.com