Thursday, October 01, 2015

Contrary to the Way Results Were Reported, New Study Did Not Find a Reduction in Cigarettes Smoked with Low-Nicotine Cigarettes

New research published in the New England Journal of Medicine is widely being reported by anti-smoking groups and advocates as having found that subjects who received low-nicotine cigarettes significantly decreased their cigarette consumption. For example, the Campaign for Tobacco-Free Kids claimed that: "After six weeks, smokers given cigarettes with 2.4 mg of nicotine or less smoked significantly fewer cigarettes per day... ." Dr. Stan Glantz claimed that "smokers smoke less" after big cuts in nicotine in cigarettes. And the study itself concluded that "these data suggest that if nicotine content is adequately reduced, smokers may benefit by smoking fewer cigarettes... ."

The Rest of the Story

Once again, these anti-smoking groups and advocates are deceiving the public. The truth is that the study found no significant change in cigarette consumption (the number of cigarettes smoked per day) among smokers assigned to the very low-nicotine cigarettes. Subjects assigned to smoke the very low-nicotine cigarettes smoked an average of about 15 cigarettes per day at baseline and an average of about 15 cigarettes per day at follow-up. Thus, there was essentially no change in their cigarette consumption. Moreover, the exhaled carbon monoxide levels did not change significantly among the very low-nicotine group, indicating no significant reduction in tobacco smoke exposure.

The study did find a significant difference in the number of cigarettes smoked at follow-up between the very low-nicotine and higher nicotine groups. The mean difference in cigarette consumption between the groups was significant. This is because cigarette consumption among the higher nicotine groups actually increased.

These data do not support the conclusion that very low-nicotine cigarettes result in a significant reduction in the number of cigarettes smoked per day among smokers switching to such products. In fact, there was no observed reduction in cigarette consumption at six weeks, so such a conclusion cannot be supported by these data. But at very least, the reports that smokers smoke less after cuts in nicotine or that smokers given low-nicotine cigarettes smoked fewer cigarettes afterwards are incorrect.

It is difficult for me to see how a study which found no significant change in cigarette consumption among smokers who switched to very low-nicotine cigarettes can possibly support the conclusion that regulating nicotine levels in cigarettes would result in a significant reduction in cigarette consumption among smokers. Such a conclusion appears to reflect a bias in the interpretation of the study results that favors a nicotine regulation policy.

In contrast, there is strong evidence that switching to electronic cigarettes results in a substantial reduction in cigarette consumption. The majority of smokers in a similar clinical trial of e-cigarettes cut their actual cigarette consumption by more than 50%.

So why is it that anti-smoking groups and advocates are jumping on top of the idea of very low-nicotine cigarettes but completely shunning the idea of e-cigarettes?

The answer is simple: ideological bias.

NEJM Commentary Written by Anti-Tobacco Researchers Hides Conflicts of Interest with Big Pharma

An article published today in the New England Journal of Medicine discusses the results of a clinical trial of low-nicotine cigarettes for reducing smoking. The article recommends that low-nicotine cigarettes should be a part of a national strategy to reduce tobacco use. However, it fails to recommend that electronic cigarettes be considered as a part of this strategy, even though e-cigarettes are much more effective in getting smokers to cut down on the amount they quit, much more effective in getting smokers to quit completely, and much safer. But e-cigarettes are a threat to pharmaceutical companies that manufacture smoking cessation drugs. Therefore, readers may naturally be curious whether the authors of this commentary have any history of financial conflicts of interest with pharmaceutical companies.

Fortunately, readers can be rest assured that there were no relevant conflicts to disclose. Both of the co-authors - Dr. Michael Fiore and Dr. Timothy Baker - completed disclosure forms indicating that they have nothing to disclose, which implies that there is no relevant history of financial relationships of any of these authors with pharmaceutical companies.

Specifically, in completing section 5 of the form, each of the authors proclaimed that there were: "No other relationships/conditions/circumstances that present a potential conflict of interest." This section refers to financial interests that were not disclosed earlier in the form. The disclosures earlier in the form relate to financial interests present during the past 36 months. Importantly, however, the additional disclosures in section 5 do not have any stated time frame. The directions indicate that authors must "use this section to report other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what you wrote in the submitted work."

Since both authors indicated in section 5 that there are no other relationships or activities that readers could perceive to have influenced their work, we are led to believe that neither of these authors has any significant history of financial relationships with Big Pharma.

The Rest of the Story

The rest of the story is that both authors are hiding relevant financial conflicts of interest with Big Pharma that I believe should have been disclosed in the paper.

Dr. Fiore

The truth is that Dr. Fiore actually has a long history of significant financial relationships with pharmaceutical companies that manufacture smoking cessation drugs, none of which are acknowledged in his disclosure. Here is what is being hidden from readers:

1. According to his own 2008 JAMA article: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

2. According to his own sworn testimony, at the time of his chairing in 2008 of an expert NIH panel to make recommendations about the recommended clinical strategies for promoting smoking cessation, Dr. Fiore received up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

3. In 2006, Dr. Fiore acknowledged that "I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

4. In 1998, the University of Wisconsin appointed him to a named chair, made possible by an unrestricted gift to the University from GlaxoWellcome.

5. In the past, "Dr. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."

6. Dr. Fiore directs a tobacco research center that received nearly $1 million in funding from makers of quit-smoking medicine in 2004 and $400,000 in 2005.

7. In a recent set of two articles on treatment for smoking cessation published in the Annals of Behavioral Medicine in April 2011 (article 1; article 2), the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Michael C. Fiore served as an investigator on research studies at the University of Wisconsin that were funded by Nabi Biopharmaceuticals."

8. In a December 2010 article on treatment for smoking cessation published in the Wisconsin Medical Journal, the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Dr Fiore has served as an investigator in research studies at the University of Wisconsin that were funded by Pfizer and Nabi Biopharmaceuticals."

Amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma. I imagine that most readers would be shocked to find out about this intense and long history of financial conflict with Big Pharma, given that Dr. Fiore reported no conflicts of interest.

Dr. Baker

The truth is that Dr. Baker also has a long and significant history of financial relationships with pharmaceutical companies that manufacture smoking cessation drugs. Here is what is being hidden from readers:

1. In 2008, Dr. Baker reported that: "he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

2. In 2000, Dr. Baker disclosed as follows: "Timothy Baker has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, and Lederle."

3. As recently as 2012, Dr. Baker disclosed in an article that his research involved financial support from GlaxoSmithKline in the form of free medication provided to study participants.

4. In another 2012 paper, Dr. Baker also acknowledged that GlaxoSmithKline provided financial support in the form of free study medication. The same disclosure was made in another 2012 paper. And in another paper as well.

5. According to a 2011 paper: "Timothy B. Baker has served as a consultant, given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline, Nabi Biopharmaceuticals, Pfizer, and Sanofi-Synthelabo."

6. In a 2010 paper, Dr. Baker acknowledged "research grants from Pfizer, GlaxoSmithKline, Nabi Biopharmaceuticals, and Sanofi."That paper itself involved research with financial support from GlaxoSmithKline in the form of free study medication.

Again, amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma.


For years, we in tobacco control have attacked tobacco industry-funded scientists or researchers who consulted for tobacco companies for not disclosing their conflicts of interest. It is therefore quite unfortunate, and ironic, that tobacco control researchers do not appear to take their own conflicts of interest seriously and that they, too, are hiding these conflicts from the public.

As I previously articulated, the hiding of these conflicts of interest damages public health in four ways:

  1. It violates public health ethics and could be damaging to the entire field of tobacco control;
  2. It degrades the research integrity of tobacco control;
  3. It makes us hypocrites when we criticize failed tobacco industry disclosures; and
  4. It hides the influence of Big Pharma money on the field of tobacco control and hinders smoking cessation efforts.

New Study Violates Research Ethics by Assigning Subjects to Smoke, Instructing Them to Smoke, and Failing to Provide Mandated Care

A study published today in the New England Journal of Medicine describes the results of a clinical trial in which adult smokers who expressed no intent to quit at baseline were randomly assigned to smoke their regular brand of cigarettes or reduced nicotine cigarettes at varying levels of nicotine.

(See: Donny EC, et al. Randomized trial of reduced-nicotine standards for cigarettes. New England Journal of Medicine. Published online ahead of print on October 1, 2015. DOI: 10.1056/NEJMsa1502403.)

According to the study: "Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6."

The results of the study, which were accompanied by an editorial, have been widely reported in the media. However, I have not seen any discussion of the ethics of this study.

The Rest of the Story

A basic principle of human subjects research is that of non-maleficence, or doing no harm. Also critical is the principle of harm minimization. You cannot knowingly put human subjects in harm's way when there is an alternative that is safer and will still answer the research question at hand. In particular, subjects being treated in a medical setting must, at a minimum, receive the standard level of care for the disease, condition, or behavior being studied.

This issue arises because most clinical trials involve randomization of subjects to receive an investigational treatment or no treatment. However, when someone has a medical condition, it is obviously not ethical to provide them with no treatment. Therefore, it is well recognized that subjects must, at a minimum, be offered the standard or usual treatment for that disease, condition, or behavior.

For example, suppose you want to investigate the effectiveness of a potential new treatment for severe hypertension (high blood pressure). The treatment involves a new drug. You cannot randomize patients to receive either the new drug or a placebo because it would be unethical to deprive subjects who have severe hypertension of any treatment. At a minimum, you would have to provide the control group with the minimum standard of care, which would almost certainly involve treatment with a standard drug usually used to treat high blood pressure.

In fact, the failure to provide standard care is one of the main problems in the tragic Tuskegee study, which is what in many ways led to the promulgation of ethical standards in research with human subjects. In that study, subjects with syphilis were randomized to receive antibiotic treatment or no treatment. It was unconscionable that subjects were left untreated when there was a known treatment available.

Believe it or not, this same failure occurred in the present study, although obviously not as blatantly or with as tragic the consequences. Nevertheless, the violation of basic research ethics was similar.

In the present study, smokers were assigned to either smoke their usual brand of cigarettes or to smoke a low-nicotine cigarette (at varying levels of nicotine). They were instructed to smoke the assigned cigarettes for six weeks. Although the subjects were free to quit smoking, they were not encouraged to quit unless they informed study staff that they had tried or intended to make a quit attempt.

According to the study protocol: " Participants will be instructed to use the research cigarettes for 6 weeks, at which point they are to discontinue product use." In other words, study subjects were instructed not to quit smoking for at least six weeks!

Moreover, the study protocol did not call for encouraging research participants to quit smoking, nor did it call for providing all subjects the usual standard treatment for smokers, which consists - at very least - of advising patients to quit. In a non-research setting, it would probably represent medical malpractice for a physician to instruct a patient to continue smoking for six weeks. At very least, there is an obligation - under standard medical principles - to advise the patient to quit smoking. Even less acceptable would be to make no recommendation regarding smoking. But to actively instruct the patient to continue smoking would be unethical.

The problem is compounded by the fact that study subjects were provided with a free 14-day supply of cigarettes. Not only does this make it more difficult for them to quit smoking, but it encourages them to continue smoking and sends the implicit message that if they don't continue to smoke, they are violating study protocol. It appears that the subjects were not explicitly told that quitting smoking is encouraged and will not violate the protocol or endanger their receiving compensation in any way.

Furthermore, offering smokers treatment with a smoking cessation medication and/or referral to a smoking cessation clinic or program is not only usual care, but it is actually mandated under the hospital accreditation standards.

The ethical breach becomes even more serious when one examines the informed consent form used in the study. The form states as follows:

"You will smoke your assigned cigarette for the remainder of the study. We will give you more than enough cigarettes to replace the amount that you usually smoke each week. We will ask you to try to smoke only the cigarettes we give you. We will work with you to achieve this goal as it is very important for the study."

Here, subjects are being told that they will smoke their assigned cigarette for the entire six weeks of the study. Moreover, they are informed that their continuously smoking their assigned cigarette brand for six weeks is a goal of the study and is very important. The implication, of course, is that if a subject quits smoking, he or she is not following the protocol and is compromising the study.

Although subjects are later informed that they may quit if they want, nowhere are they encouraged to quit smoking.

Finally, nowhere in the consent form are subjects told that one of the risks of the study is that by continuing to smoke for six weeks rather than quitting, they are subjecting themselves to the risk of health damage from continued smoking. The form does not acknowledge that one of the risks of participation in the study is that it could impede quitting, at least for six weeks.

To me, what puts the nail in the coffin of the ethical breach in this study is that there is an alternative approach that would have yielded the same information, but without violating ethical principles. An alternative approach would have been to encourage all subjects to quit smoking, refer them to smoking cessation clinics or programs, and offer to provide them with nicotine replacement therapy or other treatment. Because the smoking cessation rate with "FDA-approved" or "hospital-mandated" treatment is so low, such a procedure would not have interfered significantly with the ability of the study to answer the research question at hand. If anything, it would have added to the importance of the research by examining the critical question of whether low-nicotine cigarettes can actually enhance smoking cessation.

The rest of the story is that this study violated basic principles of ethical research conduct by failing to provide standard of care treatment for smokers being seen and treated in a medical setting. Even worse, smokers were in fact assigned to smoke, instructed to smoke, and led to believe that the protocol called for them to continue to smoke for the entire study period (which it did). In addition, subjects were not adequately informed of the study risks.

Wednesday, September 30, 2015

As Youth Smoking Rates Continue to Plummet, Anti-Smoking Advocates Continue to Claim E-Cigarettes are a Gateway to Youth Smoking

New data from the Florida Department of Health show that in 2015, smoking among Florida youth dropped to its lowest all-time level, with only 6.9% of high school students reporting past 30-day use of cigarettes. The sharp decline in youth smoking occurred contemporaneously with the tripling of e-cigarette use among Florida youth during the past two years.

Nevertheless, health officials continue to claim that e-cigarettes are a gateway to youth smoking and that e-cigarettes are normalizing smoking. According to an article in the Gainesville Sun:

"After decades of aggressive work to try to keep teens from picking up the deadly habit, health officials worry that e-cigs will undo that progress. ... the increase in e-cig use has the potential to normalize smoking again after decades of work to stigmatize it, the health department's Community Health Promotion Division Director Shannon Hughes said in a press release."

The Rest of the Story

The rest of the story is that the claims of anti-smoking advocates are simply not supported by the available data. If e-cigarette experimentation were a significant gateway to youth smoking, or if vaping normalized smoking, we would not expect to see youth smoking plummeting in the past two years, dropping to its lowest historic levels, at the same time as e-cigarette use among youth has tripled.

The truth is that the advent of e-cigarettes has made smoking even less attractive because there is a safer, cleaner, tastier alternative. Vaping is unquestionably contributing to a further denormalization of smoking. The truth is the exact opposite of what many anti-smoking groups are claiming.

It is time for anti-smoking advocates to recognize that the only thing vaping is normalizing is vaping. Although short-term use of electronic cigarettes does not appear to pose any significant health risk (other than to pregnant women), the spread of e-cigarette use among youth is still concerning. But it is not concerning because it is leading to smoking. It is concerning because many youth are now vaping. Ultimately, we don't want to see youth using nicotine at all. But the problem needs to be defined accurately.

What is contributing to the renormalization of smoking are the actions of anti-smoking groups, who have misled the public into believing that smoking is no more hazardous than using a non-tobacco-containing, non-combusted product. This has completely undermined the public's appreciation of the severe hazards of smoking. In fact, surveys have shown that a substantial proportion of the public actually believes that vaping is no safer than smoking. This is an untenable situation that normalizes smoking by demonizing electronic cigarettes and protecting cigarette sales. 

Health groups that continue to advise against the use of e-cigarettes in smoking cessation attempts, such as the American Academy of Family Physicians (AAFP), which recently issued a recommendation that physicians counsel against the use of e-cigarettes, are also contributing to the renormalization of smoking by helping to maintain cigarette use. The AAFP's recommendation, if followed by physicians, will lead to many smokers failing to quit and many ex-smokers returning to smoking because their doctors do not condone e-cigarette use.

Electronic cigarettes truly have the potential to be a game-changer in tobacco control. They could contribute to a massive transformation of the nicotine market in which combustible tobacco products eventually become obsolete. This is in fact the value proposition for all of the independent e-cigarette companies. But this transformation is being blocked by the unlikeliest of entities: the tobacco control movement itself.

Tuesday, September 29, 2015

FDA Completely Misinterprets Food, Drug, and Cosmetic Act in Warning Letters to E-Cigarette Company

My examination of the warning letter written by the FDA to Johnson Creek reveals that the agency is completely misinterpreting the Food, Drug, and Cosmetic Act's (FDCA) definition of what is considered a "therapeutic claim." This warning letter, issued in 2010 to Johnson Creek - an e-liquid manufacturer - asserted that certain claims being made by this company were therapeutic claims, and therefore, the products made by the company were considered drugs and had to be pulled from the market as they were not approved by the FDA as drugs.

However, upon examination, I found that this letter misinterpreted the meaning of "therapeutic claim" and used as evidence to support its assertion statements that do not actually represent therapeutic claims at all.

Below, I review many examples from the warning letter of the agency's misinterpretation.

The Rest of the Story

Examples of Purported Therapeutic Claims From the Letter to Johnson Creek

"If i had to wait two weeks, most likely I would have been back on smoke within a few days and I don't ever want to go there again, with as good as I feel right now. Daniel L. ... 

I have been off tobacco cigarettes for a week. I have been using an NJOY. I just received my first of many orders from your company. Norman S."

These two comments from customers simply express their experiences with electronic cigarettes. In both cases, these customers were able to switch completely from cigarettes to e-cigarettes. The company is not making any therapeutic claims, but is merely sharing the experience of customers who were able to switch from cigarettes to e-cigarettes. There is nothing in these comments which suggests that Johnson Creek e-liquids are intended either to prevent or treat any disease or to affect the function or structure of the body. Nothing in the comments expresses anything about improved health. They simply convey the fact that these individuals have switched from tobacco cigarettes to electronic cigarettes.

To see misguided the FDA is on this point, consider the following claim that is currently being made by GNC in the same context (a testimonial from a customer):

"GNC is the supplement industry leader in providing the highest quality supplements at an affordable price. I would like to thank GNC for making me a better athlete and a healthier person through the GNC supplements that I include in my daily nutrition."

Here, GNC is directly claiming that using its products will improve your health. This certainly seems like a therapeutic claim. After all, improving your health implies prevention of lack of health (i.e., disease or a harmful condition). This appears to run afoul of federal law, which prohibits nutritional supplements from making "disease" claims. The manufacturers of these products are not allowed to make any claim which states or implies that their products are intended to or can prevent a disease or adverse health condition. Apparently, the FDA does not view this as a health claim, since it allows claims like this to be made daily by GNC and similar companies. Also, the manufacturers are required to notify the FDA of the claims they are making, so presumably the agency is aware of this claim but has not taken any action against GNC, even though they are hounding Johnson Creek for making what is in comparison an innocuous claim.

Consider also the following claims which are being made by Faith & Family Nutrition, another nutrition supplement seller:

"J. Randsdorp on real pain relief without drugs or surgery
Dear Doctor, I saw you on TBN-TV ... I then ordered the vitamins for joint integrity, and I cannot believe I have my life back. I am a Christian, but everyday I had started my day with pain. After taking the vitamins, I painted a room! And now everyday when my feet hit the floor, it is without pain. I can't believe it but it’s true. I thank God for you. My right leg is completely pain free and there’s just a small amount in my left leg. — D.H., Monroe, La.
...He truly is doing better! His sense of humor has returned. He is already remembering words, not stammering over them. His 'pleasant' personality is being restored. His driving, which we could not get him to stop, is much better." (on Alzheimer's supplement recommendation plan) — R.D., Ortonville, Mich.

My husband has been taking the supplements for Alzheimer's for two months and is doing quite well. His long-term and short-term memory is starting to return. I took him out of the nursing home to give him the supplements, and the nurses at the nursing home are amazed at his improvement and want to know what he has been given. (on Alzheimer's supplement recommendation plan) — M.H. Huron, S.D.

My father was having epileptic seizures. Those stopped with the Relief Pills. He has trouble with short- and long-term memory and is doing much better. He is even seeing better: He can see colors now. Before he only had peripheral vision." (on Brain Food, Seizure Relief and other various supplements)
— C.S, Molalla, Ore.

I had a bad case of insomnia. I'm sleeping great now due to 5-HTP. And my husband's hair is growing thicker since taking IGF Growth Factor. — P.M., Nashville, Tenn.
I had a torn rotator cuff in my shoulder, and Natural Joint Integrity took away the pain. (The doctor said my shoulder was messed up pretty bad.) It also has helped my back. I used to get acupuncture, but haven't had to in a long time since taking Natural Joint Integrity. — D.W., Sullivan, Mo."
Here, the nutritional supplement company is making claims - presumably reviewed by the FDA and not judged to be disease claims - which directly assert that its products will relieve pain, treat the symptoms of Alzheimer's disease, prevent seizures in patients with epilepsy, treat insomnia, and relieve pain from a rotator cuff injury.

Yet the FDA does not consider these to be disease claims! Instead, it is writing threatening letters to companies whose testimonials do not even mention any disease or condition.

Other examples from the warning letter to Johnson Creek:

"E-Smoking vs. Cigarette Smoking ... To many who take up e-smoking, it completely takes over for regular cigarette smoking. In fact many report never picking up a cigarette again after starting to e-smoke ... 

Why E-Smoke? . .. Most people who smoke, do so because they enjoy the tactile, emotional and physical sensations. E-smoking provides pleasures similar to those commonly associated with traditional smoking ..."

The first claim simply notes that many customers were successful in switching from tobacco cigarettes to e-cigarettes. It doesn't mention or imply the prevention or treatment of any disease.

The second claim actually is an "anti-drug" claim. In other words, it makes it exquisitely clear that this product is meant to replace the physical and emotional stimuli associated with smoking, rather than to treat nicotine addiction. How does this statement possibly represent a therapeutic claim, especially in light of the "non-disease claims" being made by nutritional supplement companies?

In contrast, some of the claims being made by E-Cigarette Direct, another company to which FDA sent a warning letter, are therapeutic claims.

For example:

"Wean yourself off of nicotine and quit smoking for good! . . . Our new program is designed to naturally and slowly wean your body off of the nicotine cravings by slowly decreasing them. . . . The Nicotine Withdrawal System consists of everything you need to decrease your nicotine cravings over a period of 3-6 months, depending on how quickly you'd like to accomplish your goal. . . .

E-cigarettes Reducing 400,000 American Deaths per year to 10,000. 

Experience better health without the toxins, tar and other poisons traditional cigarettes contain. Your body will notice the relief of cutting out all of those added poisons. Our customers tell us that they feel better, their skin is better looking and they breathe better.

The Electronic Cigarette or e-cigarette, is a patented sophisticated electronic device that atomizes purified liquid nicotine and produces a vapor that, when inhaled, satisfies a smoker's craving for nicotine . . . .

When using the E-cigarette, drawing on it produces the physiological effect that a smoker seeks . . . ."

These are perfect examples of what are therapeutic claims. Here, the company is claiming that the product will treat nicotine dependence, wean smokers off nicotine (i.e., treat nicotine addiction), reduce deaths, satisfy the physiologic need for nicotine, and affect the physiological function of the body. Both structure/function and disease claims are being made here.

This warning letter, therefore, is legitimate and is a proper interpretation of the FDCA. The question is: Why isn't the agency consistent in its interpretation of the Act? Why is it lumping together claims that are therapeutic claims with those which are not because they represent neither structure/function nor disease claims?

The rest of the story is that it is not clear to me that the FDA is using a consistent and proper interpretation of the FDCA definition of therapeutic claims with respect to statements being made by electronic cigarette companies. And as I discussed yesterday, the FDA now wants to codify this misinterpretation into a formal rule.

Monday, September 28, 2015

FDA's Proposed Rule on Allowable E-Cigarette Claims Runs Afoul of Both the Constitution and the Law

Last week, the FDA gave notice of its intent to promulgate a rule that clarifies the classification of e-cigarettes as either drugs or recreational tobacco products based on certain claims made by the seller. The rule also explains the type of claims that would deem an electronic cigarette brand to be a modified risk tobacco product.

Based on my analysis of the proposed rule, I believe that it runs afoul of both the Constitution and federal law. Moreover, promulgation of this rule would increase the popularity of electronic cigarettes among youth and make it harder to promote these products for harm reduction purposes that would substantially improve the public's health. Thus, I believe that the proposed regulation is not only unlawful, but that it is not in the best interests of the public's health.

The Rest of the Story

Let's start with the aspect of the proposed rule that I believe is unconstitutional, since that is simpler than the aspect which I believe runs afoul of federal law, which is more complicated.

Why the Proposed Rule Violates the Constitutional Rights of the E-Cigarette Companies

The proposed rule violates the free speech (First Amendment) rights of electronic cigarette companies by prohibiting them from making factual claims about their products that provide critical information needed by consumers and in a way that advances no legitimate government interest. Specifically, by applying the modified risk tobacco product provisions of the Family Smoking Prevention and Tobacco Control Act to electronic cigarettes, the FDA would thereby be prohibiting e-cigarette sellers from truthfully informing their consumers that electronic cigarettes:
  1. contain no tobacco; and
  2. are safer than cigarettes.
The first piece of information (e-cigarettes contain no tobacco) would be prohibited (without prior FDA approval) because the proposed rule defines as a modified risk claim one which states or implies that: "the tobacco product or its smoke does not contain or is free of a substance." Thus, any implication that e-cigarettes are free of tobacco (which is obviously a substance) would constitute a modified risk claim under the proposed rule. (Note: companies could inform consumers that e-cigarettes do not produce smoke because of an exception under section 911(b)(2)(C) of the Act.)

The second piece of information (e-cigarettes are safer than cigarettes) would be prohibited (without pre-approval from FDA) because the proposed rule defines as a modified risk claim one which states or implies that: "The tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products." Thus, any implication that e-cigarettes are safer than tobacco cigarettes would constitute a modified risk claim under the proposed rule.

In general, the courts have looked negatively upon attempts by the government to prevent corporate speech that provides purely factual information and is not misleading. In such situations, the courts are almost certain to apply the Central Hudson standards, which require that the regulation advances a significant government interest.

To be sure, the claims that e-cigarettes contain no tobacco and are safer than cigarettes are truthful. Moreover, they are not at all misleading. If anything, failing to inform consumers that electronic cigarettes are not "tobacco" products and that they are safer than cigarettes is extremely misleading to the public. We know this for sure because in the absence of such claims, an extraordinarily high proportion of the public believes that cigarette smoking is no more dangerous than vaping. This has created a dangerous situation that is undermining the protection of the public's health.

There is no substantial government interest in preventing companies from hiding from consumers truthful information that does not mislead and which is absolutely critical to their understanding of the comparative benefits of the product. Prohibiting cigarette companies from falsely implying, through the use of terms such as "light" or "mild," that certain cigarette brands are safer than others does advance a legitimate government interest because it prevents the public from being misled into thinking - incorrectly - that light cigarettes are safer than non-lights. Such a prohibition would certainly pass constitutional muster under the four prongs of the Central Hudson test.

In contrast, because electronic cigarettes truly are much safer than cigarettes and because they truly do not contain tobacco (which explains why they are much safer), prohibiting electronic cigarette companies from making such claims cannot possibly be intended or necessary to prevent misleading consumers in any way. The proposed prohibition serves no legitimate public health purpose and clearly would not get by even the second prong of Central Hudson.

The FDA's application of section 911 of the Tobacco Act to e-cigarettes would almost certainly be challenged by the e-cigarette industry, and I don't see any way in which those provisions, as applied to e-cigarettes, have any chance of passing the Central Hudson test. This would be a clear violation of the free speech rights of the e-cigarette companies.

In effect, this regulation would force companies to hide critical information from their customers, which is essentially forcing them to lie to their customers for no legitimate reason. Moreover, it would result in damaging public confusion about the relative safety of smoking compared to the use of a non-combusted, non-tobacco-containing product. This does not advance a public health purpose; it actually impedes the protection of the public's health.

Why the Proposed Rule Runs Afoul of Federal Law

The proposed rule would prohibit e-cigarette companies from informing consumers that e-cigarettes may be effective in helping smokers quit. According to the rule, smoking cessation claims imply a therapeutic effect of a product and thus result in the product being classified as a drug or device (or drug-device combination) rather than as a tobacco product. This would, of course, force such an e-cigarette off the market, as it would be prohibitively costly and time-consuming for a company to fund and conduct all the clinical trials necessary to get an e-cigarette approved as a drug.

However, I believe that the FDA is misinterpreting the Food, Drug, and Cosmetic Act (FDCA) because under FDCA, to be a drug claim a communication must either: (1) claim (or imply an intention) to prevent, cure, mitigate, or treat a disease; or (2) claim (or imply an intention) to affect the structure or function of the body.

Smoking is not a disease. It is simply a behavior. Nicotine dependence, in contrast, is classified as a "disease" (under the DSM manual). A claim that a product will change one's behavior is therefore not a drug claim, unless it states or implies that such a change will prevent, cure, mitigate, or treat a disease or states or implies that it will treat nicotine dependence (i.e., wean someone off nicotine by preventing nicotine withdrawal symptoms). Thus, the pure claim that e-cigarettes may help smokers quit - in the absence of any assertion that this will prevent disease or treat nicotine dependence - cannot be properly interpreted as a drug claim under the FDCA. (For a detailed treatment of this argument, see my previous commentary).

The reason why nicotine replacement products are properly classified as drugs is that they are intended specifically to treat nicotine dependence. They deliver nicotine with the sole purpose of preventing nicotine withdrawal symptoms and thus, helping a smoker get off of nicotine. There is no long-term intention for the smoker to continue using the nicotine replacement product beyond the act of quitting smoking. In fact, the FDA does not approve the use of these drugs as alternatives to cigarettes.

In contrast, electronic cigarettes are not intended purely for use in quitting smoking. The clear intention of these products is to replace smoking. In other words, the manufacturer truly desires that the customers will replace cigarettes with e-cigarettes, not that they will quit smoking and then immediately stop using e-cigarettes as well. In fact, the clear economic incentive is for these companies to get smokers to switch to e-cigarettes and then stay on e-cigarettes long-term. It is not in their interests for smokers to quit smoking via e-cigarettes and then stop using the e-cigarettes as well. Thus, there is no inherent intention to treat nicotine dependence. In fact, the entire strategy is the opposite. A person switches to e-cigarettes, which amounts to quitting smoking, but they remain dependent on nicotine.

So far as I am aware, no electronic cigarette company advises consumers to stop using e-cigarettes after a certain amount of time. The clear intention is to replace smoking. In other words, e-cigarettes are not properly considered drugs. Instead, they are recreational alternatives to smoking. They are an alternative form of nicotine delivery. The effect they have on quitting smoking is simply an inherent consequence of completely substituting e-cigarettes for cigarettes.

The FDA misinterprets the law because it automatically deems a smoking cessation claim to imply therapeutic intent. The FDA writes:

"Products made or derived from tobacco have historically been regulated as medical products when they are marketed for intended uses that fall within the disease prong. For example, FDA has approved a number of drug products made or derived from tobacco as nicotine replacement therapies with indications to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. Accordingly, FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction and its symptoms to be within FDA’s “disease prong” jurisdiction." ...

"As discussed previously, claims related to smoking cessation have long been recognized as claims conferring drug or device jurisdiction. Smoking cessation claims have also long been associated with curing or treating nicotine addiction and its symptoms. For example, the approved labeling for nicotine replacement therapies includes the following statements: “Purpose: Stop smoking aid; Use: reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.” Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of therapeutic benefit to the user that generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose."

In writing that "claims related to smoking cessation have long been recognized as claims conferring drug or device jurisdiction," the FDA fails to explain that the reason why such claims have generally been recognized as conferring drug jurisdiction is that they state or imply an intent or effect of treating nicotine dependence by reducing nicotine withdrawal symptoms. As the FDA admits within the same paragraph, the approved labeling for NRT specifically states that the product is intended to "reduce withdrawal symptoms."

But the FDA misspeaks when it then states that smoking cessation claims have also long been associated with curing or treating nicotine addiction and its symptoms. No, cessation claims have not also been associated with treating addiction, they are drug claims because they are associated with treating addiction.

In contrast, as anti-smoking advocates are quick to acknowledge, electronic cigarettes do not treat addiction. They actually maintain addiction. Or at least that is their primary intent. They maintain addiction by providing an alternative to smoking. This is not a therapeutic intention, absent a specific claim or expressed intent to treat nicotine dependence or addiction or to prevent disease.

The effect of this rule would be to force e-cigarette companies to promote their products based on benefits that do not correspond to the primary intended use of the product. This completely contravenes the legislative intent of the Food, Drug, and Cosmetic Act. The purpose of the Act is to make sure that drugs are safe and effective, not to require that drug manufacturers hide the primary intended use of their products.

Moreover, by preventing companies from being truthful about the primary intended use of e-cigarettes, this rule would encourage (and serve as a de facto requirement) that companies promote their products in other ways, such as advertising them as being sexy, youthful, or glamorous or as being primarily intended for use in places where smoking is not allowed. This would have a negative effect on the public's health because it would make e-cigarettes more attractive to youth. In contrast, if e-cigarette companies were allowed to be truthful about the purpose of their products, the resulting advertising would lose its youth appeal (especially to nonsmokers).

Therefore, both of these proposed rules are not only without legal merit, but both are detrimental to the public's health.

Friday, September 25, 2015

Important New Study Documents that Dual Use is Not a Negative Consequence of E-Cigarette Use, But a Positive One

An important new study led by Dr. Christopher Russell of the Centre for Drug Misuse Research in Glasgow and presented recently at the 2015 Tobacco Science Research Conference reveals that contrary to the claims of many anti-tobacco advocates, dual use (of e-cigarettes and tobacco cigarettes) is not a negative consequence of e-cigarette use, but a positive outcome that could well stand on a pathway to eventual smoking cessation.

(Russell C, McKeganey N, Hamilton-Barclay T. An online survey of 5,000 vapers' perceptions and experiences of using electronic cigarettes as an aid to smoking cessation. Glasgow, Scotland UK: Centre for Drug Misuse Research. Presented at the Tobacco Science Research Conference, September 22, 2015.)

In the study, a worldwide internet survey was conducted and was available in seven languages. It was advertised on social media and through e-cigarette fora. The recruitment materials invited the participation of all adults who had ever used an electronic cigarette, even a puff. Importantly, it was not restricted to experienced vapers who had success quitting smoking. There were 7,326 respondents.

The most important study findings were as follows:

  • Of the dual users, 64% reported having reduced their cigarette consumption;
  • Of the dual users, 56% had cut their cigarette consumption by 50% or more;
  • Of the dual users, 81% reported having quit smoking for a period of at least one week;
  • Of the dual users, 70% reported the intention to quit smoking within six months;
  • Of the dual users, 88% reported that they planned to cut their cigarette consumption by at least half in the next six months;
  • Of the dual users, 63% predicted that they would quit smoking completely within six months, and another 27% predicted that they would cut their cigarette consumption within six months.
The Rest of the Story

Although this sample is of course not representative of the population, it does reveal important information about the attitudes and behavior of a large sample of dual users. The recruitment methods likely attracted a sample that had a disproportionately positive experience with electronic cigarettes, so these results should not be generalized to the overall population. However, within this subset of the population, it is clear that there are a substantial number of dual users for whom electronic cigarettes are having substantial positive consequences, even though they have not quit smoking completely.

This is critical information because most tobacco control advocates and groups have argued that quitting smoking is the only potential benefit of electronic cigarettes and that dual use is a negative consequence. These study results call those assumptions into question.

First, it is clear that a large percentage of the dual users had significantly cut down on the amount they smoked. This, in itself, confers substantial health benefits, especially in terms of respiratory symptoms and progression of respiratory disease. It also reduces smoking addiction and makes it easier for these smokers to quit in the future.

Second, it is clear that electronic cigarettes are being used as a part of an overall plan to quit smoking and that dual users largely were committed to eventually quit smoking completely. Even more importantly, nearly two-thirds of the dual users had positive self-efficacy for quitting, predicting that they would be smoke-free in six months time.

These results also call into question the claims of many anti-tobacco advocates that use of electronic cigarettes is inhibiting smoking cessation by removing the intention or desire to quit. It appears that among at least a subset of dual users, the e-cigarettes are being used as part of a smoking cessation plan and the intention to quit remains. In fact, the level of self-efficacy of these dual users is much higher than we observe in general smokers in the population.

This study certainly points the need for a similar survey to be conducted among a representative sample of smokers who try electronic cigarettes but fail to quit (i.e., a large, representative sample of dual users). However, the preliminary data from this study suggest that the use of e-cigarettes by adult smokers should be viewed as an integral part of an overall plan to quit smoking and improve one's health. And vaping appears to be helping smokers achieve both.

Thursday, September 24, 2015

Physicians Continue to Make Unsupported Claims About E-Cigarettes

In an op-ed piece published in the Daily Hampshire Gazette (MA), the vice president of the Hampshire District of the Massachusetts Medical Society claims that vaping is a proven path to smoking addiction. In the piece, entitled "Vaping is proven path to tobacco addiction," she writes:

"New state regulations limiting the sale of e-cigarettes to children take effect Friday. And they come not a moment too soon. This is because of the association of “vaping” in children with their regular use of tobacco cigarettes — a link around which there is a growing consensus. ... All the data are not yet in, but it is clear from multiple studies that young people using e-cigarettes are more likely, not less, to smoke cigarettes."

The Rest of the Story

Contrary to the claims made in this article, it is not at all clear that experimentation with e-cigarettes leads young people to tobacco addiction. In fact, all of the evidence at the current time points in the other direction: it appears that e-cigarettes may actually be deterring youth from using the real thing.

In fact, a new study out of the Florida Department of Health revealed that while youth experimentation with e-cigarettes is rising rapidly, youth smoking in Florida is rapidly disappearing. Frequent smoking among high school students has dropped to just 2.5%, and among middle school students is only 0.6%.  As the article notes:

"Frequent cigarette smoking youth are now almost extinct in the state. With just 0.6 percent of middle-schoolers and 2.5 percent of high-schoolers have smoke more than 20 cigarettes in the past 30 days at the time of the survey. That's down from 5.4 percent of middle-schoolers and 13.3 percent of high-schoolers in 1998.  You might remember that Gov. Lawton Chiles won a $11 billion dollar lawsuit against the tobacco industry and used that money to launch one of the most thorough anti-smoking campaigns targeted at kids in the country back in 1998. Since then Florida's youth tobacco use has plummeted and remains well below national levels. However, in the past couple of years it appears that drops in rates of traditional cigarette smoking have more to do with the emergence of e-cigarette alternatives."

The survey results also provide evidence that e-cigarettes are not leading many youth to nicotine addiction. While 14.7% of middle school students reported having tried e-cigarettes, only 0.9% were frequent e-cigarette users. Similarly, while 37.6% of high school students reported having tried e-cigarettes, only 2.9% were frequent users. With smoking rates plummeting to historic lows in Florida, this suggests that:

(1) Electronic cigarettes are not particularly addictive (and are much less addictive than regular cigarettes); and

(2) Electronic cigarettes appear to be deterring many youth who would otherwise have chosen to become smokers.

I happen to agree with the author of this piece that state regulations which ban the sale of e-cigarettes to minors are warranted. However, I think we can support these policies with the truth. I don't feel a need to support the regulations by lying to the public about the scientific evidence or by misrepresenting the evidence.

Through the constant and persistent misrepresentation of the science, I fear that the anti-tobacco movement is going to lose its credibility and reputation. And once we lose that, we have nothing.

And so I ask: Why is the truth not enough?

The answer is clear: Because the truth does not support our position that e-cigarettes are a gateway to youth smoking addiction and that e-cigarettes are renormalizing smoking. But rather than accepting the truth, we are twisting it to conform to our pre-conceived notions. This is known in psychology as "confirmation bias."

The largest problem with confirmation bias is that it leads to poor decision-making. This is precisely what we are observing in the anti-tobacco movement, as evidenced by actions of numerous government agencies, including the CDC, FDA, and California Department of Health Services.

Perhaps the best, and most recent, example of the poor decision-making which is resulting from this confirmation bias is the recent action of doctors and health groups in South Australia, who called for a ban on the sale of e-cigarettes, but want tobacco cigarette sales to continue unencumbered.

Wednesday, September 23, 2015

D.C.'s Electronic Cigarette Tax is an Insane Policy that Will Help Renormalize Smoking

On October 1, the District of Columbia will impose a 67% tax on all electronic cigarettes and vaping products. As an article in the Daily Caller explains, this tax will put many vape shops out of business.

According to the article: "A steady stream of customers poured in to M Street Vape Friday afternoon to get flavor refills for their vaporizers, but they may not be able to do that for long after a new city law takes effect. Starting Oct. 1, a new 67 percent excise tax on vapor products takes effect in Washington, D.C., and it will likely put the shop out of business, its owner says. The tax will treat e-cigarettes just the same as regular tobacco-burning cigarettes, despite the fact that there is no actual tobacco being burnt, but a juice containing nicotine that is heated to produce water vapor."

The Rest of the Story

This is one of the most insane "public health" policies I've ever heard of. Taxing e-cigarettes at a whopping 67% rate is nothing more than a gift to Big Tobacco. Undoubtedly, it will put many vaping shops out of business, resulting in significant numbers of ex-smokers returning to smoking and many smokers who would otherwise have quit using e-cigarettes not doing so. The policy protects cigarette profits at the expense of the public's health.

Ironically, Chicago is considering a similar tax on e-cigarettes under the guise of trying to fight Big Tobacco. The rest of the story is that such a tax would be a present for Big Tobacco by protecting cigarettes from competition from the much safer vaping products. If enacted, this policy will help renormalize smoking and will cost lives.

I understand that the city of Chicago wants to raise revenue, but to do so at the expense of the public's health and the lives of its citizens is unconscionable.

Tuesday, September 22, 2015

IN MY VIEW: Electronic Cigarettes are Not Renormalizing Smoking, Anti-Tobacco Groups Are

In an op-ed piece published in the Lexington Herald-Leader, Audrey Darville - a tobacco treatment specialist at the University of Kentucky and an assistant professor in the UK College of Nursing - writes:

"In the 1970s, the U.S. Congress banned tobacco ads to protect our impressionable youth from perceiving smoking as socially desirable. Now, for the first time in decades, advertisements portraying the recreational use of tobacco products are reappearing in popular media. Advertisements present e-cigarettes and vaporizers as safer alternatives to conventional cigarettes. Tobacco control advocates fear this type of exposure will unravel decades of progress in America by renormalizing smoking."

Besides the fact that Darville is misleading the public by claiming that e-cigarettes are "tobacco products" and therefore insinuating that they contain tobacco, she also claims that e-cigarettes, as safer alternatives to conventional cigarettes, are going to renormalize smoking.

Darville is not alone. Most of the mainstream anti-tobacco organizations are also demonizing electronic cigarettes on the grounds that they are going to renormalize smoking.

The Rest of the Story

The truth is the exact opposite: electronic cigarettes denormalize smoking because they are an alternative to smoking. The more people use e-cigarettes, the less they smoke. And as cigarette consumption declines, smoking is denormalized, not renormalized. What electronic cigarettes are normalizing is e-cigarette use, not smoking.

Instead, what is renormalizing smoking are the bogus claims of anti-tobacco groups throughout the country, which are trying to convince the public (with some success) that vaping is basically as bad as smoking. What these groups are doing is completely undermining decades of public education about the severe health consequences of smoking. Now, they are maintaining that it is not the tobacco combustion that makes smoking dangerous, but simply the act of inhaling any chemicals.

Tobacco has been completely taken out of the equation. By modern anti-smoking group standards, inhaling nicotine with a few other chemicals is what is hazardous, and the fact that smoking involves the combustion of tobacco (adding tens of thousands of chemicals and scores of carcinogens) adds little to the mix.

The public is being brought to the fallacious belief that smoking isn't really any worse than inhaling nicotine from a device that uses no tobacco whatsoever. The message is clear: "Smoking isn't really as bad as we previously told you. In fact, we don't even know that it's any worse than using a nicotine delivery device that contains no tobacco at all!"

Short of bringing back tobacco billboards and race cars, I can't think of anything that could do more to renormalize smoking than to completely obfuscate the role of tobacco in creating the greatest preventable health risk to mankind. But most ironically, this is exactly what the anti-tobacco groups are doing.

Embracing electronic cigarettes as devices intended to help smokers switch to a much safer alternative (i.e., quit smoking) is inherently contributing to the denormalization of smoking. What the anti-tobacco groups are doing is instead contributing to the protection of tobacco cigarettes from serious potential competition.

If tobacco control advocates were truly interested in an "end-game" strategy, what could possibly be better than vaping devices, which for the first time make it possible to envision the eventual transformation of the nicotine market, resulting in the near complete elimination of combustible tobacco (i.e., smoking)? After all, eliminating smoking is not possible in the absence of an acceptable alternative. Vaping products could be that alternative. But anti-tobacco groups are doing everything in their power to prevent this from happening. They are doing everything they can to prevent any kind of massive decline in smoking that would otherwise be a possibility.

The rest of the story is that electronic cigarettes serve inherently to denormalize smoking. At the same time, anti-smoking groups are serving to renormalize smoking by protecting tobacco cigarettes from potential competition. This did not have to be the case. The anti-smoking groups had a choice. Sadly, their choice was a bad one, and it is going to result in the prolongation of disease and death from smoking.

Monday, September 21, 2015

Nominee for FDA Commissioner Has Massive Conflicts of Interest and is Not an Appropriate Choice

President Obama's nominee for the position of FDA Commissioner - Dr. Robert Califf - has massive financial conflicts of interest that I believe should preclude him from being eligible for this position.

Because the FDA regulates drug companies, it is essential that the Commissioner of this agency not have severe conflicts of interest by virtue of having financial relationships with pharmaceutical companies; in particular, recent financial relationships. In fact, Dr. Califf's conflicts of interest are both severe and recent.

In his most recent disclosure in 2014 from his position as director of the Duke Translational Medicine Institute, Dr. Califf reported the following financial relationships with Big Pharma:
  • Research funding from: Amylin, BMS, Ely Lilly, Janssen, Merck, and Novartis;
  • Consulting fees from: Amgen, Bayer, BMEB Services, Medscape, Merck, Novartis, Regado, and Roche; and
  • Equity in N30 Pharma, and Portola.
In his most recent published paper, which appeared just last week, Dr. Califf provided the following disclosure:

"Dr Califf currently holds the post of Deputy Commissioner for Medical Products and Tobacco, US Food and Drug Administration. Prior to holding this post, Dr Califf received grant funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, the US Food and Drug Administration, Merck, Roche, Aterovax, Bayer, Janssen Pharmaceuticals, Eli Lilly & Company, and Schering-Plough; grants and personal fees from Novartis, Amylin, Scios, and Bristol-Myers Squibb/Bristol-Myers Squibb Foundation; and personal fees from WebMD, Kowa Research Institute, Nile, Parkview, Orexigen, Pozen, Servier International, Bayer Healthcare, Bayer Pharma AG, CV Sight, Daiichi Sankyo/Lilly, Gambro, Gilead,–Bayer, Medscape, Pfizer, Regeneron, TMC, GlaxoSmithKline, Genentech,–Daiichi Sankyo, and Amgen.
Dr Califf also reported holding equity in Nitrox/N30 and Portola. A full listing of disclosure information for Dr Califf for this interval is available at" 

The Duke Clinical Research Institute, for which Dr. Califf worked prior to joining the FDA as a deputy commissioner, reports receiving recent funding from more than 100 companies, most of them in the pharmaceutical or device business. According to an article in the New York Times, the multi-million dollar institute that Dr. Califf ran at Duke received more than 60% of its funding from industry.

According to the same article, Dr. Califf "has deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory...".

The article notes that: "“He has amassed an extensive record of close collaboration with industry, through consulting fees, speaking fees and research grants supporting his salary,” said Dr. Michael Carome, the director of the health research group at Public Citizen, a consumer advocacy group. “This will color his views when it comes to making regulatory decisions.”"

The Rest of the Story

According to the New York Times article: "Through the F.D.A., where he has served as a deputy commissioner since March, Dr. Califf declined a request for an interview. A spokesman for the Department of Health and Human Services, Kevin Griffis, said that Dr. Califf had been through “a comprehensive screening process for conflicts of interest,” and that officials had “put in place measures to ensure that he is appropriately recused from matters that would give rise to conflicts,” including the new cholesterol medicines."

If this is what FDA's comprehensive screening process for conflicts of interest looks like, I would hate to see the agency's trimmed down screening process looks like. I could understand an agency missing one or two conflicts of interest, but how can you miss more than 20 of them?

The idea that these conflicts of interest can be managed by having Dr. Califf recuse himself from matters that would give rise to conflicts is inane. His conflicts do not only hold for new cholesterol medicines. They hold for all issues related to the regulation of pharmaceutical products. He would essentially have to recuse himself from every decision the FDA makes. It would be a plum job, as he wouldn't have to do anything. I should try that with my job. "I'm sorry, but I have to recuse myself from all of the work you've asked me to do." 

This does not bode well for electronic cigarettes because they represent a huge threat to pharmaceutical smoking cessation products.

To remind readers, this has nothing to do with Dr. Califf's integrity, character, or qualifications. It simply has to do with existing conflicts of interest, which in my opinion preclude him from occupying this position. The commissioner of the FDA clearly has to be an individual who does not have conflicts of interest with Big Pharma. We can't have someone with severe pharmaceutical conflicts of interests regulating the very companies from which he has received hundreds of thousands of dollars. It is like the fox guarding the hen house.

Friday, September 18, 2015

Anti-Tobacco Researcher Criticizes Vape Shops for Trying to Get Smokers to Quit

In the tobacco control field, one would expect that we would applaud businesses that are attempting to get as many smokers as possible to quit smoking. And one would think that we would praise companies or businesses whose value proposition is to make cigarette smoking obsolete.

Not so, however.

The Rest of the Story

Instead of praising businesses that are trying to get as many smokers as possible to quit, most tobacco control groups and advocates are condemning businesses for such efforts.

One example is a communication from Dr. Stan Glantz, who criticizes a vaping shop in the UK for trying to get smokers to quit by switching to a much safer alternative nicotine-delivering product (electronic cigarettes). The vaping shop has a sign on the front of the store noting that the National Health Service declared that electronic cigarettes are much safer than tobacco cigarettes.

What is there to criticize? The vaping shop is telling the truth. Vaping is much safer than smoking. And the vape shop's objective is to get as many smokers as possible to quit smoking by switching to this much safer alternative. It's value proposition, clearly, is to make cigarette smoking obsolete. The more people who quit smoking by switching to electronic cigarettes, the more money vape shops make. And they make more money if smokers switch completely to e-cigarettes (that is, quit smoking), than if they become dual users.

What's not to like?

Essentially, vape shops are doing the work of public health. Yes, they are businesses and they are making money, but the work they are doing is contributing to the improvement of the public's health.

In fact, many vape shops have essentially become a type of "smoking cessation clinic." The only difference is that these vape shops are much more effective than typical smoking cessation clinics. They create an entire culture around quitting smoking. There is a tremendous amount of social support. They create an identity for the smoker who is attempting to quit. They create what becomes a type of "hobby" that helps to sustain the new behavior.

While I agree that there is a need for regulations to regulate vape shops (and all other e-cigarette sellers and manufacturers) to ensure uniform quality control standards, I believe that these shops are to be praised, not condemned, because they are helping thousands of smokers to quit smoking, and many more to cut down on the amount they smoke. The public health benefits of the products they are selling is substantial.

Thursday, September 17, 2015

FDA Says Some Cigarettes are Safer than Others, But Not Electronic Cigarettes

In a guffaw of epic proportions, the FDA has essentially told the public that some cigarettes are safer than others. But even more preposterous than this is the fact that while the FDA views some cigarettes as being safer, it does not view e-cigarettes as being safer than tobacco cigarettes.

On Tuesday, the FDA ordered four cigarette brands - Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 - off the market because the agency believes that these products may be more detrimental to the public's health than other cigarettes on the market. Essentially, the FDA is saying that it believes some cigarette brands are more dangerous than others.

In its press release, the FDA states: "The scientific basis for these four decisions include a failure to demonstrate that increased yields of harmful or potentially harmful constituents, higher levels of menthol, and/or the addition of new ingredients in the currently marketed products when compared to the predicate products do not raise different questions of public health."

The FDA is basically arguing that different yields of harmful constituents and different levels of menthol or other ingredients in currently marketed tobacco cigarettes result in a significant difference in the safety of these products.

Ironically, while the FDA is challenging the long-held belief that there is no substantial difference in risk between different brands of cigarettes, it maintains that there is not sufficient evidence that electronic cigarettes, which contain no tobacco at all and involve no combustion - are safer than conventional cigarettes. This is despite the fact that electronic cigarettes have been documented to release aerosol that is free of hundreds of harmful and potentially harmful constituents that are present in tobacco smoke.

The Rest of the Story

How can it be that a tobacco cigarette which is essentially designed in the same way as all other brands on the market (i.e., it burns tobacco) and which may only contain one additional ingredient can possibly be safer than other brands, yet a product which is designed completely differently (i.e., it contains no tobacco and involves no combustion) and which is free of hundreds of hazardous tobacco smoke constituents is no safer than cigarettes?

It is a good thing for the Department of Justice that it already prosecuted the tobacco companies because if they tried the same thing today, they could no longer use the key argument than won that case: the fact that lower yields of tobacco smoke constituents do not translate into a safer product. After all, the tobacco industry correctly argued that its products that were labeled as "low-tar" or "lights" did have lower yields of tar and/or nicotine. The key to the government's argument was that differing yields of nicotine and tar are not important from a public health standpoint. The yields do not translate into differences in public health risk. There is no existing cigarette that is safer than other cigarettes.

By reversing this long-held belief, the FDA has destroyed the government' primary argument in the DOJ case. After all, the FDA is maintaining that differences in constituent yield do translate into differences in health risk.

This is not only incorrect, but it is a terrible message to send to the public. Combined with the FDA's message that e-cigarettes are no safer than tobacco cigarettes, this translates into a public health communications disaster.

The public is being told that slight differences in tobacco smoke constituents change the health risks of smoking, but that taking the tobacco out completely does not alter the health risks.

The absurdity and irony of this story did not escape the notice of Lane Filler of Newsday, who wrote a scathing piece which points out the damage being done by the FDA's action. He writes: "What message are people supposed to take from the decision by the federal Food and Drug Administration to ban the sale of certain new cigarette brands because they may be more dangerous than brands previously sold. Can the new brands kill people twice? Do knives occasionally shoot out of these smokes and plunge into shocked smokers' eyes?" ...

"Having the FDA pick and choose which cigarettes can legally be sold to smokers is like having the FDA determine which brands of rat poison can be sold as dietary supplements." ...

"I don't support a ban on cigarettes. But I do support a ban on the FDA approving of some cigarettes and not approving of others. You cannot smoke cigarettes safely. The federal government can ban cigarettes because they kill people, or it can stop having the FDA regulate them. What it can't reasonably do is draw these fine distinctions between different killer products, and in appearance give the government stamp of safety and approval to ones that may be a bit less deadly than others."

Tuesday, September 15, 2015

Campaign for Tobacco-Free Kids Touts Major Victory: Camel Crush Bold Taken Off the Market

The Rest of the Story would like to extend our congratulations to the Campaign for Tobacco-Free Kids, whose successful effort to promote the 2009 Family Smoking Prevention and Tobacco Control Act has just resulted in a major public health victory: the removal of Camel Crush Bold from the market.

Why is this such a victory for public health?

Because of these Camel brands currently available to consumers:
  • Camel
  • Camel Filters
  • Camel Filters Wides
  • Camel Filters 99's
  • Camel Blue (Lights)
  • Camel Blue Wides (Lights)
  • Camel Blue 99's (Lights)
  • Camel Platinum (Silver) (Ultra Lights)
  • Camel Platinum (Silver) 99's (Ultra Lights)
  • Camel Menthol (Crush)
  • Camel Menthol Silver (Lights)(Crush)
  • Camel Crush (Lights)
  • Camel Crush Bold (Full Flavor)
  • Camel Crush Menthol
  • Camel Turkish Royal
  • Camel Turkish Gold (Lights)
  • Camel Turkish Silver (Ultra Lights)
  • Camel No. 9
  • Camel No. 9 100's
  • Camel No. 9 Menthe
  • Camel No. 9 Menthe 100's
  • Kamel Red
  • Kamel Red Smooth Taste (Lights)
  • Camel Wides
  • Camel Wides Menthol
  • Camel Wides Menthol Green (Lights)

Now, only these brands will be available:
  • Camel
  • Camel Filters
  • Camel Filters Wides
  • Camel Filters 99's
  • Camel Blue (Lights)
  • Camel Blue Wides (Lights)
  • Camel Blue 99's (Lights)
  • Camel Platinum (Silver) (Ultra Lights)
  • Camel Platinum (Silver) 99's (Ultra Lights)
  • Camel Menthol (Crush)
  • Camel Menthol Silver (Lights)(Crush)
  • Camel Crush (Lights)
  • Camel Crush Menthol
  • Camel Turkish Royal
  • Camel Turkish Gold (Lights)
  • Camel Turkish Silver (Ultra Lights)
  • Camel No. 9
  • Camel No. 9 100's
  • Camel No. 9 Menthe
  • Camel No. 9 Menthe 100's
  • Kamel Red
  • Kamel Red Smooth Taste (Lights)
  • Camel Wides
  • Camel Wides Menthol
  • Camel Wides Menthol Green (Lights)
As you can easily see, this is a major public health victory. My best scientific estimate of the number of lives this FDA action will save is:

Image result for free clip art

But at least our politicians in Congress and at the Campaign for Tobacco-Free Kids can rest easily, knowing that they are able to take public credit by deceiving people into thinking that this is a public health accomplishment that will reduce tobacco use and save lives, when in reality, the action has absolutely no relevance to public health. We did not witness any upsurge in youth cigarette smoking since Camel Crush Bolds entered the market. And we won't witness any downsurge in youth smoking now that this product is being taken off the market. Nor is the removal of Camel Crush Bold going to in any way make the cigarette market safer. However, this is exactly what the Campaign is implying in its self-congratulatory propaganda, which suggests that some cigarettes are less harmful than other cigarettes.

I find it quite ironic (and disturbing) that the major anti-smoking groups in the U.S. are willing to claim that some cigarettes are safer than others, but they are not willing to tell the public that electronic cigarettes are safer than tobacco cigarettes.

According to the Campaign: "The FDA must continue to vigorously enforce the law in order to reduce tobacco’s terrible toll on America’s families. "Unfortunately, the law does nothing to reduce tobacco's terrible toll. And the only two actions that the FDA could have taken that would have made a difference (banning menthol and restricting nicotine to extremely low levels) are actions that the FDA has not taken and will not take.

My best scientific estimate of the number of lives that the Family Smoking Prevention and Tobacco Control Act's regulatory provisions have saved is:

Image result for free clip art

Here is the tally of lives saved by provision:

Prevention of new cigarettes from entering market: 0
Disclosure of ingredients: 0
Listing hazardous and potentially hazardous constituents: 0
Preventing youth access: 0
Promulgating cigarette product safety standards: 0 (no standards have been promulgated)
Raising the age of sale to 21: 0 (precluded by law)

The FDA has literally done nothing in terms of regulatory actions that has resulted in saving any lives. And they won't. To make matters worse, the FDA has focused much of its attention not on setting cigarette safety standards, but on establishing burdensome electronic cigarette regulations that are going to actually result in increased cigarette smoking.

Congratulations to the Campaign for Tobacco-Free Kids on a job well done. It has spewed forth some of the best propaganda that I have ever seen spewed.

Monday, September 14, 2015

IN MY VIEW: Reporting of Findings from JAMA Pediatrics Study is Inaccurate

Last Tuesday, I discussed the results of a study which purported to show that e-cigarettes are a gateway to traditional cigarette smoking. The rest of the story was that there were only 6 subjects in the study who had progressed to "smoking" and that "smoking" was defined as ever having taken even one puff of a cigarette.

As I wrote: "Because the study defined smoking as any use of a cigarette, even a puff, we don't know that any of the youth who had "progressed to traditional cigarette smoking" had actually become smokers. They may simply have tried a puff on a cigarette and decided it was not for them. In fact, it is entirely possible that they tried a puff on a cigarette, decided that the e-cigarette was much better tasting, and that they chose to vape instead of smoke. In this way, e-cigarettes could have actually served as a deterrent to smoking among this population."

I also argued that it is premature to conclude that e-cigarettes are a gateway to smoking based on a total sample size of only 6 young people.

Finally, I pointed out that e-cigarette use at baseline was defined as ever having tried an electronic cigarette. It is entirely possible that this sample included a large number of young people who merely tried an e-cigarette once and never used one again.

Today, I extend my discussion of this story by focusing not on the validity of the study conclusions, but on the way the study findings were publicly presented and whether the presentation of findings was accurate.

The Rest of the Story

It is critical to keep in mind that the study demonstrated merely that young people who had ever tried an e-cigarette were more likely to progress to taking a puff of a cigarette during the follow-up period.

However, the title of the paper states that the study examined "progression to traditional cigarette smoking." So the key question is whether taking a puff of a cigarette is the same thing as traditional cigarette smoking. I would argue that it is not. I don't think that when tobacco control scientists think about traditional cigarette smoking, their conception is one of kids who have merely taken a puff of a cigarette. More importantly, I doubt that there are any lay persons who would consider a youth taking a single puff of one cigarette as constituting a "smoker." To determine whether that youth had progressed to "traditional cigarette smoking," I believe one would have to ascertain whether the youth actually smokes cigarettes at the present time (or at least whether that youth had actually smoked cigarettes for some period of time during the follow-up period). Because the study did not address these questions, I don't see how it can present its findings as showing that these youth had progressed to "traditional cigarette smoking."

In the results in Table 2 of the paper, the youth who had at least a puff of a cigarette were reported under the category of "smoker." I don't find this to be accurate, because all we know is that these subjects were "puffers," not that they were actually "smokers." Again, we don't know whether they even actually smoked a whole cigarette. So how can they be reported as being smokers?

Much more problematic, however, is the way the results were apparently reported to the media and as a result, the way the study findings were reported to the public.

According to an article from CBS Boston, a study author reported that: "Of the e-cigarette users, 38 percent by a year later were smoking cigarettes." I don't think this is accurate. From the study, all we know is that these are young people who had at some point taken a puff of a cigarette. The study does not provide data to determine that these young people were currently smoking cigarettes. The study does not even provide data to determine that these young people had ever smoked a single whole cigarette.

According to an article in the NY City News, a study author reported that: "Our report did find that initial e-cigarette users were very likely to progress to regular cigarette smoking." This clearly appears to be inaccurate, as the study only reported on subjects progressing to having puffed on a cigarette. The study reports no data on whether the subjects were actually regular smokers at follow-up. Regular smoking is a scientific term used in the tobacco control research field to denote youth who have progressed to a point where they are smoking whole cigarettes on a regular basis. Even if by "regular smoking," the intended meaning was "tobacco cigarette" smoking (rather than vaping), the presentation of findings is still inaccurate because the study does not even provide data to determine that these young people had ever smoked a single whole cigarette.

An article from New Jersey 101.5 also quoted a study author as claiming that the study showed that e-cigarettes were associated with progression to regular smoking: "Our report did find that initial e-cigarette users were very likely to progress to regular cigarette smoking."

An article from the Fred Hutchinson Cancer Research Center also cites a quote from a study author reporting that the study found that young people who used e-cigarettes were more likely to progress to "regular smoking." The quote is as follows: "The most striking finding of the study was that initial e-cigarette users were very likely to progress to regular smoking, even though initially they did not intend on smoking regular cigarettes."

The bottom line is this: the study, as published, did not report finding a progression to smoking. It merely reported a progression to having taken a puff of a cigarette. The subjects who are being reported as being smokers may have simply tried a cigarette once. Moreover, they may have had one puff, hated it, and decided never to smoke again. They may even have decided to use electronic cigarettes rather than real ones and it is even possible that it was their use of a flavored e-cigarette that led to their failure to progress from puffing to "regular smoking."

The rest of the story is that it appears that these study results were inaccurately reported, both in the paper itself and through representations of the findings to the media. The clear impression given to journal readers and to the public is that they study found an association between e-cigarette use and progression to smoking. However, the truth is that what the study reported is an association between e-cigarette use and progression to having tried a cigarette.
Our report did find that initial e-cigarette users were very likely to progress to regular cigarette smoking

Read More: Study: E-cig usage may lead to 'regular' smoking |

Thursday, September 10, 2015

Why are Anti-Smoking Groups and Agencies Lying to the Public About E-Cigarettes: A Political History Explanation

For the past 5 years, I have been trying to figure out why anti-smoking groups are so opposed to electronic cigarettes and why they have gone so far as to spread hysterical and false propaganda about the health and safety issues regarding vaping and smoking (and especially about the relative risks between the two). Up until now, the most compelling explanation I could come up with is that the anti-smoking movement is largely blinded by ideology, which prevents it from objectively analyzing the actual scientific evidence. This ideology has led to a pre-determined conclusion and all evidence is interpreted to support this conclusion, even if the facts need to be manipulated to conform with the entrenched ideology.

I still believe that this is at least a partially valid explanation for the campaign of lies and deception being waged by so many anti-smoking groups and agencies. However, after reading a new book by Andrew Burt (Fellow at Yale Law School) entitled "American Hysteria," I now have another possible explanation for the anti-smoking movement's behavior.

The Rest of the Story

In the book, Burt characterizes and analyzes the recurrent episodes of political hysteria that have occurred in the United States, such as the Red Scare of 1920 and McCarthyism, attempting to describe their defining characteristics as well as to find an explanation for the origins of these episodes. Ultimately, Burt comes to the conclusion that episodes of political hysteria occur when groups that previously enjoyed status experience a loss of their prestige. Usually, this loss of prestige occurs because of a philosophical, cultural, or ideological threat. But because this threat is intangible and abstract, that is, it cannot actually be seen, the groups project real threats onto these symbolic threats to create "a physical stand-in to symbolize the harm its constituency is actually confronting" (Burt, 2015, pg. 16). Because these threats are contrived and not based on evidence or truth, the movement is overcome by political hysteria.

How does this relate to the anti-smoking movement and its political hysteria regarding electronic cigarettes?

I believe that the advent of electronic cigarettes presents a threat to the status of the tobacco control movement in four ways.

First, the concept of using a cigarette-like device that delivers nicotine without using or burning tobacco as a smoking cessation strategy came from outside the tobacco control movement. We did not think of it. We did not develop it. It was essentially thrust upon us suddenly and without warning. And it is precisely because the strategy appeared to be so successful, with exponential growth of the market, that we felt threatened. It is because this technology has the potential to completely transform the nicotine market by producing drastic reductions in combustible tobacco use and an unprecedented improvement in the public's health that we feel a threat to our status. After all, we have been working for decades to reduce smoking and now suddenly outsiders come along and develop a new strategy that appears to be more effective, or at least as effective, as the strategies that we developed.

To make matters worse, this new strategy was developed and implemented by corporate entities -- entities outside of the pharmaceutical field. The tobacco control movement has long been tied to pharmaceutical companies and their cessation products. The financial relationships and partnerships run deep. The concept of using drugs that affect nicotine receptors is one that was conceived of by our movement and which was then developed in collaboration with the pharmaceutical industry. However, the electronic cigarette companies came out of nowhere. They had nothing to do with us. So neither the idea itself or the entities that were promoting and developing the strategy were part of our movement.

I firmly believe that if the idea of an electronic cigarette was conceived by individuals, researchers, or groups within the tobacco control movement, our reaction to these products would be completely different. It would not represent a threat to our status and prestige because we could claim credit for the "victory," for the accomplishment, for the transformation of the tobacco industry, for the unprecedented magnitude of the saving of lives. Even if the idea were conceived and developed by the pharmaceutical industry, it would not have represented a threat to us because pharmaceutical companies and products are a part of the entrenched and accepted system.

Second, electronic cigarettes represent a philosophical and ideological threat to the tobacco control movement because they involve a strategy in which a behavior which looks like smoking is embraced as a method of quitting smoking. This is completely beyond the mindset of 95% of tobacco control practitioners, researchers, and organizations. It is not even conceivable. Thus, it represents a severe threat to us from a philosophical and ideological standpoint.

I firmly believe that if "vaping" involved a behavior that did not look like smoking, it would have been received quite differently by the tobacco control movement. For example, if it involved some sort of inhaler-type device, I don't think anti-smoking groups would have so vehemently demonized the idea. Certainly, when nicotine inhalers were found to deliver tobacco-specific nitrosamines, we didn't hear a peep from any anti-smoking group about the potential risks of these devices. But when electronic cigarette aerosol was found to contain tobacco-specific nitrosamines at exactly the same concentration, anti-smoking groups hysterically informed the public that these devices were full of carcinogens, with some groups going as far as telling the public that e-cigarettes can cause cancer.

Third, electronic cigarettes also represent a philosophical and ideological threat to the tobacco control movement because they involve a harm reduction rather than an abstinence approach. Furthermore, the strategy involves continuing the use of an addictive substance. Neither of these concepts are within the ideological framework of the tobacco control movement. These ideas represent a severe threat to our "grand design." Our blueprint only has room for complete abstinence from nicotine use and complete elimination of addiction. When combined with an activity that looks like smoking and was developed by outsiders, the threat becomes intolerable.

Finally, electronic cigarettes also represent a philosophical and ideological threat to the tobacco control movement because they challenge the entrenched principle that nicotine is the sine qua non of smoking addiction. In fact, the tobacco control movement almost never refers to "smoking addiction." We almost always refer to "nicotine addiction." Nicotine itself, rather than morbidity and mortality, has become the villain. All of our beloved smoking cessation drugs are based on the theory that if nicotine withdrawal can be addressed, smokers will quit.

The truth, however, is that smoking addiction involves far more than simply the delivery of nicotine. Every smoker will tell you that there are other aspects of the addiction which are equally important. These include behavioral, psychological, and social factors, such as the feel of the cigarette, the oral sensation, the throat hit, the behavioral associations with smoking a cigarette, and the social aspects of smoking in groups or being identified as a smoker.

Ironically, the reasons for the widespread success of electronic cigarettes is precisely that they violate the entrenched anti-tobacco movement's philosophy, which has led to smoking cessation strategies with dismal effectiveness. Our "accepted" therapies work only about 10% of the time. By challenging the principles that abstinence and freedom from addiction are paramount, that a behavior which looks like smoking could improve the health of smokers, and that nicotine is the sine qua non of smoking addiction, the developers of e-cigarettes were able to create a product which overcomes the major limitations of existing cessation products. For once, we have a product that addresses both the physiological and behavioral/psychological/social aspects of smoking addiction. For once, we have a product that allows smokers to quit smoking without having to give up smoking "behavior." For once, we have a product that allows smokers first to quit smoking and then to work on eliminating their addiction to nicotine, but to do so under conditions of relatively low risk.

The tobacco control movement has responded to these threats exactly as Burt describes. Instead of addressing the actual perceived threat (the challenge to our prestige and to our ideology), we have created a symbolic threat (the ideas that every youth is going to try electronic cigarettes, become addicted, and progress to cigarette smoking, the idea that e-cigarettes will normalize smoking, the idea that e-cigarettes are significantly harmful and not necessarily safer than cigarettes, and the idea that e-cigarettes actually inhibit quitting) that has been taken to hysterical extremes (such as the claims that vaping is as hazardous as smoking, that vaping is as addictive as smoking, that e-cigarettes are a gateway to smoking, etc.). These claims are being made either without any evidence or with evidence to the contrary. And because of the severity of the threat, the truth no longer matters. As is typical with political hysteria, we are so threatened, our philosophical underpinnings so challenged, our prestige so undermined, that we have resorted to lying, deception, and the misrepresentation and misinterpretation of scientific evidence.