Thursday, May 26, 2016

IN MY VIEW: American Lung Association Would Rather Smokers Die than Save their Lives "the Wrong Way"

Re-defining the meaning of paternalism, the American Lung Association on Tuesday boldly and unashamedly told smokers that if they quit smoking the wrong way, it doesn't count, essentially condemning the nearly 7 million Americans who are vaping instead of smoking.

In a Reuters article, the American Lung Association told the nation's smokers that: "We think there are certainly more and better ways to quit. When you're going to e-cigarettes, you're not quitting, you're switching."

The Rest of the Story

This is perverse paternalism. It is an attempt to so strongly control the lives of smokers that the American Lung Association is literally lying to smokers in trying to control their behavior.

What the American Lung Association is telling smokers is not merely that they should quit, but that they must quit in the way that the ALA tells them to or they might as well continue smoking. Thus, this message insinuates that the ALA would rather these smokers die than quit the wrong way.

Let me set the record straight and try to undo some of the damage that the American Lung Association is causing. There is no right or wrong way to quit smoking. What matters for your health is that you quit. The body doesn't know how you quit; what it knows is that you are no longer inhaling tobacco smoke with its tens of thousands of chemicals and more than 60 known human carcinogens. Whether you quit using a nicotine patch, a pill, hypnosis, vaping, acupuncture, or natural magick, you have successfully quit smoking, are no longer inhaling toxic tobacco smoke, have essentially saved your life, and I congratulate you for having accomplished the single most important - and most difficult - thing you can do to protect your health.

In contrast, the American Lung Association only congratulates you if you quit in the ways that it approves. If you quit by switching to vaping, you are not going to be congratulated by the ALA. In fact, they don't even consider you to be an ex-smoker, apparently. The ALA would redefine the clearly established definition of "former smoker" that has been used by the CDC for decades in order to avoid having to call a single-use vaper an ex-smoker.

This, of course, is lying to the American public. It simply is not true that if you switch from smoking to vaping, that you are still a smoker. You are a successful quitter, not merely a "switcher."

The public health damage being done by the American Lung Association and other anti-vaping groups with similar messages is immense. In the past year, the proportion of U.S. adults who incorrectly believe that smoking is no more hazardous than vaping rose from 38% to 47%. Thanks to the messages being disseminated by the American Lung Association and similar groups, nearly half of all adults fail to recognize that smoking is any more dangerous than vaping. This is outrageous and sinful. The health groups are doing as much to undermine the public's appreciation of the severe hazards of smoking as the tobacco companies used to do (and which led to Big Tobacco companies being recognized as adjudicated racketeers).

The natural question that arises is why is the American Lung Association going to this extreme of lying to the public in order to support a position which is clearly in direct conflict with its own avowed mission?

The answer, I have concluded, is that like so many organizations these days, the American Lung Association has lost sight of its true public health mission and is being diverted by ulterior motives, such as preserving an underlying ideology that justifies its schema with which it views the world, appeals to potential donors, and protects the organization from what it perceives as threats to its world view.

Put simply, I believe that groups like the American Lung Association are threatened by the idea that someone could possibly derive any pleasure from nicotine and that a form of nicotine use could be associated with an actual improvement in their health. This concept is simply too foreign to their world view, which cannot accommodate this notion. So rather than altering its world view, the organization has to change the facts, misrepresent the science, and re-define basic definitions in order to force what this phenomenon to fit into its world view.

Ironically, it is precisely the fact that vaping is so much safer than smoking that I think truly threatens these groups. They are comfortable with the status quo and their long-time perspective: people who smoke cigarettes and become addicted are punished because smoking is so toxic that they develop disease or die. Addiction is a human flaw and it is punished appropriately. The idea that someone could be a "nicotine addict" but be worthy of praise is just not coherent with the world view of groups like the American Lung Association. Without the natural consequences of these "addicts" dying of cancer or lung disease, the ALA must concoct its own punishment and castigation for these people.

The rest of the story, however, is that these people number in the millions. And they are people who should be congratulated for having finally succeeded in quitting smoking - something that they were unable or unwilling to do using the methods that the American Lung Association recommends.

Furthermore, the public health miracle of 2016 - an unprecedented drop in adult smoking rates (the largest year-to-year drop ever observed) - would likely not have occurred if smokers actually followed the American Lung Association's advice. Instead of having probably about 5 million adults crossed out from the current smoker category and placed into the former smokers who are vaping, we would most likely have had several million adults remain in the current smoker column.

But apparently, the American Lung Association would rather see these millions of people smoking rather than vaping because the idea that literally millions of people might be benefiting from the use of a product that contains nicotine is simply too hard to bear. It doesn't fit nicely into the organization's world view, so it must be dismantled.

Tuesday, May 24, 2016

Why Anecdotal Evidence Proves that Electronic Cigarettes ARE Helpful for Smoking Cessation

One of the widest scientific misconceptions about evaluating the effectiveness of electronic cigarettes for smoking cessation - and one promulgated by anti-vaping groups and health agencies like the CDC and FDA - is that anecdotal evidence is insufficient to demonstrate that electronic cigarettes can be effective in helping smokers to quit smoking. In fact, this is a widespread fallacy. The truth is that the abundant anecdotal evidence of e-cigarettes helping many smokers quit is actually sufficient evidence to conclude that e-cigarettes are helping many smokers quit.

How can this be the case? Haven't we all been taught that anecdotal evidence is not sufficient? Aren't more rigorous research designs necessary to draw a conclusion that e-cigarettes can help some smokers quit? Since anecdotal evidence that a drug helps improve a medical condition among some patients cannot be used to conclude that the drug is an effective treatment, how can anecdotal evidence that many smokers have quit using e-cigarettes be used to conclude that e-cigarettes are effective for smoking cessation for many smokers?

The Rest of the Story

To understand this, we need to consider exactly why it is that anecdotal evidence is not sufficient to conclude that a drug is effective. Suppose a person with high blood pressure takes a medication for a week and her diastolic blood pressure is lower by 5 after one week (say it drops from 130/95 to 130/90). There are basically three possibilities that could explain the drop in blood pressure:

1. It would have dropped anyway, for reasons not related to her taking the drug.
2. The drop was caused by a placebo effect. It would have dropped had she taken a pill that just had sugar in it and not the medication.
3. The drop was caused by the medication.

So to conclude that the explanation for the drop in blood pressure is #3 above, we need to eliminate #1 and #2 as alternative explanations.

How do we eliminate #1? The way we eliminate #1 is to employ a control group: that is, a group of people with high blood pressure who are followed for one week without taking the medication to see whether their blood pressure drops anyway.

How do we eliminate #2? The way we eliminate #2 is to give a control group a placebo instead of the actual medication. If this group also experiences a decline in blood pressure, then it may be a placebo effect rather than a true drug effect.

In practice, conducting a placebo-controlled trial will address both #1 and #2 in one study because if either explanation #1 or #2 is true, then the blood pressure will drop in the control group and there will be no significant difference in blood pressure at follow-up between the treatment and the control group.

Now let's consider a behavioral outcome instead of a clinical (disease) outcome. Suppose a smoker uses a nicotine patch and at six month follow-up has stopped smoking. There are again three possible explanations:

1. The smoker would have quit anyway because by virtue of taking the nicotine patch, it is clear that he was motivated to quit and trying to quit. So it is quite plausible that the smoker would have quit even without the nicotine patch. The act of trying the patch indicated a desire to quit and a certain level of motivation to do so, above and beyond the motivation of other smokers.

2. The nicotine patch had a placebo effect. Simply by putting a patch on, it helped the person to quit due to placebo effect, not due to the actual nicotine.

3. The nicotine patch was effective in helping the smoker to quit.

To eliminate possible explanations 1 and 2, we again conduct a placebo-controlled trial, comparing the quit rate among a treatment group with the quit rate among a control group that receives a placebo patch. If either explanation 1 or 2 is correct, then there will be no difference in the cessation rate between the treatment and control groups.

Now, let's apply to same reasoning to a smoker who decides to try electronic cigarettes and is able to quit smoking. There are again three possible explanations:

1. The person may have quit smoking anyway, even had she not tried e-cigarettes. The act of trying e-cigarettes for smoking cessation could indicate a heightened level of motivation to quit smoking.

But there's a major problem with this explanation. It's not consistent with the available scientific data. The available data demonstrate that as a group, smokers who try electronic cigarettes are less motivated to quit and have much less confidence in their ability to quit. In fact, the very reason that smokers turn to e-cigarettes in the first place is that they have been unable to quit using other methods and have no self-efficacy regarding their ability to quit smoking otherwise. The data also show that smokers who try e-cigarettes tend to have higher levels of nicotine dependence and are thus much less likely to quit. In other words, the evidence supports the contention that the alternative to not trying e-cigarettes for most vapers is not quitting, but continuing to smoke. This alternative explanation therefore does not appear to hold water in most cases.

2. The person may have quit smoking due to a placebo effect. The act of using the e-cigarette (which simulates smoking) may be the reason for the successful cessation.

But there's a major problem with this explanation as well. The placebo effect is precisely the "mechanism of action" of vaping. It is a huge part of the reason why vaping could potentially be effective for cessation. The whole point of vaping products is to substitute for smoking by simulating the smoking experience. So in arguing that the observed association between vaping and smoking cessation is a placebo effect, one is actually arguing that the smoking cessation was a consequence of the e-cigarette use, since it works through a placebo effect. Therefore, this alternative explanation does not refute the third explanation: that the smoking cessation was attributable to the use of the e-cigarette.

The rest of the story is that the abundant anecdotal evidence of smokers quitting successfully using e-cigarettes is strong evidence that e-cigarettes are - for these smokers - effective in helping them quit. The FDA's view on this issue is misguided because it doesn't understand the basic scientific reasoning behind this relationship. The agency is used to evaluating drug studies, which must include placebo-controlled trials rather than rely on anecdotal evidence.

Please note: I am not arguing that clinical trials of smoking cessation with e-cigarettes compared to other approaches are not needed. I've made it very clear that conducting such trials should be a research priority. Neither am I arguing that anecdotal evidence that e-cigarettes can help smokers quit provides any estimate of the magnitude of the effect: we cannot, from the anecdotal evidence, determine what proportion of smokers who attempt to quit using e-cigarettes will succeed.

However, the argument that we do not have evidence to conclude that e-cigarettes can help smokers to quit is fallacious. The abundant anecdotal evidence available provides substantial evidence that e-cigarettes can and do help many smokers to quit.

Thursday, May 19, 2016

Why is the American Cancer Society Lying to Its Members About the E-Cigarette Regulations?

In an urgent action alert, the American Cancer Society (through its Cancer Action Network) is encouraging its members to write their federal legislators and demand that Congress not strip the FDA of its authority to regulate electronic cigarettes.

The "suggested" letter which the ACS pre-populates for its members states: "Congress should not strip FDA of its oversight authority when electronic cigarette use by high school students has jumped to 16 percent in a very short time... ."

This action alert seems to be clearly informing ACS members that Congress is considering stripping the FDA of its authority to oversee the regulation of electronic cigarettes.

The Rest of the Story

Now why is it necessary for the American Cancer Society to lie about the pending Congressional legislation, which absolutely does not strip the FDA of its authority to regulate electronic cigarettes. The legislation would merely change the predicate date for new products, meaning that it would allow vaping products now on the market to continue to compete against cigarettes for a share of the nicotine market, but in a much safer, tobacco-free form. The FDA would still have the authority to regulate vaping products and in fact, the Cole-Bishop amendment would force the agency to be more aggressive in its regulations by requiring it to set uniform safety standards for vaping products.

I don't see the inherent value in the American Cancer Society lying to its members. Does it think its membership is too stupid to be able to handle a more subtle and nuanced message? Does it even care about the truth, or is it just using its members as pawns on a chessboard to manipulate them to do its work for it? Does the ACS not see the damage it could be causing to itself, its reputation, and its relationship with its membership if members find out that they were being lied to? What is wrong with being candid, frank, and transparent? I know that we don't expect that from our politicians, but we should it expect it from the non-profit public health advocacy groups.

I had to change the pre-populated text of my message in order to exculpate the lie and replace it with the truth. I told my Congressmembers that in contrast to what the ACS told me to tell them, the Cole-Bishop amendment would not strip the FDA of its regulatory authority over e-cigarettes, but instead would strengthen it by forcing the agency to promulgate uniform safety standards as well as to regulate e-cigarette marketing, something it failed to do in its deeming regulations. The Cole-Bishop amendment would not strip the FDA of its regulatory authority. Quite the opposite. It would strengthen the FDA's regulatory authority by forcing it to actually do something to protect the health of the American people, rather than to simply create a gigantic bureaucracy that accomplishes little else than to shield toxic tobacco cigarettes from competition from a much safer, tobacco-free alternative.

Tuesday, May 17, 2016

American Lung Association Disseminates Negligent Medical Advice About Vaping

The president of the American Lung Association yesterday disseminated negligent medical advice regarding vaping through a tweet that included advice from six physicians.

Each of these six physicians provides negligent medical advice regarding smoking cessation using electronic cigarettes.

1. Chicago: This advice is negligent because it misrepresents the benefit-risk profile of electronic cigarette use for the individual patient. The physician is telling all smokers that the risks of trying e-cigarettes outweighs the potential benefits. But this is not at all consistent with the science. The science unequivocally demonstrates that there are tremendous medical benefits to patients who are able to quit or cut down substantially using e-cigarettes. And there are essentially no harms because smokers who use e-cigarettes are precisely those who believe they are unable to quit using other methods. This is a complete distortion of the risk-benefit ratio for the individual patient, and it therefore constitutes negligent medical advice.

2. Germany: This advice is negligent because the physician is telling patients that vaping is the same as smoking. This is categorically false. Vaping involves no tobacco whatsoever, and it involves no combustion. E-cigarette aerosol eliminates tens of thousands of the chemicals present in tobacco smoke, including more than 60 known human carcinogens. Switching from smoking to vaping results in dramatic and immediate improvement in respiratory symptoms and lung function. This physician is spreading false information, and it therefore constitutes negligent medical advice.

3. Texas: Like the physician from Germany, this physician is telling patients that e-cigarette health risks are analogous to those for real cigarettes. This is false information, and the medical advice is therefore negligent.

4. Colorado: This physician is telling patients that e-cigarettes are likely no safer than tobacco cigarettes. This is categorically false. Vaping involves no tobacco whatsoever, and it involves no combustion. E-cigarette aerosol eliminates tens of thousands of the chemicals present in tobacco smoke, including more than 60 known human carcinogens. Switching from smoking to vaping results in dramatic and immediate improvement in respiratory symptoms and lung function. This physician is spreading false information, and it therefore constitutes negligent medical advice.

5. Baltimore: This physician is telling patients that vaping harms their lungs. However, there is no clinically meaningful evidence to back this up. While e-cigarette aerosol is a mild respiratory irritant, it has not been shown to affect lung function as measured by spirometry. And it certainly is going to do a lot less harm than continuing to smoke. This stops just short of being negligent medical advice.

6. Minnesota: This physician is telling patients that using e-cigarettes is not a way to quit smoking. Well, it certainly has been a way to quit smoking for hundreds of thousands of Americans who quit smoking by switching to vaping. It is irresponsible for this physician to essentially lie to her patients about the fact that e-cigarettes have helped so many tens of thousands of people to quit smoking. It may not be the way that she wants them to quit, but it is a legitimate way to quit. For putting her own concerns over the best interests of the patient, this is negligent medical advice.

The Rest of the Story

It is difficult to understand what the American Lung Association's objective is here. The effect of this communication is certainly going to be to discourage quit attempts among thousands of smokers who might otherwise have been able to achieve smoking cessation using e-cigarettes. And it might also dissuade thousands of ex-smokers from continuing to vape and instead, cause them to return to smoking. Either way, I don't see how this is in any way helping to improve lung health in this country.

It is, however, public health malpractice, which I define as advice which when given to an individual patient would constitute medical malpractice, but which is instead being disseminated to the general public.

For example, if I tell my patient that vaping is just as hazardous as smoking and therefore I advise my patient not to quit using e-cigarettes, I would consider that negligent medical advice because it is false information and it had the effect of causing the patient to assume an increased risk that he otherwise might not have assumed. Thus, disseminating the same information and advice to the general public is an example of public health malpractice, or negligent public health advice.

The difference is not in the harm that is caused by the two; it is simply in that one comes with liability and the other does not.

Monday, May 16, 2016

American Lung Association and CVS Health Campaign Downplays the Importance of Smoking in Preventing Lung Cancer

Ad Looks Like Big Tobacco Ad from the 20th Century 

The American Lung Association (ALA), with primary financial support from CVS Health (CVS), has initiated a campaign called "Lung Force." The campaign features a video ad with the theme of "Anyone Can Get Lung Cancer." Although the ad cites the fact that lung cancer incidence among women has increased over the past decades and mentions radon and air pollution as causes, nowhere in the ad is smoking even mentioned.

I went to the Lung Force fact sheet on lung cancer and found that the #1 most important fact is as follows:

"1. Anyone can get lung cancer."

If you click on the link to get more information, it brings you to the video ad with the theme of "Anyone Can Get Lung Cancer" which doesn't mention smoking.

In a detailed sheet which summarizes the campaign, there is not a single mention of the importance of smoking as a cause of the increasing incidence of lung cancer among women, even though the sheet emphasizes how important it is to get out all the facts and educate women about the "basics" and even though the sheet mentions air pollution, radon, family history, and secondhand smoke as risk factors.

And in a detailed summary of the Lung Force campaign, it again fails to mention smoking. Instead, it de-emphasizes smoking by hiding the fact that smoking is overwhelming the chief cause of lung cancer among women. In fact, it appears that the main objective of the campaign is to downplay the role of smoking in causing lung cancer among women:

"We aim to change people’s minds about what it means to have lung cancer—so that everyone understands that anyone can get lung cancer."

In a long video about lung cancer featuring numerous lung cancer survivors, smoking is not mentioned a single time, other than in an attempt to suggest that smoking is not as important a risk factor for lung cancer as previously thought.

In fact, the campaign actively suppresses the sharing of the fact that smoking is overwhelmingly the leading cause of lung cancer. For example, in presenting Kellie Pickler's involvement in the campaign, sparked by the death of her grandmother from lung cancer, it fails to mention the important fact that her grandmother was a long-term smoker.

The Rest of the Story

I'm not sure that I can overstate my level of condemnation of this campaign. It is disturbing, and it is damaging. It undermines decades of education about the severe health hazards of smoking and about the role of smoking as the overwhelming most predominant cause of lung cancer. About 90% of the suffering that the campaign highlights could be prevented if we made smoking history. But instead, the campaign talks about air pollution, which only causes about 1% (at the most) of lung cancer.

The campaign's theme, and the video ad, look like a Big Tobacco campaign from the 20th century, downplaying the role of smoking in lung cancer by emphasizing that "anyone" can get lung cancer. I'm not sure the tobacco industry itself could have done a better job of downplaying the role of its products in the devastating lung cancer epidemic. 

Moreover, not only does the campaign fail to mention smoking as a leading cause of lung cancer and not only does it downplay the role of smoking, but it actively tries to confuse women about the role of smoking. By emphasizing that most lung cancer is diagnosed in nonsmokers and omitting the important fact that most of these women are former smokers, it appears to be intentionally trying to get women to think that smoking is not the predominant cause of lung cancer. Furthermore, it does not once mention the role that the tobacco industry played in the epidemic of lung cancer among women.

The tobacco industry should really send a thank-you note to the Lung Force campaign for running a public awareness campaign that downplays the role of smoking in a way that even Big Tobacco would not do, and is not doing, in the 21st century.

Sunday, May 15, 2016

FDA is Defending Deeming Regulations from Well-Placed Criticism By ... ... Lying

Last week on The Source, a Texas Public Radio news show, a spokesperson for the FDA's Center for Tobacco Products (CTP) was confronted with a very solid and well-placed criticism of the agency's e-cigarette deeming regulations. The host asked her how she could defend these regulations in the face of uniform statements by vaping companies that "this is so onerous that this is going to drive them out of the business."

In response, the CTP spokesperson defended the regulations by stating: "It's important to remember that we're talking about products that kill people."

The Rest of the Story

Let's get the facts straight. Yes, it is true that we're talking about products that kill people. But those products are not called e-cigarettes; they're called real tobacco cigarettes.

That the FDA is forced to resort to lying in order to defend its regulations suggests that it realizes it doesn't have a leg to stand on. If there were a legitimate public health reason for putting an onerous, expensive burden on vaping businesses that is going to drive most of them out of business, I'm sure that the FDA would immediately be able to tell us what it is. Destroying thousands of small businesses is not something that we in public health take lightly.

But the rest of the story is that the FDA cannot tell us what the reason is. The only thing they can resort to in defending their onerous regulations is lying. The regulations are needed because we're talking about products that kill people.

Well, let's get one thing straight. The products that are killing people are real cigarettes. And the FDA has chosen to give these cigarettes a completely free ride by putting every possible economic burden in front of much safer smoke-free, tobacco-free cigarettes so that they have little hope of being able to compete with the killer products.

Wednesday, May 11, 2016

First Lawsuit Filed Challenging FDA Deeming Regulations

Yesterday, the first lawsuit was filed which challenges the legality of the FDA’s electronic cigarette deeming regulations. The suit was filed in the D.C. District Court by Nicopure Labs, a maker of vaping devices and e-liquids. The complaint alleges that the FDA deeming regulations are in violation of the Administrative Procedure Act (APA) and the First Amendment.

There are three claims under the APA:

1. The FDA has interpreted the term “tobacco products” way too broadly and in a way which is inconsistent with the Tobacco Act.

Nicopure points out that the FDA has construed the term “tobacco product” so broadly that it includes not only e-liquids which actually do contain nicotine, but also batteries, wicks, electronic displays, and glass vials, which do not contain nicotine and are not derived from tobacco or any constituent of tobacco.

Comment: This seems like a good point. If I am a manufacturer of batteries for electric toothbrushes and people start using my batteries in their vaping devices, and I then put a note on my web site stating that these batteries may be used in vaping devices, I am now a tobacco product manufacturer under the regulations and must comply with all provisions. This means I must label my product as a tobacco product (falsely stating that it contains tobacco) and furthermore, that I cannot make any changes to my batteries after August 8, 2016, even if those changes are critical safety improvements, unless I receive pre-market authorization approval from the agency. If I am a manufacturer of glass vials and I am reasonably aware that many consumers are using these vials to store e-liquids, I could possibly be deemed to be a tobacco product manufacturer. If I advertise that these glass vials would make good containers for e-liquids, then I am most definitely considered a tobacco product manufacturer.
           2. The FDA regulations are arbitrary and capricious and impose a huge burden on businesses but without any rational connection to the protection of the public’s health.

Comment: The best example of this is the setting of August 8, 2016 as a date beyond which manufacturers cannot make any changes, including safety improvements, to their products. That date is arbitrary, as is the treating of products on the market on August 8th systematically different from products on the market as of August 7th. Moreover, there is no rational basis for imposing huge burdens on businesses through the pre-market tobacco application requirements because these requirements do not directly advance any public health objective. In fact, the FDA has failed to show that there is any substantial threat to the public’s health posed by vaping products or that its regulations will mitigate that threat. There is certainly no rational basis for preventing companies from making safety improvements to their products after August 8th.

3. The FDA’s cost-benefit analysis grossly underestimates the costs while exaggerating, and failing to even quantify the benefits of the regulations.

Comment: This is also a valid point. The deeming rule estimates that there will be 750 PMTAs submitted each year. However, one company alone will submit more than 750 PMTAs. A single company that sells 190 flavors of e-liquid, each in four nicotine strengths, will have to submit 760 PMTAs. That’s just a single company. It seems clear that an accurate cost-benefit analysis would have revealed that the costs of imposing these regulations are astronomical. Moreover, the FDA did not even quantify the benefits of the regulations. The agency pointed to no evidence that vaping products are causing public health harm. Nor did it quantify any of the supposed harms. It is difficult to see how the hypothetical benefits of regulation, which couldn’t even be quantified, justify the imposition of literally billions of dollars in capital costs on the vaping industry, including thousands of small business owners.

 4. The regulations violate the free speech rights of the company under the First Amendment by prohibiting it from making truthful and non-misleading statements about its products, and without any legitimate government interest.

Comment: I believe this is the strongest of the legal arguments. Without question, by subjecting vaping products to the modified risk provisions in section 911 of the Tobacco Act, the FDA has prohibited companies from claiming, truthfully, that their products are safer than real cigarettes, contain no tobacco, produce no smoke, or produce aerosol that contains levels of certain chemicals that are much lower than in tobacco smoke. These are all accurate and non-misleading claims that are in fact essential for consumers to understand, and these are the primary benefits of the product that companies need to be able to convey.
Moreover, the prohibition of these truthful claims advances no substantial government interest. In fact, it doesn’t advance any government interest. What government interest is there in banning companies from informing consumers that these products do not contain tobacco? How does that threaten the public’s health? The truth is that not informing consumers that these products do not contain tobacco is what will threaten the public’s health. It will hide from the public critical information necessary for people to make rational, informed decisions in choosing between smoking real, tobacco cigarettes and vaping fake, non-tobacco ones.

Because the FDA is prohibiting truthful claims that are in no way misleading, the test of whether these restrictions will survive First Amendment scrutiny will certainly be under strict scrutiny, or under the Central Hudson criteria. The government will have to show that these restrictions are based on a substantial government interest and that they will effectively advance that interest.

But I can think of no government interest in precluding a company which makes a much safer product than cigarettes from informing its consumers that its product is safer. I see no government interest in forcing companies to hide from their consumers the basic fact that their products do not contain tobacco. There is certainly a justification for forcing ingredient disclosure, but I cannot think of a legitimate interest that is served by forcing ingredient non-disclosure. I think it will be quite clear to the court that companies have a right to voluntarily disclose their ingredients and that the government has no interest in prohibiting that unless such disclosure would somehow be misleading. In this case, not disclosing that these products do not contain tobacco and do not produce smoke is what would be misleading.

The Rest of the Story

This is the first of what I imagine will be many lawsuits challenging the deeming regulations. The First Amendment challenge I think is extremely strong. There is a high likelihood of success on legal grounds, and enforcing the modified risk provisions would clearly cause severe and irreparable harm to the vaping companies. Thus, I think there is a solid chance that the court will grant injunctive relief and enjoin the FDA from enforcing this aspect of the regulations while the full case is heard. Because of the severability of the regulation provisions, only the modified risk provisions would be subject to injunctive relief under this aspect of the complaint.

It is more difficult to predict what the court will do with the APA claims. Of those, I believe the flawed cost-benefit analysis is the strongest claim because it will be easy to show that the FDA greatly underestimated the costs it is imposing on businesses. Essentially, the FDA underestimated the cost by at least two if not three orders of magnitude. The FDA estimated that there would be 750 PMTA’s per year. But the FDA itself acknowledged that there are 4,600 vape shops that mix their own liquids. Assuming, conservatively, that each vape shop sells only 10 e-liquid flavors, this amounts to 46,000 applications. And this is just from small businesses. It doesn’t include the large e-liquid manufacturers. Given the high likelihood of success of this argument and the severe and irreparable harm that enforcing it would produce, I think there is at least a solid chance that the court could provide injunctive relief on this claim, which would temporarily enjoin the FDA from enforcing the PMTA requirements.

The other two claims are compelling, but courts generally give federal agencies a huge amount of discretion when using the “rational basis” test.

The rest of the story is that Nicopure’s complaint outlines several compelling arguments which demonstrate that the FDA has exceeded its authority in its deeming rule in violation of the APA and in a way that cannot stand scrutiny under the First Amendment. I’m certain that this is only the first of many more lawsuits to come. This is not unexpected when a federal agency puts onerous and financially prohibitive burdens on an industry that result in a de facto elimination of the bulk of that industry.

Tuesday, May 10, 2016

FDA Regulations Present an Imminent Threat to the Safety of the Public: Urgent Changes are Needed

While I have already argued that the FDA deeming regulations pose a long-term threat to the public's health because they will result in the removal of most vaping products from the market (so cigarette sales will continue uncontested), today I explain why these regulations pose a substantial immediate threat to the public's health.

As of August 8, 2016, no new vaping products will be allowed on the market. Because the FDA considers virtually any change in a product to constitute a new product, this means that the deeming regulations will essentially "freeze" the vaping market as it exists on August 8. From that date forward, not only will companies not be able to introduce new products but they will also be unable to make changes in their existing products. Such changes would require a substantial equivalence (SE) determination (which is unlikely because few, if any products are similar to a predicate product on the market in 2007), an SE exemption (which is unlikely because the company cannot show that the product is essentially the same as a predicate product on the market in 2007), or a new product application (which will be prohibitively expensive for most companies). Moreover, these regulations will discourage companies from undertaking any revisions to their products. Several companies have already decided to freeze their inventory and discontinue their innovation research and development.

To be clear, even small changes in products will not be allowed. For example, changes to the battery will not be allowed. If a company wanted to change to a new type of battery in a rechargeable model they produce, this will not be allowed because it would represent the introduction of a new tobacco product into the market for interstate commerce. Similarly, if a company wanted to change their propylene glycol supplier and use a different grade of propylene glycol, this would not be allowed.

The Rest of the Story

The FDA deeming regulations present an imminent threat to public safety. Why? Because after August 8, companies will not be able to make changes to their products to improve product safety.

Suppose company X finds out on August 7 that one its e-cigarettes exploded. The company does an investigation and finds that the batteries they are using do not contain the proper safety features to prevent explosion. The company wants to change batteries in their products to protect the public from an immediate and severe safety hazard. In the absence of the deeming regulations, the company could replace the batteries the next day. But the deeming regulations actually prevent the company from making such a change to its product. You can easily see how these regulations impose an imminent threat to public safety.

Suppose that a company finds a way to prevent potential safety hazards by introducing a new battery overcharge protection system. After August 8, the company cannot do that.

Suppose a company wants to change from a low-grade propylene glycol to a much purer, USP propylene glycol. That would not be allowed because it would represent the introduction of a new tobacco product into the marketplace.

Suppose the company determined that the voltage setting on its battery was too high and resulted in the formation of formaldehyde. Is that company allowed to lower the voltage setting to avoid this problem? Once again, the answer is no because it would represent the unlawful introduction of a new tobacco product into the marketplace.

The regulations will have a chilling effect on product innovation, including safety improvements. This is obviously not in the interests of protecting the public's health. And to the contrary, it actually introduces safety concerns that would not otherwise have been present if companies were permitted to make improvements in their products without pre-authorization.

I can't see how these regulations are going to hold up in court because there needs to be a public health rationale behind them. There is no public health rationale behind the prohibition of product safety improvements.

Remember that in banning the introduction of new products, the FDA is not only preventing the potential introduction of new products that could represent an increased threat to public safety, but it is also preventing the introduction of much safer products.

The rest of the story is that the FDA is essentially freezing any defective products that are on the market as of August 8th, producing a substantial safety hazard.

If defective batteries are on the market as of August 8th, those batteries will continue to explode and cause damage, even if the manufacturers recognize the danger and want to eliminate the hazard.

It should have been clear to the FDA that the requirement for pre-market approval of new cigarettes does not fit the regulation of vaping products. The only reason for the prohibition of new cigarette products in the 2009 Tobacco Act is that there was a history of tobacco industry product changes that resulted in harm to the public's health. For example, companies added ammonia to their products to make them more addictive, introduced light cigarettes to deceive consumers into thinking these products were safer, etc. That is the reason for the pre-market approval for cigarettes.

But it makes no sense to apply that framework to electronic cigarettes because there is no evidence and no reason to believe that companies are manipulating their products in a ways that make them more hazardous to consumers. In fact, it is quite the opposite. For the most part, the innovations that have taken place are improving the safety profile of vaping products. For example, it appears that the diethylene glycol problem has essentially been resolved, we now have many brands on the market which have been shown not to produce detectable levels of any hazardous volatile organic compounds, and the prevalence of unsoldered joints and other manufacturing defects appears to be decreasing.

Since the FDA seems determined to continue to try to force a round peg into a square hole, it is now incumbent upon Congress to intervene and create a new statutory regulatory framework for vaping products. That framework should eliminate any requirements for pre-market approval of vaping products and instead, should require the FDA to simply promulgate a set of uniform safety standards, including batteries that do not explode.

Sunday, May 08, 2016

FDA Draft Guidance Confirms that Deeming Regulations Will Decimate the E-Cigarette Industry

Last Thursday, I provided a review and commentary on the FDA e-cigarette deeming regulations based on my initial reading of the 499-page document released that morning. Now, I have had more time to fully digest the new regulations as well as the draft guidance on pre-market tobacco product applications (PMTAs) that the FDA also released last Thursday. Based on my review, it is even more apparent that these regulations will decimate the e-cigarette industry because the requirements necessary to complete a PMTA are prohibitively expensive for all but the very largest of e-cigarette manufacturers.

The reason for this strengthening in my belief that these regulations make it financially impossible for all but the largest of manufacturers to prepare successful applications is that the draft guidance places extremely burdensome conditions on companies in terms of what they must demonstrate in a PMTA. While the outline below is not exhaustive, these selections from the guidance illustrate the reasons why it will not be possible for most e-cigarette manufacturers to survive.

The Rest of the Story

Below is a sampling of some of the specific provisions of the draft guidance that demonstrate the huge financial burden that the deeming regulations impose on e-cigarette manufacturers. I conclude that a PMTA application will cost a minimum of $1 million - a capital cost that the overwhelming majority of manufacturers will simply not be able to afford. I predict that without Congressional intervention, most e-cigarette manufacturers will take whatever business they can get in the next three years and then find some other line of work. Most will not even bother to submit an application (or if they do, it will come nowhere close to meeting the FDA's guidelines). Another possibility is that e-cigarette companies will trim their inventory down to the bare bones, eliminating most of their flavors and just choosing a small number of products to sell. While this could perhaps result in more companies surviving, it will still decimate the market because it will greatly restrict the choices that consumers have and it will certainly eliminate products that many tens of thousands of current vapers are using.

Moreover, it is not even clear to me that any company - even the largest - will be able to successfully complete a PMTA within two years. As you will see below, the applications will require large, long-term epidemiological studies and clinical trials that I do not think can be completed in 24 months.

1. Every combination of nicotine strength and flavorings will be considered to be a different product.

The draft guidance confirms that even minor differences in e-liquid composition result in a different product, requiring a separate PMTA and a specific showing of public health benefit for that specific product. Thus, if an e-cigarette manufacturer produces four types of starter kits, four types of cartomizers, five types of mods, and 40 e-liquid flavors, each coming in three nicotine strengths, then that manufacturer will have to submit 133 pre-market tobacco applications! This is a conservative estimate, as there are many companies that sell more than 100 flavors of e-liquids. These companies are being required to submit approximately 300 different product applications. The companies have to demonstrate that each one of the 300 different products will be beneficial for the public's health. This alone will be enough to preclude most manufacturers from being able to afford the PMTA process, but it is only the beginning of a long saga.

2. Manufacturers are asked not only to compare the public health implications of their products to cigarettes, but also to other e-cigarette/e-liquids that are on the market.

This is a Herculean undertaking. It is not enough to compare your product to tobacco cigarettes. You also have to compare the public health implications of introducing your product into the marketplace with the risks associated with other vaping products. As the guidance states:

"Because it is expected that consumers of current products that are in the same product category may  switch to a newly marketed product, it is important that FDA be able to evaluate whether this  switching would result in a lower or higher public health risk. As an example comparison between products within the same category, if your PMTA is for an e-liquid, we recommend a comparison to other e-liquids with similar nicotine content, similar flavors, or other similar ingredients."

This is not something I had anticipated, and it greatly complicates the criteria that must be met to demonstrate that your product is beneficial to the public's health. You not only have to show that it is beneficial compared to real cigarettes, but now you also have to show that it offers public health benefits when weighed against other vaping products that are on the market.

3. Manufacturers are asked to compare the health effects of their products to the health effects of not only cigarettes, but other vaping products as well.

Similar to #2, this adds to the complexity of the task, as you must not only study your own product, but must provide data about other vaping products as well in order to make this comparison.

4. Manufacturers are asked to quantify the levels of aerosol constituents for each product under a range of operating conditions and use patterns. 

This means that if you sell an e-cigarette with three voltage settings and you sell 100 flavors, then you will have to quantify the level of aerosol constituents for each flavor at each of the three voltage settings and under conditions of light, medium, and heavy use. Thus, you will have to contract with a laboratory to conduct a gas chromatographic/mass spectrometric analysis of 900 samples. Even at the bargain basement price of $300 for an analysis, we are talking about a capital cost of $270,000 for chemical testing alone.

5. Manufacturers must, for each product, quantify the likelihood that nonsmokers will start using the product, the likelihood that former smokers will relapse back to nicotine use by using the product, the likelihood that nonsmokers who do start using the product will progress to cigarette smoking, the likelihood that former smokers who relapse back to nicotine use will then progress to smoking, the likelihood that consumers will use the product in conjunction with other tobacco products, and the likelihood that smokers who start using the product would otherwise have quit smoking.

Answering these questions will require a huge research undertaking lasting several years and costing millions of dollars. I don't even think that existing NIH research - in its totality - will be able to answer all of the above questions for a single product within two years. Imagine having to answer these questions for each of your products!

These questions simply cannot be answered without conducting clinical trials with hundreds of subjects and costing millions of dollars. I budgeted a bare bones clinical trial to answer just one of these questions at the bargain basement price of $2.8 million. I'm not sure that any company, with the possible exception of tobacco companies, can afford this.

6. Chemical analyses must be conducted on a minimum of three different batches with at least 10 replicates per batch.

So you can scratch everything I wrote in #4 above because now it turns out that the 900 samples that must be analyzed by the typical e-cigarette company outlined above must be analyzed for 10 replicates of three different batches. That brings the total number of analyses to 27,000. Even if a lab offers you an "economy of scale" discount at $100 per analysis, you're still looking at a capital cost of $2.7 million. Moreover, at that volume of sampling, you will basically be occupying the entire resources of the lab for months at a time. There is not even the capacity of chemical testing labs to handle the required volume of sampling so that it can be completed within 24 months.

7. Chemical testing must be done for a minimum of 29 different chemicals, including volatile organic compounds, tobacco-specific nitrosamines, and metals. 

OK - so this means that you can throw out the estimate in #6 above because now we can no longer rely on one type of chemical analysis. Now we have to conduct at least two different types of tests because we must quantify metals in addition to volatile organics. So now a typical manufacturer is looking at having to conduct 54,000 analyses in order to keep all its current products on the market. And we're up to $5.4 million in capital costs for the chemical testing alone.

8. The manufacturer is asked to provide a full report of the stability of the product over time, including changes in aerosol constituents over the product's lifetime.

Throw away the estimate in #7. For now, the manufacturer must test each product not only at baseline, but after it ages for its shelf-life. At a minimum, this doubles the number of tests that must be conducted. We're up to 108,000 analyses and $10.8 million.


I just can't go on any longer. And we haven't even come to the safety testing requirements. All we've done up to this point is found out what's in the aerosol of each product under various conditions. Now, we have to study the toxicity of each component of the aerosol. For each, we have to now conduct toxicology studies and possibly clinical studies as well. We also have to consider using "computational modeling using surrogate chemical structures" if we aren't able to complete toxicological testing of each constituent.

And we still haven't come to the required assessment of the acute and chronic health effects, user typography, consumer perception of product risk, packaging, and labeling, consumer comprehension of product labeling and instructions, and a study of unintended uses of the product, including abuse liability. Plus, for each constituent in the aerosol, we need to provide data on health effects, including "changes in physiological measurements, such as heart rate and blood pressure, changes in lung, cardiac, and metabolic function; adverse experiences, such as throat irritation and cough; and changes in laboratory values, such as mediators of inflammation and complete blood count indices."

The rest of the story is that these regulations are absolutely insane. The FDA has no idea what it is doing. And what it is doing is completely losing its perspective. The agency is prepared to divert nearly all of its resources to implement and process the PMTA applications, which do nothing to directly protect the public's health and which actually harm the public's health by decimating a product that would otherwise compete with combustible tobacco cigarettes.

It is difficult to believe that a public health agency could promote the continuation of the cigarette smoking epidemic in the way that the FDA is doing with these regulations.

Saturday, May 07, 2016

My Interview on Wall Street Journal's Opinion Journal Addressing the FDA Electronic Cigarette Deeming Regulations

Friday's Wall Street Journal Opinion Journal included a 4-minute segment in which I was interviewed about the FDA electronic cigarette deeming regulations.

Kulik and Glantz Response to Criticism of their Paper is Censored by Journal, Undermining Its Own Conflict of Interest Policies

According to a commentary posted last week on Dr. Stan Glantz's blog, the journal Addiction has refused to publish a response he wrote to a critique of an article he and Dr. Margarete Kulik had published in the journal Tobacco Control on the "hardening" hypothesis of smoking cessation.

Drs. Kulik and Glantz published the original article in Tobacco Control on June 24, 2015. In February 2016, the journal Addiction accepted for publication a manuscript by Plurphanswat and Rodu which provided a critique of the Kulik and Glantz article. Drs. Kulik and Glantz were therefore invited to submit a response to the manuscript, which is customary practice for every journal. Authors whose papers are criticized are always given an opportunity to respond to the criticism.

Drs. Kulik and Glantz did submit a response to the critique. In their response, they made two major points. First, they noted that one of the authors of the critique has a substantial conflict of interest because of his previous and current funding by tobacco companies and they explained how and why this conflict needs to be considered in evaluating the validity of the critique. Second, they pointed out what they claimed was a statistical error in the critique which invalidated the analysis.

The journal responded by refusing to publish their response and instead, ordering them to remove all reference to the conflict of interest if they wished to have their response published:

"Thank you for your reply to the Rodu and Plurphanswat Journal Club article.  Ultimately, regardless of what we might perceive as potential biases in the reasons for conducting studies, or as here, follow-ups of published studies, it is the science that must either stand or fall on its technical merits. In the final section of your reply article, starting, "The substance of...," you appear to make a strong case that Rodu and Plurphanswat's science may not stand up. This is extremely important to focus on. To this end, I would like to publish this section alone, and to give the authors the opportunity to reply. If you are willing to do this, I would also ask you to change the title of your letter to something more along the lines, "Model over-specification and the hardening hypothesis". If you are agreeable to this plan, please resubmit your paper as a revision, including the section I mention above and a new title... ."

Kulik and Glantz protested this decision, arguing that the conflict of interest was entirely relevant to the evaluation of the validity of the critique and that leaving this section out would not accurately reflect their views:

"Making the changes that you request will mean that the resulting manuscript would not fairly represent our point of view.  Therefore, we request that our comment be published as submitted." 

The journal rejected this request, and instead of publishing the critique and an author's reply, it apparently will only publish the critique:

"I am truly sorry that you have declined for a second time to accept the journal’s offer to publish the key scientific part of your letter, which I believe may have had sufficient substance to not go unchallenged. I am also somewhat surprised at your decision on this occasion, because I know you to be a pre-eminent worker in this field who always tries to place scientific probity and the unbiased interpretation of data before all else."

The Rest of the Story

In my view, the story here is essentially one of censorship. It is important to note that when asking authors to provide a response to criticism of their work, journals typically allow authors wide discretion to respond as they see fit. The response is not subject to the type of rigorous review that an original manuscript would receive because the authors essentially have a "right" to respond to the criticism of their article.

Of course, the journal will screen the response for any material that is inappropriate or out of line, but I have never seen a journal dictate the grounds upon which the authors can respond to the criticism. And I have never seen a journal dictate that the authors cannot use a particular line of argument in responding.

It is entirely appropriate to address conflicts of interest that are present because these conflicts may well have influenced the conduct of the research and the interpretation and reporting of the results. Addressing and considering conflicts of interest is not only a legitimate aspect of responding to a critique, but it is a "scholarly" response. Kulik and Glantz went beyond the call of duty here and provided a detailed accounting of the conflict of interest, noting and documenting the conflicts with 26 references (which is very strong documentation considering that this is merely a response to a critique).

To argue that addressing conflicts of interest is not relevant to evaluating a manuscript is to undermine the entire purpose of requiring that such conflicts be disclosed. Essentially, what the journal is saying is that while they require authors to disclose conflicts, they do not see those conflicts as having any relevance to the evaluation of the research. Well if that is the case, then why bother publishing the conflict of interest disclosures?

The very purpose of disclosing conflicts of interest is to allow readers to take that conflict into consideration in evaluating the validity of the article.

Now I firmly believe that one should never simply dismiss an article because of a conflict of interest; every article must also be evaluated in terms of its scientific content. However, it is not appropriate to go to the opposite extreme and argue that conflicts of interest must be ignored. Both are legitimate and important points to consider in evaluating a paper. And in this case, Kulik and Glantz did also address the scientific aspects of the statistical analysis conducted in the critique.

The rest of the story is that the refusal to allow the authors to address conflicts of interest present in the paper criticizing their work essentially amounts to censorship. The journal is dictating the scholarly points that can and cannot be made and not allowing the authors discretion in how they respond to criticism of their own work. Moreover, the arguments made by the journal in rejecting the authors' response undermine the entire purpose of conflict of interest disclosure.

We do not publish conflict of interest disclosures and then right after that, publish an additional disclosure which reads: "In evaluating this paper, please ignore the above conflicts of interest." But that is exactly what the journal is asking its readers to do.

Thursday, May 05, 2016

My Op-Ed in Wall Street Journal Points Out Folly of FDA E-Cigarette Deeming Regulations

My op-ed published today in the Wall Street Journal summarizes the reasons why the FDA deeming regulations make no sense from a public health perspective.

(Note: There was one error - where it says "For example, R.J. Reynolds now owns Vuse" it should instead say: "For example, Imperial Tobacco now owns Blu.")

FDA E-Cigarette Deeming Regulations are a Disaster for Public Health

Ninety minutes ago, the FDA released its long-awaited electronic cigarette deeming regulations. Sadly, the "deeming regulations" would better be called "The Cigarette Smoking Promotion Regulations of 2016." They regulate tobacco-free and smoke-free electronic cigarettes much more stringently than real tobacco cigarettes, which the agency knows kills more than 400,000 Americans each year. And by essentially decimating the vaping industry, stifling innovation, and forcing dishonest marketing, the regulations prevent these much safer products from competing with cigarettes - the deadliest consumer product on the market.

I will have much to say about the regulations in the coming days, but for now, I want to outline the three major provisions of the regulations and discuss their impact on public health.

1. Pre-Market Tobacco Applications

As expected, the regulations require virtually every manufacturer of a vaping device and/or e-liquid to submit a burdensome and costly pre-market tobacco application (PMTA) for each of its devices and products. The FDA established a grandfather date of February 15, 2007, meaning that unless your product was already on the market in 2007, you must submit a PMTA. Although the FDA allows a pathway for products that are "substantially equivalent" (SE) to predicate products that were on the market in 2007, virtually none (if any) existing products are substantially equivalent to products on the market in 2007.

To demonstrate substantial equivalence, the FDA will require the manufacturer to show that the product is not only similar to the predicate product, but that any differences between the products raise no "questions of public health." Since virtually every aspect of the design of e-cigarettes and e-liquids affects its public health implications, unless a product was actually on the market in 2007, it will not be able to demonstrate substantial equivalence. This means that, as expected, the PMTA pathway will be the only available pathway for virtually every vaping product whose manufacturer wishes to stay on the market.

The effective date of the regulations will be approximately August 10, 2016. Manufacturers will have two years from that date to submit PMTA's for every product (meaning every vaping device and every e-liquid) they wish to stay on the market. If the manufacturer submits a PMTA within this two-year period, it will be allowed to stay on the market for one additional year unless the FDA makes a decision on its application prior to that additional 12 months. If the application is not approved, the product must be taken off the market.

In addition, no new vaping products or e-liquids will be allowed on the market from August 2016 forward unless the manufacturer submits and obtains approval of a PMTA.

What constitutes a vaping product or e-liquid? Every different vaping device is considered a separate product, and a PMTA must be submitted for each. Similarly, every different e-liquid is considered a separate product and a PMTA must be submitted for each. E-liquids with different nicotine strengths are different products. So are e-liquids with different flavors or any differences in ingredients. Thus, if you are a manufacturer that makes 20 different e-liquid flavors and each comes in three nicotine strengths, you will have to submit 60 different PMTA applications, each one demonstrating that the particular e-liquid in question, when used in a variety of different vaping devices, will be beneficial for the public's health.

To demonstrate that a product is beneficial for the public's health, the manufacturer will have to consider not only the risks and benefits to smokers, but the risks and benefits to nonsmokers (including youth) and former smokers. Manufacturers will have to demonstrate not only that the product is safer than cigarettes, but that it is effective for smoking cessation and its cessation benefits will not be outweighed by uptake of the product by nonsmokers, including youth.


The FDA has conservatively estimated the cost of a PMTA to be $330,000. While I think this is a gross underestimate, even if we accept this as accurate, a manufacturer of 20 e-liquid flavors with three nicotine strengths each is looking at a capital cost of $19.8 million. Quite clearly, this is a cost that only a very small number of manufacturers (the tobacco companies and the very largest of the independent manufacturers) can afford. This is why the e-cigarette industry will be devastated and thousands of companies will be forced out of business.

Although vape shops will not themselves have to submit PMTA's unless they mix their own liquids, the companies that produce the products sold in vape shops are almost uniformly small manufacturers that will be forced out of business. Thus, there is no way vape shops will be able to survive. The only products remaining on the market will be those produced by the largest companies, and those are typically sold in convenience stores and drug stores rather than vape shops. Thus, these regulations are going to specifically decimate the more than 16,000 vape shop businesses, creating a significant negative economic impact and putting tens of thousands of people to the unemployment line.

More importantly, the severe contraction of the market will limit the growth of the overall market. I don't see the possibility for the continued growth of this market under these circumstances and believe that the level of e-cigarette use will plateau within five years. Thus, the prediction that vaping products could produce a public health miracle - decreasing tobacco cigarette consumption by 50% in the next decade - has been extinguished by the FDA.

Moreover, the regulations will stifle innovation. They not only take away any incentive for innovation because of the burdensome new product application process, but they also make it literally impossible for all but the largest manufacturers to commit the resources necessary to develop and test the new products extensively enough to submit a successful new product application. The public health impact of this requirement is that it will greatly impede the development of even safer and much more effective vaping products that can help a greater proportion of smokers to quit in a way that minimizes any long-term health risks.

2. Modified Risk Claims

As of the effective date of the regulations (approximately August 10, 2016), manufacturers will not be allowed to make modified risk claims. This means two things: (1) they will not be able to truthfully inform consumers that vaping is much safer than smoking; and (2) they will not be able to truthfully inform consumers that vaping does not produce smoke, that e-cigarettes do not contain tobacco, or that the levels of constituents in the e-cigarette aerosol are much lower than in tobacco smoke, or absent altogether. The FDA has specifically stated that companies cannot even describe their products as a "smoke-free" alternative to smoking.

While a company could apply to be allowed to make a modified risk claim, the regulations make it extremely unlikely that a successful application could be developed. To make a claim that e-cigarettes are safer than real cigarettes, one would most likely have to conduct or cite relevant human studies demonstrating long-term benefits of the product. This would be a time-consuming and cost-prohibitive process that could only be conducted by the very largest of the manufacturers.

To make a reduced exposure claims, such as that e-cigarettes contain lower levels of a particular carcinogen or that they are smoke-free, one would have to show that consumers will not interpret this to mean that the product is safer than cigarettes. I believe this is an impossible showing.

There are two major implications of the modified risk provisions of the regulations. First, it means that manufacturers will not be able to market their product based on the three most important benefits of the product: (1) that they can help people quit smoking; (2) that they are safer than cigarettes; and (3) that they contain no tobacco and produce no smoke. This severely hampers the ability of the companies to market their products and of course, this will reduce the potential demand for vaping products. This will also result in the protection of cigarette sales because it eliminates the most effective competitive market claims that could possibly be made to convince people to switch from tobacco cigarettes to tobacco-free vaping products.

Second, it will prevent companies from telling consumers the truth and will effectively force them to lie to the public. Remember that deception can occur not only from what a company says, but from what the company fails to say. By forcing companies not to tell consumers that the products are intended to help smokers get off cigarettes and to reduce the risks from smoking, the FDA is essentially forcing companies to deceive the public. For this reason, I believe this aspect of the regulations is unconstitutional as it violates the free speech rights of vaping manufacturers.

3. Listing of Potentially Harmful Aerosol Constituents

Within three years of the effective date of the regulations, every company will have to submit - for every one of its products - a list of all of the potentially hazardous constituents present in the aerosol. This is itself very costly, as it requires contracting with a testing laboratory, the testing is expensive, and every single flavor or variation must be tested separately.

This aspect of the regulations - although burdensome - will not actually increase the burden of the regulations because in order to submit a successful PMTA, a company would have to present the results of chemical testing of the aerosol produced by every one of its products anyway. So this requirement is superfluous because you can't submit a PMTA without providing this information anyway.

The Rest of the Story

Without question, the FDA has done a huge favor for the continued strength of cigarette consumption in the United States. It has blocked what would otherwise been a wonderful opportunity to develop a strong competitor to tobacco cigarettes that could have eventually eroded the cigarette market by nearly 50%, resulting in what could have been literally a public health miracle in terms of the number of lives saves and diseases and suffering averted.

Instead, the FDA basically preserves the status quo, with more than 400,000 Americans dying each year from a cause that is very much preventable.

This is a huge disaster for public health.

What Can Be Done
The only way out of this disaster would be for Congress to enact legislation that prevents the FDA from requiring PMTA's for vaping products and forces the FDA instead to develop actual safety standards for these products. While the Cole amendment is a step in the right direction, it is still problematic because PMTA's would still be required for new products. We need to encourage innovation, not stifle it. That is the only way to develop safer and more effective products that will maximize the benefits while minimizing the risks associated with this much safer alternative to cigarette smoking.

Tuesday, May 03, 2016

Harvard Medical School Teams Up with Makers of Bacardi Rum, Smirnoff Vodka, Jim Beam Bourbon, and Jack Daniels Whiskey, Providing Great PR at Bargain Rates

Last July, Harvard Medical School and its Cambridge Health Alliance accepted $3.3 million from the Foundation for Advancing Alcohol Responsibility to create an endowed chair in behavioral sciences research at Harvard Medical School and the Cambridge Health Alliance. The Dean of the Harvard Medical School proudly announced the acceptance of this money and praised the Foundation for Advancing Alcohol Responsibility, while acknowledging a long-standing alliance between the two entities: "The Foundation for Advancing Alcohol Responsibility has long been a strong supporter of the research program at Cambridge Health Alliance, particularly in the Department of Psychiatry."

The Rest of the Story

This would be a wonderful story except for a couple of things. First, the Foundation for Advancing Alcohol Responsibility isn't some independent foundation that provides grants for a wide spectrum of alcohol research. Instead, it is an alcohol industry organization that is funded by several alcohol companies, including Bacardi (the maker of Bacardi rum), Diageo (the maker of Smirnoff vodka), Beam Suntory (the maker of Jim Beam bourbon), Brown-Forman (the maker of Jack Daniels), and Constellation Brands (maker of Svedka vodka and Corona Extra beer). Its primary purpose is, as I discussed yesterday with respect to Anheuser Busch InBev, to obscure the devastating health hazards associated with "responsible" drinking by suggesting that as long as you drink alcohol responsibly, there is no problem.

While the Foundation claims to provide "the facts," you won't find anything about the health effects of "responsible" drinking on the web site. I could not find the word "cancer" mentioned once, even after extensive searching. Obviously, the Foundation has something to hide. How can a medical school possibly team up with Big Alcohol like this in a way that provides tremendous public relations for the companies, and at the bargain price of only $3 million. If you're going to prostitute your integrity by playing a role in the alcohol companies' marketing strategy and provide the companies with the public relations opportunity to boast about how they are partnering with the prestigious Harvard University, then you ought to at least haggle for a lot more than 3 million.

Second, the Foundation isn't the only entity with something to hide. The medical school has not exactly been forthcoming about the fact that it is partnering with Big Alcohol and accepting huge amounts of money from these companies. For example, in a medical school news article about the donation, the school mentions that the funding is coming from the Foundation, but it hides from readers the fact that the Foundation is none other than a group of alcohol companies.

The biography of Dr. Shaffer (the first endowed chair under the Big Alcohol-funded program) provided by the Cambridge Medical Alliance omits any mention of the fact that Dr. Shaffer's financial support comes largely from the alcohol industry.

Potentially even more problematic is the fact that in a 2015 paper published in the Archives of Scientific Psychology on which Dr. Shaffer was a co-author, there is no disclosure informing readers that Dr. Shaffer has received research support from alcohol companies. Yet according to the alcohol companies, they provided research support for four years (presumably 2012 through 2015) to Dr. Shaffer and his colleagues in the Division of Addiction. The Foundation states: "Over the past four years, with multi-year support from the Foundation for Advancing Alcohol Responsibility, Dr. Shaffer and his colleagues at the Division of Addiction have begun work to develop and test a computerized clinical report generator tool, the Computerized Assessment and Referral System (CARS), for use in DUI intervention and treatment settings." If this is true, then it should have been disclosed in the 2015 paper and it certainly creates the appearance that the authors were trying to hide this financial relationship. If the Harvard Medical School is really so proud of accepting alcohol money, then why are they apparently afraid of disclosing that they are taking alcohol money?

After further investigation, I found that it does appear to be true, as the Cambridge Health Alliance Division on Addiction acknowledges research support from the Foundation for Advancing Alcohol Responsibility, stating: " In partnership with the Foundation for Advancing Alcohol Responsibility (FAAR), a nonprofit organization with a focus on preventing DUI, we have refined and expanded
CARS, and tested its usability within multiple Massachusetts DUI treatment settings." This is from a 2014 publication, so it certainly should have been disclosed in the 2015 paper. Tellingly, despite a detailed description of CARS, the Division of Addiction does not disclose that the funding is coming from alcohol companies. Deceptively, all it says is that FAAR is "a nonprofit organization with a focus on preventing DUI." This appears to be blatant and intentional deception to hide the Alliance's partnership with Big Alcohol.

The partnership between Harvard Medical School and Big Alcohol is itself problematic because it helps to advance the goals of the Foundation, whose overall program has been carefully crafted to avoid any focus on the many, substantial adverse health effects of alcohol use, including liver disease, esophageal cancer, oral cancer, breast cancer, liver cancer, gastric ulcers, heart disease, stroke, hypertension, pancreatitis, suppression of the immune system, and adverse effects on the brain, including depression. These effects can occur even in persons who do not engage in binge drinking, underage drinking, or drink-driving. In epidemiological studies, increased risk for most of these effects occurs at levels of drinking just 2 drinks per day (for women). On an individual level, some of these effects can occur at much lower levels of alcohol use.

By focusing only on the "harmful" use of alcohol through its promotion of "responsible" drinking, the Foundation diverts attention away from the substantial burden of disease caused by heavy drinking. The alcohol companies are not interested in telling you about the harmful effects related to the "responsible" drinking of their products. They love telling you about the hazards associated with "harmful" drinking because that implies that responsible drinking is perfectly safe. Adverse effects of alcohol only occur to those who abuse it is the message that the Foundation is paying $3 million to send.

In essence, the goal is to actually promote alcohol use by ignoring and obscuring the devastating effects that "responsible" drinking has on the population. That Harvard Medical School is partnering with the Foundation and enabling the alcohol companies to help achieve this goal, and apparently not readily disclosing the connection, is disgraceful.

Anheuser Busch "Smart Drinking" Initiative is a Complete Farce

Last December, Anheuser-Busch InBev (AB InBev) announced its commitment of more than $1 billion over ten years to promote "Smart Drinking," whose major purported purpose is to "reduce the harmful use of alcohol" by reducing "binge drinking, underage drinking and drink-driving." The company claims that this represents "Doing Right, While Doing Well." A major goal is to reduce the "harmful use of alcohol" by at least 10% in six cities within 10 years.

The Rest of the Story

The truth is that this initiative is essential a huge scam designed to promote alcohol use, to divert attention away from the alcohol industry's culpability in the damage caused by alcohol, and to also divert attention away from much more effective public health programs and policies to reduce alcohol-related morbidity and mortality.

Promoting Alcohol Use

This campaign was carefully crafted to avoid any focus on the many, substantial adverse health effects of alcohol use, including liver disease, esophageal cancer, oral cancer, breast cancer, liver cancer, gastric ulcers, heart disease, stroke, hypertension, pancreatitis, suppression of the immune system, and adverse effects on the brain, including depression. These effects can occur even in persons who do not engage in binge drinking, underage drinking, or drink-driving. In epidemiological studies, increased risk for most of these effects occurs at levels of drinking just 2 drinks per day (for women). On an individual level, some of these effects can occur at much lower levels of alcohol use.

By focusing only on the "harmful" use of alcohol, the campaign diverts attention away from the substantial burden of disease caused by heavy drinking. The alcohol companies, including AB InBev, are not interested in telling you about the harmful effects related to the "responsible" drinking of their products. They love telling you about the hazards associated with "harmful" drinking because that implies that responsible drinking is perfectly safe. Adverse effects of alcohol only occur to those who abuse it is the message that AB InBev is spending $1 billion to send around the globe.

In essence, the goal is to actually promote alcohol use by ignoring and obscuring the devastating effects that "responsible" drinking has on the population. In fact, AB InBev admits as such. They state: "We also know that it is not in the long-term interests of our company for consumers to misuse our beers. We would rather that consumers enjoy our products responsibly on a more frequent basis than misuse them on any occasion."

Indeed. The company's goal is to promote alcohol use, not to discourage it. They admit that they want people to drink more frequently. The only thing that needs to be avoided is irresponsible drinking, meaning don't binge drink and don't drink and then drive. But keep in mind that someone who consumes 2-3 drinks a day is, by definition, not binge drinking. And if they don't drink and drive, then they are a "responsible" drinker. Nevertheless, we know that such a person is at increased risk for cancer and many other diseases.

The rest of the story is that this is a brilliant, yet deceptive campaign to promote alcohol use under the guise of "doing well." The campaign is able to - at the same time - promote more frequent drinking while hiding behind a pretense of being a responsible corporate citizen.

Thus, the "Smart Choices" initiative must be viewed as a marketing program. In fact, it's a brilliant marketing program. But let's not confuse this marketing program with being a public health initiative.

Diverting Attention Away from the Alcohol Industry's Culpability

Corporate sponsorship of health-related initiatives is a well-recognized marketing tactic used by the tobacco and alcohol industries. The purpose of sponsorship - such as the "Smart Choices" initiative - is to improve the company's public image, divert attention away from the industry's role in promoting the consumption of its potentially hazardous products, and to develop brand capital, all of which help to increase sales and improve the bottom line.

The "Smart Choices" campaign is brilliant because it puts the focus on individual choices, rather than on the decisions that AB InBev has made, such as: (1) deciding to heavily promote alcohol to underage youth by advertising in media with high youth audiences; (2) deciding to promote heavy use of alcohol by portraying positive images of heavy alcohol use in its advertising and marketing; and (3) deciding to undermine public health efforts to reduce alcohol use by opposing advertising restrictions, excise taxes, and essentially any and all public policies that would reduce alcohol use.

Spending $1 billion on the "Smart Choices" initiative is a very smart choice for AB InBev, because as a marketing initiative, it will work wonders and help take the focus off of its culpability, which will protect it from detrimental (to its profits) public health policies throughout the world.

Diverting Attention from More Effective Public Health Programs that Would Reduce Alcohol Use

We know from a multitude of research that the most effective strategies for reducing alcohol-related morbidity and mortality are increasing alcohol taxes, restricting advertising that targets underage youth, and conducting aggressive alcohol counter-advertising campaigns that expose the marketing tactics being used by alcohol companies to recruit underage drinkers, promote heavy drinking, and hide from consumers the myriad of adverse health effects associated with heavy "responsible" drinking. Of course, the "Smart Choices" initiative avoids doing any of these. If AB InBev were sincerely interested in reducing the adverse consequences of alcohol use, it would take the $1 billion and give it to public health officials for use in an alcohol counter-advertising campaign. At best, the "social norms" campaign that AB InBev will run will have a marginal effect.

Moreover, the "social norms" that it advances will not be social norms related to the adverse health effects of alcohol. Instead, the campaign is intended to make drinking a norm (albeit not involving actual binge drinking or drinking and driving). The campaign does not, for example, encourage people with a family history of alcohol dependence to avoid alcohol. Everyone is instructed to drink, albeit to drink in a "responsible" manner (which is a manner that could very well increase your risk of disease and death).

A Brilliant, But Deceptive Farce

AB InBev's "Smart Drinking" initiative is a brilliant one. Its brilliance rivals the fraudulent campaigns that the tobacco industry used to run. And we know how sincere the tobacco companies were in their supposed desire to reduce tobacco consumption. Here, the initiative is also fraudulent because its underlying purpose is far different than what is being presented to the public. The only difference between the strategies of the tobacco and alcohol industries is that Big Tobacco didn't have the ability to promote "smart smoking" because there is no such thing. The alcohol industry has the advantage of producing a product that causes a large amount of damage from acute over-consumption. Thus, AB InBev can accomplish the dual purposes of promoting drinking and discouraging "harmful" drinking at the same time. Sadly, a large proportion of that "smart drinking" is going to result in disease and death.

Sunday, May 01, 2016

Research Forum Claiming that Moderate Drinking Improves Health is Deliberately Hiding Its Conflicts of Interest with Big Alcohol

An organization calling itself the "International Scientific Forum on Alcohol Research" (ISFAR) has published on its web site a scathing review of a recent meta-analysis which concluded that moderate alcohol consumption does not reduce mortality as previously thought. The review contains statements from 14 members of ISFAR, and every one of the 14 blasts the study, with the review concluding that the study "markedly distorts the accumulated scientific evidence on alcohol and CVD [cardiovascular disease]."

The International Scientific Forum on Alcohol Research claims to be committed to providing a "balanced" analysis regarding alcohol and health. A co-director of the Forum asserts that: "Serious scientists should focus on the content and quality of research and their findings without bias in the interest of furthering our knowledge of alcohol and its effects on the human body."

The 14 Forum members (scientists) who provided the reviews of the paper were:
  • Elizabeth Barrett-Connor, MD,
  • Giovanni de Gaetano, MD, PhD
  • R. Curtis Ellison, MD
  • Ramon Estruch, MD, PhD
  • Harvey Finkel, MD
  • Tedd Goldfinger, DO, FACC
  • Ulrich Keil, MD, PhD
  • Dominique Lanzmann-Petithory, MD, PhD
  • Fulvio Mattivi, MSc
  • Erik Skovenborg, MD
  • Creina Stockley, PhD, MSc
  • Pierre-Louis Teissedre, PhD
  • Fulvio Ursini, MD
  • Andrew L. Waterhouse, PhD
Dr. Ellison is a co-director of the Forum and director of the Institute on Lifestyle and Health at Boston University Medical Center, which is the scientific center for the Forum. He claims that: "Our chief goal is to make it possible for the Institute to serve as a balanced, scientifically sound, and unbiased source of information on alcohol and health, making up-to-date information readily available to all who are interested."

The Rest of the Story

While the Institute on Lifestyle & Health and the International Scientific Forum on Alcohol Research would like the public to think that they are "unbiased" and presenting "balanced" critiques, especially as they read this recent review on the health effects of moderate drinking, the truth is that the review is hiding from readers critical information which renders it highly biased and wholly unbalanced.

Most importantly, the review does not reveal to the public that far from being an "unbiased" source of information, the Institute on Lifestyle & Health and the International Scientific Forum on Alcohol Research are alcohol industry-funded entities. Nowhere on the web page where the review is published is this information revealed. That is quite an important piece of information to fail to disclose to readers of this review.

Moreover, it appears to be a deliberate attempt to hide this information from readers of the review, since the Institute and ISFAR do disclose this information on the home page for the Institute and Forum. Even that disclosure is in some respects hidden, because you have to click to another page to see it; the Institute does not reveal its alcohol industry funding on the home page itself, and anyone who does not click through will have no idea that Big Alcohol is funding this project.

But the deception does not end there.

It turns out that five of the Forum members who reviewed the article have conflicts of interest by virtue of either their having received research funding from the alcohol industry or serving on advisory boards of alcohol industry-funded organizations, yet none of these conflicts are disclosed.

One reviewer - Dr. Ramon Estruch - is on the board of or receives money from three different research foundations, each of which is funded by alcohol companies. According to a published article: "Dr. Estruch reports serving on the board of and receiving lecture fees from the Research Foundation on Wine and Nutrition (FIVIN); serving on the boards of the Beer and Health Foundation and the European Foundation for Alcohol Research (ERAB)."

Well, it turns out that the Research Foundation on Wine and Nutrition is funded by alcohol companies.

And the Beer and Health Foundation is funded by the Spanish beer industry.

And the European Foundation for Alcohol Research acknowledges that it: "is supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."

A second reviewer - Dr. Creina Stockley - is listed as being with the Australian Wine Research Institute, which is also an alcohol industry institute.

A third reviewer - Dr. Pierre-Louis Teissedre - elsewhere acknowledges that his research team has received financial and in-kind support from a wine manufacturer (the maker of Perrin et Fils).

A fourth reviewer - Dr. Andrew Waterhouse - has received research funding from E & J Gallo Winery.

A fifth reviewer - Dr. Erik Skovenborg - is listed as being on the Board of ERAB, which is funded by the alcohol industry.

Unfortunately, that's not the end of the deception either.

The other co-director of the Forum is Helena Conibear, the Executive Director of Alcohol-in-Moderation (AIM) in the UK. BeamSuntory (manufacturer of Jim Beam bourbon and several other alcohol brands) states that it provides financial support to AIM.

Also, six of the Forum reviewers are listed as Alcohol in Moderation (AIM) Council Members:
  • Curtis Ellison
  • Harvey Finkel
  • Giovanni de Gaetano
  • Tedd Goldfinger
  • Erik Skovenborg
  • Creina Stockley
While the Council Members are not paid, their association with a foundation that apparently receives "financial support" from alcohol companies represents a conflict of interest that should have been disclosed.

Because of its alcohol industry funding and the fact that at least four of its members have financial conflicts of interest with Big Alcohol, the so-called "balanced" and "unbiased" International Scientific Forum on Alcohol Research is neither balanced nor unbiased. Stating that ISFAR is unbiased is like claiming that research on global warming funded by ExxonMobil is unbiased or that research on the health effects of smoking funded by Philip Morris was unbiased.

But while bias is simply a natural and unavoidable consequence of the corporate funding of research, hiding these conflicts of interest from the public is neither natural nor unavoidable. It represents, in my view, a deliberate attempt to deceive the public by hiding critical information.

If the Forum were so committed to transparency and full disclosure, why wouldn't it disclose, on the review page itself, that the Forum is alcohol industry-funded and that four of the article reviewers have received alcohol industry funding and a fifth is on a Board of a foundation that is funded by the alcohol industry? The failure to disclose is in some ways more problematic than the acceptance of alcohol industry money because it represents deception.

The Institute on Lifestyle & Health's deception of the public is even more evident in the biographies it provides of its Forum members. These biographies actively hide from readers the alcohol funding of several of these Forum members.

For example, Dr. Estruth's biography states that he is a member of the Advisory Board for "ERAB." The reader is not told what ERAB stands for, but that's of little consequence. What is of consequence is that the biography hides from the public the fact that ERAB is "supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."

Dr. Stockley's biography states that she works for the Australian Wine Research Institute. But it hides the fact that this Institute is funded by the alcohol industry.

Dr. Teissedre's biography fails to disclose that his research group received alcohol industry funding.

Dr. Waterhouse's biography hides the fact that he has received alcohol industry research funding.

Dr. Skovenborg's biography fails to disclose that he is on the Board of ERAB, which is funded by the alcohol industry.

Believe it or not, the deception goes even further.

While ISFAR claims that it is presenting a "balanced" review of the meta-analysis study, guess how many of the 14 reviewers are scientists who had a vested personal interest in the issue because they had published research that reported positive effects of moderate alcohol consumption and presumably had a pre-existing belief that moderate alcohol use improves health?

The answer, absurdly, is all 14!

The following Forum reviewers have previously published articles reporting positive health effects of moderate alcohol use:
  • Elizabeth Barrett-Connor
  • Giovanni de Gaetano
  • Curtis Ellison
  • Ramon Estruch
  • Harvey Finkel
  • Tedd Goldfinger 
  • Ulrich Keil
  • Dominique Lanzmann-Petithory
  • Fulvio Mattivi
  • Erik Skovenborg
  • Creina Stockley
  • Pierre-Louis Teissedre
  • Fulvio Ursini
  • Andrew L. Waterhouse
Sample articles documenting all of the above authors are:
Paper 1
Paper 2
Paper 3
Paper 4
Paper 5
Paper 6
Paper 7
Paper 8
Paper 9
Paper 10
Paper 11

It is absolutely ludicrous to attempt to provide a "balanced" review of a scientific question by having that review conducted by 14 people, all of whom have published research drawing a conclusion in the same direction. If there was any serious intent in providing balance, you would think that perhaps they could have asked one, even just one, scientist who had not published on this issue to provide a review. Talk about stacking the deck!

The issue of ISFAR hiding its conflicts of interest is not restricted just to its web site. In an October 2014 Medscape article in which Dr. Ellison was interviewed about research on the health effects of moderate alcohol consumption, he discusses the work of the International Scientific Forum on Alcohol Research. He is asked specifically to describe what the Forum is. However, nowhere on the web page or in the interview does he disclose that the Forum receives funding from alcohol companies.

Moreover, in the disclosure that Dr. Ellison provides, he also hides the fact that his project is alcohol industry-funded. All he discloses is that he: "Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: International Scientific Forum on Alcohol Research." But the reader or listener has no way of knowing that ISFAR is an alcohol industry-funded project. This is yet another aspect of ISFAR's deception.

Before closing, let me make two points very clear. First, I am not arguing that any member of the Forum is intentionally biasing his or her interpretation of the scientific literature. Conflict of interest has nothing to do with intentional bias. It has everything to do with subconscious bias that is simply unavoidable when one is receiving corporate funding (or any type of funding for that matter). And further, there is nothing unnatural about this bias. We are programmed - our brains are wired - to engage in reciprocity. This is a well-demonstrated psychological phenomenon which has been documented to occur in situations even less obvious than the receipt of corporate funding for research. Nor is there anything inherently wrong with having a conflict of interest. Failing to disclose a significant conflict is a different story.

Second, I am not arguing that accepting corporate funding for research is inherently wrong. It is not that "black and white." In this case, however, since the declared purpose of the Forum and the Institute is to provide a balanced and unbiased summary of research literature, it is completely unacceptable and inappropriate to be funded by corporations that have a huge, vested interest in the result of those reviews. It sacrifices the scientific integrity of such an organization when many of its members have individual conflicts of interest with the corporations whose financial interests are at stake.

And it is ludicrous - almost hilarious in a dark sense - that such a "balanced" review would be obtained by stacking the deck and soliciting a review only from scientists who have previously expressed their disagreement with the views expressed in the reviewed article. That is about as strong a systematic bias as one could imagine, even if one were trying to explain the concept by giving an extreme example. 

The rest of the story is that far from being a "balanced" and "unbiased" forum for review of scientific research on alcohol and health, the Institute for Lifestyle & Medicine and the International Scientific Forum on Alcohol Research are heavily conflicted entities that have strong ties to the alcohol industry. These ties occur not only through the Institute receiving alcohol funding, but through several of the Forum members having received alcohol industry funding or serving on Boards of organizations that are alcohol industry-funded.

But what makes the actions of these organizations even more inappropriate and scientifically dishonest and deceptive is the fact that they are largely hiding these immense conflicts of interest from the public.