Sunday, January 07, 2018

International Scientific Forum on Alcohol Research (ISFAR) is Still Hiding Conflicts of Interest of Its Members

The International Scientific Forum on Alcohol Research (ISFAR) claims to be "an independent organization of scientists that prepares critiques of emerging research reports on alcohol and health." The Forum describes itself as "an international group of invited physicians and scientists who are specialists in their fields and committed to balanced and well researched analysis regarding alcohol and health." It is "a joint undertaking of Boston University School of Medicine in the United States and Alcohol in Moderation (AIM) of the United Kingdom. Its Co-Directors are R. Curtis Ellison, MD, Professor of Medicine & Public Health, Boston University School of Medicine, and Helena Conibear, Executive Director, Alcohol-in-Moderation (AIM), UK."

The Rest of the Story

About a year and a half ago, I reported that ISFAR was hiding its conflicts of interest with Big Alcohol. At that time, ISFAR published a scathing review of a meta-analysis which concluded that moderate alcohol consumption does not reduce mortality as previously thought. The review contained statements from 14 members of ISFAR, and every one of the 14 blasted the study, with the review concluding that the study "markedly distorts the accumulated scientific evidence on alcohol and CVD [cardiovascular disease]."

It turns out that five of the Forum members who reviewed the article had 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 were disclosed.

Not only did ISFAR hide its conflicts of interest with alcohol companies on its web site, but it also hid these conflicts in a public interview.

More recently, one of the Forum members and reviewers was forced to publish a correction to a journal article because he failed to disclose that he is a beer industry consultant.

Has ISFAR reformed itself, and is it now disclosing the conflicts of interests of the reviewers who write its critiques?

The answer, unfortunately, is no.

Nowhere on its website does it list the specific conflicts of interest of its members/reviewers. Nowhere in its critiques does it disclose these conflicts of interest. And to top it all off, the biographies provided for its members do not disclose their conflicts of interest.

For example, Dr. de Gaetano's bibliography fails to disclose that he consults for the beer industry -- the precise conflict of interest for which he was forced to publish a correction in the Journal of the American College of Cardiology.

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, hiding 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."

Ms. Stockley's biography states that she works for the Australian Wine Research Institute, which it states is "an independent, not-for–profit research institution." But it hides the fact that this Institute is funded by the alcohol industry. Far from being independent, the Australian Wine Research Institute is actually the "wine industry’s own research organisation."

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 was on the Board of ERAB, which is funded by the alcohol industry.

Dr. Mattivi's biography fails to disclose that he has received alcohol industry research funding.

Dr. Klatsky's biography fails to disclose that in the past, he received alcohol industry funding.

Dr. Lanzmann-Petithory's biography fails to disclose that in the past, she has received alcohol funding.

Dr. Gretkowsky's biography fails to disclose that in the past, she has received alcohol funding.

So of the supposedly "independent" and "balanced" reviewers, at least 10 of them have conflicts of interest with the alcohol industry that are not disclosed on the web site, even in their own biographies.

Unfortunately, ISFAR continues to be essentially an industry front group that is providing highly biased reviews without readily disclosing the intricate details of the financial connections of many of its reviewers to the alcohol industry.

They should not fool anybody any longer. The time to end this scam operation is now. Especially in a period in which the federal government has basically tossed scientific objectivity out the window.

Sadly, what ISFAR is doing bears a strong resemblance to the fraudulent public relations activities of the tobacco industry many years ago. 

On a personal note, I feel somewhat ashamed that the Boston University School of Medicine has been playing a role in this scam, as ISFAR has been hosted, in part, by our medical center.

On a larger note, this story illustrates why the alcohol industry-funded NIAAA study of the potential cardiovascular benefits of moderate drinking is so problematic. The background research that informs the study is tainted by serious conflicts of interest. But the worst is yet to come -- as I will reveal shortly, the research is not an objective attempt to get at the answer to this research question.

Tuesday, December 05, 2017

First Major Action of Foundation for a "Smoke-Free World" Shows that It is Largely a Scam

I have already written about why I refused to participate in the activities of the Foundation for a Smoke-Free World, which I believe is essentially a front-group created by Philip Morris International (PMI) primarily to promote its business interests. I explained that if PMI were serious about creating a smoke-free world, it would stop aggressively marketing its deadly products throughout the world and stop opposing public health policies to reduce tobacco use.

The Foundation for a Smoke-Free World recently released a call for research proposals for preliminary projects that entail research to help the Foundation obtain the background information necessary for it to proceed effectively in its supposed mission to create a smoke-free world. By reviewing the call for proposals, we are now able to understand just how the Foundation is essentially a scam operation.

The Foundation calls for “scoping projects” to study strategies to reduce smoking. But nowhere in the five-page document does it mention anything about interventions to: (1) severely restrict or curtail cigarette advertising and marketing; (2) require plain packaging; (3) substantially increase cigarette taxes; (4) promote 100% smoke-free environments; and (5) heavily fund aggressive, state-of-the-art anti-smoking media campaigns.

In fact, the word “industry” appears only once, and it is not clear that marketing, taxation, clean indoor air, or counter-advertising are what the Foundation has in mind (especially since it groups “industry” with “farming”).

In contrast, the Foundation does want to support research on the role of genetics, physiology, individual choices and activities and environmental influences.

Frankly, this is all essentially a waste of time. We already know what interventions are most effective in reducing smoking rates. We don’t need more research to find out what works. What we need to do is to heavily fund programs to promote these tried and true policy strategies.

If the Foundation were serious about wanting to create a smoke-free world, then instead of wasting this money on research into topics like genetics and individual choices and activities, it would use its money to fund programs to implement – worldwide – policies and programs that we know are effective. These are: 1) severely restrict or curtail cigarette advertising and marketing; (2) require plain packaging; (3) substantially increase cigarette taxes; (4) promote 100% smoke-free environments; and (5) heavily fund aggressive, state-of-the-art anti-smoking media campaigns. It would also provide funding to create or supplement tobacco control infrastructure in countries throughout the world and to support the development of grassroots coalitions to promote policies to fight the tobacco industry.

In other words, these are all the programs that the Foundation fails to mention at all in its call for proposals.

Sometimes, what you don’t say is more important than what you do say. That is certainly the case here. The Foundation says nothing about the most effective interventions to reduce smoking, while focusing almost exclusively on areas that have little to no relevance.

You might argue that the Foundation can’t fund programs to promote bans on cigarette marketing, high cigarette taxes, plain packaging, and aggressive anti-smoking media campaigns that attack the industry because it is funded by the tobacco industry. Well … that’s exactly the point. A foundation funded by a large, multinational tobacco company is not in a position to carry out the types of initiatives that are most effective in reducing smoking. This is why I believe the Foundation is essentially a scam operation.

Monday, November 27, 2017

Tobacco Control Researcher Calls for Boycott of Journal, Apparently Because the Editor Supports E-Cigarettes for Harm Reduction

In a comment posted on Dr. Stan Glantz's blog yesterday, Dr. Thomas Eissenberg--a researcher studying electronic cigarettes at Virginia Commonwealth University--called for a boycott of the journal Addiction because of his claim that the editor of the journal exhibited bias in fast-tracking an article that reported low levels of aldehydes in e-cigarette aerosol.

Specifically, Dr. Eissenberg called for researchers to boycott the journal by not submitting articles to it and not reviewing for it "until it has published the means by which it will manage the apparent conflicts of conscience among its editorial staff...". Presumably, Dr. Eissenberg is referring to what he views as a significant conflict of interest of the journal's editor--Dr. Robert West--who he claims violated the peer review process in fast-tracking a 2015 article that defended e-cigarettes against the claim that they expose users to high levels of formaldehyde.

The situation is a bit complex, so let me try to summarize the background as best as I understand it:

In May 2015, Dr. Konstantinos Farsalinos and colleagues published an article in Addiction which reported the results of an experiment showing that e-cigarettes only produce aldehydes (such as formaldehyde, a carcinogen) under dry puff conditions. A dry puff occurs when a vaping device overheats the e-liquid, resulting in an unpleasant taste. Most vapers will discontinue vaping when they experience a dry puff. Therefore, if aldehydes are present only under dry puff conditions, then they do not present a major health concern for vapers.

In September 2015, Dr. Eissenberg--along with Dr. Alan Shihadeh and Soha Talih--published a letter to the editor of Addiction in which they accused him of having a "conflict of conscience" that led to a lack of rigorous peer review and inappropriate fast-tracking of the Farsalinos et al. article. The authors' complaint was two-fold: (1) that the review period was only 11 days, which is uniquely brief for this journal; and (2) that the editor--Dr. West--has a significant conflict of interest because he was once quoted in a newspaper article as (according to Eissenberg et al.) stating that: "E-cigarettes are about as safe as you can get… E-cigarettes are probably about as safe as drinking coffee."

Eissenberg et al. went on to accuse Dr. West of exhibiting bias in handling what they call a "flawed" manuscript: "These statements suggest a potential conflict of conscience in the handling of a flawed report that reinforces Dr West's professed faith in e-cigarette safety...".

Addiction published the extremely long letter by Eissenberg et al. (which itself is unusual), along with a response from Dr. West stating that the accusation is false because he didn't even handle the paper: he designated the review to a different editor. Moreover, the paper went through the same peer review process as any other paper (although it was fast-tracked because of particular urgency of this topic). In fact, the authors went through not one, but two rounds of revisions before the manuscript was accepted for publication.

That is where the story stood until yesterday, when Dr. Eissenberg called for the boycott of the journal, apparently sticking to his accusation against Dr. West despite West's response.

The Rest of the Story

Ironically, while Dr. Eissenberg is accusing Addiction of unscientific and biased actions that threaten scientific integrity, it is actually Dr. Eissenberg's actions here that are inappropriate, biased, and a threat to scientific integrity.

First, Dr. Eissenberg makes a serious accusation against the editor of Addiction without sufficient evidence to justify the claim. He (and his co-authors) provide no substantial evidence that the peer review process was botched, that the Farsalinos et al. article was seriously flawed, or that a severe bias on the part of the editor led to a botched review and acceptance of an article that should not have been published.

As it turns out, Dr. West apparently had no role in the review of the manuscript, so Dr. Eissenberg's accusation was incorrect. Moreover, the paper did go through the normal review process, although in expedited fashion. It is perfectly legitimate for journals to fast-track articles of particular interest, and many journals do that all the time. The article was peer reviewed and the authors were required to respond to reviewer comments twice. Thus, there was nothing qualitatively different about this peer review process from the review of any other paper submitted to the journal. No evidence is provided to support the accusation that the review process was flawed in any way.

Dr. West ended his response by stating: "I hope that this will give them (Eissenberg et al.) pause for thought before making serious accusations about colleagues." I agree. The allegations against the editor and the journal were serious but no evidence was provided to support them. Making an unjustified accusation and then calling for a boycott of the journal based on that unsupported allegation is the threat to scientific integrity in this story.

Second, Eissenberg et al.'s claim that Dr. West has a "conflict of conscience" because he believes e-cigarettes are relatively safe is a perversion of the concept of conflict of interest. In fact, it would be impossible for any journal editor not to have a "conflict of conscience" according to the definition that Dr. Eissenberg and colleagues are asking us to accept. Everyone involved in tobacco control has some personal view on the relative safety of e-cigarettes. The idea that researchers should boycott the journal because the editor has expressed his personal views on the relative safety of e-cigarettes is ludicrous.

Interestingly, in making their accusation that Dr. West has some sort of unusual "conflict of conscience" that would make it inappropriate for the journal to consider papers on e-cigarettes, Eissenberg et al. only quoted a small portion of Dr. West's comments in the newspaper article. I could just have easily accused Dr. West of having a strong personal bias against e-cigarettes by selectively quoting him from the newspaper article as stating:

"This is a danger. Regulators should monitor this."

In fact, Dr. West's views as expressed in the newspaper article appear to me to be balanced and evidence-based. His full comment to the paper explains the scientific reasoning behind his view, which I find quite reasonable:

"We have such a massive opportunity here. It would be a shame to let it slip away by being overly cautious. E-cigarettes are about as safe as you can get. We know about the health risks of nicotine from studies in Sweden into the use of "Snus", a smokeless tobacco. Nicotine is not what kills you when you smoke tobacco. E-cigarettes are probably about as safe as drinking coffee. All they contain is water vapour, nicotine and propylene glycol [which is used to help vaporise the liquid nicotine]."

But more to the point, the entire concept of suggesting that researchers boycott a journal based on the scientific views of the journal editor is a dangerous one. It is basically setting up a system where the only journals that survive would be ones whose editors express opinions that are in line with the mainstream scientific opinion. In fact, the very idea that researchers should boycott journals based on the opinions of the journal editor is nonsensical. Should we boycott the journal Tobacco Control because the editor does not personally believe that e-cigarettes are orders of magnitude safer than real cigarettes? Once we start going down that path, we end up challenging the existence of scientific integrity in research reporting.

This is the reason why journals screen for financial conflicts of interest, rather than conduct a McCarthy-like witch hunt to determine whether a researcher may be biased because of opinions they have expressed. Believe me, we don't want to go down that path.

There may be unusual situations in which an editor may have such a personal connection to an issue that it may be appropriate to recuse themselves from review and ask a deputy or assistant editor to handle the review, but that's certainly not true in this case. Here, the review was apparently handed off to a different editor anyway, even though I don't see any reason whatsoever why that would have been necessary.

What is perhaps most ironic about the letter to the editor by Eissenberg et al. is that although they accuse the editor and the journal of a serious conflict of interest, the letter itself fails to disclose an apparent financial conflict of interest of one of its authors. The letter fails to disclose any conflicts of interest among its authors (this link is to the PDF version of the letter which I checked to make sure a disclosure statement wasn't just missing in the online version). Thus, one would assume that none of the authors has any connection to the tobacco industry, such as -- for example -- having received funding from an organization chaired by a tobacco industry executive.

But it appears that Dr. Shihadeh -- the lead author of the letter to the editor -- has failed to disclose that he has, in the past, received funding from an organization chaired by a tobacco industry executive. Dr. Shihadeh is the co-author of several papers that acknowledge funding from the International Development Research Centre, which -- at the time -- was chaired by Barbara McDougall, who was on the Board of Directors of the Imperial Tobacco Company.

In addition, Dr. Eissenberg -- the senior author of the letter to the editor -- also acknowledged having received funding from the same organization, which was at the time chaired by a tobacco company executive.

I find it ironic that the only real conflict of interest in this story is the fact that two of the authors of the letter to the editor have, in the past, received funding from an organization that was chaired by a tobacco industry executive. And that conflict of interest is not disclosed by the authors.

Now, to be very clear, I am not accusing Dr. Shihadeh or Dr. Eissenberg of voluntarily accepting tobacco industry-related funding. They stated that they were unaware, at the time of the funding, that the chair of the organization was a tobacco industry executive. So I'm not blaming them for accepting that funding. However, they were certainly aware in 2015 - when they wrote the letter to the editor - that they had been funded by an organization chaired by a tobacco industry executive. It seems to me that is a fact that should have been disclosed. That lack of disclosure, by the way, stands in contrast to Dr. West's full disclosure of his industry-related funding from pharmaceutical companies and his clear statement that he has never been funded by the tobacco or e-cigarette industries.

The rest of the story is that in my view, Dr. Eissenberg is falsely accusing the journal Addiction of having violated scientific principles of peer review because of a personal bias on the part of the editor. Worse still, he has now called for a boycott of the journal based on these unsupported allegations.

It would truly be a shame if researchers followed this misguided recommendation.

Monday, October 30, 2017

NIAAA Promotes Alcohol Industry Public Relations Program; Violates Ethical Standards by Appearing in Anheuser-Busch Promotional Video

In what I believe is a clear ethics code violation, senior employees of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) have appeared in an Anheuser-Busch InBev promotional video that is designed primarily to serve the company's public relations interests.

The video was brought to light in an article by Miriam Shuchman at Wired which was published last Thursday.

In the video, Anheuser-Busch InBev boasts to the public about its "Smart Drinking Goals" program, which is purportedly designed to reduce "hazardous" drinking. Several Anheuser-Busch executives-- including its CEO, Chief "Health" Officer, and Chief Legal and Financial Officer--appear in the video, boasting about how wonderful this program is and implying how great a company Anheuser-Busch is for funding this program and how much it cares about the public's health.

But the Anheuser-Busch executives aren't the only ones who appear in this promotional, public relations video.

Shockingly, this Anheuser-Busch PR effort (i.e., public relations effort) is also endorsed and promoted by senior officials of the Executive Branch of the United States government. And even worse, those senior officials are the Director and the Director of Global Alcohol Research of the NIAAA!

The Director of Global Alcohol Research at NIAAA provides a glowing endorsement of the program, describing it as "wonderful" (see 0:27-0:34 in the video). The Director of NIAAA also endorses the program, asserting that it will "go far in moving the field forward" (see 3:17-3:26).

Brilliantly, Anheuser-Busch intersperses promotional statements from its own executives with promotional statements from the NIAAA officials, thus creating a clear endorsement of the program by the NIAAA itself, which is a public relations coup for the company.

The true purpose of the video is revealed at 3:42, when an Anheuser-Busch Global Advisory Council reveals the company's aspiration: "We're no longer a neighborhood's beer or a country's beer. We're in fact a corporation representing the world."

The video is clearly marketing Budweiser and other beers produced by Anheuser-Busch. As the company acknowledges, they are running this international program because they don't just want to be a neighborhood's beer or a country's beer; they want to be the world's beer.

There's nothing wrong with that aspiration. In fact, were I a shareholder, I would be very pleased with this amazing public relations ploy. I would be more than thrilled that the company was able to get the leadership of NIAAA to endorse this effort to make Anheuser-Busch the world's beer. However, there is something very wrong with NIAAA officials appearing in this promotional video and endorsing this marketing ploy.

The Rest of the Story

The rest of the story is that the Director of NIAAA and the Director of Global Research at NIAAA are essentially endorsing a public relations effort of the world's largest beer company by appearing in a promotional video whose true purpose is to expand Budweiser sales so that it becomes the world's beer.

This is entirely inappropriate, as the NIAAA has no business aiding Anheuser-Busch in its marketing efforts. Nor does the NIAAA have any business endorsing a public relations effort, or any other program, of this alcohol company.

Not only does the appearance of the Director of the NIAAA in this video undermine the public health mission of the National Institutes of Health, but in my view, it is a clear ethics violation.

According to Title 5, Chapter 45, Part 5501 of the Code of Federal Regulations--a section known as the Supplemental Standards of Ethical Conduct for Employees of the Department of Health and Human Services--no employee of the NIH may:

"Engage in any employment or self-employed business activity that involves the sale or promotion of products or services of a substantially affected organization or a health care provider or insurer, except for the purpose of commercializing invention rights obtained by the employee pursuant to Executive Order 10096, 15 U.S.C. 3710d, or implementing regulations." 

[Section 5501.109 - Prohibited outside activities applicable to employees of the National Institutes of Health - at (c)(1)(iii)].

The appearance of the NIH Director and the NIH Director of Global Research in this Anheuser-Busch InBev promotional video violates this standard because it involves the promotion of a product or service of Anheuser-Busch, which is a substantially affected organization because its profits may be directly impacted by an activity of the NIAAA (namely, the agency's research on the health benefits or risks of alcohol use).

In his defense, the NIAAA director told Wired: "It always surprises me when people are critical of us even talking to industry."

If NIAAA was merely talking to industry, it wouldn't be a problem. But appearing in an Anheuser-Busch promotional video is not merely talking to industry. It is actually promoting and endorsing a company product or service. By doing so, the NIAAA has participated in a marketing ploy of the company. Essentially, NIAAA is helping Anheuser-Busch to market beer and achieve its goal of becoming the world's beer.

In my view, NIAAA has been corrupted by the alcohol industry because it is acting as essentially a marketing branch for Anheuser-Busch. With the promotion of Anheuser-Busch's interests that NIAAA is providing, the company hardly needs its own marketing division. It can simply call the director of NIAAA it's de facto Director of Marketing and Public Relations. The alcohol industry couldn't have a better friend in a higher place.

Friday, October 06, 2017

My Response to an Invitation to Consult for the Foundation for a Smoke-Free World

Below is my response to an invitation to consult for the Foundation for a Smoke-Free World, funded by Philip Morris International:

Unfortunately, I will not be able to consult or play any advisory role on this project. Since Philip Morris International (PMI) continues to aggressively market cigarettes internationally and to aggressively fight public health efforts to reduce tobacco use, this is just not a project that I can participate in as a public health practitioner. PMI cannot be sincere in its intention to establish a smoke-free world when it continues to aggressively lobby against public health efforts to reduce tobacco use.

Thursday, August 31, 2017

Center for Tobacco Products is Lying to the Public About Youth Tobacco Use

This month, the FDA's Center for Tobacco Products (CTP) updated a chart purporting to show trends in youth tobacco use over the past 5 years.

Here are the facts (i.e., the "true" facts) displayed in the chart:

1. Youth cigarette use (among high school students) dropped by a huge amount from 2011 to 2016.
2. Cigar use dropped substantially from 2011 to 2016.
3. Pipe use dropped substantially from 2011 to 2016.
4. Smokeless tobacco use dropped slightly from 2011 to 2016.
5. Hookah use was essentially the same in 2011 and 2016.

Given those facts, here is the key question:

What happened to overall use of tobacco among high school students during the time period 2011-2016?

It doesn't take any fancy math or statistics to figure out that overall tobacco use among high school students must have declined substantially from 2011 to 2016. Since youth cigarette use dropped by a huge amount, cigar use dropped substantially, pipe used dropped substantially, smokeless tobacco use didn't change  much, and hookah use didn't change much, it stands to reason that overall tobacco use went down substantially. There is no way that youth tobacco use went up or even stayed the same from 2011 to 2016 because it dropped substantially for three categories of use but didn't change much in the other two categories.

The Rest of the Story

But that is not what the Center for Tobacco Products chose to tell the public.

Here is what the Center for Tobacco Products titled the chart:






















The CTP chose to tell the public that there was no significant decline in overall tobacco use over the past 5 years. However, as I showed above, that is simply not true. Youth tobacco use declined substantially.


So how does CTP justify this dishonesty?


It plays a trick on the public. It classifies e-cigarette use as a form of tobacco use and includes e-cigarette use in the totals for overall tobacco use. Since there was a huge increase in e-cigarette use from 2011 to 2016, CTP is able to completely undermine the fact that there was a dramatic drop in youth smoking, cigar use, and pipe use by adding youth who experimented with e-cigarettes. 


This is dishonest and inaccurate because e-cigarette use is not a form of tobacco use. The truth is -- and CTP knows this -- that e-cigarettes do not contain tobacco. In fact, the whole point of e-cigarettes is that they are an alternative to using tobacco. 

The rest of the story is that the Center for Tobacco Products is lying to the public. This is unfortunate because it risks losing the public's trust. It is also unfortunate because this deception could have deleterious public health effects, as misinforming people to think that e-cigarettes contain tobacco may dissuade many smokers from quitting and may even induce many ex-smokers to return to smoking. On top of all of this, it is - in my view- unethical to lie to the public, even if the aim were to discourage us from engaging in a potentially harmful behavior. I think the public deserves to know the truth. Someone has to start telling them the rest of the story. 


Note: Thanks to Clive Bates for alerting me to the deceptive headline in this dishonest communication.