In another example that demonstrates the hidden influence of Big Pharma on tobacco treatment policy and the extent to which many defenders of nicotine replacement therapy (NRT) are going to hide their conflicts of interest, an article (letter to the editor/reply) defending NRT from criticism that was published online ahead of print in the Journal of Clinical Epidemiology fails to disclose the serious conflicts of interest of its lead author.
The article is a response to a paper published recently in the Journal which concludes that once one accounts for publication bias, there is no significant effect of NRT on smoking cessation.
The published article (a PDF of the accepted manuscript) does not disclose any conflicts of interest that the authors may have. There is no conflict of interest statement at all.
The Rest of the Story
The rest of the story is that the lead author has a long string of financial relationships with pharmaceutical companies, including some that manufacture drugs for smoking cessation, such as NRT.
In 2016, the lead author was the recipient of a Pfizer research award for the study of nicotine dependence. That announcement reports that he "has received consulting fees, honoraria and grants from several
for-profit and non-profit organizations that develop smoking-cessation
devices, medications, and services, including Pfizer."
The lead author's online CV acknowledges that he has performed consulting services for: "Abbot Laboratories,Acrux Ltd, ALZA Corporation, American Cynamid, Anesta, Aradigm, BASF/Knoll, Begbies Traynor; Boehringer-Ingelheim Pharmaceuticals, Celtic Pharmaceuticals, Ciba-Geigy, Cygnus, DynaGen Corporation, Elan/Sano, Eli Lilly Pharmaceuticals, Glaxo Wellcome, Dupont Merck Pharmaceuticals, Hoechst Marion Rouseau/Marion Merrell Dow/Merrell Dow Lakeside, Lederle Pharmaceuticals, McNeil Pharmaceutical/McNeil Consumer, Nabi, Inc, Neuromedical Technologies, Inc., Neuroscience Ventures, Pacific Pharmaceuticals, Parke Davis Pharmaceuticals, Pfizer Pharmaceuticals, Pharmacia & Upjohn/AB Leo Pharmaceuticals/Kabi Pharmacia/Pfizer, Proctor & Gamble, Sano Pharmaceuticals, Propagate Pharmaceuticals, Sanofi/Synthelabo Pharmaceuticals, SmithKlineBeecham/Glaxo SmithKline Consumer Healthcare, Xenova Limited."
The lead author reports (in the online CV) having received grants from Pfizer (Chantix), McNeil Pharmaceuticals (Nicotrol inhaler and nicotine nasal spray), Pharmacia & Upjohn/Smith Klein Beecham Healthcare (nicotine gum), ALZA (Nicoderm), Marion Merrell Dow (Nicorette), and DynaGen (NicErase).
There doesn't appear to be any question that this author's financial conflicts of interest are hugely significant and highly relevant to the subject matter of the manuscript. Therefore, these conflicts of interest should have been disclosed in the published article so that readers can be aware of the conflicts and take that potential source of bias into consideration when evaluating the validity of the paper's conclusions.
It is not clear whether the failed disclosure in the published article is the fault of the authors or of the journal itself (i.e., it is possible that the authors disclosed these conflicts during the submission process but that the journal failed to add these disclosures to the published article). However, it doesn't matter because either way, readers are deprived of knowing about these important conflicts of interest. In addition, I believe it is the authors' obligation to ensure that the conflicts of interest are disclosed in the actual published paper. The authors are able to make such a correction when reviewing the manuscript proofs.
This is not the first example I have highlighted on this blog of the hiding of financial conflicts with Big Pharma in papers defending nicotine replacement therapy or other smoking cessation drugs. This is a general pattern I have observed. To me, it suggests that many defenders of NRT really do have something to hide. The evidence supporting NRT as a population-based strategy for smoking cessation is already flimsy, and it becomes even more flimsy once one considers the severe conflicts of interest of so many investigators who are evaluating these drugs. So it makes sense that there would be an effort to hide these conflicts from the public. But it is not an ethical practice, and it does a great disservice to the public and to the public's health.
(Thanks to John Polito for the tip.)
Thursday, September 29, 2016
Wednesday, September 28, 2016
FDA Issues New Draft Guidance on Regulation Compliance for Certain Types of E-Cigarettes; CDC Comments
The FDA took steps yesterday to clear a big point of confusion that has arisen concerning a subset of electronic cigarettes on the market. Due to novel technology that allows nicotine to be extracted in concentrated form from potatoes, a number of e-cigarette companies have switched to using potatoes as a source of nicotine for their e-liquids. Several companies have asked the FDA's Center for Tobacco Products for guidance on whether they need to comply with the tobacco product regulations, since their products do not contain tobacco and the nicotine used is not derived from tobacco.
Here is the relevant excerpt from the FDA's guidance document which explains how these products will be treated by the agency:
On May 10, 2016, the agency published a final rule that deems all products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to FDA's tobacco product authorities under chapter IX of the FD&C Act. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product,” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” and does not mean “an article that is a drug under subsection (g)(1), a device under subsection (b), or a combination product described in section 353(g) of this title.”
Products that contain nicotine derived from tobacco meet the definition of a tobacco product under the FD&C Act and are required to bear a health warning on packages and in advertisements stating: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” For products that are made or derived from tobacco (but do not contain nicotine), manufacturers may submit a certification to FDA and, instead, bear the statement “This product is made from tobacco.”
The definition of “tobacco product” as set forth in section 201(rr) of the FD&C Act includes all components, parts, and accessories of tobacco products (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). FDA interprets components and parts of a tobacco product to include any assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product. E-liquids that do not contain nicotine or other substances derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not meet the definition of accessory.
E-liquids that contain nicotine derived from potatoes do not meet the statutory definition of "tobacco product" unless they are reasonably expected to be combined with a tobacco product. However, since e-liquids that contain nicotine derived from potatoes are "potato products," the agency declares that such products must comply with Marketing Order No. 946, as amended (7 CFR part 946), regulating the handling of potatoes, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
Under the order, regulated potatoes must be inspected and certified by FSIS. As authorized under the order, the Committee uses information included on FSIS inspection certificates as a basis for collecting assessments and compiling industry statistics. The order requires handlers to submit reports to provide information on the volume of red types of potatoes handled for the fresh market. The order includes handling regulations for all varieties or varietal types of potatoes grown in the production area. These regulations can include minimum grade, size, quality, maturity, and inspection requirements. They can also provide for the size, capacity, weight, dimensions, pack, marking, or labeling of containers used in the handling of such potatoes.
Because the agency has deemed e-liquids using nicotine derived from potatoes to be "potato products," these e-liquids and any vaping devices intended for use with these e-liquids are subject to inspection and certification by FSIS. These e-cigarette manufacturers must also submit reports to provide information on the volume of red potatoes handled for the fresh market. They must also comply with the handling regulations for all varieties or varietal types of potatoes grown in the production area.
The Rest of the Story
I have to give the FDA credit for at least following its own logic. If e-liquids that use nicotine derived from tobacco are "tobacco products," then e-liquids using nicotine derived from potatoes are "potato products," and their manufacturers should be subject to all regulations for potatoes, including handling, inspection, packaging, labeling, and production requirements. However, I have to question why the agency ignored the recent emergence of companies that are using nicotine derived from eggplants to prepare e-liquids. Clearly, these products should be deemed "eggplant products" and should be required to comply with all USDA regulations governing the production, inspection, and labeling of eggplants.
Understandably, many small business owners who are in the e-liquid potato nicotine extraction business were upset. The president of NicoSpud E-Liquids was quoted as saying: "These regulations are going to decimate the potato nicotine extraction business. As a small company, we cannot afford the expense of complying with the detailed reporting, inspection, packaging, and labeling requirements. The FDA has basically handed the entire market over to Big Potato." Indeed, the two largest potato manufacturers have each put their own brand of potato-derived e-cigarettes on the market. The R.D. Offutt Company is now selling its "E-Tater" brand in major convenience stores across the country. J.R. Simplot is test-marketing its "SafeSpuds" in Colorado and Utah.
But the national anti-vaping groups defended the FDA's action. According to the Campaign for Tobacco-Free Kids: "Following the playbook of Big Tobacco, e-cigarette companies are using sweet flavors to entice kids to what could turn into a lifetime addiction to nicotine." The Campaign called out "Sweet Potate," a Tampa-based company, for using the word "sweet" in the very name of the product (Sweet Potate Cigs).
The CDC also supported the new guidance, saying: "The use of nicotine in any form is hazardous and can cause impaired brain development in adolescence. The great gains we have seen over the past decades in reducing youth smoking are sadly being undermined by their increased use of potato products."
The CDC, in classifying e-cigarettes using nicotine derived from potatoes as "potato products," has recently documented a large increase in youth potato use. While actual youth consumption of potatoes has fallen significantly, overall potato use among high school students has increased over the past two years.
I do not understand why the FDA and CDC need to lie about these e-cigarettes. They are not potato products simply because the nicotine in their e-liquids happens to be derived from potatoes. And classifying the use of these e-cigarettes as "potato use" is disingenuous at best. Why do we need to lie in order to make our point? Wouldn't it be enough to tell kids that these products are not made from potatoes and therefore do not carry the same safety profile as potatoes. Already, there is evidence of widespread public confusion. More than 50% of youth surveyed believe that e-cigarette use is no more hazardous than eating candied yams.
The rest of the story is that by treating e-cigarettes like NicoSpud, SafeSpud, and SweetPotate exactly like potato products and by classifying them as potato products, the FDA and CDC are essentially telling the public, including our children, that the hazards of vaping these products are virtually identical to those of consuming potatoes.
What will it take for these agencies to understand that just because the nicotine in the latest generation of e-cigarettes happens to be derived from potatoes, that does not mean they are potato products? It is misleading if not outright dishonest to talk about these e-cigarettes as "potato products," to classify them as potato products in surveys, and to claim that youth who are using these products are engaging in potato use.
Here is the relevant excerpt from the FDA's guidance document which explains how these products will be treated by the agency:
On May 10, 2016, the agency published a final rule that deems all products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to FDA's tobacco product authorities under chapter IX of the FD&C Act. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product,” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” and does not mean “an article that is a drug under subsection (g)(1), a device under subsection (b), or a combination product described in section 353(g) of this title.”
Products that contain nicotine derived from tobacco meet the definition of a tobacco product under the FD&C Act and are required to bear a health warning on packages and in advertisements stating: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” For products that are made or derived from tobacco (but do not contain nicotine), manufacturers may submit a certification to FDA and, instead, bear the statement “This product is made from tobacco.”
The definition of “tobacco product” as set forth in section 201(rr) of the FD&C Act includes all components, parts, and accessories of tobacco products (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). FDA interprets components and parts of a tobacco product to include any assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product. E-liquids that do not contain nicotine or other substances derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not meet the definition of accessory.
E-liquids that contain nicotine derived from potatoes do not meet the statutory definition of "tobacco product" unless they are reasonably expected to be combined with a tobacco product. However, since e-liquids that contain nicotine derived from potatoes are "potato products," the agency declares that such products must comply with Marketing Order No. 946, as amended (7 CFR part 946), regulating the handling of potatoes, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
Under the order, regulated potatoes must be inspected and certified by FSIS. As authorized under the order, the Committee uses information included on FSIS inspection certificates as a basis for collecting assessments and compiling industry statistics. The order requires handlers to submit reports to provide information on the volume of red types of potatoes handled for the fresh market. The order includes handling regulations for all varieties or varietal types of potatoes grown in the production area. These regulations can include minimum grade, size, quality, maturity, and inspection requirements. They can also provide for the size, capacity, weight, dimensions, pack, marking, or labeling of containers used in the handling of such potatoes.
Because the agency has deemed e-liquids using nicotine derived from potatoes to be "potato products," these e-liquids and any vaping devices intended for use with these e-liquids are subject to inspection and certification by FSIS. These e-cigarette manufacturers must also submit reports to provide information on the volume of red potatoes handled for the fresh market. They must also comply with the handling regulations for all varieties or varietal types of potatoes grown in the production area.
The Rest of the Story
I have to give the FDA credit for at least following its own logic. If e-liquids that use nicotine derived from tobacco are "tobacco products," then e-liquids using nicotine derived from potatoes are "potato products," and their manufacturers should be subject to all regulations for potatoes, including handling, inspection, packaging, labeling, and production requirements. However, I have to question why the agency ignored the recent emergence of companies that are using nicotine derived from eggplants to prepare e-liquids. Clearly, these products should be deemed "eggplant products" and should be required to comply with all USDA regulations governing the production, inspection, and labeling of eggplants.
Understandably, many small business owners who are in the e-liquid potato nicotine extraction business were upset. The president of NicoSpud E-Liquids was quoted as saying: "These regulations are going to decimate the potato nicotine extraction business. As a small company, we cannot afford the expense of complying with the detailed reporting, inspection, packaging, and labeling requirements. The FDA has basically handed the entire market over to Big Potato." Indeed, the two largest potato manufacturers have each put their own brand of potato-derived e-cigarettes on the market. The R.D. Offutt Company is now selling its "E-Tater" brand in major convenience stores across the country. J.R. Simplot is test-marketing its "SafeSpuds" in Colorado and Utah.
But the national anti-vaping groups defended the FDA's action. According to the Campaign for Tobacco-Free Kids: "Following the playbook of Big Tobacco, e-cigarette companies are using sweet flavors to entice kids to what could turn into a lifetime addiction to nicotine." The Campaign called out "Sweet Potate," a Tampa-based company, for using the word "sweet" in the very name of the product (Sweet Potate Cigs).
The CDC also supported the new guidance, saying: "The use of nicotine in any form is hazardous and can cause impaired brain development in adolescence. The great gains we have seen over the past decades in reducing youth smoking are sadly being undermined by their increased use of potato products."
The CDC, in classifying e-cigarettes using nicotine derived from potatoes as "potato products," has recently documented a large increase in youth potato use. While actual youth consumption of potatoes has fallen significantly, overall potato use among high school students has increased over the past two years.
I do not understand why the FDA and CDC need to lie about these e-cigarettes. They are not potato products simply because the nicotine in their e-liquids happens to be derived from potatoes. And classifying the use of these e-cigarettes as "potato use" is disingenuous at best. Why do we need to lie in order to make our point? Wouldn't it be enough to tell kids that these products are not made from potatoes and therefore do not carry the same safety profile as potatoes. Already, there is evidence of widespread public confusion. More than 50% of youth surveyed believe that e-cigarette use is no more hazardous than eating candied yams.
The rest of the story is that by treating e-cigarettes like NicoSpud, SafeSpud, and SweetPotate exactly like potato products and by classifying them as potato products, the FDA and CDC are essentially telling the public, including our children, that the hazards of vaping these products are virtually identical to those of consuming potatoes.
What will it take for these agencies to understand that just because the nicotine in the latest generation of e-cigarettes happens to be derived from potatoes, that does not mean they are potato products? It is misleading if not outright dishonest to talk about these e-cigarettes as "potato products," to classify them as potato products in surveys, and to claim that youth who are using these products are engaging in potato use.
ADDENDUM: It has come to my attention that many readers did not realize that this is a parody – my attempt at
satire. It is a sad state of affairs that the FDA’s logic has been so
terrible that my readers don’t know if this is true or not. That was my exact point in doing this piece. I wanted to show
the absurdity of the FDA’s approach – and I think this analogy points it out in
a way that many anti-vaping organizations would not understand in any other way. If there is any doubt about whether the deeming regulations are "arbitrary and capricious," this is the proof.
Tuesday, September 27, 2016
FDA and CDC are Lying About the Most Basic of Facts; How Can We Trust Them on More Complex Issues?
Donald Trump is not the only one who needs some fact-checking. My analysis of the September 22 article by the CDC's Office on Smoking and Health and the FDA's Center for Tobacco Products reveals that these agencies are misleading the public by lying to them about the most basic of facts: namely, whether or not electronic cigarettes contain tobacco.
According to the article: "e-cigarettes were the most commonly used tobacco product by middle (3.9%) and high (13.4%) school students. Use of tobacco in any form, whether it be combusted, noncombusted, or electronic, is unsafe."
Clearly, the CDC and FDA are telling the public that e-cigarettes represent the "use of tobacco" in electronic form. But this is untrue. Electronic cigarettes do not contain any tobacco. In fact, that is what distinguishes them from conventional cigarettes and from all tobacco products. In contrast to tobacco products, which contain tobacco, electronic cigarettes do not contain tobacco.
If you can't get past that most basic point, then there is no point continuing the discussion any further.
The FDA and CDC go on to state that: "Regardless of mode of exposure to nicotine (inhaling, chewing, or electronic), such exposure during adolescence (a critical time for brain development) may have lasting adverse consequences for brain development. Nicotine exposure during adolescence also causes addiction and may lead to sustained use of tobacco products." While there is evidence that this is true for cigarettes, I'm aware of no evidence that the use of e-cigarettes causes abnormal brain development. Further, I'm aware of no evidence that e-cigarettes cause nicotine addiction or that they lead to sustained use of tobacco products.
The study reiterates that it is examining "curiosity about tobacco." But curiosity about e-cigarettes is not curiosity about tobacco. In fact, it is the exact opposite. It is curiosity about a non-tobacco product. It is curiosity about a tobacco-free product. If the FDA and CDC can't be trusted to make that critical distinction and to communicate it accurately to the public, then how can they be trusted to address more complex issues such as developing policies on cigarettes and e-cigarettes that are going to maximize the protection of the public's health?
The Rest of the Story
A number of my colleagues have suggested to me that although the FDA and CDC are not telling the truth, the end goal of scaring kids into thinking that e-cigarettes are just as bad as cigarettes is a good one and will have a beneficial outcome, because it may help turn the tide of increasing experimentation with these products. I don't agree for three reasons:
1. Dishonesty is never justified in public health communication: The public health code of ethics requires that we be honest in our communications to the public. This is not simply an option that we have to consider among other possible options. This is an underlying principle that should not be discarded, even if we perceive that being dishonest may yield short-term public health gains.
2. Being dishonest risks losing public credibility and trust: Even if lying to the public - such as telling them that e-cigarettes are a form of tobacco use - were to produce short-term gains, these gains are far outweighed by the risk of doing long-term damage to the credibility and trust of public health. Once that credibility and trust are lost, it is not going to come back for a long time. And then, even when we do tell the truth, the public will not believe us.
3. The FDA and CDC's misleading the public about the fact that e-cigarettes contain no tobacco is actually having adverse public health consequences: Even if one were to throw concerns about honesty out the window, I don't believe that misleading the public by making them think that e-cigarettes are just another form of tobacco use has even short-term benefits. Conversely, by obscuring this critical difference between cigarettes and vaping products, this deception is leading many smokers to give up on attempts to quit smoking and it is causing many ex-smokers to consider returning to smoking because they don't see any benefit to vaping over smoking if they are simply alternative ways of using tobacco. Why continue vaping if it doesn't offer clear health benefits over smoking?
Would it kill the CDC or the FDA to once, just once, acknowledge that electronic cigarettes are tobacco-free products? I don't believe I have ever seen even a single communication, public statement, or article from either agency which acknowledges that e-cigarettes do not contain tobacco. This is absurd when you think about it because it is doing the greatest favor to cigarette profits that one could imagine: hiding the fact that there is a tobacco-free alternative which people can use by which they can avoid the use of tobacco as well as the combustion of tobacco.
The cigarette companies couldn't pay for a more effective marketing campaign to protect cigarette sales against competition.
According to the article: "e-cigarettes were the most commonly used tobacco product by middle (3.9%) and high (13.4%) school students. Use of tobacco in any form, whether it be combusted, noncombusted, or electronic, is unsafe."
Clearly, the CDC and FDA are telling the public that e-cigarettes represent the "use of tobacco" in electronic form. But this is untrue. Electronic cigarettes do not contain any tobacco. In fact, that is what distinguishes them from conventional cigarettes and from all tobacco products. In contrast to tobacco products, which contain tobacco, electronic cigarettes do not contain tobacco.
If you can't get past that most basic point, then there is no point continuing the discussion any further.
The FDA and CDC go on to state that: "Regardless of mode of exposure to nicotine (inhaling, chewing, or electronic), such exposure during adolescence (a critical time for brain development) may have lasting adverse consequences for brain development. Nicotine exposure during adolescence also causes addiction and may lead to sustained use of tobacco products." While there is evidence that this is true for cigarettes, I'm aware of no evidence that the use of e-cigarettes causes abnormal brain development. Further, I'm aware of no evidence that e-cigarettes cause nicotine addiction or that they lead to sustained use of tobacco products.
The study reiterates that it is examining "curiosity about tobacco." But curiosity about e-cigarettes is not curiosity about tobacco. In fact, it is the exact opposite. It is curiosity about a non-tobacco product. It is curiosity about a tobacco-free product. If the FDA and CDC can't be trusted to make that critical distinction and to communicate it accurately to the public, then how can they be trusted to address more complex issues such as developing policies on cigarettes and e-cigarettes that are going to maximize the protection of the public's health?
The Rest of the Story
A number of my colleagues have suggested to me that although the FDA and CDC are not telling the truth, the end goal of scaring kids into thinking that e-cigarettes are just as bad as cigarettes is a good one and will have a beneficial outcome, because it may help turn the tide of increasing experimentation with these products. I don't agree for three reasons:
1. Dishonesty is never justified in public health communication: The public health code of ethics requires that we be honest in our communications to the public. This is not simply an option that we have to consider among other possible options. This is an underlying principle that should not be discarded, even if we perceive that being dishonest may yield short-term public health gains.
2. Being dishonest risks losing public credibility and trust: Even if lying to the public - such as telling them that e-cigarettes are a form of tobacco use - were to produce short-term gains, these gains are far outweighed by the risk of doing long-term damage to the credibility and trust of public health. Once that credibility and trust are lost, it is not going to come back for a long time. And then, even when we do tell the truth, the public will not believe us.
3. The FDA and CDC's misleading the public about the fact that e-cigarettes contain no tobacco is actually having adverse public health consequences: Even if one were to throw concerns about honesty out the window, I don't believe that misleading the public by making them think that e-cigarettes are just another form of tobacco use has even short-term benefits. Conversely, by obscuring this critical difference between cigarettes and vaping products, this deception is leading many smokers to give up on attempts to quit smoking and it is causing many ex-smokers to consider returning to smoking because they don't see any benefit to vaping over smoking if they are simply alternative ways of using tobacco. Why continue vaping if it doesn't offer clear health benefits over smoking?
Would it kill the CDC or the FDA to once, just once, acknowledge that electronic cigarettes are tobacco-free products? I don't believe I have ever seen even a single communication, public statement, or article from either agency which acknowledges that e-cigarettes do not contain tobacco. This is absurd when you think about it because it is doing the greatest favor to cigarette profits that one could imagine: hiding the fact that there is a tobacco-free alternative which people can use by which they can avoid the use of tobacco as well as the combustion of tobacco.
The cigarette companies couldn't pay for a more effective marketing campaign to protect cigarette sales against competition.
Monday, September 26, 2016
American Lung Association Tells Public that Smoking May Be No More Hazardous than Vaping
Despite the abundance of scientific evidence, including clinical studies, which demonstrate that vaping is much safer than smoking, the American Lung Association - as recently as last week - told the public that smoking may be no more hazardous than vaping.
A UPI article quoted the American Lung Association's senior scientific advisor as stating: "We have no idea what the long-term effects are because they [e-cigarettes] haven't been around long enough, but there's no reason to consider e-cigarettes safe. Whether they're going to cause less disease than tobacco cigarettes, we'll eventually get that answer but it's going to take years."
The Rest of the Story
Unfortunately, in my view, the American Lung Association has completely lost any semblance of scientific credibility. They are telling the public that smoking may be no more hazardous than vaping, which is inconsistent with the scientific evidence, which definitively demonstrates that vaping is much safer than smoking. While one might argue about the exact magnitude of the decreased risk, there is no legitimate scientific argument that vaping is not drastically safer than smoking.
Even the fiercest vaping opponents - like Stan Glantz - agree that smoking is much more hazardous than vaping.
The evidence that vaping is dramatically safer than smoking continues to build. Recently, a study out of the Roswell Park Cancer Institute demonstrated substantial reductions in carcinogens and toxicants in vapers who had switched from cigarettes:
"Researchers measured levels of seven nicotine metabolites and 17 biomarkers of exposure to carcinogens and toxicants present in cigarette smoke. Their analysis revealed that while the nicotine metabolites remained unchanged among the majority of study participants – suggesting that e-cigarettes deliver nicotine effectively – the levels of the 17 toxicants and carcinogens measured dropped significantly after just one week of switching to e-cigarettes. For 12 of these 17 chemicals, the decline in was similar to the decline seen among tobacco users who quit smoking. “Toxins and carcinogens we measured in the body almost disappeared – the body cleared the 17 different chemicals we were looking for,” Goniewicz said. “They are safer, less toxic. It’s the first time we have very strong evidence that we will be able now to give (smokers) that the answer is, yes , this you should consider a transition, a substitute for your tobacco cigarette that will save your life.”"
You have to go back at least 16 years - and to the old playbook of the tobacco industry - to find another example of an organization lying so blatantly to the public about the severe hazards of smoking and undermining decades of education by public health officials. It is just far too ironic that the organization reverting to this tactic is a health group that is supposed to be fighting smoking in order to reduce lung disease.
It is highly irresponsible for the American Lung Association to be undermining the public's appreciation of the severe hazards of smoking in such a blatant and destructive way. This not only does a disservice to the American Lung Association's donors and contributors, but it also threatens the credibility of the ALA and other public health groups and undermines the stated mission of the ALA which is supposed to be to fight against, not for, lung disease.
The ALA should be jumping for joy to see a feasible alternative to smoking that is popular among smokers and which is successfully helping millions of smokers to quit smoking completely or to cut down substantially on the amount they smoke. They should be encouraging all smokers to quit, even those who want to try to quit using e-cigarettes. By demonizing these products, they are actually promoting smoking by deterring many smokers from trying to quit and by getting many former smokers who quit by vaping to think about going back to smoking, since if there is no clear health benefit, then why not just go back to smoking?
Anyone who cares about the integrity and reputation of the American Lung Association should be protesting this fallacious statement and urging the ALA to get back into the business of telling the truth.
A UPI article quoted the American Lung Association's senior scientific advisor as stating: "We have no idea what the long-term effects are because they [e-cigarettes] haven't been around long enough, but there's no reason to consider e-cigarettes safe. Whether they're going to cause less disease than tobacco cigarettes, we'll eventually get that answer but it's going to take years."
The Rest of the Story
Unfortunately, in my view, the American Lung Association has completely lost any semblance of scientific credibility. They are telling the public that smoking may be no more hazardous than vaping, which is inconsistent with the scientific evidence, which definitively demonstrates that vaping is much safer than smoking. While one might argue about the exact magnitude of the decreased risk, there is no legitimate scientific argument that vaping is not drastically safer than smoking.
Even the fiercest vaping opponents - like Stan Glantz - agree that smoking is much more hazardous than vaping.
The evidence that vaping is dramatically safer than smoking continues to build. Recently, a study out of the Roswell Park Cancer Institute demonstrated substantial reductions in carcinogens and toxicants in vapers who had switched from cigarettes:
"Researchers measured levels of seven nicotine metabolites and 17 biomarkers of exposure to carcinogens and toxicants present in cigarette smoke. Their analysis revealed that while the nicotine metabolites remained unchanged among the majority of study participants – suggesting that e-cigarettes deliver nicotine effectively – the levels of the 17 toxicants and carcinogens measured dropped significantly after just one week of switching to e-cigarettes. For 12 of these 17 chemicals, the decline in was similar to the decline seen among tobacco users who quit smoking. “Toxins and carcinogens we measured in the body almost disappeared – the body cleared the 17 different chemicals we were looking for,” Goniewicz said. “They are safer, less toxic. It’s the first time we have very strong evidence that we will be able now to give (smokers) that the answer is, yes , this you should consider a transition, a substitute for your tobacco cigarette that will save your life.”"
You have to go back at least 16 years - and to the old playbook of the tobacco industry - to find another example of an organization lying so blatantly to the public about the severe hazards of smoking and undermining decades of education by public health officials. It is just far too ironic that the organization reverting to this tactic is a health group that is supposed to be fighting smoking in order to reduce lung disease.
It is highly irresponsible for the American Lung Association to be undermining the public's appreciation of the severe hazards of smoking in such a blatant and destructive way. This not only does a disservice to the American Lung Association's donors and contributors, but it also threatens the credibility of the ALA and other public health groups and undermines the stated mission of the ALA which is supposed to be to fight against, not for, lung disease.
The ALA should be jumping for joy to see a feasible alternative to smoking that is popular among smokers and which is successfully helping millions of smokers to quit smoking completely or to cut down substantially on the amount they smoke. They should be encouraging all smokers to quit, even those who want to try to quit using e-cigarettes. By demonizing these products, they are actually promoting smoking by deterring many smokers from trying to quit and by getting many former smokers who quit by vaping to think about going back to smoking, since if there is no clear health benefit, then why not just go back to smoking?
Anyone who cares about the integrity and reputation of the American Lung Association should be protesting this fallacious statement and urging the ALA to get back into the business of telling the truth.
Friday, September 23, 2016
FDA Violated Ethics Rules to Censor Dissenting Opinions about Its E-Cigarette Regulations
According to a shocking exposé in the October 16th issue of Scientific American written by Charles Seife, the FDA censored dissenting opinions about its e-cigarette regulations by prohibiting journalists covering the release of these regulations from speaking with anyone who might oppose them.
The FDA's e-cigarette regulations were initially released on April 24, 2014. On April 23, the FDA's Center for Tobacco Products held a press briefing for a select group of reporters to provide information so that they could publish news stories about the regulations at the expiration of the embargo, which was set for April 24th. It is not uncommon to set an embargo date and time for the release of a story by media outlets. It helps ensure that all media outlets have an equal opportunity to publish the story in a timely fashion and not to get "scooped" by one favored media outlet.
However, the FDA went beyond the simple step of setting an embargo date and time for the publication of media stories. First, the agency only invited a select group of reporters to the media briefing, ensuring that only reporters who were "friendly" to the FDA's position would be able to cover the story in a timely fashion and that such "friendly" reporters would get a scoop on the story.
Second, the FDA prohibited the reporters at the media briefing from talking to anyone else about the regulations prior to the embargo, meaning that in the articles coming out about the regulations at the expiration of the embargo, there was no possible way for reporters to provide quotes from individuals who might have dissenting opinions about the regulations. In other words, the FDA ensured that only its own position could be presented to the public.
The article explains that reporters at the briefing were told: "You will not be able to reach out to third parties for comment on this announcement."
In addition, reporters were sent an email stating that: "Third-party outreach of any kind was and is not permitted for this announcement. Everyone who participated agreed to this. ... We take this matter very seriously, and as a consequence any individuals who violated the embargo will be excluded from future embargoed briefings with the agency."
The FDA thought that its little scheme to prevent the public from reading dissenting opinions about the regulations had worked to perfection. It apparently did work to perfection in terms of the nature of the media coverage, which of course failed to present any dissenting opinions from experts. However, one courageous reporter exposed the fact that the FDA was censoring media coverage by not allowing reporters to seek comments from experts who might have dissenting opinions. In her article, she noted that:
"FDA officials gave journalists an outline of the new rules on Wednesday but required that they not talk to industry or public health groups until after Thursday's formal release of the document."
According to Scientific American: "'I felt like I wanted to be clear with readers,' Sabrina Tavernise, the author of the story, later told Sullivan, the New York Times' public editor at the time. 'Usually you would have reaction in a story like this, but in this case, there wasn't going to be any.'"
The FDA then blasted Tavernise in an email to her, stating: "I have to say while I generally reserve my editorial comments, I was a little surprised by the tone of your article and the swipe you took at the embargo in the paper—when after combing through the coverage no one else felt the need to do so in quite that way."
The FDA was apparently not only prohibiting reporters from presenting an alternative perspective on its regulations but also prohibiting them from informing readers that they were not allowed to seek out alternative opinions. So the FDA was engaging not only in censorship but in a cover-up of that censorship.
At the time, Eric Boehm of Watchdog.org wrote about the FDA's censorship: "Essentially, the Times agreed to feed the public information about new regulations, but without being able to talk to any of the people affected by the regulations. What did that leave them in terms of perspective? Only those who favored the new regulations, of course."
According to Seife, the FDA is violating its own ethics policy, established in 2011, which states that: "A journalist may share embargoed material provided by the FDA with nonjournalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third party to uphold the embargo."
In a revealing section of his article, Seife explains that:
"Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story. At the same time, the FDA cultivates a coterie of journalists whom it keeps in line with threats. And the agency has made it a practice to demand total control over whom reporters can and can't talk to until after the news has broken, deaf to protests by journalistic associations and media ethicists and in violation of its own written policies."
Seife concludes that: "By using close-hold embargoes and other methods, the FDA, like other sources of scientific information, are gaining control of journalists who are supposed to keep an eye on those institutions. The watchdogs are being turned into lapdogs."
The Rest of the Story
The rest of the story is that the FDA, including the Center for Tobacco Products, used censorship to ensure one-sided coverage of its e-cigarette regulations, thus denying the public the opportunity to receive a balanced perspective on the important public health issues at stake. In spite of the First Amendment, this censorship was successfully achieved by offering select reporters a sneak preview of the regulations and an opportunity to "scoop" other reporters, but forcing them to agree not to seek third party comments in order to secure this privileged status. In doing so, it appears that the FDA and CTP violated their own ethics rules. The end result was censoring any dissenting views on the e-cigarette regulations and ensuring that the public would only be presented with the FDA's side of the issue.
In my view, this is a clear violation of scientific ethics as well as the public health code of conduct. This is something you might expect out of the playbook of Big Tobacco or other corporations, not out of a federal agency charged with protecting the public's health.
The FDA's e-cigarette regulations were initially released on April 24, 2014. On April 23, the FDA's Center for Tobacco Products held a press briefing for a select group of reporters to provide information so that they could publish news stories about the regulations at the expiration of the embargo, which was set for April 24th. It is not uncommon to set an embargo date and time for the release of a story by media outlets. It helps ensure that all media outlets have an equal opportunity to publish the story in a timely fashion and not to get "scooped" by one favored media outlet.
However, the FDA went beyond the simple step of setting an embargo date and time for the publication of media stories. First, the agency only invited a select group of reporters to the media briefing, ensuring that only reporters who were "friendly" to the FDA's position would be able to cover the story in a timely fashion and that such "friendly" reporters would get a scoop on the story.
Second, the FDA prohibited the reporters at the media briefing from talking to anyone else about the regulations prior to the embargo, meaning that in the articles coming out about the regulations at the expiration of the embargo, there was no possible way for reporters to provide quotes from individuals who might have dissenting opinions about the regulations. In other words, the FDA ensured that only its own position could be presented to the public.
The article explains that reporters at the briefing were told: "You will not be able to reach out to third parties for comment on this announcement."
In addition, reporters were sent an email stating that: "Third-party outreach of any kind was and is not permitted for this announcement. Everyone who participated agreed to this. ... We take this matter very seriously, and as a consequence any individuals who violated the embargo will be excluded from future embargoed briefings with the agency."
The FDA thought that its little scheme to prevent the public from reading dissenting opinions about the regulations had worked to perfection. It apparently did work to perfection in terms of the nature of the media coverage, which of course failed to present any dissenting opinions from experts. However, one courageous reporter exposed the fact that the FDA was censoring media coverage by not allowing reporters to seek comments from experts who might have dissenting opinions. In her article, she noted that:
"FDA officials gave journalists an outline of the new rules on Wednesday but required that they not talk to industry or public health groups until after Thursday's formal release of the document."
According to Scientific American: "'I felt like I wanted to be clear with readers,' Sabrina Tavernise, the author of the story, later told Sullivan, the New York Times' public editor at the time. 'Usually you would have reaction in a story like this, but in this case, there wasn't going to be any.'"
The FDA then blasted Tavernise in an email to her, stating: "I have to say while I generally reserve my editorial comments, I was a little surprised by the tone of your article and the swipe you took at the embargo in the paper—when after combing through the coverage no one else felt the need to do so in quite that way."
The FDA was apparently not only prohibiting reporters from presenting an alternative perspective on its regulations but also prohibiting them from informing readers that they were not allowed to seek out alternative opinions. So the FDA was engaging not only in censorship but in a cover-up of that censorship.
At the time, Eric Boehm of Watchdog.org wrote about the FDA's censorship: "Essentially, the Times agreed to feed the public information about new regulations, but without being able to talk to any of the people affected by the regulations. What did that leave them in terms of perspective? Only those who favored the new regulations, of course."
According to Seife, the FDA is violating its own ethics policy, established in 2011, which states that: "A journalist may share embargoed material provided by the FDA with nonjournalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third party to uphold the embargo."
In a revealing section of his article, Seife explains that:
"Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story. At the same time, the FDA cultivates a coterie of journalists whom it keeps in line with threats. And the agency has made it a practice to demand total control over whom reporters can and can't talk to until after the news has broken, deaf to protests by journalistic associations and media ethicists and in violation of its own written policies."
Seife concludes that: "By using close-hold embargoes and other methods, the FDA, like other sources of scientific information, are gaining control of journalists who are supposed to keep an eye on those institutions. The watchdogs are being turned into lapdogs."
The Rest of the Story
The rest of the story is that the FDA, including the Center for Tobacco Products, used censorship to ensure one-sided coverage of its e-cigarette regulations, thus denying the public the opportunity to receive a balanced perspective on the important public health issues at stake. In spite of the First Amendment, this censorship was successfully achieved by offering select reporters a sneak preview of the regulations and an opportunity to "scoop" other reporters, but forcing them to agree not to seek third party comments in order to secure this privileged status. In doing so, it appears that the FDA and CTP violated their own ethics rules. The end result was censoring any dissenting views on the e-cigarette regulations and ensuring that the public would only be presented with the FDA's side of the issue.
In my view, this is a clear violation of scientific ethics as well as the public health code of conduct. This is something you might expect out of the playbook of Big Tobacco or other corporations, not out of a federal agency charged with protecting the public's health.
Wednesday, September 21, 2016
Helena Miracle? Not So Much; New Study Casts Doubt on Conclusions of Anti-Smoking Groups
For many years, anti-smoking groups have been claiming that smoking bans result in an immediate and dramatic decline in hospitalizations for heart attacks. This claim is based on studies like that conducted in Helena, in which the authors concluded that there was a 40% reduction in heart
attack admissions within 6-18 months after a bar and restaurant smoking
ban was implemented.
When these studies were first published, I warned anti-smoking groups not to use these conclusions to promote smoking bans because I believed that the conclusions were not adequately supported by the data. In particular, I criticized these studies and questioned their conclusions because they did not adequately account for secular trends in heart attack rates that were occurring even in the absence of smoking bans.
I also argued that it was not plausible to see such large effects in so short a time span because it takes many years for heart disease to develop. In contrast, I noted that respiratory effects might be observed immediately.
Finally, I argued that these findings were largely a result of publication bias. Cities for study were not chosen randomly. Instead, in places where there appeared to be a dramatic decline in heart attacks, that community was chosen for study. The few studies that did systematically examine this research question failed to find an immediate effect of smoking bans on heart attack hospitalization rates.
This week, a new study was published in the journal Medical Care Research and Review which re-examines the relationship between smoking bans and heart attack hospitalization rates.
(See: Ho V, et al. A nationwide assessment of the association of smoking bans and cigarette taxes with hospitalizations for acute myocardial infarction, heart failure, and pneumonia. Medical Care Research and Review 2016. Published online ahead of print on September 12, 2016. DOI: 10.1177/10775587/16668646.)
The authors summarize the study as follows:
"We examine the association between county-level smoking-related hospitalization rates and comprehensive smoking bans in 28 states from 2001 to 2008. Differences-in-differences analysis measures changes in hospitalization rates before versus after introducing bans in bars, restaurants, and workplaces, controlling for cigarette taxes, adjusting for local health and provider characteristics. Smoking bans were not associated with acute myocardial infarction or heart failure hospitalizations, but lowered pneumonia hospitalization rates for persons ages 60 to 74 years."
The Rest of the Story
The results of this study support the arguments that I made back in 2006, and which I have continued to emphasize on this blog over the past 10 years. The key finding of the study is that once you account for time-specific local trends in heart attack hospitalization rates, there is no longer a significant observed decline in heart attack rates associated with the implementation of these smoking bans.
The key data are in Table 2. Helpfully, this table provides regression estimates both with and without the inclusion of region-specific (in this case, county-specific) time trends in the rate of hospitalization for heart attacks. Note that without the county-specific time trends, the authors do find a significant decrease in hospitalizations for heart attacks associated with the implementation of smoking bans. But once they control for these local time trends, there is no longer a significant effect.
What this suggests is that communities that implemented smoking bans happened to be those which had a higher pre-existing rate of decline in heart attacks and that once you adjust for that, there is no difference associated with the implementation of the smoking bans.
The authors further demonstrate that the previous conclusions were spurious by showing that when you examine the impact of smoking bans on hospitalizations for hip fractures (which are not plausibly related to smoking bans), you find a significant effect of smoking bans when you don't include regional time trends. That spurious effect disappears once you control for the regional time trends.
The regional time trends are important to consider in these models because without them, you are making the assumption that the secular rates of decline in heart attacks at baseline were the same in communities with and without smoking bans. Apparently, this is not a fair assumption because the nature of cities that enacted smoking bans differed from that of cities which did not enact such laws. And those differences were reflected in higher rates of decline in heart attacks in the intervention communities.
It is interesting to note that it was my expression of the above opinions about these studies back in the mid-2000's that led to my "expulsion" from the tobacco control movement, including being thrown off several list-serves, ostracized by many of my colleagues, accused of being a "tobacco mole," being characterized by my hero and mentor - Stan Glantz - as being "a tragic figure," having copyright to one of my articles violated by an anti-smoking organization, no longer being invited to speak at tobacco conferences, not being able to present at tobacco control conferences anymore, not being able to obtain further research grants, and having colleagues refuse to appear with me at conferences to discuss these or any other scientific issues. In fact, it was this censorship that led to the creation of the Rest of the Story in the first place.
Nearly three million page views later, perhaps these groups knew what they were doing because it appears that I may have been right all along. By silencing me, these groups were able to disseminate their pre-determined conclusions widely to the public through the media long enough for the conclusions to be generally accepted. Now, it is too late to undo the damage. The media and the public have already made up their minds, and one article noting the results of this new study is not going to correct or undo 10 years of dissemination of unsupported and errant scientific conclusions.
To be clear, this issue has nothing to do with my support for smoking bans. My readers understand that I have and continue to support 100% smoke-free policies for all workplaces (including bars, restaurants, and casinos). However, I do believe that we can advocate for such policies without misrepresenting scientific evidence or exaggerating findings beyond what is scientifically defensible.
When these studies were first published, I warned anti-smoking groups not to use these conclusions to promote smoking bans because I believed that the conclusions were not adequately supported by the data. In particular, I criticized these studies and questioned their conclusions because they did not adequately account for secular trends in heart attack rates that were occurring even in the absence of smoking bans.
I also argued that it was not plausible to see such large effects in so short a time span because it takes many years for heart disease to develop. In contrast, I noted that respiratory effects might be observed immediately.
Finally, I argued that these findings were largely a result of publication bias. Cities for study were not chosen randomly. Instead, in places where there appeared to be a dramatic decline in heart attacks, that community was chosen for study. The few studies that did systematically examine this research question failed to find an immediate effect of smoking bans on heart attack hospitalization rates.
This week, a new study was published in the journal Medical Care Research and Review which re-examines the relationship between smoking bans and heart attack hospitalization rates.
(See: Ho V, et al. A nationwide assessment of the association of smoking bans and cigarette taxes with hospitalizations for acute myocardial infarction, heart failure, and pneumonia. Medical Care Research and Review 2016. Published online ahead of print on September 12, 2016. DOI: 10.1177/10775587/16668646.)
The authors summarize the study as follows:
"We examine the association between county-level smoking-related hospitalization rates and comprehensive smoking bans in 28 states from 2001 to 2008. Differences-in-differences analysis measures changes in hospitalization rates before versus after introducing bans in bars, restaurants, and workplaces, controlling for cigarette taxes, adjusting for local health and provider characteristics. Smoking bans were not associated with acute myocardial infarction or heart failure hospitalizations, but lowered pneumonia hospitalization rates for persons ages 60 to 74 years."
The Rest of the Story
The results of this study support the arguments that I made back in 2006, and which I have continued to emphasize on this blog over the past 10 years. The key finding of the study is that once you account for time-specific local trends in heart attack hospitalization rates, there is no longer a significant observed decline in heart attack rates associated with the implementation of these smoking bans.
The key data are in Table 2. Helpfully, this table provides regression estimates both with and without the inclusion of region-specific (in this case, county-specific) time trends in the rate of hospitalization for heart attacks. Note that without the county-specific time trends, the authors do find a significant decrease in hospitalizations for heart attacks associated with the implementation of smoking bans. But once they control for these local time trends, there is no longer a significant effect.
What this suggests is that communities that implemented smoking bans happened to be those which had a higher pre-existing rate of decline in heart attacks and that once you adjust for that, there is no difference associated with the implementation of the smoking bans.
The authors further demonstrate that the previous conclusions were spurious by showing that when you examine the impact of smoking bans on hospitalizations for hip fractures (which are not plausibly related to smoking bans), you find a significant effect of smoking bans when you don't include regional time trends. That spurious effect disappears once you control for the regional time trends.
The regional time trends are important to consider in these models because without them, you are making the assumption that the secular rates of decline in heart attacks at baseline were the same in communities with and without smoking bans. Apparently, this is not a fair assumption because the nature of cities that enacted smoking bans differed from that of cities which did not enact such laws. And those differences were reflected in higher rates of decline in heart attacks in the intervention communities.
It is interesting to note that it was my expression of the above opinions about these studies back in the mid-2000's that led to my "expulsion" from the tobacco control movement, including being thrown off several list-serves, ostracized by many of my colleagues, accused of being a "tobacco mole," being characterized by my hero and mentor - Stan Glantz - as being "a tragic figure," having copyright to one of my articles violated by an anti-smoking organization, no longer being invited to speak at tobacco conferences, not being able to present at tobacco control conferences anymore, not being able to obtain further research grants, and having colleagues refuse to appear with me at conferences to discuss these or any other scientific issues. In fact, it was this censorship that led to the creation of the Rest of the Story in the first place.
Nearly three million page views later, perhaps these groups knew what they were doing because it appears that I may have been right all along. By silencing me, these groups were able to disseminate their pre-determined conclusions widely to the public through the media long enough for the conclusions to be generally accepted. Now, it is too late to undo the damage. The media and the public have already made up their minds, and one article noting the results of this new study is not going to correct or undo 10 years of dissemination of unsupported and errant scientific conclusions.
To be clear, this issue has nothing to do with my support for smoking bans. My readers understand that I have and continue to support 100% smoke-free policies for all workplaces (including bars, restaurants, and casinos). However, I do believe that we can advocate for such policies without misrepresenting scientific evidence or exaggerating findings beyond what is scientifically defensible.
Tuesday, September 20, 2016
FDA-Induced Crumbling of E-Cigarette Market Begins: NJOY Files for Bankruptcy
It didn't take long after the FDA enacted its deeming regulations for the first of many e-cigarette companies to lose their ability to stay in the market. Just one and a half months after the FDA's deeming regulations went into effect, NJOY - one of the largest independent e-cigarette manufacturers in the U.S. - has filed for bankruptcy.
While a major reason for NJOY's inability to stay afloat was the failure of its King cig-a-like product, the company also cites the "substantial expenses of preparing for the Food and Drug Administration (FDA) deeming regulations."
As I have argued for some time, the capital costs involved in preparing pre-market applications under the deeming regulations are prohibitive for all but the tobacco companies and perhaps the largest independent manufacturers. With the loss of NJOY, it is not even clear whether any of the independent companies will survive, and even if they do, whether there will be any significant diversity in the e-cigarette market that remains.
The result will be the devastation of the overall e-cigarette market and the squandering of an amazing opportunity to substantially reduce smoking-related disease and death.
Today's story illustrates how the change in the e-cigarette market away from cig-a-likes and toward more advanced vaping products - including open systems - has been the key to the growth of the market. By essentially making it impossible for the smaller companies that manufacture more advanced products like open systems to survive and restricting the market to the more traditional cig-a-likes, the FDA has ensured that market growth will be stunted, essentially blocking the shift from combustible cigarettes to safer alternatives.
It is a sad day for public health because the FDA has contributed toward putting an anti-smoking company out of business. NJOY's value proposition was to make smoking obsolete," which is exactly what the FDA should be trying to do.
The Rest of the Story
The rest of the story is that the FDA is perversely pursuing the exact opposite of what it should be doing. The FDA is committed to the preservation of cigarette smoking and to the protection of cigarettes from competition from much safer products. The agency's obsession with the pre-market approval process - which was never intended for e-cigarettes - is destroying the long-term potential to replace combustible tobacco products with much safer tobacco-free and smoke-free products, at the expense of the protection of the public's health.
The result of the FDA's actions will be the re-normalization of smoking as the predominant vehicle for nicotine use in the United States. It is becoming clear that this really could be about "a billion lives."
While a major reason for NJOY's inability to stay afloat was the failure of its King cig-a-like product, the company also cites the "substantial expenses of preparing for the Food and Drug Administration (FDA) deeming regulations."
As I have argued for some time, the capital costs involved in preparing pre-market applications under the deeming regulations are prohibitive for all but the tobacco companies and perhaps the largest independent manufacturers. With the loss of NJOY, it is not even clear whether any of the independent companies will survive, and even if they do, whether there will be any significant diversity in the e-cigarette market that remains.
The result will be the devastation of the overall e-cigarette market and the squandering of an amazing opportunity to substantially reduce smoking-related disease and death.
Today's story illustrates how the change in the e-cigarette market away from cig-a-likes and toward more advanced vaping products - including open systems - has been the key to the growth of the market. By essentially making it impossible for the smaller companies that manufacture more advanced products like open systems to survive and restricting the market to the more traditional cig-a-likes, the FDA has ensured that market growth will be stunted, essentially blocking the shift from combustible cigarettes to safer alternatives.
It is a sad day for public health because the FDA has contributed toward putting an anti-smoking company out of business. NJOY's value proposition was to make smoking obsolete," which is exactly what the FDA should be trying to do.
The Rest of the Story
The rest of the story is that the FDA is perversely pursuing the exact opposite of what it should be doing. The FDA is committed to the preservation of cigarette smoking and to the protection of cigarettes from competition from much safer products. The agency's obsession with the pre-market approval process - which was never intended for e-cigarettes - is destroying the long-term potential to replace combustible tobacco products with much safer tobacco-free and smoke-free products, at the expense of the protection of the public's health.
The result of the FDA's actions will be the re-normalization of smoking as the predominant vehicle for nicotine use in the United States. It is becoming clear that this really could be about "a billion lives."
Monday, September 19, 2016
Deciding Vote in FDA Advisory Committee Recommendation to Remove Black Box Warning for Chantix is Cast by Pharmaceutical Company President; FDA Review Process is Badly Tainted
Last Wednesday, a pair of FDA advisory committees - meeting jointly - voted 10-9 to recommend that the FDA remove the black box warning for Chantix (varenicline). Currently, the black box warns about the potential for severe psychiatric side effects of Chantix, including depression and suicidal ideation. The recommendation is not binding, and the FDA is free to follow or ignore the advisory panel's vote.
According to an article at MedPage Today: "a few of those who voted to remove the warning said the study supplied the evidence needed to make them comfortable using Varenicline to address a major public health problem. 'The risk-benefit ratio is as clear as anything I have ever seen,' said David Pickar, MD, a Johns Hopkins Medical School psychiatry professor who said he works with psychiatric patients. Looking at his fellow committee members, Pickar added: 'For you, these are adverse events, but the benefit to these patients could be substantial in the most fundamental thing, which is being alive.'"
The Rest of the Story
What this article and similar ones are not telling you is that the advisory committee member mentioned above - who cast the deciding vote - is, believe it or not, the president of a pharmaceutical company!
In a whopping conflict of interest that is apparently not disclosed in the article, it turns out that Dr. Pickar, according to his own web site, is "Founder and President of Gabriel Sciences, a company whose mission is advancing the development of a novel treatment for schizophrenia." Prior to that, he was "Co-Founder of Comprehensive Neuroscience, Inc., a clinical trials and medical communication company where he served as a Director, Executive Vice-President and Chief Science Officer." On top of that, he "is the inventor on two US patents."
Dr. Pickar's curriculum vitae confirms that he is the founder and president of a pharmaceutical company (Gabriel Sciences). Prior to that (going back to 2001), he was the founder and president of Potomac Pharma, Inc., a biopharmaceutical company which has transferred assets to Gabriel Sciences. Thus, it appears that Dr. Pickar has been a pharmaceutical company president for the past 15 years. Dr. Pickar's patents appear to be related to strategies for the pharmacological treatment of schizophrenia. The patents were licensed exclusively to Potomac Pharma, Inc.
I have previously pointed out the problems inherent in having advisory panel members who have personal conflicts of interest with Big Pharma, but here you actually have a pharmaceutical company president serving on the advisory panel!
I view this as an enormous conflict of interest. This pharmaceutical company president, whose company specializes in research and development of psychopharmacologic drugs, is serving on an FDA advisory board to evaluate psychopharmacologic drugs! The name of the advisory committee is the "Psychopharmacologic Drugs Advisory Committee." I can't think of a more pertinent conflict of interest. If you are going to allow this type of a conflict, then you might as well throw conflict of interest policies out the window completely and just let the CEO's of various pharmaceutical companies serve as the advisory committee. I do not understand how the FDA can possibly allow this type of a conflict of interest.
Even in decisions regarding drugs that are not used for treatment of psychiatric illnesses - such as Chantix - the conflict is still present because the way that the FDA deals with one drug is relevant to how it deals with other drugs. In this case, the decision sets a precedent that could benefit drugs that are subsequently developed by Gabriel Sciences. For one thing, the decision accepts the principle that it is acceptable to have conflicted investigators conducting clinical trials on drugs, even when their financial conflict of interest is with the company that manufactures the very drug being tested.
As I reported last week, investigators at 32 of the 139 study sites involved in the recent study of adverse psychiatric effects related to Chantix had a financial conflict of interest by virtue of having received more than $25,000 in the past five years in speaking fees related to the promotion of Chantix or other Pfizer products. To be very clear, at my institution, investigators with such a conflict of interest would not be permitted to conduct such research.
I should point out that I am not criticizing Dr. Pickar here. My criticism is directed at the agency for allowing members of its advisory committees to have these kind of conflicts.
The rest of the story is that in my view, the FDA is in violation of the regulations issued by the Office of Government Ethics related to conflicts of interest among FDA advisory committee members (5 CFR part 2640), which state that financial conflicts are disqualifying for committee membership unless a waiver is granted and that to grant a waiver, it must be determined that "the disqualifying financial interest is not so substantial that it is likely to affect the integrity of an employee's services to the government." In this case, the FDA is clearly in violation of these regulations.
By the way, the statement that Dr. Pickar made, as quoted by MedPage Today, is not relevant to the issue of whether or not the black box warning should be maintained. He was quoted as stating: "The risk-benefit ratio is as clear as anything I have ever seen. For you, these are adverse events, but the benefit to these patients could be substantial in the most fundamental thing, which is being alive." These expressed concerns are relevant to the question of whether Chantix should remain on the market, but the decision about whether or not to require a black box warning should not be based on the risk-benefit ratio of the drug, but on the evidence related to the drug's adverse effects.
In my view, there needs to be a serious review of the FDA's adherence to federal conflict of interest regulations because it appears that the agency is blatantly violating these rules and that the public is being placed at potential risk because of it.
According to an article at MedPage Today: "a few of those who voted to remove the warning said the study supplied the evidence needed to make them comfortable using Varenicline to address a major public health problem. 'The risk-benefit ratio is as clear as anything I have ever seen,' said David Pickar, MD, a Johns Hopkins Medical School psychiatry professor who said he works with psychiatric patients. Looking at his fellow committee members, Pickar added: 'For you, these are adverse events, but the benefit to these patients could be substantial in the most fundamental thing, which is being alive.'"
The Rest of the Story
What this article and similar ones are not telling you is that the advisory committee member mentioned above - who cast the deciding vote - is, believe it or not, the president of a pharmaceutical company!
In a whopping conflict of interest that is apparently not disclosed in the article, it turns out that Dr. Pickar, according to his own web site, is "Founder and President of Gabriel Sciences, a company whose mission is advancing the development of a novel treatment for schizophrenia." Prior to that, he was "Co-Founder of Comprehensive Neuroscience, Inc., a clinical trials and medical communication company where he served as a Director, Executive Vice-President and Chief Science Officer." On top of that, he "is the inventor on two US patents."
Dr. Pickar's curriculum vitae confirms that he is the founder and president of a pharmaceutical company (Gabriel Sciences). Prior to that (going back to 2001), he was the founder and president of Potomac Pharma, Inc., a biopharmaceutical company which has transferred assets to Gabriel Sciences. Thus, it appears that Dr. Pickar has been a pharmaceutical company president for the past 15 years. Dr. Pickar's patents appear to be related to strategies for the pharmacological treatment of schizophrenia. The patents were licensed exclusively to Potomac Pharma, Inc.
I have previously pointed out the problems inherent in having advisory panel members who have personal conflicts of interest with Big Pharma, but here you actually have a pharmaceutical company president serving on the advisory panel!
I view this as an enormous conflict of interest. This pharmaceutical company president, whose company specializes in research and development of psychopharmacologic drugs, is serving on an FDA advisory board to evaluate psychopharmacologic drugs! The name of the advisory committee is the "Psychopharmacologic Drugs Advisory Committee." I can't think of a more pertinent conflict of interest. If you are going to allow this type of a conflict, then you might as well throw conflict of interest policies out the window completely and just let the CEO's of various pharmaceutical companies serve as the advisory committee. I do not understand how the FDA can possibly allow this type of a conflict of interest.
Even in decisions regarding drugs that are not used for treatment of psychiatric illnesses - such as Chantix - the conflict is still present because the way that the FDA deals with one drug is relevant to how it deals with other drugs. In this case, the decision sets a precedent that could benefit drugs that are subsequently developed by Gabriel Sciences. For one thing, the decision accepts the principle that it is acceptable to have conflicted investigators conducting clinical trials on drugs, even when their financial conflict of interest is with the company that manufactures the very drug being tested.
As I reported last week, investigators at 32 of the 139 study sites involved in the recent study of adverse psychiatric effects related to Chantix had a financial conflict of interest by virtue of having received more than $25,000 in the past five years in speaking fees related to the promotion of Chantix or other Pfizer products. To be very clear, at my institution, investigators with such a conflict of interest would not be permitted to conduct such research.
I should point out that I am not criticizing Dr. Pickar here. My criticism is directed at the agency for allowing members of its advisory committees to have these kind of conflicts.
The rest of the story is that in my view, the FDA is in violation of the regulations issued by the Office of Government Ethics related to conflicts of interest among FDA advisory committee members (5 CFR part 2640), which state that financial conflicts are disqualifying for committee membership unless a waiver is granted and that to grant a waiver, it must be determined that "the disqualifying financial interest is not so substantial that it is likely to affect the integrity of an employee's services to the government." In this case, the FDA is clearly in violation of these regulations.
By the way, the statement that Dr. Pickar made, as quoted by MedPage Today, is not relevant to the issue of whether or not the black box warning should be maintained. He was quoted as stating: "The risk-benefit ratio is as clear as anything I have ever seen. For you, these are adverse events, but the benefit to these patients could be substantial in the most fundamental thing, which is being alive." These expressed concerns are relevant to the question of whether Chantix should remain on the market, but the decision about whether or not to require a black box warning should not be based on the risk-benefit ratio of the drug, but on the evidence related to the drug's adverse effects.
In my view, there needs to be a serious review of the FDA's adherence to federal conflict of interest regulations because it appears that the agency is blatantly violating these rules and that the public is being placed at potential risk because of it.
Wednesday, September 14, 2016
Pfizer Study of Psychiatric Risks of Chantix Marred by Financial Conflicts of Interest and Under-Reporting of Adverse Events
According to a briefing document for today's joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the black box warning for Chantix (varenicline), Pfizer's study of the potential serious psychiatric side effects of Chantix, which reported no significant increased risk of adverse events, was marred by financial conflicts of interests of many of the study investigators and by under-reporting of adverse events, including potential episodes of suicidal ideation and depression that could have been drug-related.
According to the document, investigators at 32 of the 139 study sites had a financial conflict of interest by virtue of having received more than $25,000 in the past five years in speaking fees related to the promotion of Chantix or other Pfizer products. Moreover, at the sites with financially conflicted investigators, the reporting of adverse drug events was substantially lower than at non-conflicted sites. For example, while the rate of adverse neuropsychiatric events was 6.4% at non-conflicted sites, the rate was only 1.8% at sites at which an investigator had a conflict of interest.
In some cases, the under-reporting of adverse events seems quite blatant. For example, the document cites one patient, who was coded as not having an adverse neuropsychiatric event, as having reported: "I think I am having a major depression. I am worried. I cry easily. I have apathy, I have no desire to do things, insomnia, increased appetite, guilt, I have death thoughts (without suicidal ideation)."
The Rest of the Story
This story illustrates why investigators with personal financial interests in a drug company should not be conducting clinical trials on drugs manufactured by that company. The conflict of interest taints the research and could easily be seen as having influenced the conduct, analysis, or reporting of the research.
In this investigation by the FDA, not only did the agency find financial conflicts of interest of a large number of study researchers, but it also found significant under-reporting of adverse events which was highly correlated with whether a site had a conflicted researcher. This certainly creates the appearance that personal financial conflicts of interest with Pfizer created a bias in the conduct of the study and that the results may therefore be tainted and not trustworthy.
This story also explains my concern about an unreported financial conflict of interest in a newspaper article summarizing the results of an in vitro study in which the conflicted investigator improperly extrapolated the results to have clinical significance in humans and made what I see as a negligent medical recommendation to the public. In that case, the study showed that e-cigarette aerosol caused damage to respiratory cells in culture yet the investigator concluded that vaping can cause fatal lung disease and advised vapers to get vaccinated for bacterial lung infections, even though he failed to make the same recommendation for smokers.
In my opinion, investigators with personal financial conflicts of interest should not be conducting clinical research on products that are manufactured by the relevant company or its competitors. This is not just to protect the integrity of the research, but to protect the investigators and their institutions.
According to the document, investigators at 32 of the 139 study sites had a financial conflict of interest by virtue of having received more than $25,000 in the past five years in speaking fees related to the promotion of Chantix or other Pfizer products. Moreover, at the sites with financially conflicted investigators, the reporting of adverse drug events was substantially lower than at non-conflicted sites. For example, while the rate of adverse neuropsychiatric events was 6.4% at non-conflicted sites, the rate was only 1.8% at sites at which an investigator had a conflict of interest.
In some cases, the under-reporting of adverse events seems quite blatant. For example, the document cites one patient, who was coded as not having an adverse neuropsychiatric event, as having reported: "I think I am having a major depression. I am worried. I cry easily. I have apathy, I have no desire to do things, insomnia, increased appetite, guilt, I have death thoughts (without suicidal ideation)."
The Rest of the Story
This story illustrates why investigators with personal financial interests in a drug company should not be conducting clinical trials on drugs manufactured by that company. The conflict of interest taints the research and could easily be seen as having influenced the conduct, analysis, or reporting of the research.
In this investigation by the FDA, not only did the agency find financial conflicts of interest of a large number of study researchers, but it also found significant under-reporting of adverse events which was highly correlated with whether a site had a conflicted researcher. This certainly creates the appearance that personal financial conflicts of interest with Pfizer created a bias in the conduct of the study and that the results may therefore be tainted and not trustworthy.
This story also explains my concern about an unreported financial conflict of interest in a newspaper article summarizing the results of an in vitro study in which the conflicted investigator improperly extrapolated the results to have clinical significance in humans and made what I see as a negligent medical recommendation to the public. In that case, the study showed that e-cigarette aerosol caused damage to respiratory cells in culture yet the investigator concluded that vaping can cause fatal lung disease and advised vapers to get vaccinated for bacterial lung infections, even though he failed to make the same recommendation for smokers.
In my opinion, investigators with personal financial conflicts of interest should not be conducting clinical research on products that are manufactured by the relevant company or its competitors. This is not just to protect the integrity of the research, but to protect the investigators and their institutions.
Tuesday, September 13, 2016
Unlike Samsung Galaxy, FDA Regulations Don't Allow E-Cigarette Companies to Fix their Exploding Batteries
Last week, Samsung temporarily took its Galaxy Note 7 smartphone off the market while it works to solve the problem of exploding batteries, which occurred while the devices were charging. A Samsung investigation found that the problem was a battery cell made by one of its two battery suppliers. The problem stemmed from a defect in the manufacturing process, which is now being corrected.
At the same time, a number of e-cigarette companies have noted a similar problem with batteries in their devices, possibly related to a similar manufacturing defect. However, in contrast to Samsung, these companies are actually not allowed to fix the problem.
Why?
Because the FDA has prohibited e-cigarette companies from fixing exploding batteries - or any other manufacturing defect - in their products.
This unprecedented consumer "safety" regulation actually puts the public at great risk. No matter how many manufacturing defects are discovered, no matter how severe they are, no matter how easy they are to fix, and no matter how much the companies want to fix the problem to ensure the safety of their products, these safety improvements are simply not allowed, due to the stupidity of the FDA's e-cigarette deeming regulations.
The only thing worse than the FDA issuing such inane regulations is the fact that the major anti-tobacco groups supported this absurd approach to tobacco and nicotine product regulation.
The Rest of the Story
The FDA is completely butchering the intent of Congress in including new product applications as part of its Family Smoking Prevention and Tobacco Control Act of 2009. The only reason the requirement for pre-market tobacco applications was included in the law is that tobacco companies had a history of altering their products in a way that increased public health harm. For example, they might increase nicotine delivery by adding ammonia to change the pH, market low-nicotine cigarettes which don't actually reduce risk, or alter the blend of tobacco types which might increase the level of certain carcinogens. From the perspective of Congress (a perspective with which I don't happen to agree but that is irrelevant to this commentary), the tobacco companies simply couldn't be trusted. Any changes they made to their products could potentially place the public at increased risk while at the same time giving them the false impression that the products were safer.
This justification does not hold for applying the same requirement to electronic cigarettes and vaping products. There is absolutely no history of the companies making product changes designed to make the products more dangerous while giving consumers the impression that the product is safer. In fact, the opposite is the case. There is a long history of product improvements over time, such that the safety of vaping devices has substantially improved from when they were first introduced into the market.
One example of this is the problem of diethylene glycol contamination. In 2009, the FDA found diethylene glycol contamination in two brands of electronic cigarettes. This problem probably resulted from the use of non-pharmaceutical grade propylene glycol. Apparently, the problem was corrected because since that time, I am not aware of any further testing that has revealed diethylene glycol in e-liquids of any manufacturer.
The companies have also consistently made quality improvements over time, resulting in more effective products. More effective products have a greater public health impact because the better these devices are in helping smokers quit, the greater their contribution to improving the public's health.
Therefore, it makes absolutely no sense to prevent the e-cigarette companies from making safety and quality improvements to their products.
The rest of the story is that in its application of the law to e-cigarettes, the FDA has completely run afoul of the intent of Congress in enacting the Family Smoking Prevention and Tobacco Control Act. The result is a set of regulations that not only fail to protect the public's health, but which place the public at imminent and substantial risk.
At the same time, a number of e-cigarette companies have noted a similar problem with batteries in their devices, possibly related to a similar manufacturing defect. However, in contrast to Samsung, these companies are actually not allowed to fix the problem.
Why?
Because the FDA has prohibited e-cigarette companies from fixing exploding batteries - or any other manufacturing defect - in their products.
This unprecedented consumer "safety" regulation actually puts the public at great risk. No matter how many manufacturing defects are discovered, no matter how severe they are, no matter how easy they are to fix, and no matter how much the companies want to fix the problem to ensure the safety of their products, these safety improvements are simply not allowed, due to the stupidity of the FDA's e-cigarette deeming regulations.
The only thing worse than the FDA issuing such inane regulations is the fact that the major anti-tobacco groups supported this absurd approach to tobacco and nicotine product regulation.
The Rest of the Story
The FDA is completely butchering the intent of Congress in including new product applications as part of its Family Smoking Prevention and Tobacco Control Act of 2009. The only reason the requirement for pre-market tobacco applications was included in the law is that tobacco companies had a history of altering their products in a way that increased public health harm. For example, they might increase nicotine delivery by adding ammonia to change the pH, market low-nicotine cigarettes which don't actually reduce risk, or alter the blend of tobacco types which might increase the level of certain carcinogens. From the perspective of Congress (a perspective with which I don't happen to agree but that is irrelevant to this commentary), the tobacco companies simply couldn't be trusted. Any changes they made to their products could potentially place the public at increased risk while at the same time giving them the false impression that the products were safer.
This justification does not hold for applying the same requirement to electronic cigarettes and vaping products. There is absolutely no history of the companies making product changes designed to make the products more dangerous while giving consumers the impression that the product is safer. In fact, the opposite is the case. There is a long history of product improvements over time, such that the safety of vaping devices has substantially improved from when they were first introduced into the market.
One example of this is the problem of diethylene glycol contamination. In 2009, the FDA found diethylene glycol contamination in two brands of electronic cigarettes. This problem probably resulted from the use of non-pharmaceutical grade propylene glycol. Apparently, the problem was corrected because since that time, I am not aware of any further testing that has revealed diethylene glycol in e-liquids of any manufacturer.
The companies have also consistently made quality improvements over time, resulting in more effective products. More effective products have a greater public health impact because the better these devices are in helping smokers quit, the greater their contribution to improving the public's health.
Therefore, it makes absolutely no sense to prevent the e-cigarette companies from making safety and quality improvements to their products.
The rest of the story is that in its application of the law to e-cigarettes, the FDA has completely run afoul of the intent of Congress in enacting the Family Smoking Prevention and Tobacco Control Act. The result is a set of regulations that not only fail to protect the public's health, but which place the public at imminent and substantial risk.
Monday, September 12, 2016
Anti-Vaping Researcher Gives Negligent Advice to the Public
An anti-vaping researcher, citing findings solely from an in-vitro cell culture study without clear clinical significance, has claimed that vaping can cause fatal respiratory infections. Based on his extrapolation from an in-vitro study to human disease, this researcher has advised all vapers to be vaccinated for serious bacterial lung infections. However, at the same time, he failed to advise smokers to be vaccinated against these same serious infections.
According to an article in the Times of London, a professor of pediatric respiratory and environmental medicine at Queen Mary University of London "has found that the chemical propellants and nicotine used in ecigarettes both have a powerful effect on lung cells,effectively opening them up to infection by the bacteria that cause pneumonia." Based on this finding, he has warned that "Vaping may raise people’s risk of pneumonia and other deadly bacterial infections."
Despite the fact that these findings related only to a cell culture and cannot be extrapolated to living humans, the researcher nevertheless recommended that "People who vape should consider vaccination against bacterial pneumonia." The researcher did not make a similar recommendation for smokers.
The researcher presented these results at the annual meeting of the European Respiratory Society, although they have not yet been published in a medical journal.
The Rest of the Story
Lipinski and Hopkins explained that the findings of in vitro (or ex vivo, as in this case) study cannot be extrapolated to have clinical significance in humans: "Whether the aim is to discover drugs or to gain knowledge of biological systems, the nature and properties of a chemical tool cannot be considered independently of the system it is to be tested in. Compounds that bind to isolated recombinant proteins are one thing; chemical tools that can perturb cell function another; and pharmacological agents that can be tolerated by a live organism and perturb its systems are yet another. If it were simple to ascertain the properties required to develop a lead discovered in vitro to one that is active in vivo, drug discovery would be as reliable as drug manufacturing."
Extrapolating from in vitro studies to humans can actually be quite dangerous. For example, anthrax was not found to cause problems when derived in vitro, but the same extract derived from living animals was highly toxic.
Clinical experience actually suggests that switching from smoking to vaping decreases the risk of pneumonia and severe lung infection and does not support the contention that vaping significantly increases the risk of fatal lung infections. Despite the millions of people using electronic cigarettes, including many nonsmokers, I am not aware of a single case of a fatal lung infection attributable to vaping.
Therefore, the advice being given by this researcher is negligent. It is negligent not only because there is as yet no evidence supporting a clinical indication for vaccination among people who vape, but also because he fails to recommend vaccination among smokers, who in many cases are at increased risk of serious respiratory infections.
Many people reading this article might conclude that vaping is more dangerous than smoking, since vaccination is only recommended for vaping, but not for smoking. What the researcher has done here in misleadingly communicating the implications of his research is, in my view, negligent because it is unsupported by credible scientific evidence, contradicted by clinical experience, and damaging to the public health.
To make matters worse, that smokers are at risk of serious respiratory infections and in some cases should be vaccinated is not the only thing that the researcher hides from the public in this article. He also hides his financial conflict of interest with Big Pharma, and specifically, with GlaxoSmithKline, a company which stands to lose financially if electronic cigarettes become increasingly popular, as they are a competitor to Glaxo's nicotine gum, lozenges, and patches. The researcher has apparently served as a paid consultant for GlaxoSmithKline, a fact that is not revealed in the newspaper article, thus hiding from readers knowledge of this important conflict of interest which has the appearance of biasing the researcher's reporting of the significance of his study findings.
And to add insult to the injury done by this misleading communication of scientific findings, the European Respiratory Society annual meeting itself is financially conflicted, since it received support from Big Pharma, including Pfizer, GlaxoSmithKline, Novartis, CSL Behring, Hoffman LaRoche, Astra Zeneca, Pneum-Rx, Bayer, Merck, and many more.
This story encompasses the conglomeration of what is wrong with the reporting of science in the area of tobacco control today.
According to an article in the Times of London, a professor of pediatric respiratory and environmental medicine at Queen Mary University of London "has found that the chemical propellants and nicotine used in ecigarettes both have a powerful effect on lung cells,effectively opening them up to infection by the bacteria that cause pneumonia." Based on this finding, he has warned that "Vaping may raise people’s risk of pneumonia and other deadly bacterial infections."
Despite the fact that these findings related only to a cell culture and cannot be extrapolated to living humans, the researcher nevertheless recommended that "People who vape should consider vaccination against bacterial pneumonia." The researcher did not make a similar recommendation for smokers.
The researcher presented these results at the annual meeting of the European Respiratory Society, although they have not yet been published in a medical journal.
The Rest of the Story
Lipinski and Hopkins explained that the findings of in vitro (or ex vivo, as in this case) study cannot be extrapolated to have clinical significance in humans: "Whether the aim is to discover drugs or to gain knowledge of biological systems, the nature and properties of a chemical tool cannot be considered independently of the system it is to be tested in. Compounds that bind to isolated recombinant proteins are one thing; chemical tools that can perturb cell function another; and pharmacological agents that can be tolerated by a live organism and perturb its systems are yet another. If it were simple to ascertain the properties required to develop a lead discovered in vitro to one that is active in vivo, drug discovery would be as reliable as drug manufacturing."
Extrapolating from in vitro studies to humans can actually be quite dangerous. For example, anthrax was not found to cause problems when derived in vitro, but the same extract derived from living animals was highly toxic.
Clinical experience actually suggests that switching from smoking to vaping decreases the risk of pneumonia and severe lung infection and does not support the contention that vaping significantly increases the risk of fatal lung infections. Despite the millions of people using electronic cigarettes, including many nonsmokers, I am not aware of a single case of a fatal lung infection attributable to vaping.
Therefore, the advice being given by this researcher is negligent. It is negligent not only because there is as yet no evidence supporting a clinical indication for vaccination among people who vape, but also because he fails to recommend vaccination among smokers, who in many cases are at increased risk of serious respiratory infections.
Many people reading this article might conclude that vaping is more dangerous than smoking, since vaccination is only recommended for vaping, but not for smoking. What the researcher has done here in misleadingly communicating the implications of his research is, in my view, negligent because it is unsupported by credible scientific evidence, contradicted by clinical experience, and damaging to the public health.
To make matters worse, that smokers are at risk of serious respiratory infections and in some cases should be vaccinated is not the only thing that the researcher hides from the public in this article. He also hides his financial conflict of interest with Big Pharma, and specifically, with GlaxoSmithKline, a company which stands to lose financially if electronic cigarettes become increasingly popular, as they are a competitor to Glaxo's nicotine gum, lozenges, and patches. The researcher has apparently served as a paid consultant for GlaxoSmithKline, a fact that is not revealed in the newspaper article, thus hiding from readers knowledge of this important conflict of interest which has the appearance of biasing the researcher's reporting of the significance of his study findings.
And to add insult to the injury done by this misleading communication of scientific findings, the European Respiratory Society annual meeting itself is financially conflicted, since it received support from Big Pharma, including Pfizer, GlaxoSmithKline, Novartis, CSL Behring, Hoffman LaRoche, Astra Zeneca, Pneum-Rx, Bayer, Merck, and many more.
This story encompasses the conglomeration of what is wrong with the reporting of science in the area of tobacco control today.
Friday, September 09, 2016
Conde Nast Promotes Cancer Research ... and Cancer: A Guest Commentary and Open Letter by Alan Blum, MD
"Glamour. This is one of the many publications whose chief function is to
publish ads for cosmetics, clothes, and other items for young women. The
tobacco industry, having almost reached the saturation point of male smoking,
is out to get a majority of women. Glamour
hired Dr. Henry C. Link to write an article (Jan '46) saying that smoking
cigarets is one of the most important of all bad habits."
Nearly 70 years later, Glamour is still ignoring the dangers of smoking and running cigarette ads. And now Glamour is published by Conde Nast, which also publishes influential magazines like The New Yorker, Wired, and Vanity Fair.
Tonight Stand Up To Cancer holds its fifth fundraising telethon for cancer research. Its slogan is "This is where the end of cancer begins." But several of SU2C's Publishing Partners still accept advertising for the leading cause of cancer, cigarettes. Because The New Yorker prides itself on exposing the hypocrisy of public figures and trusted institutions, it is only fair to ask its editor how the magazine can ignore the hypocrisy of its publisher, whose slogan could well be "This is where cancer begins."
Sent: Sunday, September 04, 2016 3:39 PM
Subject: In the spirit of Thomas Whiteside...
But such local columns are trees falling in the forest, and here we are nearly half a century after Thomas Whiteside's condemnation of the cigarette makers in The New Yorker. I hope you will raise concerns about Conde Nast's wanting to appear to be an ardent foe of cancer while still accepting a considerable
Publishing Partners of Stand Up To Cancer that still publish
cigarette advertisements:
http://www.standup2cancer.org/supporters/publishing
American Media, Inc. (AMI) owns and operates the leading celebrity and health & fitness media brands in the country. Our magazines have a combined total circulation of 5.9+ million and reach 53+ million men and women each month. Our digital properties reach a total of 41+ million unique visitors and 313+ million page views monthly.
http://www.americanmediainc.com
AMI's most well known publication THE NATIONAL ENQUIRER still runs cigarette ads. The company cultivates an image of health with some magazines as Men's Fitness, Muscle & Fitness, and Muscle & Fitness Hers.
Bonnier Corporation is one of the largest consumer-publishing groups in America and is the leading media company serving passionate, highly engaged audiences through 50 special-interest magazines and related multimedia projects and events. Popular brands include Saveur, Parenting, Popular Science, Field & Stream and TransWorld SKATEboarding. Bonnier Corp. is the U.S. division of the Bonnier Group, a 200-year-old family-owned media group based in Sweden with business operations in 25 countries.
http://www.bonniercorp.com/
FIELD & STREAM and POPULAR SCIENCE feature cigarette and smokeless tobacco advertisements in every issue.
Condé Nast is a premier media company renowned for producing the highest quality content for the world’s most influential audiences. Attracting 95 million consumers across its industry-leading print, digital and video brands, the company’s portfolio includes some of the most iconic titles in media: Vogue, Vanity Fair, Glamour, Brides, Self, GQ, The New Yorker, Condé Nast Traveler, Details, Allure, Architectural Digest, Bon Appétit, Epicurious, Wired, W, Lucky, Golf Digest, Golf World, Teen Vogue and Ars Technica.
http://www.condenast.com/
VOGUE, VANITY FAIR, GQ, CONDE NAST TRAVELER, and WIRED all regularly feature advertisements for cigarettes and smokeless tobacco.
Hearst Magazines is one of the world’s largest publishers of monthly magazines, with 21 U.S. titles and close to 300 international editions. Hearst Magazines also publishes 19 magazines in the United Kingdom through its wholly owned subsidiary, Hearst Magazines UK. Hearst’s properties include, among others, Cosmopolitan, Good Housekeeping, O the Oprah Magazine, Redbook, Town&Country, and the newly launched Food Network Magazine. Hearst is pleased to support the Entertainment Industry Foundation and its efforts to Stand Up to Cancer.
http://central.hearstmags.com/
COSMOPOLITAN still accepts advertisements for cigarettes and smokeless tobacco.
Time Inc., a Time Warner company, is a world class branded content company, investing in the future and engaging more than 138 million consumers monthly; whenever, however, and wherever they are. With 22 magazines and 26 web sites in the U.S., it is the country’s largest consumer publisher. Each month, one out of every two American adults reads a Time Inc. magazine, and one out of every five, who are online, visits a company web site (more than 52 million monthly unique visitors). Time Inc.’s popular brands and successful franchises extend to online, mobile and digital reading devices, television, events and branded products.
www.timeinc.com
TIME and SPORTS ILLUSTRATED feature advertisements for cigarettes and smokeless tobacco in almost every issue.
--George Seldes, In
Fact, July 28, 1947
Nearly 70 years later, Glamour is still ignoring the dangers of smoking and running cigarette ads. And now Glamour is published by Conde Nast, which also publishes influential magazines like The New Yorker, Wired, and Vanity Fair.
Tonight Stand Up To Cancer holds its fifth fundraising telethon for cancer research. Its slogan is "This is where the end of cancer begins." But several of SU2C's Publishing Partners still accept advertising for the leading cause of cancer, cigarettes. Because The New Yorker prides itself on exposing the hypocrisy of public figures and trusted institutions, it is only fair to ask its editor how the magazine can ignore the hypocrisy of its publisher, whose slogan could well be "This is where cancer begins."
An open letter to David Remnick:
Sent: Sunday, September 04, 2016 3:39 PM
Subject: In the spirit of Thomas Whiteside...
David Remnick
Editor, The New
Yorker
Dear Mr. Remnick,
Since as a longstanding subscriber to The New Yorker I receive a weekly email from you, I hope you will be interested in a letter from a loyal reader with a suggestion for an editor's note.
The late Thomas Whiteside, most well known for his expose in The New Yorker of the use of the herbicide Agent Orange in the Viet Nam War, also wrote two scathing articles for the magazine in 1963 and 1970 (plus a third in The New Republic) about the tobacco industry and cigarette advertising that were published as a book, Selling Death.
By this time The New Yorker had stopped accepting cigarette advertising. But nearly half a century later The New Yorker's publisher Conde Nast is still running cigarette ads in several of its magazines, notably Vanity Fair, Wired, and Glamour. That's certainly its prerogative, as it is of the tobacco companies under the First Amendment to advertise cigarettes, a legal, albeit lethal, product.
However, Conde Nast is also a Publishing Partner of Stand Up To Cancer (SU2C), the cancer cure research fund-raising organization whose fifth national telethon is September 9. The publication by Conde Nast of advertisements for SU2C, including in The New Yorker, that call for the public to support research to find a cure for cancer, strikes me as the epitome of hypocrisy. I believe that Thomas Whiteside would have called out Conde Nast. I think you should do so now.
Even while it no longer published cigarette ads per se, throughout the 1980s, 1990s, and well into the 2000s The New Yorker published countless 2-page image-burnishing advertisements byPhilip Morris USA (subsumed, since 2003, under its newly named parent, Altria) touting its support for the arts and various charitable causes from food banks and minority-hiring programs to efforts to end illiteracy and domestic violence. More recently, Altria was a co-sponsor of The New Yorker's Aspen Ideas Festival, and the Altria logo was featured in advertisements in the magazine. All of these ads were aimed at opinion leaders among The New Yorker's readership. Altria/Philip Morris is the manufacturer of the world's top-selling brand of cigarettes, Marlboro.
I have heard your interview with Terry Gross on "Fresh Air," in which you praise Sy Newhouse for the free hand he has given you at the helm of The New Yorker. I also admire Mr. Newhouse for his commitment to the print medium and for his contributions to education (my son is a graduate of the Newhouse School at Syracuse).
But it should be a no-brainer to point out the egregious contradiction of a publisher promoting a foundation that seeks to find cures for cancer while still promoting the leading preventable cause of cancer, cigarettes, which are responsible for upwards of a third of all cancer deaths.
As a regular op-ed contributor to The Birmingham News, I first wrote about your publisher's (and others') hypocrisy in a column in 2014, which was picked up by The Cancer Letter (attachment) and other outlets including Fair Warning (an investigative journalism group) and the Knight Science Journalism Tracker. I wrote about it again a few weeks ago:
http://www.al.com/opinion/index.ssf/2014/09/stand_up_to_cancer_not_standin.html
Since as a longstanding subscriber to The New Yorker I receive a weekly email from you, I hope you will be interested in a letter from a loyal reader with a suggestion for an editor's note.
The late Thomas Whiteside, most well known for his expose in The New Yorker of the use of the herbicide Agent Orange in the Viet Nam War, also wrote two scathing articles for the magazine in 1963 and 1970 (plus a third in The New Republic) about the tobacco industry and cigarette advertising that were published as a book, Selling Death.
By this time The New Yorker had stopped accepting cigarette advertising. But nearly half a century later The New Yorker's publisher Conde Nast is still running cigarette ads in several of its magazines, notably Vanity Fair, Wired, and Glamour. That's certainly its prerogative, as it is of the tobacco companies under the First Amendment to advertise cigarettes, a legal, albeit lethal, product.
However, Conde Nast is also a Publishing Partner of Stand Up To Cancer (SU2C), the cancer cure research fund-raising organization whose fifth national telethon is September 9. The publication by Conde Nast of advertisements for SU2C, including in The New Yorker, that call for the public to support research to find a cure for cancer, strikes me as the epitome of hypocrisy. I believe that Thomas Whiteside would have called out Conde Nast. I think you should do so now.
Even while it no longer published cigarette ads per se, throughout the 1980s, 1990s, and well into the 2000s The New Yorker published countless 2-page image-burnishing advertisements byPhilip Morris USA (subsumed, since 2003, under its newly named parent, Altria) touting its support for the arts and various charitable causes from food banks and minority-hiring programs to efforts to end illiteracy and domestic violence. More recently, Altria was a co-sponsor of The New Yorker's Aspen Ideas Festival, and the Altria logo was featured in advertisements in the magazine. All of these ads were aimed at opinion leaders among The New Yorker's readership. Altria/Philip Morris is the manufacturer of the world's top-selling brand of cigarettes, Marlboro.
I have heard your interview with Terry Gross on "Fresh Air," in which you praise Sy Newhouse for the free hand he has given you at the helm of The New Yorker. I also admire Mr. Newhouse for his commitment to the print medium and for his contributions to education (my son is a graduate of the Newhouse School at Syracuse).
But it should be a no-brainer to point out the egregious contradiction of a publisher promoting a foundation that seeks to find cures for cancer while still promoting the leading preventable cause of cancer, cigarettes, which are responsible for upwards of a third of all cancer deaths.
As a regular op-ed contributor to The Birmingham News, I first wrote about your publisher's (and others') hypocrisy in a column in 2014, which was picked up by The Cancer Letter (attachment) and other outlets including Fair Warning (an investigative journalism group) and the Knight Science Journalism Tracker. I wrote about it again a few weeks ago:
http://www.al.com/opinion/index.ssf/2014/09/stand_up_to_cancer_not_standin.html
But such local columns are trees falling in the forest, and here we are nearly half a century after Thomas Whiteside's condemnation of the cigarette makers in The New Yorker. I hope you will raise concerns about Conde Nast's wanting to appear to be an ardent foe of cancer while still accepting a considerable
amount of money to
advertise cigarettes--and will also forward my letter to Mr. Newhouse for his
consideration.
I look forward to
hearing from you.
Sincerely,
Sincerely,
Alan Blum, MD
Professor and Gerald
Leon Wallace, MD, Endowed Chair in Family Medicine
Director, The University
of Alabama Center for the Study of Tobacco and Society
University of Alabama
School of Medicine
Phone: 205.348.2880 ablum@cchs.ua.edu
_______________________________________________________
http://www.standup2cancer.org/supporters/publishing
American Media, Inc. (AMI) owns and operates the leading celebrity and health & fitness media brands in the country. Our magazines have a combined total circulation of 5.9+ million and reach 53+ million men and women each month. Our digital properties reach a total of 41+ million unique visitors and 313+ million page views monthly.
http://www.americanmediainc.com
AMI's most well known publication THE NATIONAL ENQUIRER still runs cigarette ads. The company cultivates an image of health with some magazines as Men's Fitness, Muscle & Fitness, and Muscle & Fitness Hers.
Bonnier Corporation is one of the largest consumer-publishing groups in America and is the leading media company serving passionate, highly engaged audiences through 50 special-interest magazines and related multimedia projects and events. Popular brands include Saveur, Parenting, Popular Science, Field & Stream and TransWorld SKATEboarding. Bonnier Corp. is the U.S. division of the Bonnier Group, a 200-year-old family-owned media group based in Sweden with business operations in 25 countries.
http://www.bonniercorp.com/
FIELD & STREAM and POPULAR SCIENCE feature cigarette and smokeless tobacco advertisements in every issue.
Condé Nast is a premier media company renowned for producing the highest quality content for the world’s most influential audiences. Attracting 95 million consumers across its industry-leading print, digital and video brands, the company’s portfolio includes some of the most iconic titles in media: Vogue, Vanity Fair, Glamour, Brides, Self, GQ, The New Yorker, Condé Nast Traveler, Details, Allure, Architectural Digest, Bon Appétit, Epicurious, Wired, W, Lucky, Golf Digest, Golf World, Teen Vogue and Ars Technica.
http://www.condenast.com/
VOGUE, VANITY FAIR, GQ, CONDE NAST TRAVELER, and WIRED all regularly feature advertisements for cigarettes and smokeless tobacco.
Hearst Magazines is one of the world’s largest publishers of monthly magazines, with 21 U.S. titles and close to 300 international editions. Hearst Magazines also publishes 19 magazines in the United Kingdom through its wholly owned subsidiary, Hearst Magazines UK. Hearst’s properties include, among others, Cosmopolitan, Good Housekeeping, O the Oprah Magazine, Redbook, Town&Country, and the newly launched Food Network Magazine. Hearst is pleased to support the Entertainment Industry Foundation and its efforts to Stand Up to Cancer.
http://central.hearstmags.com/
COSMOPOLITAN still accepts advertisements for cigarettes and smokeless tobacco.
Time Inc., a Time Warner company, is a world class branded content company, investing in the future and engaging more than 138 million consumers monthly; whenever, however, and wherever they are. With 22 magazines and 26 web sites in the U.S., it is the country’s largest consumer publisher. Each month, one out of every two American adults reads a Time Inc. magazine, and one out of every five, who are online, visits a company web site (more than 52 million monthly unique visitors). Time Inc.’s popular brands and successful franchises extend to online, mobile and digital reading devices, television, events and branded products.
www.timeinc.com
TIME and SPORTS ILLUSTRATED feature advertisements for cigarettes and smokeless tobacco in almost every issue.
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