Wednesday, December 23, 2015
Announcing First-Ever Tobacco Harm Reduction Conference - April 22, 2016
To the best of my knowledge, the first-ever national tobacco harm reduction conference will be held this spring. The "Tobacco Harm Reduction Conference" will take place on Friday, April 22, 2016 at the New York City College of Technology in downtown Brooklyn. The conference will be jointly sponsored by the New York City College of Technology, City University of New York and Community Access.
Among the topics to be discussed at the conference are the efficacy of nicotine patches and other medications, the efficacy of electronic cigarettes, the safety and relative safety of electronic cigarettes, current e-cigarette controversies, regulation of electronic cigarettes, and mental illness and nicotine use.
Confirmed speakers include:
Among the topics to be discussed at the conference are the efficacy of nicotine patches and other medications, the efficacy of electronic cigarettes, the safety and relative safety of electronic cigarettes, current e-cigarette controversies, regulation of electronic cigarettes, and mental illness and nicotine use.
Confirmed speakers include:
- Dr. Shadi Chamany, director of clinical and scientific affairs for the New York City Department of Health and Mental Hygiene;
- Dr. Riccardo Polosa, director of internal medicine and clinical immunology at the University of Catania,
Italy; - Kevin McGirr, associate professor in urban health, community health, and communication and behavior at the New York City College of Technology;
- Helen Redmond, harm reduction specialist with Community Access; and
- Dr. Michael Siegel, professor of community health sciences, Boston University School of Public Health.
Tuesday, December 22, 2015
Anti-Vaping Advocate Testifies that E-Cigarette Aerosol is More Toxic than Secondhand Smoke
According to an article in Latinos Health, the head of the Muskogee Wellness Initiative told county health officials that the aerosol produced by electronic cigarettes is more hazardous than the smoke produced by tobacco cigarettes.
The article states:
"According to Muskogee Phoenix, the elected leaders in the county is planning to revisit in January the proposal that prohibits the use of e-cigarettes and other vaping products on the city property. The said issue was rejected for about nine months already. The leaders come up to the said decision after a representative from the Muskogee Wellness Initiative made an impassioned plea to restrict the use of the said products which he believes is "more dangerous than second-hand smoke." Dr. James Baker was joined by three students at the podium and cited a recent study that found some liquid use in vaping devices contained chemicals used in artificial food flavoring. The said chemicals were found to be health hazards in industrial settings. ... "Who knows what they could put in there, I mean any juicer or anybody involved in the vaping sales could put any number of products in there," Baker said. "Without FDA (Food and Drug Administration) monitoring ... all of that could be exposed to children and lead to a much greater problem and epidemic than we have ever realized - at least with cigarettes we know what is going in there."
The Rest of the Story
Dr. Baker's attitude seems to be typical of anti-vaping health officials: e-cigarettes have unknown risks so we feel more comfortable advocating smoking because at least its risks are well-known.
The rest of the story is that many anti-vaping health advocates would rather that smokers continue to smoke than that they try to quit using electronic cigarettes, whose risks are not as well characterized as those of real cigarettes. Better that people should die due to known risks than take a chance on a product that is certainly less harmful than tobacco cigarettes but for which the precise long-term risks are not known.
Regardless of one's position on the policy issues, we should all agree that health practitioners should tell the truth and not lie to or deceive the public. Unfortunately, the Muskogee Wellness Initiative is lying to the public when it claims that e-cigarette aerosol is more dangerous than secondhand smoke.
There is abundant evidence that e-cigarette aerosol is much, much safer than tobacco smoke. E-cigarette aerosol results from heating, not combustion. Moreover, e-cigarettes contain no tobacco. Most importantly, the number and levels of toxins in e-cigarette aerosol are dramatically lower than in tobacco smoke. With regard to the chemical alluded to by Dr. Baker (i.e., diacetyl), the average level in e-cigarette aerosol is 750 times lower than that in tobacco smoke. Levels of the known carcinogens NNN and NNK are approximately 1400 times lower in e-cigarette aerosol than in the smoke produced by a Marlboro cigarette.
Why are so many anti-vaping advocates lying to the public about these basic facts? I believe it is because they feel severely threatened by electronic cigarettes. These products could actually save tens of thousands of lives, but when people use the products, it looks like they are smoking. Many of my colleagues in tobacco control are demonizing vaping because they have transformed a health battle to prevent smoking-related morbidity and mortality into a moral crusade against the use of nicotine or any behavior that resembles smoking, regardless of whether it may be saving people's lives.
This is a tremendous disservice to the thousands of vapers who have quit smoking using e-cigarettes, many of whom are thinking of switching back to smoking because of the false statements being made by groups like the Muskogee Wellness Initiative. It is also a disservice to the many smokers who are being discouraged by these scare tactics from trying to quit smoking using electronic cigarettes.
The article states:
"According to Muskogee Phoenix, the elected leaders in the county is planning to revisit in January the proposal that prohibits the use of e-cigarettes and other vaping products on the city property. The said issue was rejected for about nine months already. The leaders come up to the said decision after a representative from the Muskogee Wellness Initiative made an impassioned plea to restrict the use of the said products which he believes is "more dangerous than second-hand smoke." Dr. James Baker was joined by three students at the podium and cited a recent study that found some liquid use in vaping devices contained chemicals used in artificial food flavoring. The said chemicals were found to be health hazards in industrial settings. ... "Who knows what they could put in there, I mean any juicer or anybody involved in the vaping sales could put any number of products in there," Baker said. "Without FDA (Food and Drug Administration) monitoring ... all of that could be exposed to children and lead to a much greater problem and epidemic than we have ever realized - at least with cigarettes we know what is going in there."
The Rest of the Story
Dr. Baker's attitude seems to be typical of anti-vaping health officials: e-cigarettes have unknown risks so we feel more comfortable advocating smoking because at least its risks are well-known.
The rest of the story is that many anti-vaping health advocates would rather that smokers continue to smoke than that they try to quit using electronic cigarettes, whose risks are not as well characterized as those of real cigarettes. Better that people should die due to known risks than take a chance on a product that is certainly less harmful than tobacco cigarettes but for which the precise long-term risks are not known.
Regardless of one's position on the policy issues, we should all agree that health practitioners should tell the truth and not lie to or deceive the public. Unfortunately, the Muskogee Wellness Initiative is lying to the public when it claims that e-cigarette aerosol is more dangerous than secondhand smoke.
There is abundant evidence that e-cigarette aerosol is much, much safer than tobacco smoke. E-cigarette aerosol results from heating, not combustion. Moreover, e-cigarettes contain no tobacco. Most importantly, the number and levels of toxins in e-cigarette aerosol are dramatically lower than in tobacco smoke. With regard to the chemical alluded to by Dr. Baker (i.e., diacetyl), the average level in e-cigarette aerosol is 750 times lower than that in tobacco smoke. Levels of the known carcinogens NNN and NNK are approximately 1400 times lower in e-cigarette aerosol than in the smoke produced by a Marlboro cigarette.
Why are so many anti-vaping advocates lying to the public about these basic facts? I believe it is because they feel severely threatened by electronic cigarettes. These products could actually save tens of thousands of lives, but when people use the products, it looks like they are smoking. Many of my colleagues in tobacco control are demonizing vaping because they have transformed a health battle to prevent smoking-related morbidity and mortality into a moral crusade against the use of nicotine or any behavior that resembles smoking, regardless of whether it may be saving people's lives.
This is a tremendous disservice to the thousands of vapers who have quit smoking using e-cigarettes, many of whom are thinking of switching back to smoking because of the false statements being made by groups like the Muskogee Wellness Initiative. It is also a disservice to the many smokers who are being discouraged by these scare tactics from trying to quit smoking using electronic cigarettes.
Monday, December 21, 2015
Tobacco Free Amarillo Makes Up the Facts to Demonize Electronic Cigarettes
When the actual facts do not support their position, what do anti-vaping groups like Tobacco Free Amarillo do?
Quite simple ...
... they make up facts.
In other words, they lie.
Take, for example, Tobacco Free Amarillo's "fact sheet" on electronic cigarettes. According to this organization:
1. "As a result of widespread information about the dangers of tobacco and the increase in tobacco policies in the United States, the tobacco industry developed these new products, allowing consumption of nicotine without the use of a cigarette."
This statement is untrue. The tobacco industry did not develop e-cigarettes. These products were developed by independent companies that had nothing to do with Big Tobacco. In fact, electronic cigarettes were on the market for six years in the United States before any tobacco company entered the e-cigarette market. That occurred in 2012 when Lorillard acquired blu.
2. "While manufacturers state these products are safe alternatives to traditional cigarettes, e-cigarettes are not inspected or regulated by the FDA, so consumers should question the safety of these products."
At very best, this statement is misleading. It is true that two or three of the hundreds of electronic cigarette companies have claimed that their products are safe. However, the overwhelming majority of companies, including the tobacco companies which market e-cigarettes, are making no such claims. Most companies simply claim that these products are safer than real cigarettes, which is undoubtedly true.
3. "The long-term health effects of e-cigarettes are not yet known, but short-term lung changes are similar to those caused by traditional cigarettes."
This statement is also untrue. Short-term lung changes are not similar to those caused by traditional cigarettes. In fact, most of the short-term lung changes observed with traditional cigarettes are not seen with e-cigarettes. Most importantly, while traditional cigarette smoking causes decrements in lung function (as measured by spirometry), the electronic cigarettes that have been tested do not. Several studies have shown that smokers who switch to electronic cigarettes experience dramatic improvement in their respiratory symptoms and marked improvement in their lung function.
The Rest of the Story
The rest of the story is that when the facts are not enough to support the e-cigarette demonizing position of anti-vaping organizations like Tobacco Free Amarillo, these organizations simply make up the "facts" in order to support their positions. In other words, they lie to the public in order to make e-cigarettes sound as dangerous as real ones.
But what they are doing, in effect, is making smoking seem only as hazardous as vaping. In other words, because of the statements of these anti-vaping groups, the public largely believes that smoking is only as hazardous as using a non-tobacco-containing product which involves no combustion and which has been shown to be much safer than tobacco cigarettes.
Thus, the effect of the campaign of deception that is being waged by anti-vaping groups is to undermine decades of progress in educating the public about the severe hazards of cigarette smoking.
Those with an interest in increasing cigarette sales could ask for no greater favor from these health groups. Unwittingly, and ironically, they have entered the realm of helping to protect cigarette profits by protecting cigarette sales from competition and by making sure that the cigarettes which smokers use are tobacco-full rather than tobacco-free. Thus, organization names like "Tobacco Free" Amarillo appear to be a misnomer. They are opposing, rather than supporting a transition from tobacco-full to tobacco-free cigarettes and from deadly combustible tobacco products to much safer tobacco-free products that have the potential to save tens of thousands of lives.
Quite simple ...
... they make up facts.
In other words, they lie.
Take, for example, Tobacco Free Amarillo's "fact sheet" on electronic cigarettes. According to this organization:
1. "As a result of widespread information about the dangers of tobacco and the increase in tobacco policies in the United States, the tobacco industry developed these new products, allowing consumption of nicotine without the use of a cigarette."
This statement is untrue. The tobacco industry did not develop e-cigarettes. These products were developed by independent companies that had nothing to do with Big Tobacco. In fact, electronic cigarettes were on the market for six years in the United States before any tobacco company entered the e-cigarette market. That occurred in 2012 when Lorillard acquired blu.
2. "While manufacturers state these products are safe alternatives to traditional cigarettes, e-cigarettes are not inspected or regulated by the FDA, so consumers should question the safety of these products."
At very best, this statement is misleading. It is true that two or three of the hundreds of electronic cigarette companies have claimed that their products are safe. However, the overwhelming majority of companies, including the tobacco companies which market e-cigarettes, are making no such claims. Most companies simply claim that these products are safer than real cigarettes, which is undoubtedly true.
3. "The long-term health effects of e-cigarettes are not yet known, but short-term lung changes are similar to those caused by traditional cigarettes."
This statement is also untrue. Short-term lung changes are not similar to those caused by traditional cigarettes. In fact, most of the short-term lung changes observed with traditional cigarettes are not seen with e-cigarettes. Most importantly, while traditional cigarette smoking causes decrements in lung function (as measured by spirometry), the electronic cigarettes that have been tested do not. Several studies have shown that smokers who switch to electronic cigarettes experience dramatic improvement in their respiratory symptoms and marked improvement in their lung function.
The Rest of the Story
The rest of the story is that when the facts are not enough to support the e-cigarette demonizing position of anti-vaping organizations like Tobacco Free Amarillo, these organizations simply make up the "facts" in order to support their positions. In other words, they lie to the public in order to make e-cigarettes sound as dangerous as real ones.
But what they are doing, in effect, is making smoking seem only as hazardous as vaping. In other words, because of the statements of these anti-vaping groups, the public largely believes that smoking is only as hazardous as using a non-tobacco-containing product which involves no combustion and which has been shown to be much safer than tobacco cigarettes.
Thus, the effect of the campaign of deception that is being waged by anti-vaping groups is to undermine decades of progress in educating the public about the severe hazards of cigarette smoking.
Those with an interest in increasing cigarette sales could ask for no greater favor from these health groups. Unwittingly, and ironically, they have entered the realm of helping to protect cigarette profits by protecting cigarette sales from competition and by making sure that the cigarettes which smokers use are tobacco-full rather than tobacco-free. Thus, organization names like "Tobacco Free" Amarillo appear to be a misnomer. They are opposing, rather than supporting a transition from tobacco-full to tobacco-free cigarettes and from deadly combustible tobacco products to much safer tobacco-free products that have the potential to save tens of thousands of lives.
Thursday, December 17, 2015
Campaign for Tobacco-Free Kids is Out of Its Mind Declaring that Appropriations Rider Would Have Been a Gift to the Tobacco Industry
Unfortunately, the budget deal reached in Congress this week fails to include a rider which would have changed the "grandfather" or predicate date for electronic cigarettes from February 15, 2007 to the effective date of the regulation. This means that every electronic cigarette and vaping product on the market will have to submit a new tobacco product application to the FDA in order to stay on the market. In contrast, when the Tobacco Act was originally enacted in 2009, almost all cigarettes on the market received a free pass, not having to do anything to stay on the market. And since that time, not a single safety requirement has been placed on cigarettes by the FDA. In other words, the FDA's regulation of cigarettes has given these products a free ride with no safety requirements, no applications, and no required changes.
Despite the free ride given to cigarettes and the burdensome and prohibitively expensive new product applications required for electronic cigarettes, the Campaign for Tobacco-Free Kids had the gall to declare that regulating e-cigarettes in the same way as real cigarettes would have been a "giveaway" to the tobacco industry.
In a press release yesterday, entitled "Budget Agreement Protects Kids and Health by Rejecting Tobacco Industry Giveaways," the Campaign for Tobacco-Free Kids stated:
"The budget agreement reached by congressional negotiators delivers critical victories for America’s kids and health over the tobacco industry by rejecting proposals to greatly weaken FDA oversight of electronic cigarettes and cigars and slash funding for the CDC’s programs to reduce tobacco use. By rejecting these special interest giveaways to the tobacco industry, this agreement bolsters the nation’s fight against tobacco use, the number one cause of preventable death. The budget agreement does not include a provision, approved by the House Appropriations Committee, to limit FDA oversight of e-cigarettes and cigars already on the market, including many candy- and fruit-flavored products that have been introduced in recent years and proven popular with kids. The agreement preserves the FDA’s ability to review these products and take action to protect our kids."
(Note: I am not in disagreement with the Campaign's opposition to slashing funding for tobacco control programs.)
The Rest of the Story
Far from being a giveaway to the tobacco industry, the appropriations rider would have actually made it much more difficult for cigarettes to compete in the market, because it would have opened the market to stiff competition from tobacco-free cigarettes (e-cigarettes and vaping products). Instead, the FDA regulations will now decimate the electronic cigarette industry, allowing tobacco cigarettes to have free reign over the entire nicotine market. Financial analysts had predicted that if allowed to remain on the market, electronic cigarettes would have eventually taken over 50% of the tobacco cigarette market. So the truth is that by rejecting the rider and devastating the chief competitors to cigarettes, Congress has unquestionably bequeathed the tobacco industry with a giveaway.
In what way does the Campaign believe that regulating tobacco cigarettes less stringently than tobacco-free cigarettes is a blow to the cigarette industry? The reality is that had the rider passed, it would have cut into the profits of tobacco companies by ensuring that the vaping market is not contracted. Instead, the FDA regulations are going to result in the elimination of most of the vaping market, leaving only the cigarette companies and a few large independent e-cigarette companies to control the market. As I have noted, the cigarette companies (Altria and Reynolds American) were both supporting the rider in spite of their short-term economic interests because they are actually committed to a vigorous tobacco-free nicotine market in the United States. In contrast, the Campaign for Tobacco-Free Kids is doing everything it can to make sure that the only choice for smokers is to continue smoking the deadliest of consumer products: tobacco cigarettes.
The Campaign is wrong in stating that the appropriations rider would have removed the FDA's ability to review e-cigarette products and take action to protect our kids. The rider would have actually strengthened the FDA's ability to review and oversee these products and to protect kids by forcing the agency to actually set safety standards for these products, put an end to exploding batteries, and ensure quality control for all products. The rider would not have prevented the FDA from regulating, reviewing, overseeing, or requiring changes in the safety, sale, or marketing of these products.
Gregory Conley, president of the American Vaping Association, hit the mark in stating:
"This deal protects cigarette markets. Congressional leaders have squandered a real opportunity to benefit both public health and small businesses across the country. The perverse outcome of this failure to act is that smoke-free vapor products will be treated far more harshly by the FDA than deadly tobacco cigarettes ever have been."
To add insult to injury, it was the Campaign for Tobacco-Free Kids which negotiated the deal that led to the 2009 Tobacco Act and which crafted it in such a way so that it gave a free pass to virtually all cigarettes on the market. Moreover, it was the Campaign which opposed banning menthol cigarettes, demonstrating that it is full of crap in pretending to be concerned about the protection of "our kids."
With the rejection of this rider, the next best hope of doing something meaningful to combat the smoking epidemic is that the Office of Management and Budget will reject the FDA deeming regulations, sending them back to the agency and requiring it to comply with Executive Order 12866.
Despite the free ride given to cigarettes and the burdensome and prohibitively expensive new product applications required for electronic cigarettes, the Campaign for Tobacco-Free Kids had the gall to declare that regulating e-cigarettes in the same way as real cigarettes would have been a "giveaway" to the tobacco industry.
In a press release yesterday, entitled "Budget Agreement Protects Kids and Health by Rejecting Tobacco Industry Giveaways," the Campaign for Tobacco-Free Kids stated:
"The budget agreement reached by congressional negotiators delivers critical victories for America’s kids and health over the tobacco industry by rejecting proposals to greatly weaken FDA oversight of electronic cigarettes and cigars and slash funding for the CDC’s programs to reduce tobacco use. By rejecting these special interest giveaways to the tobacco industry, this agreement bolsters the nation’s fight against tobacco use, the number one cause of preventable death. The budget agreement does not include a provision, approved by the House Appropriations Committee, to limit FDA oversight of e-cigarettes and cigars already on the market, including many candy- and fruit-flavored products that have been introduced in recent years and proven popular with kids. The agreement preserves the FDA’s ability to review these products and take action to protect our kids."
(Note: I am not in disagreement with the Campaign's opposition to slashing funding for tobacco control programs.)
The Rest of the Story
Far from being a giveaway to the tobacco industry, the appropriations rider would have actually made it much more difficult for cigarettes to compete in the market, because it would have opened the market to stiff competition from tobacco-free cigarettes (e-cigarettes and vaping products). Instead, the FDA regulations will now decimate the electronic cigarette industry, allowing tobacco cigarettes to have free reign over the entire nicotine market. Financial analysts had predicted that if allowed to remain on the market, electronic cigarettes would have eventually taken over 50% of the tobacco cigarette market. So the truth is that by rejecting the rider and devastating the chief competitors to cigarettes, Congress has unquestionably bequeathed the tobacco industry with a giveaway.
In what way does the Campaign believe that regulating tobacco cigarettes less stringently than tobacco-free cigarettes is a blow to the cigarette industry? The reality is that had the rider passed, it would have cut into the profits of tobacco companies by ensuring that the vaping market is not contracted. Instead, the FDA regulations are going to result in the elimination of most of the vaping market, leaving only the cigarette companies and a few large independent e-cigarette companies to control the market. As I have noted, the cigarette companies (Altria and Reynolds American) were both supporting the rider in spite of their short-term economic interests because they are actually committed to a vigorous tobacco-free nicotine market in the United States. In contrast, the Campaign for Tobacco-Free Kids is doing everything it can to make sure that the only choice for smokers is to continue smoking the deadliest of consumer products: tobacco cigarettes.
The Campaign is wrong in stating that the appropriations rider would have removed the FDA's ability to review e-cigarette products and take action to protect our kids. The rider would have actually strengthened the FDA's ability to review and oversee these products and to protect kids by forcing the agency to actually set safety standards for these products, put an end to exploding batteries, and ensure quality control for all products. The rider would not have prevented the FDA from regulating, reviewing, overseeing, or requiring changes in the safety, sale, or marketing of these products.
Gregory Conley, president of the American Vaping Association, hit the mark in stating:
"This deal protects cigarette markets. Congressional leaders have squandered a real opportunity to benefit both public health and small businesses across the country. The perverse outcome of this failure to act is that smoke-free vapor products will be treated far more harshly by the FDA than deadly tobacco cigarettes ever have been."
To add insult to injury, it was the Campaign for Tobacco-Free Kids which negotiated the deal that led to the 2009 Tobacco Act and which crafted it in such a way so that it gave a free pass to virtually all cigarettes on the market. Moreover, it was the Campaign which opposed banning menthol cigarettes, demonstrating that it is full of crap in pretending to be concerned about the protection of "our kids."
With the rejection of this rider, the next best hope of doing something meaningful to combat the smoking epidemic is that the Office of Management and Budget will reject the FDA deeming regulations, sending them back to the agency and requiring it to comply with Executive Order 12866.
Wednesday, December 16, 2015
New National Survey Refutes CDC Claim that E-Cigarettes are Addicting Kids and Leading to Smoking
The Centers for Disease Control and Prevention (CDC) has claimed that electronic cigarettes are condemning youth to lifetime addiction to nicotine and serving as a gateway to cigarette smoking. New data released today by the National Institute of Drug Abuse (NIDA) from the 2015 Monitoring the Future (MTF) survey demonstrate that the CDC's claims are baseless.
First, the MTF survey revealed that despite the huge number of youth using electronic cigarettes and the dramatic increase in use of e-cigarettes by youth over the past four years, the rate of youth smoking has declined dramatically during the same time period. Moreover, the decline in smoking continued from 2014 to 2015. If e-cigarettes were a significant gateway to smoking, we would have expected to see an increase in youth smoking, or at least a discontinuation of the rapid rate of decrease in youth smoking. However, from 2014 to 2015, daily smoking among high school seniors dropped from 6.7% to 5.5% (an 18% decline, which nearly matches the 21% decline from 2013 to 2014). This is the second largest decline in daily smoking among high school seniors that has been observed in the past 25 years.
Second, the MTF survey revealed that the majority of youth who use e-cigarettes reported using non-nicotine-containing products. Across all grades, more than 60% of youth who used e-cigarettes in the past month reported using a product with just flavoring (without nicotine). Among high school seniors, only 22.2% reported using a nicotine product. Nearly two-thirds (65.4%) of youth past-month e-cigarette users reported using a non-nicotine, flavored product. Just over six percent (6.3%) reported not knowing what the product contained. Based on these data, it appears that the majority of youths who are using e-cigarettes may not actually be using a nicotine-containing product. This certainly casts doubt upon CDC's claim that e-cigarettes are leading to a lifetime of nicotine addiction among youth users.
The Rest of the Story
Although severe damage has already been done, I believe that the CDC needs to immediately correct its baseless claims.
In light of the fact that the past two years have marked the two largest year-to-year declines in daily smoking among high school seniors, it is inexcusable for the CDC to be telling the public that e-cigarettes are a gateway to real cigarette smoking.
And in light of the finding that only one-fifth of high school seniors who used e-cigarettes in the past month reported using a nicotine-containing product, it is also inexcusable for the CDC to be telling the public that e-cigarette use is condemning youth to a lifetime of nicotine addiction. We don't even know whether e-cigarettes are creating nicotine addiction in the first place.
Clearly, more research is necessary to characterize the nature of the electronic cigarette products that youth are using. It is not clear whether youth are accurately reporting the absence of nicotine in the products they are using. Also, some brands that are labeled as zero nicotine have been found to contain nicotine. So caution is necessary in interpreting the survey findings regarding nicotine-containing e-cigarette product use. However, there is no existing evidence that large numbers of youth are becoming addicted to nicotine via experimentation with electronic cigarettes.
Surprisingly, NIDA expressed disappointment that daily cigarette use was lower than daily marijuana use (for the first time in history) and that overall marijuana use exceeded that of cigarette use. Youth marijuana daily use has remained stable at around 3% to 4% for the past two decades. So by stating that they are disappointed that marijuana use exceeds daily cigarette use, NIDA is essentially saying that they would have preferred to see daily cigarette smoking rates remain above 4%. I feel quite differently. I am very pleased that youth daily smoking rates have dropped below the stable rate of daily marijuana use. It means that fewer people will die, which it seems to me is a good thing.
According to an article in the New York Times, NIDA also expressed disappointment that youth seem to be transitioning from real cigarettes that kill people to fake ones that are much safer and which do not appear to have any serious acute health effects.
In another complete misinterpretation of the data, the Campaign for Tobacco-Free Kids stated: "These results also indicate e-cigarettes are more likely to be a pathway to tobacco addiction than away from it." Nothing in these data suggests that e-cigarettes are a pathway to tobacco addiction. The Campaign for Tobacco-Free Kids is just completely making this up. There's not a shred of evidence in the MTF survey that e-cigarette experimentation is leading to tobacco use. If anything, the findings of this survey suggest the opposite.
The rest of the story is that our major health agencies and supposedly anti-tobacco organizations do not appear to want kids to refrain from smoking unless they refrain from anything that looks like smoking. And they appear to prefer that kids smoke tobacco cigarettes than use tobacco-free cigarettes. Sadly, such an attitude is going to cost us a huge number of lives, as these organizations truly are condemning youth to a lifetime of nicotine addiction, disease, and death.
First, the MTF survey revealed that despite the huge number of youth using electronic cigarettes and the dramatic increase in use of e-cigarettes by youth over the past four years, the rate of youth smoking has declined dramatically during the same time period. Moreover, the decline in smoking continued from 2014 to 2015. If e-cigarettes were a significant gateway to smoking, we would have expected to see an increase in youth smoking, or at least a discontinuation of the rapid rate of decrease in youth smoking. However, from 2014 to 2015, daily smoking among high school seniors dropped from 6.7% to 5.5% (an 18% decline, which nearly matches the 21% decline from 2013 to 2014). This is the second largest decline in daily smoking among high school seniors that has been observed in the past 25 years.
Second, the MTF survey revealed that the majority of youth who use e-cigarettes reported using non-nicotine-containing products. Across all grades, more than 60% of youth who used e-cigarettes in the past month reported using a product with just flavoring (without nicotine). Among high school seniors, only 22.2% reported using a nicotine product. Nearly two-thirds (65.4%) of youth past-month e-cigarette users reported using a non-nicotine, flavored product. Just over six percent (6.3%) reported not knowing what the product contained. Based on these data, it appears that the majority of youths who are using e-cigarettes may not actually be using a nicotine-containing product. This certainly casts doubt upon CDC's claim that e-cigarettes are leading to a lifetime of nicotine addiction among youth users.
The Rest of the Story
Although severe damage has already been done, I believe that the CDC needs to immediately correct its baseless claims.
In light of the fact that the past two years have marked the two largest year-to-year declines in daily smoking among high school seniors, it is inexcusable for the CDC to be telling the public that e-cigarettes are a gateway to real cigarette smoking.
And in light of the finding that only one-fifth of high school seniors who used e-cigarettes in the past month reported using a nicotine-containing product, it is also inexcusable for the CDC to be telling the public that e-cigarette use is condemning youth to a lifetime of nicotine addiction. We don't even know whether e-cigarettes are creating nicotine addiction in the first place.
Clearly, more research is necessary to characterize the nature of the electronic cigarette products that youth are using. It is not clear whether youth are accurately reporting the absence of nicotine in the products they are using. Also, some brands that are labeled as zero nicotine have been found to contain nicotine. So caution is necessary in interpreting the survey findings regarding nicotine-containing e-cigarette product use. However, there is no existing evidence that large numbers of youth are becoming addicted to nicotine via experimentation with electronic cigarettes.
Surprisingly, NIDA expressed disappointment that daily cigarette use was lower than daily marijuana use (for the first time in history) and that overall marijuana use exceeded that of cigarette use. Youth marijuana daily use has remained stable at around 3% to 4% for the past two decades. So by stating that they are disappointed that marijuana use exceeds daily cigarette use, NIDA is essentially saying that they would have preferred to see daily cigarette smoking rates remain above 4%. I feel quite differently. I am very pleased that youth daily smoking rates have dropped below the stable rate of daily marijuana use. It means that fewer people will die, which it seems to me is a good thing.
According to an article in the New York Times, NIDA also expressed disappointment that youth seem to be transitioning from real cigarettes that kill people to fake ones that are much safer and which do not appear to have any serious acute health effects.
Here is what the article had to say about NIDA's position: "Dr. Volkow and others were displeased, however, by what appeared to be a lack of progress in areas related to smoking. For
the first time in the survey’s 41 years, the percentage of high school
seniors who said they smoked marijuana daily (which remained steady at 6
percent) exceeded those who smoked traditional cigarettes daily (5.5
percent, a large drop from last year’s 6.7). Although this derived
mostly from the continued decrease in cigarette smoking since the 1970s, many students appear to be transitioning to e-cigarettes, which are unregulated and can contain nicotine and other harmful products, Dr. Volkow said."
The good thing is that NIDA seems to be acknowledging, unlike the CDC, that what we are observing is a transition in youth-preferred products from tobacco cigarettes to e-cigarettes (i.e., non-tobacco cigarettes). Why NIDA would be displeased that youth are transitioning away from smoking boggles my mind.
In another complete misinterpretation of the data, the Campaign for Tobacco-Free Kids stated: "These results also indicate e-cigarettes are more likely to be a pathway to tobacco addiction than away from it." Nothing in these data suggests that e-cigarettes are a pathway to tobacco addiction. The Campaign for Tobacco-Free Kids is just completely making this up. There's not a shred of evidence in the MTF survey that e-cigarette experimentation is leading to tobacco use. If anything, the findings of this survey suggest the opposite.
The rest of the story is that our major health agencies and supposedly anti-tobacco organizations do not appear to want kids to refrain from smoking unless they refrain from anything that looks like smoking. And they appear to prefer that kids smoke tobacco cigarettes than use tobacco-free cigarettes. Sadly, such an attitude is going to cost us a huge number of lives, as these organizations truly are condemning youth to a lifetime of nicotine addiction, disease, and death.
Monday, December 14, 2015
FDA Wants to Know if Your Cigarette is Defective, Damaged, or Contaminated, But Doesn't Care if It Kills You
In a communication I thought I would never see from a public health agency, the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) has alerted consumers to notify them if their cigarettes are defective or contaminated, but not if they cause severe adverse health effects, like cancer, heart disease, lung disease, stroke, or death.
The tweet from CTP states: "There's no safe#tobacco product, but if it’s defective, damaged, or contaminated, let us know." It then refers consumers to a link where they can report the defective product.
However, the FDA provided no link to report the actual, devastating health consequences of smoking. Apparently, the 400,000 deaths that occur each year from smoking are just fine, but God forbid if a cigarette ever is contaminated or doesn't work "properly."
It's not even clear what the FDA means by a "defective" cigarette. I suppose that electronic cigarettes could all be viewed as defective, since unlike real cigarettes, they don't give you heart disease, cancer, lung disease, stroke, or death. Perhaps all vapers should be reporting to the FDA in droves, complaining that unlike the "approved" FDA cigarettes, these unregulated vaping devices are causing no harm.
Ironically, while the FDA seems very concerned about cigarettes that don't work properly or which are "contaminated," they have not shown a shred of concern about the actual disease and death being caused by these products. In fact, the FDA has yet to take a single action to reduce the risk posed by cigarettes. It has not established a single safety standard. It has not reduced the tar or nicotine levels in the product. It has not required the removal of harmful additives. It has literally done nothing to address the safety of tobacco cigarettes. On the other hand, it is poised to essentially pull almost all of the tobacco-free cigarettes from the market.
The Rest of the Story
Today I am starting a campaign, entitled "Don't Settle for Less," which is aimed at vapers nationwide. The key message is this:
"Vapers: Demand health damage from your e-cigarettes! Don't let cigarettes get away with being the only cigarette-like "tobacco product" to kill many of their users. Complain to the FDA and tell them that you, too, want to experience severe shortness of breath, lose your mobility due to a severe stroke, die from cancer, and have to use an oxygen tank because of emphysema. Demand that e-cigarette companies be forced to use actual tobacco in their products and to provide devices that burn, instead of heat the tobacco so that you can once again experience the huge health risks of inhaling more than 10,000 chemicals and more than 60 known human carcinogens."
"Don't settle for a defective cigarette that has been shown not to have the cytotoxicity of the real thing. Don't settle for a defective tobacco product that doesn't even contain tobacco. And certainly don't settle for a defective cigarette that improves your breathing within days, rather than worsening your respiratory symptoms. Tell the FDA that you want to experience the full health risks from cigarette use, not the piddly risks associated with low levels of a few chemicals. Demand that you get your money's worth and can inhale more than 10,000 chemicals, rather than just a few. You're paying for it. So don't settle for less when you could have it all. Demand full toxicity."
"Insist that all cigarettes, even electronic ones, use real tobacco. After all, according to the FDA, you're using a "tobacco" product. So demand that you get tobacco in your product! Only then will you be able to ensure that your favorite product stays on the market and that it doesn't have to go out of business because of the costs of completing a 100,000-page application for approval. Tell the FDA that you want the security of knowing that your product of choice has been grandfathered in and is approved for perpetual sale and marketing in the United States."
"Most importantly, tell the FDA that you want known health risks from your product, not speculative or hypothetical risks. Look, you're paying real money, not hypothetical money. So demand real risks."
The "Don't Settle for Less" campaign was developed and produced by The Rest of the Story. It has been trademarked by the United States Patent and Trademark Office.
Any infringement of this trademark or its use without the authorization of the trademark owner is a violation of the exclusive rights of The Rest of the Story.
(Thanks to Carl Phillips for noticing this revealing tweet.)
The tweet from CTP states: "There's no safe
However, the FDA provided no link to report the actual, devastating health consequences of smoking. Apparently, the 400,000 deaths that occur each year from smoking are just fine, but God forbid if a cigarette ever is contaminated or doesn't work "properly."
It's not even clear what the FDA means by a "defective" cigarette. I suppose that electronic cigarettes could all be viewed as defective, since unlike real cigarettes, they don't give you heart disease, cancer, lung disease, stroke, or death. Perhaps all vapers should be reporting to the FDA in droves, complaining that unlike the "approved" FDA cigarettes, these unregulated vaping devices are causing no harm.
Ironically, while the FDA seems very concerned about cigarettes that don't work properly or which are "contaminated," they have not shown a shred of concern about the actual disease and death being caused by these products. In fact, the FDA has yet to take a single action to reduce the risk posed by cigarettes. It has not established a single safety standard. It has not reduced the tar or nicotine levels in the product. It has not required the removal of harmful additives. It has literally done nothing to address the safety of tobacco cigarettes. On the other hand, it is poised to essentially pull almost all of the tobacco-free cigarettes from the market.
The Rest of the Story
Today I am starting a campaign, entitled "Don't Settle for Less," which is aimed at vapers nationwide. The key message is this:
"Vapers: Demand health damage from your e-cigarettes! Don't let cigarettes get away with being the only cigarette-like "tobacco product" to kill many of their users. Complain to the FDA and tell them that you, too, want to experience severe shortness of breath, lose your mobility due to a severe stroke, die from cancer, and have to use an oxygen tank because of emphysema. Demand that e-cigarette companies be forced to use actual tobacco in their products and to provide devices that burn, instead of heat the tobacco so that you can once again experience the huge health risks of inhaling more than 10,000 chemicals and more than 60 known human carcinogens."
"Don't settle for a defective cigarette that has been shown not to have the cytotoxicity of the real thing. Don't settle for a defective tobacco product that doesn't even contain tobacco. And certainly don't settle for a defective cigarette that improves your breathing within days, rather than worsening your respiratory symptoms. Tell the FDA that you want to experience the full health risks from cigarette use, not the piddly risks associated with low levels of a few chemicals. Demand that you get your money's worth and can inhale more than 10,000 chemicals, rather than just a few. You're paying for it. So don't settle for less when you could have it all. Demand full toxicity."
"Insist that all cigarettes, even electronic ones, use real tobacco. After all, according to the FDA, you're using a "tobacco" product. So demand that you get tobacco in your product! Only then will you be able to ensure that your favorite product stays on the market and that it doesn't have to go out of business because of the costs of completing a 100,000-page application for approval. Tell the FDA that you want the security of knowing that your product of choice has been grandfathered in and is approved for perpetual sale and marketing in the United States."
"Most importantly, tell the FDA that you want known health risks from your product, not speculative or hypothetical risks. Look, you're paying real money, not hypothetical money. So demand real risks."
The "Don't Settle for Less" campaign was developed and produced by The Rest of the Story. It has been trademarked by the United States Patent and Trademark Office.
(Thanks to Carl Phillips for noticing this revealing tweet.)
Thursday, December 10, 2015
New Study Finds that Average Diacetyl Exposure from Vaping is 750 Times Lower than from Smoking
In a new study that appears designed to send a scare to vapers throughout the country, researchers from the Harvard T.H. Chan School of Public Health reported finding diacetyl in 39 of 51 flavors of e-liquids tested, with levels ranging from below the level of quantification to 239 micrograms per e-cigarette cartridge. The chemical diacetyl has been linked to a serious and often fatal lung disease called bronchiolitis obliterans or "popcorn lung" (so named because it was found disproportionately among workers manufacturing a butter-flavor for popcorn whose chief component was diacetyl).
(See: Allen JG, et al. Flavoring chemicals in e-cigarettes: Diacetyl, 2,3-pentanedione, and acetoin in a sample of 51 products, including fruit-, candy-, and cocktail-flavored e-cigarettes. Environmental Health Perspectives. Published online December 8, 2015.)
The authors conclude: "Due to the associations between diacetyl, bronchiolitis obliterans and other severe respiratory diseases observed in workers, urgent action is recommended to further evaluate this potentially widespread exposure via flavored e-cigarettes."
The paper resulted in widespread, hysterical media coverage, warning that because of the finding of diacetyl in e-cigarette aerosol, vapers are at risk of fatal lung disease. One article, for example, wrote that: "This latest research adds to the mounting evidence that e-cigarettes may not be that much safer than traditional tobacco cigarettes." Another headline stated: "Harvard Study Confirms Dangers of Vaping." That article goes on to tell the public that vaping does cause fatal lung disease.
Given the huge scare being created by the publicity around this article, it is quite likely that a large number of vapers will give up e-cigarettes and go back to smoking in fear that they may develop "popcorn lung." The newspaper coverage of this scare will undoubtedly result in an increase in smoking, both by discouraging vapers from continuing to stay away from cigarettes and by discouraging smokers who might otherwise have used e-cigarettes to quit.
The Rest of the Story
There's just one minor fact that is omitted completely in the article, as well as in all the media coverage. In fact, this piece of information is found nowhere in the article at all. And by omitting this information, it virtually assured that the scientific meaning of the article would be misrepresented to the public.
That fact: All conventional cigarettes produce tobacco smoke that contains diacetyl, and the levels of diacetyl in cigarettes are a lot higher than those produced by e-cigarettes.
In the study, Allen et al. found that the average diacetyl content of the products tested was 9.0 micrograms per e-cigarette cartridge. Assuming that a vaper uses one cartridge per day, the average daily inhaled dose of diacetyl associated with vaping is therefore 9.0 micrograms.
Fujioka and Shibamoto conducted a study to measure the diacetyl exposure from active smoking. They found that the average diacetyl content of the cigarettes tested was 335.9 micrograms per cigarette. Assuming that a smoker consumes one pack per day (20 cigarettes), the average daily inhaled does of diacetyl associated with smoking is therefore 6718 micrograms.
Table 1. Average inhaled daily diacetyl dose associated with smoking vs. vaping
Vaping: 9 micrograms
Smoking: 6718 micrograms
Daily exposure to diacetyl from smoking is therefore 750 times higher, on average, than exposure to diacetyl from vaping.
Even if one looks at the maximum detected level of diacetyl in the electronic cigarettes vs. real cigarettes tested, the exposure of a smoker is much higher than that of a vaper.
Table 2. Maximum inhaled daily diacetyl dose associated with smoking vs. vaping
Vaping: 239 micrograms
Smoking: 20340 micrograms (see Pierce et al., 2014)
Thus, the "worst" e-cigarette tested produces diacetyl exposure that is 85 times lower than that of the "worst" cigarette tested.
There is a second important fact that was omitted from the journal article (and from the ensuing media coverage).
That fact: Despite the much higher levels of diacetyl in tobacco smoke than in e-cigarette vapor, smoking has not been associated with "popcorn lung."
Thus, it is clearly misrepresenting the scientific evidence to conclude that vaping increases the risk of "popcorn lung" or that vaping causes "popcorn lung."
The authors of the article argue that "due to the associations between diacetyl, bronchiolitis obliterans and other severe respiratory diseases among workers inhaling heated vapors containing diacetyl, urgent action is recommended...".
However, nowhere in the article do the authors recommend that "urgent action" be taken due to the presence of high levels of diacetyl in tobacco smoke (750 times higher, on average, than in e-cigarette aerosol).
Similarly, while the article insinuates that the FDA should probably regulate diacetyl exposure from vaping, it does not suggest that the agency take similar action regarding the much higher diacetyl exposures resulting from cigarette smoking. Yet the FDA does have the regulatory authority to regulate the maximum levels of diacetyl allowable in tobacco smoke. Of course, the FDA won't do anything about the high levels of diacetyl exposure among smokers because this issue has long since left the realm of being about the public's health and is now more about preserving a certain ideology.
With all of this said, I do want to emphasize several important points:
1. The finding of diacetyl in many brands of electronic cigarettes (despite diacetyl not being an actual ingredient in the e-liquid) is concerning, and further research is definitely warranted to identify the source of the diacetyl and how its presence may be prevented. What is the difference between e-liquids that produce diacetyl when heated and those which do not? Is there a particular flavoring associated with it? We need to try to make e-cigarettes as safe as possible, and diacetyl exposure must be added to the list of major safety concerns with these products that need to be addressed by the FDA through research and regulation.
2. The FDA should set uniform safety standards for e-cigarettes and e-liquids that include a maximum allowable level of diacetyl. There doesn't seem to be a need for an e-liquid with 238 micrograms of diacetyl to be on the market when the average for the brands tested was only 9 micrograms.
3. There is no reason at all for diacetyl itself to be used as a flavoring in e-liquids, and the FDA should simply ban the use of diacetyl as an e-liquid flavoring.
Nevertheless, it is disingenuous and actually damaging to the public's health to spread the message that vaping causes fatal lung disease or even that it appears to increase the risk for popcorn lung. And it is especially disingenuous and damaging to send these messages to the public without telling us that smoking produces exposure to diacetyl that is on average about 750 times higher than vaping.
This is a situation where it is critical that the public understands "the rest of the story."
(See: Allen JG, et al. Flavoring chemicals in e-cigarettes: Diacetyl, 2,3-pentanedione, and acetoin in a sample of 51 products, including fruit-, candy-, and cocktail-flavored e-cigarettes. Environmental Health Perspectives. Published online December 8, 2015.)
The authors conclude: "Due to the associations between diacetyl, bronchiolitis obliterans and other severe respiratory diseases observed in workers, urgent action is recommended to further evaluate this potentially widespread exposure via flavored e-cigarettes."
The paper resulted in widespread, hysterical media coverage, warning that because of the finding of diacetyl in e-cigarette aerosol, vapers are at risk of fatal lung disease. One article, for example, wrote that: "This latest research adds to the mounting evidence that e-cigarettes may not be that much safer than traditional tobacco cigarettes." Another headline stated: "Harvard Study Confirms Dangers of Vaping." That article goes on to tell the public that vaping does cause fatal lung disease.
Given the huge scare being created by the publicity around this article, it is quite likely that a large number of vapers will give up e-cigarettes and go back to smoking in fear that they may develop "popcorn lung." The newspaper coverage of this scare will undoubtedly result in an increase in smoking, both by discouraging vapers from continuing to stay away from cigarettes and by discouraging smokers who might otherwise have used e-cigarettes to quit.
The Rest of the Story
There's just one minor fact that is omitted completely in the article, as well as in all the media coverage. In fact, this piece of information is found nowhere in the article at all. And by omitting this information, it virtually assured that the scientific meaning of the article would be misrepresented to the public.
That fact: All conventional cigarettes produce tobacco smoke that contains diacetyl, and the levels of diacetyl in cigarettes are a lot higher than those produced by e-cigarettes.
In the study, Allen et al. found that the average diacetyl content of the products tested was 9.0 micrograms per e-cigarette cartridge. Assuming that a vaper uses one cartridge per day, the average daily inhaled dose of diacetyl associated with vaping is therefore 9.0 micrograms.
Fujioka and Shibamoto conducted a study to measure the diacetyl exposure from active smoking. They found that the average diacetyl content of the cigarettes tested was 335.9 micrograms per cigarette. Assuming that a smoker consumes one pack per day (20 cigarettes), the average daily inhaled does of diacetyl associated with smoking is therefore 6718 micrograms.
Table 1. Average inhaled daily diacetyl dose associated with smoking vs. vaping
Vaping: 9 micrograms
Smoking: 6718 micrograms
Daily exposure to diacetyl from smoking is therefore 750 times higher, on average, than exposure to diacetyl from vaping.
Even if one looks at the maximum detected level of diacetyl in the electronic cigarettes vs. real cigarettes tested, the exposure of a smoker is much higher than that of a vaper.
Table 2. Maximum inhaled daily diacetyl dose associated with smoking vs. vaping
Vaping: 239 micrograms
Smoking: 20340 micrograms (see Pierce et al., 2014)
Thus, the "worst" e-cigarette tested produces diacetyl exposure that is 85 times lower than that of the "worst" cigarette tested.
There is a second important fact that was omitted from the journal article (and from the ensuing media coverage).
That fact: Despite the much higher levels of diacetyl in tobacco smoke than in e-cigarette vapor, smoking has not been associated with "popcorn lung."
Thus, it is clearly misrepresenting the scientific evidence to conclude that vaping increases the risk of "popcorn lung" or that vaping causes "popcorn lung."
The authors of the article argue that "due to the associations between diacetyl, bronchiolitis obliterans and other severe respiratory diseases among workers inhaling heated vapors containing diacetyl, urgent action is recommended...".
However, nowhere in the article do the authors recommend that "urgent action" be taken due to the presence of high levels of diacetyl in tobacco smoke (750 times higher, on average, than in e-cigarette aerosol).
Similarly, while the article insinuates that the FDA should probably regulate diacetyl exposure from vaping, it does not suggest that the agency take similar action regarding the much higher diacetyl exposures resulting from cigarette smoking. Yet the FDA does have the regulatory authority to regulate the maximum levels of diacetyl allowable in tobacco smoke. Of course, the FDA won't do anything about the high levels of diacetyl exposure among smokers because this issue has long since left the realm of being about the public's health and is now more about preserving a certain ideology.
With all of this said, I do want to emphasize several important points:
1. The finding of diacetyl in many brands of electronic cigarettes (despite diacetyl not being an actual ingredient in the e-liquid) is concerning, and further research is definitely warranted to identify the source of the diacetyl and how its presence may be prevented. What is the difference between e-liquids that produce diacetyl when heated and those which do not? Is there a particular flavoring associated with it? We need to try to make e-cigarettes as safe as possible, and diacetyl exposure must be added to the list of major safety concerns with these products that need to be addressed by the FDA through research and regulation.
2. The FDA should set uniform safety standards for e-cigarettes and e-liquids that include a maximum allowable level of diacetyl. There doesn't seem to be a need for an e-liquid with 238 micrograms of diacetyl to be on the market when the average for the brands tested was only 9 micrograms.
3. There is no reason at all for diacetyl itself to be used as a flavoring in e-liquids, and the FDA should simply ban the use of diacetyl as an e-liquid flavoring.
Nevertheless, it is disingenuous and actually damaging to the public's health to spread the message that vaping causes fatal lung disease or even that it appears to increase the risk for popcorn lung. And it is especially disingenuous and damaging to send these messages to the public without telling us that smoking produces exposure to diacetyl that is on average about 750 times higher than vaping.
This is a situation where it is critical that the public understands "the rest of the story."
Wednesday, December 09, 2015
Changing Grandfather Date Does Not Mean FDA Cannot Review E-Cigarette Products; Instead, It Will Force Agency to Regulate E-Cigarettes Properly
Groups that are against tobacco-free cigarettes, and which want to make sure that all cigarettes continue to contain tobacco, continue to mislead the public into thinking that changing the grandfather date in the FDA deeming regulations will prevent the FDA from reviewing electronic cigarette products.
According to an article in the Washington Examiner, Gregg Haifley, director of federal relations for the American Cancer Society's Cancer Action Network, stated that the idea behind the grandfather date was to "not let the market be completely flooded with new products without any consideration of the impact of public health. Obviously, the industry is maneuvering to escape that kind of review by the FDA."
And according to Erika Sward, assistant vice president for national advocacy for the American Lung Association, the rationale for the law in the first place was to prevent tobacco companies from putting new products on the market that fraudulently claimed to be safer, but really were not, and in some cases were more addictive: "The 2009 law recognized that the tobacco industry is constantly trying to find new products to entice kids and made it harder for smokers to quit."
The Rest of the Story
It is simply not true that changing the grandfather date precludes the FDA from reviewing electronic cigarette products. The FDA is free to set any rules it wishes for the review of electronic cigarettes, including setting uniform safety standards that all products must meet. In fact, moving the grandfather date to the effective date of the deeming regulations has the great advantage of forcing the FDA to regulate electronic cigarettes properly: that is, by directly setting uniform safety standards.
So the truth is that the industry is not trying to escape review by the FDA. The industry is trying to escape from prohibition of virtually all of its products. The industry would still be subject to stringent product review based on any specific features that the FDA set as standards.
It is also important to point out that the only reason for the new product approvals in the first place was that cigarette companies had a history of introducing products that they claimed were safer, but were actually just as dangerous. In some cases, new products contained additives that made them more addictive. Congress decided in 2009 that it wanted to prevent any of this from continuing. That's why it required FDA approval for new cigarette products.
However, the electronic cigarette industry is a total different story. It is not coming out with new products with an intent to deceive consumers into thinking they are safer. It is trying to come out with new products that actually are safer and more effective. Thus, the need for new product approval is not relevant with these products. The FDA should simply not make e-cigarettes subject to the new product approval provisions of the Tobacco Act.
The rest of the story is that anti-vaping groups continue to mislead the public and policy makers into thinking that changing the grandfather date will remove the FDA's ability to regulate and review electronic cigarettes, giving them a free pass. This is untrue. The FDA can regulate electronic cigarettes as stringently as it wishes. And in fact, that is exactly what it should be doing, rather than creating a huge bureaucracy to deal with tens of thousands of cumbersome new product applications.
The real effect of failing to change the grandfather date is the decimation of most of the electronic cigarette market. What the anti-vaping groups are really doing is helping to ensure that all cigarettes on the market remain full of tobacco, rather than working to transform the market so that a huge proportion of cigarettes are tobacco-free.
The Campaign for Tobacco-Free Kids may want kids to be tobacco-free, but it certainly does not appear to want smokers to be tobacco-free.
According to an article in the Washington Examiner, Gregg Haifley, director of federal relations for the American Cancer Society's Cancer Action Network, stated that the idea behind the grandfather date was to "not let the market be completely flooded with new products without any consideration of the impact of public health. Obviously, the industry is maneuvering to escape that kind of review by the FDA."
And according to Erika Sward, assistant vice president for national advocacy for the American Lung Association, the rationale for the law in the first place was to prevent tobacco companies from putting new products on the market that fraudulently claimed to be safer, but really were not, and in some cases were more addictive: "The 2009 law recognized that the tobacco industry is constantly trying to find new products to entice kids and made it harder for smokers to quit."
The Rest of the Story
It is simply not true that changing the grandfather date precludes the FDA from reviewing electronic cigarette products. The FDA is free to set any rules it wishes for the review of electronic cigarettes, including setting uniform safety standards that all products must meet. In fact, moving the grandfather date to the effective date of the deeming regulations has the great advantage of forcing the FDA to regulate electronic cigarettes properly: that is, by directly setting uniform safety standards.
So the truth is that the industry is not trying to escape review by the FDA. The industry is trying to escape from prohibition of virtually all of its products. The industry would still be subject to stringent product review based on any specific features that the FDA set as standards.
It is also important to point out that the only reason for the new product approvals in the first place was that cigarette companies had a history of introducing products that they claimed were safer, but were actually just as dangerous. In some cases, new products contained additives that made them more addictive. Congress decided in 2009 that it wanted to prevent any of this from continuing. That's why it required FDA approval for new cigarette products.
However, the electronic cigarette industry is a total different story. It is not coming out with new products with an intent to deceive consumers into thinking they are safer. It is trying to come out with new products that actually are safer and more effective. Thus, the need for new product approval is not relevant with these products. The FDA should simply not make e-cigarettes subject to the new product approval provisions of the Tobacco Act.
The rest of the story is that anti-vaping groups continue to mislead the public and policy makers into thinking that changing the grandfather date will remove the FDA's ability to regulate and review electronic cigarettes, giving them a free pass. This is untrue. The FDA can regulate electronic cigarettes as stringently as it wishes. And in fact, that is exactly what it should be doing, rather than creating a huge bureaucracy to deal with tens of thousands of cumbersome new product applications.
The real effect of failing to change the grandfather date is the decimation of most of the electronic cigarette market. What the anti-vaping groups are really doing is helping to ensure that all cigarettes on the market remain full of tobacco, rather than working to transform the market so that a huge proportion of cigarettes are tobacco-free.
The Campaign for Tobacco-Free Kids may want kids to be tobacco-free, but it certainly does not appear to want smokers to be tobacco-free.
Tuesday, December 08, 2015
New Study Shows that Anti-Vaping Groups' Misinformation is Confusing the Public and Resulting in More Smoking
A new study published recently in the journal Drug and Alcohol Dependence shows that in the UK between 2013 and 2014, the percentage of smokers who believed smoking to be more hazardous than vaping actually declined significantly, and this resulted in fewer smokers switching to e-cigarettes, thus resulting in more smoking.
(See: Brose LS, et al. Perceived relative harm of electronic cigarettes over time and impact on subsequent use. A survey with 1-year and 2-year follow-ups. Drug and Alcohol Dependence 2015; 157:106-111.)
The study involved a cohort of past-year smokers followed for 2 years, with 1-year and 2-year follow-ups. Perception of the relative harms of electronic cigarettes vs. tobacco cigarettes was measured at all three waves, along with e-cigarette use and smoking status.
The main findings were as follows: "Perceived relative harm changed; the proportion perceiving e-cigarettes to be less harmful than cigarettes decreased from 2013 to 2014. ... Perceiving e-cigarettes to be less harmful than cigarettes predicted subsequent use, adjusting for other characteristics (OR = 1.39; 95% CI: 1.08–1.80, p = 0.011)."
The most important conclusion of the study was as follows: "The present findings suggest that misperceptions of relative harm may impede switching. If e-cigarette use was avoided in favour of stopping nicotine use entirely, smokers’ health would benefit, however, the risk is that smokers continue smoking instead. One recent US survey for example found that a substantial proportion of respondents who had tried an e-cigarette reported that health concerns had led them to stop e-cigarette use; all continued smoking instead (Biener and Hargraves, 2015)."
The Rest of the Story
In light of the postings on this blog during the past few years, this study demonstrates two very important points.
First, the misinformation campaign being disseminated by electronic cigarette opponents is working. They are successfully undermining the public's appreciation of the severe hazards of smoking.
Second, this campaign is causing public health damage and promoting smoking, as public confusion about the relative safety of vaping vs. smoking has led to higher rates of smoking than would otherwise have occurred. The undermining of the public's appreciation of the hazards of smoking is deterring smokers from quitting using e-cigarettes and causing some ex-smokers to return to smoking.
The rest of the story, then, is that through their campaign of misinformation about the relative hazards of electronic cigarettes compared to real ones, e-cigarette opponents have undermined the public's appreciation of the severe hazards of smoking, resulting in more smoking than would have occurred if they had simply told the public the truth.
(See: Brose LS, et al. Perceived relative harm of electronic cigarettes over time and impact on subsequent use. A survey with 1-year and 2-year follow-ups. Drug and Alcohol Dependence 2015; 157:106-111.)
The study involved a cohort of past-year smokers followed for 2 years, with 1-year and 2-year follow-ups. Perception of the relative harms of electronic cigarettes vs. tobacco cigarettes was measured at all three waves, along with e-cigarette use and smoking status.
The main findings were as follows: "Perceived relative harm changed; the proportion perceiving e-cigarettes to be less harmful than cigarettes decreased from 2013 to 2014. ... Perceiving e-cigarettes to be less harmful than cigarettes predicted subsequent use, adjusting for other characteristics (OR = 1.39; 95% CI: 1.08–1.80, p = 0.011)."
The most important conclusion of the study was as follows: "The present findings suggest that misperceptions of relative harm may impede switching. If e-cigarette use was avoided in favour of stopping nicotine use entirely, smokers’ health would benefit, however, the risk is that smokers continue smoking instead. One recent US survey for example found that a substantial proportion of respondents who had tried an e-cigarette reported that health concerns had led them to stop e-cigarette use; all continued smoking instead (Biener and Hargraves, 2015)."
The Rest of the Story
In light of the postings on this blog during the past few years, this study demonstrates two very important points.
First, the misinformation campaign being disseminated by electronic cigarette opponents is working. They are successfully undermining the public's appreciation of the severe hazards of smoking.
Second, this campaign is causing public health damage and promoting smoking, as public confusion about the relative safety of vaping vs. smoking has led to higher rates of smoking than would otherwise have occurred. The undermining of the public's appreciation of the hazards of smoking is deterring smokers from quitting using e-cigarettes and causing some ex-smokers to return to smoking.
The rest of the story, then, is that through their campaign of misinformation about the relative hazards of electronic cigarettes compared to real ones, e-cigarette opponents have undermined the public's appreciation of the severe hazards of smoking, resulting in more smoking than would have occurred if they had simply told the public the truth.
Monday, December 07, 2015
Yet Another Tobacco Researcher Tells the Public that Smoking May Not Be Any More Hazardous than Vaping
A tobacco researcher from the University of Southern California last week told the public that smoking may not be any more hazardous than using an electronic cigarette, which involves no tobacco and no combustion, and which has been found to have carcinogen levels and free radical levels that are orders of magnitude lower than in real cigarette smoke.
According to an article by Reuters Health:
"Almost 10 percent of 11th and 12th graders are using e-cigarettes, and other alternative tobacco products are increasingly popular, according to a new study. ... “From this analysis we can say that there are two groups of youth that are concerning: those who are likely using e-cigs and hookah concurrently and those youth who are likely using three or more products,” said lead author Tamika D. Gilreath of the University of Southern California in Los Angeles. ... “Are these products safer?” Gilreath said. “In my opinion, long-term studies are needed before the safety question can be answered definitively.”"
The Rest of the Story
The rest of the story is that despite an abundance of current evidence that electronic cigarettes are safer than real tobacco cigarettes, including evidence that they contain levels of carcinogens and free radicals that are orders of magnitude lower than in cigarettes, that they contain no tobacco and involve no combustion, that they are far less toxic in cytotoxicity assays, and that they improve respiratory health, both subjectively and objectively, in smokers who switch to them, this tobacco researcher is telling the public that it is too early to say that smoking is any more dangerous than vaping.
Even the cigarette companies, which have everything to gain from this researcher's conclusion that smoking may be no more harmful than vaping, have clearly rejected such a conclusion, and against their interests in selling more cigarettes, have admitted that cigarettes are far more dangerous to health than e-cigarettes.
It is ironic that the most vocal and vehement undermining of the public's appreciation of the severe hazards of smoking is coming not from Big Tobacco, but from a number of anti-tobacco researchers and groups which continue to question whether smoking is any more dangerous than inhaling aerosol from a heated solution that contains no tobacco - only propylene glycol, glycerin, nicotine, and perhaps a few flavorings.
If Big Tobacco ever made such an assertion, we would take them to court within minutes, accusing them of conspiracy to commit fraud in violation of the Racketeer Influenced and Corrupt Organizations Act. But the same equally fallacious statement coming out of anti-tobacco groups is apparently not a problem.
According to an article by Reuters Health:
"Almost 10 percent of 11th and 12th graders are using e-cigarettes, and other alternative tobacco products are increasingly popular, according to a new study. ... “From this analysis we can say that there are two groups of youth that are concerning: those who are likely using e-cigs and hookah concurrently and those youth who are likely using three or more products,” said lead author Tamika D. Gilreath of the University of Southern California in Los Angeles. ... “Are these products safer?” Gilreath said. “In my opinion, long-term studies are needed before the safety question can be answered definitively.”"
The Rest of the Story
The rest of the story is that despite an abundance of current evidence that electronic cigarettes are safer than real tobacco cigarettes, including evidence that they contain levels of carcinogens and free radicals that are orders of magnitude lower than in cigarettes, that they contain no tobacco and involve no combustion, that they are far less toxic in cytotoxicity assays, and that they improve respiratory health, both subjectively and objectively, in smokers who switch to them, this tobacco researcher is telling the public that it is too early to say that smoking is any more dangerous than vaping.
Even the cigarette companies, which have everything to gain from this researcher's conclusion that smoking may be no more harmful than vaping, have clearly rejected such a conclusion, and against their interests in selling more cigarettes, have admitted that cigarettes are far more dangerous to health than e-cigarettes.
It is ironic that the most vocal and vehement undermining of the public's appreciation of the severe hazards of smoking is coming not from Big Tobacco, but from a number of anti-tobacco researchers and groups which continue to question whether smoking is any more dangerous than inhaling aerosol from a heated solution that contains no tobacco - only propylene glycol, glycerin, nicotine, and perhaps a few flavorings.
If Big Tobacco ever made such an assertion, we would take them to court within minutes, accusing them of conspiracy to commit fraud in violation of the Racketeer Influenced and Corrupt Organizations Act. But the same equally fallacious statement coming out of anti-tobacco groups is apparently not a problem.
Thursday, December 03, 2015
Once, Twice, Three Times a Liar: AAFP Letter to Congress on E-Cigarette Predicate Date Lies Three Times, Yet Still Fails to Make Its Point
In a letter sent yesterday to Representatives Paul Ryan, Kevin McCarthy, and Nancy Pelosi, the American Academy of Family Physicians (AAFP) opposes legislation that would change the predicate date for electronic cigarettes from February 15, 2007 to the effective date of the FDA deeming regulations.
According to the letter: "The TCA [Tobacco Control Act] requires that any new tobacco product introduced, or modified, after February 15, 2007, be reviewed by the FDA before it can be sold. HR 2058 would exempt from review all currently commercially available tobacco products that are not currently regulated by the FDA by changing the statutory “grandfather” date for tobacco products."
Unfortunately, in its attempt to persuade Congress to retain the 2007 predicate date, the AAFP lies to the House members ... not once, not twice, but three times.
The Rest of the Story
Lie #1: "The proposed bill would entirely undermine the FDA’s ability to review tobacco products, such as cigars and e-cigarettes."
The truth is that the bill would not undermine the FDA's ability to review electronic cigarette products. The FDA could still review any aspect of electronic cigarette products that it wished to. In fact, the FDA could promulgate safety standards that all products must follow, such as standards for battery safety, overcharge protection, restriction of certain dangerous flavorings (e.g., diacetyl), leak-proof cartridges, temperature regulation, and quality control. And the FDA could require all companies to document that they are in compliance with these standards, Thus, the FDA could directly review the safety of electronic cigarettes; in fact, in a way that is much more direct than what the AAFP is supporting. Using pre-market tobacco applications to review electronic cigarette products is not only a huge waste of time and resources, but it will result in undermining the public's health by allowing substandard and dangerous products, such as exploding batteries, to remain on the market for years. Direct promulgation of safety standards could take care of such issues in a matter of months.
Lie #2: "Were HR 2058 to pass ... the states would lose any ability to regulate or review tobacco products."
The truth is that the bill would not affect the ability of the states to regulate or review electronic cigarette products. The states are already going to be preempted from regulating aspects of electronic cigarette safety that are occupied by the FDA; however, this legislation does not in any way further tie the hands of the states. They are still free to take any legislative or regulatory actions that are not preempted by federal law.
Lie #3: "Because e-cigarette manufacturers are not yet required to undergo FDA review prior to introducing new products to the market, the FDA is not able to assess whether the thousands of flavors used in these products would likely contribute to the rise in youth e-cigarette use or present other health concerns."
The truth is that the FDA can still assess whether flavors used in e-cigarettes are appealing to youth or presenting other health concerns, even after these products are on the market. In fact, the FDA could set safety standards requiring companies to document basic aspects of flavoring safety. The FDA can also independently assess the safety and youth appeal of e-cigarette flavorings.
Despite this trio of lies, the letter still fails to make its intended point because it does not demonstrate how the public's health will be harmed by the passage of this bill. Every harm it claims will occur as a result from the bill is a lie. All that is left, then, is that the FDA would establish a huge bureaucracy that would take many years to review tens of thousands of product applications, while batteries continue to explode in consumers' faces. This is no way protects the public's health.
(See the op-ed by Scott Ballin and me published in The Hill for a more complete explanation of why the proposed legislation would greatly benefit the public's health.)
According to the letter: "The TCA [Tobacco Control Act] requires that any new tobacco product introduced, or modified, after February 15, 2007, be reviewed by the FDA before it can be sold. HR 2058 would exempt from review all currently commercially available tobacco products that are not currently regulated by the FDA by changing the statutory “grandfather” date for tobacco products."
Unfortunately, in its attempt to persuade Congress to retain the 2007 predicate date, the AAFP lies to the House members ... not once, not twice, but three times.
The Rest of the Story
Lie #1: "The proposed bill would entirely undermine the FDA’s ability to review tobacco products, such as cigars and e-cigarettes."
The truth is that the bill would not undermine the FDA's ability to review electronic cigarette products. The FDA could still review any aspect of electronic cigarette products that it wished to. In fact, the FDA could promulgate safety standards that all products must follow, such as standards for battery safety, overcharge protection, restriction of certain dangerous flavorings (e.g., diacetyl), leak-proof cartridges, temperature regulation, and quality control. And the FDA could require all companies to document that they are in compliance with these standards, Thus, the FDA could directly review the safety of electronic cigarettes; in fact, in a way that is much more direct than what the AAFP is supporting. Using pre-market tobacco applications to review electronic cigarette products is not only a huge waste of time and resources, but it will result in undermining the public's health by allowing substandard and dangerous products, such as exploding batteries, to remain on the market for years. Direct promulgation of safety standards could take care of such issues in a matter of months.
Lie #2: "Were HR 2058 to pass ... the states would lose any ability to regulate or review tobacco products."
The truth is that the bill would not affect the ability of the states to regulate or review electronic cigarette products. The states are already going to be preempted from regulating aspects of electronic cigarette safety that are occupied by the FDA; however, this legislation does not in any way further tie the hands of the states. They are still free to take any legislative or regulatory actions that are not preempted by federal law.
Lie #3: "Because e-cigarette manufacturers are not yet required to undergo FDA review prior to introducing new products to the market, the FDA is not able to assess whether the thousands of flavors used in these products would likely contribute to the rise in youth e-cigarette use or present other health concerns."
The truth is that the FDA can still assess whether flavors used in e-cigarettes are appealing to youth or presenting other health concerns, even after these products are on the market. In fact, the FDA could set safety standards requiring companies to document basic aspects of flavoring safety. The FDA can also independently assess the safety and youth appeal of e-cigarette flavorings.
Despite this trio of lies, the letter still fails to make its intended point because it does not demonstrate how the public's health will be harmed by the passage of this bill. Every harm it claims will occur as a result from the bill is a lie. All that is left, then, is that the FDA would establish a huge bureaucracy that would take many years to review tens of thousands of product applications, while batteries continue to explode in consumers' faces. This is no way protects the public's health.
(See the op-ed by Scott Ballin and me published in The Hill for a more complete explanation of why the proposed legislation would greatly benefit the public's health.)
Wednesday, December 02, 2015
Physicians from Weill Cornell Medical College Recommend that Pediatricians Lie to Adolescents About Electronic Cigarettes
A group of researchers from Weill Cornell Medical College have recently published a review article on electronic cigarettes in which they provide recommendations for pediatricians on what to tell their patients regarding e-cigarettes.
(See: Hildick-Smith GJ, et al. A practitioner's guide to electronic cigarettes in the adolescent population. Journal of Adolescent Health 2015; 57:574-579.)
The authors appropriately recommend that pediatricians screen patients for electronic cigarette use, correct any misconceptions they may have about these products, and counsel the patients regarding cessation.
They write: "We suggest that practitioners integrate the following three steps into their routine substance use counseling provided to adolescents and preteens: (1) screen patients for ENDS use; (2) identify and correct misconceptions about ENDS products; and (3) counsel patients with regard to cessation."
In terms of the second recommendation, correcting misconceptions about electronic cigarettes, the article emphasizes that: "It is especially important to educate current ENDS users about these products by emphasizing that ENDS are in fact a tobacco product, they provide users with the highly addictive substance nicotine, the vapor does not contain just water and nicotine, the risks to their health are not yet fully understood, and a minority of teens use such products."
The Rest of the Story
While I wholeheartedly support the recommendation to correct adolescent misconceptions about electronic cigarettes, I would suggest that the way to do this is to tell the truth to the patients, not to lie to them. Yet lying is precisely what this article recommends.
Specifically, the article recommends informing adolescents that electronic cigarettes are a "tobacco product." Every adolescent will naturally interpret this as meaning that electronic cigarettes contain tobacco.
However, this is a lie. Electronic cigarettes do not contain tobacco. They do not heat tobacco. And there is no tobacco present in the e-liquids.
In fact, the most important distinguishing feature of electronic cigarettes compared to real ones is the fact that they do not contain tobacco and that they do not involve combustion. Rather, than involve heating of a solution that contains a number of chemicals that generally include nicotine, but not tobacco.
I do not understand why it is necessary to lie to adolescents in order to discourage them from vaping. Isn't it adequate for us to simply tell them the truth, informing them that vaping is not safe, that there are chemicals that could present health risks, and that nicotine itself poses a number of health hazards, including the potential for addiction.
It seems to me even worse that an article would actually recommend that pediatricians throughout the nation lie to their patients regarding the single most important fact regarding electronic cigarettes (i.e., that they differ from real cigarettes by virtue of not containing tobacco). In fact, we often distinguish conventional cigarettes from e-cigarettes by referring to them as "tobacco cigarettes." Electronic cigarettes are, in a sense, "non-tobacco" cigarettes.
Hopefully, the journal will publish a correction, noting that electronic cigarettes do not contain tobacco and that pediatricians should not be advised to lie to their patients by insinuating that e-cigarettes do contain tobacco.
(See: Hildick-Smith GJ, et al. A practitioner's guide to electronic cigarettes in the adolescent population. Journal of Adolescent Health 2015; 57:574-579.)
The authors appropriately recommend that pediatricians screen patients for electronic cigarette use, correct any misconceptions they may have about these products, and counsel the patients regarding cessation.
They write: "We suggest that practitioners integrate the following three steps into their routine substance use counseling provided to adolescents and preteens: (1) screen patients for ENDS use; (2) identify and correct misconceptions about ENDS products; and (3) counsel patients with regard to cessation."
In terms of the second recommendation, correcting misconceptions about electronic cigarettes, the article emphasizes that: "It is especially important to educate current ENDS users about these products by emphasizing that ENDS are in fact a tobacco product, they provide users with the highly addictive substance nicotine, the vapor does not contain just water and nicotine, the risks to their health are not yet fully understood, and a minority of teens use such products."
The Rest of the Story
While I wholeheartedly support the recommendation to correct adolescent misconceptions about electronic cigarettes, I would suggest that the way to do this is to tell the truth to the patients, not to lie to them. Yet lying is precisely what this article recommends.
Specifically, the article recommends informing adolescents that electronic cigarettes are a "tobacco product." Every adolescent will naturally interpret this as meaning that electronic cigarettes contain tobacco.
However, this is a lie. Electronic cigarettes do not contain tobacco. They do not heat tobacco. And there is no tobacco present in the e-liquids.
In fact, the most important distinguishing feature of electronic cigarettes compared to real ones is the fact that they do not contain tobacco and that they do not involve combustion. Rather, than involve heating of a solution that contains a number of chemicals that generally include nicotine, but not tobacco.
I do not understand why it is necessary to lie to adolescents in order to discourage them from vaping. Isn't it adequate for us to simply tell them the truth, informing them that vaping is not safe, that there are chemicals that could present health risks, and that nicotine itself poses a number of health hazards, including the potential for addiction.
It seems to me even worse that an article would actually recommend that pediatricians throughout the nation lie to their patients regarding the single most important fact regarding electronic cigarettes (i.e., that they differ from real cigarettes by virtue of not containing tobacco). In fact, we often distinguish conventional cigarettes from e-cigarettes by referring to them as "tobacco cigarettes." Electronic cigarettes are, in a sense, "non-tobacco" cigarettes.
Hopefully, the journal will publish a correction, noting that electronic cigarettes do not contain tobacco and that pediatricians should not be advised to lie to their patients by insinuating that e-cigarettes do contain tobacco.
Tuesday, December 01, 2015
World Lung Foundation Disseminates Conclusion that E-Cigarettes are a Gateway to Smoking Based on a Bogus Study
In a tweet yesterday, the World Lung Foundation disseminated the conclusion that electronic cigarettes are a gateway to smoking:
@WorldLungFdn: Alarming study among teens in #Scotland finds that #ecigarettes do act as a gateway to #tobacco use https://t.co/4Cy1K0Y0i8
A subsequent tweet, citing the same newspaper article, stated:
"Alarming study among teens in#Scotland finds that #ecigarettes do act as a gateway to #tobacco use http://ow.ly/VgYfs."
This conclusion was based on a newspaper headline in an article published in the Edinburgh Evening News which claimed that this was the conclusion of a study conducted by the Royal Society for Public Health in Scotland.
The headline of that article states: "E-Cigarettes 'Lead Pupils to Smoking'." According to the article: "School children are using e-cigarettes as a gateway to smoking, according to a new study, led by Edinburgh University. ... The study was lead by researchers from Edinburgh and Stirling University, and published by the Royal Society for Public Health."
The Rest of the Story
There's just one problem here.
The actual study was based solely on a qualitative analysis of statements made by a small group of 13-16 year-olds in Fife as part of a study that was not aimed at determining whether e-cigarettes are a gateway to smoking. In fact, according to the study authors: "E-cigarettes were not included in the research design as they did not feature in interventions. However, in discussions in all participating schools, e-cigarettes were raised by students unprompted by researchers."
More importantly, nowhere in the study does it conclude that e-cigarettes are a gateway to smoking. In fact, the only reference to e-cigarettes as a possible gateway is a barely coherent statement of one student who said: "... ah [I] think that’s why most people go on tae [to] fae [from] e-cigarettes to actual [cigarettes], just to see what it’s like, the actual wans [ones], an’[and] then they get addicted tae [to] it."
Unfortunately, the reporter who wrote this article badly misinterpreted and misrepresented the actual findings and conclusions of the study.
It appears that the original source of the article was an earlier article published in the Scottish Sun. The headline of that article: "Scots school pupils are using e-cigarettes as a gateway to smoking."
But once again, the reporter's conclusion is based on the barely coherent statement of one student, and the study itself was neither designed to examine this question nor did it draw such a conclusion.
While I suppose that the reporters ultimately take responsibility for the content of their articles, I cannot help but believe that their behavior was heavily influenced by the continuing campaign of propaganda coming out of the anti-tobacco-free-cigarette movement in the U.S. and elsewhere, which has repeatedly disseminated the conclusion that tobacco-free cigarettes are a gateway to smoking. This misleading propaganda goes as high as the level of the director of the Centers for Disease Control and Prevention, who claimed (based solely on a single cross-sectional survey) that "Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes."
However, the most embarrassing and irresponsible behavior in this story is that of the World Lung Foundation, which disseminated the conclusion that e-cigarettes are a gateway to smoking based on the barely comprehensible quote of a single kid in Fife.
Is this what the scientific rigor of the tobacco control movement has come to? We are willing to draw definitive conclusions on issues of major policy importance and to disseminate those conclusions worldwide based on science no rigorous than the statement of some kid in Fife?
Sadly, the answer is yes. For this is precisely what happened.
Apparently, nobody in the anti-tobacco-free cigarette movement even cared to read the actual study, or if they did, they did not care about the quality of the evidence or whether the authors of the study themselves came to the same conclusion. It was enough that some newspaper headline somewhere gave them a great quote that they could use in a tweet. This would be unacceptable even in an assignment completed by a third grader!
The rest of the story is that the World Lung Foundation disseminated worldwide the scientific conclusion that e-cigarettes are a gateway to smoking based on a barely coherent statement made by a single teenager in Fife.
The scientific rigor of the anti-tobacco-free cigarette movement has reached an all-time low. Need I say more?
(Thanks to Dr. Christopher Russell of the Centre for Drug Misuse Research for the tip.)
@WorldLungFdn: Alarming study among teens in #Scotland finds that #ecigarettes do act as a gateway to #tobacco use https://t.co/4Cy1K0Y0i8
A subsequent tweet, citing the same newspaper article, stated:
"Alarming study among teens in
This conclusion was based on a newspaper headline in an article published in the Edinburgh Evening News which claimed that this was the conclusion of a study conducted by the Royal Society for Public Health in Scotland.
The headline of that article states: "E-Cigarettes 'Lead Pupils to Smoking'." According to the article: "School children are using e-cigarettes as a gateway to smoking, according to a new study, led by Edinburgh University. ... The study was lead by researchers from Edinburgh and Stirling University, and published by the Royal Society for Public Health."
The Rest of the Story
There's just one problem here.
The actual study was based solely on a qualitative analysis of statements made by a small group of 13-16 year-olds in Fife as part of a study that was not aimed at determining whether e-cigarettes are a gateway to smoking. In fact, according to the study authors: "E-cigarettes were not included in the research design as they did not feature in interventions. However, in discussions in all participating schools, e-cigarettes were raised by students unprompted by researchers."
More importantly, nowhere in the study does it conclude that e-cigarettes are a gateway to smoking. In fact, the only reference to e-cigarettes as a possible gateway is a barely coherent statement of one student who said: "... ah [I] think that’s why most people go on tae [to] fae [from] e-cigarettes to actual [cigarettes], just to see what it’s like, the actual wans [ones], an’[and] then they get addicted tae [to] it."
Unfortunately, the reporter who wrote this article badly misinterpreted and misrepresented the actual findings and conclusions of the study.
It appears that the original source of the article was an earlier article published in the Scottish Sun. The headline of that article: "Scots school pupils are using e-cigarettes as a gateway to smoking."
But once again, the reporter's conclusion is based on the barely coherent statement of one student, and the study itself was neither designed to examine this question nor did it draw such a conclusion.
While I suppose that the reporters ultimately take responsibility for the content of their articles, I cannot help but believe that their behavior was heavily influenced by the continuing campaign of propaganda coming out of the anti-tobacco-free-cigarette movement in the U.S. and elsewhere, which has repeatedly disseminated the conclusion that tobacco-free cigarettes are a gateway to smoking. This misleading propaganda goes as high as the level of the director of the Centers for Disease Control and Prevention, who claimed (based solely on a single cross-sectional survey) that "Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes."
However, the most embarrassing and irresponsible behavior in this story is that of the World Lung Foundation, which disseminated the conclusion that e-cigarettes are a gateway to smoking based on the barely comprehensible quote of a single kid in Fife.
Is this what the scientific rigor of the tobacco control movement has come to? We are willing to draw definitive conclusions on issues of major policy importance and to disseminate those conclusions worldwide based on science no rigorous than the statement of some kid in Fife?
Sadly, the answer is yes. For this is precisely what happened.
Apparently, nobody in the anti-tobacco-free cigarette movement even cared to read the actual study, or if they did, they did not care about the quality of the evidence or whether the authors of the study themselves came to the same conclusion. It was enough that some newspaper headline somewhere gave them a great quote that they could use in a tweet. This would be unacceptable even in an assignment completed by a third grader!
The rest of the story is that the World Lung Foundation disseminated worldwide the scientific conclusion that e-cigarettes are a gateway to smoking based on a barely coherent statement made by a single teenager in Fife.
The scientific rigor of the anti-tobacco-free cigarette movement has reached an all-time low. Need I say more?
(Thanks to Dr. Christopher Russell of the Centre for Drug Misuse Research for the tip.)
Monday, November 30, 2015
Op-Ed in The Hill Argues for a Change in the Predicate Date for E-Cigarettes; Supports Appropriations Rider that Would Accomplish This
Today, Scott Ballin and I published an op-ed article in The Hill which argues that the predicate date for electronic cigarettes should be changed from February 15, 2007 - as proposed by the FDA - to at least the effective date of the final deeming regulations. We therefore support a House Appropriations rider that would accomplish precisely this. Discussion on that rider begins today. We hope that this piece will help inform that debate.
Sunday, November 29, 2015
New Study Suggests Very Little Risk Associated with Passive Vaping, At Least with MarkTen E-Cigarettes
A new study published online last week in the Journal of Occupational and Environmental Hygiene provides strong new evidence that passive vaping poses very little health risk, at least for MarkTen e-cigarettes, the brand used in the study.
(See: Maloney JC, et al. Insights from two industrial hygiene pilot e-cigarette passive vaping studies. Journal of Occupational and Environmental Hygiene, November 17, 2015, doi: 10.1080/15459624.2015.1116693.)
In the study, a series of six 1-hour vaping sessions were held over the course of a 12-hour day in a 137 cubic meter room designed to simulate a conference room setting. MarkTen e-cigarettes were used. The room air exchange rate was approximately 1.5 per hour. Active air sampling was employed, both under background and vaping conditions. Air samples were analyzed for propylene glycol, glycerine, nicotine, menthol, particulate matter, and formaldehyde.
The major study results were as follows: "Results of the active samples were below the limit of quantitation of the analytic methods. Near real-time data were below the lowest concentration on the established calibration curves. Data from this study indicate that the majority of chemical constituents [all but formaldehyde] were below quantifiable levels. Formaldehyde was detected at consistent levels during all sampling periods [the levels were no different during vaping compared to background]."
The study concludes: "These two studies found that indoor vaping of MarkTen prototype e-cigarette does not produce chemical constituents at quantifiable levels or background levels using standard industrial hygiene collection techniques and analytical methods."
The study was conducted and reported by scientists at Altria Client Services.
The Rest of the Story
In summary, this study showed that under realistic conditions of vaping in a public place, MarkTen e-cigarettes did not produce ambient levels of propylene glycol, glycerine, nicotine, menthol, or particulate matter above detectable levels, and that while formaldehyde was detected, it was present at background levels measured without vaping occurring.
The results of the study suggest that there is minimal risk associated with passive vaping under realistic conditions, at least with the use of MarkTen e-cigarettes. Of course, one cannot determine from this study whether risks associated with the vaping of other brands of e-cigarettes would be similar. Thus, it is important for similar studies to be conducted with all brands of e-cigarettes.
Importantly, however, the study demonstrates that it is possible to produce an electronic cigarette that produces very low risk of adverse health effects upon bystanders. In this study, exposure of bystanders to nicotine, propylene glycol, menthol, particulates, and formaldehyde was not a problem.
Based on the overall evidence to date, any conclusion that passive vaping poses a substantial public health risk is not justified. Therefore, I would argue that there is not a sufficient scientific basis to support bans on vaping in all public places, as there is with secondhand smoke.
It should also be recognized that an additional benefit of electronic cigarettes is that they may be effective in reducing or eliminating secondhand smoke exposure for many nonsmokers in the population, especially for children living in homes with smokers who were previously smoking in the home but who are able to switch to vaping. This is an additional benefit of electronic cigarettes that has not adequately been considered in previous cost-benefit analyses.
(See: Maloney JC, et al. Insights from two industrial hygiene pilot e-cigarette passive vaping studies. Journal of Occupational and Environmental Hygiene, November 17, 2015, doi: 10.1080/15459624.2015.1116693.)
In the study, a series of six 1-hour vaping sessions were held over the course of a 12-hour day in a 137 cubic meter room designed to simulate a conference room setting. MarkTen e-cigarettes were used. The room air exchange rate was approximately 1.5 per hour. Active air sampling was employed, both under background and vaping conditions. Air samples were analyzed for propylene glycol, glycerine, nicotine, menthol, particulate matter, and formaldehyde.
The major study results were as follows: "Results of the active samples were below the limit of quantitation of the analytic methods. Near real-time data were below the lowest concentration on the established calibration curves. Data from this study indicate that the majority of chemical constituents [all but formaldehyde] were below quantifiable levels. Formaldehyde was detected at consistent levels during all sampling periods [the levels were no different during vaping compared to background]."
The study concludes: "These two studies found that indoor vaping of MarkTen prototype e-cigarette does not produce chemical constituents at quantifiable levels or background levels using standard industrial hygiene collection techniques and analytical methods."
The study was conducted and reported by scientists at Altria Client Services.
The Rest of the Story
In summary, this study showed that under realistic conditions of vaping in a public place, MarkTen e-cigarettes did not produce ambient levels of propylene glycol, glycerine, nicotine, menthol, or particulate matter above detectable levels, and that while formaldehyde was detected, it was present at background levels measured without vaping occurring.
The results of the study suggest that there is minimal risk associated with passive vaping under realistic conditions, at least with the use of MarkTen e-cigarettes. Of course, one cannot determine from this study whether risks associated with the vaping of other brands of e-cigarettes would be similar. Thus, it is important for similar studies to be conducted with all brands of e-cigarettes.
Importantly, however, the study demonstrates that it is possible to produce an electronic cigarette that produces very low risk of adverse health effects upon bystanders. In this study, exposure of bystanders to nicotine, propylene glycol, menthol, particulates, and formaldehyde was not a problem.
Based on the overall evidence to date, any conclusion that passive vaping poses a substantial public health risk is not justified. Therefore, I would argue that there is not a sufficient scientific basis to support bans on vaping in all public places, as there is with secondhand smoke.
It should also be recognized that an additional benefit of electronic cigarettes is that they may be effective in reducing or eliminating secondhand smoke exposure for many nonsmokers in the population, especially for children living in homes with smokers who were previously smoking in the home but who are able to switch to vaping. This is an additional benefit of electronic cigarettes that has not adequately been considered in previous cost-benefit analyses.
Tuesday, November 24, 2015
Thanks to Invalid NEJM Formaldehyde Study, Public is Being Told that Cancer Risk from Vaping is 15 Times Higher than from Smoking
According to an article published yesterday at CapeCod.com, the cancer risk from vaping is 5 to 15 times higher than the cancer risk from smoking.
The article states: "A look at the dangers of inhaling formaldehyde published in the New England Journal of Medicine earlier this year included two studies that showed that the risk of developing cancer from long-term vaping is five times as high as that of smoking a pack of regular cigarettes a day. The second study suggested the risk was 15 times higher."
This alarming statistic was echoed by a physician who was interviewed for the story. Dr. John Mendelsohn, an emergency room physician and toxicology expert at Falmouth Hospital, was quoted as stating: "Formaldehyde is present in cigarettes as well, but it’s felt that the exposure of formaldehyde in the e-cigarette compared to a regular cigarette has probably a five times greater risk of toxicity."
Indeed, the article from the New England Journal of Medicine did conclude that: "Among persons with a body weight of 70 kg, the incremental lifetime cancer risk associated with long-term cigarette smoking at 1 pack per day may then be estimated at 9×10−4. If we assume that inhaling formaldehyde-releasing agents carries the same risk per unit of formaldehyde as the risk associated with inhaling gaseous formaldehyde, then long-term vaping is associated with an incremental lifetime cancer risk of 4.2×10−3. This risk is 5 times as high (as compared with the risk based on the calculation of Miyake and Shibamoto shown in Figure 1), or even 15 times as high (as compared with the risk based on the calculation of Counts et al. shown in Figure 1) as the risk associated with long-term smoking."
My colleagues and I have already pointed out that the formaldehyde in the NEJM study was only detected during high voltage conditions and was not a problem at the low voltages typically used by electronic cigarette users. Moreover, the high voltage condition produced a phenomenon known as the "dry puff," which creates a terrible taste that would not be tolerated by the vaper. As I have previously argued: "the researchers actually argued that vaping might be 15 times worse than smoking in terms of cancer risk! Yet it turns out that their conclusion was invalid and that while e-cigarettes can produce formaldehyde under normal conditions, the levels appear to be minimal and certainly do not produce a risk that compares to that of smoking."
The Rest of the Story
This story demonstrates just how misinformation about the relative risks of smoking vs. vaping are spreading widely to the public and policy makers.
It all starts with a misrepresentation in a scientific article: in this case, the article claimed that the long-term cancer risk associated with vaping is 5 to 15 times higher than that associated with smoking one pack per day.
Then, that misinformation spreads to the media, which widely disseminate it to the public.
Next, physicians reading this misinformation incorporate it into their own beliefs on the health risks of electronic cigarettes.
They then feed back the misinformation to the media, which further disseminates the scary but inaccurate information to the public and policy makers.
It becomes a self-perpetuating, vicious cycle.
We now know that the campaign of deception being waged by anti-nicotine researchers and groups is working. The public is widely confused about the relative risks of smoking and vaping. In fact, over time, the public has become more likely to falsely believe that smoking is no more hazardous than vaping.
As Jacob Sullum has noted: "misinformation about e-cigarettes, including sensational press coverage of weak or overinterpreted studies, is warping public perceptions of the risks posed by vaping, possibly deterring smokers from making a switch that could save their lives. British surveys indicate that misperceptions have increased in recent years. A survey of adults sponsored by the British group Action on Smoking and Health—which, unlike the American group of the same name, supports e-cigarettes as an aid to quitting—found that the share of respondents who incorrectly described e-cigarettes as “more harmful” than tobacco cigarettes or “equally harmful” rose from about 8 percent in 2012 to 20 percent in 2014."
Sullum is absolutely correct that this misinformation is problematic not only because it is unethical to lie, but because the "warped" public perceptions of the risks posed by vaping compared to smoking may actually deter smokers from trying to quit using e-cigarettes and potentially save their lives. The misinformation may also cause former smokers who quit using e-cigarettes to return to smoking, since if vaping is no safer than smoking, what's the point of giving up real cigarettes?
It is high time for another "truth" campaign. This campaign, however, is necessary not to correct damage done by the historical lies of the tobacco companies, but to correct the damage done by the current lies of the tobacco control movement.
The article states: "A look at the dangers of inhaling formaldehyde published in the New England Journal of Medicine earlier this year included two studies that showed that the risk of developing cancer from long-term vaping is five times as high as that of smoking a pack of regular cigarettes a day. The second study suggested the risk was 15 times higher."
This alarming statistic was echoed by a physician who was interviewed for the story. Dr. John Mendelsohn, an emergency room physician and toxicology expert at Falmouth Hospital, was quoted as stating: "Formaldehyde is present in cigarettes as well, but it’s felt that the exposure of formaldehyde in the e-cigarette compared to a regular cigarette has probably a five times greater risk of toxicity."
Indeed, the article from the New England Journal of Medicine did conclude that: "Among persons with a body weight of 70 kg, the incremental lifetime cancer risk associated with long-term cigarette smoking at 1 pack per day may then be estimated at 9×10−4. If we assume that inhaling formaldehyde-releasing agents carries the same risk per unit of formaldehyde as the risk associated with inhaling gaseous formaldehyde, then long-term vaping is associated with an incremental lifetime cancer risk of 4.2×10−3. This risk is 5 times as high (as compared with the risk based on the calculation of Miyake and Shibamoto shown in Figure 1), or even 15 times as high (as compared with the risk based on the calculation of Counts et al. shown in Figure 1) as the risk associated with long-term smoking."
My colleagues and I have already pointed out that the formaldehyde in the NEJM study was only detected during high voltage conditions and was not a problem at the low voltages typically used by electronic cigarette users. Moreover, the high voltage condition produced a phenomenon known as the "dry puff," which creates a terrible taste that would not be tolerated by the vaper. As I have previously argued: "the researchers actually argued that vaping might be 15 times worse than smoking in terms of cancer risk! Yet it turns out that their conclusion was invalid and that while e-cigarettes can produce formaldehyde under normal conditions, the levels appear to be minimal and certainly do not produce a risk that compares to that of smoking."
The Rest of the Story
This story demonstrates just how misinformation about the relative risks of smoking vs. vaping are spreading widely to the public and policy makers.
It all starts with a misrepresentation in a scientific article: in this case, the article claimed that the long-term cancer risk associated with vaping is 5 to 15 times higher than that associated with smoking one pack per day.
Then, that misinformation spreads to the media, which widely disseminate it to the public.
Next, physicians reading this misinformation incorporate it into their own beliefs on the health risks of electronic cigarettes.
They then feed back the misinformation to the media, which further disseminates the scary but inaccurate information to the public and policy makers.
It becomes a self-perpetuating, vicious cycle.
We now know that the campaign of deception being waged by anti-nicotine researchers and groups is working. The public is widely confused about the relative risks of smoking and vaping. In fact, over time, the public has become more likely to falsely believe that smoking is no more hazardous than vaping.
As Jacob Sullum has noted: "misinformation about e-cigarettes, including sensational press coverage of weak or overinterpreted studies, is warping public perceptions of the risks posed by vaping, possibly deterring smokers from making a switch that could save their lives. British surveys indicate that misperceptions have increased in recent years. A survey of adults sponsored by the British group Action on Smoking and Health—which, unlike the American group of the same name, supports e-cigarettes as an aid to quitting—found that the share of respondents who incorrectly described e-cigarettes as “more harmful” than tobacco cigarettes or “equally harmful” rose from about 8 percent in 2012 to 20 percent in 2014."
Sullum is absolutely correct that this misinformation is problematic not only because it is unethical to lie, but because the "warped" public perceptions of the risks posed by vaping compared to smoking may actually deter smokers from trying to quit using e-cigarettes and potentially save their lives. The misinformation may also cause former smokers who quit using e-cigarettes to return to smoking, since if vaping is no safer than smoking, what's the point of giving up real cigarettes?
It is high time for another "truth" campaign. This campaign, however, is necessary not to correct damage done by the historical lies of the tobacco companies, but to correct the damage done by the current lies of the tobacco control movement.
Monday, November 23, 2015
Why are Altria and Reynolds American Supporting Increased Competition Against Cigarettes While Health Groups are Protecting Cigarette Profits?
Altria and Reynolds American are Supporting Policies that are Not in Their Best Economic Interest but which Protect the Public's Health
Anti-Smoking Groups are Protecting Economic Interests of Cigarette Companies at the Expense of the Public's Health
In an ironic twist that boggles the mind, both Altria and Reynolds American have taken a public policy position that protects public health despite being a threat to their cigarette profits, while the major anti-smoking groups are urging the FDA to stifle competition against cigarettes and thus protect the stream of profits for cigarette companies.
The irony concerns the positions of the two major domestic tobacco companies (Altria and Reynolds American) and the leading national anti-tobacco advocacy organization (the Campaign for Tobacco-Free Kids) on the issue of the predicate date that should determine whether or not electronic cigarettes need to file pre-market tobacco applications (PMTAs) in order to remain on the market.
The Background
The deeming regulations which FDA sent to the Office of Management and Budget for approval declare February 15, 2007 as the predicate or "grandfather" date for electronic cigarettes. Any existing e-cigarette or vaping product which was not on the market as of that date -- which is essentially every e-cigarette and vaping product currently on the market -- will have to submit a PMTA, which is an extremely burdensome, expensive, and nearly impossible to complete process.
In contrast, since virtually all tobacco cigarette brands currently on the market were already on the market in 2007, every cigarette brand is automatically "grandfathered in," meaning that it can continue on the market without having to submit any application or meet any safety standards.
In other words, the FDA wants to force electronic cigarette companies to submit burdensome applications just to stay on the market, while real cigarettes get a free ride and don't need to do anything (other than to simply note that they were on the market in 2007).
This is an insane position because it essentially means that the FDA views electronic cigarettes as a much greater threat to the public's health than real cigarettes, which kill more than 400,000 Americans each year.
Moreover, this policy would result in the decimation of the electronic cigarette industry, removing at least 99% of current e-cigarette and vaping products from the market. Most of these products are made by small manufacturers or vape shops which simply don't have the resources or expertise to put together the scientifically complex and unduly expensive applications that will be required for their products to stay on the market. The result of the removal of so many of these products from the market would be a public health disaster: many smokers who quit using e-cigarettes would be forced to return to cigarette smoking, and many smokers who would otherwise have quit using e-cigarettes will instead continue to smoke.
The FDA's decision to establish a predicate date of February 15, 2007 for electronic cigarettes would have the effect of stifling competition against tobacco cigarettes by removing from the market hundreds of brands of much safer alternative products. These vaping products are presently providing vigorous market competition against cigarettes. But the FDA would effectively remove this competition and allow cigarettes to continue their market dominance, along with an unfettered profit stream.
Financial analysts had predicted that based on volume growth during the period 2011-2014, e-cigarettes could literally transform the nicotine market, decreasing cigarette sales by as much as 50% over the next decade. The FDA deeming regulations will almost certainly ensure that such a public health miracle does not occur.
However, there is one chance to save the situation: A rider has been added to a House appropriations bill that would establish a predicate date for electronic cigarettes, by statute, of the effective date of the final e-cigarette deeming regulations. This would allow all e-cigarette and vaping products currently on the market to remain on the market without having to file PMTAs. These products would, of course, still be subject to any safety standards or other regulations promulgated by the FDA, including marketing, labeling, manufacturing, and flavoring restrictions.
The Campaign for Tobacco-Free Kids' Position
Shockingly, the Campaign for Tobacco-Free Kids has come out in opposition to the House legislation. The Campaign insists that the predicate date of February 15, 2007 not be changed, so that every e-cigarette product has to submit onerous and expensive applications to stay on the market. The main argument the Campaign provides is that changing the predicate date would prevent the FDA from ensuring the safety of the electronic cigarettes on the market and would tie the agency's hands in addressing the targeting of children with candy-like flavorings such as "cotton candy" and "gummy bear."
However, the Campaign for Tobacco-Free Kids is lying. It is simply not true that the FDA would be prevented from ensuring the safety of electronic cigarettes or that its hands would be tied in terms of addressing candy flavorings. In fact, the truth is quite the opposite. Regardless of the predicate date, the FDA is free to set any safety standards, including flavoring and marketing restrictions, that it wishes to set. And it can propose such standards at any time, including tomorrow morning if it wanted to.
Moreover, without being overburdened by the imposing requirement to review literally tens of thousands of pre-market tobacco applications, the agency could put its full attention and resources to simply promulgating safety standards for electronic cigarettes and vaping products. Rather than having to wait years to address problems such as battery safety and toxic flavorings, the agency could address these problems tomorrow morning. Changing the predicate date would free the agency to focus on setting safety standards immediately. This would put a quick end to the exploding batteries and other quality control issues that are impacting the safety profile of these alternative nicotine products.
But rather than pushing for effective regulation, the Campaign instead is favoring what essentially amounts to a prohibition-like approach. This approach offers the best protection for cigarette profits that money could buy: the removal of serious competition from the market.
The Altria and Reynolds American Positions
The two major U.S. tobacco companies, unlike the major anti-smoking groups, are supporting policies that make it easier, not more difficult, for alternative nicotine-containing products to compete with combustible products.
Altria has come out strongly in support of the House legislation that would change the predicate date from February 15, 2007 to the effective date of the final regulation. This is a striking position because it is not in the best economic interests of the company. The onerous, burdensome, and expensive PMTAs that the FDA wants to require for every e-cigarette product would help Altria to corner the market in e-cigarettes because it is the company best positioned to be able to carry out the Herculean task of successfully completing a PMTA. The predicate date of 2007 would put most e-cigarette companies out of business, allowing Altria to gain a huge share of the market. So it is worth noting that Altria's position is sacrificing its own interest in gaining market share for Mark Ten, and instead, demonstrates a sincere interest in saving and preserving a thriving e-cigarette and vaping market. Despite the economic ramifications for domestic cigarette sales, Altria seems committed to opening up the nicotine market to alternative products, beyond cigarettes.
Lorillard, which is now a part of Reynolds American (after being acquired by Reynolds American earlier this year), has also come out strongly in favor of changing the predicate date from 2007 to the effective date of the final regulation. And RAI Services Company (a wholly owned subsidiary of Reynolds American) has argued that either the predicate date should be changed to the effective date of the regulations, or that a clear pathway needs to be created to ease pre-market authorization for electronic cigarettes (which the FDA has clearly not done in its final deeming regulations). Thus, also against its own economic interests, Reynolds American is supportive of a change in the predicate date, demonstrating its own commitment to promoting a transformation of the domestic nicotine market.
And with the recent announcement that it is pursuing vapor-like technology for its VUSE e-cigarette product, it is clear that Reynolds American is now committed to the expansion of both the traditional e-cigarette and the newer vaping device market (notwithstanding its earlier reservations about open system vapor devices).
The Rest of the Story
So the dramatic irony is now clear. While the two largest cigarette companies are committed to a transformation of the nicotine market that would allow much safer electronic cigarettes and vaping products to compete with traditional, combustible tobacco cigarettes, the major anti-smoking groups are committed to halting this transformation and maintaining the status quo: the continued death of more than 400,000 Americans each year because they are forced to continue smoking the most highly toxic nicotine-delivery product, rather than any of a wide range of much safer alternatives that could save their lives.
It is baffling why the anti-smoking groups are so much more devoted, at this point in time, to halting e-cigarette use than to putting a huge dent in smoking. They appear to be devastatingly afraid of any increase in the number of Americans who are "addicted" to nicotine, regardless of whether that increase comes at the "expense" of saving thousands of lives. And to make matters worse, the best current scientific evidence suggests that the benefits of e-cigarettes will likely accrue without any significant increase in the number of "nicotine addicts." There is no evidence that e-cigarettes are resulting in any substantial proportion of non-smoking youth who are becoming addicted to nicotine, and the same is true for adult nonsmokers.
The battle against smoking-related morbidity and mortality -- which is the battle I joined in 1985 as a junior at Brown University -- has now been completely transformed into a battle against nicotine itself. The battle against death and disease has been transformed into a battle against addiction itself. The goal is no longer to make smoking history, but to put up a brick wall against the idea that someone, somewhere, might be actually deriving some measure of satisfaction or relief from a psychoactive substance called nicotine.
The tobacco control movement has now become reminiscent of the social movement which declared "war" on drugs, but then went on to promote ineffective and racist policies that sent minor marijuana offenders to prison as felons, while at the same time having little problem with (mostly white, upper-class) people having a few too many martinis at a business cocktail party and then killing someone on the way home. The black marijuana user ends up in prison, while the white drunk driver gets a slap on the wrist and perhaps a three-month license suspension but never sees what the inside of a prison looks like. But worst of all, the policies don't work. What has been lost is the goal: is it to punish people for their particular method of dealing with life stress or is it to find the most effective way to promote the overall health and well-being of the public?
For the tobacco control movement, it has ceased to be about finding the most effective way to promote the overall health and well-being of the public. The movement is now dead set on punishing people for having a particular method of dealing with life stress: the use of nicotine. And we now know that, in the mind of the tobacco control movement, even if that use of nicotine is literally saving a person's life, there is no good that comes out of saving that life at the expense of continued dependence on that particular chemical substance.
The rest of the story is that over the course of the past 30 years (and mostly during the last five), the tobacco control movement has lost its bearings. And the loss of that perspective is evidenced today by the most unexpected, shocking, and ironic turn of events: the tobacco companies have a vision of a transformed and much safer nicotine market, while the anti-tobacco groups are doing everything they can to preserve the current status of the market, where the most toxic consumer product known to mankind -- tobacco cigarettes -- continues to reign supreme.
Anti-Smoking Groups are Protecting Economic Interests of Cigarette Companies at the Expense of the Public's Health
In an ironic twist that boggles the mind, both Altria and Reynolds American have taken a public policy position that protects public health despite being a threat to their cigarette profits, while the major anti-smoking groups are urging the FDA to stifle competition against cigarettes and thus protect the stream of profits for cigarette companies.
The irony concerns the positions of the two major domestic tobacco companies (Altria and Reynolds American) and the leading national anti-tobacco advocacy organization (the Campaign for Tobacco-Free Kids) on the issue of the predicate date that should determine whether or not electronic cigarettes need to file pre-market tobacco applications (PMTAs) in order to remain on the market.
The Background
The deeming regulations which FDA sent to the Office of Management and Budget for approval declare February 15, 2007 as the predicate or "grandfather" date for electronic cigarettes. Any existing e-cigarette or vaping product which was not on the market as of that date -- which is essentially every e-cigarette and vaping product currently on the market -- will have to submit a PMTA, which is an extremely burdensome, expensive, and nearly impossible to complete process.
In contrast, since virtually all tobacco cigarette brands currently on the market were already on the market in 2007, every cigarette brand is automatically "grandfathered in," meaning that it can continue on the market without having to submit any application or meet any safety standards.
In other words, the FDA wants to force electronic cigarette companies to submit burdensome applications just to stay on the market, while real cigarettes get a free ride and don't need to do anything (other than to simply note that they were on the market in 2007).
This is an insane position because it essentially means that the FDA views electronic cigarettes as a much greater threat to the public's health than real cigarettes, which kill more than 400,000 Americans each year.
Moreover, this policy would result in the decimation of the electronic cigarette industry, removing at least 99% of current e-cigarette and vaping products from the market. Most of these products are made by small manufacturers or vape shops which simply don't have the resources or expertise to put together the scientifically complex and unduly expensive applications that will be required for their products to stay on the market. The result of the removal of so many of these products from the market would be a public health disaster: many smokers who quit using e-cigarettes would be forced to return to cigarette smoking, and many smokers who would otherwise have quit using e-cigarettes will instead continue to smoke.
The FDA's decision to establish a predicate date of February 15, 2007 for electronic cigarettes would have the effect of stifling competition against tobacco cigarettes by removing from the market hundreds of brands of much safer alternative products. These vaping products are presently providing vigorous market competition against cigarettes. But the FDA would effectively remove this competition and allow cigarettes to continue their market dominance, along with an unfettered profit stream.
Financial analysts had predicted that based on volume growth during the period 2011-2014, e-cigarettes could literally transform the nicotine market, decreasing cigarette sales by as much as 50% over the next decade. The FDA deeming regulations will almost certainly ensure that such a public health miracle does not occur.
However, there is one chance to save the situation: A rider has been added to a House appropriations bill that would establish a predicate date for electronic cigarettes, by statute, of the effective date of the final e-cigarette deeming regulations. This would allow all e-cigarette and vaping products currently on the market to remain on the market without having to file PMTAs. These products would, of course, still be subject to any safety standards or other regulations promulgated by the FDA, including marketing, labeling, manufacturing, and flavoring restrictions.
The Campaign for Tobacco-Free Kids' Position
Shockingly, the Campaign for Tobacco-Free Kids has come out in opposition to the House legislation. The Campaign insists that the predicate date of February 15, 2007 not be changed, so that every e-cigarette product has to submit onerous and expensive applications to stay on the market. The main argument the Campaign provides is that changing the predicate date would prevent the FDA from ensuring the safety of the electronic cigarettes on the market and would tie the agency's hands in addressing the targeting of children with candy-like flavorings such as "cotton candy" and "gummy bear."
However, the Campaign for Tobacco-Free Kids is lying. It is simply not true that the FDA would be prevented from ensuring the safety of electronic cigarettes or that its hands would be tied in terms of addressing candy flavorings. In fact, the truth is quite the opposite. Regardless of the predicate date, the FDA is free to set any safety standards, including flavoring and marketing restrictions, that it wishes to set. And it can propose such standards at any time, including tomorrow morning if it wanted to.
Moreover, without being overburdened by the imposing requirement to review literally tens of thousands of pre-market tobacco applications, the agency could put its full attention and resources to simply promulgating safety standards for electronic cigarettes and vaping products. Rather than having to wait years to address problems such as battery safety and toxic flavorings, the agency could address these problems tomorrow morning. Changing the predicate date would free the agency to focus on setting safety standards immediately. This would put a quick end to the exploding batteries and other quality control issues that are impacting the safety profile of these alternative nicotine products.
But rather than pushing for effective regulation, the Campaign instead is favoring what essentially amounts to a prohibition-like approach. This approach offers the best protection for cigarette profits that money could buy: the removal of serious competition from the market.
The Altria and Reynolds American Positions
The two major U.S. tobacco companies, unlike the major anti-smoking groups, are supporting policies that make it easier, not more difficult, for alternative nicotine-containing products to compete with combustible products.
Altria has come out strongly in support of the House legislation that would change the predicate date from February 15, 2007 to the effective date of the final regulation. This is a striking position because it is not in the best economic interests of the company. The onerous, burdensome, and expensive PMTAs that the FDA wants to require for every e-cigarette product would help Altria to corner the market in e-cigarettes because it is the company best positioned to be able to carry out the Herculean task of successfully completing a PMTA. The predicate date of 2007 would put most e-cigarette companies out of business, allowing Altria to gain a huge share of the market. So it is worth noting that Altria's position is sacrificing its own interest in gaining market share for Mark Ten, and instead, demonstrates a sincere interest in saving and preserving a thriving e-cigarette and vaping market. Despite the economic ramifications for domestic cigarette sales, Altria seems committed to opening up the nicotine market to alternative products, beyond cigarettes.
Lorillard, which is now a part of Reynolds American (after being acquired by Reynolds American earlier this year), has also come out strongly in favor of changing the predicate date from 2007 to the effective date of the final regulation. And RAI Services Company (a wholly owned subsidiary of Reynolds American) has argued that either the predicate date should be changed to the effective date of the regulations, or that a clear pathway needs to be created to ease pre-market authorization for electronic cigarettes (which the FDA has clearly not done in its final deeming regulations). Thus, also against its own economic interests, Reynolds American is supportive of a change in the predicate date, demonstrating its own commitment to promoting a transformation of the domestic nicotine market.
And with the recent announcement that it is pursuing vapor-like technology for its VUSE e-cigarette product, it is clear that Reynolds American is now committed to the expansion of both the traditional e-cigarette and the newer vaping device market (notwithstanding its earlier reservations about open system vapor devices).
The Rest of the Story
So the dramatic irony is now clear. While the two largest cigarette companies are committed to a transformation of the nicotine market that would allow much safer electronic cigarettes and vaping products to compete with traditional, combustible tobacco cigarettes, the major anti-smoking groups are committed to halting this transformation and maintaining the status quo: the continued death of more than 400,000 Americans each year because they are forced to continue smoking the most highly toxic nicotine-delivery product, rather than any of a wide range of much safer alternatives that could save their lives.
It is baffling why the anti-smoking groups are so much more devoted, at this point in time, to halting e-cigarette use than to putting a huge dent in smoking. They appear to be devastatingly afraid of any increase in the number of Americans who are "addicted" to nicotine, regardless of whether that increase comes at the "expense" of saving thousands of lives. And to make matters worse, the best current scientific evidence suggests that the benefits of e-cigarettes will likely accrue without any significant increase in the number of "nicotine addicts." There is no evidence that e-cigarettes are resulting in any substantial proportion of non-smoking youth who are becoming addicted to nicotine, and the same is true for adult nonsmokers.
The battle against smoking-related morbidity and mortality -- which is the battle I joined in 1985 as a junior at Brown University -- has now been completely transformed into a battle against nicotine itself. The battle against death and disease has been transformed into a battle against addiction itself. The goal is no longer to make smoking history, but to put up a brick wall against the idea that someone, somewhere, might be actually deriving some measure of satisfaction or relief from a psychoactive substance called nicotine.
The tobacco control movement has now become reminiscent of the social movement which declared "war" on drugs, but then went on to promote ineffective and racist policies that sent minor marijuana offenders to prison as felons, while at the same time having little problem with (mostly white, upper-class) people having a few too many martinis at a business cocktail party and then killing someone on the way home. The black marijuana user ends up in prison, while the white drunk driver gets a slap on the wrist and perhaps a three-month license suspension but never sees what the inside of a prison looks like. But worst of all, the policies don't work. What has been lost is the goal: is it to punish people for their particular method of dealing with life stress or is it to find the most effective way to promote the overall health and well-being of the public?
For the tobacco control movement, it has ceased to be about finding the most effective way to promote the overall health and well-being of the public. The movement is now dead set on punishing people for having a particular method of dealing with life stress: the use of nicotine. And we now know that, in the mind of the tobacco control movement, even if that use of nicotine is literally saving a person's life, there is no good that comes out of saving that life at the expense of continued dependence on that particular chemical substance.
The rest of the story is that over the course of the past 30 years (and mostly during the last five), the tobacco control movement has lost its bearings. And the loss of that perspective is evidenced today by the most unexpected, shocking, and ironic turn of events: the tobacco companies have a vision of a transformed and much safer nicotine market, while the anti-tobacco groups are doing everything they can to preserve the current status of the market, where the most toxic consumer product known to mankind -- tobacco cigarettes -- continues to reign supreme.
Friday, November 20, 2015
My Public Comment to OIRA on FDA Deeming Regulations
This morning, I met with several staff of the Office on Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB) of the White House Executive Office to provide feedback on the proposed FDA deeming regulations for electronic cigarettes (RIN#0910-AG38). I am grateful for having had the opportunity to share my analysis of the regulations as pertaining to the provisions of Executive Order 12866, which outlines the criteria a regulation must meet in order to be approved by OIRA.
The OIRA staff was very interested in my analysis and appreciative of the insights I was able to provide, especially as they related to the specific provisions of Executive Order 12866 which I believe the deeming regulations violate.
The Rest of the Story
Here is a link to my public comment. It may be helpful to others as it articulates the specific provisions of Executive Order 12866 which I believe the FDA deeming regulations violate.
Please note that OIRA cannot disapprove the regulation and return it simply because it disagrees with the approach. There are specific criteria that the OIRA must follow in its review, and these are outlined in the Executive Order.
In particular, I believe that the deeming regulations are in violation of the following sections of Executive Order 12866:
The OIRA staff was very interested in my analysis and appreciative of the insights I was able to provide, especially as they related to the specific provisions of Executive Order 12866 which I believe the deeming regulations violate.
The Rest of the Story
Here is a link to my public comment. It may be helpful to others as it articulates the specific provisions of Executive Order 12866 which I believe the FDA deeming regulations violate.
Please note that OIRA cannot disapprove the regulation and return it simply because it disagrees with the approach. There are specific criteria that the OIRA must follow in its review, and these are outlined in the Executive Order.
In particular, I believe that the deeming regulations are in violation of the following sections of Executive Order 12866:
- 1(b)(5)
- 1(b)(6)
- 1(b)(8)
- 1(b)(11)
- 1(b)(12)
Wednesday, November 18, 2015
Nominee for New FDA Commissioner Derived Salary from Six Pharmaceutical Companies LAST YEAR
In President Obama's first inauguration speech, he promised to restore science to its proper place in government by shielding the regulatory process from corporate influence. One of his specific proposals to carry out this promise was to prevent anyone with a severe corporate conflict of interest from serving in the executive branch until at least one full year had gone by without the conflict in place. Thus, if you received salary from a pharmaceutical company in 2014, you would not be permitted to serve as the FDA Commissioner at least until 2016.
Unfortunately, as we have repeatedly seen campaign promises wither, this one too seems to have died a quiet death. For it was revealed yesterday by the Washington Post that President Obama's nominee for the Commissioner of the FDA - Dr. Robert Califf - received salary support from not one, not two, not three, not four, not five, but six pharmaceutical companies last year (2014). In addition, Dr. Califf was paid by eight pharmaceutical companies for consulting services and had personal equity in two pharmaceutical companies. In all, in 2014, Dr. Califf had significant financial interests in 14 different pharmaceutical companies!
To make matters worse, according to the FDA itself, a clinical trial led by Dr. Califf was sharply criticized by Public Citizen's Health Research Group for failing to quickly anti-coagulate patients treated with an experimental anti-coagulant drug who were then taken off that drug, resulting in an excess of 16 strokes among these patients. According to the FDA report: "The Division received comments from Public Citizen’s Health Research Group indicating concern that the applicant’s failure to “1) pre-specify criteria for transition to appropriate anticoagulation in the 30 days following study-drug discontinuation or 2) provide clear, standardized instructions to investigators on how to transition patients deemed eligible for further anticoagulation” exposed subjects to unnecessary harm and therefore was unethical. While it is obvious that the applicant can not have intended XARELTO subjects to have had a greater number of strokes while they were being followed because it worsens the apparent risk-benefit profile of XARELTO, it also true that lack of care in designing and conducting ROCKET could have resulted in some XARELTO subjects suffering unnecessary strokes." Recently, Project on Government Oversight (POGO) executive director Danielle Brian stated: "Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry."
The worst of the story, however, is that during his Senate confirmation hearings, Dr. Califf apparently defended his conflicts of interest with Big Pharma, demonstrated a misunderstanding of what conflict of interest is all about, and expressed no awareness of the severity of the problem of conflict of interest in making government regulatory decisions.
According to the Washington Post article: "President Obama’s nominee to lead the Food and Drug Administration defended his past ties to the pharmaceutical industry on Tuesday, saying that drug company dollars never influenced the outcome of his academic research and vowing to maintain the agency’s standards for ensuring that approved treatments are safe and effective. Robert Califf, a cardiologist and long-time Duke University researcher, acknowledged that pharmaceutical companies helped fund many of the clinical trials he oversaw. But the drug industry routinely funds such studies, he noted, and Duke’s contract requirements protected the independence of investigators to publish research outcomes, whatever the results."
This demonstrates a misunderstanding of the problem of conflict of interest. Conflicts of interest are a problem not because they lead to conscious manipulation of study findings by investigators, but because they could lead to subconscious bias in the conduct or reporting of the results of these studies. A conscious bias in reporting the results would represent academic misconduct, not merely conflict of interest. It is the subconscious bias produced by pharmaceutical company funding that is at issue here. That is what conflict of interest policies are designed to protect against - not the conscious manipulation of study findings, which is an ethical issue. Conflict of interest is not an issue about ethics as much as it is an issue about protecting the integrity of the research and regulatory process.
The Rest of the Story
It is difficult to understand how this nominee, who just last year had significant financial relationships with 14 different pharmaceutical companies, could - one year later - be confirmed as the head of the agency which regulates those 14 companies.
Clearly, Dr. Califf would have to recuse himself from any decisions regarding any of those 14 companies. However, since these represent some of the largest pharmaceutical companies in the nation (including Merck, Novartis, Roche, Eli Lilly, Bayer, Janssen, and Amgen, he would essentially have to recuse himself from all regulatory decisions made by the FDA. Therefore, it is apparent that because of his extensive financial conflicts of interest with Big Pharma, he is not qualified to serve as the FDA Commissioner.
Regardless of the integrity of his decision-making, the agency would always be under the public perception of a bias towards the pharmaceutical companies emanating from the Commissioner's conflicts of interest with these companies. This is simply not tolerable, and it is the precise reason why federal agencies have conflict of interest policies in the first place.
If Dr. Califf is appointed as the FDA Commissioner, I believe that he would be in violation of the Office of Government Ethics (OGE) regulations which state as follows: "a Federal employee may not personally and substantially participate in an official capacity in any particular matter which, to his knowledge, he or any other person (whose interests are imputed to the employee under 18 U.S.C. 208) has a financial interest if the particular matter will have a direct and predictable effect on that interest (5 CFR 2640.103(a))."
To avoid being in violation of this law, Dr. Califf would have to recuse himself from all FDA-related work.
Now, you might respond to this argument by pointing out that the prospective Commissioner is now divested of his financial interests and therefore, while he had financial interests in the past, he no longer holds them. So there is no violation of the government ethics regulations. Putting aside the point that this clearly violates the spirit of the law, though not the letter of the law, let's consider this further.
It is a good point. However, you are forgetting 5 CFR 2635.502(a), which clearly states that:
"Where an employee knows that a particular matter involving specific parties is likely to have a direct and predictable effect on the financial interest of a member of his household, or knows that a person with whom he has a covered relationship is or represents a party to such matter, and where the employee determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question his impartiality in the matter, the employee should not participate in the matter unless he has informed the agency designee of the appearance problem and received authorization from the agency designee in accordance with paragraph (d) of this section."
So what is the definition of a "covered relationship" with a "person?"
First, please note that according to the definition of "person": under 5 CFR 2635.102(k), a "person" includes a "corporation," "company," or "firm."
According to 5 CFR 2635.502(b)(1)(iv), a covered relationship includes: "Any person for whom the employee has, within the last year, served as officer, director, trustee, general partner, agent, attorney, consultant, contractor or employee."
Because it appears that Dr. Califf has, within the last year, served as a consultant and/or contractor for a number of pharmaceutical companies, it appears that his being appointed FDA commissioner at this time would violate 5 CFR 2635.502(a), unless he were specifically cleared for every activity he participates in by receiving authorization from the agency designee following a judgment that "the interest of the Government in the employee's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations." (see 5 CFR 2635.502(d)) He would have to receive such an authorization based on the above determination for each and every matter in which he participates. Obviously, this makes it clear that he is simply not in a position to be appointed as the FDA Commissioner given his extensive and recent history of Big Pharma conflicts of interest.
Finally, one might say: "Well, Dr. Siegel, I see your point but since it is almost 2016, it will be more than one year since the financial relationships so there is no problem and no technical violation of the law."
To which I would respond: "If that is the extent to which you have to go to defend this nomination and you still don't see a problem, then you are missing the forest for the trees."
The rest of the story is that the nominee for FDA Commissioner has such a severe, recent, and extensive history of financial interests with multiple pharmaceutical companies that it would violate all principles of scientific and regulatory integrity to appoint him to head the agency which regulates those very companies.
Unfortunately, as we have repeatedly seen campaign promises wither, this one too seems to have died a quiet death. For it was revealed yesterday by the Washington Post that President Obama's nominee for the Commissioner of the FDA - Dr. Robert Califf - received salary support from not one, not two, not three, not four, not five, but six pharmaceutical companies last year (2014). In addition, Dr. Califf was paid by eight pharmaceutical companies for consulting services and had personal equity in two pharmaceutical companies. In all, in 2014, Dr. Califf had significant financial interests in 14 different pharmaceutical companies!
To make matters worse, according to the FDA itself, a clinical trial led by Dr. Califf was sharply criticized by Public Citizen's Health Research Group for failing to quickly anti-coagulate patients treated with an experimental anti-coagulant drug who were then taken off that drug, resulting in an excess of 16 strokes among these patients. According to the FDA report: "The Division received comments from Public Citizen’s Health Research Group indicating concern that the applicant’s failure to “1) pre-specify criteria for transition to appropriate anticoagulation in the 30 days following study-drug discontinuation or 2) provide clear, standardized instructions to investigators on how to transition patients deemed eligible for further anticoagulation” exposed subjects to unnecessary harm and therefore was unethical. While it is obvious that the applicant can not have intended XARELTO subjects to have had a greater number of strokes while they were being followed because it worsens the apparent risk-benefit profile of XARELTO, it also true that lack of care in designing and conducting ROCKET could have resulted in some XARELTO subjects suffering unnecessary strokes." Recently, Project on Government Oversight (POGO) executive director Danielle Brian stated: "Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry."
The worst of the story, however, is that during his Senate confirmation hearings, Dr. Califf apparently defended his conflicts of interest with Big Pharma, demonstrated a misunderstanding of what conflict of interest is all about, and expressed no awareness of the severity of the problem of conflict of interest in making government regulatory decisions.
According to the Washington Post article: "President Obama’s nominee to lead the Food and Drug Administration defended his past ties to the pharmaceutical industry on Tuesday, saying that drug company dollars never influenced the outcome of his academic research and vowing to maintain the agency’s standards for ensuring that approved treatments are safe and effective. Robert Califf, a cardiologist and long-time Duke University researcher, acknowledged that pharmaceutical companies helped fund many of the clinical trials he oversaw. But the drug industry routinely funds such studies, he noted, and Duke’s contract requirements protected the independence of investigators to publish research outcomes, whatever the results."
This demonstrates a misunderstanding of the problem of conflict of interest. Conflicts of interest are a problem not because they lead to conscious manipulation of study findings by investigators, but because they could lead to subconscious bias in the conduct or reporting of the results of these studies. A conscious bias in reporting the results would represent academic misconduct, not merely conflict of interest. It is the subconscious bias produced by pharmaceutical company funding that is at issue here. That is what conflict of interest policies are designed to protect against - not the conscious manipulation of study findings, which is an ethical issue. Conflict of interest is not an issue about ethics as much as it is an issue about protecting the integrity of the research and regulatory process.
The Rest of the Story
It is difficult to understand how this nominee, who just last year had significant financial relationships with 14 different pharmaceutical companies, could - one year later - be confirmed as the head of the agency which regulates those 14 companies.
Clearly, Dr. Califf would have to recuse himself from any decisions regarding any of those 14 companies. However, since these represent some of the largest pharmaceutical companies in the nation (including Merck, Novartis, Roche, Eli Lilly, Bayer, Janssen, and Amgen, he would essentially have to recuse himself from all regulatory decisions made by the FDA. Therefore, it is apparent that because of his extensive financial conflicts of interest with Big Pharma, he is not qualified to serve as the FDA Commissioner.
Regardless of the integrity of his decision-making, the agency would always be under the public perception of a bias towards the pharmaceutical companies emanating from the Commissioner's conflicts of interest with these companies. This is simply not tolerable, and it is the precise reason why federal agencies have conflict of interest policies in the first place.
If Dr. Califf is appointed as the FDA Commissioner, I believe that he would be in violation of the Office of Government Ethics (OGE) regulations which state as follows: "a Federal employee may not personally and substantially participate in an official capacity in any particular matter which, to his knowledge, he or any other person (whose interests are imputed to the employee under 18 U.S.C. 208) has a financial interest if the particular matter will have a direct and predictable effect on that interest (5 CFR 2640.103(a))."
To avoid being in violation of this law, Dr. Califf would have to recuse himself from all FDA-related work.
Now, you might respond to this argument by pointing out that the prospective Commissioner is now divested of his financial interests and therefore, while he had financial interests in the past, he no longer holds them. So there is no violation of the government ethics regulations. Putting aside the point that this clearly violates the spirit of the law, though not the letter of the law, let's consider this further.
It is a good point. However, you are forgetting 5 CFR 2635.502(a), which clearly states that:
"Where an employee knows that a particular matter involving specific parties is likely to have a direct and predictable effect on the financial interest of a member of his household, or knows that a person with whom he has a covered relationship is or represents a party to such matter, and where the employee determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question his impartiality in the matter, the employee should not participate in the matter unless he has informed the agency designee of the appearance problem and received authorization from the agency designee in accordance with paragraph (d) of this section."
So what is the definition of a "covered relationship" with a "person?"
First, please note that according to the definition of "person": under 5 CFR 2635.102(k), a "person" includes a "corporation," "company," or "firm."
According to 5 CFR 2635.502(b)(1)(iv), a covered relationship includes: "Any person for whom the employee has, within the last year, served as officer, director, trustee, general partner, agent, attorney, consultant, contractor or employee."
Because it appears that Dr. Califf has, within the last year, served as a consultant and/or contractor for a number of pharmaceutical companies, it appears that his being appointed FDA commissioner at this time would violate 5 CFR 2635.502(a), unless he were specifically cleared for every activity he participates in by receiving authorization from the agency designee following a judgment that "the interest of the Government in the employee's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations." (see 5 CFR 2635.502(d)) He would have to receive such an authorization based on the above determination for each and every matter in which he participates. Obviously, this makes it clear that he is simply not in a position to be appointed as the FDA Commissioner given his extensive and recent history of Big Pharma conflicts of interest.
Finally, one might say: "Well, Dr. Siegel, I see your point but since it is almost 2016, it will be more than one year since the financial relationships so there is no problem and no technical violation of the law."
To which I would respond: "If that is the extent to which you have to go to defend this nomination and you still don't see a problem, then you are missing the forest for the trees."
The rest of the story is that the nominee for FDA Commissioner has such a severe, recent, and extensive history of financial interests with multiple pharmaceutical companies that it would violate all principles of scientific and regulatory integrity to appoint him to head the agency which regulates those very companies.
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