Monday, December 09, 2019

Outbreak of Salmonella Poisoning from Contaminated Vegetables in Massachusetts But DPH Refuses to Release Data on Which Products are Involved and Where They Were Purchased

Despite an outbreak of vegetable-associated Salmonella poisoning linked to products sold at Massachusetts restaurants that has affected 90 Massachusetts residents and resulted in three deaths, the Massachusetts Department of Public Health is refusing to release any information on the restaurants at which the patients ate or the exact products they consumed. The Department has revealed only that the outbreak is associated with "vegetable products" and that some of the patients reported having eaten vegetables at restaurants in the Commonwealth.

The Department of Public Health is not even telling the restaurant owners themselves that their products may have been implicated in the outbreak. There have been 90 confirmed and probable cases of Salmonella poisoning. According to DPH, the only thing that links all the cases is that they all reported eating vegetables. However, DPH has not released information on how many of the patients reported eating vegetables at restaurants and how many purchased their vegetables off the unregulated black market, such as the many "farmers' markets" that are held weekly in cities across the Commonwealth.

In response to the outbreak, the Department of Public Health issued emergency regulations that shut down all restaurants in Massachusetts for three months until the source of the outbreak could be identified. Of the 16 confirmed cases in which the patients were interviewed to determine what products they consumed, 14 of the 16 reported having purchased Romaine lettuce at farmers' markets. Only two of the patients denied having purchased vegetables from farmers' markets, although published studies have shown that patients in Massachusetts are reluctant to report that they frequent illicit farmers' markets because of the social stigma associated with that behavior.

A recent study released by CDC found that 100% of the patients whose stool samples were tested were found to have consumed a strain of Romaine lettuce that is not sold at restaurants, but only at farmer's markets and black market produce stands. Nevertheless, it is possible that one or two restaurant chains may have cut corners and purchased this contaminated strain of Romaine lettuce from shady farmers. The Department of Public Health, however, will not release to the public any information on what restaurant chains were reported as having been frequented by case patients who denied buying from farmers' markets.

Of the 16 confirmed cases, none were associated with the purchase of vegetables from restaurants. However, there are six probable cases who admitted to having purchased vegetables from restaurants; DPH has refused to release information on what restaurants those vegetables were purchased from or what the specific vegetables were.

At a hearing last week, the Massachusetts Lettuce Commission, which is in charge of ensuring the safety of the lettuce supply at restaurants in the Commonwealth, complained about the lack of information being shared with it by DPH. Several commissioners told a DPH staff panel that the Department refused to provide them with any information on what vegetable products were reported being purchased at restaurants in the state and at which restaurants they were purchased.

Fortunately, the Massachusetts Lettuce Commission was finally able to get DPH to enter into an agreement to release limited data on the vegetable products reported by case patients. However, the data will be released only to one person - the executive director of the Commission - and he will have to enter into a non-disclosure agreement, certifying that he will not share the information and under no circumstances will release it publicly, even if it becomes clear that a specific product at a specific restaurant is contaminated. In addition, the executive director of the Commission had to put up as collateral his David Ortiz, Bobby Orr, Tom Brady, and John Havlicek jerseys.

Notably, DPH was not being asked to release any personally identifiable information or any information protected by patient confidentiality laws. The only data being sought was aggregated, de-identified product information, not linked to any particular patients but aggregated over the population of case patients.

One piece of critical information that DPH refused to release was whether or not the six patients who reported consuming vegetables at restaurants had also eaten vegetables bought off the street. There is a suggestion that at least one of the patients who ate at a restaurant also ate vegetables that they purchased from an unnamed, makeshift corner farm stand, and it is possible that all six of the patients who reported having eaten vegetables at a restaurant also purchased from makeshift farm stands. Without that information, the Lettuce Commission is hard-pressed to figure out whether any of the products it regulates are involved and if so, where they are coming from and what specific lettuce strains are potentially contaminated.

In what appears to be a possible step forward, DPH has posted the first information it shared in months on some of the products reported being consumed by case patients. Here are some of the data:

First, although there were a total of 49 case patients interviewed, only 16 of these were confirmed cases and the other 33 were probably cases. Looking just at the confirmed cases, 14 of the 16 admitted to having eaten Romaine lettuce that was purchased at black market farm stands. There were only two patients who reported only eating vegetables from restaurants, but they purchased a non-lettuce product that is not regulated by the Commission. So none of the confirmed cases reported having purchased a lettuce product from a Massachusetts restaurant.

Second, there were six of the probable cases who reported having consumed Romaine lettuce from a Massachusetts restaurant.

Third, some of the products that were reported by patients included:
  • Dank Romaine
  • Dr. BLT
  • Sweet Leaf
  • Tossed Salad
  • Naked Salad
  • Wettuce
Despite the CDC's finding that a specific, contaminated strain of Romaine lettuce was detected in samples of 29 out of 29 case patients, the most recent communication from the DPH reports that the cause of the outbreak is "unknown." All that DPH is telling the public is that it is "vegetable-associated."

Moreover, the product summary information sheet for providers states that the cause of the outbreak has not been determined. This despite the fact that both the FDA and CDC have concluded that contaminated black market Romaine lettuce is the predominant, if not only, cause of the outbreak.

Due to an order by the Massachusetts Superior Court, all restaurants in Massachusetts will be allowed to re-open this Wednesday. However, on the same day, the Department of Public Health is expected to release regulations that will ban the sale of flavored Romaine lettuce as of next July. This is not expected to affected large chain restaurants because they sell a plethora of products. However, it is expected to put the state's specialized lettuce shops completely out of business.

The Rest of the Story

CORRECTION: I apologize but I got the story slightly wrong. The numbers are all correct; however, the outbreak is not Salmonella poisoning but acute respiratory failure and the implicated product is not vegetables but e-cigarettes, or vaping products. The contaminant identified in 29 of 29 samples tested by CDC is vitamin E acetate oil, which is a thickening agent that is used only in black market THC vape cartridges and perhaps some shoddy CBD oil cartridges, as well as possibly a small number of legal THC vape cartridges sold by dispensaries, although it is not clear if any Massachusetts products are involved.

It is inexplicable why the Massachusetts Department of Public Health has been so secretive about the products being used by outbreak cases, especially the confirmed cases. Not only does the Massachusetts Cannabis Commission need this information to determine whether any regulated THC vape products are involved, but the public needs this information to be able to make informed decisions about what products to avoid.

For example, the fact that 14 of the 16 confirmed outbreak cases who provided information on the products used reported having vaped black market THC cartridges is game-changing. These data point strongly towards the recognized vitamin E acetate oil adulteration of black market THC vape cartridges as being the predominant, if not only, cause of the outbreak. This information is hidden on the web site, and not reported in summaries of the data that DPH is providing, which combine probable and confirmed cases, which is problematic because many probable cases will turn out not to be actual confirmed cases.

This information casts serious doubt on the rationale behind the emergency order which closed down the state's vape shops, leading large numbers of former smokers to return to smoking. It also makes it inexcusable that the Department of Public Health is continuing to tell the public that it has no idea what is causing the outbreak and that DPH is doing absolutely nothing to try to curtail the outbreak by: (1) telling the public explicitly that black market THC vape cartridges should be avoided; and (2) identifying and shutting down the sources of black market THC vape carts being sold in the Commonwealth.

The entire point of an outbreak investigation is to identify the cause of the outbreak so that this information can be communicated to the public in order to avoid further cases. Despite having shut down hundreds of small businesses, some permanently, DPH has done literally nothing to actually curtail the outbreak. If anything, its actions have resulted in more cases than would have occurred if DPH had shared, honestly, the information that it did have available rather than hide the truth from the public.

In fact, it kind of has the appearance that the reason why DPH has been hiding this information is that it doesn't support its apparently pre-ordained conclusion that traditional e-cigarettes are causing respiratory disease.

It is unconscionable that in order to obtain critical data to help ensure the safety of the THC vape product supply, the Massachusetts Cannabis Commission has to enter into a non-disclosure agreement with DPH.

Thursday, December 05, 2019

American Lung Association's Lies About E-Cigarettes are Dangerous and Irresponsible

Earlier this week, I revealed that, ironically, in a campaign attacking e-cigarette companies for lying to the public, the American Heart Association was itself lying to the public by asserting that e-cigarettes cannot help smokers quit.

Today I reveal that, not to be outdone, the American Lung Association is lying even more blatantly to the public and in a way that is not only irresponsible but dangerous for the public's health.

In a press release issued yesterday, the American Lung Association made the following claims:
  • Cigarette smoking is no more hazardous than using e-cigarettes.
  • E-cigarettes cannot help smokers quit.
  • If you have switched completely from smoking to using e-cigarettes, you have not quit smoking.
  • The use of e-cigarettes has caused recent hospitalizations and deaths.

Specifically, the American Lung Association stated:
  1. "While the e-cigarette industry tells smokers falsely that switching to their products is safer and can help them quit, the American Lung Association is urging the FDA to reject these false quit smoking claims, and is also urging smokers to "Quit, Don't Switch." 
  2. "Switching to e-cigarettes does not mean quitting."
  3. "One of the biggest problems with e-cigarettes is that many people have switched to e-cigarettes believing it will help them quit tobacco products, which it doesn't."
  4. "E-cigarettes are tobacco products. No tobacco product is safe, and that includes e-cigarettes. Recent hospitalizations and deaths related to vaping underscore the fact that vaping is in fact harmful."  
In a separate fact sheet, the American Lung Association reiterates its assertion that if someone quits smoking by switching to e-cigarettes, they have not quit smoking: "Despite what Juul and e-cigarette companies want you to believe, switching to vaping (e-cigarettes) is not quitting smoking."

In the same fact sheet, the American Lung Association reiterates its claim that e-cigarette use is causing irreversible lung damage, as seen in the vaping-associated respiratory illness outbreak: "E-cigarettes still produce a number of dangerous chemicals including acetaldehyde, acrolein, and formaldehyde. As we’ve recently seen on the news, the inhalation of harmful chemicals can cause irreversible lung damage, lung diseases—and even death."

On another web page, the American Lung Association asserts even more definitively that e-cigarettes can cause irreversible lung damage, as has been seen in the recent EVALI outbreak: "While much remains to be determined about the lasting health consequences of e-cigarettes, there’s evolving evidence about the health risks of e-cigarettes on the lungs—including irreversible lung damage and lung disease."

The Rest of the Story

Ironically, all four of the assertions made by the American Lung Association are false, even though they are made in the context of criticizing the e-cigarette industry for lying to the public.

1. Cigarette smoking is no more hazardous than using e-cigarettes.

There is abundant evidence that smoking is much more hazardous than using e-cigarettes. Smoking kills more than 400,000 people each year, while the use of e-cigarettes has not been confirmed to have caused any deaths to date. Tobacco smoke contains more than 10,000 chemicals, including at least 60 known human carcinogens, while e-cigarette aerosol has been shown to contain only a few chemicals of concern and biological monitoring has demonstrated that smokers who switch to e-cigarettes have lower levels of toxins in their body and experience improvement in both cardiovascular and respiratory health.

2. E-cigarettes cannot help smokers quit.

A randomized clinical trial published in the New England Journal of Medicine demonstrated not only that e-cigarettes can help smokers quit, but that e-cigarettes were actually more effective than nicotine replacement therapy, which is typically viewed as the gold standard.

3. If you have switched completely from smoking to using e-cigarettes, you have not quit smoking. 

This is such an absurd statement that it hardly requires refutation. It is essentially stating that: "If you have quit smoking (using e-cigarettes), you have not quit smoking." A person who switches completely from smoking to e-cigarettes has quit smoking. They are no longer smoking. It's not clear what is so difficult to understand about that fact. If you have completely stopped smoking, then you have quit smoking.

4. The use of e-cigarettes has caused recent hospitalizations and deaths.

There is no solid evidence that e-cigarettes are responsible for any cases of the EVALI outbreak. The predominant cause is the vaping of THC and CBD cartridges that contain vitamin E acetate oil as a thickening agent. There is no evidence to support the assertion that traditional e-cigarettes, sold legally in retail stores, are responsible for the outbreak.

These lies are so egregious that it is difficult for me to explain why the American Lung Association is going to such lengths to deceive the public. The only explanation that seems plausible to me is that the American Lung Association simply cannot tolerate the concept that a device which is used similar to a cigarette and which delivers nicotine could possibly be helping people to quit smoking. This is apparently such a difficult concept for the American Lung Association to accept that they have gone to the extreme and nonsensical assertion that if you quit smoking using e-cigarettes, you have not actually quit smoking.

It appears that the American Lung Association is only prepared to acknowledge that a person has quit smoking if that person quits the way the ALA wants them to quit: using FDA-approved medications produced by Big Pharma companies with which the ALA has a financial relationship (and has had a long-term financial relationship, receiving hundreds of thousands of dollars). In the first two quarters of 2019 alone, the American Lung Association received $182,000 from Pfizer, the maker of Chantix, a smoking cessation drug that the American Lung Association is recommending that smokers use rather than e-cigarettes.

The American Lung Association simply cannot tolerate the thought that someone could use a product in a way that "looks like" smoking to quit smoking, even though it is much safer than smoking and has been shown to be a much more effective of quitting smoking than using a nicotine patch or other nicotine replacement products. E-cigarettes are currently the most effective strategy for quitting smoking for anyone who is unable to quit cold turkey (which is the overwhelming majority of smokers).

It's fascinating to me that the American Lung Association, whose goal is supposed to be to prevent lung disease, would be condemning vapers rather than congratulating them. This is rubbing vapers' noses in the ground and is extremely disrespectful to them. These are the very people whose stories the American Lung Association should be celebrating! These are the kind of successes that the American Lung Association should treasure.

The rest of the story is that the American Lung Association is acting in a way suggesting that protecting the public's health is not their most critical value. Their primary value seems to be purity: that is, freedom from any tobacco product. This suggests that they are viewing tobacco use on moral terms, not health ones. If you use tobacco products, you are a bad person. It is a character flaw. It is a vice that cannot be tolerated or accepted. You have to cleanse yourself completely or you remain tainted. Even if switching to vaping has saved your life!

This is not public health. It is some form of puritanism. But more importantly, it is a type of public health malpractice. Recommending that ex-smokers who are relying on vaping to keep them smoke-free stop vaping is tantamount to telling them to return to smoking, since that would be the practical effect if they actually took such advice. If a physician instructed a vaping patient to return to smoking, that would essentially be malpractice.

Whatever the biases or political views that are motivating the American Lung Association, it is clear that this organization is not in any position to be giving medical advice. And it certainly not in any position to be criticizing the e-cigarette companies for lying to the public.

Monday, December 02, 2019

Massachusetts State Health Department is Completely Irresponsible in Hiding the Cause of Vaping-Associated Respiratory Illness

The Department of Public Health's Silence is Putting the Lives of the State's Youth at Risk

I was startled this morning to read what the Massachusetts Department of Public Health (DPH) is currently telling the public about the vaping-associated respiratory illness outbreak that has affected more than 2,000 people and resulted in 47 deaths. This information appears on the emergency web page that the Department has created , entitled "Vaping Public Health Emergency."

There are three critical pieces of information provided regarding the outbreak. 

First, here is what DPH is currently saying about the cause of the outbreak:

"The cause of e-cigarette or vaping product use associated lung injury (EVALI) remains unknown and under investigation at both the state and federal level"

Second, here is the DPH recommendation for all members of the public:
"The Department of Public Health recommends that people do not use e-cigarettes or vaping products."

Third, DPH advises readers to check back for updates:
"Please check back for updates."

The most recent information provided by the governor's office is a press release issued on November 27. In the release, the state health department reiterates its recommendation that: "people not use any e-cigarette or vaping products." 

In addition, here is what the press release tells the public about the cause of the respiratory disease outbreak:

"The cause of e-cigarette- or vaping product use-associated lung injury (EVALI) remains unknown and is under investigation at both the state and federal level."

The Rest of the Story

In the face of a severe respiratory illness outbreak that is resulting in thousands of cases of severe, life-threatening respiratory failure, many requiring mechanical ventilation, it is unconscionable that the Massachusetts Department of Public Health and the Office of the Governor are telling people that the cause of the outbreak is "unknown."

That is it!

Nothing else!

The only thing the state health department is telling people about the cause of this disease outbreak is that the cause is unknown.

This is completely irresponsible and frankly, quite shocking to me. After all, we do know the cause of the overwhelming majority of these cases. The major cause is the vaping of THC vape carts that contain vitamin E acetate oil. 

There is no controversy about this. Both the FDA and the CDC state unequivocally that THC vaping cartridges that contain vitamin E acetate oil are playing a major role in the outbreak and are linked to the overwhelming majority of the cases. The CDC has reported that of 29 patients whose lung fluids were tested, all 29 (100%) contained vitamin E acetate, demonstrating that in all of these cases, a single product explains them: THC or CBD vape carts containing this viscous oil-based thickening agent.

In light of this definitive evidence and the conclusions of both the FDA and CDC that THC vaping is the #1 cause of the outbreak, how could the Department of Public Health possibly hide this information from the public? 

Lives are at stake here. People need to know--and urgently--that if they vape black market THC oil (which is the only kind now available in Massachusetts), they are putting their lives at risk. It is critical that young people in particular be informed that the supply of THC vape carts in the state is extremely dangerous because it has been adulterated with vitamin E acetate oil, which can literally be deadly.

But the Massachusetts Department of Public Health is not telling them! 

Instead, DPH continues to put out a general warning not to vape and all of its statements focus not on the risks of THC vaping, but on the risks of electronic cigarettes.

Not only does hiding the truth from the public put young people's lives at risk, but the state's recommendation that everyone stop vaping puts at risk the health of adult e-cigarette users who are former smokers. If they follow the advice of DPH, then they may very well decide to stop vaping, which for most of them means returning to cigarette smoking. That would be the worst possible thing they could do for their health. As long as they are vaping legal e-cigarettes and not THC, they should absolutely continue to vape.

I am struggling to come up with an explanation for why the state health department in Massachusetts would want to hide the main (if not only) cause of the respiratory disease outbreak from the public. Can the Department's venomous attitude about e-cigarettes be so strong that it is choosing to put the lives of the public at risk in order to avoid letting people in on its secret: that e-cigarettes are not the driving force behind the outbreak?

The rest of the story is that this is precisely what the Department of Public Health is doing.

Wednesday, November 27, 2019

New York City: Where You Can Get Cigarettes at Every Corner Store But There's Not an E-Cigarette to Be Found

The New York City Council yesterday passed a law that bans the sale of all e-cigarettes, with the sole exception of tobacco-flavored ones, but allows cigarettes - including menthol-flavored brands - to continue to be sold at any gas station, convenience store, or other retail store in the city.

On the heels of the New York City ban, the governor of Massachusetts today signed a law that bans the sale of all e-cigarettes in the state, with the sole exception of tobacco-flavored ones, but allows cigarettes to continue to be sold at any gas station, convenience store, or other retail store in the state.

There is no public health justification for banning the sale of fake cigarettes but allowing the real ones to remain on the shelves, especially since the fake ones are much safer than the real ones.

Moreover, these policies are going to have a severe, negative impact on the public's health, since they are going to result in many former smokers returning to smoking and many others turning to black market products.

The Rest of the Story

Although these policies strike a severe blow to the protection of the public's health, they are not bad for everyone. They are a tremendous gift to Big Tobacco, especially the cigarette companies which stand to gain financially from the removal of what is currently the greatest threat to cigarette sales.

This gift to Big Tobacco is reflected in the unanimous assessment by tobacco stock analysts: these e-cigarette bans are going to result in a substantial shift from flavored e-liquids to tobacco cigarettes. Because of the removal of competition and the increase in cigarette sales, these analysts are recommending that investors buy tobacco stocks.

You can see how well Altria stock has done since several states implemented or announced emergency bans on e-cigarette sales:

Tuesday, November 26, 2019

More Evidence that Vitamin E Acetate Oil, Not E-Cigarettes, Is the Cause of the Respiratory Disease Outbreak

A new study published today by the Centers for Disease Control and Prevention (CDC) in the weekly MMWR (Morbidity and Mortality Weekly Report) bolsters the evidence that vitamin E acetate oil, rather than e-cigarettes, is causing the "vaping-associated" respiratory illness.

The study reports the results of laboratory testing conducted in the state of Minnesota, where 96 confirmed cases occurred through October 31. Here are the critical findings:

1. Of 58 patients interviewed, 53 (91%) reported the use of black market THC vape carts. A total of 14 reported using CBD products, of whom 11 stated that they used CBD products with illicit THC. Only 2 of the patients reported exclusive use of nicotine-containing products.

2. Two patients reported using nicotine e-liquids exclusively, but were found to have THC in their lung fluids, confirming exposure to THC products.

3. Every vape cartridge recovered from a drug seizure in 2018 did not contain vitamin E acetate oil, while every vape cartridge recovered from a drug seizure in 2019 did contain vitamin E acetate oil.

4. Of the 12 patients from whom THC cartridges were obtained for testing, products used by 11 of them tested positive for vitamin E acetate. However, the 12th patient admitted to using Dank Vapes, but that was not included among the samples submitted for testing. In addition, every Dank Vapes cartridge tested contained vitamin E acetate oil.

The Rest of the Story

This study not only provides very strong evidence that vitamin E acetate oil, rather than e-cigarettes, is the cause of the outbreak, but it also helps to explain why approximately 10% of patients are not reporting the use of THC-containing products. For one, some of the patients are apparently using CBD products that may contain vitamin E acetate oil. Second, there is clearly substantial under-reporting occurring. Patients who reported using nicotine-containing liquids exclusively have nevertheless tested positive for THC and/or vitamin E acetate oil. Third, there is tremendous product multi-use occurring, so it is not clear that the reporting of nicotine-only product use is reliable.

The hardest evidence we have is that every single patient whose lung fluids were tested were found to have vitamin E acetate in the lungs and that every patient who used THC vape carts and submitted samples was found to have at least one cart that contained vitamin E acetate oil.

This is about the strongest imaginable evidence that one could possibly expect if the outbreak were due exclusively to vitamin E acetate oil.

Moreover, the findings of this study help explain the timing of the outbreak. The findings provide evidence that vitamin E acetate oil was not present in the illicit THC vape cart supply in 2018, but appeared extensively in the supply this year.

In addition, two-thirds of the case patients reported the use of a single common product - Dank Vapes - which was found to contain vitamin E acetate oil.

Furthermore, none of the nicotine-containing e-liquids was found to contain vitamin E acetate oil or any other toxicant of concern.

Based on these findings, the study recommends that people not use THC vape cartridges and not use black market vape cartridges, but does not provide a recommendation not to use legally purchased e-cigarettes.

This study provides a strong justification for the Massachusetts Department of Public Health to rescind its emergency order banning the sale of nicotine-containing e-cigarettes at retail stores. It also confirms that there is no rational basis for the decision of several other states to issue emergency regulations banning the sale of traditional e-cigarettes at retail stores.

Why E-Cigarette Flavor Bans are Misguided: The Flavor's Not the Problem, It's the Nicotine Salts

The obsession of policy makers, politicians, and health groups on banning flavored e-cigarettes as a solution to the youth vaping epidemic is misguided and is detracting attention from the real issue: the use of nicotine salts that have greatly increased the addiction potential of e-cigarettes.

Prior to the introduction of JUUL, three-fourths (74%) of nonsmoking youth e-cigarette users reported using e-cigarettes no more than about once a week and only 4% used them every day, a sure sign of addiction. But by 2018, 12% of nonsmoking youth vapers used e-cigarettes every day, a tripling of the percentage of youth e-cigarette users who were addicted, and less than half (42%) of non-smoking youth e-cigarette users only used them less than once a week. 

This change is what has created a public health crisis. So what explains this change?  

Was it the introduction of flavors?

Absolutely not. Back in 2015, there were just as many flavors on the market as there are now. There were plenty of sweet, fruity, candy flavors available. If anything, JUUL offered fewer flavors than most other e-cigarettes. 

What changed is that JUUL discovered that if you use a nicotine salt to deliver the nicotine rather than freebase nicotine, it is absorbed into the bloodstream much more rapidly. The upshot of this is that the product delivers a nicotine hit or buzz, unlike virtually all other e-cigarettes on the market. 

So when products like JUUL, Suorin, SMOK, and Phix entered the market with their nicotine salts, they quickly became popular among teenagers. All of these brands use a different nicotine formulation from virtually all other e-cigarettes. They use a nicotine salt at very high concentrations, as much as 50 mg/mL, compared to most other e-cigarettes on the market, which do not use nicotine salts and generally have nicotine concentrations that are less than 25 mg/mL. The use of nicotine salts allows the nicotine to be absorbed into the bloodstream much more quickly, simulating the pattern you get with a real cigarette. This is why so many youth are now becoming addicted to vaping. It’s not the flavors. It’s the nicotine. And more specifically, it's the nicotine formulation and to some extent, the concentration.

The combination of nicotine salts and high concentrations of nicotine is what changed youth e-cigarette use from a problem to a crisis. It's not the flavors that created this crisis, it's the nicotine absorption pattern of these new products. 

The reality is that prior to JUUL and its copycats, nicotine addiction was not a problem among youth e-cigarette users. Patterns of use were not habitual, but were almost exclusively social. There were plenty of cotton candy e-cigarette available. But e-cigarette use was not a crisis. There were plenty of gummy bear flavors around. But e-cigarette use was not a crisis. Kids weren't getting addicted to cherry, strawberry, or banana vapes. Nicotine salts--not the flavors--changed everything.

And so now, policy makers are deceiving themselves if they think that banning e-cigarette flavors is the answer to this crisis. No - what's going to happen is that many youth are going to switch over to the e-liquids that remain easily accessible: THC vape carts. Yes, the ones that are causing the respiratory disease outbreak that has killed 49 people and sent more than 2,000 to the hospital with respiratory failure. 

It's even possible that many youth will switch over to the tobacco flavors. Not only will they continue to be addicted to nicotine, but then a transition to cigarette smoking will become a real risk, something that is not the case today because a youth is not going to transition from a sweet-flavored e-cigarette to a Marlboro. But switching from a tobacco-flavored JUUL to a Marlboro is probably much more realistic.

So beyond the devastating effects of flavored e-cigarette bans on adult vapers - leading them to return to smoking or to a new, potentially dangerous black market - flavor bans are actually going to make things worse for youth as well, by driving them towards cigarette use or towards black market products that are even more acutely dangerous.

The most effective solution is right before our eyes, but it's being hidden because of the obsessive and misguided focus on cotton candy, bubble gum, and gummy bear. What we need to do is not ban bubble gum flavor, but severely restrict and control the use of nicotine salts as well as limit the allowable nicotine concentrations in all products.

The Rest of the Story

The biggest myth out there is that there is such a thing as an unflavored e-cigarette. There is no such thing. Every e-cigarette (i.e., e-liquid) is flavored. It's just a question of what the flavor is.

This is another reason why arguing that the flavors are the problem is a meaningless statement. Every e-cigarette is flavored, so how can you argue that the flavors are the problem. 

E-cigarette flavor bans, then, are not actually flavor bans. What they are is policy makers dictating to e-liquid manufacturers that they can only produce one flavor out of a list of thousands: tobacco-flavor. 

Even tobacco flavor is not a single flavor. There are many varieties of tobacco flavor on the market: classic tobacco, Virginia tobacco, regular tobacco, golden tobacco, and so on. Youth will find a way to make the tobacco flavors more palatable. Already, they are using mints to accomplish this. Soon they will be buying their own flavorings and adding it to the tobacco e-liquids. At least, youth are aren't exclusively vaping THC will be doing this.

The only effective way to substantially reduce youth access to flavored e-cigarettes would be to ban them completely. Otherwise, there will always continue to be flavored e-cigarettes available. However, a complete ban on e-cigarettes would be even worse for adult smokers and vapers than banning non-tobacco-flavored e-cigarettes (although probably not much worse).

Policy makers who are using the respiratory disease outbreak as a justification for banning e-cigarette flavors are perhaps the most irresponsible of all. If they truly believe that e-cigarettes present a risk of life-threatening respiratory disease, then how can they possibly allow tobacco-flavored e-cigarettes to remain on the market? There is simply no justification for that and by their own admission, they are knowingly putting the lives of youth at risk.

In fact, every public health advocate who has used the respiratory disease outbreak as a justification for the need to ban e-cigarette flavors is acting irresponsibly because by allowing tobacco flavored e-cigarettes to remain, they are knowingly putting the lives of youth at risk for what is essentially political gain.

The real question is really more basic: Do we allow e-cigarettes or do we not allow them? 

The good news is that we can choose the first option while at the same time putting an end to the youth vaping crisis. The sad truth is that the real objective is not to end the youth vaping crisis and to protect youth from the most important risks they face. Instead, it's to get flavors off the market in order to punish e-cigarette companies so that we can feel better about the fact that so many youth are Juuling.

Monday, November 25, 2019

Oregon State Health Department Claims that Nicotine-Based E-Cigarettes are Causing Respiratory Disease Outbreak

In an op-ed piece published yesterday in the Oregonian, the Oregon state health department claims that a substantial proportion of cases of the vaping-associated respiratory illness outbreak are caused not by THC/CBD vaping, but by nicotine-containing electronic cigarettes. The piece claims that: "we can say the hospitalizations and deaths are not exclusively attributable to cannabis use."

This is very different from claiming that we do not yet know definitively whether some nicotine-containing e-liquids are causing the illness. Instead, the statement claims that we do know that many cases are being caused by electronic cigarettes.

The Rest of the Story

The fact that there are 11% of case patients who did not admit to using THC vape carts does not mean that 11% of cases are being caused by e-cigarettes.

There are several reasons why not every patient diagnosed with EVALI has admitted to THC use. For one, there is tremendous under-reporting of THC use by hospitalized patients, especially youth. Young people may be very reluctant to admit to THC use, both because they don't want their parents to know and because there are severe consequences, such as suspension from school or inability to participate in sports. In addition, many youth do not know what they are vaping. They are not purchasing the e-liquids themselves from stores but getting them from social sources. Moreover, some nicotine-containing products are adulterated with vitamin E acetate oil, so a person could actually be using a nicotine product but unknowingly vaping contaminated THC oil.

It is critical to note that many of the patients who denied the use of THC were later found to have vaped THC oils. In fact, three of the patients who were found to have vitamin E acetate in their lung fluids had insisted that they only used nicotine-containing e-liquids. In the absence of THC urine drug testing, not a single case of EVALI attributable to legal, nicotine-containing e-cigarettes has yet been confirmed.

The fact that 100% of EVALI patients tested had vitamin E acetate oil in their lungs is incredibly strong evidence that THC/CBD oil vapes that contain vitamin E acetate oil as a thickening agent is the cause of this outbreak. 

To continue to tell the public that e-cigarettes are causing this disease and to downplay the role that THC oils are playing is irresponsible.

What I find fascinating is that in the midst of an outbreak that we know definitively is being caused, at least in large part, by the vaping of THC carts containing vitamin E acetate oil, the Oregon state health department would be publicly downplaying and undermining this fact. Why is the state health department emphasizing to the public that nicotine-containing e-cigarettes are implicated when there is not yet any evidence that this is the case?

Frankly, this has the appearance that the health department is taking advantage of this tragic outbreak to carry out some sort of vendetta against e-cigarettes.

It is one thing to mislead the public about the health risks of e-cigarettes outside the context of any specific health recommendation. But I believe it is inexcusable to deceive the public about the role that THC vape carts are playing in an outbreak that is actually killing people and sending thousands to the hospital with respiratory failure requiring mechanical ventilation.

In public health, we don't play with people's lives like this. We don't put the lives and health of the public at risk because we want to further our own agendas, even if that agenda were to be a valid one. Of course, I do not think that demonizing e-cigarette use is a valid agenda. But even if it were, you don't play with the lives of the public (and especially youth) to further your agenda.

The Oregon state health department needs to immediately correct this misleading op-ed piece.

Sunday, November 24, 2019

Massive Irony: American Heart Association is Lying to the Public in a Campaign Attacking E-Cigarette Companies for Lying

The American Heart Association has unveiled a new campaign which uses the hashtag #QuitLying and the website The campaign is directed against "Big Vape" and it attacks e-cigarette companies for lying to the public. Among the lies that the American Heart Association claims e-cigarette companies are making are:

(1) that vaping is different than smoking; and

(2) that e-cigarettes can help smokers to quit smoking.

They claim that the lying on the part of e-cigarette companies is "leading more people to smoking" and has "landed hundreds of e-cigarette users in hospitals."

The Rest of the Story

In a massive ironic twist, it is actually the American Heart Association that is lying, and their lies -- unlike anything that e-cigarette companies have asserted -- are actually leading more people to smoking and possibly landing some vapers in hospitals.

The American Heart Association's claim that vaping is no different than smoking is blatantly false. Vaping is fundamentally different than smoking because it involves the heating of an e-liquid that doesn't contain tobacco, while smoking involves the combustion of tobacco. Vaping does not produce any smoke; it produces an aerosol. Smoking produces smoke because that is the product of the combustion process.

The American Heart Association's claim that e-cigarettes cannot help smokers to quit is also false. A recent randomized clinical trial published in the prestigious New England Journal of Medicine demonstrated that e-cigarettes are actually twice as effective as the nicotine patch in helping smokers quit. The epidemiological technique that you get from this study to the claim that e-cigarettes cannot help smokers to quit is called lying.

Even more ironically, the end result of the American Heart Association's lies is precisely what they attack the e-cigarette companies for doing: these lies are leading more people to smoking and may be landing vapers in hospitals.

The American Heart Association's lies are leading more people to smoking because by making smokers think that vaping is no different than smoking and that it can't help them quit, they are undoubtedly persuading many ex-smokers to switch back to cigarettes. After all, if vaping is the same as smoking and if it cannot help you quit smoking, then why bother vaping? You might as well just go back to smoking. These lies are also undoubtedly deterring many smokers from trying to quit using e-cigarettes. If e-cigarettes cannot help you quit, then why bother trying?

The truth, of course, is that at least 2.5 million smokers in the U.S. have quit smoking completely using e-cigarettes. By ignoring this evidence and claiming instead that vaping cannot help anyone quit smoking, the American Heart Association is both persuading some vapers to return to smoking and dissuading some smokers from switching to vaping. This will lead people to smoking and eventually result in an increase in smoking-related disease and death.

So what about the claim that vaping company lies about e-cigarettes are sending hundreds of people to the hospital? That's not true either. What is sending hundreds of people to the hospital are not e-cigarettes, but tainted THC vaping products in which vitamin E acetate oil has been used as a thickening agent. This lie is undoubtedly going to make the public think that e-cigarettes rather than THC vaping is causing the respiratory disease outbreak, and that will almost certainly result in more people continuing to vape THC than would have if the American Heart Association had told the truth and explicitly warned them not to vape THC.

To make matters worse, the American Heart Association is also encouraging teachers to lie to our students about the health facts regarding e-cigarettes and smoking. They instruct teachers to inform students that "There are many unfounded beliefs that vaping is safer than combustible cigarettes." Of course, these beliefs are not unfounded. What is unfounded is the American Heart Association's claim that smoking is no more hazardous than using an e-cigarette. To instruct teachers to further promulgate this lie among students is quite irresponsible.

The American Heart Association is also lying to teachers when it states that e-cigarettes "have no standards and can say/claim almost anything to get you to buy them." Actually, e-cigarettes are regulated by the FDA and cannot make any claim they want. For example, they are not allowed to make drug claims, they are not allowed to claim that they are to be used for smoking cessation, and they are not allowed to claim that they are safer than any form of tobacco product use.

The rest of the story is that it would be a major public service is someone could fund a #QuitLying campaign to get the American Heart Association to stop lying about electronic cigarettes and to stop putting the lives of the nation's youth at risk by misleading them into thinking that e-cigarettes, rather than THC vapes, are causing the vaping-associated respiratory disease outbreak.

Friday, November 22, 2019

My Testimony Today Regarding the Massachusetts Emergency Ban on the Sale of Electronic Cigarettes

Testimony of Michael Siegel, MD, MPH
Professor, Boston University School of Public Health
November 22, 2019

The Department of Public Health justified its emergency order by arguing that removing vaping products from the market would protect the public – and especially youth – from the vaping-associated respiratory disease outbreak that has now affected more than 2,000 people and caused 47 deaths.
However, unbeknownst to many, this emergency order was not successful in removing all vaping products from the market. In fact, the Department’s emergency order exempted – and therefore failed to remove from the market - a large number of flavored e-liquid products that are highly popular among youth and which Massachusetts youth continue to use, despite the emergency order. These flavored e-liquids are used by 63% of youth who vape regularly. Unfortunately, all of the following flavors are exempt from the ban and remain on the market today throughout the Commonwealth, easily accessible to youth.

The exempted flavors include all of the following:
  •      "Mario Carts Vanilla Glue,"
  •      "Heavy Hitters Vape Strawberry,"
  •      "Honey,"
  •      "Gelato,"
  •      "Blueberry,"
  •      "Banana Sherbet,"
  •      "Jillybean,"
  •      "Super Lemon Haze,"
  •      "Romulan Grapefruit,"
  •      "Sour Tangie,"
  •      "Biscotti,"
  •      "Pineapple Express,"
  •      "Mango,"
  •      "Juicy Melon,"
  •      "Strawnana,"
  •      "Granddaddy Purp,"
  •      "Forbidden Fruit,"
  •       "Lemon Lime,"
  •       "Golden Goat,"
  •         "Butter,"
  •         "Orange Cream,"
  •         "Banana Cream,"
  •         "Strawberry Banana,"
  •         "Grapevine,"
  •         "Lime Sorbet,"
  •         "Potent Pineapple,"
  •         "Pure Pear,"
  •         "Red Apple,"
  •         "Blue Raz,"
  •         "Strawberry Sherbet,"
  •         "Grape Soda,"
  •         "Pink Sherbet,"
  •         "Cactus Cooler,"
  •         "Sunset Sherbet Sauce,"
  •         "Sunset Gelato,"
  •         "It's Yo Birthday,"
  •         "Wedding Cookies,"
  •         "Orange Cookies,"
  •         "Girl Scout Cookies,"
  •         "Grape Pie,"
  •         "Cookies n Cream,"
  •          "Apple Jacks,"
  •          "Banana OG,"
  •          "Birthday Cake,"
  •          "Black Berry Kush,"
  •          "Blue Dream,"
  •          "Blueberry Kush,"
  •          "Bubble Gum,"
  •          "Candy Land,"
  •          "Cherry Pie,"
  •          "Cotton Candy,"
  •          "Fruity Pebbles,"
  •          "Gelato,"
  •          "Grape Ape,"
  •          "Honey Berry,"
  •          "Honey Dew,"
  •          "Ice Blue Raspberry,"
  •          "Key Lime Pie,"
  •          "Lemon Berry,"
  •          "Lemon Head,"
  •          "Lemon Slushie,"
  •          "LSD,"
  •          "Mai Tai,"
  •          "Mango Kush,"
  •          "Maui Wowie,"
  •          "Mimosa,"
  •          "Mojito,"
  •          "Orange Chai,"
  •          "Orange Cookies,"
  •          "Orange Daiquiri,"
  •          "Peach,"
  •          "Pineapple Express,"
  •          "Pot of Gold,"
  •          "Purple Punch,"
  •          "Rose Gold,"
  •          "Russian Cream,"
  •          "Sour Apple,"
  •          "Strawberry Shortcake,"
  •          "Sweet Aromatic,"
  •          "Tangie,"
  •          "Vanilla Kush,"
  •          "Water Melon,"
  •          "Wedding Cake," and
  •          "Zskittlez."
All of these flavors remain on the market, despite what policy makers are telling the public. The truth is that while the sale e-liquids that contain nicotine has been banned, all of the above flavors, which are available in THC vape cartridges, remain on the market.

And in fact, it is these products, not the nicotine e-liquids sold in retail stores, that are responsible for the respiratory disease outbreak. Recently, the CDC found that the lungs of every single one of the 29 patients whose lung fluids were tested contained vitamin E acetate. This is a thickening agent that is used only in THC vape carts and possibly in black market, counterfeit or adulterated nicotine cartridges, but not in legal nicotine-containing e-liquids sold at stores.

You can now easily see why the ban on the sale of nicotine e-liquids at retail stores is no longer justified. There is simply no evidence that these products are causing the outbreak, and there is incontrovertible evidence that vitamin E acetate oil – or some chemical contained in that oil – is now implicated as the culprit. Therefore, the only rational action for the Department to take at this point is to discontinue the emergency ban on nicotine-containing vaping products sold at retail stores in the Commonwealth.

Not only is this ban not preventing any outbreak cases – because those cases are not being caused by the banned products – but the ban is likely making the outbreak worse. Why? Because youth who can no longer access nicotine e-liquids are simply switching over to many of the sweet, fruity, alcohol-based, and other attractive flavors that are readily available in THC vape products.

The tragedy, of course, is that these flavored THC e-liquids are precisely the ones that are killing many people and causing life-threatening illness. Banning nicotine e-liquids is not preventing youth from dying due to respiratory failure. But it may actually increase the number of kids who develop respiratory failure.

With flavors like Girl Scout Cookies, Cookies and Cream, Mimosa, Banana Sherbet, It's Yo Birthday, Russian Cream, Gelato, Grape Soda, Potent Pineapple, and Super Lemon Haze available, do you really think that youth are just going to completely stop vaping?

In the short time that JUUL has limited access to many of its flavors (such as mango and creme), youth have just shifted over to vaping the mint-flavored JUUL pods. They didn't stop vaping because some flavors were taken off the market. Youth are resourceful, vaping is cool, and they will simply switch to whatever flavors are available.

Those flavors will be vape juices like Zskittlez, Bubble Gum, Cotton Candy, and Cherry Pie.

And the only difference will be that instead of the risk of mild respiratory irritation (with most nicotine-containing e-liquids) or nicotine addiction (with JUUL), the major risk for our nation's youth will now be DEATH from lipoid pneumonia or chemical pneumonitis. How is that good public health policy?

Moreover, the ban on electronic cigarettes is already having devastating impacts on the public’s health.

Sales data reported by PiperJaffray for the four weeks ending October 20 (when the Massachusetts emergency ban was in effect for 25 of the 28 days) and the four previous weeks (mostly before the ban went into effect) were compared to sales data for the previous year. The PiperJaffray analysis revealed that there has been a substantial shift from vaping to smoking in the state. This indicates that ex-smokers in Massachusetts who were reliant on e-cigarettes to stay smoke-free are now returning to smoking in large numbers.

Nationally, there was very little difference in the rate of decline in cigarette sales between these two time periods from 2018 to 2019. The rate of decline decelerated by just 0.3 percentage points (from -7.8% to -7.5%). However, in Massachusetts, the rate of decline decelerated by a massive 5.7 percentage points (from -9.8% to -4.1%).

The emergency ban on e-cigarettes did not prevent any respiratory disease cases, but it did send tobacco stocks soaring. Because the stock analysts understood that this ban would result in a substantial return to smoking among vapers.

In fact, recent survey data of Massachusetts e-cigarette users revealed that a substantial proportion of them reported returning to smoking after the emergency order went into effect.

As you may know, I did not believe that the emergency order was justified when it was issued on September 24th because it was clear to me that the outbreak was being caused primarily, if not solely, by THC vaping products. However, even if it was justified on September 24th, it is not justified on November 22nd, after overwhelming evidence has been uncovered that unequivocally ties the outbreak to cannabis vaping cartridges or other black market products that have been adulterated with vitamin E acetate oil.

I therefore recommend that the Department rescind the emergency order as it relates to nicotine e-cigarettes sold at retail stores in the Commonwealth.