Wednesday, October 30, 2019

Sales Data Show that Massachusetts Vaping Product Ban Has Already Caused Severe Harm as Vapers Migrate to Smoking in Large Numbers

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 as I predicted, 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 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%).

Another way of expressing this is that in September 2019, national cigarette sales were 92.5% of what they were in September 2018, and in October 2019, they were 92.2% of what they were in October, 2018. Thus, there was little change in the rate of decline.

However, in Massachusetts, while cigarette sales in September 2019 were 90.2% of what they were in September 2018, in October 2019, they were 95.9% of what they were in October 2018, a substantial lowering of the rate of decline in cigarette sales.

The Rest of the Story

What these sales figures mean is that the emergency ban on the sale of all vaping products in Massachusetts has resulted in an increase in cigarette consumption, most likely due to large numbers of vapers going back to smoking.

Because cigarette consumption is roughly linearly related to smoking-related disease and death, this means that unless the state reverses course, the vaping products sales ban is going to result in a substantial increase in disease and death.

The state is justifying causing this known harm to the public's health based solely on pure speculation that although 90% of outbreak cases admit to vaping THC purchased off the black market, store-bought e-cigarettes are causing a substantial proportion of these cases. This assumes that the 10% of case patients who didn't report using THC: (1) know exactly what the ingredients were in the products they used even though the vapes may have been given to them by friends or purchased off the street or the internet; (2) know that the products are not counterfeit or tampered with; and (3) are not under-reporting their THC use even though we know that a huge proportion of youth who present in emergency rooms do under-report their THC use to physicians.

These known negative health consequences are also occurring in the absence of any documentation that a substantial proportion of confirmed case patients who reported using nicotine-only products tested negative for THC in a urine drug screen.

And furthermore, these known adverse health outcomes are occurring without any finding that a single nicotine-containing e-liquid sold by a retail store was contaminated with a chemical that could be causing the respiratory failure observed in outbreak case patients.

The principle tenet of all public health practice is "Do no harm." As a central principle, we try to avoid doing known harm to the public's health. In this case, states that are banning e-cigarettes (or flavored e-cigarettes) are violating this principle because they are knowingly causing substantial harm to the public's health while producing no known benefits in terms of helping to curtail the outbreak. And, on top of this, they are likely going to make the outbreak worse.

Thursday, October 24, 2019

Analysis Reveals that 44% of State Health Departments are Not Explicitly Warning Youth Not to Vape THC and Three States are Committing Public Health Malpractice

This is part 1 of an analysis of the health warnings that state health departments are issuing to the public regarding the outbreak of vaping-associated respiratory illness. Here, I analyze the warnings issued by the first 25 states (Alabama through Montana).

For each state, after briefly summarizing the warning, I categorize the warning based on three criteria:
  1. Is there an explicit warning not to vape THC?
  2. Does the warning inform the public that THC vape cartridges are playing a major role in the outbreak?
  3. Does the warning mention THC at all?
Based on the warning and these three criteria, I then classify the state health department warnings into six rating levels:
  1. Excellent: There is an explicit warning not to vape THC, the state informs the public that THC is playing a major role in the outbreak, and the state goes beyond CDC by not undermining its warning about vaping THC
  2. Good: There is an explicit warning not to vape THC and the state goes beyond CDC by not undermining this warning, but the state either fails to inform the public that THC is playing a major role in the outbreak or issues too vague a warning.
  3. Fair: There is an explicit warning not to vape THC but the state undermines that warning by emphasizing that no single product has been associated with all cases.
  4. Poor: There is an explicit warning not to vape THC but it is undermined by a vague warning or the failure to acknowledge that THC plays a major role in the outbreak.
  5. Very poor: There is no explicit warning not to vape THC.
  6. Public health malpractice: There is no mention of THC in the warning.
My rationale for this classification is that at this point, it is very clear that THC vape cartridges are playing a major role in the outbreak and both CDC and the FDA have now acknowledged that. Given that fact, it is imperative that state health departments issue an explicit warning to the public, and especially to youth, not to vape THC (at least black market THC products). Finally, this message should not be undermined by other statements in the warning.

Here are the results of my analysis:

The Rest of the Story

The most striking finding of this analysis is that 3 states - Alabama, Illinois, and Kentucky - are committing public health malpractice by not even mentioning THC at all in their warnings. This is inexcusable and puts the lives and health of residents, especially youth, at risk.

The second most striking finding is that 11 of the 25 states (44%) are not explicitly warning the public not to vape black market THC cartridges. These states are (in addition to the 3 states above): California, Georgia, Idaho, Indiana, Kansas, Louisiana, Massachusetts, and Montana.

In only 3 states are the warnings rated as excellent: Connecticut, Maine, and Minnesota.

Links to the warnings for each state that I used in the analysis are provided below:


Alabama
Arizona
Arkansas
California
Connecticut
Colorado
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana

Tuesday, October 22, 2019

New CDC Report Out Today Makes it Even Less Likely that Store-Bought Nicotine E-Cigarettes are Playing Any Role in the Outbreak

A new report published today in the MMWR summarizes the results of the most detailed investigation to date of cases of the outbreak of vaping-associated respiratory illness, focusing on the 83 confirmed cases occurring in the state of Utah. The key findings of the report are as follows:
  1. 92% of the patients for whom product use was ascertained admitted to using THC vapes (only 3 out of 53 - 6% - did not).
  2. Of the THC products tested, 89% contained vitamin E acetate oil.
  3. No abnormalities were found in any of the nicotine e-liquids tested.
  4. The report concludes that “unregulated THC-containing cartridges play an important role in this outbreak.”
Another interesting and important finding was that: "Use of three brands of prefilled THC-containing cartridges was reported frequently by patients; these included Dank Vapes (21, 40%), Rove (19, 36%), and Golden Gorilla (11, 21%)."

The Rest of the Story

It is critical to note that as the investigation progresses, the proportion of cases that are being associated with THC vaping cartridges is steadily increasing, while fewer and fewer cases are being linked to the exclusive use of nicotine-containing products.

Over the last three CDC updates, the proportion of cases reporting using nicotine only has decreased from 17% to 13% to 10%. In the states that have released data in the past two weeks, the proportion of case patients who admitted to using THC is in the range of about 92% and higher. And now, in the most comprehensive investigation to date, the proportion of patients who admitted to using THC vaping cartridges is 92%, with only 3 patients not admitting to THC use (and no toxicology testing results were reported on those patients).

Moreover, there were no contaminants found in any of the nicotine e-liquids tested, while it appears that vitamin E acetate oil was detected in THC cartridges used by every THC-using case patient from whom product was obtained. This is consistent with the reported results from testing in New York State and nationally. So far, vitamin E acetate oil has been present in most of the THC vape cartridges recovered and no contaminants have been detected in any of the nicotine e-liquids tested.

The finding that 92% of patients admitted to vaping THC is quite striking, especially since young people (particularly young males) are highly likely to under-report their use of marijuana. In a 2006 study of male emergency room patients ages 18-24, only 25.8% admitted to marijuana use, but drug testing revealed that 48.1% had used marijuana. Given this huge degree of under-reporting, it is not at all unlikely that 3 of 53 patients might not admit to THC use even though they actually did use THC.

In other words, it is entirely possible that the outbreak is a result of contaminated THC vaping cartridges, period. It appears that it is not necessary to invoke nicotine e-liquids, but especially those purchased in brick-and-mortar retail stores, in explaining the outbreak. Nevertheless, there is still some chance that there are some black market nicotine-containing products that are either counterfeit or otherwise adulterated and which could be contaminated with vitamin E acetate oil and therefore involved in the outbreak. For example, one of the e-liquids samples recovered from a Utah patient contained both nicotine and THC, suggesting that a nicotine e-liquid had been adulterated with THC oil.

At any rate, it is being more and more clear every day that the actions of the CDC and many state health departments as well as policy makers in multiple states is putting the lives of the public at risk. The irrational obsession with going after legally sold e-cigarettes at vape shops and other stores while completely ignoring the distribution and use of black market THC vape cartridges is irresponsible and is almost certainly causing more outbreak cases than we would be seeing if health agencies would simply tell the public the truth and address the actual cause of the outbreak, rather than continuing to demonize electronic cigarettes and the businesses which sell them.

Friday, October 18, 2019

Tennessee Department of Health Appears to Have Deliberately Blamed E-Cigarettes for a Death It Knew Was Caused by THC Carts

Yesterday, I revealed that the Tennessee Department of Health reported its first death from vaping-associated respiratory illness as follows: "The Tennessee Department of Health has reported one death in a patient with serious respiratory disease associated with use of electronic cigarettes or other vaping devices. This is the first such death reported in Tennessee."

As it turns out, it appears that this death was not caused by electronic cigarettes, but by THC vape carts.

I suggested that the health department's reporting of the death as being associated with the use of "electronic cigarettes or other vaping devices" would be like reporting a death from contaminated lettuce by saying: "The Tennessee Department of Health has reported one death in a patient with severe Salmonella poisoning associated with the consumption of lettuce or other vegetables."

However, I realize that this analogy is not actually correct. More precisely, it would be like reporting a death from contaminated lettuce by saying: "The Tennessee Department of Health has reported one death in a patient with severe Salmonella poisoning associated with the consumption of artichokes or other vegetables."

The Rest of the Story

It seems to me that one wouldn't report a death associated with the consumption of contaminated lettuce as being "associated with the consumption of artichokes or other vegetables" unless you were intentionally trying to deceive the public into thinking that artichokes were responsible for the death.

Wouldn't you just report the death as having been associated with the consumption of contaminated lettuce? By adding in a product that you know was not responsible for the death, it has the appearance of:
  1. deliberately trying to mislead the public;
  2. trying to undermine the public's connecting of the death with contaminated lettuce; and
  3. intentionally trying to blame artichokes for something you know was not associated with artichokes.
While it does appear that the Tennessee Department of Health has deliberately misled the public, I still believe that the CDC bears some responsibility for the failures in communication that are coming from many state health departments because it continues to undermine the demonstrated connection between the outbreak cases and the vaping of THC.

Even the name that the CDC is using for the disease is an indication of an intentional attempt to attribute the outbreak to electronic cigarettes rather than THC vape carts. Originally, the CDC called this "vaping-associated respiratory illness" (VARI). But they have now changed the name to "e-cigarette or vaping product use associated lung injury."

I am quite sure that if 90% of the patients reported using nicotine and only 10% reported exclusively using THC, they would not be calling this "THC or vaping product use associated lung injury." It seems clear that in the very name itself, the CDC is trying to primarily blame e-cigarettes for an illness that they know is predominantly linked to THC vaping products.

Thursday, October 17, 2019

Tennessee Department of Health Tragically Misleads the Public in Order to Falsely Blame a Death on E-Cigarettes

Sadly, Tennessee recently experienced its first death from vaping-associated respiratory illness.

Here's how the Tennessee Department of Health reported it: "The Tennessee Department of Health has reported one death in a patient with serious respiratory disease associated with use of electronic cigarettes or other vaping devices. This is the first such death reported in Tennessee."

So which one was it? Was it the use of "electronic cigarettes" or was it the use of "other vaping devices." If the Tennessee Department of Health truly wants to prevent further cases of this illness, it is incumbent upon the agency to inform the public which of these two products it was. They are completely different products so it makes a world of difference for the public to know which one it was.

The Rest of the Story

It turns out that this tragic death was associated with the use not of electronic cigarettes, but of THC and CBD vape cartridges. The rest of the story, that the health department is hiding from the public, is that this patient died from vaping THC. And it was most likely black market THC carts because marijuana use is not legal in Tennessee for either recreational or medicinal purposes.

Why, in describing the product associated with the death, would the health department intentionally lump electronic cigarettes into the mix, knowing that it was THC vaping that caused the death?

It would be like reporting a death from contaminated lettuce by saying: "The Tennessee Department of Health has reported one death in a patient with severe Salmonella poisoning associated with the consumption of lettuce or other vegetables."

Clearly, that would be irresponsible. The only conceivable reason why the health department would lump other vegetables into the picture would be to intentionally deceive the public so that the connection in their minds between consumption of lettuce and Salmonella poisoning would be completely undermined.

In other words, the Tennessee health department is intentionally deceiving the public in order to undermine the connection in their minds between THC vaping and the severe, acute respiratory disease outbreak. I can hardly think of anything that could be so irresponsible.

I just don't understand why so many state health departments and the CDC are trying so hard to undermine the connection between THC vaping and the outbreak. It is as if they are trying to protect illegal marijuana drug dealers by switching the focus over to legal, responsible, vape shops. And it is as if they don't actually want to prevent further cases of the disease.

Frankly, if they truly wanted to prevent further cases of the disease, if they truly wanted to honor the memory of this incredible individual whose life ended tragically because of contaminated THC vape carts produced by an illicit drug operation, the health department would clearly communicate to the public that there was a death in the state associated with vaping THC and nobody in the state should even touch a THC vape cart. If you need THC, then just smoke a joint. Right now, it is simply much too dangerous to be vaping THC in the state of Tennessee since there is no legal supply of safe THC vaping products.


Monday, October 14, 2019

The CDC is Still Misleading the Public about the Cause of the Respiratory Disease Outbreak: Why?

Last Thursday, CDC finally revised its warning to the public about the vaping-associated respiratory disease outbreak to state clearly that vaping THC-containing products is playing a major role in the outbreak. It stated that: "The latest national and state findings suggest products containing THC, particularly those obtained off the street or from other informal sources (e.g. friends, family members, illicit dealers), are linked to most of the cases and play a major role in the outbreak. Therefore, CDC recommends that you should not use e-cigarette, or vaping, products that contain THC."

In addition, CDC finally recommended that clinicians test case patients for THC with a urine drug screen, something I recommended more than a month ago.

This is a huge step forward because prior to this, the CDC was hiding from the public the fact that THC vaping was playing a major role in the outbreak and failed to provide an explicit warning to stop vaping THC.

The Rest of the Story

However, the very next day, CDC issued the following Tweet:

"CDC and @US_FDA have not identified the cause or causes of lung injuries associated with e-cigarette, or vaping, products. The only commonality among all cases is patients report the use of e-cigarette, or vaping, products."

This is a meaningless statement because in an outbreak investigation, one almost never finds a commonality that ties together every single one of the patients. If you did, you wouldn't need a special CDC team to investigate it. The cause would be quite obvious. In fact, the reason why an epidemiologic investigation is necessary to identify the cause of a disease outbreak is that not all the cases report a common exposure and so special epidemiologic methods are required.

For example, in 2017, CDC investigated an outbreak of Salmonella poisoning in which there were 19 identified cases in seven U.S. states and British Columbia. Many, but not all of the 19 cases reported eating pre-cut coconut pieces from grocery chain A. Specifically, 12 of the 19 cases (63%) reported eating pre-cut coconut pieces from grocery chain A. Records collected at grocery chain A locations and distribution centers uncovered that many of the cases had consumed products from a potentially contaminated lot of pre-cut coconut pieces imported from Indonesia.

The CDC did not tell the public:

"CDC has not identified the cause or causes of grocery A-related Salmonella poisoning. The only commonality among all cases is patients report having shopped at grocery store A. Most of the cases report having eaten pre-cut coconut pieces. However, no single product was common to all of the cases. CDC recommends that people who are concerned about Salmonella poisoning should consider not shopping at grocery chain A."

What did CDC do? They concluded that the pre-cut coconut pieces were the source of the Salmonella outbreak and facilitated a recall of these products. They don't close every one of these stores down completely because they weren't able to find a single product that was common to all of the cases.

Note that unlike youth THC use, there is no stigma associated with eating pre-cut coconut pieces and it is perfectly legal. So even without a good reason for under-reporting, the CDC was still able to identify a common exposure in only 63% of the cases. In fact, they did go back and re-interview some of the patients and in at least one case, they found a store receipt proving that the person had purchased pre-cut coconut pieces even though they had denied it.

If that can happen for pre-cut coconut pieces, then one would certainly expect under-reporting to occur for the use of illegal black market THC vape carts purchased from drug dealers on the street.

I have never before, in any outbreak investigation, heard the CDC withhold a specific warning because not every case reported a common exposure. There is something underneath the surface that is making the CDC reluctant to provide the public with the information and warnings that they need in order to curtail this outbreak.

The rest of the story is that the CDC's communication about the cause of this outbreak has been steadily improving, but we still have a long way to go.

Like the Telephone Game, CDC's Lack of Clarity is Becoming Completely False Facts at the Local Level

Do you recall the telephone game? Players sit in a circle and the first person whispers a phrase into the ear of the second person, who whispers it to the third person, and so forth, until it gets to the last player, who then repeats the phrase that they heard. Typically, the phrase changes substantially from the beginning because a series of small, progressive changes add up to a completely different phrase at the end.

The only way to prevent this is for the first person to deliver such a clear message that it cannot be mistaken.

In this commentary, I show how the lack of clarity by the CDC and other health groups in communicating about the health risks of electronic cigarette use is leading to the dissemination of completely false information at the local level.

The Rest of the Story

In an article in the Williston Herald (North Dakota), a respiratory therapy care manager at CHI St. Alexius Health in Bismarck informs the public about the vaping-related lung disease outbreak that we are experiencing. She has apparently been involved in the management of several affected patients in North Dakota.

In the article, she tells the public that: "Propylene glycol is not water soluble, and that could be behind the recent vaping illnesses that are emerging. “The lungs don’t tend to absorb anything that is not water soluble, so they can’t get rid of it,” Backman said. “So those patients we are hearing about in the news who come into an ER or hospital are the ones heavily using these devices.”"

She did get some of the facts right. It is true that the lung has difficulty getting rid of oil-based liquids and that many of the outbreak patients who come into the hospital are using vaping devices with THC oils that are not water-soluble.

However, she gets one key fact wrong: "Propylene glycol is not water soluble," she tells the public, implying that the inhalation of propylene glycol is what is likely causing the outbreak. But propylene glycol is soluble in water and is almost certainly not the chemical responsible for the outbreak. If it were, we would see as patients many vapers of all ages using virtually all brands of nicotine-containing e-liquids, including many products sold at retail stores. If nicotine liquids were oil-based, I would be the first one telling everyone not to use e-cigarettes because they  pose a high risk of developing a potentially fatal lung disease.

I do not completely blame the individual who was passing along this misinformation because when the CDC communicated to the public about the fact that many of the identified case patients were presenting with lipoid pneumonia, it did not explain that all nicotine-based e-liquids sold in stores are water-based and thus cannot be the cause of lipoid pneumonia, but that many black market THC vape liquids are oil-based and must be avoided. This has apparently led to massive confusion among the public.

The rest of the story is that our communication about the health risks of vaping has been a complete failure. The public health community has completely fouled this up. This example shows how the lack of clarity at the level of the CDC can ultimately result in the provision of completely false information at the local level. This is why it is essential that CDC be as clear as possible in its messaging, something it has largely failed to do during this outbreak investigation.

Friday, October 11, 2019

News Headline Shows How Misinformation About Respiratory Disease Outbreak is Spreading

The featured headline of a news article published yesterday at NorthJersey.com (the North Jersey Record) was: "Vaping with JUUL Damaged NJ Woman's Lungs, Left Her Hospitalized."



The headline of the article itself read: "'My Lungs Were Chemically Burned': NJ Victim Speaks Out Against Vaping."

These headlines certainly give the impression that this unfortunate 21-year-old woman developed acute respiratory failure due to her use of JUUL.

If true, this would be an absolute disaster because there are an estimated 7 million JUUL users.

This is no doubt going to contribute to the public's belief that electronic cigarettes sold at retail stores, not tainted THC vape carts sold mostly on the black market, are responsible for the terrible respiratory disease outbreak that has now affected nearly 1,300 people and caused 26 deaths.

The first paragraph of the story reinforces the impression that JUUL was the cause of this woman's respiratory failure: "[She] started smoking cigarettes when she was 17 or 18, she said. Hoping to find a “safer alternative” — one that wouldn’t leave a smell — she picked up a Juul, a popular electronic cigarette device, and began vaping."

The Rest of the Story

It isn't until you get to the fine print that you found out the following:

"[She] began using vaping devices more and more, eventually taking hits almost every 10 minutes, she said. She first had other people purchase her vapes, and she began buying them from stores and unregulated dealers as soon as she was old enough."

Since nicotine products sold by retail stores are all regulated, it appears that by unregulated dealers she is referring essentially to illegal, black market products.

Of course it is not clear what specific product caused the illness. However, it certainly cannot be definitively attributed to JUUL since the patient was also apparently purchasing black market vaping products as well.

One must look at the overall epidemiologic data, and what those data tell us is that the vast majority of affected patients admit to vaping THC cartridges, most of which were purchased off the street or over the internet, not from licensed retail stores.

But this story illustrates how easy it is for misinformation to be disseminated widely enough so that the public gets the inaccurate impression that JUUL products are responsible for this outbreak. There are plenty of dangers associated with youth use of JUUL - namely, the potential for addiction - but acute respiratory failure is not one of them. If it were, we would certainly be seeing numerous cases of the illness among adults of all ages who report using JUUL.

Although there may be a tendency to blame the media, I believe that the media coverage is actually framed largely by the way we as health professionals communicate the information to the media. And I think the coverage is most profoundly influenced by the way the CDC has communicated about the causes of the outbreak.

While the CDC's most recent communication finally admits that THC vaping products are playing a role in the outbreak, it may be too little too late. The public clearly has the impression that your every day, retail sold, nicotine-containing e-cigarettes are what is causing this outbreak. This is reflected by large reductions in the sale of these products over the last few weeks.

Sadly, the tragic consequences of this failed communication include an increase in the sale of real cigarettes (as many vapers try to avoid the alleged risks by switching back to smoking) and I suspect a larger number of people continuing to use THC vape carts than would be had the CDC been transparent from the start.