Tuesday, February 16, 2021

Vapers Can Draw Inspiration from this Type 1 Diabetes Story: We Are Not Waiting

 

Vapers, I hope you are inspired by the following story.  It’s about how do-it-yourselfers in the Type 1 diabetes community have achieved advances in treatment that are entirely independent of the medical and pharmaceutical industries, and of FDA regulation.  The manner in which these advancements were obtained mirrors how DIYs in the smoking community have promoted vaping devices that are substantially replacing deadly cigarettes.

People with Type 1 diabetes (PWDs for short) lack a functioning pancreas, making them reliant on a continuous external source of insulin.  There have been considerable advances in managing Type 1 over the past two decades, including better forms of insulin, small wearable pumps that provide the essential hormone 24/7, and continuous glucose monitors (CGMs) – tiny sensors that provide blood sugar levels day and night.  Remarkable as these advances are, PWDs must still be on guard 24/7 – even in the middle of the night – to maintain a normal blood sugar range.  With Type 1, blood sugar levels can soar or plunge in an instant.  Too much time at the high end can damage blood vessels, kidneys and other organs, while low blood sugars can trigger brain shutdown, coma and even death.

Of late, PWDs were convinced that insulin pumps and CGMs could be integrated into an “artificial pancreas”, but device manufacturers and the FDA were not moving fast enough.  In response, DIYs went into action (as described in a recent article in Healthline), and in 2013 the hashtag #WeAreNotWaiting became “the rally cry of folks in the diabetes community who are taking matters into their own hands by developing platforms, apps, and cloud-based solutions, and reverse-engineering existing products,” with a focus on developing an artificial pancreas.

Artificial pancreas systems (insulin pump, CGM and controller) have been available for several years.  One app, called Loop, is used by 10-15,000 people worldwide (here).  In my own 18-month experience with it I have found it truly life-changing.    

A DIY artificial pancreas program called Tidepool has just been submitted for FDA review.  If approved, it would be the first DIY product to have passed FDA scrutiny.  PWDs are hopeful, but those already using artificial pancreas solutions will never give them up.

 The reason this story is important for vapers is that you have been using unapproved devices as substitutes for cigarettes in order to lead longer and healthier lives.  Like PWDs, you are not waiting for FDA-approved options to step away from the fire. 

E-cigarettes and vapor products are scheduled for daunting reviews by the FDA, but vapers, you have demonstrated that, in order to quit smoking and stay smoke-free, you are not waiting.  Take heart with this diabetes story.

 

 

 

Monday, February 8, 2021

Author and Editors Defend the Indefensible Stanford Study on Vaping & Covid


In August, I discussed a Stanford University study published in the Journal of Adolescent Health (JAH) claiming that young people who ever use e-cigarettes are five to seven times more likely to be diagnosed with Covid-19.  A group of harm reduction researchers subsequently wrote that the claims are implausible and the results “so suspect that any conclusions drawn from it [sic] cannot be relied upon…the paper should be retracted.”

The JAH recently published four letters to the editor regarding that study (available here).  The letters were followed by a response from only one of three original contributors: senior author Bonnie Halpern-Felsher.  One is left to wonder about why her original co-authors didn’t sign on to the reply.  Halpern-Felsher’s response did have five co-signers from four other institutions defending the article that they had not written.  Additionally, the JAH editors penned their own response – indicating that they recognized that they had problems with Halpern-Felsher’s article.

The four letters focused on a variety of issues, including these key ones.

1. Halpern-Felsher writes “We adjusted our sample to be representative of the U.S. population.”

Halpern-Felsher incorrectly claimed that her results apply to the entire U.S.  The group calling for retraction noted that the number of participants Halpern-Felsher asserts were Covid-tested would have accounted for almost half of the nation’s 10.4 million tests (here).  In fact, youth and young adults were rarely tested early in the pandemic. 

In the following table I use the 2020 National Youth Tobacco Survey and the 2019 National Health Interview Survey (the most recent available) to estimate populations of 13-17, 18-21 and 22-24 year-olds, according to whether they were ever, or never users of e-cigarettes.  I then multiply these numbers by the percentages who had a positive diagnosis for Covid-19, according to Table 1 in Halpern-Felsher’s response. 

 

Number of Covid Cases Among Youth and Young Adults in the U.S. On May 14, 2020, According to Dr. Bonnie Halpern-Felsher




Age Group (years)Population*Percent Covid+**Number Covid+




13-17


Never Vape13,461,2500.4763,268
Ever Vape6,022,5783.26196,336




18-21


Never Vape12,179,4150.7388,910
Ever Vape4,684,0182.68125,558
22-24


Never Vape7,682,8211.51116,011
Ever Vape4,169,2037.43309,772




All48,200,285
899,855

*Population estimates from NYTS 2020 (13-17 years) and NHIS 2019.        **From Table 1, Halpern-Felsher et al. https://www.jahonline.org/article/S1054-139X(20)30631-5/fulltext 

Her assertion that her numbers are nationally representative means that the total number of Covid-19 cases among youth and young adults in the U.S. when her survey ended on May 14, 2020, was 899,855.

In reality, according to the World Health Organization, the U.S. had a cumulative total of 1,361,522 Covid cases on May 14, 2020.  While it is widely acknowledged that the early epidemic in the U.S. impacted older Americans disproportionately, Halpern-Felsher’s national estimate means that 13-24 year-olds accounted for 66% of all U.S. cases.

2. Halpern-Felsher’s claims, based on tiny numbers.

In our letter, Nantaporn Plurphanswat and I used a standard epidemiologic table to estimate the numbers of cases underlying Halpern-Felsher’s five and seven times claims, as she had refused our request to publish the actual figures.   Her response confirmed that her claims were based on very small numbers.

3. Halpern-Felsher and the editors obtained questionable “independent” reviews.

In her response, Halpern-Felsher wrote, “we voluntarily decided to re-review our data set and analyses, and voluntarily asked another statistician not involved in the original study or any tobacco-related research to rerun the analyses.”  It is not clear to whom the “we” in that sentence refers, since, as noted above, the original co-authors of her article did not sign the response letter.  Further, her statement lacks substantive meaning.  Saying she “voluntarily asked another statistician” to “rerun the analyses” and later noting that “the results of the original main analyses were confirmed…by the independent analysis, and there are no changes to…the core study findings” simply means that there was no error in the analysis.  This response offers no clue as to the quality of the analytic approach, or whether the statistician thought that the whole project was worthless. 

Interestingly, the editors, in their response, also mentioned that “The independent re-analysis confirmed the original main findings” and they seemed to praise the effort by adding that “three independent scientific reviewers [were tasked] from the fields of sociology, epidemiology, and biostatistics.”

Unless the four heralded “independent” reviews are made available for scrutiny, they lend no credibility to the original work.

4. Halpern-Felsher failed to disclose conflicts of interest.

Our letter addressed the fact that Halpern-Felsher, “who is an editorial board member of the Journal of Adolescent Health, may have breached its policy on conflicts of interest” by failing to disclose that she had participated in a lawsuit against an e-cigarette manufacturer.

Halpern-Felsher responded by claiming to update her disclosure, but as of this date she had not done so.  And she reciprocated by accusing the letters’ authors of hiding conflicts themselves: “Several scientists who have raised concerns about this study receive funding from the tobacco industry, and as such, should disclose those conflicts of interest.”  She provided no evidence to support this claim.

The editors supported Halpern-Felsher’s demand, writing that “all potential conflicts of interest should be disclosed by authors… Accordingly, we have asked authors of all letters to update their disclosures.”  Importantly, the editors noted that disclosure “is a standard expectation within the scientific community.”  That is the only acknowledgment of Halpern-Felsher’s egregious disregard of the journal’s disclosure policy.

JAH editors should have better served their readers and public health by retracting the highly flawed Halpern-Felsher article.

 

 

 

Monday, February 1, 2021

U.S. Preventive Services Task Force on E-Cigarettes: We Just Don’t Know!

 

The U.S. Preventive Services Task Force (USPSTF) released its updated recommendations for smoking cessation (here), and the outcome is utterly unsurprising and unacceptable: “the current evidence is insufficient to assess the balance of benefits and harms of e-cigarettes for tobacco cessation in adults.”

The task force claims that “Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.”

In fact, the recommendations are in lock-step with the policies of all other federal agencies.

The only “evidence” the task force deemed acceptable consisted of five randomized clinical trials (RCTs), and it briefly acknowledged that two showed success.  However, the report prominently notes that all trials were conducted outside the U.S., used e-cigarettes that were not available here, and “continued e-cigarette use rang[ed] from 38% to 80%. One study reported that 26.9% of all study participants were using e-cigarettes at 1 year.”

U.S. authorities are obsessed with the idea that only clinical trials can provide valid evidence that smokers can switch (here).  They are also excessively worried about continued use of e-cigarettes after smokers step away from the fire, which plays into their insistence that smoking cessation requires tobacco and nicotine abstinence.

The task force exposes its bias when discussing the “harms” of e-cigarettes, introducing four additional RCTs.  The worst symptoms reported were not serious: “coughing, nausea, throat irritation, and sleep disruption.”

In keeping with federal agency practice, this report cites e-cigarette or vaping product use-associated lung injury (EVALI), even though this pseudo-epidemic was linked conclusively to illicit marijuana products.  The task force does mention the real culprit – vitamin E acetate – but asserts disingenuously that we don’t know if nicotine e-cigarettes were involved.  They were not.

It is striking that the task force describes with conviction minor adverse effects of safer tobacco products, but feigns uncertainty about any positive effects, such as helping smokers quit or having no association with EVALI.  At least they put one honest statement at the top of their report: “480,000 deaths annually are attributed to cigarette smoking.”

The report closes with lists of “research needs.”  For e-cigarettes, this involves finding more evidence for anything negative.  For cessation, “[s]tudies must be well-designed RCTs.”  No matter how much evidence is found in government surveys (here and here), it won’t count.  Unsurprisingly, we need to know about “smoking relapse rates in adults who have used e-cigarettes for smoking cessation.”  Did the task force ever call for similar research for “FDA-approved methods”? 

Finally and most importantly, “More research is needed on understanding how to help adults quit e-cigarettes.”  For the task force, no other outcome, even for products that are vastly safer than cigarettes, is valid.