Vol. 218 September 15, 2019 Vaping and Fatal Pneumonia

September 15, 2019

“The rise in vaping-associated illness is a frightening public health phenomenon.”

– Andrew Cuomo, NewYork Governor

 

Severe pneumonia in over 400 people, including 10 deaths, in 36 states have been associated with vaping certain products. The CDC is investigating the phenomenon as a mysterious, previously unrecognized epidemic. Patients from 18 to 88 years of age have been arriving at Emergency Rooms with severe shortness of breath, cough, little or no fever, and a chest Xray with markedly abnormal diffuse infiltrates. Blood cultures show no bacteria, and the response to the usual antibiotics is sluggish or absent. Some patients require intubation and artificial ventilation in order to maintain oxygenation of their blood. A few die. All have a history of vaping, most often using flavored vaping solutions purchased “on the street” or over the internet, i.e. not from licensed vape shops.

The speculation at this point is that flavored vaping solutions have additives that are causing this illness.  The current focus is on Vitamin E oil, added to flavored vaping solutions as a thickening agent. Vitamin E is well recognized as a beneficial skin emollient and an oral nutrient supplement, so it sounds harmless and enjoys a “good-health” reputation. It is inexpensive and readily available, so is a “logical” additive for cheaper, unlicensed vaping solutions sold on the black market (“street-made”) and the internet. The street vendors use the cheaper additives to cut the expensive THC oil and make more profit per vaping cartridge.

In an e-cigarette the Vitamin E oil is heated up and vaporized by a battery-fed hot wire, and the vapor is inhaled. As the temperature of the Vitamin E oil vapor lowers to the normal body temperature of 98.6 degrees Fahrenheit the Vitamin E vapor in the lungs reverts to its liquid form, oil. Any form of oil is extremely toxic to lung tissue. Just ask any physician who has dealt with a patient with oil-aspiration pneumonia, sometimes called “lipoid pneumonia“. The first case report of lipoid pneumonia after vaping was actually reported in 2015 in the journal Chest  as a unique, interesting, never-before seen case of a 31 yo. West Virginian woman who required intubation in the ICU after presenting to the ER in severe respiratory distress after vaping.

There are so many additives in vaping solutions that it is not absolutely certain that Vitamin E oil is the culprit, but some of the counterfeit vaping solutions used by recent respiratory-distress patients contained more than 50% Vitamin E oil!  A 2015 Harvard study that tested 51 of 7,000 vaping solutions found Vitamin E oil in all the flavored ones, and it commented on the potential dangers of inhaling flavored vaping solutions. None of the vaping solutions containing “only” nicotine  or marijuana (THC) contained Vitamin E oil. By the way, the FDA and the various state cannabis commissions have NO idea of the ingredients and additives in vaping solutions. There are currently NO regulations requiring the listing of vaping solution ingredients, even those sold in licensed vape shops. “The cannabis commission does not regulate the ingredients in licensed marijuana stores’ vape cartridges. . . Licensed producers can source their ingredients from anywhere.”

As an aside, this reminds me of a story told by my cousin, a biochemical Ph.D candidate in the 1960’s researching how chlorophyll (the green substance) carried on photosynthesis. In his chromatographic analysis of all sorts of substances, including tobacco, he determined that Marlboro cigarettes had no tobacco in them. They appeared to be made of cabbage leaves infused with nicotine. Incensed (he was a smoker), he wrote an emphatic letter to the company documenting his findings and scolding them for false advertising.. The company’s response was a polite letter pointing out that at no time did they claim in their ads that their cigarettes had any tobacco in them, that they merely promised a smooth taste  . . .and “good luck on your quest to synthesize an artificial chlorophyll.”

The CDC is foraging ahead aggressively with detailed investigations, state legislatures are composing all sorts of ingredient disclosure laws for vaping manufacturers, and, I am sure, many personal injury lawyers are trolling for potentially lucrative suits. In the meantime, I think it would be the better part of valor if everyone stopped vaping until the dust . . . er . . . the vapor settles. Who would guess that we would ever say, “It appears to be much safer to just smoke a joint!”


Vol. 129 July 15, 2015 Update on FDA & Sunscreens and Bath Salts

July 15, 2015

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“Herbal incense” may sound organic,
but it sure ain’t good for you.

 

Sunscreens (1)
Previous blogs have noted that the FDA has limited authority over and regulations for sunscreens, but it does have some. Despite “the common wisdom” that the FDA is slow to approve new prescription drugs, its approval process is generally faster than Europe’s and in 2014 the FDA approved the highest number of new drugs in 18 years – 41 products. (1)

Over-the-counter (OTC) products like sunscreens are regulated by a different process using the standard:  “ generally recognized as safe and effective”. But, in 2014 the FDA declined to permit use of 8 new ingredients in sunscreens even though they have been in use in Europe for 5 years. It cited lack of safety studies, gaps in data, and reports of adverse events. This action prompted an understandable, if   a bit of an over-the-top reaction, from the Wall Street Journal calling to “strip the sunscreen police of all powers over the stuff.”

It is obvious that the FDA has mixed, and unfunded, responsibilities for review of OTC products. A new law, the Sunscreen Innovation Act of 2014 (only in America could we come up with a name like that), tried to clarify the situation, but no new resources were allocated to implement it. In the meantime both the FDA and the CDC continue their efforts to discourage use of tanning beds and promote prevention measures against melanoma which claim 10,000 deaths a year in the U.S.

Synthetic Cannabinoids (SC) (2)

Synthetic cannabinoids (SC) arrived in the U.S. from Europe in 2008 as herbal incense, spice, and bath salts “not for human consumption”. Since 2011 the DEA has placed over 40 SCs into Schedule I of controlled substances which means they are obtainable only by prescription. The problem is that manufacturers of these SCs merely change one or more chemical bonding group or a single chemical chain and the new compound falls outside such a regulation. The compounds are easily obtained on the internet for use in e-cigarettes or are added to energy drinks. They are still labeled “not for human consumption”, and may even carry the assurance that the product “contains no regulated compounds”.

Widespread distribution and marketing have led to recent clusters of serious illness and even deaths, particularly among the young and inexperienced users. Many users reported that they used SCs in order to get high without risking a positive drug test. SCs are NOT detected by the usual urine or blood lab tests, have no available antidote, and can produce serious symptoms which are not readily identifiable as symptoms specific to SC toxicity. Some users have died before reaching an emergency department.

The number of adverse events is increasing. During a two month period in early 2015 Mississippi reported 1200 SC-related visits to the ER and 17 deaths. One reason for this uptick may be the distribution of novel SC compounds that are easily and rapidly synthesized and marketed in response to regulatory actions. They can have new, unknown effects resulting in idiosyncratic toxicity such as delirium, seizures, psychosis, kidney failure, hallucinations, coma, and death.

Ninety-one per cent of users interviewed in one study inhaled vaporized SCs from refillable e-cigarette cartridges. E-cigarettes seem to be garnering more very bad “unintended consequences” than originally predicted by its advocates.

References:
1. NEJM July 9, 2015, pg. 101; A Spotlight on Sunscreen Regulation; J.A. Sharfstein, MD, Johns Hopkins School of Public Health
2. NEJM July 9, 2015, pg. 103, Synthetic Cannabinoids – Related Illnesses and Deaths, DEA, CDC, and University of California


Vol. 125 May 15, 2015 E-cigarettes and Adolescents

May 15, 2015

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                   2
E = M J

 

Seventeen per cent of high school seniors used E-cigarettes in 2014.  E-cigarette use in non–smoking adolescents increased from 79,000 in 2011 to 263,000 in 2013. The current models of E-cigarettes were developed in China in 2003 and introduced to the U.S. in 2007, though Philip Morris had been researching them since the 1990’s. (1)

The original E-cigarettes looked like a cigarette and contained a battery-powered heating element that vaporized liquid containing liquid nicotine which could be inhaled. The amount of nicotine in a single E-cigarette could vary from 36 mg. (about the amount in one Lucky Strike cigarette) to zero. Zero? Yes, zero. People vape those E-cigarettes for their various flavors which are multiple and diverse. “Vape” is the new verb to describe the process. Multiple YouTube videos compare the pros and cons of Smoking vs. “Vaping”. The major pro of vaping according to its advocates is that you can get the nicotine without the tars and other carcinogens.

The newer generation of E-cigarettes don’t look like cigarettes. They can be pen sized (called “pens”) or bigger (called “tanks”), up to 10 -12 inches long. Pens and tanks are rechargeable by the user. Multiple websites offer all kinds of flavors and nicotine strengths of E-liquids.

As E-cigarette use has increased, the use of combustible cigarettes (the traditional ones you light with a match) have decreased among children in grades 8 through 12. Some think this is good news. Others point out that even if E-cigarettes have 10x-100x LESS carcinogens than combustible cigarettes, there are still carcinogens present. Established researchers remark that “not all the ingredients in E-cigarette fluids are known or listed”. Manufactures of E-liquids rebut that by insisting that there are only four ingredients – propylene glycol, glycerin, flavoring, and nicotine – all used in other FDA-approved sprays and vaporized medicines.

E-cigarettes are not regulated by the FDA. The practical consequences of this are that 1) “face-to-face” purchase is not required (as with combustible cigarettes) and 2) there are no restrictions on youth-targeted advertisements. One of the biggest E-cigarette brands, “Blu”, may be best known for its Sports Illustrated swim suit issue ad zooming in on a blue bikinied bottom. “Seduce Juice” is the registered trademark of a variety of E-liquids, all with “snake oil” as a secondary label. Despite the fact that 40 states prohibit the sale of E-cigarettes to minors, they are readily available on the internet.

Do E-cigarettes help cigarette smokers stop smoking? One study of 5,000 attempted quitters in the U.K. suggested that it did help. (2) Studies in U.S. suggest that the use of FDA-approved nicotine vaporizers (Nicorette Quick Mist) prescribed by a physician can help people quit smoking, and many E-cigarette critics recommend that as the preferred method.  Another study showed that E-cigarettes were used by “intermediate risk” students in high schools unlike the use of combustible cigarettes by “high risk” students. Because of that use of E-cigarettes has been called a “harm reduction” strategy. Others citing the same study results suggest that E-cigarettes could act as a gateway to real cigarettes. Neither the American Heart Association nor the American Cancer Society have endorsed E-cigarettes as an aid to stop smoking.

Of course, it didn’t take long for adolescents to learn that if you could buy a rechargeable hand vaporizer and a variety of flavored liquids to put into it, why not put some marijuana juice in it.? And they do. The hashish oil used to charge pens and tanks is highly concentrated liquid THC, the active chemical of marijuana. NPR called pot-vape pens the “crack cocaine of marijuana” a year ago.  Unlike alcohol where a “shot is a shot, 30 ml., 1 oz.” the world over, a single puff from hashish oil is much stronger than a puff from a joint, and the user may not be able to reliably predict its effect. But, there is plenty of advice on how to do so on the internet. The weedblog. com has a colorful infographic explaining “How to Vape MJ rather than Smoke It.”

The contemporary pediatrician has had to add to his or her litany of history questions poised to adolescents over recent years: “Do you smoke cigarettes?”; “Are you attracted to boys or girls?”; “Do you have a gun in the house?”; and now “Are you vaping anything?” (3)

E use could = marijuana squared!

References:
(1) JAMA Pediatrics 2015 ; 169(2): 177-82
(2) Addiction 2014; 109 (9): 1531-40
(3) Scott E. Hadland, MD MPH, Harvard Medical School, May 6, 2015  Course in Adolescent Medcine


Vol. 121 March 1, 2015 Friends Don’t Let Friends … Smoke

February 28, 2015

hub20 established causes of deaths caused by cigarettes:
(Surgeon General Report 2014)
11 cancers – Lip and oral, esophageal, stomach, colorectal, liver, pancreatic, laryngeal, lung, urinary bladder, kidney, and
acute myeloid leukemia
6 vascular – ischemic heart disease, other heart disease, stroke, atherosclerosis, aortic aneurysm, other arterial diseases
2 pulmonary – Pneumonia and influenza, COPD
Diabetes

These diseases account for about 83% of the total excess mortality (higher mortality rates than non-smokers) observed among current smokers.

Several causes of death newly associated with cigarette smoking have recently been added as a result of a study of 1 million men and women over a 10 year period. (NEJM 372;7, Feb 12, 2015)
About 9% of both men and women were current smokers.
42% (women) and 58% (men) were former smokers. (56-70% quit over 20 years ago)
49% (women) and 32% (men) never smoked.

Causes of deaths newly associated with smoking (with relative risk compared to non-smokers)
(1.0 is the mortality risk of a non-smoker)
ischemic disorder of intestines – 5.6 (nearly 6 times that of a nonsmoker)
liver cirrhosis – 3.6
cancers of unknown sites – 3.2   ( 2-6% of all cancers)
hypertensive heart disease – 2.9
all other digestive disorders – 2.6
renal failure – 2.1
all infections –  2.2
prostate cancer – 1.2

Most of the remaining 15-17% of excess mortality of smokers over nonsmokers is accounted for by these newly designated diseases.

The relative risks of death for smokers went up as the number of daily cigarettes smoked went up.
The relative risks went down among former smokers as the number of years since quitting went up.

How do people stop smoking?

YES
Conscious decision “cold turkey” (after being scared to death by statistics like this) – 4-7% success rate
nicotine replacement therapy (NRT) –  gum,patch, aerosol, lozenges
prescription medication – Wellbutrin, Chantix (always needs to be combined with support or cognitive therapy – even just telephone
counseling) 25% success rate at 6 months
support groups – NA, quitnet.com, Great American Smokeout

 MAYBE
hypnosis, acupuncture, mind-body practices, herbals
E-cigarettes – the jury is still out; no consistency of ingredients among brands is one problem in evaluating health risks.

NO
filter cigarettes – do not reduce nicotine inhaling; actually can increase craving
magnet therapy – “a small magnet on each ear”
chewing or other oral tobacco

The addiction to nicotine and to marijuana can be mapped using functional MRIs to the same part of the brain – the part of the brain that “lights up” with cocaine ingestion.  Some treatment programs and several research projects are honing in on this “dual addiction” of cigarettes and joints.

Interestingly, ingestion of the most common food “addictions”, ice cream, pizza and french fries, also maps to this same part of the brain.  Maybe as we get fatter and happier as a nation by using these substances other than tobacco, we will smoke less cigarettes, and live longer!


Vol. 109 September 1, 2014 Today’s Buzzword is “HARM REDUCTION”

September 1, 2014

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Harm reduction is a policy of encouraging and supporting an individual
to take incremental actions to reduce the potential harm of high-risk behaviors
which a person can’t or won’t stop.

 

 

The American Heart Association (AHA) last week reiterated its concern about the negative health effects of e-cigarettes (electronic cigarettes that deliver vaporized nicotine only), but cautiously noted that it considered e-cigarettes as an acceptable “last resort” for those who can’t stop smoking after using nicotine patches and other medications . This is the most recent example of a “harm reduction” strategy.

Aruni Bhatnagar, Professor of Medicine at the University of Louisville in Kentucky and the lead author of the AHA’s statement, wrote: “If someone refuses to quit, we’re not opposed to them switching from conventional to e-cigarettes…Don’t use them indefinitely. Set a quit date for quitting conventional, e-cigarettes and everything else.”

There is scant evidence that using e-cigarettes help people to stop smoking, but e-cigarettes do not deliver tars and other carcinogenic chemicals to the lungs. Hence, smoking an e-cigarette can reduce harm. The American Cancer Society jury is still out.

The “harm reduction” strategy, identified in the 1980‘s, began to really be promoted as an alternative to abstinence around 2000. It was initially focussed on psychoactive drug abuse, but was later expanded to include alcohol and all substance abuse. Its strategies are also incorporated into adolescent sex education, HIV prevention, and homeless health programs. Tactics include school-based distribution of condoms, community needle exchange programs, methadone maintenance, housing without sobriety for the homeless, and, in some countries, heroin dispensing clinics and clean injection facilities.

The DARE (Drug Abuse Resistance Education), or “just say no”, program was that was based on a zero tolerance principle, and it was not effective in reducing drug abuse.

Critics of the harm reduction strategy claim that such an approach can “normalize” the risky behavior that society wants to change. They think harm reduction policy can raise an expectation that such risky behavior is acceptable and even “expected”, particularly for adolescents.

Proponents of harm reduction quote extensive literature that shows that it is “inexpensive, evidence-based, and effective” . The designated driver awareness policy is an excellent example of a successful harm reduction tactic. It is one factor in the reduction of teen age car accidents and deaths. A few years ago the homeless health center with which I am associated stopped requiring alcohol abstinence, sobriety, on the part of a client prior to being placed in transitional housing. Its rates for successful stable housing, subsequent employment, and duration of sobriety increased among those clients.

 MYTH
Harm reduction is opposed to abstinence and therefore conflicts with traditional substance abuse treatment.
Harm reduction encourages drug use.
Harm reduction permits harmful behavior and maintains an “anything goes” attitude.

FACT
Harm reduction is not at odds with abstinence; instead, it includes it as one possible goal across a continuum of possibilities.
Harm reduction is neither for nor against drug use. It does not seek to stop drug use, unless individuals make that their goal.
Harm reduction focuses on supporting people’s efforts to reduce the harms created by drug use or other risky behaviors.
Harm reduction neither condones nor condemns any behavior. Instead, it evaluates the consequences of behaviors and tries to reduce the harms that those behaviors        pose for individuals, families and communities.

Despite all the scientific evidence, it is sometimes hard to fully embrace the concept of “harm reduction” emotionally. I sometimes feel that small moral tug of “whatever happened to right and wrong”. After all, the Ten Commandments say “Thou shall not commit adultery”; not “Try very hard not to commit adultery and, at least, don’t cause an unwanted pregnancy”. But, many studies  show that harm reduction strategies can benefit the individual, the family, and the community. We will be hearing a lot more about it, so we should get used to it.


Volume 3 August 1, 2009 Health Care Lobbyists, Things That Can Threaten Life or Limb

August 1, 2009

Amount spent nationally in 2008 for all healthcare lobbying: $484 million    Amount per day: $1.3 million                                                                          Amount per each congressman and senator per day: $2,600

Number of health care lobbyists in 2008 and increase since 1998:  3,627 / x2

Number of health care organization in the top ten spenders for Massachusetts lobbyists: 5  Which?: MHA, BC/BS, SEIU 1199, Mass Assoc. of Health Plans, Partners Health Care

Per cent of total health care lobbying money attributed to pharmaceutical interests:  > 50

Amount spent by pharmaceutical companies for lobbying in just the first quarter of 2009: $66 million

Per cent increase that is over last year’s amount: +25

Rank of pharmaceutical industry spending on lobbyists of 121 industries monitored since 1998: 1

Number of years new drug patents are “exclusive” which prohibits generic manufacture: 12

Amount contributed this year by Amgen to the Edward M. Kennedy Institute for the United States

Senate at the University of Massachusetts: $1 million

Rank of health professionals lobbying and spending level compared to pharmaceutical: 12 and 1/2

Top five health professional organizations making political contributions in 2008 and amount spent:

Am Med Assoc./ $20.1 million; Am Coll. of Radiology/ $3.4 million; Am. Acad. of Family Practice/

$3.1 million; Am. Assoc. of Orthopedic Surg./ $1.7 million; Am Coll. of ER Physicians/ $1.6 million

Amount of money paid for “No.9” electronic cigarettes in the past two years: $100 million

No. 9 is an E-cigarette that dispenses propylene glycol and liquid nicotine and the plastic tip

glows when you inhale. It dispenses 1/5 as much nicotine and costs about one-half as much as a

real cigarette. One scientist has stated, “There is simply no evidence at this time that electronic

cigarette use poses any significant risk to non-smokers (emphasis added).”

Per cent of Massachusetts registered drivers over 75 and per cent of all auto accidents involving a

driver over 75 respectively: 7 / 3.6

Per cent change since 2004 of Massachusetts accidents involving over 75 year old drivers: -18

This is heartening to those of us who have noticed the recent spurt of stories about the

over 75 year old drivers who have confused the accelerator pedal with the brake pedal.

Ratio of fatalities in accidents at intersections for over 75 and those aged 26 to 64 yrs.:  2:1

Factor by which a driver using a cell phone is more apt to cause an accident: 4x

Chance of reducing that increased risk of an accident by use of a hands-free cell phone: 0

Per cent alcohol level in drivers having the same risk of an accident as a cell phone user: .08

Per cent of 50 states that define drunk driving as a blood alcohol level of .08 or more: 100

Conclusion: If you meet an over 75 year old on a cell phone at an intersection, get out and walk.

Number of Massachusetts soldiers killed in action between 2002 and 2007:  78

Number of Massachusetts  residents dying of a drug overdose in the same period:  3,265

Increased chance of having a blood clot develop in your leg during a long sedentary trip: x3

Per cent increase in risk for each two hour interval of travel: 18 (26% for air travel)

Absolute risk of developing a blood clot during an airplane trip: 1 in 4,600 flights


Quotable Quote

“Confidence is what you have before you understand the problem. Woody Allen

Seton Hall University Law School; http://www.healthreformwatch.com/2009/06/27/

Center for Responsive Politics, http://www.opensecrets.org

Boston Globe July 18, 2009,   Mass Secretary of State’s office statistics

Boston Globe, Biotech Firms Push Hard to Protect Profits, July 21, 2009, p.A1

Boston Globe, July 21, 2009, p. G22, Alex Beam

Boston Globe, July 19, 2009, p. B1, David Abel; Mass RMV; US Government Accounting

Office;Insurance Institute for Highway Safety

Boston Globe, July 19, 2009, p. A9, Matt Richtel

Massachusetts Oxycontin and Heroin Commission

Annals of Internal Medicine, Vol. 151: Issue 3, 2009, D. Chandra, et al.


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