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

July 15, 2015



“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.

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



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!

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

September 1, 2014


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.

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.

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.

Vol. 107 July 15, 2014 Update on Sunscreens

July 15, 2014


“Consumers continue to [erroneously] perceive high-SPF sunscreens as more effective than lower ones.”
– Consumer Reports, July 2014


My last blog on sunscreens a year ago was largely based on a testing of products by Consumer Reports. So is this one.

1. The FDA does NOT test sunscreen products before they are put on sale.
The FDA does require manufacturers to meet certain standards in order to label their product with these three terms:
“SPF  number “- level of protection from UVB rays that cause sunburn
“broad spectrum” – also protects against UVA rays that can increase skin aging
“water-resistant” – claims protection for 80 minutes after immersion
In 2011 the FDA requested more data from manufacturers about sunscreen sprays and is currently evaluating it.

2. Any SPF over 30 provides little more protection, and will cost you more.
SPF 15 = 93% protection
SPF 30 = 97% protection
SPF 50 = 98% protection
SPF 100 = 99% protection

3. Sunscreen for kids is a marketing gimmick.
Though half of parents who use sunscreen on their children think that sunscreen for kids is “safer” and “gentler”, that is simply NOT true. The FDA makes no distinction in standards for children’s sunscreens and the ingredients of most “children’s” sunscreens are identical to and are present in the same concentration as regular sunscreen. Some may  be reformulated to be “tear-free” or “sting-free”, but that is the only difference.

4. Use more of it, and earlier than you think.
Apply the sunscreen at least 15 minutes before exposure because the chemicals take that long to interact before providing protection. Apply at least an ounce (2 tablespoons or one shot glass full) to cover your face and body adequately.  Reapply every 2 hours.

5. “Natural” sunscreens are no safer nor more effective than “chemical” ones.
There are no effective “natural” sunscreens, however defined, on the market. Zinc oxide and titanium oxide are natural minerals, but if used in their natural (unprocessed) state your zinc oxide covered nose would be black and covered with lead! Sunscreen lotions with zinc oxide and titanium oxide NANOPARTICLES are clear, neither black nor white, but nanoparticles still have their safety critics. “Natural” sunscreens, often labeled as “mineral” rather than “chemical”, can also clump and lose uniformity of SPF.

6. The jury (NIH and the FDA) is still out on the safety of nanoparticles in sunscreens, but the risk appears to be very small.
Nanoparticles do not penetrate skin cells and actually provide very good protection against the effects of the sun, but the potentials effects of inhalation (powders) or ingestion (lip balm) have generated some caution. Nanoparticles have long been used in a whole variety of cosmetics, combine with cells in very tiny amounts, and are approved in sunscreens in Europe. According to the Environmental Working Group, a watch-dog  organization that has been monitoring the use of  nanoparticles in cosmetics for years, “Nanoparticles are a lower hazard than most sunscreen ingredients approved for the U.S. market.”

7. Sunscreen sprays are not recommended.
Correct spray patterns are key for good protection, even spraying the same area twice is recommended, and it is not a good thing to breathe in the spray. The best way to use a spray is to spray it in your hand and then apply it, so why bother with a spray? The FDA is investigating the potential risks of spray sunscreens; like standing too close to a grill after you have sprayed and getting burned when the propellant ignites.

A selected list of products (not all recommended) Consumer Reports tested: (7 of 24 tested products were “recommended”)
(scores are result of UVB and UVA protection measured by wave length and effects of a soak in the tub for 80 minutes: 100 is the maximum)

Up and Up  Sport Spray (Target)           SPF 50     $0.80 per ounce    score: 90 Rec.
Coppertone Water Babies                        SPF 50     $1.38 per ounce     score: 81 Rec.
Equate Ultra Protection (Walmart)      SPF 50      $0.56 per ounce    score: 80 Rec.
No-Ad Sport                                                SPF 50      $0.63 per ounce    score: 69
Up and Up Kids (Target)                         SPF 50      $0.64 per ounce    score: 39
Banana Boat Kids                                     SPF 50      $1.25 per ounce     score: 16

1. Consumer Reports, July 2014, “The Truth About Sunscreens”.

Vol. 109 March 15, 2014 “Misfearing” – Misperceptions of Health (and Other) Risks

March 15, 2014


“Heart Attack Three Times as Likely With Drug A.”

We are all familiar with headlines like this, sometimes not as dramatic, but still attention-getting. It’s enough “to strike fear into your heart”.  As we read on we see the actual numbers, often buried more than half way through,  “ 1000 patients were given drug A and 3 of them had a heart attack. 1000 similar patients were not given the drug and only 1 of them had a heart attack.” 3 is 300% more than 1, but look how low the risk is: an increase from 0.1% to 0.3% risk invokes a lot less fear. By reporting the relative risk percentages rather than the absolute risk percentages the article nurtures “misfear” ; instinctive fear rather than factual fear.

When women are asked what they think the number one killer of women is, most respond, “breast cancer”.  The correct answer is “heart disease”. Clearly women fear breast cancer more than they fear heart attacks.

Which is a greater danger to a child, a gun in the house or a swimming pool?
Each year in the U.S. one child is killed by a gun for every 1,000,000 gun owners. One child drowns for every 11,000 residential swimming pools. Residential swimming pools are much more dangerous to children, but they won’t get the headlines until perhaps a whole birthday party drowns in one. It is less expensive to take steps at home to safeguard guns than it is to build a fence and install alarms around a swimming pool.This raises the issue of cost-benefit analysis in risk assessment. Does the cost of prevention efforts result in a significant benefit? Do we spend a lot of money to try to reduce small risks and little or nothing to reduce big risks? (2)

Sex Offenders
Our current policy of publicly identifying names and addresses of past sex offenders is based on two specific cases (3): an 11-year-old boy kidnapped by a masked gunman in 1989 and never found and Megan, a seven-year old raped and killed by a neighbor in 1994.  “Megan’s Law”  requiring states to publish personal information about sex offenders was passed by Congress in hopes of helping people to protect their children and prevent such crimes. Unfortunately that has not been the result. Two 2008 studies found no decrease in such crime rates and concluded that public notifications “tell the public nothing about the actual risks of a sex crime.” The resulting “misfear” may lead to all sorts of school bus stop, day care drop-off, shopping mall, etc. regulations which may do nothing to reduce risks. In addition such notification may be harmful by making it harder for the “ex-con” to reintegrate into society, find a job, and avoid harassment of fearful neighbors.  In my town such a discharged sex offender killed an adult neighbor with a baseball bat during an afternoon argument on the neighborhood street. As the story unfolded, the dead victim, who had no young children, was described as the only neighbor that had not accepted the presence of the discharged and publicly identified offender, and who was reported to have repeatedly disparage and verbally harass him.

“One in 7 Young People Solicited For Sex Online” is enough to start a moral panic about the internet. The actual report that on which this headline was stated that nearly all of the solicitations were from teens’ peers and other young adults, and that most teens did not find such encounters as upsetting. (4) “Misfear” has led to numerous attempts to regulate the internet “to control sexual predators” rather than fund programs to help vulnerable youth. Statistically such sexual victimization is more likely to occur through school or church participation than through the internet.  One expert decries the blooming of this “misfear” into a general distrust of adult strangers which can blunt “the teenager’s exploration and learning of the world.”

Examples of past “misfears” include – (5)
Elevator Sickness (1892): Scientific American reported that the new 600 feet per minute elevators (that made skyscrapers possible)  could cause “dizziness, irregular sleep, a constant desire to void, and motion sickness” through the herky-jerky motion of internal organs. The elevator was also feared as a spreader of contagious disease through shared conveyances, the originator of the concept of claustrophobia, and  a source of psychological stress about new kinds of “stranger etiquette”. (6)

Bicycle Face (1890): “Nearly all bicyclists have an expression either anxious, irritable, or at best stony… due to the nervous strain of balancing on two wheels.” Now “joggers face” is something I can believe in. I have never seen a jogger with a smile on their face.

Television Neck and Legs (1950): ‘ Viewing your favorite shows too intently could permanently limit the range of motion of your head.”  The AMA warned teens not to sit too long watching TV lest they develop “lack of flexibility” below the waist. That “misfear” of “lack of flexibility” has been translated by modern statistical research into the real fear of childhood obesity.

Examples of present “misfears” include:
Drinking bottled water: More than half of the parents studied chose bottled water for their children believing it was safer, cleaner, and more convenient than tap water. Several other studies have shown that except for increased convenience, those reasons are not true. Besides noting that the average cost of $23 a month for the bottled water, public health experts decry its use because of its lack of fluoride to improve pediatric oral health. (7)

Lice: The launching of the “Lice Protocol” by schools and day care centers currently rivals the launching of the “Concussion Protocol” and the“Bullying Protocol” in terms of drama and “misfear”-mongering. Lice do not cause any disease, hardly ever cause any symptoms except some mild itching, are spread only by direct contact, but are the subject of wide-spread fears and treatments. Such “misfear”, perhaps bolstered by the yuck factor, has spurred development of $200 per visit home delousing services (NitWits, Lice Aunties, Desperate Lousewives) (8)  The Academy of Pediatrics recommendations state,  “Head lice are the cause of much embarrassment and misunderstanding, many unnecessary days lost from school and work, and millions of dollars spent on remedies. Because of the lack of evidence of efficacy, classroom or school-wide screening should be strongly discouraged. No healthy child should be excluded from or allowed to miss school time because of head lice. “No nit” policies for return to school should be discouraged.” 

Wind Turbine Syndrome: Much too long and complicated a subject for this brief blog. Maybe in the near future, if it turns out to be the result of “infrasound” rather than going the way of elevator sickness.

1. “Misfearing”,NEnglJMed 370;7 Feb. 13, 2014, p.595, Lisa Rosenbaum, MD
2.  “Avoiding the Cost of Needless Fear,” BosGlobe Ma.r 6 2014, pg. K6, Cass Sunstein, Prof. Harvard law School)
3.  “Follow Evidence, Not Gut Feeling, on Sex Offenders”, BosGlobe August 28, 2011, Gareth Cook, p. K9
4. “Parents, Forget the Online Bogeyman”,Bos Globe Mar 9. 2014, pg.K10, David Finkelhor at the Crimes Against Children Research Center.
“Its Complicated: The Social Lives of Networked Teens.”, Danah Boyd, Microsoft Research, in press
5. Bos Globe Feb. 19, 2012, p.K12
6. Bos Globe March 2, 201, p.K1, Leon Neyfakh, Daniel Levinson Wilk, Assoc Prof of History at Fashion Institute of Technology, NY.
7. ArchPediatrAdolesc Med 2011 Jun 6
8. “Cleaning Up With Lice Treatments”,Bos Globe May 27, 2011, p. B5, Jenifer McKim

Vol. 100 November 1, 2013 Paranoia and Other Scary Bits

November 1, 2013

Cheney cartoon

“Just because you’re paranoid doesn’t mean they aren’t out to get you.”
– Joseph Heller, Catch 22

Even the powerful can get paranoid
Former Vice President Dick Cheney recently said during a “60 Minute” interview that he had his cardiologist turn off the wireless function in his implanted pacemaker “in case a terrorist tried to send his heart a fatal shock.” Years later, he saw that scenario played out in an “Homeland” episode. (1) We knew that his DC residency was pixellated in the Google satellite view. We wondered if he was on the NASA phone surveillance list, but then we remembered that he ordered that.

Sometimes “They” are right
Surveys of over a million people nationwide revealed that Northeast people were described as “irritable, impulsive, and quarrelsome”. Ever drive in Boston? Midwest and Deep South people were considered “conventional, friendly, sociable, compliant, and emotionally stable”, while the West weighed in as “creative and relaxed, reserved, and perhaps somewhat distant.” Well, California IS distant from Boston and New York. (2)

“Whenever physicians are talking about quality, they are talking about money”
From 2005 to 2010 the urology practices that owned a new radiation technology (IMRT) for treatment of prostatic cancer used IMRT twice as much as urologists who did not own the machine so had to refer patients to others for IMRT. Treatment of prostatic cancer with IMRT cost about $31,000 as compared to about $16,000 for surgery or implantation of radioactive seeds. (3)

“I can’t find a primary care physician!”
In 2006 the Association of American Medical Colleges (AAMC), fearing a future doctor shortage, recommended a 30% increase in medical school slots. That goal may be reached by 2016. BUT, there has been no federal support for increased residency training slots. The AAMC states that there is currently a 15,000 shortage of residency training slots. Medicare funding of Graduate Medical Education (GME) is the major support of residency training, and it was reduced by $11 billion during the ACA debates. It is unlikely to be restored during the 2014 budget debates.  “Physician shortages may become more apparent as the ACA’s coverage expansion takes hold.” (4)

“Not another new flu?!”
Chinese health officials announced in March that a “novel” influenza A virus (H7N9) had infected 132 people and that 37 of them had died. BUT, there has been no evidence of human-to-human transmission and very few of the 20,000 Chinese with flu-like illness actually showed infection with H7N9.  A new element in the tracking of the virus was the recognition of huge spikes in tweets containing the word “H7N9” in both Chinese and English. “Digital Disease Surveillance” is the new term.

Why does a state refuse federal money via Obamacare to subsidize its Medicaid program ?
The New England Journal of Medicine says there are 33 such states, and John Stewart says there are 26. These states are declining to set up health insurance marketplaces (“exchanges”) under Obamacare (ACA) and have acquiesced to the federal government to do so. As a result these states will NOT receive the ACA federal subsidy (up to 100%) of their Medicaid costs for the next three years. John Stewart’s incredulous search for a common denominator of why these states would “bite off their nose to spite their face” came up with only one, a Republican governor and/or a Republican-controlled legislature. (5)

“Umpires are always ruling against my team!”
A study of a million pitches in or near the strike zone, but not swung on, revealed that umpires are less likely to call close ones against batters who are catchers. Presumably due to the rapport that the two develop over long hours of being in close proximity.  Also, the strike zone for the next pitch when the count is no balls and two strikes is apparently 26% smaller than the strike zone when the count is 3 balls and no strikes.(6)

There is no free lunch…or free drugs.
Coupons for free prescription drugs were available in 2011 for nearly 400 brand-name drugs or about 11% of all brand-name prescriptions. 75% of the coupons were for drugs treating chronic conditions (those needing six months or more of treatment), and 58% of those brand-name drugs had lower-cost alternative drugs available. By the time the brand-name coupons expire or run out, the pharmaceutical companies seem to hope that the patient has developed a loyalty for it or resists a change to a lower cost equivalent because of its perceived effectiveness.(7)

“I could be killed by lightning playing golf in the rain.”
Who would think otherwise with all those golfers out there swinging metal golf clubs under big antenna-like umbrellas in the rain? It turns out that anglers, campers, and boaters account for more of the 152 fatal lightning strikes over the past seven years than golfers.  About half of the anglers and boaters were struck while seeking safety. The others were clueless and presumably victims of a “bolt from the blue.”

Fear of terrorism
Polls taken in Boston after the Marathon bombings indicate that more people think that “such attacks are likelier, but fewer live in dread of them.”…”In the United States since 9/11 Islamic terrorism has resulted in the deaths of 37 people. During that same period, ten thousand times that many have been killed by guns wielded by their countrymen or themselves.” (8)

“Will my baby’s flat head harm the brain?”
The American Academy of Pediatrics 1992 recommendation to reduce sudden infant death (SIDS) by having the infant sleep on his/her back has worked. The incidence of SIDS has dropped by 50%, but referrals to subspecialty clinics for plagiocephaly (flat head) have increased.  In a recent study of four Canadian communities 47% of 440 infants had observable plagiocephaly (a flat side of the head). Most were mild and needed no treatment, but the mothers probably stayed worried until time and normal activity rounded things out. (9)

1. Boston Globe, 10/26/2013, report from interview on “60 Minutes”
2. Boston Globe, 10/27/13, report from Journal of Personality and Social Psychology
3. NEJM, 369;17,  October 24, 2013
4. NEJM, 369;4,  July 25, 2013
5. NEJM, 369;13, September 26, 2013
6. Boston Globe, 7/122/13, report from “Social Pressure at the Plate: Inequality, Aversion, Status, and Mere Exposure”
7. NEJM 369;13,  September 26, 2013
8. The New Yorker, May 20, 2013, p. 36
9. Pediatrics 2013 Aug; 132:298

Vol. 90 May 15, 2013 Medical Marijuana and Other Designer Drugs

May 15, 2013


The implied expectation of the term “medical marijuana” is that a physician can write a prescription like any other prescription; one with a drug name, a precise dosage, a frequency, a mode of administration, and a quantity for a stated duration. For example, “Penicillin, 250 mg. tablets, take three times a day for 10 days”. Fat chance when it comes to a prescription for marijuana. There are over a hundred different types and strengths of marijuana (cannabis) and each marijuana product itself contains at least 460 active chemicals. The breeding efforts and expertise that has gone into producing “a better marijuana” is impressive. Anyone that protests “genetically engineered” tomatoes or oranges should not be smoking marijuana. Prescribing cannabinoids, a single active chemical often referred to as “synthetic marijuana”, in tablet or capsule form has been used as medical marijuana by oncology  and pain management centers for years.  “It just ain’t the same” according to marijuana advocates, and some research suggests that with 460 active chemicals in marijuana they may be right.

The Massachusetts Department of Health has just issued 52 pages of regulations for dispensing medical marijuana. They will require a prescription to have a maximum amount that is expected to be sufficient for 60 days, defined as 10 oz. Ten ounces is about 284 grams and a “blunt” is about 1 gram, so that would be about 4 “blunts” a day for 60 days. Prescriptions can be written for patients over 18 yrs. with a “debilitating medical condition” (7 are specifically named plus “others”) or a “life-limiting illnesses” (expected death in 2 years). Patients under 18 yr. may get a prescription for the same reasons as agreed to by two physicians, one of whom is a pediatrician. Independent labs will be responsible for testing the product for contamination, usually a variety of heavy metals. The strength of the dispensed product and the degree of its effects will be variable.

So, what is so bad about marijuana? Use of marijuana (MJ) can acutely slow reflex time, impair motor coordination, and alter perceptions, similar to alcohol. Of course, these functions are all important for safe driving. There are more permanent and potentially more significant effects of heavy use of marijuana in adolescents.

According to recent research MJ is really not so bad for you if you are over 20 years old. Using the new techniques of functional MRI (fMRI) by which brain function as well as structure can be measured, it has been shown that contrary to previous thought, the frontal lobe is still undergoing maturation up to the age of 20.  Maturation of the brain as measured by the increase of white matter, the “tissue of connections” between all the components of the brain, is retarded by heavy (daily) use of MJ, especially in “early users” (start at age 13). The old TV spot of “This is your brain, and this is your brain on drugs” using the frying egg image may be correct for MJ use by those under 20. Adolescents in general tend to be impulsive and have some difficulty in judging the long-term consequences of present actions, and these are functions of the frontal lobe.

Unlike tobacco use that can be measured easily  in terms of number of cigarettes smoked per day and alcohol use that can be measured in ounces drunk per day or per hour, the variety of MJ product’s strength is so diverse that “daily use” is the only reliable marker for heavy users of MJ. Unlike tobacco and alcohol, heavy use of marijuana can NOT kill you. Lester Grinspoon, MD years ago called marijuana “the safest drug in the world”  since it is impossible to commit suicide with it. It is rare to hear about an accidental “marijuana overdose”.

MJ-morphine cartoon

The three drugs of adolescent choice today, tobacco, alcohol, and marijuana, do share a common denominator in that those who use one of the three drugs by age 13, will use one or more of the others before 18 yr. There is no evidence that one is the “gateway” to another. In fact, one research remarked that the concept of a gateway is more of a myth than a reality. He called development of addiction to one or the other substance as a “shared vulnerability”.

By their senior year in high school 36% in one survey had tried MJ. There is no way of predicting which of those could eventually become heavy (daily) users in danger of suppressing their higher neuro-cognitive functions. It is not a question of access to MJ. Student users in a treatment program and researchers presenting at a recent conference made it clear that access to MJ in middle and high school was currently wide open.  In fact, remember that Dr. Grinspoon’s wife got marijuana for their son undergoing chemotherapy for cancer in his schoolyard in 1967! Medical marijuana dispensaries are NOT going to increase access to MJ for adolescents.

Spice is a vegetable product sprayed with synthetic marijuana, cannabinoids, that can be smoked or brewed as a tea. It is sold in convenience and incense stores with the label “not for human consumption” to avoid FDA regulations. The cannabinoids can have 50 to 100 more of an affinity for binding to marijuana sites in the brain than MJ itself. Its effects are similar to but can be much stronger than “smoking a joint”, and about 11% of high school seniors have tried “Spice”. Cannabinoids are easily manipulated synthetic chemicals so that simple chemical changes are made in manufacturing to skirt FDA regulations.

Bath Salts are completely useless for baths. It is a white crystal of chemicals (cathinones) that produce amphetamine effects when ingested, smoked, or snorted. Like Spice it carries the label “not for human consumption”. It was sold as an over the counter health supplement free of FDA regulations.  Both Spice and Bath Salts were first introduced in the U.K. and  Europe, and after much commercial success there they have come to the U.S. and Canada. Bath Salts were Federally banned in the U.S. in July 2012.

“Take home messages”:
1. Marijuana use before the age of 20 does have structural and functional effects on brain development, primarily but not limited to the frontal lobe. (“The frontal lobe, responsible for impulse control, is the last to develop and the first to go.”)

2. After the age of 20 there is little current evidence that MJ causes any permanent effect on brain function or structure.

3. There are  currently no predictors that will identify an occasional user of MJ as one who will become dependent or addicted to MJ (daily use), but the earlier one starts using marijuana (13 yo.) the more likely brain function will be effected.

4. Despite the “trustworthy karma” of medical marijuana, marijuana prescriptions will result in the dispensing of varied, complex, and inconsistent products.

5. Access to marijuana by middle and high school students in 2013 is now so easy according to both students and researchers  that medical marijuana dispensaries will provide little increased access to adolescents.

1. The National Center on Addiction and Substance Abuse at Columbia University
2.ASAP, Adolescent Substance Abuse Program, Boston Children’s Hospital, Sharon Levy, MD MPH, Director

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