Vol. 146 April 15, 2016 The Bathroom Bill and Another Unintended consequence

April 15, 2016

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“Bathroom Bill passes the House and goes to the Senate next month.
Governor Baker still on the fence.”

Gender politics are currently heating up in North Carolina, Massachusetts, and other states about proposed bills banning discrimination against transgender people “in public accommodations”. Many states have already passed laws or issued Executive Orders banning discrimination against transgender people in government and other jobs. The lightening rod in these new bills is the clause allowing transgender people to use the public restroom appropriate for what “they look like”.  This effort to “ban transgender discrimination in all public accommodations” has been succinctly reframed as “which restroom are they allowed to use”, hence the name “bathroom bill”.  Groups in favor of letting transgender people use the bathroom “that matches how they look” advocate passionately for the rights of transgender people. Opponents raise the specter of men masquerading as women assaulting women in public bathrooms. If it weren’t for the strong emotions swirling throughout this largely symbolic conflict these discussions might be another source of “comic relief” in this election season.

Screen Shot 2016-04-15 at 10.50.35 AMAs previously blogged  different kinds of gender-benders can look the same.  These proposed laws will set rules based on how people LOOK, but transgender people define themselves by how they think. “Transvestites, transexuals, and cross-dressers can be defined by who they go to bed WITH. Transgender people are defined by who they go to bed AS.”

These bills mark our continuing evolution of trying to deal with the changing views of gender identification. In 2014 ABC News found 58 possible gender identifications allowed by Facebook, though many of them are just slight variations of the same term; ex: “Male to Female” and “MTF”, “Cisman” and “Cisgender Man”. The list also includes “Other” and “Two Spirit”.  In 2015 California colleges in response to a 2011 California law started giving 6 choices for voluntary gender identification on student applications: “male; female; trans male/trans man; trans female/trans woman; gender queer/gender non-conforming; and different identity.”   They also added a question asking the student to voluntarily identify their sexual orientation. All of this apparently for state government data collection purposes, and, perhaps, to help make appropriate roommate assignments. The California colleges have stated repeatedly that the new information does not enter into the admission decision process itself. 

Not surprisingly a demand on a number of college campuses has risen for more “gender neutral” restrooms as one logical solution to this gender conundrum.. In Europe, and in select small public facilities in the U.S., they are  called “Unisex” restrooms. If you are wondering how you could identify such a facility, you might just look for this sign.:gender neutral symbolwpid-167_4817_6960

UnCHOF
My most recent nomination to the Unintended Consequence Hall of Fame (UnCHOF) goes to the Novartis pharmaceutical company. They make Voltaren (diclofenac) a non-steroidal anti-inflammatory drug commonly used  for joint stiffness and pain when simple Advil doesn’t help. It has been associated with a small risk of cardiac toxicity in humans.

Years ago farmers in India started giving diclofenac to their aging, limping, stiff cows in hopes of getting another year or two of use out of them. When the cows died their carcasses were left in the fields as was the custom in India and millions of vultures quickly reduced them to piles of bones. The vultures of India have been providing this necessary and efficient service for centuries.  But, the vultures ingested the diclofenac remaining in the cow carcasses, and it so happens that vultures lack the enzyme that metabolizes diclofenac. The rising blood levels of the drug were toxic to their kidneys.  Millions of vultures in India and Pakistan, as in ALL of them, had died by 2008 of renal failure. “Today there are many young Indians who have never seen a vulture.” (1)

When the “vulture clean-up service” died out the cow carcasses were trucked away to dumps. Feral dogs found the dumped carcasses to be a ready source of food, and the feral dog population in India exploded. Recently there have been more frequent sightings of leopards, yes leopards, in some Indian urban areas. The leopards are there to eat the dogs.

So, veterinarian use of a very common non-steroidal drug consumed by millions of humans has in India killed off a whole species and has produced a new type of urban danger, hungry leopards!  QED

References:
1. A River Runs Again; India’s Natural World in Crisis;  by Meera Subramanian, 2015


Vol. 140 January 15, 2016 A Review of 2015 Hubslist Blogs

January 15, 2016

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Click on the date to see the full blog

 

January 1 – 5 out of 10 of my resolutions were “kept”. You guess which ones.

January 15 – 6 reasons why patients are non-compliant , excuse me, “non-adherent”- the new PC term, with their medications.

February 1 – incidence of sudden death while watching the Super Bowl (Patriot fans probably don’t have to worry about that THIS year.)

February 15 – some myths revealed about cholesterol in your diet, global warming, measles vaccination rates, herbal supplements, and Dr. Oz, vendor of snake oil(s).

March 1 – 8 new causes of death caused by cigarette smoking added to the previously identified 12; a total of 20.

April 1 – Athena Health purchases MySpace which raises more concerns about privacy of health care data (April Fools edition).

April 15 – what does a “board certified physician” mean, and what does it have to do with Presidential candidates (Rand Paul)?

May 1 – physicians’ prognoses are often too optimistic for the same reasons patients’ are.

May 15 – E-cigarettes open new avenues for adolescent use of marijuana and synthetic cannabinoids (“bath salts”).

June 1 – annual review of sunscreens and bug repellents plus less universities providing student access to tanning booths.

June 15 – new forensic techniques of identifying individuals by bacterial, viral, and DNA “fingerprints”.

July 1 – 6 positive access outcomes and 4 positive health care delivery outcomes of Obamacare at 5 years of age.

July 15 – dangers of synthetic cannabinoids (attn: Chandler Jones?) and the minimal (“pending”) review of sunscreens by FDA.

August 1 – two websites with the best “symptom diagnosis” track record for helpfulness, and the one that is the worst.

August 15 – [ family vacation in a lighthouse without electricity or running water]
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September 1 – why new drugs cost so much, no “gay gene” identified yet, and the myths of low testosterone, chronic Lyme, and  8 glasses of water a day.

September 15 – The health benefits of our “microbiome” and the “microbiome” of the New York City subway.

October 1 – the misleading, untruthful attacks on Planned Parenthood.

October 15 – the scope and magnitude of adverse effects of dietary supplements.

November 1 – transgender, transsexual, transvestite, and hermaphrodite, oh my!

November 15 – toddlers shooting people and other “norms” of gun deaths – “By Degrees“.

December 1 – changing advice about what NOT to eat during the holidays.

December 15 – the benefits of research using fetal tissue, short history of political attacks on Planned Parenthood, and why if you are NOT fat and live a long life you should thank your parents.

HAPPY NEW YEAR


Vol. 139 January 1, 2016 HEROIN: Cape Cod, USA

January 1, 2016

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A HBO documentary shown on December 28, 2015

 As a pediatrician and a parent I found this moving documentary of eight white, middle class heroin addict kids from stable families on Cape Cod to be very disconcerting. It was brutally honest with several scenes of addicts preparing and injecting heroin. The repetitive, “almost-expected”, relapses after detox, and the seemingly casual acceptance of inevitable drug deaths of other addicts set a tone of hopelessness. The onset of addiction in half of these addicts followed standard treatment with opioids for post-accident or post-surgical pain. 30-day detox programs, despite their noble intent, were depicted as mostly fruitless in the long run, like spitting in the ocean. (None of the eight addicts appeared to be enrolled in a heroin-replacement program – Suboxone or methadone) The recognition by the addicts that their craving drove them into behavior they themselves detested confirmed that insight is not enough.

 One addict said that “one dose of heroin was all that was needed to get you addicted”, but NIH statistics suggest that 23% of first heroin users become addicts. Even so, those one-in-four odds are worse than the odds of Russian roulette with a six-shot revolver! One could consider appropriate opioid treatment for post-surgery pain as a “screening test” to find those one-in-four addicts!

For the past decade physicians have been told that the patient should direct pain control. “How bad is your pain on a scale of 1 to 10?” Hospitals and doctors were, and are still, graded on their ability to reduce patient-reported pain quickly. Many of us physicians remember the pain control conferences that basically told us “you are not giving enough”. Perhaps that mind set contributed to the current easy access to opioids.

The Massachusetts Medical Society just promulgated lengthy opioid therapy guidelines consisting of 11 statements for acute care and 16 statements for chronic treatment (over 60 days). The guidelines are sprinkled with words like “function and pain”, “quality of life”, “short-term trial”, “minimum dosage”, “partial-fill prescriptions”, “low-dose sequential prescription”, and “useful consultation with a specialist or a second opinion”. Treatment of cancer. hospice, palliative care, and hospital inpatients is exempt from the guidelines.

The simple patient pain scale of 1 to 10 has been trumped by 11-16 sentences. If you think that is an overstatement then consider these words in the new guidelines,  “The guidelines will provide valuable guidance to physicians [mostly primary care] in their practices and as evidence of best practices and to the Board [of Registration in Medicine] in its responses to patient complaints, accusations of substandard care, or accusation of inappropriate prescribing.” [emphasis added].

The multiple pathways to addiction, its frequent appearance in several members of a family, and on functional MRIs similar active areas of the brain common to all types of addicts suggest a genetic basis of addiction. If that is true, than the cure for heroin addiction in the long run will depend on identification of the responsible genes and the development of drugs that will block or modify those specific genes.

In the short run, maybe we can do more in the U.S. to reduce the harms of addiction; overdose deaths, infectious diseases, and criminal behavior. One mother in the parents’ group eloquently summed up the need to “destigmatize” heroin addiction. ( “No one sent me casseroles when my son died of an overdose.”) To “destigmatize” addiction we will need to “decriminalize” it and treat it as a medical condition. Other countries (Switzerland 1994, Portugal 2000, Vancouver B.C. 2003, Netherlands 2009, Germany 2009, and U.K. 2009) have done that with both “heroin-replacement” and “heroin-assisted” treatment programs. Those programs have resulted in a reduction of overdose deaths and AIDS/Hep C infections WITHOUT increasing drug use.

According to the Boston Globe the “supervised injection site” in Vancouver (called “Insite”) has been shown by 30 peer-reviewed studies to have “saved thousands of lives, saved millions of dollars in both health care and public safety costs, reduced transmission of AIDS and hepatitis C, and promoted entrance into treatment without increasing drug use or drug-related crime”. (1) The Cato Institute studied the results of the successful Portugal program in 2009 and confirmed the same positive results. Critics remarked that such a model would not work in the U.S. because of our size, heterogeneity, and politics.

Isn’t that a shame?

References:
1. Boston Globe, December 27, 2015, K5, “Massachusetts needs safe injection sites”


Vol. 134 October 15, 2015 Supplements Are Not Harmless.

October 16, 2015

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“The belief is that they [dietary supplements] are entirely safe,
but now science says that they’re not.”
– Pieter Cohen, MD, Harvard Medical School

A recent study of 63 hospitals from 2004 to 2013 estimated that over 20,000 ER visits and 2000 hospital admissions annually in the U.S. were due to adverse effects of dietary supplements. Adverse events included allergic reactions, excess doses, unsupervised ingestion by children, or other events (e.g., choking). Cases involving death, intentional self-harm, drug abuse, or withdrawal were excluded.  Adverse effects commonly involved cardiovascular adverse effects from weight-loss or energy herbal products among young adults, unsupervised ingestion of micronutrients (iron) by children, and swallowing problems associated with micronutrients (multi-vitamins) among older adults. (1)

The supplements listed included orally administered herbal products (Echinacea, Coenzyme Q10, Gripe Water, etc.), complementary nutritional products (fish oil, body building protein , chondroitin/glucosamine, etc), vitamins and minerals (including calcium and iron), and topically administered herbal or homeopathic products. Energy drinks and herbal tea beverages were excluded from the study.

In the U.S. there were more than 55,000 dietary supplements on the market in 2012, and about half of all adults reported having used at least one dietary supplement in the past month. 150 million people in the U.S. take supplements, including children’s vitamins. In 2007, out-of-pocket expenditures for herbal or complementary nutritional products reached $14.8 billion, which equaled one-third of the total out-of-pocket expenditures for prescription drugs.

  • Weight loss supplements or herbal energy products led the list of supplements with adverse effects in this study.
  • More than half of emergency department visits for supplement-related adverse events involved female patients.
  • Sexual-enhancement products or bodybuilding products were implicated in 14% of emergency department visits for supplement-related adverse events among male patients; there were too few cases among female patients to calculate a reliable estimate.
  • 20% of ER visits involved children who took supplements without supervision.
  • Most ER visits for unsupervised ingestion of supplements by children involved multivitamins (34%), iron (12%), supplements for weight loss (11%), and supplements for sleep, sedation, or anxiety (9%). Child-resistant packaging is not required for dietary supplements other than those containing iron (the amount of iron in the usual bottle can be lethal to small children) , but despite such packaging, iron supplements were the second most commonly implicated type of supplement in unsupervised ingestion by children.

Although the numbers of ER visits and hospitalizations were less than the 5% of the ER visits that have been reported for pharmaceutical products, dietary supplements are unregulated and marketed under the presumption of safety. The FDA is actually BARRED from regulating dietary supplements by the Dietary Supplement Health and Education Act of 1994. (Wouldn’t you like to know the history of that particular bill, or at least, the lobbyists involved?)

When you or someone you know has a good effect from a supplement (like taking glucosamine for knee pain) it natural to think that anyone with knee pain should take it, and that every physician should know about this “miracle supplement”. In medicine that kind of anecdote is called a “case report”.  Case reports can lead to studies of a large number of people, called “statistical studies”. Results of those studies can be persuasive, but the truly scientifically skeptical physician will wait for the results of an organized, randomized, double-blind study with controls (people who don’t get the supplement). Such organized, controlled studies have not found a whole lot of benefit, if any, from taking dietary supplements, especially vitamins, but that is the subject for another whole blog… or two.

References;

1. Emergency Department Visits for Adverse Events Related to Dietary Supplements
Andrew I. Geller, M.D., et al, N Engl J Med 2015; 373: 1531-1540; October 15, 2015


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. 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.


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