AAPS News October 2017 – Drugged America
Volume 73, no. 10 October 2017

https://aapsonline.org/aaps-news-october-2017-drugged-america/ 

Worse than the AIDS epidemic at its peak. Fatalities nearly double the global terrorism death toll. The “U.S. heroin crisis is so bad it’s raining ‘needles’.” In March 2017 alone, San Francisco collected 13,000 discarded syringes, compared with 2,900 in March 2016 (http://tinyurl.com/y8d8hy6a).

Annual opioid overdose deaths nearly tripled from 1999 (8,048) to 2011 (22,784) (JAMA 8/1/17). In 2016, there were 60,000 overdose deaths, according to Attorney General Jeff Sessions. He did not break it down by drug. This is almost as many American deaths as in 12 years of the Vietnam War, writes Edwin Mora. Coroners are experiencing personnel shortages and equipment failures across the U.S. (http://tinyurl.com/y7s9b969).

Blame the Doctor

Previous dogma was that the gateway drug was marijuana; therefore, cannabis had to be banned for all purposes, without consideration of its own safety profile. Where is the outcry about current legalization in a number of states? In rural Oregon, some wonder whether one can get a “second-hand high” because of the pervasive odor of maturing marijuana plants. It is now suggested that medical cannabis might actually mitigate the opioid crisis (http://tinyurl.com/y77f4u88).

The new gateway drugs are prescribed. According to CNN’s chief medical correspondent Dr. Sanjay Gupta, “today’s typical heroin addict…was likely unwittingly led to heroin through painkillers prescribed by his or her doctor” (http://tinyurl.com/kkt4y8s).

Nearly 92 million U.S. adults, about 38% of the population, took a prescribed opioid in 2015. The rate of prescribing has quadrupled since 1999, and so has the number of opioid overdose deaths—although the former is decreasing, and the latter continues to rise. More than 50% of those who misuse opioids got the drugs from friends or relatives (http://tinyurl.com/ycp7zhvy).

According to Dr. Jack Ende, president of the American College of Physicians (ACP), the broken system has its roots in the belief that pain should be treated as the “fifth vital sign” (ibid.). The Joint Commission denies responsibility, and notes that pain management experts, in response to growing concerns about the undertreatment of chronic pain, allayed concerns about opioid use for non-malignant pain (http://tinyurl.com/y8bj25mc).

The pharmaceutical industry also gets blamed, despite its influence on Congress. For example, Opana (oxymorphone hydrochloride extended release) is being withdrawn from the market because illegal use by injection was linked to an outbreak of human immunodeficiency virus (HIV) and hepatitis C. The manufacturer will eliminate 875 jobs (WSJ 7/21/17). Will someone benefit from loss of a competitor?

Physicians for Responsible Opioid Prescribing and other groups are petitioning the Food and Drug Administration (FDA) to ban opioid pills that, when taken as directed, would add up to a daily dose of more than 90 mg of morphine (http://tinyurl.com/y6wphg96).

The “most promising” approaches are said to be: careful selection of patients for opioid therapy; reduced diversion of prescribed drugs; taking back leftover supplies; more research on pain and nonopioid treatment; increased availability of naloxone; and better access to “effective drug treatment for OUD [opioid use disorder]. (JAMA, op.cit.). The American Medical Association’s End the Opioid Epidemic Task includes these recommendations, plus “putting an end to stigma.”

The use of the tern “abuser” leads to cognitive bias, writes Professor John Kelly of Harvard, creator of the “Addiction-ary,” which contains “stigma alerts” (http://tinyurl.com/ycfc7bbb).

Stigmatization (and imprisonment) of physicians who prescribe opioids for pain continues. And every state now has a prescription drug monitoring program (PDMP) for tracking opioids and hundreds of other controlled substances prescribed by physicians. Some PDMPs issue quarterly report cards, grading physicians as normal, outlier, or extreme outlier. While the ability to check a patient’s drug history may be helpful, more than 16 states require a physician to check the PDMP before writing a prescription for any controlled substance for any patient. But there has been no decrease in overdose deaths from prescribed drugs, writes Dr. Jeffrey Singer, while PDMPs “may be related to increased mortality from illicit drugs” (http://tinyurl.com/y76a4wd7).

The Heroin Gap

Heroin alone was responsible for one-quarter of the overdose deaths in 2015 (Mora, op. cit.). The full contribution of illicit drugs to total mortality is not known and may be greatly underestimated. Street heroin has become cheaper than OxyContin. Black marketeers are frequently blending it with fentanyl, a highly potent synthetic heroin.

While reporting that drug overdose has become the “leading cause of death in Americans under 50” (http://tinyurl.com/y9x3ubqw), states a retired law enforcement officer who prefers to be anonymous, the NY Times “will not inform the readers of where the poison comes from”—a transnational criminal organization that could not flourish without political protection. He notes that Mayor Bloomberg of NYC was decrying trans fats and excess sugar while schoolchildren were injecting heroin mixed with OTC cough syrup (“Cheese”). Anything less than full investigation of the facts is simply providing cover for organized crime.

Opioid Facts and Figures

Labor force participation rate dropped to a 40-year low of 62.4% in 2015. The decrease began in 1999, at about the same time as the increase in opioid deaths. Nearly half the prime-age men not in the labor force are on opioid painkillers (http://tinyurl.com/ybol2hme).
A lethal dose of fentanyl can be as low as 2–3 mg. It may be incorporated in hundreds of thousands of doses of counterfeit pills that look like oxycodone, Adderall, or Xanax, and sold over the internet. Most is produced in China. The largest seizure to date of 63.8 kg powdered fentanyl plus 30,000 tablets, with a street value of $1.2 billion, was found in a tractor-trailer rig at a checkpoint near Yuma, Ariz. (http://tinyurl.com/yaldw4bk).
In Berkeley County, W.V., two-thirds of the emergency medication budget is spent on Narcan. In the county seat of Martinsburg, population about 18,000, emergency personnel responded to calls about 145 overdoses, 18 of them fatal, between January and April this year (New Yorker 6/5-12/17, http://tinyurl.com/ybn53aut).
In an overdose death, the average number of drugs identified is six. But if a prescription opioid is detected, the case is signed out as a “prescription opioid death” (http://tinyurl.com/ybfjsoew).
Jeffrey Singer, M.D., cites a Cochrane analysis showing that less than 1% of well-screened pain patients become addicted to opioids, and a study showing that the risk of overdose in non-cancer patients treated chronically with opioids is less than 0.2% (http://tinyurl.com/y76uw28q).

Drug Networks

It’s not just a border problem: More than 1,000 U.S. cities have been infiltrated by at least one of four Mexican drug cartels. A retired law enforcement officer suggests superimposing the map (http://tinyurl.com/7vlnmxp) on that of U.S. sanctuary cities. There were more than 50,000 drug-related slayings in Mexico between 2006 and 2012. A number of journalists and Mexican mayors have been assassinated.

While many drugs cross the southern border, a wall will not stop those that are hidden in vehicles, and many come by boat or air—as via human couriers on commercial flights into Newark (http://tinyurl.com/y74ntkp3).

The money may get back to the source after being laundered through legitimate-appearing businesses in upscale settings—a bank, a cellphone distributor, a car dealership, etc. Suburban export businesses in Doral, Florida, transferred millions of dollars in operations that went on for years, despite penetration by undercover agents who stashed tens of thousands of dollars in cash in places like a police trailer (http://tinyurl.com/yd36yn7q).

On the permanence of government programs such as SCHIP and ACA, “our politicians subscribe to the rules of the ancient Persian government described in the book of Esther (9:8): ‘For a writ that is written in the name of the king and sealed with the king’s ring cannot be rescinded.’”

Daniel Horowitz, http://tinyurl.com/ybvj8szs

Other Beneficiaries of the Opioid Epidemic

The U.S. spends about $12 billion annually on substance abuse treatment (http://tinyurl.com/ydyd7pum), with 30-day inpatient programs often costing $20,000. The trendy new approach is medication-assisted treatment (MAT), with Rhode Island becoming the first state system to offer it to all prison inmates (http://tinyurl.com/ybkcyvlf). The three approved therapies are methadone and buprenorphine (often called Suboxone) and Vivitrol, an injectable that blocks opioid effects (cost: around $1,000/month). Currently, doctors licensed to prescribe Suboxone are limited to treating 275 patients per year, increased from 100 in 2016—the only medication with such a restriction. More federal money for opioid treatment is sought (http://tinyurl.com/hd7y436).

Suboxone is also abused; some was smuggled into a prison in a Bible, disguised as yellow highlighting (http://tinyurl.com/ybjetuv9).

The success rate of the drug treatment industry is abysmal. Only 20% of patients are still sober after one month of conventional therapy, and up to 98% have relapsed by one year.

A sobriety-centric, primary-care approach called the Massachusetts Plan, pioneered by Dr. Punyamurtula Kishore, was achieving a one-year success rate of 37% to 60%, benefiting some 250,000 patients in 52 clinics. Then the Massachusetts attorney general shut it down by prosecuting Dr. Kishore (see p. 3).

The method stresses home detoxification under the guidance of primary physicians, followed by “sobriety enhancement” with community-based support, including jobs, hobbies, and spiritual guidance. In 2015, the Yale School of Medicine started a pilot program that is virtually a carbon copy of the plan (Chalcedon, http://tinyurl.com/ycxadrxh). After spending 8 months in prison, Dr. Kishore provides education through the National Library of Health and Healing in Waldoboro, Maine, although he was forced to surrender his medical license and can provide no medical diagnosis or treatment (http://tinyurl.com/y9njydqk). The failed conventional method remains the “standard of care.”

Depression Relief in the Elderly

At the beginning of a 6-week, nonacademic study, a group of 11 residents of a retirement community in Bristol, England, all in their late 80s, were nearly all identified as depressed, two of them severely. At the end of the study, none were depressed, and there were significant improvements in other metrics; 80% improved their “timed up and go” score. The treatment: a timetable of activities involving interactions with 10 children, age four.

“Children are open-minded. They love attention and take an interest in adults,” write Melrose Stewart and Malcolm Johnson (http://tinyurl.com/ydy5683b).

AAPS Calendar

Oct 5-7. 74th annual meeting, Tucson, AZ.

Oct. 3-6, 2018. 75th annual meeting, Indianapolis, IN.

A Model Prosecution

The prosecution of Dr. Punyamurtula Kishore used the tactics described in Harvey Silvergate’s book Three Felonies a Day, according to a 16-part series by Chalcedon (op. cit.).

The accusations centered around the fact that Dr. Kishore allegedly ordered too many urine screenings from laboratories he owned. Frequent drug screens, up to three times weekly at $100–$200 each, were an important part of his protocol. He was accused of defrauding Medicaid through a scheme so “convoluted” that it was very difficult to figure out what law he may have violated. Regulators that had previously scrutinized his business practices “to the nth degree” concluded that he was correctly following “safe harbor” rules in his laboratory.

Dr. Kishore was at first determined to fight to prove his innocence, but the prosecution piled on 80 charges. Losing on a single one would have meant 5 years in prison and deportation. After spending nearly $2 million on lawyers, he was destitute and relying on friends to pay for gasoline. The court was forcing his lawyers to work without compensation, but he had good reason to think their representation was inadequate. They called no expert witnesses and failed to subpoena prosecution witnesses for cross-examination. The government turned up the pressure on his family, as by auditing his wife’s very simple medical practice. Ultimately, he pled guilty to a single charge of larceny of more than $250. Such plea bargains require the defendant to “agree” to the government’s statement of the “facts,” and to give up the right to appeal. He spent 8 months in prison and faces 10 years probation.

The prosecution portrayed him in the press as a demon. The $4.9 million his practice collected annually from Medicaid was allegedly victimizing the state’s “most vulnerable” patients, even though his success rate was at least 750% higher than the state’s big-name programs. The state has deprived Dr. Kishore of the right to defend himself, but patients he saved years ago have mounted a rearguard action; the last chapter is not yet written.

Meanwhile, Medicaid provides “free” access to prescription drugs. In 2015, the seven states with the highest drug overdose death rates were all Medicaid expansion states. Rather than helping to fix the overdose problem, government programs may be fueling it (http://tinyurl.com/y8o75p82). Medicare Part D has become the largest payer for opioids; it now covers 20%-30% of their cost, paying more for these drugs for enrollees under 65 than Medicaid or other insurance (http://tinyurl.com/y7g8fktg).

The Medicaid and CHIP Payment and Access Commission (MACPAC) (http://tinyurl.com/ycov74je) reports that Medicaid enrollees in New York were prescribed painkillers at twice the rate of non-Medicaid enrollees; in 2012, Medicaid paid more than 34 million claims for opioids (>$500 million, fee-for-service only), and one-third of opioid prescriptions were for a month’s supply.

No Right to Medical Aid in Dying

The New York Court of Appeals, which is the supreme court of that state, ruled in Myers v. Schneiderman (2017 NY Slip Op 06412) that the state constitution’s Due Process clause does not encompass a fundamental right to medical aid-in-dying (physician-assisted suicide), and statutes that prosecute physicians who provide lethal prescriptions are not unconstitutional. This prohibition, the court held, is rationally related to legitimate state interests.

Brain-Dead Girl May Be Alive, Judge Rules

After suffering complications from a routine tonsillectomy in 2013, Jahi McMath was declared brain dead. Refusing to accept the doctors’ conclusion, the family got her moved from California to New Jersey, where she has been on life support. Starting in 2014, the family reported that she sometimes seemed to respond to commands. At this point, she no longer meets the criteria for brain death, testified Dr. Alan Shewmon, but appears to be in a “minimally conscious state.” Now that a California judge has ruled that she may not meet the technical criteria for brain death (a jury must decide), her malpractice case might be allowed to proceed. In California, damages for wrongful death are capped at $250,000. If the patient is alive, her family may be able to recover the costs of treatment. Since being declared brain dead, the patient has gone through puberty (http://tinyurl.com/ybbrv5vr).

Prior Restraint on Speech Challenged

Undercover recordings by David Daleiden of the Center for Medical Progress, of conversations about the sale of aborted baby parts at the National Abortion Federation’s annual trade show, are the subject of an unprecedented gag order by San Francisco Judge William Orrick III. Daleiden and CMP are petitioning the U.S. Supreme Court for writ of certiotari.

“Here, the lower federal courts imposed a prior restraint that is breathtakingly broad in scope, preventing communication with state and local law enforcement,” writes attorney Andrew Schlafly in an amicus brief filed on behalf of the Legal Center for Defense of Life. “The First Amendment would mean little if federal courts are permitted to censor politically related speech in unpublished opinions,… and then dodge full review by this Court.”

CPSO Threatens Conscientious Objectors

A 2015 policy by the College of Physicians and Surgeons of Ontario (CPSO) states that it may suspend or sanction a physician who will not participate in assisted suicide, and it is aggressively defending that position against a court challenge.

The college is arguing that doctors are obliged to provide access to all legal “medical services,” regardless of their personal beliefs. “Is it not one of our fundamental precepts in medicine to not abandon our patients?” CPSO president Dr. Dave Roussell asked, adding that a patient “should just be able to ask for a service.” Physicians must provide an “effective referral” for abortion or euthanasia, or “perform the act itself in emergency situations.”

Some argue that “doctors’ colleges may face interventions from human rights commissions if they fail to adopt this policy.”

A court decision may take 6 months. Meanwhile, doctors are subject to CPSO policy (http://tinyurl.com/yackalsa).

Marranos in the U.S.?

In medieval Spain and Portugal, especially during the Spanish Inquisition, Jews who secretly maintained their Judaism while living in public as Catholics were called marranos. Millions of Americans, suggests Dennis Prager, may be hiding their conservative or pro-Trump views because they fear ostracism and inability to practice their profession (http://tinyurl.com/ybd8jskc).

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