Legal challenge filed against DEA’s new marijuana extract rule

Legal challenge filed against DEA’s new marijuana extract rule

www.thecannabist.co/2017/01/13/hemp-dea-extracts-marijuana-cbd-judicial-review/71387/

The hemp industry has taken the DEA to court in the wake of a controversial new rule on marijuana extracts.

Denver’s Hoban Law Group, representing the Hemp Industries Association, Centuria Natural Foods and RMH Holdings LLC, on Friday filed a judicial review action against the U.S. Drug Enforcement Administration, alleging the agency overstepped its bounds when enacting a rule establishing coding for marijuana derivatives such as cannabidiol (CBD) oil. The action, Hoban attorneys allege, puts at risk a booming cannabis and hemp industry and a wide variety of hemp-based products currently on the market.

“We’re talking about jobs and the economy and agricultural (revival),” attorney Bob Hoban said in an interview with The Cannabist on Friday.

The DEA last month confounded many in the cannabis industry with the filing of a final rule notice establishing a Controlled Substances Code Number for “marihuana extract,” and subsequently maintaining marijuana, hemp and their derivatives as Schedule I substances.

DEA officials said the code number would assist in the tracking of materials for research and would aid in complying with treaty provisions. However, compliance attorney Hoban and others expressed concern at the time that the language could result in federal agencies viewing products produced from marijuana and hemp as illegal.

Hoban’s petition seeks a judicial review of the final rule on the basis that the action was inconsistent with the law — including the U.S. Controlled Substances Act and the Agricultural Act of 2014, or the Farm Bill — and effectively amounts to a scheduling action.

A scheduling action, Hoban said, would need congressional approval.

According to the lawsuit:

“Additionally, the final rule creates this new drug code, indicative of being a controlled substance, for substances which are in fact not controlled pursuant to the (Controlled Substances Act),” Hoban attorneys wrote in the lawsuit. “Specifically, the final rule dictates that the mere presence of ‘cannabinoids,’ which are not controlled substances, is the determinative factor of whether a compound is a ‘marihuana extract.’

“Further, the final rule overbroadly defines ‘marihuana extract,’ without reflecting that certain portions and varieties of the genus Cannabis sativa L. are congressionally exempted from the CSA and/or are exempted from being treated as controlled substances altogether pursuant to the relevant laws, as enacted by Congress.”

Hoban said Friday that his firm also intends to file an administrative petition next week with the DEA, formally requesting the administration to rescind the definition.

“(The new rule) certainly has caused quite a chill in the marketplace over the last three or four weeks,” Hoban said, adding that he’s heard from producers who have had trouble keeping their products on e-commerce or retailer platforms. “The number of calls we get on a daily basis, you couldn’t even quantify. … That is indicative to me of an environment where people are scared, they’re nervous.”

Hoban said he does not expect a spike in enforcement — especially as long as spending bill provisions stay in place — but he encouraged producers to maintain strict processes and to conduct an audit of their businesses to ensure that they are in compliance with state and federal regulations.

DEA spokesman Russ Baer said he could not comment on a petition that he has not yet seen.

Earlier Friday, Baer addressed the agency’s positions on CBDs, marijuana and hemp extracts in an e-mail:

CBD oil and other extracts derived from cannabis (which includes hemp) have been and will continue to be Schedule I controlled substances, unless and until they are determined to have a current accepted medical use. We need conclusive scientific evidence to make these determinations and the lack of evidence regarding the efficacy of cannabis is impressive. To handle any controlled substance, an entity or individual must be a DEA registrant to be authorized to conduct research with the particular controlled substance.

Under U.S. law (the CSA), the definition of marijuana includes all parts the cannabis plant that are the source of cannabinoids. The CSA definition of marijuana also includes “every compound, manufacture, salt, derivative, mixture, or preparation” of such parts of the cannabis plant – and CBD produced from the cannabis plant clearly falls within this category. Thus, CBD, being a derivative of marijuana, is marijuana under U.S. law (and hemp is marijuana). Accordingly, because marijuana is a schedule I controlled substance under the CSA (as set forth in 21 U.S.C. § 812(c), Schedule I(c)(10)), CBD is a schedule I controlled substance under the CSA.

And as for hemp, specifically:

The Farm Bill did not remove industrial hemp from the list of controlled substances and, with certain limited exceptions, the requirements of the Federal Food, Drug, and Cosmetic Act and the CSA continue to apply to industrial hemp-related activities, nor did it change the requirements of the CSA that apply to the manufacture, distribution, and dispensing of drug products containing controlled substances.

DEA cannot provide an exhaustive list of “hemp” products that are exempted from control. Nonetheless, in order to provide clarity to your question, the following are some of the more common “hemp” products that are exempted (non-controlled), provided they are not used, or intended for use, for human consumption: paper, rope, and clothing made from fiber derived from cannabis stalks, industrial solvents made with oil from cannabis seeds, and bird seed containing sterilized cannabis seed mixed with seeds from other plants (or other ingredients not derived from the cannabis plant). Personal care products (such as lotions and shampoos) made with oil from cannabis seeds are also generally exempted.

Baer previously said that the new rule on extracts does not change the DEA’s enforcement priorities.

John Hudak, deputy director of the Center for Effective Public Management and a senior fellow at the Brookings Institution, said earlier this week that the extracts rule was not a change in policy but rather “a clarification for an industry that for a long time has misinterpreted policy.”

The biggest challenge is that marijuana laws have become a “telephone game” in which rumors, guesses or ideas are translated from one person to another to the point where they’re viewed as facts, he said.

As Baer stated Friday: “DEA has consistently opined that marijuana and its constituent parts or derivatives, including CBD and hemp, are Schedule I controlled substances – so these determinations are deeply rooted in the CSA and not new.”

And that was the case with extracts.

Products such as CBD oil were regarded as not subject to the same control requirements as marijuana and extracts could cross state lines and international waters without issue.

“The government was aware of this and issued (the final rule notice),” Hudak said, adding that officials effectively conveyed, “‘Listen, you have misinterpreted our laws regarding CBD and you have one month to become compliant.”

 

 

Medical Marijuana Facing Prejudice and Unnecessary Restrictions in its Way to Save Lives

Medical Marijuana Facing Prejudice and Unnecessary Restrictions in its Way to Save Lives

http://www.latinoshealth.com/articles/23254/20170116/medical-marijuana-facing-prejudice-and-unnecessary-restrictions-in-its-way-to-save-lives.htm

Cannabis is under strict regulations of DEA and prejudice from NIDA despite eighteen states issuing permission to medical cannabis. Scientists are facing numerous difficulties in carrying researches to find out the potential benefits of the drug. Other restricted compounds like MDMA, psilocybin or LSD are more easily available for further researches as DEA has allowed growing them or creating them in the lab.

Marijuana’s unrevealed valuable components that can be used in life-saving drugs are still out of reach of man. The pot is available for recreational uses and the public is having no big deal in obtaining it, reports Popular Science.

Treating illness by cannabis is just a few steps away if the schedule 1 study is reclassified. With an easy access to marijuana, the studies can be expanded and more data can be gathered in a short time. Now when marijuana is more widely accepted, the 16 member committee releases a report with recommendations to a smooth supply of cannabis for research purposes.

Since marijuana is classified as a medicine, then its study as a helpful medicine must be much wider, said pharmacologist Karen Wright of Lancaster University in England. There are more questions than answers about the mental and physical influences of cannabis on the health. The little data that is available about the drug has strong indications that the potential of marijuana to treat ailments and sickness is much higher than expected.

Cannabinoids is proved to be effective for the treatment of chronic pains, chemotherapy-induced nausea and vomiting in adults, reports Science News. A lot of essential investment on marijuana remains illegal because the drug is a linchpin in the War on Drugs, comments Brad Burge, the director of communications for the Multidisciplinary Association of Psychedelic Research (MAPS).

National Institute on Drug Abuse has taken a biased stance towards cannabis. It allows the growth of cannabis and researches on the drug only to prove its negative effects in order to control the substance and prohibit drug abuse but it is not interested to help establishing cannabis as a medicine drug.

Could Indiana’s SB 74 could it be a basis of a prescriber “WITCH HUNT ” ?

New death certificate proposal could change how law enforcement combats drug epidemic

http://wsbt.com/news/local/new-death-certificate-proposal-could-change-how-law-enforcement-combats-drug-epidemic

It has been reported that the DEA only seizes 4% of the drug cartels’ production. There has also been a study that stated that only 8.3% of those who OD’d had a legal prescription for the opiate that showed up in toxicology and another study that stated that only 1.3% of addiction started with a prescription. This proposed bill -IMO- looks like justification to do data mining of Indiana’a PMP (Inspect) to find pts that had opiates prescribed to them and go after the prescriber that gave them opiate. Will it really make any difference if toxicology shows up a whole array of various legal and illegal drugs and with such a cocktail how does the coroner determine if a single drug entity actually caused the death ?

Changes could be coming to death certificates in Indiana.

A new bill seeks to change the way deaths are listed in the hopes of keeping more people alive.

State Senator Jim Merritt’s proposal, SB 74, would require county coroners to declare what drug killed someone on their death certificate. He says the inconsistent tracking from county to county makes it difficult to fight the heroin epidemic.

Some counties already list which drugs are involved in the overdose death, including St. Joseph County, but many coroners in other counties will usually not list the drugs a person overdosed on.

Dave Wells is Commander of the St. Joseph County Drug Investigations Unit. They focus on violent drug trafficking, major drug distribution, and drug overdose death investigations. He supports this new bill.

“We need to know. We need to know what people are dying from,” says Wells. “That way we can allocate our resources if we’re seeing a lot of heroin with fentanyl, for example. How much of it is out there? How frequently are we seeing it? That helps us kind of direct our resources into where it’s coming from – what side of town possibly is it coming from.”

In St. Joseph County, they are already tracking specific drugs listed on death certificates.

“With the counties and jurisdictions that aren’t doing that – I would suggest that they get on that and start doing that,” urges Wells.

In Elkhart, County Coroner James Elliott says they typically do not list the specific drugs a person overdosed on. He says he and many other coroners do so to respect the family’s privacy.

“However, I can understand the need for that to be used to track these problems – because there is a serious problem, not only in this area – but all over the United States.”

Drug testing becomes very expensive.

The new proposal would require a coroner’s death investigation to include a comprehensive drug panel. Each costs anywhere from $250 to $1000 a piece.

In Elkhart County, they investigate 220-240 cases per year. That can add up fast.

“It sounds to me like they’re wanting every case that we investigate drug tested – and right now, we can’t afford that in Elkhart County,” says Elliott. “So there’s going to have to be some kind of funding coming from somewhere else if they want us to drug test every case we investigate.”

Many coroners, particularly in smaller, rural counties are concerned about how much this will cost.

If this bill becomes law, the state will reimburse funds to county coroners to cover those additional tests. Officials estimate this will cost Indiana up to a million dollars a year.

Some in law enforcement believe it is well worth the price tag.

Wells says, “If you’re going to fight something that is killing people – killing our kids – you’re going to have to spend money. If you’re going to do it adequately and do it properly.”

Elliott agrees about the severity of the drug epidemic and the importance of fighting it, but he says making the information public record is not the right solution for tracking.

“If it needs to be tracked – which it can become tracked and not become public – I think that’s probably the way to go in my opinion,” says Elliott.

The Indiana State Coroners Association supports the proposal and is working with Senator Merritt to address their concerns with the bill.

Jail officer loses job, charged with crimes over Tylenol pills

Jail officer loses job, charged with crimes over Tylenol pills

http://www.newslocker.com/en-us/region/oklahoma-city/jail-officer-loses-job-charged-with-crimes-over-tylenol-pills/view/

WALWORTH COUNTY, Wis. – For the past 12 years, Cheyne Count has been a jail officer for Walworth County.

However, that long-term job suddenly ended because of four Tylenol tablets.

“I don’t have any more of this story. It was over Tylenol,” Count told WISN.

Count was fired last May after being caught giving Tylenol to a work-release inmate who had a broken tooth. Count says he asked for the inmate to be sent to an emergency room, but that request was denied.

“I was there to provide safety and wellness to the inmates- that’s my job. I thought that’s what I was doing,” he said.

He was asked to resign and then charged with two felonies for encouraging a probation violation and disorderly conduct. Those were eventually reduced to misdemeanors.

Court documents show that jail supervisors thought the inmate was using the broken tooth as an excuse to go the same emergency room as his mother, who was also an inmate at the time.

Count says he was just trying to help someone he thought was in pain. Now, he is hoping the charges against him will be dropped.

 

SUGAR… the next CONTROLLED SUBSTANCE ?

In the Shopping Cart of a Food Stamp Household: Lots of Soda

www.nytimes.com/2017/01/13/well/eat/food-stamp-snap-soda.html

When some else pays “the bills” they believe that they can dictate on what items the “money” can be spent on. If anyone is paying attention..this is the same thing that a lot of pts with chronic health issues are running up against… with Medicare/Medicaid and Insurance companies.  Of course, none of these entities “EARN THE MONEY” that they are using to pay for products/services… their whole purpose is to RE-DISTRIBUTE the money that is given to them… via taxes or premiums.

What do households on food stamps buy at the grocery store?

The answer was largely a mystery until now. The United States Department of Agriculture, which oversees the $74 billion food stamp program called SNAP, has published a detailed report that provides a glimpse into the shopping cart of the typical household that receives food stamps.

The findings show that the No. 1 purchases by SNAP households are soft drinks, which accounted for 5 percent of the dollars they spent on food. The category of ‘sweetened beverages,’ which includes fruit juices, energy drinks and sweetened teas, accounted for almost 10 percent of the dollars they spent on food. “In this sense, SNAP is a multibillion-dollar taxpayer subsidy of the soda industry,” said Marion Nestle, a professor of nutrition, food studies and public health at New York University. “It’s pretty shocking.”

For years, dozens of cities, states and medical groups have urged changes to SNAP, or the Supplemental Nutrition Assistance Program, to help improve nutrition among the 43 million poorest Americans who receive food stamps. Specifically, they have called for restrictions so that food stamps cannot be used to buy junk food or sugary soft drinks.

But the food and beverage industries have spent millions opposing such measures, and the U.S.D.A. has denied every request, saying that selectively banning certain foods would be unfair to food stamp users and create too much red tape.

While the report, published recently, suggests that a disproportionate amount of food stamp money is going toward unhealthful foods, the U.S.D.A. said it was unfair to single out food stamp recipients for their soft drink consumption.

The report compared SNAP households and non-SNAP households. While those who used food stamps bought slightly more junk food and fewer vegetables, both SNAP and non-SNAP households bought ample amounts of sweetened drinks, candy, ice cream and potato chips. Among non-SNAP households, for example, soft drinks ranked second on the list of food purchases, behind milk.

“Sweetened beverages are a common purchase in all households across America,” Kevin Concannon, the U.S.D.A. under secretary for food, nutrition and consumer services, said in an interview. “This report raises a question for all households: Are we consuming too many sweetened beverages, period?”

The report was based on data from an unnamed, nationwide grocery chain, which provided the U.S.D.A. with monthly records of food items bought in 2011 by more than 26 million households, about three million of them food stamp recipients. The grocery chain identified and tracked SNAP households by their use of SNAP benefit cards at the checkout aisle. One limitation of the report was that it could not always distinguish when SNAP households used their benefits, other money or a combination of the two to pay for transactions.

Nonetheless, the report provides a striking look at the foods American households typically buy.

Across all households, the report found, “more money was spent on soft drinks than any other item” — a finding that reflects the fact that, while consumption of sugary drinks is lower today than it was a decade ago, the United States still consumes more sugary drinks than almost any other developed country, studies show.

The U.S.D.A. report found that milk, cheese, potato chips, beef, cold cereal and baked bread were among the top purchases for all households. It indicated that all Americans bought ample amounts of desserts, salty snacks, candy and other junk foods. But the SNAP households spent slightly less money on nutritious foods, including fruits and vegetables, beans, eggs, nuts and seeds.

Over all, the report found, SNAP households spent about 40 cents of every dollar at the grocery store on “basic items” like meat, fruits, vegetables, milk, eggs and bread. Another 40 cents of every dollar was spent on “cereal, prepared foods, dairy products, rice and beans.” Lastly, 20 cents of each dollar was spent on a broad category of junk foods that included “sweetened beverages, desserts, salty snacks, candy and sugar.”

SNAP households spent 9.3 percent of their grocery budgets on sweetened beverages alone, not including soft drinks. That was slightly higher than the 7.1 percent figure for households that do not receive food stamps.

Photo

 
A shopper in Secaucus, N.J., choosing from an array of colorful sodas lining the shelves of a major retailer. Credit Karsten Moran for The New York Times

The U.S.D.A. concluded that both food stamp recipients and other households generally made similar purchases.

But several public health experts said the findings were deeply troubling.

David Ludwig, the director of the New Balance Foundation Obesity Prevention Center at Boston Children’s Hospital, said the purpose of SNAP was to protect the health and well-being of the nation, not to ensure that poor households had ample access to sugary drinks.

“We have more evidence for the harms of sugary beverages than for any other category of food,” he said, “and yet it tops the list of reimbursed products in SNAP.”

Dr. Ludwig said other government programs had common-sense restrictions. The Special Supplemental Nutrition Program for Women, Infants and Children, better known as WIC, and the national school lunch program have strict nutrition standards. Medicare pays for necessary medical procedures but does not reimburse for ones it considers harmful, ineffective or unnecessary. SNAP, Dr. Ludwig said, should be structured similarly.

“No one is suggesting poor people can’t choose what they want to eat,” he said. “But we’re saying let’s not use government benefits to pay for foods that are demonstrably going to undermine public health.”

The federal government provides SNAP benefits to roughly 23 million households each month, many of them single-parent homes at or below the poverty line. The average household receives about $256 in monthly benefits. That means a household that spent 10 percent of its SNAP money on soda could buy at least 20 two-liter bottles of orange Crush soda at a Fine Fare supermarket in New York City, or about 50 cans of Sprite at a Walmart in Oakland, Calif.

Since 2004, a number of cities and states have sought to restrict sugary drinks from their SNAP programs, including Maine, Minnesota and New York City under Mayor Michael R. Bloomberg in 2011. But doing so requires permission from the U.S.D.A., and the agency has denied every official request.

Mr. Concannon at the U.S.D.A. said the agency had “intermittent dialogue” with municipalities across the country about prohibiting the purchase of sugary drinks through SNAP. But he said the agency would grant a state or city permission to do so only on the condition that it first conducted “a rigorous pilot study” and offered food stamp recipients the ability to opt out of the soda restrictions.

“We’d want rigorous evaluation to see what is the impact of such a policy,” he said.

PepsiCo lobbied the federal government to prevent restrictions on food stamp purchases in 2011, 2012 and 2013, according to the Center for Responsive Politics, a nonprofit that tracks money in politics. Coca-Cola, Kraft Foods and the sugar industry lobbied against a Florida bill in 2012 that would have banned using food stamps to buy soda and junk food. And in 2011, the Snack Food Association teamed up with beverage industry lobbyists and the National Confectioners Association, which represents candy companies, to defeat New York City’s proposed ban on using food stamps to buy sugar-sweetened beverages.

Mr. Concannon said the U.S.D.A., rather than restricting junk foods, had made incentive programs that encourage nutritious foods a priority. The federal farm bill that designates money for the SNAP program, for example, set aside $100 million for programs that increase the value of food stamps that are used to buy fruits and vegetables at retail stores or farmers’ markets.

“Our goal has been to nudge people in the right direction,” he said.

While there is evidence that people do buy more fruits and vegetables when given incentives, research suggests that banning sugary drinks would have a far more powerful impact on health.

In 2014, a group of Stanford researchers studied 19,000 SNAP participants and compared whether banning sugary drinks or incentivizing fruits and vegetables would affect obesity rates. The researchers found that the incentive program would not. But banning sugary drinks from SNAP, they said, “would be expected to significantly reduce obesity prevalence and Type 2 diabetes incidence, particularly among ages 18 to 65 and some racial and ethnic minorities.”

Michele Simon, a public health lawyer who published a critical 2012 report on the food stamp program, said the new report showed that the federal government was subsidizing many foods that its own dietary guidelines explicitly told Americans to consume less of.

“This is the first time we’ve had confirmation that this massive taxpayer program is promoting all the wrong kinds of foods,” she said. “I think we now have the data to back up the policy argument that this program needs to be improved.”

 

 

I’m a doctor who wants to treat addiction, but the rules won’t let me

I’m a doctor who wants to treat addiction, but the rules won’t let me

www.washingtonpost.com/national/health-science/im-a-doctor-who-wants-to-treat-addiction-but-the-rules-wont-let-me/2017/01/13/faaa6ee4-d2b0-11e6-9cb0-54ab630851e8_story.html

Mr. B undid his arm bandages and revealed two large, gaping wounds where he injected his heroin. He lay back in his hospital bed, looked up at the ceiling and said with a quivering voice, “I can’t inject into my veins anymore because they are all shot. I know I have a problem, Doctor. I’ve been trying to quit, but it’s so hard.”

Mr. B (I’m identifying him only by his initial to protect his privacy) had been using heroin for 20 years after originally being prescribed a common opioid, oxycodone, to treat his pain. He, like many others who had fallen victim to the opioid epidemic, was trying to quit, but methadone hadn’t worked for him. “It made me feel ill,” he said.

I knew of a medication that would treat his addiction and possibly save his life. It has been around for years, is simple to use and is safer than other options. Sadly, I can’t prescribe it. We need to fix this.

The drug’s name is buprenorphine, which was approved by the Food and Drug Administration in 2002. Once absorbed into the blood, buprenorphine targets the same receptor as opiates, partially blocking their effect and limiting the symptoms of withdrawal. Decreased respiratory drive, which can occur with other opioids and can lead to death in overdose, occurs at a very low rate with buprenorphine. As such, it has become the first-line treatment for opioid addiction, but many patients like Mr. B still have trouble getting access to the drug.

 Unfortunately, buprenorphine has been limited by regulations that significantly hinder the drug’s widespread acceptance. Any physician who wishes to prescribe buprenorphine has to take an eight-hour online training course. Physicians don’t have to be specially certified to prescribe other medications, and so most physicians aren’t even aware that such barriers exist. Unsurprisingly, 97 percent of physicians are not certified to prescribe buprenorphine.

Arbitrary rules handcuff the few physicians who can prescribe buprenorphine, capping the number of patients that each certified physician can treat. In 2000, federal legislation limited the number of patients undergoing buprenorphine treatment to 30 per physician in the first year, and 100 thereafter. In July, new legislative changes increased the cap to 275 patients. While this represents an improvement, it still limits access to crucial addiction treatment and prevents physicians from devoting their entire practice to opioid treatment. Because of these caps, some stable patients may be forced out of buprenorphine treatment prematurely to make room for a new patient with a more urgent need. Patients like Mr. B, finally able to admit that they have problems with addiction, may have nowhere to turn.

Buprenorphine has been singled out for regulation because it is the first addiction treatment that is safe enough to be prescribed at a regular doctor’s appointment. The United States has always placed strict rules on addiction treatment, partly because past addiction medications such as methadone could lead to overdose or illicit sale on the black market.

But buprenorphine is different. While buprenorphine can be sold illicitly, physicians can switch a patient-turned-seller to methadone, which is administered in specialized clinics to prevent such activity. Additionally, the risk of buprenorphine overdose is one-fourth that of methadone, as a 2009 study of 16,000 people in Australia demonstrated.

Even if I completed all necessary training to comply with federal regulation, I still wouldn’t be able to prescribe the drug. That’s because at the primary-care clinic where I work as a physician-in-training, none of the supervising doctors are certified to prescribe buprenorphine. I have been told that I shouldn’t become certified because “you don’t want to attract those patients to your practice.”

It’s true that many clinicians view patients with chronic pain and opioid addiction as some of the hardest to take care of. We often feel torn between treating real pain and prescribing opioids to feed an addiction that could end in death. This is frustrating because even with the best intentions, we are caught between pain on the one hand and overdose on the other. But this is a false dichotomy. Treating addiction with buprenorphine instead of with opioid painkillers may make these interactions less frustrating, as patients like Mr. B get the care they need.

This can and should be a positive feedback loop. If more doctors become familiar with addiction treatment, stigma will diminish and more physicians will feel comfortable prescribing buprenorphine. But to unleash the potential of well-meaning physicians in combating our nation’s opioid epidemic, the first step must be to remove the barriers to prescribing this medication.

Herein lies our nonsensical system: We physicians have little trouble prescribing opioids, the very drugs that get people addicted. But despite an epidemic where 91 Americans die every day of opioid use, we face arbitrary roadblocks to prescribing addiction treatment such as training sessions and caps on the number of patients who can receive lifesaving medications.

Mr. B was found to have a bacterial infection in his blood, an extremely dangerous condition. Even so, he left the hospital before he could complete a course of antibiotic treatment. He left, in part, because his opioid withdrawal symptoms were too disabling for him to deal with. He probably won’t be counted among those who die of an opioid overdose. But when his infection finally overtakes his body, it will be the lack of access to addiction treatment that truly is to blame.

SUICIDE is a CRIME.. UNLESS the bureaucracy approves it ?

Physician Aid in Dying Gains Acceptance in the U.S.

www.nytimes.com/2017/01/16/health/physician-aid-in-dying.html?ribbon-ad-idx=3&rref=health&module=ArrowsNav&contentCollection=Health&action=swipe&region=FixedRight&pgtype=article

Judith Katherine Dunning had been waiting anxiously for California to adopt legislation that would make it legal for her to end her life.

The cancer in her brain was progressing despite several rounds of treatment. At 68, she spent most of her day asleep and needed an aide to help with basic tasks.

More centrally, Ms. Dunning — who, poignantly, had worked as an oral historian in Berkeley, Calif. — was losing her ability to speak. Even before the End of Life Option Act became law, in October 2015, she had recorded a video expressing her desire to hasten her death.

The video, she hoped, would make her wishes clear, in case there were any doubts later on.

“She felt she had completed all the important tasks of her life,” recalled her physician, Dr. Michael Rabow, director of the symptom management service at the University of California, San Francisco. “When she could no longer communicate, life was no longer worth living.”

 In recent months, this option has become available to a growing number of Americans. Last June, aid-in-dying legislation took effect in California, the most populous state. In November, Colorado voters approved a ballot measure by nearly a two-thirds majority. The District of Columbia Council has passed a similar law, and the mayor quietly signed it last month.

Aid in dying was already legal in Washington, Vermont, Montana and Oregon. So even if the District of Columbia’s law is blocked, as a prominent Republican representative has threatened to do, the country has arrived at a remarkable moment: Close to 20 percent of Americans live in jurisdictions where adults can legally end their lives if they are terminally ill and meet eligibility requirements.

The laws, all based on the Death With Dignity Act Oregon adopted in 1997, allow physicians to write prescriptions for lethal drugs when patients qualify. The somewhat complicated procedure involves two oral requests and a written one, extensive discussions, and approval by two physicians. Patients must have the mental capacity to make medical decisions.

Photo

 
Credit David Plunkert

While that process took shape in Oregon two decades ago, the cultural and political context surrounding it has changed considerably. The states recently considering the issue differ from earlier adopters, and as opposition from some longtime adversaries has softened, new obstacles have arisen.

Historically, aid in dying has generated fierce resistance from the Catholic Church, from certain disability-rights activists, and from others who cite religious or moral objections. Even the terminology — aid in dying? assisted suicide? death with dignity? — creates controversy. But the concept has long drawn broad support in public opinion polls.

Polltakers at the University of Chicago have asked a representative national sample this question since 1977: “When a person has a disease that cannot be cured, do you think doctors should be allowed by law to end the patient’s life by some painless means if the patient and his family request it?”

The proportion of Americans responding affirmatively, always a substantial majority, has bounced between 66 and 69 percent for 15 years. But support was not evenly distributed: Such laws initially were enacted in states with predominantly white populations like Oregon, and to date the vast majority of patients who have used them are white.

“I hear people talk all the time about this being a rich white person’s issue,” said Donna Smith, legislative manager for the District of Columbia at the group Compassion and Choices, who is African-American. “Now, we have proof on the ground that that is not true.”

Indeed, aid in dying has expanded to more diverse locales. Non-Hispanic whites represent a minority of Californians. Colorado is more than 21 percent Latino. In the District of Columbia, nearly half of whose residents are African-American, five of six black council members voted in favor of the legislation.

State medical societies, once active foes of aid-in-dying initiatives, also have begun shifting their positions, citing deep divisions among their members. The California Medical Association, the Colorado Medical Society and the Medical Society of the District of Columbia all took officially neutral stances as legislators and voters debated, depriving opponents of influential allies. So has the state medical society in Maryland, where legislators plan to reintroduce a bill (the third attempt) this month.

The American Medical Association — an opponent since 1993 — has agreed to study whether it should also move to neutrality on physician-assisted death.

But even as the idea gains acceptance, passage of a bill or ballot measure does not always make aid in dying broadly available to those who want it. In addition to the safeguards the law requires, its practice can be balky — at least in the early stages.

State opt-out provisions allow any individual or institution to decline to provide prescriptions. In California, Catholic health care systems have opted out, predictably, but so have a number of others, including Vitas, the nation’s largest hospice chain.

Moreover, California hospitals and hospices can forbid their affiliated physicians to write the necessary prescriptions, even if they are acting privately. Some health systems with hundreds of doctors have done so. (Vermont, Colorado and the District of Columbia allow doctors to make individual decisions.)

“The shortage of participating providers has led to a lot of patient and family frustration,” said Dr. Laura Petrillo, palliative care physician at the San Francisco V.A. Medical Center, in an email.

“They had the expectation that it would be available and happen seamlessly once the law went into effect, and then find themselves needing to do a lot of legwork” to find doctors willing to prescribe lethal drugs and pharmacies to fill prescriptions, she said.

Sometimes, when patients have waited until late in their illnesses, they die before they can become eligible for assisted death. Or they become too physically or mentally incapacitated to take the drugs themselves, as legally required, even if they do qualify.

In areas where many providers opt out, very sick patients may have to travel long distances to use the law. And costs can also prove a barrier.

Some private insurers pay for the necessary doctors’ visits and drugs. In California, most do, said Matt Whitaker, state director of Compassion and Choices, the leading aid-in-dying advocacy group. But Congress has long prohibited the use of federal dollars for aid in dying, so Medicare and the Department of Veterans Affairs will not cover it. States like California and Oregon have agreed to cover the costs for Medicaid recipients; others do not.

Cost mattered less years ago, when a lethal dose of barbiturates ran a couple of hundred dollars. But in 2015, as California legislators introduced their bill, Valeant Pharmaceuticals acquired Seconal, the most commonly used aid-in-dying drug. The company, known (and condemned) for a similar strategy with other medications, spiked the price, a move Mr. Whitaker called “ethically and morally bankrupt.”

Now, patients whose insurers will not cover aid in dying face paying $3,000 to $4,000 for the drug. Valeant has denied the suggestion that it was exploiting the new law. As a result, physicians are turning to alternative — and less-well-understood — combinations of opioids and sedatives for those who cannot afford the standard medication.

Despite such obstacles and disappointments, an emboldened Compassion and Choices,, with a staff that has tripled since 2008 and an annual budget that has nearly quadrupled to $16.9 million — is eyeing its next targets. Over several years, its leaders think they can help legalize aid in dying in Maryland, Hawaii and New York.

Aid in dying, it should be noted, may be a vehemently debated issue, with campaigns that can involve thousands of participants and millions of dollars — but it ultimately has affected a tiny proportion of people.

The number of residents taking advantage of these laws in Oregon and Washington has climbed in the past two years. Still, after nearly 20 years in Oregon and eight in Washington, far fewer than 1 percent of annual deaths involve a lethal prescription. (Of those residents who do receive one, about a third do not use it.) It’s not the way most Americans choose to die, even when they have the legal option.

Yet the end of life care most people receive needs substantial improvement. While partisans fight over aid in dying, skeptics like Dr. Rabow note, the complicated and expensive measures that could improve end-of-life care for the great majority — overhauled medical education, better staffed and operated nursing homes, increased access to hospice and palliative care — go largely unaddressed.

Still, Ms. Dunning was Dr. Rabow’s longtime patient. When California’s act took effect, she began the process of requesting lethal medication. Her speech had slurred further, but not yet enough to render her unintelligible.

Dr. Rabow did not want to see her die, and he is no fan of the aid-in-dying movement. But Ms. Dunning had been clear, consistent and determined. He wrote the prescription.

“She was ready to have her life end, and no amount of support or medication or counseling would change the situation,” he said.

In September, she invited him to her home, where she planned to swallow the fatal slurry of barbiturates. On the appointed day, Dr. Rabow arrived to find “a house full of people who didn’t want her to end her life, but were there to support her and respect her well-considered decision.”

Over the course of the day, people said their goodbyes, then withdrew to leave Ms. Dunning with her closest relatives, her hospice nurse and her doctor. Her son mixed her Seconal solution and she swallowed it, no simple task for someone with advanced cancer.

She lost consciousness almost immediately and died several hours later.

“I wished she could have had a natural life span,” Dr. Rabow said. “And I would have made a different choice. But I was honored to be there to watch this very dignified woman live her life the way she wanted to.”

Medical culture encourages doctors to avoid admitting mistakes

Medical culture encourages doctors to avoid admitting mistakes

www.statnews.com/2017/01/13/medical-errors-doctors/

If you become the victim of a medical error, should you trust your doctor to be forthright about his or her role in the mistake? That could be a bad idea. An alarming new study says that most doctors would try to obscure their role in the mistake, and most wouldn’t even apologize.

The study, conducted by a national team of researchers, posed two hypothetical scenarios involving medical error to more than 300 primary care physicians and asked how they would react. The first scenario involved a delayed diagnosis of breast cancer; the second involved a delayed response to a patient’s symptoms due to a breakdown in the coordination of the patient’s care. Most (more than 70 percent) of the physicians surveyed said they would provide “only a limited or no apology, limited or no explanation, and limited or no information about the cause.” The report was published last fall in the journal BMJ Quality and Safety.

The researchers noted that the strongest predictors of disclosure were “perceived personal responsibility, perceived seriousness of the event and perceived value of patient-centered communication.” In other words, doctors decide whether a mistake is a big enough deal to reveal to their injured patients.

In reality, the factor that most influences doctors to hide or disclose medical errors should be clear to anyone who has spent much time in the profession: The culture of medicine frowns on admitting mistakes, usually on the pretense of fear of malpractice lawsuits.

But what’s really at risk are doctors’ egos and the preservation of a system that lets physicians avoid accountability by ignoring problems or shifting blame to “the system” or any culprit other than themselves.

The lengths to which some doctors will go to shirk their responsibility to be upfront about medical errors are astounding. I consulted with one patient who experienced this kind of blame-shifting firsthand.

After what was supposed to be a routine spinal fusion procedure, Natalie (not her real name) awoke in extreme pain. The neurosurgeon put her on steroids for pain relief. Two days later, a different neurosurgeon discovered in post-operative imaging that the surgeon who performed the procedure had put a screw inside Natalie’s spinal canal — far from where it should have been and a tiny distance from damaging her spinal cord.

The original surgeon’s explanation? “The screw migrated.” Buffalo and geese migrate. Medical screws placed properly and carefully into bone do not.

As patients, we are conditioned to assume that our doctors know best and always have our best interests in mind. When they refuse to own their mistakes, they betray that trust and foster an environment in which patient safety takes a backseat to doctors’ reputations.

The end result is a medical culture in which errors cause 250,000 deaths per year in the United States alone, making it the third leading cause of death, behind heart disease and cancer, according to research published last year by Dr. Marty Makary, a Johns Hopkins surgeon and outspoken patient safety advocate, and research fellow Michael Daniel.

What is a patient to do in this environment? The first thing is to be aware of your own predisposition to take everything your doctor says at face value. Listen closely and you may hear cause for more intense questioning.

You will likely never hear the terms negligence, error, mistake, or injury in a hospital. Instead, these harsh but truthful words and phrases are replaced with softer ones like accident, adverse event, or unfortunate outcome. If you hear any of these euphemisms, ask more questions or seek another opinion from a different doctor, preferably at a different facility.

Most doctors would never tell a flagrant lie. But in my experience as a neurosurgeon and as an attorney, too many of them resort to half-truths and glaring omissions when it comes to errors. Beware of passive language like “the patient experienced bleeding” rather than “I made a bad cut”; attributing an error to random chance or a nameless, faceless system; or trivialization of the consequences of the error by claiming something was “a blessing in disguise.”

When a serious preventable medical error occurs, the physician who made it always has the option to do the right thing and fully disclose what happened. He or she can make an honest apology, which must include accepting responsibility for the error. He or she can also explain what options are available for compensation. Anything less is a pseudo-apology at best and a cover-up at worst.

Lawrence Schlachter, MD, is a board-certified physician, a medical malpractice attorney, and the author of “Malpractice: A Neurosurgeon Reveals How Our Health-Care System Puts Patients at Risk” (Skyhorse Publishing, January 2017).

 

Is the DEA criminalizing CBD oil in crazy power grab?

 

Is the DEA criminalizing CBD oil in crazy power grab?

vimeo.com/199602046

 

What happens if kratom becomes illegal?

A Thai Malay Muslim drug user breaks up the kratom leaf into a pan to form part of a popular cheap narcotic drink called 4 x 100 on September 1, 2011i n Narwathiwat, southern Thailand. Photo by Paula Bronstein/Getty ImagesWhat happens if kratom becomes illegal?

BY PBS NewsHour  January 15, 2017 at 12:56 PM EST

The U.S. Drug Enforcement Administration (DEA) has received thousands of comments on whether it should make a psychoactive painkiller called kratom illegal because some say it could be key to battling the country’s opioid epidemic.

The DEA announced in August that it would list kratom, which is typically sold as a powder in capsules or for tea and can produce both a narcotic and a stimulant effect, as a Schedule 1 drug — along with heroin, LSD and ecstasy. Schedule 1 drugs are illegal because they have a “high potential for abuse” and there is no existing research that would make it acceptable for medical use. ”[With kratom] we’re basically running a huge unconsented medical experiment on the whole population.”

But some researchers studying kratom are pointing to several laboratory studies on mice that suggest it could help wean users off opioids – an overly prescribed, highly addictive class of drugs that killed 28,000 people in 2014. Other critics also say that making it illegal will only spur demand on the black market, instead of getting rid of it.

Responding to pushback, the DEA in October withdrew its decision and opened a public comment period. It garnered 23,000 comments and 140,000 petition signatures urging the government to keep it legal.

Mark Kleiman, Professor of Public Policy at New York University’s Marron Institute of Urban Management and at NYU Wagner, unpacked the debate for the PBS NewsHour Weekend.

What is kratom and where did it come from?

Kratom is the leaves of a plant native to Thailand. It’s a psychoactive drug. One of the things it does it have some of the same effects that opiates have — that is to say, it binds to the same receptor. So it is a pain reliever. It makes some people cheerful. Has some other effects that are like the effects of the opiates. People can get some pain relief from it and get some cheerfulness from it, but it seems to have a ceiling; they can’t keep taking more and more of it. We know that some people who use it for a while, when they stop using it, get withdrawal effects. Apparently not as strong as people tend to get from the opiates.

What can we say for sure?

We know very little about it. The problem that the DEA just faced was that if it’s not a controlled substance than it’s essentially a food substance, basically unregulated. Twenty years ago, Congress basically gave in to the nutraceutical industry and freed them from all of the restrictions that real pharmaceutical companies are under. So they’re not, in principle, allowed to make health claims, though they can imply them pretty strongly, but they can sell stuff that’s never been tested in humans in as much quantity as they want. And the Food and Drug Administration has to prove it’s harmful in order to get it off the market. While for a pharmaceutical drug, the sponsoring manufacturer has to prove it’s safe and effective before they can sell it.

So [with kratom] we’re basically running a huge unconsented medical experiment on the whole population.

You advise the state of Washington in aspects of its drug policy. What would you advise the DEA to do?

You’ve got two choices. You can schedule it, which has all the consequences you’d expect. You’ll probably get some illicit market in it. People [will] be using substitutes. Some of the people using kratom now will now go on to use the opiates because they don’t have their kratom. That’s not something you want. And you may be frustrating research into what could turn out to be a very beneficial drug, including for drug treatment.

READ NEXT: If DEA blocks kratom, promising research on opioid alternative may suffer

So do you want to ban it? Well, I’d be reluctant to ban it. But I’d like to put some kind of control on it. So what I’d say to the DEA is, ‘Let’s put on some lesser measure of control.’ And they would come back to me and say, ‘We don’t have that power.’ So either DEA can make it illegal and you go to jail for having it, or they can sit on their hands. They do not have a third option.

There’s no wiggle room?

The policy does not exist. So the Controlled Substances Act … desperately needs revision.

People make fun of DEA about cannabis all the time. They say, well you’ve got cannabis in schedule 1 with heroin? Seriously? And that misunderstands the way the law works. Because what the law says is, if a drug has abuse potential…

And if there is no proven or known medical benefit or treatment benefit…

Then it’s illegal, and it’s got to be in Schedule 1. Schedules 2 through 5 are for [drugs] with demonstrated medical benefit to a fairly high standard of demonstration. The DEA could have decided 30 years ago, ‘Lots of oncologists think that cannabis helps their patients with nausea. That’s accepted medical use. We’re going to treat it as accepted medical use.’ But they decided the other way, so that’s the current definition of the law that the courts have upheld. And that leaves no place in the law for a drug of moderate abuse potential and no [proven] medical use.

Now all we need is Congress to rewrite the Controlled Substances Act to allow room for drugs that have moderate abuse potential and no accepted use, and drugs that may have medical use but it hasn’t been proven yet.

The current act does not give us a good way to deal with drugs [like] kratom, of which there are many. Congress could also pass a law creating a class of drugs that can be sold only behind the counter. If such a category existed and the kratom question came along, I think my advice to DEA is, ‘Let’s put it behind the counter while we find out whether it’s a big problem or not.’

If the DEA decides to schedule it, what are the consequences for people who use it?

It’ll become more expensive; it’ll become less available. People will counterfeit it. People will adulterate it. People will get arrested for using it. People who can’t get it will move on to other drugs.

The problem is, let’s imagine that you decided that kratom has medical value, and you’d like to set up a company to do that medical research and, once it’s approved, sell it. You can’t even start using it in humans experimentally until you’ve run a lot of mice through it. So that’s a few million dollars’ worth of work and a couple years at least. Then if you’re lucky you’ll be able to start phase 1 human trials just to see if it’s safe. Then if that works then you get to start to phase 2, small-scale studies to see if it’s effective in various populations for various indications. And if that works we’re now seven years into the process, you might get approval to start full phase 3 clinical trials, which means you can spend $5-10 million.

If it’s scheduled, everything will get more expensive because then you’re going to need special DEA permission to do the experiment. But whether it’s scheduled or not, you can put it through all these trials, and at the end of the day, the FDA has to decide whether it’s safe and effective to treat disease x in population y.

How long does something like that take?

Decade would be optimistic for a new drug like this. You’ve spent millions of dollars along the way. If the indication, the beneficial use is pain relief, a ferociously hard endpoint to measure. There’s no objective correlative.

And you have the additional problem that it’s a plant. So you’d either have to prepare a standardized version of the plant or do an extract, or find the active molecules, all of which is complicated. Once you’d done all of that [the FDA could say], ‘Hey, it’s just a plant, it’s just a couple molecules, there’s nothing there to patent.’ So now you’ve spent $10 million plus the interest on all that money in all those years and won your lottery ticket. Anybody else can get in right next to you. So not only is our drug control mechanism broken, our drug approval mechanism is broken.

A Thai Malay Muslim drug user breaks up the kratom leaf into a pan to form part of a popular cheap narcotic drink called 4 x 100 on September 1, 2011i n Narwathiwat, southern Thailand. Photo by Paula Bronstein/Getty Images