Maine drug deaths remain high in early 2018, with fentanyl on the rise

www.pressherald.com/2018/06/01/drug-deaths-decline-slightly-in-early-2018-but-fentanyl-on-the-rise/

The number of people killed by drug overdoses in Maine during the first three months of the year fell slightly from last year, state authorities said Friday, although deaths caused by Maine’s ongoing opioid crisis are still near all-time highs.

Between January and March, 86 people died of overdoses, down from 89 such deaths during the same time period in 2017, according to the offices of the Maine Attorney General and the Chief Medical Examiner. A record 418 people died of drug overdoses in 2017. More people now die from drug overdoses than motor vehicle accidents, according to federal statistics.

Although the total number of deaths declined during the first three months of 2018, more people who die from overdoses were killed by illegal substances, including fentanyl, as opposed to pharmaceutical opioids.

About 65 percent of the deaths recorded in the first quarter were due to fentanyl or fentanyl analogues, up from 52 percent in 2016 and 59 percent in 2017. Fentanyl is a cheaper, more powerful alternative to heroin, and many users who believe they are taking heroin are actually using fentanyl.

“The shift we are seeing from heroin to cheap, deadly fentanyl is deeply troubling,” Attorney General Janet Mills said in a statement. Mills, one of seven Democratic candidates for governor, oversees the medical examiner’s office.

“We must break the stranglehold that opioid use has on our state,” she said. “The figures released today demonstrate dramatically that we have not yet turned the tide against opioids and there is still much work to be done.”

Addiction experts denounced the state’s anemic response to the opioid crisis.

“This is sad, sad, sad,” said Dr. Lisa Letourneau, associate medical director of Maine Quality Counts, a health advocacy nonprofit and a former member of the state’s opioid task force. “The state is failing to respond appropriately to this epidemic. We need doubly accelerated strategies. We are not doing enough.”

One proven tool for reducing overdose deaths is finally becoming more widely available in Maine. The Board of Pharmacy last week published new rules for making naloxone, a lifesaving drug that reverses the effects of an overdose, available without a prescription. Republican Gov. Paul LePage had repeatedly vetoed bills to expand access to naloxone, sold under the brand name Narcan, and slowed down the administrative rulemaking process. But the Legislature finally mustered the votes needed to override his opposition and provide access to naloxone for anyone.

A bill that would provide $6.6 million to help about 500 uninsured Mainers gain access to substance use disorder treatment is in limbo, as the Legislature adjourned this spring before deciding whether to fund that bill and others. The Legislature may return in a special session, but the fate of the bill is unclear.

Meanwhile, expanding Medicaid would provide access to treatment for about 70,000 Mainers, although it’s unclear how many of those newly eligible for coverage would need treatment. Maine voters approved Medicaid expansion 59 percent to 41 percent in 2017, but implementing the expansion is on hold.

LePage and House Republicans have been refusing to expand Medicaid, arguing that the Legislature needs to appropriate money for it, while Democrats say there doesn’t need to be a specific appropriation. An advocacy group is suing the LePage administration, saying Mainers should be able to sign up by July 1.

Malory Shaughnessy, executive director of the Alliance for Addiction and Mental Health Services, said that while efforts to help alleviate the opioid crisis stall, Mainers are dying.

“Things have not gotten any better,” she said. “It’s a travesty.”

The Legislature did approve a bill in 2016 that placed more restrictions on prescribing opioids, and opioid prescribing dropped 32 percent from 2013 to 2017, in part because of the new law and also because of changes in prescribing practices and Medicaid rules in Maine that also constricted opioid prescribing.

Dr. Mark Publicker, an addiction treatment specialist and past president of the Northern New England Society of Addiction Medicine, said the state has had limited success in increasing the number of doctors who are certified to prescribe Suboxone, a leading medication used to treat opioid use disorder. But Publicker said demand for treatment still far outstrips the supply, and the new prescribing law may be having the unintended consequence of pushing more people into illicit drug use. The law sets caps on dosage and length of opioid prescriptions, although there are many exceptions, such as end-of-life care.

“There’s lots of people dying still. It’s a tragic and terrible situation,” Publicker said.

Mills urged more treatment, education and prevention efforts, and called on the Legislature to act on the issues.

According to Maine DHHS, 8,627 Mainers received medication-assisted treatment, including methadone and Suboxone, in 2016, the latest year figures were available.

While there’s no estimate of how many Mainers lack access to opioid treatment, a U.S. Substance Abuse and Mental Health Services Administration survey estimates about 25,000 Mainers struggling with all forms of drug addictions believe they don’t have access to treatment programs.

The figures released were compiled by Dr. Marcella Sorg of the University of Maine’s Margaret Chase Smith Policy Center.

In all of 2017, 418 people died of drug-related causes. In 2016, that figure was 376 deaths—many of which were chronicled in a Portland Press Herald/Maine Sunday Telegram series, Lost: Heroin’s Killer Grip on Maine’s People.

Joe Lawlor can be contacted at 791-6376 or at:

jlawlor@pressherald.com

Twitter: joelawlorph

Matt Byrne can be contacted at 791-6303 or at:

mbyrne@pressherald.com

Twitter: MattByrnePPH

Filed under: General Problems | 1 Comment »

https://arstechnica.com/science/2018/06/new-drug-access-law-intended-to-weaken-fda-according-to-lawmaker-behind-it

Senator Ron Johnson (R-Wis.) isn’t mincing words about his so-called “right to try” bill, signed into law by President Trump on Wednesday. In a feisty letter to Food and Drug Administration Commissioner Scott Gottlieb Thursday, Johnson put things bluntly: “this law intends to diminish the FDA’s power.”

The revelation substantiates a leading criticism of the law, which was otherwise pitched as a compassionate measure to help people suffering from life-threatening illnesses obtain easier access to experimental therapies. Critics feared it would simply undercut the agency’s regulatory power to ensure experimental treatments are used safely, while offering little aid to patients. After all, the FDA already has a prompt and lenient system for providing such patients access to experimental treatments, and 38 states already have similar “right to try” laws. Proponents, meanwhile, said the new federal law would give desperate patients hope and dismissed concerns that it would weaken the FDA.

But Johnson laid bare his regulatory intentions after being apparently infuriated by some of Gottlieb’s recent comments to reporters and on Twitter. Specifically, in a May 22 tweet, Gottlieb wrote, “When the House passes #RightToTry legislation I stand ready to implement it in a way that achieves Congress’ intent to promote access and protect patients; and build on #FDA’s longstanding commitment to these important goals #RTT.”

And in news articles, Gottlieb was quoted as saying he would work to “build in additional patient protections” alongside the law to ensure access but also safety.

Johnson is having none of that, according to his letter. “[This law] is not meant to grant FDA more power or enable the FDA to write new guidance, rules, or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments.”

Johnson went on to request a meeting with Gottlieb as soon as possible in which he can further “discuss the law’s intent and FDA’s plans to implement the law consistent with that intent.”

Right to do what now?

As it stands, the right to try bill signed into law, which Johnson sponsored, will cut out the FDA’s role in approving and overseeing the use of experimental drugs in patients with life-threatening diseases. Such patients will be able to work directly with a doctor and a drug company to gain access—outside of a clinical trial—to an experimental therapy that has only made it through early clinical trials and not obtained FDA approval.

Prior to the new law, such patients in all states could do the same thing, but if their state didn’t have its own “right to try” law, they had an added step of getting the FDA’s approval. That said, through the agency’s “expanded access” pathway, the FDA granted 99 percent of those requests and usually processed them in mere days. In emergency situations, the FDA granted them “immediately over the phone.”

In a recent commentary piece in the New England Journal of Medicine, medical ethicists raised concerns about cutting the FDA from the process. Namely, they noted that FDA sometimes gives guidance on how patients and doctors should go about their experimental treatment safely—and that guidance is sometimes based on undisclosed data to which the FDA has access.

Thus, the law “would cause patients to lose the benefit of meaningful safety-oriented changes that the agency recommends in 10 percent of expanded access approvals on the basis of confidential information that is often unavailable to treating physicians,” they wrote.

Other opponents fear that the law would leave patients vulnerable to less-than-scrupulous doctors or predatory drug developers, such as the hundreds of shady stem cell clinics that have popped up around the country.

“The agency has made substantial progress in balancing the needs of desperate patients and the principle that all patients deserve evidence that the benefits of medical products justify their risks,” the commentary authors conclude. “We upset that balance, and diminish the FDA’s public health mission, at our peril.”

Johnson, meanwhile, touts the new law as being “fundamentally about empowering patients.”

what exactly is a pt with  a “life-threatening disease”…  and just what is an “experimental therapy”…  could many of the substances that the DEA has designated as having “no valid medicinal value” could be now eligible as “experimental therapy” ?

After all each of us is basically terminal… no one is going to live forever… it is just trying to figure out … when the end is going to come and just exactly how that is going to happen.

Vague laws… often end up with some/many unintended consequences …just a matter of time…

Filed under: General Problems | 1 Comment »

Latest NDTA Shows Opioids Pose Significant Impact to Public Health

https://nabp.pharmacy/wp-content/uploads/2018/06/Kentucky-Newsletter-June-2018.pdf

Filed under: General Problems | 1 Comment »

Settlement clarifies discrimination for buprenorphine use

https://www.behavioral.net/article/ethics/settlement-clarifies-discrimination-buprenorphine-use

A Massachusetts skilled nursing facility reached a settlement recently with a U.S. attorney’s office in a pivotal discrimination case. It’s the first known case involving a patient being refused admission based on the patient’s use of buprenorphine for opioid use disorder.

Perhaps more significant is the prevailing position of skilled nursing facilities nationwide refusing buprenorphine patients. Under the Americans with Disabilities Act (ADA), such a patient is considered disabled.

Experts say the settlement provides a practical caution for healthcare providers, indicating that refusing to treat individuals solely based on their addiction disorders will be considered discrimination under ADA.

Sally Friedman, legal director of the Legal Action Center, who has worked with the Department of Justice on ADA violations, says the law doesn’t expect healthcare providers to offer care beyond their expertise or scope of practice. However, it also won’t allow them to discriminate against patients because of their disability.

“Here, the skilled nursing facility refused admission to someone with opioid use disorder because they were receiving treatment with buprenorphine,” Friedman tells Behavioral Healthcare Executive. “The person was otherwise qualified for the service. It was just that one discriminatory variable.”

The Charlwell House facility will pay a civil penalty of $5,000 and agreed to implement non-discrimination training programs. But the settlement could represent larger implications by setting a precedent for all healthcare providers—including those in behavioral health.

Abstinence programs vulnerable

Philosophical clashes in the behavioral health specialty have long pitted abstinence programs against programs using medication assisted treatment (MAT). However, there are no major rulings to provide legal guidance for abstinence programs that systematically refuse treatment for individuals using medications for addiction.

“You could make the argument that that violates ADA, but it’s trickier,” Friedman says. “It’s not the same as the skilled nursing case.”

She believes that depending on the circumstances, there might be room for a discrimination claim if a patient using MAT is refused treatment in a program in which abstinence is a core philosophy, but there’s no indication of how a court might ultimately rule.

Legal risks are a different proposition for recovery homes where the Fair Housing Act might also apply in addition to ADA, Friedman says. Many operators are concerned about diversion and expect individuals living there to remain drug-free as a condition of residency.

“I have not heard a legitimate reason for a recovery home not allowing medication,” she says. “I think they’re vulnerable under law.”

For example, she says, residences could offer reasonable accommodation to store take-home doses of methadone or buprenorphine securely in the home under lock and key. And ADA requires that states, cities and homeowner associations provide “reasonable accommodations” to individuals with disabilities, including those in recovery.

Industry leaders are more vocal now than ever before about the efficacy of MAT, and their influence is having some effect in communities. Just recently, Caron Treatment Centers introduced a stand-alone treatment unit exclusively for patients with opioid use disorders. Leaders informed local recovery residences that if they want to continue to receive referrals from Caron, they must accept and allow the patients to use anti-craving medication post-discharge

Filed under: General Problems | 1 Comment »

https://www.wkyc.com/article/money/consumer/whistleblower-files-lawsuit-against-cvs-caremark-for-falsifying-drug-prices/95-560447195

Filed under: General Problems | Leave a Comment »

Listen to podcast by clicking the above link

On this episode of Chicago Injury Alert, we look at how a nationwide opioid shortage has caused medication errors throughout hospitals.

Filed under: General Problems | 2 Comments »

https://www.kiro7.com/news/local/dea-waiting-for-analysis-kratom-may-soon-be-banned/759828681

SEATTLE – Kratom grows in Southeast Asia. Its leaves can be chewed, made into pills, ground and steeped into tea or added to food.

The leafy green plant is widely available and advertised as a safe, organic and natural “cure” for opioid addiction, pain relief and even cancer.

In 2016, kratom products exceeded sales of $1 billion in the U.S. alone.

But there’s a problem.

Kratom — a natural opioid — has not been approved by the Food and Drug Administration and may soon be banned in the U.S.

“I don’t know anything about the cancer claims,” said Kenneth Thummel, PhD. “That’s a bit of a stretch to me.”

Thummel, the chairman Chair of the University of Washington’s department of pharmaceutics, is concerned by the lack of research that has been done on kratom to determine its efficacy and safety.  

He’s also concerned kratom is widely available for sale – in stores and online — with no instructions for dosage or serving size.

“The dose makes the poison,” he told KIRO 7 from his office at UW on Wednesday. “How much are people taking, and is there any instruction about what you shouldn’t exceed?” he asked. 

Another problem, according to Thummel, is “adulteration of the product. There’s no regulation on the manufacturing of it. There are cases where products clearly were adulterated with very potent opioids to enhance the product, and that can be fatal,” he said.

The FDA claims kratom has contributed to the deaths of at least 36 people. Click here for more information.

On Wednesday, Special Agent Melvin Patterson told KIRO 7 that the Drug Enforcement Administration is “still waiting for analysis” before deciding whether to designate kratom a Schedule I drug, illegal because it has high abuse potential, no medical use and severe safety concerns.

Heroin, LSD and cocaine are all Schedule I drugs.

Shilo Jama believes making kratom illegal “would be the most idiotic thing” the DEA could do.  

As executive director of the People’s Harm Reduction Alliance in Seattle, Jama said he’s seen people successfully treat their opioid addictions using kratom.

“I’m not against kratom in any way,” Jama said. “Kratom has shown to be successful, and for the people who use it for treatment, I think it’s great they found an easy solution that they don’t have to go through a doctor” to utilize.

Jama said kratom is a valuable option for addicts who live in areas where treatment options are not widely available.

He believes, however, that the strength and dosages of kratom should be regulated.  “I am for regulations. I’m not for limiting people’s access to a potential treatment option” he said.

Before consumers believe the widespread claims that kratom can cure addictions abd even cancer, Dr. Thummel would like it to be carefully studied, which he admits would be more difficult if it is designated a Schedule I drug.

“The public is taking a risk in believing the claims,” Thummel said.  “I’m not saying that it’s a very unsafe product, but research needs to be done to establish one way or the other about safety.”

What is the difference in the terms “contributed to the deaths” and “caused the death”.. quite a bit… if a person OD’s and there is a “cocktail” of various substances … it is nearly impossible to determine which single substance was the cause of death…  BUT… if your agenda is to POINT A FINGER… you come out stating that it “contributed” to the OD. Similar to the concept of GUILTY UNTIL PROVEN INNOCENT..

36 deaths.. over what time frame ?… last year… 48 kids/babies died because their parent left them in a closed car. But apparently the death of 48 INNOCENT BABIES does not rise to the level of a “epidemic” as opposed to 36 people who have CHOSEN to take several legal/illegal substances in an attempt to GET HIGH.

NOTHING has changed about it being IMPOSSIBLE TO LEGISLATE MORALITY.

Filed under: General Problems | 4 Comments »

https://www.conspiraciesagainstwellness.com/

Filed under: General Problems | 1 Comment »

Psychological Interventions Beneficial for Chronic Pain in Older Adults

https://www.clinicaladvisor.com/pain-information-center/psychological-interventions-for-chronic-pain-treatment/article/767105/

Patients with noncancer chronic pain can benefit from psychological interventions, according to a study published in JAMA Internal Medicine.

Bahar Niknejad, MD, of the Department of Medicine at Eastern Virginia Medical School in Norfolk, and associates conducted a systematic review and meta-analysis to understand if older adults with chronic pain would benefit from psychological therapies and the effectiveness of such treatments.

The main outcome studied was pain intensity, with secondary outcomes including pain interference, depressive symptoms, anxiety, worsening beliefs, self-efficacy for pain management, physical function, and health.

The investigators examined 22 studies involving 2608 volunteers (69% women; average age, 71.9 years). Average differences were standardized and recorded for pain intensity (d_D=-0.181), pain interference (d_D=-0.133), depressive symptoms (d_D=-0.128), anxiety (d_D=-0.205), worsening beliefs (d_D=-0.184), self-efficacy (d_D=-0.193), physical function (d_D=0.006), and physical health (d_D=0.160) at posttreatment.

The only category with evidence of persisting effects after posttreatment analysis was pain (d_D=-0.251).

“Psychological interventions for the treatment of chronic pain in older adults have small benefits, including reducing pain and catastrophizing beliefs and improving pain self-efficacy for managing pain,” the authors reported.

“These results were strongest when delivered using group-based approaches. Research is needed to develop and test strategies that enhance the efficacy of psychological approaches and sustainability of treatment effects among older adults with chronic pain,” they concluded. 

Filed under: General Problems | 1 Comment »

Florida is a sicker state because of Gov. Rick Scott’s partisanship

http://www.sun-sentinel.com/opinion/fl-op-column-randy-schultz-florida-health-care-rick-scott-20180529-story.html

In a new Senate ad, Gov. Rick Scott claims that voters must send business executives like himself to Washington. “If you’re not getting the results, you’re not in business.”

So let’s look at Scott’s results as governor on health care in Florida.

They stink.

The Centers for Disease Control and Prevention just reported that the rate of Floridians without health insurance rose again last year, to 20.1 percent from 19.8 percent. Since Scott took office in 2011, Florida has ranked near the bottom on access to basic health coverage.

It gets worse. The Commonwealth Fund just ranked Florida above only Louisiana, Oklahoma and Mississippi, based on a study of 43 health care metrics. Commonwealth ranked Florida below average in the South, which was by far the worst region.

Florida fared a little better in the new report from the Institute for Women’s Policy Research. Mortality rates among women for breast cancer, lung cancer and heart disease have declined. So has the number of women diagnosed with AIDS.

The report also noted, however, that “Florida ranks poorly on a cluster of data points related to women’s mental health — suicide mortality, average number of days per month of poor mental health, and average number of days per month that women have limited activity due to poor mental or physical health.” More women need “adequate access to preventive care.”

Only education consumes a larger share of the state budget than health care. Education and health care thus should be among any governor’s priorities. Education isn’t a Scott priority. Nor is health care for the man whose hospital company paid a $1.7 billion fine for defrauding the federal government.

The main reason for Florida’s poor performance is that Scott has refused to expand Medicaid under the Affordable Care Act. Though Scott expressed support for Medicaid expansion in 2013, he quickly backed off. Two years later, he sided with the Florida House against a Senate proposal that could have provided coverage for about 800,000 of the state’s working poor.

Every credible survey has shown that Medicaid expansion benefits those who obtain coverage and the states themselves. The Kaiser Family Foundation found that the roughly 15 million new Medicaid enrollees nationwide had fewer out-of-pocket medical expenses, lower medical debt and better credit. They also were less likely to face bankruptcy.

Unlike Scott, other Republican governors and legislatures have looked past their party’s opposition to the Affordable Care Act and focused on helping their states. Under GOP leadership — notably Gov. John Kasich — Ohio expanded Medicaid. Among enrollees, Kaiser reported, 50 percent no longer have any medical debt. Providers in Ohio have had to eat less in uncompensated care.

Medicaid expansion began in January 2014. In upholding most of the Affordable Care Act, the Supreme Court made expansion a state option, not a requirement. The federal government paid 100 percent of states’ expansion costs for three years. It’s now 95 percent and will be phased in to 90 percent by 2020.

So Scott and Republican leaders in Tallahassee have passed on many billions that could have improved lives, boosted Florida’s economy and made the state’s health care system better. That 2015 Senate plan to expand Medicaid included Republican favorites such as work requirements and co-pays by recipients. Expansion would have ended if federal reimbursement fell below 90 percent.

Yet the governor who stresses “results” has chosen politics and ideology — he opposed the ACA as a private citizen — over policy. Scott also ignores what Kaiser determines to be 202 studies refuting criticisms that Medicaid expansion limits access and provides poor care.

Scott might have a defense if he had offered any alternative to Medicaid expansion. But his only health care initiative was the hospital commission he formed in 2015. He did that to distract from his administration’s incompetence that nearly cost Florida federal money for hospitals that treat the uninsured.

Under Scott, Florida did lead the nation in one health care category — rate of new AIDS infections. That came after Scott had cut public health budgets for several years. The Scott administration responded by “revising” the number of new cases downward.

With more Floridians living paycheck to paycheck, health coverage becomes vital to keeping them stable. Scott has had nearly eight years to work on this issue. The results speak for themselves.

Randy Schultz’s email address is randy@bocamag.com.

Filed under: General Problems | Leave a Comment »