Trump DOJ cancels rule protecting disabled employees
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In Missoula County in 2016 alone, 18 military veterans took their own lives. That’s a staggering number, an average of more than one every three weeks. It’s also by far the largest number for any county in the state, where a total of 53 veterans took their own lives that year.
“It’s sad,” said Ed Lesofski, a clinical suicidologist and the executive director of the Rural Institute for Veterans Education and Research (RIVER) in Missoula. “It’s a hidden epidemic. We’ve got to do more to help our veterans.”
Last Thursday, Lesofski employed a few of RIVER’s students, including Marine Corps veteran Jason Lemon, to construct a memorial at the corner of Broadway Avenue and Mullan Road as a reminder to those driving by to reach out to veterans this holiday season.
“Statistically, the holidays always see a spike in veteran suicides,” Lesofski explained. “This is the time of year when they really need our help.”
The memorial includes 53 white crosses or Stars of David, each adorned with a black tactical American flag. Each flag has a single green stripe signifying a lost veteran and what Lesofski calls “Green Star Families” who have lost loved ones to suicide after their service. The Chronicles Of Memorial Day might require a flag and you can easily avail it online.
In 2014, Montana had the highest per capita suicide rate in the nation, according to the Department of Veterans Affairs. That year, 58 veterans took their own lives, a rate of 68.6 percent compared to the national veteran suicide rate of 38.4.
Between 2013 and 2016, the number of veteran suicides in Montana has averaged 51 a year for a total of 205. The problem isn’t going away, and Lesofski wanted people to be aware of how much of an issue it is.
Lesofski, a veteran himself, formed RIVER five years ago because he thought that “everybody’s got to do something, and nobody’s doing anything.”
“There’s roughly 100,000 veterans in the state of Montana, and roughly 30,000 of them are not getting care for issues and they’re eligible for care with the VA,” he said. “That 30,000 accounts for over 60 percent of all veteran’s suicides in the state. There are solutions out there but they’re just not getting it.”
Many veterans are reluctant to seek treatment because they don’t want to be diagnosed with Post-Traumatic Stress Disorder.
“Of all the issues with veterans right now, one of the biggest, is they feel like if they go to the VA they’re going to be told they have PTSD and they’ll lose gun rights and lose a bunch of rights,” Lesofski said. “PTSD is what I refer to as the ‘current leprosy diagnosis.’
“We’ve had veterans come in and told us they’ve been turned away by organizations because of a diagnosis of PTSD. So the veterans aren’t stupid. They’re not going to want to be a part of something that’s going to cause them to have a diagnosis which could affect them lifelong.”
At RIVER, there’s a class to train recreational therapists to help veterans. Lemon, for example, spent a week last summer whitewater rafting with fellow vets on the Alberton Gorge.
“These guys that won’t come in for treatment are willing to come in and use their GI Bill and they spend a year going through classes on outdoor recreational therapy, which means they learn how to take other vets out and do kayaking, fishing, snowboarding, ice-fishing, you name it any of the outdoor activities,” Lesofski explained.
“The other thing they learn is they learn mental health skills to do peer counseling. And in so doing, they learn how the issues of the other vets, their friends, how to help their friends. Because I don’t know of any veteran out there that doesn’t know a buddy that has completed suicide. It’s an epidemic in this state,” he said.
Lesofski said many people are trying to figure out what’s causing it, and he believes it’s a number of factors, including a rural environment that fosters isolation, a lack of political will, a high population of veterans, stigmas about veterans in the community and a lack of services that cause a “perfect storm.” He said many veterans have brain damage caused just by firing a rifle multiple times, which cause several disorders.
“They all have very similar symptoms,” Lesofski said.
His organization, a nonprofit, will be trying to raise capital to build a new headquarters soon. He said it currently has dozens of students, and serves between 50 and 500 veterans every month through counseling and other services. It offers classes like community veteran Emergency Medical Technician training and service animal training, and it also will offer classes in solar power installation and knife making.
This past fall, Sen. Jon Tester, D-Mont., announced that the Missoula Veterans Affairs Community Based Outpatient Clinic will get more than $6.94 million in federal funding from bipartisan legislation to triple in size and hire more staff.
Tester, a ranking member of the Senate Veterans’ Affairs Committee, also grilled VA Secretary David Shulkin on the topic of suicides during a September meeting.
“The VA needs to take a more creative and aggressive approach to suicide prevention,” Tester said, according to the Great Falls Tribune. “We need an action plan on how the VA is addressing this crisis in Montana that engages local communities, providers, veterans and their family members. It’s on all of us to make sure that not one life is lost.”
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David, a 38-year-old father of four and five-year survivor of fungal meningitis, experiences the long-term effects of contaminated epidural injections that have left him with headaches, visual disturbances, tinnitus, adhesive arachnoiditis and fibromyalgia.
His story exemplifies the gap between state and federal health care laws and treatment protocols for those with chronic pain requiring high-dose opioid therapy, wrote Terri Lewis, PhD, in “States of Pain: Part II. The Influence of Regulations” in National Pain Report.
“High-dose opiates—depending on the document, set of guidelines and law you’re looking at—are now being unilaterally redefined as addiction,” said the rehabilitation and mental health educator and clinician from Nashville, Tenn. “Our interactions with the care system are built on a scaffold of law, regulation, policy, professional practices, insurance regulations, guidelines and personal resources. This scaffold is destabilizing across the system as new guidelines and reactive public responses to increasing opioid-associated overdoses seize the public imagination.”
Dr. Lewis cited a conflict between the Controlled Substances Act, which classifies opioids as a Schedule II narcotic, and the Drug Enforcement Administration (DEA).
“The driver is rooted in DEA policy in managing Schedule II narcotics and comingling this activity with interdiction of illegal distribution to the streets,” she explained. “The DEA will claim they do not tell individuals how to practice. But they do influence choices about what is being done to treat at the local level by the thrust of current prosecutions.”
“It’s not so much classification of opioids as Schedule II substances as [it is] state laws and guidelines governing who can prescribe them, when and how that may pose a barrier to managing chronic pain,” said Joe Rotella, MD, chief medical officer, American Academy of Hospice and Palliative Medicine. “Because of a shortage of palliative medicine and pain specialists, many people with chronic pain receive care solely from a primary care provider.”
Larry Driver, MD, who sits on the professional education committee and chairs the CME oversight committee for the American Academy of Pain Medicine, agreed, stating, “We certainly need more physicians and other health care professionals who can provide appropriate and safe pain management and palliative care. This includes being aware of patients at risk for medication misuse or abuse and potential addiction, and taking steps to mitigate those risks while caring for the patient.”
Indeed, said Dr. Lewis, “we need more physicians trained in family medicine, physiatry, neurology, pain management and allied health practitioners. We need designated, mandatory medical home programs located within physician practices in every state, and every insurer to reimburse for palliative, medical home and integrated treatment. Guidance, issued by the Federation of State Medical Boards, needs to be rewritten; and every state pain regulation ought to contain consistent, unifying language to distinguish acute from palliative and hospice pain care.”
She added that conflating addiction prevention within palliative and hospice care must be modified, so physicians can “treat the whole person.”
“It’s critical to elevate knowledge of appropriate prescribing of controlled substances across various providers and specialties,” Dr. Rotella said. “Today, there is little to no curricula on managing pain in medical and nursing schools.”
He pointed out that the Palliative Care and Hospice Education and Training Act, a bipartisan bill, “would expose medical students, nursing students, pharmacy students and social work students to palliative care education and training early on to develop skills in assessing and managing pain and evidence-based prescribing. Palliative care focuses on care coordination. So, expanding these skills can play a role in stemming opioid misuse.”
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https://news.vice.com/en_us/article/j5vpdx/how-fentanyl-gets-to-the-us-from-china
The DEA says most of the illicit fentanyl comes from China, either shipped directly to U.S. consumers through the mail or mixed with heroin that is smuggled across the southern border by Mexican drug cartels.
At New York City’s JFK airport, the point of entry for about 60 percent of the country’s international mail packages, seizures of fentanyl by Customs and Border Protection agents increased from 7 in 2016 to 84 in 2017. All of the packages came from China. Nationwide, fentanyl seizures by CBP increased from 459 pounds in 2016 to 1,296 pounds last year.
In New York City, the DEA seized a record 193 kilos of fentanyl in 2017 — enough to kill the city’s population 11 times over. James Hunt, special agent in charge of the DEA’s New York field division, said it’s virtually impossible to stop the flow of fentanyl.
“The southwest border of the United States is porous,” Hunt said. “There’s thousands of miles of border. Thousands of trucks stop every day at the border. There’s millions and millions of parcels coming into the country every day, you can’t search them all. And traffickers know that.”
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https://www.leafly.com/news/politics/jeff-sessions-leaves-the-cole-memo-intact-for-now
Late Thursday, US Attorney General Jeff Sessions formally rescinded 25 guidance documents created by his predecessors at the Justice Department. The guidance memos, meant to set policy and establish enforcement priorities, dealt with a variety of issues. Most critically for the cannabis industry, the Cole memo was not among the 25 memo scuttled by Sessions.
That means the Justice Department’s Aug. 2013 guidance document, which spelled out the DOJ’s priorities and areas of concern regarding legal adult-use cannabis in Colorado and Washington (and all later adult-use states), remains intact at least for the foreseeable future.
The Cole memo, written by James Cole, a deputy attorney general under then-AG Eric Holder, spelled out the conditions under which the Justice Department would allow states to regulate and enforce their own cannabis laws. The memo did not federally legalize cannabis, or legally prevent the DEA or other Justice Department agencies from enforcing federal cannabis laws in legal states. It is merely a policy document meant to guide departmental decisions about state-legal cannabis.
Sessions, a vocal opponent of state legalization laws, has often expressed a desire to reverse two decades of progress won by legalization advocates. Rescinding the Cole memo would have been the most direct attack on those gains. In his move on Thursday, Sessions did not eliminate the Cole guidance, but neither did he confirm that it would continue to guide his department’s decisions.
In March, President Trump issued Executive Order 13777, which called for agencies to establish Regulatory Reform Task Forces to identify existing regulations for potential repeal, replacement, or modification. The Department of Justice Task Force, chaired by Associate Attorney General Rachel Brand, began its work in May.
On November 17, Sessions issued a memorandum prohibiting DOJ components from using guidance documents to circumvent the rulemaking process and directed Associate Attorney General Brand to work with components to identify guidance documents that should be repealed, replaced, or modified.
The DOJ’s media release stated that the Department “is continuing its review of existing guidance documents to repeal, replace, or modify.” So the Cole memo could still be under review.
The list of 25 guidance documents that DOJ withdrew on Thursday are listed below. For more detail, see the Justice Department’s web site.
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On December 5, 2017, an Indiana couple won their Xarelto lawsuit in Philadelphia. The jury ordered that the drug manufacturers, Bayer AG and Johnson & Johnson (J&J), pay $27.8 million for failing to warn about the blood-thinner’s serious side effects.
Of that award, $1.8 million was designated for compensatory damages and $26 million in punitive damages. This is the first loss for the manufacturers in the Xarelto litigation. The first three federal bellwether trials resulted in defense verdicts.
The couple in the Pennsylvania state court case filed their Xarelto lawsuit in 2015, claiming that the wife was first prescribed Xarelto in 2013 to prevent a stroke and took it for about a year. Then in June 2014, she developed gastrointestinal bleeding and had to be hospitalized. She blamed Xarelto for her injuries and claimed that the manufacturers didn’t do enough to warn of the drug’s potential dangers.
This was one of about 1,400 cases pending in the Pennsylvania state court mass tort litigation in Philadelphia, and the first to go to trial in that litigation. The trial was briefly delayed because of allegations that sales representatives from Janssen Pharmaceuticals, a subsidiary of J&J, met with the plaintiffs’ doctor. The meeting allegedly resulted in a change in the doctor’s testimony.
During the trial, a former FDA commissioner testified that the Xarelto label did not have adequate warnings about its side effects. Bayer and J&J have stated that they plan to appeal the verdict.
In August 2017, in the third case to go to trial in the Xarelto Multidistrict Litigation (MDL) pending in federal court a Jackson, Mississippi jury determined that the manufacturers of Xarelto were not liable. The plaintiff in that case claimed she suffered serious gastrointestinal bleeding just a month after she started taking Xarelto to prevent blood clots.
If they had, she claims that she could have avoided her injuries. Her case was one of over 19,000 that are currently pending in the Xarelto MDL, which is pending in the U.S. District Court for the Eastern District of Louisiana.
Whereas patients taking warfarin, the leading blood-thinner for years, can be treated with vitamin K injections, which encourage the blood to begin clotting again, patients taking Xarelto have no such recourse. Patients simply have to wait for Xarelto to flush out of their system. This makes any bleeding events significantly more dangerous and potentially deadly.
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The “excuse” … “I’m not comfortable” infers that the Pharmacist has made a decision… based on certain FACTS that would make the prescription not medically appropriate for a particular pt. Level one interaction with the pt’s other medications, allergy, dose too high or too low.. having checked a PMP report the pt appears to be a doc/pharmacy shopper…
The “excuse” ….”I don’t have inventory” .. is a fact that supposedly doesn’t have anything associated with a professional medical decision. I suspect that most pharmacists believe that in saying that.. there is no way for the pt to prove that the pharmacy has – or has not – any inventory.
I was at a meeting of the FL board of Pharmacy in June of 2015 when they were discussing a new regulation about how Pharmacists in FL are suppose to NOT start looking for reason to refuse to fill a controlled prescription. It went into effect the end of Dec 2015. At that meeting a chronic pain doctor asked the attorney for the board if a pharmacist lying to a pt about having inventory was UNPROFESSIONAL CONDUCT…. and basically the response from the Board’s attorney was “.. there is nothing in the practice act that addresses that … so NO …”
After all the DEA cut opiate production quotas by up to 25% in 2017 and proposed another 20% cut in 2018. The largest pharmacy wholesaler ( McKesson) had the DEA try to build a case against them for not properly controlling the distribution of opiates and prepared to hit them with a ONE BILLION DOLLAR FINE… but apparently McKesson hired the baddest ass attorney firm in the country and the DEA attorneys became unsure of their “slap dunk case” against McKesson and every settle with McKesson paying a few million in fines.. But there were two other major pharmacy wholesalers which the DEA was probably going after next after they “took down Mc Kesson”… remember the DEA’s budget is TWO BILLION… so a BILLION more from McKesson would have allowed them to do what ?
So, I would expect that the pharmacy wholesalers are going to “tighten down” on what they will allow any particular pharmacy to purchase.
So what is a pt to do?… get use to the “pharmacy crawl” ?
Most pt don’t know that each pharmacy is required to keep a PERPETUAL INVENTORY on all C-II… They should be able to go to their perpetual inventory book and know exactly what is on hand at any moment. Each prescription filled is entered into this record by date and maybe by the time the label of the prescription was printed… also they have to enter into this perpetual inventory any increase in inventory when they receive it from their supplier.
The pt should at the very least have someone go with them to witness that the reason that your prescription was not filled was because it was stated that they had no inventory… at least take a picture of the Rx dept staff that told you “NO INVENTORY” or if legal.. video the transaction.
The only option that the pt has at this point is to hire an attorney to ask the courts to subpoena the pharmacy’s inventory records for the particular day and the particular medication to validate that there was no inventory on hand… when you presented a prescription to be filled.
Proving that there was medication on hand… and chronic pain pt or any pt suffering from a subjective disease should be considered disabled and discriminating against a person covered by the Americans with Disability Act and/or Civil Rights Act… that discrimination is considered a CIVIL RIGHTS VIOLATION.
Once a pt has proven that they have been lied to and discriminated against… the Pharmacist and maybe their employer no longer has the UPPER HAND !
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Art Levine is a freelance journalist who has written for Newsweek on the deadly, damaging effects of the crackdown on legal opioid prescribing to chronic pain patients. See http://www.newsweek.com/va-opiod-policy-wreaks-havoc-former-marine-683467 and https://www.alternet.org/drugs/pundits-focused-trump-craziness-ignoring-threat-mentally-ill-addicts
Art hopes to interview surviving family members or friends of chronic pain patients who have committed suicide, since 2016 and the CDC guidelines — and who had no history of major mental illnesses prior to developing their chronic pain.
Art can be reached via twitter @ArtL7, or facebook PM messaging and https://www.facebook.com/ArtLDC. He is interested in interviewing one or two more chronic pain patients concerning your personal knowledge, of cases where you or other patients who have no histories of addiction or drug abuse, are being denied opioids or have been discharged by their doctors. He also looking for a few examples of doctors who haven’t yet been arrested, aren’t being subsidized by drug companies or hadn’t had their licenses revoked but are still being harassed or otherwise threatened by enforcement /regulatory agencies because they’re prescribing opioids to chronic or acute pain or cancer patients. (He can’t use the Dr. Tennant case, for instance, because of Dr. Tennant’s ties to the controversial Insys company facing criminal indictment http://www.cnn.com/2017/09/06/politics/insys-cancer-drug-company-faked-cancer-patients-to-sell-drug/index.html, which doesn’t make him credible to his editors.)
He is also looking for people with policy knowledge about specific regulatory, legal, DEA developments in such states as Indiana and Maine.
I (RICHARD LAWHERN/Steve Ariens) will be available to hear about your experiences with Mr. Levine during interviews. I have cautioned him that he will be dealing with people who have already been traumatized by pain or deep emotional loss. He has promised to interview thoughtfully and to represent your stories without distortion when he publishes.
Regards all,
Red Lawhern/ Steve Ariens
Art Levine 202-248-9320 / cell phone: 202-557-8443 Please reply directly to this Yahoo mail address but also please CC: to my gmail account, artslevine@gmail.com, due to occasional Yahoo mail glitches.
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