https://wvrecord.com/stories/511356818-class-action-lawsuit-filed-against-purdue-pharma-for-babies-born-addicted-to-opioids
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https://wvrecord.com/stories/511356818-class-action-lawsuit-filed-against-purdue-pharma-for-babies-born-addicted-to-opioids
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http://thehill.com/policy/healthcare/376335-sessions-to-dea-evaluate-opioid-production-quota
Attorney General Jeff Sessions is asking the Drug Enforcement Administration (DEA) to evaluate whether changes are needed to the amount of opioids drug makers are allowed to produce.
In Sessions’s memo to the DEA, he noted that studies have indicated the U.S. is an outlier compared to other countries in how many opioid prescriptions are given out each year.
Every year, the DEA sets the production and manufacturing quotas for Schedule I and II controlled substances.
“Given the urgency of this crisis, with an estimated 175 Americans dying per day, we need the DEA to act quickly to determine if changes are needed in the quotas,” Sessions wrote in the memo.
In July, 15 Democratic senators and Independent Sen. Angus King (Maine) sent a letter to then-acting DEA administrator Chuck Rosenberg, asking him to reduce the opioid quotas for 2018. They noted that between 1993 and 2015, the DEA approved a 39-fold increase of oxycodone, 12-fold increase of hydrocodone and a 25-fold increase of fentanyl.
They praised the DEA’s decision to decrease nearly all opioid production quotas by 25 percent or more for 2017, but wrote that “however, the 2017 production quota levels for numerous Schedule II opioids remain dramatically higher than they were a decade ago.”
In December, West Virginia Attorney General Patrick Morrisey (R) filed a lawsuit against the DEA challenging the production quotas for 2018 and seeking more transparency and input in the process.
The filing deadline for initial submissions had been extended twice, and was set for March 1. In light of Sessions’s announcement, Morrisey put the lawsuit on hold while the DEA evaluates the quotas.
“I heartily applaud Attorney General Sessions for the major step he is taking and for his continued collaboration with our office to protect West Virginians from this deadly scourge of opioid excess,” Morrisey — who is running for the Senate — said at a press conference. He didn’t make his lawsuit public at the time, discussing it for the first time publicly on Thursday.
The opioid epidemic has hit both urban and rural areas all across the country and shows no sign of abating.
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BOISE, Idaho (AP) — A proposal to legalize oil extracted from cannabis plants is likely dead for the year after a group of lawmakers on Monday broke out in turmoil during a last-minute attempt to advance the bill.
Republican Sen. Tony Potts asked the Senate Health and Welfare Committee to give HB 577 a hearing after supporters of the bill said they were being blocked by legislative leaders.
“I think we have to remember that we represent people, people who vote for us, people who are our friends,” Potts said, who was appointed to the Idaho Falls’ legislative seat in October. “If you’re constituents are anything like mine, there is a large amount of individuals who desire the health benefits of this (CBD oil).”
Cannabidiol, otherwise known as CBD oil, comes from cannabis but contain little or no THC. Supporters tout CBDs as a supplement that can help alleviate pain, reduce stress and improve skin health, although there’s little data on whether they work or what kind of side effects they might have.
While Potts defended his motion — which focused on his recent child’s seizures and why his family would want to use the product — he was quickly gaveled down by Chairman Lee Heider.
“If anyone on this committee wants to talk about this, they can do so in my office,” Heider said.
The majority of the panel then headed toward Heider’s office to discuss Potts’ motion.
Heider denied a request by The Associated Press, who followed lawmakers into the office, to sit in on the meeting.
Heider said, who could be heard shouting to his members by the AP on the other side of the door.
Idaho lawmakers passed legislation in 2015 that would have allowed children with severe forms of epilepsy to use CBD oil. That bill was vetoed by Republican Gov. C.L. “Butch” Otter, who received pressure from law enforcement groups that feared it would lead to further loosening of the state’s drug laws. Otter has since said his position has not changed in the past three years.
Heider also warned Potts that his motion was unusual and should not have been made. Other lawmakers could be heard defending the legislative process, while others argued to allow Potts’ motion to be debated.
The committee only broke up after being warned by a reporter that their actions were breaking the state’s Open Meeting Law.
According to Senate rules, “all meetings of any standing, select, or special committee shall be open to the public at all times.”
Once broken up, members returned to the public committee room and a separate motion was made to hold HB 577 in committee — a legislative procedure essentially halting the bill from moving forward.
“The concern with the motion that I have, it doesn’t get it where we need to be,” Potts said, before voting against the action.
Potts’ concerns were overruled by other members on the committee via a voice vote and HB 577 will likely not advance this legislative session.
The measure had already cleared the House with a veto-proof majority.
Currently, 18 states allow use of “low THC, high cannabidiol (CBD)” products for medical reasons in limited situations or as a legal defense.
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More FDA edicts that are intended to “protect the addicts” ?
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Sen. Joe Manchin, D-W.Va., introduced legislation to restore enforcement power to the Drug Enforcement Administration to target suspicious drug distributors.
The powers were stripped in a 2016 bill after heavy influence from the pharmaceutical industry, according to a report in the Washington Post. The scandal surrounding the bill, which passed Congress nearly unanimously and was signed into law by former President Barack Obama, caused Rep. Tom Marino, R-Pa., who led the legislation, to withdraw his nomination to serve as President Trump’s drug czar.
“This bill will make sure that the DEA regains the legal authority that was wrongly stripped from the agency in 2016 to ensure that they can go after companies taking advantage of the system, including those companies that send millions of opioid pills to tiny towns in West Virginia,” Manchin said.
Both the House and the Senate are pursuing legislation to target opioid abuse. The House Energy and Commerce Committee is considering eight bills that address the tide of the powerful synthetic opioid fentanyl and would expand treatment options.
But committee Chairman Rep. Greg Walden, R-Ore., recently told reporters that a bill to restore powers to the DEA isn’t in the works. He said the committee is awaiting guidance from the agency on the best way to proceed.
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http://www.dispatch.com/news/20180305/ohio-doctors-contine-to-prescribe-fewer-pain-pills
While overall drug overdose deaths continue to climb, Ohio doctors for the fifth straight year prescribed fewer opioid painkillers to patients.
The report also showed an 88 percent drop since 2011 in the number of patients going from doctor to doctor in search of drugs.
“Ohio has one of the most comprehensive and aggressive approaches in the country to tackling the opioid epidemic,” said Ohio Board of Pharmacy Executive Director Steven W. Schierholt.
“Through improvements to OARRS, new prescribing rules and guidelines, shuttering pill mills and aggressive regulatory action against unscrupulous prescribers, the state is making considerable progress in reducing the supply of prescription opioids and other controlled substances that can be abused or diverted.”
Much of the spike was attributed to fentanyl, a highly potent and deadly synthetic opioid being mixed into street drugs like heroin, cocaine, marijuana and other illegal substances. Meanwhile, deaths from prescription opioids last year were at their lowest levels since 2009.
Do you think that Gov Kasich and the rest of the bureaucrats in OHIO will ever figure it out that addiction(s) is a mental health issue and prohibition and abstinence will never do much to resolve the opiate addiction problem ? They all “scream and shout” about opiates don’t work for long term treatment of chronic pain .. because there is no long term clinical studies, but all of these bureaucrats seem to believe that reducing access to opiates – especially legal opiates will cause “demand” for opiates to drop and go away… but the BODY COUNT would suggest that they are DEAD WRONG…but this is just anecdotal evidence that suggest that this will not work… but.. there does not appear that there are any clinical studies on the horizon to validate.
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http://www.bnd.com/news/local/article202972584.html
The family of a baby born addicted to opioids filed a class action lawsuit Wednesday against 20 pharmaceutical companies they accused of being negligent and responsible for the mother’s addiction to opioids and heroin.
The lawsuit tells the story of a baby, only identified by his initials T.W.B. He was born March 21, 2017, and spent the first days of his life in “excruciating pain” as he was weaned from his opioid addiction, inherited from his mother.
“Baby T.W.B. will require years of treatment and counseling to deal with the effects of prenatal exposure,” the lawsuit says. “Baby T.W.B. and his mother are victims of the opioid crisis that has ravaged Illinois, causing immense suffering to those born addicted to opioids and great expense to those forced to deal with the aftermath.”
Alton residents Deric and Ceonda Rees, the baby’s grandparents, filed the lawsuit Wednesday in the U.S. District Court of Southern Illinois. Ceonda Rees declined to comment, saying she had been advised not to discuss the lawsuit.
The baby was diagnosed with Neonatal Abstinence Syndrome, which can cause breathing and feeding problems, and require a longer hospital stay while they are experiencing withdrawal symptoms.
Taking opioids during pregnancy can also cause babies to be born with birth defects, according to Stanford Children’s Health. The number of babies born with this disease has increased fivefold since 2000, according to the National Institute on Drug Abuse.
At birth, Baby T.W.B. shook, refused to feed and cried excessively as he arched his back from the pain, according to the lawsuit. It was difficult to soothe him, and his development was delayed.
The baby’s mother became addicted to opioids when she was prescribed them for a broken ankle and broken hand as a young teenager. Her addiction to prescription opiates functioned as a gateway to heroin addiction, according to the lawsuit. The lawsuit alleges the mother consumed drugs made and distributed by each of the 20 defendants, including Dilaudid, Percocet, Oxycodone and Hydrocodone.
The lawsuit accuses the pharmaceutical companies of creating an environment where opioids freely flow due to “false, negligent and unfair marketing/unlawful diversion of prescription opioids.”
The Reeses asked for equitable relief and medical monitoring to identify developmental issues that will “almost inevitably appear as they age,” and fund services and treatment.
“Baby T.W.B.’s experience is part of an opioid epidemic sweeping through the United States, including Illinois, that has caused thousands of infants great suffering and continuing developmental issues,” the lawsuit says.” This epidemic is the largest health care crisis in U.S. history.”
A similar lawsuit was filed in Louisiana on Tuesday.
The pharmaceutical companies included in the lawsuit released the following statements:
Notice that they are not suing any prescriber or doctor… did this woman get all her opiate from the street or friends and all 20 of these companies are: responsible for the mother’s addiction to opioids and heroin. The last time I looked… no AMERICAN PHARMA COMPANY LEGALLY PRODUCES HEROIN and the GRANDPARENTS ARE DOING THE SUING… and ONLY ONE SET OF GRANDPARENTS !!!
Apparently the Mother of this baby… COULD CARE LESS… Nothing in the article states or suggests that the Mother is now sober ?
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The Justice Department announced a new federal policy Wednesday to help state and local police take cash and property from people suspected of a crime, even without a criminal charge, reversing an Obama administration rule prompted by past abuse by police.
Deputy Attorney General Rod J. Rosenstein said the Justice Department will include more safeguards to prevent the kind of problems that have been documented in the past. Police departments will be required to provide details to the Justice Department about probable cause for seizures, and federal officials will have to more quickly inform property owners about their rights and the status of the seizures.
” Rosenstein said at a news briefing. “This is going to enable us to work with local police and our prosecutors to make sure that when assets are lawfully seized that they’re not returned to criminals when there’s a valid basis for them to be forfeited.”
[Jeff Sessions’s Justice Department turns a $65 million asset forfeiture spigot back on]
Two years ago, then-Attorney General Eric H. Holder Jr. barred state and local police from using federal law to seize cash and other property without criminal charges or warrants. Since 2008, thousands of police agencies had made more than 55,000 seizures of cash and property worth $3 billion under a Justice Department civil asset forfeiture program, which allowed local and state police to make seizures and then share the proceeds with federal agencies.
A Washington Post investigation in 2014 found that state and local police had seized almost $2.5 billion from motorists and others without search warrants or indictments since the terrorist attacks of Sept. 11, 2001. The Post series revealed that police routinely stopped drivers for minor traffic infractions, pressed them to agree to searches without warrants and seized large amounts of cash when there was no evidence of wrongdoing.
Police then spent the proceeds from the seizure with little oversight, according to the Post investigation. In some cases, the police bought luxury cars, high-powered weapons and armored cars.
“You’re never going to eliminate allegations of abuses,” Rosenstein said, “never going to eliminate mistakes 100 percent. But I think this new policy is going to position us very well to make sure there are very few credible allegations of abuse, and where there are we’re going to make it a priority to follow up.”
The new policy from Attorney General Jeff Sessions authorizes federal “adoption” of assets seized by state and local police when the conduct that led to the seizures violates federal law. Rosenstein said that the department is adding safeguards to ensure that police have sufficient evidence of criminal activity when property is seized. Property owners will receive notice of their rights within 45 days, which is twice as quickly as required by current law. Law enforcement agencies will be required to provide officers with more training on asset forfeiture laws, he said.
State and local law enforcement officials supported the change, but Democratic and Republican lawmakers were skeptical.
Rep. Darrell Issa (R-Calif.) called Sessions’s policy “troubling” and said it would “expand a loophole that’s become a central point of contention nationwide.”
[Jeff Sessions’ defense of civil asset forfeiture, annotated]
Holder tweeted that Sessions’s policy was “another extremist action” and said the Obama administration policy was “a reform that was supported by conservatives and progressives, Republicans and Democrats.”
Kanya Bennett, legislative counsel for the American Civil Liberties Union, called the action “outrageous.”
“We are talking about people who have not been convicted of a crime and are often not given a day in court to reclaim their possessions,” Bennett said. “Civil asset forfeiture is tantamount to policing for profit, generating millions of dollars annually that the agencies get to keep.”
At a meeting with county sheriffs on Feb. 7, President Trump made clear to law enforcement officials that he is a strong supporter of the civil asset forfeiture program and told the Justice Department to rescind the Obama administration restrictions.
On Wednesday, Sessions defended the reversal at a meeting with representatives from the Fraternal Order of Police, the National Sheriffs’ Association, the Major Cities Chiefs Association and other law enforcement officials who back the new policy.
“Civil asset forfeiture is a key tool that helps law enforcement defund organized crime, take back ill-gotten gains and prevent new crimes from being committed, and it weakens the criminals and the cartels,” Sessions said.
But the ACLU’s Bennett said, “The problem is that we are not talking about criminals.”
“We are talking about Americans who have had their homes, cars, money and other property taken through civil forfeiture, which requires only mere suspicion that the property is connected to a crime,” she said.
I thought that Session was functioning with a 70’s & 80’s mindset – early war on drugs period… Our judicial system declared opiate addiction was a CRIME not a DISEASE… in 1917… So apparently Session’s mindset is back 100 yrs ago in what was referred to as our country’s “Prohibitionist Period”.. That is before alcohol was prohibited and while women still did not have the RIGHT TO VOTE…
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https://khn.org/morning-breakout/kennedy-gingrich-anti-opioid-group-funded-by-maker-of-opioid-addiction-medication/
Braeburn Pharmaceuticals, which won approval last year to market an implant that continuously dispenses the opioid addiction medicine buprenorphine, entered into an agreement to make a $900,000 charitable donation to Advocates for Opioid Recovery. Media outlets report on the crisis out of California, Ohio, Pennsylvania, Missouri, New Hampshire and Massachusetts as well.
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In my former life prior to chronic pain and illness I had many important and fascinating jobs. One was as a peer reviewer for the United States National Institutes for Health (NIH), Center for Mental Health Services (CMHS), and Substance Abuse and Mental Health Services (SAMHSA); and New York State’s Education Department, Office of Mental Health, and Office of Alcohol and Substance Abuse Services. I reviewed multi-million dollar grants, provided consumer input to agencies, and served on publication committees and focus groups. When the opportunity arose to comment on the draft “CDC Guideline for Prescribing Opioids for Chronic Pain”, I looked forward to reawakening my peer reviewer skills to objectively identify the strengths and weaknesses of the document.
Unfortunately, I found it near impossible and beyond frustrating to review this document in an objective manner. The guideline is not organized like a typical guideline or tool kit. It is nothing more than a literature review of the harms and risks of opioids. It is not objective, therefore, I found it impossible to be objective. It was biased which made me completely biased (in the other direction). Reading this document left me scared—really scared. It left me wondering what happened to the United States and to the rights of patients? How could this be? No consumer groups or chronic pain patients were included in their peer review or “experts” process. A huge no no. Here is the comment I posted on the CDC site (I omitted my introduction):
As a consumer and citizen, I request you halt further activity regarding these guidelines until a consumer board can be developed—one that is solely made up of chronic pain patients who have experienced primary care access issues to opioid medication. I also request you conduct focus groups of chronic pain patients who are on opioids. Only then will you have guidelines that serve the public, the primary care doctors, and the chronic pain patients.
It is imperative a section in the guideline be created detailing how adequate pain control is a fundamental right of every patient. Point to the Joint Statement from 21 Health Organizations and the Drug Enforcement Administration, “Promoting pain relief and preventing abuse of pain medications: A critical balancing act” which states “Effective pain management is an integral and important aspect of quality medical care, and pain should be treated aggressively… Preventing drug abuse is an important societal goal, but it should not hinder patients’ ability to receive the care they need and deserve” (http://www.deadiversion.usdoj.gov/pubs/advisories/painrelief.pdf). In addition, in this section provide a thorough review of the risks of untreated chronic pain, i.e. suicides, depression, unemployment, lower quality of life, etc.
Throughout this document it is mentioned there are no adequate long term studies that prove opioid medication is effective, leading the reader to believe opioid medication never helps patients long term, which is not true. If you conducted a focus group of chronic pain patients you would understand the complexities of opioid pain management and long term effect. It became clear to me this document was written in a biased manner when I read the “Effectiveness of Alternative Treatments” section. It boasted these treatments effective under 6 months. Nowhere in this document did I see a similar positive citation for opioid treatment for short term use though hundreds exist. The writers excluded the fact these alternative treatments, like opioids, had no proven long term benefits. Furthermore, the alternative pharmacological agents, i.e. gabapentin, SSRIs, NSAIDs, etc. are touted as excellent treatments with little to no risks. The writers should have included information on the hundreds of possible side effects, some very serious, each of these drugs carry. The risk of death, overdose and suicide is very real for some of these medications and literature citations stating as such was discluded.
The statistics in the Background section do not delineate criminal activity from actual chronic pain patients in a pain management type setting. It also does not define whether in overdoses there were additional drugs or alcohol contributing to the overdose (polydrug overdose) and whether these overdoses were legitimate pain patients or illegally obtained prescriptions. These guidelines should not include such statistics. This is not a paper about criminal activity and misuse. Only statistics for actual pain patients should be included.
Information must be included describing the fact primary care doctors may be the only opioid prescriber in their area as most pain management doctors no longer manage chronic pain with opioids and specialists refuse to prescribe. Primary care doctors have by default become pain management doctors. As such, pain patients should not be punished for this trend. I did like that you included a few sentences encouraging physicians to be compassionate. Please expand on this. Most of us are treated like a nuisance and criminal. Include information on the difference between physical dependence, tolerance, and addiction/misuse of opioid medications.
Information about actual pain conditions is slim, which is disconcerting. The fact you include cataracts as a painful condition and not severely painful conditions like chronic pancreatitis, complex regional pain syndrome, shingles, back and spine issues, trigeminal neuralgia, endometriosis, adhesion pain, kidney stones, and more shows the lack of familiarity of the team of writers with true chronic pain populations.
Teach patients basic opioid safety—keeping the opioids locked away and out of teenagers’ hands. Many patients are naïve to think their teens would never consider experimenting with their meds or visitors won’t snoop through a medicine cabinet. Providing real-world information will prevent unnecessary overdoses NOT limiting chronic pain patients their pain medication. Also, the naloxone section should be removed or limited to a sentence. True chronic pain patients rarely experience overdose and should be dealt with by emergency personnel.
—End of comment—
The CDC is clearly not the appropriate agency to spearhead opioid prescribing guidelines. They are good at authoring literature reviews on ebola and trying to find cures for diseases. They are NOT equipped to publish guidelines of this manner. This is not an epidemic and they are incapable of being objective. A document like this must be objective and unbiased.
Brooke Keefer is a mom to three sons ages 28, 19, and 4 and has a 2 year old granddaughter. Brooke has a Bachelor of Science degree in Mathematics from the State University of New York at Albany. For over 15 years she worked as a not-for-profit director, lobbyist, advocate, and a grants writer, manager, and reviewer in the field of children’s mental health. Brooke suffers from several painful conditions—sphincter of oddi dysfunction (a defect in the pancreatic/biliary valves), chronic pancreatitis, and fluoroquinolone toxicity syndrome (long term adverse reaction of the nervous system to Levaquin). Though these have disabled her, she writes health articles, advocates for patient rights, and runs the Sphincter of Oddi Dysfunction Awareness and Education Network website, www.sodae.org.
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