Class action filed against drug firms for opioid-addicted newborns

https://wvrecord.com/stories/511356818-class-action-lawsuit-filed-against-purdue-pharma-for-babies-born-addicted-to-opioids

CHARLESTON – A class action lawsuit has been filed against Purdue Pharma for babies who were born with Neonatal Abstinence Syndrome, a condition suffered by babies of mothers addicted to opioids.

Purdue Pharma L.P.; Purdue Pharma Inc.; the Purdue Frederick Company Inc.; McKesson Corporation; Cardinal Health Inc.; AmerisourceBergen Corporation; Teva Pharmaceutical Industries Ltd.; Teva Pharmaceuticals USA Inc.; Cephalon Inc.; Johnson & Johnson; Janssen Pharmaceuticals Inc.; Ortho-McNeil-Janssen Pharmaceuticals Inc.; Janssen Pharmaceutica Inc.; Endo Health Solutions Inc.; Endo Pharmaceuticals Inc.; Allergan PLC; Watson Pharmaceuticals Inc.; Watson Laboratories Inc.; Actavis LLC; and Actavis Pharma Inc. were all named as defendants in the suit.

Walter Salmons and Virginia Salmons filed the lawsuit on behalf of W.D., a minor child, and all others similarly situated, according to the suit, which was filed March 2 in U.S. District Court for the Southern District of West Virginia.

“Like thousands of children born every year, minor W.D. was born addicted to opioids,” the complaint states. “Prenatal exposure to opioids causing severe withdrawal symptoms and lasting developmental impacts.”

The plaintiffs claim W.D. was born four months ago and the first days of his life were spent in excruciating pain as doctors weaned the infant from opioid addiction.

W.D. will require years of treatment and counseling to deal with the effects of prenatal exposure, according to the suit.

“Minor W.D. and his mother are victims of the opioid crisis that has ravaged West Virginia, causing immense suffering to those born addicted to opioids and great expense to those forced to deal with the aftermath,” the complaint states.

The plaintiffs claim at birth, W.D. was diagnosed with Neonatal Abstinence Syndrome and was forced to endure a painful start to his life; crying excessively, arching his back, refusing to feed and shaking.

NAS is a clinical diagnosis, and “a consequence of the abrupt discontinuation of chronic fetal exposure to substances that were used or abused by the mother during pregnancy.”

“Minor W.D.’s mother began her addiction before 2016, before minor W.D.’s gestation, she had had a prescription for the opioid medication and she also obtained opioids via the diversionary market,” the complaint states.

W.D.’s mother consumed opioids manufactured and/or distributed by the defendants, according to the suit.

“Minor W.D.’s experience is part of an opioid epidemic sweeping through the United States, including West Virginia that has caused thousands of infants great suffering and continuing developmental issues,” the complaint states. “This epidemic is the largest health care crisis in U.S. history.”

The plaintiffs claim they are bringing the class action to eliminate the hazard to public health and safety caused by the opioid epidemic and to abate the nuisance caused by the defendants’ false, negligent and unfair marketing and/or unlawful diversion of prescription opioids.

“Plaintiffs further seek the equitable relief of medical monitoring to provide this class of infants the monitoring of developmental issues that will almost inevitably appear as they grow older and equitable relief in the form of funding for services and treatment,” the complaint states.

The incidence of NAS in newborns born to opioid-dependent women is between 70 and 95 percent, according to the suit.

The plaintiffs claim the NAS epidemic and its consequences could have been, and should have been, prevented by the defendants who control the U.S. drug distribution industry and the defendants who manufacture the prescription opioids.

“These Defendants have profited greatly by allowing West Virginia to become flooded with prescription opioids,” the complaint states. “The drug distribution industry is supposed to serve as a ‘check’ in the drug delivery system, by securing and monitoring opioids at every step of the stream of commerce, protecting them from theft and misuse, and refusing to fulfill suspicious or unusual orders by downstream pharmacies, doctors, clinics or patients.”

The defendants woefully failed in this duty, instead consciously ignoring known or knowable problems and data in their supply chains, according to the suit.

The plaintiffs claim the defendants intentionally and negligently created conditions in which vast amounts of opioids have flowed freely from drug manufacturers to innocent patients who became addicted, to opioid abusers and even to illicit drug dealers—with distributors regularly fulfilling suspicious orders from pharmacies and clinics, who were economically incentivized to ignore “red flags” at the point of sale and before dispensing the pills.

“Defendants’ wrongful conduct has allowed billions of opioid pills to be diverted from legitimate channels of distribution into the illicit black market in quantities that have fueled the opioid epidemic in West Virginia,” the complaint states. “This is characterized as ‘opioid diversion.’”

The plaintiffs claim acting against their common law and statutory duties, the defendants have created an environment in which opioid diversion is rampant.

As a result, unknowing patients and unauthorized opioid users have ready access to illicit sources of diverted opioids, according to the suit.

The plaintiffs are seeking compensatory and punitive damages, as well as medical monitoring and a fund that would be released to the children when they turned 18. The plaintiffs are represented by Kevin W. Thompson and David R. Barney Jr. of Thompson Barney.

U.S. District Court for the Southern District of West Virginia case number: 2:18-cv-00385

According to Wikipedia  https://en.wikipedia.org/wiki/Neonatal_withdrawal

neonatal abstinence syndrome  can result from the Mother use/abusing a whole list of different substances

Methadone

Heroin

Amphetamine

Alcohol withdrawal

Marijuana

Lysergic acid (LSD)

Caffeine and nicotine

Was the Mother immediately sent to rehab or arrested for being a “drug abuser”.. some states considers having an illegal substance in your blood… “possession of an illegal substance”. Did she admit that she was addicted/abusing opiates and which opiate she was abusing..

Was she a regular smoker, or drank caffeinated beverages (Coffee, Tea, Soda) or consumed one of the many forms of ALCOHOL ?  If so, why isn’t the class action including all the various manufacturers and distributors of those legal products ?

It is stated in the article that she was abusing Heroin… why isn’t her “dealer(s)” being sued for facilitating her addiction ?

Another class action case that goes after the “deep pockets” of corporate America to line the pockets of the ambulance chasing attorneys ?

 

Sessions to DEA: Evaluate opioid production quota

Sessions to DEA: Evaluate opioid production quota

Sessions to DEA: Evaluate opioid production quota

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.

If needed, potential alterations could be made through an interim final rule, which allows an agency to issue a new regulation effective immediately without first going through the notice and comment period.

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.

Opioid overdose deaths increased nearly 28 percent from 2015 to 2016, according to the Centers for Disease Control and Prevention.

Opiate Rxs are at a 10 yr low… OD’s up 50% over 10 yrs…  Does this suggest that AG Session needs to find out a way to curtail ILLEGAL OPIATES FLOODING INTO THE COUNTY ?

 

Idaho: Politicians elected by the PEOPLE… doesn’t want to represent the PEOPLE ?

Senate Panel Kills Bill Allowing Use of Marijuana Derivative

https://www.usnews.com/news/best-states/idaho/articles/2018-03-05/senate-panel-kills-bill-allowing-use-of-marijuana-derivative

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.

 Under HB 577, Idahoans seeking to use the oil for medical purposes for themselves or their minor children would have to apply to the Idaho Board of Pharmacy for a cannabidiol registration card.

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.

 Yells could be heard from multiple members inside Heider’s office.

“The governor’s office doesn’t want this bill, the prosecutors don’t want this bill, the office on drug policy doesn’t want this bill,”

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.

Opioid Addiction Medications Should Not Be Withheld From Patients Taking Benzodiazepines or CNS Depressants Opioid addiction medications

Opioid Addiction Medications Should Not Be Withheld From Patients Taking Benzodiazepines or CNS Depressants Opioid addiction medications – buprenorphine and methadone – should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS), advises FDA. The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care providers can reduce these risks, notes a safety alert. FDA is requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatmentdrugs and benzodiazepines together. Health care providers should take several actions and precautions and should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants. Additional information may be found in an FDA Drug Safety
Communication announcement at   www.fda.gov/Drugs/DrugSafety/ucm575307.htm.

More FDA edicts that are intended to “protect the addicts” ?

Sen. Manchin: re-election campaign didn’t get enough pharma money ?

Joe Manchin aims to restore DEA power in opioid bill

http://www.washingtonexaminer.com/joe-manchin-aims-to-restore-dea-power-in-opioid-bill/article/2650695

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.

 Manchin’s bill, introduced Monday, would restore the DEA’s authority to go after suspicious drug distributors that divert powerful painkillers to corrupt doctors who distribute them. The authority was softened in the 2016 bill.

“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.

OHIO: Opiate Rxs down 28% in FIVE YEARS… OD up 33% in two years

See the source image

Ohio Doctors continue to prescribe fewer pain pills

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.

 

In 2017, 568 million pain pills were dispensed, down 28 percent from a high of 793 million in 2012, according to an annual report released Monday by the Ohio Board of Pharmacy.

The report also showed an 88 percent drop since 2011 in the number of patients going from doctor to doctor in search of drugs.

State officials credited increased use of the Ohio Automated Rx Reporting System, OARRS, which tracks prescriptions. Nearly 89 million patient queries were made in 2017, up from 1.8 million in 2011.

“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.”

 Still, Ohio had a record 4,050 overdose deaths in 2017, up 33 percent from 2015.

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.

 

Opioid-addicted baby at center of class action lawsuit in Southern Illinois

 

http://www.bnd.com/news/local/article202972584.html

March 05, 2018 07:33 AM

Updated 5 hours 23 minutes ago

Sessions greenlights police to seize cash, property from people suspected of crimes BUT NO CHARGED !

https://www.washingtonpost.com/world/national-security/sessions-greenlights-police-to-increase-seizures-of-cash-and-property-from-suspected-criminals/2017/07/19/3522a9ba-6c99-11e7-96ab-5f38140b38cc_story.html?

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.

“The goal here is to empower our police and prosecutors with this important tool that can be used to combat crime, particularly drug abuse,

” 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.”

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.”

 “Criminals shouldn’t be able to keep the proceeds of their crime, but innocent Americans shouldn’t lose their right to due process, or their private property rights, in order to make that happen,” Issa said in a statement.

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…

Kennedy-Gingrich Anti-Opioid Group Funded By Maker Of Opioid Addiction Medication

Kennedy-Gingrich Anti-Opioid Group Funded By Maker Of Opioid Addiction Medication

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.

Stat: Mystery Solved: Addiction Medicine Maker Is Secret Funder Of Kennedy-Gingrich Group A company that sells a new opioid-addiction medication is a secret funder of an advocacy group fronted by Newt Gingrich and Patrick Kennedy that is pushing for more government funding and insurance coverage of such treatments. Gingrich, the former Republican House speaker and a Trump confidant, and Kennedy, a former congressman and son of former US Senator Edward Kennedy, are paid advisors to Advocates for Opioid Recovery. They have generated a flurry of media attention in those roles, including joint interviews with outlets ranging from Fox News to the New Yorker. (Armstrong, 3/3)

A Former Federal Peer Reviewer’s Analysis of the Draft CDC Guidelines

www.nationalpainreport.com/a-former-federal-peer-reviewers-analysis-of-the-draft-cdc-guidelines-8828910.html

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.