Pfizer Agrees to Support CDC Opioid Guideline

https://www.painnewsnetwork.org/stories/2017/8/4/pfizer-agrees-to-support-cdc-opioid-guideline

By Pat Anson, Editor

Since its release in March 2016, the CDC’s opioid prescribing guideline has had a chilling effect on chronic pain patients, as doctors, regulators, states and insurance companies have adopted the CDC’s recommendations as policies or even laws. As a result, it has become harder for many pain patients to get opioids prescribed or even find a doctor willing to treat them.

Now one of the world’s largest drug makers has agreed not to make any statements that conflict with the CDC guideline and to withdraw support for anyone who does.

In an agreement signed last month with the Santa Clara County, California Counsel’s Office, Pfizer promised to abide by strict standards in its marketing of opioids and to “not make or disseminate claims that are contrary to the ‘Recommendations’ of the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain.”

That voluntary guideline only discourages primary care physicians from prescribing opioids for chronic pain, but has been widely implemented by many doctors, regardless of specialty.

Pfizer also agreed to stop funding patient advocacy groups, healthcare organizations or any charities that make “misleading statements” about opioids that are contrary to the CDC guidelines. Pfizer notified Pain News Network by email today that it was rescinding a charitable grant recently awarded to PNN. Pfizer’s had been a sponsor of PNN’s newsletter for the past year.  

“This agreement is an important step in ensuring that doctors and patients in California receive accurate information about the risks and benefits of these highly addictive painkillers,” Santa Clara County Counsel James Williams said in a press release. “Such information is essential to curbing — and ultimately ending — the opioid epidemic plaguing Santa Clara County, the State of California, and many parts of the country.”

Santa Clara County was not pursuing any legal action against Pfizer, although it had filed a lawsuit against Purdue Pharma and four other opioid manufacturers, alleging that they falsely downplayed the risks of opioid painkillers and grossly exaggerated their benefits.

“We applaud Pfizer’s willingness to work with us to combat the dramatic rise in opioid misuse, abuse, and addiction in California and the corresponding rise in overdose deaths, hospitalizations, and crime,” said Danny Chou, an Assistant County Counsel for the County of Santa Clara. “Pfizer has set a stringent standard that we expect all other opioid manufacturers to meet.”

Opioids make up only a tiny part of Pfizer’s business. The company sells just one opioid painkiller, an extended release medication called Emedea.

As part of its agreement with Santa Clara County, Pfizer promised not to market opioids off-label for conditions they are not approved for and said it would “make clear” in its marketing that there are no long-term studies on the safe use of opioids.

Interestingly, the CDC guideline suggests the use of gabapentin and pregabalin as alternatives to opioids for treating pain. Pfizer makes billions of dollars annually selling both of those drugs, under the brand names Neurontin and Lyrica.

In recent years, Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for. Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is widely prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses.

Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries. Lyrica is also prescribed off-label to treat a wide variety of other chronic pain conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.

Since  I don’t receive any money from Pfizer – except for some dividends from some Pfizer stock that I have owned for nearly 10 yrs..  I can say whatever I think about this announcement..

First of all … Santa Clara County, California has a population of about 1.9 million or about 0.5% of the population of the USA… which means that this county prosecutor in CALF has been able to impose his will, belief, opinions on the other 99.5% of the country’s population… 

WHAT A EGO.. and clearly demonstrates that our judicial system has gotten totally out of control. Just like recently AG Session wanted to be granted the power to allow him to impose his opinions on the entire population … especially when it came to the war on drugs.

The CDC ( Center of Disease Control) produced these “guidelines” and some believe that the CDC did not have the legal authority to do so…  Up until the release of these guidelines.. the CDC primary focus on communicable diseases and vaccines that help prevent communicable diseases and/or establish treatment plans to deal with communicable disease.

It has been stated that the studies/data that the CDC based it guidelines on were of the poor quality… with 1= excellent and 4 = unreliable and most of the studies they used had a rating of 3 or 4 and they refused to accept any anecdotal evidence of the benefit of opiates used long term in helping pts manage their chronic pain.

The head of the CDC at the time –  Tom Frieden – was quick to make public statements pointing out once these guidelines were released that they were merely GUIDELINES and did not bear the weight of law.

However, many entities – like the VA – was quick to adopt some of the most strict portion of the CDC guidelines and ignored some of the exceptions in order to properly manage the pain of chronic pain pts with more severe pain.

It amazes me that both the FDA and Pfizer does not recommend the use of one of Pfizer’s medications in ESI and all too many pts have been inflicted with Arachnoiditis https://en.wikipedia.org/wiki/Arachnoiditis     and meningitis and no one seems to be interested in this very popular procedure that may be considered insurance fraud and causing insurance companies expending untold dollars treating Arachnoiditis… which is both incurable, extremely painful and costly to treat.

It would seem that our judicial system is more interested in the loss of life from people abusing illegal substances than those pt losing their quality of life from physicians “pushing” procedures using medications in an unproved methodologies.

 

 

Filed under: General Problems | 5 Comments »

Essentia Health Hosts Panel on Opioid Crisis

Business leaders gather to discuss ways drug epidemic can be solved

www.kvrr.com/2017/08/03/essentia-health-hosts-panel-on-opioid-crisis/

FARGO, ND — It’s a drug killing more than 90 Americans every day: opiates.

One mother understands that after sending her two sons to jail.

“I was trying to save their lives,” Mary Locken said.

Locken’s sons, 23-year-old Joe and 21-year-old Nicholas, were caught up in the storm of addiction.

They started drinking alcohol and smoking marijuana at a young age, but eventually, it wasn’t enough.

“The game changer for both of them, no mistake, [was] prescription drugs,” Locken said.

Essentia Health wants to change that.

They held a panel discussion for business leaders to address ways to combat opioid addiction in the community.

Essentia has already started to take more precautions in giving chronic pain patients prescriptions with opioids.

“We have an opioid agreement that spells out what their obligations are,” said Dr. Richard Vetter, who is Essentia Health’s clinical chief of primary care. “What the clinicians obligations are and really helps us have that conversation about risk benefits.”

According to the National Institute on Drug Abuse, about 21-29 percent of patients prescribed opioids for chronic pain misuse them.

Vetter said the panel is a good place to discuss further ways this crisis can be solved because it’s about working together.

“I think it’ll require a collaborative effort to really deal with this problem,” Vetter said. “But I think there’s hope. I think there’s a lot of hope because there are treatments out there that are effective. We just have to get them to the patients that need them.”

Locken has discovered that hope once again.

“Where I had given up hope for my sons, literally, I thought they were walking death, that they would not survive,” Locken said. “I now have hope for both of my sons.”

Locken’s son Joe was just released from prison, while Nicholas is still serving his sentence.

Joe will be attending Minnesota State Moorhead.

Filed under: General Problems | 4 Comments »

Drug overdose calls decreasing in Louisville

http://www.whas11.com/news/local/drug-overdose-calls-decreasing-in-louisville/461561141

LOUISVILLE, Ky. (WHAS11) — Drug overdose calls within the city of Louisville are down since February which is an encouraging sign for health care workers.

“I knew that there was a crisis in Hepatitis C, but I didn’t know the opioid crisis was as bad as it is,” said Donald Davis.

He formed the Kentucky Harm Reduction Coalition two and a half years ago. It is a non-profit that educates the public on how to treat and respond to overdoses and the benefits of needle exchanges.  “More people who are participating in the exchange are using and they are getting naloxone,” Davis explained.

It may be the main reason overdose calls are down in Louisville. Davis says more people are getting their hands on NARCAN, the brand of naloxone that’s used by first responders. 

The coalition offers naloxone training at least twice a month. Davis says families are becoming more familiar with it.  “Family members will come to our trainings and get it because they have a family member who is using and they want to make sure they have it,” he said.

Overdose runs by Louisville EMS are down each month since February, which was at its highest with 869.  First responders were called to 595 overdoses in June, the lowest all year.

The drop-in calls is significant, but health care workers believe that’s because addicts are using NARCAN to reverse the overdose.

For more information on the resources provided by the Kentucky Harm Reduction Coalition, click here.

So from this article it appears that addicts/substance abusers are getting their hands on Naloxone/Narcan and ODing and being revived “in private” .. so they are not having to call 911 for the OD.. and their OD is not counted as one of the statistics and don’t have to deal with “do-gooders” wanting to help them “go straight”..

This is from North Carolina ….

Filed under: General Problems | Leave a Comment »

Middlemen Who Save $$ On Medicines — But Maybe Not For You

http://khn.org/news/little-known-middlemen-save-money-on-medicines-but-maybe-not-for-you/

For the past seven months, the GOP push to replace the Affordable Care Act has consumed Washington. All the while, many consumers continue to be focused on the rising costs of prescription drugs.

Pharmacy benefit managers — companies that are often unnoticed and even less understood by most consumers — hold an important place in the prescription drug-pricing pipeline. In this video, Kaiser Health News details the emergence of these multimillion-dollar corporations and the impact they have on medication costs and patients’ access to these treatments.

KHN also offers other videos examining hot topics such as selling insurance across state lines, high-risk insurance pools, Medicare’s observation care status and how the health law could be disassembled through the congressional budget reconciliation process.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation and its coverage in California is funded in part by Blue Shield of California Foundation.

Categories: Cost and Quality, Health Industry, Multimedia, Pharmaceuticals

Tags: Drug Costs, Prescription Drugs
jappleby@kff.org | @Julie_Appleby

Filed under: General Problems | Leave a Comment »

Pain patients are being cut off from their drugs. Here’s why.

http://www.kevinmd.com/blog/2016/09/pain-patients-cut-off-drugs-heres.html

In March, 2016, the CDC released guidelines for prescribing opioids.  The guidelines were a response to a serious and growing problem: millions of pain patients became addicted to prescribed opioids, and hundreds of thousands died as a result.

Since the guidelines were released, reports of pain patients being abruptly cut off of their medication or having their medication abruptly reduced have become rampant. These patients report they were using opioids long term, sometimes for decades, with no evidence of addiction. Many patients who moved long distances report being unable to find a doctor who would treat them, or, if they found one, who would give them their usual dosage of medication. These patients report significant increases in pain and severe deterioration in function. Usually, no alternative treatments were offered.

Why would a doctor do this to a patient?  Here are a few reasons:

Doctors have been criminally prosecuted for prescribing opioids

As the opioid epidemic grew, it became obvious that many patients were becoming addicted to pain medications.  Not wanting to blame drug companies, who had lied about the drugs’ addiction risks, the authorities focused on doctors.  There were a few unscrupulous ones who had set up “pill mills,” practices where people without any legitimate medical need for the drugs could obtain opioids for the right price.  Apparently, there weren’t enough of those to make a big enough impression, so the Drug Enforcement Agency (DEA) started targeting other physicians.

Some doctors have been tried as drug kingpins and dealers and prosecuted for manslaughter when their patients died of an overdose. When convicted they are subject to the same mandatory sentencing laws as violent individuals dealing illegal drugs. The assets of suspected drug dealers can be seized without hearings or trial; consequently, they are stripped of the assets they require to defend themselves.

Dr. James Graves, a pain management specialist in Florida, was tried and convicted in 2002 for racketeering, drug trafficking, and manslaughter. Graves was the first doctor to be convicted of manslaughter as a result of prescribing painkillers to patients who died of an overdose. During his career, Graves worked as a medical missionary and served 17 years as a Navy flight surgeon before being honorably discharged in 1994.

Graves worked a series of temporary jobs before opening his own practice in 1998. Graves was reported to the authorities for allegedly dealing drugs by a former employer who believed that Graves was violating a non-compete clause in his employment contract. Graves was arrested, and his practice was closed down in 2000. He had no income or savings. The court declared him indigent, and he was represented by public defenders.

Prosecutors persuaded drug addicts facing extended jail time to testify against Graves in exchange for more lenient sentences.

Two doctors testifying for the defense stated that Graves’s treatment of the patients who died was within the standard of care of medical practice and was for a legitimate medical purpose. The prosecution failed to prove that he was medically negligent, or even that he was the cause of his patients’ deaths. Some of the deceased patients named were not even his patients or had died long after he stopped treating them. It was never proven that he accepted any money in return for drugs. Despite all this, Graves was convicted and sentenced to 64 years in prison.

Grave’s case became a precedent for prosecutors to use against doctors across the country. Other physicians have lost their licenses under similar scrutiny.  Some have prevailed against charges, but only after spending enormous sums in their defense.

Cases such as Graves’s allow the government to assert that it is doing something to address the problem of prescription painkiller addiction while allowing these dangerous—but very profitable—drugs to stay on the market.  These cases have had a chilling effect on many medical practices.

With the promulgation of the CDC opioid prescribing guidelines, physician’s worries increased.  Practice guidelines are generally treated as “standards of care” and physicians who don’t adhere to them are at greater legal risk if a complaint is filed.

Many physicians no longer make the policy decisions about their practices

Because of the pressures put on physicians by insurance companies, many have joined large practice groups or sold their practices to hospitals.  In these circumstances, physicians are often being told how to treat their patients by practice managers or the legal counsel’s office of the hospital. These individuals are usually even more risk-averse than the doctors themselves and make decisions without seeing their impact on patients.

Physicians have not been trained in how to appropriately withdraw patients from medications

Physicians mainly get their education in how to prescribe drugs from pharmaceutical company drug representatives or from “thought leaders,” respected physicians hired by the drug companies to deliver scripted talks about drug benefits.  Pharmaceutical companies like having lifelong customers so they rarely discuss how to safely withdraw patients from drugs.  If they do offer guidance, a faster than optimum dose reduction schedule is often recommended so that patients develop withdrawal symptoms that are only relieved by going back on the drug, “proving” they need it.

Physicians lack knowledge about and access to alternative pain treatments

The CDC guidelines recommend that patients be provided with nonpharmacological therapies prior to a gradual taper from opioids.  Physicians have limited knowledge of these treatments. There is little to no insurance coverage, and most pain patients can’t afford them.  Also, many of these services are not available in many communities.

What needs to be done

The DEA’s reign of terror over physicians needs to end.  Physicians need more education about addiction and safely withdrawing patients from opioids. Patients who are comfortable with their long-term opioid use who show no evidence of addiction should be offered alternative treatments but allowed to stay the course.  Alternative pain treatments need to be adequately covered by insurance companies, and all physicians and patients need to be educated about them.

Cindy Perlin is a social worker and author of The Truth About Chronic Pain Treatments: The Best and Worst Strategies for Becoming Pain Free.

Filed under: General Problems | 4 Comments »

Senate Confirms Surgeon General, Other HHS Picks

http://www.medscape.com/viewarticle/883770

The US Senate has approved Jerome Adams, MD, to be the next surgeon general.

Dr Adams, along with four other nominees for positions in the Department of Health and Human Services, were confirmed today without a full floor vote but with the Senate’s full consent. The legislators were finishing up as much business as possible before leaving for an already-delayed summer recess.

The senators also approved Elinore McCance-Katz, MD, PhD, as the assistant secretary for mental health and substance use, a new position that has been called the mental health “czar”; Lance Robertson as assistant secretary for aging; Brett Giroir, MD, as assistant secretary for health; and  Robert Kadlec, MD, as assistant secretary for preparedness and response.

The full Senate’s backing was not unexpected, as all the nominees made it through a Senate confirmation hearing relatively unscathed on August 2.

Dr McCance-Katz currently serves as the chief medical officer of Rhode Island’s Department of Behavioral Health Care, Disabilities, and Hospitals and was the chief medical officer of the Substance Abuse and Mental Health Administration from 2013 to 2015. She will be the first to hold the position of assistant secretary for mental health and substance use, a position created by the 2016 Helping Families in Mental Health Crisis Act.

Dr McCance-Katz, a psychiatrist, was endorsed for the new position by the American Psychiatric Association and the National Alliance on Mental Illness.

Filed under: General Problems | Leave a Comment »

Town Hall Meeting In Southaven Talks About The Opioid Addiction Epidemic

http://www.localmemphis.com/news/local-news/town-hall-meeting-in-southaven-talks-about-the-opioid-addiction-epidemic/780813906

SOUTHAVEN, Miss (localmemphis.com) – Fighting the opioid addiction epidemic brought a team of Mississippi state agencies to Southaven Tuesday.

The Opioid Town Hall Rally is part of a series making its way through the Magnolia state

According to the Desoto County Coroner, there have been around 18 or 19 opioid or heroin related deaths so far in 2017. He said in all of 2016; there were 23.

“This is not about pointing fingers. This is about working together to find the solutions. We all have to take our fair share of responsibility but also the responsibility to bring solutions to the table, and that’s our effort,” said Steve Parker, Deputy Director of the Mississippi Board of Pharmacy.

All hands on deck approach Parker stressed was just one of the focuses at Tuesday’s town hall that drew about 100 people.

In the audience were people with organizations working to tackle the growing issue of opioid addiction, people who lost someone to addiction or struggled with it themselves, and local elected officials.

Organizers shared information on what opioids are and the destruction they can cause.

For instance, a representative with the Bureau of Narcotics shared Mississippi sees an unprecedented rise in the number of pharmacy burglaries and robberies.

They drove home that opioid addiction, whether it’s prescription pills or heroin, does not discriminate. It can hit people of all backgrounds.

Many at the town hall agreed solving the problem starts with eliminating the stigma tied to addiction.

“Until we take the stigma off a that and off a mental illness we’re going to continue to have people to die. People gotta be willing to stand up and say you know I’m not ashamed to talk about this anymore I got a loved one that has a disease,” said Marshall Fisher, Commissioner of the Mississippi Department of Public Safety.

Filed under: General Problems | 1 Comment »

Medical community, law enforcement partner against opioid epidemic

Groups working together to fight local opioid epidemic

http://www.southbendtribune.com/news/publicsafety/medical-community-law-enforcement-partner-against-opioid-epidemic/article_f5cd53bf-d40a-5096-b39f-ce9c731a4408.html

Filed under: General Problems | 3 Comments »

CVS Health removes 17 drugs as part of its 2018 formulary management strategy

http://www.drugstorenews.com/article/cvs-health-removes-1-drugs-part-its-01-formulary-management-strategy

Filed under: General Problems | 1 Comment »

prosecutors will help addiction-ravaged cities

http://abcnews.go.com/Health/wireStory/ag-sessions-address-opioid-epidemic-hard-hit-ohio-48980919

Sessions:

The Justice Department will dispatch 12 federal prosecutors to cities ravaged by addiction who will focus exclusively on investigating health care fraud and opioid scams that are fueling the nation’s drug abuse epidemic, Attorney General Jeff Sessions said Wednesday.

He unveiled the pilot program during a speech in hard-hit Ohio, where eight people a day die of accidental overdoses.

“In recent years some of the government officials in our country I think have mistakenly sent mixed messages about the harmfulness of drugs,” Sessions said. “So let me say: We cannot capitulate intellectually or morally unto this kind of rampant drug abuse. We must create a culture that’s hostile to drug abuse.”

Sessions said the group of prosecutors he has dubbed the “opioid fraud and abuse detection unit” will rely on data in their efforts to root out pill mills and track down doctors and other health care providers who illegally prescribe or distribute narcotics such as fentanyl and other powerful painkillers.

Such prescription opioids are behind the deadliest drug overdose epidemic in U.S. history. More than 52,000 Americans died of overdoses in 2015 — a record — and experts believe the numbers have continued to rise. Sessions has made aggressive prosecutions of drug crime a top priority, saying the deadly overdoses necessitate a return to tougher tactics.

The Health Department says opioid-related overdoses killed 3,050 Ohioans in 2015, with that number expected to jump sharply for 2016.

In June, the coroner serving the greater Columbus area said overdose deaths through April of this year rose to 173, a 66 percent jump from the same period a year ago.

The prosecutors will be based in U.S. attorney’s offices in the Middle District of Florida; the Eastern District of Michigan; the Northern District of Alabama; the Eastern District of Tennessee; Nevada; the Eastern District of Kentucky; Maryland; the Western District of Pennsylvania; the Southern District of Ohio; the Eastern District of California; the Middle District of North Carolina; and the Southern District of West Virginia.

In May, Sessions instructed the nation’s federal prosecutors to bring the toughest charges possible against most crime suspects. Critics assailed the move as a return to failed drug-war policies that unduly affected minorities and filled prisons with nonviolent offenders.

The announcement was a reversal of Obama-era policies that is sure to send more people to prison and for much longer terms.

Advocates warned the shift would crowd federal prisons and strain Justice Department resources. Some involved in criminal justice during the drug war feared the human impact would look similar.

Sessions said. “So let me say: We cannot capitulate intellectually or morally unto this kind of rampant drug abuse

I question what Session knows about INTELLIGENCE AND MORALITY…  The DEA has cut the Pharma’s production quota on opiates… legal opiate prescriptions are down and opiate OD deaths are UP..  and they keep quoting higher and higher drug OD deaths…  INTELLIGENCE would suggest that the legal opiate prescriptions are NOT THE CAUSE..

Besides it would appear that SESSION does not believe in personal responsibility… apparently our judicial system has put themselves in charge of the country’s morality.

Have you noticed that recently they have added the charges of Medicare/Medicaid/Insurance fraud and money laundering and when they make announcement about “busting” a prescriber/providers they lists all the ASSETS that they were able to seize.  Seizing illegal substances costs the DEA money… they have to inventory, store and destroy… it is a NET-NET-NET LOSS for the DEA to go after the CARTELS.   Where is the INTELLIGENCE within the DOJ/DEA as to the real underlying causes of all of these OD’s ?

This move by SESSION and recent moves by Chris CHRISTIE is just to funnel more MONEY into the war on drugs … as if the 81 billion/yr that we are already spending and > ONE TRILLION we have spent since the Control Substance Act 1970 was signed into law is not enough..  and Congress was already discussing adding 4.5 billion/yr. 

Notice that both Session & Christie are ATTORNEYS and they are proposing more MONEY being funneled into the JUDICIAL SYSTEM… the FRATERNITY that they are part of !  Could this be consider a form of SELF SERVING ?

Filed under: General Problems | 3 Comments »