Drug maker thwarted plan to limit OxyContin prescriptions at dawn of opioid epidemic

www.statnews.com/2016/10/26/oxycontin-maker-thwarted-limits/

ELCH, W.Va. — The warning signs of what would become a deadly opioid epidemic emerged in early 2001. That’s when officials of the state employee health plan in West Virginia noticed a surge in deaths attributed to oxycodone, the active ingredient in the painkiller OxyContin.

They quickly decided to do something about it: OxyContin prescriptions would require prior authorization. It was a way to ensure that only people who genuinely needed the painkiller could get it and that people abusing opioids could not.

But an investigation by STAT has found that Purdue Pharma, the manufacturer of OxyContin, thwarted the state’s plan by paying a middleman, known as a pharmacy benefits manager, to prevent insurers from limiting prescriptions of  the drug.

The financial quid pro quo between the painkiller maker and the pharmacy benefits manager, Merck Medco, came to light in West Virginia court records unsealed by a state judge at the request of STAT, and in interviews with people familiar with the arrangement.

“We were screaming at the wall,” said Tom Susman, who headed the state’s public employee insurance agency in the early 2000s and led the push to limit OxyContin prescribing in West Virginia.

“We saw it coming,” he said of the opioid epidemic, which today causes 28,000 overdose deaths a year in the United States. “Now to see the aftermath is the most frustrating thing I have ever seen.”

Overprescribing of OxyContin and other opioid painkillers is blamed for helping to plant the seeds for the current opioid crisis. West Virginia has been hit harder than any other state: It suffers the highest per capita drug overdose death rate in the country — more than double the national average. It also has one of the highest rates of painkiller prescribing.

In McDowell County, where the court records from a state lawsuit against Purdue were unsealed, the local sheriff said prescription pill abuse is so rampant that the county plans to file a new lawsuit against painkiller makers.

The strategy to pay Merck Medco extended to other big pharmacy benefit managers and to many other states, according to a former Purdue official responsible for ensuring favorable treatment for OxyContin. The payments were in the form of “rebates” paid by Purdue to the companies. In return, the pharmacy benefit managers agreed to make the drug available without prior authorization and with low copayments.

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AT&T earns millions selling call data to law enforcement without court order

http://www.phonearena.com/news/AT-T-earns-millions-selling-call-data-to-law-enforcement-without-court-order_id87067

When it comes to call info sweeps, nothing beats the NSA, one might think, but they would be wrong. Back in 2013, the New York Times discovered that the DEA – you know, the department in charge of the “war on drugs” – appears to have logged billions of AT&T call records, in fact a 26-year amount, and counting. Dubbed Project Hemisphere, the undertaking lifted off in 2007, and has apparently never looked back.

We are talking here about actual AT&T personnel sitting in DEA’s offices, helping with the data collection and assisting with, say, tracking those “burner” phones drug dealers use, says the Sunday Times. The report was based on a 27-slide PowerPoint presentation by the DEA, meant for law enforcement officials. The government is apparently chipping in for the expenses connected with all that snooping that goes back to phone records from 1987, and includes every call that has ever passed through the AT&T network, including from other carriers.

This is a pretty dangerous precedent, and AT&T has the incentive to keep the scheme going. After all, municipalities are paying well for using Hemisphere, from $100 thousand to more than a million a year, so why ruin a good thing with extra privacy precautions. The money then get reimbursed through that same police militarization program that supplies Iraq insurgency level equipment to local police departments, so ultimately it’s the taxpayer covering the costs on their own court order-less snooping.

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FDA’s Opioids Action Plan: A Midyear Checkup

http://blogs.fda.gov/fdavoice/index.php/2016/10/fdas-opioids-action-plan-a-midyear-checkup/

By: Robert M. Califf, M.D.

As FDA works to address the opioid epidemic of abuse, misuse and addiction, it’s valuable to see firsthand some of the ways the crisis is affecting our communities.

This summer, I toured areas hard-hit by the opioid crisis in Tennessee, West Virginia, and Kentucky, visiting  with survivors of opioid addiction and overdose as well as community activists, government officials, and health care providers, all of whom are working diligently and creatively to address and overcome this crisis.

My visit to the nationally-recognized neonatal intensive care unit at East Tennessee Children’s Hospital was deeply moving and set the stage for the rest of my tour and underscored the urgency of fighting this epidemic. More than a third of the babies admitted to the NICU have neonatal opioid withdrawal syndrome (NOWS), a condition which can be life-threatening if not recognized and treated

Watching a nurse treat a fretful baby suffering from NOWS underscored the complexity of the opioid problem.  Many women taking opioids haven’t planned their pregnancy, don’t immediately know they are pregnant and may not be aware of the risk that opioids pose to their unborn child. This includes those women who are taking medication as part of medication-assisted treatment (MAT) which also includes counseling and behavioral therapies. For women on MAT, the risk of NOWS must be balanced against the additional dangers of untreated opioid addiction during pregnancy.

How best to prevent NOWS and treat opioids use disorder was a continued theme of my trip, and among the issues we grappled with during a roundtable at the University of Tennessee’s Medical Center hosted by Surgeon General Vivek Murthy, who is traveling the country to discuss solutions to opioid abuse as part of his TurnTheTideRx campaign. I’m pleased that expanding access to and the use of evidence-based MAT is a key focus area for the Administration, is a part of the HHS-wide opioid initiative, and is an approach supported by a recent FDA advisory committee.

In Charleston, WV, I met with several patients who are reclaiming their lives with the use of MAT including “Dave.” Like so many others, Dave became addicted to opioid pain medication after being treated for an injury. As a result of his addiction, his marriage failed and he lost contact with his children. But with treatment, he has reunited with his family and next spring will graduate from college and hopes to taper off of his treatment.

Throughout my tour, I heard that opioid education – including training during medical school and residency and greater public awareness far and wide – is a key component in fighting the opioid epidemic. At a roundtable in Charleston, Gov. Earl Ray Tomblin and U.S. Sen. Joe Manchin singled out their state’s model mandatory education program for prescribers and they told me the state is leading an effort to implement the CDC’s Guideline for Prescribing Opioids for Chronic Pain as a best practice for their state-run Medicaid program.

At a firehouse in the town of Williamson, WV, I met with those on the frontlines of the opioid epidemic – the firefighters and first responders who carry life-saving naloxone to help reverse an overdose. They told me more education about naloxone was needed and told me that they appreciate our efforts to help make naloxone more available to the general public.

My last stop this summer was to Kentucky where I toured the emergency room at the Pikeville Medical Center and participated in a roundtable with physicians, pharmacists, and state policy and community leaders brought together with the help of the regional organization Operation UNITE. UNITE coordinates treatment for those with substance use disorder as well as support for their families and friends, and educates the public about the dangers of drug use. These measures, combined with a recent state law requiring prescribers to register with a prescription drug monitoring program are working, we were told.

Throughout my travels, I listened and learned more about how FDA can help end this crisis. I also had the chance to share what FDA has been doing this year to implement a multipart plan to address the opioid epidemic.

Our milestones so far include:

• Developing warning and safety information for immediate release opioids and requiring that prescription opioid analgesics and opioid-containing cough product labels include strengthened warnings about the risk of using benzodiazepines at the same time.
• Working to better understand the long-term safety of using extended release/long acting opioids. Sponsors must now conduct a number of studies to generate postmarket data on these products.
• Issuing draft guidance for industry to support the development of generic versions of approved opioids with abuse-deterrent formulations.
• Seeking advice from the National Academy of Science Engineering and Medicine on how to balance both the needs of patients with pain and the need to address opioid misuse and abuse.
• Supporting increased access to naloxone; for instance, by awarding a contract to conduct consumer behavior studies based on model product labeling for a potential OTC version of the antidote and by launching a competition to create a mobile app that could help find the closest available naloxone treatment in an emergency.
• Approving the first implantable treatment for the maintenance treatment of opioid dependence.

The community-based successes I observed on my three-state tour reinforced my view that we are making important progress in addressing this crisis.  But continued hard work, creative ideas, and collaboration — across government, with the medical profession, health care providers, industry, and, most importantly, patients and their families, is still required.

We at FDA will continue to work with all of these groups, using all the resources at our disposal, to improve the judicious and responsible use of opioids and to help bring an end to this epidemic.

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

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Montgomery pharmacist facing malpractice suit

MONTGOMERY, AL (WSFA) –

A Montgomery pharmacist is facing legal action for allegedly revealing her customers’ private information.

The Alabama State Board of Pharmacy has also taken action against pharmacist Dee Parks.

According to court documents, Parks is the focus of a civil malpractice suit for allegedly giving patient information to a third party.

Attorney Virginia Lucci says Parks issued a lease to one of Lucci’s client. On the back of the lease were three dozen patients of Parks Pharmacy, along with their prescription information, doctor’s name and doctor’s number.

Lucci says it appears Parks decided to print the lease on the blank side of a paper that had been used for her pharmacy’s dispensing report log.

“The HIPAA law was created so that people wouldn’t know what kind of medication you are on. It’s an invasion of privacy,” Lucci said.

In the wrong hands, Lucci believes more than just HIPAA laws could have been violated. She says many of the prescriptions are controlled substances like hydrocodone.

“That information out there, it’s real easy to track these folks down. A lot of these people are older and could become targets for crime to steal their medication,” Lucci said.

Emily Nichols with the Attorney General’s Office says although personal information that can be used in identity theft, like social security numbers, wasn’t compromised, this still should serve as a reminder to be more careful.

“Keep an eye on things like our credit reports, credit card statements, prescriptions. Make sure when we go to the pharmacy to pick up a prescription, there’s not multiple prescriptions in our name. If you are there to pick up one and they say there is two here, find out why there is two there in your name. Be sure to ask questions,” Nichols said. “So many people are hesitant or shy about asking questions and being up front about their own identity and their information. There is no reason that you need to be shy about asking questions.”

We reached out to Parks for a comment, and she said she is waiting for her day in court.

After several violations from a different case, including operating a pharmacy without a permit, not having a valid DEA registration and State Controlled Substances registration, storing drugs in a warehouse and not in a pharmacy, the State Board of Pharmacy suspended Parks license to practice pharmacy and state controlled substance permit for five years.

One more reminder when it comes to protecting your personal information, the Attorney General’s Office advises you never to leave your mail sitting out in public view and invest in a shredder to destroy documents that you might have otherwise just tossed into the trash. 

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Feds: Most states to see steep ObamaCare rate hikes

http://thehill.com/policy/healthcare/302569-feds-most-states-to-see-steep-obamacare-rate-hikes

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Obama Floods US with Opioids; Kills DEA Enforcement Program

https://larouchepac.com/20161025/obama-floods-us-opioids-kills-dea-enforcement-program

Looks like all of these attorneys from Obama/Holder on down… are more interested in job security for the DEA than anything else. Remember, Holder left office being held in contempt of Congress… there has been THREE MEMBERS of the Obama administration and/or affiliated with the Democratic Party/Clinton https://en.wikipedia.org/wiki/Contempt_of_Congress  that still have the charge of CONTEMPT OF CONGRESS  against them and no legal actions taken against them.

But the information in this article along with what we know about all those chronic pain pts having their opiates cut back or discontinued and/or their prescribers being charged with fabricated charges and hundreds or thousands of pts being “thrown to the street”.. and some have committed suicide or started using “street drugs”… and now we have so many ODing because of Acetyl Fentanyl or Carfentanyl being mixed with street Heroin and the DEA does not seem to be capable of stop the importing of these very lethal drugs into our country and on to our streets.

If you read/listen to all the DEA press releases it FOCUSES on all the OD DEATHS… which it seems that they may be the root cause of people being forced to turn to “street drugs” ?

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Insurance Company Would Rather Stephanie Packer Die Than Pay For Her Cancer Treatment

thefederalistpapers.org/us/insurance-company-would-rather-stephanie-packer-die-than-pay-for-her-cancer-treatment

This is what leftist medicine has wrought:

A terminally ill woman in California had coverage for her chemotherapy treatment denied by her insurance company, but they’ll gladly pay for her to commit suicide.

The new California law permits physician-assisted suicide, and as a result, it appears that insurance companies have found a great cost-saving measure: kill their sickest patients.

Stephanie Packer, a wife with four children, was diagnosed with a terminal form of scleroderma. She said her insurance company initially told her it would cover but switching to a different chemotherapy drug at the advice of her doctors, The Washington Times is reporting.

For a while, five months or so, we’ve been trying to get me on a different chemotherapy drug for the infusions, because my doctor felt that it would be less toxic than some of the other drugs that we were going to be using,” Ms. Packer said in a video distributed by The Center for Bioethics and Culture Network on Monday.

But shortly after California’s “End of Life Option Act” went into effect – authorizing doctors to diagnose a fatal dose of medication with a prognosis of six months or less to live, Packer’s insurance company quickly reversed themselves and denied the request:

“And when the law was passed, it was a week later I received a letter in the mail saying they were going to deny coverage for the chemotherapy that we were asking for,” Ms. Packer said.

She said she called her insurance company to find out why her coverage had been denied. On the call, she also asked whether suicide pills were covered under her plan.

“And she says, ‘Yes, we do provide that to our patients, and you would only have to pay $1.20 for the medication,’” Packer said.

All of this comes as other states and areas are considering their own “assisted suicide” bills. Oregon has a “Death with Dignity” act, and the D.C. City council is considering permitting physician-assisted suicide.

After the right-to-die movement began garnering national attention, Ms. Packer said she noticed a change in tone at her support groups for terminally ill patients. While the meetings were formerly positive and encouraging, she said the specter of suicide now hangs above them like a dark cloud.

“And people, once they became depressed, it became negative, and it started consuming people,” she said in the video. “And then they said, ‘You know what? I wish I could just end it.’”

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Heroin Boom: Afghanistan Producing 25 Times More Opium Since U.S. Invasion

http://www.breitbart.com/national-security/2016/10/24/heroin-boom-afghanistan-producing-25-times-opium-since-u-s-invasion/

The estimated opium poppy plant production and its cultivation area in Afghanistan have increased more than 25-fold over the course of the ongoing war in the country to 4,800 metric tons and 201,000 hectares (ha), respectively, according to the United Nations.

Meanwhile, eradication efforts appear to have collapsed this year despite the estimated $8.5 billion in American taxpayer funds that the United States has already spent on anti-narcotics measures in Afghanistan since the war started in October 2001.

Each year, the UN Office on Drugs and Crime (UNODC) issues the Afghanistan Opium Survey to show production and cultivation trends of the deadly drug in the country, considered the world’s top producer of opium and its heroin derivative.

“The potential opium production in 2016 might be an underestimation,” acknowledges the UNODC, noting that it had to rely on satellite images to calculate estimates due to the worsening security conditions in top opium-producing regions.

According to the latest UN survey, since the U.S. invaded Afghanistan on October 7, 2001, the area under opium cultivation has increased nearly 25 times from 8,000 ha in 2001, when the ruling Taliban regime had imposed an opium ban across the country, to 201,000 ha this year, which is equivalent to an area more than 11 times the size of Washington, D.C.

Both the increase in cultivation area and the decrease in eradication efforts were attributed to deteriorating security conditions across the country. Taliban jihadists, who use proceeds from the sale of opium and heroin to fund their terrorist activities, are primarily responsible for the crumbling security conditions in Afghanistan.

Meanwhile, estimated opium production shot up to 4,800 metric tons in 2016, from 185 tons when the U.S. invaded. The dramatic increase in opium production is reportedly not only the result of a larger area under cultivation but also due to the higher opium yield per hectare.

Opium production and cultivation have increased dramatically since 2015 alone, notes the latest survey. The UN reports that estimated production jumped 43 percent and cultivation rose 10 percent this year compared with 2015 levels.

Areas under cultivation this year marked the third-largest in two decades, following historic highs in 2013 and 2014.

UNODC Executive Director Yury Fedotov indicated that the most recent survey shows “a worrying reversal in efforts to combat the persistent problem of illicit drugs and their impact on development, health and security.”

Eradication efforts appear to have disappeared this year with an area of 355 ha uprooted, marking a 91 percent drop when compared to 3,760 ha in 2015.

Most (54 percent) of the opium in Afghanistan is cultivated and produced in southern provinces that border Pakistan and have historically been Taliban strongholds, namely Helmand and Kandahar, the deadliest provinces for U.S.-led coalition forces of the ongoing war.

Opium is cultivated and/or produced in nearly two-thirds (21) of the 34 provinces that make up Afghanistan, the UN reveals.

U.S. government officials maintain Afghan heroin is not fueling the growing heroin overdose epidemic taking American lives on a daily basis in the United States.

In June, the DEA reported, “In 2014, 10,574 Americans died from heroin-related overdoses, more than triple the number in 2010.”

In its latest National Drug Threat Assessment, the DEA notes that only a small portion of Afghan heroin makes it into the U.S., smuggled primarily by Nigerian traffickers on commercial airlines.

In 2012, the latest year for which data is provided, Afghan heroin reportedly accounted for about four percent of estimated total weight of heroin seized in the United States.

The DEA acknowledges that most of the heroin flowing into Canada primarily originates in Afghanistan, but it maintains that Mexico and “to a lesser extent Colombia” are the top providers of the fatal drug in the United States.

Nevertheless, the White House and other government agencies have sounded the alarm on the Afghanistan heroin going into Canada, suggesting it may be flowing into the U.S.

Some American soldiers in Afghanistan have been investigated “on suspicion of using or distributing heroin, morphine or other opiates during 2010 and 2011,” the Associated Press (AP) pointed out in 2012.

Pentagon data analyzed by Breitbart News shows the number of U.S. service members testing positive for heroin has increased over the course of the war in Afghanistan.

In December 2014, the U.S. Special Inspector General for Afghanistan Reconstruction (SIGAR), reported that some U.S. taxpayer-funded reconstruction efforts, “such as improved irrigation, roads, and agricultural assistance,” may have contributed to the booming opium trade in Afghanistan.

In 2014, the DEA drug threat assessment shows, Mexico produced an estimated 42 metric tons of heroin. Afghanistan produced 6,400 metric tons of opium that same year.

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If You’re Prescribed Opioids after Injury or Surgery, Will You Become Dependent?

nationalpainreport.com/if-youre-prescribed-opioids-after-injury-or-surgery-will-you-become-dependent-8831759.html

We’ve all seen the massive media attention on the opioid epidemic and as the dust settles and changes are made to how opioids are viewed, we are left with a few takeaways.  One of them is that if someone is injured or has had surgery, prescribing opioids is a bad thing because many will become dependent.

A new study presented at the American College of Surgeons refutes this notion, reporting that up to one year after discharge from the hospital, only about 1 percent of trauma patients were reportedly still taking prescription opiates, or opioids, such as hydrocodone, oxycodone, morphine, and fentanyl.

“Our findings in patients who sustain traumatic injury contradict the popular narrative about the role that appropriate use of opioids may play in the rate of opioid abuse in this country,” said senior investigator Andrew Schoenfeld, MD, an orthopaedic surgeon at Brigham and Women’s Hospital and assistant professor at Harvard Medical School, Boston.

This new study is one of the largest investigations of prescription opiate use among patients who sustained trauma and may have the longest continued follow-up one year after hospital discharge.

Their research was conducted using the 2007 to 2013 database of TRICARE, the Department of Defense health care system that insures active-duty military, reserve members, retired veterans, and their dependents. Because most TRICARE plan members are currently civilians, Dr. Schoenfeld said the study findings are generalizable to the U.S. population.

Included in the study were patients aged 18 to 64 years whose injuries were severe, as indicated by an Injury Severity Score of 9 or higher.  Patients with major trauma could be expected to receive opiate prescriptions after their hospitalization.  In all, 15,369 patients were included and none of the patients had filled an opiate prescription within six months before their injuries.

Although more than half of the patients in the study, or 8,282, filled at least one opiate prescription soon after discharge, only 8.9 percent (1,371 patients) continued to fill opiate prescriptions three months later, the investigators reported.  Continued prescription opiate use reportedly dropped to 3.9 percent (597 patients) at six months and 1.1 percent (175 patients) at one year.

“We were really surprised by how low the numbers were for long-term opiate use,” Dr. Schoenfeld said.  “It appears that traumatic injury is not a main driver for continued opioid use in patients who were not taking opioids prior to their injuries.”

To identify predictors of continuing use of prescription opiates after hospital discharge, the researchers evaluated patients’ demographic and medical factors and found increased risk of continued opioid use among the following:

• Patients ages 45 to 64 compared to those 18 to 24.
• Lower socioeconomic status
• Those who are married (although these finding probably cannot be generalized to the U.S. population, according to Dr. Schoenfeld, because military families tend to marry earlier than civilians do.)

“We wish to emphasize that health care providers should not withhold opiate painkillers because a patient has any of the identified risk factors from this study,” Dr. Schoenfeld said.  “At-risk patients can benefit from closer follow-up with their health care providers and, for those at high risk, a referral to the hospital’s pain management service.”

The study results were presented at the 2016 Clinical Congress of the American College of Surgeons.

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