DEA admits that weed has never killed anyone

http://www.mauinews.com/opinion/letters-to-the-editor/2017/07/dea-admits-that-weed-has-never-killed-anyone/

The Drug Enforcement Agency-Department of Justice released its latest 94-page report, “Drugs of Abuse,” on June 28.

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Hot Spots for the Opioid Crisis

Problematic pockets in every state, CDC reports

https://www.medpagetoday.com/PainManagement/PainManagement/66477

New county-level data from the CDC highlight the extreme geographic variation in opioid prescription rates, with some areas showing average morphine equivalents per capita 10 times greater than those of less-impacted counties. As seen in the map below, Appalachia appeared to be one giant hot spot. But every state had at least one county with a high per-capita rate of prescribed opioid use.

Overall prescribing has fallen in the past few years, but the amount of opioids per person was still three times higher in 2015 than it was in 1999.

Those were the major findings in a Vital Signs release from the CDC, which focused on opioid prescribing. The data looked at trends through 2015, which notably does not include the agency’s 2016 opioid guidelines. The numbers will serve as a baseline to measure the impact of those guidelines going forward, said acting CDC Director Anne Schuchat, MD.

“The bottom line remains, we still have too many people getting these opioid prescriptions for too many days at too high a dose,” she said.

In a statement, Patrice A. Harris, head of the American Medical Association’s opioid task force, said she was pleased to see the report confirm that physicians have been making “more judicious” prescribing decisions. She also called for increased prescribing of naloxone and pointed to the AMA’s own task force recommendations.

Enough opioids were prescribed in 2015 to medicate every American for three weeks straight. To combat overprescribing, she said physicians should do so only when benefits outweigh risks. Behavioral and physical therapy and NSAIDs should be first choices.

The average days’ supply has increased annually for the past decade, from 13.3 in 2006 to 17.7 in 2015. If opioids are prescribed, the CDC recommends the duration of the prescription should be short — three days or less — and dose amounts should be as low as possible to achieve adequate pain relief.

In that way, the trendline is encouraging. The average daily morphine-equivalent dose per prescription has declined each year since 2006. Schuchat said she expects to see further reductions as the 2016 recommendations are implemented.

“We won’t be able to solve it overnight, but changes … hold promise that prescribing practices can improve,” she said.

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July 7, 2017

Scott Gottlieb, MD

Commissioner of Food and Drugs,

U.S. Food and Drug Administration

10923 New Hampshire Avenue

Silver Spring, MD 20993

RE: Docket No. FDA-2017-D-2497

Dear Dr. Gottlieb,

Physicians for Responsible Opioid Prescribing (PROP) is pleased that FDA intends to revise the Blueprint

for Prescriber Education for Extended-Release and Long-Acting (ER/LA) Opioids Risk Evaluation and

Mitigation Strategies (REMS). When the original Blueprint curriculum was released as a draft in 2011,

PROP urged FDA to make changes (see attached). Our 2011 letter was signed by some of the nation’s leading experts in the fields of Pain, Addiction, Public Health, Primary Care and Internal Medicine.

Unfortunately, FDA disregarded our requested changes.

PROP has serious concerns about the revised Blueprint curriculum. We believe that serious flaws in the original Blueprint remain unaddressed. Furthermore, the Blueprint curriculum contradicts key

recommendations found in the 2016 Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain, which recommended “nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain” and the more recent Department of Veterans

Affairs (VA) and Department of Defense (DoD) Clinical Practice Guideline for Opioid Therapy for Chronic Pain which recommended “against initiation of long-term opioid therapy for chronic pain.” We believe

the REMS curriculum should be based on the CDC guideline and the VA/DOD guideline.

Specific example of inconsistencies between the Blueprint and the CDC and VA/DOD guidelines include the following:

1) The CDC and VA/DOD guideline warn against prescribing high doses of opioids and specifically

recommend against doses greater than 90mg morphine equivalents. The Blueprint omits this critical topic.

2) The CDC and VA/DOD guideline highlight the lack of evidence supporting long-term use of opioids for chronic pain. The Blueprint omits this critical topic.

3) The VA/DOD guideline rejected the recommendation for opioid rotation as a strategy for managing tolerance, and the CDC guideline notes that the practice is not supported by evidence.

The Blueprint encourages opioid rotation.

4) The VA/DOD guideline describes the practice of prescribing immediate release (IR) opioids to patients on ER/LA opioids for “breakthrough pain” as controversial and the CDC guideline notes that the practice is not supported by evidence. The Blueprint calls for teaching this practice.

5) The CDC guideline states that when opioids are prescribed for acute pain “three days or less will often be sufficient; more than seven days will rarely be needed.” The Blueprint omits this critical prevention recommendation.

Since the purpose of the Blueprint is to teach more cautious prescribing the focus should be first and foremost on when to use opioids for acute and chronic pain, and secondly, on how to use opioids as safely as possible. The Blueprint does not need to teach how to make a pain diagnosis, or what alternatives there are to opioids, both of which should be considered beyond the scope of REMS.

We believe the Blueprint should be revised to include the following educational messages for prescribers:

1) Opioids are rarely needed for chronic pain. Given the poor safety profile for long-term opioid therapy, indications should be restricted to those where evidence suggests that benefit predictably exceeds risk. There are many common pain conditions, particularly chronic pain conditions where a central component is dominant, for which no such evidence exists, and for which alternatives to opioids have demonstrated superior long-term efficacy, in addition to greater safety. This includes fibromyalgia, pelvic pain syndromes, irritable bowel disease, chronic non-structural back pain, other non-specific musculoskeletal disorders and headache.

Recent evidence-based guidelines for these conditions emphasize avoiding opioids.

2) ER/LA versus IR opioids. Evidence increasingly suggests that when opioids are required A) intermittent IR opioid therapy at low doses is often sufficient, B) tolerance, dependence and dose escalation are more likely to arise with continuous (round-the-clock) opioid therapy than with intermittent therapy. Tolerance and dependence reduce efficacy and increase risk. Many clinicians are under the false impression that physiological dependence is benign and that opioids can be easily tapered. REMS education should help correct this serious misunderstanding. It is well established that daily long-term use and higher dose therapy are associated with greater risk, including greater risk for addiction and death.

3) Evidence suggest that children and adolescents are at greater risk of developing future misuse and addiction when exposed to addictive drugs, even when the exposure is brief and for acute pain, such as after dental extraction. Young people have a greater range of options for treating pain without the need to resort to opioids.

4) While close monitoring of patients using opioids is essential, due to inherent risks of overdose, physiological dependence and prescription opioid use disorder, there is no evidence that recommended monitoring practices, including risk screening, treatment agreements, urine drug screening and regular follow-up visits, are effective in reducing risks of overdose or prescription opioid use disorder. There is evidence that reducing opioid prescribing and lowering opioid doses can reduce risks of prescription opioid use disorder and opioid overdose.

In summary, we believe a prescriber education effort to improve outcomes for patients with pain will be ineffective unless past misinformation on risks and benefits are explicitly and forcefully corrected.

Prescribers are in need of education that will allow them to properly weigh risks versus benefits before prescribing opioids. An educational effort that fails to do this and instead continues to equate treatment of pain with a prescription for opioids is likely to worsen rather than improve the opioid crisis.

Until opioids are prescribed more cautiously it will not be possible to bring the opioid addiction epidemic under control. In 2011, FDA disregarded concerns of experts about its REMS Blueprint and an opportunity to promote more cautious prescribing was lost. Over the past 6 years, opioid overprescribing has led to many lost lives and many new cases of addiction. We hope FDA gets it right this time.

Sincerely,

Jane C. Ballantyne, MD, FRCA

President, PROP;

Professor, Anesthesiology and Pain Medicine

University of Washington

Andrew Kolodny, MD

Executive Director, PROP;

Co-director, Opioid Policy Research Collaborative

Heller School for Social Policy and Management

Brandeis University

Gary M. Franklin, MD, MPH

Vice President, State Affairs, PROP;

Research Professor, Departments of Environmental Health, Neurology, and Health

Services

University of Washington;

Medical Director, Washington State Department of Labor and Industries

Michael Von Korff, ScD

Vice President, Scientific Affairs, PROP;

Senior Investigator,

Kaiser Permanente Washington Health Research Institute

Chris Johnson, MD

Board of Directors, PROP;

Chair, MN Dept. of Human Services Opioid Prescribing Work Group;

Board of Trustees, Minnesota Medical Association

Anna Lembke, MD

Board of Directors, PROP;

Chief of Addiction Medicine

Stanford University School of Medicine

Rosemary Orr, MD

Board of Directors, PROP;

Professor of Anesthesiology and Pain Medicine,

University of Washington and Seattle Children’s Hospital

Danesh Mazloomdoost, MD

Board of Directors, PROP;

Medical Director

Wellward Regenerative Medicine

Jon Streltzer, M.D.

Board of Directors, PROP;

Professor Emeritus of Psychiatry,

University of Hawaii School of Medicine

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Sheriff won’t let officers use Narcan, says life-saving drug not helping heroin epidemic

http://www.foxnews.com/health/2017/07/07/sheriff-wont-let-officers-use-narcan-says-life-saving-drug-not-helping-heroin-epidemic.html

An Ohio sheriff is taking a stand in the war on heroin addiction that he said will get at the root of the epidemic, and that seems to fly in the face of standard police practices.

Sheriff Richard K. Jones of Butler County, Ohio, told the Cincinnati Enquirer that he believes the drug naloxone, a substance used to revive overdose victims that is known by its brand name Narcan, is more trouble than its worth.

“I don’t do Narcan,” Jones told the Enquirer, noting that his deputies “never carried it… nor will they.”

Jones’ position raises eyebrows for a number of reasons. In his state alone, health care costs related to the epidemic totaled some $1.1 billion in 2015, with Ohio tallying more prescription opioid overdose deaths that same year than any other state in the nation.

And it’s not as if his county has been immune, either. According to the Ohio Department of Health, there were less than two dozen unintentional drug overdose deaths in Butler county in 2003. By 2015, that number had skyrocketed to 195.

In June, Middletown city council member Dan Picard proposed a three-strike style policy for repeat-overdose victims. He said his proposal wasn’t meant to address the heroin issue, but to help the city budget cope with the high uptick in overdose calls. 

“My proposal is in regard to the financial survivability of our city,” Picard told The Washington Post. “If we’re spending $2 million this year and $4 million next year and $6 million after that, we’re in trouble. We’re going to have to start laying off. We’re going to have to raise taxes.” 

In Dayton, Ohio, the drug has been used to reverse overdoses more than 160 times since December 2015.

While there are no laws mandating the use of naloxone by law enforcement, data from the North Carolina Harm Reduction Coalition (NCHRC), a group committed to getting the drug into the hands of community members and law enforcement, suggests that 1,214 law enforcement agencies nationwide are using it as of December 2016.

For Jones, these numbers mean little when weighed against the safety of his deputies. Jones said that users can often become violent, or start vomiting once the drug is administered, and that for his officers “to get on the ground and spray it in their nose is simply dangerous.”

Jones told Fox News that another point he thinks is being missed in the debate over Narcan is that the drug has “helped revive and save some lives but not bring down the usage of heroin.”

Jones said the heroin problem is so bad in his county that “heroin parties” are being held with designated Narcan providers who can buy it at a health department. 

He said there have been at least three babies born in his county jail in the last 18 months that were addicted to heroin.

“I’ve held these little kids and their legs quiver,” Jones said. ” It’s sad.”

Jones isn’t alone in his reluctance to have officers carry the drug.

Chief Craig Bucheit of Hamilton, Ohio, won’t have his officers carry Narcan because the paramedics do.

“It would duplicate efforts,” Bucheit told Fox News.

The idea that using Narcan borders on a medical procedure, and thus should be left to people like EMT’s, is a philosophy embraced by some officers, as well. According to a man identified as a senior officer serving with a North Carolina municipal police department, the issue of whether officers should be carrying Narcan presents something of a Pandora’s Box.

“Officers have years of training and experience in enforcing the law and making arrests,” the officer wrote in Calibre Press. “It takes a unique mindset and specialized skills. It’s not realistic to ask an officer to switch all of that off in an instant and become a medical professional. Where do we draw the line? Do officers carry EpiPens? Anti-seizure medication? Nitroglycerin pills? These are things that can all save lives, too.”

 

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Shakeel A. Kahn, MD

www.doctorsofcourage.org/shakeel-a-kahn-md/

This should be interesting–two dogs fighting over the same bone. Shakeel Kahn and his wife, Lyn Kahn, of Casper, Wyoming were indicted by the Federal Government in two different states in order to steal the same property. But since the winning district reaps the reward of the forfeited assets, these two districts will definitely be at odds.

In January, 2017 Dr. Shakeel A. Kahn, MD, a family practitioner specializing in pain management, was indicted in Wyoming on 21 illegal charges from the usual adulteration of the Controlled Substance Act. As stated in the indictment, “It was a part of the conspiracy that S. Kahn would use his Wyoming and Arizona DEA registrations to prescribe large amounts of Oxycodone and other controlled substances to his customers outside of the usual course of professional practice and to customers without a legitimate medical need,” and failed to conduct any legitimate medical examinations.

Then in March, 2017, Dr. Kahn was also indicted in Arizona.

Wyoming’s Case

Dr. Kahn had his license suspended in Wyoming in November, 2016.

The DEA search warrant used as their justification that the agents believed Dr. Kahn was taking cash payments to prescribe oxycodone to patients in Wyoming, Arizona and elsewhere. Well, let’s see–he’s a doctor in pain management. That sounds like he was doing his job, and the government violated his 4th amendment rights of unreasonable search and seizure. More about that experience later.

By affidavit, which is supposed to be sworn truth, a DEA agent stated that the investigation was prompted by a complaint from the Wyoming Board of Pharmacy. That could be true. The government is actually in cahoots with the Boards of Medicine. Supposedly that happened in my case as well, with a Board of Pharmacy investigator actually going around to pharmacies looking for prescriptions to use against me for the government. I wonder where the salaries of these Benedict Arnolds come from–probably the government.

Now for the crux of the attack: Prosecutors sought (and succeeded in) seizing bank accounts and other assets owned by Dr. Kahn, as well as other totally uninvolved members of his family, such as his father, who kept his entire life savings at home in a safe. So we have Wyoming in possession of Dr. Kahn’s and his family’s assets. In the fight with Arizona, will possession be 9/10 of the law?

Because of the fact that they were left with nothing, the Kahn’s have had to ask for public defenders. That’s how the government wins most cases. Public defenders’ salaries come from the government. They don’t work for the defendant at all. In fact, I suspect they get paid bonuses for losing.

Arizona’s Case

Dr. Khan’s Arizona license was suspended by the Board of Medicine in August, 2016.

The Arizona indictment alleged that Dr. Kahn required customers to primarily pay him in cash. This sounds like a perjurous statement from a government agent. A statement about Dr. Kahn’s office says “Shakeel A. Kahn, MD practices Pain Medicine in Casper, WY. Dr. Kahn accepts multiple insurance plans including Aetna and Cigna.” But the truth doesn’t ever get stated to the Grand Jury. Government agents commit perjury all the time to indict any doctor they want to. And they do it without retribution. We, the people, have to change that. Immunity for criminal acts by government agents has to end.

Also, if Dr. Kahn was only taking cash, and patients with insurance were paying it, then that meant he was the only pain management physician available. By shutting him down, potentially hundreds of chronic pain patients are thrown to the streets for self-treatment. I wonder how many deaths have been the result. The government is a danger to public safety, not the doctors.

The US District of Arizona is pursuing forfeiture of assets including two Fort Mohave properties and another in Wyoming. The forfeiture effort also targets about $1-million in cash seized in Kahn’s Arizona home, $130,000 in cash in bank accounts, and three vehicles.

To add insult to injury, the local law enforcement agency (Mohave Area General Narcotics Enforcement Team or MAGNET) is conducting an in rem seizure of other property, namely a gun collection that was gifted to his father and brothers and eight vehicles including two that were purchased in another country and anything else that is of any value.

Dr. Kahn’s wife, Lyn, was dragged into the case so that ALL of their assets could be confiscated. She is accused of being involved in the sale of painkiller prescriptions by allegedly using her husband’s prescription database account to look up information on former patients and violating federal laws that protect patient privacy. This sounds like another attempt of the government to create a crime where there is no crime. Spouses often help in the administrative end of a business, often without pay. My husband did. How is the government going to support the charge of “knowingly obtaining individually identifiable health information under false pretenses”?  I tell you, the government agents creating these false charges are someday going to be standing in front of the judgement seat of God. I feel sorry for them. It is a sin to falsely accuse someone of a crime. In fact, all of these US Attorneys in all of these false cases against doctors are going to have a clubhouse in hell. To make matters worse, Lyn Kahn was threatened with the loss of her infant child unless she agrees to perjure herself and testify against her husband and brother-in-law.

That’s how this person can become this person: 

The eyes tell it all: the trauma and suffering.

Lyn Kahn’s eight charges are: one count of conspiracy to distribute oxycodone and alprazolam, two counts of dispensing oxycodone and five counts of unlawful use of a communication facility. What the heck does that mean?

Dr. Kahn has been continuously incarcerated since January. This is another ploy of the government to prevent an innocent doctor from defending himself. Obviously, they don’t have much to go on if they have to hold the defendant in jail so he can’t work on his defense.

 

Eyewitnesses of the searches of Dr. Kahn’s homes have shared the unbelievable horror of what happened. When you read this, put yourself in their position. You haven’t broken any law. You are an honest, productive citizen, and one day there is a knock on your door and a gun in your face.

http://doctorsofcourage.org/charged/shakeel-khan-md/

Or you hear a sound of someone in your home:

http://doctorsofcourage.org/charged/raid-on-dr-khans-arizona-home/

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Meet the Doctor Who Refuses to Stop Prescribing Opioids to Pain Patients

Pain patients from across the country are flocking to a boundary-pushing pain specialist in West Covina, California because they can’t get the treatment they need in their home states.

A growing “opioid epidemic” in the U.S. has led law enforcement agencies to crack down on so-called pill mills, leading to the arrest of several physicians. Last year, the Drug Enforcement Agency (DEA) clamped down on painkillers, reducing the allowed production of opioid medications by about 25 percent. Some states have filed lawsuits against pharmaceutical manufacturers, and, earlier this year, the Center for Disease Control (CDC) issued guidelines advising physicians against prescribing high doses of these drugs, which can be particularly lethal when combined with alcohol or anti-anxiety medications. Many doctors will only prescribe opioids as a last resort.

Dr. Forest Tennant, 76, says this regulatory backlash is preventing chronic pain sufferers from getting the drugs they need to alleviate their conditions, and he refuses to go along. Critics have denounced his unapologetic style and unorthodox methods, but his patients depict him as one of the only physicians in America to put the needs of his patients first.

“[Tennant was] the first doctor to say, ‘our goal is to relieve your pain,'” says Kristen Ogden, whose husband Louis Ogden has suffered from chronic pain for decades. They travel to Dr. Tennant’s office from Virginia for treatment every three months. “Every other doctor had said, ‘our goal is to get you off any opioid medications.'”

Many physicians have even begun to adjust the way that they think about pain.

In a New England Journal of Medicine article, one of the pain specialists advising the CDC recommended that pain patients “use coping and acceptance strategies that primarily reduce the suffering associated with pain and only secondarily reduce pain intensity.” That opioids are never an effective chronic pain treatment is quickly becoming conventional wisdom, and the American Medical Association (AMA) has even begun to advise physicians to abandon the pain rating scale when assessing patients.

“I take the Hippocratic oath seriously, that my job is to relieve pain and suffering,” says Dr. Tennant. “So when I see the AMA decide that they’re not going to assess pain, I’m not with them.”

Tennant has run a pain clinic since the 1970s when he mostly treated patients with pain resulting from cancer and polio. He’s never shied away from the public spotlight.

In addition to serving as mayor of his city, he ran some of Los Angeles County’s earliest methadone clinics to treat heroin addicts and in the late ’80s served as a drug adviser for the NFL, NASCAR, and the Los Angeles Dodgers.

Controversy swirled around him in many of these roles.

He angered the NFL when he publicly disclosed plans to monitor several New England Patriots players for drug use. One NASCAR racer even accused him of colluding to falsify drug tests to target him.

Tennant simply told the New York Times that “[n]o mistakes were ever made.”

Tennant says it’s true that opioids were overprescribed in the past and should generally be a last resort for pain treatment. But he believes the media and government have now gone too far in demonizing them, and it’s legitimate pain patients who are paying the price.

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DEA Allowed Criminal Cops to Build Their Own Drug Empires for Over a Decade

www.thefreethoughtproject.com/dea-ignored-agents-selling-drugs-for-over-a-decade/

According to a whistleblower inside the DEA, the agency “allowed and promoted” multiple officers to run their own personal drug cartels for years

New Orleans, LA — For over a decade, agents with a New Orleans-based DEA task force sold drugs, intimidated informants and stole cash on the job with total impunity.

According to the Advocate, Chad Scott, the former leader of the task force has been fired in the midst of the investigation. It was reported that Scott and some of the officers working under him had a massive operation selling painkillers and that they would sometimes sell other drugs that they managed to steal from dealers during raids.

“There were a series of complaints that went back years. This is a guy who probably shouldn’t have been allowed to run his own task force,” an anonymous law enforcement official said.

The good news, in this case, is that a large and growing number of federal criminal drug cases are being reversed and nonviolent offenders are being set free due to the fact that this corruption has been exposed.

The FBI is now involved in the investigation and is reviewing the allegations against the officers. Many of the crimes that were committed by these officers happened so long ago that they can’t even be charged with them anymore, but their crime spree continued long into recent times so there is still a large amount of evidence against them.

DEA Special Agent Debbie Webber said in a statement that “DEA takes very seriously any allegations of wrongdoing or misconduct and holds our employees to the highest possible standards. Due to this being an ongoing investigation and with respect to all parties involved, the DEA cannot and will not comment on personnel matters or inquiries related to this investigation.”

The most disturbing thing about this case is that the DEA may have known about these crimes all along but allowed the officers to continue anyway.

The Advocate reported that four different whistleblowers within the DEA came forward to admit that they warned the DEA over a decade ago about this illegal activity. Unfortunately, their warnings were ignored and the guilty officers saw no consequences for their actions.

One anonymous whistleblower and former colleague of the members of the task force said that Scott could do pretty much whatever he wanted within the DEA.

“The DEA allowed it, if not promoted it,” the whistleblower said, going on to describe Scott as a “cowboy.” The officer also said that Scott was not alone and that a culture of corruption existed within the task force.

Last year, one of the whistleblowers even filed a lawsuit claiming that Scott protected informants who sold drugs and committed other crimes in exchange for tips that would help him get more arrests and improve his arrest numbers.

The veteran DEA agent said in the lawsuit that he faced repeated retaliation from superiors after telling them about what Scott was doing on the job. The Justice Department agreed to an out of court settlement worth $200,000.

The informant “stated that he was only doing as instructed by the ‘authorities’ because he feared for the safety of his family,” according to DEA documents.

These officers were essentially running their own cartels — granted to them by the DEA.

Adding to the growing pile of evidence, Johnny Domingue, another former member of the task force, was arrested and pled guilty, admitting to using his position to “to acquire quantities of cocaine hydrochloride and other Schedule II controlled dangerous substances, marijuana, methamphetamine, other prescription pills, cash from the sale of these drugs and cash seized from individuals who were arrested or ‘shaken down’ while acting under the color of law enforcement.”

Domingue even admitted to stealing over 300 grams of cocaine from the evidence locker at the DEA’s New Orleans Field Division.

Domingue said that when he joined the task force this type of activity was already extremely common.

Douglas Bruce, an investigator with the Justice Department, testified in court that when he interviewed Domingue, he was told that corruption “was a practice that was already in place when he came on board, and he inserted himself sort of in that circle.”

What this case illustrates is the criminal incentive created by the war on drugs and the monopoly of power granted specifically to those tasked with carrying it out. Making arbitrary substances illegal, and then tasking individuals with the control of those substances creates a temptation of easy money that is hard to pass up. 

This case is hardly isolated as this scenario is but a broken record of corruption, playing over and over again in departments across the country.

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S.D. Cops Forced Catheters for Drug Testing

https://www.usnews.com/news/national-news/articles/2017-07-07/south-dakota-cops-indulged-sadistic-desires-forcing-catheters-into-men-aclu-lawsuit-says

Although some men volunteered to give urine samples for drug testing, the Pierre Police Department forcibly catheterized them any way, according to a lawsuit.

Clarified on July 7, 2017: This article has been updated to clarify Samantha Cook’s experience.

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Endo Pharma Agrees to Pull Abuse-Deterrent Opioid

http://www.medscape.com/viewarticle/882578

Endo Pharmaceuticals has agreed to remove its abuse-deterrent extended-release formulation of oxymorphone (Opana ER) from the US market, about a month after the US Food and Drug Administration (FDA) asked the company to stop selling the pain medication.

In a statement, the company said it “continues to believe in the safety, efficacy, and favorable benefit-risk profile” of Opana ER when used as intended. “Nevertheless, after careful consideration and consultation with the FDA following the FDA’s June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market.”

As previously reported by Medscape Medical News, the FDA asked Endo Pharmaceuticals to take Opana ER off the market on the basis of a review of postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal administration to injection after the product’s reformulation.

Injection abuse of reformulated Opana ER has been associated with an outbreak of HIV infection and hepatitis C virus infection, as well as cases of thrombotic microangiopathy, the FDA said.

This is the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale because of the public health consequences of abuse.

The request by the FDA came on the heels of a March meeting of an FDA advisory panel of independent experts who voted 18 to 8 that the benefits of reformulated Opana ER for relief of severe pain no longer outweigh its risks.

Endo Pharmaceuticals said it will work with the FDA to coordinate the “orderly removal” of Opana ER to minimize treatment disruption for patients and allow patients sufficient time to seek guidance from their healthcare provider on other treatment options.

According to the company, net sales of Opana ER were $158.9 million in 2016 and $35.7 million in the first quarter of 2017.

 

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Trump’s Surgeon General Pick Built Reputation Fighting HIV And Opioids In Indiana

http://www.npr.org/sections/health-shots/2017/07/05/535618770/surgeon-general-nominee-championed-policies-to-curb-indiana-s-opioid-epidemic

Several weeks before President Trump nominated Indiana’s state health commissioner Jerome Adams to be the next U.S. Surgeon General, Adams toured the Salvation Army Harbor Light detox center in Indianapolis, Ind., the only treatment facility in the state for people without insurance.

His supporters say the visit is an example of how he’s prioritized the opioid epidemic during his tenure as Indiana’s top health official. Addiction specialists and advocates say he’s led important progress in implementing lifesaving policies. They believe that if confirmed, Adams would use his on-the-ground experience to guide national policy.

“I believe that Dr. Adams understands the value of community grassroots efforts, that they should be included at the table with decision makers,” says Justin Phillips, founder of the prevention-focused group Overdose Lifeline, who toured the detox center with Adams. “They need to understand what’s realistic in the field.”

A practicing anesthesiologist, Adams was appointed Indiana Health Commissioner by then-Gov. Mike Pence in October 2014. Four months into the job, he announced an HIV outbreak in rural Scott County, Ind., after health workers documented 26 cases of HIV there. By May 2015, the number of confirmed infections had risen to 158, spread almost entirely through injection drug use. 88 percent of them also tested positive for hepatitis C. Today, the number of confirmed HIV cases has reached 219.

Pence had expressed moral reservations about syringe exchanges — a sentiment that Adams told the New York Times he originally shared. But in March 2015, the governor acted on advice from Adams and the Centers for Disease Control and Prevention and authorized a 30-day emergency syringe exchange, citing a public health emergency. Later that spring, Pence signed a law legalizing syringe exchanges in Indiana.

Beth Meyerson, co-director of Indiana University’s Rural Center for AIDS/STD Prevention, worked closely with Adams throughout that period. She says early on, when it became clear to legislators that a clean syringe exchange program was needed to reduce the spread of HIV and hepatitis C, Adams was able to bring public health evidence to the table.

“Dr. Adams navigated the very ideological political environment that was created by then-Gov. Pence,” she says. “There’s just no doubt the governor wouldn’t have listened to me or listened to the leaders in the legislature, but he would listen to Jerome Adams.”

She thinks Adams will have sway working with Vice President Pence on a national scale, too. “He will navigate [Washington], I suspect, the same way that he did in Indiana, which is to listen to communities, work with several partners across the arena, and bring public health evidence to the table again as an advocate for community health,” Meyerson says.

Adams has since supported other state laws aimed at curbing the opioid epidemic, including a bill that increased access to the overdose antidote naloxone, and another that restricts the amount of opioid medication a prescriber may give to adult patients who have not previously taken opioids and to children.

Still, Meyerson says expectations about what Adams might do in Washington have to be tempered by political reality. Even in Indiana, the laws he helped pass haven’t been as comprehensive as she and other public health workers would have liked. The original syringe exchange law “was an administrative nightmare,” she says. It has since been updated by Indiana Gov. Eric Holcomb, making it easier for counties to start exchanges.

Funding also remains an issue. Indiana ranks 49th in the country in public health spending. “So all of these counties who have tried to move forward for syringe access are doing so with both hand tied behind their backs, because they do not have the resources to make this happen,” Meyerson says.

If confirmed by the Senate, Adams would be the second health official from Pence’s home state to join the Trump administration. Seema Verma, who helped shape Indiana’s Medicaid expansion, now heads the Centers for Medicare and Medicaid Services.

This past March, this physician – head of the Indiana Health Dept – made a presentation to a meeting of the Indiana Pharmacist Alliance.  I came away impressed by the common sense of this young – at least to me – doctor.

I was not sitting far from where he was standing and had the opportunity to ask some pointed questions about content of his presentation…  after about the second question.. he turned to the audience and said ” he is actually NOT A PLANT” and then turn to me and said that “maybe I should take you with me to presentations”… at that time .. I extended my hand with my BUSINESS CARD… which he walked over to me and accepted and put in his coat pocket  🙂

According to this article he was first opposed to the clean needle program in Scott Co Indiana but upon realizing the alternatives, was able to make a intellectual change of mind.

That was two years ago and according to recent local news reports, there is a measurable change in Scott Co and the number of substance abusers.

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