https://youtu.be/zC0GOmI0nns

This is probably the most important “News Shot” I’ve done to date. Countless millions suffer from chronic pain…. a REAL epidemic! What’s even more appalling is the fact that relief exists for those who are suffering, but the relief is out of reach…. NOT because of a shortage, but because of a phony “War on Drugs” that does nothing but make the rich, richer and the suffering, suffer horribly. The truth is a lonely warrior…. https://www.yahoo.com/news/armed-data… https://www.cdc.gov/nchs/fastats/lead… Read more at http://www.TheDailySheeple.com and #WakeTheFlockUp

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Senate committee focuses on pain sufferers denied painkillers amid opioid crisis

https://www.foxnews.com/health/chronic-pain-patients-opioids-senate-committee-hearing

As the national focus on the opioid crisis centers on cracking down on overprescribing practices and addressing addicts, Sen. Lamar Alexander, who chairs the upper chamber’s health committee, is putting a spotlight on a critical side of the debate that has been neglected — people who suffer chronic debilitating pain.

The veteran Tennessee Republican lawmaker is holding hearings — one was in February, and another may take place this summer — to hear from sufferers of debilitating pain, who in the last two years have reported being forcibly tapered down or outright abandoned by doctors who had been treating them.

The senator said he is determined to expand the focus on opioids at the same time other federal and state officials have begun to acknowledge that many doctors are taking drastic and medically dangerous steps out of fear of being targeted by authorities in the current anti-opioid climate.

The result is what public health experts are calling a “pain crisis,” with numerous patients across the country being undertreated for intense pain that has driven many to consider or carry out suicide, and others to turn to heroin.

“As we address the opioid crisis, we must keep in mind the millions of Americans who are in chronic pain,” Alexander said in an email to Fox News.

Alexander said that the next hearing before the Senate Health, Education, Labor and Pensions Committee will take up a federal task force’s just-released recommendations on how to balance the needs of pain patients against policies tightening opioid prescription practices. The task force is an advisory committee of the Department of Health and Human Services that was authorized by the Comprehensive Addiction and Recovery Act (CARA), which was signed into law in July 2016.

“I am grateful for the work of this task force, and I’m reviewing the final report,” Alexander said. “Earlier this year, the Senate health committee held a hearing on the causes of pain and how we can improve care for patients with pain. I plan to hold another hearing this year to discuss the recommendations of the task force.”

Chronic pain patients number 50 million, and for at least half of them, prescription opioids are the only – or a crucial part of – treatment that brings enough relief to allow them to get out of bed without suffering. They are medically dependent on, but not addicted to, legal opioids.

But the drug overdose epidemic that has claimed tens of thousands of lives has resulted in a sweeping war on prescription painkillers, even though most of the fatalities or emergency room cases have involved black-market opioids such as illicit fentanyl and heroin.

“The main impetus for the hearing,” Alexander told Fox News in a telephone interview, “was knowing that in a country where you have more than 50 million Americans who have chronic pain, and 20 million who have high-impact chronic pain, when you put in concerted efforts to take away the most effective painkiller for them, you’re going to have trouble.”

Alexander said it’s been eye-opening to learn about the unintended consequences of hardline actions to address the overdose epidemic.

“There’s no doubt that the goal was not to end the use of opioids, which are effective painkillers,” Alexander said. “Our goal was to stop abuse of opioids, which was caused by overprescribing by doctors or diversion by people who got their hands on opioids and used them for the wrong purpose.”

At least 33 states have enacted some type of legislation related to prescription limits, according to the National Conference of State Legislators. Many of the policies and regulations put into place have been based on a since-revised 2016 guideline by the Centers for Disease Control and Prevention (CDC) that was meant as a resource, not a mandate for primary care physicians prescribing opioids to patients who were taking them for the first time.

Earlier this month, both the Food and Drug Administration (FDA) and the CDC warned doctors not to abruptly stop prescribing opioid painkillers to patients who are taking them for chronic debilitating pain, generally lasting more than three months.

The FDA is also amending labels on opioids that inform doctors how to taper them.

“We found that there was a good deal of misunderstanding about what the CDC guideline was intended to do,” Alexander said. “They’re not supposed to be a substitute for an individual doctor’s decision about what the appropriate prescription is for a patient. We have this problem when the federal government or a government agency issues guidelines, they suddenly become ‘law.’ People become afraid. You have insurance companies refusing to reimburse for opioid prescriptions. It’s easier just to follow [the guidelines] rather than make your own decision.”

In legislation he has co-sponsored to combat the overdose epidemic, Alexander said, “We resisted federal rules on opioid prescription limits…It was the wisest thing we did in the entire legislation. That’s why our hearing [in February] was important and why another hearing, on the HHS task force review and possible revision of the CDC guidelines, [is] in order.”

“Now that we have started to turn the train around and head in a different direction on the use of opioids, everyone – doctors, nurses, insurers, and patients – will need to think about the different ways we should treat and manage pain,” he said.

Though they are an accepted tool to treat severe pain from serious injuries, surgery and cancer, opioid medications can be addictive and dangerous even when used under doctors’ orders. Prescriptions have fallen in the U.S. by nearly a quarter since peaking at more than 255 million prescriptions in 2012.

But health care experts and pain patients argue that targeting legal opioids has done nothing to solve the overdose fatality rate, which has continued to rise.

One of the most often-heard complaints by prescribers about why they are undertreating or abandoning pain patients who long have been given opioids for their conditions is that they fear the Drug Enforcement Administration (DEA) coming after them, which has been happening with more frequency when the agency suspects that a doctor may be prescribing beyond what is necessary.

The DEA did not respond to requests for comment, but in past interviews, told Fox News that contrary to the criticism, they are not gunning for doctors or other prescribers.

Alexander said that requesting DEA officials go to the next hearing to respond to the criticism of prescribers and explain how they decide whom to pursue “seems to be in order.”

Texas Medical Board President Dr. Sherif Zaafran, who served on the HHS task force, said it would be an important move for Alexander to have DEA officials testify.

“It would be very helpful if the hearing and Congress hold them accountable,” Zaafran said. “Doctors know they’re prescribing correctly, but they’re afraid to keep prescribing. They say ‘Yeah, but the DEA comes on my neck.’ It creates a lot of confusion, the DEA puts them in a bind, the DEA is practicing medicine without a license.”

“Congress can direct the DEA to work more closely with state regulatory agencies,” he said. “There has to be clear direction to make sure patients’ needs are balanced with illicit use of drugs that are out there.”

Many pain patients, along with the doctors who treat them and advocacy groups — long frustrated by discussions about prescription opioids that excluded their voices — are starting to feel optimistic that their experience with painkillers as being safe and crucial to their ability to have a quality of life is finally gaining attention.

“Things are really starting to shift,” said Kate Nicholson, a former federal prosecutor who credits her opioid treatment with allowing her to function after years of being bedridden. “There’s the work of the HHS task force, the HHS, and other federal agencies saying there’s a problem with the CDC guideline.”

“Senator Alexander has been a leader on the issue, he’s courageous, he’s been willing to hear from people with chronic pain,” said Nicholson, who has met with the senator’s aides about the issue.

My money is on that whatever DEA representative that shows up for this hearing – if they bother to show up at all  – will LIE THRU THEIR TEETH about how they are NOT going after prescribers…. or… the committee will ask such “softball questions” that the whole process will be mostly meaningless.

After all Senator Alexander is one of the attorneys that makes up about 40% of Congress.  With TN having one of the more severe opiate crisis… and the state legislature passing some very draconian laws effecting chronic pain pts… does it seem logical that Alexander would have a very different mindset towards pain management ?

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Judges: Feds must act if asked to take a fresh look at pot

http://www.dailyjournal.net/2019/06/03/us-marijuana-lawsuit/

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Some of you may or may not be aware, but I have gestational diabetes while I am pregnant. That means I have to take insulin while I am pregnant to control my blood sugar, but it should return to normal after the baby is born. This post, however, is not about me…

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The Future of Rebates: The Black Swan Scenario

https://www.drugtopics.com/latest/future-rebates-black-swan-scenario

What lies ahead for the specialty pharmacy industry?

That is the question that Adam J. Fein, PhD, CEO of the Drug Channels Institute, attempted to answer during a panel entitled, “Specialty Pharmacy Industry Outlook: What’s Next?” at the 2019 Asembia Specialty Pharmacy Summit in Las Vegas in April.

Fein is often called on to discuss the future of specialty pharmacy and opened the panel by stating the industry was at an important “turning point.” referring to the HHS proposed rule to eliminate safe harbor protections for the rebates paid by drug manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans, and Medicaid managed care plans.

“We are at an inflection point that will potentially change the entire commercial model of the pharmaceutical industry for the first time in a generation,” he said. “We are potentially on the verge of moving to a world without PBM rebates—which will lead to a total change in the way we do business.”

But in order to offer his thoughts on what this brave new world might bring, Fein said it was important to consider the various factors that led to this point. He noted that, back in 2014, drug list prices were increasing in double-digit rates.

“Can you think of any other thing you buy where the same thing goes up 13.5% over one year and then another 11.9% the next?” he asked the audience. When industry executives like Mylan’s chief executive officer Heather Bresch were called to account by the U.S. government to explain the skyrocketing costs, they explained that they only received 45 cents on the dollar—the other 55 cents were going to other players.

That’s shined a light on how rebates and kickbacks were influencing drug pricing—and hurting patients.

In his talk, Fein also addressed what he called the “gross-to-net bubble.” In the past few years, there has been a significant difference between list and net prices, or the cost of drugs after discounts and rebates. Such a bubble is simply unsustainable, he said .

“In 2013, $83 billion in rebates and other discounts were provided by manufacturers off the list price—by last year, that number was $166 billion,” he shared. “These things have essentially created a crisis for patients, who are paying out-of-pocket costs, their copay,s or deductibles, based on the list price.”

Given these issues, it’s not surprising that HHS proposed the antirebate rule—which many believe will be finalized in the next few months. Fein said, if it is finalized, it will “blow up the entire system” and require everyone in the specialty pharmacy industry to rethink how they do business. But, even if the rule does not go through, he said, the issues that brought us here still need to be addressed. Too much has been revealed about the inner workings of the industry, where the model is now that the sick subsidizing the healthy, he said.

“If approved, the entire way that plans and premiums manage specialty pharmacy would change,” he said. “We need to start focusing on the true net cost of drugs. You may see many brand name drugs vanish from formularies. And you will probably seem benefit design being to change. There will be a world of greater competition.”

He believes this kind of previously unfathomable “black swan” scenario will require physicians and patients to make direct cost and value trade-offs differently than they do at present.

“There will be an extensive amount of usage management. There will be a lot of formulary management,” he said. “You’ll see specialty pharmacies navigating a whole new world with their patients—and the rationale for the gross-net-bubble will disappear.”

On the precipice of such radical change, the industry will have to rethink the way it has traditionally done business, he said. But, as with any other time of great uncertainty, there is the potential for remarkable opportunity.

“This is an exciting time. It’s a dynamic time. It’s a time of greater change than I’ve ever seen in this industry,” Fein concluded. “With all this change, with all this trouble, with all this complexity, try to stay positive

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Heartburn Drugs Linked To Fatal Heart And Kidney Disease, Stomach Cancer

https://www.news-line.com/PH_news28872_enews

Extended use of popular drugs to treat heartburn, ulcers and acid reflux has been associated with an increased risk of premature death. However, little has been known about the specific causes of death attributed to the drugs.

Now, a study by researchers at Washington University School of Medicine in St. Louis and Veterans Affairs St. Louis Health Care System has linked long-term use of such drugs — called proton pump inhibitors (PPIs) — to fatal cases of cardiovascular disease, chronic kidney disease and upper gastrointestinal cancer.

More than 15 million Americans have prescriptions for PPIs. Further, many millions more purchase the drugs over the counter and take them without being under a doctor’s care and often indefinitely.

The researchers also found that such risk increases with the duration of PPI use, even when the drugs are taken at low doses.

The study is published online May 30 in the journal The BMJ.

“Taking PPIs over many months or years is not safe, and now we have a clearer picture of the health conditions associated with long-term PPI use,” said senior author Ziyad Al-Aly, MD, an assistant professor of medicine at the School of Medicine. He has led several studies associating PPIs to chronic kidney disease and an increased risk of death. The urologist melbourne’s  helps you in the kidney disease.

Other researchers independently have linked PPIs to adverse health problems such as dementia, bone fractures, heart disease and pneumonia, among others.

PPIs — sold under brand names such as Prevacid, Prilosec, Nexium and Protonix — bring relief by reducing gastric acid. PPIs are among the most commonly used classes of drugs in the U.S.

For the study, researchers sifted through de-identified medical records in a database maintained by the U.S. Department of Veterans Affairs. Examining medical data acquired from July 2002 to June 2004, the researchers identified 157,625 people — mostly Caucasian men ages 65 and older — who had been newly prescribed PPIs, and 56,842 people who had been newly prescribed another class of acid-suppression drugs known as H2 blockers. They followed the patients — 214,467 in total — for up to 10 years.

The researchers found a 17 percent increased risk of death in the PPI group compared with the H2 blocker group. They calculated 45 excess deaths attributable to long-term PPI use per 1,000 people. Death rates for PPIs were 387 per 1,000 people, and death rates for H2 blockers were 342 per 1,000.

“Given the millions of people who take PPIs regularly, this translates into thousands of excess deaths every year,” said Al-Aly, a nephrologist and clinical epidemiologist.

PPI use was associated with deaths caused by cardiovascular disease, chronic kidney disease and upper gastrointestinal cancer. Specifically, 15 per 1,000 of the PPI users died from heart disease; four per 1,000 from chronic kidney disease, and two per 1,000 from stomach cancer. Death rates due to cardiovascular disease were 88 among the PPI group and 73 among the H2 blockers group. For stomach cancer, death rates were six in the PPI group and four in the H2 blockers group. Death rates due to chronic kidney disease were eight and four in the PPI and H2 blocker groups, respectively.

Additionally, the study found that more than half of the people taking PPIs did so without a medical need, although the data did not indicate why the patients had been prescribed PPIs. Among this group, PPIs-related deaths were more common, with almost 23 people per 1,000 dying from heart disease, almost five per 1,000 from chronic kidney disease, and three from stomach cancer.

“Most alarming to me is that serious harm may be experienced by people who are on PPIs but may not need them,” Al-Aly said. “Overuse is not devoid of harm.”

The study also found that more than 80 percent of PPI users were on low doses of the prescription drug, or those equivalent to doses offered in over-the-counter versions. “This suggests the risk may not be limited to prescription PPIs, but it also may occur at over-the-counter doses,” he said.

The U.S. Food and Drug Administration has expressed interest in data presented by Al-Aly’s research team. “PPIs sold over the counter should have a clearer warning about potential for significant health risks, as well as a clearer warning about the need to limit length of use, generally not to exceed 14 days,” he said. “People who feel the need to take over-the-counter PPIs longer than this need to see their doctors.”

Al-Aly’s research team will continue to study adverse health effects related to PPIs, in particular regarding those at the highest risk.

“A lot of people may be taking PPIs unnecessarily,” Al-Aly added. “These people may be exposed to potential harm when it is unlikely the drugs are benefiting their health.

Our study suggests the need to avoid PPIs when not medically necessary. For those who have a medical need, PPI use should be limited to the lowest effective dose and shortest duration possible.”

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People in Pain: Navigating Opioid Crisis Politics

https://www.forbes.com/sites/forbesbooksauthors/2019/05/30/people-in-pain-navigating-opioid-crisis-politics/#43b18d484a9e

If you told me that I would get a barrage of angry emails and social media posts for writing The United States of Opioids: A Prescription for Liberating a Nation in Pain,  I would not have believed you . Who could possibly have a problem with my trying to change the conversation to solving the opioid crisis?

Whoops. Even before the book came out, I got a stream of surprising messages. They came from people living with severe and chronic pain, for whom the focus on opioids has made it difficult and, in many cases, impossible, to get the opioid pain medication they depend on. The messages boiled down to a common cri de coeur:  

• I used opioids prescribed by my doctor responsibly for serious pain that I live with.
• The opioid crisis is about abusers: irresponsible people who took too much and got addicted and/or people using opioids illegally without prescriptions.
• Now my doctors won’t prescribe opioids or pharmacies won’t dispense them because of the abusers—and you are making it worse by conflating responsible users and abusers, stirring the pot, and calling unnecessary attention to the “crisis.”

One of the trickiest aspects of the opioid crisis is that at the same time that others were overdosing and becoming addicted, for many people, opioid medication was really working fine in managing pain and allowing for a night’s sleep. For these people, the problem is not opioids, but the focus on the opioid crisis, which has given rise to a DEA and state licensing board crackdown that has left doctors and pharmacies afraid to prescribe.

While we focus so much on the overdose deaths and people living with addiction, people in pain are the most commonly overlooked victims of the crisis, and not few in number. One in five adults—50 million Americans—report living in chronic pain. For one in twelve adults—20 million people—pain limits their ability to work and function most or every day. For people in pain, the neurobiological effect on receptors in our neurons and nervous systems make opioids uniquely powerful. They relieve pain in a way which no other medication can currently match (just ask anyone who depends on opioids for severe, chronic pain relief if ibuprofen or acetaminophen will do the trick for their pain).

Over the past 25 years of advising doctors on prescribing compliance, I’ve seen the pendulum shift on treating pain. In the 1990s and early 2000s, the pressure was on physicians to make sure people in pain got the medication they needed. This pressure reflected a shift from a half-century of concern about overtreating pain. In the early 2000s, doctors were disciplined by the state medical board of being too stingy with medication after patients complained. Pain was the “fifth vital sign,” which doctors and hospitals ignored at their peril.

Fast forward to the present and the pendulum has swung hard the other way. Around the country, tens of thousands of doctors and hundreds of pharmacies are currently being investigated for overprescribing opioids. Here in California, the Medical Board and the California Department of Public Health are reviewing death certificates for thousands of patients. They are cross-checking causes of death suggestive of possible overdoses (such as heart attacks) with medical records from doctors, hospitals, and coroners. The investigation is the broadest review of physician prescribing in state history. It encompasses more than 2,000 cases to date and has lead to licensing discipline and, in some cases, criminal investigations against hundreds of physicians. Add DEA investigations to the mix, and doctors are living in a climate of fear.

For many chronic pain patients who have been taking opioids with positive outcomes for years, the pressure on physicians is a problem. One pain medicine doctor recounted to me only prescribing higher doses of opioids for a small subset of long-term patients who have tolerated opioids for over a decade. This doctor prescribes in these cases because the patients are unable to taper off usage. Many more patients receiving long-term opioid prescriptions have been cut off altogether, as their doctors retire or simply get nervous.

In writing The United States of Opioids, my goal was to change the conversation by calling attention to the full scope of the current crisis, including the people living in pain and unable to access needed care. For some people, non-medication treatments offer promising alternatives. For others, opioids are the only thing that has ever worked well.

For these patients, the problem is that finding a middle ground to meet patients’ needs has become virtually impossible. The medical community has circled the wagons around the view that opioids shouldn’t be the first line option for treating pain. However, we are missing guidelines and protocols that would give doctors confidence on safe pathways to prescribe opioid medications to patients needing them on a longer-term basis.

The tragic consequence of this gap is that people in need of care are being turned away, suspected of being drug-seekers. It’s not just the doctors and emergency rooms that are turning people away. If you talk to any patient who depends upon opioids to manage chronic pain, pharmacies have become the most recent barrier to obtaining legitimate opioid pain medication. Many pharmacies are now protecting themselves by simply declining to fill any prescriptions for opioids. In other cases, pharmacies will not fill prescriptions until confirmation that the doctor has provided documentation of the prescription to the patient’s health plan. These hurdles, intended to prevent abuse, make the process of getting medications even more miserable for patients who are legitimately in need.

The long-term answer to this problem? I would like to highlight five things that we ought to be focusing on:

1. Developing condition-specific protocols for the use of opioid medications to create clear standards for doctors to prescribe to people in pain without fear of disciplinary or criminal charges: You might think that protocols have been disseminated for how doctors can safely prescribe opioids. The CDC came out with primary care guidelines, but many doctors have complained that they are more useful as a tool for prosecuting doctors for noncompliance rather than simplifying the pathway for treatment. The bigger problem is that we need simpler guidelines for doctors to prescribe for a whole host of different conditions to liberate doctors from fear-based avoidance of pain treatment.
2. Demanding access and reimbursement parity: One recurrent challenge is the lack of alternative pain treatment options. Even when clients find promising options, such as infusion therapies or neurofeedback, payor coverage guidelines often limit options by not covering forms of treatment. Reimbursement limitations also prevent physicians from extended discussions about non-pharmacologic options. One doctor I interviewed for my book said that it takes “30 seconds to say yes [to meds], and 30 minutes to say no.” There is a need for advocacy to enact mandates and expand access to non-opioid and non-pharmacologic treatment of pain. 2008 was the beginning of mental health parity. We need to campaign for pain medicine parity from traditional forms like acupuncture to new, technology-driven approaches and neurostimulation.
3. Increasing research on pain therapeutics: We desperately need to advance research on alternative pain therapeutics, not just medications but nerve stimulation devices and digital tools. We need solutions so people in pain can sleep through the night. We need to push for the removal of regulatory obstacles, insurance coverage mandates for new devices and digital therapeutics, and expanded funding options to treat pain.
4. Promoting integrative approaches to reduce pain: A growing body of research supports the mind-body connection pioneered by Dr. John Sarno, meaning that the way we think and feel can positively and negatively affect our biological functioning. Even as we advocate for more access to medication and non-medication alternatives for people in pain, there is an enormous opportunity to expand resources for integrative approaches. These approaches can offer a supplemental pathway to reduce the experience of pain, including in the workplace and communal settings.
5. More public awareness and advocacy: The lack of attention to the needs of pain patients reflects a lack of public awareness. The voices of the 50 million adults in America suffering from chronic pain and pain advocates need to be heard. Expanding recognition and acknowledgment of pain will help drive government and healthcare policy away from the current anti-medication environment to a more balanced position.

Often when I share my perspective with people in chronic pain, people will reconsider that talking about the opioid crisis makes things worse for them. The current reality is an opioid media barrage in which it can be hard for voices proposing solutions to be heard. It will be through more dialogue about tensions and complexities, not less, that patients will get the treatment they deserve.

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ACLU-NH, state medical society look to block DEA access to prescription drug records

https://www.unionleader.com/news/courts/aclu-nh-state-medical-society-look-to-block-dea-access/article_eab66edb-ffa8-5579-82bf-3c5a1c118b4b.html

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News9.com – Oklahoma City, OK – News, Weather, Video and Sports |

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