44 state AGs ask Congress to repeal law favoring drug companies

http://www.jurist.org/paperchase/2017/11/44-state-ags-ask-congress-to-repeal-law-favoring-drug-companies.php

Attorneys general from 44 states on Tuesday signed a letter [text, PDF] asking Congress to repeal the Ensuring Patient Access and Effective Drug Enforcement Act [text, PDF], which they claim prevents the Drug Enforcement Agency (DEA) from using effective drug enforcement efforts.

The National Association of Attorneys General sent the letter to Republican and Democratic leaders in light of an investigation earlier this year that revealed the disabling effects of the Act on the DEA in preventing pharmaceutical companies from “spilling [WP report] prescription narcotics onto the nation’s streets.” The letter cites to federal laws affected by the Act and explains the Act’s affect on the DEA’s most important tool:

In the midst of this deepening public health crisis—at a time when our nation needs every available weapon at its disposal to combat the opioid epidemic—the Act effectively strips the Drug Enforcement Administration of a mission-critical tool, namely, the ability to issue an immediate suspension order against a drug manufacturer or distributor whose unlawful conduct poses an imminent danger to public health or safety.

Reports concerning the investigation were especially startling, considering Congress unanimously consented and “approved the law last year without a vote in either chamber” [WP report].

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AHA, ACC release new clinical guideline for managing hypertension in adults

http://www.clinicaladvisor.com/cardiovascular-disease-information-center/almost-half-of-us-adult-population-now-hypertensive/article/707709/

The American Heart Association (AHA) and the American College of Cardiology (ACC) have released a new clinical practice guideline on managing high blood pressure in adults, redefining hypertension as 130 mm Hg/80 mm Hg from the previous 140 mm Hg/90 mm Hg.

With this new definition of hypertension, approximately 14% more US adults are categorized as hypertensive (from 32% to 46%).

The new guideline, published in the Journal of the American College of Cardiology and in Hypertension, divides systolic blood pressure (SBP) and diastolic blood pressure (DBP) into categories, giving patients a more specific definition of hypertension and the associated recommendations:

• Normal BP is defined as <120 mm Hg/<80 mm Hg. According to the guideline, this group of patients practices healthy living styles and should have yearly checks to monitor their BP. 
• Elevated BP is defined as 120 to 129 mm Hg/<80 mm Hg. This group is advised to make healthy changes in lifestyle and to reassess their BP in 3 to 6 months.
• High BP is subcategorized into two stages:
  • Stage 1: BP ranging from 130 to 139 mm Hg/80 to 89 mm Hg. Clinicians must assess 10-year heart disease and stroke risk. If the risk is <10%, the patient is highly encouraged to make immediate lifestyle changes, including medication with follow-ups until the BP is well-controlled.
  • Stage 2: BP ≥140 mm Hg/≥90 mm Hg. Clinicians must stress lifestyle changes with 2 different classes of medications and monthly follow-ups until BP is well-controlled. Healthy life choices, according to the guideline, include quitting smoking, moderating alcohol consumption, increasing physical activity, and maintaining a healthy diet. Healthy life choices might also include medication and taking additional preventive risks for patients with higher, uncontrolled BP.

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DEA Raids Dr. Forest Tennant’s Pain Clinic

https://www.painnewsnetwork.org/stories/2017/11/16/dea-raids-forest-tennants-pain-clinic

dr. forest tennant (courtesy montana public radio)

Tennant, who has not been charged with a crime, believes the raid is part of a broader effort to smear not only his reputation, but to discredit and intimidate other doctors who prescribe opioids to pain patients.  

“They’re not just going after me, they’re going after patients,” said Tennant. “I think the country better understand what they’re doing here. They’re saying that regulations don’t count, standards don’t count, and they’ll decide who can get drugs and how much.

“I’d be worried about every pain patient right now, not just mine.”

Insys makes an oral spray called Subsys that contains fentanyl, a potent synthetic opioid. Subsys is only approved for the treatment of cancer pain, but Insys aggressively marketed Subsys to have doctors prescribe it “off label” to treat other pain conditions, allegedly resulting in hundreds of overdose deaths.

Several company officials, including Insys’ billionaire founder, have been indicted on federal charges that they bribed doctors with kickbacks and lucrative speaker fees in order to promote Subsys.  

Tennant says he stopped taking payments from Insys in 2015 and was dropped from the company’s speaker’s bureau last year.

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http://www.jems.com/articles/print/volume-42/issue-11/departments/street-science/mortality-rates-for-overdose-patients-who-refuse-transport.html

What’s the mortality rate for patients who receive naloxone and then refuse transport?

The Research

Levine M, Sanko S, Eckstein M. Assessing the risk of prehospital administration of naloxone with subsequent refusal of care. Prehosp Emerg Care. 2016;20(5):566-569.

The Science

The authors of this study reviewed a three-year period (July 1, 2011, to Dec. 31, 2013) for all patients who received naloxone (Narcan) by EMS providers with the Los Angeles Fire Department, and who subsequently refused additional medical care and were released at the scene.

They examined the coroner’s records to determine if any of these patients died within 24 hours, 30 days, or six months of their EMS encounter.

Of the 205 cases identified, the median age was 41 and 13% were female. Only one subject died within 24 hours of EMS care. The cause of death was coronary artery disease and heroin use. Two died within 30 days, one from coronary artery disease and cirrhosis and the other from unknown causes.

The authors conclude, “The practice of receiving prehospital naloxone by paramedics and subsequently refusing care is associated with an extremely low short- and intermediate- term mortality.”

Medic Wesley Comments

This study was published March 28, 2016. The data obtained was from 2011-2013. Oh, how quickly things change in the drug trade. The Centers for Disease Control (CDC) reported the number of opioid-related deaths in 2014 was a 9% increase from the previous year.1 The illegal drug trade changes every day. More potent forms of opioids are being manufactured, and with that, more deaths occur.

Releasing patients after administration of naloxone is a risk. The trend in this country is to blame someone else for our own bad choices and consequences-and to a certain degree, that liability rests with us, the healthcare professionals who had an opportunity to intervene and get these victims the help they need.

Once a patient is brought back to a functional respiratory status, or in some protocols, brought into consciousness, the patient is still at risk of relapse. Because the drug will outlast the antidote, the patient can’t be deemed competent or have the capacity to make a rational judgment.

The “treat and street” method works for some calls; however, there are just too many unknowns to say it’s a safe practice in today’s illicit drug use.

Don’t get me wrong. I understand that there aren’t enough resources to transport every drug overdose or to house those making reckless decisions. However, there are enough groups that think drug users are a vulnerable class, and therefore it’s public safety’s responsibility to rescue those individuals from the edge of death, at any cost. There are many in the legal profession willing to take this issue to court at the expense of your agency.

Rely on medical direction to see you through these cases, and make decisions in the best interest of the patient. The fact that a patient made a dangerous decision doesn’t relieve us from our professional and ethical duty to be a patient advocate.

Doc Wesley Comments

I agree with Medic Wesley that a “treat and street” approach may represent increased liability. Unfortunately, there’s no data to support that claim. I agree that this paper may not address the possible effects of significantly more powerful opiates such as carfentanyl, since it and other opiates didn’t become prevalent until after the study period reviewed by the authors.

It would be interesting to learn what percentage of known carfentanyl overdoses are returned to a clinically sober condition after naloxone administration. My experience has been that their respiratory status is improved, but they’re neither awake nor clear-headed enough to ambulate without assistance and competently refuse care.

Our EDs are sinking under the overwhelming amount of patients with drug, alcohol and mental illness. I understand the pressure that society places on us to protect them from themselves, but we have to stop trying to save everyone and concentrate on those that want help.

Those that want help will take it when offered. We live in a society that places the highest priority on patient autonomy; we’ve accepted standards to test the competency of a person who may be under the influence of drugs or alcohol. If this paper does anything, it should cause you to review your policies and determine if you’re meeting that standard when you release these patients from the scene.

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DEA wants researchers to grow less cannabis for medical studies in 2018

www.cannabisnewsbox.com/2560/news/dea-wants-researchers-grow-less-cannabis-medical-studies-2018/

The U.S. Drug Enforcement Administration (DEA) wants federally-licensed researchers to grow 443,680 grams of cannabis for scientific studies in 2018.

The government-cultivated proposed cannabis, that amounts to a little more than 978 pounds, is slightly less compared to this year’s level. According to the DEA, the 2018 aggregate production quotas will “provide for the estimated medical, scientific, research [and] industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks.”

The DEA will also allow the production of 384,460 grams of tetrahydrocannabinols (THC) in 2018.

The Federal Register filing was signed by Acting DEA Administrator Robert W. Patterson, and it established the initial 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act.

The order also allocates quotas of 92,120 grams of cocaine, 40 grams of LSD, 45 grams of heroin, 30 grams of psilocybin, 30 grams of ibogaine and varying levels of many other substances.

This year’s drug production quotas set a limit of 472,000 grams of cannabis and 409,000 grams of THC, which is a higher amount compared to next year’s proposal. To be able to pursue further medical research, the DEA would have to allow for an increased supply of cannabis.

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Cost of diabetes epidemic reaches $850 billion a year

https://www.reuters.com/article/us-health-diabetes/cost-of-diabetes-epidemic-reaches-850-billion-a-year-idUSKBN1DD2SW

The number of people living with diabetes has tripled since 2000, pushing the global cost of the disease to $850 billion a year, medical experts said on Tuesday.

The vast majority of those affected have type 2 diabetes, which is linked to obesity and lack of exercise, and the epidemic is spreading particularly fast in poorer countries as people adopt Western diets and urban lifestyles.

The latest estimates from the International Diabetes Federation mean that one in 11 adults worldwide have the condition, which occurs when the amount of sugar in the blood is too high.

The total number of diabetics is now 451 million and is expected to reach 693 million by 2045 if current trends continue.

The high price of dealing with the disease reflects not only the cost of medicines but also the management of a range of complications, such as limb amputations and eye problems.

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GOP Tax Plan Would Cut Medicare Pay to Providers by $25B in 2018

https://www.medscape.com/viewarticle/888619

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https://www.medscape.com/viewarticle/888593

Posted today on FDA about 2 hours ago This is what the FDA posted. “The FDA is concerned about harmful unapproved products that have been crossing our borders in increasing numbers. The agency has a public health obligation to act when we see people being harmed by unapproved products passed off as treatments and cures for serious conditions. Over the past several years, a botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. Today, the agency issued a public health advisory related to the FDA’s mounting concerns regarding risks associated with the use of kratom.

Kratom is plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. It has gained popularity in the U.S., with some marketers touting it as a “safe” treatment with broad healing properties. Proponents argue that it’s a safe substance largely because it’s a plant-based product. The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider. We also know that this substance is being actively marketed and distributed for these purposes. Importantly, evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death. Thus, it’s not surprising that often kratom is taken recreationally by users for its euphoric effects. At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning. It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. Stenabolic (SR9009) has been referred to as “cardio in a shell”. There are few studies, which also include those published journals that the drug can help you in increasing your endurance and stamina while losing fats. The reason is that SR9009 can significantly increase the metabolic activity of your muscles, which mimics the results when you had gone through hours on a treadmill or lifting a few rounds of weights during workouts at the gym, You can read his response here.

There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs. There’s clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms. Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits. I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people’s health. his response

We have issued guidance on the proper development of botanical drug products. The agency also has a team of medical reviewers in the FDA’s Center for Drug Evaluation and Research that’s dedicated to the proper development of drug applications for botanicals. To date, no marketer has sought to properly develop a drug that includes kratom. We believe using the FDA’s proven drug review process would provide for a much-needed discussion among all stakeholders. Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom. Moreover, the FDA has evidence to show that there are significant safety issues associated with its use. Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with. Moreover, Congress has also established a specific set of review protocols for scheduling decisions concerning substances like kratom. This is especially relevant given the public’s perception that it can be a safe alternative to prescription opioids. The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements. To fulfill our public health obligations, we have identified kratom products on two import alerts and we are working to actively prevent shipments of kratom from entering the U.S. At international mail facilities, the FDA has detained hundreds of shipments of kratom. We’ve used our authority to conduct seizures and to oversee the voluntary destruction of kratom products. We’re also working with our federal partners to address the risks posed by these imports. In response to a request from the Drug Enforcement Administration (DEA), the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom. Kratom is already a controlled substance in 16 countries, including two of its native countries of origin, Thailand and Malaysia, as well as Australia, Sweden and Germany. Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee and Wisconsin and several others have pending legislation to ban it. We’ve learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene. From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold. As a physician and FDA Commissioner, I stand committed to doing my part to prevent illegal substances that pose a threat to public health from taking their grip on Americans. While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse. They must be put through a proper evaluative process that involves the DEA and the FDA. To those who believe in the proposed medicinal uses of kratom, I encourage you to conduct the research that will help us better understand kratom’s risk and benefit profile, so that well studied and potentially beneficial products can be considered. In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products”said Gottieb

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Can you please give me some advise on how to get my valid pain medication refilled. I have been getting the same Rx for several years. I have had to stop taking my prescriptions to the big pharmacies because they always claim not to have them and they won’t order them. I’m disabled and I am forced to pay a local pharmacist $100 on the side for him to fill them. This is very difficult to accept because of my limited funds. But every month I am forced to pay off my pharmacist just to get my meds. Is this illegal of my pharmacist? 

Please help this is crushing me. No one here in Los Angeles fills pain meds unless your with a Kaiser or Cedae Sinai who fill all their patients scripts. I have a horrible blue cross plan. I can go to CVS but only if it’s in a Target store. This whole situation is horrible. Yeah you can get your meds by paying extra. My pharmacist even intimated one time he screwed up on a prior approval I asks him to fill it and we can handle it later he then said give me $300 and he would fill it. Next claiming that he k owe what they’re worth on the street. I don’t sell my Rx I need them . Just an example of what people are have g to go through because of irresponsible doctors and pharmacists. I didn’t get Oxyc tin over prescribed to me. But look what me a genuine pain victim is forced to live with.

Could this Pharmacy/Pharmacist be guilty of UNPROFESSIONAL CONDUCT… PBM/Insurance contracts that pharmacies have with them normally prohibits the pharmacy from charging the pt more than the copay that the PBM computer system states is the correct co-pay.

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Next year ( Nov 2018) 34 Senators are up for re-election

https://www.painnewsnetwork.org/stories/2017/11/13/senators-pressured-dea-to-cut-rx-opioid-supply

“As the gatekeeper for how many opioids are allowed to be sold legally every year in the United States, we commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” Democratic Sen. Dick Durbin of Illinois wrote in a letter to DEA Acting Administrator Chuck Rosenberg on July 11.

“However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.”

SEN. DICK DURBIN

rosenberg (left) meeting with durbin and other senators

“In today’s meeting, I asked him to continue this effort and further lower the opioid quotas for 2018.  Fewer pills on the market means less addiction and, hopefully, fewer deaths.”   

The August 3 meeting is important, because the very next day the DEA announced it would publish a notice in the Federal Register that it was planning a 20% reduction in Schedule II opioids for 2018.

The notice opened up a 30-day public comment period on the DEA’s proposal. Over a hundred people wrote in, most of them pain sufferers who warned the DEA it was going too far.

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