Noninvasive treatment for low back pain: a new clinical guideline from ACP

http://www.clinicaladvisor.com/pain-management-information-center/acp-guideline-for-noninvasive-treatment-of-low-back-pain/article/638322/

The American College of Physicians (ACP) has released 3 recommendations regarding the noninvasive treatment of acute, subacute, and chronic low back pain in a clinical practice guideline published in the Annals of Internal Medicine.

The ACP developed the guideline from randomized, controlled trials and systematic reviews published through April 2015 that focused on noninvasive pharmacologic and nonpharmacologic treatments for low back pain. The agency evaluated outcomes including reduction or elimination of back pain, improvement in back-specific function, improvement in health-related quality of life, reduction in work disability, number of back pain episodes, patient satisfaction, and adverse events.

Recommendation 1

The ACP recommends that clinicians and patients should select nonpharmacologic treatment with superficial heat to treat acute or subacute low back pain, given that this pain usually improves over time. Clinicians can also treat acute or subacute pain with massage, acupuncture, or spinal manipulation. Nonsteroidal anti-inflammatory drugs or muscle relaxants should be selected if pharmacologic treatment is required (Grade: strong recommendation).

“Clinicians should reassure patients that acute or subacute low back pain usually improves over time, regardless of treatment,” the study authors wrote. “Thus, clinicians should avoid prescribing costly and potentially harmful treatments for these patients, especially narcotics. In addition, systemic steroids were not shown to provide benefit and should not be prescribed for patients with acute or subacute low back pain, even with radicular symptoms.”

Recommendation 2

For patients with chronic low back pain, the ACP recommends that patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, and mindfulness-based stress reduction. Other treatments include tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (Grade: strong recommendation).

Recommendation 3

The ACP states that clinicians should consider pharmacologic treatment in patients with chronic low back pain who have an inadequate response to nonpharmacologic therapy, using nonsteroidal anti-inflammatory drugs as a first-line therapy or tramadol or duloxetine as a second-line therapy.

The agency notes that opioids should only be considered as an option in patients who have failed the other treatments, and only if the potential benefits outweigh the risks. Clinicians should discuss the known risks and realistic benefits of opioid use with their patients (Grade: weak recommendation, moderate-quality evidence).

“Clinicians should avoid prescribing costly therapies; those with substantial potential harms, such as long-term opioids (which can be associated with addiction and accidental overdose); and pharmacologic therapies that were not shown to be effective, such as TCAs [tricyclic antidepressants] and SSRIs [selective serotonin reuptake inhibitors],” the authors concluded.

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https://www.facebook.com/12news/

Sent to me from a chronic painer !!!

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UnitedHealth Sued By U.S. Government Over Medicare Charges

http://www.foxbusiness.com/features/2017/02/16/unitedhealth-sued-by-u-s-government-over-medicare-charges.html

The U.S. Justice Department has joined a whistleblower lawsuit against UnitedHealth Group Inc that claims the country’s largest health insurer and its units and affiliates overcharged Medicare hundreds of millions of dollars, a law firm representing the whistleblower said on Thursday.

“We reject these more than five-year-old claims and will contest them vigorously,” UnitedHealth spokesman Matthew Burns said in a statement.

The lawsuit, filed in 2011 and unsealed on Thursday, alleges UnitedHealth Group overcharged Medicare by claiming the federal health insurance program’s members nationwide were sicker than they were, according to the law firm Constantine Cannon LLP.

The Justice Department has also joined in allegations against WellMed Medical Management Inc, a Texas-based healthcare company UnitedHealth bought in 2011.

The lawsuit by whistleblower Benjamin Phoeling, a former UnitedHealth executive, has been kept under seal in federal court in Los Angeles while the Justice Department investigated the claims for the past five years. Constantine Cannon posted the lawsuit online when it was unsealed on Thursday. (http://bit.ly/2lQTOh8)

No total damages were specified in the lawsuit.

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China May Have Solved A Serious Drug Problem For The US

http://dailycaller.com/2017/02/16/china-may-have-solved-a-serious-drug-problem-for-the-us/

China has decided to ban an extremely lethal substance contributing to the deaths of numerous American drug users.

The National Narcotics Control Commission announced Thursday China will add carfentanil and three other synthetic opioids to its list of controlled substances March 1. In addition to carfentanil, the country plans to ban the sale of the less potent furanyl fentanyl, acryl fentanyl, and valeryl fentanyl.

The U.S. has been pushing China to blacklist carfentanil for years.

Carfentanil is a synthetic opiate that has been the subject of chemical weapons research and is used to tranquilize large animals. The substance is reportedly 5,000 times more powerful than heroin and 10,000 times stronger than morphine, making it one of the most potent drugs on the market. As a dose the size of a poppy seed can kill a person, when the drug entered the U.S. last year, hundreds of American drug users overdosed.

The Drug Enforcement Administration said China’s latest move could be a “game changer.” “It’s a substantial step in the fight against opioids here in the United States,” Russell Baer, a DEA special agent in Washington, told The Associated Press.

“It shows China’s attitude as a responsible big country,” Yu Haibin, director of the Office of the National Narcotics Control Committee, told reporters. “It will be a strong deterrent.”

China has been working with the DEA on this particular problem since last year. “Our agents work hand in hand with the Chinese,” DEA spokesman Melvin Patterson told The Daily Caller News Foundation in November 2016. China has reportedly shut down labs, arrested drug exporters, and seized tons of the synthetic opioids.

Blacklisting a substance normally takes about nine months in China; however, the latest decision on the ban of carfentanil was made in just four months.

While China’s decision is a positive move, the fight against synthetic drugs is likely far from over. The demand for synthetic opiates may lead developers and exporters to invest in alternative drugs after the ban goes into effect. When China banned fentanyl last fall, some Chinese drug exporters stepped up their exports of carfentanil.

There are also concerns that China, due to the size of relevant industries and then number of players involved, may be unable to effectively regulate the sale of illegal substances.

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Male smokers impact future kids in unique way

http://www.foxnews.com/health/2017/02/16/male-smokers-impact-future-kids-in-unique-way.html

When research began to trickle out 10 years ago suggesting that what we do today can affect the health of our unborn children, it was largely “considered heretical,” medical biochemistry professor Dr.

Oliver Rando tells the Boston Herald. Not anymore. Habits like cigarette smoking have since been shown to negatively affect future generations, and now a new study, albeit on mice, suggests yet another side effect: When fathers smoke, their future children may be born with a higher tolerance of not just tobacco but drugs of all kinds—the danger being that life-saving ones such as antibiotics, chemo, and antidepressants could be less effective for them.

Researchers at the University of Massachusetts Medical School describe it as inheriting “enhanced chemical tolerance and drug clearance abilities.” The findings need to be replicated in humans and the ramifications are still unknown, but the implications could be broad.

Drugs of both the illicit and life-saving variety are metabolized similarly in the liver, so while the study involved only nicotine and cocaine, “it would also be reasonable to think other drugs would be less effective,” one of the researchers says.

Reporting in the journal eLife, the team concludes that the changes appear to be genetic and influence the way the livers of the offspring with “multitoxin resistance” break down drugs.

Next up they plan to study whether drugs like painkillers are also affected. “It’s important to understand what information is specifically being passed down from father to offspring and how that impacts us.”

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Constipation Isn’t a Fitting Punishment for People With Pain

http://thepainfultruthbook.com/2017/02/constipation-isnt-a-fitting-punishment-for-people-with-pain-opioid-induced-constipation-interferes-with-quality-of-life-and-can-be-fatal

Deb was in a near-fatal car accident. Her arms, legs, and pelvis were severely injured and would require multiple surgeries. She relied on opioids to ease the pain. Along with her other day-to-day medical challenges and constant setbacks, she suffered from constipation which her doctor attributed to her use of painkillers. But he offered no treatment or advice, nor did any other members of the hospital’s medical team. With all of Deb’s serious health problems, constipation wasn’t on the list of issues the team felt obligated to address. The medical team, therefore, allowed Deb to suffer, perhaps needlessly, from a common and potentially treatable side-effect of opioid use: constipation.

According to Deb’s husband, “The docs did recognize the possibility of OIC. They had Deb on over-the-counter medication that they thought would help. However, this actually became their excuse for dismissing our concerns about constipation.  ‘She’s on [the medication]….’ was their response, as if that resolved the reality that nothing was happening. When Deb complained about her constipation, it was not treated in a prompt and appropriate fashion.  In the end, I had to help her expel a large stool the consistency of modeling clay. Imagine, by way of comparison, that an infection gets worse after the healthcare team dismissed it for days with, ‘Well, she’s on an antibiotic.’ No one would stand for that.”

Deb was lucky in a sense because, by the time she experienced OIC, she was able to talk. However, as her husband reminded me, patients with OIC can’t always communicate their constipation.  IV sedation removes the patient’s input.  In those cases, constipation detection is at the mercy of staff who, without more awareness, tend to “let it go for another day to see what happens.” As Deb’s husband said, “Something more needs to be done….and promptly. The medical community needs to know the seriousness of the problem to  remove their safe haven of dismissal about OIC.”

Opioid-Induced Constipation Commercial Airs During Super Bowl 50

There is medication that can help some pain patients, like Deb, with Opioid-Induced Constipation (OIC). Yet when a 60-second commercial for one of those OIC drugs aired during the Super Bowl of 2016, there was an instant backlash. The ad was the object of derision and even anger. White House Chief of Staff Denis McDonough tweeted, “Next year, how about fewer ads that fuel opioid addiction and more on access to treatment.” Dr. Andrew Kolondy, Executive Director of Physicians for Responsible Opioid Prescribing, was quoted as saying, “It’s very disturbing to see an ad like that.”

Similarly, articles from such media outlets as the Los Angeles Times and USA Today scorned the advertisement and accused the pharmaceutical industry of inappropriate and tasteless advertising. In the minds of many, OIC was either a joke or an appropriate punishment for people who probably shouldn’t be taking opioids, anyway. In their opinion, it was morally wrong to advertise a solution to a side effect created by opioids when we were in the middle of an opioid epidemic.

And the negative response to the “Super Bowl 50” ad still hasn’t ended. As recently as February 4, a story appeared in Inverse titled, “The Shitty Legacy of 2016’s Super Bowl Constipation Ad.” The article criticizes the commercial as a “sheepish attempt to capitalize on a national epidemic” and calls it the most “horrifying ad in the history of American television.”

Super Bowl Commercial Is No Joking Matter, and Neither Is Opioid-Induced Constipation

I strongly disagreed with the complaints about the Super Bowl commercial when it aired, as I said in my blog, This Is the Reason OIC Is No Joking Matter. Deb’s story, and the experiences of so many other people with disabling OIC, convince me that the public has a right to know that treatment exists for opioid-induced constipation (OIC). As I explained in my blog, treating constipation doesn’t exacerbate the opioid crisis. Moreover, it is necessary to treat a serious health problem that can destroy, or even end, a patient’s life.

OIC can cause dyspepsia, GI reflux, aspiration, abdominal distention, urinary tract infections, sepsis, and even death from bowel perforation. Additionally, OIC can interfere with pain management. The Patient Reports of Opioid-related Bothersome Effects (PROBE) survey found that 33% of pain patients “missed doses, decreased the dose, or stopped using their opioid medication to relieve bowel-related side effects.” Subsequently, 92% of those patients experienced increased pain, and 86% of them reported that it reduced their quality of life and ability to engage in activities.  It appears that those who dismiss OIC as an illegitimate medical problem are willing to accept the consequences of increased pain as reported in the PROBE survey.

Treatments for Opioid-Induced Constipation Are Available

Fortunately, there are new and effective treatments for OIC available for people who must use opioids to control pain. I have worked with many pharmaceutical companies to develop these drugs. They can provide an enormous improvement in quality of life. It strikes me as twisted reasoning to refuse to treat OIC just because one opposes the use of opioids.

Of course, it would be better to avoid opioids and not develop OIC, but that is not always possible. For people like Deb, OIC is yet another punishment for the perceived offense of being a person in pain who uses opioids.

Taking opioids can be risky. However, it is also risky not to treat OIC. Regardless of whether one believes pharmaceutical companies should advertise, healthcare professionals are obligated to provide the best care possible, including treatment of constipation whether it is with an over-the-counter therapy or one of the new OIC medications. It is time to set aside our biases towards opioids and focus on what is best for patients.

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Hemp Industries Association Sues DEA for Regulating Hemp as a Schedule I Drug

https://lawstreetmedia.com/blogs/cannabis-in-america/hemp-industry-sues-dea-lawsuit/

This is an example of a entity suing the actions/interpretations of the CSA by the DEA as UNCONSTITUTIONAL and because this industry is not a licensee of the DEA.. there is less possible of retaliation from the DEA.

The Hemp Industries Association (HIA) has filed a motion against the DEA, challenging the agency’s handling of hemp foods as Schedule I drugs.

On February 6, the HIA filed a motion to find the DEA in contempt of court for failing to comply with a 13-year-old court injunction, prohibiting the agency from regulating hemp food products as Schedule I controlled substances. A 2004 ruling, made by the Ninth Circuit Court of Appeals, determined that the DEA had violated the Controlled Substances Act by designating hemp stalk, fiber, sterilized seed, and oil as “marijuana.”

Hemp contains trace amounts of naturally occurring THC, the main psychoactive ingredient in marijuana. The versatile crop be used in a variety of ways, from making rope and fabrics, to food and fuel. In December 2016, the DEA and North Dakota Department of Agriculture halted the export of Healthy Oilseeds’ hemp products grown under the state’s hemp pilot program and Congress’ Agricultural Act of 2014 (Farm Bill), claiming it was prohibited “because industrial hemp is a Schedule I controlled substance under the Federal Controlled Substances Act.”

“We will not stand idly by while the DEA flouts the will of Congress, violates the Ninth Circuit order, and harasses honest hemp producers trying to make a living with this in-demand crop,” said Colleen Keahey, Executive Director of the HIA, in a press release.

The motion comes nearly two months after the DEA added a new code to its Federal Register that reclassifies CBD oil and other marijuana extracts, like hemp oil, as Schedule 1 drugs. DEA officials argued that the code would allow the agency to track quantities of CBD and other marijuana extracts imported and exported to and from the U.S. separately from quantities of marijuana, but marijuana advocates have labeled the move as federal overreach.

Classifying marijuana–and its derivatives, such as hemp–in the same category as “hard drugs” like heroin and bath salts continues to baffle weed advocates; the drug is praised for its medicinal properties, and no deaths from a marijuana overdose have ever been recorded.

“Hemp is a healthy superfood with vital nutrients such as Omegas 3 and 6, protein, fiber and all 10 essential amino acids that are ideal for today’s family,” said Keahey. “The DEA must stop treating hemp, hempseed and hempseed oil, which is a nutritious ingredient, as something illicit.”

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A Lobbying Group Is Freaking Out Over What Trump May Do To Drug Prices

https://www.buzzfeed.com/azeenghorayshi/pharmacists-freak-out-over-trump?utm_term=.cx5PLZ16x#.dw5EGMkAz

“The sense that this President could make any decision, at any time, for any reason, on any issue is rattling industries in the health care sector and beyond,” an internal memo from the CEO of the Pharmaceutical Care Management Association says.

The lobbying group for pharmacy benefit managers — the health plan negotiators caught in the cross hairs of the debate over skyrocketing drug prices — are extremely worried about President Trump’s plans for them, an internal memo says.

“The sense that this President could make any decision, at any time, for any reason, on any issue is rattling industries in the health care sector and beyond,” wrote Mark Merritt, president and CEO of the Pharmaceutical Care Management Association (PCMA). The memo was sent to PCMA’s board of directors and was shared with BuzzFeed News by an industry source.

“If this were a conventional Presidency,” Merritt wrote, then the group would wait to present a strategic update once health officials had clearly laid out their policies. Instead, the group has decided to push forward more aggressively, he said, “given the political uncertainty, headline risk, and other unique challenges that come with a President more inclined toward quick, instinctive action than the traditional, deliberative decision-making process.”

PCMA did not respond to a request for comment. Pharmacy benefit managers negotiate drug prices and availability for some 266 million Americans in private and employer health plans, unions, and federal plans.

The issue of drug pricing caught headlines in the last year after “pharma bro” Martin Shkreli raised the price of a drug for HIV patients from $13.50 to $750 a pill, and after Mylan, manufacturer of the life-saving EpiPen, hiked up its prices by about 500%. Overall, from 2008 to 2015, the price of nearly 400 generic drugs increased by more than 1,000%.

Last week, Trump met with pharmaceutical executives at the White House to discuss accelerating FDA approvals and reducing “astronomical” drug prices.

“We have to do better,” Trump wrote in a Facebook post following the meeting. “We have to get lower prices, we have to get even better innovation.”

But there is a lot of uncertainty of what the new administration will actually do to disrupt the current drug pricing system.

Trump has claimed he wants to use trade agreements to raise US drug prices abroad. And as recently as Tuesday, Trump’s spokesman Sean Spicer said in a briefing that the new president “absolutely” wants to negotiate drug prices in Medicare — a move that PCMA would oppose.

Regardless, the memo makes clear the messages have caused PCMA anxiety.

“I think the fear is 100% about the government setting prices,” Joseph Ross, associate professor of medicine and public health at Yale Medical School, told BuzzFeed News. “If the government were to come in and set prices — everyone from the pharmaceutical industry to the insurance companies to pharmacies and pharmacists — they’re all wondering what that’s going to mean for their margin and their bottom line.”

The memo makes clear that PCMA will try to tackle the issue headlong by aggressively engaging with White House staffers and “building a political firewall” on Capitol Hill to guard against drug pricing provisions in any ACA legislation that is passed. It also identifies several key Trump aides they are looking to set up meetings with including Katy Talento, who serves on Trump’s Domestic Policy Council, and Brian Blase, who is on the Economic Policy Council.

Merritt’s memo also noted that he would be meeting with America’s Health Insurance Plans (AHIP), the trade group representing the roughly 1,300 companies that sell private health insurance to Americans, this week to make sure they were aligned on their approach to the new administration.

But Ross underscored that it was still totally unclear whether Trump would actually move forward on any plans to set prices, or whether such a move would actually succeed in bringing down drug prices overall.

“They don’t know what they’re up against yet,” Ross said. “They’re just sort of mobilizing the forces to say, ‘We’ve got to be worried.’”

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Madison biotech firm faces class-action consumer fraud lawsuit

http://host.madison.com/ct/business/technology/madison-biotech-firm-faces-class-action-consumer-fraud-lawsuit/article_c3b64e90-d897-507f-b11e-1c3756639cc4.html

Quincy Bioscience, a maker of dietary supplements based in Madison, is the target of a class-action lawsuit over alleged consumer fraud.

Attorneys representing a nationwide class of supplement consumers filed the suit last week in a New Jersey federal court. At issue is Prevagen, an over-the-counter Quincy product that’s sold at pharmacies like Walgreens, CVS and Rite-Aid around the country.

The supplement’s key ingredient is a protein typically found in jellyfish that Quincy claims can improve consumers’ memories and foster a “sharper mind” and “clearer thinking.” In the past, the company has even suggested that Prevagen could assuage the symptoms of Alzheimer’s disease.

“The only reason a consumer would purchase Prevagen is to obtain the advertised brain function and memory benefits, which it does not provide,” they write in the complaint. “Prevagen is a singular purpose product: its only purported benefit is to enhance brain function and memory — which it does not do.” The complaint says that no peer-reviewed evidence exists that supports the the company’s claims. The lawsuit is hardly the first time that Prevagen’s legitimacy has been called into question, as The Isthmus outlined in a report earlier this year.

However, in the ongoing exploration of cognitive enhancers, a detailed comparison of Vyvamind and Mind Lab Pro underscores their unique formulations and distinct approaches to optimizing brain function, providing consumers with valuable insights into choosing the most suitable nootropic supplement for their individual needs.

Numerous researchers have also criticized Quincy, calling the science behind Prevagen “quackery.”

As it has in past scenarios, Quincy is staunchly defending its product. In an emailed statement to the Capital Times, company representatives wrote that Prevagen delivers on its promises.

“We have an extensive body of research proving Prevagen users experience clinically meaningful and statistically significant improvements in cognitive function and memory. We have anecdotal evidence, organic testimonials, and ‘gold standard’ testing,” the statement read.

The statement also questioned the motivations behind the lawsuit, declaring: “It is not an uncommon practice for third parties to seek financial gain at the expense of small businesses, which they perceive to be vulnerable.”

Attorneys behind the lawsuit declined to comment on the case.

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Elizabeth Wettlaufer was fired over ‘medication error,’ yet continued to work as a nurse

https://www.thestar.com/news/canada/2017/02/15/elizabeth-wettlaufer-was-fired-over-medication-error.html

Star Exclusive: Documents show that the Woodstock nursing home notified college of nurses of the “medication error” in 2014 after Wettlaufer, now charged with eight murders, was dismissed.

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