Honesty/Ethics in Professions

http://www.gallup.com/poll/1654/Honesty-Ethics-Professions.aspx

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I just posted the following note to 15,000 people on Facebook.  Feel free to pass this on to blogs where you are active.

I am sometimes asked “how can I help” with efforts to stop the war against chronic pain patients by their own government. One of the ways may be to write the editors of media outlets that are brave enough to publish dissenting voices such as the article in NY Post, “How the Feds Are Fueling America’s Opioid Disaster”. Please share your own experience as a patient briefly (~250 words is ideal), and especially do so if you have experienced difficulty with doctors who now refuse to treat your pain with effective medications, because of fears of DEA malicious prosecution.

Write at letters@nypost.com . Begin with “I read your recent article on “How the Feds Are Fueling America’s Opioid Disaster”. Then add your own story.

Best regards,
Red Lawhern

Regards and well wishes,
R.A. “Red” Lawhern, Ph.D.
Personal Homepage — “Giving Something Back”
http://www.lawhern.org
lawhern@hotmail.com

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New opioid douses pain without being addictive or deadly in primates

http://arstechnica.com/science/2016/09/new-opioid-douses-pain-without-being-addictive-or-deadly-in-primates/

I wish that I had a dollar for every time that there has been a “media hype” about a new drug discovery because it showed some promise in some animal study…but.. all of its promise(s) quickly fades before it comes to human clinical trials or somewhere along the three human clinical trials… everything FALLS APART. Over my career I have seen “non-addicting” drugs coming to market to only have them to quickly becoming a new drug of choice to abuse.  I would like nothing better to see some medication that will address chronic pain without being abused or produce troublesome side effects like opiates do.  Lyrica was suppose to be the “new & improved” Gabapentin…only to have a few people in the clinical trials to claim that it made them “high” and guess what… the DEA saw a medication for pain that a few people claimed that it made them high and we ended up with a NEW CONTROLLED SUBSTANCE.

Even if  BU08028 survives all the necessary testing and clinical trials to get FDA approval.. no one is going to a prescriber to write for it for 10-15 yrs.

While the opioid epidemic continues kill more than 40 Americans every day, researchers and health experts are frantically searching for ways to curtail use of the highly addictive, pain-quenching drugs. In March, the Centers for Disease Control and Prevention even released new guidelines directing doctors to simply refrain from prescribing opioids. But if a new study holds up, the health agency may be able to reverse course.

According to a report in the Proceedings of the National Academy of Sciences, an opioid drug referred to as BU08028 was able to alleviate pain in a dozen monkeys just as well as other opioid painkillers, such as morphine. Yet, unlike every other opioid drug, BU08028 showed no signs of being addictive. Even at high dose—at which other opioid drugs inhibit the respiratory and cardiovascular system, which can be fatal—BU08028 was harmless.

“Based on our research, this compound has almost zero abuse potential and provides safe and effective pain relief,” Mei-Chuan Ko, a professor of physiology and pharmacology at Wake Forest Baptist Medical Center and lead author of the study, said in a statement. “This is a breakthrough for opioid medicinal chemistry that we hope in the future will translate into new and safer, non-addictive pain medications.”

In pain experiments, which involved dipping monkeys’ tails into hot water, BU08028 was a potent pain-killer. A single dose relieved pain for up to 30 hours. Next, in experiments in which the monkeys were trained to self-medicate, BU08028 proved no more habit-forming than a control dose of saline. Scientists forced one group of monkeys to take BU08028, while another group was forced to take morphine. When the drugs were taken away, the monkeys who had taken BU08028 showed no withdrawal symptoms, unlike the monkeys who had blazed on morphine.

BU08028’s lack of nasty side-effects may hinge on its dual-action biochemistry. Like other opioids, it controls pain by targeting the nervous system’s classic μ-opioid peptide receptors, called MOP receptors. But BU08028 also targets “nonclassical” opioid receptors, called NOP receptors for nociceptin receptors, in the nervous system. These receptor proteins generally don’t interact with opioid drugs, yet they share similarities with the receptors that do. NOP receptors regulate pain, like their MOP counterparts, but they are also involved in a host of other brain functions, such as memory, cardiovascular functions, and anxiety.

“To our knowledge, the present study provides the first functional evidence in nonhuman primates that BU08028 with mixed MOP/NOP agonist activities is an effective and safe analgesic without apparent abuse liability or other opioid-associated side effects,” the authors conclude.

Next, the researchers hope to test BU08028 at treating chronic pain without risks of addiction or overdoses. Regardless of BU08028’s fate in subsequent trials, the researchers are hopeful that the strategy of co-activating NOP and MOP receptors will eventually lead to a safer painkiller.

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How the feds are fueling America’s opioid disaster

nypost.com/2016/12/19/how-the-feds-are-fueling-americas-opioid-disaster/

One has to look at this problem from those on “both sides of the fence”… while it is definitely worse for not only those with chronic pain… it also impacts all those pts that have a valid medical necessity for using a controlled substance… which includes more than just opiates for pain. It has impacted prescribers, wholesalers, pharmacies, pharmacists and all those involved in the legal distribution of medications.  From the other side of  “the fence”… those within our judicial system that part or all of their job on fighting the war on drugs… We officially declared the war on drugs in 1970 and we have spent > ONE TRILLION dollars since then and continue to spend 51 BILLION/yr in fighting this war. One has to wonder if the actions taken by bureaucrats have more to do with job security by those in our judicial system than actually trying to address the problem… The only other “social war” that has been going on longer and we have spent more money on is the “war on poverty” which was declared in 1965 and some believe has had a similar success rate.  After spending 15 TRILLION dollars and we currently have 15% of Americans living in poverty… the highest percent ever of the population since we started fighting that war.

Federal policy is unquestionably making the nation’s opioid problem worse — while also inflicting collateral damage on Americans in genuine need of pain medication.

And this disaster is being further driven by a myth that has gained additional credence from the Centers for Disease Control and Prevention’s latest guidelines for prescribing opioids.

The myth: that lax prescription of opioid drugs, such as oxycodone, is a primary driver of addiction. This notion has triggered a nationwide crackdown on these prescriptions in the name of preventing addiction and saving lives, an action that has been a catastrophe by almost any measure.

Dissenting opinions do exist. Physicians for Responsible Opioid Prescribing, a group that promotes strict control of prescriptions, admits that chronic pain patients have a “very legitimate fear” of restrictions. Yet the group, which was involved in formulating the CDC guidelines, nonetheless recommends a one-size-fits-all daily cap on the permissible opioid dose, regardless of the patient.

Reviewers have rightly criticized PROP for using shoddy evidence in support of its findings. In the past decade, more than a dozen professional papers — including a systematic analysis known as a “Cochrane Review” of 26 other studies, and a 38-study review in the journal Pain — have debunked the idea that addiction routinely starts with legal use. In most cases, it doesn’t; people who use prescription opioids properly and legally rarely become addicts.

Overwhelmingly, the ones who become addicted are those who start off using opioids for recreational purposes. The next stop is street drugs.

Paradoxically, the CDC guidelines managed to harm both addicts and patients with legitimate needs in one fell swoop. Consider OxyContin — a major drug of choice for addicts that in 2010 was reformulated to make it far harder to abuse.

Illegal OxyContin use did indeed plummet immediately — but abusers then switched in droves to heroin, which is far more dangerous, and deaths from heroin overdose soared from 3,000 in 2009 to 13,000 in 2015.

Worse still, black-marketeers are now blending fentanyl — a highly potent, synthetic version of heroin — with heroin itself, or substituting it outright for the “natural” drug. That’s responsible for much of the soaring ODs.

The Department of Health in Ohio — which has the highest number of opioid deaths in the nation — reported in 2015 that more than 80 percent of opioid deaths arose from heroin or fentanyl, up from 20 percent in 2010. Health agencies in Florida and Massachusetts report similar trends. It’s now indisputable that most recent opioid deaths result from heroin/fentanyl, not pain pills.

Another side of the equation is the cruel and needless suffering inflicted on blameless Americans who can no longer easily get pain medications. Just as addicts will do almost anything to feed their addiction, people in severe pain will do what is needed to escape it — even suicide.

Indeed, escaping pain is becoming increasingly difficult. People who have been treated appropriately and responsibly for years are now finding it difficult to obtain the relief they need, even from the same doctors. And you can’t blame the doctors.

Physicians rightly view the CDC “advice” as anything but voluntary. With the DEA looking over their shoulders, they fear losing their licenses for overprescribing. This creates just another wall between doctors and patients, many of whom are now forced to cope with their pain by using non-opioid, over-the-counter drugs such as Advil and Tylenol. These drugs are less effective and also carry their own risks, chiefly liver, kidney, stomach and heart toxicity.

But perhaps nothing illustrates the folly of government policies better than the rising number of pain sufferers who turn to street heroin because they can no longer get legal medication. What a travesty.

As a nation, we now find ourselves in a worse place than before this simple-minded crackdown began. While the most vulnerable suffer, rivers of the real killer drugs pour into our country illegally unabated.

“First, do no harm” is the essence of the Hippocratic Oath. Federal policymakers should honor that principle — and abandon their cruel and unconscionable war on pain medication.

Josh Bloom is director of Chemical and Pharmaceutical Sciences at the American Council on Science and Health.

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MatchMyRx: An App that helps patients understand their prescriptions by matching their Meds with their Conditions

http://www.digitaljournal.com/pr/3180788

Miami, FL PRX Control Solutions, a digital health company that offers a smart prescription platform to health plans and payers recently launched a Web App to help patients increase awareness of their medications.

According to the Centers of Disease Control and Prevention, more than 100 million* Americans with chronic ailments often suffer from multiple conditions and take multiple medications at the same time, making it harder for them to understand which treatment goes with each illness. At the same time, patients often don’t receive a complete diagnosis, leaving their records uncoded, which may affect the patient’s future quality of care. A recent case study conducted by PRX with more than 1 million prescriptions from Medicare patients, revealed that more than 13% of the prescriptions didn’t match a diagnosis of the patient.

MatchMyRx is a free web application that let’s patients match their conditions to medications, alerting them of improper prescriptions, controlled substances and off-label indications. MatchMyRx  also wants to empower patients to take more control over their health, improving their medication adherence and the communication with their healthcare providers.

With MatchMyRx patients get a free prescription record they can share with their doctors and family members. The Web App may also be used by healthcare professionals to provide more prescription data to their patients and by med students to learn prescription patterns.

MatchMyRx also wants to prevent medical errors, prescription abuse and reduce overall healthcare costs.

The team behind PRX believes that a solution like MatchMyRx may help patients be more aware and informed about their medications and help reduce the abuse and waste of opioids and antibiotics, which costs the US government billions of dollars each year.**

Twitter: @matchmyrx

Facebook: https://www.facebook.com/matchmyrx

About PRX Control Solutions: PRX is digital health company based in Miami, Florida that offers a smart prescription platform to health plans and payers, focused on detecting improper prescriptions, abuse and waste, and on providing better prescription data to their clients. PRX has been part of Wayra and Venture Hive’s accelerator program in Miami. 

Media Contact
Company Name: FL PRX Control Solutions
Contact Person: Alfredo Vaamonde
Email: alfredo@prxcontrolsolutions.com
Country: United States
Website: matchmyrx.com

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Beijing denies US claim that China is synthetic drug king

http://newsok.com/article/feed/1134723

There are people/entities in China that are addicted to the money that is being generated by all the illegal synthetic drugs that they are producing and selling in the USA… the DEA is addicted to the power and budgets that they are in denial that they are only seizing only 4% of what is being produced and eventually gets sold on our “streets” and TENS OF THOUSANDS are dying every year from using/abusing and INCREASING…

BEIJING (AP) — U.S. assertions that China is the top source of the synthetic opioids that have killed thousands of drug users in the U.S. and Canada are unsubstantiated, Chinese officials told The Associated Press.

Both the U.S. Drug Enforcement Administration and the White House Office of National Drug Control Policy point to China as North America’s main source of fentanyl, related drugs and the chemicals used to make them.

Such statements “lack the support of sufficient numbers of actual, confirmed cases,” China’s National Narcotics Control Commission told DEA’s Beijing office in a fax dated Friday.

In its letter, which the commission also sent to AP, Chinese officials urged the U.S. to provide more evidence about China’s role as a source country.

+1 photos

DEA officials said their casework and investigations consistently lead back to China. DEA data also shows that when China regulates synthetic drugs, U.S. seizures plunge.

“China is not the only source of the problem, but they are the dominant source for fentanyls along with precursor chemicals and pill presses that are being exported from China to the U.S., Canada and Mexico,” said Russell Baer, a DEA special agent in Washington.

Beijing is concerned enough about international perceptions of China’s role in the opioid trade that after AP published investigations highlighting the easy availability of fentanyls online from Chinese suppliers, the narcotics commission made a rare invitation to a team of AP journalists to discuss the issue at the powerful Ministry of Public Security, a leafy complex just off Tiananmen Square at the historic and political heart of Beijing.

U.S.-China cooperation is essential for mounting an effective global response to an epidemic of opioid abuse that has killed more than 300,000 Americans since 2000. The presence of fentanyl, a prescription painkiller up to 50 times stronger than heroin, and related compounds in the U.S. drug supply began to rise in 2013, after dealers learned they could multiply profits by cutting the potent chemicals into heroin, cocaine and counterfeit prescription pills.

Even as the U.S. Congress considers legislation to punish opioid source countries, no government agency has produced comprehensive data on seizures of fentanyl-related substances by country of origin.

The national database on drug seizures overseen by DEA does not require reporting by source country and may not accurately reflect seizures of all fentanyl-related compounds. Baer said it didn’t even have a “fentanyl” category until around two years ago. It also takes time for chemists to identify seized drugs, which means fentanyl-related samples may get incorrectly logged as other drugs.

The White House Office of National Drug Control Policy declined to comment.

U.S. Customs and Border Protection said it had data by country of origin only for 2015: Nearly two-thirds of the 61 kilograms (134 pounds) of fentanyl seized last year came from Mexico. The rest came from China.

DEA officials say Mexican cartels are key bulk suppliers of fentanyl to the U.S., but portray Mexico as a transshipment point. Mexican officials, speaking on condition of anonymity because they were not authorized to be quoted, said fentanyl and its precursors were coming from China. Only two labs trying to produce fentanyl from scratch have been located in Mexico in recent years, with others apparently taking simpler steps to turn precursors into fentanyl, the officials said.

Mexican authorities did not immediately respond to requests for seizure data by country of origin.

There is plenty of anecdotal evidence indicating that China plays an important role in the fentanyls trade, and despite disagreements, Chinese authorities have been proactive in trying to stop fentanyl manufacture and export.

Chinese companies offering to export synthetic opioids are easy to find, the AP found in investigations published in October and November. China’s narcotics commission said it was scrutinizing 12 opioid vendors the AP identified, along with others that advertise fentanyl analogs.

In some cases, China has enacted faster, more comprehensive changes to its drug control laws than much of the rest of the world. Beijing already regulates fentanyl and 18 related compounds and is considering designating four more: carfentanil, furanyl fentanyl, acryl fentanyl and valeryl fentanyl, the narcotics commission told AP. In the meantime, the commission told AP it warned Chinese vendors and websites that carfentanil and other analogs are harmful and should not be sold.

The resulting ripple of anxiety prompted some companies to recommend alternative opioids, like U-47700, the AP found in conversations with a dozen vendors. “Friend, fent is illegal in China,” wrote one. “It is dangerous for us.”

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Meet The Bureaucratic Roadblock Behind New Restrictive Painkiller Rules

www.disabledveterans.org/2015/02/20/meet-bureaucratic-roadblock-behind-new-restrictive-painkiller-rules/

New federal rules governing narcotic painkiller prescriptions have taken a toll on countless thousands of veterans relying on them to treat pain from missing limbs and other conditions.

Over the past six months, many veterans have written me about problems they experienced getting refills for their controlled painkillers. These veterans with chronic pain suddenly hit roadblocks whenever they sought the medication they previously received without problems.

Come to find out, new opioid prescription rules from the Drug Enforcement Administration (DEA) are behind the roadblock. DEA created the new rules to curb perceived abuses of opioids nationwide. Instead of helping, veterans claim the new rules have caused a dramatic uptick in depression due to increased pain, panic attacks, and other problems associated with sudden withdrawals that result when the refills are suddenly stopped.

In dramatically curtailing access to the highly addictive painkillers, the government is trying to roll back what the Centers for Disease Control and Prevention has termed “the worst drug addiction epidemic in the country’s history, killing more people than heroin and crack cocaine.” The rules apply to “hydrocodone combination products,” such as Vicodin.

More than half a million veterans are now on prescription opioids, according to the VA.

Pain experts at the VA say that in hindsight they have been overmedicating veterans, and doctors at the Pentagon and VA now say that the use of the painkillers contributes to family strife, homelessness and even suicide among veterans. A study by the American Public Health Association in 2011 also showed that the overdose rate among VA patients is nearly double the national average.

To help veterans combat the changes in prescriptive rules, VA’s national director for pain management, Rollin Gallagher, implemented a policy for staff to meet personally with patients. I am unclear how meeting personally with patients dependent on the painkillers to treat missing limbs, cancer and related ailments will assuage the pain.

What do you think about the DEA rule change and how that affects veterans? Should the policies be applied differently at VA in light of the less common ailments veterans face in coping with the hardship of war causing more serious injuries than those faced by the general population? Were the rules created using the right statistical analysis or will they disproportionately harm seriously injured or sick veterans more than the overall American population?

Best I can tell, VA could have handled the change better and treated veterans affected with more compassion while they suffered through withdrawals. A big problem with the change was that VA failed to warn and did not explain exactly why they change was going on. Veterans that pushed for the painkillers they previously received were labeled as “drug seeking”.

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‘Suspicious’ drug order rules never enforced by state

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As many of us have often noticed… there is a lot of bitching, whining and moaning from those within the chronic pain community and little activity outside of Face Book…

I have created a Twitter account  https://twitter.com/painedlives  and Twitter has a way of creating lists (groups) that a tweet can be sent out to everyone on the list.

I am looking for people to help me create the lists for Senators, Representatives, Media and others.. so once the project is completed or matured anyone can send a tweet out to large numbers very easily.

Send out stories from various sources about chronic painers being denied their medication because of DEA raids, CDC guidelines and others to Congress and the various media outlets… Flood the market with press releases that will attempt to counteract all the BS sent out by the DEA and others. These entities will only respond to NUMBERS…the larger the better

Anyone wants to “sign on” to get this moving ?  I have the databases of all the links to members of Congress and all the media contacts.  Just needs to be moved from these lists to the lists on Twitter.

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We need to speed up our acceptance of the opioid guidelines

http://www.kevinmd.com/blog/2016/12/need-speed-acceptance-opioid-guidelines.html

This was forwarded to me by a reader with the following comments on the article:

and she thinks she knows what she’s talking about.  I’ve had difficulty with 2-3 NPs in the past, and didn’t really know the source of my difficulty until I asked an old friend (who’s a NP) to have dinner with me.  Didn’t take me long to figure out that on issues of anxiety, pain, addiction, and behavioral medicine – he couldn’t tell his ass from his elbow. I knew more about it than he did! (the rigor of a B.S. in Mechanical Engineering, the broad liberal arts education of a Master of Divinity, a Clinical Pastoral Education residency at M.S.K.C.C. surrounded by the likes of Richard Payne and Steve Passik didn’t hurt).  In the end, I was far more competent than my friend and the NPs I was having difficulty with, yet they did not recognize my competence, and in fact came to the (inevitable) conclusion that I was exhibiting aberrant drug seeking behavior.

Anyway, what the hell makes Kathryn Takayoshe, NP-C think she’s so knowledgeable and competent on these issues?  Perhaps some of your blog followers may wish to comment.  I think it is partly the Dunning-Kruger Effect (“a cognitive bias in which low-ability individuals suffer from illusory superiority, mistakenly assessing their ability as much higher than it really is” – https://en.wikipedia.org/wiki/Dunning%E2%80%93Kruger_effect)

A couple of years ago, I inherited a patient who was on both a patch for the powerful painkiller fentanyl and a high dose of oxycodone four times daily — and she didn’t have cancer.

I had 15 minutes with that patient to get her medical history, review her medications, assess her current complaints, and decide whether or not to continue her opioid prescriptions. I had no paper records and a very poor electronic medical record system. I lacked a lot of the information I needed in order to prescribe such a high opioid dose.

However, if I refused to continue the opioid prescriptions, I would force the patient into withdrawal. I weighed my options and came up with a reasonable plan, but it would have gone much better if I’d had some guidelines to fall back on. Amid the hubbub of the community health center where I work as a nurse practitioner, I felt stuck and alone.

We primary care practitioners want to do what’s best for our patients, including those with chronic pain, who are often some of the most challenging patients to manage. We do not want to overprescribe a potentially addictive and lethal opioid medication. In the primary care setting, all of this decision-making is happening at once, and the patient is waiting for your decision.

At the time I saw that patient on fentanyl and oxycodone, there were no formal guidelines to help me. Every provider on my team practiced differently. Some were quite liberal with their prescriptions; others rarely prescribed controlled substances. It seemed like everyone was making a personal judgment call and no one knew where to turn for proper standards of care.

These clinical decisions are not so clear-cut. For a practitioner, it is emotionally draining and time-consuming to halt opioids for a patient who has been prescribed them for years. Working in a community health center in Lynn, which, like many small New England cities, is ravaged by the opioid crisis, I have not met a single primary care provider who has decided to start opioids for a patient.

Rather, we are dealing with the “inherited” pain patient, who has been prescribed opioids by someone else. These patients usually end up with us because their previous provider left the practice, their insurance changed and they cannot see their old provider, or they burned their bridges and are looking for a new prescriber.

It’s hard to write guidelines for the management of chronic opioid therapy. The Centers for Disease Control finally came out with their first attempt in March of this year. Before that, there were a few government agencies that attempted to write guidelines on the topic, but they were weak at best, and certainly not widely followed.

Our health center decided not to wait, and has been working on our own set of guidelines for the past year. We saw the need, and we stepped in to improve our care. We created a task force that includes primary care providers, RNs, behavioral health clinicians, and an addiction specialist. We looked at existing guidelines, literature on chronic opioids and chronic pain, and expert recommendations.

The CDC guidelines are excellent, but ours go further in focusing on behavioral health and addiction treatment: We require a urine drug screen at each monthly visit. We have fully integrated behavioral health into primary care, sharing the space. Every chronic opioid patient has to get a comprehensive pain evaluation — also a step beyond the CDC. And we have our own suboxone clinic — suboxone treats opioid dependence — though we’re working to provide suboxone in primary care rather than making patients go to a separate clinic.

We are now in the process of spreading our knowledge and putting our guidelines into practice throughout the health center. So far, we have decreased the overall number of patients on risky opioid medications. More specifically, we have greatly reduced the number of those on the highest-risk medication combination: opioids and benzodiazepines. We have also increased our referrals to addiction treatment and improved our access to behavioral health treatment.

If that same patient on the fentanyl patch and opioid pills came to me today, I would be much better prepared. Perhaps more importantly, I would feel more confident and empowered. I now have standards of care and a health-center-wide task force to rely on. I would feel more supported in my decision-making. Patients need to know that they are in good hands. Our work has helped make this possible.

It has certainly been difficult. Providers are initially defensive when it comes to their prescribing practices. This is to be expected. But we need to start looking at chronic pain and opioid prescribing as we do other disease processes.

We have studies that tell us that chronic opioid therapy is not effective in improving function (and sometimes even pain) over time. We have studies that tell us that chronic opioids can cause low testosterone levels in males, chronic constipation, and even an increased pain response, among other side effects.

We have experts that tell us to prescribe only low doses of opioids and never to prescribe opioids and benzodiazepines together. We need to listen to these experts. The surgeon general recently sent individual letters to providers pleading with them to reduce their opioid prescribing.

It seems that we are always slow to adopt new guidelines. We are skeptical and resistant to change. This is one of those times when we need to speed up our acceptance. Talking about overprescribing is not enough. Primary care providers are good at following new diabetes guidelines. It’s time we do the same for chronic opioids.

Kathryn Takayoshi is a nurse practitioner. This article originally appeared in WBUR’s CommonHealth.

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