Trump administration drug officials clash over how to combat fentanyl copycats

https://wkzo.com/news/articles/2019/jul/09/trump-administration-drug-officials-clash-over-how-to-combat-fentanyl-copycats/916053/

WASHINGTON (Reuters) – Trump administration officials are divided over part of a proposal to crack down on illicit versions of fentanyl, the deadly synthetic painkiller that U.S. President Donald Trump targeted in declaring a national opioid abuse emergency.

In an inter-agency dispute that highlights the challenges of curbing opioid abuse, the U.S. Drug Enforcement Administration (DEA) is publicly backing tighter rules for fentanyl analogues, which are slightly altered copycat versions of the powerful drug fueling an explosion in overdoses.

But an office of the U.S. Department of Health and Human Services (HHS) is raising concerns outside of public hearings, sources told Reuters, about the DEA-backed legislation, offered by Senator Ron Johnson and Representative Jim Sensenbrenner, both Republicans.

Normally, the DEA and the U.S. Food and Drug Administration review chemical compounds individually to assign each one a controlled substance classification, with the FDA determining if such “scheduling” decisions are scientifically valid.

In this case, the bill would cut the FDA out of the time-consuming review process by letting the DEA permanently classify illicit fentanyl analogues as Schedule I drugs, like heroin, which are deemed to be addictive with no medical use.

The DEA says these legal changes would help prosecutors keep pace with criminals who constantly churn out chemically tweaked fentanyl analogues to evade strict Schedule I regulations.

But an expert from HHS’s National Institute on Drug Abuse (NIDA) quietly warned Senate staff at a private June 20 briefing that permanently placing all fentanyl analogues into Schedule I poses problems, according to an attendee who spoke to Reuters anonymously because the briefing was private.

The draft bill would not only put all fentanyl analogues into Schedule I before anything is known about their potential medical benefits, but would also make it harder for researchers to win approval to study the analogues to potentially develop new approaches to tackling the surge in overdoses, the NIDA expert said.

An HHS spokesperson told Reuters that the department has no position on the DEA-backed bill, but confirmed that HHS does have some concerns.

“These compounds can be used to develop and test new medications for preventing opioid addiction and overdose,” the spokesperson said, noting that putting fentanyl analogues into Schedule I without accommodating scientists with a streamlined approval process “could slow valuable research aimed at addressing the opioid crisis.”

Of 70,200 U.S. drug overdose deaths in 2017, according to the CDC, about 41% involved synthetic opioids, such as fentanyl and illicit analogues of it. Most of them are made in China.

Fentanyl, some versions of which are approved to treat cancer pain, is 100 times more potent than morphine.

APPROACHING DEADLINE

While the debate over fentanyl analogues dates back to the Obama administration, the rising death toll has made the issue more urgent.

Adding to that urgency is a February 2020 deadline, when a temporary 2018 DEA emergency order that placed all fentanyl analogues into Schedule I will expire.

During a July 1 press briefing, DEA Assistant Administrator John Martin downplayed the bill’s impact on research, but acknowledged HHS’s concerns.

“They have some concerns,” he said, adding that DEA is “trying to eliminate the perception out there in the research community that it’s going to be a hindrance.”

Because Schedule I drugs have high risk of abuse, the DEA imposes strict regulations for research applicants. It requires the drugs to be stored in a safe bolted to the floor and each compound must have a separate DEA registration.

“Trying to do research on Schedule I compounds is really difficult for scientists. There are all kinds of regulatory hurdles,” said Sandra Comer, public policy officer for the College on Problems of Drug Dependence, a scientific group.

Exactly how many fentanyl analogues would be impacted by the bill is unknown.

While Martin said it could involve “hundreds to maybe a thousand” fentanyl analogues, another DEA official who attended the June 20 briefing told Reuters it would affect “millions” to “an infinite” number.

Some groups are urging lawmakers to oppose the bill, saying it would chill research and give the DEA too much power.

“This administration has tried to take a criminal justice approach to the overdose crisis,” Drug Policy Alliance national affairs director Michael Collins said, “when it is very clear it is a public health crisis.”

(Reporting by Sarah N. Lynch; Editing by Kevin Drawbaugh and Bill Berkrot)

If you notice that in the picture two of the bags of Fentanyl that has been seized and they are labeled as “FENTANYL HCL” and that Fentanyl analog is an ILLEGAL Fentanyl analog. The only Fentanyl analog approved for human use in the country is Fentanyl citrate.

According to Wikipedia, there are some 1400  known Fentanyl analogs… they are either legal – FDA approved – Fentanyl analogs OR THEY ARE NOT.

Has the DEA lobbied/convinced these two members of Congress – Senator Ron Johnson and Representative Jim Sensenbrenner – to introduce bills that would give the DEA ABSOLUTE POWER in determining the control schedule of a particular med without the input of the FDA which FDA determines if such “scheduling” decisions are scientifically valid.

Are we seeing a POWER GRAB BY DEA ?

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Judge Reverses Trump Rule Mandating Drug Ad Price Disclosures

Said it lacked authority for mandate

https://www.broadcastingcable.com/news/judge-reverses-trump-rule-mandating-drug-ad-price-disclosures

In a victory for drug companies and marketers, a federal district judge has vacated a Trump Administration rule that drug manufacturers have to disclose their list prices in direct-to-consumer (DTC) TV, radio and online drug ads.

Drug companies had argued that the mandate would cause confusion, exceeded the Administration’s authority, and was unconstitutional.

In May, the Department of Health and Human Services (HHS) as part of the Administration’s effort to lower drug prices, said that drug companies had to “disclose the list price to patients for prescription drugs and biological products in their TV (broadcast, cable and satellite) and online ads.”

Related: WLF Says Trump Administration Can’t Force Drug Companies to List Prices

In his ruling Monday (July 8), Judge Amit P. Mehta said that the court was not questioning the motives behind the effort, or the wisdom of doing so.

“[The] policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized,” he wrote.

“The court finds that HHS lacks the statutory authority under the Social Security Act to
adopt the Disclosure Rule. Neither the Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The Rule is therefore invalid. In view of this holding, the court does not reach Plaintiffs’ First Amendment challenge.”

Courts generally avoid weighing into First Amendment arguments if a decision can be reached on narrower grounds, i.e., without getting into the thicket of constitutionality.

HHS had acknowledged that Congress had not explicitly provided it with the authority to compel drug price disclosures in ads, but also said there was a “clear nexus” between that disclosure and the Social Security Act’s requirement that Medicaid and Medicare be run efficiently.

It said that while the drug industry had to disclose the “major side effects” a drug can have on a user’s health, it is not required to disclose the impact it can have on wallets and purses. That is changing as a way to try and lower drug prices,” it said.

No it isn’t, said Mehta, at least not with this legal underpinning. He suggested that allowing such authority could open the door to other healthcare changes Congress did not expressly authorize.

“To be sure, the costs imposed by the Disclosure Rule amount to a rounding error for
the pharmaceutical industry,” he wrote. “But that argument misses the point. It is the agency’s incursion into a brand-new regulatory environment, and the rationale for it, that make the Rule so consequential.

“To accept the agency’s justification here would swing the doors wide open to any regulation, rule, or policy that might reasonably result in cost savings to the Medicare and Medicaid programs, unless expressly prohibited by Congress. Indeed, the agency identifies no limiting principle, aside from an express statutory withholding of authority. So, this case is not just about whether HHS can force drug companies to disclose their list prices in the name of lowering costs. Rather, the WAC Disclosure Rule represents a significant shift in HHS’s ability to regulate the health care marketplace.”

At about the same time the Trump Administration announced its blueprint for lowering prices, Pharmaceutical Research and Manufacturers of America (PhRMA) looked to head off that effort, announcing that their members would be providing “more transparency” about the costs of their medicines in DTC ads, including “direct[ing] patients to information about medicine costs,” including the list price as well as “available financial assistance.”

But the key to that is the “directing patients” part, since PhRMA suggests that could be to a Web site where the information would be, rather than in the body of the ad.

“Our member companies are taking a new approach to how they communicate about medicines in DTC television advertisements to make it easier for patients to access information about medicine costs,” said PhRMA president Stephen J. Ubl. “The Administration and Congress have called on our industry to provide cost information in DTC advertisements, and our members are voluntarily stepping up to the plate.” But PhRMA suggested the Web site approach was better than putting the actual prices in the ads.

If the chronic pain community had not been so “passive” when the CDC published their CDC opiate dosing guidelines and challenged their legal authority to publish such guidelines.  WHERE WOULD WE BE TODAY ?

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https://youtu.be/7RBWuYFeg9Y

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Finally the inevitable has arrived.

After suffering four and a half years of chronic pain, multiple different meds, and doctors. And now unable to get medication, I have taken the next step. Buying my meds, referred to as drugs from now on, off the street, illegally.
I feel I have no other choice but to do this. My Doctor has been great, but there is nothing he can do.
I now do not have my doctor who can treat me the right way, and must rely on myself to control my own use. I know this will end bad, but I am not living another day in the pain I am in. I have not taken this decision lightly.
So far all has gone well, acquiring and self adminstration my drugs. Hopefully I will get a year or two of being able to work before the inevitable happens.
I can walk properly, I am now sleeping.
I am 29, I used to work as a chef, I am type one diabetic, I only weigh 132 lbs. I know the risks.
I don’t condone this method of action, and hope you all can find a better why to relieve your pain. I have lost all hope in being treated.
Thank you for your time, wish everyone the best.

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Bad and Distorted Research Used By Health Canada Leads to Tragedy for Many Canadian Patients

For Your Information
Edmonton, AB
July 8, 2019

In order to deal with overdose deaths among illicit drug users, Health Canada decided to go after chronic pain patients and their doctors this in the purported belief that they could reduce deaths. The department’s website, press releases, TV advertising, and the Minister’s statements all make clear that Health Canada is blaming part of the increase in overdoses on some imagined increase in the use of prescribed opiate medicines by Canadian patients. Prescribing of these drugs in Canada has, in fact, plunged.
Beginning in February 2018, the Chronic Pain Association of Canada (CPAC) attempted to find out from Health Canada what was informing their claims and actions. After several written requests with no reply, CPAC simply asked – What is it that you are basing your continual claim on that prescription opiates are to blame for your said “opioid crisis”?
In addition to written requests for answers, we also visited the offices of MPs, sent e-mails and made phone calls. Near the end of 2018, we sent the Minister a user-friendly synopsis of applicable research. Finally, in December 2018, we received a reply and found it wanting. We spent some time re-evaluating the studies they provided as their proof (we already knew them) and wrote back with our analysis.
We were quite surprised at how bad their grasp of the available research was.
Everything they referenced acknowledged that illicit drugs, not prescribed opiates, are driving overdoses. None of it provides any basis for curbing prescriptions. Ottawa’s own “Opioid-Related Harms in Canada” (2017) states that opiate-involved hospitalizations increased 53% in the ten years since 2007—bringing us to a rate of just 0.015% a year. The report specifies that most hospitalizations involved heroin and synthetic opiates like street fentanyl, not drugs prescribed by doctors. That’s been confirmed repeatedly by the coroners of BC and Alberta, with the latest BC numbers showing involvement of street fentanyl in a full 92% of overdose deaths, most of which also involve a mix of other street substances. Alberta numbers likewise show fentanyl driving 89% of deaths.
The report also says the fastest rise in hospitalizations is in young people, owing to street drugs and suicide attempts. There’s no basis here for curbing prescriptions, which most often go to older people.
Health Canada also cited a study that estimated that 83,000 adults used a prescription opiate in 2015, but not for pain. This data is from unreliable self-reporting. And that’s also just one quarter of one percent of us—not much on which to hang the one million Canadians desperately needing these medications.
Likewise, they cite their own 2016-2017 Canadian Student Tobacco, Alcohol, and Drugs Survey to say that 61,000 kids said they used a prescription analgesic to get high. The survey says the rate is stable; they don’t mention that. And, like the other stat above, the number reads quite differently when put into perspective: it’s a mere 3% of kids, and pretty benign compared to the more than 250,000 kids—four times as many—who tried cough syrup, Nytol, Gravol and the like to get high. And so these surveys also provide no basis for curbing prescriptions..
They ended their rationalization by citing four papers by Canadian “scientists.” But three of these are from researchers caught fudging their conclusions: last year, acting on complaints by readers of an online draft, the editor-in-chief of the medical journal PAIN made David Juurlink and Tara Gomes strike intentional distortions from a paper they’d submitted. Juurlink and Gomes write and speak frequently about the supposed dangers of medically-managed opiates. News media seems to believe Juurlink is an authority on the subject, given how often they quote him.
Our reply pointing out these problems went to the Minister in April. She has not responded.
Based on the faulty and misinterpreted research Health Canada used, the majority of Canada’s one million intractable pain patients who have successfully relied upon opiates to deal with their pain have had their medications discontinued or drastically reduced. Patients who had been doing well for years are now attempting to cope with significant increases in their pain and significantly reduced quality of life. They and their families are devastated.
The Food and Drug Administration in the US, the Centers for Disease Control, the authors of the American opiate prescribing guideline on which Canada’s is based, the US Health and Human Services Department, and even the Surgeon General have all publicly acknowledged that cutting pain patients down or off their medications has been wrong, unethical, and dangerous. Numerous US medical organizations including the American Medical Association have spoken out against the practice.
In fact, we wrote to the minister and called on her publicly to change her prohibition policy based on what the US has done. One of our press releasescalled upon the Minister to restore proper treatment to pain patients just as some doctors are prescribing opiates to addicts to keep them safe. No reply!
Neither Health Canada, the authors of the Canadian opiate guideline, nor the Canadian Medical Association have uttered one word. As pain patients are thrown into disability and more suffering, Health Canada policy has also increased the death toll. Pain patients have died from medical collapse, suicide, and now from the poisoned street drug supply that more and more are turning to out of desperation as they lose their managed care.
Health Canada’s response to this devastation has been to set up a Task Force to report back in three years. And, as in 2016 when pain experts and patients were shut out of the federal opioid “summit,” once again pain experts and the severely pained remain excluded without explanation from this new panel.
The Chronic Pain Association of Canada again calls upon the Minister of Health to rectify the dire problems they have caused and to help pain patients regain their health and lives.
The Chronic Pain Association of Canada receives no public or industry funding and believes in treating pain by whatever method works.

Contact: Barry Ulmer, Executive Director Chronic Pain Association of Canada
Telephone (780) 482-6727 | Fax (780) 433-3128 Box 66017 Heritage Postal Outlet, Edmonton Alberta T6J 6T4 Chronicpaincanada.com | cpac@chronicpaincanada.com

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ABC57 investigation uncovered startling number of nurses stealing, abusing drugs

https://abc57.com/news/abc57-investigation-uncovered-startling-number-of-nurses-stealing-abusing-drugs

On the above link there is a video report… website would not allow me to get a link to embed it on this blog

SOUTH BEND, Ind. — We trust them to take care of us and family members in the hospital, nursing homes and the doctor’s office. But, ABC57 is uncovering a startling number of nurses are stealing and abusing powerful drugs while on the job.

Just this past may, Creekside Village Nursing Home in Mishawaka, made a police report claiming someone had stolen liquid morphine and replaced it with cough syrup. In April, the Attorney General’s office filed a complaint against the nursing license of a former St. Joseph Hospital employee accused of stealing pain medications. Those are just two recent examples of what people in the medical profession call “diversion,” or the theft of prescription drugs.

In a review of just 90 days of complaints filed against nurse licenses across the state, ABC57 found 39 of 66 involved the abuse or theft of medications. That’s nearly 60 percent of all of the cases.

It’s such a problem, the state has a contract with a company aimed at treating addictions of nurses, doctors and pharmacists.

“We currently have 417 in active monitoring.” Tracy Traut, a Clinical Case Manager with Indiana Professionals Recovery Program, said. “Indiana professionals recovery program is what we refer to as an alternative to discipline program for medical professionals in the state of Indiana.”

IPRP took over the state contract less than a year ago. In the 11 months it’s been working with the state, they’ve dealt with nearly 650 medical professionals, mainly Nurses. Traut says it’s a national problem. The criminal defense lawyers based in Orange County area is where you can get legal help.

“3 to 6 percent of nurses currently engaged in active practice, have an alcohol or drug addiction problem.” She said.

IPRP serves essentially as a middleman. If a nurse has been accused of stealing drugs, fails a drug test or has a DUI, the state’s licensing board will have the company do an assessment, then recommend treatment. Traut and her team then monitor their treatment, pass info along to the state and, many times, the employer.

“You have an accountability system.” Traut explained.

That accountability system is essential for nurses who are allowed to go back to work on a probationary license, Traut says. Many times those nurses will have restrictions on handling narcotics and could be monitored by Traut’s team for up to 5 years.

“What we want to do is make sure everyone is make sure everyone is feeling good and stable and back on their feet, before they go back to the hustle and bustle of work.” She said. “We have many nurses who go back to have successful careers, happy lives, who go back to being pharmacists, pharm techs and really do beautifully for most of their lives.”

Traut says it’s common for any addict to relapse. In fact, about 50 percent relapse in the first 6 months of recovery. Traut says the goal is 5 years of sobriety. At that point, the chance of relapse drops by half. IPRP says they’ve had clients relapse, but, so far, none of it’s clients have been caught taking medications from their employer during or after monitoring.

ABC57 reached out to multiple state offices for comment. The state licensing board would not answer our questions. Indiana Attorney General, Curtis Hill’s, Office did not return our messages.

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https://www.foxnews.com/opinion/ed-henry-im-becoming-a-liver-donor-for-the-sister-i-love-so-she-can-live-a-long-and-healthy-life

This could prove to be interesting… here we have two relatives (Brother/Sister) that are both under going surgery… most likely, Ed (brother) is not a chronic pain pt but his sister it is unknown because of her failing liver.  BUT.. both are under going multiple hour surgery that is going to be cutting through their abdominal muscles…  Which I suspect is going to end up being a VERY PAINFUL RECOVERY PERIOD.

Fox cable appears to only has three personalities that are pro opiate for pain management… Greg Gutfeld – probably the most adamant supporter, Kennedy and Eliz Mac Donald – who interview Robt Rose on Fox Business channel a couple of months back… concerning his lawsuit with the VA.

Henry is just 47 and Sister is two years younger.. so the surgery should not be that much of a risk – older age really complicates surgeries.

It will be interesting what is said after Henry comes back after recovery… if pain management is even mentioned. Of course, being on Fox cable… he is probably being viewed by his doc and hospital and having a fairly large podium from which to speak and may not go down the path of “there is a couple of Tylenol for your post-op pain .  It will also be interesting if Fox cable takes a softer tone on our fabricated “opiate crisis” ?  Stay tuned… there could be some serious REVELATIONS coming to Fox cable.

https://www.foxnews.com/politics/transplant-specialist-breaks-down-ed-henry-liver-donation

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https://apprisshealth.com/blog/new-resource-page-for-patients-and-families/

https://apprisshealth.com/solutions/narxcare/

Appriss Health has created this MASSIVE website to supposedly to  help healthcare professionals to understand what they are doing – or attempting to do – in assisting healthcare professionals treat chronic pain pts and help call attention to those pts that are at risk of being substance abusers.

I find the websites EXCESSIVELY WORDY and at a point confusing and don’t know many healthcare professionals are going to have the time to read and digest all of this information.

I just wonder if this MASSIVE PRESENTATION is more to impress non healthcare professionals who are corporate executives who are being asked to pay dearly to provide this service to their employee healthcare professionals and how the “use” of this will help protect the corporation and provide “better care” to the pts that they serve.

Is this complex system and its reports just going to give healthcare professionals to JUST SAY NO.. because they don’t have the time to properly evaluate the information provided in the format that it is provided in.

Color me SKEPTICAL

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