“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Attached is a link to an interesting unanimous panel decision from the Sixth Circuit Court of Appeals in an opioids case. This is the very same court that would hear appeals from cases from decisions by Judge Dan Polster, Judge of the United States District Court for the Northern District of Ohio. Judge Polster, it will be recalled, has been selected by a federal judicial panel to preside over more than 200 consolidated prescription opioid-related lawsuits in multi-district litigation (MDL).
In the instant case, the plaintiff (a pharmacist working at Walmart WMT+0.6%) sued that company and others under the federal False Claims Act (FCA). The claim is that this pharmacist received large numbers of heavy opiate prescriptions written by the same doctor. Walmart allegedly filled these prescriptions, whose small copay indicated to the plaintiff that Walmart was obtaining Medicare and/or Medicaid reimbursement. The plaintiff believed these prescriptions to be fraudulent (both because of their number and because of the high dosage) and thus that the federal reimbursement to Walmart was fraudulent. He notified his employer of his decision to file his complaint, and claims he was fired as a result (adding a retaliation count to his suit).
Typically in such cases, the federal government intervenes to support the claim of alleged fraud and the claimant (here, the pharmacist) receives a reward for his initiative. Here, though, the government expressly declined to intervene, so the pharmacist persevered alone. But Walmart and the other defendants demurred (that is, claimed that the plaintiff’s suit did not state a cause of action) and won at trial. A unanimous Circuit Court panel here confirmed.
The reasoning is interesting and potentially applicable to Judge Polster’s MDL. The panel held that the tiny amount ($1 or $2) paid by patients for each prescription was no proof that the federal government had expended any money at all, or even that any demand for federal payment had ever been made. It also held that the mere fact that doses were high was no evidence at all that they were medically “too” high. It held that the mere fact the plaintiff was discharged in no way established any causation with his FCA claim. Finally, it held that the federal government’s decision not to intervene in the case demonstrated that it too found the allegations lacking. Essentially, the panel wondered how Walmart could believe the prescriptions to be fraudulent when the government itself clearly doesn’t think so.
It’s pretty clear that bare-bones lawsuits against a seemingly fat target (Walmart in an opioids suit) are not going to be met with favor in the Sixth Circuit. Plaintiffs had better be equipped, both in individual case and in the MDL, with detailed medical expert evidence about patients’ needs and about federal fraud.
A Toronto man says he went to the hospital with excruciating leg pain but was not believed and sent away after he disclosed a mental illness. To read more: http://cbc.ca/1.5871307 »»» Subscribe to CBC News to watch more videos: http://bit.ly/1RreYWS Connect with CBC News Online: For breaking news, video, audio and in-depth coverage: http://bit.ly/1Z0m6iX Find CBC News on Facebook: http://bit.ly/1WjG36m Follow CBC News on Twitter: http://bit.ly/1sA5P9H For breaking news on Twitter: http://bit.ly/1WjDyks Follow CBC News on Instagram: http://bit.ly/1Z0iE7O Subscribe to CBC News on Snapchat: https://bit.ly/3leaWsr Download the CBC News app for iOS: http://apple.co/25mpsUz Download the CBC News app for Android: http://bit.ly/1XxuozZ »»»»»»»»»»»»»»»»»» For more than 75 years, CBC News has been the source Canadians turn to, to keep them informed about their communities, their country and their world. Through regional and national programming on multiple platforms, including CBC Television, CBC News Network, CBC Radio, CBCNews.ca, mobile and on-demand, CBC News and its internationally recognized team of award-winning journalists deliver the breaking stories, the issues, the analyses and the personalities that matter to Canadians.
This is my friend Kimberly Derewenko-Freitas who lost her life today because the CDC guidelines on opioids destroyed her right to live and raise her young son! Constant pain threatens Chronic pain patients everyday! The government took our rights away to live! People want to get out of bed and play with their kids and grandkids but can’t because of an illness or injury! Opioid theropy is an absolute way of life for people who use opioids correctly! Torture and punishment is the way the government handles pain patients because most are broke and live on social security and have few or very little because of injuries or illnesses…. Kimberly just had brain surgery and lack of treatment causes death! She was an awesome person just trying to live man! How sad we have come to this! We can do something about it…. its called fighting back! Look it can be you next time a drunk flies throw a light or simple surgery turns into a disaster…like me! The government is picking on people that can’t defend their selves! It is so important to understand this could be your mother or your child! Chronic Pain Patients are suffering reach out and call your congressman or senator’s! Mention it to your doctors or medical professionals and ask what you can do to help! Her name was Kimberly and she meant something and did nothing wrong! Help us find a way out of this nightmare and give the doctors back their prescription pads to folks that can prove their pain…. contact American Pain and Disability Foundation to ask how you can help! Don’t be the next pain patient and have to live in our hell! Bob Sheerin VPO American Pain and Disability Foundation
When you see about a medical office practice, pharmacy and/or any other entity that has the legal right to handle, prescribe or dispense controlled substances …being raided and shut down… Who is conducting the raid… NOT THE FDA… NOT THE CDC…
Typically, the raiding of the office practice or others is done by the DOJ/DEA/FBI/local law enforcement.
Who has the statutory authority to permit a medication to be prescribed and dispensed in the USA — How about the FDA. ?
Who has the authority to establish and approve the appropriate medical use for a particular substance/medication, the appropriate dosage range, the potential lethal dose and all the other related items as to the safe use of a particular substance/medication.
Who was the entity who “jumped on” the CDC guidelines in 2016 and attempted to get the guidelines recognized as standard of care and best practices ? When >50% of the prescribers in a given area, state, region follow these guidelines… the becomes a de-facto law.
Does the FDA utilize these de-facto laws/rules and search the various states’ PDMP databases to find prescriber who is “exceeding” these opiate dosing guidelines and fabricate a “probable cause case” that a particular prescriber is routinely prescribing an excessive amounts of opiates and controlled substances and labeled as operating a “pill mill” ?
Has anyone noticed that when the states are unhappy with what the FEDS do… what do they do… THEY SUE… they don’t sign petitions, they don’t send letters, texts, faxes, emails to members of Congress.
Human Psychology strongly suggests that people will continue to do something that they consider illegal, immoral or unethical until they suffer some bad personal consequences. No matter if you are talking about the Insurance/PBM industry, large hospital systems, chain pharmacies…etc…etc… they can – and have – denied care, abused pts – intentionally throwing pts into cold turkey withdrawals – directly – indirectly causing chronic pain pts to commit suicide… and have any of these entities had to deal with any consequences — personally, financially ?
They have NO REASONS for changing what they have been doing… in fact… it would seem that many have increased the number of chronic pain pts that have been adversely impacted.
Just think “Lucy” as the various bureaucracy, the “football” as some proposed change in rules/regulations and “Charlie Brown” the chronic pain community…
How many times is “Lucy” going to put the “football” in place with the theoretical promise to hold it in place .. and then just as “Charlie Brown” gets ready to kick the football… Lucy pulls it way – once again.. How many times is the chronic pain community going to live thru this “Groundhog Day” scene ?
Pain patients beg FDA for more options, easier access to opioids
People with chronic conditions cope with prescription restrictions and limited alternative therapies amid the nation’s opioid crackdown.
SILVER SPRING, Md. — One pain patient lay on the floor. Another leaned against the wall, easing her back. A third paced to and fro.
At this week’s Food and Drug Administration hearing on chronic pain, accommodations were at the forefront.
And the agency says it wants to be accommodating in other ways as it tackles the opioid crisis. Thus, a meeting was called simply to listen to people’s stories about their pain and how they may, or may not, handle it.
It was a room full of some very unhappy people.
“Suicide is always an option for us,” said Mariann Farrell of Pittsburgh, who says she has multiple conditions, including fibromyalgia and the post-herpetic pain that can linger after shingles. Farrell was one of several dozen people who traveled to the FDA’s headquarters outside Washington to ask the agency to ease restrictions that they say has made it harder for them to get opioids.
Sandra Flores, a former emergency room nurse from Tucson, Arizona, roused rounds of applause as she told of her repeated efforts to get opioid prescriptions for her pain. Flores said she was diagnosed with adhesive arachnoiditis, an inflammation of the membranes protecting the brain, spine and nerve endings.
“I am seeing the true face of medicine,” Flores said. “Now they are throwing me in the trash.”
The FDA said it wants to consider the needs of patients with chronic, intractable pain as it considers the problem of opioids, and as it encourages drug companies to come up with safer alternatives.
“We don’t want to perpetuate practices that led to the misuse of these drugs, and the addiction crisis. At the same time, we don’t want to act in ways that are poorly targeted, and end up disadvantaging legitimate patients,” FDA Commissioner Dr. Scott Gottlieb said in a statement.
“In most circumstances, opioids should only be used for the treatment of acute pain and prescribed for short durations of time,” he added.
“However, the FDA is aware that there are certain circumstances — such as in the treatment of metastatic cancer pain and the episodic treatment of migraine pain — where the drugs are administered over longer periods. In select patients and for certain medical conditions, opioids may be the only drugs that provide relief from devastating pain.”
The FDA, Centers for Disease Control and Prevention and other medical groups agree not only that there’s an opioid crisis, but that it has been driven in no small part by overprescribing.
The CDC reported last year that the number of prescriptions for the painkillers tripled between 1999 and 2015. “A generation of providers dispensed these medicines too liberally, and were slow to address the signs of misuse and addiction,” Gottlieb said.
The CDC says more than 42,000 people died from opioid-related overdoses in 2016, a 30 percent increase from the year before. Synthetic opioid overdoses killed 20,000 of them. Opioid overdose deaths are so numerous they have helped drive down U.S. life expectancy.
So the CDC has issued guidelines recommending that doctors cut back on opioid prescriptions, and advising patients to try anything else they can before asking for the powerful and addictive drugs.
They recommend first trying Tylenol or drugs such as ibuprofen or naproxen, which are in a class called non-steroidal anti-inflammatory drugs, or NSAIDs. They also recommend trying low-tech options such as ice, physical therapy and massage. And, the CDC says, patients may have to change their expectations about living with pain.
But the CDC and FDA do not regulate physicians. States do.
At least 28 states have some limits on opioid prescriptions, according to the National Conference of State Legislatures. Seventeen limit prescriptions to three to 14 days.
Others have prescription drug monitoring programs to keep watch for providers who might be writing prescriptions too freely.
The pain patients who traveled from across the country to testify to the FDA say they are feeling the effects.
Flores, who said she was diagnosed with her painful condition two years ago, said she can no longer find a doctor to prescribe her opioids.
“I have yet to have a doctor accept me as a patient,” Flores told NBC News.
“No doctors will fight. They just don’t want to get into trouble. They have forgotten the people these drugs were made for.”
Flores said she worried she was failing as a mother, her teenaged son unwilling to put her down as an emergency contact. “He knows I often don’t answer the phone because I am in bed,” she said.
“When can I have medicine so I can just be comfortable in my body?” she asked.
It’s clear who they blame for their reduced ability to get opioids.
“To the FDA — we are begging you. Correct the CDC’s egregious mistakes,” said Rose Bigham of Seattle, who spoke on behalf of the Alliance for the Treatment of Intractable Pain.
“The CDC recommendations have done irreparable harm to people in pain.”
Fears of being denied pain relief
More than 90 percent of the patients at the FDA meeting and watching online said they had used NSAIDs and more than 80 percent said they had used opioids to control their pain. And 77 percent said they had used gabapentin (Neurontin) or pregabalin (Lyrica), both anticonvulsant drugs also approved to treat pain.
As for non-prescription treatments, 68 percent said they had used dietary supplements or herbal remedies to treat pain, 47 percent said they had tried medical marijuana or other cannabis-based products, 68 percent had tried acupuncture, massage or other complementary therapy and 47 percent had tried counseling or other psychological treatment.
“None of them are covered by insurance,” Bigham noted, to applause and loud cheers.
Rose Bigham has chronic pain and wants the FDA to help find better treatments.
Bigham said she has ankylosing spondylitis, a form of arthritis affecting the spine.
She said she has tried NSAIDs, muscle relaxants, antidepressants, injectable drugs, cortisone and an electric current therapy called transcutaneous electrical nerve stimulation. “I remain on opioids to this day,” she said.
“My new worst nightmare is being admitted to the hospital, being in agony, and being denied pain relief,” Bigham said to more applause.
Charlotte Diggs of Atlanta said it’s not easy to get alternatives to opioids, either. Her physician was not forthcoming about possibilities when he was treating her for complex regional pain syndrome. “He didn’t offer it,” she said. “I had to hear about it and then ask him,” Diggs told NBC News.
Flores said she wasn’t sure if talking to the FDA would help. “I don’t know if it is just a formality.”
But the FDA staffers said they genuinely wanted to consider patient perspectives, and listened quietly to lengthy, often tearful, tales of untreated pain, lost jobs and days spent in bed.
“We don’t have expectations for what we are asking,” said Dr. Sharon Hertz, director of FDA’s Division of Anesthesia, Analgesia and Addiction Products.
RIP HERO . We’re so sorry you thought this was the only way to peace. 🙏. Shared , Colt Schermer took his life 2 Days ago. He was with 2/4 as a Cpl. He was a MARSOC Master Sergeant well decorated and 2 weeks out from being married. His Officers said he was the best of the best
6/7/21, former DEA Agent (2006 to 2015), Joe Rannazziai said, “ The DEA does not work directly in that Closed System, but instead provides guidance and investigates when needed.”
This “Closed System” is: physicians prescribe and pharmacies fill these prescriptions both of which are DEA LICENSED.
Rannazzisi said, “I believe that the facts should be presented in this case, because the public needs to be aware of what went on and this is my opportunity to do that.”
What went on, was the DEA had been intimidating Physicians to lower treatment under the DEA’s OWN AUTHORITY,
“2004 DEA Opioid Prescribing Guideline”, which was determined to be illegal and withdrawn in 2005,
and closing legitimate Pain Clinics to lower the volume of opioids being prescribed.
The DEA were in fact, that I am a witness, actively screwing with this “Closed System”, since 2004 to lower the NUMERIC amount of treatment for ALL functionally disabled patient’s clinically determined need.
It is a boldfaced LIE for him to testify: prescribing was a “Closed System” in which they, the DEA, did not work directly” to upset balance of professionally determined need. Even in 2005, patients were forced to street drug replacement near the DEA Hquarters in DC, which is now common across the country.
The DEA alone made the assumption Physicians lowering treatment would stop the diversion and abuse, which is what has caused the overdose crisis today.
I was treated in a Clinic closed by the DEA in 2005 in a Washington DC suburb, Dulles, VA. The DEA were in fact disrupting this “Closed System”!
Once a Physician lowers treatment from DEA intimidation, the DEA claims they were OVER-TREATING, before a treatment reduction, made by that doctor.
The FDA’s blessing of a controversial treatment on spotty evidence threatens to harm the agency’s reputation, America’s health budget and the quality of drug research.
“Follow the science” has been a consistent refrain during the pandemic, and it’s usually a core mandate of the Food and Drug Administration in evaluating medicines. But when it came to one of the agency’s most consequential decisions —
the approval Monday of Biogen Inc.’s controversial Alzheimer’s drug aducanumab — science took a back seat.
Alzheimer’s is a devastating illness with no treatments that do anything but ease symptoms. Biogen’s drug is the first said to slow decline. If there was good evidence that it did so, it’d be a breakthrough, but the data is inconclusive at best. And while the FDA is and should be flexible when patients have no options, this decision does more than bend standards — it shatters them.
For Biogen investors, the approval is a huge victory, setting the stage for a blockbuster drug worth billions in sales and added market value for the company; already, after an initial halt the stock surged 50% on Monday’s news. For everyone else, it’s a mistake; the FDA’s blessing threatens to harm the agency’s reputation, America’s health budget and the quality of drug research, including for Alzheimer’s.
Buy the News
The approval of Biogen’s Alzheimer’s drug aducanumab in spite of limited evidence sent its shares soaring
Here’s the issue: Biogen started two identical studies in 2015 to test whether the drug slowed early Alzheimer’s. However, the company halted them in March 2019 after an early analysis suggested a low chance of success. It was the presumptive end for the medicine until Biogen popped up a few months later with the shocking announcement that one of the two trials showed a benefit — once it added new data — and that it planned to file for approval.
The early halt was problematic. Biogen collected a fraction of the patient data it wanted, introducing statistical uncertainty. But the biggest issue is that the second study failed, and it wasn’t close. The FDA’s desired standard for approval in Alzheimer’s is evidence from two positive studies. There are good reasons to want a high bar and duplication. It’s much harder to objectively measure mental decline than the size of a tumor, making definitive evidence especially critical.
The FDA ducked this standard by giving the drug a so-called accelerated approval, using a regulatory pathway that lets the agency accept different types of evidence in areas where patients lack options. That doesn’t make the decision more defensible. In this case, the approval centers on aducanumab’s ability to remove amyloid brain plaques believed to play a role in Alzheimer’s. Biogen’s drug (which it will market under the brand name Aduhelm at a hefty price of about $56,000 a year) cuts plaque, but the resulting patient benefit in even the positive trial is so modest that it may not be significant.
Many other medicines have targeted amyloid. Unfortunately, all failed to help patients, leading scientists to question whether removing the plaque does anything. Biogen’s opposing results only add to the uncertainty about the role of amyloid; they don’t make it acceptable as the basis for a multibillion-dollar approval. What is certain is that removing the plaque causes sometimes serious side effects, including brain swelling.
Biogen has explanations for the failed trial, blaming insufficient dosing and a few rapidly declining patients. But, unfortunately, this is what’s known as post-hoc analysis, or less politely cherry-picking, and it is fundamentally and irrevocably biased. Good scientists use such methods to generate ideas for future tests, not as tentpoles for generationally significant drug approvals.
You’d expect the FDA to push back. But, in this case, a part of the agency not only shifted its standards but collaborated with Biogen through an approval process in which it was so cozy with Biogen that consumer advocacy group Public Citizen has asked the government to investigate. That’s even as an independent panel of experts convened by the FDA to evaluate the drug universally advised against approval in November. Moreover, the regulator’s own statistical expert was highly critical of the evidence presented in a briefing packet presented as part of the November review. And on June 2, the American Geriatrics Society, a group of health professionals dedicated to older adults, wrote directly to the FDA’s interim commissioner advising against approval.
The FDA seems to have yielded to the pressure to give hope to patients, even if it may be false, despite the consequences. And there are many. If the agency approves drugs with middling evidence, that’s what it will get. Companies will be more likely to seek approval or advance programs based on weak results, wasting time and research dollars and the health of patients who participate in clinical trials. As for Alzheimer’s, future drugs may be badly delayed. With an approved treatment available, it will likely become harder to recruit people to participate in trials. And now that the FDA has validated amyloid as a target, companies may focus on it at the expense of other potentially more fruitful avenues.
The price of the drug is just the beginning of the financial damage. Getting it will require doctor’s visits and scans to establish eligibility and monitor side effects, creating significant additional costs for Medicare, patients and their caregivers. Multiply those costs by even a fraction of the millions of Americans with Alzheimer’s, and you have a budget crisis.
With a newly implemented outpatient palliative care program in my current oncology practice, patients are often hesitant to see me due to fear, misconceptions, and stigma. One of the most common comments I receive from families is “my loved one isn’t ready for palliative care, they are not dying.” Few patients understand the meaning of palliative care and much of my time is spent explaining my role.
Many people also assume that palliative care is just for patients with cancer. However, patients with other chronic illnesses such as heart disease, lung disease, neurologic diseases, and dementia also benefit from palliative care. All of these chronic illnesses can cause symptoms that may negatively impact quality of life (eg, shortness of breath, pain, fatigue, depression, decreased appetite, anxiety, or nausea).
Therefore, the first consultation typically involves patient education on what palliative care is and how it differs from hospice care. I explain that palliative and supportive care should be part of the treatment plan from the time of diagnosis of an illness through the end of life, incorporating hospice care if and when the time presents.
Benefits of Palliative Care for Chronic Illnesses
In a randomized study involving patients with metastatic non–small-cell lung cancer who received early palliative care plus standard oncologic care or standard oncologic care alone, patients given early palliative care had significantly better quality of life and were less likely to report depressive symptoms at 12 weeks compared with patients given standard care group.1 Additionally, patients in the early palliative care group lived nearly 3 months longer than the standard care group despite receiving less aggressive care at the end of life.
Symptom management and emotional support are major goals of palliative care. Early integration and development of a relationship with palliative advanced practice practitioners (APPs) help ensure that patients will confide in and communicate their needs during the disease course as symptoms or side effects may develop or increase. Palliative APPs also may lessen some of the burden on physicians with time constraints and heavy patient loads.
In a retrospective cohort study, patients with advanced cancer given early referrals to palliative care (ie, more than 3 months before death) had significantly fewer emergency room visits, hospital admissions, and hospital deaths in the last 30 days of life compared with those given late referrals.2 Patients who received outpatient referrals to palliative care showed improved quality of end-of-life care compared with patients who were referred to palliative care in the inpatient setting.
It is time to accept supportive and palliative care as an essential element of early care and treatment of cancer and other chronic diseases. Let us allow palliative care to become an extra layer in the comprehensive team approach to care and not to be driven by fear or misconception. Early integration of a palliative and supportive team with a focus on symptom management, supportive care, and quality of life helps us meet the emotional, physical, and spiritual needs of the patient.
John Martin of ABC News says “Gerald Posner is one of the most resourceful investigators I have encountered in thirty years of journalism.” Garry Wills calls Posner “a superb investigative reporter,” while the Los Angeles Times dubs him “a classic-style investigative journalist.” “His work is painstakingly honest journalism” concluded The Washington Post. The New York Times lauded his “exhaustive research techniques” and The Boston Globe determined Posner is “an investigative journalist whose work is marked by his thorough and meticulous research.” “A resourceful investigator and skillful writer,” says The Dallas Morning News.
Posner was one of the youngest attorneys (23) ever hired by the Wall Street law firm of Cravath, Swaine & Moore. A Phi Beta Kappa and Summa Cum Laude graduate of the University of California at Berkeley (1975), he was an Honors Graduate of Hastings Law School (1978), where he served as the Associate Executive Editor for the Law Review. Of counsel to the law firm he founded, Posner and Ferrara, he is now a full time journalist and author.
In the past, he was a freelance writer on investigative issues for several news magazines, and a regular contributor to NBC, the History Channel, CNN, FOX News, CBS, and MSNBC. A former member of the National Advisory Board of the National Writers Union, Posner is also a member of the Authors Guild, PEN, The Committee to Protect Journalists, and Phi Beta Kappa. He lives in Miami Beach with his wife, author, Trisha Posner, who works on all his projects (www.trishaposner.com).
This is abt a 38 minute interview. Posner’s position is to target Purdue Pharma and the Sackler Family and all the profits that they made off of the marketing/selling of Oxycontin and of course … to sell his new book.
He talks about a lot of issues surrounding the fabricated opiate crisis.. he describes the health issue of Hyperalgesia without ever mentioning the name of Hyperalgesia.
He at times injects the fact that “some” people actually needs opiates for long term pain – abt 30 days ?
He mentions a couple of Mothers who lost children to overdoses and how they took action after their kids OD.
He blames everyone for failing to control the distribution of opiates – FDA, Pharmas, Drug Wholesalers, prescribers, Pharmacy/Pharmacists… I do not remember the first word about the failure of the DEA ?
He didn’t mention the DECADE OF PAIN LAW https://www.congress.gov/bill/106th-congress/house-bill/2260 where prescribers were encouraged to adequately treat pt’s pain and the Joint Commission made proper pain management – the 5th vital sign – and a MAJOR STANDARD.
There was no mention that addiction was a MENTAL HEALTH ISSUE
Tucker even mentioned having some dental procedure and receiving TWO PRESCRIPTIONS – did not indicate what they where – put stated that he did not take them and FLUSHED THEM. He also made the statement that he had previously had some surgical procedure and was given Morphine IV and “..didn’t like how it made him feel..” It would seem obvious that Tucker is opiophobic.
Anyone can get a 7 or 30 day FREE TRIAL of www.foxnation.com… if anyone really wants to watch this lopsided piece of literature.
