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Bob Sheerin addressing when prescribers taking pts off pain meds
Posted on April 20, 2022 by Pharmaciststeve
FDA: warns about tests may not be supported with “sound scientific evidence” BUT remains silent on the MME system use
Posted on April 20, 2022 by Pharmaciststeve
FDA Issues Warning on Prenatal Genetic Tests
https://www.medpagetoday.com/obgyn/generalobgyn/98285
Relying on results could lead to inappropriate medical decisions, agency warns
The FDA warned in a safety communication that non-invasive prenatal tests (NIPT) are screening tests — not diagnostic tests — and patients and healthcare providers may make inappropriate healthcare decisions based on their results.
The agency said it’s aware of reports that people have made such decisions using the results of these tests without additional confirmatory testing.
“Pregnant people have ended pregnancies based on the results of genetic prenatal screening alone, without understanding the limitations of the screening test and that the fetus may not have the genetic abnormality identified by the screening tests,” the agency stated in a press release.
FDA’s warning follows recent media coverage of a Hastings Center report that found the marketing around the tests often included misleading information, which could lead parents to terminate a normal pregnancy. The New York Times had also reported on rates of false positives with the tests earlier this year.
The agency said in its statement that it is “concerned” that advertising claims on the tests, such as that they are “reliable” and “highly accurate,” may not be supported with “sound scientific evidence.”
The issue centers around the likelihood of a result being a false positive. For instance, with very rare conditions caused by a microdeletion — a small missing piece of a chromosome — a positive result is more likely to be false than it is that the fetus has the disease.
“In other cases,” the agency stated, “a positive screening result may accurately detect a chromosomal abnormality, but that abnormality is present in the placenta and not in the fetus, which may be healthy.”
FDA said additional testing of a genetic screening result, such as amniocentesis or chorionic villous sampling, may be needed to confirm whether the fetus indeed has the genetic disorder.
The agency also warned that none of the NIPT tests are authorized or approved by the FDA. Rather, they’re all classified as laboratory developed tests (LDTs), which means their accuracy and performance aren’t evaluated by FDA. The agency has had a general policy of “enforcement discretion” for most LDTs, which means it doesn’t generally enforce applicable regulatory requirements for these tests.
FDA stated in its press release that it is “continuing to work with Congress on legislation to establish a modern regulatory framework for all tests, including LDTs.”
“While genetic non-invasive prenatal screening tests are widely used today, these tests have not been reviewed by the FDA and may be making claims about their performance and use that are not based on sound science,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy. We strongly urge patients to discuss the benefits and risks of these tests with a genetic counselor or other health care provider prior to making decisions based on the results of these tests.”
Josephine Johnston, director of research at The Hastings Center, told MedPage Today that the FDA’s safety communication “is a way of doing a little bit of regulation of an area they don’t regulate. … This is the only thing they can do.”
She noted that FDA’s review of its LDT regulatory policy has been ongoing for several years. “Tests are falling under this exemption they were never intended for, but it’s never changed,” she said. “There are probably strong and forceful arguments on both sides of the issue.”
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Judge Declares CDC’s Federal Public Transportation Mask Mandate Unlawful
Posted on April 20, 2022 by Pharmaciststeve
Back in Aug 2021, the CDC tried to extend the rent eviction moratorium but the Supreme court said they didn’t have the statutory authority to do this. TWICE in less than a ONE YEAR PERIOD – the CDC’s edits have been struck down by our courts.
The Supreme Court Will Allow Evictions To Resume. It Could Affect Millions Of Tenants
Does this suggest that the CDC did not/does not have the statutory authority to create/publish the 2016 and 2022 opiate dosing guidelines ? We know that the CDC has no statutory authority to enforce or prevent any entity from codifying the guidelines and/or turning the guidelines into some sort of black/white corporate policies and procedures.
Could it be that the only reason that the CDC opiate dosing guidelines have been allowed to be imposed on the chronic pain community is because those who have been impacted by these guidelines, did not get together and create a legal defense fund to have these guidelines declared unconstitutional. This is an excellent example of how bureaucrats can get rules/laws passed that are unconstitutional and they can enforce them until they are challenged in our court system and having them declared unconstitutional. The community may have a small window of opportunity to get the 2016 opiate dosing guideline declared unconstitutional and prevent the 2022 proposed guidelines from being officially published.
Judge Declares Federal Public Transportation Mask Mandate Unlawful
A federal judge threw out the federal government’s mask mandate for airports, airplanes and other public transportation Monday, ruling the Centers for Disease Control and Prevention exceeded its authority by imposing the mask requirement days after the agency extended it another two weeks.
A traveler wearing a face mask is seen at Ronald Reagan Washington National Airport in Arlington, … [+]
Xinhua News Agency/Getty Images
Key Facts
U.S. District Judge Kathryn Kimball Mizelle, who was appointed by former President Donald Trump, issued a ruling that declared the mask mandate unlawful and blocked it by vacating the order and sending it back to the CDC “for further proceedings.”
The anti-mandate Health Freedom Defense Fund had sued the CDC and federal officials in July over the mask requirement, asking the court to declare the order unlawful and set it aside under the Administrative Procedure Act.
Mizelle ruled the CDC did not have authority to impose the mask mandate under the Public Health Services Act of 1944, claiming that the law only lets the CDC impose measures related to “inspection, fumigation, disinfection, sanitation, pest extermination [and] destruction” to curb disease transmission and mask-wearing doesn’t fall under any of those.
The CDC also erred by not having an adequate public comment period before it imposed the mandate, Mizelle ruled, and said the mask mandate is “arbitrary and capricious” because the agency didn’t sufficiently explain the reasoning behind imposing it.
While the federal government had asked Mizelle to just block the mandate as it applied to the plaintiffs challenging it, the judge said she had to throw out the entire mandate because “the difficulty of distinguishing” the plaintiffs from other travelers “almost ensures that a limited remedy is no remedy at all.”
A Biden Administration official told Forbes the transportation mask mandate will no longer be enforced as a result of Mizelle’s ruling, though the federal government is still “reviewing the decision and assessing potential next steps.”
Crucial Quote
“It is indisputable that the public has a strong interest in combating the spread of [Covid-19],” Mizelle wrote in her opinion, quoting a past ruling in a different case and noting the CDC imposed its mask mandate “in pursuit of that end.” The judge wrote the court still “declares unlawful and vacates the mask mandate” anyway, however, as “our system does not permit agencies to act unlawfully even in pursuit of desirable ends.”
Tangent
Several airlines—including United, Delta, Southwest and Alaska—announced Monday that masks are no longer mandatory for domestic flights following the ruling.
Surprising Fact
Mizelle was just 33 years old when she was appointed to the federal bench in 2020, and the American Bar Association gave her a rating of “not qualified” to hold the position due to her lack of experience. “Since her admission to the bar Ms. Mizelle has not tried a case, civil or criminal, as lead or co-counsel,” the ABA wrote in a letter to the Senate Judiciary Committee, noting that Mizelle was only admitted to practice law in 2012—which is a “rather marked departure” from the at least 12 years of experience that’s recommended for federal judges.
Big Number
60%. That’s the share of Harris poll respondents that said in early April they wanted the federal mask mandate to be extended. A Morning Consult poll similarly found at least three in five respondents support customers and employees wearing masks on planes, though a recent Kaiser Family Foundation poll was more split, with a narrow 51% majority saying they wanted the federal mask mandate to expire.
Key Background
The CDC first imposed its federal mask mandate soon after President Joe Biden took office in February 2021. Though the order was expected to expire Monday, the CDC announced last week it would extend the mask mandate another two weeks in light of a new rise in Covid-19 cases linked to the highly transmissible omicron BA.2 subvariant. The CDC had also said it was developing a “framework” for when masks should be required once the order expires, which might depend on factors like the rate of severe illness from Covid-19 or if new variants are emerging. The lawsuit against the order comes as the mask mandate had faced more resistance in recent months as it stayed in place even as other mask orders lifted, with 21 GOP-led states suing the Biden administration to block the mask order and airline CEOs calling for it to end in an open letter.
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Ohio doctor found not guilty in 14 hospital patient deaths
Posted on April 20, 2022 by Pharmaciststeve
Ohio doctor found not guilty in 14 hospital patient deaths
https://apnews.com/article/health-ohio-columbus-e9dcc1356cfd9ec3dbeda4e6526bcc20
COLUMBUS, Ohio (AP) — An Ohio doctor accused of ordering excessive amounts of painkillers that led to multiple patient deaths at a Columbus-area hospital was acquitted of 14 counts of murder Wednesday following a weeks long trial.
Dr. William Husel, 46, was accused of ordering the drugs for patients in the Mount Carmel Health System. He was indicted in cases that involved at least 500 micrograms of the powerful painkiller fentanyl.
Prosecutors said ordering such dosages for a nonsurgical situation indicated an intent to end lives. Husel’s attorneys argued he was providing comfort care for dying patients, not trying to kill them.
Franklin County Judge Michael Holbrook told jurors before the start of deliberations that they could also consider lesser charges of attempted murder. They deliberated for six days.
Husel would have faced a sentence of life in prison with parole eligibility in 15 years had he been found guilty of just one count of murder.
Prosecutors presented their case beginning Feb. 22 and put on 53 prosecution witnesses before resting on March 29. Those witnesses included medical experts who testified that Husel ordered up to 20 times as much fentanyl as was necessary to control pain.
Husel gave enough fentanyl to some patients to “kill an elephant,” testified Dr. Wes Ely, a physician and professor of medicine at Vanderbilt University.
Other prosecution witnesses included medical experts, Mount Carmel employees, investigators, and family members of all 14 patients.
By contrast, defense lawyers called a single witness — a Georgia anesthesiologist — to testify that Husel’s patients died from their medical conditions and not Husel’s actions. The defense rested on March 31 after one day.
The age of the patients who died ranged from 37 to 82. The first patient death was in May 2015. The last three died in November 2018.
During closing arguments April 11, David Zeyen, an assistant Franklin County prosecutor, told jurors that regardless of how close a patient is to death, it’s illegal to speed up the process.
Husel’s attorney Jose Baez during a remote news conference after the verdict repeated his assertion that prosecutors didn’t produce “a shred of evidence” to back up their claims. He called Husel an “incredible doctor” who with his family are “incredibly relieved the nightmare is over.”
“I’m deeply saddened William had to go through this,” Baez said.
The Franklin County Prosecutor’s Office released a brief statement that concluded: “We accept the jury verdict.”
Husel was fired by the Mount Carmel Health System. It concluded he had ordered excessive painkillers for about three dozen patients who died over several years. He was initially charged with 25 murder counts, but the judge agreed to dismiss 11 of those counts in January.
Husel’s colleagues who administered the medications weren’t criminally charged, but the hospital system said it fired 23 nurses, pharmacists and managers after its internal investigation and referred various employees to their respective state boards for possible disciplinary action.
Mount Carmel has reached settlements totaling more than $16.7 million over the deaths of at least 17 patients, with more lawsuits pending.
One patient, 82-year-old Melissa Penix, was given 2,000 micrograms of fentanyl and died a few minutes later. Dr. John Schweig of Tampa Bay General Hospital testified for the prosecution that Penix “definitely was not terminal, nor was continuing medical care futile.”
“She was a fighter,” said Penix’s daughter, Bev Leonhard, of Grove City, according to The Columbus Dispatch. “She didn’t deserve to die the way she did.”
What has not been made clear in this case – unless I missed it , in what has been posted. Were these pts already on opiates of some sort and did they already have a substantial opiate tolerance. There is a lot of difference in providing a pt that many mcg as a “push” as opposed to putting the pt on a Fentanyl drip over many hours… much like pts who use Fentanyl patches or pts that have Fentanyl in their implanted pain pumps. I have not seen the details of the Georgia anesthesiologist‘s testimony.
Since Husel was found NOT GUILTY… the hospital system may find itself with a lot of other lawsuits from all the other hospital system employees that were fired after it’s investigation fired more than TWO DOZEN employees and apparently filed complaints with the individuals’ respective licensing boards. If those various licensing boards revoked, suspended or took some other action against those healthcare practitioners.
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Please Donate American Pain and Disability Foundation
Posted on April 20, 2022 by Pharmaciststeve
Man character need help. Vector flat cartoon illustration
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CDC launches new forecasting center for infectious diseases
Posted on April 19, 2022 by Pharmaciststeve
CDC launches new forecasting center for infectious diseases
https://abcnews.go.com/Health/wireStory/cdc-launches-forecasting-center-infectious-diseases-84163365
The new Center for Forecasting and Outbreak Analytics launched Tuesday. Its leaders say predicting the course of the COVID-19 pandemic in the U.S. has been hampered by data-collection problems.
In contrast, the United Kingdom uses regular population sampling with swab tests and blood draws to get a clearer picture of who’s been infected, said Marc Lipsitch, the new center’s science director. He said similar sampling should be considered in the U.S.
And the Centers for Disease Control and Prevention needs to have better access to data from state governments and hospitals, said Caitlin Rivers, the center’s associate director.
CDC has been granted temporary authority for COVID-19 data collection, but the agency broadly relies on voluntary reporting and complex data agreements with states, Rivers said.
The center is housed at CDC. Its initial $200 million in funding came from the 2021 coronavirus relief package. The center has awarded $21 million to academic institutions to develop modeling and forecasting methods.
It looks like the CDC is going to have to find a way around the 14th Amendment – you know that pesky “unreasonable search and seizure ” A few years ago the then AG of Indiana, decided that he was going to have better control of the opiate crisis… and he FORCED the state licensing board to pass as an emergency rule making process …. the proposed regulation was NOT POSTED, NO COMMENT PERIOD… just made a NEW MANDATE…
That mandate was that anyone prescribed > 15 MME of a opiate on a daily basis – was to have their urine tested MONTHLY… WELL… the ACLU took the Medical Licensing Board to COURT over violation of the 14 th Amendment… and I don’t remember if there was a actual trial, mediation or summary judgement. BUT the court told the Indiana Medical Licensing Board to immediately rescind that ILLEGAL regulation. That no bureaucracy can mandate a person to submit to any test without the pt’s consent… so called “unreasonable search and seizure ” that the 14th Amendment protects.
It appears that the CDC also believes that they are more powerful than any judge… since a “Trump appointed judge” did revoke the mask mandate that the Biden Administration put into affect and that is what the ABC video is all about
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“DEA practicing Medicine without a license requires a DEA Congressional Oversight Hearing”
Posted on April 18, 2022 by Pharmaciststeve
“DEA practicing Medicine without a license requires a DEA Congressional Oversight Hearing”
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Health System on the Hook for $22M Over Unnecessary Spine Surgeries
Posted on April 18, 2022 by Pharmaciststeve
UNNECESSARY PROCEDURES… how many pts have been forced into getting ESI (Epidural Spinal Inj) in order to have the physician to write the a Rx for oral opiates, when the ESI provide the pt little/no relief. The FDA and the Pharma ( Upjohn) that makes the corticosteroid DOES NOT RECOMMEND that corticosteroids should be used in ESI. There is already a couple of COUNTRIES that make those ESI ILLEGAL.. Apparently this hospital system didn’t get in trouble until a WHISTLE BLOWER that two surgeons were provided POOR CARE and care that was not appropriate (necessary). Providing ESI involving corticosteroids and the pt doesn’t get any/much relief… then that is unnecessary medical care and billing insurance … is INSURANCE FRAUD. It may also be a violation of a part of the Sherman Antitrust Act – called Tying commerce – where a person/entity is forced to buy something that they don’t want in order to be able to buy something that they do want. Doesn’t that describe what happens when a practitioner REQURIES/FORCES a pt to have a EDI procedures involving corticosteroid in order to have the practitioner to provide the pt a prescription for oral opiates ?
Health System on the Hook for $22M Over Unnecessary Spine Surgeries
https://www.medpagetoday.com/special-reports/exclusives/98247
Providence Health & Services agreed to pay $22.7 million to settle allegations that two of its neurosurgeons falsely billed federal healthcare programs for medically unnecessary spine surgeries, in the largest-ever healthcare fraud settlement in the Eastern District of Washington, according to the Department of Justice (DOJ).
The health system, the U.S. federal government, and the state of Washington reached a joint settlement Tuesday following a whistleblower complaint, which alleged that two spine surgeons employed at Providence St. Mary’s Medical Center in Walla Walla provided poor care and committed billing fraud from 2013 to 2018.
Providence, a large health system that has 51 hospitals in seven states, paid neurosurgeons based on a productivity metric, which gave them a financial incentive to perform more surgeries of greater complexity, the DOJ alleged. From 2014 to 2017, one of the surgeons in question earned between $2.5 and $2.9 million a year based on this metric, according to the settlement agreement.
The health system admitted that during the time period that the spine surgeons were employed, other medical staff expressed concerns that they endangered patients, performed surgeries that resulted in complications, conducted surgeries on patients when they were not appropriate, and did not adequately document their procedures.
Providence also acknowledged that while it did eventually place both of these surgeons on administrative leave, it allowed both doctors to resign while on leave, and did not take any action to report them to the National Practitioner Data Bank or the Washington State Department of Health.
“Ensuring that surgical procedures are medically appropriate and properly performed is critical to building safe and strong communities here in the Eastern District of Washington,” said U.S. Attorney Vanessa Waldref in a press release.
“Patients with back pain and spinal injury deserve top-notch care from a provider who puts the patient first and is not improperly influenced by how much he can bill for the procedure,” Waldref said. She added that Providence’s failure to ensure that its physicians were performing safe and necessary procedures, despite repeated warnings, “put patients’ lives and safety at serious risk.”
In a statement to MedPage Today, a spokesperson from Providence said that the events in question have prompted an internal investigation of policies, practices, and procedures to ensure the delivery of high-quality care.
“We are committed to taking specific, concrete actions to ensure this isolated incident in Walla Walla does not happen again,” the spokesperson stated. “Providence has strong existing protocols and safeguards to ensure we deliver quality care and make continuous improvements that further enhance those protocols and safeguards.”
In January 2020, a whistleblower had filed a complaint stating that two spine surgeons at Providence St. Mary’s Medical Center — Dan Elskens, MD, and Jason Dreyer, DO — provided substandard care from 2013 to 2018. Elskens and Dreyer were not named in the settlement agreement.
The whistleblower, also a neurosurgeon, had found that Elskens committed several surgical errors upon an internal review, the complaint stated, including operating on incorrect spinal sections requiring emergency remedial surgery.
The whistleblower allegedly reported these concerns to Providence’s chief medical officer, recommending that Elskens be terminated. However, Providence rejected that initial recommendation. The whistleblower then discovered that Elskens allegedly botched an additional surgery — nearly paralyzing the patient — before Providence placed Elskens on a suspension.
During this time, the whistleblower also began to review the work of Dreyer, who studied under Elskens. His review found that Providence billed the federal government for procedures that Dreyer never performed. In addition, he complained that Dreyer was “fabricating patient diagnoses and treatments to justify complex operations and to increase the reimbursement of both himself and Providence.”
Some of the incidents caused the federal government to pay amounts exceeding $150,000 for unnecessary and underperformed procedures, the complaint stated. The whistleblower reported these concerns in November 2017 and again in May 2018 before Providence suspended Dreyer, they alleged.
Both Elskens and Dreyer resigned during their suspensions, according to the complaint. Elskens’ medical license has been restricted in Washington and Michigan, but remains active in Indiana and Ohio. Dreyer’s medical license remains active in Washington and Michigan, and no actions have been taken by state medical boards.
The whistleblower will receive approximately $4 million as a result of the settlement.
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Andrew Kolodny: BELIEVES that the pharmas collaborated to increase prescriptions for opioids across America
Posted on April 16, 2022 by Pharmaciststeve
I find it very interesting that the “expert” ( Andrew Kolodny) for the plaintiff “broke down how HE BELIEVES that the companies named – among others – collaborated in the 1980’s and 1990’s to increase prescriptions for opioids across America and ESPECIALLY IN WEST VIRGINIA.”
So the plaintiff appears to be totally counting on and basing their case on the OPINION of this “expert”. My understanding is that any measurable perceived “opiate crisis” did not really again any traction until after Purdue Pharma introduced Oxycontin – which wasn’t until 1995-1996 and another potential stimuli was the Decade of Pain Law that was passed and signed into law in 2000.
Generic Vicodin first became available in 1983 and typically once a pharma loses a patent on a brand name med and the generic becomes available. The pharma does less promotion of the brand name, because most all states have mandatory generic substitution – unless brand name is specified by the prescriber, but most PBM/insurance will not pay for the brand name and/or charge a very large copay when a brand name is dispensed when a generic is available.
If there was few/no brand name opiates without a generic available. Historically, there is little/no promotion of a brand name opiates being promoted directly to prescribers.. the number of Rxs being prescribed will generally “fall off”. Pharmas making generics typically do not support a marketing staff to call on prescribers. The marketing to physicians is a very expensive endeavor and generic pharmas not have the profit margins to support a marketing staff.
This newspaper article did not elaborate on what was entailed in Kolodny’s “broke down how he believes the companies collaborated “
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When a pharmacist holds a pt’s meds at hostage
Posted on April 14, 2022 by Pharmaciststeve
Hello,
I have been disabled for over 10ys. I have lived in the same place and gone to the same pharmacy and received the same prescription for the duration. Recently I went to pick up my monthly prescription and was told because I had picked it up early a few months prior that the pharmacist would be adding those days to my new prescription and it would not be available for pickup for an additional 6 and 10 days. These are legal perscriptions given to me by my health care provider and approved by my insurance to be paid for yet because a “floater” came into the pharmacy, looked into my history, and decided I now needed to wait 36 and 40 days for my 30 day supply of medications. Is this legal? Do I have ANY recourse? I am religious in the way I take my medication and I have NEVER abused it. This is evident by what happened 4 months ago and because my medication was “not in stock” again (which it hasn’t been in stock for over 2 years and I always have to wait a few days), and I had to wait FOURTEEN DAYS to get my medication. Had I not gone in early on those times I did I would have ended up dead without my medication. Lucky for me I did have extra on hand because I don’t abuse my medication but if it was exactly 30 days every single time, which is what I’m apparently being punished for this time, I honestly would not be here to write this email.
I sure could use some help. I’ve got enough meds to last through this whole thing but I’m fearful for what my future may look like if this persists. I tried to call and all I was told was to call and have my doctor transfer my prescription to a different pharmacy. I have a feeling that would have put me on some kind of list for shopping around my prescription so I’m just going to wait for this date they magically came up with. My question is why only go back a few months and hold my prescription hostage? Why not go back 10 year and really stick it to me? I mean they clearly aren’t following any guidelines. It seems petty and a power play but its MY life and they just don’t seem to care. I need to know where to go from here. Please help me. Thank you for your time
When a pharmacist thinks that holding a pt’s medication as hostage because – according to their calculation – they pt should have a few doses still on hand. So the pt is suppose to just believe that the Pharmacist did not make some math errors in their calculation ? I wonder if these are the same pharmacist’s “mindset” that when they require the pt to wait until they are ready to take their last dose from the previous fill and they are out of stock of their meds… and they have no concerns that they won’t be able to get the pt’s med back in stock for several days… I am sure that the pharmacist has no idea of what is in like for a chronic pain pt to be thrown into cold turkey withdrawal and maybe into a torturous level of pain… maybe miss a couple of days of work… Filed under: General Problems | 8 Comments »