Email steve@steveariens.com 502-938-2414
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I got a message from two of my regular readers a few minutes ago with this messaage:
I just made a new post with a hyperlink to my blog and it DID NOT GET REJECTED !!!
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A Food and Drug Administration advisory panel voted against green-lighting COVID-19 booster shots Friday for most people — throwing up a major hurdle for President Biden’s plan to dole out a third dose to most Americans.
But the independent panel, which reviewed a 23-page FDA briefing document highlighting recent studies, recommended emergency use of a third dose for Americans over age 65 and those at high risk of severe infection.
The panel said more data is needed before it can okay boosters for people ages 16 and older, and that the two-dose Pfizer regimen is still highly protective against the spread of the super-contagious Delta variant for most people.
“In particular, there is a lack of data on effectiveness and duration,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said at the meeting Friday.
“Current evidence does not appear to show a need for boosting.”
The FDA is not bound to follow the advice of the independent advisory panel but has followed its guidance so far on COVID-19 vaccinations.
Overall, the panel voted 16-2 not to recommend a third dose for people 16 years and up while unanimously green-lighting it for people 65 years and older.
In coming to its decision, the advisory panel scrutinized several studies to determine whether a booster shot was effective and necessary at least six months after a second dose.
The panel noted research published in the New England Journal of Medicine in July showing that people who have received both doses of Pfizer’s COVID-19 vaccine are still 88 percent protected against getting sick from the Delta variant.
The much-anticipated vote comes after a key member of the panel, Dr. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, last week called third doses “premature.”
The independent group of experts on Friday also reviewed a Pfizer study of 306 people showing that virus-fighting antibodies jumped threefold after a booster shot was given around six to eight months after the second dose.
But Meg Seymour, of the National Center for Health Research, argued there wasn’t enough data for older adults.
“The total safety sample is very small,” she said. “Twelve people over 65 is much too small to draw conclusions about safety.”
Another study out of Israel, which was also highlighted by the vaccine maker, tracked about 1 million people age 60 and older and found that a third jab was “roughly 95 percent” effective at protecting against the Delta variant.
The efficacy is comparable to the protection seen shortly after the vaccine’s rollout earlier in the year.
Still, the panel was ultimately not convinced by those studies and others.
The FDA’s reviewers had suggested ahead of the vote that they preferred to focus on research involving Americans, insisting that domestic studies “most accurately represent vaccine effectiveness in the US population.”
Meanwhile, President Biden and the country’s top health advisers insisted last month that booster shots would be needed — and likely available the week of Sept. 20.
Dr. Anthony Fauci, the nation’s top infectious diseases expert, said he was “certain” that Americans would need a booster shot eight months after their second shot.
But not everyone in the scientific community agrees. The World Health Organization recently argued against boosters, saying that rich nations shouldn’t dole out a third dose when poor countries don’t have enough vaccines for their first.
“It is unfortunate the While House announced the need for booster shots prior to the FDA’s assessment of the data,” Seymour admitted at the panel meeting Friday.
Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the FDA, acknowledged the divisive viewpoints during opening remarks to the advisory panel.
“We know there may be differing opinions in interpreting the data,” he said. “We strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex and evolving.”
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This is a question & answer zoom call that I had with RSDSA – whose mission statement is: Reflex Sympathetic Dystrophy Syndrome Association (RSDSA) mission is to provide support, education, and hope to all affected by the pain and disability of CRPS/RSD, while we drive research to develop better treatments and a cure.
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Looks the FDA is finally starting to pay attention to the MME system… I made this post on my blog a couple of weeks ago Was/is the CDC 2016 guidelines built on a “false foundation ” and created a covert genocide on a protect class of people ? and shared a article that would STRONGLY SUGGEST that the MME system had no double blind clinical study nor science behind it. I had to go down THREE LAYERS DEEP to find out who was participating in this PUBLIC WORKSHOP and in scanning over the participants … the workshop appeared to be “pretty heavy” on bureaucrats, people from academia, and groups that mostly deal with ADDICTION.
In my professional opinion, it will be IMPOSSIBLE to create any MME system that was highly accurate and results can be replicated, but I am sure that the FDA workshop will try to cobble something together that they can claim is based on science and is supported by some hypothetical clinical study/data.
In the short paragraph about the public workshop below, the word “discuss” is mentioned THREE TIMES. Probably just more SMOKE & MIRRORS
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ‘‘Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.’’ The purpose of the workshop is to bring stakeholders together to discuss the scientific basis of morphine milligram equivalents (MMEs) with the goals of providing an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications.
https://www.fda.gov/media/149829/download
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When did CORPORATIONS have “personal beliefs” ? The LGBTQ+ community not withstanding, So the SC state legislature exempts all parts of the SC medical system is going to be exempted from civil rights discrimination of disabled under the Americans with disability act and civil rights act ? This appears to be in the same category as a few states passing laws that is supposedly going to protect prescribers from the DEA coming into the state and enforcing the Controlled Substance Act from prosecuting a prescriber that they believe has violated the law.
Can you imagine that a insurance/pbm company refusing to pay for opiate pain management because they fear that a pt could become addicted and they neither wish to cause a person to become a addict, nor be responsible for the cost of treating a pt for addiction. Basically, their beliefs that prescribing opiates could affect their BOTTOM LINE. Since a insurance/pbm company does not have a DEA license – unless they have a mail order pharmacy… they have neither the legal authority to prescribe nor dispense controlled substances, so any denial of paying for opiate/controlled meds would have to be for a concern of their bottom line.
Of course, this article indicates that this bill has just passed the SC House and has yet to be taken up by the SC Senate and even if passed by both Houses, it could be vetoed by SC governor, but both SC Houses have at or near a super majority of <R> so it could be possible for the SC legislature to over ride the Governor’s veto.
The bill would excuse medical practitioners, health care institutions and health care payers from providing care that is inconsistent with their personal beliefs.
South Carolina lawmakers on Friday passed a bill allowing medical professionals and insurance companies to deny care based on personal belief. Some say the legislation, which now heads to the state Senate for consideration, would disproportionately impact LGBTQ+ people, women, and people of color.
Under the bill, titled the “Medical Ethics and Diversity Act,” South Carolina law would be altered to excuse medical practitioners, health care institutions and health care payers from providing care that violates their “conscience.” It would also shield those who decline to provide medical services to patients from civil, criminal or administrative liability.
Dozens of state residents in February testified against the bill, calling it vague and overbroad. They also shared concerns that the legislation would disproportionately impact marginalized communities.
In a statement on Friday, Human Rights Campaign Legal Director Sarah Warbelow said she finds it “disturbing” that politicians in South Carolina are prioritizing individual providers’ beliefs over the wellbeing of patients.
“This legislation is dangerously silent in regards to the needs of patients and fails to consider the impact that expanding refusals can have on their health,” she said. “Religious freedom is a fundamental American value that is entirely compatible with providing quality, non-discriminatory healthcare. It is not a license to deprive others of their rights simply because of personal beliefs.”
Warbelow said the bill sends a message to patients with non-medical views inconsistent with that of their doctors that they are “not equal members of society entitled to dignity and respect.”
“Let’s call this what it is – a vicious, discriminatory attack on vulnerable patients, including those who care for LGBTQ+ people,” Warbelow said.
According to the HRC, the bill could enable administrative staff to decline to submit insurance claims or health care providers to override patients’ end of life directives. Receptionists may also be entitled to turn away patients and medical researchers could refuse to publish the results of a state-funded study because the scientific evidence is inconsistent with their personal beliefs.
The South Carolina bill is just one of more than 320 pieces of legislation under consideration in state legislatures which discriminate against LGBTQ+ people, according to the HRC, which tracks such legislation.
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Information for new patients! Tests from OCTOBER 2019 and retested JANUARY 2020! BTW Morphine held up to all the standard test as well as Prialt which explains why they are FDA approved and Hydromorphone and Fentanyl are not but very effective in proper dosing
The FDA does not recommend that pharmacy compounded meds be used in implanted pumps. in fact there is only one commercially available opiate that is approved by the FDA to be used in implanted pump. Infumorph (Morphine). Medtronic has done stability studies of Infumorph in their pumps in vivo (in the body)… and their studies shows that Infumorph will retain at least 90% of originally potency at SIX MONTHS.
Barb has been using infumorph in her pump since having the first one was implanted in 2006 and her 40 ml pump allows her to only needing her pump refilled abt every 6 months. Without any noticeable change in her pain management. Another one my concerns – as a pharmacist – every time that a pt’s pump is refilled, there is a risk of the sterile field being contaminated and it is possible, if this happens, the pt may end up with dealing with meningitis.
Here is an real horror stories about how non-sterile/contaminated products being injected in the intrathecal spinal fluid and the “bad outcomes” that can happen to pts
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Does anyone – other than me – find it strange that United Health/OptumRx is endorsed by AARP according to the AARP website:
https://www.aarp.org/about-aarp/aarp-services/
Hundreds of small, independent drugstores are accusing UnitedHealth Group Inc. of short-changing them by more than $100 million, and the health-care giant is trying to head off a lawsuit before it goes to court.
UnitedHealth’s Optum Rx unit filed more than 200 legal cases this week in federal court in California to force the cases into individual arbitration processes, rather than allow a joint lawsuit to go forward, according to legal filings.
At least 1,000 independent U.S. pharmacies are challenging payment practices at Optum Rx, UnitedHealth’s pharmacy benefits management unit that negotiates drug prices for health plans and companies, according to Mark Cuker, a lawyer representing the drugstores. About 500 are involved in the current dispute, while others have already filed cases in different courts. Making each of them enter arbitration is costly and limits the information they could gather through discovery, Cuker said.
“They want each of these pharmacies to have a separate arbitration, 500 separate arbitrations,” even though the pharmacies are raising common issues, Cuker said. Optum Rx is “gaming the system,” he said.
State courts have rejected other attempts to compel private arbitration over similar claims he’s brought against Optum Rx, Cuker said.
“Optum Rx is focused on delivering affordable access to prescription drugs,” the company said in a statement. “The more than 67,000 retail pharmacies in Optum Rx’s networks are important partners in these efforts, and we continue to work with them to balance the need to fairly compensate pharmacies while managing costs.”
The pharmacies involved in the cases say Optum Rx reimbursed them less than required and clawed back payments, according to UnitedHealth’s filings. They also said Optum Rx sometimes called medications brand-named drugs when dealing with health plans but considered the same medicines lower-cost generics when paying pharmacies. Cuker estimated the total value of payments from Optum Rx that his clients are disputing exceeds $100 million over almost a decade.
Optum Rx received notice of the dispute from more than 500 pharmacies in December and said that the pharmacies’ lawyer would only resolve the dispute in court. The pharmacies have not yet filed litigation against Optum Rx.
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https://www.medscape.com/viewarticle/971241
Lumbar epidural steroid injections (LESIs) are associated with a heightened risk for infection after lumbar spine decompression surgery, a new meta-analysis shows.
In a review that included more than 174,000 total patients, those who received a LESI within 6 months before their lumbar spine decompression surgery had more than a twofold risk of developing an infection postoperatively compared with patients who did not receive such an injection.
“Many patients with compressive lesions, such as foraminal stenosis or spinal stenosis, have significant pain, and it’s not uncommon for them to receive an epidural steroid injection prior to an elective operation,” lead author W. Michael Hooten, MD, president of the American Academy of Pain Medicine (AAPM) and professor of anesthesiology at the Mayo Clinic, Rochester, Minnesota, told Medscape Medical News.
“However, as our study shows, receipt of that injection is associated with over twice the risk of developing a postoperative infection,” Hooten said.
The findings were presented this month at the AAPM 2022 Annual Meeting in Scottsdale, Arizona.
Hooten and his team conducted a literature search and identified four studies that reported on the association of preoperative LESIs with postoperative infection.
The studies included 24,191 patients who received LESIs and 149,942 patients who did not. The latter served as the control group.
The analysis showed that risk for infection was greater when injections were given closer to time of surgery.
The incidence of postoperative infections was significantly greater in patients receiving LESIs less than 1 month prior to lumbar spine decompression surgery vs the control group (P = .01).
Similarly, the incidence of postoperative infections was significantly greater if patients received their injections within 1-3 months before their surgery compared with members of the control group (P = .05).
No significant difference in postoperative infections was observed in patients receiving injections within 3 to 6 months of their surgery (P = .07).
Nevertheless, overall, patients receiving LESIs anytime within the 6-month period before their lumbar spine decompression surgery were 2.24 times more likely to develop postoperative infections compared with those who had not received the injections (P = .0003).
The risk for infection is most likely due to the immunosuppressive effects of steroids, Hooten noted.
He added that in his team’s previous research, they reported the half-life of epidural administration of triamcinolone is over 253 hours, “which is substantial.”
In addition, immunosuppression “is a known effect of steroid administration,” whether taken orally, intravenously, or, as the current analysis suggests, administered epidurally.
“The steroids are in the lumbar spine for a very long period of time, so this is the most likely mechanism for the occurrence of infection,” said Hooten.
This risk should be considered in patients who may be planning to go for elective lumbar spine decompression surgery, he added.
Hooten noted the purpose of the analysis was to raise awareness about this type of complication, not only among pain medicine practitioners but also among spine surgeons.
“If I see somebody in the clinic today who has a lumbar spine stenosis, I can give an epidural for pain relief but I don’t know if that person will go to see a spine surgeon in the next 30 to 60 days, who will then do an operation. But if the spine surgeon is aware of this risk, they could suggest delaying the operation as long as possible, especially as the risk seems to reduce or decline over time,” he said.
Commenting on the study for Medscape Medical News, Ann Hansen, DVM, MD, a pain and internal medicine specialist in Ketchum, Idaho, agreed it is important for clinicians to be aware of the associated risks of steroid epidural injections.
“This is a timely meta-analysis focused on a clinically important topic,” said Hansen, who was not involved with the research.
“Given the widespread application of spinal interventions, it is important for primary care providers, surgeons, and pain specialists to understand the risks and benefits of these procedures,” she added.
Hansen noted LESIs are frequently performed for therapeutic purposes or in the context of preoperative diagnostic algorithms — and are generally considered to be safe when administered by specialists following modern standards of care.
“We recognize that intra-articular steroids are contraindicated within 3 months prior to joint surgery, but it is still accepted practice to instill epidural steroids prior to planned lumbar spine decompression surgery,” she said.
“And, as this meta-analysis documents, there is an increased risk of infection in patients receiving the steroids within 6 months of surgery. Further research is warranted to assess the impact of variables and to substantiate the conclusion,” she added.
Hansen noted the cornerstone of high-quality patient care includes shared decision-making, including a forthright discussion of the clinical diagnosis, treatment options, potential outcomes, and known complications.
“An educated, informed patient is empowered to make the most appropriate personal health decisions and to engage in longitudinal care with a trusted provider. Pain specialists must have a good understanding of the entire spectrum of multidisciplinary pain care to best advise their patients,” she concluded.
Hooten and Hansen have disclosed no relevant financial relationships.
American Academy of Pain Medicine (AAPM) 2022 Annual Meeting. Presented March 19, 2022.
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