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AUSA Douglass Dreier, The annals of history bear witness to dark chapters where power exploited knowledge for sinister purposes. One such instance lies in the chilling connection between statistical manipulation, legal battles, pseudoscience, and the misuse of data analytics during the heinous Nazi era, echoing disconcertingly in contemporary times.
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FORMER US AG JEFFEREY BEAUREGARD SESSION’s IMPLEMENTATION OF CREATIVE JUDICAL STRONG-ARMING OF HEALTHCARE PROVIDER AS THE FINAL SOULUTION OF HIS OPIOID ELIMINATION TOOL BOX PACKAGE
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DEA DIRECTOR ANNE MILGRAM: The concept of “pre-crime,” once relegated to science fiction, has taken on a chilling reality in contemporary law enforcement practices. In a thought-provoking article titled “Pre-Crime” and the Danger of “Risk Assessments” authored by Paul J. Hetznecker, the issue of “pre-crime” and the utilization of “risk assessments” by law enforcement is brought to the forefront.
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“…in using statistics, the government now has the road map to switch from knowledge to deeds…”
Richard Khorer, Adolf Hitler’s statistician
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An important objective of the project is to develop solutions that improve heart disease and prevent stroke in all communities.
Cardiovascular disease is the leading cause of death in the United States and is influenced by socioeconomic status, environmental conditions, institutional factors, structural racism, various forms of discrimination, and other factors pertaining to health equity.
One of the most common issues of pts dealing with under/untreated pain is typically high blood pressure and/or blood pressure at an emergency crisis level (>200/100). Look at the third section in the below chart. It doesn’t come out and say what damage can occur, but the other graphic does.
There is about 4 different categories of pharma meds to treat high blood pressure. Many pts have told me that after their opioids were reduced, stopped that their blood pressure typically increased dramatically and their PCP put them – one at a time – all four of these categories of BP meds and their BP typically doesn’t respond and remained at/near/past a hypertensive crisis level.
Perhaps this article and the two graphics will allow the pt to start a discussion concerning their hypertensive crisis level blood pressure levels and the potential physical consequences to the pt if their blood pressure is not lowered. I would hope that the pt would be able to get access to their medical records and if not available, start taking their BP and create a chart of your BP and the MME/day of the opioids that you were taking before having a forced reduction. Most pt would expect to see their BP increase as their MME/day went down and the intensity of their pain went up.
That chart should be an excellent “show & tell” to get a practitioner or pharmacist to defend their rationale as to why the pt’s BP is up as is the pt’s pain intensity is up and MME/day is down and mark on the graphic where pharma BP med is added.
If all else fails, the pt may wish to file a complaint, with HHS and/or CMS
WASHINGTON, DC—The American Pharmacists Association (APhA) announced today that it has entered into a contracted project agreement with CDC’s Applied Research and Evaluation Branch in the Division for Heart Disease and Stroke Prevention to accelerate the implementation of pharmacy-based strategies to advance health equity and prevent heart disease and stroke.
APhA’s vision to inspire, innovate, and create opportunities for its members and pharmacists worldwide to optimize medication use and health for all is aligned with the CDC’s goal to improve cardiovascular health equity. APhA will work toward this goal by
An important objective of the project is to develop solutions that improve heart disease and prevent stroke in all communities.
Cardiovascular disease is the leading cause of death in the United States and is influenced by socioeconomic status, environmental conditions, institutional factors, structural racism, various forms of discrimination, and other factors pertaining to health equity.
Michael D. Hogue, PharmD, FAPhA, FNAP, FFIP, executive vice president and CEO of APhA, said “Pharmacists are trusted community health professionals who are highly accessible to patients and who increasingly engage in team-based care in practice settings that historically work with medically underserved patients. This project will build on the trust that people already have in their pharmacists to provide health screenings, education, and medication adherence counseling as they thoughtfully and comprehensively address patient concerns. Pharmacists, working together with public health entities, are a crucial partner in reducing the risk of heart disease and stroke in the United States.”
This project was funded in part by a contracted 
project agreement with CDC, which is an agency of HHS.
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On Friday, President Joe Biden has now issued an official declaration that all Americans with a prior marijuana use record, including those who have not been detained or prosecuted, will be granted federal pardons.
All U.S. citizens and lawful permanent residents who are in possession of marijuana for personal use, as well as those convicted of comparable federal offenses, are eligible for the comprehensive pardon. Additionally, marijuana consumers in the District of Columbia are pardoned.
It excludes individuals incarcerated for the unlawful sale of marijuana, in violation of federal law, as well as those convicted of other marijuana-related offenses like operating a motor vehicle while under the influence of an illicit substance.
The potential consequences of Biden’s commutation are substantial, given that criminal records related to marijuana possession and use have hindered access to housing, employment, and educational prospects.
Those who have violated state law are not eligible for pardons; furthermore, documentation of a pardon must be obtained through an application process administered by the Department of Justice.
A year ago, Biden also granted a comparable commutation and made a commitment to implement further reforms. Further, all instances of simple marijuana possession or use were expunged from federal law under this year’s proclamation, including those who had never been charged.
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https://www.medpagetoday.com/neurology/painmanagement/107922
Independent studies suggested that spinal cord stimulation improved chronic pain no more than placebo, but industry-funded critics cast doubt on these findings, researchers said.
Recently published papers “found evidence of no benefit on pain and risk of harms,” wrote Adrian Traeger, PhD, of the University of Sydney in Australia, and Lisa Bero, PhD, of the University of Colorado in Aurora, in a JAMA Internal Medicine viewpoint article. “Authors funded by the spinal cord stimulator industry were swift to respond.”
“The responses to recent research on spinal cord stimulation illustrate how corporations continue to undermine independent science,” Traeger and Bero observed. “At a minimum, readers should recognize that attacks on independent science are often sustained and repetitive industry tactics to protect profits and should discount these criticisms.”
Spinal cord stimulation is a costly and invasive procedure and “clinicians and patients need to know what the evidence says about likely benefits and harms,” Traeger noted in an email to MedPage Today.
“As with many procedures to manage chronic pain, there are cases and anecdotes of people improving with spinal cord stimulation,” he continued. “But the best evidence available — from a Cochrane review — suggests that these devices may work no better than a credible placebo. Serious adverse events include infection, lead migration, neurological damage, and re-operation.”
A 2023 Cochrane review of randomized trials led by Traeger reported that data did not support the use of spinal cord stimulation to manage low back pain outside a clinical trial and concluded that spinal cord stimulation probably did not have sustained clinical benefits that would outweigh its costs and risks. A 2001 Cochrane review, which Traeger was not involved in, found very low‐certainty evidence that spinal cord stimulation may not provide clinically important benefits on pain intensity compared with placebo.
In JAMA Neurology, a retrospective comparative effectiveness study showed that the use of a permanent spinal cord stimulator was not associated with a reduction in opioid use or nonpharmacologic pain interventions compared with conventional medical management. Nearly one-fifth of patients treated with spinal cord stimulators experienced complications and required device revision or removal.
And in JAMA, a randomized clinical trial of patients with chronic radicular pain after lumbar spine surgery showed that spinal cord burst stimulation led to no significant difference in back pain-related disability compared with placebo. A follow-up study showed similar results.
Traeger and Bero identified 18 critiques in academic literature of the Cochrane reviews and the JAMA and JAMA Neurology articles. “Industry-funded critics of independent studies often do not follow the usual route of scientific discourse,” they reported.
“Rather than respond to the journal where the original study was published, critics frequently publish in journals where they are the editors and can control the discourse (15 of 18 letters criticizing the independent studies cited in this article appeared in journals with industry-affiliated editors),” they wrote. “The journal can then choose to paywall the subsequent response from the independent authors, giving critics the last word.”
Other strategies included attacking the credibility of the researchers instead of the research and criticizing the Cochrane reviews for assessing clinical trials instead of real-world studies.
Critics also claimed that because the FDA had approved spinal cord stimulators and they’ve been used for decades, there already is evidence for efficacy and safety.
“This is not the case,” Traeger and Bero wrote. “Provision 510(k) requires that new medical devices need only be ‘substantially equivalent’ to a product already on the market, even if the earlier product is itself untested.”
Part of the concern may stem from the small number of trials comparing spinal cord stimulation and placebo, suggested Shravani Durbhakula, MD, MPH, MBA, of Johns Hopkins School of Medicine in Baltimore, and co-authors in a critique of the 2023 Cochrane review published in Pain Medicine
While Durbhakula and colleagues have ties to industry, they pointed out that independent physician investigators have struggled to complete these studies. “Meanwhile, industry is disincentivized from performing such studies, as the U.S. Food and Drug Administration does not require them for regulatory approvals in the presence of a predicate device, they are costly and hard to accrue patients into, and the risk-benefit ratio does not favor companies and their shareholders,” they wrote.
In the 1950s, the tobacco industry used campaigns of criticism to defend their products, Traeger and Bero noted. Other industries have used similar approaches to cast doubt on independent studies, they added.
Debate is an important part of the scientific process, Traeger pointed out. “When corporations interfere with the scientific process, it puts patients at risk,” he said.
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According to the article – The AvertD test is intended to be used before patients who are being considered for a 4- to 30-day prescription for acute pain (e.g., for a planned surgical procedure) are first exposed to oral opioids. Does this suggest that anyone taking opioids > 30 days should be diagnosed with SUD or OUD? After all, the DEA states that ALL OPIOIDS ARE HIGHLY ADDICTIVE! Is the FDA aligning with PROP and the opiophoic “experts” that created the 2016 & 2022 CDC opioid dosing guidelines?
https://www.medpagetoday.com/neurology/opioids/107962
The FDA approved the first test that uses DNA to identify whether adults have an elevated risk of developing opioid use disorder (OUD), the agency said Tuesday.
The AvertD test is intended to be used before patients who are being considered for a 4- to 30-day prescription for acute pain (e.g., for a planned surgical procedure) are first exposed to oral opioids. It is not intended for patients being treated for chronic pain, the agency said.
“AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA granted approval of AvertD, a prescription-use-only genetic laboratory test, to AutoGenomics, a unit of SOLVD Health. In October 2022, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.
The earlier AvertD version detected the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. At the advisory committee meeting, SOLVD presented results of an observational study that demonstrated a sensitivity of 82.76% and a specificity of 79.23% for detecting OUD.
Following the advisory committee meeting, the FDA worked with AutoGenomics as it revised its test. The company subsequently submitted a premarket approval application for the modified test.
The test involves swabbing a patient’s cheek to collect a DNA sample. As part of the approval order, AutoGenomics must provide training to healthcare providers to help ensure the test is being used appropriately. The company also must conduct a large post-marketing study to assess AvertD’s performance in patients and regularly report the study’s progress to the FDA.
The primary risks associated with AvertD are false-negative and false-positive results, the FDA noted. A false-negative result could lead to a false sense of security for a patient who has an increased risk of OUD; a false-positive result could lead to inadequate pain management.
“The risks of false-negative and false-positive results can be mitigated, in part, through accurate, transparent product labeling and a healthcare provider training program,” the FDA said. “It is critical that users of the test (healthcare providers and patients) understand how to interpret the test result and use it not in isolation, but as part of a comprehensive clinical evaluation and risk assessment.”
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