More than 100 pets died, over 200 sickened from recalled pet food, FDA says

Posted on January 29, 2021 by Pharmaciststeve

More than 100 pets died, over 200 sickened from recalled pet food, FDA says

https://www.foxbusiness.com/lifestyle/more-than-100-pets-died-over-200-sickened-from-recalled-pet-food-fda-says

19 products that still may be on stores shelves have been recalled

Hundreds of pets have died and others have been sickened after eating recalled pet food manufactured by Midwestern Pet Foods, according to the Food and Drug Administration’s (FDA) updated recall notice.

As of Jan. 21, the FDA became aware that more than 110 dogs died and over 210 others fell ill after consuming food from the company’s Oklahoma plant “that may contain potentially fatal levels of aflatoxins.”

However, as new information becomes available, “case counts and the scope of this recall may expand,” the FDA said.

Earlier this month, the company expanded its recall “out of an abundance of caution” to include all pet food products containing corn that were manufactured in the company’s Oklahoma manufacturing plant and have an expiration date on or before July 9, 2022. Overall, this recall includes 19 products that “may still be on store shelves, online, or in pet owners’ homes,” according to the FDA.

In December, Midwestern initially issued a recall of nine different lots of Sportmix dry cat and dog food following reports that at least 28 dogs died and eight were ill after consuming the recalled pet food.

By conducting product tests, the Missouri Department of Agriculture discovered “very high levels” of the toxin in multiple samples at the company’s Oklahoma plant. However, not all of these cases have been officially confirmed as aflatoxin poisoning, the FDA said.

Aflatoxin is a mold byproduct that has the ability to grow on corn and other grains, which are commonly used as ingredients in pet food. At very high levels, “aflatoxins can cause illness and death in pets,” the FDA said.

The FDA and Midwestern Pet Foods are urging pet owners to safely discard the products due to toxin, which can be present even if the mold isn’t visible, according to the agency.

Pets that have been poisoned by the toxin may seem sluggish and have a loss of appetite. They may also experience vomiting, jaundice (yellowish tint to the eyes or gums due to liver damage) and/or diarrhea, the FDA said. In some cases, pets may also suffer from liver damage without even showing symptoms.

Unlike people, pets are “highly susceptible” to aflatoxin poisoning because they generally eat the same food, according to the FDA.

“If a pet’s food contains aflatoxin, the toxin could accumulate in the pet’s system as they continue to eat the same food,” the FDA said.

Midwestern is also urging customers to wash and sanitize any pet bowls and areas where the food was stored. Retailers are encouraged to contact customers who have purchased the affected products.

Midwestern announced in a statement on its website that it has never experienced a recall in its nearly 100-year history and has been “committed to ensuring” that its products are safe.

“We continue a thorough review of our facilities and practices in full cooperation with FDA in an effort to better serve our customers and pet parents who put their trust in us,” Midwestern said.

The investigation into the matter is ongoing.

The FDA will continue to work with veterinarians and state partners to follow up on suspected cases of aflatoxin poisoning and plans to conduct follow-up activities at the manufacturing facility.

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Biden urged not to give top FDA job to official over her role in opioid crisis

Posted on January 29, 2021 by Pharmaciststeve

Biden urged not to give top FDA job to official over her role in opioid crisis

https://www.theguardian.com/us-news/2021/jan/28/fda-janet-woodcock-opioids-biden

Dr Janet Woodcock is accused of presiding over ‘one of the worst regulatory agency failures’, say groups fighting opioid epidemic

Groups fighting the US opioid epidemic have called on Joe Biden to appoint a new head of the Food and Drug Administration (FDA) after describing the acting commissioner as unfit for the post because of her part in the mass prescribing of painkillers that have caused hundreds of thousands of deaths.

In a letter to the administration, 28 groups accused Dr Janet Woodcock of presiding over “one of the worst regulatory agency failures in US history” as head of the FDA department responsible for approving new prescription opioids, the Center for Drug Evaluation and Research (CDER).

Woodcock was named acting FDA commissioner by the new administration on the day Biden took office. The letter urged the president not to nominate her to permanently head the agency.

“In its opioid decision-making, Dr Woodcock, and the division she supervised, consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis,” the letter said.

The Guardian has contacted the FDA for comment.

The signatories of the letter include the medical group Physicians for Responsible Opioid Prescribing, the consumer advocacy organisation Public Citizen, and campaign groups representing families harmed by opioids such as Fed Up!.

The letter accused Woodcock of “dereliction of duty” for allowing opioid manufacturers to spend years disseminating false claims that narcotic painkillers were less addictive and more effective than they really were, contributing to the rise of mass opioid prescribing and spread of an epidemic that has claimed more than 500,000 lives.

“Recent reports that the pharmaceutical industry enthusiastically supports Dr Woodcock’s candidacy for FDA Commissioner do not surprise us,” the letter said.
“We strongly urge that her position as Acting Commissioner be a very short transition prior to President Joe Biden nominating a Commissioner who has a track record focused on public health.”

Two US senators who have previously criticised the FDA’s handling of opioids, Ed Markey and Maggie Hassan, backed the call for a different person to head the agency.

“The FDA’s decision-making processes for the approval and labelling of opioid drugs going back decades remain of serious concern, and it’s important that the next FDA Commissioner is someone who has demonstrated that they have learned from the FDA’s past mistakes – not someone who has been involved in repeating them,” they said in a joint statement.

It is not clear whether Biden intends to nominate Woodcock to head the FDA permanently.

The criticism comes at a sensitive time for the FDA after its credibility was shaken by political interference by Donald Trump over coronavirus. But the agency was already facing accusations that it was less interested in regulating opioid manufacturers than protecting their financial interests.

The FDA helped unleash the epidemic two decades ago when it approved the sale of a high-strength narcotic pill, OxyContin, as safer and more effective than other painkillers based on the false claims of the manufacturer, Purdue Pharma. Since then the agency has approved other opioids for wide prescribing even as the evidence mounted that the drugs were addictive, open to abuse and often not effective for long-term use.

The FDA was also embarrassed by revelations that officials responsible for opioid approvals were taking part in “pay to play” schemes where manufacturers paid tens of thousands of dollars to attend meetings to draw up the criteria for approving prescription narcotics.

In 2017, President Trump’s opioid commission identified the failure of the FDA and other federal institutions to properly regulate opioids as an important factor in the rise of the epidemic.

The letter noted that Woodcock was instrumental in the approval of a powerful opioid, Zohydro, even though the FDA’s own scientific advisory committee voted 11-2 to keep the drug off the market because it was unsafe. The FDA leadership has the authority to override the decisions of its advisory committees.

Dr Raeford Brown, a former chair of the FDA’s opioid advisory committee, described Woodcock as a very able administrator who played an important role in maintaining continuity at the agency when commissioners changed with each new administration. But he said the part she played in unleashing prescription opioids into America without sufficient controls or oversight made her “unfit” to head the FDA.

“The way the whole issue of opioids played out, and the development of policy in CDER, was clearly a cause of the opioid crisis because there was a wilful blindness.

“They didn’t want to see that the things they were doing were causing the problem. She was in charge of that. She more than anybody should be held accountable. I’m shocked she hasn’t been held accountable,” said Brown.

“She chose to support the pharmaceutical industry and neglect the public health issues.”

 

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Biden EO caused this mother not to afford to buy her son’s insulin prescription because it’s now $1,000

Posted on January 29, 2021 by Pharmaciststeve

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IV Tylenol Bombs For Post-Op Pain Control – In a Randomized Controlled Trial

Posted on January 29, 2021 by Pharmaciststeve

IV Tylenol Bombs For Post-Op Pain Control – In a Randomized Controlled Trial

https://www.acsh.org/news/2021/01/28/iv-tylenol-bombs-post-op-pain-control-randomized-controlled-trial-15307

IV Tylenol is commonly used to control pain following surgery. But, should it be? A randomized, double-blind, placebo-controlled trial – the gold standard – of patients who underwent abdominal surgery gave us a very clear answer. Take a wild guess.

Image: Pixy

It should be fairly clear that I’m not a big fan of Tylenol. It is dangerous and barely works for anything, but that hasn’t stopped IV Tylenol from becoming the darling of surgeons and anesthesiologists who want to deny or minimize opioid treatment – even for a short time following surgery. The big push toward the drug (brand name Ofirmev, generic name is IV acetaminophen), which earned Mallinckrodt $112 million (1) in the fourth quarter of 2019 alone, is driven by the pervasive anti-opioid mentality that still grips our country as well as the desire to avoid post-op nausea and vomiting (2). That’s all well and good, but if IV Tylenol isn’t effective for pain control its use in order to minimize nausea and vomiting becomes absurd.

“We live in an era of opioid-related problems, and everybody is trying to use nonopioid alternatives…One of these is intravenous acetaminophen, which drove a lot of attention when it was first introduced.”

Alparslan Turan, MD, Professor of the Dept. of Outcomes Research, Cleveland Clinic, in Anaesthesiolgy News, 1/21/21

The literature is jam-packed with studies about the effect (or lack thereof) of IV Tylenol in controlling pain from a variety of surgical procedures, but virtually all of them are retrospective studies, which are inferior to controlled prospective studies with a predetermined endpoint(s) and a control group (usually placebo). See my colleague Dr. Alex Berezow’s excellent discussion of the relative merit of different types of studies.)

Well, we now have a randomized, double-blind, placebo-controlled trial (the gold standard of clinical stials) and if this doesn’t take the Tylenol needle out of your arm nothing will. Lead author Alparslan Turan, MD, et. al., published the results in JAMA (there is also a summary of the JAMA paper in Anesthesiology News). 

The trial

The Cleveland Clinic group enrolled 580 participants, all of whom were scheduled to have abdominal surgery. Half of the participants received one gram of IV Tylenol, the rest got a saline placebo. Doses of each were given every six hours for up to 48 hours (3). 

The primary outcome was the amount of time that the patients had a blood oxygen saturation (SpO2) level less than 90% (hypoxemia).

This is rather bizarre. The reason that someone might get hypoxemia is opioid consumption. In other words, the primary outcome seems to be a surrogate marker for the real primary outcome – the amount of opioids consumed (!). It is the opioids that cause the hypoxemia, not the Tylenol or saline. But the secondary outcomes included post-op opioid consumption (which sure sounds like a primary outcome to me), as well as pain, nausea and vomiting, sedation, and respiratory function. I don’t know why they did it this way, but it makes no difference:

“This was shocking to us…The difference [between IV Tylenol and placebo] is almost nothing.”

Alparslan Turan, MD

But not to any chronic pain patient.

The results

  • Hypoxemia

The placebo group was hypoxemic for 0.7 minutes per hour. For the Tylenol, that number was 1.1 minutes per hour. This difference is clinically insignificant, and since the P-value was 0.29, it’s not even close to being statistically significant either. Translation: the groups had the same oxygen levels because they consumed the same amount of an opioid. Why? Because the Tylenol did nothing to reduce their pain.

Opioid consumption

  • The Tylenol group consumed 50 mg (measured as morphine milligram equivalents) of an opioid while the placebo group consumed 58 mg, but there was no statistical significance between the groups. In other words, both groups required the same amount of an opioid drug.

Pain Scores

  • During the 48 hours post-op, the numerical pain scores were virtually identical: 4.2 for the Tylenol group and 4.4 for the placebo group.

Other secondary endpoints (postoperative nausea and vomiting, sedation, and respiratory function) were identical between the two groups.

Bottom Line

This trial was squeaky clean in the way it was designed, carried out, and the results measured and analyzed. At least for abdominal surgery, it is safe to say that IV Tylenol is thoroughly useless. It performed identically to placebo. Although it is possible that IV Tylenol would be of any use in other types of surgeries, that would be the real surprise.

Another Bottom Line

Pain patients, acute or chronic, have been getting a drug that has no utility for pain from abdominal surgery. In the mad dash to get away from opioids, we have become human guinea pigs for untested, unproven drugs. And it’s not just Tylenol. Other drugs, possibly just as useless, such as antidepressants (SSRIs and tricyclics) and Neurontin, all with limited evidence of efficacy are being force-fed to pain patients in need of a real medicine simply to decrease opioid use just for the sake of doing so.

Some bad advice

Next time you run to the ER with a kidney stone and they offer you Tylenol, you might as well just ask for saline solution. It’s cheaper and works just as well. Or not. Emergency rooms are not exactly the best places to make a statement.

NOTES:

(1) No wonder they made so much. A one-gram dose of Ofirmev will set you back $40. The actual cost of the undissolved drug is negligible.

(2) Post-operative nausea and vomiting from opioid use aren’t uncommon but can be minimized by the use of antiemetic drugs and choice of the opioid used. 

(3) The dosing time was less than 48-hours when the patient was discharged before that time.

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Generic Prescription Drug Prices in the U.S. Are 16% LOWER than other nations

Posted on January 28, 2021 by Pharmaciststeve

Prescription Drug Prices in the U.S. Are 2.56x Higher Than Other Nations – Brand-Named Drugs 3.44x Higher

https://scitechdaily.com/prescription-drug-prices-in-the-u-s-are-2-56x-higher-than-other-nations-brand-named-drugs-3-44x-higher/

Prescription drug prices in the United States are significantly higher than in other nations, with prices in the U.S. averaging 2.56 times those seen in 32 other nations, according to a new RAND Corporation report.

The gap between prices in the U.S. and other countries is even larger for brand-named drugs, with U.S. prices averaging 3.44 times those in comparison nations.

The RAND study found that prices for unbranded generic drugs — which account for 84% of drugs sold in the U.S. by volume but only 12% of U.S. spending — are slightly lower in the U.S. than in most other nations.

“Brand-name drugs are the primary driver of the higher prescription drug prices in the U.S.,” said Andrew Mulcahy, lead author of the study and a senior health policy researcher at RAND, a nonprofit, nonpartisan research organization. “We found consistently high U.S. brand name prices regardless of our methodological decisions.”

The RAND analysis is based on 2018 data and provides the most up-to-date estimates of how much higher drug prices are in the U.S. as compared to other countries in the Organisation for Economic Co-operation and Development. The affordable accountants in Nottingham is what a business needs to help sort their finances.

Researchers calculated price indexes under a wide range of methodological decisions. While some sensitivity analyses lowered the differences between U.S. prices compared to those in other nations, under all the scenarios overall prescription drug prices remained substantially higher in the U.S.

The analysis used manufacturer prices for drugs because net prices — that is, the prices ultimately paid for drugs after negotiated rebates and other discounts are applied — are not systematically available. Even after adjusting U.S. prices downward based on an approximation of these discounts to account for these discounts, U.S. prices remained substantially higher than those in other countries.

The one consistent area where prices were lower in the U.S. was generic drugs, where prices were 84% of the average paid in other nations.

“For the generic drugs that make up a large majority of the prescriptions written in the U.S., our costs are lower,” Mulcahy said. Even you can try this out for the least cost. “It’s just for the brand name drugs that we pay through the nose.”

The study found that among G7 nations, the United Kingdom, France and Italy generally have the lowest prescription drug prices, while Canada, Germany and Japan tend to have higher prices.

Although several prior studies compared drug prices in the United States with those in other countries, the most recent of these studies used data that are almost a decade old.

RAND researchers compiled their estimates by examining industry-standard IQVIA MIDAS data on drug sales and volume for 2018, comparing the U.S. to 32 nations that belong to the OECD. The data include most prescription drugs sold in the U.S. and comparison countries.

Researchers say that conducting such comparisons requires a variety of decisions and assumptions to calculate price indexes. The U.S. had consistently higher drug prices regardless of how the researchers calculated price indexes and treated outliers in the data.

The RAND team examined several subsets of prescription drugs, including brand-name originator drugs, unbranded generic drugs, biologics and nonbiologic drugs.

Some of the highest-priced drugs in the United States are brand-name drugs that can cost thousands of dollars per treatment and treat life-threatening illness such as hepatitis C or cancers.

“Many of the most-expensive medications are the biologic treatments that we often see advertised on television,” Mulcahy said. “The hope is that competition from biosimilars will drive down prices and spending for biologics. But biosimilars are available for only a handful of biologics in the United States.”

Researchers estimated that across all of the OECD nations studied, total drug spending was $795 billion. The U.S. accounted for 58% of sales, but just 24% of the volume.

Recent estimates are that prescription drug spending in the U.S. accounts for more than 10 percent of all health care spending. Drug spending in the U.S. jumped by 76% between 2000 and 2017, and the costs are expected to increase faster than other areas of health care spending over the next decade as new, expensive specialty drugs are approved.

###

Reference: “International Prescription Drug Price Comparisons: Current Empirical Estimates and Comparisons with Previous Studies” by by Andrew W. Mulcahy, Christopher M. Whaley, Mahlet G. Tebeka, Daniel Schwam, Nathaniel Edenfield and Alejandro U. Becerra-Ornelas, 28 January 2021, RAND Corporation.
URL

The study was sponsored by the Office of the Assistant Secretary for Planning and Evaluation in the U.S. Department of Health and Human Services.

The report, “International Prescription Drug Price Comparisons: Current Empirical Estimates and Comparison to Previous Studies,” is also available on the website of the U.S. Department of Health and Human Services.

Other authors of the report are Christopher Whaley, Mahlet Tebeka, Daniel Schwam, Nathaniel Edenfield and Alejandro U. Becerra-Ornelas.

RAND Health Care promotes healthier societies by improving health care systems in the United States and other countries.

Comparing Rx prices in other countries to ours.. is a apple to orange comparison. Particularly when other nations have a national/single payer system.

Our healthcare system has numerous middlemen… the two primary ones being insurance and PBM industries.  Each with  a overhead cost of operations and a desire to generate a profit. There are no such middlemen in national/single payer system.

The enclosed graphic show the typical “share” of the Rx price at the prescription counter and where it goes.  It has been claimed that the insurance/PBM industry will demand a discount/rebate/kickback up to 75% from the Pharma of the average wholesale price.

With the current average Rx price nearly $70… meaning that abt $33.00 is going to the insurance/PBM industry on each Rx filled out of abt 4 billion Rxs that we fill every year. that comes to abt $132 BILLION in profits going to the Pharmacy middlemen

The above graph shows who gets the lion’s share of the Rx price at the register.  Please note that all of the final Rx price that the pharmacy wholesaler and pharmacy share about 8% GROSS PROFIT while the middlemen get about 47% of the Rx price… and they only provide basically an accounting system.

What is also interesting in this article that it points out that in the USA the price of our generic Rxs is abt 16% LESS than other countries and they are abt 84% of all prescriptions here.

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Another Biden campaign promise – expanding OUD MAT treatment – appears to be broken

Posted on January 28, 2021 by Pharmaciststeve

Biden Administration to Reverse Trump’s HHS Directive Expanding OUD MAT Prescribing Policy

https://www.lexology.com/library/detail.aspx?g=476bb89e-15c5-4a3e-bbcf-10a23200393d&utm_source=Lexology+Daily+Newsfeed&utm_medium=HTML+email+-+Body+-+General+section&utm_campaign=Lexology+subscriber+daily+feed&utm_content=Lexology+Daily+Newsfeed+2021-01-28&utm_term=

We last alerted you on the Trump administration’s last-minute directive on reducing the “X-waiver” mandate which limits prescribers’ ability to prescribe medications aimed at battling the opioid use disorder (OUD) epidemic. According to the American Medical Association, the OUD epidemic has seen a sharp rise in 2020, especially in overdose-related deaths. Issue brief: Reports of increases in opioid-related overdose during COVID pandemic | AMA (ama-assn.org). In response, the Trump administration hurried through this HHS directive to enable more physician-prescribers to readily treat OUD. This January 14, 2021 move was applauded by prescribers and patient advocate groups who view the “X-waiver” as an unnecessary burden in prescribing medication-assisted therapies (MAT) for OUD patients.

Previously, to obtain an “X-waiver, prescribers were required to undergo an eight-hour training series before being permitted to prescribe drugs such as buprenorphine. Buprenorphine is an opioid medication approved by the FDA to treat OUD. According to the HHS’ Substance Abuse and Mental Health Services Administration (SAMSHA):

[b]uprenorphine is an opioid partial agonist. It produces effects such as euphoria or respiratory depression at low to moderate doses. With buprenorphine, however, these effects are weaker than full opioid agonists such as methadone and heroin. When taken as prescribed, buprenorphine is safe and effective. Buprenorphine has unique pharmacological properties that help:

  • Diminish the effects of physical dependency to opioids, such as withdrawal symptoms and cravings;
  • Increase safety in cases of overdose, and
  • Lower the potential for misuse.

The January 14, 2021 directive eliminated the need for physicians to obtain an “X-waiver” to treat their OUD patients with buprenorphine. To ensure patient safety and greatly lessen the potential for abuse, physicians without an “X-waiver” were limited to treatment of only 30 in-state patients. Non-physician prescribers such as NPs and PAs were still required to obtain the waiver.

In what many frontline operators in the OUD battle see as a disappointing move, the Biden Administration plans to retract this Trump administration HHS directive. While the immediate reason is unclear, anonymous sources in the Biden administration hint that they are concerned with the Trump directive’s authority to effectuate limited the “X-waiver” program by possibly circumventing Congress’ authority and the speed with which it went through HHS.

Biden moving to nix Trump plan on opioid-treatment prescriptions – The Washington Post. This is particularly surprising because Biden’s campaign platform vowed to expand OUD treatment and lift undue restrictions on prescribing medications for substance use disorder. See The Biden Plan to End the Opioid Crisis | Joe Biden for President: Official Campaign Website. The hope is, perhaps, the Biden administration will keep its campaign promises to better combat the OUD epidemic by effectuating their own changes to MAT limitations.

The Biden administration has been issuing 3-5 executive orders (EO) per day, which is potentially circumventing Congress’ authority and the number of his EO’s exceeds the total number of his 4 predecessors’ EO’s  all together in a similar time frame.  President Biden’s son Hunter – is at best a substance abuser/addict in recovery.

So, Biden has no immediate interest in all those 200+ substance abuser/addicts that die every day of a opiate overdose… to postpone potential treatment of untold number of substance abuse/addict that may have received treatment and not OD’d ? Lives that could have been potentially saved, but for what appears another incident of Biden just putting a STOP to anything that Trump had implemented.  Regardless of the costs to others… including unnecessary opiate OD’s that may have been prevented.

 

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Opioid Deaths Fall When Cannabis Stores Rise, Analysis Suggests

Posted on January 28, 2021 by Pharmaciststeve

Opioid Deaths Fall When Cannabis Stores Rise, Analysis Suggests

Can legal marijuana ease the opioid crisis?

https://www.medpagetoday.com/neurology/opioids/90922

Access to legal cannabis stores was linked with fewer opioid deaths in the U.S., a new analysis suggested.

The number of marijuana dispensaries in a county was negatively related to log-transformed opioid mortality rate, adjusted for age (β -0.17, 95% CI -0.23 to -0.11), reported Balázs Kovács, PhD, of Yale University School of Management in New Haven, Connecticut, and Greta Hsu, PhD, of University of California Davis Graduate School of Management.

This means that increasing the number of storefront dispensaries from one to two was tied to a 17% reduction in death rates of all opioid types, and an increase from two to three stores was associated with a further 8.5% reduction in mortality, Kovács and Hsu noted.

The relationship was stronger — leading to an estimated 21% drop in mortality — when only deaths from synthetic non-methadone opioids like fentanyl were considered (β -0.21, 95% CI -0.27 to -0.14), they wrote in The BMJ.

“We find this relationship holds for both medical dispensaries, which serve only patients who have a state-approved medical card or doctor’s recommendation, as well as for recreational dispensaries, which sell to adults 21 years and older,” Kovács said.

As business school researchers, Kovács and Hsu first became interested in the increasing prevalence of legal cannabis stores as an organizational issue.

“We tracked evolving cannabis markets across the U.S. from 2014 onwards in an effort to understand how this new category of organizations emerged,” Kovács told MedPage Today. “We realized, however, that our county-level database could also be used to examine whether the availability of legal cannabis in an increasing number of geographic areas has any implications for opioid misuse.”

Their findings add to a mixed evidence base about the relationship between legal marijuana and opioid overdoses. In 2014, an analysis suggested that states with medical cannabis laws experienced slower increases in opioid overdose mortality. However, a subsequent study showed that those findings didn’t hold over a longer period, and that associations between state medical cannabis laws and opioid-related mortality reversed direction and remained positive after accounting for recreational cannabis laws.

Kovács and Hsu based their analysis on data from 812 counties in 23 states (plus the District of Columbia) that allowed legal cannabis dispensaries to operate by the end of 2017. They combined 2014-2018 CDC mortality data with census data and storefront information from Weedmaps, collecting data on dispensaries operating within each county on a monthly basis from 2014 to December 2017. Mortality analysis focused on deaths of people 21 and older.

Eight states and the District of Columbia allowed for recreational storefronts; 15 allowed for medical dispensaries only. An increase from one to two medical dispensaries led to an estimated 15% mortality rate reduction in the study; an increase from one to two recreational dispensaries led to an 11% drop.

Two points about this analysis need to be considered, noted Sameer Imtiaz, PhD, of the Institute for Mental Health Policy Research in Toronto, and colleagues, in an accompanying editorial.

First, the mechanism underlying the association is unclear. “In the context of medicinal cannabis legalization, reduced deaths from opioid overdose do not coincide with reduced non-medicinal use of pain relievers or with opioid distribution, defined as the flow of substances from the manufacturers to retail distributors,” they wrote. “The absence of concurrent changes in such opioid-related outcomes questions the premise of substitution.”

Moreover, inferences about individuals cannot be drawn from aggregate-level data in an ecologically designed study like this, the editorialists pointed out. Both harmful and beneficial associations between opioids and cannabis have been seen at the individual level, they observed.

The findings suggest a potential relationship between the increased prevalence of cannabis dispensaries and reduced opioid-related mortality and do not show causality, Kovács emphasized. “While we find a particularly strong association between the prevalence of storefront dispensaries and fentanyl-related opioid deaths, it is not clear whether cannabis use and fentanyl mortality rates are more specifically linked, or if the strength of the association is due to the rise in fentanyl use and mortality rates during the study period,” he said. Potential harms of cannabis, including the cognitive development of adolescents, medical conditions such as schizophrenia, and public safety risks, should not be ignored, he added.

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Moderna’s vaccine is less potent against one coronavirus variant but still protective, company says

Posted on January 27, 2021 by Pharmaciststeve

Moderna’s vaccine is less potent against one coronavirus variant but still protective, company says

https://www.statnews.com/2021/01/25/moderna-vaccine-less-effective-variant/

Moderna is studying adding booster doses to its vaccine regimen after finding its Covid-19 vaccine was less potent against a coronavirus variant that was first identified in South Africa, the company said Monday.

In lab research that involved testing whether blood from people who had received the vaccine could still fend off different coronavirus variants, scientists found that there was a sixfold reduction in the vaccine’s neutralizing power against the variant, called B.1.351, than against earlier forms of the coronavirus, Moderna reported.

There was no loss in neutralization levels against a different variant, called B.1.1.7, that was first identified in the United Kingdom. Both variants are thought to be more transmissible than other forms of the SARS-CoV-2 virus.

Moderna said that despite the reduction in neutralizing antibodies against B.1.351, the antibody levels generated by its vaccine “remain above levels that are expected to be protective.” Still, it said it was going to start testing whether adding a booster dose to its existing two-dose regimen could increase the levels of neutralizing antibodies even further, and that it was going to start investigating a booster specifically designed against B.1.351.

“These lower titers [of antibodies against B.1.351] may suggest a potential risk of earlier waning of immunity to the new B.1.351 strains,” Moderna said.

The announcement from Moderna gets at a nuance that scientists have been trying to stress as fears around vaccines and variants grew. Both the Moderna vaccine and the immunization from Pfizer-BioNTech produce such powerful levels of immune protection — generating higher levels of antibodies on average than people who recover from a Covid-19 infection have — that they should be able to withstand some drop in their potency without really losing their ability to guard people from getting sick.

“There is a very slight, modest diminution in the efficacy of a vaccine against it, but there’s enough cushion with the vaccines that we have that we still consider them to be effective,” Anthony Fauci, the top U.S. infectious diseases official, said Monday on the “Today” show.

The coronavirus has been evolving throughout the pandemic, and scientists had expected that eventually, the virus would change so much that vaccines would need to be upgraded to better match dominant variants. But the appearance in recent months of the variants, which picked up mutations at much higher rates than the coronavirus was adding at the beginning of the pandemic, has moved up the date at which that might need to occur.

Experts say they need to now figure out how much less effective the vaccines can get before upgrades are needed, and what the regulatory process for approving such tweaks would look like.

Pfizer and BioNTech scientists have already reported their vaccine holds up against B.1.1.7, though they have not reported data yet against B.1.351. But researchers have been more concerned about B.1.351 because it contains a different set of mutations that, at least in lab experiments, had already helped the virus evade some of the immune protection generated in people who had an initial Covid-19 case.

Some of those same mutations of concern also appear in a different variant first seen in Brazil, called P.1.

In the meantime, if mutations do arise that deliver a blow to the vaccines’ strength, experts still say people should get them. Having some immune memory to the virus (which vaccines provide, almost like a substitute for an initial infection) is better than being completely vulnerable. You might still be able to get infected, and maybe even get sick, but giving your immune system even a small edge can reduce the chances you’ll get seriously ill.

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Experts recently told Fox News there is little to no evidence behind ‘double masking

Posted on January 25, 2021 by Pharmaciststeve

Fauci backs ‘double-masking’ in coronavirus fight, says ‘likely more effective’

https://www.foxnews.com/health/fauci-backs-double-masking-in-coronavirus-fight-says-likely-more-effective

Dr. Anthony Fauci, President Biden’s chief medical adviser on COVID-19, said two face masks are likely more effective than one against the novel coronavirus, despite significant uncertainty on the subject.

“If you have a physical covering with one layer, you put another layer on it just makes common sense that it likely would be more effective,” Fauci told NBC News on Monday.

Infectious disease experts from Stanford Health Care, Mayo Clinic and Johns Hopkins University recently told Fox News there is little to no evidence on the issue.

Neysa Ernst from Johns Hopkins University, where she serves as nurse manager of the Biocontainment Unit, agreed, though she proposed that anecdotal evidence suggests additional layers could offer “psychological safety” to some. 

“In this pandemic psychological safety is important, it provides a sense of control in an unknown environment,” Ernst wrote.

According to the Centers for Disease Control and Prevention (CDC), masks should have two layers of breathable fabric, with a snug fit covering the nose and mouth.

There is some conflicting advice on double-masking, which suggests there isn’t enough research behind it yet. When worn correctly, a single face mask made of “appropriate material” typically offers enough protection, Paula Cannon, a distinguished professor of molecular microbiology and immunology at the Keck School of Medicine of University of Southern California (USC), previously said in an email. 

“However, wearing two can provide additional protection. A second mask can create a tighter seal around your face, and also help secure the masks so they don’t slip down,” she added. 

Another physician, Dr. Dave Hnida, previously told CBS that two masks can create more of an “obstacle course” for viral particles in an attempted route from the air, through the body and into the lungs.

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Even if you’re on the right track, you’ll get run over if you just sit there. Will Rogers

Posted on January 24, 2021 by Pharmaciststeve

The statistic gatherers have so much data against opioids its impossible to stop pain regulations

Law enforcement has stats

Brds have stats on opioids

Profess organization has stats on opioids

Cities have stats on opioids

Treatment centers have stats on opioids

All of them use stats to support funding to justify their activities

The pandemic situation has caused the statistic folks to have data going through the roof on ODs deaths and addiction related bad outcomes

I have yet to run across someone reporting the pandemic has caused them more pain, didn’t allow them to get an Rx for pain meds, was turned down by their pain team…..

Just no universal collection of data, just individual anecdotes = no triggering event to jell a pain lives matter organization to rise up and get a voice

With the stats on elderly deaths in folks in their 70s and 80s, I predict the nursing home residents will be the next area of required tapering, who knows maybe CMS will treat them as anti-psychotics, that is what my gut says

The above is from a email that I received from a pharmacist friend of mine in another state… we exchange one or more emails almost daily.    He knows where I stand in regards to abuse and denial of care of chronic pain pts. In a email I made my observation that there are a lot of similarities between the chronic pain community and the pharmacists community… Pharmacists especially those working for the chains are being abused – too much volume and not enough staffing.  Chronic pain pts are being abused by practitioners… denied opiates for their pain and/or bullying into being routinely subjected to ESI – many/most medically unnecessary.

Both groups are big on whining, bitching and moaning and damn little action.  We have a serious and growing surplus of pharmacists and if they stand up they know that there is someone waiting to take their job, but most have a six figure student loan to pay off and finding a new job… will be difficult at best and what Pharmacists are getting paid is dropping and most are only being offered 28-32 hrs/wk..  At best, they are making about HALF of what was being paid when they started pharmacy school 6 + yrs earlier.

Chronic painers are in a similar position, if they SPEAK UP… they fear being discharged from the practice and finding a new prescriber will be difficult … so they accept what the prescriber will give them and can’t/won’t SPEAK UP.

I found his observations quite interesting…  all of those entities that have some skin in the game… collecting data … so that they can get more grant money… to keep fighting the war on pts/drugs that no one – who would tell the truth – would state that they are not even holding their own over the last 50 yrs…since the Controlled Substance Act 1970 was signed into law.

IMO, the gist of all his comments have to do with optics, the lack of unity within the community and all the infighting …  This is from basically a state bureaucrat that has no attachment with the community and a lot of what he knows … he has got from reading my blog.

The conclusion that I come away with from his comments is that the conclusion from the optics that the community is displaying is that the community is NOT A THREAT to anyone and in all likelihood it will be a long time before – if at all  – becomes a threat to anyone who opposes opiate prescribing or has a interest in trying to make the opiate crisis go away.  The community knows that since the CDC opiate dosing guidelines came to be that we have more chronic painers being denied adequate pain management, we have untold number of have or are thinking about committing suicide and more uncountable number that are now suffering/dealing with PTSD from trying to deal with living/existing in a torturous level of pain.

There is no KNIGHT ON A WHITE HORSE coming over the horizon to save your ass, nor is there someone name “george” coming to save your ass.

My blog is in its 9th year and I could have written all of this in a post 9 yrs ago and it would have been current then as it is today.

 

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