FDA announces recall of 2 cardiovascular medications due to labeling mix-up

https://cardiovascularbusiness.com/topics/clinical/pharmaceutics/fda-announces-recall-2-cardiovascular-medications-due-labeling-mix

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Polk County Sheriff Grady Judd: People have a right to be safe in their homes… I highly recommend, if a looter enters your home, you grab your gun and you shoot him, you shoot him so he looks like grated cheese. 😬🔥🔥 pic.twitter.com/OxUnsg30c7

— Charles Weber – AKA “THE Jew from Boca” (@CWBOCA) October 7, 2022

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DEA – all knowing – is rationing controlled med products… and when the pts with valid medical necessity for a specific controlled substance the DEA apparently decide who gets the medically necessary medications. when the DEA’s weegee board or crystal ball isn’t giving accurate numbers of specific that is really need by pts with valid medically necessity.

The spokesperson explained that Sandoz, as with other drugmakers, forecasts manufacturing based on customer pre-orders and is granted permission to fulfill the predicted level of ordering by the U.S. Drug Enforcement Administration. If a customer orders more than what drugmakers forecast due to increased demand, manufacturers are unable to fulfill those orders, and they are considered “back-ordered.”

As long as the part of the DOJ – DEA – is allowed to juggle the volume of controlled meds that are allowed to be produced and sent to pharmacies to have to dispense to pts with a valid medical necessity.  It would appear that many pts will be denied their medically necessary medication  and probably intentionally forced into some sort withdrawal.

https://www.foxbusiness.com/economy/adderall-shortages-impacting-adhd-patients

Pharmacists are sounding the alarm

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If this come to be… our country can a just about say good bye to just about all new medication introductions.  Clinical trials for a new product can take 10-12 years and can involve investing hundreds of millions of dollars just to be it thru clinical trials and approved by the FDA to bring it to market. I can’t count the number of times that a Pharma get a med thru 1st & 2nd clinical trial stages and the drug is dropped because of some unforeseen issues in the 3rd stage of clinical trials… and hundreds of millions of clinical trial dollars is literally FLUSHED DOWN THE DRAIN.

I have seen some mentioned that the “price target” for the government on any/all of the medications.. is what the Veteran Admin pays for those medications. The VA works from a fixed medication formulary …. they send out bids for which pharma is going to provide a particular medication for a particular class of med.  I don’t know if the VA orders meds directly from the Pharma, or they have their own regional warehouses or they have “deals” with the major drug wholesalers to stock and ship their contract meds for an administration fee.   There is no insurance company nor PBM nor any other “middleman” with their own built in overhead costs and desire to show a profit. The VA – I would suspect – to ask for fixed prices on a particular med for a mutli-year contract and for a guaranteed number of doses the VA will purchase over the length of the contract.  It is not unusual for the VA to purchase BRAND NAME MEDS for a price lower than community pharmacies pay for the generics of those brand name meds.

Believe it or not, we are seeing some of the same consequences within the petroleum industry.  CALF is first, but other will follow that by 2035 all new cars sold there MUST BE ELECTRIC.  Again in CALF all new homes must have a certain amount of solar energy cells on the roof..  Some states are outlawing central home furnaces to run on kerosene or heating oil…  These petroleum companies that must invest 100 of million of dollars to develop a field that is producing petrochemicals, when bureaucrats are busy trying to create less demand for those products ? 

Businesses do not invest their capital into a infrastructure to produce a product or providing a service if there is a substantial risk of some bureaucrat making some rule/law/regulation that dictates what you should charge for your product or service and the bureaucrats are mostly clueless about what it costs the company to develop, produce, deliver a particular product or service. If a business is forced to accept a lower price for their product or service… the business is going to reduce the number of employees, the hours of operation , the quality of their product or service or even just stop providing the product or service altogether.

Becerra leaves door open to march-in rights to lower drug prices

https://www.axios.com/2022/10/07/becerra-drug-price-march-in-rights

Despite newly enacted drug pricing measures, the Biden administration hasn’t ruled out more sweeping actions to lower the cost of medicines, including asserting control over the patents of treatments developed with the government’s help.

Why it matters: The Inflation Reduction Act signed by President Biden in August for the first time allows Medicare to negotiate lower prices for some drugs. But Health and Human Services Secretary Xavier Becerra on Thursday left an even bigger sword hanging over the pharmaceutical industry, saying so-called march-in rights are not “off the table.”

Between the lines: Progressive advocates have been pushing for years for the federal government to use power under a 1980 law to “march in,” take over the patent of a drug and license it to other manufacturers as a way to lower the price.

• Even the Obama administration rejected the idea, a sign of how out of the ordinary any move by the Biden administration would be.
• Then-National Institutes of Health director Francis Collins wrote in 2016 that the power was meant to be used in instances like when a drug is in short supply, not when it simply has a high price.
• The federal government narrowed the circumstances under which it could assert the rights for some prospective COVID-19 drugs.

What they’re saying: “We will continue to explore every option we have,” Becerra told reporters when asked about march-in rights. “We’ve never taken anything off the table. And we will work on every one of those aspects of lowering drug prices. Why don’t I leave it at that?”

Be smart: It would be a major shock if HHS actually went through with using march-in rights, especially because Congress just took action on drug pricing.

• But it is notable that Becerra isn’t ruling out the idea, and is content to at least let the threat linger.

The big picture: The idea has gained ground in the Democratic Party. Multiple 2020 presidential candidates touted the idea, though it tended to be progressives like Sens. Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.) more than Joe Biden.

• Progressive advocates are keeping up the pressure, protesting outside HHS headquarters in support of march-in rights on Thursday.
• Peter Maybarduk, a drug pricing advocate at Public Citizen, said at the protest that the Inflation Reduction Act is a “generational victory,” but more action is needed to target launch prices of new drugs and disrupt “the monopoly control that is the root of corporations’ pricing power.”
• Drug companies argue the move would upend the system that allows for innovation and encourages development of new treatments.

The bottom line: While further action hangs as a possibility, HHS must also begin implementing the Inflation Reduction Act. Asked about relations with pharmaceutical companies given their opposition to the law, Becerra said he’s seeking an open process as details are worked out.

• “We’re going to include them all the way through,” he said.

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EXCLUSIVE: ‘No basis in science or data… just ideology’: Critics slam Harvard children’s hospital for claiming babies know in the WOMB if they’re transgender

https://www.dailymail.co.uk/health/article-11280475/Harvard-hospital-claims-babies-know-WOMB-transgender.html

A Harvard-affiliated children’s hospital has sparked outrage after claiming some babies know they are transgender ‘from the womb’.

In a now-deleted video, the Boston Children’s Hospital suggested an even larger number of minors know ‘as soon as they can talk’.

Critics told DailyMail.com the claim was was not based on science and suggested  medics at the clinic are unwilling to question children who are often vulnerable.

The hospital, part of the Harvard University medical system, also faces claims it rushed under-18s into life-altering sex change surgery.

In the clip posted to the Boston hospital’s official YouTube page in August, psychologist Dr Kerry McGregor explains the type of patients she sees.

She says: ‘So most of the patients we have in the clinic actually know their gender, usually around the age of puberty.

‘But a good portion of children do know as early as – seemingly – from the womb.

‘And they will usually express their gender identity as very young children, some as soon as they can talk… kids know very, very early.’ 

It comes as several states begin to clamp down on puberty blockers being prescribed to children. Texas Gov. Greg Abbott has previously likened it to ‘child abuse’. 

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This quote from this professor is such HOR$E $HIT… 

“This is the entitlement generation,” Starnes said. “I don’t want any surgeon cutting on my body who failed organic chemistry. I want the best of the best.”

I had a surgeon who was a good friend and his biggest concern – and he shared it often –  he was somewhat insecure on his ability to properly diagnose health issues that needed a surgical intervention…  He would say that he would rather someone else diagnosed “what needed to be cut out “…  he was very confident of his surgical skills.

Personally, I see very little relationship between being able to pass Organic Chemistry and being a competent surgeon.

Actually the Professor that I had for Inorganic chemistry was probably the biggest arrogant ba$tard of all my college professors.  At the time, I was a chemistry major and I was going to a local extension of Indiana University.  There was abt 100 students in two different chemistry classes – one day class abd one night class – both taught by the same professor…  The first day of class this professor told the class that 60%-70% would not be taking the second semester of Chemistry… BECAUSE that is typically how many of his students gets a “D” or “F” in the first semester class.  This was a first level college chemistry course, but his doctorate was in physical chemistry – which is course work you take after taking Inorganic and Organic level courses..  and much of his instruction was more about physical chemistry level work.  Explains why most of student taking this/his course….  most everyone – at best – had only had some high school chemistry.  I got a “B” this semester … so on I go with about 30 others in the class to second semester inorganic chemistry class – with the same professor.   When the final for the second semester came around… this ARROGANT JERK… said that the final was going to be over BOTH SEMESTERS.  The test was suppose to be a TWO HOUR TEST… and I was the first one done at 2:10 -2:20 and I got a 94 on the test and the JERK would not give me a “A”, I guess my grade point average for the semester was in the “B” range.  I guess that getting a “A” grade on a two semester final … was no proof to him that I knew the material.  It was useless to argue about the grade, because I was already accepted and going to Butler U in the fall to major in pharmacy and grade points do not transfer… just credit for taking and passing courses at another accredited university. This was the only teacher/professors in my 13 yrs of education to have a semester final test over both semesters of the course work.  Pursuit of a college degree can be such an interesting journey 🙁

An organic chemistry professor at New York University has been fired for being a tough grader.

Maitland Jones Jr., who has taught college students for decades, was booted from teaching after students petitioned his removal. The students complained that his class was too difficult.

The 84-year-old educator also told the Times that the real loss of focus by students began years ago, but the pandemic made matters worse.

He also reported that students weren’t showing up to his class, and those complaining weren’t putting in the work needed to succeed.

National radio host Todd Starnes slammed the snowflake students on the “Todd Starnes Show” Thursday.

“This is the entitlement generation,” Starnes said. “I don’t want any surgeon cutting on my body who failed organic chemistry. I want the best of the best.”

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It looks like the monthly Medicare Part B will be lower for 2023…. They may be because last year, Medicare “jumped the gun” and instead of following the law in how the Part B premiums are suppose to be determined and because of a newly approved Alzheimer meds that was approved late in 2021.. that was going to have a yearly cost of some $40,000/yr.  Part B Premium are suppose to be calculated on the cost per Medicare beneficiary for 2 yrs back… 2023 rates were suppose to be based on the per capital expenditures  for 2021.  But Medicare based the 2022 rates on the ANTICIPATED costs of this new Alzheimer’s med being used… BUT… the clinical studies and pt outcomes were overly optimistic on this particular med and the pharma introducing this med cut its price by HALF.  So this new med was not used as much as anticipate and charges were per dose were cut in half. Looking at what we paid/month for Medicare part B for 2022… 2023 Medicare Part B premium should be about $10/month LESS.

Here is the hyperlink that should allow you to compare various Medicare program options for 2023.   https://www.medicare.gov/plan-compare/#/?year=2023&lang=en  REMEMBER that Medicare Part D and Medicare Advantage (Part C) are provided by FOR PROFIT INSURANCE COMPANIES… who are paid so many $$$/pt/month to provide services/products to a pt.

Zero-premium Medicare Advantage plans: What to know

Enrollment for 2023 opens next week

https://www.foxbusiness.com/personal-finance/zero-premium-medicare-advantage-plans-what-to-know

The annual open enrollment period for joining, switching or dropping Medicare Advantage health insurance plans provided by private companies starts next week, and zero-premium offerings are expected to be more popular than ever with Americans feeling the squeeze of inflation.

Starting Oct. 15 and running through Dec. 7, people ages 65 and older, or younger individuals with certain disabilities who qualify under the government’s guidelines, can apply for coverage that begins at the start of 2023.

But not all plans are the same, and experts say shoppers are advised to do their research to be sure they are receiving optimal coverage even if no premium is charged — and there could be other costs involved.

“It’s not a one-size-fits-all program,” Melissa Brenner, an insurance broker in Charlotte, North Carolina, told the Associated Press. “You don’t want to look at a zero plan and just enroll in it.”

Medicare Advantage plans are similar to traditional government-run plans, except they typically require patients to visit health care providers or pharmacies within a network. Individuals with the private plans will also still need to pay the monthly cost of Medicare Part B to cover doctor’s visits.

Next year, that cost will come out to $164.90 a month and is usually deducted from Social Security checks.

Brenner recommends that shoppers review the networks, co-pay costs and annual out-of-pocket maximums when comparing plans rather than just looking at the price of premiums (or lack thereof).

No-premium plans can be great for people who are healthy and do not require a lot of medical services, but plans with less coverage can be a greater risk for those who are not and amount to more significant out-of-pocket costs.

Experts recommend that shoppers do their homework early when it comes to comparing plans and not wait until the end of the enrollment period in early December to sign up, because there is a rush at the end, and people who are late can be locked out.

To enroll in Medicare, call the Social Security Administration at 1-800-772-1213 or visit ssa.gov/.

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All of this is the new warning texts on Indiana’s PDMP INSPECT login page and Bamboo Health is who operates Narxcare and Bamboo Health is owned byhttps://www.experian.com/ I have read that they have moved all of their databases off shore to a country where our HIPAA laws don’t apply.  If INSPECT database is the template of other state PDMP’s,  I don’t see any way for a individual user to enter specific data on a individual. But I am sure that most pharmacy software system has a way to enter specific data on a pt… Of course, the pt is patronizing a chain pharmacy… I am sure that whatever a pharmacist puts into that particular chain’s pharmacy software system… will show up on the computer terminal in any of their Rx depts…  I have been told that at least at Walgreens,  a Pharmacist can “black ball” a pt at one store and that pt will be “black balled” at all the chains Rxs dept… with Walgreens and CVS… that will be 9,000 Rx depts of each chain.  Of course, if you are patronizing a independent pharmacy, where you will be dealing with the Pharmacist/owner…  the pt can only be black balled in that ONE STORE’S COMPUTER.  Here is a hyperlink to search for a independent pharmacy by zip code and mile radius  https://ncpa.org/pharmacy-locator

Bamboo Health End User Agreement

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I am having pts reach out to me with what I see is a fairly disturbing pattern…  One of the basic functions of the practice of medicine is the starting, changing or stopping a pt therapy.  It use to be that if a pharmacist refused to filled a Rx – C-II in particular, the pharmacist should hand the paper Rx back to the pt.

Now with all- or nearly all – Rxs being transmitted electronically, if a Pharmacist refuses to fill a C-II… the particular C-II literally becomes a INVALID RX.  Unless the DEA has changed their rules/regulations, any chain using a central server/database… any store in the chain can pull the E-Rx C-II on the central server and fill it…

At least ten years ago, Walgreen granted their Pharmacists the permission to “black ball” any pt… for any particular reason – or no reason at all  – and the pt is “black balled” in all 9,000 stores. There is rumors that CVS has adopted the same procedure/protocol.  Each of those chains has abt 9,000+ stores, so a single pt can be black balled in a single store in each chain and they are black balled in about 25% – 30% of all the retail/community pharmacies in the country.

Any electronically sent Rx – other than C-II – can be transferred to another pharmacy either verbally by the Pharmacist or simply print out the electronic Rx data and fax it to the store that it is to be transferred to.

I think that a pt that has a pharmacist to refuse/decline to fill a electronic C-II,  should ask the Pharmacist to print out the electronic Rx data – it can’t be a valid C-II – because in order for it to be a legal  C- II hard copy is for it to be SIGNED IN INK by the prescriber.

Shouldn’t the pt be entitled to a copy of the prescribed med/strength, quantity and directions with the pharmacist’s name and license number and be signed by the Pharmacist. Ask that any notes added by Pharmacy staff on the Rx be print out as well.

CLINICAL REASON(S) FOR DENYING TO FILL the C-II

In health care… it is typically quoted … “if it isn’t documented ….  IT DID NOT HAPPEN …”

If the Pharmacist refused/declines to provide a hard copy of the Rx data information.

I can’t think of any valid reason that a Pharmacist would use to not give a pt a copy of the Rx info.  What if the Pharmacist put notes of the Rx … “I’m not comfortable filling this”… “the pt appears to under the influence…”  or some other derogation comments about the pt.

It is not outside the possibility- it has happened before –  that the Rx dept staff are refusing to fill C-II… so that they can fill it after the pt has left … for diversion purposes.   Many of the opiates are “worth $1/mg ” on the street.

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Walgreens sued for denying leave to pregnant worker who miscarried

https://www.reuters.com/legal/government/walgreens-sued-denying-leave-pregnant-worker-who-miscarried-2022-09-29/

Sept 29 (Reuters) – Walgreen Co has been sued by the U.S. Equal Employment Opportunity Commission (EEOC) for allegedly refusing to allow a pregnant, diabetic retail worker in Louisiana to take emergency medical leave, forcing her to quit hours before she miscarried, the agency announced on Thursday.

The EEOC filed a lawsuit on Wednesday in Alexandria, Louisiana federal court claiming a manager in December 2020 told the worker she had asked for “too many accommodations” and could not leave to see her doctor unless she found a replacement.

The EEOC said the worker identified as Jane Doe had asked to leave after she noticed that she was spotting, then quit before having a miscarriage later that day.

A spokesperson for Walgreens declined to comment.

The EEOC accused Walgreens of violating the federal Pregnancy Discrimination Act (PDA) and Americans with Disabilities Act by refusing to grant Doe a reasonable accommodation related to her pregnancy and disability.

In a 2015 case involving UPS Inc, the U.S. Supreme Court said the PDA requires employers to grant pregnant workers the same accommodations that they give to employees who are injured or disabled.

The EEOC in Wednesday’s complaint said Walgreens ordinarily permits employees to leave work if they are having an emergency.

The commission is seeking backpay and compensatory and punitive damages on behalf of Doe.

In a statement, EEOC lawyers said the case highlights that emergency leave can be considered a reasonable accommodation.

“No one should have to choose between losing a pregnancy and losing a job,” said Andrew Kingsley, a senior trial attorney.

The case is EEOC v. Walgreen Co, U.S. District Court for the Western District of Louisiana, No. 1:22-cv-05357.

For the EEOC: Andrew Kingsley

For Walgreens: Not available

(NOTE: This article has been updated to reflect that Walgreens declined to comment on the lawsuit. A previous version of the article also incorrectly identified Walgreen Co as Walgreens Co.)

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