“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
call the Supreme Court to share your public opinion of the mandates and freedom, ahead of the hearing on Friday. Call one of these Supreme Court of the United States phone numbers to leave your message: Clerk’s Office: 202-479-3011 or Public Information Office: 202-479-3211 Choose to leave ONE of these messages (or make your own brief message) with the Supreme Court:
Message 1: I would like the Court Justices to know, with the utmost of respect, that I am concerned about the infringement of Americans’ Constitutional freedom that imposing vaccine mandates presents. Please let them know that Americans desire our guaranteed freedom.
Message 2: On Friday, the Justices will be hearing about the vaccine mandates. I wish to respectfully register my concern about the infringement of personal and religious freedom that these mandated medical treatments have trampled on.
Message 3: Please relay to the Justices that I am praying for each one of them by name as they hear a critical religious freedom, medical freedom and personal freedom case of the vaccine mandates.
It cannot be the least bit surprising that there is another Covid variant in the news. I wrote about this several weeks ago and wondered, since the next Greek letter is pi, whether it would be given the name American Pi should it be first detected in the US.
My viral prognosticative powers are not what they should be; not only was the new kid on the block not discovered in the US, but it didn’t even get the proper name!
The World Health Organization naming system for variants has been a joke. In order to avoid “causing offense to any cultural, social, national, regional, professional or ethnic groups,” the WHO decided to use Greek letters to name the variants. How well did that work out? Not very.
For example, the original virus from Wuhan was called just about everything except the Wuhan variant. The press settled on the bland and meaningless term “novel coronavirus,” which is rarely used anymore. Then the Greek letters started (1):
Alpha (UK)
Beta (South Africa)
Gamma (Brazil)
Delta (India)
Omicron (South Africa and multiple other countries)
(While it may seem that South Africa is no more than a virus spawning ground, this is dead wrong. As I recently wrote, the country got punished (border closings) because its scientists did a superlative job of isolating and identifying new variants, which were almost certainly circulating in other countries, but missed. See Dear Clueless Media: S. Africa Deserves Praise, Not Blame.)
A few observations
First, it is clear that there are missing letters. This is partly because not all variants rose to the level of Variant of Concern (VOC), so while epsilon, theta, etc. did exist, they shamefully faded away, becoming nothing more than another piece of historical detritus of woefully inadequate variants, a humiliation they will never live down. The last variant to “earn” a name was the mu variant, which stuck around just long enough to generate some press hysteria and then entered the virus witness protection program, never to be heard from again.
The next two variants were supposed to be nu and xi, but these were skipped in favor of the next letter, omicron. Why? The WHO claimed that nu sounded too much like new and xi is a very common last name in China. This explanation does not exactly ring true. In fact, it brings to mind a word rhyming with “wool knit.”
But it got worse. Since the Greek letter system, even if it had been scrupulously followed, is inherently confusing, we began to see things like “the Delta variant, which originated in India…” If you understand how this destigmatizes India, please leave a comment with your explanation. Completing the circle of inanity, the original virus that started the gigantic mess which the world is still mired in is now routinely referred to as the “Wuhan strain.” Can’t make this s##t up.
The self-aggrandizing French
With the exception of bakers, the use of the letter pi, which is supposedly reserved for the next (and inevitable) variant, is unlikely to offend anyone. So it is only logical (as if anything is right now) that pi would assume its role as the variant du jour. Yet, this is not the case. Another variant, this one with 46 mutations, which was detected in someone who traveled to Cameroon and returned to France, was identified by the IHU – Méditerranée Infection in Marseilles. Did they name it pi? No, they named it after themselves, leaving us with a variant called the B.1.640.2 aka the IHU variant, aka the “not pi but should be” variant. Some nerve! Will the Greeks be offended that a bunch of French scientists disrespected their alphabet?
“The mutation set and phylogenetic position of the genomes obtained here indicate based on our previous definition a new variant we named “IHU”’
I hate to burst “le balloon” but these guys, even though they may be the first to name it after themselves, are hardly the first group to sequence a variant. Not even close. As of December 2021, six million variants have been sequenced and entered into the GSAID database (short for Global Initiative on Sharing Avian Influenza Data), and to my knowledge, there are no examples of scientists naming another variant after their place of employment, themselves, or their parakeets.
In 1992, Jim Gray, a conservative judge in conservative Orange County, California, held a press conference during which he recommended that we rethink our drug laws. Back then, it took a great deal of courage to suggest that the war on drugs was a failed policy. Today, more and more Americans are coming to the realization that prohibition’s costs—whether measured in lives and liberties lost or dollars wasted—far exceed any possible or claimed benefits. Reason.tv’s Paul Feine interviewed Gray about drug policy and the prospects for reform. The interview was shot by Alex Manning and edited by Hawk Jensen. Judge Jim Gray is the author of Why Our Drug Laws Have Failed and What We Can Do About It: A Judicial Indictment of the War on Drugs.
Could all this “dust up” over mandatory vaccinations, mandating mask wearing… no testing for antibodies to determine “natural immunity ” .. failure of the current administration to order adequate supplies of various “stuff” deemed necessary to stop the spread of the COVID-19 virus – which has mostly failed miserably… the lack of monoclonal antibodies … because they were not ordered by the current administration.
Could all this bring into focus what legal right the federal/state bureaucracies have to force citizens to take certain vaccinations and/or prohibit people from taking certain categories of medications approved by our FDA – as being safe for human use. Could this COVID-19 pandemic potentially force the change of the Federal/State bureaucracies’ policies on all drug use and/or abuse. After all the two drugs that contribute to the deaths of abt 550,000/yr of US citizens is Alcohol & Nicotine… are PERFECTLY LEGAL SUBSTANCES/DRUGS…. they are not MEDICATIONS… there is a difference between a medication and a drug.
That is abt 7-8 times the people killed in 2021 by the use/abuse of illegal controlled substances… which everyone is screaming from the roof tops about. When did some deaths become socially acceptable and others are demonized… could the big difference be the healthy tax revenue stream that goes to the Feds & states… that comes from those two legal drugs – Alcohol & Nicotine ?
One health expert says it’s ‘unconscionable’ that the FDA’s advisory panel is not being consulted on boosters
President Biden is yet again facing backlash over the FDA’s booster approval process, which recommended boosters for children this week without convening a panel of advisors to weigh in on the matter.
“Dear President Biden, FDA is bypassing it’s scientific advisors to authorize boosters for all kids 12-15 next week. This is unconscionable – undermines the integrity of the FDA’s standard process! Please require FDA to put this authoriz [sic] before the VRBPAC advisory comm for a vote!” Dr. Marty Makary, chief of the Johns Hopkins Islet Transplant Center and Fox News contributor, tweeted Saturday.
WASHINGTON, DC – DECEMBER 27: President Joe Biden and the White House COVID-19 Response Team participate in a virtual call with the National Governors Association from the South Court Auditorium of the Eisenhower Executive Office Building of the Whit ((Kent Nishimura / Los Angeles Times via Getty Images) / Getty Images)
The Vaccine and Related Biological Products Advisory Committee voted against giving the Pfizer-BioNTech’s COVID-19 booster shots to most people back in September. It instead voted to limit boosters to those aged 65 and older, as well as to people at risk of severe illness, citing the lack of evidence showing the boosters are safe for younger people.
“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value,” committee member Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said at the time.
The controversy over boosters in the early fall was compounded when two FDA officials – the director of the FDA’s Office of Vaccines Research & Review, Marion Gruber, and its deputy director Phil Krause – resigned from the agency.
WASHINGTON, DC – AUGUST 22: U.S. President Joe Biden speaks in the Roosevelt Room on the continuing situation in Afghanistan and the developments of Hurricane Henri at the White House on August 22, 2021 in Washington, DC. (Photo by Samuel Corum/Getty (Photo by Samuel Corum/Getty Images / Getty Images)
The pair issued a scathing criticism of the widespread use of boosters in a piece published in the Lancet on Sept. 13, which was co-authored by a handful of experts warning that “current evidence does not appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.”
By November, however, the FDA approved the Pfizer-BioNTech and Moderna vaccine boosters for everyone 18 and older without input from the advisory committee.
The agency said at the time that it did not convene its advisory panel because the committee had already discussed the use of boosters and “the requests do not raise questions that would benefit from additional discussion,” the New York Times reported on Nov. 19.
The FDA approved the Pfizer-BioNTech COVID-19 vaccine booster for 16 and 17-year-olds last month, and broadened eligibility Monday to 12-15 year olds.
Former FDA commissioner during the Trump administration, Scott Gottlieb, said during an appearance on “Face the Nation” Sunday that schools should not mandate boosters for children, noting that the durability of vaccines in 12 to 16-year-olds “has been more robust than what we’ve seen in adults.” He added that kids overall are “at less risk overall from the infection.”
Dr. Makary agrees.
“It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board… FDA is quietly doing this because their experts previously voted it down, voicing concerns about medical harms,” Makary tweeted Saturday.
Makary added in comment to Fox News on Monday that it’s within Biden’s “jurisdiction to demand that his FDA put the decision to a vote by the experts as was done with other major FDA [Emergency Use Authorizations].”
An employee draws up a syringe with the Pfizer vaccine against the coronavirus and the COVID-19 disease at vaccination bus in Berlin, Germany, Tuesday, Nov. 23, 2021. Germany battles rising numbers of coronavirus infections. (Kay Nietfeld/dpa via AP) (Kay Nietfeld/dpa via AP / AP Newsroom)
Dr. Marc Siegel, professor of Medicine at the NYU Langone Medical Center and Fox News contributor, said he supports the advisory board taking up the issue because they need to “figure out the utility of it.”
“I don’t want anybody to be suggesting this vaccine, or its boosters, are unsafe for that group. That’s wrong. And the purpose of convening the advisory committee is not to question safety. It’s to question who should get it,” Siegel told Fox Digital on Monday.
“If we start suggesting that this, this vaccine is unsafe, then we’re playing into the hands of the anti-vaxers, who are filling hospitals.”
The New York Times reported on Dec. 30 that some experts said that the Biden administration’s focus on getting younger people boosters is misguided and officials should instead work on vaccinating those who have not yet gotten the shots. Offit told the outlet that getting such shots to young Americans was “focusing on the people who are already protected.”
Republican Sen. Rand Paul, who is also a physician, criticized the Biden administration on Twitter Sunday for the government “ignoring its own rules to push booster vaccines on kids for a disease is that is less deadly in children than the seasonal flu.”
Makary argued in a Wall Street Journal op-ed published last month that booster mandates for young people “will cause medical harm for the sake of transient reductions in mild and asymptomatic infections.” He cited a December study by Oxford researchers that found “young people suffered myocarditis, pericarditis and arrhythmias more frequently from Moderna’s vaccine than from Covid itself.”
While the long-term cardiac effects of boosters in younger people is “unknown.”
“Forcing immune, young, healthy, low-risk students to get a third vaccine shot is excessive and wasteful. These precious vaccine doses should be going to poor countries that still don’t have enough,” Makary concluded in his op-ed.
The White House referred Fox News to the FDA when approached for comment on the concerns from health officials.
The FDA directed Fox News later Monday to a press call where the director of the Center for Biologics Evaluation and Research within the FDA said the advisory board is called upon at the discretion of FDA officials.
“The reason for not taking it to our advisory group: We use our discretion when we bring things to advisory group. When we feel like there is some question that is likely to actually need public discussion,” Dr. Peter Marks said on the call. “We sometimes consult our advisory committee chairs to decide what questions to bring to committee.”
He explained that the increase in cases in the last 48 hours prompted officials “to try to move as quickly as we possibly could.”
White Plains, New York – January 4th, 2022 – A new report published by PharmacyChecker entitled “Not Made in the USA” shows that 68% of the top 100 highest dollar finished drug formulations (FDFs) paid through Medicare Part D in 2018 were imported. Additionally, 78% of the active pharmaceutical ingredients (APIs) of those same 100 drugs are foreign made. Contrary to most imported generic medications, these FDA-approved brand-name drug formulations are made in high-income countries that have comparable to, if not stronger, systems of pharmaceutical manufacturing than the United States. Sixty-seven, all except one of the imported medications, were made in either the European Union, Canada, Japan, Singapore, Switzerland, or the United Kingdom. Brand Neurontin (gabapentin), was imported from India.
For reasons of drug affordability, safety, and national security, there is cause for concern among American consumers and policymakers about where prescription drugs are made. Over the last 20 years, the U.S. Government Accountability Office, academic and public policy researchers, and the media have relied on FDA data to inform the public that 80% of APIs and, for over a decade, that 40% of FDFs sold in U.S. pharmacies are imported. Those figures were never backed up with supporting data and had gone unquestioned in Congressional reports. The global pandemic has brought important discussions to the forefront about drug quality, healthcare affordability, and U.S. dependence on foreign countries for pharmaceutical supplies, all of which are addressed in “Not Made in the USA.”
“The public should know that importation is unequivocally the main artery of our drug supply chain,” stated Gabriel Levitt, primary author. “Unfortunately, not only transparency, but accuracy, is lacking about where drugs are made. The FDA does not seem to publish or even have good data for internal purposes. The industry, while simultaneously fearmongering about drug importation, relies on drug importation to sell medications at much higher prices than available in all other high-income countries. Common sense, facts, and public health need to be at the forefront of how we approach importation and prescription drug affordability moving forward.”
For its dataset, “Not Made in the USA” relied on the Medicare Part D Drug Spending Dashboard and Data. The top 100 drugs in terms of total spending were analyzed, which represented 57% of all spending in Medicare Part D for 2018. To determine the countries of origin for both FDFs and APIs, PharmacyChecker carefully reviewed prescription drug labels as found in the U.S. National Library of Medicine. While federal law under the FDA’s jurisdiction does not require drug manufacturers to publish the source country of a medication, other laws, notably the Tariff Act of 1930, do require such disclosures for imported products, including drugs. Where a pill bottle often doesn’t have this information, the actual drug manufacturer’s label usually does.
Of the 100 drugs analyzed that are accessible online, the average international mail-order prices were 75.53% lower than average U.S. pharmacy prices. Average prices available among drugs from Canadian pharmacies, specifically, were 70.18% lower than average U.S. pharmacy retail prices.
Because the pharmaceutical industry was able to stave off larger policy lifts in the Build Back Better Act, importation could become far more important in realizing a future where U.S. drug prices are comparable to the lower prices available in other high-income countries. Despite current regulatory restrictions, according to a survey by the Kaiser Family Foundation, about eight percent (20 million) of Americans have imported prescription drugs for personal use.
“Americans should have full access to wholesale and personal importation of brand name drugs and the regulatory hurdle is worth the resulting savings,” said Levitt.
About PharmacyChecker
PharmacyChecker, based in New York, is the only independent company that verifies the credentials of and accredits international online pharmacies, publishing a list of accredited online pharmacies and drug price comparisons based on those pharmacies. PharmacyChecker insight and accreditation have been recommended and/or referenced by AARP Magazine, the New York Times, the People’s Pharmacy, Yahoo Finance, and others. For more information, visit www.pharmacychecker.com.
Press Contact: Lucia Mueller, Director of Communications for PharmacyChecker.com | lucia.mueller@pharmacychecker.com | (718) 554-306
Drug companies raised the prices on hundreds of medications on Jan. 1, with most prices up 5% to 6% on average.
Why it matters: The start of the new year is the most popular time for drug companies to hike prices, and even though high drug prices remain one of the biggest political health care issues, increases in 2022 are tracking in line with other recentyears.
The number of drugs that had price increases on Jan. 1 of prior years according to 46brooklyn: 629 (2021), 385 (2020), 359 (2019), 538 (2018) and 494 (2017).
Many drugmakers implement price hikes on other days throughout January, so expect more increases in the coming days.
Between the lines: Several blockbuster drugs were included in this initial batch of 2022 price hikes.
Gilead: ⬆️ 5.6% on HIV drugs Biktarvy and Descovy.
Vertex: ⬆️ 4.9% on Trikafta, a blockbuster cystic fibrosis medication that has no competitors and already has a list price of more than $311,000 per year.
Yes, but: These actions affect the drugs’ list prices. Pharmacy benefit managers negotiate lower drug prices in the form of rebates, so drugmakers often collect lower net prices.
However, list prices still matter because they are what the uninsured pay, and deductibles and coinsurance rates are often based on a drug’s list price.
Drug companies also capture most or all of a list price increase for patented drugs that have little competition, like those mentioned above.
What they’re saying: “We expect net prices to continue to decline due to increased rebates and discounts,” a Gilead spokesperson said in response to the company’s price hikes. The spokesperson did not answer specific questions about the rebates for those drugs.
“The modest increase is necessary to support investments that allow us to continue to discover new medicines and deliver those breakthroughs to the patients who need them,” a Pfizer spokesperson said. When posed specific questions about Ibrance’s rebates, the spokesperson said: “We do not disclose detail at the product-level.”
Vertex’s price increases on Trikafta and its other cystic fibrosis drugs “are the first price increases for a Vertex medicine since 2017, and the first ever for … Trikafta, and they “reflect the significant value these medicines bring to patients.” Vertex similarly did not respond to questions about rebates.
Our thought bubble: List price increases don’t tell the entire story about U.S. drug pricing, but drug company claims about how net prices are falling right now distort how much prices have increased over time.
The above graphic shows where a “lion’s share’ of the money pay’s at the register goes… to a bunch of middleman, that produce no products and have no inventory and yet decides how much profit the pharmacy grosses and the pharma manufacturer makes. These middlemen EXTRACT discounts, rebates, kickback from the Pharma’s for putting a particular pharma med on their approved formulary – no prior authorization is needed for the pt to get the medication that their prescribers wants for the pt… It has been claimed that on some meds those $$$ could reach up to 75% of Average Wholesaler Price.. and that overall these middlemen can increase the price of the med to the pt by as much as DOUBLING IT… and all of those EXTRA DOLLARS drops into the middleman’s coffers. This all started back in the 70’s and one has to wonder how politicians/bureaucrats were convinced that having more middlemen in our healthcare system – each with their own overhead and profit goal – would/could help lower overall healthcare costs. When I first became licensed Pharmacist, none of these middlemen were around and Rxs were abt 6% of overall medical costs and today they are up in the 12% range. Even though “back in the day” we had 90%-95% brand name meds to fill Rxs and today we have about a 90% generic utilization.
