Tag: FDA

Join Jim and Greg as they dissect Pres. Biden’s attempt to declare the withdrawal from Afghanistan an “extraordinary success” while also trying to blame President Trump for things going wrong and throwing out his bogus straw man arguments yet again for the decisions he made. They also welcome the scathing critique of the withdrawal from former Democratic Sen. Jim Webb, who is demanding vigorous oversight of the exit from Afghanistan. And they discuss the resignations of the two top vaccine officials at the Food and Drug Administration and how little the media seem interested in the news.

Warp-Speed the FDA

 

The FDA has granted full approval of the Pfizer COVID vaccine, in record time, based on less than 6 months of data on 44,000 patients. They are said to have presented 360,000 pages of data to the FDA. That’s about 9 pages per trial patient, a rather de minimis amount of information collected over a very short period of time. What we “know” is that the incidence of serious side effects, which include myocarditis in pericarditis, appears to be very low, and most cases of these appear to be mild with full patient recovery over a few days. Or so the data from Pfizer suggests. Blood clot data seem to be better than with the J and J vaccine, though even that is of very low risk, we are told. Pfizer acknowledges that the actual incidence and course of these complications are not known precisely. The updated package insert continues to say that no guidance on use of the vaccine in pregnancy can be provided.  It is not approved in pregnancy. So if you want to go shopping for maternity clothes in NYC, yer on yer own. The thousands of deaths reported on the VAERS site attributed to the vaccine apparently played no role in the FDA’s review leading to full approval of the vaccine.

This is not your father’s FDA. Being a crotchety old-timer I remember the good old days when the FDA took half a century to finally approve Metformin for use in diabetes (thought by the FDA, erroneously,  to be a very highly dangerous and potentially lethal drug) even with 270,000 patient-years (many millions of pages) of data from Canada alone showing no deaths at all from the drug. (The drug is so safe it can be used in Pregnancy. Indeed, it turns out to be a drug that enhances fertility in patients with PCOS, and may reduce miscarriages in those patients). And then it took the three greatest diabetologists of the time (Ralph DeFronzo, Alan Garber, Gerald Reaven) 10 years to convince the FDA to approve it. Then it took a gutsy pharmaceutical company, Bristol Meyer Squibb, to market it. The first five years it was on the market the airwaves were saturated with ads:  Have you had a loved one die from taking metformin? Call our law firm! The ads ceased after about 5 years when the lawyers finally realized they were wasting their ad money. Today, you can regale yourself reading on the internet all the calamitous results of taking metformin.   The irony with metformin was that data from a small subset of patients in the UKPDS study of diabetes had suggested that metformin might reduce all-cause mortality in obese type 2 diabetes patients by almost 50%!  Thus, a fifty-year delay in approval, during a massive increase in the number of patients with type 2 diabetes, a leading cause of mortality,  may have cost many tens or hundreds of thousands of lives, or more. Meanwhile, metformin was being used worldwide from the 1940s. Just not in America, until 1995, courtesy of the FDA. This history seemed to confirm the viewpoint of those who feel that the purpose of the FDA is to keep life-saving medicines out of the hands of American patients.

Member Post

 

People who normally support large government bureaucracies like the Food and Drug Administration intended to ensure absolute safety (see for example Democrats, at least some officials at the federal Centers for Disease Control, and teachers’ unions) now agree with libertarians that review of drugs and vaccines by the FDA is unnecessary and should be stopped. […]

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Hubwonk host Joe Selvaggi talks with precision medicine expert Hannah Mamuszka and Pioneer Institute’s Bill Smith about the promises and pitfalls of the newly approved Alzheimer’s drug Aduhelm, and the challenges presented when new, expensive drugs of dubious benefit are introduced to the nation’s formulary.

Guest:

Join Jim and Greg as they update the “incident” at the Natanz nuclear site and enjoy learning how it was much more devastating than first reported. Then they feel very weird agreeing with former Senate Majority Leader Harry Reid but believe he right to warn the Democrats against court packing. They discuss the significance of the FDA and CDC calling for a pause in administering the Johnson & Johnson COVID vaccine. And they discuss the inexplicable error of a Minnesota police officer in a recent shooting death there but also hammer Michigan Rep. Rashida Tlaib for suggesting this case is further proof that we need to abolish police and incarceration.

Dr. Rachel Levine, Failing Up

 

One of my favorite phrases is “failing up.” That’s when someone who is perceived to be unsuccessful, even a failure, is promoted. People who’ve worked in the federal government know what I’m talking about.

Recently Dr. Anthony Fauci, the 80-year-old, 30+ year head of the National Institute for Infectious Diseases and Allergies – allegedly our nation’s top epidemiologist – has been used, perhaps unfairly, as an example of failing up.

But today, we have a new candidate. Dr. Rachel Levine, President-elect Joe Biden’s announced nominee for Assistant Secretary for Health at the Department of Health and Human Services. It is perhaps the number three position at HHS, responsible for several hugely important agencies, from the Food and Drug Administration to the Public Health Service. It is arguably one of the top scientific positions in all government and the nation’s top health official (although Dr. Fauci was asked to be President Biden’s “chief medical advisor“).

In 2011, Melayna Lokosky blew the whistle on what she perceived as fraud on the behalf of her employer, Acclarent, Inc., a medical device company owned by Johnson & Johnson. In July of 2016, the company’s former CEO and the former Vice President of Sales received a split decision in Federal Court in Massachusetts – acquittal on 14 felony counts but conviction on 10 misdemeanor counts of introducing adulterated and misbranded medical devices into interstate commerce. The following month, the Department of Justice reached an $18M settlement with Johnson & Johnson to settle outstanding civil claims.

Concurrent with her whistleblower work with the DOJ, Lokosky developed “The Sociopathic Business Model” to help the DOJ understand venture capital startup fraud and is the owner of MMpiHer (pronounced “Empire”) Strategic Consulting. Melayna joins Carol Roth to talk about how and why she became a whistleblower and how she helped get a dangerous $40 million/year medical device off the market. She shares her opinions on fraud being rampant in unicorn VC funding and other challenges faced in regulation for consumer safety.

Member Post

 

Potential role of the common food additive manufactured citric acid in eliciting significant inflammatory reactions contributing to serious disease states: A series of four case reports: Citric acid naturally exists in fruits and vegetables. However, it is not the naturally occurring citric acid, but the manufactured citric acid (MCA) that is used extensively as a […]

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James R. Copland joins Brian Anderson to discuss how America’s uniquely cumbersome regulatory system impeded the national response to the Covid-19 crisis and how costly litigation could damage the economy even further.

The FDA and CDC’s administrative failings in the early days of the crisis proved costly. The federal process for reviewing and approving drugs and medical devices, writes Copland, still leaves much to be desired. And a wave of coronavirus-related lawsuits poses a serious threat to future business viability.

How Much Does Dr. Fauci Really Care?

 

Dennis Prager spoke the hard truth Monday morning: Dr. Fauci is a lifelong government employee with a salary and benefits package perfectly insulated from the economic consequences of his words. He has absolutely no skin in the game. If Dr. Fauci truly believes it is necessary to put hourly workers, waiters, bartenders, and small businesses out of work, destroying them economically, then let him and the head of the CDC ante up.

Dr. Fauci’s easiest path is completely shutdown of our economy, doing maximum damage to people who were just starting to see real success and a brighter future. He can claim noble motives, even as he seeks to avoid blame for early failures. Words of concern and supposed sympathy tripping off a career bureaucrat’s lips ring hollow and are bitter to those he ruins.

So, President Trump needs to put this to the coronavirus crew immediately, giving them the chance to volunteer giving up their salaries until the federal guidelines no longer limit American jobs. Then, if they push back, he needs to drop it on them in front of the cameras. Let’s all see their real faces and real positions when they are made to live with the real consequences of their words.

Member Post

 

President Trump has continued to act within the boundaries of our Constitution and laws, including in his declaration of a national emergency for COVID-19. He has not used this crisis to seize power for himself, or to direct goodies to his party, supporters, or family. I will lay out some chunks of law and the […]

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Fly Me to the Moon is Made of American Cheese – For Now

 

“What Sort of All Hallows’ Eve Trollop Art Thou?” PIT Seventeen asks. I’m not sure. I’m fairly sure what sort of trollop I’m not — I’m not the sort to consider glitter and body paint an acceptably modest substitute for undies. At least not on me. Nonetheless, The Sun alleges the black, bespangled, and quite bare bat bum is this Halloween’s fashion trend (any “trend” involving bums, of course, being of great interest to The Sun).

I stumbled on this so-called trend while perusing The Sun‘s investigation into snake handling, the ritual wherein Christian oppressors manhandle (“personhandle” would be more gender-neutral, but “manhandle” properly names and shames the unjust kyriarchy) innocent serpents, possibly without the serpents’ consent, purportedly for God’s glory. These oppressors — typically poor Appalachian whites — are themselves oppressed, of course, themselves victims of the same kyriarchy which enables their cross-species molestation. As one of Ricochet’s resident reptilians (I only self-identify as human online), I ought to have been outraged by the speciesist presumption that conscripts nonhuman species into human worship without even asking permission. Instead, I got distracted by sparkly bums.

Jim Geraghty of National Review and Greg Corombos of Radio America serve up only good martinis today, although the last one comes with a twist.  They cheer Congress and President Trump for enacting “Right to Try” legislation, allowing terminally ill patients to undergo promising treatments not yet approved by the Food and Drug Administration.  They also get a lot of enjoyment out of the excerpt from an upcoming HBO documentary that shows Obama Deputy National Security Adviser Ben Rhodes truly speechless after Donald Trump was declared the winner on Election Night 2016.  And just two days after ABC fired Roseanne Barr for her horrible tweet about Valerie Jarrett, Samantha Bee puts the left on the spot after using a vile word to describe Ivanka Trump.

FDA Asks Diarrhea Treatment to Contain Itself

 

Over a year ago, I noted that both the DEA and NIDA had expressed concern over the diarrhea treatment loperamide, widely known by the brand name Imodium. Loperamide is an opioid that, with normal use, mostly stays in the gut where it belongs, but which, if it’s taken in massive doses or combined with a P-glycoprotein inhibitor, works its way into the bloodstream and crosses the blood-brain barrier for a pathetic sort of high. Or, if you believe methadone treatment works, the high becomes somewhat less pathetic: loperamide has gotten a reputation among addicts as the poor man’s methadone, a means of easing withdrawal for those done with the dope.

One reason methadone is supposed to work as an addiction treatment is that it’s metabolized so slowly. It has an extremely long half-life (15-55 hours) compared to heroin’s (2-3 minutes). This smooths out the highs and lows to help those treated establish a normal life. Since methadone treatment is dispensed at clinics, not by pushers, it redirects addicts’ dependency toward authorized channels, which regularizes their life in another way. Loperamide has a half-life between heroin’s and methadone’s (9-14 hours). That half-life makes loperamide tempting as “DIY methadone treatment”.

Big Government, Public Health, and E-Cigarettes, Part III

 

This is the last in a three-part series on e-cigarettes. Part I is available here. Part II is available here.

E-cigarettes or vapor products aren’t specifically mentioned in the Tobacco Control Act. The FDA had no expressed mandate to do anything. But that isn’t stopping them from trying. If the FDA actions are not significantly changed by the administration, the Congress, and potentially the courts, FDA regulations will certainly do more to harm public health than benefit it. The nexus used by the FDA to sweep vapor products into its regulatory regime was that nicotine in the products was “tobacco derived.” Most, or all of it, is, just like the nicotine used in gums and patches. Frankly it’s cheaper to acquire nicotine from tobacco than it is to acquire it from other plants (it’s in tomatoes, eggplant, and other nightshades) or to create it in a lab. But, as regulatory agencies often do, the FDA has indicated that they will broadly exercise authority to regulate devices (that contain no nicotine and are not tobacco-derived) or zero nicotine liquids.

Most significantly, the FDA deeming rule related to these products creates an effective ban on tens (if not hundreds) of thousands of existing products. The Tobacco Control Act and subsequent FDA regulations allowed all cigarette products sold before 2007 to remain on the market so long as they complied with existing rules. Rather than allow existing vapor products to remain on the market upon publication of the deeming rule, the FDA immediately banned any new products from entering the market and will require all existing products to complete a prohibitively expensive and largely arbitrary application process, with no clear guidance from the FDA and little or no likelihood of approval.