Tag: FDA

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.

In this AEI Events Podcast, a group of experts convene to discuss the Food and Drug Administration’s (FDA) excessive regulation of e-cigarettes and what might be done to further encourage their use as an alternative to smoking. AEI’s Sally Satel begins by surveying the epidemiology of smoking and the potential of e-cigarettes to function as a cessation tool. In the following conversation, panelists discuss the history of e-cigarette regulation, potential legislative fixes to current regulations, and the role of pending litigation in scaling back the FDA’s regulations.

Panelists include Azim Chowdhury (Keller and Heckman LLP), Greg Conley (American Vaping Association), Sally Satel (AEI), Saul Shiffman (University of Pittsburgh), and Alan D. Viard (AEI). The discussion is moderated by Stan Veuger (AEI).

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

 

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

Vapor products contain no tobacco. They produce no smoke. Most contain nicotine and it’s the same nicotine used in FDA-approved gums and patches. While the devices look different, they all operate by heating a liquid solution (propylene glycol and/or vegetable glycerin, nicotine and flavor) to produce an aerosol. Importantly, the products allow users to replicate the act of smoking. Like smokers, vapers engage hands and mouths in a ritual similar to the one they practiced every day for many years as a smoker. Like a smoker, the vaper inhales and exhales and can both feel and see the vapor produced. But unlike cigarette smoke, the aerosol dissipates quickly. There’s no smoke, no tar, and no carbon monoxide – the things that cause half of all smokers to get sick and some to die. Nicotine doesn’t cause lung cancer or make smokers sick. As far as its heath impact, it’s comparable to caffeine. As long as you don’t consume caffeine or nicotine through smoking, most people can use it without incident for an entire adult lifetime. Nicotine also seems to bring health benefits for some.

There is little doubt that part of the consternation of tobacco control groups and regulators simply arose from the fact that products are called e-cigarettes and using them resembles smoking. That reaction is emotional, not rational. Perhaps we can appreciate that it motivates tobacco controllers to investigate further. Rather than investigate and try to understand, however, the FDA initially stepped in and attempted to shut the industry down by banning the importation of e-cigarettes as unapproved medical devices. And electronic cigarette company, NJOY (previously Sottera), was targeted by the FDA and had imported products seized at the US border. NJOY fought the federal government, ultimately winning in court.

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

 

Since the US Surgeon General’s report on smoking and health in 1964, governments (local, state, federal) and tobacco control groups have waged a comprehensive campaign to encourage smokers to quit and discourage non-smokers from starting. They have used every tool available with cost being of little concern.

They’ve educated about the harms associated with smoking. When that didn’t do the trick, they attempted to shock and scare smokers away from the habit with graphic images. They’re in a half-century cycle to fight for increased taxes. They’ve banned smoking anywhere people congregate. They’ve filed individual lawsuits, class action lawsuits, and lawsuits from state attorneys general (resulting in the tobacco master settlement agreement that forced tobacco companies to pay billions to the states, all costs passed on to consumers via increased prices).

They’ve restricted the ability of companies to sell and market products, restricted use of brand-name advertising and eventually they decided scaring children might discourage them from becoming smokers. They also thought sending terrified kids home to shame their smoking parents could only benefit their cause.

Member Post

 

This is just a short fun story from a while back that I found in my drafts, and quickly finished. I was sitting in the dining hall with a good friend and two others, and I brought up the failings of the FDA. (It was relevant enough.) Two of my tablemates launched into, “Well, they’re […]

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