Tag: FDA

Two Must-Reads: Politics at Health Agencies and the Emerging Democratic Train Wreck

 

Remember when the Democratic partisans and the media (but I repeat myself) complained that President Trump and his Administration were politicizing important health agencies, like the Centers for Disease Control (CDC), National Institutes of Health (NIH), and Food and Drug Administration (FDA). Good times!

“’I’ve been following health regulatory decisions for decades and have never seen this amount of White House arm twisting to force agencies like FDA and CDC to make decisions based on political pressure, rather than the best science,’” said Jerome Avorn, a professor of medicine at Harvard Medical School, who decried the ‘routine policy distortions we now see nearly every week,’” exclaimed in an August 2020 op-ed in the Washington Post (also appearing in other newspapers) during the Covid pandemic.

Then there’s Dr. Richard Besser, a former CDC director who now is CEO of the Robert Wood Johnson Foundation in New Jersey. Here’s what he told the taxpayer-funded Public Broadcasting System (PBS) “News Hour” two years ago (July 14, 2020):

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Part I can be found here. Books and movies have forever influenced culture. But some have had an outsized influence on public policy and laws. Rachel Carson’s 1962 “Silent Spring” influenced the John F. Kennedy Administration and future regulators to curb or eventually ban the use of chemical insecticides like DDT. The movie “One Flew […]

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Which federal agency is most intimately involved in your life (that you’re not working for)? The answer may surprise you. If you’re reading this from a federal prison or court bench or sitting across from an IRS auditor (I’m sorry), you’d understandably answer otherwise. It’s the Food and Drug Administration (FDA). Everybody eats – including […]

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Join Jim and Greg as they cheer the Supreme Court decision confirming that gun owners do not need to “show cause” to get a concealed carry permit. They also criticize four Senate Democrats for demanding Google not include any information on pregnancy resource centers when people search for abortion services. And they wonder why the Biden administration is banning Juul vaping products.

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The infant formula crisis is just the latest example of another crisis exacerbated by a Biden-directed federal agency. The FDA appears to have other priorities. It was a bright sunny winter day in Washington, DC, on January 20, 1981, when Ronald Reagan, having just been sworn in as the nation’s 40th president, uttered these oft-quoted […]

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Jim & Greg marvel at how dumb Democrats are to turn the heat up on Sen. Manchin. They also slam the FDA and the Biden administration for COVID tests being very hard to get. And their jaws drop at a new new poll showing Latinos overwhelmingly disapproving the job Biden is doing as president.

 

Fraudci-lent ‘Science’

 

justice and COVID-19The Hill story promoting Fraudci’s latest line caught my eye. Consider the following, and the related story on the FDA advisory panel’s entirely unscientific conduct. Scientific study, we don’t need no stinkin’ studies! This is Fraudci-lent “science.”

ABC’s Martha Raddatz asked Fauci on “This Week” if the millions of Americans who received the Johnson & Johnson (J&J) COVID-19 vaccine should be concerned after a Food and Drug Administration (FDA) advisory committee voted unanimously to recommend adults receive a booster shot of the vaccine.

“No, not at all, Martha. I think that they should feel good about it because what the advisers to the FDA felt is that, given the data that they saw, very likely this should have been a two-dose vaccine to begin with,” Fauci said.

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The Great Uniter/Dear Leader has spoken and his patience is all used up.  The shot is safe, effective and free!  What is anybody waiting for?  There are no more excuses.  If you remain unvaxxed at this point, you are lower than pond scum.  (Except illegals!)  You are a potential murderer.  (Except illegals!)  All your societal […]

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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.

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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.

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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.