Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, July 10, 2024

Prevagen: The Poster Child For Media Failure On Quackery

"New York Attorney General Letitia James today announced that a federal judge in Manhattan accepted a jury’s finding that Quincy Bioscience Holding Company, Inc., Quincy Bioscience, LLC, Prevagen, Inc., Quincy Bioscience Manufacturing, LLC (Quincy), and four corporate defendants made fraudulent and deceptive statements about the supplement Prevagen and are liable for violating New York’s consumer protection laws. Quincy advertised its supplement, Prevagen, in media markets across New York, including in Albany, Syracuse, New York City, and the Southern Tier, as a way to reduce memory problems, improve memory, and support cognitive health. After a two-week trial, the jury concluded that Quincy had not substantiated any of its claims about Prevagen with reliable scientific evidence." (link)

Why are supplements legally advertised? There must be more than the FDA's warning, you can hardly read it because it's so small.

Wednesday, February 7, 2024

Hidden Dangers Of Vitamins And Supplements

"In 2016, FRONTLINE, The New York Times, and the Canadian Broadcasting Corporation examined the hidden dangers of vitamins and supplements, a multibillion-dollar industry with limited FDA oversight. 

"When 'Supplements and Safety' aired, it was estimated that half of all Americans took a health supplement daily, from fish oil to multivitamins to diet pills. However, the acting commissioner of the Food and Drug Administration at the time noted in 'Supplements and Safety' that, 'The FDA does not review dietary supplements before they come onto the market, and I think that all consumers need to understand this.”

Click on the link below for the classic 53-minute video that is as relevant today as it was 8 years ago. The only changes that I can see are that some recent studies do support a daily multivitamin if there is a question of quality of diet (link) and the Omega 3 in fish oil has been found to lower blood pressure and perhaps has a positive effect on heart health (link).

Supplements and Safety (full documentary)

Wednesday, August 9, 2023

The Truth About Supplements

"Though many supplements are certainly beneficial to your health, evidence varies widely, and it’s important to know which can benefit your health and which may be harmful."

Click on the links below for the details:

5 Things You Need to Know About Dietary Supplements

What's really in that sports supplement?

Bottom line: do NOT take supplements without your primary care provider's supervision and after appropriate blood tests for vitamin and mineral deficiencies:

Vitamin Deficiencies And Nutrition Levels From Blood Testing

Oh, if the product is marketed as a "supplement", you can count on it NOT being tested medicine. Please look for the FDA disclaimer, such as:


On the positive side, Omega 3 Fatty Acids promote health and most people do not get enough.

Sunday, August 28, 2022

The Latest On GMOs From The FDA

"August 4, 2022

Today, the U.S. Food and Drug Administration (FDA) released new “Feed Your Mind” educational materials to provide science-based information on genetically modified organisms (GMOs) to consumers, health educators, dietitians, and other health care professionals. “Feed Your Mind” is an education initiative launched in 2020 to help increase consumer understanding of GMOs and was developed in partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency."

Click on the link below for the details:

FDA Releases New "Feed Your Mind" Educational Materials On GMOs

Saturday, January 30, 2021

Medicine For The Brain

If you are exposed to any media, you are deluged with alternatives to medicine pseudoscience, including brain health supplements such as Prevagen. Regarding the brain, the best things you can do for its health are simple and inexpensive. Neurosurgeon Sanjay Gupta, MD, has some advice in a new book, "Keep Sharp." The book is supported by the fact that we now know that the brain is able to grow new cells throughout life. The big revelation to me was the following:
  • "I think that crossword puzzles and brain training exercises can be quite helpful at making the roads in your brain that you use a lot already, keeping them strong. ... It's kind of the "practice makes perfect" part of your brain. And some of the brain games can actually increase your processing speed, the speed at which you process new content and new information. But I really do draw a line between that and keeping a brain sharper and building cognitive reserve throughout your life. That's different. You want to be doing different things in order to build that reserve, as opposed to doing the same thing better and better. There's a role for both, but if it's cognitive reserve you're looking for, doing different things — things that *get you outside your comfort zone* — it's probably going to have a much bigger payoff."
Click here for an NPR interview with Dr. Gupta.
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*to include learning why others have different opinions than you?*
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UPDATE: 2/24/2021

Below are more links on this topic:






Tuesday, March 24, 2020

Understand WHY Complete Drug Testing Is Mandatory!

"At a Thursday news briefing, Trump trumpeted that chloroquine had shown 'very, very encouraging early results' and said 'we’re going to be able to make that drug available almost immediately.' Minutes later, FDA Commissioner Stephen Hahn, an oncologist, clarified that the drug would be available 'in the setting of a clinical trial — a large, pragmatic clinical trial — to actually gather that information and answer the question that needs to be answered and — asked and answered.'

"Friday, the President said, 'It may work, it may not work. I feel good about it. That’s all it is. Just a feeling.' At the same press conference, Anthony Fauci, a physician who heads the NIAID and a veteran of outbreaks going back to HIV, emphasized the need for a methodical clinical trial."

Thanks to Trump, and quacks like Dr. Oz (link to his latest action) and many other magical thinkers, people are dying from hydroxychloroquine, a valid antimalaria drug, in efforts to avoid the coronavirus effects. Below are the steps ALL drugs MUST go through before approval for a particular disease:
  • Phase 1 studies (typically involve 20 to 80 people). Phase 2 studies (typically involve a few dozen to about 300 people). Phase 3 studies (typically involve several hundred to about 3,000 people).
"The study referenced by Trump, and other studies done so far of potential treatments for Covid-19, are small and hastily designed even by the standards of Phase 1 studies. So how often do infectious-disease drugs that enter Phase 2 studies reach the market? An analysis by the Biotechnology Industry Organization says they worked out only 27.5% of the time between 2009 and 2015. That means that three-quarters of the time, medicines against infectious disease that looked promising in small studies either were ineffective or had side effects that made them unusable. Even for medicines that reached Phase 3 trials, just 63% succeeded."
Why President Trump is at odds with his medical experts over using malaria drugs against Covid-19


Sunday, February 23, 2020

Dietary Supplements: Let The Buyer Beware

"Most people think that dietary supplements and herbs are closely regulated to ensure that they are safe, effective, and truthfully advertised. Nothing could be further from the truth. Although some aspects of marketing are regulated, the United States Congress has concluded that “informed” consumers need little government protection. This conclusion was embodied in the Dietary Supplement Health and Education Act of 1994—commonly referred to as “DSHEA”—which severely limits the FDA’s ability to regulate these products."

Click on link below:

Don't Depend on the FDA to help you

Monday, November 25, 2019

Monday, May 21, 2018

Dietary Supplements Are Not Medicine

Contrary to the ubiquitous advertising of these products, dietary supplements are NOT medicine. They have not gone through the rigorous testing for safety and effectiveness that drugs and medical products have to go through. Look carefully at the label on all dietary supplements in pharmacies and on media advertisements. If you see the following required label, it is not a medical product:














Generally, if one is healthy, one does not need dietary supplementation.  However, if you do have a medical problem that may benefit from them, your physician may recommend that you take them. Click here for a list of dietary supplements.

Tuesday, April 26, 2016

The FDA Gets It Correct

"In a confrontation between the hopes of desperate patients and clinical trial data, advisers to the Food and Drug Administration voted on Monday not to recommend approval of what would become the first drug for Duchenne muscular dystrophy.

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Choose how you look at reality wisely. Yes, it is a binary choice.
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SCIENCE JUSTIFIES ITSELF

SCIENCE JUSTIFIES ITSELF
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