The FDA dropped the ball on Alzheimer's drug approval

[BacktoCricaddict]

The US FDA recently approved a new drug for treating Alzheimer's disease.  Based on the mediocre success in clinical trials, I am calling it a "meh-dicine" that just does not merit FDA approval.  

 

https://blogs.sciencemag.org/pipeline/archives/2021/06/24/open-the-floodgates

 

So if you look at the disease landscape not knowing the back story, things look great: the FDA just approved a new Alzheimer’s drug and now there are two more Breakthroughs right behind it! But if you do know what’s going on, it’s downright depressing: the agency approved a drug that shows no solid evidence of helping anyone (and more believable evidence of its ability to cause harm), and this mistake is allowing everyone else to jump on the same damn bandwagon with data that are no better. Put out more flags.

 

 

[Jimmy Cliff]

 

 

Well done FDA . 

[Straight Drive]

Big Pharma usually gets what they want.

[BacktoCricaddict]

On 6/26/2021 at 2:07 AM, Straight Drive said:

Big Pharma usually gets what they want.

But the mediocre data are out there for everyone to see.  The medical and scientific community is decrying this approval based on the data that the company had to submit.  This is the opposite of what is happening with vaccines.  The are robust data in support of the vaccines.  Almost the entire scientific and medical community is in support of them.  But still people scream "Big Pharma."  

 

My point of posting this news is this:  People, please dump the broad brushes.  Examine everything case-by-case with available data.  In every case, before thinking of something sinister ask "where are the data?  What do they say?"

Edited July 1, 2021 by BacktoCricaddict

[Texy]

This should never have been approved in the 1st place,they are basically no more effective than placebos and have not passed phase III clinical trials. This approval benefits pharma, not patients. My professional opinion

Edited July 3, 2021 by Texy

[nevada]

7 hours ago, Texy said:

This should never have been approved in the 1st place,they are basically no more effective than placebos and have not passed phase III clinical trials. This approval benefits pharma, not patients. My professional opinion

Isn't there a phase 4 after phase 3? How can they approve when phase 3 itself hasnt been cleared? 

 

 

 

[BacktoCricaddict]

4 hours ago, nevada said:

Isn't there a phase 4 after phase 3? How can they approve when phase 3 itself hasnt been cleared? 

 

 

 

Phase 4 is post-market analysis.

 

Two separate Phase 3 studies were completed.  The results were unimpressive.

https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12213

 

Yet it was approved when Biogen submitted revised analysis.  I am still trying to wrap my mind around what the revision was.  

 

Most drugs don't make it through the regulatory process:

 

 

 

On the other hand, alternative "medicine," including herbal preparations and supplements (market size expected to exceed $400 billion in 2028) do not need FDA approval - they can say whatever the eff they want, hide all their side-effects, and just sell their stuff over the counter with no regulation.  I suspect that a lot of the anti-vaccination and anti-pharmaceutical blather on the internet emanates from people benefitting from this industry.  

 

https://www.statnews.com/2016/12/29/alternative-medicine/comment-page-2/

 

Edited July 3, 2021 by BacktoCricaddict

[BacktoCricaddict]

https://www.usatoday.com/story/news/nation/2013/06/18/book-raises-alarms-about-alternative-medicine/2429385/

 

Many consumers view alternative medicine industry as more altruistic and home-spun than Big Pharma. But in his book, Offit paints a picture of an aggressive, $34 billion a year industry whose key players are adept at using lawsuits, lobbyists and legislation to protect their market.

"It's a big business," says Offit, best known for developing a vaccine against rotavirus, a diarrheal illness that killed 2,000 people each day, mostly children in the developing world.  

 

"This is not just Mom and Pop selling herbs at the farmer's market," says Josephine Briggs, a physician and director of the National Center on Complementary and Alternative Medicine, part of the National Institutes of Health, who shares Offit's concerns.  In the best cases, Offit says, alternative remedies are ineffective but relatively harmless, functioning as expensive placebos that may appear to relieve symptoms such as pain, largely because people expect them to. An example of this is homeopathy, in which key ingredients are diluted to the point of oblivion, making these remedies basically sugar pills, Offit says.

Yet supplements aren't risk-free.  A 2010 report from the Government Accountability Office found supplements were being sold with deceptive marketing practices.

Tests have found heavy metals in ayurvedic medicines, used in India for thousands of years to treat a variety of conditions and also popular in the USA, Briggs says.

 

In some cases, dietary supplements are just prescription medications in disguise.  The most common offenders tend to be supplements claiming to aid weight loss, build muscles or boost sexual performance, Briggs says. Although such supplements may be marketed as "natural," the FDA has found hundreds of brands actually contain real drugs, from anabolic steroids to the active ingredient in Viagra. Several weight-loss supplements were found to contain the active ingredient in Meridia, a prescription diet drug pulled from the market due to an increased risk of heart attack and stroke.

 

 

 

 

 

[nevada]

44 minutes ago, BacktoCricaddict said:

https://www.usatoday.com/story/news/nation/2013/06/18/book-raises-alarms-about-alternative-medicine/2429385/

 

Many consumers view alternative medicine industry as more altruistic and home-spun than Big Pharma. But in his book, Offit paints a picture of an aggressive, $34 billion a year industry whose key players are adept at using lawsuits, lobbyists and legislation to protect their market.

"It's a big business," says Offit, best known for developing a vaccine against rotavirus, a diarrheal illness that killed 2,000 people each day, mostly children in the developing world.  

 

"This is not just Mom and Pop selling herbs at the farmer's market," says Josephine Briggs, a physician and director of the National Center on Complementary and Alternative Medicine, part of the National Institutes of Health, who shares Offit's concerns.  In the best cases, Offit says, alternative remedies are ineffective but relatively harmless, functioning as expensive placebos that may appear to relieve symptoms such as pain, largely because people expect them to. An example of this is homeopathy, in which key ingredients are diluted to the point of oblivion, making these remedies basically sugar pills, Offit says.

Yet supplements aren't risk-free.  A 2010 report from the Government Accountability Office found supplements were being sold with deceptive marketing practices.

Tests have found heavy metals in ayurvedic medicines, used in India for thousands of years to treat a variety of conditions and also popular in the USA, Briggs says.

 

In some cases, dietary supplements are just prescription medications in disguise.  The most common offenders tend to be supplements claiming to aid weight loss, build muscles or boost sexual performance, Briggs says. Although such supplements may be marketed as "natural," the FDA has found hundreds of brands actually contain real drugs, from anabolic steroids to the active ingredient in Viagra. Several weight-loss supplements were found to contain the active ingredient in Meridia, a prescription diet drug pulled from the market due to an increased risk of heart attack and stroke.

 

 

 

 

 

Eating healthy and exercising is key. The so called herbal medicine seems dodgy at best. 

[BacktoCricaddict]

1 minute ago, nevada said:

Eating healthy and exercising is key. The so called herbal medicine seems dodgy at best. 

Very true; it can minimize issues.  But often, you cannot avoid the effects of genetics or are forced to eat unhealthy due to busy lifestyles (e.g., traveling job) and must take medications.  I would much rather take something that is regulated than not.  

[BacktoCricaddict]

 

https://www.science.org/content/blog-post/aduhelm-so-far

 

Start on numbered page 247 of the review document: is that misinformation? That's the part that Biogen would really rather we all forget: a group of independent, highly experienced reviewers, experts on the interpretation of clinical trials saying that the company had not proved its case and that their application should be rejected until they have better data. Just because the higher-ups at the agency rammed through an approval in the face of this advice (and that of the advisory committee, who came to the exact same conclusion) doesn't make these arguments disappear. So if Biogen wants to call those recommendations "misinformation", that, friends, is what we call a lie. What else exactly are they referring to?

 

 

-‐------------------

 

More evidence that the FDA effed up on this. Just imagine, the same scientists who are solidly behind the FDAs approval of the Covid vaccines are strongly criticizing them for approving this in favor of big pharma.  But in the case of the vaccines, it is evident that they work. 

 

Objectivity is easy - just considef events on a case by case  basis. Take off the conspiracy lenses and see that, sometimes, the FDA plays into big pharma's hands, sometimes they dontt. Not everything is sinister.  Dont approach everything with "they are out to get us" attitude. 

Edited September 29, 2021 by BacktoCricaddict