New FDA objectives......who could be against this?

[kmall]

For all of the "fake" science fear mongering from the defeated left, a revamping of FDA objectives focusing on healthier food sources by eliminating artificial dyes, certain fats and sugar - with a direct correlation to autism, diabetes and heart disease which affects millions of Americans.......how could you not support this much needed overhaul of a Govt Agency? -Kmall

https://www.reuters.com/business/health ... 025-03-11/

[bucbeard]

word to the wise KMall, you are losing me and likely others with your clearly divisive political language.

"For all of the "fake" science fear mongering from the defeated left"

BioPearl - this needs to stop immediately.

[kmall]

Buc - with all due respect, don't really think trying to remove harmful chemicals and additives to our food is political in nature. Hence the rub, when those lacking knowledge and seeking the status quo label others for pointing out what are potentially harmful ingredients to children and society it kind of reeks of hypocrisy......so you're saying you want your children and grandchildren to be ingesting harmful food dyes?

That makes sense. -Kmall

[biopearl123]

Hi guys we can definitely have this discussion without making it “political “. I submit for your consideration: trans fatty acids , remember them and carminic acid derived from red ants (eg red dye).

[biopearl123]

I will take it one step further (without getting political). I was once doing volunteer medical work in a third world country. At dinner I noted that the vegetables were perfect and tasted great. I asked my hosts how they accomplished this. The answer was, “that’s simple, we use DDT.” There certainly is plenty going on in our environment worthy of examination, something we can all get behind regardless of our political inclinations. Microplastics, air pollution, just being a couple of ubiquitous examples.

[KTArsenal]

Kmall states that “the left is defeated.”

Did Elon Musk use the nazi salute—not once, but TWICE when DJT won the election? Answer the question, right-wingers.

In Germany, nazism is illegal, along with the use of the swastika. Why isn’t it illegal in the United States to use?

DJT’s entire purpose is to destroy our economy and democracy. His rhetoric is purposeful. His loyalists are in on the joke.

Russia is not our ally and never has been.

You don’t call a plumber to pull a tooth, and you don’t put a FoxNews talking head in charge of the Pentagon.


Period. No debate necessary.

[bucbeard]

really? the fact that I have to explain this to the two of you is embarrassing for your sake.

i have no issue with the subject matter discussion.

this line to open up post was completely political and completely UNNECESSARY.

"For all of the "fake" science fear mongering from the defeated left"

ridiculous. absurd. yap yap yap about wanting to avoid political conversations, while then allowing this.

beyond disappointing.

[biopearl123]

Shut it down guys, please. There is no question that the FDA is being guided toward a change in focus. Left or right is immaterial to this discussion.

[bucbeard]

sharing a very relevant post of concern.

are we still ignoring the unnecessary threat and impact of HHS and FDA cuts THAT ARE HAPPENING?

The entire state of any and all biotech/pharma investments, very much including Geron, are deeply at risk.

reply/comment or meet this with crickets, i don't really care...but minimizing, politicizing or even worse, ignoring what is actually happening, will serve no industry investor well.

--------------------------------------------------

Bruce BoothBruce Booth
• 2nd2nd
Partner at Atlas VenturePartner at Atlas Venture
5h • 5 hours ago

FDA turmoil is creating huge uncertainty for biotech... so much institutional knowledge is being lost... and upheaval is never good for productivity.

One of the most challenging aspects of this uncertainty is it's not clear (at least to me) what the direction of travel will be for the regulation of new medicines... the "new" FDA could evolve into either a tougher FDA for new patented pharma/biotech drug approvals, or will it be an FDA with far lower standards for new "medicines"?

Several senior FDA leaders have obviously left, including some controversial ones. In a number of high profile recent drug approvals, these leaders lowered standards of approval - and decided to override more skeptical or conservative FDA reviewers and biostatisticians. Those may have been right decisions, or not. That's a debate for another time. But will the new FDA leadership be even more flexible about drug approvals, or more stringent? Will efficacy and safety data standards for Pharma/Biotech drugs go up or down? Will they override more or will they follow biostats/reviewer recommendations more in the future? Unclear to me.

One observation: over the past decade, the FDA has gotten tougher for new clinical program starts (INDs). The vast majority of our emerging biotechs start their clinical work outside the US (in Australia, EU, UK, China, etc). Will new leadership exacerbate this stringency (in their dislike of patented biopharma drugs), or will they open up the FDA to accepting more early clinical innovation?

The juxtaposition of being anti- "Big Pharma"/anti-science but also wanting less gov't intrusion into patient choices and pushing new medicines (including many flavors of snake oil) to the market... just creates more uncertainty as to how this evolves. Because less regulation should mean more Big Pharma drug approvals.

If FDA approval standards and stringency go down, we may see a flood of new "drugs" in 2-3 years. In this scenario, lots of unsafe or ineffective agents could come to market. In this case, I expect (hope) that insurance/payors step up and create new data-driven health technology assessments for their own approvals (like what happened with Aduhelm). This likely creates a much higher "second hurdle" for the industry.

If FDA approval standards for pharmaceuticals go up (or the new FDA leadership listens more to risk-averse biostats/reviewers than in the past), then patients will see fewer new medicines in the US and other geographies may capture the leadership on innovation.

Lots of questions about where we're heading...

One thing, though, is sure: regulatory uncertainty isn't going away any time soon. And investors (and companies) generally hate uncertainty.

[KTArsenal]

Human beings dislike uncertainty, so no surprise there. We all push back against change; for the good or bad.

It’s a good thing that Geron has MDS under its belt already for the US and Europe. It’s a bad thing that real science is taking a backseat to homeopathic medicine and fringe beliefs that fluoride causes autism and prenatal issues that are frowned upon in the world of real pediatric science. Don’t forget that they’re also discussing how the polio vaccine is potentially quack science.

Utah is banning (or has banned) fluoride in their water system as we speak, due to our new head of the FDA’s feelings on fluoride and autism WITHOUT sufficient data to back it up.

As always,

cheers

[huntingonthebluffs]

bucbeard whatever is happening at HHS, I doubt the sky is falling. In any case, RFK Jr has had less than two months in the job, a little early to use the guillotine. I doubt but if he is as radical as the media says he is, we should have some facts eventually to make the judgement and grade the results. And while Bruce Booth has legitimately highlighted areas of concern, he didn't and has no facts to conclude.

In all the years I've spent in corporate America and the many downsizings I lived through, I don't remember any significant and certainly no core critical muscle being cut, only fat. I think we all know the government bureaucracy has a lot of fat. I think you could agree that efficiency and effectiveness doesn't occur because of the fat. IMO downsizing and streamlining can re-energize most organizations, why shouldn't it work with the HHS bureaucracy?

Yes, the new HHS leadership and strategy will likely result in functions and related processes / regulations being changed, added or eliminated which will change results. However, again it's much too early to evaluate or pass judgement.

I'll say again, in the case of the FDA, we know it was unwilling to use the newer tools at hand to expedite and support Geron's CTs when all the evidence and KOL opinions screamed otherwise. The FDA review of Imetelstat was shameful as well, so IMO there is room for improvement and maybe major changes which could be majority positive. I personally am optimistic, of course time will tell.

[biopearl123]

Good posts, thanks guys. There is no question that the focus of the FDA and NIH are likely to change to some degree. There will certainly be efforts to restore public trust after the COVID shutdown. Like it or not, some areas like fluoridation of drinking water, COVID vaccine recommendations etc will be reexamined. There will likely be shifts to study autism causes, cancer, food additives, type II diabetes in greater detail, especially with an epidemiologist at the helm at NIH (Dr. Bhattacharya). You will recall that he took some slings and arrows during the COVID era, but was vindicated in large measure in retrospect. In some ways Geron is lucky in that they are leaders in holding IP and experience in a large area of chromosomal real estate, namely the telomere. Geron also does not rely on government grants for research purposes. I think the NIH in their reexamination of large public health problems may shine a spotlight on the telomere and its role in cancer, (and longevity). I think the focus will shift to prolonging OS and QOL not just on symptom control. As everyone here knows, disease modification has been elusive in heme cancers and Geron seems to be one of the few treatments directed toward killing the cancer stem cell itself. I don't think the sky is falling and I do think reexamining some of the established public health thinking with reproducible studies may prove valuable.