T Nation

Maybe SOME Good News from the FDA


#21

Actually, you said it much better than I did.

Gauntlet indeed. I believe you are correct–about 1 in 5,000 or 10,000. Varies by company of course because of differences but yep


#22

Just FYI, I also work in this field (biostatistician in cardiovascular outcomes research) and I have, in detail, explained the entire process from Phase 0 through Phase 4 on a different Zeppelin-led thread. It had no effect.


#23

Correct.


#24

It makes all the difference and the fact that you can’t see that is the problem. Controlling information to he benefit of the corporations and detriment of the public s propaganda.


#25

The Real News is funded by viewers not corporations so the bias is towards the public interest not the corporate interest which is almost the opposite of what the public needs or wants.


#26

So your own bias is obviously the best one.


#27

Is regenerative treatment a drug? In Japan there is only a Phase 1 for these treatments. The U.S. continues to drag it’s feet on this therapy. Meanwhile people have to travel outside the country to get this treatment instead of suffer. Since Big Pharma hasn’t figured out a way to patent this therapy, they will have their paid lackeys in the FDA drag it’s knuckles on the approval process. And try to have the public purchase their garbage and much less effective drugs. Meanwhile it is approved in various countries already and having great success.

And this proposal is one of Trump’s appointees for the FDA.


#28

None of what you said explained why stem-cell therapy is being done successfully im other countries.


#29

Hi Zep,

Thanks for your question. To be totally honest, I don’t know. My work is predominantly in oncology and neurology, so I’m not sure what, specifically, is meant by “regenerative treatment.” You can review Big Brother’s definition of ‘drug’ in 21USC321(g). As I’m sure you’re aware, not all drugs are created equal, and some are subject to additional standards (e.g., biologic products under 42USC262).

In any event, I don’t recall the article indicating that progressive approval would apply solely to efforts within the field of regenerative medicine, and if I’m being honest, I’m not interested in limiting discussion to that specific topic.

edit: typo correction CFR->USC for drug definition.


#30

The proposal being considered is a blanket proposal, I believe. So this has some potential good and bad consequences. The issue of Phase 1 only applies to Japan’s process involving regenerative therapies(I.e.stem cell treatment).


#31

Controlling information to the benefit of the donors and detriment of the public is propaganda.

You’re a literal moron.


#32

Do you support this proposal across the board, or just for regenerative treatments?


#33

You don’t know the difference between public and corporate donors? And I’m the moron. You’re just a brainwashed fool.


#34

At the moment, just for regenerative medicine. The revolving door between the FDA and Big Pharma must be closed.


#35

It was initially funded by a grant funded by corporate wealth. This is an inescapable fact.


#36

One wants news slanted towards their bias and benefit, and is willing to pay for it.

The other wants news slanted towards their bias and benefit, and is willing to pay for it.


#37

What hinges on the revolving door between the FDA and Big Pharma are most troublesome for the field of regenerative medicine?

And what are your thoughts on allowing companies to market drugs without having done any research on their safety / efficacy?


#38

Corporate news sources continue to consolidate their opinion in an effort to stave off dissent.

Public news sources are far and few. Whatever happened to the notion that the press was there to hold people accountable? It doesn’t exist any longer. So news sources like The Real News had to pick up the baton as public opinion wasn’t being heard. But in your dessiccated ideology there is no difference


#39

It belongs with you on the island of misfit toys.


#40

The revolving door favors profits over health by design. It ought to be illegal to work for both Big Pharma and the FDA. Will this law stop all corruption? No. But why make it easier for them?

No company should be allowed to market drugs without having done solid verifiable studies on their safety, but they do anyway. How many people have died using “approved drugs”? What evidence has been buried that these drugs were harmful so that Big Pharma can make more money? Phase 2 and 3 are very expensive and it is a tool used by Big Pharma to weed out any competition. We have a disgusting healthcare system in this country. It is not about health it is about profit. Further pharmaceutical companies seek to suppress symptoms rather than get to the root cause. Absolutely disgusting.