Maybe SOME Good News from the FDA

[Aragorn]

@anonym

Coming up with new molecules is (surprisingly) pretty straightforward in and of itself, particularly nowadays with advances in combinatorial chemistry, high throughput screening, computer-aided drug design processes, and an increasingly robust understanding of the human body…

Coming up with drugs that are able to run the gauntlet to become one of those cheerfully dismal commercials you see on TV is much more difficult

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

[ActivitiesGuy]

@anonym

Out of curiosity, do you know what the purpose of Phase II and Phase III trials are?

If you do, could you please explain your reasoning for supporting the marketing of pharmaceutical products backed by no efficacy data in humans, and with safety data limited to however well a handful (e.g., up to 100) of (typically) healthy individuals tolerated various dosages?

Do you know how many trials are dropped during either Phase II (hint: ~70%) or III (hint: ~50%) due to safety / efficacy concerns?

Look, I can appreciate the cost of drug development – I work in the industry – but proposing to gut the process in such a manner is stunningly irresponsible. It’s a knee jerk attempt to answer a question that doesn’t yet need to be asked.

Tell y’all what: before we talk about how to make the drug development process more affordable, why don’t we first talk about why it costs so damn much in the first place? It’s not just because of Big Brother’s red tape and Big Pharma’s greed.

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.

[ActivitiesGuy]

@anonym

Look, I can appreciate the cost of drug development – I work in the industry – but proposing to gut the process in such a manner is stunningly irresponsible. It’s a knee jerk attempt to answer a question that doesn’t yet need to be asked.

@EyeDentist

As a physician, I can say with confidence that this is a terrible idea–an example of Peter Thiel’s extremist political views run amok. One can’t make ethical treatment recommendations/decisions without efficacy/effectiveness data concerning the treatments under consideration, and it would be virtually impossible to get such data outside of the constrained conditions employed in Phase II and III trials.

Correct.

[Zeppelin795]

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.

[Zeppelin795]

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.

[SkyzykS]

So your own bias is obviously the best one.

[Zeppelin795]

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.

[Zeppelin795]

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

[anonym]

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.

[Zeppelin795]

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).

[countingbeans]

@Zeppelin795

Controlling information to he benefit of the corporations and detriment of the public s propaganda.

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

You’re a literal moron.

[anonym]

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

[Zeppelin795]

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

[Zeppelin795]

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

[Legalsteel]

@Zeppelin795

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.

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

[countingbeans]

@Zeppelin795

You don’t know the difference between public and corporate donors? And I’m the moron.

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.

[anonym]

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?

[Zeppelin795]

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

[Zeppelin795]

It belongs with you on the island of misfit toys.

[Zeppelin795]

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.