Xtandi pricing change attempts

[ragnar2020]

This SubStack posting concerns the backstory about a term known as “March in..” involving pharma pricing for Medicare and Medicaid and specifically for Xtandi.

hartmannreport.com/p/the-ou...

[cujoe]

As a tidbit of good news on the published research end, the government is finally going to require open access to all published research that gets public funding . . . starting in 2026! Hopefully, we will all still be alive to use it.

nature.com/articles/d41586-...

[NPfisherman]

Thanks for posting,

I have a Ragnar for President T shirt... Indeed, Big Pharma has been making out like bandits for years... They delay partnering with small biotechs to squeeze them in negotiations on drugs ready for Phase III ... There are a number of drugs ready for Phase III, but with no partner for the 50 million dollar Phase III, then the drugs sit.... and people die... Osteodex is one drug that has sat there for over a year... good against bony metastasis.. what can I say??

SOSDD,

Fish

[CAMPSOUPS in reply to NPfisherman]

I kind of drool over Osteodex. You brought it up before. Its like Zometa +, or Zometa on steroids. I think I would jump on a trial if it were available.

[NPfisherman in reply to CAMPSOUPS]

Me too... the idea of controlling bone mets with an infusion, and without ADT or ARPI drugs... no more hot flashes, memory issues, emotional lability... put me in coach, I'm ready to play...

[mypk in reply to NPfisherman]

"There are a number of drugs ready for Phase III, but with no partner for the 50 million dollar Phase III, then the drugs sit.... and people die... Osteodex is one drug that has sat there for over a year... "

According to clinicaltrials.gov the phase IIb trial was terminated [Poor patient recruitment].

It looks like they were only able to enroll 3 men in 15 months, even though they wanted to enroll a ttotal of 66.

[NPfisherman in reply to mypk]

Ummm, you mean these results...

news.cision.com/dextech/r/p...

reuters.com/article/brief-d...

from this artcle--guess you missed the 2nd Phase IIb.. :

ncbi.nlm.nih.gov/pmc/articl...

DexTech initiated a phase IIb randomized, double-blind, placebo-controlled multicenter study evaluating efficacy and tolerability of Osteodex in patients with metastatic castration-resistant prostate cancer (CRPC) in 2015, but it was terminated in 2016 because of poor patient recruitment. They initiated a second phase II randomized, double-blind, dose-finding, repeat dose Phase II multicenter study ODX in 2016 of 55 patients with castration-resistant prostate cancer with skeletal metastases (ClinicalTrials.gov NCT02825628). The primary objective was to evaluate relative changes from baseline in serum alkaline phosphatase and P1NP at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX). Secondary objectives are progression-free and overall survival. The company has reported encouraging results without serious side effects on their website, and suggested that ODX treatment slowed down the course of the skeletal disease in the majority of patients who completed the 5 months of treatment (news.cision.com/dextech/r/p..., but results from the last recruited patients will not be reported until June 2020.

Already reported....and it sits...

[mypk in reply to NPfisherman]

Oh yes, you are right. I missed their second attempt. I didn't notice it yesterday on clinicaltrials.gov: clinicaltrials.gov/ct2/show...

Unfortunately, most people responsible for a study do not publish results on clinicaltrials.gov.

[NPfisherman in reply to mypk]

Do you believe that posters on a cancer forum are posting information that is accurate to help others?? If so, then do we not have an obligation to research an issue thoroughly, before putting out information to indicate that they are misleading others??

I encountered two poster profiles on a forum

that seemed to lack proper decorum...

they tried to throw shade

but I was able to evade

and left them with a conundrum...

My, my...

by, by...

Fish the poet..

[cesanon in reply to NPfisherman]

"If so, then do we not have an obligation to research an issue thoroughly, before putting out information to indicate that they are misleading others??"

(A) No, not actually.

(B) The world does not revolve around you. Honest. LOL

[NPfisherman]

I will not go into the long history of Big Pharma buying drugs out of Phase II from small biotechs and making a killing by doing so...If you have a desire, you can research it for yourself...go look at the prices Big Pharma pays for drugs in development, and what they make afterwards... The real issue is the cost of Phase III amounts to 50 million dollars... if this cost were the cost of a Phase II, then Big Pharma would be done...

[NPfisherman]

Ummm, the government squeezes everyone... Big Pharma is not exclusive on this issue... I could talk about taxes, but why?? it makes me cry or curse and I prefer the happy road...

[NPfisherman]

Got you beat... we have preferred status with the IRS... lucky us...

[maley2711 in reply to NPfisherman]

How do I join that club???

[NPfisherman]

Really... we had a toxic train wreck near by... I'll put on my happy face.... the one with the 3rd eye in the middle... I have Stage IV Prostate Cancer also BTW... Please do not tell me I have nothing to complain about... my life is my own... thanks

[NPfisherman]

Yeah, just trust me...that's me...here's an article...

ncbi.nlm.nih.gov/pmc/articl...

as per the article:

Unfortunately, a biotech that depends on large cap pharma for financing often gives considerable control and profits to the drug company. This is often necessary to secure future marketing, distribution, clinical trials testing, and revenue for a product in development.

The vast majority of research drugs are made by small biotechs, but who reaps the biggest profits....hmmm

Sorry, not getting in a peeing contest over Big Pharma...if you think they are the hero...good for you... we are done here...

[maley2711 in reply to NPfisherman]

Do you consider big pharma a monopoly????

[NPfisherman in reply to maley2711]

I could engage in that question, but I am moving on to other posts...

[cesanon in reply to maley2711]

Technically they are an oligopoly.

[NPfisherman]

I guess my focus was on the considerable control and profits they are forced to give away to Big Pharma to get their drug to the finish line... silly me...

[maley2711 in reply to NPfisherman]

Same challenge many smaller companies in many different industries face....sufficient capitalization. Do these small biotechs actually want to be manufacturers?

[NPfisherman in reply to maley2711]

I wouldn't know as I am not employed by a small biotech..

[NPfisherman]

Thanks for your interest in my noodle and its usage...

Yankee Doodle

Used his noodle

Riding on a pony, and eating his Christmas pie,

he stuck in his thumb,

and pulled out a plum,

and said,"What a good boy am I..!!"...

Please folks, use your noodle in a careful and responsible manner... be respectful and kind to one another and ...

Have a great weekend,

Fish

PS: Welcome to the forum all newcomers...

[maley2711]

so do you have some FACTs as to the degree of impact you are suggesting???

[maley2711]

Larry King said the bigger his tax bill was, the happier he was......bigger tax = bigger income. Mom paid approx $30k Fed tax on $150k income...I did her taxes. She didn't jump for joy, nor did she complain. She managed to live on $10k per month somehow???? He says with sarcasm!!!

[NPfisherman]

Done !!!

mypk response

[cesanon]

WHY THIS IS, AND WHY THERE IS ONLY ONE WAY TO REFORM IT

This is to be expected so long as we continue to vote in a party that vigorously supports the right to legally bride legislators under the theory that Corporations are people, not artificial entities created by law.

That have they have the rights of individuals. That they have the right to spend their money publicly, and in the form of dark money, in pursuit of their economic interests.

We are getting what we deserve. Most especially given the demographics of prostate cancer patients, cranky old white men. We all know how we vote. And those votes go to the politicians who quite transparently support and protect the pay to play system.... including stuffing the courts with jurists who support and extend the system.

Don't you find it strange that so few of use recognize that?

No flames please. Please stay on topic.

That topic is why we have such high pharma prices in the US as opposed to Europe where dark money bribery is prohibited and jurists are not selected for their politics.

Thank you in advance. If you have any bile you want to share, please use private messaging. Let's keep it on an intellectual level please.

[NPfisherman in reply to cesanon]

"(B) The world does not revolve around you. Honest. LOL"

Perhaps, you could follow the advice you gave me earlier...

Politics is not what this forum is about, so perhaps you could post on a political forum. I believe this post is about drug pricing on prostate cancer drug (s). It's amazing how many posters are trying to engage me in a challenging manner on this post... Maybe, on this post, the world or posters do revolve around me... So much reviling and so little time, but since I must help another poster out..

TTFN

[cesces in reply to NPfisherman]

The US and EU share the same economic system.

Pharma pricing varies substantially.

You can't talk about the difference in pricing without talking about the legalization of Corporation is a Person right to legally purchase laws and votes in the US.

Sooo.... maybe you should just pass on this subject... or join in... in an open minded non-emotional manner.

But I don't think whining about the contribution of others contributes all that much.

Whining about the lack of civility in others, particularly those who agree you, might help a lot.

I don't know how it is possible to talk honestly and factually about the cost of pharma in the US without talking about the political system that controls that cost through it's rule making.

Do you?

[cesanon]

All companies must invest capital in themselves.

Have you ever wondered why the Pharmas are the most profitable companies in the world (deriving 1/2 to 2/3 of those profits from the US market)

More profitable than even oil companies.

It's not that they have to invest capital. Oil companies have to do so as well.

It is why they get such a high return on that capital. And only in the US. And funny thing is most of that capital is spent overseas (like China and India?). But the return is captured in the US.

People deserve the government they get. Don't you think?

[cesanon]

Bir Pharma are corporations. They are artificial creatures of state.

They should exist to serve our interests. Not the reverse.

How about that for an idea. Seems to work OK in Europe and Scandinavia.

How did these corporations come to have more voting power in congress than individual citizens? Why would that be a good thing.

It's definitely not a good thing for pharma prices. Is it?