Advanced Prostate Cancer
5,189 members4,850 posts

I Don't Get It..Why Is The FDA (Fu*kin Dumb Asses) Making

drug companies seek approval of Darolutamide and I also believe Apalutamide for 0MCRPCa...this is crazy...how many guys have CRPCa that is non-metastatic...this means if Xtandi fails and your Doc writes a prescription for D or A your Ins company will deny coverage if your medical record has any mention of metastasis....Dr. Strum says the crooks at the FDA never should have banned low dose DES because its time to failure was far longer than Xtandi - Zytiga - or any of these new anti-androgens...could it be that DES 1mg $79 and Xtandi and Apalutamide $10,000...no can't be..that would mean are friends at the FDA are in bed with the drug companies.

Gus

20 Replies
oldestnewest

I'd like to take a poll here and see how many people on this forum are castrate resistant non-metastatic.

Agree, this is F*cked up for sure. In the Darolutamide video you posted, the guy at the end makes the following observation: "Perhaps because of its different structure, and we don't know the answer to this, perhaps its going to have clinical efficacy in patients who experience progression on Enzalutamide or Apalutmide." Yeah DUH!

So why aren't you testing it for that? Something is wrong with this picture. This is one problem I see with the system of clinical trials. Often there is only one narrow indication approved when it's obvious the drug would work in other indications, but sorry for those who need it. F*cked up is right.

4 likes
Reply

Isn't it also true that DES is the least toxic treatment there is?

Reply

Gus, I do not think they banned DES,I think a year supply would cost $200. Gregg High dose DES 5 mg, did have blood clot issues and required anticoagulation, it had much less blood clot issues with low dose , either 1 or 2 mg , as reported by Glode et.al.

2 likes
Reply

It seems to me that the cardiovascular issues have been exaggerated. From what I've read, they are manageable, especially at the lower doses. It's proven to work, so I can't see why I wouldn't try it at some point. It's also far less toxic than many other options.

Reply

And it is extremely cheap, would not even need insurance to pay.

1 like
Reply

Just need someone to write the script.

1 like
Reply

The CV issues have not been exaggerated, but it is more an issue for the pills, less so for the patch. The peaks and valleys in blood levels from taking pills wreaks havoc on the liver, which results in blood clots. The steady blood levels achieved with a patch are less hepatotoxic but not without risk. the large PATCH trial in the UK, which uses estradiol (not DES) will settle the matter in 2021.

clinicaltrials.gov/ct2/show...

2 likes
Reply

Yes, I should have specified. The patch is definitely better for CV and liver issues.

Reply

When I did the patches , I think one of the reasons they worked so well for me is that I prepped the area with 90% alchohol solution, I think this increased absorption of estradiol and made the patches stick better too. I used 6- .1 mg climera patches per week around my abdomen and above waistline, changing one every day, 6 out of 7 days in an attempt to get an even amount daily. I achieved very high estradiol levels, which should be measured when on this therapy. The generic mylan patches are too bulky and do not work as well as either climera or vivelle dot patches. Sartor has said he has seen DES work when the estradiol patches did not. IMO this may be a result of not getting proper absorption with the patches.

2 likes
Reply

Dan, Did you have any problem with gynecomastia while you used the patches? Did they let you take tamoxifen with it to block the estrogen receptors in breast tissue?

Reply

They did do one time breast radiation, but I still had a bit of gynomastia, that I was able to live with. I knew about tamoxifen due to reading what Strum had written in the day, but was unsuccessful in convincing my MO. I think part of the Gynomatia was due to increased weight on adt. Now I am back to a better weight and Gynomatia is not so much of a issue. In those days I just wore baggy shirts and was happy to be alive.

1 like
Reply

Mr Tall Allen, Thank You so much for being here and helping us all, It is a comfort to have your knowledge on this forum.

Sincerely,

Dan

3 likes
Reply

Gus, I'm with you regarding DES vs newer, ridiculously expensive ADT drugs. I have previously posted my family's history with PCa and the use of DES. My grandfather, father, and his two brothers all were diagnosed with PCa around 60, had RPs, received DES upon recurrence (no radiation or chemo), and did quite well (with the exception of grandpa who died at 73) into their late 80s with few of the nasty side effects of the newer drugs. My dad died at 89 while on a fishing trip in Wisconsin, and my two uncles died at 87; however, one was dealing with bone mets for about three years before he died. None of them ate particularly healthy since Czech diets consist of lots of fried meats, and bakery. I recently asked my MO (a doc who has been practicing for about 38 years) at Loyola Univ. Hospital in Chicago about using DES since I live in Thailand and have no ins here. He suggested using 2mg doses along with a 80mg aspirin, or "Oestrogel" (17 B estradiol). "The use of low-dose aspirin (100mg daily) with DES resulted in only 1 of 38 vascular events." I'm waiting for my next PSA to decide on doing something, or continue doing nothing (other than surgery) as I have been for 13 years.

Reply

Gus, Can't the new drug, apalutamide, be used 'off label' for metastatic now that it's been approved FOR non-metastatic, castrate resistant pca?

DES and estrogen patches may still be good fall back options--IF ONE CAN FIND AN MO who will write the script! I know, I know: if he says no, change docs. Not so easy when DES and patches are simply not yet in approved standard protocols as far as I know.

Reply

sure..the problem is getting insurance to pay

Reply

Gus, but wait. While apulatamide may just have been approved for non-metastatic (i.e, what I call 'intermediary' advanced pca) has it previously been approved/used for metastatic CRPCA?

Reply

We can buy "Oestrogel" (17 B Estradiol 80 gm) here in Thailand otc for $10. I believe DES is also available here...will check tomorrow.

Reply

Since the FDA is staffed with BigPharma "loaners" did anyone think otherwise? Getting your old job back at an increase in pay depends on how much money you make them while on loan to the FDA. Ain't amurica great? But to be fair- check out the history of DES- another drug in search of a cure- started out being used to prevent miscarriages and then became fair game for any problem that didn't have a targeted drug. Metformin looks like it's headed down the same path as DES. The Navy- in the 50's and 60's handed out pills called APC's for every problem- I think the A was for Aspirin- the C for caffeine- not sure about the P but they were known to us as All Purpose Concoction- then they were discontinued with no reason given. They could get away with that back then.

1 like
Reply

I was on DES for about seven years. It quickly brought my PSA down to 0.2 from 15.0. Unfortunately, my supplier got arrested for selling DES packaged as a blend of five natural ingredients without mention of the DES and for selling a prescription drug without a prescription. Some of you may have experience with it too, it was called Prostasol. Today, Prostasol is still sold but without the DES and is no longer effective against Prostate cancer.

I got seven years of worry free control with only one capsule per day. Since eliminating the DES, I had to go on the Lupron rout following the drug trail to a point where I have tried every appropriate treatment in the big Pharms arsenal until now where I under Hospice care.

Prostasol contained about 1 mg of DES.

1 like
Reply

what a shame....when the FDA banned DES for blood clots it was because 3mg dose was to high...1mg works just fine....the real story...the crooks at the FDA has just approved Lupron at $7000 a shot and the URO's got a $2000 kick back for every shot they administered...the problem was DES at $200 for a years supply so the stooges at the FDA used their usual solution...ban DES....3 cycles of Lupron and most guys are castrate resistant...the usual time to DES failure 14 years and no castrate resistance, so Lupron would work at this point

1 like
Reply

You may also like...