Supplements: What would I get if money were no object?

Prato, a number of the ingredients in one of the supplements that Dr. Katz had you take (Inflammatone) are similar to the ingredients in Zyflamend, the supplement that my husband takes on the advice of his surgeon.

The ingredients in Zyflamend are rosemary, turmeric, ginger, holy basil, organic green tea, hu zang, Chinese goldthread, barberry, organic oregano, and Chinese skullcap.

While I don't think it is harmful for my husband to take this supplement, I am not in favor of it. The reason is just that I don't favor supplements, in general. Last night I made fish for dinner and one of the ingredients was fresh oregano. I use fresh rosemary, ginger, oregano, and basil in recipes I make. Many of them also include turmeric. I prefer to use a fresh version of the ingredients in this supplement.

As far as the BroccoProtect that Dr. Katz recommended - why not just eat some broccoli.

Alright, since we are going down this road, I'll share.
From time to time I take Organic Sulfur.

I have posted at HWPC several times about my experience with the equivalent of an experimental drug called Apatone. It must not be interesting, as no one (that I remember anyway) has ever shown any interest, not even to tell me what a crackpot or fool I am to bother with such unproven things.

But I did find the drug listed at the FDA, under orphan drug status, which means that in the unlikely event they win FDA approval, they don't think there would be enough users to recoup the cost of development. Not sure if that means they are asking the FDA to cut them some slack or not. Here is a link I just pulled up, not a study, just info:
www.eurekalert.org/pub_releases/2007-10/shs-rcf100407.php

article said...
In a significant advancement in the ongoing battle against cancer, a group of researchers from Summa Health System, IC-MedTech and other institutions have completed the first ever FDA-approved human clinical trial of Apatone®.,,,,,,,,,,,,
Apatone was discovered by Dr. Henryk Taper from the Catholic University of Leuven in Brussels, Belgium
Showing delays in the biochemical progression in end-stage prostate cancer patients, the trial successfully demonstrated the safety and efficacy of orally administered Apatone. Research is continuing and insights into how this drug works have lead to collaborations and discoveries in the field of liquid crystal compounds. Apatone is a Liquid Crystal PharmaceuticalTM........
"Ultimately, Apatone is intended to be administered intravenously prior to chemotherapy so it can break down the substances in a tumor that protect it from the chemotherapy and allow a greater cell kill," continued Dr. Jamison. "Between cycles and following completion of chemotherapy, Apatone will be taken orally to help prevent or slow tumor regrowth."

Although the researchers are still working to receive FDA approval for chemotherapy in conjunction with Apatone, the FDA granted orphan drug status to IC-MedTech this year for the use of Apatone as treatment for metastatic, or locally advanced, stage III and IV bladder cancer. An orphan drug designation grants special status to a product to treat a rare disease or condition.

Additional clinical trials are planned for intravenous administration of Apatone in patients who have failed chemotherapy.

So, via other links at pub med, I had been following this drug during in vitro, then animal (in vivo) and then 2 small human trials(all but test tube/petri dish with oral doses). (links available upon unlikely request) All seemed quite encouraging to me, but you know how that goes. One has this study, another has another showing something else, even if I have not yet found the bad ones on this stuff. But all I could find seemed very promising, and animal and human trials showed no significant SEs during the trials, and I was waiting for my surgery with a possibly spreading G9, and I found out about it from a Harvard trained MD who has given me several other very good recommendations over the years, so I decided to go for it. Plus, all of my docs told me "there is NO PROOF that anything helps, but it probably won't hurt so if it makes you feel better, go for it". So I took it for 2 months prior to surgery.

Coincidentally I suppose, my PSA dropped 26% in 2 months, first time I have ever had even a tiny decrease over many years of checking it, (yes, I know: anecdotal, and/or placebo)and similar to what was seen in ONE of the studies on end stage patients(other human study with lower dose on end stage: no drop, just stopped the rapid increase and doubling time). With no apparent SEs as long as I didn't take a handful on an empty stomach. I needed to take with food, or in smaller, more frequent amounts.

But here is the thing: I did not actually take Apatone. Because you can't easily get Apatone, though I read from at least one fellow who somehow did, and VERY expensive. But, I could not get it, I suppose because it is not yet an FDA approved drug. It is still classified as an orphan drug being studied. But this so called drug is nothing more than Vitamin C with Vitamin k in a precise ratio. So I just took the Vitamins in that ratio and at the doses used in the human trials. Here itis at the FDA website:
www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=394313
notice the "generic" name: sodium ascorbate and menadione sodium bisulfite, AKA Vit C ad Vit K:

en.wikipedia.org/wiki/Sodium_ascorbate "Sodium ascorbate is one of a number of mineral salts of ascorbic acid (vitamin C). The molecular formula of this chemical compound is C6H7NaO6. As the sodium salt of ascorbic acid, it is known as a mineral ascorbate. It has not been demonstrated to be more bioavailable than any other form of vitamin C supplement"
medical-dictionary.thefreedictionary.com/menadione+sodium+bisulfite
"menadione/men·a·di·one/ (men″ah-di´ōn) vitamin K3" (K3 I THINK is the synthetic version of K1 and has potential toxicity unlike K1, and probably only available by prescription)



So the reason for this post is not to try and get anyone to take Vitamin C and K. In fact, please do not take anything just based on my experiences, PLEASE! It is just to point out that this company seems to desire to get a patent on these vitamins when used in this ratio, and also to ask some questions related to that. If approved, it will then be trademarked and marketed as Apatone. Now, if by some fluke they actually manage to win the coveted FDA approval as safe and effective, what happens then?

Can we still use the vitamins in that ratio without getting a prescription for the no doubt very expensive Apatone?

Will the FDA then allow people to use their free speech to say: studies have shown that Vit C/Vit K is helpful in the battle against PC or other cancers(it has been studied in more than just PC)? And in fact issue an apology for forbidding anyone to make such claims during the previous decades? Or will they come down on the sellers of non-prescription Vit C/K as though they were making health claims that Cherries are very good for you?

And is that in fact why there is a need for this Orphan Drug Status? Because the Apatone folks know that they are really only offering Vit C/K, and if they get approval they are going to be competing against the much cheaper supplements?

Feel free to consider the questions rhetorical, or to answer or give opinions. It's all just food for thought.

Allen, I wonder sometimes about the anti Inflammatory supplements. I guess its good to have no inflammation. (common sense) on the other hand, I sometimes wonder if its not a good idea to mask inflammation that may be trying to tell us something (like PSA, caused by inflammation?)

Post Edited (Pratoman) : 2/17/2015 3:51:33 PM (GMT-7)

Pratoman said...
Allen, I wonder sometimes about the anti Inflammatory supplements. I guess its good to have inflammation. (common sense) on the other hand, I sometimes wonder if its not a good idea to mask inflammation that may be trying to tell us something (like PSA, caused by inflammation?)

May I comment on this, Prat? If memory serves, (not stopping to look it up, Y'all just correct me if I am wrong) in that study that Allen mentioned elsewhere, the one where (I think it was) beta-carotene made lung cancer among smokers (?) more likely: Seems to me I read that one theory on why this was so is because of the anti-oxidant properties. Where as to much oxidation(infamation?) can cause problems for us, oxidation is one of the bodies ways of killing of cancer cells as well as various germs/viruses.

If you looked at my above post on Vit C/K, I'd like to give another detail. Every study I have seen has put forth that the way this works is by oxidation. It is supposed to be the PRO oxident effect of the combo, having to do with hydrogen peroxide,via superoxide, which kills the cancer cells. So, how can these vitamins be pro-oxidant? Isn't Vit C an antioxidant? Apparently these can work in different ways according to what the body needs.

I also saw another study which compared that Vit C/K combo with other anti-oxidants by themselves and given togethr. Melatonin by itself results: "LNCaP cell viability decreased 16 percent(PC3 increased 4%) after a
three-day exposure to melatonin (100 μM)., but Melatonin combined with VC:VK quenched the oxidizing
effect, ". When combined at the same time with the Vit C/K, melatonin totally wiped out the normally much greater effect of the C/K( cell viabilty with C/K alone increase from only 66% to 99% with melatonin added!)

So this antioxidant melatonin completely wiped out the pro-oxiadant effect of C/K, if given at the same time. Because of melatonin's short 1/2 life, it did not cause this if given hours apart.

So, point is, we need to be careful with the whole antioxidant thing sometimes, because it seems sometimes we need pro-oxidants to kill various invaders!

Post Edited (BillyBob@388) : 2/17/2015 1:27:25 PM (GMT-7)

Since the thread has gone from "what should I take" to "should you take anything at all because most is worthless and might even hurt you", then here is a bit more devil's advocate from me.

Don't know, just seeking information: if Cialis/Viagra etc were not already on the market for their well known abilities to increase fun, could they be approved by the FDA as safe and effective for penile rehab post RP? Especially looking back say several years ago, about when Mulhall's book came on the market, were the studies there? The big, expensive studies been done to a level of proof? Have the RCTs been done on these various drugs for this purpose? If not, how do we know for sure it really helps?

We all know how dreadfully expensive these drugs are, and some of us know that they can have intolerable SEs. And I know that there is some level of evidence out there that they may be helpful. But thinking back on Mulhall's book, I can not remember that the evidence was huge, more like very suggestive and Mulhall felt like the evidence would be strong in the future. Any one remember, is that about correct?

Actually, I am looking in his book right now, and at location 1832 of Kindle edition, I see "there is great debate about this topic, and what many physicians(even urologists) and patients do not understand is that there is excellent animal and SOME interesting(sounds like me LOL!) human data to support the use of these medications"(in rehab). Not exactly overwhelming. I could actually say the same thing about Vitamin D data or Vitamin C/K.

And yet how many of us faithfully buy (big $) and swallow these pills, even after months of never seeing the first twitch, in hope's of a future restoration? A whole bunch of us, including me. Despite the sometimes bothersome or rarely serious SEs. Not to mention all the other drugs we usually take with no debate to help us fight our cancers or other diseases, despite sometimes terrible risk and side effects from those drugs. And some times evidence of very much help seems scant. I know after we went through the agonies of our daughter in laws chemo before she died, every one in the family was questioning if the chemo did not actually contribute more to her demise than it helped. It is highly doubtful that she could have died any faster( 4 or 5 months post diagnosis) without the chemo, and it definitely added to her misery until it was stopped. But, hey, all FDA approved and doctor recommended, so nothing to worry about there, right?

But with all that I just mentioned, while we will take that Cialis with little evidence available ( might be more now since Mulhall's book), is it really a comparatively big worry that that dirt cheap Vitamin D3 ( or whatever supplement or food) might not yet have as much proof as it should that it can help my prognosis? That it might not do as much for my PC as some studies appear to indicate, or might not even do anything at all? And finally, that if we take a whole bunch of it and get way up on the blood level curve, it might even do us harm? (and just how much evidence is there for that, compared to studies showing the apparent benefits of medium to high blood levels?) Is this really that much of a concern?(he asks as he pops another Viagra).

Rant over

DA Bill in MS (from the Devil's Advocate Office)

BillyBob,
For a low cost supplement, like Vitamin D, no company can afford to go through the vigorous testing that would be required to prove it works.

If you have a proven best seller (like the PDE5s) why pay for the testing to prove they work for a very small market (penile rehab after PCa surgery)?

In either case, the money will never be there to "prove" they work. Maybe some anecdotal, after the fact studies that show a relationship, but not the expensive double blind, etc. etc. tests to that some people require for proof.