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
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 prescript
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 prescript
ion 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-prescript
ion 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.