Things that puzzle me about PCa # 12 in an endless series

[Guest guest]

Here are the results of three studies, all reported

in peer reviewed journals. I’m always puzzled by the difference in

acceptance levels.

1. Provenge, technically known as sipuleucel-T, is

the first autologous immunotherapy drug to be approved for any cancer by the

U.S. Food & Drug Administration (FDA). It was approved in April 2010 for

use in men with metastatic, androgen-independent prostate cancer who did not

have symptoms or had only minimal symptoms. The key evidence came from a large

clinical trial that demonstrated a survival advantage of 4.1 months (25.8

months median survival in the Provenge arm, versus 21.7 months in the

“placebo” arm, which was actually a delayed, frozen version of

Provenge given when disease progressed). That 4.1-month advantage was better

than results for all therapies for metastatic cancer except three over the past

15 years. Another encouraging result was that 33 percent of patients in the

Provenge arm of the trial were alive at the 3-year point, versus just 11

percent in the placebo arm. With survival results at least as good as those for

current chemotherapy drugs, many eligible patients were attracted to

Provenge’s strong safety profile and mild side-effect record, a marked

contrast with the well-known rough side effect consequences of chemotherapy

drugs.

Cost US$93,000

2. Zytiga™ The original analysis (performed

when just 552 patient deaths had occurred) demonstrated a statistically

significant improvement in overall survival (OS) in patients

receiving abiraterone acetate compared to those on the placebo-containing arm (hazard ratio

---

=

0.646). The median OS was 14.8 months in the abiraterone +

prednisone arm versus 10.9 months in the placebo + prednisone

arm. However, an updated OS analysis, conducted after 775 patients had died,

demonstrated a median OS of 15.8 months in the abiraterone + prednisone arm

versus 11.2 months in the prednisone + placebo (HR = 0.740) and

showing a survival benefit of 4.6 months as compared to the initial survival

benefit of 3.9 months.

Cost TBA (No doubt based on what the market will bear

3. Vitamin C (ascorbate) The ascorbate-treated

patients were found to have a mean survival time about 300 days greater than

that of the controls. Survival times greater than 1 yr after the date of

untreatability were observed for 22% of the ascorbate-treated patients and for

0.4% of the controls. The mean survival time of these 22 ascorbate-treated

patients is 2.4 yr after reaching the apparently terminal stage; 8 of the

ascorbate-treated patients are still alive, with a mean survival time after

untreatability of 3.5 yr.

Cost about $12 per month

The last of these three studies ultimately led to the

rejection of ascorbate as a potential therapy on the grounds that the study

could not be replicated. As far as I know, there have been no attempts to replicate

the sipuleucel-T or abiraterone studies. There is a general acceptance that the

study aimed at replicating the original ascorbate study did not follow the

protocols agreed.

I’m not starting or entering a Vitamin C

argument or even suggesting (before someone uses the “ C for Conspiracy”

word) that there is anything but C for Capitalism at work here, but I do

really find the excitement and enthusiasm generated by the non-replicated

studies for very expensive drugs quite puzzling when compared with the

universal rejection of what seems to be something that may be even better –

and certainly cheaper.

Parties interested in some of the aspects of Vitamin

C may like to read this http://healthjournalclub.blogspot.com/2010/05/vitamin-c-second-look.html

All the best

Prostate men need enlightening, not frightening

Terry Herbert - diagnosed in 1996 and still going

strong

Read A Strange Place for unbiased information at http://www.yananow.org/StrangePlace/index.html

[Guest guest]

Terry Herbert wrote:

....

> I’m not starting or entering a Vitamin C argument or even

> suggesting (before someone uses the “ C for Conspiracy†word)

> that there is anything but C for Capitalism at work here, but I

> do really find the excitement and enthusiasm generated by the

> non-replicated studies for very expensive drugs quite puzzling

> when compared with the universal rejection of what seems to be

> something that may be even better – and certainly cheaper.

....

I agree with your general point. It's almost universally the

case that companies are not in business to provide specific

services but to make money. Companies that develop drugs to

treat cancer are doing it for the money, not the cancer

treatment. Cancer treatment is just the way to make money. If

the company found a treatment for dandruff or bad breath or grey

hair and it turned out to be more profitable than their cancer

research, they'd be happy to divert the funds from cancer

research into the more profitable line. In fact we could even

say that they'd be foolish not to. Their shareholders would

revolt and their competitors would roll over them.

That's a fact of economic life that we can mitigate by government

funding of research, but can't completely overcome.

But having said that I'd like to add that at least some of the

cheap and non-patentable treatments do get a lot research. We're

all old enough to remember when Linus ing made his famous

statements about megadoses of Vitamin C, starting in 1970.

Millions of people began taking Vitamin C, many in megadoses.

There was a flurry of research then and it continues to the

present day. As of today, a search on " vitamin C cancer " in

Pubmed gets 3,973 hits, including 28 that have been published in

the first few months of 2011 alone. It's a pretty large number.

Right now we're near the very center of the Provenge and

Abiraterone enthusiasm. Trial results were recently published.

FDA approvals were recently granted. Desperate patients and

their families saw a gleam of hope. The excitement is probably

not different from the kind generated by ing's first

announcements in 1970, though it's in a much smaller patient

community. People are excited.

Five or ten years from now I think we'll have a more reasoned and

experienced view of Provenge and Abiraterone. We'll be past the

hype and better able to see how well they work.

As for the Vitamin C controversy, there's a really nice

discussion of it in the Wikipedia article on Linus ing. It

takes no sides but reviews the claims and counter claims of

ing and his critics.

I'm not competent to judge which one is right, though I confess

that I consider ing to be a great hero. His elucidation of

the nature of the covalent bond, the three dimensional structure

of proteins, and many other discoveries, were phenomenal

advances. His ability to think " outside the box " is legendary.

And I believe that his humaneness and commitment to world peace

(for which he won one of his two Nobel prizes) had a real impact.

So when ing says that Vitamin C prevents or treats cancer, I

will at least take him seriously.

[i note however that in his trial he used megadoses administered

intravenously - something we can't do at home.]

Alan