The British Medical Journal has laid into another tobacco science trial
Three articles below, first on a tobacco
trial on prostate cancer, the second on chemical castration to decommission the prostate and thus shrink it modestly while
ending sexual desires and functions, and the third is on how a biopsy leads to harm by calling a cancer cells that never develop
into cancer, and then treating the patient for cancer.
With the latest science the results are essentially the same. The use of multi-parametic
magnetic resonance imaging (mpMRI) of the prostate and adjacent area was reported in a March 2018 BMJ article a 12% increase
in cancers compared to just a biopsy (at https://www.bmj.com/content/360/bmj.k1268.full). However, given that only about 1% of all cancer deaths are from prostate cancer, this entails again the calling benign
tumor, once that never will progress to metastatic or locally invasive cancer, calling these benign tumors cancer. "The 5-year survival rate in the
United States is 99%." Wikipedia prostate cancer. Case rests.
https://www.bmj.com/content/360/bmj.k1385?utm_medium=email&utm_campaign_name=20180388&utm_source=etoc_weekly 27 March 2018
BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k1385 (Published 27 March 2018)Cite this as: BMJ 2018;360:k1385
What’s the latest take? Operate
or watchful wait?
As reluctant as surgeons
are to do nothing, an important trial published last year put a crimp in their
confidence. PIVOT followed 731 men with early prostate cancer who were
randomised to prostatectomy or observation and followed up for almost 20 years.
It found that surgery didn’t lead to lower mortality from all causes or from
prostate cancer.1
So, lots of men risked impotence or
incontinence for nothing?
That’s it, in a nutshell. But wait . . .
What for?The
counter-attack, of course. PIVOT has been criticised since the day it was
published in the New England Journal of Medicine. Critics
said it was underpowered and that during the course of the trial some men
changed sides: more than a fifth allocated to prostatectomy didn’t have the
operation, while a similar proportion of the observation group did.
Chipping away
Spreading doubt,
certainly. Then last week at the European Association of Urology Congress a
presentation, also published in European Urology,2 claimed
that the PIVOT participants were not typical of US men in general. They were
between three and eight times as likely to die in the time period covered by
the trial as real world patients would have been. [The picking infirmed elderly
men in 3 ways
makes treatment look better than it would in a real world population: 1) not
functioning sexual, the loss of
performance is under reported; 2) the side effects of chemical castration, the
loss of sex drive, muscle loss, depression, lack of motivation, and weight
gain, all side effects of andropause are not noticed since most have undergone
andropause prior to the treatment; 3) deaths from other cause increase thereby
diluting deaths from the medical treatment—JK].
What would that mean?
Firas Abdollah, lead author of the new critique, said that the
patients in PIVOT were older and sicker than the typical US patient with early
stage prostate cancer. He couldn’t say for certain what the result would have
been in a like for like comparison, but added, “I think everyone would be
surprised if this didn’t tip the survival data more towards surgical
intervention.”
So, are guidelines based on PIVOT now
wastepaper?
Not so fast. It’s unlikely that this argument has run its
course. And quite unlikely that another randomised controlled trial would gain
approval, given the entrenched views of so many urologists that denying men
surgery would be unethical.
Are the critics all surgeons, by any
chance?
The majority are not unacquainted with the scalpel.
Protecting their turf?
I couldn’t possibly say.
References
Follow-up of prostatectomy versus observation
for early prostate cancer. N Engl J Med2017;377:132-42. doi:10.1056/NEJMoa1615869 pmid:28700844 CrossRefPubMedGoogle Scholar
Re: Follow-up of prostatectomy versus observation for early
prostate cancer. Eur Urol2018;73:302-3. doi:10.1016/j.eururo.2017.11.009 pmid:29174482 CrossRefPubMedGoogle Scholar
What is said of Finasteride has been
shown to be true of the others related patented drugs. Thus most if not all of
the drugs used to treat BPH, male pattern boldness, and chemical castrate
patients with prostate cancer have the same family of drugs, though of course
their manufacturers claim a difference, and their dupes repeat it to
patients.
Two things: One I would not take the drugs prescribed for
BPH, benign prostatic hyperplasia; and two undergo a biopsy of the
prostate. The journal articles below and
my commentary reveal why. This is what I
would do and have done. I am not recommending
others to do as I did. Oh, and
as for ovaries, as part of the
hysterectomy the surgen believes (thank you pharma) that the ovaries are of no
use and so he should take them on the mistaken belief that it will lower the
risk of cancer of the breast and of course it prevents ovarian cancer (a fairly
rare one). What he isn’t informed in CME
classes or medical textbooks is the effect of near zero estrogens is that it
raises the risk modestly of breast cancer, and very significantly of osteoporosis,
sarcopenia (muscle loss), obesity, heart
attack, stroke, Alzheimer’s disease, dementia, thin wrinkled skin, pendulous breasts
and other unwanted effects. A low level
of the estrogens is better than a near zero level, and a youthful level of natural HRT is wonderful, but bad
for pharma. Dyskinesia
General warning: About pharma-funded clinical
trials: there is always scientific fraud
in such trials. Pharma (the drug
manufacturer) owns the trial raw data and won’t share their results, which is
used for the journal articles. Thus a
peer reviewer can’t see where the fraud, called positive bias
occurred. However, this has been
repeatedly and consistently found when as through a court case the raw data is
made public. See one rare such exposure
where the Positive
bias averaged 32% for 74 journal articles.
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Finasteride
(sold as Propecia and Proscar]) blocks the conversion of testosterone (TTT) to
dihydrotestosterone (DT), and is sold on the basis that it
reduces male pattern hair bolding and the size of a large prostate, a condition
called BPH (benign prostazte hyperplastia) based on the theory that DT causes
both.
The scientifically aimed bullet to fix
BPH and male pattern
baldness: Finasteride is one of a family of drug which blocks testosterone
(TTT) conversion to dihydrotestosterone (DT) by blocking
partially 5-alph-reductase, and thus reducing supposedly only DT.
Sound great, only affecting DT,
whose main function is masculinization, and thus not affecting the very
significant TTT of mature men. This
biochemical razzal-dazzal is generated by the manufacturer Merck. Merck does
the research and creates the
method of action (this is the business norm for pharma). Finasteride likely
affects much more, but the
literature is lacking. And since the
drug is taken for years, long term evidence is essential for an
evaluation. And it stays in the body
much longer than its half-life because “As an unconjugated
steroid, Finasteride is a highly lipophilic compound”
Wiki. Having said that and given its many side
effects, which
include loss of libido, impotency, depression, and thus lower quality of life
and stress upon spouse. These side
effect persist and are very common, thus given the label ‘post-finasteride
syndeome’[1]
Given the side effects it must lower the
production of TTT. There are
other long-term side effects since TTT and estradiol (which about 10% of
TTT is converted to). Both are
important to health, they significantly lower the risk for heart attacks, Alzheimer’s,
osteoporosis, dementia, arthritis, and others The
magic DT bullet is a shot-gun blast to our hormonal regulators.
FDA approval: uses patented include for hair loss and BHP (benign
prostatic hyperplasia). All the drug have
to do is be a couple of percent better than nothing at all (a placebo) for
approval, and rarely are side effects sufficient for denial of a patent. Welcome
to the world of regulatory façade. A few other regulatory agencies have taken
stronger action than a black-bock warning:
The Swedish Medical
Products agency concluded a safety investigation of
finasteride and advised that finasteride may cause irreversible sexual
dysfunction. Similar reports were issued for UK and Italy. http://en.wikipedia.org/wiki/Finasteride
As for preventing prostate cancer, the
numbers are based on an aggressive
use of “adenocarcinoma’; viz., calling benign tumors cancer based upon abnormal
nuclei. Low TTT has been repeatedly
shown in population studies to be significantly associated with aggressive
prostate cancer; thus, no surprisingly, the rate of aggressive prostate cancer
increased by 27%, as expected.
Extending the use of their patented drugs, to this
end pharma does clinical trials which are always flawed by design—a point
proven by Prof. Ben Goldacre in his book Bad
Pharma. A
new use would be to take the drug to reduce the risk for prostate cancer, which
has a 3% lifetime risk. The drug
manufacturer has done a very large trial (18,800 men) to “prove” that Finasteride
reduces the rate of prostate cancer.
Published in the NEJM 2013
it “showed” about 1/3 case reduction: thus 100 would have to take it lifetime
for 1 to avoid prostate cancer. There
are several down sides to this use of a Finasteride. One is that it increases the risk of high grade prostate cancer
by 16.4%. (Again I remind you that those numbers favor
the drug manufacturer—positive bias). Merck’s
trial showed that at 15 years the total survival of the placebo group was slightly
higher than that of those given prophylactic
Finasteride. So why take a drug that
doesn’t extend life and has terrible side effects. Add to this the 32%
positive bias average (above)
and it shortens life significantly.
Even the highest figures for side effects are deceptive. A 2017 review of men
with BPH found that “Overall, 5ARIs determined an increased risk of hypoactive
sexual desire [very low libido][OR = 1.54 (1.29; 1.82); p < 0.0001]
and erectile dysfunction [OR = 1.47 (1.29; 1.68); p < 0.0001]. Two
of that
class were tested, “No difference between finasteride and dutasteride. . .
.” An IR if 1.54 means
54% have major decline is sex drive (thus who are young enough to have a sex
drive), and 47% can’t get an erection. Since
the drug has gone off patent, pharma will be switch him to a new improve
5-alpha reductase inhibitor, and he might be told of those high rates so as to
switch his prescribing. (There is a
saying: “It is amazing how quickly a
good drug becomes a bad drug when it goes off patent”.) The doctor will
likely be told of the study
used on rxlist.com for the new drug in which it has 0.6% of men in the trail
experience abnormal sexual function, 4.1% impotence more than the placebo
group. And it gets much worse, for one
thing the question asked of the men in the trial and circumstance are not
supplied, the company which funded the study writes it up and has their KOLs
(Key Opinion Leaders) sign off on
it and as part of the contract they give up the right to violate the company’s
privacy clause. One way to put the
question to get the desired answer would be to first use a cohort that is not
sexual active, thus in their 60s and 70s most men have zero sex with their
wife. Secondly if the sex goes from an
average of once a month to zero, that isn’t a significant decline that is drug
caused rather caused by aging and
andropause. The uses of “significant”
in a survey, rather than
having a log of pretreatment, during treatment, and post treatment sexual
encounters is a clincher. This is scientific
fraud when the method of getting a pro-business result is not revealed in the
journal article. Relying on memory with
an embarising question promotes the pro-business answer. What 90% of doctors
believe about 5-alpha
reductase inhibitors benefits and its side effects are worlds apart. These
dupes are taught that hormones are
bad, thus women don’t need their ovaries once past bearing children or the
hormones they produce; and men don’t need TTT,
DT, or their testes and prostate, moreover
without them cancer risks go down, for both men and women, and without
affecting quality of life or causing other health problems. We all suffer because
pharma isn’t blocked from
the education process which includes the public through corporate media.
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A danger of biopsy
is that if
there is truly a cancer with the ability to be or become metastatic, then the
needle used for the biopsy will shed cancerous cells in its path of
travel. I found this mentioned in an
article on liver cancer, which in passing explained why biopsy is not used to
confirm liver cancer. On the basis of
this I would not undergo a biopsy. I am
not recommending this for the reader; consult your doctor.
The
article below supplies another reason, the calling benign non-cancerous cells cancer,
adenocarcinoma. Allow me to
explain:
The lead author
Abraham
Morgentaler, M.D., Harvard Professor. Within a decade his
position
on prostate cancer and the role of testosterone has completely changed. He uncovered
that testosterone does not
promote the growth of prostate cancer.
However, those with low testosterone are more likely to have aggressive
prostate cancer, and two, if the level is raised to the normal level for one
who has prostate cancer, the cancer will grow faster. See his 2009 Testosterone for Life where
he explains when it is abnormally low,
as with cancer treatment how raising the level stimulates the growth of
cancer. Morgentaler recommends that
those with low testosterone “recharge your vitality, sex drive, muscle mass and
overall health by taking testosterone.”
There
has been a storm of controversy of the fact that most of those being diagnosed
with prostate cancer would never had died from prostate cancer; in other words
their treatment only harmed the patient, including shortened very significantly
their lives. The article below confirms
the diagnosis of those without cancer having cells with abnormal nuclei as
being labeled cancerous, which then leads to treatment for most. In the study
it was found that 14% of those
with normal PSA--the low risk group--had prostate cancer based on biopsy. However,
the lifetime risk is but 3%. Given that fact and given this is the
low-risk group, their should have been under 1% at that time being diagnosed
with prostate cancer. Thus the standard
for calling cells cancer is very, very flawed, and the harm done is a terrible,
terrible thing. Most of those treated
for prostate cancer will be chemically castrated long-term, and poisoned by
chemotherapy. We have tobacco ethics at
its worse in an industry who sells us the idea that they are promoting our health,
while in fact they are acting like their brothers in the tobacco industry.
https://jamanetwork.com/journals/jama/article-abstract/411964
December 18, 1996
Occult Prostate
Cancer in Men With Low Serum Testosterone Levels
Abraham
Morgentaler, MD; Carl
O. Bruning III, MD; William
C. DeWolf, MD
JAMA. 1996;276(23):1904-1906. doi:10.1001/jama.1996.03540230054035
Abstract
Objective. —To determine
the prevalence of occult prostate cancer in men with low serum total
testosterone or free testosterone levels.
Design. —Retrospective
analysis of a consecutive series of men.
Setting. —Academic
teaching hospital.
Patients. —Seventy-seven
men with low total testosterone or free testosterone levels, with normal
results of digital rectal examination and prostate-specific antigen (PSA)
levels of 4.0 ng/mL or less. The mean age was 58 years.
Interventions. —Sextant
prostate needle biopsies with ultrasound guidance.
Main
Outcome Measures. —Results
of prostate needle biopsies, transrectal ultrasound, prostate volume, PSA
level, PSA density, total and free testosterone levels.
Results. —Prostate cancer was identified in 14% (11/77)
of the entire group and in 10 men (29%) aged 60 years or older. The median age
for men with cancer was 64 years.
Histologic examination showed Gleason scores of 6 or 7 for all cancers [7
is the highest rating as to a cancerous appearance of the cells taken in a
biopsy]. No significant differences were
noted between the cancer and benign groups with regard to PSA level, PSA
density, prostate volume, total testosterone level, or free testosterone level.
[This is more evidence that that biopsy isn’t of a cancer,]
Conclusions. —A high prevalence of biopsy-detectable
prostate
cancer was identified in men with low total or free testosterone levels despite
normal PSA levels and results of digital rectal examination. These data suggest
that (1) digital rectal examination and PSA levels are insensitive indicators
of prostate cancer in men with low total or free testosterone levels, and (2)
PSA levels may be altered by naturally occurring reductions in serum androgen
levels. [Note: other studies have
shown that the risk of
this group is modestly higher, however, the chance for it to be aggressive is
significantly higher.]
INTERNAL SITE SEARCH ENGINE by Google
Prof. Marcia Angell, Harvard: “We certainly are in a health care crisis, ... If we had set out to design the worst system
that we could imagine, we couldn't have imagined one as bad as we have.” Her excellent 77 minute lecture on pharma http://www.youtube.com/watch?v=ZqKY6Gr6D3Q
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