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Pharma and their dupes want to castrate you or steal your ovaries

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 2018360 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 compoundWiki.  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.    




1.    [1]   Margo J (26 September 2012). "Looking at care with a critical eye". Australian Financial Review.

2.    Jump up^ "Post-Finasteride Syndrome Foundation official website". 


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. 

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

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, MDCarl O. Bruning III, MDWilliam 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.]

 

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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