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PROSTATE CANCER UPGRADING: more fear­mongering

Prostate cancer upgrading means that a prostate cancer grade and score (or measure of prostate cancer aggressiveness) found in a surgically removed prostate gland can, sometimes, be of a higher grade than diagnosed in the initial needle biopsy of the prostate. This so­called upgrading phenomenon is marketed by urologists to imply that prostate cancer upgrading is a likely significant event and that most prostate cancers are worse than the needle biopsy suggests. This gross misrepresentation is designed to push men into seeking treatments when any treatment is often unnecessary. Unnecessary, because even though the ubiquitous Gleason 3+3=6 is called a “cancer”, this “cancer”, fails to behave like a cancer. http://www.urologyweb.com/when-cancers-behave-noncancerous/

What are the facts about prostate cancer upgrading?
> the grade and score of the prostate cancer as estimated by pathologists in the surgically removed specimen can be the same or, even of a lower grade than estimated in the initial needle biopsy of the prostate
> the most common upgrade (if it occurs) is the Gleason 3+4=7 score which in reality, behaves similar to the non health­risk Gleason 3+3=6 prostate pseudo­cancer
> less common is an upgrading of the prostate cancer to a Gleason 4+3

Therefore, rather than sensationalizing and misrepresenting how prostate cancers may be underestimated at initial presentation, the reality is that most prostate cancer upgrades are insignificant if they occur at all. In fact, you are far more likely to be mislead by your urologist into having an unnecessary debilitating treatment than having your life “saved” from an unlikely significant upgrade. Furthermore, the USPSTF has concluded already, that the risks of PSA­based screening, evaluation and treatments for most prostate cancers far outweigh the perceived benefits. http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancer-screening

Prostate cancer upgrading represents mostly the problem of observer error and subjective interpretation issues amongst pathologists reviewing your pathology. To a lesser degree, the sampling error associated with the needle biopsy of your prostate may add to the issue. Therefore, before considering any treatment you should obtain several pathology opinions from pathologists well versed in prostate pathology so that you may form a consensus from these opinions. Additionally, certain biomarker studies may allow an assessment of the biological potential of your pathology and or, you may undertake an mp­MRI with a radiologist experienced in prostate cancer MRI imaging. This mp­MRI imaging is especially attractive since it appears to identify only the important high­grade prostate cancers which demand treatment and ignores the non health­risk Gleason 3+3=6 pseudo­cancer which does not require treatment. Also, should you have a small, high­grade prostate cancer which was missed on your needle biopsy, expert monitoring will detect it in a timely fashion to allow focal therapy.

The sensationalizing of prostate cancer “upgrading” comes hard on the heels of a long line of reprehensible scare tactics and half­truths marketed by the prostate cancer industry. All of these many misrepresentations are designed to give you the impression that you are dealing with a disease worse than it is or, has the potential to progress quickly.

For example:
> urologists calling the most common prostate cancer, a “cancer” when it behaves as noncancerous. In fact, the very common Gleason 3+3=6 prostate “cancer” LACKS the hallmarks of a cancer on both clinical and molecular biology grounds. It is a pseudo­cancer, is not a health­risk and does not progress. http://www.cancernetwork.com/prostate-cancer/active-surveillance-not-only-reduces-morbidity-it-saves-lives

> grade “creep”. This represents mostly grade inflation and subjective interpretation errors on the part of pathologists reviewing the initial prostate needle biopsy sample. In other words, some pathologists are assessing a higher grade to your prostate cancer in the needle biopsy than actually exists or, they are assigning higher grades to the same disease compared to what they did in the past. This issue is similar to prostate cancer “upgrading” but whereas “creep” is an inflated grade based upon your initial biopsy the so­called upgrade is inferring that the cancer grade found in your surgically removed prostate is greater than was originally believed from your initial needle biopsy sample. Both “creep” and “upgrade” are used to mislead you into getting treatment or, have you believe that you made a good choice after undergoing a debilitating treatment. http://www.urologyweb.com/prostate-cancer-grade-creep/

> inflating the incidence and significance of most prostate cancers. Men do not die from the Gleason 3+3=6 prostate pseudo­“cancers”. In fact, only 3% of all men with a prostate cancer label in the US will die from their disease but, only if they have the high­grade form of the disease. Unfortunately, the misrepresentations about prostate cancer and the toxic radical prostatectomy treatment will cause an additional 3,000 deaths within 30 days of this misguided surgery each year because of its many complications, according to A. Horan MD, “The Big Scare. The Business of Prostate Cancer”.

> implying that the FDA approval for the robotic assisted radical prostatectomy was based upon scientific studies involving prostate cancer when this FDA approval for the robotic assisted radical prostatectomy was based upon low­level gallbladder and Nissen fundoplication studies only. In fact, the fraudulent approval of radical surgery/robotic prostatectomy comes with more false hope and complications than for any other cancer operation. http://www.urologyweb.com/wp­content/uploads/BEWARE­BEWARE­FDA­_APPROVE D_­ROBOTIC­PROSTATECTOMY­CARE­1.pdf

In addition to these gross misrepresentations by urologists have been a slew of underhanded and reprehensible actions on their part attempting to influence and undermine Government oversight agencies such as the FDA and the USPSTF. As well, there was the egregious torpedoing of the minimally invasive HIFU application by FDA urology panelists attempting to protect their radical prostatectomy franchise. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevic es/MedicalDevicesAdvisoryCommittee/Gastroenterology­UrologyDevicesPanel/UCM420537.pdf

Also, there was the unconscionable influencing of Senate Staff attempting to capitalize on their medical illiteracy and, through a National Prostate Cancer Council, have them initiate a pushback on the USPSTF so urologists can continue their self­serving but misguided PSA­based screening for prostate cancer. A prostate cancer screening program which has a much greater probability of causing harm than from the remote possibility of saving a life. http://urologytimes.modernmedicine.com/urology­times/news/prostate­cancer­council­bil l­earns­aua­support?page=full

Finally, more and more men are wise to the fact that the common Gleason 3+3=6 “cancer” is not a health­risk, grossly overtreated and, should NOT be called a cancer. However, to counter a potential drop off in patient traffic, urologists are engaging in all sorts of prostate cancer misrepresentations such as “upgrading”. This egregious fear­mongering ploy is designed simply to spook men into having prostate cancer treatments they never needed and, afterwards, fooling them into thinking they were survivors when they were only survivors of a debilitating treatment. http://www.urologyweb.com/robotic­prostate­cancer­surgery­a­public­health­nightmare/

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Study Finds MRI Accurate Predictor of Low­Risk Prostate Cancer

Is watchful waiting the best choice for prostate cancer patients? According to a recent study from the Memorial Sloan­Kettering Cancer Center in New York City, published in the J​ournal of Urology,​prostate MRI testing can help doctors decide whether or not this less invasive option is the right way to approach a low­risk prostate cancer patient. This was the first time the ability of an MRI to predict confirmatory biopsy results had been examined.
In the study, 388 men who were recently diagnosed with low­risk prostate cancer were given an endorectal MRI. Radiologists then reviewed the MRI and assigned it a score. Then, the patients’ biopsy results were studied. Patients who had a low imaging score from an endorectal MRI had a greater than or equal to 95 percent negative predictive value and specificity for upgrading on biopsy. For those with a higher score, 90 percent had a correlation with upgrading.

Prostate cancer, when it is not growing or aggressive, is a very low risk disease. In fact,
many forms of prostate cancer do not behave like cancers at all, and as such do not need aggressive treatments.​Watchful waiting, therefore, allows doctors to keep tabs on the tumors and determine when they need further treatment, if they ever do.

What does this data mean? This study shows that MRI can be an affective tool for the initial assessment of a patient to determine whether a watchful waiting approach is a safe course of action. Because watchful waiting requires identifying patients who have low­risk disease, this is valuable information. Tumor visualization of high­grade disease only using MRI allows for a targeted prostate biopsy. MRI may help contribute to the assessment process in determining whether a patient is a candidate for a watchful waiting approach or focal therapy.

This is important information because so many newly diagnosed prostate cancer patients are over­treated. The National Comprehensive Cancer Network also recommends watchful waiting as a treatment option for patients who have low­risk disease. When the life expectancy of the patient is at least 10 years, the risks and quality of life issues created by treating can often be worse than the tumors themselves.

While further research may be forthcoming, this shows, again, the fact that prostate cancer does not behave like a typical cancer, and as a result should be treated less aggressively until proven that it needs an aggressive treatment to prolong and save a patient’s life.

Read More >
http://www.urologyweb.com/wp-content/uploads/BEWARE-BEWARE-FDA-_APPROVED_-ROBOTIC-PROSTATECTOMY-CARE-1.pdf

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MRI May Reduce Need for Prostate Biopsy

Prostate biopsies are one of the only ways to predict an aggressive cancer, but they are painful, inconvenient and somewhat inaccurate. A report from Dr. Ahmed Haddad, fellow at the University of Texas Southwestern Medical Center in Dallas, presented at the American Urological Association annual meeting showed that multiparametric MRI scans following a suggestive PSA test or digital rectal exam could reduce the need for a biopsy while still providing an accurate prediction for prostate cancer patients.

In his report, Dr. Haddad and his colleagues found a 73 percent reduction in the need for a biopsy when using the multiparametric MRI scan, identifying fewer potential cancers and requiring fewer biopsies as a result. Interestingly, the cost for MP­MRI is slightly lower than at transrectal ultrasound­guided biopsy. However, the study also found that the MP­MRI missed a few cancers, identifying 16 cancers for every 100 men compared to 20.4 cancers out of 100 men for the biopsy.

In deciding the best way to treat prostate cancer, doctors must weigh the risks of treatment, including its affect on quality of life for patients, against the potential benefit and life­saving capabilities of treatment. Because so m​any prostate tumors do not behave like typical cancers, and do not pose a risk to the patient’s life,​urologists are constantly looking for ways to better predict the outcome of a particular cancer. This particular study showed the potential for the use of MRI technology to identify cancers even without the use of a biopsy.
According to Dr. Haddad, the study was successful in determining that MP­MRI was able to reduce the number of prostate biopsies for patients in a cost equivalent way. However, he did state that further study was needed to determine the clinical significance of the cancers missed by the MRI. As an initial study, it shows promise, and further study in the future will help determine whether this can be an effective diagnostic choice.

http://www.urologyweb.com/robotic-prostate-cancer-surgery-a-public-health-nightmare/
http://www.urologyweb.com/wp-content/uploads/BEWARE-BEWARE-FDA-_APPROVED_-ROBOTIC-PROSTATECTOMY-CARE-1.pdf

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MRI Guidance for Prostate Biopsies Increases Chances of Finding Aggressive Cancers

Traditionally, biopsies to detect prostate cancers rely on ultrasound guidance but a recent study published through the Washington University School of Medicine in St. Louis indicates that MRI may be a more accurate technology. Presented on May 19 at the American Urological Association meeting in Orlando, Florida, the research found a direct correlation between more accurate prostate biopsies and the use of MRI technology to guide the placement of needles.

Patients who are in a watchful waiting therapy for prostate cancer typically are given a biopsy when their PSA number rises above 4.0 ng/ml. This rise in PSA levels may indicate a growth in the tumors, and biopsies can help predict how aggressive the cancer is becoming. However, ultrasound technology cannot visualize tumors well, so urologists will randomly biopsy the prostate gland to gather tissue samples. This random process leads to a higher risk of a false negatives because the needle may have missed areas of cancer.
In the Washington University study, Dr. Gerald Andriole and radiologists from the Mallinckdrodt Institute of Radiology used MRI scans of the prostate to biopsy 70 men with PSA scores of just above 8.0 ng/ml, on average. Dr. Andriole took tissue samples from those areas that looked suspicious on the MRI, as well as any areas where the MRI was not able to visualize well . H​is results showed that these targeted biopsies were nearly three times as effective at finding cancer than non­targeted biopsies.​In addition, they were four times more likely to detect aggressive tumors effectively, and therefore order treatment only for patients who had this disease.

The study was not perfect, however. Dr. Andriole noted that the process predicted positive biopsies around 62 percent of the time. Researchers believe, however, that improvements in MRI technology may make it an even more viable option for prostate cancer screening, allowing doctors to rule out the need for a biopsy when the MRI result is negative.

Read More >
http://www.urologyweb.com/wp-content/uploads/BEWARE-BEWARE-FDA-_APPROVED_-ROBOTIC-PROSTATECTOMY-CARE-1.pdf

http://www.urologyweb.com/robotic­prostate­cancer­surgery­a­public­health­nightmare/

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A Look at the Status of Focal Therapy Treatments for Prostate Cancer

At the American Urological Association’s Annual Meeting held in May of 2015 in New Orleans, Peter A. Pinto presented information highlighting the current status of focal therapies for prostate cancer. According to the report, over 27,500 men were estimated to die from prostate cancer in 2015, pointing to the need for a more effective and definitive therapy for their treatment. Because of the potential harm of whole­gland treatment, including the risk of incontinence and impotence, MRI­guided focal therapy and MRI­focal ablation as a treatment for prostate cancer is growing in popularity, both with patients and physicians.
Focal ablation uses energy from a variety of sources, including high­intensity focused ultrasound (HIFU), photodynamic therapy, lasers, and cryotherapy, to destroy the cancer inside the prostate gland. Focal laser ablation was the focus of the report at the AUA meeting as this treatment is compatible with MRI scanning and doctors can localize precisely the areas they are targeting and protect the surrounding soft tissues.
According to the report, clinical trials on 12 patients at the University of Chicago found minor adverse affects to the laser treatment. Patients had no significant changes in IPSS and SHIM scores, while 8 patients had no tumors at the ablation site. Two patients had contralateral Gleason 6 and four patients had residual disease. A repeat study with 15 patients at the National Cancer Institute found similar results. In the second study, 13 patients had no tumors while 2 patients had residual disease, one with G6.
This study points to the potential benefit of focused laser ablation to effectively treat prostate cancer while protecting the quality of life of the patients. Further study as to the effectiveness of the treatment is needed.
Read More >
http://www.urologyweb.com/wp­content/uploads/BEWARE­BEWARE­FDA­_APPROV ED_­ROBOTIC­PROSTATECTOMY­CARE­1.pdf

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Focal Therapy and Image­Guided Treatment the Future of Prostate Cancer Treatment

At the 2015 European Congress of Radiology, Dr. Hashim Ahmed, senior lecturer at the University College London, presented data on his results using HIFU to treat over 500 men with prostate cancer. According to his results, this treatment, and other treatments that target the cancer rather than the entire gland, have excellent results.

Traditionally, men with aggressive prostate cancers are treated by destroying or surgically removing the entire gland. While this can effectively remove the cancer, it is damaging to the patient’s overall quality of life, causing significant harm and removing part of the body that may not need to be removed. In fact, at the best treatment centers, over half of patients suffered from erectile dysfunction after prostatectomy. This prompted Dr. Ahmed to study focal therapy as a way to treat prostate cancer while preserving quality of life.
In his research, Dr. Ahmed treated over 500 patients with prostate cancer using high­intensity focused ultrasound (HIFU) through trials or in his clinical practice. At a median follow up of three years, he had a 100 percent survival rates. Just 0.5 percent of the patients required salvage therapy, and redo rates were 13.6 and 18.6 percent. Metastasis­free survival rates were over 99 percent for the patients as well.
Focal treatments, like HIFU, allow doctors to target only those areas of the prostate gland that actually need treatment. Instead of treating the entire gland or all areas of cancer, doctors can treat only those areas that are aggressively growing. Doctors can even treat one cancer area, which is identified as aggressive, while leaving a smaller area alone for active surveillance. This improves survival rates while protecting quality of life.
Improved imaging, including improvements in MRI, are helping doctors be more confident when choosing these treatments and following patients through active surveillance. This, in turn, is lowering the number of unnecessary procedures and doctors work with patients to preserve quality of life while living with prostate cancer.

Dr. Ahmed and his colleagues are convinced that image­guided therapies, like HIFU, are the future of prostate cancer treatment, allowing for good cancer control, retained potency, retained continence and a much better quality of life.
Read More >
http://www.urologyweb.com/wp­content/uploads/BEWARE­BEWARE­FDA­_APPROV ED_­ROBOTIC­PROSTATECTOMY­CARE­1.pdf

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THE MANY ROBOTIC PROSTATECTOMY COMPLICATIONS

B​ert Vorstman MD, MS, FAAP, FRACS, FACS w​ww.urologyweb.com
The robotic prostatectomy is probably associated with more complications than any other surgical procedure. Furthermore, it is the only procedure where its many complications will also impact your spouse/partner and, commonly lifelong.
The following will let you understand why the robotic prostatectomy and its many complications is not for you.
> the dangers of the robotic prostatectomy are clearly evident from a Google search by the endless lawsuits filed against surgeons and the robot device manufacturer
> the scores of self­reported harms listed on the FDA’s own product safety system, MAUDE (Manufacturer and User Facility Device Experience) ­ representing only about 8% of actual adverse events
> the warnings issued by the USPSTF (U.S. Preventive Services Task Force), a Government oversight agency and that the harms of PSA­based prostate cancer screening and treatment outweigh any benefits
> the many warnings from a number of physicians and organizations
> the robot makers themselves who clearly recognize the device dangers for radical prostatectomy as their disclaimers are getting longer with each revision
These many warnings about​the dangers of the robotic prostatectomy are even more egregious when you also realize that:
> the FDA urology panelists approved fraudulently, the robotic device as safe and effective for use in the radical prostatectomy on the basis of some low­level and irrelevant gallbladder studies only and, without a single case of prostate cancer being included in that trial
> the AUA labelled the radical prostatectomy as “standard” for treating the common Gleason 3+3=6 “cancer” which LACKS the very hallmarks of a cancer. In essence, many men are treated for a disease which needs no treatment, undergo surgery with a scientifically unproven device and, are often left limp and leaking
> 2­3% of ALL men diagnosed with prostate cancer will die from their disease but only if they have high­grade prostate cancer. The Gleason 3+3=6 is NOT a health risk
Read More about the many Robotic Prostatectomy Complications >
http://www.urologyweb.com/robotic­prostatectomy­complications/

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​PROSTATE CANCER GRADE CREEP

B. Vorstman MD, MS, FAAP, FRACS, FACS
w​ww.urologyweb.com
The most common cause of prostate cancer grade creep is NOT some progressive worsening of a prostate cancer grade (aggressiveness), but a tendency for some pathologists to overestimate or inflate a Gleason grade and score to have a man thinking that his disease is more significant than it really is. In other words, grade creep is commonly grade inflation.
Currently, many men diagnosed with the Gleason 3+3=6 prostate “cancer” are well aware that this so­called cancer LACKS the hallmarks of a cancer (on both clinical and molecular biology grounds) and that they do not need any treatment. However, men can be deceived into thinking they should be treated if their Gleason grades and score have been inflated.
2­3% of ALL men diagnosed with prostate cancer will die from their prostate cancer but, ONLY if they have high­grade prostate cancer, not the 3+3=6 disease. Furthermore, the 3+3=6 does NOT progress to become high­grade cancer.
Although, it is evident now that the mp­3T MRI (in the right hands) is becoming quite reliable for detecting and diagnosing only the high­grade prostate cancer (and not the 3+3=6 which does not need treatment) to a point where a confirmatory prostate needle biopsy may not even be necessary, MRI prostate cancer screening is yet to be funded by insurance companies. Until then, there are some steps you can take to get some confidence about the real state of your pathology. Many of these steps also, may not be funded by your insurance company but they can be important for those men diagnosed with the Gleason 3+4=7 and those with high volume Gleason 3+3=6 disease. Only high­grade disease needs treatment.
> pathology validation. Any diagnosis of prostate cancer should be validated by an independent pathology reference laboratory to minimize the chance of under­reading or, inflating the Gleason grades and score. Validating your pathological diagnosis is especially important as many pathologists are employed now by robotic or radiation groups and these associations can be affected by the most powerful conflict of interest which is being financially incentivised to “treat” or, not to treat
> biomarkers such as ERG and PTEN immunohistochemistry studies, ProMark (an immunofluorescent study), Oncotype DX and Prolaris (assays the cell cycle gene signature) may assist in identifying more adverse pathology
> a confirmatory 12 core prostate needle biopsy 12 months later
> 6­12 month PSAs, PSA derivatives and PSA density while monitoring PSA kinetics for any persistent upward trending which may suggest the need for another biopsy or mp­3T MRI
Read More About the Deceptions in the Prostate Cancer Arena >
http://www.urologyweb.com/wp­content/uploads/BEWARE­BEWARE­FDA­_APPROVED_­ROBOTIC­PROS TATECTOMY­CARE­1.pdf

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Beware, Beware, FDA “Approved” Robotic Prostatectomy Care

CORAL SPRINGS, FL—MAY 18, 2015— A South Florida‐based urologist today has
issued a stinging report critical of the Food and Drug Administration (FDA) decision
to approve robotic surgery for treating prostate cancer on the basis of only some
low‐level and irrelevant gallbladder studies.

Dr. Bert Vorstman is a proponent of focal therapy in certain cases of prostate cancer
and his dire warnings regarding the misrepresentations, lack of ethics and chicanery
surrounding the robotic prostatectomy have been echoed by a number of physicians
and organizations.

Said Dr. Vorstman, “Not only has the healthcare public been totally duped into
thinking that robotics have been scientifically proven to be safe and effective in the
treatment of prostate cancer (when it has not) but the robotic prostatectomy is
commonly used to treat the Gleason 3+3=6 “cancer” which lacks the hallmarks of a
cancer. In essence, many men are treated for a disease which needs no treatment,
undergo surgery with an unproven device and are often left limp and leaking.”

In his report, Dr. Vorstman added, “The dangers of the robotic prostatectomy are
clearly evidenced by the endless lawsuits filed against surgeons and the device
manufacturer; the scores of self‐reported harms listed on the FDA’s own product
safety system, MAUDE (Manufacturer and User Facility Device Experience)
representing only about 8% of actual adverse events, as well as the warnings
issued by the USPSTF (U.S. Preventive Services Task Force), a Government oversight
agency and the robot makers themselves who clearly recognize the device dangers
as their disclaimers are getting longer with each revision.”

Dr. Vorstman continued, “The intentional withholding of information, deceptions, and distortions regarding the radical prostatectomy being perpetrated now by robotics advocates know no bounds. Even worse than the fraudulent approval of robotics for treating prostate cancer without a single case of prostate cancer ever being tested for that study was the recent shameful FDA denial of the high‐intensity‐focused‐ultrasound (HIFU) application. For this HIFU device evaluation, emboldened FDA urology panelists protected their fraudulently approved robotic prostatectomy franchise even further by conjuring up trial criteria ensuring the HIFU application would fail.”

Furthermore, said Dr. Vorstman, “Embarrassingly, some urologists have stooped
even lower recently by exploiting the medical illiteracy of Senate Staff for a political
pushback on the USPSTF to discredit its “D” grading of PSA‐based prostate cancer
screening and their conclusion that screen‐detected prostate cancer treatment
benefits are outweighed by the harms.”

Dr. Vorstman warned, “The FDA is responsible for protecting the public health by
assuring the safety of medical devices. However, when powerful urologists are able
to penetrate the nation’s oversight agencies and exert influence to satisfy self-serving needs, it signals a dangerous failure of regulatory oversight. Sadly, the need
to protect a surgical “truth” which only urologists can see, has trumped patient
safety in favor of profit.”

To review Dr. Vorstman’s full report, please go to
http://www.urologyweb.com/wp-content/uploads/BEWARE-BEWARE-FDA-_APPROVED_-ROBOTIC-PROSTATECTOMY-CARE-1.pdf

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ROBOTIC PROSTATECTOMY “ FDA APPROVAL” DECEPTION

Bert Vorstman MD, MS, FAAP, FRACS, FACS
www.urologyweb.com

The FDA approval of robotics for prostate cancer treatment in 2000 was based upon a trial conducted by the robotic company itself. Aside from this serious conflict of interest, the trial had two other major problems:
a) the study was undertaken only on diseased gallbladders
b) when the 113 men who had robotic surgery were compared to the 132 men who had laparoscopic surgery, the robotic surgery proved no more effective than the standard and less costly laparoscopic surgery
However, underhandedly, using an arbitrary “soft­tissue” classification to include both the gallbladder and prostate, the FDA urology panelists were able to finagle an “FDA approval” of robotics for “treating” prostate cancer without the device ever having been tested directly on any prostate cancer for safety or effectiveness.
To read more about how these FDA urology panelists pulled off this fraudulent exercise and continue to endorse the radical robotic prostatectomy as “standard”, go to: Beware, Beware FDA “APPROVED” Robotic Prostatectomy Care

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