Gat Goren, PAE, LUTS, Part 5

Clap: Apparently most countries do not accept patenting a medical procedure.

Adopted by the 51st World Medical Assembly, Tel Aviv, Israel, October 1999
and amended by the 60th WMA General Assembly, New Delhi, India, October 2009

PREAMBLE
Under the law of some jurisdictions medical procedures are patentable. Patents on medical procedures are often called medical procedure patents. A medical procedure patent or patent claim is one that only confers rights over procedural steps and does not confer rights over any new devices.

Over 80 countries prohibit medical procedure patents. The practice of excluding medical procedures from patentability is consistent with the Uruguay Round of Amendments to the General Agreements on Tariffs and Trade Agreement on Trade Related Aspects of International Property Rights (GATT-TRIPs), which states: "Members may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals" (Article 27).

http://www.wma.net/en/30publications/10policies/m30/

Liam: Thanks for your update. As I mentioned before, your improvement came quickly, at least compared to mine. I didn't notice any improvement at all for 3.5 months, and satisfactory improvement didn't come until two full years. Which only goes to prove that every case is different.

The main value of this board is first-person reports from people who actually had the procedure (GG, PAE or other). I look forward to future updates from you.

Skateman: Thanks for the background on the GG patents. It doesn't bother me that Dr. Gat's theories may have had predecessors. As I indicated in my previous post, some great breakthroughs turn out to be rediscoveries of older unappreciated insights that for one reason or another didn't catch on the first time.

Martin: Dr. Gat told me once, or I read from his papers, that the failure of the ISV valves is associated with age, height and some types of heavy-duty physical activity (e.g., weight lifting). Seems reasonable to me. It's quite remarkable that a simple (though expensive) procedure suffices to restore flow enough to undo some of the damage of the prostate.

Now regarding the speculation here that the apparent lack of interest by interventional radiologists undercuts claims about the efficacy of GG.... In a perfect world, where the interests of the physician are 100% aligned with the health of the patient, perhaps that conclusion might be valid. Sadly, we do not live in such a perfect world. Doctors need to take into account practical factors, too. If a doctor wants to keep his standing in his professional organization (urologists, etc.), he needs to abide by the guidelines of his organization. And if he wants to get paid for his efforts, he needs to do procedures that have been pre-approved by the authorities and the insurance companies. Most doctors are too busy with their regular work to delve into the details of experimental (that is, not "officially approved") procedures. All of this is perfectly self-evident to me, having had my share of run-ins with both doctors and dentists. Should insurance companies start covering GG tomorrow, then the day after every IR in the US will be doing it (slight exaggeration for effect). It's how the system works.

As for the supposed lack of data on GG, here's a 2008 paper listed on the clinic's web site:
http://www.pirion.co.il/images/pdf/Reversal%20of%20benign%20prostate%20-%20ANDROLOGIA.pdf
Study 3 is relevant; it is the 28 patients that Martin mentioned. Peer-reviewed papers like this played a large part in my decision to have the procedure 3.5 years ago.

Clap: No one knows for sure what the success rate of GG is. Like most medical or surgical procedures, it no doubt depends on many factors.

One factor is probably how severe the case is. As I've written before, my greatest regret about GG is that I didn't have it done before my symptoms became severe. Even five years earlier would have helped me avoid a lot of discomfort. And had my doctors known about it in 1991, when my prostate problems first surfaced, or in 1980, when my urinary frequency started to become a minor issue, who knows how much grief I could have avoided.

Post Edited (Chicago Dave) : 11/17/2014 8:07:26 PM (GMT-7)

I'm about a month into the urolift procedure. I'm just beginning to experience some improvements. The studies show improvements will have manifested within the first 3 months. At this point I can't give a thumbs up or down. I'll keep you posted on that.

As I read the back and forth on Gat Goren I find it keeps pointing to the elephant in the room…..the varicocele procedure. My educated guess is that Gat Goren discovered that the varicocele procedure, widely used in infertility treatment round the world including the US, resulted in prostate shrinkage. It seems to use the same methodology of sclerosing the spermatic veins and is available in the US covered by medicare if you have varicose veins of the balls or available at at 1/4 to 1/5 the cost of the Gat Goren procedure if you pay out of pocket. If my memory serves me 3 or 4 guys have reported here as to going that route with Frank of Florida being the last. This seems to be an obvious candidate as the most bang for the buck and reports have been pretty positive. I mentioned it to my urologist and he said he'd ask his friends who do infertility work if they've noticed prostate shrinkage from varicocele but I
haven't heard back from him.

Hi Dusab,

1. I hope your varicocele procedure is a rousing success.
2. What is the name of the Belgian interventional radiologist, and what is that radiologist's success rate?

Ira

Following up on Mark Daner's insight, I checked the Internet for California doctors that engage in varicocele removal to overcome male infertility. I found one named Paul Turek. One of his web pages is here:

http://theturekclinic.com/services/male-fertility-infertility-doctor-treatments-issues-zero-sperm-count-male-doctors/varicocele-surgery-symptoms-treatment-repair-pain-cost/

I sent this message (using his form contact page) to him:

Skateman said...
Dear Dr. Paul Turek,

There is discussion among BPH sufferers who also have varicocele about whether or not removal of the varicocele will tend to cause the size of the prostate to shrink, with consequent diminishment of BPH symptoms. One discussion of the subject can be seen here:
https://www.healingwell.com/community/default.aspx?f=35&m=3079381&p=6

Doctors Ygal Gat and Menachem Goren, who currently practice in Israel and Cyprus, contend that it does. Their application for patent in connection with the subject can be seen here:
http://www.google.com/patents/EP2178594A2?cl=en

Their webpage on the subject can be seen here:
http://www.pirion.co.il/index.php?option=com_content&view=article&id=6&Itemid=69&lang=en

If I understand correctly the information on your website, you have performed 100s of varicocelectomy procedures. I suspect that most of your patients tend to be younger, and not yet suffering from BPH.

However, at least some of your patients likely were suffering from BPH symptoms.

One question is this: Did any of these patients indicate to you a reduction in those symptoms?

Another question: Do you remove the same, less, more veins than do Drs. Gat and Goren (as described in their application for patent)?

Thank you in advance for your response.

Ira

Edit: I also sent similar queries to Drs. Gary Bellman and Philip Werthman

Post Edited (Skateman) : 11/18/2014 6:30:22 PM (GMT-7)

Skatman: 'One question is this: Did any of these patients indicate to you a reduction in those symptoms? Another question: Do you remove the same, less, more veins than do Drs. Gat and Goren (as described in their application for patent)?'

Great! Thank you for taking the trouble.

I have been assimilating the attempt of Gat/Goren to register a patent in the USA which is not an original idea. The more I think about it and other relevant 'missing material' that a future 'client' should have, the more I think that the good doctors are quite concerned with money.

Not that I have any problem with people becoming rich. Just not off the back of people suffering from prostate problems when the results are certainly not clear.

1.

ClapTheHammer---emphasis in original said...
I have been assimilating the attempt of Gat/Goren to register a patent in the USA which is not an original idea.

Don't be put off by a patent applicant's attempt to patent a method, process, article of manufacture, or system that turns out to not be "new." That is, even though not new, the idea may still be original. So, while the process, article of manufacture or system would not be patentable because it is not new, the applicant may still be acting in good faith because his development was "original" (i.e., not copied by him from another source).

2.
Regarding my queries to doctors such as Turek, Bellman and Werthman, while I hope to receive responses, I expect to get none. Medical doctors are reticent about putting anything in writing.

3.
In 1897 Dr. Spinney of Buffalo, NY advertised "Varicocele . . . cured. No cutting." See advertisement in lower right corner of this web page:

http://fultonhistory.com/Newspapers%2021/Buffalo%20NY%20Courier/Buffalo%20NY%20Courier%201897/Buffalo%20Ny%20Courier%201897%20a%20-%201759.pdf

4.
Thanks, Dusab, for Thoorens' name. I've looked, and cannot find anything about him on the Internet.

Ira

DUSAB. I appreciated the fact that he also worked a lot to find and penetrate the right side ISM vein because the upper valve was still functionning somewhat there. In many case IV radiologists dont insist if after 15 minutes they fail to find and penetrate the right ISM vein

Yes. In Gat/Goren's favor is the fact that they know their way around the veins in that area. Something that would put them in good standing relative to 'beginners'.

But that doesn't explain or excuse the complete absence of peer-reviewed statistical data as to the relative success or failures involved.

This is still in the realms of experimental surgery and should not be done for financial gain. Which, I understand, is why the Ministry of Health in Israel has banned 'the good doctors' from performing the procedure in Israel for financial recompense.

All my previous comments express some nagging suspicion of something odious in the way that the 'good doctors' behave. The have been silent on this thread, (a four year old thread in its various pieces), and I am sure that some commenters are alerting them to its contents.

Yet their 'silence' continues.

Skateman
You will not find any Belgian interventional radiologist advertising for varicocele treatment on the internet it is forbidden by law (for any doctor). They have there a national compulsory health insurance for years. Now it is mainly the urologists who diagnose varicocele and they scleroze themselves the ISM vein (mainly only the left side and using an access by surgery). My Belgian urologist claimed nothing was wrong with my ISM veins. His diagnostic was wrong as a bad left ISM failure was discovered by thoorens angioscopy. For an interventional radiologist to cure a varicocele he needs a prescription by a doctor having made a varicocele diagnostic and so it is accepted by the health insurance which pay for it.

To find the radiologist thoorens, you must Google "centre regional hospitalier de Huy " when on site you click "services" then you click on "imagerie medicale" Then there you click on "equipe" and the list of radiologists appear.In this hospital Pierre thoorens only is a qualified interventional radiologist of the same generation as GG who has a long experience in varicocele treatment trough an iliac vein catheter. To find him first I looked on the site of the International interventional radiologist association

Opinions have been expressed that if the GG procedure was valid then the Establishment, personified by Urologists on one hand, Radiologists on the other, would have embraced it, wouldn't they?
Well, no.
The Great Men of the Urology specialty undoubtedly know about Gat Goren, as there have been several papers in various journals of that profession since 2008. They keep silent because not only is there nothing in it for them, it actually represents a serious threat to their comfortable money stream. Generally speaking, no urologist has the skills to perform the Gat Goren procedure, it's a different skill set, and if any significant number of their traditional clientelle is lured away, it will only get worse. So they are dismissive, angrily so at times, hoping that it will go away.
The radiology profession has not embraced it for a good reason. When was a sufferer of BPH last referred to a radiologist for an opinion, instead of an urologist? The radiologists do the hack work. The Urologists certainly aren't going to tell them that their previously private gold mine is now accessible to radiologists. So the radiologists remain in a fog of unawareness and I'll bet that very few of them have ever heard of Gat Goren.
Thus it is up to those of us who find the GG alternative to paddle our own canoe.

Hi Liamireland and Golfosca,

1. I hope your results are positive ones.

2. If you've read AND UNDERSTOOD my comments and the comments of others, you would know that many of us believe that the Gat Goren theory makes sense. You would know that I, an experienced engineer and lawyer, and others realize that good theories sometimes turn out to be partly or even fully wrong. Further, you would know that at least I pointed out that objective measurements could be made. So, the consternation of some of us on this forum at the lack of statistics from GG procedures should be understandable to you.

3. Golfosca, you wrote, "Success rate 85% or so including extreme cases, over 250 procedures to date." From where did you get that statistic? And, what is the threshold for a procedure's being considered a success?

4.

Golfosca said...
Suspicion and misinformation seem to have dominated this forum since my last look.
The Gat Goren procedure does not remove any vein. It does not remove any organic material. It does nothing to any artery. It does nothing to the Internal Spermatic Vein. It scleroticises (blocks) the very small transverse veins that otherwise convey (spermatic) venous blood from the base of the ISV across to the prostate, where it bathes the prostate in 130 times its normal concentration of free testosterone.

I think you've been misreading the comments here. No one has said that GG removes veins or any other organic material (except to the extent that the body itself removes necrotized material after a GG procedure).

Regarding something being done to the internal spermatic vein, if GG's patent application (which can be found here: http://www.google.com/patents/EP2178594A2?cl=en) is to be believed, at least one of the internal spermatic veins is sclerotized. See this:

GG patent application (emphasis added) said...

"In exemplary embodiments of the invention, the reflux is prevented or impeded by occlusion, of the internal spermatic vein, or veins, that have effected the hydrostatic pressures and back flow (e.g. by embolization, sclerosis, or occlusion). Optionally or alternatively, some or all veins through which the reflux flows to the prostate are occluded. Optionally or additionally, bypass veins 136 that might have developed (for example, as a result of the hydrostatic pressure) are occluded if they carry blood from the testis to the prostate. Optionally, the veins carrying blood to the prostate, such as the deferential vein, are occluded initially in order to prevent testicular venous blood rich in testosterone (relative to normal circulation) from reaching the prostate, allowing recovery from the venous congestion and shrink the swelling and/or tumor. Optionally, a spermatic vein which affected the excessive hydrostatic pressure is occluded, optionally after treatment of veins leading blood to the prostate, to allow drainage of testosterone rich blood to the body via vessels such as the scrotal veins or other bypass veins 136. Optionally, the occlusion is applied in the opening of a vein or at a spot or region along the vein so that blood cannot flow in the vessel.
***

"In exemplary embodiments of the invention, the reflux is prevented or impeded by occlusion (e.g. embolization or sclerosis), of the left internal spermatic vein 102 and/or the right internal spermatic vein 130 that has effected the excessive hydrostatic pressures EP. Optionally and additionally, some or all veins through which the reflux flows, such as the deferential vein 110 and the pampiniform plexus 118, are occluded. Optionally or additionally, bypass veins 136 that might have developed are occluded too. In exemplary embodiments of the invention, deferential vein 110 is occluded to block the backflow of testicular venous blood into the prostate, relieving it of the excessive pressure and high testosterone, and allowing it to recover. Optionally, other veins are not treated for backflow and/or varicocele, at least for a certain time duration."

Perhaps GG have modified their procedure. If they haven't, then something certainly is being done to at least one of the internal spermatic veins.

Skateman

Golfosca and Liamireland...I wish both of you success with your recent procedure. I too was very optimistic 27 months ago when I visited Israel. The 85% of good results per the website, resounded in my mind like a prayer from heaven. The day I would not have to go visit the urinal at night, sleep well and avoid the complications of a TURP...barbarism personified, filled me with hope. I also was in contact with another former member of this board, an Israeli, whose prostate after the procedure shrunk 50%.

At 72 I am in perfect health. Never visited a hospital, excellent blood chemistry, low 0.6 PSA, play singles tennis for an hour twice a week in 90 degree Florida heat with my Tennis pro (he taught Serena and Venus Williams when they were children). Never take a drug, rarely an aspirin and certainly no flomax, uroxotrol and other prostate drugs that cause side effects.

My urologist on June 25, 2012, diagnosed me with a 41 g enlarged median lobe with narrowing of bladder neck. Without the median lobe gland volume would be about 25g. The bladder base appeared normal, no hypo echoic areas noted, no calculi and bladder volume post void of 97cc. There was a median lobe seen at the level of the bladder neck consistent with BPH. . A TURP was advised.

In August 2012, I traveled to Israel to have the procedure done. Everything went normal. For 6 months afterwards I saw no improvement. On Feb. 14, 2013 I went back to my urologist. Diagnosis: "The estimated gland volume is relatively stable at about 50g, perhaps some decrease in the central portion of the gland transitional zone region subjectively, but median lobe is still very prominent. There has not been much significant change since preoperatively. Impression: Mild to moderate symptoms of BPH with mainly median lobe with about 45 to 50g prostate. He is status post bilateral internal spermatic vein occlusion and the prostate was expected to shrink and it has not shrunk very much after the Gat Goren procedure."

I wrote Dr. Gat. I did not hear back. Perhaps with his busy schedule my email was misplaced. More than a year ago, I faxed an IPSS survey form at the request of Dr. Gat's office. I have not heard posting of this survey on the internet or any personal followup.

Despite my disappointing results, I believe the Gat Goren procedure has worked for many people and has considerable merit. The science and pressure flow dynamics behind it sound outstanding. In my case though, I do not understand how the prostate can shrink without the mid lobe also being effected. Perhaps their are multiple causes to BPH causing venous pressure gradients to increase from compromised spermatic valves resulting in excess DHT bathing the prostate. Hormone imbalance, diet, weight, exercise, disease etc. may play a part. Based upon the fact that Orientals do not have such problems as Westerners, I feel this might be the case. I have had high levels of SHBG. For one month on stinging nettle root (5ml.) I have seen my nightly urinal visit go from 3 hours to 5 hours. Here's hoping!

Good luck to both of you.