Doctors and Referrals

I recently had a question asked of me and I answered. I thought perhaps the answer may be of interest to others.

QUESTION:
Why doesn't an oncologist or other treater have an ethical obligation to make people aware of other trials and treatments that are available outside of their own facility? For example, when I asked about Satraplatin, I am simply told it is not available. It may not make a difference to us, but I think that information might be invaluable to other people at prior stages in this relentless disease.


ANSWER:
Primarily it is money. The Universities are paid on a per patient basis when they enter them into trials. They are paid either by the drug company or the NCI or other Federal and sometimes States. The money goes to keep the departments running (and the doctors paid). No trials - no money - simple as that.

However many University doctors (usually very senior doctors who have earned the right to be more independent) will advise about other trials at other Universities where they think it might be useful. And there is information on the Internet about the availability of trials across the United States.

The other interesting little known fact is that the Universities doing the trials will pay the non-university referring doctor a set amount to refer a patient to a trial. I know $2000 has been paid to Urologists for that referral. I do not know the complete range of the payment. Of course this payment is never disclosed to the patient from the Urologist of the people running the trial. One of the interesting side issues of this practice is having a great University and its medical school in your back yard but the local Urologist refers patients to a lessor one maybe 400 miles away because the far away University pays a finders fee or a higher finders fee than the local University.

Also this money becomes important referring patients within the University. For example if you are seeing a Urologist in a University setting he may refer you to a Radiation Oncologist, Medical Oncologist, etc., within the University. It is assumed by the Doctor/professors involved that these are the top of the line doctors. This is simply not true. The referring of doctors only within the University is an unwritten rule. If you want to stay employed there and have peace with your fellow Professors - you better feed them.

We do see great surgeons and some other fields in Universities but the run of the mill doctor in the university may or may not be (and frequently are not) the best in the business. This is why we talk about individual "Doctors of Excellence" and not treatment centers. A well know treatment center may be well know because of the politics involved or simply because they treat all disease with various levels of expertise. And that expertise is usually not prostate cancer. One should be able to pick their center based on the results of that center in the disease that you have and the particular doctor that has the most expertise. Many know who the "best" doctors are in any particular field but it is almost impossible for a lay person to find that information and, therefore, he relies on this primary doctor for referrals - perhaps a bad thing to do.

There is very little that goes on in the Medical industry that does not involve the exchange of money in some way. the old "follow the money" is as important here as it is elsewhere. The "old boy network" is extremely strong here and if you want to play you better bring in the money.

It is often said as a Professor you must "publish or perish". It really means "produce money or perish". This production of money is also involved with getting donations, outside of the trials, for Chairs, new equipment, new buildings, etc. You could be the greatest in the world but if you don't produce income from trials, etc - you will not be there long. It is a requirement (maybe unwritten but well understood) in these institutions.

I have asked for years to bring the trials down to the level of the just diagnosed. There is little being done on this even today. Why do we not attack this disease with things that we use in advanced or end stage disease to see if these protocols may be successful at the beginning stage. Again it may well be money. When the drug companies are making huge sums of money off of end stage disease - do they really want to fund trials that may cut off the sources for these end stage medications. Imagine if you will if we could cure all prostate cancer (and other cancers) at the front end - how much money would be lost at the back end of this disease.

I think the other thing we overlook is that Universities are really large corporations no different than the large corporations that we have seen do wrong things in any industry. I have seen similar things within the Universities - it just does not make the news - or if it does it is on the back page.

If you don't believe me look at the thousands and thousands of patients are killed in hospitals because of wrong diagnosis, wrong medications, infections, on and on. These come up occasionally in the newspaper - but little seems to ever get done. If we had something else out there killing these thousands - all hell would break loose. We have had some 3000+ over 4 years of our young men killed in Iraq and the population is up in arms. Yet me kill more than this on a monthly basis in hospitals across this country and nothing is said. To me there is little difference in killing on the battlefield and killing by the medical profession. Both should be given equal time and both could be prevented.

OK, enough of my soapbox.

Why treating prostate cancer is a guessing game.

I think that most failures of conventional treatments with a Gleason 3+3=6 is due to the mis-reading of the Gleason score or other diagnostic items. It is my belief that if we had a true 3+3 and nothing else, no 4 or 5, no spread, nodes not involved, no extra capsular penetration, no margins (in surgery), small volume of tumor - at the hands of an "expert" the person is 100% curable.

Every failure may the fault of mis-diagnosis or unknowns.

PSA is a very unreliable gage of the cancer at the time of early diagnosis. The higher the Gleason the lower the PSA. For example we can have a Gleason score of 8, 9 or 10 and have a PSA of 1 or so. On the other hand we could have a PSA of 10 or so with a Gleason of 3+3=6.

We look at doubling time of PSA as being an important findings. However with a Gleason score of 8, 9 or 10 and a low PSA - the doubling time may be very long. With a Gleason 3+3=6 the doubling time can be short or long.

Why the difference - the difference may be in the tertiary grade. For example if we had a high Gleason (8, 9 or 10) and no tertiary grade we would always have a low PSA and probably a low doubling time. In addition there are places in the Gland that cannot be reached by our normal needle biopsy. These could have lots of tumor of high grades and we don't even know it.

If any gland had any Gleason grade 3 in it (regardless of reported grades) than we could have a higher PSA and a higher doubling time.

Two more important variables:
1. The volume of the tumor could make a large difference and what is the grade of that volume. One could have a 3+3=6 with a very small spot and a 3+3=6 where their is a lot of cancer. Two different diagnosis with two different treatment considerations.

2. Prostate cancer has many different cell variations. We know that some cell types will respond differently to different treatments (this is never taken into consideration by the doctors in their diagnosis - there is no lab tests that are commonly used to show this. I believe the cell types would apply to different Gleason Grades and perhaps different growth patterns and different production of PSA. There may be 30 or more different types. And there is no known attempt to type cells and study the differences.

The doctor only works with the known diagnostic information and makes decisions, based on studies, of these known findings. If there is no higher Grades reported, if there is no reported volume of all grades, if there is no known "variants" (see http://www.cancer.prostate-help.org/capathl.htm), etc., etc. etc. he is very limited in recommending treatments based on studies.

Any study based on the initial diagnosis is short of diagnostic information and is only as reliable as the doctor or doctors who report the findings. If you show a sample of gland tissue to 10 different pathologist you would get many opinions and readings. If you send the same blood to many different labs you would get many different readings. And these differences could all be significant.

Now when you consider that a CT scan is worthless unless there is massive tumors growing elsewhere in the body. Then you consider there may well be bone tumors (prostate cancer of the bone) that are yet too small to be seen with our present procedures. One may well have a spread of the disease that can not be seen or diagnosed with any reliability. In these procedures the only thing you know when they report negative findings is simply that they did not see any - not that it wasn't there.

With the guessing game we have - you see why I believe that prostate cancer should always be treated with more than one modality of treatment.

We simply don't know with our present diagnostic procedures how really sick a man might be with this disease and why sometimes a man is only diagnosed when he experiences a high level of bone pain - and then it is too late.

The PC Spes story - in the beginning. Part II

I was diagnosed in 1997 and was through treatment by the end of the same year. At this point I had heard of PC-Spes but could find little solid information - only the miracle stories of how it reduced the PSA and cured prostate cancer. I attended a Prostate Cancer Conference which I think was in early 1998. I remember seeing a booth for information about PC-Spes. I picked up some information and begin to ask questions. I found out at this booth that one does not ask questions of the PC-Spes followers that might show a shadow over its use. It was very evident that they would not answer challenging questions and furthermore really did not even want to speak to you. This is where the gauntlet was laid down in my subsequent investigation of PC-Spes.

Dr. Stephen Strum had started a study of the product and had to stop the study due to the fact that a number of the patients were suffering DVT's (Deep Vein Thrombosis) - a number far greater than the normal population. He gave no explanation as to why this might happen but at that time I thought of DES because DES went out of style as a prostate cancer treatment mainly because of the DVT's in the patients. This was well known and accepted as a dangerous side effect of DES. Dr. Strum continued to support PC-Spes even past the point that lab reports had shown it contained DES - he stayed loyal to the product to the end.

Shortly after this almost every patient taking PC-Spes had their PSA spike upwards. The only way this could happen had to be a change in the ingredients in the drug. I inquired and had an answer, said to be from Sophie Chen, that they had changed the makeup of the drug to see if they could stop the DVT's. Soon. however the PSA's started going down again. At this point I believe that they dropped the dose of DES in the product but when the PSA's went up they knew they had to do something or loose sales. I figured they increased the dose to what it had been and had added something that would decrease the danger of DVT's. That product would most likely be Warfarin.

Not one person that I knew in the PC-Spes movement (including the doctors involved) would agree with me as to what had happened. The fight begins!!! I quickly became the most hated person in the prostate cancer community of those who had formed their own cult of PC-Spes worshipers.

I that point I knew I had a tiger by the tail and that I was hanging on for the ride as I searched for the truth and hoped that the truth would force the scam off the market. It was a long ride but it was finally forced off the market. I am proud of what I accomplished and believe my early voice was the beginning of the end for PC-Spes.

Stay tuned for the my additional experiences along the way.

The PC Spes story - when do we believe? Part I

A sad story!!

Today I should be jumping for joy because of a recent judgment in a supplement case which vindicate almost ten years worth of my writing concerning the lacing of the product. However I cannot be joyful when I am aware of many who thought the supplement was going to be their savior but in reality was their death warrant. Many of the times when they had relied on this supplement and found it to be lacking - they were too late and their disease had advanced beyond the curable period.

The herbal supplement was called PCSpes and was laced by the addition of DES, Warfarin, Indomethacin, and Estradiol (all prescription drugs). As the court found " The Laboratory testing of PC-SPES performed in 1998, 1999, 2000, 2001, 2002, without exception showed that every batch of PC SPES unlawfully contained dosage levels of the synthetic chemicals DES and Warfarin, as well as Indomethacin and Ethinyl Estradiol." This was known, or should have been known, by doctors who were pushing the product and by others (including LEF) who were selling the product.

The judgment for the class action was for 24 million dollars - the defendants or their attorneys did not even appear at the trial. The company IMR is bankrupt and Sophie Chen, the brains behind the fraud, has fled to England and has probably hidden the millions she received from the sale of the product in China, her native country, and elsewhere. I am afraid the class of plaintiffs may get little to nothing after the attorneys get theirs.

Why am I telling you this. It is a long story - let me start from the beginning. But before I start let me point you to the actual court "Statement of Decision with Findings of Fact and Conclusions of Law". Click on PCSpes Decision and read the document.

Now let me break the story down in several installments, each posted as I complete them. It is a long story and interesting story about the common supplementation of herbal products with other prescription drugs almost always in China and almost every imported supplement. Even when the drugs may come into the country pure - the Chinese behind the supplements in this country add the laced drugs.

This is just one of many but one which has gone to court and a court has issued an order. Unfortunately this is a story that has been repeated over and over in our history and is being repeated yet today. It seems that we have propensity to never learn from past experiences.

When is good enough treatment really "Good Enough"

The simple answer is: Any treatment claim, by any doctor or clinic, that is not backed up with substantial evidence is NOT GOOD ENOUGH. What kind of evidence? Publication of their treatment record for at least a five year period in a peer reviewed journal is the minimum you should look for. In general, the longer the study, in terms of years of patient records, and the more men included in the study, the more stock you can place in the guidance that a study provides. (However, a number of "games" can be played within studies. The most common are discussed later in this paper.)

The bottom line is this: A treatment claim that is not backed up with at least five years of data is a hollow claim. Without a peer reviewed, published, study any treatment selection is a crap shoot. Most of us do not want to make our prostate cancer treatment decisions as a crap shoot, and should not allow our doctor or medical team to make unsupported treatment recommendations for us either.

While it is life threatening, prostate cancer is not like a heart attack. We don’t have to make a treatment decision in the next 30 seconds, 30 minutes, or even 30 days. Yet, as a newly diagnosed patient, you may feel a lot of pressure to make all important treatment decisions rapidly and without enough information. Your physician, your family, and even your own survival instincts may cause you to feel the pressure to make a quick decision. Take your time. Become informed, don’t rush the decision. As difficult as it is to fathom cancer within your body, as repugnant as the thought is, it has probably been there for several years before you discovered it was there. Taking another month or two or three to make a good treatment decision is time well spent, it is just not easy for us to do when we are frightened and feeling the pressure all around us. Resist the temptation to take the first option offered by your doctor, or pressed on you by family. Fall back, calm down, and make the BEST decision, not the easiest or quickest or most convenient one.

While you have some time to make a good decision, be aware that prostate cancer is a life threatening disease. Left untreated it will kill you, if something else doesn’t kill you first. So, we can’t bury our heads in the sand either. There is also something else to think about and be aware of: There aren’t many places "to retreat to if you decide to proceed with a treatment and it fails. There are ways to delay the disease, but your first shot at a "cure" is by far your best shot. So, take careful aim, know what the best treatment options are, given your Gleason score, stage, etc., and take your best shot, because it is often the only shot you get for a "cure". Most of the time, a second shot is only to keep the enemy at bay, and is not likely to be a complete victory. Make your first shot count.

To make intelligent treatment decisions we can look at published studies and come to conclusions as to the record of the particular clinic and compare it directly with other published studies. By reducing studies all down to a common denominator they can be directly compared over a ten-year period. However one must always understand that the particular results of any doctor or clinic and their treatment modalities, are not transferable over to other doctors or clinics. All doctors are not equal in their skills - even though they may have been trained by the best. I could take golf lessons from Tiger Woods, but would I ever be able to golf as well as Mr. Woods? Most of us know the truth of the golf analogy, so why would we think differently about the skills of a doctor? Just because a doctor receives instruction from a doctor with an excellent, proven and published, record, doesn’t mean that he or she will be as good as the doctor that gave them lessons.

What makes a skilled doctor? Intelligence helps a great deal but it does not replace the hand coordination and skill of the best and well-trained physician. A well trained doctor who is good with his hands and can coordinate this hand skill with his intelligence and common sense makes the skilled doctor that we want doing our procedure in surgery, brachytherapy or Cryo. When you consider any external beam radiation, the hand skill is not as important (replaced by careful measurement and machine precision,) but the application of intelligence and common sense based on his training and experience would be what we are looking for. And, a full training course on the exact equipment is vital. A doctor who was skilled to do a simple Four Box EBRT may not have the intelligence and computer skills to be as expert in the use of IMRT.

HOW THEN DO WE KNOW THAT A TREATMENT IS THE BEST
Only one way - through comparison of studies published in the leading peer reviewed medical journals, reading them carefully and allowing for changes in the definition of failure. You also must pay attention to and balance for such things as Stage, pre treatment PSA, Gleason, Length of follow-up, range of follow-up (anything less than five years minimum has little value), median or mean figures, the publication it was published in, how it was conducted, how much radiation was used, and other factors. (It appears that even the order in which treatments are given can alter the outcomes significantly.) The question becomes where can one learn how to do this and to make those adjustments. It is not easy and it takes years of reading of studies to fully understand what they say. If you don’t read the paper referred to above (2) you must either have this ability or know someone who does and regularly publishes comments on the various studies. There is only one place that you can consistently get this information and that is Prostate-Help on its web sites (4), Groups (5) and Conference/Chats (6). Yet, you must still do some reading and you must still pursue the truth in order to make a good, informed, decision for yourself.

TREATMENT CHOICES BASED ON???
We are fighting a life threatening disease. There is only one criterion that should be considered first and that is the chance of being cured and living a long life. If all else is equal in terms of disease freedom - then and only then should one consider the morbidities! If you die from this disease one really doesn't care what the morbidities might be. If you worry about becoming impotent and make your choice of treatment based on this one item - remember always that an erection on a corpse does you no good. (How good is sex after death? How good is sex when your bones are so fragile and the pain is so great from advanced disease that you can no longer have sex?) Try not to fall into the trap of making sub-optimal decisions. Sub-optimal decisions are those that are made to maximize the possibility of something happening that is less important than something else happening. In this case, making a decision based on having the highest probability of an erection, rather than the highest probability of being alive and well in ten years.

DIAGNOSTIC TOOLS - ARE THEY USED CORRECTLY
Years ago Urologists bought ultrasound machines as their latest toy. They found that they could locate the prostate and could insert 4 needles, one in each section (we hope) for a biopsy. They were all stuck into a single dish and taken to the pathologist. Then they moved to 6 needles as that is what became common and today most of them are still doing 6 needles. However the world of biopsies has moved on to 10, 12 and 15 needles (or more) still using the same ultrasound machine. Those who are really expert may locate an area that looks suspiciously like a tumor and they insert a needle directly into the tumor. These docs are few and far between because most Urologists are probably doing well if they do one biopsy a month.

Then we have the real experts like Dr. Fred Lee who uses Color Doppler to confirm the actual tumor before he biopsies. If he sees no suspicious areas - he does not do a biopsy. The point is that there are, at most, only a handful of real experts in the country. Is it worth the time, expense and effort to be examined by a real expert? That is a question that you must answer for yourself. At least try to find a urologist that is up to date. This probably means at least 12 needles. This certainly means keeping the needles separate, and clearly labeling the location of each stick in the prostate. Discuss this before the biopsy.

When does a visit to a real expert become paramount? Lets put it this way: Something is causing an elevated PSA. If infection and/or enlargement have been ruled out as causes, and a well done biopsy doesn’t find cancer, then what? Something is causing the elevated PSA, so it may take a real expert to find out if there is cancer present.

My theories - probably without basis!

Someone asked me what theories I had formed over the ten years that I have studies this disease. Below is my responce.

I believe that this disease is a combination of many different cell types any or all may be present at any given time. Further each of these cell types may respond differently to various treatments. For example Cell Type A may be cured only by treatment D or partially cured by treatment C, but not touched by treatment A, etc. We need to better understand the cell types and the best treatment for each cell type.

It is my belief that our research is at the wrong end of this disease. We should be spending more money on the front end, identifying the various cell types and following them up in long term studies. No one at this time is identifying cell types in the individual disease and following them up to see which treatment works best.

Then we have the far forward research that I would like to see done starting with a boy before puberty and following him for 50 years or so. Again my theory is that this disease starts in the teen age years when the boys are playing and eating a lot of junk foods and not eating good at all or even taking care of themselves. We need to look for causes at this age and treatments at this age rather than waiting to an old age and maybe incurable cancer.

Finally I believe a well rounded diet is needed from beginning to end without an excess of anything. I am not yet convinced that red meats are bad for us or some of the other things that they preach that are bad for us - are actually bad - but it is the excess of these things that may be bad. All too often we see things preached as being good only to discover in later years that they were bad.

I am in agreement with the recent findings on vitamins and supplements that appear to cause a more aggressive cancer. If you think about it at the time we are trying to make our bodies better by these vitamins and supplements might we also be feeding the cancer growth - I would guess they like the stuff as well as we think we like it.

To many of the studies and the trials are so often just repeats of what we have done before. I would guess that most of the doctors involved really already know the answer before they start. The industry runs on money, money that is funded from government to the Universities where it is necessary to pay the salaries and the costs of running the research groups in the Universities. If the government didn't fund the Universities we would see far less research. Then the research would have to be funded by drug companies, who are profit making institutions, and are in need of the Trials to get their drugs approved for sale. There is a big difference here in the reasons for fundings and the real needs of the industry.

If I had the money to fund - my funding would all go to research at the front end. When does this disease start, why and what can we do at the very beginning, maybe even before the tumors are formed, to treat the causes and do away with the old man's disease.

All theories, of course, just theories.

A return to the China problem!

More on China
Added July 3, 2007
An addition to "Vitamins and China" below.

Since this all started we are learning more and more about China. Let me start by telling you the last time we were there we could not drink any water other than the special water prepared by the hotel or beer. With that in mind let me continue on the new revelations.

Today's press says that seafood from China raises alarms. The FDA is restricting the sale of certain seafood products because the regulators are finding carcinogens and excessive antibiotics. Many of the seafood products are raised in the Pearl River Delta which is well know for the dumping of industrial chemicals, farm runoffs and I believe human and animal waste. The reason for the excess antibiotics is they have to keep the fish alive.

One company, Xulong, is the worlds largest processor of eel and claims to be the cleanest food processor in China yet on occasions they cannot pass muster with our regulators. If they can't understand what is required than not many others would be able to. China is the leading producer of seafoods, garlic and apple juice concentrates imported to the US who imports 80% of our seafoods. China is gaining market share of processed vegetables and frozen foods.

Last week the FDA banned some of China's biggest imports including shrimp, catfish, eel and a type of Carp.

They are presently third behind Canada and Mexico in food imports to the US. As this increases out regulars are not staffed to properly inspect that much food coming from China.

In a sense this reminds me of the early 1900s where we had no regulation on foods and they were coming to us in any form and with any dirt they picked up along the way. The big difference is the dirt that is picked up today from China comes along with industrial chemicals, human waste, farm runoffs, and the never ending air pollution (sometimes you can't see the ground from a tall hotel the pollution is so bad. By the way much of the pollution from China ends up along our West coast and we have no control over reducing that pollution. The same pollution may be effecting our own California grown food products over time.

We buy far more things from China than China buys from us. They are loudly protesting the problems their products are causing in this country and the little we do in restricting their imports. Food exporting is a very large business in China and if the word gets out and we stop buying - they have a real problem.

To me the present scare is far worse than the "Mad Cow Disease" scare of some years ago.

Vitamins and China

There has been information lately concerning contaminated Chinese imports of vitamins, supplements, prescription drugs, pet food, fish and various other food products.

The Chinese government has recently closed 160 contaminated food producing companies - probably only a small part of the total picture - the tip of the iceberg if you will. Unfortunately, I suspect these companies will soon be replaced by thousands more.

It is common knowledge that a large percentage of herbal products imported from China have contained other products including both prescription and non-prescription drugs. Some of the products have contained anywhere from zero percent to a far greater percent of the particular product listed in the contents.

For example, millions of dollars have been made on the sale of PC-SPES, which was sold to men to treat prostate cancer and found to have as many as 4 prescription drugs contained in the product. This was proved in numerous lab tests and the product was removed from the marketplace. We know the drugs _ would, in fact, treat prostate cancer whereas the herbal products included have no effect on prostate cancer. This was represented as a Chinese herbal medicine - it was not. According to expert Chinese doctors, none of the herbal products included would ever be used for prostate cancer in traditional Chinese medicine. It is believed many men have died as a result of taking this product. Currently there are million dollar lawsuits in the courts against this product.

Now, with the above in consideration, recall the recent publicity about the use of multiple kinds of vitamins which leads to a higher incidence of prostate cancer. It is as if the vitamins may be feeding the cancer. You can read more about this at Are Vitamins Killing Us? . I would suggest that you take the time to read it if you have not done so.

This is one time that I am looking for an answer that may not be forthcoming - certainly the two subjects above raised some red flags, at least to me.

Could it be the men in the study who were taking a large number of vitamins, etc. may well be using contaminated products from China and may well be contaminated with something that caused them to have a higher incidence of aggressive cancer?

Could the men, not in a study, be experiencing the same thing? Is it the mega vitamins we may be taking that is causing cancer to begin and causing more aggressive cancers of all kinds? Are these Chinese manufactured products contaminated with products that are causing the problem prior to diagnosis?

Is there a direct link to the above two findings? Is two and two adding up to more than four?

Maybe just maybe these two findings are something each of us should consider and perhaps not take vitamin pills or other Chinese products until the Chinese fix their system (which probably will not happen in our life time). Actually there is very little (if any) scientific evidence created in long term double blind studies that taking vitamins has any beneficial effect on our bodies.

Perhaps the vitamins we think we need are better supplied in natural food products and maybe it is in that food product where the combination of _ vitamins and other things that make the difference. The vitamins alone, in pill form, leave out many other benefits that may be from the combinations of ingredients in the foods themselves.

Something to think about!!!!

PSA - What does it measure?

To All

This is a rather long post with a lot of references to pages on my websites about PSA. It should be read by anyone who has started this prostate cancer process and those who are on line helping others with their decision making process. Every person dealing with prostate cancer should have a full understanding of the PSA as to what it is and what it isn't.

As we all know (but some never seem to get in their mind) that the PSA is not a good marker for prostate cancer - but it is about all we have so we have to use it.

For example we know that most biopsies are made when the PSA climbs over 4.0 yet we know that many prostate cancers are found with a PSA of less than 4.0. We also know that biopsies only catch cancer about 30% of the time - and the men who do not show cancer go away thinking they have no cancer. Yet we know that a biopsy is like sticking a needle in a haystack and could miss a lot more than it finds. We know men who have high PSA's and multiple biopsies and the cancer is not found. They may or may not have cancer - we just don't know. Now these decisions on the diagnosis of prostate cancer are made on the basis of PSA's - any PSA. At the same time we know there are many things that will cause the PSA to rise that have nothing to do with prostate cancer.

After we are diagnosed we watch the PSA and the slightest movement up scares us that the cancer has returned. We seem to forget at that point how inaccurate the PSA is to track our disease. We follow it like a God when in fact it may be more like a devil because it tells us so little. As we get into metastatic disease it is all we have and we do follow it closely.

But lets forget, for a moment, all of the other things that cause the PSA to go up and down and concentrate on only one thing - the use of the various assays for measuring PSA - they are a long way from being the same and even inaccurate among themselves.

PSA results vary considerably due to several factors.

The first is random lab error which is always present because nothing can be measured with 100% accuracy.

The second factor is called systematic error. These are errors that result because one lab may use a different analytical technique (assay) for reading the PSA, or a particular labs may calibrate differently.

Lastly, other events may, and do, influence the PSA level in the blood. Ejaculation, bike riding, or any manipulation of the prostate, such as a DRE, all have the tendency to raise the PSA in the blood. Furthermore, there are theories that the time of day a sample is drawn and the day within a 28 day cycle may affect the PSA level. Also, inflammation of the prostate (prostatitis) is also a frequent source of raised PSA.

LAB TESTING ON STANDARD SAMPLES

The one factor we cannot control is random lab error. Periodically a survey is taken of 1000's of labs to detect their random error in measuring PSA. Identical blood samples are sent to all labs for a PSA reading. In the study available to us at this time, six samples were sent to over 2500 labs, each sample contained a blood sample of a different PSA level from about 0.2 to 19.4. The results reported be each lab were analyzed to obtain the mean reading, the standard deviation from the mean for each lab and for each PSA level (of the six different samples sent to each lab). This allowed for the determination of a 95% confidence range -- a range around the mean value reported that there is a 95% chance the real PSA value falls within (hence, 1 in 20 reported readings will be out of this range). Here is a sample of their data.

                                      95% Confidence
Labs Low  Med.  High | Mean  S.D. %rekSD   Range
2672 10.8 19.4  34.5 | 19.67 2.14  10.9  15.39-23.95
2653  7.2  9.8  18.0 |  9.92 1.11  11.2   7.70-12.14
2689  5.3  7.3  12.8 |  7.36 0.79  10.7   5.78- 8.94
2509  2.1  3.0   4.7 |  3.03 0.33  10.8   2.37- 3.69
2504  0.6  0.7   1.5 |  0.73 0.11  14.5   0.51- 0.95
2591  0.1  0.2   0.8 |  0.24 0.10  40.2   0.04- 0.44

Remember each of these labs got the exact same sample to test and report on. They had no idea as to what it should be. Note the Range and compare them against the Mean. Just look at the last line for example the mean was 0.24 and the range was as low as 0.1 all the way to 0.8. The upper range alone is 8 times the lower range. I think that this is perhaps due to the low numbers we are dealing with and is out of line somewhat with the others but it gives you an idea of the variance.

More information on this can be found at
http://www.cancer.prostate-help.org/capsava.htm .

LAB TESTING ON HUMAN SUBJECTS

Now let us look at what it does when it is applied to humans and in addition lets look at the different assays used. Here we want to concentrate on the range within an Assay and the difference between the assays.

These figures come from the study as follows:

Clin Chem. 2006 Jan;52(1):59-64. Related Articles, Links
Interchangeability of measurements of total and free prostate-specific antigen in serum with 5 frequently used assay combinations: an update.
Stephan C, Klaas M, Muller C, Schnorr D, Loening SA, Jung K.
Departments of Urology and Laboratory Medicine and Pathological Biochemistry, University Hospital Charite, Berlin, Germany.

In this study they looked at the PSA and the %Free PSA in 314 prostate cancer patients (PCa) and 282 non prostate cancer patients (NPCa) and how there blood was read by 5 different Assays. If you want to read the actual numbers you will have to get the actual study but let me give you a few of the findings:

For the PSA they found a overall range in PCa of a low of 4.98 to a high of 7.27. For NPCa they found an overall range of 2.8 to 5.03.

Within the same Assay for PCa there seems to be a difference of about 0.7 across the board. For example the same specimen was measured from 6.5 to 7.27 in one Assay. For NPCa the difference varied from about 0.6 to 1.2 in the individual Assays.

But perhaps the most upsetting is not the range in the PSA as shown above for which we are fully aware of but the range in the %free PSA. For example across all ranges the %free PSA ranged from a low of 8.07 to a high of 14.9 for those patients with prostate cancer and for those non prostate cancer patients the range was 14.4 to 25.3. In each assay the same sample was measured within 2 to 3 points. Look at these carefully and see what differences it might make in the decision making process depending on which Assay was used.

You can see yet another table showing the differences in the PSA by various Assays at http://www.diagnosis.prostate-help.org/assays.htm

I think we will look at the %free PSA in a little different light and wonder where the Assay that was used stands in the line.

When you consider both the LAB TESTING of standardized samples and on human subjects it adds a whole new complexity of trying to understand the PSA measurement. It does make it very clear as to why one needs multiple PSA's using the same LAB and the same ASSAY before making decisions that effect your health in one way or another.

For additional reading on the PSA read:
http://www.cancer.prostate-help.org/capsava.htm
http://www.cancer.prostate-help.org/popsacli.htm
http://www.cancer.prostate-help.org/popsafl.htm
http://www.diagnosis.prostate-help.org/pcpsaid.htm
http://www.diagnosis.prostate-help.org/pcpsaot.htm
http://www.diagnosis.prostate-help.org/assays.htm

Artists/non-Artist Who to believe?

Artists, Non-artist and Who do I Believe

To All Another very long missive.

I set here thinking after reading some posts today and answering a few. The problem is, as I see it:
1. Artists vs. non-artists
2. Studies done by both
3. Studies done by both in the same clinic
4. Are studies or journals equal5. What does it all mean anyway

1. Artists vs. non-artists There is no way that we can ever measure a procedure done by a non-listed artist against those who are listed (see "Physician Artists of Excellence" at http://cancer.prostate-help.org/canames.htm). The reason is that only the "artist" publishes to any great extent. The frequency of the procedure is all important and there are simply not many (if any non-artist who have done 300 in three years with 100 in the past year and have written peer reviewed studies. I think the 300/3 is the least we can expect of any doctor and call him skilled.

2. Studies done by both We do not have studies that are done by two or more artist in their field with exactly the same criteria and exactly the same definition of failure. I can look at studies by Walsh, by Catalona and by Scardino and I can feel very comfortable in rating these great surgeons from best down as Walsh, Catalona, Scardino based on their peer reviewed studies. But are their studies equal, are their patient cohorts equal in every regard, their cut point for failures are not equal, are the years since treatment equal, minimum years of follow-up equal, etc., etc., etc. Without these being equal - it is anyone's guess as to the results. With experience we can adjust in our own minds but that is not statistical proof.

3. Studies done by both in the same clinic When we have studies done at one clinic are the doctors involved equal in skills in their respective treatment modalities. I find where we have a strong emphasis on surgery, for example, there is little emphasis and training and skill in the same clinic for brachytherapy. There is little interest in HDR or Cryo in these types of institutions - they all are 2nd or 3rd class treatments, so to speak. In addition we don't know the selection process in the clinic. For example it is frequently the thinking of these clinics to treat the younger men with surgery and the older men with some type of radiation. The results cannot be compared not can the side effects be compared. I would not, for example, go to Johns Hopkins looking for brachytherapy but their reputation for surgery may make men think they are equally good in every department - they, or others, are not.

4. Are studies or journals equal All is not equal in the lala land of publishing. Anyone can do a "study" and quote from a "study" and the study could be a study of one and it may be just an abstract. To be able to do a study and have it published in a peer reviewed journal is something else again. However there are journals and there are journals. Just because it gets into PubMed does not mean that it is a peer reviewed study (or paper) so one must look to see what journal/magazine it was published in. Not all journals are equal. When one gets ready to publish a paper - one looks down the list of journals and picks which one would be the most likely to accept the paper - may know from the beginning that the leading journals would not publish. And if that fails - moves down the line. One has thousands of journals to choose from. If one wants to work at it hard enough - eventually one could find something that would publish the paper and perhaps just with an editor checking it.

When you read a news release or an abstract you need to know:
a. Was it just an in-house paper.
b. Was there an actual study or just an abstract.
c. Was it published:
a. in a leading peer reviewed journal
b. or in a magazine
c. in a organization publicationd. name of publication and owner thereof.
d. Who are the authors of the study. This does not always work as sometimes a study is written but with agreement someone else's name is used as the author or the lead author.
e. Who paid for the study.


With that information one can begin to rank the importance and the authenticity of the study. But one much always remember if the study did not meet its predetermined guidelines for this study - it become insignificant even though the results look great. Junk in - junk out. To explain further if a study in its statistical make up has determined that it will take 300 participants to validate the study and they only can enroll 150 and continue to do the study anyway - the statistics for a valid study have already been broken and nothing written can validate the study.

5. What does it all mean anyway What does this mean? When you get down to it you cannot compare one study against another, even the same modality let alone different modalities of treatments, unless you have more information that is commonly released. Remember it is the aim of the author to write a study to give the highest results possible from his cohort of patients. He can change these figure is a number of different ways that you may never see unless you have been following the studies for years. Or maybe some inside knowledge which we mere mortals never get. One can never take the word of a patient who has been treated with any particular modality of treatment as he starts with a bias to begin with and almost always that bias shows through and many times he is very wrong in his statements. They typical say they have done a lot of studies and they find this and that and yet they have no appreciation for vagrancies in studies or even how to read and interpret them. Sometime they will throw out figures that have no basis for comparing one against the other - sometimes using their own statistical analysis to make a point - invalid as it will be.

We cannot go to a patient referred to you by a doctor as the doctor would not refer anyone to you that did not have a successful outcome. These groups are not representative of the whole population and they may be heavily biased - sometimes one way and sometime another depending on the strength of one or two members thereof.

One cannot listen to his doctor without knowing that the doctor is very biased toward his own field. Urologist do surgery (they are surgeons), Radiation Oncologists, do radiation, and those who do the other things are looking for something to give them an income. Doctors are the most biased of all - and maybe they should be. They also think that they are the best in their profession and we know better than this.

So what can one do. If he is a member of a group, he is far ahead. Here he can listen to what both sides say knowing how biased they are. He can refer to links that members might post. He can read the posts and find for himself which person seems the most believable and unbiased. He will read the websites that are dedicated to prostate cancer and preferable are not sponsored or paid for my other than the single owner and are not dependant on the parent organization for their very existent. One cannot depend on any website owned by a doctor or clinic (even Universities) to have unbiased reporting and the whole truth and nothing but the truth. They all have axes to grind and points to be made and money to be made.

One thing I am sure of and that is this decision cannot be made in weeks or a month or even three months. To be where you should be and know what you should know takes a lot of studying, reading, looking at actual studies and not just abstracts. It takes listening with a ear that is tuned very carefully to watch out for what is bull and what isn't (and probably most of what you read is). It takes common sense, a brain that can absorb and compare, a knowledge of prostate cancer and the terms we use. When you know this, have this, understand this - then you are prepared to make a decision. In order to make that decision and understand where you are you must know the answers to the following:

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
AT TIME OF FIRST DIAGNOSIS FROM YOUR UROLOGISTS
This information should be known at the time from the first exam forward.
1. DRE (Digital Rectal Exam) results?
2. PSA (History if any to time of diagnosis)?
3. Stage (Should be like T1c, T2b, etc.)?
4. Date of diagnosis (biopsy)?
5. Estimated size of the Gland?

FROM THE BIOPSY REPORT
Some Gleason reports are seriously lacking in amount of information and therefore the following may not all be provided. When you ask for a second opinion (below) I would make a request for the information at number 8 and 9
6. Gleason score (Should be like 3+3=6)?
7. How many needles used in biopsy?
8. How many needles were positive?
9. How much cancer in each needles and percent of cancer in each or what percent of cancer overall?
10. How much overall Grade 4 or 5 vs. 3 or below - was there?
11. Was there a third grade and, if so, what percent?
12. What were the findings on the size of the gland?

MOST IMPORTANT: 13. THIS IS AN ABSOLUTE MUST -: 2nd Opinion of Gleason - who and reading. See "Gleason Experts" at http://www.prostate-help.org/cagleas.htm These MUST be used.

FROM OTHER REPORTS Any other procedures that you took because of the diagnosis.
14. Results of a PAP blood test (or any other blood tests) any Bone Scan, CT scan, Endorectal MRI or any other scan or diagnostic procedure. A bone scan should be done if the PSA was over 10 or above. It should be mandatory with a PSA of 20 and above. It should be mandatory for a Gleason of 4+3=7 or above with any PSA.

OTHER INFORMATION NEEDED PERSONAL HISTORY
Information from your past history all needs to be knownto make a determination of treatment.
15. Your age at time of diagnosis?
16. What are your symptoms?
17. Any family history of breast or prostate cancer?
18. Any Prostatitis reported?
19. Any treatment for Prostatitis, if so when? and what?
20. Any BPH reported in the past?
21. Any other treatment for Urologic conditions. (TURP, etc)?
22. Any drug or supplements being taken for BPH (Saw Palmetto, etc.)?
23. Have your changed your diet - it so explain?
24. Are you taking any alternative meds or supplemental vitamins, or other products - list?
25. What prescription drugs are you taking for what condition.?
26. Are you taking Propecia for hair growth?
27. City and state (or country) that you live in, and if not a large city - what large city is it close to?
28. Your race?

REMEMBER THE MORE INFORMATION YOU HAVE THE BETTER CHANCE OF MAKING THE RIGHT DECISION FOR TREATMENT. THE MORE INFORMATION YOU HAVE THE BETTER WE CAN BE OF HELP TO YOU. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

In Summary
We can't trust peer reviewed studies, we can't trust other patients, we can't trust doctors - then who can we trust. We have to learn to trust ourselves to get the best information from a variety of sources always weighing one against the other, understanding the biases and come to a conclusion what is best for you. No one else can tell you what is best for you - not even your loved ones. You must enter into this fact finding mission to make your decision on what treatment seems to make the most sense for you and then go for it and never look back.

If you at some point in the future say "I wished I had done something else" then you have failed yourself and will forever be sorry for what you did even though it may have been the best thing ever. If you don't have the time or the will to do this than suffer the consequences of someone else making a decision for you. From this point on it is only your fault that you did not enter into the decision making process and learn what needed to be learned to make a better decision. And that is not to say you can't get help from your loved ones because you can and it can be very valuable. But the final decision has to be yours.

The Way It Is

This is going to be a long post on things I believe, and feel strongly about, in this prostate cancer community. But there will only be a handful who will have the interest to read it through. The ones who will not read are probably the ones who need it the most. Some will read the first paragraph or two and disagree with something and will not read the balance even though it might be important to them. But that is the way it is.

I have been described as "brutally honest" and so I am. I am frequently criticized for what I say and do and believe and it does creates a number of enemies and does irritate many. Many times they have not read the available material, do not study, only assume what someone tells them to be true. I do not deviate from what I believe in but will gladly change my mind when one can prove that I am wrong. I do not deviate from my thinking just to appease anyone. I have done the research, the digging and the studying to back up what I say - I find few others who have. And, you know, I don't really care what those people think of me. My life is too full of pleasure, joy and comfort in what I do, I don't worry about those who have a need to tear me down. Constructive criticism is great but destructive comments are not even worth reading - but if they are misleading to the members - they demand an answer.

I see men who say they have studied this disease extensively for the past "X" months - but really never read a study, may not know what a Free PSA is and what it means. Have no idea about Gleason's grades and other more deadly types of tumors. Men who believe that an RP will cure them with a Gleason of 9. Members who have been on these groups, studied everything and do not know that high Gleason's create low PSA's. Most of the things I send to members to read - are not read - they are too long and involved and takes some concentration. This becomes obvious when someone asks a question when they just received an answer from me in a previous post or email. It also becomes obvious when some one posts information with authority and never back it up with studies but throw out numbers as if they are the truth. There posts are many times misleading and often just dead wrong. Many times it is because they have only read what they want to read, often about only one treatment - the treatment they received. In my mind these can not be left standing on its own and must be challenged - and I do that.

I don't take anything at face value, I rarely pay any attention to data that has not been published in peer reviewed journals. I take the position if they don't publish - they do not have the figures to publish OR they don't want anyone to know there results. If they don't do enough procedures to publish - I don't want them as my doctor nor will I recommend them to others. As far as I am concerned if they don't publish they can perish. Only through understanding how studies work, what they are published in, definitions of failures, past history of other studies from the same doctor, being able to compare one against the other. Only then can one fully understand studies and their inherent problems. Only then can one interpret one against the other. Only then can one break them down to the lowest common denominator and understand fully what games are being played and what the true value is of the study. Only then do the studies have any value.

I read lots of studies and abstracts but not all abstracts have studies behind them. Each year the major medical conventions display "poster" abstracts by the thousands and only a hand full of these will ever make it to a study. Abstracts have little validity until you read the published peer reviewed studies. Sometimes the Abstracts are very misleading. Most of the time you never hear about them again - sometimes one is able to put several things together and make some sense out of them. Even at that poster abstracts are more reliable than internally produced papers because someone has read them and agreed to let them be presented.
It is a simple fact that many if not most doctors lie to their patients in one way or another. Rarely do you find one that is completely above board and truthful. Why do they do this - to them it is not a lie because they simply do not know - they don't read, they don't study, they simply are not interested in finding out. I am not a smart person but I have been told by several prostate cancer specialists I know more about prostate cancer than 98% of the doctors they deal with. That is not a pat on the back for me but it is telling me how dumb most of the doctors are about this disease and all of its ramifications and treatment modalities. It is a pox on the doctors who do not take the time to understand what they are doing - and the patient suffers.
It is strange that we want all kinds of assurances that the car we drive, the equipment we use, is all done with much safety in mind. We want our kids in approved schools, accredited universities. You want to work in a safe environment. We want the products we use to do what they are advertised to do.

But when it comes to supplements we are willing to shove anything in our body based on what a neighbor tells us is good or what someone off the internet tells us it is good. No background, no peer reviewed studies, no guarantee of safety, no idea if it will work or may be dangerous, no idea what may or may not be in it. Our body is the most precious thing we have and we want to protect it until it comes down to the taking of supplements and then almost anything goes. I seem men who are taking over $1000 a month in supplements and I doubt that they are any more healthy than the person out there who eats a good diet and exercises. And now there is evidence that in some cases vitamins and supplements may hasten the death of prostate cancer patients.

When it comes to treatment to protect that body and keep it alive we made decisions based on being impotent, temporary urinary or rectal problems, or other imaginary problems - instead of picking the treatment which has the highest chance to keep us on this earth the longest.
We listen to someone spout off about a particular treatment (conventional or alternative) and tell you how good it is with a 97% cure rate - and we believe them. And yet there is all kinds of evidence to the contrary in published peer reviewed studies. But because these studies are controlled by the "drug company conspiracy" or by the "crooked FDA" they are looked on as having no value. It even seems sometimes if the study is written by their doctor - it is infallible but if it is written by others - it is corrupt and wrong.

And the men die, and they die, and they die, or they wait too late and they die. They have a curable cancer and they do unproven (except in their minds) procedures, treatments, supplements and they die. But you out there never know they die. Seldom does a man post in the groups - that he is dying of this disease - it doesn't happen often. I am in a unique place. I see men and women come in and post to groups and then they are gone. This happens in all groups. And then one day I receive a note from a loved one who says John died of his cancer and I no longer want these posts - please remove his name. There are others that just disappear.

But you read only the good things because that is what the members post by and large. Only in the Advanced Prostate Cancer groups do you get the idea that most of these men know they are dying from this disease and it is a matter of time. Many wished they knew then what they have learned now and they would of done something different - but now it is too late. Many show anger because they did what their docs told them to do - AND IT WAS WRONG!!! And some are dying because they relied on unproven methods, unproven drugs/supplements/ and when they realize it - it is too late.

Another interesting thing is that if you have treatment and the treatment is successful you are willing to say where and what doc treated you. However if you have failed in your treatment, rarely will a member discuss who treated them to begin with. It is more important to know the latter than it is the former but the members will not disclose those names.

It is a cold, cruel prostate cancer world out there knowledge is scarce among the medical professionals. There is only a hand full of doctors out there that I would want to consult with if my primary treatment ever fails - because I know that once my treatment has failed - I am on my way to death from this disease (unless something else kills me first). And dying from this disease is a terrible way to die - usually a long slow process of pain, incapable of caring for ones self, disabilities, etc., etc., etc. I have seen it too many times, too many times.

We have men dying in these groups as we speak. Men who have had their back bones eaten away by cancer, jaw bones eaten away from treatments, liver damage, damage to the bone marrow, tumors spread to the brain, the liver, the kidneys. Believe me if I have a choice of a primary treatments with a 50%, 60% 70% 80%, 85% freedom from disease progression when published in peer reviewed journals (and all things have been brought to a common denominator) - there is little doubt that I would do anything other than the 85%. Yet everyday men chose the lower numbers because it "is right for them". As far as I am concerned nothing is right for me except the very best!!!! Many do not realize that they have only one chance of success and freedom from this disease - miss that chance and you may surely die from prostate cancer.

Men die from this disease when they don't have to. Men suffer from the treatments of this disease and they don't have to. Men make dumb decision on treatment because their doctor led them down the prim rose path. Others make dumb decisions because they listen to no one or to the wrong voices. Others make dumb decisions simply because they do not have the skill or the desire to research. Hopefully what we do in these groups is give that person information to base their decision on and hopefully that information will be unbiased and truthful.

Treatment decision have to be made in conjunction with your medical team. If you have done your research and ask questions that they can't answer - time to find a new team. If they are not smarter than you about this disease - find a new team. If they tell you things that your research tells you are wrong - find another team. Don't rely on any one doc, get second opinions, expert readings of any test that is significant (Gleason - for example). Get your medical records and read them and if you don't understand go to the internet and get answers. A delay in treatment is no where close to the dangers that a wrong decision might be. Develop what the attorneys have always used - you don't ask a question of a witness that you don't already know the answer. Ask questions of the doctors that you know the answers too just to test where they are coming from. If their answers are wrong - head for the door. If there answers are right - ask the questions you want to know the answers to.

So this is what you get from me, if it makes sense to you then continue reading - if it does not you can always leave. This is the way I am and this is the way I will probably stay!!!! I promise to bring you the best information I can gather through my database and BLOGS and make them available to you. There is no place else that you can get so much information, keep up with the latest studies, conference with experts - all under one umbrella - Prostate-Help. The Prostate-Help Gateway is at http://www.prostate-help.org .

How to play the game with numbers!

How To Play The Game:

1. SCARDINO AND HIS FIGURES
2. GAME PLAYING AT ITS BEST
3. THE ACTUAL PROVEN NUMBERS

1. SCARDINO AND HIS FIGURES
In addition the only reason that Scardino figures are better than Walsh is the simple fact that he used a definition of failure that would give him better results. He has used 0.4 vs. Walsh 0.2. In addition he has used " Treatment failure was recorded when there was either clinical evidence of disease recurrence, a rising serum prostate-specific antigen level (two measurements of 0.4 ng/mL or greater and rising), or initiation of adjuvant therapy. "

But for discussion purposes let use just the difference in numbers between 0.2 and 0.4.

In the Mayo study:"DEFINING PROSTATE SPECIFIC ANTIGEN PROGRESSION AFTER RADICAL PROSTATECTOMY: WHAT IS THE MOST APPROPRIATE CUT POINT?"
Using the identical cohort of men they found that using a definition of failure of 0.2 they arrived at a 5 year figure of 62% and a ten year figure of 43% freedom from disease progression - with the same cohort they found that using 0.4 would give them a 76% freedom at 5 years and 61% at 10 years. Therefore by using this definition to equally the scores based on 0.2 as Walsh uses we would have to subtract 14 points off of Scardino scores at 5 years and 18 points at 10 years. I now suspect that Scardino is a long way from Walsh.

Now if we use his 2nd convoluted way of defining definition of failure as per the quote above - Mayo found that by that definition (using the first date as time of failure) he arrives at even higher figures 82% at 5 years and 75% at 10 years BUT lets go one step further if he uses the second date as the failure date the figures are 86% and 61%. Lets see if we can get that in a chart:

Modification Factor Disease Freedom 5 Year 10 Year.
1. Nadir of 0.2 or less 62% 43%
2. Nadir of 0.3 or less 72% 54%
3. Nadir of 0.4 or less 76% 58%
4. Nadir of 0.5 or less 78% 61%
Nadir of 0.4 with 2 rises
5. Using 1st date of rise 82% 75%
6. Using 2nd date of rise 86% 61%
ASTRO (Official)
7. Official date of failure (1) 78% 78%
8. Modified date of failure (2) 85% 59%

2. GAME PLAYING AT ITS BEST
Now lets play games:

Assume I am a surgeon and I am about to make a report of my results at 5 years. I look at the chart above and decide that at 5 years the best definition for me to use is number 6 above and I can show a disease freedom rate of 86%. Now I accumulate data for another five years and decide to make another study and I again look at the data above and decide that this time I can get the best figures out of the ASTRO definition number 7 or even use a nadir with 2 rises (used that before) and this time use the 1st date of rise - line 5.

This is the manipulation that doctors go through - except for Walsh/JH (and some others) who more correctly uses anything over 0.2 is by definition a failure. No Mickey Mousing around - pure and simple. If you are doing a study with a minimum of 5 years of follow-up if you have a PSA over 0.2 than you have failed.

And now - compare Scardino against Walsh using adjusted figures so that we are comparing apples and apples.

3. THE ACTUAL PROVEN NUMBERS
What is really amazing and something that all should understand when reading studies or being told by a doctor his results - what is the definition of failure. In the chart above using the identical cohort of men one can achieve a range of 61% to 85% at 5 years and a range of 43% to 78% at 10 years. One can even get a 10 year figure that is better than a number of five year figures. It is a travesty of the medical doctors and there playing of statistical games for their benefit - and not for the patients benefit.

It is a game of numbers and you must understand the game. Read http://www.cancer.prostate-help.org/download/studies1.pdf for clarification. (This is a paper I have written trying to clarify how these numbers are used and what they mean. It is a rather lengthy paper - be prepared to spend some time in reading and understanding.)

In my estimation any doctor that does not use what the leading medical institutions (Johns Hopkins) for surgery uses - they are simply playing the game to get the best results they can - even though it may prove deadly for the patient. One can be slipshod and get excellent results by picking the right definition of failure. But who cares the doctors get great numbers!!! Maybe the patient should care - I did and understood this in 1997. I see no reason for differing definitions of failures for differing treatments. They all should be the same in the long term (at least 5 years minimum follow-up or even longer). All treatments will continue to fail 5, 10 and more years out. But the continuation of failure should be about the same using the same definition when you are looking at 5 and 10 year minimum follow-up.

There is no surgeon that we are aware of through published peer reviewed studies that can match the results of Walsh when figures are adjusted to a common definition of failure.

This adjustments can be made through studies like Mayo above and several others that I put online in my PDF file above. They are not made up - they are real figures as published in leading peer reviewed medical journals.

NOTE from Don Cooley - May 27, 2007:
The above was written some years ago and needs to be updated. However an updating would not change the actual figures to any great extent - if at all. In addition the PDF paper referred to is also in need of some updating and corrections.

Diagnosis - is it?

This is another one of those "the longer I have been involved with the groups and PCa, I have some strong feelings" type posts.

This one is about mono treatment of any kind, surgery, radiation, seeds, HDR, Cryo, etc., etc. I do not believe there is ever a time to risk mono treatment in the fighting of this disease. Let me list the reasons why.

1. To begin with the diagnosis itself is so uncertain in terms of the cancer in the gland, the Gleason. PSA and the staging - all very inaccurate.
A. We get 6 or more needles put into a gland that may be anything from 20cc to 160cc in size. If we are talking about a 25cc gland then 12 needles cover it much more than 12 needles in a 100cc Gland. If 12 needles is sufficient for a 25cc gland then we should use 4 times that many needles for a 4 times larger gland to get the same coverage.
B. In addition there are areas of the Gland that a normal biopsy will not cover with even 12 or more needles.
C. Not all doctors are able to see the cancer in the gland and they put the needles in with a predetermined pattern. A skilled doctor looking at the gland will see areas that are suggestive of cancer and he will stick a needle in those areas. Then we have doctors who use a Color Doppler along with a Black and White that gives them an even better chance of seeing any cancer and sticking a needle in it. Now when we look at the totally needles and total positive the doctor who sees the cancer will have more positives and may do less other needles. Thus our guidelines may not apply to the biopsies done by that doctor.
D. Some tumors are so small that they can not be seen and a small chance of ever having a needle passing through them.
E. In any positive needle that maybe shows a Gleason grade of 3 - a fraction of an inch away may have been a 4 or even a 5.

The result of all this is uncertainty and confusion. Even with the very best doing biopsies we really do not know exactly what we have. So we begin this journey with something that may be just the tip of the iceberg.

2. There is a great deal of confusion about Stage.
What we usually want to know is what was the "clinical stage" - this is the stage when the doctor does the DRE and it is what he feels. The "pathological" stage is commonly thought to be the stage that is found when the gland is removed in surgery. About 50% of the time these will be different. Also the amount of the cancer that is found following surgery will be higher. And if you had 10 doctors doing a DRE they may feel 10 different things. So at best this is very iffy. Read about stage at Reference: 5 below.

3. And now for the Gleason score.
We know that better than 50% of the time the Gleason as given at your local clinic is wrong and it is usually lower than reported. Why is this - simply local pathologists do not have the experience in looking at prostate cancer slides and assigning a Gleason score. Then if we look at the gland following surgery we also find a large difference in what was reported from the biopsy. There is little chance that the Gleason that was assigned at the local level is, in fact, the Gleason you have. This is why we always insist the slides be sent to an acknowledged expert for review. Information at Reference 3, 4 and 5 below.

4. And then we have PSA.
PSA is caused by many things. When a biopsy decision is made base on the level of PSA it is wrong as much as 75% of the time - this means that they cannot FIND cancer in 75% of the men - does not mean it is not there just that they missed it! In prostate cancer PSA is almost a "fools paradise" because so many thing by controlling the PSA they are controlling the cancer - simply not true. We have studies that show the cancer continuing to grow as the PSA gets lower. For a better understanding of PSA and all of its ins and outs read the pages on PSA in the reference #5 below.

ARE YOU CONFUSED?
So we have a rather bleak and dismal look above at diagnosis and how inaccurate it can be and how unreliable the numbers you are given may be. The result of all of the above simply tells me that most are understaged and therefore should get treated as if they had a higher grade of disease.

The other thing that I so frequently see is those who have failed their initial treatment and the cancer has come back and they are in the fight for their lives - of which many will lose. As I view those who have advanced disease I note that an overwhelming majority of them has a mono treatment at the time of diagnosis. There are a few who were diagnosed with advanced disease and they go along and get treated and if it is a mono treatment - it is sure to fail.

And something else that has to be taken into consideration is the fact that the insurance companies have a set of rules that may dictate only a mono treatment because they simply will not pay for the combination. A practice that I believe is very short sighted on their part - in the long run it will cost them more. Since the doctors knows the insurance will not pay for it he/she has to convince you that the mono treatment is the best for you. They may be just signing your death warrant - especially if you might have a more advanced stage of this disease.

Therefore as I see it if you feel and your stats are such that you are convinced that you need treatment try always to get a combination for example surgery and radiation, seeds and external beam, and you can always add some kind of hormonal ablation therapy to any of them.

Now about that "do you need treatment" bit.
I believe there are times that one can get by without having any immediate treatment and perhaps some changes in the lifestyle and the addition of some supplements and meds may keep some control. This low grade cancer is sometimes referred to as "insignificant cancer". It is further defined as a low PSA, low Gleason, high %free PSA, very low stage, and someone past 65 with no family history of prostate or breast cancer.

If you have been given these numbers and you have checked and double checked them for accuracy (sent slides to an expert) and if you are willing to take a biopsy every year and be ready to move to an active treatment at any time those numbers change (and confirmed) - then you can consider Watchful Waiting.

The strange part of this is that frequently when one is diagnosed with "insignificant cancer" the doctor makes a recommendation for a mono treatment - WHY!!!! I personally believe that if your doctor recommends a mono treatment - you must check everything out carefully and see if you meet the qualifications of having no immediate treatment at all. If you do not meet these qualification then you need a combination treatment.

Even when we see men diagnosed with "insignificant cancer" we do see them start to fail and sometime, but rarely, quickly so you must be vigilant. For more information see References: 1 and 2 below.

Take Home
The take home of this long dissertation is simply that if you need treatment you should go all the way and have a combination of treatment. And if you think you qualify for a mono treatment - maybe you don't need treatment at all at this time!!!!

Now doctors are not going to like me for the above as it means loosing patients. They will simply say "what do you expect on the Internet". But remember that the survival rate for those who are diagnosed with localized cancer (including nodes and seminal vesicles) have a 100% success rate at 5 years. Other studies tell us that one can be as successful with WW out 15 years and at that time those who chose early treatment begin to be better off.

To successfully attack this disease and win the battle there are a number of steps that you need to go through and a lot of things you need to know about your history and your diagnosis. For more details go to the web site in Reference: 6 below and go through the step by step procedures. Then and only then will you have your full suit of armor on and ready to fight the battle.

References:
1. http://tinyurl.com/2apd97
2. http://tinyurl.com/2dm4oy
3. http://www.cancer.prostate-help.org/caglegr.htm
4. http://www.cancer.prostate-help.org/canames.htm
5. http://www.diagnosis.prostate-help.org/pcdiag.htm
6. http://www.diagnosis.prostate-help.org
And for everything prostate cancer start at:
7. http://www.prostate-help.org/

It is the patients decision!

I would like to discuss this disease as it gets into the advanced stage. This is a patient diagnosed with metastatic cancer or high Gleason, PSA, Stage that might indicate metastatic cancer - or at least possible micro-mets. Or a person who has failed his initial treatment and has a rising PSA. In both of these cases the prognosis is not good.

The question arises in both of these cases as to whether the treatments for this stage will lengthen the life of the patient and at what physical or mental costs. We have conflicting data on this but we believe that at least Hormonal Ablation Therapy (HT) will extend one's life but we have no long term studies comparing patients using or not using HT. But enough that has convinced us that this is the first treatment of choice in advanced disease.

We have to assume at some point in time the advanced patient will become refractory to HT and move on to secondary Hormonal Ablation Therapy and on to Chemotherapy. In this case, unless something else kills the patient first, prostate cancer will take the life of this patient at some time. For example we have few studies that show that any chemotherapy has an effect on the extension of life for anything other than a few months. Often times we go on a treatment protocol that keeps our PSA down for a few months and we look at that as an extension of our life - but is it really? Or is it just a few months that we might have had anyway. I don't think we know.

So now we have a question that only the patient should answer - not the wife, not the girl friend, not the doctor, not a friend - only the patient. That question would be how long do I want to stay alive and at what cost to my quality of life - is quality more important than quantity. When that answer has been made by the patient after deep thought and with full truthful knowledge as to where he is in terms of the disease - it is a killer disease. Whatever the answer is at that time may be changed later - the patient should not be pressured into sticking to that first decision. It is his body, mind and soul that we are talking about - no one else.

If we try to influence the patient by telling him everything is OK and we will fight it through until we find a cure. Are we doing a disservice to the patient when we know deep down and know that all the studies say that the disease is going to kill hum. Are we doing a disservice to that patient by talking him into Chemotherapy which the treatment may be worse than the disease at times. Are we doing a disservice to the patient telling him that diet and supplements are going to cure him or even help him. Are we doing a disservice to a patient to force him all over the country or even the world trying to find a cure when there is none.

I personally feel that a lot of the time that is exactly what we are doing. We must face reality - good or bad we must face it, live it, accept it and tell it like it is!

What do I feel we should do? Face the facts! Face the inevitable death from this disease in those high risk patients. And live for the moment.

I believe once a patient can honestly say to himself that this disease is going to kill me in time and this fact is accepted by those loved ones around him - a whole new life opens up for him and those loved ones. A new life and happiness that he may have never experienced before, a happiness and satisfaction with his self that sets in to bring many joyful things to him in those remaining years. A true happiness that many me who fight this disease every day of their life never reaches or even understands.

Away with the diet, away with the supplements, away with anything else that does not bring enjoyment to the patient. If none of these help, and we have evidence that they do not at this stage, why burden the patient with a bunch of nonsense and give him false hope. Additional treatment that might be worse than no treatment and with no proof they will extend his life - its his decision and his alone. Let the patient say - no more treatments - I want to enjoy the rest of my days to the fullest. Let the patient do things he always wanted to do but never had a chance. Fishing in Alaska - go for it. Cruise in the Caribbean - take it. Learn to sky dive - get the excitement. Give him the chance along with his loved one to enjoy every minute of his life to the fullest extent possible. Don't say you can't do something - he knows himself and he can make those decisions.

Stop pressing him and let him do what he wants to do to enjoy his remaining years. In the long run the family and loved ones will find they are all ahead in doing so.

Then when the time comes that the family can no longer care for him - get the help of Hospice. If he has gone through the above he will welcome the Hospice for himself and for those that will be helped in the care of him. And when the time comes all gather together in remembrance of all of the happy times together and give his permission to pass so he does so without anguish and regret.

At least this is the way I see it and I believe that this is the best thing we can do for the patient - make his remaining days happy days!

Radiation Burn and Other Cancers

First of all there is a lot of "horror" stories about the damage done to your body and other organs during radiation (of any kind) to the prostate. The prostate is located between the rectum and the bladder - both of which may get radiation. This is where the expertise of the Radiation Oncologist comes to play. With proper mapping and being able to follow the prostate when it moves is important to the overall cure and radiation burn of other organs.

The newer methods of external beam radiation are called IMRT (Intensity Modulated RadioTherapy). There are a number of "offshoots" of this but still in the same category. The fine control the doctor has of the beam is the clue. The doctor can take a wide sweep of the area in the hope of getting all the cancer or he can narrow the beam to include the prostate and exclude the surrounding area. This is not to say the surrounding area does not get radiation but simply to say that it only gets what might have spread from the radiation to the gland. However this is not usually enough to cause radiation burn or problems with urination, etc. But the skill of the doctor is all important here. The higher the skill the less damage to the surrounding area.

A little known fact among patients is that the prostate gland moves. It actually can move up to about 1cm in any direction at any time dependant on breathing, a full bladder, a full colon, etc. In addition to this movement patients frequently have undiagnosed ECP (Extra Capsuler Penetration) or ECE (Extra Capsuler Extension). These are little nubs that are cancer that is pushing out from the prostate gland itself. Now this is not necessarily a spread of the disease outside the local area (metastatic cancer) but it does show a good chance the cancer may have spread.

Therefore when the external beam radiation is done one has to allow for the movement plus any ECE. This means the beam has to spread over an area wider than the prostate gland - and this may mean radiating some of the other organs. This may well be an area where the doctor does not leave adequate beam around the gland and you get recurrence. If the doctor is experienced in giving radiation to the prostate area he knows where he can fudge and not give a full does and where he believes may leave side effects.

In the terms of Brachytherapy (seed implants, either permanent or temporary) you really have the best most precise radiation to the gland that is possible - radiating from the inside out. Again the expertise of the doctor comes into play. Simply if he does not have the experience to not place seeds in areas that will burn other organs - then he burns. It actually is a very complicated procedure to place adequate seeds where you have cancer and reduce the dose in areas not likely to have cancer. To me it is IMRT at its best but IMRT only applies to External Beam Radiation.

How can you know which doctor has the best (or worse) record of side effects. Unfortunately you can't unless the doctor has published, in a peer reviewed journal, his record along with his side effects. But most doctors will not do this - they simply tell you everything will be OK or they tell you nothing. Simply only take what the doctor says with a grain of salt - knowing that he will make money doing the procedure and that frequently is more important than telling the patient the facts. If he does not trace his patients for studies - he really does not know the facts. I know doctors who have published their results and yet in a meeting with patients they always say their results are around 10 points higher that the published paper. He knows that few will ever question and if they do - he has a canned presentation that would make the best talking salesman you ever met - seem like a novice. Don't ever forget that money drives this business at all levels.

Then you learn the problems after the procedure is done. Some doctors may measure these side effects differently. For example does being impotent mean that you can not get an erection, you cannot hold n erection, it takes Viagra or similar drugs to get an erection. Doctors may use any of these but usually in studies they decide you are not impotent if you can get an erection with Viagra or similar drugs or other mechanical means. To me, at least, my definition would be you are impotent if you cannot get an erection without aids of any kind that last long enough to complete the sex act with you partner. But this figure would be too high and the doctors want to lower the impotency rate so they dig up other definitions.

Only with studies published in peer reviewed journals do you ever know anything about the side effects of any doctor and the same goes for the results. If you are handed a slick brochure or white paper from your doctor giving you his results - ask them where they are published. If they are not peer reviewed published studies - they really are not worth the paper they are published on. Even when you read the full study and really understand the published studies and how they work - you may be mislead. Sometimes it seems the doctors are trying to confuse you with words, etc. to hide the real truth.

Now with all of this said it seems that we have some people who will burn more easier than others. These people may well report burns even with the best and most experienced of docs. Just because someone reports major problems they have had with a procedure does not necessarily mean that the doctor did a bad job. If you could find out how many had this problem you might be able to say "bad doctor" but this kind of doctor will never let you know how often he has bad results. They believe they are all experts on level with anyone else.

As for damage done that may cause other cancers later there is some evidence that this may be so - but the cancers that are caused are created many years out - years that many of us will be gone from other causes. To me this was so far outside that it was not a consideration when I chose to have Brachytherapy followed by External Beam Radiation.

The "Artist" and who recommends

Let me ask some very simple questions to get a point across:

1. Have you ever had any member of any lists say anything but great things about their doctor and recommended him/her highly?
2. How much do you REALLY know about your doctor who treated you for you initial prostate cancer?
3. Web sites can be very impressive - why?
4. Why would you ever listen to patients that a doctor recommended to you?

1. ANSWER: The answer to the first question is it is VERY rare to have anyone say bad things about their doctor even when they failed the treatment the doctor gave them. There is a real "hero" worship for their doctor - even yet today.
2. ANSWER: The answer to the second question is that you really know very little other than what he/she has told you and very little about the truth of his long term results.
3. ANSWER: The answer to the third question is the websites are prepared by paid professionals who know how to sell any product - if they did not they would not be in business. The website is a SELLING tool first, last and always. It is ADVERTISING and should be given credit as such.
4. ANSWER: The fourth question answer is a no-brained - you should never listen to anyone on a prepared list that any doctor would give to you. Do you think for a minute that the doctor would give you a name of his patient that was unhappy with his treatment - no way!!!

Think about the answers to numbers 1 and 2 above when a patient of a doctor recommends the doctor to you. Think about the answer to number 3 when you are perusing a doctors or clinics or University web site. This is advertising and is no different than any advertising you see when you open your newspaper and see a Macy's ad or visit a website for Ford, General Motors, etc., for example. IT IS ADVERTISING and as such can be and many times is misleading. It tells you only what they want you to know. And question number 4 - not worth a discussion - forget it!!!

Basically all four questions should leave many doubts in your mind when looking for a doctor of substance.

In my "Artist" list (http://www.cancer.prostate-help.org/canames.htm) there are Urologists, Medical Oncologist, Radiation Oncologist, Color Doppler Experts, Cryo, Pathologist - all truly "Artist" by anyone's definition. They are published, they are leaders in their field, they are respected across the board for their knowledge. In some cases I have interviewed them, listened to presentations at national medical society meetings, read most all of their studies, etc. They have earned the right to be called an "Artist" for the work they have done in their medical communities AND the work they have done for their patients. They may not be all the most personable doctor there is nor have the best bed-side manners so you have to make a decision do you want expertise of bed-side manners. Personally the only thing I ever care about is the expertise of the doctor.

Let me note on thing - the writing of a book does not make one an "Artist" or an "Expert". It may be valuable information for the patient - slanted as it will always be but it is never considered when trying to add a doctor to my "Artist" list. I pay very little attention to what the doctors write in books - usually it is quite dated and almost always slanted to their view. Actually I put the books a step below good solid websites that can be updated daily.

It is these lists of "Artist" that everyone should start from and feel comfortable that you have made a wise decision if you decide they are the ones for you. It truly is your life you are playing with so spend you life wisely by making the right choices. If you have to travel - travel. If you have to dig deep in your pockets to pay - dig deep. But get the best available medical team that you can. For example my medical team was in San Francisco, Los Angeles, Atlanta and Detroit and I live in San Jose. This was 9 years ago when their was not a lot of information on the internet, not many groups, and little in the way of websites - none like Prostate-Help (http://prostate-help.org). The study I did then (5 months of study and two file cabinets full of papers and studies) was the beginning of seeking the best "Artist" available. The study continues to this day.

Did I do the right thing with the extent of the disease that I had - which could be classified as advanced localized disease (see http://mystory.prostate-help.org). The answer to that question is the fact that my PSA bounces around from 0.00 to 0.05 now since treatment in 1997.

Over the years I have removed some prominent doctors from these "Artist" list. Let me assure you they were not easily removed nor were they removed because of any patients complaints. They were removed because information came to me, usually from many sources, which made me question the skills, the practice, the procedures, and/or the purported results they may have published (or not published). Their removal was not from one single thing but from a series of things that happened over a period of time (some as long as 3 years) before I was comfortable with my removal decision. Believe me it is much easier to add someone to the list than it is to remove them and admit that I made a mistake. So I am especially careful about any removal - and such removal always creates a series of inflammatory posts from the patients as per number 1 above as well as reactions from the doctors involved.

And sure their may be and probably is many "experts" out there who are not on my lists. But I would say there is none better than those on my lists - and why not go to be best! I do add "Artist" as I make a determination they should be on the list - in itself not an easy decision.

Nuff said!