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.