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.

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.

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.

Do the Doctors Manipulate Numbers?

Definition of failure: There are many definitions of failure used by different clinics and different definitions on each of their studies. It appears that with computers they can run their numbers with one definition and if the results do not make them happy - try another definition. This goes on until they find something they like and makes their studies look better than what they really are. (Back to our golf analogy: This is like saying that any ball within six inches, or a foot, or three feet, of the cup is in the hole! Most of us could improve our golf scores by changing the definition of "in the cup.")

Simply put, less stringent definitions of failure tend to result in a higher reported "cure" rate. As you read journal articles be aware of what definition of failure is being used, and how that is likely to affect the reported results.

During the past 10 years as I have read hundreds of studies. I decided that there had to be a way that we could find a common denominator in which we could weigh the various treatments and doctors. I researched every paper I could find that had anything to do with definition of failure for prostate cancer. In doing so I found the necessary data for me to come to some logical conclusions. Now I can look at any study and reduce it down, based on a PSA nadir of 0.2 at 10 years, and compare each of them side by side.

One of the more interesting developments is the use of the ASTRO definition (3). This definition was developed by the Radiation Oncology Society from data of patients who had prostate cancer and who were treated with radiation. However now other modalities of treatments outside of radiation, having realized the great benefit it makes to their figures, have started using the ASTRO definition. Using it in places where it was never designed for and has never been designed for or even tested for. It is in the process of changing yet today as I write this. I would guess they are looking for a better way yet to give them high scores.

Now we are finding that some studies are coming out with a bastardized manipulation of the ASTRO definition that adds things that were never there - and they still refer to it as the ASTRO definition. Undoubtedly this is being done to make results look better.

Who is included and who is not included in a study: Another way to "manipulate" the results of a study is through the definition of which patients are included in a study. What is an average golf score? If we include only touring professional golfers, we will come up with one answer. If we include All golfers who have ever played a round of golf, we will see quite a different answer. Which is the truth? They are both the truth, but based on a very different group of people. If we publish a prostate cancer paper that is based on men with stage T1c disease and Gleason scores of 5 or below, we will get a very different result than if we include all men that present with prostate cancer. Which is the truth? Which group do you fit into?

Look carefully at who is included in the study. Common things to look for: Including men (or at least too many men) in the study who have not been treated long enough ago to experience failure! Including men that can’t yet have failed is bound to increase the "cure" rate. (This is the main reason that studies of less than five years duration are not very useful, and may be just plain misleading.) Another is including only men who have the highest probability of success: Men with low Gleason scores for instance. That, too, will increase the "cure" rate reported.

There are many games to play, just be aware of who is included, and think critically about how this might affect the reported results. The ideal is a study that includes all comers: That is, all men treated at a facility irrespective of stage, Gleason score, etc. (No study is likely to have all comer’s because some refuse to participate by providing on-going information. Yet, a high percentage of those treated should be included.) Yet, there is even a caution here: Some clinics weed out men who are not likely to benefit from their treatment. That, too, will increase the reported "cure" rate.