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.
Sunday, August 12, 2007
Friday, August 10, 2007
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.
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.
Thursday, August 9, 2007
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.
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.
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