February 1, 2013 Newsletter
Greetings to all PDI and DCI Warriors,
Welcome to this February 2013 PD Institute newsletter. It has been said, “In the Midwest winter is not a season, it is an occupation.” I agree.
This newsletter will be different than others because even though it is primarily written about Dupuytren’s contracture, it is provides great information and helpful background for all Peyronie’s disease readers. Usually these newsletters are written the other way around – directly about PD, with information indirectly related to DC. Since these two conditions are so similar and often appear in the same individual, I think all of this information is helpful for you to know as you consider how to manage your DC and PD problems.
February 2013 Special – FREE SHIPPING Priority Mail in U.S. for orders $200 or more
For United States customers only, free Priority Mail shipping during the month of February on any PDI or DCI order of $200 or more. Just enter promotion code FREESHIP at checkout to receive the shipping credit. The promotion code FREESHIP must be used at the time of checkout. Credits will not be given after an order has been submitted.
There is a lot of interest in Xiaflex , or collagenase clostridium histolyticum, a prescription drug manufactured by Auxilium Medical. I get many questions about it directly, I see the Xiaflex articles that are found on the PDI and DCI websites are very popular, and the people who write into the many PD forums seem to be preoccupied with Xiaflex, hoping that it will solve all the problems of their world. Xiaflex was recently approved to treat adults with Dupuytren's contracture when a "cord" can be felt. For many years Auxilium Medical has tried to complete drug trials to also get Xiaflex approved for treatment of Peyronie’s disease, to weaken or dissolve the PD scar.
Have you ever wondered why it is taking so long for Xiaflex to be given approval for treatment of Peyronie’s disease? Ever wonder why the company keeps on saying that the results look very good, and FDA approval should come within the next six months…and then the next six months…and then the next six months…and then the next six months.
For a possible answer for this continued delay in approval you only have to look at what is happening to those people who have received Xiaflex injections in their hands to dissolve the Dupuytren’s cords. Two basic reasons that could be at play for the ongoing delay in Xiaflex for Peyronie’s treatment should be kept in mind if anyone is remotely considering Xiaflex injections in the hand for Dupuytren’s contracture or in the shaft for Peyronie’s disease.
The first reason is demonstrated below in a comment that was posted a few weeks ago on the DCI website by a lady named Linda. She wanted to tell me and everyone else what happened to her as a result of Xiaflex injection surgery into her hand:
“I had a hand specialist inject xiaflex in 5 different areas of my left hand & fingers! FDA recommends one injection one cord!! Then came the aggressive manipulation that ripped open all 5 areas of injection! FDA recommends passive manipulation! My hand looked like a pit bull chewed it up. I have constant varying levels of pain, burning, swelling and now have two fingers with boutonniere deformity! I can lay my hand flat on the table now! GREAT!! I can't make a fist & my left ring finger & pinky finger only bend at middle joint! I am clearly NOT better off and wish I would have left it alone!”
Interesting story, don’t you think? This does not at all sound like any of the Xiaflex trial results the manufacturer posts, does it? I could relate many other stories like this one from Linda, but you get the point. The really sad thing about her story is this: She will likely only get worse in time. These things tend to deteriorate over time as more and more fibrous infiltration takes place; if someone talks her into surgery to correct the effects of the Xiaflex she will find that they do not improve with more surgery.
I hear more and more of these problems arising after Xiaflex use. The problem is not one of “Does Xiaflex dissolve tissue or not?” Xiaflex is collagenase and this enzyme surely does dissolve collagen. The problem with Xiaflex is not so much with the drug. To my estimation as I have seen time and time again, the problem with Xiaflex injections is with the doctors lacking the skill, ability and knowledge to administer Xiaflex. In the above example, for instance, I suspect that Linda’s double boutonniere deformity is the result of her “hand specialist” terribly botching the her Xiaflex injections. Her doctor not only made a mistake of injecting the Xiaflex into one or her finger tendons, he did it twice! Her doctor botched the injections that went into at least two tendons, and caused her to now have two fingers with tendons that have been destroyed by Xiaflex.
Linda’s hand problem is not the problem or fault of the Xiaflex, per se, but the doctor who did not do the work correctly. But if you cannot trust a hand specialist to inject Xiaflex, who can you trust? I will answer that question – as best I can – a little later down with a series of eight things you should keep in mind if you get to the end of your rope and begin thinking about Xiaflex. .
There are good farmers and bad farmers, good teachers and bad teachers, and good cooks and bad cooks. Those who are bad might just lack basic talent no matter how hard they try to be good; some might be having personal problems of their own that have reduced their talent and skill so that while they started out good they are now bad; some might lack genuine interest in what they are doing because they are bored or find themselves in a job they no longer enjoy; and some might simply not care because it is their nature to be sloppy. We have all encountered situations in which we found people like this. Linda may have encountered a bad hand specialist.
When a bad MD treats patients the results are often hidden from the public for a very long time because the medical fraternity always protects its own; no one wants to be a snitch because silence protects all members of the fraternity if and when any member of the fraternity makes a mistake – as we all eventually do. Silence in the medical profession is maintained because doctors mistakes are kept secret and everyone who keeps those secrets benefits, to the degree that patients lose.
If you put a Stratovarius violin in the hands of Itzhak Perlman his skill and personal touch will fill the air with music that can make you cry. God forbid, if I tried to play a Statovarius I could only hurt your ears. I would bet that Itzhak Perlman could do a pretty good job with a violin from the average high school orchestra. It is not the violin itself that makes the magic; it is primarily the ability of the violinist that is key to the quality of the music. And, it is not in the case of PD and DC, the skill of the doctor is just as important as the efficacy of the drug he or she uses.
When Xiaflex was tested for FDA approval it was given to special MDs to conduct the drug trial tests, not the run-of-the-mill doctor down the street. The doctors who conducted these drug trials were invited to test Xiaflex – they were handpicked – because they are at the top of their field; highly skilled and greatly experienced, and known to be the best based on their attention to detail and ability to perform skillful surgeries that others would not dare to perform. These types of doctors are always used for this type of testing because they will always produce the best possible results in a drug trial. Drug companies do not use doctors who volunteer and they do not accept just anyone to conduct these tests because this assures the best result possible so that they will eventually receive drug approval from the FDA.
In this case with Xiaflex after the FDA grants approval of Xiaflex to dissolve Dupuytren’s cords, to become authorized as a XIAFLEX providers, the manufacturer insists that physicians must enroll in the XIAFLEX Xperience® Program, which was developed as part of the Auxilium effort to make Xiaflex safer. This XIAFLEX Xperience® Program is a 19 minute – yes, 19 minute! – video that is watched online so that physicians receive training in the XIAFLEX administration procedure and relevant safety information. There is no failing the program, there is no test to prove they know how to use Xiaflex, there is no way to prove they understand or have the skill to inject the Xiaflex only into the cord and not into tendons, nerves, arteries and veins – all they have to do is watch. All doctors can now give Xiaflex injections for Dupuytren’s contracture after saying they have watched a 19 minute video on the internet.
This is why I maintain that the Xiaflex results will tend to be not as good when done by average doctors, because these doctors do not have the same level of talent or skill of the doctors used in the drug trial. Xiaflex or collagenase injection is a very technical procedure that apparently not all doctors can achieve – they make mistakes, they might lack skill, experience or training; they under- and over-estimate and so put the Xiaflex where it does not belong and it causes catastrophic results for their patients. They are the reason that Linda has a worse problem now than before that doctor got hold of her.
To understand what I mean about the technical aspects and precise methods needed to administer Xiaflex correctly, Goggle the phrase, “procedure training video Xiaflex.” Click on the first Google response from Auxilium Medical. Then click on the button, “Begin training program.” Watch and listen to the 19 minute training film that doctors watch to learn how to use Xiaflex. You will see how precise and detailed is the technique to place the Xiaflex exactly where it belongs. You will also see how easy it is to make a mistake with a drug that can dissolve many different types of tissue in your hand – or penis – if a mistake is made.
I have predicted time and again in the DCI and PDI websites that as more and more patients are treated with Xiaflex the results and outcomes will get worse. This has proven to be so. The reason for this is because:
1. Collagenase (Xiaflex) does not only attack Dupuytren’s cords or Peyronie’s scar tissue; it indiscriminately dissolves collagen wherever and whenever it comes in contact with it. It is called collagenase because it is specific for this protein called collagen. It is not call Dupuytrenase or Peyroniase because it is not specific for these problems. Collagen is the cement that holds tissues together. Collagen is found in all muscle tissue, all tendons, all ligaments, all joint capsules, all skin, all nerve sheaths and all blood vessel walls; it is even in the brain, bones and teeth, and all organs of the body as basic support tissue. If collagenase is put in contact with any of these tissues, they are dissolved. Period. The more collagenase that comes in contact with the tissue, the more tissue is dissolved and destroyed.
That is why in her story Linda said “the aggressive manipulation…ripped open all 5 areas of injection!” The doctor either put in too much collagenase into her cords that made it leak out and destroy the skin of her palm, or the doctor directly allowed the collagenase to come in contact her skin by being sloppy when the drug was being injected. Not only was this mistake made, it was made five times!
2. When a drug trial is being conducted for something like Xiaflex (collagenase), these highly skilled and specially selected doctors know their work is being monitored by the drug companies, and they will try harder to be more precise and careful than usual. That is just the nature of people and the nature of knowing that someone else is watching what you are doing.
Average MDs are, well, average. Perhaps they are good for most basic procedures but not something that is more precise like injecting a precise amount of collagenase in a precise location. And when they are not being monitored or made to report their results to the manufacturer the technique used and the details kept in mind are probably not going to be as good.
Even doctors who are concerned about the potential for abuse want to limit the kind of doctor who can inject Xiaflex. Some doctors want to restrict the distribution of Xiaflex to prevent rheumatologists and dermatologists from performing this procedure to say nothing of general practitioners. Some doctors want to prevent general practitioners from using Xiaflex. Many want the procedure limited to orthopedic hand surgeons and plastic surgeons who have more knowledge and experience with the relationship of the Dupuytren’s cords to the tendons in an involved hand.
The highly regarded, “Financial Times” reported about this issue in its July 27, 2009 edition, “Auxilium’s Xiaflex Advisory Panel to focus on surgeon education program to limit tendon rupture, nerve damage, surgeons say.”
In the average medical office, a doctor is not being watched by drug companies or anyone else; the doctor can be tired from working 60-80 hours a week, and can be often rushed because he/she is working behind in his schedule as doctors so often are. This is why we hear so much about the many mistakes that are made in medical practice.
3. The errors and problems that arise during drug trials are often under-reported and down-played in an effort to produce a more favorable outcome. This is the reason that so many drugs are taken off the market because they produce either such bad side effects that were not reported in the initial drug trials, or they do not get the same great results that were reported in the initial drug trials. How else could so many drugs get FDA approval, only to be taken off the market a few years later if not for inaccurate drug trial results?
To support this point about the Xiaflex drug trial for Dupuytren’s cord treatment might be inaccurate or not report all facts as they occurred, please read a copy of a post taken from the forum of the International Dupuytren’s Society:
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08/26/09 03:19
ArtistHands not registered
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Re: Think Xiaflex is safe? Read this
In the article at the tiny url there is this statement
"Kaplan also described nerve injury as surprisingly low and added that no one reported temporary numbness." I was in the III stage clinical study and reported numbness in my finger. It was temporary and it was minor (lasting about six weeks) – but I did have numbness – so Kaplan is incorrect in his statement. |
So what we have here is a statement from ArtistHands revealing he/she participated in the phase III trial of Xiaflex for Dupuytren’s contracture and he/she reported numbness that lasted six weeks. However, a doctor who was actually in that Xiaflex trial said that numbness did not occur during the drug trial. How is this possible since a patient who was actually in the drug trial had this very same problem, and reported it, but it was later said to not occur? I have read about other people who reported adverse drug reactions during the Xiaflex trial that were not recorded in the final trial results. It is this kind of distortion and non-reporting of known adverse reactions that allow a bad drug to get FDA approval.
I wonder how many other people like ArtistHands also reported numbness of the fingers after getting Xiaflex injections and were also not reported or dismissed from the results. We will never know.
The questions confronting the person with Dupuytren’s contracture and Peyronie’s disease is not only about Xiaflex safety and effectiveness to dissolve the foreign protein material, but more importantly the skill, talent and attitude of the doctor performing the Xiaflex injections.
Here is my advice and opinion about who to trust concerning Xiaflex injections:
1. Be informed. Trust yourself to make the right decision about Xiaflex based on what you know and understand. Read, study and compare reports from many sources, including your treating doctor. I suggest that you actually watch the 19 minute Xiaflex training video so you know what is going to take place. I suggest that you make notes so you will be informed. I suggest that you ask questions of the doctor who is going to do this procedure. Take those notes with you in the room to refer to. If you are told you cannot do this, ask why – and become very suspicious. If the drug is not mixed correctly, you will know it. If the doctor is going to do something that is not in the training film, you will know it. If the doctor wants to know why you want to know, ask why the doctor is doing something different than in the training film. If the doctor does not do the little test shown the training film to prove the needle is not in a tendon, stop the procedure. Protect yourself. If a mistake is made the medical fraternity and a good lawyer will project the doctor, and you will have a bad hand.
2. Do not dismiss the eventual use of Xiaflex (collagenase) if it becomes necessary if you cannot make the Alternative Medicine approach work for you. But consider using it only as the absolute last resort.
3. Thoroughly explore all non-drug and non-surgical options for at least six months before considering something as permanent and radical as Xiaflex injections. Work very aggressively and explore all possible Alternative treatment options before deciding you have done everything your can to treat your Dupuytrens or Peyronies problem conservatively.
I get emails and phone calls from men and women from around the world who try the DCI and PDI approach for three or four weeks and when a miracle does not fall on top of them, they decide that this approach does not work. That is not only short-sided, it is immature and foolish for an adult to think that a problem as complex and difficult as PD and DC should respond in a few weeks of conservative intervention.
4. Remember that after Xiaflex injections the Dupuytren’s contracture problem will return. For a further discussion see, Do Xiaflex injections really have a low Dupuytren recurrence rate? This means that you might get great results from a Xiaflex injection today, but you will likely have to repeat it again within a few years and maybe as soon as one year. Each time you have a Xiaflex injection you lose normal tissue and make the next episode come just that much faster. This can start a rapidly escalating cycle of hand surgeries that cannot go on forever. Eventually you could run out of options other than amputation – that can and does happen, especially if you are younger than older when you have your first Xiaflex injection or hand surgery. The same can be said for PD intervention with surgery, or Xiaflex in the future.
5. Remember that when the Xiaflex injection weakens the cord and the doctor breaks it, the two remaining pieces are still in the palm of your hand, where they can still continue to grow and thicken. A Xiaflex injection does not remove the cord; it only breaks in half. These two remaining cord pieces are still inside the palm, and can pull and distort the hand just as easily as the original cord before the injection. This is the basis of the many people who are so disappointed with the results they get not only with Xiaflex injections but also with Needle Aponeurotomy. It might not be apparent immediately, but recurrence happens sooner or later in a high percent of cases after disruption to the cord (or the Peyronie’s scar).
6. Remember that the Xiaflex injection will only work to give you temporary relief if it is done correctly. A treatment that breaks down the collagen of the cord in the hand or the scar in the shaft does not cure the problem, and eventually the problem will recur. From my experience in communicating with people from around the world, those recurrences are usually worse than the original problem – the question is how much worse. Most doctors do not mention the recurrence factor, how fast the problem can recur, that the eventual recurrence is often a greater problem than the first time around, and the mess that can happen when this tissue is disrupted by Xiaflex or any type of direct surgery.
7. When people feel they are worse off after Dupuytren Xiaflex injections or hand surgery, there is absolutely no way to reverse or un-do surgery with more surgery. More surgery and more injections to clean up botched surgery results in more problems. Many times when I read about how happy and satisfied a person is after a Xiaflex procedure or hand surgery, I notice that the procedure was done recently. “I had Dupuytren hand surgery done three months ago I am so happy.” Not often do I read “I had Dupuytren hand surgery done three years ago I am so happy.” Many problems take 6-12-24 months to surface, so beware. A year or two is a super-short period of time to get relief for taking a risk on causing a worse problem.
8. Read my article, “Peyronie’s Surgery – Finding a surgeon for your Peyronie’s surgery” to learn how to go about finding a good surgeon to do your Peyronie’s or Dupuytren’s procedure, if you feel it must be done. You must remember that both of these conditions are unlike any other health problems that affect people for the reason that excess scar or fibrous tissue is at the heart of the problem. When you do surgery, or deliver a Xiaflex injectgion, to an area that is already making excess fibrous tissue you can create a problem worse than the original one. So be careful and very cautious about what you do and who you allow to do it. Go way out of your way to get the very best person possible to touch your hand or shaft.
This concludes our discussion of Xiaflex (collagenase) treatment of Dupuytren’s contracture and Peyronie’s disease. I hope everyone found this issue of the PDI Newsletter interesting and informative so you can do a better job of helping your own PD or DC condition.
If you want to contact me about your problem, please send an email.
Let me know if I can help you in any way. Stay focused on your treatment plan.
Regards,
Theodore R. Herazy, DC, LAc
