But it is FDA approved!!

SO WHAT!! Who do you think sits on the advisory boards that approve drugs, artificial discs, or any of the other new appliances and gadgets that are approved. A five person panel of Physicians usually associated with the field that the new product will be used in. The politics and lobbying there is just as great as it is anywhere else in Washington, D.C. Am I saying that everything that the FDA passes is bad. Certainly Not! I am saying that more and more The FDA is influenced by politics and lobbying of big drug and device companies.

The Charite disc is one very recent example. This disc was designed at Charite, hospital in Berlin, Germany almost 20 years ago and the results have been dismal at best. I have personally followed it for 15 years myself. It was purchased by a company owned by Johnson and Johnson and over the objections of several high profile "Ethical Spine Surgeons", it made it through the FDA pretty fast and is now being implanted in to the Lumbar Discs of people like me.

Dr. Charles Rosen and several other great Spine surgeons have started a new Association, Association For Ethics in Spine Surgery. Dr Rosen is one of The Surgeons who has called for the FDA to remove The Charite disc from the market. You can read about his remarks at Whats Wrong with The Charite Disc

There are many great professional surgeons in this country who practice by the oath they took, on the other hand "THERE ARE MANY SURGEONS WHO ARE GREEDY AND DO NOT HAVE THE PATIENTS HEALTH FIRST, WHICH IS WHERE IT SHOULD BE". When I had this new FDA approved procedure that I have talked so much about the Chemopapain injection, the Doctor that performed the procedure on me never mentioned the down side or the possible things that could happen. All he talked about was what a great medical break through it was and how much better I was going to feel. I WISH!!

For a look at one of the Nations Top Surgeons who has been there and done that, read what Dr. Charles V. Burtons views are on this Subject and I will take you to his site so you can read his article complete.

----------------------------------- Dr. Charles V. Burton ------------------------

"During the 1970's the Editor was a representative of organized neurosurgery in the drug and device areas. This involved the writing of standards and it wasn't unusual for standards groups to create rules which "were smarter than they were". Being in Washington at the genesis of medical device legislation the editor experienced firsthand the sport of "character assassination" so well described by Vincent Foster prior to his suicide. In providing testimony to the Congress of the United States government the editor observed a prominent consumer advocate providing false testimony. When this was later brought to his attention in private he acknowledged that he had lied but retorted: "but I made the point didn't I?". This also was quite an eye opener regarding the true nature of the "playing field".

Other "eye openers" have been the government's political agendas. The editor, as a Food and Drug Administration medical device panel chairman observed the process by which knowledgeable consultants were removed from serving on FDA panels because of potential or real conflicts of interest. Rather than protect the public interest by the application of "sunshine" principles, these experts were replaced by politically "correct" minorities for the purpose of "balance". Unfortunately, these choices reflected an expediency dictated by the wrong motives and thus deprived the public of important guidance in the areas under consideration. Effective means of keeping experts as consultants while at the same time negating their potential conflicts of interest were not utilized.

As a member and chairman of local and national ethics committees the Editor became aware that it was not a popular deed to bring up discussions as to what was in the patient's best interest rather than those of the physician or hospital. Minnesota physicians are well-known for placing their patients best interests at the forefront in the physician-patient relationship. The Burton Experience has been that this ethic deteriorates rapidly as the issues go beyond those of immediate patient needs.

Few medical professionals have evidenced to the Editor an awareness of what ethics are or the reasons as to why they are important in health care. Those who have appeared to understand ethics frequently suffer from memory lapses when confronted by self-interest. Medical ethics has been, and continues to be, an afterthought in the medical community. It needs to be reinvented."
The Burton Experience
This is copyrighted material and reprinted with the permission of Dr Charles V. Burton.

The Tale of the Floppy Eared Bunny

"(The Saga of Chymopapain)
As the laboratory staff watched in awe the rabbit's ears began to wilt following the intravenous injection of the enzyme chymopapain. It remained for orthopedic surgeon Lyman Smith to turn this observation into a new therapy for the treatment of herniated discs. Why, he reasoned couldn't chymopapain also dissolve the collagen in a herniated disc? From this basic observation the saga of chemonucleolysis (enzymatic dissolution of disc collagen) with chymopapain (the active ingredient in Adolf's meat tenderizer) was born. It turned out to be a textbook example of how not to do things in medicine including high grade marketing blitz (the " M2H" factor). This resulted in a patient stampede to have chemonucleolysis.
There can be no question but that the M2H factor for chymopapain was one of highest ever recorded. Because it wasn't released by the United States Food and Drug Administration until November 10, 1983 a large cottage industry had been created in Canada starting in the 1970s. This was a modern version of the "underground railroad" where lines of U.S. clients were often passed through enzymatic assembly lines (a process which has become reversed in recent years). The good news was that only a small number of Canadian Orthopedists and Neurosurgeons practiced chemonucleolysis and they were expert at it. But even the doctors became caught up in the hype. One prominent Canadian orthopedic chymopapain advocate stated at a medical meeting that all he required was a "few cc's of chymopapain" to take care of all of his spine patients! The widespread Canadian expertise was unfortunately not also reflected in the United States where approximately 7,000 orthopedic and neurosurgeons took a one day "training" course in this needle technique and pronounced themselves fully qualified to perform chemonucleolysis at their local hospitals (whose credentialing committees nodded in assent) after Food and Drug Association approval. Those few hospitals who believed that some degree of apprenticeship was required by these neo-procedurists typically gave in to the argument that since other institutions weren't requiring such that their physicians would become non-competitive and thus loose patients. Their credentialing committees then rubber stamped this example of poor medical practice and hospital self-interest.
While some of the 7,000 American trainees actually had some prior experience with needling techniques and fluoroscopic imaging many did not. The sad part of this tale is that the inadvertent deposition of chymopapain into nerve tissue as well as the sub-arachnoid space created some horrendous problems (including stroke, paraplegia, and death) for a significant number of patients. Even though injecting chymopapain simply required placing the tip of a needle in the nucleus pulposus of a disc many practitioners learned that this was not as simple as it seemed. These needles often ended up in other locations as shown below.

Observations
The incidence and prevalence of unnecessary, but serious, complications with the use of chymopapain gave it such a bad name that it soon fell into disuse in the United States. Now, one might think that this is was the end of this tale, but it isn't. Chemonucleolysis with chymopapain (or other enzymes such as collagenase) really weren't a bad idea if qualified people were involved in injecting them. The real problem was the high M2H factor which created a feeding frenzy for patients as well as their physicians.
As it turned out, even when chymopapain was injected into the right location there were important associated liabilities. A major example of this was replacing leg pain (by dissolving the disc) with incapacitating back pain caused by the sudden collapse of the disc interspace producing pressure on the facet joints. Another problem was the high level of allergenicity of the drug itself.
Unfortunately the use of chymopapain created new problems for patients. Could the resulting back pain have been addressed?. The answer is yes, by the use of anti-gravitational traction (but it wasn't). After a respectful period of time chemonucleolysis with chymopapain began to re-emerge in Europe in a lower dose application....where it remains today. In the United States it continues to remain unused and shunned. Despite the tale of chymopapain and its unfortunate demise the M2H phenomenon is still alive and well in the over-promoting of medical devices and techniques even today. "

The above article is the property of and used with the permission of Dr. Charles V. Burton
http://www.burtonreport.com/infspine/mininvasprocchemonucleolysis.htm

It is with the discovery of his website and the study of his vast knowledge and material that has helped me endure and understand the truth of the first of many procedures, that would take me down my 25 year (so far) path to devastating Chronic Pain.

"There are many minimally invasive spine procedures being performed today. Some, such as epidural steroid injections are often used with little appreciation or understanding of the patient's real diagnosis ("shotgun therapy") and sometimes with no understanding that the patient does not even have an anatomic epidural space (i.e. obliterated by prior spine surgery). Most certainly, in the "physician do no harm" department ill-advised and ill-performed epidural steroid injections have created devastating lifelong problems for significant numbers of unsuspecting patients.

Other minimally invasive procedures such as percutaneous radio-frequency facet blocks (PRFFNB) which have benefited many over many decades are therapeutic, but destructive, in that they cauterize normal nerves to achieve their effect. The value of such a procedure is that the benefit to the patient outweighs the minimal risk."

Source: Dr। Charles Burton, M.D. read more at http://www.burtonreport.com/InfSpine/RestorativeSpineCare,Min-Invasive.htm

If there is one person in this country that I consider an expert on the spine, it is Dr. Burton. I thank him for giving me permission to use some of his information.

As I may have said before, the procedures performed on me in the early 1980s have destroyed my life, yet the very surgeon that I am presently seeing wants to do fusions on the affected discs. But when I try to talk to him about the present condition of the nerves in my spinal cord he want even talk about it. It is like he don't believe there is a condition called "Adhesive Arocnoditis." Evidently they aren't taught the failures in medical school. This much I do know. I will be staying up until 4:00 A.M. in the morning. Why? I am in to much pain to sleep. Try living like that for a few weeks much less years like I have done.