The US is falling behindPosted by Heinrich on 11/09/04 at 00:37 (163296)
Very interesting website and board. The United State spends more money on healthcare than any civilized country, gets a lot of care but does not always get the best care for the dollar.
Europe has seen, for almost a decade and a half that surgery for plantar fasciitis is defunct because ESWT works. At first, we knew little about how ESWT was to be applied. Years of progress and experience has shown that the most cost effective treatment is the repetition of low energy ESWT. There are over a dozen manufacturers making smaller and smaller ESWT models. Even the manufacturer of Ossatron, HMT, now makes the low energy Reflectron for use in Europe. Low energy is safer, requires no hospital nor anesthesia and is much cheaper than high energy. The manufacturers realize that the US is a big market but the politics in American healthcare is enough to destroy any reasonable profits. Remember that ESWT is not an expensive treatment. Americans have made it so by politcally fixing the price high and doing everything possible to make use of low energy difficult. The 'big buck' high energy ESWT people can lobby the FDA because of the big money involved. It is a shame because they are making the American people suffer and pay outrageous fees for a simple, effective treatment. I have seen websites in which low energy is commonly being used on American race horses. The animals are getting treatment that humans cannot and you must really thing hard about this. Why do you think that low energy works so well on race horses? This board has people looking for help but is a sounding board for anonymous manufacturers representatives like John who sound like experts but will not tell people who they really are. A moderator should make these people tell the truth about who they really are. I am a ultrasound technician involved in ESWT for 12 years. I have treated thousands of people successfully with low energy ESWT which thousands of people can testify and vouch for its efficacy. We don't need more studies in Europe as we have the experience of seeing hundreds of thousands of cures and surgery for plantar fasciitis becoming a very rare thing indeed.
Thank you for listening. I will not become a regular poster here but feel that a disservice is being done when people are being given bits and pieces of information and not the whole truth.
Re: The US is falling behindDr. Z on 11/09/04 at 01:26 (163298)
Thanks for coming to this web site. Which is better in your opinion Ultrasound guilded low energy ESWT or low energy ESWT? It is my opinion that it is the European manufactors that came to the USA and made a CHOICE of what level of approval that would apply to the FDA for approval.
The USA has a process but the manufactors determined and made a choice as to how they would use this process. Ossatron was the first and set an example that only the French would be proud of
So what machine, manufactor do you treat patients with.? One last question. Is it true the Germany stopped paying for ESWT low energy treatments due to the over use of the procedures and then determined that there must be more multicenter,double blind, randonized studies of low energy before the Germany govt will pay for ESWT. I believe that in 1996 there were more ESWT ( about 60,000) procedures done in Germany then in thre were ESWL procedures done. What happen to the studies that were required before Govt payment would begin again.
Re: The US is falling behindjohn on 11/09/04 at 01:36 (163300)
I find your subject 'The US is falling behind' offensive.
The reason that low energy ESWT is not approved in the United States is because the manufacturers of low energy ESWT have not applied for FDA approval. Let's not forget, Healthtronics and Dornier submitted study results to the FDA showing the effectiveness of high energy ESWT and received FDA approval. Any manufacturer can submit study results and ask for FDA approval.
I think that you and Dr. Davis should be asking why low energy ESWT manufacturer's have not conducted studies showing the efficacy of low energy ESWT in the treatment of plantar fasciitis. Really, it is not enough to say that low energy ESWT works, here in the United States, the FDA requires properly conducted scientific studies to prove that it works.
Finally, I don't really care about animals being treated by low energy ESWT. Animals are always the first to receive experimental treatments.
Re: The US is falling behindJulie on 11/09/04 at 02:56 (163303)
I am entering this discussion for the first and last time.
Heinrich, thank you very much for your post and for giving people here a European view. As an American living in England I have been aware of the great difference in ESWT costs, and attitudes towards it, and I think you have given the reasons for this very cogently.
John, for someone who has clearly has an agenda, and who has been asked several times to reveal your identity and your vested interests, you are out of order calling someone else's post offensive - especially as Heinrich's statement, 'America is falling behind', would seem to be a statement of fact, no more, no less.
I was glad to see Heinrich's post, but was not going to say anything until I saw John's, which made me so cross that I had to say something. I do realise my post adds nothing to the discussion, and I will now withdraw.
Re: The US is falling behindDr. Z on 11/09/04 at 07:02 (163306)
I agree that John should have used a different word then offensive however past that his pointed is very well taken.
Why did the European manufactors such as dornier, Healthronics come to the US and start with high energy. The price of the machines are the same whether it is in the USA or Europe.
I just would like to know why. When I ask Dornier who uses low energy, and high energy treatment they tell me that high energy is better.
As for the FDA approval process European Manufactors ( healthronic's) created the rules by being the first to determine what level of testing needed to be done. When I had the big O it was healthronics that set out to destroy the big O. The FDA accepted the big O's applications and knew that it was an ESWT machine in the applications Hey maybe this is all political and I agree with Heinrichs post. Ok never mind.
I still think that John does offer alot of good information regardles of who, and where he comes from
Now that I am starting to think about posts about ESWT and are they from a company I am started to notice that there are other companies representative on this board. I just never think about it and just take the post for the post. I could point out a post from another company that posted just last nite.
Ok off to work. Every one have a good morning
Re: The US is falling behindskull on 11/09/04 at 07:35 (163310)
I've had ultrasound and it didn't help at all. It seemed downright silly - like trying to put out a raging fire with a thimble of water.
Re: The US is falling behindEd Davis, DPM on 11/09/04 at 10:12 (163328)
Hopefully you will consider coming back to post. I thank you for speaking your mind. Maybe it is offensive to John but you are basically speaking the truth. I am familiar with Piezovet, the low energy ESWT used on animals in the US. If it can cure the heavy tendons and ligaments of a race horse, then it can have an effect on the human foot.
Skull, we are not even talking about ultrasound so I am not sure what the relevance of your post is.
John, Heinrich has done more to identify himself and you still remain the mystery industry insider here pushing a narrow agenda. Why would you not give us the most basic information about your background? I cannot take offense at someone who has come here to point out basic facts.
As far as coverage issues, I don't even think that Cananda has governmental coverage of ESWT, low nor high. Countries with solcialized medicine offer a degree of rationing of services. Canadians pay out of pocket for ESWT. One should not confuse coverage with efficacy. Oregon, for example used a list based on severity of conditions to decide on Medicaide coverage. I would never use the presence of absence of reimbursement as an end means to decide on the efficacy of any health modality. No one covers nutritional supplements yet many deem them critical to health.
Re: The US is falling behindEd Davis, DPM on 11/09/04 at 10:15 (163329)
ps. Most Blue Cross?Blue Shield individual plans in WA don't cover maternity so we don't decide that maternity is not valid for medical care. For years the APMA based helth insurnace plan did not cover maternity...
Re: The US is falling behindEd Davis, DPM on 11/09/04 at 11:14 (163331)
I can only speculate as to the answer to your question but when the Orby was removed, only the high energy model had a sufficient cost structure to pay the 'piper,' ie the cost of studies and FDA approval.
I am interested in talking to people at HMT to see what motivated them to switch production to the Reflectron.
Re: To "John"Jan R. on 11/09/04 at 11:14 (163332)
Having the FDA approve a shock wave device and providing effective treatment may sometimes be 2 different things.
Regarding the recent publication by Dr. Ogden in JBJS-Am please read the e-Letter comments from me and from Dr. Buchbinder:
Dr Ogden and colleagues recently reported the results of a trial of shock- wave treatment for chronic plantar fasciitis (1). We seek clarification on whether this is a reanalysis of a previously published trial (2), and if so, why the sample sizes are significantly different. While the results appear similar, the authors now claim a significant difference in the mean score of subject self-assessment of pain at 12 weeks favouring the active treatment group (p=0.014). While this cannot be verified from the data presented, as no measures of variance are provided, independent t-test comparison of mean scores for subject self-assessment of pain at 12 weeks using data published in the original trial report submitted to the US Food and Drug Administration found no statistically significant difference between groups (mean (SD) scores: 3.48 (3.11) and 4.18 (3.04) in 115 and 114 patients in the active- and placebo-treated groups respectively; mean difference = 0.7 (95% CI -0.1 to 1.5), P = 0.08)(3).
The alleged efficacy of this single dosed, high-energy, anaesthetically based treatment has already been discussed in an exhaustive way by Buchbinder et al.(3)in 2002: Regarding the HealthTronics sponsored FDA tria1,(4) Buchbinder critizised that the presence of plantar fasciitis was determined solely on clinical grounds. It was uncertain whether the 2 groups in the trial were comparable at baseline. Ogden et al.(1)had defined overall success of treatment at 12 weeks if all 4 of the following criteria were fulfilled: (1st) minimum 50% improvement over baseline in investigator assessment of pain (by dolorimeter), with a VAS score of 4cm or less; (2nd) minimum 50% improvement over pre-treatment baseline in subject´s self assessment of pain on first walking in the morning and VAS score of 4 cm or less; (3rd) minimum 1 point or greater improvement on a 5-point scale of distance walked without heel pain, or maintenance of baseline assessments of no pain or minimal pain; (4th) and no prescription of analgesics for heel pain int the treated heel between 10 and 12 weeks after treatment. While success in the 3 criteria other than investigator assessment of pain also favored the active treatment, none was statistically significant (subject´s self-assessment of pain criterion: 59.7% in ESWT group vs. 48.2% in placebo group, p= 0.08; subject´s self assessment of activity level: 71.4% in ESWT group vs. 67.2% in placebo group, p= 0.49; and use of pain medications: 69.7% in ESWT group vs. 67% in placebo group, p=0.41).
I wonder why Ogden, who quoted the Buchbinder paper in his article, did not specifically respond to these objections.
How is it possible that suddenly significant differences are calculated at 3-month follow-up while in the original FDA paper,(4) no statistically significant difference had been observed at the same follow-up?
Let us talk data and discuss the FDA trial in detail.
Re: To "John"Ed Davis, DPM on 11/09/04 at 11:24 (163334)
Than you again for your post. You, as I, are not anonymous but are 'real' people who can be contacted. John seems to feel the need to hide behind anonymity and wonder why.
Did the German authorities remove coverage as Dr. Z mentioned and what is the status of that? I realize, as most, that official government and corporate coverage decisions are not always based on efficacy of a medical treatment, let alone the public interest but such decisions can be used as a 'weapon' by detractors of a treatment. Naturally, pointing out that individual health insurance policies in my state do not cover maternity is compelling because how can one argue that medical care for pregnancy and deleivery is 'not medically necessary' based on the coverage policy of an insurer.
Re: To "John"Dr. Z on 11/09/04 at 11:34 (163337)
What was the response by Dr. Odgen?
Re: To "John"Jan R. on 11/09/04 at 13:34 (163353)
There was no response so far.
Prof. Buchbinder and I have officially informed the Editorial Board of the Journal of Bone and Joint Surgery about the discrepancies in Ogden's studies.
Re: To "John"Ed Davis, DPM on 11/09/04 at 15:42 (163366)
Is HMT still making the Ossatron or going primarily with the Reflectron to the best of your knowledge? I may send them an email as I am curious to understand their view.
Re: To "John"john on 11/09/04 at 18:58 (163387)
I have not read the recent Ogden article so I don't know how it compares to the FDA study. I would be disappointed if there were significant differences. Was it published in a reputable journal and properly peer reviewed?
Sunny has said that ESWT is not covered by the German National Health plan,
can you give us some insight into the reasons for the lack of coverage? Are they asking for additional research in order to give coverage? Here in the US, many insurance companies are looking for additional studies in order to approve ESWT.
Do you expect that ESWT will eventually be covered in Germany?
Your comments could give us insight into the pitfalls of getting insurance coverage for ESWT.
Re: The US is falling behindDonald Iain Scott on 11/09/04 at 20:52 (163397)
In Australia ESWT is also an out of pocket expense. The national Medicare system does not cover ESWT. ESWT is also big in the horse racing industry.
(I cannot comment on all the Asian countries that are using ESWT Long before america starting using ESWT. So, yes america is falling behind
Sorry people, Americans,not all can be so full of themselves and as I have stated here before the FDA does not rule here in the Southern Hemisphere.
We have been instructed on how to treat patients using ESWT and we will not change just for the way the Americian FDA thinks it should be done.
And whose bright idea was it that patients needed L.A. or G.A. for P.F. using ESWT??? Where is the paitent feedback??????
Donald Iain Scott
Re: The US is falling behindDr. Z on 11/09/04 at 21:03 (163399)
Did we ever determine that your protocol up to level nine is really considered repetitive high energy treatment without anesthesia.?
All of the repetitive low energy treatments that I have read about don't go to level nine ( above 0.5 mj/mm2 ) The reason I asked is this is some new to me and in all of the literature I have read. It is an interesting protocol and might be new. I haven't read anything in any textbooks or on the International Shockwave Thereapy Web site. Would you comment on this and tell us about how your cases and results. Could be a very good paper.
Re: The US is falling behindDr. Z on 11/09/04 at 21:06 (163400)
Hey come back here !!!. I want to learn and would like to know about your protocol. My goal is get results so please share your specific protocol and any advice that you may have with great the best results. The bottom line in my eyes is patients gettting better so lets talk about patient protocols and how to improve results
Re: The US is falling behindDonald Iain Scott on 11/09/04 at 21:44 (163403)
Good point Dr Z.
For P.F. over a 3 treatment course we reach level 9 (.5mJ/mm2) since 1998 (South Coast X-Ray) myself since 2002(South Coast Podiatry) in Australia.
Other body sites
Level 1 to Level 5 for Achilles
Level 9 Shoulder with L.A. (Only because the focal point is the deposit of calcium)
Level 1 to Level 9 Elbows, Patella, Hip, Peyronie's Disease etc.
Donald Iain Scott
Re: The US is falling behindDonald Iain Scott on 11/09/04 at 21:52 (163404)
It is so true, at the end of the day, the patient is No.1
Is it OK by Scott R to put my email address on this site for Dr. Z
Donald Iain Scott
Re: The US is falling behindDr. Z on 11/09/04 at 21:59 (163405)
Please e-mail I want to talk more about your three session high energy ESWT protocol for PF (email removed) I would like to discuss the goals for each session. How high can you go per session. You can answer here or e-mail Dr.Z
I would like have each level of energy for your dornier again.
Re: To "John"Jan R. on 11/10/04 at 02:06 (163417)
This is what I was afraid of. I am glad that you made this frank statement.
How can one give his opinion - pro or con - if not familiar with the current literature?
The Ogden article was published in the American Volume of the Journal of Bone and Joint Surgery, the 'bible' of Orthopaedic Surgeons worldwide.
Re: To "John"john on 11/10/04 at 03:59 (163420)
Given that the Journal of Bone and Joint Surgery is the 'bible' of Orthopaedic Surgeons worldwide, don't you think that they peer reviewed the Ogden article? Don't you think that the reviewers were top surgeons worldwide? I trust that the reviewers of JBJS carefully reviewed the Odgen article. This is the academic standard of peer-review that we live by.
Re: To "John"Jan R. on 11/10/04 at 11:06 (163443)
Until reading Ogden´s article I shared your opinion.
Now I am less convinced of the capabilities of the Editorial Board (more precisely of the reviewers working for them).
And my concerns were supported by one of the most renowned epidemiologists in the field. Generally, I don´t like Dr. Buchbinders conclusions too much. But here, she is completely right.
Unless Ogden and colleagues cannot produce a very reasonable explanation for the obvious discrepancy of their statistical calculations serious trouble is coming up.
Re: To "John"john on 11/10/04 at 14:28 (163462)
Thank you for your candid response.
I have my own concerns with the articles written by Dr. Buchbinder that I would be happy to discuss at another time. I do not like the way she dismisses positive, well constructed articles. I also think that her NEJM article undermines her crediability by applying a higher standard to ESWT than she applied to surgery.
I hope that there is a resonable explanation for the discrepancy in Ogden's article since it very serious situation if the data were faked. At a minimum, it would undermine the confidence in the original study.
I am disappointed that the reviewers did not compare the FDA study and the article submission, an obvious first step in reviewing the article. I agree that the conclusions in the article must match the FDA study.
In my first reading of the article, I had trouble with the section titled 'Complications' at the bottom of p2223. The article did not recognize that during the FDA study two patients had midsubstance plantar fascia tears. I expected them to explain that tears were observed in their study. They did not.