you know that there is no patent on EDTA & it is not profitable for a drug company to do studies..it has given countless patients relief with few if any side effects...has been used orally, rectally & IV with most dramatic effects IV....yeah wait on a drug company to do studies that are not needed & cost to patient will be unaffordable..economics again overrule patient benefits in this case..

There were at least 3 previous controlled clinical trials with chelation therapy for advanced atherosclerotic lesions. Two I believe were in subjects with claudication and one in subjects with coronary artery disease. Before and after angiograms showed no significant difference in plaque size so any claim that chelation therapy reverses atherosclerotic lesions or improves blood flow seems unlikely. Given the fact that EDTA infusion has risk and is not approved for use in those with CAD makes it an inappropriate Tx for advanced atherosclerotic disease. Also the absense of a viable mechanism by which EDTA may reduce the risk of plaque rupture is problem for those who advocate it use to Tx CAD. While the results of this recent study do suggest the "chelation cocktail" may have some benefit in those with type 2 DM data from this study alone are hardly sufficient to warrant the FDA to recognise chelation therapy as an effective Tx for CAD. For all we know the benefit if it turns out was not some statistical fluke might well be due to the magnesium infused with the EDTA. There is reason to believe many people with type 2 DM may have low tissue levels of magnesium and this might contribute to their increased risk of CVD events. I do share Melissa's skepticism to a large degree but also agree with S. Nelson that the results of this trial do warrant further study to determine what part (if any) of the "Chelation cocktail" used might actually have had some beneficial impact perhaps on inflammation or plaque rupture. Melissa's suggestion for potential markers of inflammation in a follow-up study seem like a step we would all support.

Gee Sid,  I stated that further study should include inflammatory biomarkers.  You sure know how to hurt a girl. :)

Melissa

Melissa - Upon rereading, i see  you were talking about the science behind the effect, not the epidemiology.  And we certainly have to go over the published data in detail.  But I still think that these results are good news, not difficult news, and we should embrace it until we see data suggesting otherwise.

Melissa, no harm intended, of course.  And thanks so much from your readers for all of your AHA reporting efforts! We wish we were there!

Thank you S !!! Having a good meeting. Lots to cover.....! appreciate your post!

Melissa

 

One could get the same benefit, if not more, from appropriate dietary modification. In advanced end-stage CAD that might be an Ornish or Esselstyn type diet, which has been shown to robustly regress plaque and reduce events.

Hello Melissa,

I agree with S. Nelson on this one.

TACT is a secondary prevention trial, and based on the early reports, the primary end-point was driven by fewer revascularizations. This is actually the "clam" most chelation practioners suggest is the reason to proceed with this therapy in the first place. Their claim is that you won't need CABG or PCI if you follow their recommendations ("Bypassing Bypass Surgery" Dr. Cranton). as such, the result of TACT will likely reinforce those views, in my opinion.

The 3 RCTs referred by DoctorJay, combined don't amount to 300 patients if I recall well, with the PATCH trial (Wyse et al) having studied 84 patients total. Its primary end-point being time to ischemia on a treadmill test. The other studies were done for PAD patients and/or with other non-clinical outcome end-points. Thus the "evidence" of refutal involves a pot-luck of studies with different end-points and under powered designs to objectively make a determination one way or the other...clinical equipoise if you will. This was the impetus for TACT to be funded and to be carried out.

Plenty of articles by Drs. G. Mitchell and J. Vita (among others) in the past decade or so, show plausible beneficial effects by high-doses of anti-oxidants (VIT C/B-Complex, etc) on endothelial function and this may indeed be the actual mechanism of action of the chelate, rather than EDTA (the Twinkie preservative), to which fewer revascularizations occured and why diabetics fared better?

Even with the recruiting issues, TACT did manage to study more patients than any other trial to date and at the very least yielded more insight into plausible mechanisms of action. Although not "conclussive" it nevertheless has taken science to a larger step closer to finding out if the therapy or a component of it may be of use in the future. 

Thank you for your posts Melissa. Highly appreciated and greatly enjoyed.

Alan 

Dear Melissa,well, since you brought it up, let me tell you (lemmi tellya, actually) that I would have loved to see you wearing both a stethoscope and a pair of floral-print Bermuda shorts...;-)If I may, I would ask you a tangential question. An observational study found that statins increase the calcium content of coronary artery, and yet reduce CAD mortality: is all (coronary) calcium created equal? Although this might well be part of the healing process of a soft plaque, how would this interfere with the interpretation of a calcium score?Thank you for your inspiring and, yes, heartfelt posts.Giovanni GulliP.S.: If Dr Lamas really said that “"clinical application can't be recommended based on the current unexpected  results”, well, maybe science is safen and Sid Nelson’s remarks are more than to be agreed with.

 

Dr. Melissa is right on target in my opinion. And there's an elephant in the room that chelation proponents hope we won't notice - namely that the study drug in TACT, which is prescribed in the ACAM protocol, disodium EDTA (Edetate disodium, Endrate) was removed from the market for safety reasons by FDA in June, 2008: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-13273.htm

 Did Dr Lamas mention that in his AHA presentation?

 

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113738.htm

I found this confusing. Would you please comment on this FDA web page? Does it support your statement? Thank you.

 

I agree the link you cite could be confusing. At the bottom of the FDA's Public Health Advisory on Edetate disodium you'll find a link to the page you found: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051138.htm

At the top of the Public Health Avisory is a notice of Edetate disodium's withdrawal & link to the Federal Register notice. IIRC the FR notice links back to the Public Health Advisory.

 

it is naive for any one to beleive that plaque and calcification formed over decacdes can be reduced in a matter of weeks by any therapy, chelatin or  otherwise. we have a local concoction going around in our culture in pakistan ; equal amount of juices of garlic, lemon, ginger and vinegar in honey ; that reduces angina.  the temporaray relief, psychologocal or physical, provided by sych therapis through pathways of reduced inflammation , or bacteria etc cannot form basis of being called " curative tretaments"

I apologize. I realized I responded to your question but didn't use the Reply button.

Here is what I posted 

I agree the link you cite could be confusing. At the bottom of the FDA's Public Health Advisory on Edetate disodium you'll find a link to the page you found: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051138.htm

At the top of the Public Health Avisory is a notice of Edetate disodium's withdrawal & link to the Federal Register notice. IIRC the FR notice links back to the Public Health Advisory.

 

Sorry for the confusion.

 

What is most frustrating is that there are several "alternative" ideas (conventional and otherwise) and that it sure seems like those who want us to go slow do not understand that each and everyday is an "urgent" day for those who have this dsease and that we need to be willing to reach out and actually be bolder in finding the brass ring.

If Chelation has any merit,  let us begin "aggressive" trials!

In response to the above,  Apolipoprotein A-I (ApoA-I) & ApoA-1 Milano infusions are as good as any in reversing in Weeks/Months..............

Let's MOVE FASTER!!!!!!!!!!!!!!!!!!!!!!!!!!

I appreciated the article because it does make it very hard to decide what to do, but

the FEAST trial done at VA a few years back swayed my thinking. Inflammation

might really be the cornerstone of some of these approaches not the calcium

removal. At the Libin they really are focusing on flow patterns rather than

the lesions. Iron and copper are hugh factors in inflammation states and getting

the levels down in the vessels might very well be an advantage. Phebology

like approach like in hemochromatosis, deferiprone for NBIA?

What a messy state of affairs! Even after decades of extensive studies, we still do not know whether calcium is a 'healer' or a 'killer', or what is the exact cause of plaque formation and rupture. Till that is established beyond reasonable doubt, there will be multitudes of treatment - from physical to sublimal - and all claiming to give the best results for the hapless patients suffering chest pain or dying from heart attacks and its aftermaths. In that scenario everyone will try to prove their points and take their pie, no matter the reality is. Yes, it will require far more rigorous trials to understand which components of the 'cocktail' works; and if the benefit is due to the combinations, how does it helps. Statistical analysis may point to the truth but can never be the 'Truth' in scientific terms. 

Missing from the discussion is the fact that most of the plaque is not calcium except in end stage renal failure.Further this dystrophic calcification only very slowly exchanged-over40 years ago t1/2 was estimated >300 days.Contrast this to the turnover of lipids and plaque stability,regression and decrease in CHD:for every1m/mol reduction 25% less and 20%less stroke.Let's go with the science not the bearded crystal "healers"-alot has happened since the summer of love 1967!!!!