The National Institutes of Health 7 year study of IV Chelation is now completed. The NIH named their study the Trial to Assess Chelation Study [TACT]. This double blind study of 1708 patients with active heart disease revealed a reduction of “serious cardiac events’ in the group who received the IV Chelation protocol vs. those who received only a placebo.
Tact Results on Effectiveness
- Overall reduction of risk 18%
- Reductions in patients with greatest risk:
a. Diabetes 39%
b. History of Anterior Heart Attack [most dangerous type] 37%
In other words the greater the heart disease risk the participant had, the greater the reduction of heart disease from the IV Chelation Protocol.
Tact Results on Safety
NIH researchers noted that:
Both groups of patients, that is those receiving chelation and those receiving only the placebo, were found to be free of significant side effects.
Comment on Safety:
This very positive result on safety brings up an interesting point: the Chelation IV Protocol now needs be compared on basis of safety alone with the procedures it could possibly be used in place of, not only a placebo.
After all, in ‘real life’ patients are often choosing between chelation and bypass or angioplasty, not between chelation and a placebo. The lowest current rates of risk of mortality and morbidity from bypass surgery reported in California are as follows (for full results, click here):
- Mortality 2.2%
- Morbidity 3.6%
- Non fatal [strokes, clots, etc.]
In other words, a program using the IV Chelation Protocol in lieu of bypass statistically could result in the saving of 22 deaths and 36 strokes for every 1000 bypass surgeries not done. That is simply the difference in the risks between the two procedures themselves.
Commentary On Results
Directly comparing the level of benefits between bypass and IV Chelation remains to be done. Until that study is done, the study below deserves our attention in making decisions:
The VA did do an interesting direct comparison between; 1. Medical therapy alone & 2. Medical therapy plus bypass surgery. Any benefit from the 2 treatment protocols was measured by comparing the length of life of participants after beginning each of the 2 protocols. The study was left open for data collection for 18 years! It is a very rare study, which is independent and funded enough to stay open that long.
Results? A small benefit in longer life in those who had the medications plus the surgery initially was found. However, it peaked at 5 years, then diminished to zero over the next 6 years. The improvement was confined to those participants who had a ‘poor natural history”. Researchers were taken aback when, after 11 years, those treated with medication alone began to show a small increase in life span over the group given both surgery and medication. This small benefit of longer life span in those not getting surgery persisted and did not diminish through the end of the study after 18 years.
These results obviously raise real questions about the continued use of bypass surgery as the established protocol of therapy for stable angina and clogged arteries.
Read more here.
Remember that the NIH TACT study was in effect a comparison between 1, Medication alone & 2, Medication plus IV Chelation for patients with stable angina and clogged arteries. In other words, the placebo group and IV Chelating groups both continued to take their medications.
What was the main result of the publishing of the VA study? It was not to reduce the overall activity in surgical units. Surprised? Here is how it worked out:
Bypass surgeries were reduced. But the balloon angioplasty industry blossomed, so to speak. Since the angioplasty/stented arties clogged up so often and needed to be redone, the total number of surgical interventions actually increased. The advocates of ballooning and stenting pointed out that their survival rates were as good as with bypass surgery. That seemed to be statistically true. But as the VA study pointed out, the bypass rate of benefit is itself of very questionable value over medication alone.
Did any study evaluate angioplasty/stenting directly against medical therapy alone? At least one did. A study named COURAGE found no difference in benefit when angioplasty/ stenting was added to medical therapy in patients with stable angina and clogged arteries.
Simply stated, it appears the protocols for angioplasty/ stenting and bypass currently in use are yet to be proven statistically better than medication alone.
Tact Trial: Rated as a Research Study
The TACT TRIAL, by the way, was a well structured, designed, and conducted study. It also was a type of study now rarely done in that it was:
- Funded and conducted totally within the NIH.
- No one with a professional or financial interest had any access [influence] to the data gathering or reporting.
Clearly this is the best type, most objective, rigorous type of double blind study, No serious researcher would argue that point. But, if that is so, why is this type of study so rarely done?
Wouldn’t this most exacting type of study for instance, measure statins before being so widely prescribed? One would think that would be the case. However, in real life, the interested party, usually a large Pharmaceutical company, no longer wants to give up control when their products are being tested. Since ‘our’ FDA does not require it, the companies are pleased. In fact the pharmaceutical companies have been encouraged by the FDA in the last 20 years to maintain full funding and control of testing of their products and compile the data themselves. They then report their findings to the FDA for review and approval only. To reduce FDA costs, “our” FDA initiated this change.
For more detail on how the double blind study system has changed, click here for a detailed article on SFPMG’s website.
Sadly, it seems many double blind studies are being morphed into being infomercial-like. Thus, when we watch the TV commercials trumpeting the latest statins test results, be mindful of this whole picture. Those studies have been funded and conducted under the total control of the same company that is now attempting to sell us their product [by having us ask the doctor for it]. Pattern seem familiar? It is. Note how a statin to treat life endangering heart disease is now able to be marketed on TV in the same manner as Proctor and Gamble markets soap powder. They create a product, fully control the ‘research’, and report the results of that research to the consumer in a controlled message prepared by an advertising company who have been professionally trained to sell a product. Statins are not required to pass the vigorous type of double blind study as the IV Chelation protocol has done in the NIH TACT study.
What Happens Next
What happens post TACT trial? Will insurance coverage for chelation now begin?
We have a doctors meeting of Chelation Diplomats in Washington, D.C. in mid-March to discuss that very question, among others. Included is a schedule of visits with legislators to remind them, among other things, of the following:
The main treatment protocols now covered by insurance for stable angina and clogged arteries are bypass, angioplasty, and statins.
As noted, none of the 3 approved methods mentioned above have been studied and found successful through a rigorous definitive study comparable to the TACT trial. The TACT study result seems to have raised the bar for acceptable levels of research required for cardiovascular therapy approval. It would be rational to
- Extend Medicare coverage immediately to IV Chelation
- Require the NIH itself to do a study similar to the TACT trial on statins, and
- Give the NIH funding and total control to conduct studies of direct comparisons of benefits between IV Chelation protocols and the currently approved methods of stable angina and clogged arteries.
Appears to be reasonable and rational next steps, but…we will see.
Wishing you all the best in Health and Healing,
Paul Lynn M. D.
The San Francisco Preventive Medical Group