The following article is by BV Gokhale, B. Tech. (ITT Bombay)
BV Gockhale is very well acquainted with Chelation Therapy and has recommended Cardio Renew to patients whom he could not recommend IV Chelation where it has been used to good effect.
The recent results of Trial to Assess Chelation Therapy (TACT) gave a shock to the cardiology world. They did not expect it. For hundreds of US cardiologists it was so unbearable that some of them, within minutes after the presentation by Dr Gervasio Lamas, started questioning its truth. While the results is a big boost for proponents of low cost medication and chelation therapy in particular, the results could have been better if the manner at which TACT conducted been different.
Before going ahead with my critique of TACT, I must mention that the whole world should applaud the efforts of Senator Dan Burton in instigating TACT and Dr Gervasio Lama and his team for honest and relentless follow up in search of the truth. Surely everyone will remain indebted to these individuals.
I have seen much better results than those revealed in TACT. When I started thinking about the reasons for such poor success of EDTA Chelation Therapy in TACT, following points came to my notice.
- Double blind trials may be suitable for assessing effects of one oral drug. However, Chelation Therapy involves use of anywhere between six and 12 drugs and that too intravenously infused slowly over three hours. Each of these drugs has a specific purpose and depending upon the patient to be treated, the practitioner has to choose the drug. Such decisions make therapy very effective and safe in hands of trained and experienced practitioners. In double blind trials such approach is not allowed. Every patient is treated in a predefined manner.
Assessing Chelation Therapy by double blind trials is like testing a car governed to travel at fixed speed where driver can only control steering.
It is worth mentioning that since double blind trials involve giving sham treatment to half of the patients they are considered to be unethical in European countries.
- In double blind drug trials, the doctor has to interact with each patient only for few minutes and give him the dose of actual drug or placebo, sufficient to last for a week or more. The next meeting between the doctor and the patient takes place after a week or more. Very rarely two patients in the trial are together. Thus, patients do not interact with each other and obviously do not come to know the health status of each other.
In the double blind trial of Chelation Therapy many patients sit together for three hours in each of the 30 infusions. Obviously after about first seven or eight infusions they correctly assess, if they are getting effective or placebo treatment. Naturally, those patients, who feel that they are getting placebo treatment, discontinue their participation in the trial.
This has happened earlier in at least two double blind trials of Chelation Therapy.
This is what exactly happened in TACT also. About 60 patients in placebo group discontinued their participation in the trial most probably because they came to know that they were getting placebo treatment. Had they continued in the trial they would have been included in the statistics and the gap in end points between Chelation group and placebo would have widened.
- Double blind trials of Chelation Therapy are about 20 times more expensive and far more cumbersome than trials of oral drugs. It is worth noting that cost of TACT was $31.5 million. Had this been an oral drug trial of equal number of patients it would have cost only about $2.5 million to $3 million.
- TACT protocol was recommended by ACAM. It has been successfully used in many patients. But that does not mean it is the best.
Ms Anna Roussell, in 2009, clearly demonstrated that when vitamin C is added to a Chelation drip there is about 25% increase in the oxidative stress that enhances the process of coronary artery disease. Had TACT infusions not used the 7 grams of vitamin C or had used less quantity, the effectiveness of infusions would perhaps have been more.
One must understand that TACT protocol was formulated when the research was not known.
Vitamins B1 and B6 are very helpful in diabetic patients. Therefore, for such patients, if their quantity was increased from 100 to 200 mg the efficacy of Chelation Therapy would have been better.
- The inclusion and exclusion criteria used in TACT were fair. The only point that can be commented upon is the exclusion of smokers who had not given up smoking three months prior to randomization. This time period may have been stipulated because a person who gives up smoking for three months usually does not start it once again. As per my experience, if a person gives up smoking for more than fortnight he does not start it again. Smoking certainly enhances free radical activity and oxidative stress. In fact, smoking is considered to be one of the strongest risk factors for heart disease. Obviously, these people get the maximum benefit from Chelation Therapy. It is good that smokers were included but, in my opinion, the three month’s time period should have been curtailed to one month. With this type of exclusion criteria Chelation Therapy would have proved more effective.
- About 83% of the patients in TACT had already undergone either bypass surgery or angioplasty. This means that their health status before the therapy had already improved. No wonder in such circumstances effect of Chelation Therapy was marginally better.
It may be of interest to note that in PACH Trial the subject selected had average LVEF of about 60% and the stress test capability of 9 min 40 sec. This means that the patients virtually had no coronary artery disease. That was the reason why in PATCH Trial the improvement in chelation group was only marginal.
- The end point chosen for TACT were: death for any reason, heart attack, stroke, need for angioplasty or bypass surgery and hospitalization due to angina. Of these, heart attack and stroke are objective, and therefore, appropriate. Death due to coronary artery disease is certainly an objective end point but I do not understand how death for any reason can be such.
Hospitalization is a subjective end point. It depends upon the mental set up of the patient. For some patients a very mild angina is frightening but for others it is not.
Need for bypass surgery or angioplasty is determined by cardiologists or cardiac surgeons. Several well known cardiologists and even cardiac surgeons have often reiterated that many such procedures are done for no valid reason. Under such circumstances, it can not be considered as an appropriate end point.
Needless to say that TACT will give a boost to the propagation of Chelation Therapy. But this will not be tolerated by the anti-Chelation lobby. Only a part of results are declared. Much more is still hidden. TACT team may want to honestly declare the results, but the very strong anti-Chelation lobby will not allow them do so. There is also a possibility of twisting the results by statistical jargons. The lobby will certainly want another research to be carried out with a hidden objective of proving Chelation Therapy to be ineffective.
American College of Advancement in Medicine (ACAM) and other pro-Chelation organisations should remain very careful while participating in any future research. There is no guarantee that in the next research project the team will be like TACT and the captain will be like Dr Lamas. In fact, the likelihood of their being otherwise is far more.
By B. V. Gokhale, B. Tech., M. Tech. (IIT Bombay)