Download Failure of TACT in Correctly Revealing Potential of EDTA

Failure of TACT in Correctly Revealing Potential of EDTA Chelation
Therapy
By B. V. Gokhale, B. Tech., M. Tech. (IIT Bombay)
Information about TACT
TACT actually stands for Trial to Assess Chelation Therapy. This double blind
controlled trial was carried out by National Institute of Health (USA) with an
intention to give final verdict on the controversy about safety and efficacy of EDTA
chelation therapy in reversing coronary artery disease.
The results of TACT were partially declared in the annual meeting of American
Heart Association on Nov 4, 2012.
TACT start - Sept. 2003. Fund Allocation - US$ 31.6 million
No. of patients - 1708, Average Age - 65 Years, Gender Distribution - Male 82%,
Female 18%. CHD status - All patients had prior heart attacks and 83% of them had
bypass surgery or angioplasty.
Of these 839 were randomized to take 30 disodium EDTA chelation infusions in 30
weeks and then 10 more EDTA Chelation infusions once in 2 to 8 weeks. Other 869
patients were randomized to take placebo infusions in equal numbers. All patients
were followed up for average 55 months.
The conclusion drawn from the data collected in this trial are as under,
1
In the pilot study of 30 patients conducted before starting the main study it
was noticed that after 14 infusions the blood parameters, viz. creatinine,
hematocrit, magnesium, platelet count and potassium remained almost
unaltered in each of the patients. This means the likelihood of any adverse
event in main trial is very low.
2
Of the 839 patients taking chelation infusions only one apparently died due
to therapy. This means that chelation therapy is very safe.
3
The incidence of various end points in chelation vs. placebo was as under
End Point
Death for any reason
Heart attack
Stroke
Need for angioplasty or bypass surgery
Hospitalization due to angina
All above incidences summed up
Adverse events in diabetic patients
Patients on
Chelation
10.4%
6.2%
1.2%
15.5%
1.5%
34.8%
67 No
Patients on
Placebo
10.7%
7.7%
1.5%
18.1%
2.1%
40.1%
102 No
4
These results definitely indicated that chelation therapy is better than
placebo on every aspect and the diabetic patients are greatly benefited by
chelation therapy as they had 39% less hazard ratio of events compared to
non diabetic.
From the point 3 and 4 above it can be concluded that chelation therapy results in
healthy life extension in patients suffering from coronary artery disease,
particularly if they are diabetic.
Despite the significant benefits of chelation therapy, as revealed in TACT, many
members of American Heart Association, American Cardiology Society, and
American Medical Association etc. are still engaged in finding non existing faults
with TACT and continue branding it dangerous and ineffective. Business rather
science is behind all such criticism. It reminds me of a saying, "A man who is
sleeping can be woken up but the one who is pretending to be sleeping can not be
woken up." In most of European and other countries chelation therapy is not
hated.
Critique of TACT
In my practice of treating heart disease patients through chelation therapy, I have
seen much better results than those revealed in TACT as above. When I started
looking into the reasons for such poor success of EDTA chelation therapy in TACT,
following points came to my notice.
Double blind trials are inappropriate for assessing chelation therapy.
Double blind trials may be suitable for assessing effects of one drug, usually taken
orally, on the human body. However, chelation therapy is a therapy where many
different drugs (anywhere between 6 to 12) are mixed with carrier solution and
intravenously infused in human body. Each of these drugs has a specific purpose
and depending upon the heath parameters of the patient to be treated, the
chelation practitioner has to choose the drug. Such decisions make chelation
therapy very effective and safe. In double blind trials such approach can not be
allowed and every patient has to be 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 but can not use
accelerator or brakes.
Besides this, double blind trials are considered to be unethical in European
countries.
Blinding can be easily deciphered in chelation therapy trials
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 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 or so. Obviously they interact with each other and naturally try to assess
their own health improvement in comparison to others. In this process, after about
seven or eight drips many patients are able to correctly guess if they are getting
actual effective treatment 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.
Chelation therapy trials are very expensive and cumbersome
Double blind trials of chelation therapy are about 20 times more expensive and far
more cumbersome than trials of oral drugs. Following are the reasons.
1
Chelation therapy involves use of about 10 drugs mixed together in a bottle.
The total price of these drugs is about 40 times higher than the cost of the
pill to be tested.
2
The mixture of the drug in a chelation infusion is not uniform for all
patients. The quantity of EDTA to be mixed in the bottle is to be calculated
for each of the patients each time. This requires huge additional efforts
compared to a drug trial.
3
To ensure proper double blinding the ingredients to be mixed with carrier
solution are prepared in two syringes by a compounding pharmacy. After
appropriate labeling these syringes are transported to the treatment site
within about 12 to 24 hours. At the treatment centers where the syringes are
to be mixed with bottles and infused in the patients intravenously. This
requires huge additional efforts compared to a drug trial.
4
The number of health parameters, to be inquired from a patient or to be
measured in each of the 40 visits, is much higher than that in a drug trial.
5
Involvement of investigators and supervisors in double blind chelation trial
is on a much higher scale than that in a drug trial.
6
In a drug trial a doctor has to spend only about 5 minutes in assessing each
patient and such monitoring is done at the most once in a week. In double
blind trial of chelation therapy doctor's involvement per patient is at least
one hour per week.
7
In chelation trials the help of a nurse for full four hours is required. During
this time period she can appropriately handle at best six patients. This is an
additional expense compared to a drug trial.
8
The efforts from a patient's side in a double blind trial of chelation therapy
is also far more than that in drug trial because
He has to travel to the treatment site for each of the 40 infusion.
For every infusion has to spend four to five hours in traveling to and fro and
take infusion.
He has to bear with physical discomfort like pain at infusion site, burning
sensation in the vein etc. almost every time the infusion is administered to
him.
All this implies that a patient participating in a double blind trial of chelation
therapy has to be given much higher compensatory incentive as compared to that
in a drug trial.
It is worth noting that cost of TACT was US$ 31.5 million. Had this been an oral
drug trial of equal number of patients it would have cost only about US$ 2.5 to 3
million.
TACT Protocol was inappropriate
The protocol used in TACT was the one recommended by American College for
Advancement in Medicine for many years. It has certainly helped millions of
patients in reversing their coronary artery disease. However, this does not mean it
is the best.
Very recent research, carried out in the year 2009, Ms. Anna Roussell has clearly
demonstrated that when vitamin C is added to a chelation drip there is about 25%
increase in the oxidative stress. Oxidative stress is universally accepted to
accelerate aging process and the process of coronary artery disease. In all the
chelation drips used in TACT, 7 grams of vitamin C was used because the protocol
as recommended by ACAM was adopted in 2003, whereas the research of Ms
Roussell was published in 2009.
From my own experience I believe that if drips used in TACT were without vitamin
C the efficacy of chelation therapy would have been better.
Another factor is addition of 100 mg Thiamine and 100 mg Pyridoxines. These
vitamins are very helpful in diabetic patients. Therefore, for such patients, if the
quantity was increased to 200 mg the efficacy of chelation therapy would have
been better.
TACT exclusion criteria was flawed
The inclusion and exclusion criteria used in TACT were very fair. The only point
that can be commented upon is the exclusion of smokers who have 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 on of the
strongest risk factor for heart disease. Obviously, these people get 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.
Questionable end points in TACT
The end point chosen for TACT were: death for any reason, heart attack, stroke,
need for angioplasty of 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 very much a subjective end point. It depends upon the mental
set up of the patient. For some patients a very mild angina pain 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 cardiac surgeons have again
reiterated that many such procedures are done for no valid reason. Under such
circumstances, it can not be considered as an appropriate end point.
Appreciation of TACT
The fact that TACT has been carried out by Dr. Gervasio Lamas and other team
members in excellent manner is undeniable. However, to fully appreciate these
efforts of the TACT team some light on the background is essential.
In the year 1986, American Institute of Medical Preventics and International
Chelation Research Foundation proposed to conduct a study to assess chelation
therapy. Request for permission was made to US FDA. Antichelation organizations
like American Medical Association, American Heart Association, American
Cardiology Society etc. vehemently opposed this move with a pretext that
chelation therapy is dangerous. However, these organizations could not give any
proof about the dangers to FDA, and FDA unwillingly gave the approval. Research
was made in army hospital at Bethesda. The study almost completed but the
results were not declared by army authorities under a flimsy pretext that the
solders involved in the study have gone to fight War in Iraq. Till this date the
results are not declared.
In the decades of 1980 and 1990 more and more patient started turning towards
chelation therapy for the treatment of their coronary artery disease. Doctors
providing chelation therapy to their patients were always looked upon as criminals
by US FDA and they were harassed or arrested. To overcome all these troubles,
groups of patients and ACAM, made agitations. After listing to the woes of these
agitators, Senator Dan Burton held a hearing in 1999 and recommended that an
appropriate trial be conducted by National Institute of Health, to assess the safety
and efficacy of chelation therapy.
In reality, to carry out research of chelation therapy, in the same manner as that of
an oral drug, is very intricate, time consuming and about 20 times costlier.
Nevertheless, Dan Burton insisted upon the research and got approval of a grant of
US$ 30 million for it.
At last, the trial, named Trial to Assess Chelation Therapy, was started by NIH in
the year 2003. Being related to coronary artery disease, the controllers of the trial
were chosen from American Heart Association, a known antichelation
organization. Protocol was finalized in consultation with American College of
Advancement in Medicine.
For enrollment of patients, actual administration of the chelation drips and to
collect patient information from time to time, 134 locations were chosen. Most of
the supervising doctors at these centers were experienced in chelation treatments
over a long period of time but a few, apparently from American Heart Association
were also induced after hurriedly given training.
Antichelation lobby was putting their best efforts in keeping patients away from
participation in TACT by condemning chelation therapy as dangerous and
ineffective.
Till the year 2008 the, trial progressed at snail's pace but without much trouble
otherwise, probably because antichelation lobby was very confident that the
results will actually show chelation therapy to be at least ineffective if not
dangerous. However, by the year 2008, probably from leaked information, the
antichelation lobby realized that actually the trial is proving chelation to be safe
and effective. So the lobby spearheaded by Dr Atwood, made vehement media
attacks on the trial and made every attempt to get the trial abandoned so even the
research till that time will get buried. To resolve the issue the trial was suspended
for sometime but, fortunately, Dr Gervasio Lamas, the principal investigator
tackled the matter aptly and the trial completed.
Antichelation lobby made another last ditch attempt by funding two senators of
the presidential election of 2012 and get a law passed. This law contemplated that
right of declaring or not declaring the results of medical research rested with the
departmental head. The move failed.
Dr Gervasio Lamas and other members of the trial must certainly be congratulated
for their honest and unbiased stand. Only a part of results are declared. Much
more is still hidden. TACT team may be desirous to declare the results, but the
very strong antichelation 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.
In my honest opinion, American College of Advancement in Medicine and other
prochelation organizations should not participate in such research for the
following reasons.
Since the research will be within the domain of coronary artery disease, it will
always be dominated by the members of cardiac lobby most of whom are
antichelationist. I believe, in the panel that controlled the proceedings of TACT
the only person who had actually treated patients with chelation therapy was Ted
Rozema.
The objective of cardiology lobby will always be to condemn and bury chelation
therapy. In fact, their objective during TACT was so. Due to decades of
condemnation of chelation therapy all the members 0f cardiology lobby were so
confident about failure of chelation therapy in TACT that they never objected to it
until the positive results of chelation therapy were smelled in 2008.
Dr Gervasio Lamas remained unbiased and allowed the TACT to proceed in apt
manner but there is no guarantee that in next research project the principal
investigator will be like him. In fact the likelihood of his being otherwise is far
more.
B. V. Gokhale, B. Tech., M. Tech. (IIT Bombay), Cell - 9619436706