BV Gokhale, who has spoken about chelation therapy, offers an honest and insightful critique on the manner at which TACT trial was conducted and what could have been done, even though results were positive. He also fears possible arm-twisting that might prevent the real truth from being declared
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.
To read about the overview of the TACT results, click here
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.
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 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.
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, 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.
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 may be like TACT and the captain will be like Dr Lamas. In fact, the likelihood of their being otherwise is far more.
Click here to read about the workshop conducted by BV Gokhale held at Moneylife Foundation
(The author is a BTech and MTech (IIT Powai) and works with a team of doctors.)
In a bullish note to clients, the Indian equity research arm of Morgan Stanley has cited good fundamentals and low volatility as key for India’s impressive performance. But it cites past performance as an indicator to the future, without the context in which such past performance was achieved, namely low starting valuation and low interest rates
Morgan Stanley Research Asia-Pacific (Morgan Stanley), in its latest report titled “Secret Touch” is bullish and expects Indian markets to perform well, vis-à-vis her peers, on account of “superior macro growth story” and “diversified index in terms of sector concentration”. According to this view, which has come well after the market has rallied strongly against the consensus view of poor macro-economic fundamentals of India, the bottoms-up story is strong and is expected to keep earnings stable. Stability in earnings means reliability in forecasts. It said, “One of the underpinnings of this fundamental story (India’s story) is the relative stability in earnings and high earnings growth over the long term.” India has given an annual Earnings Per Share (EPS) growth return of 14% since 2001, with standard deviation of just 13%, the lowest amongst peers. While this may be impressive, averages are always deceptive. Besides, in the four of those years, the market valuation was low and interest rate were falling, which is the sweet spot for equities.
Read more of our stock market analysis here.
Morgan Stanley argues that India is fairly diversified, vis-à-vis NSE Nifty, when compared to its peers, and makes the market more stable. In Taiwan and Turkey some sectors occupy more than 50% of the weightage.
Read our analysis of Morgan Stanley report on ‘TINA’ for a brief background, especially on the aspects of sector weights and diversification.
One of the interesting observations in this report is that the “beat ratio” (the ratio at which companies beat expectations) of NSE Nifty companies is 63%, which is higher than the MSCI average of 50%. In other words, for every three companies in the Nifty, roughly two beat estimates. The report said, “These statistics just underscore the role of corporate fundamentals in the solid performance of Indian equities over the past decade.” One would be led to thinking that Indian companies are performing well. However, there’s a flip side to this approach; estimates sometimes are generously set low so that estimates can be beaten. “Despite historical low earnings volatility, consensus expectations are usually beaten,” the report said. Very often brokerages do this in order to induce clients to buy shares. For instance, in Morgan Stanley’s report, Axis Bank, Coal India and GAIL—all achieved “100% Beat Ratio” between 2005 and 2012. It is pertinent to note that Axis Bank hasn’t performed that well relative to its peer—HDFC Bank (88% beat ratio)—even though Axis Bank may have ‘beat’ every estimate set by brokers and investment banks alike. Thus, one should be careful in reading such broker reports. It can be misleading sometimes.
Volatility in earnings, apart from beat ratio, was another aspect focused. The less volatility, the more stable the earnings and easier to forecast and set expectations. HDFC Bank, Axis Bank, TCS, Infosys are some companies with low volatility (measured by coefficient of variation). While volatility maybe low future outlook could be different. For instance, Infosys has recently sounded the caution board and cited that 2013 will be a difficult year for them.
Read other reports of Morgan Stanley analysed by Moneylife, here.
The Supreme Court recently ruled that protection of whistleblowers is a state subject. In a murder case the Bihar State Information Commission refused to acknowledge the victim as an RTI activist; will NHRC succeed?
Perhaps not many would remember that RTI (Right to Information) activist Ram Vilas Singh who dared to use RTI to unearth corruption and misuse of development funds in the Amhara gram panchayat of Bihar was brazenly shot dead in his Bavangavan village in December last year. His crime was to ask information under RTI pertaining to financial irregularities in construction of check dams; appointment of Anganwadi workers and hoarding and black marketing of commodities distributed through the Public Distribution System.
Strangely, the Bihar State Information Commission refused to acknowledge him as a RTI activist and therefore, did not suo motu pass an order to the concerned departments of the gram panchayat to voluntarily disclose information he had asked for and put it in the public domain. Nor did the police department take immediate action, allowing miscreants to roam free.
Also, the Sub-Divisional Police Officer’s (SDPO) first report filed by his son, clearly speaks of a conspiracy to eliminate Singh due to his RTI activism. The conspiracy is said to have been hatched by one of the accused in this case who was spending time in jail on account of being an accused in another murder case. Despite this police report confirming that Singh was a RTI activist the Bihar State Information Commission has remained indifferent.
Also, the Supreme Court recently, in a hearing of a public interest litigation seeking safety for whistleblowers stated that, “the incidents of killings (of whistle-blowers and RTI activists) are tragic and unfortunate, but law and order is a state subject. It is for the state government to take action. We cannot issue guidelines…”
Taking up the cudgels of this indifference to whistleblowers and activists who stake their life for the society, social activist, Venkatesh Nayak, programme coordinator of Commonwealth Human Rights Initiative (CHRI) made a complaint to the National Human Rights Commission (NHRC) in February 2012 for justice to Ram Vilas Singh. NHRC sent a letter to the Deputy Inspector General of Police (Human Rights), Bihar, seeking a report on the incident by submitting “a further report as to the outcome of the investigation.” Nayak received a reply last week from the NHRC containing a copy of the report submitted by SDPO on the orders of the DIGP. Nayak states that the report hints at a larger conspiracy to eliminate Singh and suggests more investigations into the conspiracy angle. The NHRC has asked Nayak and other complainants to submit their suggestions on the report sent by the SDPO by 25 January 2013. Thereafter, NHRC will take further action.
According to the earlier SDPO’s report, a first information report (FIR) was filed on the basis of information given by the Late Ram Vilas Singh’s son who is an eye witness to the murder. Three accused were identified by name. Two others were mentioned in the FIR as accomplices of the accused but could not be identified in the melee. The SDPO’s investigation report identifies the remaining two accused by name. A charge-sheet was filed in the trial court in January this year. The police have arrested only two of the accused. The remaining three accused have been declared absconders and the trial is on against the two accused. The main accused Rakesh Kumar Singh alias Bambam Singh remains untraceable along with two of the accomplices. The main accused in this case is also wanted for trial in relation to other murders committed earlier.
Adds Nayak, “when he was alive, Ram Vilas Singh had also filed several RTI applications with the State Election Commission and various authorities in the Police Department asking why the main accused was not being arrested despite him moving around freely and committing offences during elections to the local bodies (panchayats) last year but he got no answers nor was any action taken.”
Nayak has made an appeal to citizens to suggest ways to put pressure on the Bihar State Information Commission to act, now that the “further report” also confirms that Singh was a RTI activist. In his appeal Nayak says: “I request readers to send suggestions for next steps in this case. Please send suggestions as to how to make the Bihar State Information Commission order disclosure of information in all the matters filed by the Late Ram Vilas Singh and pending before them instead of denying the RTI link to the murder.”
On 19 November 2012, a RTI activist in Odisha who has been filing RTI applications to procure information from the mining sector has been threatened but no protection has been provided to him despite his request. With the judiciary as well as the state throwing up its hands to protect whistleblowers, the situation for pro-active and participatory governance is very dim.
Says Nayak, “so who then will defend and protect human rights defenders such as RTI users, anti-corruption crusaders and whistleblowers of wrongdoing in government? Should they be at the mercy of that very government whose functionaries harass them or even cause their murder in collusion with criminal elements? Can we have some protective mechanism instituted by then next Human Right Day (which falls on 8th December) in December 2013? We have a whole year to discuss, debate and get some advocacy going.” Interested readers may get in touch with Nayak at: B-117, First Floor, Sarvodaya Enclave
New Delhi- 110 017, INDIA, Tel: +91-11-43180215/ 43180201,Fax: +91-11-26864688
Alternate Email: firstname.lastname@example.org
(Vinita Deshmukh is the consulting editor of Moneylife, an RTI activist and convener of the Pune Metro Jagruti Abhiyaan. She is the recipient of prestigious awards like the Statesman Award for Rural Reporting which she won twice in 1998 and 2005 and the Chameli Devi Jain award for outstanding media person for her investigation series on Dow Chemicals. She co-authored the book “To The Last Bullet - The Inspiring Story of A Braveheart - Ashok Kamte” with Vinita Kamte and is the author of “The Mighty Fall”.)