Leisure, Lifestyle & Wellness
Treating Heart: The Good, Bad and Ugly in Modern Medical Research
“Is the scientific paper a fraud?” asked Sir Peter B Medawar, Nobel Laureate in the Listener (12 Sep 1963), 377-78. 
W e claim that our research, which is based on the short-term randomised controlled trials (RCT), is very scientific and based on evidence. Is this premise right? Do our RCTs, even remotely, have anything to do with reality and science? I do not think so, especially in the realm of so-called killer lifestyle diseases like hypertension, diabetes, cancer and coronary artery disease. 
Hypertension has been my research interest for more than four decades; I have had a feeling that we have been predicting the unpredictable future of our patients based on our short and ‘dirty’ experiments called RCTs where the researcher can manipulate one measure in the cohort as s/he wants. 
Long-term observational studies, on the other hand, allow one to study what happens to the subjects over a period of time where one cannot manipulate the measures. This apart, humans are not identical, like molecules in a laboratory, to be compared with others.
I had written about this in my book on hypertension, in 1993. In retrospect, three major very long-term observational studies have now proved me right. Multiple risk factor intervention trial (MRFIT) study is a very long-term observational study of a large cohort over a period of 25 long years. It has proved that both, hypertension and diabetes, are, at best, ONLY risk factors. MRFIT clearly showed that there have been NO RISK FACTORS that could lead to heart attacks and stroke. 
Even if one were to believe in the risk factor theory and modify those risk factors with outside interventions, the risk will still be the same! MRFIT clearly shows the hollowness of our thinking in this area. What is average for the general population may be an alarming disease for any given person when we treat averages as normal in our RCTs which give a distorted version and label many healthy people as sick needing unnecessary intervention (false positives); but the industry loves that.
“Longitudinal monitoring can look at trends as a function of age in the same person, starting with presumably healthy subjects,” feels Germaine Cornellissen, head of the Halberg Chronobiology Centre at the University of Minnesota. He feels that “Blood pressure and heart rate rise during the day and fall at night. The changes are under control of the brain’s master clock, the suprachiasmatic nucleus, which orchestrates the body’s circadian rhythms. Some diagnosed cases of high blood pressure are accompanied by large swings; a daytime measure of high blood pressure may actually become low blood pressure at night, and there are some indications that this change may be a bigger concern than blood pressure itself.” 
I had been opposing the night doses of BP pills for this very reason; lest I should fall into the trap of disregarding primum non nocere (first do no harm)! 
Studying BP over a period in the same person would give us great insight into this enigma called hypertension, if it is a disease at all. Labelling hypertension with one or even many readings over a short period might have a specificity and sensitivity of less than 50% making it look like a roulette game—a big gamble. 
Of course, people have studied continuous BP monitoring over a period, may be for days at best; but that does not refine the diagnosis significantly. I tried it and stopped doing that when I realised the futility of that approach.  
I am reminded of what the German author, Jorg Blech, wrote in his book Disease Inventors about the early days of labelling hypertensives in those small cute WellMan clinic vans outside the churches and malls in Germany offering to check their BP for free! This is how it all started. He opposed it then; see how right he was in the light of new knowledge!  (Inventing Disease and Pushing Pills: Pharmaceutical Companies and the Medicalization of Normal Life, Routledge, 2006). The new findings suggest that these vascular variability disorders, called circadian over-swings, might be labelling healthy people as hypertensive when the measures of BP are checked at noon in the doctors’ clinics only. Some patients even have a shift in their timings where they peak at night and are low during the day, out of synch with the rest of their body.
Another large study, of more than 75 years’ longitudinal observation of a large cohort of healthy young men after the Second World War (The Grant and The Gluech studies), by a group of researchers from Harvard (going on to the third generation of researchers today) has thrown up some scientific surprises in this area; alcohol and smoking are the greatest killers. Love, compassion and strong relationships, including social support, came out as the leading causes of happiness and longevity. In short, as Dr George Vaillant put it “happiness and good health is love.”
A study at Tokyo Women’s Medical University tracked BP based on multiple readings (almost monitoring it) over a 48-hour period to separate simple raised pressures from those with vascular arhythmicity, either in the size of the change or in its timing. 
This, in itself, has thrown up some surprises; but the next six years’ follow-up showed that only 10% of those with genuine high BP had cardiovascular (CVS) events. Even in those with vascular problems, ONLY 29% had CVS problems. Surely 10% and 29% do not by themselves make BP a risk factor. However, in today’s world, even one raised reading, warrants chemical drugs which looks dangerous, to say the least. Of course, this is only a women’s study and has its shortcomings vis-à-vis men. 
RCTs, especially short ones, in small cohorts funded by the industry, have been a menace in the area of coronary interventions. Whereas there are no large-scale studies of either bypass surgery or angioplasty having any special benefit except pain relief, there are many small RCTs showing multiple benefits from angioplasty and coronary artery bypass grafting (CABG). 
None of those, so-called, studies has observed the patient after intervention on a long-term basis, like the observational studies quoted above. Our experience of industry-funded studies, which are published selectively and suppresses negative studies, makes the scenario in this area doubtful. In practice, they have become a menace for poor patients. See this pathetic note from a patient’ son which I received recently: 
“Sir, yesterday evening my mother got heart attack, so we took her to… heart centre, and they (have) done angioplasty and placed 3 stents. They are saying that (the) cost will be around Rs6 lakh. I cannot afford this much sir. I spoke with (the) management. They (are) saying that if our chairman agrees, they will make it in lower cost. So I request you, if possible, please speak with Dr…. and make the bill subsidised, sir.”
Is it a stent or an unscientific stunt? 
“One of the most successful physicians I have ever known has assured me that he used more bread pills, drops of coloured water, and powders of hickory ashes, than of all other medicines put together. It was certainly a pious fraud.”— Thomas Jefferson



Pradish Moorkkth puttan vettil

8 months ago

if no angioplasty and CABG are required...then why are people dying of heart attacks

Ramesh Poapt

8 months ago

Great Dr. as usual !

In Wells Fargo Case, News Really Did Happen To An Editor

Several years after I returned to New York from Oregon, I made a strange discovery. Bank accounts I was certain I had closed were inexplicably racking up service charges. It seemed bizarre, particularly because I had gone in person to a newly opened local branch of my West Coast bank to make sure the accounts were shut down.


The failure to pay these charges (bills were sent to my old address and never caught up with me) resulted in penalties and a report to a credit agency. After an increasingly frustrating series of exchanges at the local branch, the bank agreed to wipe out the charges but said I would have to deal with the credit agencies on my own.


It seemed outrageous, and as the editor in chief of an investigative news operation, I thought about asking Paul Kiel, ProPublica's crack reporter on bank shenanigans, to take a look.


But then I stopped myself.


There's an old saying in the journalism business for this sort of thinking: News is what happens to an editor.


As with so many newsroom aphorisms, it's meant to be proclaimed with an eye roll and a tone of deep sarcasm. Reporters view editor-generated stories as the bane of their existence, and not without reason. Random events and pet peeves are not often a great starting point for serious stories.


Early in my career, I worked for a newspaper chain whose leadership was obsessed with the weather. Virtually every summer day, editors assigned stories on the heat or thunderstorms to some hapless reporter unfortunate to be sitting in direct sight of the city desk. (To be fair, Landmark Communications ended up creating the Weather Channel, an asset that eventually sold for $3.5 billion. Maybe they weren't as dumb as we thought.)


Determined not to be the editor whose life events turn into assignments, I did not ask for a story on the refusal of Wells Fargo to set things right with the credit bureaus they had notified.


This month, I was more than a little chagrined when news broke that Wells Fargo was paying federal and California authorities $185 million in fines for opening accounts without customers' permission. The bank said it had fired 5300 employees for improper actions that involved as many as 1.5 million bank accounts and 565,000 credit card accounts. The employees, for their part, said they were responding to crushing pressure from managers to generate new fees.


I became even more annoyed with myself when I looked back and discovered a Dec. 1, 2013 story by E. Scott Reckard of the Los Angeles Times describing how Wells Fargo had pressured its employees to "cross-sell" accounts. One former employee was quoted by name as saying he had opened accounts for customers without their permission. Somehow, in the late-year blizzard of great stories, I had missed one.


As has become increasingly clear, Reckard had an enormous scoop.


Last week, John Stumpf, the CEO of Wells Fargo, was hauled before the Senate Banking Committee for a hearing in which he was excoriated for his handling of the scandal. Jon Tester, the Montana Democrat, specifically raised the question of whether the fake accounts and improper fees harmed customers' credit ratings.


"There must have been instances where that negative information was sent to credit bureaus," Tester said.


Stumpf acknowledged that the very act of opening a credit card can lower a person's credit score and that this undoubtedly had an effect on customers' ability to borrow.


"This is a big deal — if information was sent into the credit bureaus because of these falsely opened accounts, the impacts of this are far more than the fees and fines that could be associated with that," Tester said at the hearing.


Wells Fargo's board announced on Tuesday that it would claw back $41 million of compensation due to Stumpf. The board also announced that Carrie Tolstedt, the head of the community banking division at the time it opened fraudulent accounts, had agreed to return stock grants worth about $19 million. The bank has said it will try to help customers harmed by improper reports to credit bureaus.


As a career investigative journalist with decades of experience, I'm not quite sure what to make of all this. In this case, news had actually happened to an editor. The clue was wispy 2013 it's hard to believe that a couple of bank overcharges were the tip of an iceberg that involved 2 million illegally opened bank and credit card accounts.


Still, it is a reminder that stories can be lurking everywhere.


One of my all-time favorite examples arose in Chicago in 2004. Tim Novak, the Chicago Sun-Times' great investigative reporter, spotted a single red dump truck parked overnight at an abandoned gas station near his home. Novak noticed that there was a metal sign bolted to the truck which said it was being leased to the Chicago Department of Sewers.


Why, Novak wondered, would Chicago need to lease trucks?


The trail led to one of the most classic investigative stories of recent years. Stories by Novak and Steve Warmbir exposed a literal sewer of bribery, corruption and mob ties to, among others, Nick (The Stick) LoCoco.


It turned out that most of the $40 million a year Chicago was spending on leased trucks went to companies that did little or nothing. When it was over, the program was disbanded, dozens of city employees were convicted on federal corruption charges that included accepting bribes to steer business to favored companies.


Novak's experiences don't disprove the skepticism about news happening to editors; he is, after all, one of the best reporters in Chicago.


But it does show that news is all around us, if only we can see it.


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RBI unlikely to cut rates in policy review on Tuesday: Experts
Ahead of RBI's monetary policy review on Tuesday, that will be the first by the newly-set up Monetary Policy Committee as well as by new Governor Urjit Patel, experts said it is unlikely to lower rates at its maiden review as it awaits more data on inflation.
"RBI may choose to wait for some more time before wielding the knife as inflationary trends may accelerate going forward," Indian rating agency Crisil said in a recent research note.
"Risks to inflation could emanate from high protein inflation, which has recorded double-digit growth for 14 consecutive months, services inflation, especially in rural areas, which is keeping core inflation high and sticky and surprise pick up in oil prices," it said.
American agency Fitch group company India Rating (Ind-Ra) said the sharp fall in retail inflation in August has accentuated the rate cut proposition in the next quarter itself, although it has made achievable the RBI's target of bringing retail price inflation down to 5 per cent by March 2017.
"But it may be early to rejoice given the baffling behaviour of retail inflation in the past. The cyclical components either aggravate or soften it as is evident from the movement in wholesale prices," Ind-Ra said. 
Wholesale food price inflation was 5.3 per cent during financial years 1996 to 2005 but increased to 9.2 per cent between financial years 2006 and 2016, it said.
"Clearly, the fight on the inflation front, particularly food inflation, is far from over," it added.
India's annual rate of inflation based on wholesale prices touched a two-year high in August at 3.74 per cent from 3.55 per cent in the month before, official data showed in September.
After rising for the first time in April following 17 straight months of contraction, the WPI has cumulatively risen by 4.45 per cent in the current fiscal up to August, as against 0.23 per cent for the corresponding period in 2015.
Food articles inflation in August increased by 8.23 per cent on year-on-year basis.
Earlier data on the consumer price index had showed that the annual retail inflation had eased by 100 basis points to 5.05 per cent in August.
Japanese brokerage Nomura expects a 25 basis points cut in repo, or the RBI's short term lending, rate in December, followed by an extended pause in 2017, given upside risks to inflation and sticky underlying factors.
The six-member MPC, headed by Patel, has three members nominated by the union government. If it is divided on its decision, the Governor can use his veto.
The MPC will meet on Monday and Tuesday for the review, the RBI said.
"The Monetary Policy Committee will meet on October 3 and 4, 2016, for the fourth bi-monthly monetary policy review for 2016-17," a statement here said. 
The government last week named three academics from the country's top institutions as its nominees. They are Chetan Ghate, Professor at the Indian Statistical Institute; Pami Dua, Director at Delhi School of Economics; and Ravindra Dholakia, Professor at the Indian Institute of Management, Ahmedabad.
The elevation of Patel has raised expectations among those who were critical of Rajan for not easing enough the monetary policy by cutting rates, though his moorings are as monetarist as his predecessor and he is considered to attach the same importance to inflation control.
His views on monetary policy were expressed at the time Rajan held rates in the February 2015 review after making an unexpected rate cut a month earlier -- the first in nearly two years -- as he elaborated on the "important backdrop" to the move, citing the trend of accommodative monetary policies being adopted by developed economies.
Under Rajan, RBI has reduced interest rate by 150 basis points since January 2015.
Disclaimer: Information, facts or opinions expressed in this news article are presented as sourced from IANS and do not reflect views of Moneylife and hence Moneylife is not responsible or liable for the same. As a source and news provider, IANS is responsible for accuracy, completeness, suitability and validity of any information in this article.



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