When Radhika Nayyar, 47, at last agreed to take drugs to lower her cholesterol level, her cardiologist felt he had scored a mini victory. For months, the good doctor had tried to persuade her to go on a dosage of statins but she stoutly refused to do so.
As the world's largest selling drugs, statins have convinced millions of their power to reduce cholesterol and thereby the risk of heart attacks, but Nayyar is one of those other millions who believe them to be at best pills of dubious credibility and at worst, a tool of corporate conspiracy against humanity.
"Last time you ignored my prescription," her doctor, a cardiologist, would say. "But one more time I'm requesting you to go on statins," he would add painstakingly. But Nayyar would resist: "I am not classified as a heart patient. So why should I take drugs?"
This sort of exchange went on several times before Nayyar's cholesterol numbers became so high that she began to reconsider her decision. A compromise was then struck. She was put on a drug called Ezetimibe, a cholesterol lowering drug that is not a statin. It was only a partial victory for the doctor after all.
In Nayyar's stubbornness lies the story of patients' tussle with cholesterol and heart disease. Nobody argues with their doctors when put on medication because their upper blood pressure level is above 140 or blood sugar levels are above 140 milligram per decilitre (mg/dl). But when it comes to high cholesterol levels, people just don't want to pop pills. Nayyar argued for long that she would change her lifestyle and her cholesterol would fall. That was never achieved.
The world over, cholesterol is one of the most controversial subjects in medicine and statins are among the most critiqued treatments. The connection between cholesterol and heart attacks is still challenged by some, but even among those who accept that link, there is a large group which says the pharmaceutical industry is raking in billions in profits by selling statins to people who don't need them. These people say the fraternity of doctors also co-operates in this grand scheme. What's the proof?
They point to the fact that the recommended cholesterol level has been lowered repeatedly over the last several decades. It is not that only laymen and activists hold this view. Some veterans in the business of mending hearts think so too.
Founder of Narayana Hrudayalaya which is the world's largest centre for heart surgery, Dr Devi Shetty, says the importance of statins as a drug to prevent heart attacks has been exaggerated. "Hundred per cent it is the pharma companies. Pharma companies can influence the prescription process," he says.
At the core of the debate is the threshold number for total cholesterol (TC) in a person that would require statin medication. This number is a blend of low-density lipoproteins (LDL), or "bad" cholesterol, and high-density lipoproteins (HDL) called the "good" cholesterol. For a person to escape statins, not only must the total cholesterol be low enough, but LDL should be within limits too. And the clinical world, after dozens of studies, has been lowering these threshold numbers bringing more and more people, previously considered healthy, under the category of cholesterol patients and statin pill-poppers.
"When I was a medical student 25 years back, I was told that 150 (LDL) to 250 (total cholesterol, or TC) was all right," says a cardiologist with the All India Institute of Medical Sciences, New Delhi, Dr Bimal Chajjer. "Then they reduced it to 130 by 220 about 20 years back. Fifteen years ago, they found that 220 is also bad and made it 200. Now very recently, European Community of Cardiology revised it to 180 mg/dl as the highest. Now the figures are 130 (LDL) - 180 (TC). And I am expecting it to be even less than 130 for my patients."
The stakes are high. Pfizer, the world's largest drugmaker, makes revenues of nearly $14 billion each year from Lipitor, a branded statin. On the other hand, millions of people pay through their blood streams for the drug. Statin treatments are prescribed for five to seven years and in some cases, even a lifetime. It typically costs Rs. 15 a day.
But more importantly, heart patients as well as those who have high cholesterol levels worry whether or not to go on statins. It's a Hobson's choice between paying for medicine they believe they don't need and risking a heart attack.
How do patients like Nayyar make sense of the barrage of medical wisdom, marketing onslaught and their own knowledge gained through Google? How can they know which cholesterol threshold they must guard against and when to go on statins, if at all?
Dilemma 1: What is the good number for cholesterol?
It is easy to get confused with the lipid profile report which details the level of good cholesterol, bad cholesterol and a form of fat called triglycerides. Many patients think there is one magic number that they can pick out from a mail-order catalogue and tell the doctor whether they should be put on drugs or not. The simple answer is that there is no such wonder number. A mere look at total cholesterol could be misleading. It is important to look at the components, especially LDL. And then these numbers could be interpreted only by a doctor because what is normal in one patient could be life-threatening in another.
The recommended numbers for these variables have fallen because of better understanding of heart disease and cholesterol through numerous studies, primarily in the West. "Each time we have reduced the cholesterol level we have seen further reduction in deaths by heart attacks, strokes etc.," says Dr Chris Cannon of the Harvard Medical School.
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Dr Cannon is a senior investigator of the Thrombolysis in Myocardial Infarction (TIMI) Study Group. He is already busy with the next research that might lower the numbers further. "We are doing a trial right now to see if 50 is better than 70 [for LDL]," he says.
Many doctors in India follow 200 as the optimal level for TC and 130 for LDL for normal populations. The numbers are considerably lower for those in high-risk group such as those with a genetic condition. So, don't play the doctor for yourself. Have faith in your cardiologist; otherwise, go to another.
"I don't know how low is low," a professor of pathology at Harvard Medical School, Dr Nader Rifai, says. "We obviously have cholesterol because we need it to maintain cellular membranes, to make hormones, and many other things in the body. So clearly we need it, but not as much as we may have."
Dilemma 2: Are Cholesterol Drugs Effective?
In an article in January 2008, BusinessWeek said Lipitor treats only one person out of 100 that take the medicine. This kicked up considerable debate in the scientific community.
The piece of evidence critics cite is called Numbers Needed to Treat (NNT). NNT measures the success rate of a medicine and refers to the number of people that must take a medicine for at least one person to show the intended effect. For example, NNT for a cough syrup is 1, which means that everyone who is given a cough syrup shows its effect. NNT for statins is 150-250: At least 250 people must be on statins to prevent heart attack in at least one person.
This data is revealing, but hides a subtle truth. NNT is high only for those people who do not have any history of heart disease. For those with this disease, NNT is around 20-25. So for people who have had an attack, a statin can very well be the difference between a walk in the park and a walk in the clouds.
For others, however, statins may not be effective.
Dilemma 3: Are doctors putting healthy people on statins?
Dr Ajit Chitre is both a heart doctor and heart patient. He underwent a bypass surgery last year. He says patient vigilance can help check indiscriminate prescriptions of statins by doctors. "Patients should question doctors all the time if they are put on costly treatments to lower cholesterols. Drugs to reduce cholesterol levels are important but that should be the last choice. Dependence on drugs is an American export," he says. However, resistance where statins are necessary could be fatal. Dr. Chitre himself moved to statins a few months ago.
Dr Shetty says cholesterol is just one of the many markers for the risk of heart disease. A high lipid profile need not necessarily mean a heart attack is on the way. "We have operated on thousands of patients with absolutely perfect lipid profiles. At the same time, there are thousands of patients with grossly abnormal lipid profiles or with bad cholesterol but normal coronary arteries. So cholesterol or lipid profile is definitely one of the risk factors but it is grossly exaggerated," he says. This also suggests that a robust dose of statins may not prevent an attack.
What should patients do in light of this conflicting evidence? Research has shown that the risk of heart diseases increases exponentially if total cholesterol levels are above 200. People with such a condition and those who are genetically prone to heart disease should take statins if the doctor says so.
Dilemma 4: Can I manage with diet and lifestyle changes?
In healthy individuals, a proper diet and adequate exercise would suffice to keep cholesterol under check. But in most others, a sound lifestyle is just the first step in preventing heart attacks. "Dietary change and dietary habits are very difficult to maintain. Even when they are maintained in most individuals, they will cause 5 per cent and maximum 7-10 per cent cholesterol reduction and often that's not enough," says Dr. Rifai.
CEO of outsourcing firm Shell Transource, Venkat Raman, agrees. Having lost his grandfather, father and brother to heart attacks, Raman knows the subject quite intimately. He went through a bypass himself. Raman has led an active life after the surgery: He ran the 21-kilometre mini race at the 2008 Mumbai Marathon and finished it in 3 hours and 16 minutes.
His secret? Raman says statins have added years to his life and kept his LDL cholesterol under control.
The decibel level of the debate about cholesterol has drowned out a growing reality. India already has the largest number of heart patients in the world (estimates range from 50 million to 70 million) and the incidence of cholesterol is increasing too. "One of the things that is very alarming in developing countries like India and China… is that individuals in these countries are more and more adopting Western lifestyles," says Dr. Rifai. "With that you are going to be inheriting a lot of the problems for which we have been paying a very high price.
One is obesity which will lead to increased risk of heart disease, diabetes, hypertension. I hope with more awareness people will stick to their traditional eating habits and lifestyles and not adopt everything from the West - a lot of it is very unhealthy."
The Recommended Levels for Bad Cholesterol (LDL) and Total Cholesterol (TC) have been repeatedly lowered over the years
1984
150 LDL/ 250 TC
1989
130 LDL/220 TC
1994
130 LDL/200 TC
2009
130 LDL/180 TC
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