when the rules don’t work: cholesterol

Monday, November 18, 2013

Changing the rules of a game usually happens in response to something that happens on the field. Those charged with the integrity of the sport often tinker on the edges of the rulebook but the fundamentals of the game usually remain the same, though there was the designated hitter in baseball, the forward pass in football and the sacking of the rover, the seventh man in hockey. Major changes happen in the halls of medicine, and usually are well researched, but the latest cholesterol recommendations have not gone over so well.

There has been a sea change in medicine. Historically, it’s always been patients seeking medical care when they are ill and doctors stomping out disease. The concept of prevention is relatively new and depends upon identifying and understanding which risks might be mitigated to prevent a disease or stop its progression. Common sense is easy to preach when it comes to some diseases. Don’t drink and drive, don’t text and drive, wear a seat belt are the mantras associated with decreasing the death rate from car wrecks and it’s been working, with drunk driving deaths dipping below 10,000 per year…still a huge number but less than before.

Common sense is harder to preach when the rewards are less tangible. People see the wrecks on the side of the road and read about the victims of the drunk driver.  It is harder to appreciate the lives saved when somebody looked after their high blood pressure, managed their cholesterol levels and kept their diabetes in check for 40 years and then did not have a heart attack or stroke. There is no immediate gratification, but visits to the doctor always had a number that could be targeted. Blood pressure should be 120/80. Cholesterol should be under 200. Blood sugars and hemoglobin A1C should be between 4.5 and 6.0. There were talking points that the doctor and patient could have about the philosophy of not smoking, losing weight and exercise, but there was also a hard number where the patient could be congratulated for meeting their number.

The American Heart Association and the American Academy of Cardiology decided to alter the number based approach to cholesterol management, one of the cornerstones of preventing heart attack and stroke. Medications to control cholesterol might be beneficial to a variety of patients, even those without high levels in their blood. They included those who had heart disease, middle aged patients with type two diabetes, those with LDL levels (the bad cholesterol) greater than 190 and patients whose calculated 10 year risk of heart disease was greater than 7.5%. The organizations published an online calculator to help patients and doctors figure out the risk and now comes the murky research.

The new cholesterol guidelines may cause 35 million Americans that aren’t taking medication to begin taking cholesterol lowering statin drugs. The only problem is that the calculators that were developed are wrong…so says Dr. Paul Ridker and Dr. Nancy Cook, researchers from Harvard University who were asked to review the statistics and they found that the calculators didn’t work. In a classic connect the dots error, their assessment was not provided to the committee in charge of developing the new cholesterol guidelines. Now the AHA and the ACC are in damage control mode and the challenge they face is how to maintain the trust of doctors on the front line who will advise patients and what that advice should be.

Fortunately, this is not the case of follow the money. There is little financial interest to be gained by having more people take the drug. The most commonly prescribed statin is atorvastatin, the generic equivalent of Lipitor, and the price to the patient is about 30 cents a day, not a budget killer and not enough money to dramatically boost the bottom line of a drug company.

Unfortunately, the intangible cost is trust. We like rules in games because they provide continuity and structure. Referees follow the rule book and don’t rely on anecdotal experience to decide what is right and what is wrong. Similarly, organized medicine is perceived to make thing up on the fly, there is a fear that individual patient will rely on personal experience rather than national recommendations. High profile cases help educate about those guidelines. Amy Robach, a host on Good Morning America had to be cajoled into having a mammogram that found her early breast cancer. Yet, every day, a patient will remind their doctor that a relative smoke, drank and was obese, and still lived a healthy life to age 90.

Rule changes are tough to accept but it is made more difficult when the reasons behind the changes might be wrong. The heart doctors need to fix the cholesterol recommendations and explain why their dots aren’t connected. Patients are like fans. Whether it’s using instant replay or getting a consultation, they just want the doctors and referees to get the call right.

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