When the Gold Standard Comes Under Fire

A recent article questioned the research that was the basis for guidelines suggesting target bad cholesterol (LDL) of less than 70. It refers to the National Cholesterol Education Program (NCEP) guidelines on desirable cholesterol level that were revised in 2004. The guidelines are seen by some as a gold standard.
When they came out, these guidelines prompted some physicians to shoot for LDL cholesterol level of less than 70 for most of the patients. A perusal of the guidelines clarified that LDL cholesterol level of less than 70 is desirable only in certain special circumstances.

Ever since the cholesterol lowering medicines called statins have gone generic, we have seen direct to consumer marketing prompting people to take cholesterol-lowering medicines other than statins. One of the reasons given is that new medicines are different (just like wearing Versace is different?).

Here is my take:
- A case for aggressive lowering of cholesterol has partly been based on the data that effect of statins goes beyond just lowering cholesterol. Statins should be our first line of therapy for lowering cholesterol.
- More aggressive cholesterol goals prompt us to use higher doses of statins, and higher statin doses are more likely to cause side effects. These in turn affect patient compliance.
- There is a need for making the guidelines easier to follow, and less prone to spin by vested interests. We got some confusing signals from JNC 7 guidelines on high blood pressure as well.
- There is a growing group of people saying that standardized patient care saves money and life. The detractors think that the cookie-cutter version of medicine takes away flexibility from the treating doctors, and promotes mediocrity. The questioning of these guidelines has brought up another issue. They say that standardized care can sometimes be based on faulty guidelines. Based on that, they invoke a term from the computer world, GIGO. Advantage detractors?
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The BiDil Saga: Much Ado About Nothing

BiDil is trade name of a drug that is a combination of two medicines, Isosorbide dinitrate and Hydrallazine. Studies revealed that this combination is particularly useful in African-American patients with heart failure. This study stimulated a welcome discussion about custom-made medicine for patients based on age, gender, ethnicity etc.
A recent Wall Street Journal article talks about the tension between insurance companies and the maker of BiDil. The maker says that the nitrate and Hydrallazine combination contained in BiDil is a unique one. They claim that the unique dosage combination has an effect that the combination of generic and much cheaper Isosorbide dinitrate and Hydrallazine does not have. Moreover, based on the study data, FDA approved this combination for heart failure in African-Americans.
The insurance companies have so far refused to cover BiDil contending that the benefits from BiDil could be obtained from the much cheaper generic Isosorbide dinitrate and Hydrallazine.

Here is my take on it
1. I do not see any magic in the dosing of BiDil. Moreover, in every day practice of medicine, many times we are not able to keep patients on the doses that are used in research protocols. This is for several reasons including side effects
2. The cardiologists have used the combination of these two medicines for decades in patients who had heart failure but could not tolerate ACE inhibitors. ACE inhibitors as a group are considered first line drugs.
3. Each tablet of BiDil includes 20 mgm of Isosorbide dinitrate and 37.5 mgm. of Hydrallazine. The generic forms of these medicines are available in strengths that make achieving this dose very easy.

Action points:
1. Based on the research, there may be a case for starting African-American patients with heart failure on Hydrallazine and Isosorbide dinitrate as first line of treatment
2. A physician’s job, first and foremost is to provide best possible care to his or her patients at best possible price. I do not see any reason for the combination of generic drugs to be inferior to the combination marketed as BiDil
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