In an on-line article in The New York Times today (3.17.17), the headline states, “Cholesterol-Slashing Drug Can Protect High-Risk Heart Patients, Study Finds.” The article describes the first test of the new cholesterol-lowering medication—Repatha. Repatha is part of the PCSK9 inhibiter family that works by lowering LDL-cholesterol levels through poisoning an enzyme—PCSK9–thereby allowing LDL receptors to remain in circulation. LDL receptors can bind LDL-cholesterol, thus more LDL receptors will result in lowered LDL-cholesterol levels.
I have written about PCSK9 inhibitors before. In my book, The Statin Disaster, I wrote, “I do not think PCSK9 inhibitors will be an effective treatment for heart disease as it will disrupt a normal physiologic process in the body: the binding of LDL to its receptor.” (1)
So, let’s look at the first study which was published in the New England Journal of Medicine, March 17, 2017. This was a randomized, double-blind, placebo controlled trial involving 27,564 subjects with heart disease and LDL-cholesterol of 70 mg/dl or higher who were receiving statin therapy.
The primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. Keep in mind that hospitalization for angina and coronary revascularization (i.e., coronary artery bypass graft surgery or stent placement) are considered soft endpoints since the decision to hospitalize or place a stent is a subjective decision by the physician. The ultimate success of any cardiac medication should be based on hard endpoints such as death, heart attacks, or stroke.
After 48 weeks of Repatha therapy or placebo, the authors reported that, compared to placebo, the Repatha group significantly reduced the risk of the primary end point by 15% (9.8% in the treatment group vs. 11.3% in the placebo group.) However, as I have pointed out to you before, the 15% reduction is actually a relative risk reduction. The relative risk is a statistical term that has no meaning when considering whether to recommend or not recommend a therapy to a patient. A more accurate assessment is the absolute risk difference. In this case, the absolute risk difference between the two groups is 1.5%. A more accurate description of the results should state: as compared to placebo, taking Repatha for two years results in a 1.5% decline in a combination of outcomes including death, stroke, myocardial infarction, hospitalization for angina and coronary revascularization. Another way to look at the data is that the drug failed 98.5% who took it as they received no benefit. And, if you take out the soft endpoints, the 1.5% decline disappears.
I called Specialty Pharmacy to find out how much Repatha costs. I was told Repatha costs $2,351.05 per month for a total of $28,212.60/year). So, a two year course of the medication costs $56,425.20. (Note; The NYT article states the drug costs $14,523 per year.)
For the physicians out there, I have a question for you: Who the heck would prescribe an expensive drug, associated with serious adverse effects, that fails 98.5% who take it?
For the patients out there I have a question for you: Who the heck would spend $28,212.60/year for a drug that is associated serious side effects an fails 98.5% who take it? In this study 25% of those that received Repatha reported serious adverse effects. What were the serious adverse effects? I don’t know—they weren’t listed individually.
Repatha is another example about what is wrong with conventional medicine. President Trump just released his first budget. I would advise him to start tweeting about the failure of Repatha and why it should not be allowed in the market place. There are far too many ineffective, expensive drugs right now. We don’t need another one. Statins are a great example of ineffective drugs that fail nearly 99% who take them. Now we can add PCSK9 inhibitors to the pile of poorly-performing drugs.
More information about cholesterol lowering medications can be found in my book, The Statin Disaster.
Repatha for heart disease? Fugetaboutit!
(1) The Statin Disaster.