New Cholesterol Drug “Breakthrough”?

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new cholesterol drug

In 2013 the American Heart Association and American College of Cardiology dismantled their silly non-science based stance that a high level of “bad” LDL cholesterol on a blood test was a risk factor for heart disease. However, a tried and true Madison Avenue pseudoscience advertising campaign doesn’t die easily. Case in point is news this week that a new breakthrough cholesterol drug has hit the market to…you guessed it…lower bad LDL cholesterol? Huh?

One of the most successful Madison Avenue drug sales campaigns ever created has been the idea that cholesterol was bad. This demonization of a critical part of every cell’s membrane has changed the way we eat and spurred sales of hundreds of billions in cholesterol lowering drugs. The problem of course is that reality got in the way in that science began to show that eating cholesterol and saturated fat had little to do with harming health. Then large studies began to show that higher levels of “bad” LDL cholesterol weren’t directly associated with most heart attacks and that medications to lower cholesterol barely had any measurable positive effects. The major medical organizations eventually had to recognize that high cholesterol needed to be removed as a reason to take popular cholesterol lowering statin drugs. However, these same organizations and universities are sponsored by hundreds of millions in Pharma money annually, so the dog can’t bite the hands that feeds it. So the “Powers That Be” cooked up new guidelines without cholesterol blood tests, but still managed to increase the number of healthy Americans that needed to take the drugs! Pharma was happy, but some honest scientists cried foul.

Now the FDA has approved a “breakthrough” new cholesterol drug called Prauluent that uses antibodies to lower “bad” LDL cholesterol and costs a mere $14,000 a year! The largest market for this drug is of course patients who don’t do well with statin drugs. The drug was approved solely on the basis that it lowers bad cholesterol without any evidence that it helps patient survival or lowers heart attacks. Huh? If high LDL cholesterol is no longer a risk factor for heart disease, then why were all the major news outlets this week touting this as a breakthrough?

The fact that this drug was approved shows disturbing things about our drug approval system. The long time periods and hundreds of millions that it takes to get a drug approved are the first reason this happened. When the Pharma company that pushed this drug through the approval system began that process, lowering cholesterol was still considered valuable. However, now that the drug is approved it’s no longer important. More disturbing is that the drug was approved in the first place in 2015 solely on clinical data showing that it lowered cholesterol as the FDA knows that this is no longer a risk factor and the science behind cholesterol lowering helping prevent heart attacks is very weak. So why approve this drug?

The upshot? Hopefully the insurance companies are smart enough to realize that a drug costing 1/3 as much as the median U.S. family income that lowers cholesterol but has no other proven health benefits is not a good deal. However, the fact that this drug was approved in the first place and that the major news outlets didn’t get the memo that lowering cholesterol is no longer a national US health initiative is very disturbing!

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Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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