by Dr. Brownstein
Holistic Medicine

Do we need more cholesterol-lowering medications?  Big Pharma thinks so.

A new class of cholesterol-lowering medications called PCSK9 inhibitors is being unleashed on us.  PCSK9 inhibitors are monoclonal antibodies.  PCSK9 can bind to LDL-cholesterol receptors on the cell walls.  Once the PCSK9 binds to the LDL-cholesterol receptor, the complex is absorbed into the cell and broken down.  Therefore, circulating LDL-cholesterol cannot enter the cell and will rise in the serum.  When PCSK9 inhibitors block this reaction, the LDL-cholesterol receptors will bind the circulating LDL-cholesterol, lowering serum cholesterol levels.

Two drugs have recently been released that function as PCSK9 inhibitors:  Alirocumab and Evolocumab.  The costs for these medications average around $10-15,000 per year.

Since these drugs are indicated for patients who have cardiovascular disease, one would think that the PCSK9 drugs have been proven to have a benefit in treating/preventing cardiovascular disease.  Furthermore, you would think that the expensive price of these drugs would indicate that they are more effective than the drugs that are  presently available.

Guess what?  There are zero studies showing PCSK9 inhibitors have any real benefit.  As of yet, there are no known clinical benefits of taking a PCSK9 inhibitor.  Yes, it can lower LDL-cholesterol levels, but there are no studies showing these drugs have any benefit in treating/preventing any cardiovascular disease including stroke and/or heart attack.

It is unbelievable that the FDA can approve a new class of medications based solely on a surrogate marker—lowering cholesterol levels.  To make matters worse, the PCSK9 drugs are incredibly expensive.  So, we will have to use these expensive medications and wait to see if Big Pharma can show a cardiovascular benefit.  If the FDA was working for use, they would demand Big Pharma do the initial outcome studies before approving the drugs.  But, we all know that the FDA does not work for us.

Take a look at the ad for Repatha –evolocumab–below and see the section titled “Limitation”. (Look for the second bullet point which is below the picture at the top left.)

Here’s what I think.  Big Pharma will provide a study that shows that PCSK9 inhibitors have a benefit in treating and/or preventing heart disease.  However, this benefit will be small—around one percent which is the same benefit as the currently-used statin drugs.  Then, after a period of time, adverse effects with PCSK9 drugs will start to climb.  Why will these new drugs be shown to have adverse effects?  One could easily predict this as cholesterol is needed by every cell in the body to function optimally.  Low cholesterol levels and low LDL-cholesterol levels are associated with a host of adverse effects including depression, suicide, Parkinson’s disease, Alzheimer’s disease, infections, and cancer.

I say, avoid taking a PCSK9 inhibitor until it is shown to have safety and efficacy.  Use your money elsewhere such as buying healthier food and starting an exercise program.  Your body (and back account) will be appreciative.

More information about statins can be found in my book, “The Statin Disaster.”

Read the full article on Dr.Brownstein.com.