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 a nd 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.”
Dr. Brownstein,
I love to read the continuous stream of Statin posts! I believe you 100% yet it’s hard for me to convince those who are on statins. For someone who has a total cholesterol above 300 do you then look at the ratio to determine a course of action? Or do you ignore the number and focus on symptoms? If there is a cholesterol over 300 and there is 50% stenosis in an artery does that change the action plan?
Grover Syck, you are right. My husband will soon be 65 and will be on Medicare. The enrollment for a Medigap plan does not recognize “WP Thyroid.”
A follow up
Big Pharma hates desiccated thyroid is that 1)it is not palatable. Both because it is a naturally occurring substance, and
2) it has been used for over 100 years.
The best Cholesterol lowering “drug” is desiccated thyroid.
If most people with elevated Cholesterol had their thyroid checked, most would be hypothyroid.
My wife went on desiccated thyroid. for her hypothyroid, her cholesterol dropped form 220+or- to about 170.
It took about 6 months once she was on an adequate dose.
It is safe and inexpensive.
I agree nobody should ever take chloesterol lowering drugs of any kind. Eating more fiber is an excellent way to lower high cholesterol without any dangerous side effects. 40-50 grams a day should probably be the minimum. In response to part of what Barry said above, there is no comparison between refined and unrefined carbohydrates. Fruits, beans, and high quality unadulterated whole grains are the best things you can eat. When it comes to whole fresh fruit, you can eat as much as you feel like. I don’t recommend eating a fruitarian diet, but I know of type 1 diabetic fruitarians who handle it perfectly. No amount of whole fruit can harm your health, and this is backed by science. (http://nutritionfacts.org/video/how-much-fruit-is-too-much/)
No one should really be eating a low carb paleo type diet. 50% should probably be the minimum for carbohydrates that is consumed ( real carbohydrates, not refined white grains and added sugars). I really don’t know how anyone can think that eating loads of butter, cheese, lard, bacon, beef fat, and whole milk is good for you, but that whole fruit and high quality whole grains are bad. The fact is that the longest living populations on earth eat a high starch carbohydrate diet of whole grains, beans, and potatoes. Look up the Blue Zones and see for yourself. Also, see this comparison on low carb paleo diets and high carb whole plant food diets when it comes to insulin, again, backed by science. (http://nutritionfacts.org/video/paleo-diets-may-negate-benefits-of-exercise/)
Its a shame that the pharmaceutical, food, chemical, medical industries among others are being driven by greed. And the govt agencies that deal with these industries are not protecting the people from them as they are supposed to do.
what can we do about this, if anything?
Ruth Ann,
What we can do is take back our power. Call and meet with our elected officials and let them know you are aware of what they are doing.
DrB
Do we need more cholesterol lowering drugs? No, we don’t need more, in fact we don’t need any. Despite the fact that many people now recognise that statins are effectively poison they still talk about other ways to lower cholesterol levels which shows that consciously, or unconsciously, they still think a high (whatever that may be when Big Pharma is forever trying to dictate that lower is better – it’s not) cholesterol level needs treating. The evidence shows that those with higher cholesterol levels live longer.
PCSK9 inhibitors will, I suspect, be a health disaster. A ridiculous amount of money will be spent on these drugs if Big Pharma has its way and a truck load more on treating the adverse effects. No doubt people complaining of adverse effects will be treated with the same disdain and in denial attitude by many physicians. Take a look at this paper for an indication of what to expect http://www.ncbi.nlm.nih.gov/pubmed/16893422.
As a European I really do wonder when the American public is going to react to the vested interests and corruption that appear to drive the on-going promotion of appalling “food” products (SAD says it all), a profit above all drug industry plus an agricultural industry which uses tons of poison on crops and promotes GMO’s. Also let’s not forget the lack of meaningful regulation and flawed diet advice by the very agencies and organisations that should be protecting the American public. It’s bad enough in Europe but America is on an entirely different level.
Familial hypercholesterolemia genetic issues aside if your cholesterol level is “high” it is because of homeostasis and a reflection of what you are doing to your body by way of diet and lifestyle. Cut out junk food completely, cut carbohydrate intake (especially sugars and refined flour products that increase triglycerides and cause inflammation – which will raise your cholesterol level). You don’t have to, or need to go Paleo but you do need to seriously cut back on carbohydrate, including fruit which we have not adapted to consuming at the levels promoted by many so-called experts. If that sounds strange just consider how many oranges (or whatever your fruit of choice) go into making your glass of fruit juice or smoothie – would you eat the equivalent as raw fruit and x times per day?
If you want to be healthy eat natural foods and add vitamins and minerals that are likely to be missing as a direct result of modern food production techniques. There may be a few lucky people that have access to natural product but most are forced to eat mass produced foods. Ideally a comprehensive blood analysis will provide a starting point to determine the greatest deficiencies but it is a fair bet that most will be deficient in vitamin A, D and K2 – these three are fundamental to good health – vitamin C and most likely the B vitamins especially B12.
Vitamins A, D and K2 will work synergistically to ensure calcium is deposited in bones and teeth – not in tissue or your cardiovascular system. Ever wondered why calcium supplementation is pretty useless in preventing osteoporosis? You need vitamins A, D and K2 otherwise you are not going to protect your skeleton but risk calcium deposits in your CVS and elsewhere. Vitamin C is needed at a far higher level than recommended (think in grams and not milligrams). Just look online for Linus Pauling and vitamin C for more information.
You go, Barry!
DrB
Dr Brownstein,
It is unbelievable really. I have been trying to get my 83 yr old mother off of statins as ever since she started them she has been experiencing memory issues..
Her doctor and now neurologist stating that statins have recently been proven to actually help slow down dementia. Therefore she needs to stay on them. Furthermore both doctors state that there is absolutely no evidence that statins cause memory issues. As we know web sites are filled with people stating the opposite . .. So even though brain is made of lots of cholesterol and statins lower cholesterol, pharma is now looking to get all elderly on statins claiming recent studies prove statins actually help prevent dementia.
. It is a ridiculous, frustrating process that will make one crazy….No problem though , when that happens, I guess they will put me on a statin. .
Your statement, ” Low cholesterol levels a nd low LDL-cholesterol levels are associated with a host of adverse effects including depression, suicide, Parkinson’s disease, Alzheimer’s disease, infections, and cancer.” says it all. Creating a class of drugs that promise a healthier life, fully aware that the outcome of their therapeutic use will produce a greater revenue stream down the road, via secondary illnesses ( noting that cholesterol levels are not an illness, but only a symptom of what could be an illness), is truly a diabolical business plan. Getting consumers to the point of chemo drugs is the big bonanza for the Pharma/Medical Cartel.
So let me get this straight-LDL cholesterol is bad in the serum but OK in the cells so we push more of it into the cells circumventing the natural PCSK9 control mechanisms and this makes everything better. If it is “bad” to have it in the serum would it not be “bad” to have it in the cells. Treat the numbers, make the lab work look “better” and make billions. Nice business if you can get it.
If you go to Wikipedia to read about PCSK9 you will see the following as the third paragraph: “PCSK9 has medical significance because it acts in cholesterol homeostasis. Drugs that can block PCSK9, thus lowering low-density lipoprotein cholesterol (LDL-C). The first two PCSK9 inhibitors, alirocumab and evolocumab, were approved by the U.S. Food and Drug Administration in 2015 for lowering cholesterol where statins and other drugs were insufficient. THE MANUFACTURER DID NOT SUBMIT DATA TO SHOW THAT THE DRUGS ACTUALLY IMPROVED OUTCOMES OF CARDIOVASCULAR DISEASE, BUT THEY ASSUMED THE LOWERING CHOLESTEROL WOULD IMPROVE CARDIOVASCULAR DISEASE.[4]” [All capitals for emphasis, mine.) Need I say more?!
“Limitations of Use: The effect of Repatha on cardiovascular morbidity and mortality has not been determined.”
Allow me to boldly paraphrase what this one sentence actually says…
“We have been allowed to by-pass the usual methods for clinical testing and are introducing a new, very expensive fear-based drug that will make perhaps billions of dollars for Big Pharm. As the consumer, you will be the sole resource for the determination for the efficacy or detriment of this drug. The lack of clinical trials is an extremely important part of monetary savings for our drug company. Be assured, the savings will not be passed on to you.”
Lisa,
True. It made me laugh. Truth is certainly stranger than fiction.
DrB
Guys. If you want an effective statin that lowers cholesterol levels. Take 500 mg niacin, 50 mg b complex, and 1000 mg vitamin c 3x daily (once with each meal). Get a liver function panel and uric acid levels for monitoring. It works better than any statin. I take it and it works. My only side effect is my skin flushes
A February 20,2015 article from Formulary Watch written by Tracey Walker contains the following quote: “The cost of these drugs will add nearly $50 per month to the premium costs for every insured person in the United States,” said Don Hall, a former health plan CEO of Delta Sigma LLC, in Littleton, Colo. “If this was the last of the high-cost, high-use pharmaceuticals, the system could adjust and move forward. Unfortunately it’s only the beginning as new drugs for a range of neuromuscular diseases and cancer are poised to hit the market in the next few years. We are quickly getting to the point where healthcare costs crush our economy.” Link: http://formularyjournal.modernmedicine.com/formulary-journal/news/move-over-sovaldi-could-pcsk9-inhibitors-be-bigger-cost-challenge?page=full
D.C.,
Yet, doctors will begin to prescribe these drugs without a second thought. It is beyond ridiculous.
DrB
Unless I am mistaken, and if so please forgive me, but I think you might have meant to say in the third sentence “Once the PCSK9 binds to the LDL-cholesterol receptor, the complex is absorbed into the cell and broken down.”, omitting the word antibody. Just wanted to give you a heads up.
Thanks, Michael.
They just want to make money. The MS drugs are $5000 a month and these ~$1,00+ per month. Cholesterol is needed by the brain/body/hormones etc. If the doctors who gave drugs tried them themselves they may have a conscious about them and realize they are hurting and not helping people. No gluten/dairy/soy/sugar/GMO…vitamins/good oils/minerals..probiotic…LDN..detoxing may help heart disease. EDTA IV chelations may help unclog blood vessels. Low thyroid may make cholestrol go up. Some people may just need thyroid medicine which lowers cholesterol and gives the heart energy. Garlic lowers cholesterol. People need enough cholesterol to be healthy.
What is sad is so many people still falling for the Big Pharma hype. Thanks to you, Dr Brownstein,some of us are getting the word and spreading it. I think if the physicians who prescribe these expensive drugs were made to pay a portion for them, maybe costs would go down. Oh yeah, then there is the AMA, CDC, and the Trial Lawyers Association getting the big bucks….no help there.
Mary, I do believe there is “something that really works and does not cost an arm and a leg”, removing grains and sugars along with the consumables that turn to sugar. Sugar molecules in the bloodstream are the culprit most of the time and do damage that the cholesterol is sent in to repair. By eating plenty of healthy fats and an array of veggies and some fruit (organic as much a s possible), one will see their health improve and cholesterol levels even out. Keep in min that cholesterol is the backbone of hormones an needed for so many functions in our cells.
Kindly,Theresa
TYPO: THINK IT’S SUPPOSED TO SAY ‘US’ – If the FDA was working for use, they would demand Big Pharma do the initial outcome studies before approving the drugs.
This another drug to be avoided.
I wish they would come up with something that really works and does not cost an arm and a leg.