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Repatha Lowers LDL Better Than Statins - 8


FDA approval was granted to Amgen's evolocumab (Repatha) on Friday for the prevention of heart attacks, strokes, and coronary revascularizations in patients with established cardiovascular disease, the drugmaker announced -- making it the only PCSK9 inhibitor green-lighted for such a wide swath of adults.

Used for prevention by lowering low-density lipoprotein (LDL) cholesterol, evolocumab is now approved as an adjunct to other lipid-lowering medications and as a stand-alone therapy.


Why hasn't this drug caught on? If you read the rationale, you are told that it is the expense and reluctance of insurance companies to pay the exorbitant costs.


The untold truth is that doctors, in this instance, appear to have a conscience and have observed the harm it causes to their patients, so they are not prescribing it as predicted. Maybe I am giving doctors too much credit, and it is really driven by patients and loved ones who have observed the harm the drug causes.


The other related question is, why are statins still among the most prescribed? Usually, when a drug goes off-patent and the profit margin declines precipitously, replacement drugs that are on patent are offered. So, what is going on with the lowering of LDL? I answer that in a later blog.


The answer comes from a surprising source.


What is wrong with this image? If you have been reading and comprehending my cholesterol and statin blogs, you may be able to answer this question. Answer at the bottom of the blog.

 

Summary of facts:


Statins have multiple modes of action:

  • lowers LDL production

  • lowers CoQ10 production

  • Are antibiotics (this will be the subject of another blog and is well documented in ALL my books.

Repatha

  • lowers LDL products

The meager benefit noted for statins in men with already diagnosed severe cardiovascular disease (the only group with any benefit against heart disease - at 0.3% absolute) is due to the antibiotic effect of the statins - not the LDL lowering. It should be evident if you design a new drug that only has one mode of action. That mode is NOT the clinically effective pathway - only harm can result regardless of the drug companies' reported "favorable results."


Here is a short exchange between a friend and me, Steven Schmidt, a medicinal chemist at Warner-Lambert who developed Lipitor (statin). Pfizer bought Lipitor.


Tom: "Steve, Dr. Trempe told me that statins work because they are antibiotics."

Steve: "We know that."


"We know that" means Pfizer. In the future, I will present the history of cholesterol-lowering drugs and the understanding that statins are antibiotics.


Answer a couple of simple questions.

  1. Would you be willing to take an antibiotic for the rest of your life?

  2. Are statins antibiotics? (I hope you believe me, but I will present unequivocal data in the future.)

  3. Do the drug companies know they are antibiotics?

  4. Is "cholesterol lowering" a better marketing tool compared to pushing antibiotics?

Now you know why you have never heard about this mode of action of statins.


So why offer Repatha with no antibiotic action?


$$$

 

In my book, "Health Freedom Lost."


Injectable Medicine - Biologics


These newer drugs, led by Amgen's Repatha, were supposed to replace statins. They are very effective at lowering LDL and are also very expensive and profitable. However, they hit a serious snag. The side effects of these drugs are considerable. The CDC soft pedals on these drugs, saying they are for familial elevated cholesterol, but that was not their initial intent.


As a reminder, statins do NOT directly lower the total cholesterol value. Instead, they impact the activity of a liver enzyme responsible for producing LDL. In doing so, the total cholesterol value is usually lowered, too, because LDL is part of the total cholesterol number. Repatha is even more effective at reducing LDL production when compared to statins. This drug, made by Amgen, was approved by the FDA for its LDL-lowering capability.


*** This is an important point. Dr. Trempe told me that the FDA is so convinced about the value of lowering LDL that drugs like Repatha are judged on that ability. This means that true health endpoints WERE NOT CONSIDERED in the drug approval process. I have not substantiated this because this type of information is VERY DIFFICULT TO FIND. But Dr. Trempe never told me something on a hunch. If he told me this, he dug deep to find the information. ****


It is very important to understand that the criteria for approval, when you read the fine print, was not for a health benefit. LDL (soap) is presumed so harmful that an endpoint like reducing deaths was not needed to approve this drug. This is not a scientific approach. Every drug must only be approved by showing an actual health benefit.

Here is a press release from Amgen on the authorization of Repatha and a translation of their language.[i]


"Despite treatment with the current best therapy, many patients are still at high risk for cardiovascular events. Physicians now have a new FDA-approved treatment option to prevent cardiovascular events by dramatically lowering LDL cholesterol with Repatha, especially for patients already on maximally-tolerated statin therapy who need further LDL cholesterol lowering."


Translation: Statin drugs do not work very well, if at all. Repatha lowers LDL even further, going against all new knowledge on the value of higher LDL levels.


"Consistent with recent trials of more intensive LDL lowering, there was no observed effect on cardiovascular mortality. Similarly, there was no observed effect on hospitalization for unstable angina."


Translation: Take Repatha, and your risk of dying from heart disease does NOT change. Surely, this is true for the studies they decided to share.


The FDA does not require drug companies to submit all their data. It is important to read Dr. Demasi's paper at the end of this chapter to understand the limitations of clinical trials and the benefits they report. (you will have to get my book to read that brilliantly constructed document.)


The reported side effects from lowering LDL with Repatha, or any drug for that matter, are extensive. For Repatha, in particular, side effects that require an immediate call to your doctor include:

  • difficulty with breathing or swallowing;

  • fever;

  • hives, itching, or rash;

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals;

  • nausea;

  • reddening of the skin, especially around the ears;

  • swelling of the eyes, face, or inside of the nose;

  • unusual tiredness or weakness.

Our observations of people on Repatha include very common severe memory issues.

Memory loss is not found anywhere on the entire list of side effects, but this is not a reflection of the real effects experienced by people on this drug. A paper in the prestigious New England Journal of Medicine concluded the following with regard to Repatha and memory loss.[ii]


"In a randomized trial involving patients who received either Evolocumab (Repatha) or placebo in addition to statin therapy, no significant between-group difference in cognitive function was observed over a median of 19 months. (Funded by Amgen; EBBINGHAUS ClinicalTrials.gov number, NCT02207634.)"


Interestingly, the manufacturer also conducted the study. Also, note that a placebo in addition to statin therapy is NOT a placebo. Statins are well known to impact cognition even though this information is hard to find because of the marketing power of the statin industry.[iii] Do not be concerned, however, because Amgen has an Alzheimer's drug in case Repatha destroys your memory.


The media was quick to report on the meager benefits of Repatha.


The New York Times led with, “this new class of drug has the potential to improve the health and longevity of millions of Americans with heart disease, the nation’s leading killer, accounting for one in four deaths.” However, buried in the ninth paragraph, the article revealed that the drug “did not show a benefit in overall death rates from cardiovascular causes.”


Am I dense, or are there conflicting statements in this article?

  • "Improve the health and longevity of millions of Americans with heart disease."

  • "Did not show a benefit in overall death rates from cardiovascular causes."

NPR’s piece, written by Yale cardiologist Harlan Krumholz, displayed a bit more caution:


“Pricey New Cholesterol Drug’s Effect on Heart Disease Is More Modest Than Hoped.”


The relatively small reduction in cardiovascular events received prominent emphasis in NPR’s story. “Repatha, over about two years of study, reduced the risk of cardiovascular events, including heart attacks and stroke, by about 15 percent. For about every 66 people treated, one person avoided one of these events. There was no reduction, however, in the risk of death.”


"Avoided?" What does that really mean. Often, it means that the heart attack came a day later than the statistical norm.


Here are the absolute statistics on that data - although the data itself is questionable at best because LDL is a critically important lipoprotein.


  • Reported benefit: 15 percent;

  • Absolute benefit: (1/67) x 100 = 1.5 percent.

Even the Yale faculty will do well to repeat 4th-grade math.


Kaiser Permanente took a more pragmatic view of the data because their system is both the provider (prescriber) and payer, so cost matters. In their Health News piece in USA Today headlined,

“Cholesterol drug prevents heart attacks - but costs $14K a year.”


Journalist Larry Husten, writing on the Cardiobrief blog, wondered if “the modest efficacy of the drugs is worth their immodest cost.”


Patient advocate Dave deBronkart, also known as e-Patient Dave, explains what we all need to understand. Relative statistics do NOT explain risk relevant to you, but absolute statistics do. DeBronkart states, “Avoid relative risk reduction (headlines about percentages) and look instead for actual (absolute) numbers of patients helped.” The problem is essential all statistics for drug benefits are published in relative statistics. To find the absolute statistics, the actual data must be found and the absolute statistical value calculated. This is nearly impossible to calculate the way the data is reported.


Amgen’s own data on Repatha looks like this:

  • Major heart problems or strokes happened to 11.3 percent of patients WITHOUT the new drug and 9.8 percent of patients WITH the new drug. In other words, 1.5 percent of patients avoided a problem event, but 9.8 percent still experienced a problem event despite taking the drug.

  • 1.5 percent means, on average, 1 patient in 67 benefits from the drug.

  • Note the drug did not save lives. The same percent died whether or not they got the drug.

  • The drug costs $14,000/year, and the patients studied were monitored for an average of 2.2 years, making the cost $30,800 per patient.

  • To prevent one heart attack, the cost is 67 (the number needed to be treated to avoid one heart attack) x $30,800 (the cost for each patient) = $2.06 million.

Repatha: $2 million per patient to avoid one heart attack, yet not one death avoided!


Now you know another reason why the United States spends 2.5 times more per person for healthcare, yet our citizens live 2.5 fewer years.


 

Credible Reporting to the Public?


No new side effects were reported in the study, but this is not believable based on its mode of action - inhibiting repair and recovery by lowering LDL. But considering that Stanford University Medical School indicates that a single drug has over 300 side effects, on average, this is not necessarily good news because Repatha is usually compared to statins that have an exhaustive list of adverse side effects.[iv]


The results reported by the manufacturer were only for very high-risk patients. If your risk is lower, the benefits of the drug will not be comparable, but the side effects will be the same. If no lives are saved in the high-risk group, how many will be saved in a low or moderate-risk group? How many will be harmed? How many excess deaths?


Claims of “landmarks” and “breakthroughs” should be viewed skeptically in the absence of data. The evidence-based reality is almost always substantially less than initial reports would have you believe.


The website https://www.ehealthme.com/ allows individuals and doctors to conduct phase IV clinical trials.[v] This is a fancy phrase that means evaluating the effect of drugs after they have been approved for human use. According to ehealthme, "After a drug is approved, phase IV trials are conducted by the FDA and pharmaceutical companies to monitor its safety and effectiveness in the real world. Using big data and innovative AI/ML algorithms, eHealthme provides a platform for everyone to run their personal phase IV trials. What's more, we work with your doctors to ensure serious effects are checked out promptly."


The ehealthme database reports over 100,000 side effects from people taking Repatha as of April 3, 2022.


Emphasis on the word "reported" because memory loss is not on the list of adverse effects and may not be included in the database!


It certainly is interesting that Amgen indicates no new side effects are noted. However, the side effects that are recorded occur at very high rates based on the ehealthme data.


One of the more disturbing ones is a large reduction in white blood cell counts. The reports are rare, but it does not mean the actual incidence is rare.


Our team has had just one person on Repatha in 2021. That person was very diligent at mapping out his labs on a spreadsheet, including his white blood cell counts.


  • In 2016 his white blood cell count plummeted from 5,400 cells/mL to 1,500 cells/mL.

  • He also noted any drugs or other changes he made on the spreadsheet.

  • His wife saw the coincidence between starting Repatha in 2016 and a precipitous decline in his WBC counts.

  • Low white blood cells are strongly associated with cancer and viral infectious disease.

The Canadian Cancer Society explains low white blood cell counts.[vi] They state,

"Leukopenia refers to lowered numbers of white blood cells (WBCs) in the blood. WBCs help the body fight infection and disease. When WBC counts are low, there is a higher risk of infection."


"Leukopenia is a decrease in the total number of white blood cells. Leukocyte is another name for white blood cells. They are made in the bone marrow and are found in the blood and lymphatic tissues. Leukocytes play a key part in defending the body against viruses and bacteria, which can cause infection. Normal levels of WBCs are 4.5–11.0 x 10(9)/L (we know these ranges are not correct). A person has leukopenia when the total WBC count is less than 3.0 x 10(9)/L."


***Incorrect, a person has leukopenia when the WBC is < 4.0x10(9) counts per liter.


Our individual had a WBC of 1.5 x 109/L, which is very dangerously low.

Note: if this person dies from cancer, it will NOT be reported as a Repatha-induced death.


The Canadian Cancer group says, "It is important to do everything possible to lower the chances of infection and to seek immediate treatment even if you think you have an infection." This statement is intended for those with low white blood cell counts. I have not spoken to this person since the onset of COVID. God forbid he caught the virus with that low WBC count.


Another injectable drug is evacetrapib. It acts by siphoning cholesterol out of HDL so the cholesterol can be discarded in bile. Statins, in contrast, lower the production of LDL that carry fats, including cholesterol, through the circulatory system. It seemed logical that evacetrapib, by ridding the body of cholesterol in HDL and lowering the number of LDL proteins, would work to protect against heart disease.


Although this drug increased the so-called good and lowered the so-called bad cholesterol, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease.[vii]


Here is an excerpt from the New York Times titled, “Dashing Hopes, Study Shows a Cholesterol Drug Had No Effect on Heart Health.”[viii]


“Evacetrapib is a drug that reduces levels of LDL cholesterol, the dangerous kind, as much as statins do. And it more than doubles levels of HDL cholesterol, the good kind, which is linked to protection from heart disease. As a result, heart experts had high hopes for it as an alternative for the many patients who cannot or will not take statins.”


But these specialists^^ were stunned by the results of a study of 12,000 patients,[1]

announced on Sunday at the American College of Cardiology’s annual meeting: There was no benefit from taking the drug evacetrapib. The drug’s maker, Eli Lilly, stopped the study in October, citing futility, but it was not until Sunday’s meeting that cardiologists first saw the data behind that decision.”


^^ Translation: "specialists" = Imbeciles


“Participants taking the drug saw their LDL levels fall to an average of 55 milligrams per deciliter from 84. Their HDL levels rose to an average of 104 milligrams per deciliter from 46. Yet 256 participants had heart attacks, compared with 255 patients in the group who were taking a placebo. Ninety-two patients taking the drug had a stroke, compared with 95 in the placebo group. And 434 people taking the drug died from cardiovascular disease, such as a heart attack or a stroke, compared with 444 participants who were taking a placebo.”


Keep in mind, this is a cherry-picked patient cohort - not the real world. This is the best results they could find and report.



“We had an agent that seemed to do all the right things,’ said Dr. Stephen J. Nicholls, the study’s principal investigator and the deputy director of the South Australian Health and Medical Research Institute in Adelaide. “It’s the most mind-boggling question. How can a drug that lowers something that is associated with benefit not show any benefit?” he said, referring to the 37 percent drop in LDL levels with the drug.”


Dr. Nicholls needs to go back to his science training in college and not his medical school training. The answer to his "mind-boggling" question is straightforward. Wipe out preconceived notions and just evaluate the data. When doing this, it is very clear that lowering LDL with drugs does NOT show a benefit. Now Dr. Nicholls, freed from the slavery of a false narrative, can properly work up and treat his patients.

[1] Do we laugh or cry at how easily the brains of doctor are manipulated to ignore facts.

[i] https://www.amgen.com/newsroom/press-releases/2017/12/fda-approves-amgens-repatha-evolocumab-to-prevent-heart-attack-and-stroke, April 4, 2022. [ii] Giugliano, Robert P., et al. "Cognitive function in a randomized trial of evolocumab." New England Journal of Medicine 377.7 (2017): 633-643. [iii] Alsehli, Ahmed M., et al. "The cognitive effects of statins are modified by age." Scientific reports 10.1 (2020): 1-14. [iv] Tatonetti, Nicholas P., et al. "Data-driven prediction of drug effects and interactions." Science translational medicine 4.125 (2012): 125ra31-125ra31. [v] https://www.ehealthme.com/ [vi] https://cancer.ca/en/treatments/side-effects/low-white-blood-cell-count, 02/01/2014. [vii] Lincoff, A. Michael, et al. "Evacetrapib and cardiovascular outcomes in high-risk vascular disease." New England Journal of Medicine 376.20 (2017): 1933-1942. [viii] http://nyti.ms/233Owyl, Permalink, 10/19/2016.

 

Answer: The image shows a happy guy exercising. When you exercise, you create wear and tear that requires repair. The LDL particle "delivers" the repair. Exercising and Repatha are a bad combination.

 

Index & Upcoming (short) blogs on cholesterol and statins


Number 1: Cholesterol fun (true) facts - completed

Number 2: Is the actual cholesterol molecule important? c - completed

Number 3: What is an optimal TC value? Remember, no one knows their actual cholesterol molecule value. - completed

Number 4: Surprising fact about cholesterol as an antibiotic - completed

Number 5: TC simple math - dumb doctors - completed

Number 6: What is LDL really? - completed

Number 7: Statins - do they lower the cholesterol molecule? - completed

Number 8: What did we learn from the new "biologics" to lower "cholesterol"

Number 9: Niacin and other "cholesterol" management treatments

Number 10: What did Natasha Campbell-McBride say about cholesterol/lipids?

Number 11: What is a QALY, and how does it relate to "cholesterol"?

Number 12: Idiot doctor from Johns Hopkins, Roger Blumenthal

Number 13: Who says statins do NOT extend life?





 

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Just Incredible! if you had the time to research every drug, big pharma would be out of business!

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