Cholestrol drug news and controversies

My views first: The latest news item (as of today) is that the much touted PCSK9 inhibitor based Cholesterol / LDL lowering drug has produced lack luster results. At one time, this was considered the holy grail against fighting heart diseases (not necessarily heart failure which is a different category).

The results are out today (March 17, 2017). In the next post, let me share the content of a Science Magazine article as well as other controversial issues with the whole Pharma industry in the business of lowering LDL

Back in the 1970s, the sugar industry (driven by corn production and corn syrup lobby ) created a villain out of fat. While fat such as (Dalda kind ) hydrogenated fat is indeed very bad, the lobby made a villain out of all fat overall, which recently got reversed. The Cholesterol drug industry became a multi billion dollar industry with some Pharma companies wanting to make statin consumption a regular thing like consuming an aspirin for the whole world. However statins of late have been shown to increase incidence of Type 2 Diabetes.

Human trials involving large number of patients, mostly industry sponsored have always produced inconclusive results , if one were to ask regarding the effectiveness of these drugs on the mortality rates,

The latest lack luster results, has forced Pharma company Amgen to offer a new marketing ploy with all kinds of caveats offering money back guarantee if patients get a heart attack while on the PCSK9 inhibitor.

The real issue is that the Pharma company wants insurance companies to support these medications. However the price of this PCSK9 inhibitor is $14000 per year for patients (for possibly 12 injections) taken that too with a statin!

Here is how one publication (Cardio brief) stated the situation

"As it turns out the PCSK9 inhibitor saga ends not with a bang but a whimper. The results of the highly anticipated FOURIER trial show that the drugs work, though not as powerfully as many had hoped and expected. The question now will be whether the modest efficacy of the drugs is worth their immodest cost, at least for the vast majority of patients who are not at extreme high risk for cardiovascular disease.

FOURIER is the first cardiovascular outcomes trial with one of the new cholesterol-lowering PCSK9 inhibitors, in this case Amgen’s Repatha (evolocumab). A second trial, Odyssey Outcomes, is about a year behind FOURIER and is testing Praluent (alirocumab), the PCSK9 inhibitor from Sanofi and Regeneron, in 18,600 patients. Both drugs have generated enormous controversy due to their high cost and, until now, uncertain efficacy. In the absence of clinical data wide adoption of the drug has been resisted by many clinicians and, even more crucially, insurance companies and benefits managers."

PCSK9: Real World Data Arrives, Unfortunately

Source
http://blogs.sciencemag.org/pipeline/archives/2017/03/17/pcsk9-real-world-data-arrives-unfortunately

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March 17, 2017

So, PCSK9. A wonderful story of genetics-based drug discovery, and a huge commercial opportunity. People with loss-of-function PCSK9 genes have very low LDL cholesterol, with no other ill effects, and people with gain-of-function mutations have chronically high cholesterol. That’s about as good as the validation gets, so a number of drug companies have gone charging after the target over the last ten to fifteen years.


The two big players, with antibody-based drugs on the market, are Regeneron/Sanofi and Amgen (and they’re all currently fighting it out in court). But the drugs themselves are not the gigantic blockbusters that some had predicted by this point, mainly because everyone’s been waiting for real cardiovascular outcomes data. Insurance companies are turning down prescriptions in favor of much cheaper and far better proven statin therapy, which also lowers LDL, until they can be sure that PCSK9 is worth the steep price. Sure, you can lower LDL by taking the PCSK9 drugs – but does that really translate into lower death rates from cardiovascular events? It should, according to what most people think about LDL and heart disease, but does it really?


This morning we have three-year data from Amgen and their drug Repatha (evolocumab), an announcement that has been eagerly awaited. And it’s honestly not all that impressive. There’s a 15% relative reduction in cardiovascular risk (heart attack, stroke, etc.) relative to placebo, but investors were looking for something more over 20%. Insurance companies were probably looking for that, too, and given the price they’d have been happier to see something more like 25%. Amgen is defending the data (as quotes in this Adam Feuerstein piece show), but I don’t think that’s going to do the job. The numbers shouldn’t have to be interpreted and spun; in a three-year study with over 13,000 patients in each arm, the numbers should be able to speak for themselves, and they don’t.


Keep in mind that these are numbers relative to placebo, too – ;what would a head-to-head trial versus a generic statin show? Update: the control arm was indeed on high-dise statin therapy. Is there enough difference to justify the $14,000 list price for Repatha (or for the similarly priced Regeneron/Sanofi drug?) I have to doubt it. Look for everyone in this space to take a hit in the stock market today, and for insurance companies to continue turning down prescriptions.

Thousands Sue for Damages Against Cholesterol Drugs as Big Pharma Defends Billion Dol

Source:

http://healthimpactnews.com/2014/th...s-big-pharma-defends-billion-dollar-industry/

This news publication is not the most trusted news source in my view but they may be right in the general aspect of the stories

In any case, if anyone is on a medication, they should not stop using the drug without support of their physician. That is common sense. If you do not trust the competence of your physician, then go for another one.



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March 16, 2017

The $100 billion dollar cholesterol-lowering statin drug industry is under attack, as thousands of Americans are filing lawsuits against the manufacturers of cholesterol-lowering drugs such as Lipitor. Research continues to confirm just how dangerous these drugs are, with yet another study published recently linking increased statin drug use to type 2 diabetes.


Since the study was published by the American Diabetes Association, these known risks to cholesterol-lowering drugs can no longer be denied or defended, and the lawsuits are pouring in at a rapid pace. Most of the lawsuits at this point are from women who have suffered with diabetes as a result of taking cholesterol-lowering drugs, but lawsuits over breast cancer, Alzheimer’s, liver damage, and others may soon follow now that it is generally known how dangerous these drugs are.


This information regarding a tsunami of lawsuits against cholesterol drug manufacturers has yet to be widely published by the mainstream media, however. To find out the magnitude of the lawsuits being filed against statin drug manufacturers, we turn to law firms who are reaping the fruit of litigation against Big Pharma.


According to statistics supplied by various law firms, there were 464 claims filed against Lipitor as of April 15, 2014, which increased to 703 by May 15, and then to 846 by June 16. By mid-July 2014 over 959 claims have been filed for damages due to Lipitor alone, and that increased in August to 1162. There are also many claims currently filed against Crestor, the next nearest competitor to Lipitor, and undoubtedly other similar drugs now sold under generic labels. These lawsuits now number well over 1,200, and are increasing at a rapid pace.


Lipitor is by far the most profitable drug in the history of mankind among all pharmaceutical products, let alone being the most profitable cholesterol drug before its patent expired at the end of 2011. Sales to date from this one particular cholesterol-lowering statin drug have exceeded $140 billion.
Lipitor benefited from the change in marketing laws in 1997 that allowed pharmaceutical companies in the U.S. to advertise their products directly to consumers. Pfizer convinced an entire generation of Americans that they needed a pill to lower their cholesterol in order to prevent heart disease, in what will go down as one of the most brilliant and unethical marketing schemes of all time.


After Lipitor’s patent expired at the end of 2011, the FDA issued its first warnings against statin drugs, which includes: liver injury, memory loss, diabetes, and muscle damage. Soon after issuing these warnings, the lawsuits started trickling in. Today, with more and more studies being published linking statin drug use to various side effects, those lawsuits have become a tidal wave, even though you are not likely to hear about this in the mainstream media.


Big Pharma Fights Back – They Do Not Want you to Know Cholesterol Drugs are Worthless and Dangerous


As is often the case when learning about the criminal activities of Big Pharma, much of the research is conducted outside of the U.S. The above referenced study published recently by the American Diabetes Association, for example, was conducted in Italy.


Since the patent on Lipitor has expired, pharmaceutical companies have been searching for the next big blockbuster cholesterol drug to bring in profits like Lipitor did. One of these newer cholesterol-lowering drugs is U.S.-made Zetia by Merck. Alberto Donzelli, head of education, appropriateness, and evidence-based medicine at Milan’s public health authority in Italy, has issued warnings about the dangers of this drug, and advised doctors in Italy not to prescribe it. Merck responded with two cease-and-desist orders and the threat of suing Donzelli. Donzelli backed down, but Merck has received a lot of public pressure in Europe since the story was picked up by the British Medical Journal. It was also reported in the Wall Street Journal here in the U.S. When doctors and medical professionals oppose Big Pharma, they put their careers and sometimes their lives on the line.

The fact that cholesterol is not responsible for heart disease, and that cholesterol-lowering drugs provide no statistical advantages to prolonging life by reducing heart attacks, has been widely reported for many years now by those of us in the alternative health media. One mainstream media source in Australia, however, decided to air a documentary on the Cholesterol Myth and “Cholesterol Drug Wars”. The show featured Dr. MaryAnne Demasi and interviewed several doctors and health officials who dared to tell the truth regarding the cholesterol drug scam. It was broadcast by ABC Australia in late 2013, under vigorous protests from the pharmaceutical industry. The videos were eventually removed from their website, and the network issued a statement retracting their endorsement of the show. However, they can still be seen on YouTube for now


What’s Next in the Cholesterol Drug Wars?


One in four Americans over the age of 45 are currently on statin drugs. In spite of the increased research linking these drugs to diabetes, Alzheimer’s Disease, liver damage, breast cancer, among many others (see: Consumer Alert: 300+ Health Problems Linked To Statin Drugs), government-funded Big Pharma agencies continue to promote statin drugs and are attempting to get more Americans to take them. New guidelines put out by the American Heart Association earlier this year (2014) would more than double the number of Americans taking statin drugs. Big Pharma educated doctors and health officials have been so indoctrinated by the cholesterol theory of heart disease, that there have actually been debates about adding cholesterol lowering drugs to drinking water! In their minds, every person on the planet should be taking these cholesterol-lowering drugs.
However, as we are seeing, Americans are starting to wake up to the Cholesterol Myth and the Statin Drug scam, and those injured by these drugs are seeking damages in litigation at a very fast pace here in 2014, in spite of the mainstream media blackout due to intimidation from Big Pharma.
So what’s next?


If we follow the pattern of Big Pharma when their products can no longer be supported in a free market due to lack of consumer confidence and demand, and massive litigation due to faulty products, they will probably seek some kind of government protection from these lawsuits. Such government protection will allow them to distribute their cholesterol drugs through government drug programs such as Medicare and Medicaid, and the new Obamacare. With the baby boomer generation heading into their senior years, it is just too large of a market for them to give up without a fight.
The logic they will use with politicians in Washington D.C. will be very similar to the logic currently used by the vaccine market: Americans are too stupid to know better, so we need laws to protect us and our products against litigation so we can continue to manufacture and distribute them to people who don’t want them, because they don’t realize how much they need our drugs.


This logic is clearly seen in the above referenced American Diabetes study on statins, where they state in their conclusion: “Benefits of statins in reducing cardiovascular events clearly overwhelm the diabetes risk.” In other words, we need to sacrifice those who are harmed by our products for “the greater good” of society, because our drugs are necessary for public health.


Another study linking statin drugs to an increased rate of diabetes was just published in Scotland:
The team from Glasgow University calculated that use of statins increased the risk of type-2 diabetes by around 12 per cent after four years. Those taking the drugs also gained an average of around 240g in weight.
But after identifying that statins had this effect due to the same mechanism which led to them reducing cholesterol, the researchers said the drugs still did more good than harm and patients should continue to take them as directed.

(for more read the source article)