THE DARK STORY OF THE STATINS

THE DARK HISTORY OF STATINS

In this insight I would like to share the content of Dr. Paul Mason's beautiful lecture on the history of statins.

Paul Mason is an Australian physician who loves scientific evidence. He is one of the experts I love the most. His way of explaining and constant reference to scientific studies to support his ideas convey rigor and authority. You can find his videos at this YouTube page.

Today's lesson can be found at. here, you can turn on English subtitles and then automatic translation. I have, however, reported in writing practically everything.

Let's begin: the texts in blue are my words, those in black Paul Mason's

Today we will talk about the history of statins and how the science has been distorted.

Today millions of people take statins and they have been terribly profitable. Just think that Lipitor alone in its entire history has generated more than 150 BILLION $!

The first question is: How did statins become so popular?

The story begins in 1913 with Russian scientist Nikolai Anikov who discovered that feeding rabbits pure cholesterol could give them atherosclerosis. Over decades this discovery led to the formulation of the lipid hypothesis, which holds that cholesterol is the main cause of cardiovascular disease.

Although rabbits are herbivores and their atherosclerosis is very different from that of humans, in the mid-1950s pharmaceutical companies’ laboratories around the world were searching for a drug that could lower cholesterol.

One of these was Merrel, the same company that introduced thalidomide to America, which found a cholesterol-lowering drug: MER29, which quickly became a commercial success. Profits aside, however, it was a disaster: although the company initially claimed the drug was safe and free of side effects, it withdrew it from the market in 1962. In the same year, the FDA withdrew its permit to sell MER/29 because Merrel had not provided all the information it had on the drug's side effects: cataracts, hair loss, dermatitis, increased atherosclerosis and others.

Merrel knew about these side effects because in animal tests many problems with the drug had emerged: after 9 weeks of administering the drug only one mouse out of 44 had survived. Merrel had altered the data, concealed the side effects and instructed his salespeople to blame other drugs for any side effects. He had to pay more than $50 million in damages. (1)

This episode created a vacuum: a firm belief that cholesterol was dangerous and no drugs with which to lower it. It was in this climate that statins were born.

In 1976 a Japanese scientist Akira Endo extracted a mycotoxin known as ML236B, which became the first experimental statin. By 1979 Sankayo and Merck (two pharmaceutical companies) were both working on the same statin: whoever patented it first would make a lot of money!

In 1980, however, Sankayo stopped working on this statin: half of the dogs used in the preliminary studies for the statin had developed intestinal lymphoma (cancer), and so the drug was deemed too dangerous. Merck also stopped working on the statin. But after the insistence of scientists working on the project that it could be resumed because Japanese scientists had been wrong to hold it responsible for intestinal cancer... (2)

So it was that in 1987 Merck received FDA approval to sell its first statin, Lovastatin.

A few years later (1990), however, the NIH convened a panel to discuss the possibility that lowering the
cholesterol could be inherently dangerous. Conclusion. Yes, lowering cholesterol
can be dangerous. In fact, in 2001 Bayer recalled its Baycol statin after the following died
several people who were taking it. (3) As a result of this recall Bayer paid more than a
billion dollars in thousands of lawsuits over the damage caused by this statin.

The list of side effects caused by statins is long

Dementia (4)
Increased risk of osteoporosis (5)
Lowered testosterone level, associated with erectile dysfunction and testicular shrinkage (6)
Increased risk of becoming diabetic (in postmenopausal women the risk increases by 71%) (7)

These side effects are no secret, just read the package insert (in this case the one for Crestor)

Liver cancer
Muscle damage
Blood in urine
Increased risk of diabetes

The list of side effects observed after Crestor went on the market are even more impressive:

Arthralgia (joint pain)
Liver failure (fatal and nonfatal)
Hepatitis
Jaundice
Thrombocytopenia (low platelets in the blood)
Depression
Sleep disorders
Peripheral neuropathy (malfunction of peripheral nerves)
Interstitial lung disease (extensive alteration of the architecture of the lung alveoli and airways)
Gynecomastia (enlargement of breast tissue in men)

Of course we should be reassured that the risk of side effects for people taking statins is low: 1 in 100, sometimes even 1 in 200. Especially when these claims are made d Sir Rory Collins, a respected professor of medicine at Oxford University (8). It doesn't make much sense, however, that Rory Collins himself filed a patent for a test that identifies the gene that makes people more susceptible to muscle pain on a statin, and that the site selling that test (StatinSmart) claims that 29% of people taking statins experience muscle pain, cramping, or weakness (9).

The fact is that the 29% of people suffering side effects from statins is probably closer to the truth than the 1% stated by Collins (8).

You see very often statin studies are designed so that side effects are underestimated. For example, before the start of this large study (10) there was a “running period” during which candidates were first given a placebo and then the statin. Candidates who experienced side effects from taking the statin during this running period were excluded from the study. In this case (10) more than 11,000 people were removed, or one-third of the potential candidates. (Editor's note So the people potentially developing side effects are not the 1% as stated, but the 30%. The 1% comes from the fact that people who developed side effects during the running period were excluded from the study. Unfortunately, this practice is perfectly legal).

The truth is that 1 in 5 patients (11) does not tolerate the standard dose of statins well and develops troublesome side effects.

At this point the question arises: if statins have these side effects, how beneficial are they in prolonging life? Or more precisely: by how much will the life of the average person taking statins be extended? This excellent study (12) answers the question by collecting data from each eligible study: 11 studies with a total of 90,000 people followed:

People who had already had a heart attack gain 4.1 days to live
People who had not had heart attacks gain 3.2 days to live

After taking statins for years (Ed. and perhaps suffering from heavy side effects that decrease quality of life) people live 3 to 4 days longer.

And these values are probably overestimated because so many studies could not be taken into account because the drug companies did not make the raw data for the studies public, only the results they extrapolated from them. (Editor's note If you have nothing to hide why not share the raw data and make it available for independent analysis?)

For example, this meta-analysis (13) which analyzes the results of eight studies, concludes that for people between 50 and 75 years old, there is no life extension by taking statins. Only one of the eight studies analyzed shows a positive effect: the Jupiter Trial (14). (Editor's note Previously statins had been tested only for people with high cholesterol, whereas in this study they wanted to test efficacy as primary prevention, thus on population with low cholesterol but high C-reactive protein. C-reactive protein is an indicator of inflammation associated with cardiovascular disease).

The results of the Jupiter Trial were announced with great fanfare, completely ignoring the results of the other 7 studies. Now I would like to show you how they did it to make the results look much more impressive than they actually are. For example, this article from the New York Times (15) states that participants in the Jupiter Trial who were taking statins were almost 50% less likely to have a heart attack, need a stent or bypass. Impressive isn't it?

Elena’s tip:
It's a bit complicated here, I'll try to explain: the Jupiter Trial (14) is an RCT or rather a randomized controlled trial, where there are two groups of similar people doing two different things. One group was taking Crestor (which is a statin manufactured by Astra Zeneca), the other group a placebo. To evaluate the effectiveness of taking Crestor, the researchers decided to measure how often one of these events happened:

Nonfatal heart attacks
Nonfatal heart attacks
Hospitalizations for angina
Arterial revascularization
Cardiac death

Result:

1.5% in the group that was taking Crestor
2.7% in the group taking placebo

So subjects taking Crestor had a RELATIVE decrease in risk of 44%. Relative means relative to the other group in the study. However, “clinically the ABSOLUTE reduction in risk is more important. Because the absolute reduction in risk must be large enough to justify the risks and costs associated with prescribing a drug to healthy people.” (16). Remember that the Jupiter Trail wanted to test the efficacyin primary prevention of Crestor. Primary prevention means on healthy people.

So what was the ABSOLUTE risk reduction in the Jupiter Trial? 0.59%. A BIG difference from the 44% of RELATIVE risk reduction, right? Dr. Paul Mason made a graph that is much more immediate:

If we go to take only the most dangerous events (such as heart attack) the ABSOLUTE reduction in risk is 0.20% while the RELATIVE reduction in risk is 54%...

Do you see how they manipulate numbers to make us think something is extraordinary when it is less than mediocre? Let me explain: the absolute reduction of 0.59% on the full 5 events means that 169 people would have to take the statin for one year to prevent one event. If we look only at serious events (such as heart attack) 500 people would have to be treated for one year to prevent one event. (17) Is the risk of developing side effects that 500 people have worth the benefit that one person gets?

This number is called the NNT Number Needed to Treat: the number of people you need to treat to have a positive result. The lower the number, the more effective the drug is. If the NNT is over 50, it is like buying a lottery ticket....

After this explanation I will quote the exact words at the beginning of the New York Times article (15) on the results of the Jupiter Trial, with the hope that they may be helpful to you in understanding the level of information manipulation we are subjected to on a daily basis and which has PURPOSELY led me to stop believing what the media tells me.

“A large new study suggests that millions of people with low cholesterol could still benefit from taking statins because the drug can significantly decrease their risk of heart attacks, strokes and death.

The study found that the risk of heart attack was more than halved in the group taking statins.

Statins were considered so beneficial that an independent committee stopped the study, which was supposed to last five years, after less than two years.”

Sorry to reiterate, but the ABSOLUTE decrease in risk was only 0.59% and not more than 50% as claimed by the New York Times...

There are additional issues with the Jupiter Trial: stopping first, the study may have overestimated the effects of statins and, more importantly, failed to detect the risks associated with long-term administration of statins to a healthy population.

For example, in the group taking statins there were higher levels of glycated hemoglobin and higher incidence of diabetes. In addition, what may be the effects the long-term effects of LDL levels below 60 mg/dL? (16,17)

And now we come to the golden rule “follow the money,” follow the money. Although many of us wish things were different, the sad truth is that there are people in our society who will do anything for the god of money.

In the “methods” chapter, “trial design” section of the Jupiter Trial (14) we read the following words

“The trial was financially supported by AstraZeneca.”

The study was financially supported by AstraZeneca, the pharmaceutical company that manufactures Crestor, the statin used in the Jupiter Trial.

That pharmaceutical companies finance studies demonstrating the efficacy of their own drugs to increase the base of possible customers is common practice today. What I find unacceptable, however, is that 9 of the 14 researchers in the study had financial ties to AstraZeneca.

In addition, principal investigator Ridker had a huge personal conflict of interest as he holds a patent for the test that detects C-reactive protein values, which the study proposes as a new method to detect people potentially at risk for cardiovascular disease. (18).

I close by going off topic with an interesting quote from Ridker himself, “Of the nearly 1.7 million heart attacks and strokes in the United States, more than half are on apparently healthy patients with normal cholesterol levels.” (19) But how? We have been told for more than fifty years that high cholesterol is the cause of cardiovascular disease, and more than 50% of people who have heart attacks and strokes have cholesterol in the average??? Do you realize the society we live in?

But back to Dr. Paul Mason's video.

Now let me show you how they use this reverse number manipulation: this New York Times article states that a study found that statins Have no negative effects on memory (20). In the study (21) out of 480,000 patients, 376 in the group taking statins had severe memory loss, while in the group not taking statins only 114 patients had severe memory loss. This represents a RELATIVE increased risk of 320%, and when some confounding factors are taken into account, the risk increases to 440%.

How come in this case the New York Times did not cite relative risk as it did with the Jupiter Trial article? If it had, the headline would have been “Statins increase risk of memory problems by 400%”... (see? They decide to show us the data according to what they want us to believe...)

The moral is: don't get your health information from newspapers. Unfortunately, as we will see in my next lecture, sometimes even doctors are not trustworthy because they often feel compelled to do things, such as prescribing statins, even against their personal judgment. Remember that you have the right to question your doctors by asking them for the evidence on which they base their advice. Personally, that is exactly what I get from my patients.

Here that last sentence is just yet another reason why I madly love Dr. Paul Mason!!!

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