Cholesterol Drug CRESTOR No.2 in USA Most Prescribed List

Experts who support the use of statin medications like to keep saying how cheap the drugs are now that Lipitor has gone off patent. Here in the UK, we can often find statements like.... low dose statins only cost £1 a month per patient. Statin supporters have even laughed at the idea that money is the motivation for lowering cholesterol, insisting that the market for statins is not that great.

Well overall, the annual cholesterol-lowering market is still worth US$29 billion. And IMS have just released figures for the most prescribed drugs in the USA.

Between July 2013 and June 2014 more than 22.5 million prescriptions were written for CRESTOR, generating US$5.6 billion for AstraZeneca in one year. 

I have commented on CRESTOR before, but this issue is so important, it can’t be mentioned too much.

Crestor has become so popular, because of the JUPITER trial. The results of the JUPITER trial are summarised below in the video excerpt from $TATIN NATION. 

An honest assessment of the published trial data shows that Crestor did not provide any meaningful benefit. That's before we even start to look at the adverse effects of Crestor, which included an increase in the risk for type 2 diabetes. However, the situation is even worse than we think.

An article published in the Archives of Internal Medicine in 2010 questioned the validity of the data from the JUPITER trial and raised concerns about the role of the company sponsoring the trial. Another article published in the journal Cardiology in 2011 raised similar concerns . 

The leading question is, what the hell happened to evidence based medicine?

For more on this, please see the MedScape article 

References: 

Ridker, PM et al, for the JUPITER Study Group. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med 2008; 359:2195-207.

de Lorgeril, M et al. Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy. A critical reappraisal. Arch Intern Med. 2010; 170:1032-1036.

Serebruany, VL. Extreme all-cause mortality in JUPITER requires reexamination of vital records. Cardiology. 2011; 120:84-8

Breast Cancer Issue - What Your Doctor Doesn’t Know Might Kill You

Many people would have seen the recent media reports claiming that high cholesterol is a risk factor for breast cancer. The suggestion being that statins could be used to prevent breast cancer in the future.

What Dr Potluri of the University of Aston, who did the study,  doesn’t know is that researchers from the USA have already studied the effect that statins have on breast cancer.

Researchers from the Fred Hutchinson Cancer Research Center in Washington found that statin use was associated with more than double the risk for breast cancer (both invasive ductal carcinoma and invasive lobular carcinoma).

Nowhere in the media reports was this mentioned. Not even the spokesperson for Breast Cancer Campaign seemed to know about this.

Also, Potluri’s ‘study’ is not published anywhere! It was simply presented at a cardiology conference. So we have no idea what data he analysed or how it was analysed. We know that he used a cholesterol level above 200mg/dl as being high, but we also know that most women in the UK naturally have a cholesterol level above this number anyway and this is perfectly normal for UK women. In any case, what is a cardiologist doing looking at breast cancer data, and presenting this data at a cardiology conference? Surely, he is just fishing for research money.

Dr Potluri is a complete disgrace to his profession and the general public deserve better integrity from the media.

Reference:

Long-Term Statin Use and Risk of Ductal and Lobular Breast Cancer among Women 55 to 74 Years of Age Cancer Epidemiol Biomarkers Prev; 22(9); 1529–37. 2013 

$TATIN NATION II - First Intro Clip

Towards the end of last year, new cholesterol guidelines were introduced in the US. These guidelines have been shown to be based on flawed ‘evidence’, yet are set to double the number of people who take statin medications. 

This issue was covered fairly extensively at the time, however, it is important to keep in mind that despite the criticisms, and the flaws, the guidelines are still being forced through. Doctors will have little choice but to follow them, and millions more people will be exposed to the serious adverse effects of statins.

This video clip includes comments from Dr Malcolm Kendrick, who you probably know already, and Mr Sherif Sultan, who is a leading consultant vascular surgeon, based in Ireland. 

To read about Mr Sultan’s credentials, please click here

For Dr Kendrick’s blog, please click here

Mr Sultan’s published critique of statins 

Majority of panelists on controversial new cholesterol guidelines have current or recent ties to drug manufacturers - British Medical Journal article.

To support $TATIN NATION II please click here

70 Million Americans Set to Take a Statin and the Flawed 'Evidence'

The American National Heart, Lung, and Blood Institute (NHLBI), via the American Heart Association and the American College of Cardiology have just announced a radical change to the way that statins will now be prescribed. Despite the apparent prestige of the organisations disseminating the new guidelines, this marks the beginning of another dark chapter in the history of medicine.

As we all know, the guidelines were previously based on arbitrary cholesterol numbers. This focus on getting millions of peoples' cholesterol levels below an arbitrary threshold has caused a great deal of harm. The situation was already horrific. But now, it is set to get much worse.

Now that the cholesterol thresholds have been driven down, the next attempt to convert even more healthy people into patients is to put less emphasis on the cholesterol numbers and just start medicating almost everyone regardless. It might seem like I'm exaggerating, but I'm not.

Both the previous guidelines and the new ones use a risk scoring system to determine a person's eligibility for statin medication. Various scores are put into the calculator such as cholesterol levels, blood pressure, etc., and a magic number pops out of the algorithm that is supposed to represent a person's risk for having a cardiovascular problem of some kind in the next 10 years.

This model is of course completely flawed. It is based on not only commercial interests but also academic arrogance. The idea that we can precisely determine an individual person's risk with a few selected parameters is nonsense – especially when these parameters ignore many other factors that are known to be major contributors to heart disease. 

So, after the announcement, I downloaded the risk calculator and tried it out for myself. I entered different values for the different parameters, however, each time I changed the values a really unexpected risk score was given as the result, and in some cases I radically changed the values and this wasn't reflected in the risk score at all. In the end I gave up with it, thinking that there must be something wrong with my version of microsoft excel or something. Then, just before posting this blog entry I went back to the website and found this message:

It seems that I wasn't the only person having problems with it! However, putting this huge issue to one side, and assuming the largest health authorities in the world can eventually fix the spreadsheet,  the other major problem is the lowering of the risk threshold that is now going to be used.

Previously,  anyone who comes out of the algorithm with a 10 year risk of 20% or more was considered eligible for statin medication. Now, with the new guidelines, you only need to have a 10 year risk of 7.5% or more in order to get a statin. In fact, in the report detailing the guidelines, the expert panel even suggest that people below the 7.5% risk level could also be eligible for statins. 

There have also been some changes to the way that the calculation itself is done. All things considered, it is probably fair to say that (once the spreadsheet is fixed) the new guidelines double the number of people who are eligible for statin medications. 

According to the BBC, Dr George Mensah, of the American Heart Association, told the Associated Press news agency that the guidelines were based on solid evidence.

Considering the fact that statins do not extend life expectancy when used for prevention it is pretty impossible to believe Dr Mensah. 

We already know that the previous guidelines have led to the mass over-prescription of statins for people who, all the clinical data shows, will not benefit. If this was not bad enough, the harm that has been caused is now set to double. And this is thoroughly disgusting.  

So what evidence is Dr Mensah referring to? In the report, the expert committee state the following:

“the Cochrane meta-analysis, as well as a meta-analysis by the Cholesterol Treatment Trialists , confirms that primary prevention with statins reduces total mortality”

A closer examination of the data from the most recent Cochrane review was completed by Dr Uffe Ravnskov earlier this year. Dr Ravnskov stated:

“without statins your chance to be alive after a few years without treatment is 94.8 %, but if you take a statin every day you can increase your chance to 95.6. ... In the control group 5.17 % had died, and in the treatment group 4.41% - a difference of 0.76 %”

In addition, a previous Cochrane meta-analysis did not support the use of statins for prevention. The researchers stated the potential benefit was so small that it could have been down to chance. In this previous Cochrane meta-analysis they also highlighted the fact that around half of the clinical trials they included did not report on the adverse effects of the statin. 

The other piece of 'evidence' that is quoted in the report (the Cholesterol Treatment Trialists Study) is even less convincing. The researchers in this case did not publish the data for total mortality in the main report – in order to see that data you have to look in the supplementary appendix.

The table below is copied from the supplementary appendix published alongside the main trial report. It is immediately obvious why the researchers chose not to make a song and dance about these results. Since it is clear that the statin only reduced the risk of dying from any cause by 0.07%.

And what about all of the other studies that have shown statins have no impact on life expectancy? Such as the meta-analysis completed by Professor Kausik Ray, published in the Archives of Internal Medicine.

Even if we can trust all of the data currently published by the drugs companies about their own products, the absolute best case scenario is that statins (when used for prevention) have considerably less than a 1% benefit and a 20% risk of significant adverse effects. 

When considering the adverse effects of statins, the expert panel should also have been aware of the more than 300 adverse effects of statins that have now been documented. As reported by GreenMedInfo.com after an extensive review of the medical literature. 

This Pretty Much Sums Up the Broken Medical System

The cholesterol-lowering medication Crestor (rosuvastatin) was the most prescribed medication in the United States during the last 12 months. As reported by Medscape Medical News in response to research completed by IMS Health.

Crestor topped the list of the most prescribed medications, with 23.7 million prescriptions. In terms of sales, Crestor was 5th on the list with total sales of 5.3 billion USD. 

One of the reasons why Crestor has become so popular, is the JUPITER trial. In 2008, pharmaceutical companies and much of the world's media trumpeted the results of the JUPITER trial, which involved the use of Crestor for people with elevated levels of C-reactive Protein (a marker of systemic inflammation).

The results of the JUPITER trial are summarised below in the video excerpt from $TATIN NATION. An honest assessment of the published trial data shows that Crestor did not provide any meaningful benefit. That's before we even start to look at the adverse effects of Crestor, which included an increase in the risk for type 2 diabetes. However, the situation is even worse than we think.

An article published in the Archives of Internal Medicine in 2010 questioned the validity of the data from the JUPITER trial and raised concerns about the role of the company sponsoring the trial. Another article published in the journal Cardiology in 2011 raised similar concerns . Unfortunately, these critical papers were not given the same prominence within the medical journals as was given to the JUPITER trial results and were not mentioned in the mainstream media at all.

So, we have a situation where the most prescribed medication in the United States is causing more harm than good, and is being prescribed on heavily spun, highly questionable data. The questioning of the trial data has been ignored and millions of people just keep taking the medication.  

References: 

Ridker, PM et al, for the JUPITER Study Group. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med 2008; 359:2195-207.

de Lorgeril, M et al. Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy. A critical reappraisal. Arch Intern Med. 2010; 170:1032-1036.

Serebruany, VL. Extreme all-cause mortality in JUPITER requires reexamination of vital records. Cardiology. 2011; 120:84-