More Evidence Statins Are Harming Millions

Two new studies have shown that statins impair the immune system. One study (from Cincinnati Children’s Hospital Medical Center) found that statins impair the immune response (1). And another study (from Emory University) found that statins can block the ‘effectiveness’ of the flu vaccine in the elderly (2). 

Of course, as always, the 'experts' are all saying that further research is needed and people should carry on taking their statins. However, they are conveniently ignoring the other data confirming that low cholesterol is bad for the immune system.

Back in 1997, researchers in the Netherlands published an article in the Lancet showing that in the case of the elderly, those with the highest cholesterol are best protected from cancer and infections (3). 

Other research, led by the University of California, has confirmed that derivatives of cholesterol play an important role in the immune system and could protect humans from a wide range of viruses, such as: Ebola, Rift Valley Fever, Nipah, and other deadly pathogens (4).


When the immune system is first exposed to a new pathogen, it develops (through the production of memory cells) the ability to recognise the invader when it next enters the body. This ‘memory’ of the immune system is provided by a clustering of T-cell receptors and cholesterol plays a key part in this process.

Therefore, is it really a surprise to find that the immune system and vaccines are impaired in those who take statins? 

 

References:

  1. Influence of Statins on Influenza Vaccine Response in Elderly Individuals
  2. Impact of Statins on Influenza Vaccine Effectiveness Against Medically Attended Acute Respiratory Illness
  3. Total cholesterol and risk of mortality in the oldest old.
  4. Interferon-Inducible Cholesterol-25-Hydroxylase Broadly Inhibits Viral Entry by Production of 25-Hydroxycholesterol

http://www.eurekalert.org/pub_releases/2015-10/idso-srq102715.php

 

Extended Interview - Professor Shah Ebrahim

Professor Ebrahim is one of the authors of the highly influential Cochrane review of statins. Followers of the statins saga will already be aware that the Cochrane group radically changed their opinion of statins between the first review in 2011 and the second review in 2013.

This video is almost one hour long, sorry, I did wonder if I should split it into three videos to make it more digestible. However, I think the video is useful in appreciating the mindset of those who dogmatically support mass statin use. In my mind, the striking features of the interview are:

  1. Support for Ancel Keys work, which is now widely known to have been fraudulent.
  2. A complete disregard for any suggestion that statins might be harmful in any way, despite the fact that Cochrane themselves admitted a serve lack of data on the adverse effects of statins.
  3. Complete refusal to accept that the ‘benefits’ of statins have been exaggerated - associated with this is the opinion that it is OK to use relative percentages, which we know only serve to mislead people.
  4. Complete refusal to accept that the huge commercial influences may be a problem.

By the way, for just one of the many examples why the commercial interests are a problem, please see this other video here, which features a former editor of the New England Journal of Medicine.

Former Editor of Major Journal Exposes Statin Conflict of Interest

Jerome P. Kassirer M.D., distinguished professor and former editor of one of the world's biggest medical journals discusses conflict of interest in statin guidelines.

At the same time, a Canadian group did an analysis on the same data and came up with the opposite conclusion (that statins are not beneficial in primary prevention) - the Canadian group had no ties with the pharmaceutical companies.

Since these guidelines were introduced there have been several updates - each time, the 'experts' recommended statins for more and more people, and each time the conflicts of interest have remained in place.

Shortly after the publication of his book, Professor Kassirer lost his post at the New England Journal of Medicine. 

Source:

Providence Medical Center

 

 

Professor Sultan Wins Highly Prestigious Award

Professor Sultan, who features in Statin Nation II, has been honoured with yet another award. On Tuesday March 24th he was awarded the Title of Doctor Honoris Causa of the Lucian Blaga University of Sibiu (ULBS) in Romania. 

This is the most prestigious title in the history of ULBS and was awarded to only five other dignitaries in the history of the University.


During the last 18 months Professor Sultan travelled to Romania on three separate occasions to perform complex thoracoabdominal repairs on eight patients with life-threatening aortic pathologies. He has also supported the cardiovascular clinical training programme at Polisano Clinic in Sibiu.

Those who follow the statins and cholesterol issues will be aware of Professor Sultan’s research article that was heavily critical of the widespread use of statins. 

It is time for the medical establishment to sit up and pay attention to pioneering doctors like Professor Sultan, who are moving way beyond the ill-founded cholesterol hypothesis in order to find treatments and innovative techniques that genuinely benefit patients. 

WORLD PREMIERE - STATIN NATION II, London, Saturday 28th February 2015

I am delighted to announce the world premiere of Statin Nation II.

Duration: 75 minutes

Brief Synopsis: The film is in three parts. Part 1 explains how health authorities around the world have continued to ignore the huge amount of data suggesting that saturated fat and cholesterol do not play a causal role in heart disease. Part 2 examines the current system of using risk factors for disease prevention - which of these risk factors are correct, and can a person be reduced to a short list of numbers? Part 3 moves beyond the system currently used and investigates the real causes of heart disease - proposing for the first time, an alternative model for thinking about the disease. 

The film includes interviews with 12 leading experts in this field, and was shot on location in the UK, USA, Denmark, Sweden, France, Lithuania, Australia, Egypt and Japan.

TICKETS: £9.95  per person 

Saturday 28th February 6:00pm to 8:00pm

LOCATION:  

CHARLOTTE STREET HOTEL, CHARLOTTE STREET, LONDON W1T 1RT.


Did Dan Buettner make a Mistake with his Blue Zones?

Dan Buettner is the author of Blue Zones, a book investigating some of the places in the world where people live the longest. Buetter attempts to unlock the secrets of a long healthy life by looking at the nutrition and lifestyles of people from certain parts of Peru, Italy, the United States and Japan.

The book has considerable merit in that it describes in detail many of the lifestyle habits that have been proven to promote longevity. However, Buettner appears to have made a gross error with regards to the nutritional aspects. In particular, I’m referring to his coverage of the Island of Sardinia, Italy.

Pork Dish Typical of Barbagia Region

Pork Dish Typical of Barbagia Region

The Barbagia Region of Sardinia, and Surrounding Area

The Barbagia Region of Sardinia, and Surrounding Area

The island of Sardinia not only has a large number of people who live to be more than 100, but it is also one of the few places in the world were men live as long as women. 

Most regions of Sardinia are associated with incredibly good health, however, the region that has been highlighted as having a particularly long life is called Barbagia. 

I have had the privilege of visiting Sardinia, and several other places associated with longevity, during the filming of Statin Nation II. In Sardinia, I found the traditional diet to be in stark contrast to what Buettner describes. He states:

"It’s loaded with homegrown fruits and vegetables such as zucchini, eggplant, tomatoes, and fava beans that may reduce the risk of heart disease and colon cancer. Also on the table: dairy products such as milk from grass-fed sheep and pecorino cheese, which, like fish, contribute protein and omega-3 fatty acids. "

Unfortunately, this common myth about the traditional Sardinian diet has been copied by various websites and commentators. 

The cheese part is certainly correct. However, the Barbagia region is for the most part, up in the mountains, away from the coast, and traditionally the people who live there do not eat very much fish. Their diet manly consists of meat. Suckling pig being a particular favorite.

In fact, in 2011, Sardinians called for formal recognition of their diet insisting that the secret to a long life can be found in their traditional diet of lamb, roast piglet, milk and cheese”

Sardinian Market

Sardinian Market

I believe the reason why Buettner got it wrong was not because of a deliberate attempt to deceive, but more likely its another example of what happens when we look at the world through the current medical dietary dogma. After all, if you believe that meat and animal fats are bad for you, then by default you wouldn’t list them as contributors to longevity. Which is a shame because people might continue to be misinformed. 

Sardinia, along with many other so called paradoxes will be included in Statin Nation II.

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 

 

Is UK Medicines Licensing Agency a Mouthpiece for Big Pharma?

 

Here in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) have recently issued a position statement on their website about statin medications. This has also now been issued as a press release to the media. This statement reads “...people should continue to take their statins as prescribed because their benefits continue to outweigh the risks of any side effects.”

The MHRA is the government organisation that licenses all medications in the UK - it decides if medications work and if they are safe. During the making of $TATIN NATION, I wanted to ask the MHRA about the scientific basis for the use of statins as ‘prevention’. Since none of the clinical trials have shown any life extension when used in primary prevention. However, the MHRA declined my invitation.

This new statement from the MHRA again makes the claim that “statins can save lives”. Therefore, on Tuesday this week I again requested an interview with them. The MHRA replied by asking for more information about the film - which I provided. After that, the line of communication went cold.

It is important to note that although the MHRA is a government organisation, it is not funded by tax payers - the regulation of medications part of the MHRA is funded by the pharmaceutical industry. This can be seen in the FAQs on their website. I think that people should be aware that the organisation that licenses medications in the UK is funded by the pharmaceutical industry. This obvious conflict of interest should be placed at the end of every statement that they publish.

The publication of the MHRA’s press release was prompted by recent media coverage about statin adverse effects and the now famous BMJ article

The BMJ article was placed in the line of fire by Professor Collins of the pharmaceutical industry funded Oxford group. Professor Collins said the BMJ article exaggerated statin adverse effects. A lot has been written about the BMJ article on the web, however, I feel one additional point is of note that has been missed concerning statins and muscle damage.

A study published in the Journal of the American College of Cardiology found that statins block the adaptive response to exercise. 

When we exercise, we stimulate various physiological changes that make our cardiovascular system more efficient - this is one of the main reasons why exercise is a powerful prevention tool for many diseases. However, it has been shown that this adaptation is blocked in people who take statins. In short, statins prevent us from benefiting from exercise. This is just one of the many things that Professor Collins and the MHRA do not want you to know about.


$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

It's Not Just Adults that will be Over-Medicated

During the last few days, people within the medical community, the media, and the general public have been astonished to find the level of incompetence associated with the release of the new cholesterol guidelines. It's ironic that we are still referring to them as cholesterol guidelines; the previous approach of 'know your numbers' has now been conveniently changed to 'ignore your numbers'. Which seems to be an attempt to try and put as many adults on statins as possible. It has now been widely reported that the risk calculator (even when it is working correctly) will over-estimate risk and will result in even more over-prescription of statins.

At the same time that this has been taking place, there has been a quieter, perhaps even more alarming development. Whilst the highly complex but considerably flawed algorithm is about to be rolled out on adults, the childhood obesity problem is being used as an excuse to monitor the cholesterol levels of children. We can now see how this is playing out.

Back in 2008, the American Academy of Paediatrics called for the screening of cholesterol levels in children. Reports at the time, referred to children as young as eight being put on statin medications.

Then, in 2011, the National Heart Lung and Blood Institute (NHLBI) released new guidelines that were endorsed by the American Academy of Paediatrics. These recommended universal screening of  9 to 11-year-old children and targeted screening of some subgroups. Yes, another 'expert panel' dictating to doctors. 

Not only do these recommendations directly influence how doctors prescribe medications, but the idea also pervades everyone else's consciousness. In particular, we should be concerned about allied health professionals and others who may unintentionally do the wrong thing.

A case in point is the recent announcement that schools in Nixa, Missouri. after receiving part of a $41,916 grant, will now be able to perform cholesterol screenings on 5th graders.

The cholesterol tests will be done under the Cardiac Kids Program, which is put on by CoxHealth and Kohl’s CARDIAC Kids.

Some parts of this program will be beneficial in terms of exercise and healthier eating. Hopefully it will help to reduce the amount of processed food and sugar in the children's diets'. But monitoring, and possibly lowering cholesterol levels from such a young age would cause considerable harm. Since cholesterol is used for:

  • the repair of damaged tissues
  • a large proportion of the membrane of every cell within the body
  • the raw material to make Vitamin D
  • the raw material to make all of the steroidal hormones, such as pregnenolone, progesterone, testosterone. oestrogen, and cortisol
  • bile acids to digest fats
  • key cellular signalling mechanisms (the “intelligence” of the cell)
  • the immune system
  • the production of new neurons in the developing brain – the highest concentration of cholesterol in the body is found in the brain and the nervous system

There is no indication that the Cardiac Kids Program is funded in anyway by pharmaceutical companies, however, because of the misinformation about cholesterol well meaning people end up doing big pharma's work for them.

Here is the news clip from the local news channel reporting the Cardiac Kids Program

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

aha123.jpg

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.

riskcalc.jpg

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:

AHAwebsite.jpg

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%.

CCTdata.jpg

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

Screen Shot 2013-11-09 at 12.48.54.png

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; 120:84-8