Niacin is/was/will always be the Good One - Penberthy

Laropiprant is the Bad One; Niacin is/was/will always be the Good One

by W. Todd Penberthy, PhD

(OMNS July 25, 2014) Niacin has been used for over 60 years in tens of thousands of patients with tremendously favorable therapeutic benefit (Carlson 2005). In the first-person NY Times best seller, "8 Weeks to a Cure for Cholesterol," the author describes his journey from being a walking heart attack time bomb to a becoming a healthy individual. He hails high-dose niacin as the one treatment that did more to correct his poor lipid profile than any other (Kowalski 2001). Many clinical studies have shown that high doses of niacin (3,000-5,000 mg plain old immediate release niacin taken in divided doses spread out over the course of a day) cause dramatic reductions in total mortality in patients that experienced previous strokes (Creider 2012). High dose niacin has also been clinically proven to provide positive transformational relief to many schizophrenics in studies involving administration of immediate release niacin in multi-thousand-milligram quantities to greater than 10,000 patients (Hoffer 1964; Osmond 1962). Most importantly, after 60 years of use the safety profile for niacin (especially immediate release niacin) remains far safer than the safest drug (Guyton 2007).

Bad Reporting

So why has the media suddenly presented the following niacin alarmist headlines in response to the most recent study in the New England Journal of Medicine?

"Niacin drug causes serious side effects, study says" - Boston Globe, 7/16/14

"Niacin safety, effectiveness questioned in new heart study" - Healthday News, 7/17/14

"Doctors say cholesterol drug risky to take" - Times Daily, 7/16/14

"Niacin risks may present health risks claim scientists" - Viral Global News, 7/17/14

"Studies reveal new niacin risks" - Drug Discovery and Development, 7/17/14

"No love for niacin" - Medpage Today, 7/17/14

"Niacin could be more harmful than helpful" - Telemanagement, 7/18/14

The truth of the matter is that the study quoted and used laropiprant (trade names: Cordaptive and Tredaptive). Laropiprant is a questionable drug and the results say next to nothing about niacin. The study compared over 25,000 patients treated with either niacin along with laropiprant, or placebo. The patients in this study had previous history of myocardial infarction, cerebrovascular disease, peripheral arterial disease, or diabetes mellitus with evidence of symptomatic coronary disease. The side effects observed in those who took the laropiprant-niacin combination were serious and included an increase in total mortality as well as significant increases in the risk for developing diabetes.

For responsible reporters, this should have raised the question of which compound, the drug laropiprant, or the vitamin niacin, is the culprit.

Such side effects have not been seen in over 10 major clinical trials of niacin involving tens of thousands of patients, not in over 60 years of regular usage of niacin in clinics across the country. However, niacin causes a warm flush on the skin. Some people find the warm niacin flush uncomfortable, although many people enjoy this temporary sensation. In this study, niacin was given in combination with laropiprant, a drug that prevents the niacin flush. By including a dose of laropiprant along with the niacin to eliminate the flush, the thought was that more patients could benefit from niacin without complaint. But in fact the niacin flush is healthy. A reduced flush response to niacin is a diagnostic for increased incidence of schizophrenia, and this assay is now widely available (Horrobin 1980; Messamore, 2003; Liu 2007; Smesny, 2007).

Problems with Laropiprant

So what about the other half of the combo, the drug laropiprant?

• Laropiprant has never been approved by the FDA for use in the USA and when taken alone has been shown to increase gastrointestinal bleeding. *
• Laropiprant interferes with a basic prostaglandin receptor pathway that is important for good health.
• Last year Merck announced it would withdraw laropiprant worldwide due to complaints from continental Europe. Therefore the clinical trials in this most recent study could only be performed in the UK, Scandinavia, and China.

So why did so many media outlets and even some MDs conclude that niacin was the problem? Simple: none of the headlines mentioned laropiprant, which is quite clearly the real culprit that caused the side effects reported. The simplest way to put it is to say that sensational stories promulgated by the media are quite often completely wrong. This suggests a hidden agenda.

Confusing and fantastical headlines can increase readership for hysteria-based business models. Which headline is likely to garner the greatest attention: "Laropiprant is a Dangerous Medication that has Not Been Approved by the FDA" or "Niacin Causes Serious Side Effects"? The correct headline would be, "Niacin doesn't cause serious side effects; drugs do."

Why the B Vitamins Are So Important

The B vitamins were discovered due to terrible nutritional epidemics: pellagra (niacin/vitamin B3 deficiency) and beriberi (thiamine/vitamin B1 deficiency). We are very sensitive to a deficiency of niacin. Over 100,000 people died in the American south in the first two decades of the 20th century due to a lack of niacin in their diet. It was perhaps the worst nutritional epidemic ever observed in modern times, and was a ghastly testimony to how vulnerable the human animal is to niacin deficiency. The pellagra and beriberi epidemics took off shortly after the introduction of processed foods such as white rice and white flour. Poor diets, mental and physical stresses, and certain disease conditions have all been proven to actively deplete nicotinamide adenine dinucleotide (NAD) levels, causing patients to respond favorably to greater than average niacin dosing.

How is it possible that niacin can be useful for many different conditions? It seems too good to be true. The reason is that niacin is necessary for more biochemical reactions than any other vitamin-derived molecule: over 450 different gene-encoded enzymatic reactions (UniproKB database of the Swiss Institute of Bioinformatics; (Penberthy 2013)). That is more reactions than any other vitamin-derived co-factor! Niacin is involved in just about every major biochemical pathway. Some individuals, who have a genetically encoded amino acid polymorphism within the NAD binding domain of an enzyme protein, will have a lower binding affinity for NAD that can only be treated by administering higher amounts of niacin to make the amount of NAD required for normal health. Genetic differences such as these are why many individuals require higher amounts of niacin in order for their enzymes to function correctly (Ames 2002).

It is a deadly shame that the media so often ignores this information. Fortunately, many physicians will see through the recent headlines that give misinformation about niacin, having already personally witnessed how effective high dose niacin therapy is for preventing cardiovascular disease.

Nutrients are the Solution, Not the Problem

So what is the solution? At the end of the day the data on patients with problem cholesterol/LDL levels still support 3,000-5,000 milligrams of immediate-release niacin as the best clinically-proven approach to maintaining a healthy lipid profile. Niacin in 250mg to 1000mg doses can be purchased inexpensively from many sources. Extended-release niacin is the form of niacin that is most frequently sold by prescription, but it has more side effects than immediate release (plain old) niacin. . . and it costs much more.

Tangential to niacin but pointed to cardiovascular disease, conventional medicine is finally beginning to respect chelation therapy as an approach owing to the recent unparalleled positive clinical results for cardiovascular disease patients with diabetes - up to 50% prevention of recurrent heart attacks and 43% reduction in death rate from all causes (Avila 2014). Some times chelation therapy can be expensive. However, there are other inexpensive approaches include high dose IP6 therapy that are yet to be conventionally appreciated. Other supplements desirable for any ideal cardiovascular disease: a nutritional regimen include additional vitamin C, magnesium, coenzyme Q, fat soluble vitamins (A, D, E, and K2), and grass-fed organic butter. Your ideal intake varies with your individuality.

Nutrients such as niacin you need. Media misinformation you don't.

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FDA Approves Dangerous and Worthless Cholesterol Drug - Brownstein

FDA Approves Dangerous and Worthless Cholesterol Drug

by Dr. David Brownstein

On May 3, 2013, the FDA approved a Big Pharma Cartel founding member Merck drug Liptruzet.  Liptruzet is a combination drug of Zetia and Lipitor.  I wrote to you about the failure of Zetia in three separate blog posts.  They can all be found by clicking here:  http://blog.drbrownstein.com/?s=zetia.
Zetia is a failed drug.  It should never be prescribed and should have been pulled from the market years ago.  There is no excuse for any doctor prescribing Zetia for any condition.  Zetia works by blocking cholesterol absorption in the gut.  Conventional doctors believe that drug therapies that lower cholesterol levels reduce the risk of heart disease.  However, Zetia, which has been around for over 10 years, has never been shown to lower the risk of developing a heart attack or stroke.  Furthermore, Zetia has never been shown to prolong life.

Why the FDA would approve this combination of Zetia and Lipitor is beyond belief.  The previous combination of Zetia and Zocor, known as Vytorin, was proven to be a colossal failure in multiple studies—see my previous blog posts.

FDA’s action is a perfect example of why we spend more money on health care than any other people on the planet.  Liptruzet will cost $5.50 per pill.  This means a patient prescribed Liptruzet will spend over $2,000.00 per year on a worthless drug that will be associated with side effects such as muscle aches and pains, memory loss, and neurological disorders.  We take too many ineffective drugs that are too expensive.  Do all of these drugs translate into better healthcare outcomes?  Heck no.  As compared to every other wealthy Western country, we finish last or near the bottom on every single health indicator.  In Liptruzet’s case, there is no justifiable reason for the FDA to approve it.  This is another example, amongst many, of why the FDA should be disbanded.  The FDA gives false credibility to Big Pharma.

If you are on Zetia, I suggest talking to your doctor about stopping it.  Ask him/her for any studies showing a clinical benefit such as a significantly lowered risk for heart disease, heart attack, stroke, or increased longevity.  I can assure you that you won’t be getting any articles from your doctor since they don’t exist.   More information about cholesterol-lowering medications can be found in my book, Drugs That Don’t Work and Natural Therapies That Do. 
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Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin

Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In Italy

   

 

In response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck Merck. The cholesterol-lowering drug has been the subject of fierce controversy because it has never been shown to improve clinical outcomes. Despite the controversy, in 2013 the drugs had combined sales of more than $2.6 billion.
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Who shall guard the guardians? - Dr. Malcolm Kendrick

Who shall guard the guardians?

  

Mainstream medicine increasingly relies on Guidelines. Well, they are called guidelines, but increasingly they carry the force of law. In many countries if you try to practice outside the wise and infallible guidelines you may lose your license to practice medicine. In the US, you may well be dragged into court, and if you have not been following the guidelines, you will be sued. You can even be gaoled (or jailed, as we say in the UK).

In short, guidelines are very serious and important things indeed, and they now rule medicine with a rod of steel. In the UK up to 50% of general practice time is spend ensuring that all patients are constantly monitored to ensure that various guidelines are rigorously followed. Is the BP low enough, the cholesterol low enough, have you checked blood sugar levels etc.

But where do guidelines come from – exactly? Who gives people the right to sit on guideline committees? What are the entrance requirements? Who shall guard the guideliners?

The answer is, perhaps shockingly, that there are almost no rules to this. If a group, such as the National Institutes for Health in the US, decides to set up a committee to decide on, for example, what is the healthy level for cholesterol lowering, what happens? They ask a number of Key Opinion Leaders to join the committee. In this case the NCEP (National Cholesterol Education Programme – which is a committee, not a programme).

In 2004 this committee decided that cholesterol levels should be lowered far more aggressively than in the past. Based on, as far as I could see, very flimsy evidence.  Could it be that that committee was, in some way, biased in favour of cholesterol lowering companies?  A number of people, including me, demanded to see if any of the eight invited members of this hugely important committee had financial conflicts.

With much reluctance, the conflicts were revealed (I have highlighted, in bold, the companies who marketed cholesterol lowering agents at the time.) See below

ATP III Update 2004:  Financial Disclosure of NCEP members
Dr. Cleeman: (Chairman) has no financial relationships to disclose.
Dr. Grundy: has received honoraria from Merck, Pfizer, Sankyo, Bayer, Merck/Schering-Plough, Kos, Abbott, Bristol-Myers Squibb, and AstraZeneca; he has received research grants from Merck, Abbott, and Glaxo Smith Kline.
Dr. Bairey Merz: has received lecture honoraria from Pfizer, Merck, and Kos; she has served as a consultant for Pfizer, Bayer, and EHC (Merck); she has received unrestricted institutional grants for Continuing Medical Education from Pfizer, Procter & Gamble, Novartis, Wyeth, AstraZeneca, and Bristol-Myers Squibb Medical Imaging; she has received a research grant from Merck; she has stock in Boston Scientific, IVAX, Eli Lilly, Medtronic, Johnson & Johnson, SCIPIE Insurance, ATS Medical, and Biosite.
Dr. Brewer: has received honoraria from AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Esperion, and Novartis; he has served as a consultant for AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Sankyo, and Novartis.
Dr. Clark: has received honoraria for educational presentations from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; he has received grant/research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer.
Dr. Hunninghake: has received honoraria for consulting and speakers bureau from AstraZeneca, Merck, Merck/Schering-Plough, and Pfizer, and for consulting from Kos; he has received research grants from AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, and Pfizer.
Dr. Pasternak: has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/Schering-Plough, Sanofi, Pfizer Health Solutions, Johnson & Johnson-Merck, and AstraZeneca.
Dr. Smith: has received institutional research support from Merck; he has stock in Medtronic and Johnson & Johnson.
Dr. Stone: has received honoraria for educational lectures from Abbott, AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, Pfizer, Reliant, and Sankyo; he has served as a consultant for Abbott, Merck, Merck/Schering-Plough, Pfizer, and Reliant.

http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04_disclose.htm

Of course, as people have stated to me, the mere fact that there were seventy two financial conflicts of interest does not mean that the guidelines themselves were biased. But you know what, I don’t believe it. Imagine if eight Supreme Court judges, ruling on any issue, had seventy two direct financial conflicts of interest to do with that issue…..Well, the outcry would never end.

Yet doctors, it seems, are beyond any suspicion – of any sort. There is not the slightest possibility that any doctor would ever do anything wrong….We are, after all, superior beings. ‘But, what’s that you say skippy…. hold on.’

‘Despite a 2-year-old scandal discrediting key evidence, current guidelines relying on this evidence have not been revised. As a result of physicians following these guidelines, some researchers say, it is possible that thousands of patients may have died each year in the UK alone. It is unlikely that a true understanding of the damage will ever be known…..

The guidelines, which were published in 2009, were based on analyses of the available trials. The strongest evidence came from the DECREASE family of trials, which appeared to strongly support perioperative beta-blockade, and one other large trial, POISE, which raised concerns that beta-blockers might lead to an increase in deaths

In 2011, however, faith in the reliability of the DECREASE trials was shattered as a result of a scientific misconduct scandal centering on the principal investigator of the studies, the now disgraced Dutch researcher Don Poldermans. The issue was further complicated because, in addition to his key role in the trials, Poldermans was the chairman of the committee that drafted the guidelines.

’ http://cardiobrief.org/2013/07/31/european-heart-guidelines-based-on-disgraced-research-may-have-caused-thousands-of-deaths/

Oh well, maybe not.

The fact is that, wherever you look, guidelines are being developed by doctors who have widespread conflicts of interest. And if you go a step further back to review the studies that the guidelines are based on, they are run by, and written up by, doctors who have enormous conflicts of interest. Although sometimes, these conflicts are just…well, forgotten about.

For example, a few opinion leader were ‘named and shamed’ by the Journal of the American Medical Association, when someone pointed out that a number of the authors of the original paper they wrote might just have slipped up in declaring their conflicts:

Unreported Financial Disclosures in: ‘Association of LDL Cholesterol, Non–HDL Cholesterol, and Apolipoprotein B Levels With Risk of Cardiovascular Events Among Patients Treated With Statins: A Meta-analysis.’

 

….the following disclosures should have been reported:

 

 “Dr Mora reports receipt of travel accommodations/meeting expenses from Pfizer; Dr Durrington reports provision of consulting services to Hoffman-La Roche, delivering lectures or serving on the speakers bureau for Pfizer, and receipt of royalties from Hodder Arnold Health Press; Dr Hitman reports receipt of lecture fees and travel expenses from Pfizer, provision of consulting services on advisory panels to GlaxoSmithKline, Merck Sharp & Dohme, Eli Lilly, and Novo Nordisk, receipt of a grant from Eli Lilly, and delivering lectures or serving on the speakers bureau for GlaxoSmithKline, Takeda, and Merck Sharp & Dohme; Dr Welch reports receipt of a grant, consulting fees, travel support, payment for writing or manuscript review, and provision of writing assistance, medicines, equipment, or administrative support from Pfizer, and provision of consultancy services to Edwards, MAP, and NuPathe; Dr Demicco reports having stock/stock options with Pfizer; Dr Clearfield reports provision of consulting services on advisory committees to Merck Sharp & Dohme and AstraZeneca; Dr Tonkin reports provision of consulting services to Pfizer, delivering lectures or serving on the speakers bureau for Novartis and Roche, and having stock/stock options with CSL and Sonic Health Care; and Dr Ridker reports board membership with Merck Sharp & Dohme and receipt of a grant or pending grant to his institution from Amgen.

 

http://jama.ama-assn.org/content/307/16/1694.3.full?etoc

 

Not a bad little list.

As you can see, Dr Ridker had board membership with Merck Sharp and Dohme…… a company that has made billions from selling statins. Now, here is he is authoring a paper on the benefit of statins (which will be used to develop guidelines on cholesterol lowering), and he simply forgot about this conflict of interest. As for the others, well, they’re also busy people; things must have just slipped their minds, such as thirty three separate financial conflicts.

For this terrible crime against the integrity of medical science, none of them can ever again do medical research, or author a medical paper, or sit on guideline committees. Cue, mad cackling laughter. As you may expect, absolutely nothing happened at all, apart from the publication of that statement you in the Journal in the American Medical Journal (JAMA).

I am sorry, but the system of developing guidelines is, frankly, bust. It has been for many years, but it is a very big and dangerous looking nettle to grasp, and no-one, currently has the will to do it.

Someone, somewhere, needs to ensure that guidelines, and the evidence they are based on, and the interpretation of that evidence, is of the highest quality – and free from potential bias, and financial conflicts of interest. We are about as far from this happy state of affairs as I am from being invited onto any guideline committee, ever, anywhere.

And that, my friend, is a very, very long way away indeed. You would need to Hubble telescope to see across distances as vast as that.
 

This entry was posted in Dr Malcolm McKendrick on August 2, 2013 by Dr. Malcolm Kendrick.

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Licence for another unproven cholesterol drug - Briffa

The FDA grants licence for another unproven cholesterol drug

By Dr John Briffa on 8 May 2013

 

Ezetimibe is a drug that lowers cholesterol levels by blocking its absorption from the gut. The drug is available under the brand name Zetia. Doctors can also prescribe ezetimibe in combination with the statin drug simvastatin. This combination medication is sold under the name Vytorin. Both Zetia and Vytorin have racked up billions of dollars in sales. What a shame, then, that neither of them has been found to have any benefit at all in terms of reducing the risk of heart disease, heart attacks, strokes or risk of death.

Zetia and Vytorin are licenced on the basis of their impact on cholesterol levels. The thinking is that LDL-cholesterol must be bad, so anything that reduces it must be good. However, we know from experience that many things that ‘improve’ cholesterol do not bring broad benefits to health. And besides, it’s simply not good science or medicine to assume that a drug has benefits for health based on its impact on what is known as a ‘surrogate marker’ such as cholesterol. I mean, if arsenic reduced cholesterol it still would not make sense for us to swig back arsenic each day, would it?

This seems like perhaps an extreme analogy, but it should be borne in mind, I think, the Vytorin use has in some studies been associated with an increase (not statistically significant) in the thickening of the arteries compared to simvastatin alone. Also, there was some early evidence the Vytorin increased the risk of death from cancer, though some more recent evidence is said to have allayed fears here.

While some doctors continue to prescribe Zetia and Vytorin it’s difficult (for me) to justify this. There is some evidence that since 2008 (when we saw the first of a few negative studies on Zetia/Vytorin emerge) sales of these drugs have fallen considerably, though profit remains considerable. Make no mistake, though, the fact that Zeta/Vytorin is still on the market and was licensed in the first place is seen by some doctors and researchers as testament to the ability of drug companies to bamboozle regulatory authorities such as the Food and Drugs Administration (FDA) in the US. Either that, or the FDA is perhaps putting the needs of drug companies above those of patients.

Against this background, it is interesting to note that Merck (manufacturer of Vytorin) has been for some years attempting to get another similar drug combination passed by the FDA. The drug combines ezetimibe with the statin atorvastatin and has the brand name Liptruzet. As with Vytorin, there exists no evidence that Liptruzet benefits so-called ‘clinical’ outcomes such as incidence of heart disease and stroke.

Now, given all the controversy around Vytorin and the lack of evidence for the benefit of this product, you might imagine the FDA would be keen not to repeat its mistake by granting Liptruzet a licence. Astonishingly, though, the FDA did just this last week.

Now, normally, when a new drug hits the market the press reports parrot the drug company rhetoric about, say, the benefits of the drug and the lives it could save. What is interesting about the press reports on the licensing of Liptruzet is how many of them report scepticism regarding the wisdom of this decision expressed by doctors and researchers. See here for an example.

The piece quotes Steven Nissen, chairman of cardiology at the Cleveland Clinic in the US. According to Dr Nissen, the FDA’s decision to approve the Liptruzet “just doesn’t make any sense.” He is quoted as saying:

I find it astonishing that after all the controversy about ezetimibe the FDA would approve another combination product with a drug that has been on the market for a decade and has not been shown to improve cardiovascular outcomes. It seems like the agency is just tone deaf to the concerns raised by many members of the community about approving drugs with surrogate endpoints like cholesterol without evidence of a benefit for the disease we are truly trying to treat – cardiovascular disease.

And what does Merck have to say for itself? According to spokeswoman Pamela Eisele, Merck is “confident in ezetimibe and in the established relationship between lowering LDL cholesterol and reducing cardiovascular events.”

Merck can be confident all it likes in ezetimibe and its products Zetia, Vytorin and Liptruzet, but the fact is, none of these have been shown to lower ‘cardiovascular events’. My personal opinion is that either Merck is full of idiots or is taking us for idiots. The good news is that the sort of rhetoric spouted by Merck is immediately being recognised by some as having a distinct whiff of b.s. about it.
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Doctors criticise plans for cholesterol screening in children

Doctors criticise plans for cholesterol screening in children

Back in November 2011, a panel of experts assembled by the National Heart, Lung and Blood Institute (NHLBI) in the US published recommendations regarding cholesterol screening in children. The panel recommended that all children aged 9-11 should be screened, and that more targeted testing (in those deemed to be at high risk) should be used in 2-8 year-olds and 12-16 year olds.

These recommendations risk making millions of American children into patients with their diagnosis of ‘dyslipidemia’ (disordered blood fat levels). Many may end up on cholesterol-reducing medication, of course, which is not without risk. And what evidence is there that this strategy will reap dividends in the long term?

The problems inherent in the NHLBI panel recommendations were made plain this week in an on-line article penned by three doctor-researchers at the University of California in San Francisco which appeared on-line in the journal Pediatrics [1]. In the piece, the authors draw our attention to the fact that the guidelines are simply a matter of opinion, albeit supposedly ‘expert’ opinion. The fact of the matter is that there has been no proper study which assesses the benefits (or otherwise) of screening children or the recommendations that may come out of this screening.

Not only this, but there has been simply no effort to quantify the costs of such an endeavour. So, in addition to not knowing whether the proposed strategy would even work, we have no idea what it would cost and are therefore unable to determine if it offers value for money (and if that money might be better spent elsewhere).

The authors of the article also draw our attention to the fact that there were significant financial conflicts of interest to be found in the NHLBI panel. The website sciencedaily.com reports here that:

The authors [of the article] note that the panel chair and all members who drafted the lipid screening recommendations disclosed an “extensive assortment of financial relationships with companies making lipid lowering drugs and lipid testing instruments.”  

Some of those relevant relationships include paid consultancies or advisory board memberships with pharmaceuticals that produce cholesterol-lowering drugs such as Merck, Pfizer, Astra Zeneca, Bristol-Myers Squibb, Roche and Sankyo.

“The panel states that they reviewed and graded the evidence objectively,” said Newman [Thomas Newman – one of the authors of the article]. “But a recent Institute of Medicine report recommends that experts with conflicts of interest either be excluded from guideline panels, or, if their expertise is considered essential, should have non-voting, non-leadership, minority roles.”

Evidence is needed to estimate health benefits, risks and costs of these proposed interventions, and experts without conflicts of interest are needed to help synthesize it, according to Newman. He said that “these recommendations fall so far short of this ideal that we hope they will trigger a re-examination of the process by which they were produced.”

Pediatrics also published on-line this week a rebuttal to this article co-written by several of the panel members, including its chairman Dr Stephen Daniels [2]. Here Dr Daniels (who has worked as a consultant or advisory board member for several cholesterol drug manufacturers including Abbott Laboratories, Merck and Schering-Plough) is quoted as saying that he feels industry ties did not influence the debate among panel members. He can say what he likes, but common sense suggests otherwise, as does the distinct lack of rigour in the panel’s recommendations.

In the linked article, the NHLBI’s acting director and the person who convened the panel, Dr Susan Shurin, tells us that there are few qualified specialists which have no industry relationships. This perhaps goes to show just how the effective the industry can be in sewing up an area and ensuring it gets the ‘expert’ opinion it wants.

“We got the best people in the country to do this,” Dr Shurin is quoted as saying. What a shame the ‘best people’ come with so many of conflicts of interest attached, and that their recommendations are set to convert millions of kids into patients despite there being simply no good evidence that this will benefit them or society in general.

References:
1. Newman TB, et al. Overly Aggressive New Guidelines for Lipid Screening in Children: Evidence of a Broken Process. Pediatrics Published online July 23, 2012(
2. McCrindle BW, et al. Guidelines for Lipid Screening in Children and Adolescents: Bringing Evidence to the Debate. Pediatrics Published online July 23, 2012
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Statins for pregnant women and kids? - Kresser

Statins for pregnant women and kids?

One of my favorite researchers, Chris Masterjohn, has just launched a new blog called “The Daily Lipid” where he writes about fats, cholesterol and health. Chris is pursuing a Ph.D. in Molecular and Cell Biology and is one of the most knowledgeable contemporary writers on cardiovascular health that I’m aware of. With his permission, I am cross-posting the first two articles on his blog – which you should definitely consider adding to your blogroll!

Statins for pregnant women?

Statin manufacturers, the sycophantic researchers they pay, and the shameless hucksters who sell them are always up to no good, but their recent attempts to market them to pregnant women are simply horrifying.

According to a recent news article published in Mail online, researchers from liverpool believe that taking statins during pregnancy might help women avoid caesarean sections by promoting more robust uterine contraction. They hope to begin human trials in three to five years.

Somehow, the author of this article failed to react with the shock and horror appropriate to the situation — which should be the same shock and horror with which we would react to the suggestion that pregnant women should take thalidomide to avoid morning sickness.

Back in 2004, a report in the New England Journal of Medicine showed that the use of statins in the first trimester of pregnancy was associated with birth defects, especially severe central nervous system defects and limb deformities. In fact, 20 out of 52 women exposed to statins gave birth to offspring with such defects, which represents a birth defect rate of 38 percent, nearly 20 times the background rate of birth defects!

Even before this report was published, researchers already knew that statins caused birth defects in animal experiments, and the FDA already required the drugs to carry a label warning pregnant women to stay away from them. The article linked to above stated the following:

“FDA took this action because it was recognized that fetal cholesterol synthesis was essential for development, and because animals given statins during pregnancy had offspring with a variety of birth defects,” [one of the study's authors] said.

Less than a year later, Merck and Johnson & Johnson jointly asked the FDA for permission to market an over-the-counter statin. One of the concerns about the proposal was the risk to pregnant women. USA Today reported:

The FDA classifies Mevacor and other statins as pregnancy category X, which means they are not supposed to be taken by pregnant women. Not only have category X drugs been linked to fetal abnormalities in animal or human studies, but the FDA also has declared that the benefits of taking them do not outweigh potential risks.

According to the same article, Merck made a disturbing admission:

“Of course, there will be women who take it off-label,” acknowledges Merck executive Edwin Hemwall, referring to the use of non-prescription Mevacor by women under 55.

And what could prompt women to use statins during pregnancy against recommendations? Certainly a news article declaring that statins might prevent the need for caesarean sections and their associated complications could prompt some women to do so.

So what ground-breaking research made these Liverpool researchers so confident that taking drugs associated with twenty times the normal rate of major birth defects during pregnancy might be a good idea that they put out a press release declaring this confidence to the public before any trials were even under way?

Well, according to the article:

Tests have already shown that raising levels of cholesterol interferes with womb tissue’s ability to contract.

 Really. Raising levels of cholesterol. You might wonder how they accomplished that. Did they use cholesterol-raising drugs? I don’t know of any drugs that do that. Did they use egg yolks, or the dreaded dietary villain — gasp — saturated fats?

No, the story is quite different.

The apparent basis for this ridiculous statin cheerleading is a 2004 study published by researchers from the University of Liverpool in the American Journal of Physiology — Cell Physiology entitled “Increased cholesterol decreases uterine activity: functional effects of cholesterol alteration in pregnant rat myometrium.”

Rather than feeding anything to pregnant women or pregnant rats, the researchers took pregnant rats and killed them. So the first thing we can say is that statins might help you deliver a baby if your doctor kills you first.

Then they extracted the uterine tissue and either extracted cholesterol from it with a chemical solvent called methyl beta-cyclodextrin, or enriched it either with cholesterol mixed with this solvent or with LDL (which they didn’t measure for oxidation prior to use). Then they added drugs to induce contraction under either cholesterol-depleted or cholesterol-enriched conditions, and found that contraction was greater under cholesterol-depleted conditions.

So now we know that — wait, what is it we know?

Well, quite clearly, we don’t know anything that we can have any confidence has any physiological relevance at all. That is, except the fact that statins cause birth defects in animals, and they increase the rate of birth defects in humans by nearly twenty times, primarily by causing severe defects of the central nervous system and limb deformities.

To add to that, we also know that the vast majority of humans conceived with Smith-Lemli-Opitz Syndrome (SLOS), a genetic inability to synthesize enough cholesterol, die of spontaneous abortion in the first 16 weeks of gestation. Those who live long enough to be born suffer from mental retardation, autism, facial and skeletal malformations, visual dysfunctions and failure to thrive.
Statins for pregnant women? I don’t think so.
Article written by Chris Masterjohn

Statins for 8-year old children?

The American Academy of Pediatrics recently announced new recommendations for giving cholesterol-lowering drugs to children as young as eight years old. They also recommend giving low-fat milk to infants as young as one year old.

The New York Times published several articles on this, first announcing the recommendation the day the academy made it, then describing the backlash of saner doctors and other members of the public against it, and finally editorializing that while they were first “appalled” at the recommendation, after reading the report they were more dismayed at the state of our children’s health.

Concerning this frightful state of children’s health, the Times reported the following:

“We are in an epidemic,” said Dr. Jatinder Bhatia, a member of the academy’s nutrition committee who is a professor and chief of neonatology at the Medical College of Georgia in Augusta. “The risk of giving statins at a lower age is less than the benefit you’re going to get out of it.”

Dr. Bhatia said that although there was not “a whole lot” of data on pediatric use of cholesterol-lowering drugs, recent research showed that the drugs were generally safe for children.

An epidemic of what? High cholesterol? Not according to the academy’s report, which states that cholesterol levels in children declined between 1966 and 1994 and stayed the same between 1994 and 2000.

No, we are in an epidemic of obesity. As the Times reported:

But proponents say there is growing evidence that the first signs of heart disease show up in childhood, and with 30 percent of the nation’s children overweight or obese, many doctors fear that a rash of early heart attacks and diabetes is on the horizon as these children grow up.

Is there any evidence that statins lead to weight loss? If there is, I am not aware of it.

The point is immaterial, because the academy doesn’t claim to have any evidence for its position in the first place. For example, its report states the following:

Also, data supporting a particular level of childhood cholesterol that predicts risk of adult CVD do not exist, which makes the prospect of a firm evidence-based recommendation for cholesterol screening for children elusive.

 And further down:

It is difficult to develop an evidence-based approach for the specific age at which pharmacologic treatment should be implemented. . . . It is not known whether there is an age at which development of the atherosclerotic process is accelerated.

In other words, they don’t know what level of cholesterol is risky and at what age it starts posing a risk, but they will nevertheless assume that there is some level that does start to pose a risk at some age and they will thus have to make a guess just what that level and what that age is.

The report discusses evidence that the “metabolic syndrome” and the “recent epidemic of childhood obesity” are tied to the risk of diabetes and heart disease and evidence that even modest weight loss at a level of five to seven percent is sufficient to prevent diabetes. Yet somehow instead of making a recommendation about how to more effectively lose weight the authors derive from this data a much less logical but much more profitable conclusion that 8-year-olds should be put on statins.

As to the recommendation to feed infants low-fat milk, the Times reported the following:

The academy also now recommends giving children low-fat milk after 12 months if a doctor is concerned about future weight problems. Although children need fat for brain development, the group says that because children often consume so much fat, low-fat milk is now appropriate.

This is rather remarkable, because the academy attributed the drop in childhood cholesterol levels to the successes of the anti-fat, anti-cholesterol campaign that began in the 1950s. But now children no longer need milkfat because they are getting plenty of fat. Well which is it? Are they getting more fat now or less fat?

Of course milkfat is also a source of choline, along with liver and egg yolks, which is essential to brain development.

But even this misses the point. Cholesterol is essential to brain development!

One of the first articles I added to my section on the functions of cholesterol was an article entitled “Learning, Your Memory, and Cholesterol.” It discusses the evidence uncovered eight years ago that cholesterol is the limiting factor for the formation of synapses, which are the connections between neurons that allow learning and memory to take place.

Lowering brain levels of cholesterol can be detrimental at any age beacause of this, but the consequences for children — whose brains are still developing at a much more rapid rate — could be much more dire.

No doubt, most researchers and medical doctors mean well and are honestly trying to help our children. But surely someone in these drug companies must know that cholesterol is necessary for brain development, and that cholesterol-lowering drugs reduce mental performance in adults. Surely they must know that if we raise our next generation of children on statins during the critical periods of brain development, we may raise a whole generation with compromised intelligence.

And if that’s the case, are they trying to dumb us down? Sometimes it seems like that’s the case.
Article written by Chris Masterjohn
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Read the complete article here.

Still More Bad News For Statins - Naughton

Still More Bad News For Statins

Posted by Tom Naughton in Bad Medicine

As if we didn’t already know …
A newly-published study highlights one of the nasty side-effects of statins:
The popular cholesterol-lowering drugs known as statins might take a toll on people’s energy levels, a new study suggests.

Researchers say the potential side effect, which has yet to be confirmed by other experiments, is a particular concern for women. They estimate that out of 10 women taking Merck’s Zocor, also called simvastatin, four would have less energy or feel more tired during exercise due to the drug.

Well, that’s the thing: when a drug destroys the mitochondria in your muscles, you tend to feel a bit fatigued while exercising. Doing the same work with a weaker muscle means the muscle will wear out sooner.

As I wrote in a post last year, athletes are particularly quick to notice the loss of strength caused by statins and to stop taking them. No surprise there, since for a professional athlete, a small change in athletic performance can mean the difference between being a millionaire or a has-been. For people whose most strenuous activity is walking from the parking lot to the office doors, the damage could go undetected for a long time.

Dr. Beatrice Golomb, who led the new research, told Reuters Health that many patients experience fatigue after starting on a statin, but that the evidence until now has been limited to observations.
We’ve met Dr. Golomb before. She’s been tracking the effects of statins for years and gave an outstanding (if a bit hard to follow because she speaks so quickly) lecture on how pharmaceutical companies have corrupted medical science that I embedded in a previous post.

Statins are generally thought to be safe drugs, but may cause muscle and joint pain in some patients.
Statins are generally thought to be safe because doctors are generally misinformed about the side effects and don’t generally spot and report them. As I’ve mentioned before, my mom suffered muscle and joint pain on statins. Her doctor never made the connection and (of course) prescribed pain pills to cover the effects.

Dr. Franz Messerli, who runs the hypertension program at St. Luke’s-Roosevelt Hospital in New York and was not involved in the research, said the new findings were concerning and not unexpected given statins’ effect on muscle tissue.

But another expert cautioned that the study had some limitations and said patients shouldn’t stop taking their medication before talking to a doctor.

Gosh yes, talk to your generally misinformed doctor before dumping a medication you don’t need in the first place. That way your doctor can say, “But it makes me feel good about myself when your cholesterol score goes down, so I’d urge you to keep taking the drugs.”

“Fatigue is reversible and not fatal,” Dr. Kausik Ray told Reuters Health by email. “Risks and benefits in absolute terms should be discussed on a case by case basis.”

What the @#$% makes Dr. Ray so sure the fatigue is reversible? According to Dr. Duane Graveline, who has been studying statin side-effects for years, the damage to the mitochondria can be permanent — as it was in his case.

And are we really going to tell people it’s okay to be fatigued for the rest of their lives as long as the effect isn’t fatal?!

“I have good news and bad news, Ms. Smith.”
“What’s the bad news, Doctor?”
“You’ll probably feel tired and sore for the rest of your life.”
“What’s the good news?”
“You can live a long, long time feeling tired and sore.”

Ray, who studies heart disease prevention at St. George’s University of London, added that in his experience fatigue is not a common problem with statins.

My mom’s doctor would probably make the same statement, since she didn’t connect the muscle pain and fatigue to the statins.

But Golomb, of the University of California, San Diego, countered that doctors often fail to make the link between fatigue and statin use in their patients. “Often it doesn’t show up right away so physicians may not recognize the effect,” she told Reuters Health.

Like I said …
Neither Merck nor Bristol-Myers Squibb could provide comments on the findings, which are published in Archives of Internal Medicine.

Don’t be silly. Of course they could provide comment. They chose not to, for obvious reasons.

Studies have found that in people without heart disease the benefits of statins are very small at best. As a result, Golomb said, it’s worth considering potential side effects such as fatigue before taking the drugs.

Yes, pretty please, consider the potential side-effects: muscle damage, joint pain, cognitive impairment, diabetes, liver damage, and loss of sex drive, to name just a few.

Then tell your doctor no, you won’t be taking statins.
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Read the full article by Tom Naughton here.

The truth about statin drugs - Kresser

The truth about statin drugs

Statins have been almost universally hailed as “wonder drugs” by medical authorities around the world. The market for statins was $26 billion in 2005, and sales for Lipitor alone reached $14 billion in 2006. Merck and Bristol Myers-Squib are actively seeking “over-the-counter” (OTC) status for their statin drugs. Statins are prescribed to men and women, children and the elderly, people with heart disease and people without heart disease.

In fact, these drugs have a reputation for being so safe and effective that one UK physician, John Reckless (I’m not kidding – that’s actually his name!) has suggested that we put statins in the water supply.

That’s a bold suggestion, of course, and it begs the question: are statins really as safe and cost effective as mainstream medical authorities claim? The unequivocal answer is no.

Statins don’t increase survival in healthy people

Statins have never been shown to be effective in reducing the risk of death in people with no history of heart disease. No study of statins on this “primary prevention population” has ever shown reduced mortality in healthy men and women with only an elevated serum cholesterol level and no known coronary heart disease. (CMAJ. 2005 Nov 8;173(10):1207; author reply 1210.) In fact, an analysis of large, controlled trials prior to 2000 found that long-term use of statins for primary prevention of CHD produced a 1% greater risk of death over 10 years compared to placebo.

Statins don’t increase survival in women

Despite the fact that around half of the millions of statin prescriptions written each year are handed to female patients, these drugs show no overall mortality benefit regardless of whether they are used for primary prevention (women with no history of heart disease) or secondary prevention (women with pre-existing heart disease). In women without coronary heart disease (CHD), statins fail to lower both CHD and overall mortality, while in women with CHD, statins do lower CHD mortality but increase the risk of death from other causes, leaving overall mortality unchanged. (JAMA study)

Statins don’t increase survival in the elderly

The only statin study dealing exclusively with seniors, the PROSPER trial, found that pravastatin did reduce the incidence of coronary mortality (death from heart disease). However, this decrease was almost entirely negated by a corresponding increase in cancer deaths. As a result, overall mortality between the pravastatin and placebo groups after 3.2 years was nearly identical.

This is a highly significant finding since the rate of heart disease in 65-year old men is ten times higher than it is in 45-year old men. The vast majority of people who die from heart disease are over 65, and there is no evidence that statins are effective in this population.

Do statins work for anyone?

Among people with CHD or considered to be at high risk for CHD, the effect of statins on the incidence of CHD mortality ranges from virtually none (in the ALLHAT trial) to forty-six percent (the LIPS trial). The reduction in total mortality from all causes ranges from none (the ALLHAT trial) to twenty-nine percent (the 4S trial).

However, the use of statins in this population is not without considerable risk. Statins frequently produce muscle weakness, lethargy, liver dysfunction and cognitive disturbances ranging from confusion to transient amnesia. They have produced severe rhabdomyolysis that can lead to life-threatening kidney failure.

Aspirin just as effective as statins (and 20x cheaper!)

Perhaps the final nail in the coffin for statins is that a recent study in the British Medical Journal showed that aspirin is just as effective as statins for treating heart disease in secondary prevention populations – and 20 times more cost effective! Aspirin is also far safer than statins are, with fewer adverse effects, risks and complications.

The bottom line

1. Statin drugs do not reduce the risk of death in 95% of the population, including healthy men with no pre-existing heart disease, women of any age, and the elderly.
2. Statin drugs do reduce mortality for young and middle-aged men with pre-existing heart disease, but the benefit is small and not without significant adverse effects, risks and costs.
3. Aspirin works just as well as statins do for preventing heart disease, and is 20 times more cost effective.

So what if you are at risk for heart disease and you’d prefer not to take a statin? Other than aspirin, there are many clinically proven ways to prevent heart disease involving simple adjustments to diet and lifestyle. In fact, the recent INTERHEART study which looked at the incidence of heart disease in 52 countries revealed that over 90% of heart disease is preventable by diet and lifestyle modifications.

I’ll discuss these natural methods of preventing heart disease in my next post. Stay tuned!

Recommended links

• Dangers of statin drugs: what you haven’t been told about cholesterol-lowering drugs
• The effect of statins is not due to cholesterol lowering

Statins for Pregnant Women???

Statin manufacturers, the sycophantic researchers they pay, and the shameless hucksters who sell them are always up to no good, but their recent attempts to market them to pregnant women are simply horrifying.

According to a recent news article published in Mail online, researchers from liverpool believe that taking statins during pregnancy might help women avoid caesarean sections by promoting more robust uterine contraction. They hope to begin human trials in three to five years.


Somehow, the author of this article failed to react with the shock and horror appropriate to the situation -- which should be the same shock and horror with which we would react to the suggestion that pregnant women should take thalidomide to avoid morning sickness.


Back in 2004, a report in the New England Journal of Medicine showed that the use of statins in the first trimester of pregnancy was associated with birth defects, especially severe central nervous system defects and limb deformities. In fact, 20 out of 52 women exposed to statins gave birth to offspring with such defects, which represents a birth defect rate of 38 percent, nearly 20 times the background rate of birth defects!


Even before this report was published, researchers already knew that statins caused birth defects in animal experiments, and the FDA already required the drugs to carry a label warning pregnant women to stay away from them. The article linked to above stated the following:

"FDA took this action because it was recognized that fetal cholesterol synthesis was essential for development, and because animals given statins during pregnancy had offspring with a variety of birth defects," [one of the study's authors] said.

Less than a year later, Merck and Johnson & Johnson jointly asked the FDA for permission to market an over-the-counter statin. One of the concerns about the proposal was the risk to pregnant women. USA Today reported:

The FDA classifies Mevacor and other statins as pregnancy category X, which means they are not supposed to be taken by pregnant women. Not only have category X drugs been linked to fetal abnormalities in animal or human studies, but the FDA also has declared that the benefits of taking them do not outweigh potential risks.

According to the same article, Merck made a disturbing admission:

"Of course, there will be women who take it off-label," acknowledges Merck executive Edwin Hemwall, referring to the use of non-prescription Mevacor by women under 55.

And what could prompt women to use statins during pregnancy against recommendations? Certainly a news article declaring that statins might prevent the need for caesarean sections and their associated complications could prompt some women to do so.


So what ground-breaking research made these Liverpool researchers so confident that taking drugs associated with twenty times the normal rate of major birth defects during pregnancy might be a good idea that they put out a press release declaring this confidence to the public before any trials were even under way?


Well, according to the article:

Tests have already shown that raising levels of cholesterol interferes with womb tissue's ability to contract.

Really. Raising levels of cholesterol. You might wonder how they accomplished that. Did they use cholesterol-raising drugs? I don't know of any drugs that do that. Did they use egg yolks, or the dreaded dietary villain -- gasp -- saturated fats?


No, the story is quite different.


The apparent basis for this ridiculous statin cheerleading is a 2004 study published by researchers from the University of Liverpool in the American Journal of Physiology -- Cell Physiology entitled "Increased cholesterol decreases uterine activity: functional effects of cholesterol alteration in pregnant rat myometrium."


Rather than feeding anything to pregnant women or pregnant rats, the researchers took pregnant rats and killed them. So the first thing we can say is that statins might help you deliver a baby if your doctor kills you first.


Then they extracted the uterine tissue and either extracted cholesterol from it with a chemical solvent called methyl beta-cyclodextrin, or enriched it either with cholesterol mixed with this solvent or with LDL (which they didn't measure for oxidation prior to use). Then they added drugs to induce contraction under either cholesterol-depleted or cholesterol-enriched conditions, and found that contraction was greater under cholesterol-depleted conditions.


So now we know that -- wait, what is it we know?


Well, quite clearly, we don't know anything that we can have any confidence has any physiological relevance at all. That is, except the fact that statins cause birth defects in animals, and they increase the rate of birth defects in humans by nearly twenty times, primarily by causing severe defects of the central nervous system and limb deformities.


To add to that, we also know that the vast majority of humans conceived with Smith-Lemli-Opitz Syndrome (SLOS), a genetic inability to synthesize enough cholesterol, die of spontaneous abortion in the first 16 weeks of gestation. Those who live long enough to be born suffer from mental retardation, autism, facial and skeletal malformations, visual dysfunctions and failure to thrive.


Statins for pregnant women? I don't think so.

Article written by Chris Masterjohn
http://www.cholesterol-and-health.com/Statins-For-Pregnant-Women.html

Chris Masterjohn, has a blog blog called “The Daily Lipid”.  He writes about fats, cholesterol and health. Chris is pursuing a Ph.D. in Molecular and Cell Biology and is a knowledgeable contemporary writer about cardiovascular health.

Why small LDL particles are the #1 cause of heart disease in the US

Posted on September 15, 2011 by Dr. William Davis

Ask your doctor: What is the #1 cause of heart disease in the US?

Let’s put aside smoking, since it is an eminently modifiable risk and none of those crazies read this blog anyway. What will your doctor say? Most like he or she will respond:

High cholesterol or high LDL cholesterol

Too much saturated fat

Obesity

Pfizer, Merck, AstraZeneca and their kind would be overjoyed to know that they can add your doctor to their eager following.

I’d tell you something different. I would tell you that small LDL particles are, by far and away, the #1 cause for heart disease. I base this claim on several observations:

–Having run over 10,000 lipoprotein panels (mostly NMR) over the past 15 years, it is a rare person who does not have a moderate, if not severe, excess of small LDL particles. 50%, 70%, even 90% or more small LDL particles are not rare. Over the course of a year, the only people who show no small LDL particles are slender, athletic, pre-menopausal females.

–In studies in which lipoproteins have been quantified in people with coronary disease, small LDL particles dominate, just as they do in my office. Here’s a 2006 review.

–Small LDL is largely the province of people who consume carbohydrates, such as the American population instructed to “cut fat and eat more healthy whole grains.” Conventional diet advice has therefore triggered an expllosion in small LDL particles.

–When fasting triglycerides exceed 60 mg/dl, small LDL particles increase as a proportion of total LDL particles. This includes the majority of the US population. (This ignores postprandial, or after-eating, triglycerides, which also contribute to small LDL formation.)

If you were to read the data, however, you might conclude that small LDL affects a minority of people. This is because in most studies small LDL categorize it as either “pattern B,” meaning exceeding some arbitrary threshold of percentage of small LDL particles, versus “pattern A,” meaning falling below that same arbitrary threshold.

Problem: There is no consensus on what percentage of small LDL particles should mark the cutoff between pattern A vs. pattern B. In many studies, for instance, people with 50% small LDL particles are called “pattern A.”

If, instead, we were to set the bar lower to identify this highly atherogenic (atherosclerotic plaque-causing) particle at, say, 20-30% of total, then the number or percentage of people with “pattern B” small LDL particles would go much higher.

I see this play out in my office and in the online program, Track Your Plaque, every day: At the start eating a low-fat, grain-filled diet with lots of visceral fat (“wheat belly”) to start, they add back fat and cut out all wheat and limit carbohydrates. Small LDL particles plummet

 

About Dr. William Davis

Dr. Davis is Medical Director of the Track Your Plaque program and advocate of early heart disease prevention and reversal. He practices preventive cardiology in Milwaukee, Wisconsin.

View all posts by Dr. William Davis →

BMJ Admits Competing Commercial Interests in Wakefield Attacks Warranted Disclosure

This post is not about the primary focus normally evident here but rather the related mis-steps of  scientific journals in their presentation of believable science. Tainted is the word that comes to mind. Thank you Health Impact News Daily (http://healthimpactnews.com) for this news item.
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BMJ Admits Competing Commercial Interests in Wakefield Attacks Warranted Disclosure

BMJ editor admits that they should have disclosed competing commercial interests in Wakefield attack

By John Stone Age of Autism

British Medical Journal’s editor has been forced into an embarrassing admission that the journal should have disclosed connections with MMR manufacturers Merck and GSK when publishing attacks on the integrity of Andrew Wakefield in January  (HERE). Godlee’s admission came eight days after my letter to the journal was submitted, and three days after the publication of my article on Age of Autism (HERE). My letter was occasioned by an article in Age of Autism by Martin J Walker (HERE ) subsequently also published in  Vera Sharav’s AHRP newsletter (HERE).  I had been responding to an article highlighting the issue of free access journals and advertising: BMJ apparently did not think this applied to them.

Godlee’s admission, “We did not declare these competing interests because it did not occur to us to do so”, underlines the complacence, and even arrogance, of large journals that think they are above having interests. Nor will her defence carry much water amid the hotly disputed claims of Brian Deer’s articles that the issue was fraud so who manufactured the products did not matter. BMJ in a breach of the basic traditions of peer review journals have been unwilling to allow their and  Deer’s  allegations to be discussed directly in its columns, many letters to the journal have been blocked, Deer has never been required to respond to criticisms, and the defence of their position has been crudely legalistic (HERE ).

Godlee was also reduced to make a technical defence of the journal decision to publish the Deer articles in Age of Autism (HERE) and BMJ Rapid Responses (HERE).

However, Godlee’s admission represents a major blow against scientific journals, however large, not declaring their commercial interests: the excuse “it did not occur to us” will scarcely wash again.

This is the latest episode in a long running series of battles between Age of Autism and the journal. In February 2010 BMJ were forced to admit that Prof Trisha Greenhalgh had not only contributed to Brian Deer’s website, but had also received £1.4m in Department of Health research grants since 2003 (HERE, HERE ). In March 2010 Age of Autism highlighted the removal by BMJ of a series of letters questioning how Brian Deer obtained confidential material about Royal Free patients and MMR litigants, while in May 2010 the journal refused to acknowledge that Brian Deer was the undisclosed complainant to the GMC against Wakefield and colleagues (HERE), which has been covered by tortuous language in the latest publications, though never acknowledged in the Sunday Times. Age of Autism has also focussed on the role of Harvey Marcovitch who doubles as a BMJ associate editor, co-authoring editorials against Wakefield, and chairman of panels at the GMC (HERE ).

Read the Full Article Here: http://www.ageofautism.com/2011/03/bmj-admits-competing-commercial-interests-in-wakefield-attacks-warranted-disclosure.html

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http://healthimpactnews.com

The Diet Heart Hypothesis was just that - a Hypothesis.... a thought up scheme, never proven.

======================================
Sunday, January 23, 2011 Here Comes Another $$$ Spinner

Seems there is talk in the food industry that the Fat is bad for you hypothesis is about to lie down and die! Can't say I am sorry, should have happened years ago - sorry Ancel Old Chap!

But why now you may ask...... what could possibly bring on such a huge about face? Couldn't possibly have anything to do with the fact that patents on some pharmaceuticals like Lipitor are or have already run out could it?

The Diet Heart Hypothesis was just that - a Hypothesis.... a thought up scheme, never proven. But because it was making so much money for the investors and companies involved, they fought long and hard to get everyman (grin) and his dog on board and popping their pills.

Now the pills will not make them so much money, they have to look for the next BIG blockbuster drug, with its own peculiar methodology and religion ... to drum up fervor and zeal, thereby making gazillions for the companies and their investors.

Watch out folks the fat is bad religion is about to have a HUGE about face! (please note italics are from the actual article)

However the very foundation of this hypothesis was shaken to the core at the AHA annual conference in Chicago in 2010. Amid great excitement, the pharmaceutical giant Merck revealed results of a preliminary safety study for a drug that could usher in a new age for treatment and prevention of heart disease: a cholesterol raising drug! In the safety study lasting 18 months with 1,600 participants, total cholesterol was raised 20% by the drug anacetrapib without any side effects. An efficacy trail of 30,000 participants with several cardiovascular end-points is scheduled to begin in 2011 and end in 2015 to verify if cholesterol raising can reduce actual incidence of heart disease. But the search for cholesterol raising drugs is not new. Most of the cholesterol lowering statin drugs have reached the limits of their heart protective capabilities (and are near the end of their patent lives). For several years drug companies have been quietly searching for the next blockbuster that will be more effective than statins. One class of candidates is cholesterol raising drugs.

Get ready to throw away your Lipitor folks, they will have a new drug to prescribe you in the near future. I can't wait to see how this unfolds, how they will explain away the untold damage they have done to humankind, by insisting we lower our cholesterol numbers, to unhealthy levels.

But haven't we been told over and over to lower our cholesterol, not increase it? Yes, but the cholesterol story has been repeatedly oversimplified. Total cholesterol is made up of 2 major components, good cholesterol (LDL) and bad cholesterol (HDL). So when your doctor tells you to lower your cholesterol, he really means lower your bad cholesterol – if you inadvertently lower your good cholesterol you could increase your risk of heart disease. The statin drugs selectively lower the bad cholesterol without lowering the good – and they work, reducing risk of heart attack by about 30%. The new class of drugs is designed to increase the good cholesterol, without increasing the bad. So in this case increasing cholesterol is a good thing. The scientific community is hoping that the upcoming Merck study will show a further reduction in risk of heart attack similar in magnitude to the statins – a real breakthrough.

As far as I am concerned, that statement above in red (coloured by me) is a barefaced lie, manufactured by the pharmaceutical industry to keep doctors pushing these drugs onto their patients!

Where does this leave the diet heart hypothesis, saturated fat and the simplified "lower your cholesterol" story? It leaves it in deep trouble. The advent of drugs that increase good cholesterol and thereby reduce risk of heart disease (yet to be proven), will force scientists to take another look at the effects of food ingredients on good cholesterol, not just the total and the bad. Applying this new approach could have a significant impact on national dietary recommendations that are designed to reduce risk of heart disease.

Ohhhh I can hardly wait to see the advertising campaign they work up for this new scheme. Hopefully they will turn the Food Pyramid upside down, while at the same time telling us that fats are good for us! I can dream can't I?

A large body of data showing the effect of food ingredients on both good and bad cholesterol has already been generated over the last 40 years. So far, the evaluation of this data has mostly focused on the bad cholesterol, while neglecting or even ignoring data for good cholesterol. But a review of the data for saturated fat gives a very unexpected result. The food component that increases good cholesterol the most is saturated fat! Yes, the same "artery clogging" saturated fat that has been demonized for decades. Although saturated fat still raises bad cholesterol, it appears that it raises good cholesterol by an equivalent amount and the effect of the bad cholesterol is mostly cancelled out. In this scenario saturated fat is expected to have little or no effect on risk of heart disease.

UFFE was right folks. Eat fat and live!

But good and bad cholesterol are components of blood, and not actual disease. What about direct evidence for the effect of saturated fat on incidence of heart disease? Early in 2010 a large human study measuring the link between intake of food components and heart disease was published. The study included over 340,000 people spanning 23 years. Here is what the authors said about saturated fat: "…there is no significant evidence for concluding that dietary saturated fat is associated with an increased risk of CHD or CVD." Or in plain English - saturated fats have no effect on heart disease. Although this statement appears to fly in the face of everything we have been taught for decades, it corresponds exactly with powerful ability of saturated fat to increase good cholesterol. Neglect of the positive effect of saturated fat on good cholesterol has made it look worse that it really is.

A convincing body of evidence already exists that saturated fat is not as bad as once thought. Nevertheless public policy continues to demand further big reductions in saturated fat intake. The 2010 Dietary Guidelines Advisory Committee (DGAC) recommended reducing saturates by 5% of the diet. If this huge reduction was ever implemented, the US dairy and meat industries - the main dietary source of saturated fat - would be severely damaged, and all for nothing. Isn't it time to abandon the failed Diet Heart Hypothesis and focus our resources on issues that really make a difference to public health?

The Diet Heart Hypothesis is DEAD folks..... time we buried it and moved on.... be be very very careful, they will make a pill, another blockbuster drug to raise your HDL folks..... when all you need to do is reduce your carbohydrates, white breads, simple starches, junk foods etc, and go back to eating good health fats again.

I wonder how they will breed the fat back into the food chain? Could it be as simple as feeding cattle on grass, and stopping the hormones?

Above Article from: Food Processing.com
Also worth a read:
The Dirty Little Secret of the Diet-Heart Hypothesis
WHY THE CHOLESTEROL-HEART DISEASE THEORY IS WRONG  Dr. Malcolm Kendrick M.D.

Bad News For Statins Is Good News

Bad News For Statins Is Good News


Posted by Tom Naughton in Bad Medicine
Let’s hope this is the beginning of the end for statins. The so-called wonder drugs have been a cash cow for pharmaceutical companies for decades now, mostly because doctors bought into the idea that high cholesterol causes heart disease, therefore any drug that reduces cholesterol must also reduce heart disease. I’ve lost count of the people I know who don’t have atherosclerosis, but were prescribed statins simply because their cholesterol was above the supposedly magic number of 200. Their doctors weren’t treating heart disease; they were treating a cholesterol score.
While researching Fat Head, I became aware of quite a few doctors who insist that giving statins to people who don’t already have heart disease simply to beat down their cholesterol is worse than worthless … Al Sears, Mike and Mary Dan Eades, Uffe Ravnskov, Malcolm Kendrick, etc. I found the evidence they presented quite convincing. Unfortunately, the medical establishment and the media have tended to either ignore the anti-statin doctors or write them off as a bunch of kooks.
Not anymore … at least I hope not. A new meta-analysis of the effectiveness of statins (and lack thereof) was just released by the Cochrane Collaboration, and it’s bad news for the statin-makers — partly because the analysis itself isn’t flattering, and partly because the Cochrane Collaboration is a highly-respected organization whose work is considered both thorough and unbiased. Consequently, their report has generated quite a bit of media coverage. I’ve already read articles in the UK Telegraph (two), TIME’s online version, the Los Angeles Times, Miller McCune, and Reuter’s Health, among others.
If we piece together quotes from the articles, we end up with a nice summary of the statin story. Let’s start with how and why they became the best-selling drugs of all time:
Back in 1975, Henry Gadsden, the chief executive of the drug company Merck, expressed his frustration that the market for his company’s products was limited to those with some treatable illness. Ideally, he said, he would like to “sell to everyone”.
Three decades later, his dream would seem to have come true - epitomised by the most profitable class of drugs ever discovered, the cholesterol-lowering statins that are taken by an estimated seven million people in Britain, and tens of millions worldwide.
Yup, Merck and the other pharmaceuticals wanted to sell drugs to healthy people, and by gosh, they finally figured out how to do it.
The story starts with the arrival of “cholesterol consciousness”: the thesis that those indulging in (for example) bacon and eggs for breakfast boosted the cholesterol level in the blood, causing the arteries to become narrow, and making a heart attack more likely.
Although this idea has its critics, there is no doubt that the small proportion of the population with a genetic predisposition towards high cholesterol levels are at greater risk of circulatory disorders. Encouraging them to switch to a healthy diet had failed to lower that risk - so the idea gained ground that cholesterol-lowering drugs might be the answer.
The small proportion of the population with a genetic predisposition are those with familial hyperlipidemia. Their LDL is extraordinarily high because their LDL receptors don’t work and therefore don’t remove LDL from the bloodstream. Cholesterol-lowering drugs were shown to reduce their rate of heart disease by a teeny, tiny bit. From that result, the medical community decided cholesterol is a killer and we should all stop eating bacon and eggs — even though low-fat diets didn’t do diddly for the people with hyperlipidemia. Go figure.
An even more important factor, especially in the US, was the drive to establish “clinical practice guidelines”, under which panels would set the optimal treatment for any given condition. Successive guidelines have forced the “normal” level of cholesterol ever lower, resulting in leaps in the numbers deemed eligible for treatment. In the US, the figure went from 15 million to 40 million.
That’s how you sell drugs to healthy people: redefine normal cholesterol levels as dangerous. Among the un-medicated population, average total cholesterol was around 220 a few decades ago. Doctors rarely warned patients about heart disease unless their cholesterol was 250 or higher. But if 220 was the average, how did the new “normal” end up being 200?
After it was pointed out that those responsible for the most recent guidelines had failed to declare any potential conflicts of interest, it subsequently emerged that most of them had received research grants or consultancy fees from the drug companies involved in manufacturing statins.
That’s how. By declaring 200 to be the target level for cholesterol, the researchers (ahem, ahem) who wrote the guidelines guaranteed their paymasters millions of new customers.
Not surprisingly, quite a few clinical studies eventually concluded that statins prevent heart disease. I say “not surprisingly” because nearly all the studies were funded and conducted by the pharmaceutical companies. According to the Cochrane review, the studies might’ve been (surprise!) skewed to exaggerate the benefits and minimize the side effects:
In particular, while all the studies focused on benefits, only half provided information on the side effects of the drugs, said Dr. Shah Ebrahim, whose group’s findings are published by the Cochrane Collaboration, an international organization that evaluates medical research.
“There is evidence that the reports cherry-picked the best outcomes for presentation,” he added, “which will tend to inflate apparent benefits of treatment.”
While there appeared to be no difference in side effects between trials participants taking dummy pills and statins, the researchers say those results aren’t credible.
“Any appraisal we can make of adverse events is biased by failure to report these events,” Ebrahim said in an e-mail to Reuters Health. “We believe that trial funders, investigators and journal editors have failed to provide adequate information to doctors and their patients to assess the benefits and harms of statins in primary prevention.”
The good news is that while Merck and Pfizer may not report on negative side effects, more media outlets are:
Dr. Greg Burns (not his real name) is a 72-year-old retired radiologist living in Connecticut. Until early last year, he ran with his dog at canine agility meets, skied, ice skated and played 18 holes of golf. He is now unable to walk and is taking a course of medication that will postpone, by a few months, his death.
Burns’ rapid decline began in December 2007 when he suffered a short-acting stroke from which he fully recovered. His cholesterol level was elevated and so as a preventative measure his doctor prescribed a 20mg daily dose of Crestor, a cholesterol-lowering drug in the “statin” class.
A few months after beginning Crestor, Burns developed muscle cramps. He was assured by his doctors that these were not serious side effects of taking the drug. But in December 2008 when tests showed that his creatine phosphokinase - an enzyme that is released into the blood stream when muscle cells are damaged - was elevated, Dr. Burns stopped taking Crestor. When his enzyme levels returned to normal, he began taking Pravachol, another statin drug. He quickly developed weakness in his lower legs and a right foot drop.
Mayo Clinic cardiologists acknowledge that the side effects of statin drugs can include muscle pain, extreme fatigue, liver damage, digestive problems and neurological damage including memory loss.
Of course, not everyone who takes statins will experience side effects, so it’s a question of balancing benefits and risks, just like with any other drug. So let’s look at the supposed benefits.
If you’ve seen Lipitor ads on TV (and if you haven’t, it means you don’t watch TV), you know Pfizer claims Lipitor reduces the rate of heart attacks by 36%. As I’ve explained in previous posts, that figure may sound impressive, but basically it means that during the clinical trials, three out of every 100 men who took a placebo had a heart attack, while slightly less than two out of every 100 men who took Lipitor had a heart attack. So for every 100 men treated for ten years, we’re preventing (in theory) one heart attack. That’s one heart attack, not necessarily one death.
But even those unimpressive results were found only among with men with existing heart disease or multiple risk factors for heart disease — not among women, and not among otherwise healthy people who happen to have high cholesterol.
But of course, statins didn’t become the most profitable drugs in history by being prescribed solely to men with existing heart disease. Nope, statins became a cash cow when doctors started prescribing them to pretty much everybody whose cholesterol is above 200. (In the UK, you can even buy your future muscle or memory problems over the counter — yippee!)
The theory, of course, was that statins could prevent heart disease from developing in the first place, otherwise known as “primary prevention.” The Cochrane report casts more than a little doubt on that theory, as several media articles pointed out:
An authoritative review shows there is little evidence that the cholesterol-lowering drugs protect people who are not already at a high risk of heart disease.
Experts who advocate the use of statins say they have helped prolong thousands of lives by preventing heart attacks and other cardiovascular events. But a wide-ranging review of previous studies, published today in the journal The Cochrane Library, urges “caution” among GPs who prescribe them. It concludes that there is no “strong evidence” to suggest that statins reduce coronary heart disease deaths among those who have not suffered a heart attack or other cardiovascular event in the past.
Shah Ebrahim, a professor of public health at the London School of Hygiene and Tropical Medicine, who co-wrote the report, called on doctors to stop giving patients the drugs unnecessarily.
Just one life is currently saved for every 1,000 people who take them each year, the report says.
Great … so to prevent (in theory) one fatal heart attack among every 1,000 people who take statins, we’ve created lord-only-knows-how-many cases of muscle degeneration, memory loss, kidney failure, erectile dysfunction and liver damage. Of course, that works out well for Big Pharma — they sell drugs to treat those conditions, too.
I’ve said it before, and I’ll say it again: statins are some of the worst drugs ever. I’m just happy to see more people in the news media are catching on.