And Now for the Rest of the Story

Just this past Sunday (9 November, 2008) I posted this article on Natural Health News: Boosting Drug Sales with Studies.

I added one follow-up article earlier today, and now I am happy to give you something to think about in terms of why sound nutrition is a better option than wholesale use of drugs. Supplements certainly do edge out the pharmaceuticals in this study.

You'll also see how it is totally possible to fool a lot of the people a lot of the time -

Why treat nutritional deficiency with drugs?
(OMNS, November 13, 2008) A recent study suggested that statins might be used to avoid the effects of nutritional deficiency. Writing in the New England Journal of Medicine, the Jupiter group described a study of statin drugs in people with high C-reactive protein and low cholesterol. (1) High C-reactive protein levels are associated with inflammation and heart disease/stroke. The authors concluded that, in apparently healthy persons with elevated C-reactive protein levels, rosuvastatin (Crestor) significantly reduced the incidence of major cardiovascular events.

Their much-publicized claim, that this statin lowers the risk of heart attack by approximately one half, is technically correct though highly misleading. The reported annual incidence of coronary events was 37 people in 10,000 (controls) and 17 people in 10,000 (treated). Similar results were reported for risk of stroke. When expressed as a proportion, a 46% improvement (17/37) sounds large. However, an improvement of 20 events (37-17) in 10,000 people known to be at risk is less impressive. Such an improvement means that 500 people (10,000/20) with this increased risk would need to take the tablet daily for a year, to prevent one person suffering an event.

The paper does not explicitly report deaths. One reason for this may be that if a person on statins suffered a heart attack, that person was about three times more likely to die than a control who was not on statins.

The cost of rosuvastatin per person is approximately $1000 per year. So, treating enough people to prevent one heart attack costs $500,000 per year. Since about 70% of the heart attacks were not fatal, prevention of a single death from heart attack would cost even more, approximately $1,700,000. Giving the benefit of the doubt, we may allow for a similar reduction in stroke and say that "only" $250,000 is needed to protect one person from a stroke or heart attack. It is hardly surprising that Astra Zeneca's share price increased by $1.3 billion dollars on release of this paper and the corresponding media hype. (2)

The media suggested millions of healthy people could cut their risk of heart disease by taking statins. (3) They also claimed that statins could cut the risk of heart attack for "everyone". (4) This is inaccurate and incorrect. The study did not include normal healthy people, only a sample of a relatively small number of people, suffering from inflammation (increased C-reactive protein) - a known cause of heart disease and stroke. Out of 89,890 people considered for inclusion, 17,802 people (19.8%) met the specific criteria of poor health for the study. Widespread prescription of statins to healthy people is not supported by these findings.

The fact that statins produce a modest improvement is unsurprising, since they are known to lower inflammation, as do many nutritional supplements. It has pointed out that Crestor lowered C-reactive protein by 37%, but vitamin E lowers it (C Reactive Protein) by 32%, (5) and vitamin C by 25.3%. (6,7) These effects are similar to those of statins and would be expected to provide comparable benefits, without side effects and at a lower cost.

Crestor and other statin drugs have serious side effects. The incidence of established side-effects, such as rhabdomyolysis (0.3 per 10,000 per year), myopathy (1.1 per 10,000) and peripheral neuropathy (1.2 per 10,000 per year) seems low, (8) but may be underestimated as it takes time to establish long-term side-effects. (The depletion of coenzyme Q10 by statins is a particular concern.) The figures imply that for every ten people who avoid a cardiovascular event, at least one previously healthy person will suffer a non-trivial side effect of the statin drug.

The doctors reported a statistically significant increase (270) in diabetes in the statin group compared to the placebo group (216). Over the course of the study, this corresponds to an increased risk of approximately 61 in 10,000 people. So, the number of people on statins reported to become diabetic was greater than the number that avoided a heart attack! These people might have shorter lives and be at greater risk of heart disease in the long term.

Notably, the Jupiter study was stopped early, which the authors admit prevents assessment of how side-effects might outweigh reported benefits in the longer term. The study was to last 3-5 years and the criteria for stopping were not included in the original published design. (9) The paper claims that when the study was stopped "these [diabetic] events were not adjudicated by the end-point committee". The committee either knew about the diabetes in which case it was considered, or it did not and the committee was not doing its job properly.

The Jupiter name stands for Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; the reader might think this "justification" sounds more like a marketing plan than a scientific endeavor. The researchers did not address the underlying cause of the inflammation and increased C-reactive protein: they simply treated the condition with drugs. In many cases, raised C-reactive protein is a result of nutritional deficiency. (10)

It is worth mentioning that several nutritional supplements inhibit inflammation and lower C-reactive protein, without causing known side effects. Deficiency in vitamins A, (11) B6, C, E, A, folate, carotenoids and lycopene, (12) and selenium (for example) is associated with raised C-reactive protein. (13,14,15) We suggest that the $250,000 cost of preventing a single cardiovascular event with rosuvastatin might be better spent funding a study of such inexpensive alternatives the deficiency of which may be the cause of the problem.

The people at risk could be encouraged to supplement their diet and restore their health without using these expensive drugs to conceal their underlying sickness.

Stick with the supplements!

References:

(1) Ridker P.M. Danielson E. Fonseca F.A.H. Genest J. Gotto A.M. Kastelein J.J.P. Koenig W. Libby P. Lorenzatti A.J. MacFadyen J.G. Nordestgaard B.G. Shepherd J. Willerson J.T. Glynn R.J. for the JUPITER Study Group (2008) Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein, NEJM, 359(21), 2195-2207.

(2) Mail Online (2008) Crestor news helps AstraZeneca market value leap by more than £1.3bn, 9:25 PM, 10th Nov.

(3) Smith R. (2008) Millions could cut heart attack risk by taking statins, study finds, telegraph.co.uk, 7:55AM GMT, 10 Nov.

(4) Hope J. (2008) The new statin drug that cuts the risk of heart attacks and strokes for EVERYONE, Daily Mail, 11th Nov.

(5) Devaraj S. Tang R. Adams-Huet B. Harris A. Seenivasan T. de Lemos J.A. Jialal I. (2007) Effect of high-dose alpha-tocopherol supplementation on biomarkers of oxidative stress and inflammation and carotid atherosclerosis in patients with coronary artery disease, Am J Clin Nutr, 86(5), 1392-1398.

(6) Block G. Jensen C.D. Dalvi T.B. Norkus E.P. Hudes M. Crawford P.B. Holland N. Fung E.B. Schumacher L. Harmatz P. (2008) Vitamin C treatment reduces elevated C-reactive protein, Free Radic Biol Med, Oct 10. [Epub]

(7) Sardi B. (2008) The Headline You Should Be Reading: Statin Drugs Don't Save Lives And May Increase Your Risk For Diabetes, Knowledge of Health Report, Nov 11.

(8) Law M. Rudnicka A.R. Statin Safety: A Systematic Review, The American Journal of Cardiology, 97(8), Suppl 1, S52-S60.

(9) Ridker P.M. JUPITER Study Group (2003) Rosuvastatin in the primary prevention of cardiovascular disease among patients with low levels of low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: rationale and design of the JUPITER trial, Circulation, 108(19), 2292-2297.

(10) Ford E.S. Liu S. Mannino D.M. Giles W.H. Smith S.J. (2003) C-reactive protein concentration and concentrations of blood vitamins, carotenoids, and selenium among United States adults, European Journal of Clinical Nutrition, 57, 1157-1163.

(11) Root M.M. Hu J. Stephenson L.S. Parker R.S. Campbell T.C. (1999) Determinants of plasma retinol concentrations of middle-aged women in rural China. Nutrition 15, 101-107.

(12) Boosalis M.G. Snowdon D.A. Tully C.L. Gross M.D. (1996): Acute phase response and plasma carotenoid concentrations in older women: findings from the nun study, Nutrition, 12, 475-478.

(13) Friso S. Jacques P.F. Wilson P.W. Rosenberg I.H. Selhub J.(2001) Low circulating vitamin B(6) is associated with elevation of the inflammation marker C-reactive protein independently of plasma homocysteine levels, Circulation, 103(23), 2788-2791.

(14) Devaraja S. Jialal I. (2000) Alpha tocopherol supplementation decreases serum C-reactive protein and monocyte interleukin-6 levels in normal volunteers and type 2 diabetic patients, Free Radical Biology and Medicine, 29(8), 790-792.

(15) Upritchard J.E. Sutherland W.H. Mann J.I. (2000): Effect of supplementation with tomato juice, vitamin E, and vitamin C on LDL oxidation and products of inflammatory activity in type 2 diabetes, Diabetes Care, 23, 733-738.

Nutritional Medicine is Orthomolecular Medicine

Fertility Concerns

Several new reports show that the effect of supplements can be very helpful when conception and fertility are concerned.

Read the new news notes...

And do remember that your nutritional status has a great impact on your health, especially when planning for a baby.

Low Magnesium, High Blood Pressure

While the original purpose for ADVENTURX was to prevent arm pump in xtreme sports many other benefits have been found during the four years my formula has been available.

Most of us who study natural healing and nutrition already know how magnesium helps reduce blood pressure. Magnesium is nature's ACE inhibitor.

The added benefit of oxygen producing elements in ADVENTURX may be helpful to the process of lowering blood pressure as well.

Evidence that increased reactive oxygen species are link between magnesium deficiency and hypertension
The relationship between high blood pressure and magnesium deficiency has been explored in several studies, producing conflicting evidence. A study published in the November 2002 issue of the Journal of Hypertension submits the hypothesis that insufficient levels of magnesium may lead to hypertension by increasing the formation of reactive oxygen species, harmful molecules that cause oxidative damage.

The University of Montreal researchers divided stroke-prone spontaneously hypertensive rats into three groups that received a control diet containing normal levels of magnesium, a magnesium-free diet and a high magnesium diet, and systolic blood pressure was measured each week for sixteen weeks. In a second experiment, stroke-prone spontaneously hypertensive rats received a control diet, a magnesium-free diet and a magnesium-free diet combined with Tempol, a superoxide dismutase mimetic for seven weeks. Superoxide dismutase is one of the antioxidants naturally produced in the body.

Rats in the low magnesium group experienced an exacerbation in the development of hypertension after five weeks, accompanied by a reduction in oxidative stress markers which increased rapidly after two weeks. The ability of blood vessels to dilate in response to acetylcholine was decreased in the low magnesium group compared to controls. Vessel wall hypertrophy was greater and vascular superoxide higher in the rats who received the magnesium deficient diet compared to those on the high magnesium diet. However, rats on magnesium-free diets receiving Tempol did not experience a progression of hypertension or the vascular changes seen in magnesium deficient rats who did not receive the antioxidant.

In an accompanying editorial, Richard D Bukoski writes that the research provides, "the first link between an essential dietary nutrient and the key molecular pathways involved in regulating vascular smooth muscle growth and structure." (Journal of Hypertension 2002, 20:2141-2143)

Boosting Drug Sales with Studies

For quite a number of years many health professionals have been speaking out against the statin class of drugs.

Much of the concern is associated kidney failure secondary to muscle wasting. Other serious effects have been noted, yet the drug giants keep coming up with ways to try to convince absolutely everyone they need to be taking these drugs.

Now even the "healthy".

One of the key investigators busting this myth has been Uffe Ravnskov, MD

And what ever happened to improving health with foods and supplements to reduce or eliminate this problem.

Recall that the homogenization of milk (and lack of access to raw milk) really kicked off the march to atherosclerosis back in the 1950s.

And remember that lecithin or eating plain applesauce mixed in plain yoghurt aids healthy, clean and flexible arteries. And with major cost savings over these drugs.

Other issues are the fact that many of the statin drugs are fluoride based, such as Baychol - now off the market.

Even Red Rice Yeast can have the same side effects of the drugs.

Statins and the problems associated with their use is the result of marketing a class of drugs before it was fully investigated.

The imprecise use of statin medications is one big reason why side effects occur in more than 40 percent of patients and why 60-75 percent of statin users discontinue treatment.

Crestor averages about $2 a pill, with a range from $1.41 to $3.41 at a variety of pharmacies. The drug company profit for these drugs is in the 4000 percent range. If you get 10 mg of Crestor when you only need 1 mg, risks increase drastically. With each doubling of a statin dosage, the risk of liver injury also doubles.

Concerned about the renal effects of Crestor, some people have been openly weighing the options between taking a statin or accepting a higher cholesterol number. (For instance, is high cholesterol "normal"? Have we fallen victim to high-end marketing tactics?)

All the statin drugs can cause rhabdomyolysis and kidney failure. In most cases the kidney failure is secondary to blocking of the tiny kidney tubules by the breakdown fragments of muscle cells. The mechanism of action here is loss of cell wall integrity of the muscle cells due to interference of the statin drugs with the vital role of ubiquinone in our bodies.

Ubiquinone, known also as Co-enzyme Q10, is collaterally damaged during the statin drug effect on the so- called mevalonate pathway of cholesterol biosynthesis. Ubiquinone metabolism is a branch on the mevalonate "tree" inevitably damaged by these statin drug "reductase inhibitor" action and the stronger the statin, the more severe this effect.

Public Citizen filed a Citizen's Petition with the FDA suggesting that Crestor be removed from the market. Though the courts did not pass a judgement in favor of Public Citizen (thus allowing Crestor to remain a legally prescribed medication), the case brought to light the fact that statins like Crestor can and do cause serious problems in many patients who take them.

In May of 2005, a study published in the American Heart Association's journal, Circulation, revealed that kidney problems and muscle weakness were two to eight times more frequent among Crestor users than those taking other cholesterol-lowering drugs.

Read more

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and more

Study: Wider cholesterol drug use may save lives
By MARILYNN MARCHIONE, AP Medical Writer Marilynn Marchione, Ap Medical Writer
Sun Nov 9, 9:44 am ET

NEW ORLEANS – People with low cholesterol and no big risk for heart disease dramatically lowered their chances of dying or having a heart attack if they took the cholesterol pill Crestor, a large study found.

The results, reported Sunday at an American Heart Association conference, were hailed as a watershed event in heart disease prevention. Doctors said the study might lead as many as 7 million more Americans to consider taking cholesterol-lowering statin drugs, sold as Crestor, Lipitor, Zocor or in generic form.

"This takes prevention to a whole new level, because it applies to patients who we now wouldn't have any evidence to treat," said Dr. W. Douglas Weaver, a Detroit cardiologist and president of the American College of Cardiology.

The study also gives the best evidence yet for using a new test to identify people who may need treatment, according to a statement from Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute. The new research will be considered by experts reviewing current guidelines.

However, some doctors urged caution. Crestor gave clear benefit in the study, but so few heart attacks and deaths occurred among these low-risk people that treating everyone like them in the United States could cost up to $9 billion a year — "a difficult sell," one expert said.

About 120 people would have to take Crestor for two years to prevent a single heart attack, stroke or death, said Stanford University cardiologist Dr. Mark Hlatky. He wrote an editorial accompanying the study published online by the New England Journal of Medicine.

"Everybody likes the idea of prevention. We need to slow down and ask how many people are we going to be treating with drugs for the rest of their lives to prevent heart disease, versus a lot of other things we're not doing" to improve health, Hlatky said.

Statins are the world's top-selling drugs. Until this study, all but Crestor have already been shown to cut the risk of heart attacks and death in people with high LDL, or bad cholesterol.

But half of all heart attacks occur in people with normal or low cholesterol, so doctors have been testing other ways to predict who is at risk.

One is high-sensitivity C-reactive protein, or CRP for short. It is a measure of inflammation, which can mean clogged arteries as well as less serious problems, such as an infection or injury. Doctors check CRP with a blood test that costs about $80 to have done.

A co-inventor on a patent of the test, Dr. Paul Ridker of Harvard-affiliated Brigham and Women's Hospital in Boston, led the new study. It involved 17,802 people with high CRP and low LDL cholesterol (below 130) in the U.S. and 25 other countries.

One-fourth were black or Hispanic, and 40 percent were women — important because previous statin studies have included few women. Men had to be 50 or older; women, 60 or older. None had a history of heart problems or diabetes.

They were randomly assigned to take dummy pills or Crestor, the strongest statin on the market, made by British-based AstraZeneca PLC. Neither participants nor their doctors knew who was taking what.

The study was supposed to last five years but was stopped in March, after about two years, when independent monitors saw that those taking Crestor were faring better than the others.

Full results were announced Sunday. Crestor reduced a combined measure — heart attacks, strokes, heart-related deaths or hospitalizations, or the need for an artery-opening procedure — by 44 percent.

"We reduced the risk of a heart attack by 54 percent, the risk of a stroke by 48 percent and the chance of needing bypass surgery or angioplasty by 46 percent," Ridker said.

Looked at another way, there were 136 heart-related problems per year for every 10,000 people taking dummy pills versus 77 for those on Crestor.

Remarkably, every single subgroup benefited from the drug.

"If you're skinny it worked, if you're heavy it worked. If you lived here or there, if you smoked, it worked," Ridker said.

AstraZeneca paid for the study, and Ridker and other authors have consulted for the company and other statin makers.

One concern: More people in the Crestor group saw blood-sugar levels rise or were newly diagnosed with diabetes.

Crestor also has the highest rate among statins of a rare but serious muscle problem, so there are probably safer and cheaper ways to get the same benefits, said Dr. Sidney Wolfe of the consumer group Public Citizen.

"It is highly unlikely that (the benefits are) specific to Crestor," said Wolfe, who has campaigned against the drug in the past.

Crestor costs $3.45 a day versus less than a dollar for generic drugs.

Drs. James Stein and Jon Keevil of the University of Wisconsin-Madison used federal health statistics to project that 7.4 million Americans, or more than 4 percent of the adult population, are like the people in this study.

Treating them all with Crestor would cost $9 billion a year and prevent about 30,000 heart attacks, strokes or deaths, they calculate.

"That's pretty costly. This would be a very difficult sell" unless a person also had family history or other heart disease risk factors, said Dr. Thomas Pearson of the University of Rochester School of Medicine and Dentistry.

Pearson was co-chairman of a joint government-heart association panel that wrote current guidelines for using CRP tests to guide treatment.

Researchers do not know whether the benefits seen in the study were due to reducing CRP or cholesterol, since Crestor did both.

This study and two other government-sponsored ones reported on Sunday "provide the strongest evidence to date" for testing C-reactive protein, and adding it to traditional risk measures could identify millions more people who would benefit from treatment, Nabel's statement says.

U.S. Crestor prescriptions totaled $420 million in the third quarter of this year, up 23 percent from a year earlier. In the rest of the world, third quarter sales were $520 million, up 33 percent.

Sales have been rising even though two statins — Zocor and Pravachol — are now available in generic form.

On the Net:
New England Journal: http://www.nejm.org
Heart conference: http://www.americanheart.org
Government: http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhatIs.html

Flu deaths? Now really

The argument proferred here makes little sense.

Flu is caused by a virus. Pneumonia is more likely than not bacterial in origin. Staph aureus is a bacteria.

The "hard-to-treat complications" are not eneumerated so we cannot determine what might connect these to flu virus. I also don't quite follow the connection from flu to staph infection. Perhaps this is from wrongly administered antibiotics that do not treat a virus.

There are many serious problems with flu vaccines and this is a poor argument to convince you to take this jab.

You should be asking many more questions rather than follow blindly.

More vitamin C, vitamin A and home made chicken soup with garlic, onions, and carrots just might give you more of a healthy boost than a drug. Years ago it was proven that chicken soup did fight colds and flu because of the amino acid cysteine found in goodly amounts in the soup.

The idea of chicken soup must be a good one because its being given to some young pandas in china to help them boost their immune systems.

Jump seen in staph-linked flu deaths in kids
By LINDSEY TANNER, AP Medical Writer, Mon Oct 6, 2008

More children have died from flu because they also had staph infections, according to a new government report that urges parents to have their kids get the flu shot.

The number of deaths wasn't high — 73 during the 2006-07 flu season — but there was more than a fivefold increase in hard-to-treat complications. And preliminary figures indicate deaths rose again during this past winter's flu season.

Public health officials say the numbers underscore the importance of a brand new recommendation that all children, from 6 months through 18 years, get routine flu shots. Before this year, shots were recommended for kids under 5 years.

More than half the children who died were between ages 5 and 17 and had been healthy until they got the flu.

Parents shouldn't panic, "but it's an important message to say even healthy children develop complications and die almost before anything much can be done for them," said Dr. Gregory Poland, a Mayo Clinic infectious disease specialist. He was not involved in the federal study, but has worked with a federal vaccine advisory committee and has consulted for vaccine makers.

Flu season is just beginning, and this year's vaccine should be widely available this month.

While few children die from the flu virus, it puts about 20,000 U.S. kids in the hospital each year.

Only 6 percent of the children studied who died had been fully vaccinated against the flu. Two doses are recommended each flu season for children ages 6 months to 8 years who have not been vaccinated previously; for older kids, just one dose a year is needed.

The study, appearing in the October edition of Pediatrics for release Monday, is based on an analysis of reported flu deaths from the 2004-05 through 2006-07 seasons. Flu deaths in children during those seasons totaled 47, 46 and 73, respectively.

The percentage of those who also had bacterial infections jumped from 6 percent to almost 36 percent. Most had staph infections, and 60 percent of those involved the dangerous MRSA bug, which is resistant to antibiotics.

More recent data suggest flu deaths among children have continued to rise, with 86 tallied for the 2007-08 season in a preliminary report last month, said Lyn Finelli, the study's lead author, who is a researcher for the Centers for Disease Control and Prevention.

Preliminary information also suggests there has been no drop in fatal flu-staph cases in children, and those could still be on the rise too, she said.

Staph germs commonly live in the nose or skin without causing illness; more than one-fourth of U.S. children and adults carry them.

These bugs can become deadly when they get into the bloodstream, sometimes through wounds. The flu is thought to make people more susceptible to bacterial infections like staph, Finelli said.

Details on how children in the study died were not available, but some developed bacterial pneumonia, seizures and shock.

Finelli said parents should take children to the doctor when they have flu symptoms and signs of other complications. These could include extreme fatigue, no thirst, or in older children complaints about feeling very ill.
___

On the Net: American Academy of Pediatrics: http://www.aap.org
CDC: http://www.cdc.gov
Copyright © 2008 The Associated Press.