Frei's Final Word on the Supplement Bash

There are several things that I find interesting in his response.

• He describes the division of the 68 selected trials into high bias and low bias as subjective.
• Two studies showing positive (decreasing mortality) results were deemed to be high bias and discarded by the three authors of the study. Frei states that their justification of cutting these two is un-explained. Both of these studies had been published in two major medical journals.
• Most interesting to me is Frei's assertion that antioxidants might not be properly studied in clinical trials in the same way as drugs. Consider:

  ...clinical trials of dietary antioxidants have serious
  limitations. They may be the "gold standard" for testing
  safety and efficacy of pharmaceutical drugs, but are hardly
  suitable to test dietary compounds, which are metabolized
  in completely different ways from drugs.
  

  This makes me suspicious of those in the establishment who would prefer to lump supplements in the same category as any other chemical drug.
• Oxidative stress of patients was not assessed in any of the selected low bias trials.
• Doses of supplements were vastly different. Causes of death showed wide variation.
• Blatant misrepresentation of deaths by the meta-study authors in one particular study.

I have to conclude that anyone who thinks this study was legitimate is clearly part of the establishment which is constantly directing skepticism and doubt towards nutritional supplements. I think that's the least I can say.

One other thing to consider in this latest LPI newsletter. The report by Director of Development, Scott Palmer points out that the LPI receives a significant amount of it's funding by independent donation. The work of the institute is not geared towards patentable products. They are also not able to offer the same incentives to scientists as other institutions. All this points to a research effort which is perhaps more free of bias than others. Yet on the other hand, I know that many supplement advocates remain a bit frustrated with Dr. Frei's views on some things, especially the use of vitamin C. All this says to me that when Dr. Frei and the LPI come out and strongly condemn a meta-study as being biased, I'm going to be strongly encouraged to think they are right!

Update

[/health/vitamins]     5 comments     permalink

The Latest Round of Supplement Bashing

Response from Dr. Hickey et. al.

Excluding zero death studies clearly biases the results. However, this is a
minor point, considering the other problems with this paper. The paper
demonstrates a misuse of statistics and a lack of biological understanding.
 
The paper's foremost methodological error is the use of subjective selection.
To change a calculated relative risk ratio, you simply bias the selection
procedure. In removing zero death studies, the risk ratio would remain
unchanged only if the authors excluded studies involving supplement group or
control group deaths with appropriate and proportionate probability.
 
Consider the relative risk, calculated as the ratio of the risks, in each
group. Suppose the risk was 2 in 100 subjects in each group (2% risk in each
group, giving a 1:1 ratio). Now, remove 90 subjects from just the supplement
group: the calculated risk increases to 20% (i.e. 2 out of 10 subjects) and the
ratio of the risks becomes 10:1. There is no evidence that exclusions in the
meta-analysis study were subject to appropriate controls, to prevent this kind
of bias: the paper describes subjective selection of studies!
 
It is inappropriate to exclude preferentially studies where no risk outcome was
observed, because it affects the meaning of the risk ratio and its
interpretation. Specifically, removing studies relates the calculated risk
ratio to a smaller subset (m people) of a larger population (n people where
m<<n). Consider the inconsequential increase in risk from one death in
5,000,000,000 people to two deaths in 5,000,000,000 people (giving a relative
risk of 2). If we remove the majority of unaffected people, we get an
apparently important result: say a change from one death in 10 people to two
deaths in 10 people (relative risk still 2). Removing unaffected people makes
the risk appear more important.
 
The fact that people routinely misapply relative risks, by ignoring the
population to which they apply, is irrelevant here. However, as a general
heuristic, always mistrust relative measures, and do not try to defend a bad
paper using an argument based on relative risk.
 
Relative measures in studies should be avoided, unless the criteria are
carefully stated. Abuse of relative measures often makes a paper seem more
important, or drug effects more powerful. Generally, relative values magnify
effects in a way that is deceptive rather than illuminating. An example might
be a doubling, or 100% increase, in risk, which appears far less if it is
properly expressed as an increase from, say 0.0001 per million of the
population to 0.0002 per million. A risk ratio, considered alone, conveys
almost no information about the actual risk. It has meaning only when the real
magnitude of the risk is also provided. For further examples, try Darrel Huff's
book "How to lie with statistics," or Gert Gigerenzer's "Calculated Risks: How
to Know When Numbers Deceive You".  
 
This objection to our analysis has missed or avoided the main issue, which is
that the selection process in this study was biased. This renders the study
worthless, except as a measure of investigator bias.

Update 3

I also posted a question to the blog of Arthur Devany who is a statistician and Peleo Diet advocate. The question is in the comments of this entry. Devany would be well qualified to comment on the statistical methods used in the study. But no response as of yet.

Update 2

Notice near the beginning of the response from the Linus Pauling Institute, Dr. Frei is quoted as saying: "...the new study's focus on a selected group of clinical trials disregards the results of other more positive trials, as well as huge amounts of laboratory, animal, and human observational and experimental data." The LEF response likewise lists a large body of studies which seemingly contradict this latest meta study. I think this is another factor that should be considered. When a meta-study contradicts a large body of other studies, it should be regarded with a high dose of skepticism. Meta studies can be useful but I wonder if they should be considered ground breaking? My limited understanding suggests that they are only useful in the context of plenty of other more rigorous studies.

Update

Original Post

• Chowka's response...
• Knowledge of Health response...
• Response from the LEF...

At the bottom of Chowka's article are links to other responses. In particular the response by the Linus Pauling institute is very good.

[/health/vitamins]     32 comments     permalink

More on Vitamin Supplement Safety

The distinction between side effects and the Therapeutic Index which Michael discussed in detail is not discussed here either. In order to find out specific information about side effects, I think you would have to look at each supplement on an individual basis. For example, I am more familiar with some of the side effects attributed to vitamin C. Most of these are overblown or have been shown only to apply under certain circumstances from what I have read and understand. But if we are talking about side effects that would put a person into immediate danger, I would think these would have been reported to the poison control center and would be well documented. Notice that Dr. Saul touches on the vitamins (such as A) that are generally thought to be slightly more dangerous.

FOR IMMEDIATE RELEASE
Orthomolecular Medicine News Service, February 27, 2007

23 YEARS OF DOCUMENTED VITAMIN SAFETY
 
(OMNS, Feb 27, 2007) Over a twenty-three year period, vitamins have been
connected with the deaths of a total of ten people in the United States. Poison
control statistics confirm that more Americans die each year from eating soap
than from taking vitamins. 

Where are the bodies?
A 23-year review of US poison control center annual reports (1) tells a
remarkable and largely ignored story: vitamins are extraordinarily safe.

Annual deaths alleged from vitamins:

2005:  zero 
2004:  two
2003:  two
2002:  one
2001:  zero
2000:  zero
1999:  zero
1998:  zero
1997:  zero
1996:  zero
1995:  zero
1994:  zero
1993:  one
1992:  zero
1991:  two
1990:  one
1989:  zero
1988:  zero
1987:  one
1986:  zero
1985:  zero
1984:  zero
1983:  zero

The zeros are not due to a lack of reporting. The American Association of
Poison Control Centers (AAPCC), which maintains the USA's national database of
information from 61 poison control centers, has noted that vitamins are among
the 16 most reported substances. Even including intentional and accidental
misuse, the number of alleged vitamin fatalities is strikingly low, averaging
less than one death per year for more than two decades. In 16 of those 23
years, AAPCC reports that there was not one single death due to vitamins. 

These statistics specifically include vitamin A, niacin (B-3), pyridoxine
(B-6), other B-complex, C, D, E, "other" vitamin(s), such as vitamin K, and
multiple vitamins without iron. Minerals, which are chemically and
nutritionally different from vitamins, have an excellent safety record as well,
but not quite as good as vitamins. On the average, one or two fatalities per
year are typically attributed to iron poisoning from gross overdosing on
supplemental iron. Deaths attributed to other supplemental minerals are very
rare. Even iron, although not as safe as vitamins, accounts for fewer deaths
than do laundry and dishwashing detergents. 

References:

1. Annual Reports of the American Association of Poison Control Centers'
National Poisoning and Exposure Database (formerly known as the Toxic Exposure
Surveillance System). AAPCC, 3201 New Mexico Avenue, Ste. 330, Washington, DC
20016. Download any report from1983-2005 at http://www.aapcc.org/annual.htm
free of charge. The "Vitamin" category is usually near the end of the report. 

For 2005 http://www.aapcc.org/Annual%20Reports/05report/2005%20Publsihed.pdf 

For 2004
http://www.aapcc.org/Annual%20Reports/04report/AJEM%20-%20AAPCC%20Annual%20Report%202004.pdf 

For 2003
http://www.aapcc.org/Annual%20Reports/03report/Annual%20Report%202003.pdf 

For any other year: http://www.aapcc.org/annual.htm

Nutritional Medicine is Orthomolecular Medicine

Linus Pauling defined orthomolecular medicine as "the treatment of disease by
the provision of the optimum molecular environment, especially the optimum
concentrations of substances normally present in the human body."
Orthomolecular medicine uses safe, effective nutritional therapy to fight
illness. For more information: http://www.orthomolecular.org

The peer-reviewed Orthomolecular Medicine News Service is a non-profit and
non-commercial informational resource.

Editorial Review Board:

Abram Hoffer, M.D., Ph.D.
Harold D. Foster, Ph.D.
Bradford Weeks, M.D.
Carolyn Dean, M.D., N.D.
Erik Paterson, M.D.
Thomas Levy, M.D., J.D.
Steve Hickey, Ph.D.

Andrew W. Saul, Editor and contact person. email: drsaul@doctoryourself.com .

To subscribe at no charge: http://orthomolecular.org/subscribe.html

[/health/vitamins]     2 comments     permalink

Orthomolecular Medicine News Service

NO DEATHS FROM VITAMINS: Poison Control Statistics Prove Supplements' Safety

(OMNS Feb 23, 2007) There was not even one death caused by vitamins in 2005,
according to the most recent statistics available from the US National
Poisoning and Exposure Database. The 129-page annual report of the American
Association of Poison Control Centers published in the journal Clinical
Toxicology (1) shows zero deaths from multiple vitamins; zero deaths from any
of the B vitamins; zero deaths from vitamins A, C, D, or E; and zero deaths
from any other vitamin. 

Over half of the U.S. population takes daily vitamin supplements. Even if each
of those people took only one single tablet per day, that makes 145,000,000
individual doses per day, for a total of over 53 billion doses annually. Since
many persons take additional vitamins, the numbers are considerably higher, and
the safety of vitamins all the more remarkable.

Reference: 

1. Lai MW, Klein-Schwartz W, Rodgers GC et al. 2005 Annual Report of the
American Association of Poison Control Centers' national poisoning and exposure
database. Clin Toxicol (Phila). 2006; 44(6-7): 803-932. Free download from
http://www.aapcc.org/Annual%20Reports/05report/2005%20Publsihed.pdf . Vitamins
statistics are found in Table 22, towards the end of the report.

For further reading:

Download any Annual Report of the American Association of Poison Control
Centers from 1983-2005 free of charge at: http://www.aapcc.org/annual.htm The
"Vitamin" category is usually at the very end of the report.

Nutritional Medicine is Orthomolecular Medicine

Linus Pauling defined orthomolecular medicine as "the treatment of disease by
the provision of the optimum molecular environment, especially the optimum
concentrations of substances normally present in the human body."
Orthomolecular medicine uses safe, effective nutritional therapy to fight
illness. For more information: http://www.orthomolecular.org

The peer-reviewed Orthomolecular Medicine News Service is a non-profit and
non-commercial informational resource.

Editorial Review Board:

Abram Hoffer, M.D., Ph.D.
Harold D. Foster, Ph.D.
Bradford Weeks, M.D.
Carolyn Dean, M.D., N.D.
Erik Paterson, M.D.
Thomas Levy, M.D., J.D.
Steve Hickey, Ph.D.

Andrew W. Saul, Editor and contact person. email: drsaul@doctoryourself.com .

To subscribe at no charge: http://orthomolecular.org/subscribe.html

[/health/vitamins]     22 comments     permalink

From Orthomolecular Medicine News Service

VITAMINS FIGHT DISEASE: Nutrients Effective but Overlooked

(OMNS Jan 30 2007) Vitamin supplementation fights disease. Although medical
research has repeatedly shown this, such has not always been the case in the
news media. Recently, however, the popular press is picking up more of the good
news: Nutritional therapy is cheaper, safer, and often more effective than
pharmaceutical drugs.  

NIACIN FIGHTS CARDIOVASCULAR DISEASE

The New York Times just reported (1) that inexpensive vitamin B-3, niacin, "can
increase HDL as much as 35 percent when taken in high doses, usually about
2,000 milligrams per day. It also lowers LDL, . . . (and) triglycerides as much
as 50 percent."  The Times quoted Steven E. Nissen, M.D., president of the
American College of Cardiology, as saying: "Niacin is really it. Nothing else
available is that effective."

Niacin was first used to successfully lower serum cholesterol in 1955. (2)
Since then, placebo-controlled studies have confirmed that niacin prevents
second heart attacks, and niacin also reduced strokes. One study showed that
after 15 years, men taking niacin had an 11 percent lower death rate. Although
a warm "flush" is a common side effect of niacin, the vitamin is safer than any
drug. 

VITAMIN D PREVENTS MULTIPLE SCLEROSIS, CANCER 

The Associated Press reports (3) that "An abundance of vitamin D seems to help
prevent multiple sclerosis, according to a study in more than 7 million people
that offers some of the strongest evidence yet of the power of the 'sunshine
vitamin' against MS."

Multiple sclerosis is known to be more common among those persons living in
northern latitudes. But, says Harvard School of Public Health¿s Dr. Alberto
Ascherio, "This is the first large prospective study where blood levels are
measured . . . (providing) much stronger evidence." (4,5) 
 
AP adds that "Other studies have linked high levels of vitamin D in the blood
to lower risks of a variety of cancers."

VITAMIN E EXTENDS LIFESPAN

People who have vitamin E in their bodies live longer, according to a 19-year
study of 29,092 men. National Cancer Institute researchers concluded that
"Higher circulating concentrations of alpha-tocopherol (vitamin E) within the
normal range are associated with significantly lower total and cause-specific
mortality in older male smokers." (6) Vitamin E was found to reduce death from
all causes, including cancer and cardiovascular disease. 

VITAMIN C PREVENTS STOMACH CANCER
 
"(O)ne of the largest prospective analysis of the association of plasma and
dietary vitamin C levels with gastric cancer risk ever performed on Western
European populations" (7) indicates that having more vitamin C in your blood
plasma reduces your risk of stomach cancer. 

VITAMIN SAFETY

And best of all, vitamins are safe. There is not even one death per year from
vitamin supplementation.  (American Journal of Emergency Medicine, Vol. 22, No.
5, September 2004.
[1] )

Nutritional Medicine is also known as Orthomolecular Medicine

Linus Pauling defined orthomolecular medicine as "the treatment of disease by
the provision of the optimum molecular environment, especially the optimum
concentrations of substances normally present in the human body."
Orthomolecular medicine uses safe, effective nutritional therapy to fight
illness. For more information: [2]

The peer-reviewed Orthomolecular Medicine News Service is a non-profit and
non-commercial informational resource.

Editorial Review Board:

Abram Hoffer, M.D., Ph.D.
Harold D. Foster, Ph.D.
Bradford Weeks, M.D.
Carolyn Dean, M.D., N.D.
Erik Paterson, M.D.
Thomas Levy, M.D., J.D.
Steve Hickey, Ph.D.

Andrew W. Saul, Editor and contact person. email: drsaul@doctoryourself.com .

References:

1. Mason M. An old cholesterol remedy is new again. NY Times, January 23, 2007. 
[3]

2. Altschul R, Hoffer A & Stephen JD: Influence of nicotinic acid on serum
cholesterol in man. Arch Biochem Biophys 54:558-559, 1955.

3. "Sunshine vitamin" protects against MS: Huge study suggests vitamin D
reduces risk of debilitating disease. The Associated Press, Dec 19, 2006.

4. Munger KL, Levin LI, Hollis BW, Howard NS, Ascherio A. Serum
25-hydroxyvitamin D levels and risk of multiple sclerosis. JAMA. 2006 Dec
20;296(23):2832-8. 

5. Munger KL, Zhang SM, O'Reilly E, Hernan MA, Olek MJ, Willett WC, Ascherio A.
Vitamin D intake and incidence of multiple sclerosis. Neurology. 2004 Jan
13;62(1):60-5.

6. Wright ME, Lawson KA, Weinstein SJ, Pietinen P, Taylor PR, Virtamo J,
Albanes D. Higher baseline serum concentrations of vitamin E are associated
with lower total and cause-specific mortality in the Alpha-Tocopherol,
Beta-Carotene Cancer Prevention Study. Am J Clin Nutr. 2006 Nov;84(5):1200-7.

7. Jenab M, Riboli E, Ferrari P, et al. Plasma and dietary vitamin C levels and
risk of gastric cancer in the European Prospective Investigation into Cancer
and Nutrition (EPIC-EURGAST). Carcinogenesis. 2006 Nov;27(11):2250-7. 

--------------------------------------

Read any previous OMNS release at:
[4] 
To subscribe at no charge: [5]

[/health/vitamins]     0 comments     permalink

Vitamin C RDA Critique

My own experiments with Vitamin C are still going well. I seem to require a little less than when I was racing and riding a bit more than I am now. I have settled on 2 to 3 grams a day. I will probably pick this up a bit as I pick up the training in the next month.

[/health/vitamins]     0 comments     permalink

The Latest CTS Bash: Co Q10

...questions still remain as to 
whether it can really do all the things 
the supplement companies would have 
you believe.

I was particularly interested in the side effects mentioned. After a bit of searching, I found almost the exact same things in this article by the NCI. But strangely, I could not find any of the side effects discussed in the papers sited here. But there was no summery text in the 4th article listed so perhaps there's some mention there. I searched pub med for Coenzyme q10 and insomnia but found nothing but this which seems positive if I read it correctly. Now the NCI is not known to have a very favorable attitude towards vitamins and supplements either so it may not be surprising that there are misleading statements made here.

There was no mention of the positive effects on migraine headaches (for example).

For a good overview of Co q10, check out Professor John Ely's page on it.

So I think I have a template for CTS Essentials Nutrition Watch to use:

Vitamin or supplement name
Make up or exaggerate a claim
Look for a bogus or negative study or paper
Keep repeating over and over, "just eat a good diet..."

On the other hand, perhaps there is good reason for Carmichael to distance himself from recommending the use of any kind of supplement. There are a lot rumors and charges that Armstrong used some sort of drug or illegal enhancement to win the Tour so many times. Just a thought.

[/health/vitamins]     0 comments     permalink

CTS the Vitamin Bashers

But on to the meat of this article. The article is all about the dangers of vitamin E. It's main source is the HOPE study. This study was one of several which have come out in the past year or so warning against dangers with vitamins. This one received wide coverage in the mainstream media. The article even mentions that it was reported in the NYT. Now that gives instant credibility doesn't it? That bastion of truth and objectivity with no political or controlling interests. Of course, the NYT is also the paper which reported that the Atkins diet is widely supported by scientists and nutrition experts (yeah right).

As I was looking for a link to the original study, I found lots of critical examinations of it instead. I encourage anyone to simply do a google search of "vitamin e" and HOPE. You will get a pretty good idea of the problems involved. But I also point out health journalist Bill Sardi's excellent article about this study. It is informative. Here's a short summery of what I get out of it:

• Many of the patients in the study were taking a variety of medications besides the vitamin e control group. These medications included: Beta Blockers, Diuretics, Statins, Aspirin, and Calcium blockers. All of these medications can interfere with heart function in some way.
• The study claims that heart ejection fractions were reduced by 1.66 percent. Is this statistically significant?
• This statement by the researchers involved was not generally reported by main stream media sources: "this finding could be due to chance, although several factors persuade us to believe that it may be real." Real hard science here isn't it?

I am seriously thinking of writing a letter to CTS. Now if you think this is coming strait from Lance, think again. Here are some recommendations from Michele Ferrari who, up until this year, has worked with Armstrong and Carmichael on Lance's training.

[/health/vitamins]     0 comments     permalink

Stage 1 in the Supplement War Completed

• Report on the results of the CODEX meeting in Rome Italy which occured this month.
• How CAFTA and CODEX are related.
• Description of documentary film which discusses the dangers of CODEX.

[/health/vitamins]     6 comments     permalink

Can We Ever Get Enough Vitamin Bashing?

So who's paying the bills at the WSJ? You wouldn't suppose that lots of advertising space is paid for by large pharmaceutical companies would you?

[/health/vitamins]     0 comments     permalink

The LEF Responds to Recent Media Attacks on Supplements

What you are about to read might at first seem
unbelievable. Please remember, however, that the studies we
describe were conducted by mainstream doctors who know
virtually nothing about natural ways to prevent and treat
disease.

As you will also find out, many of the doctors who designed
and authored these flawed studies received financial
compensation from the very pharmaceutical companies that
stood to gain the most by deriding low-cost natural
approaches to disease prevention.

The liberal media is generally very supportive of mainstream medicine and is highly influenced by the Pharmaceutical industry. If you don't believe the explanations offered by the LEF, what explanation can you give for these blatant manipulations?

[/health/vitamins]     0 comments     permalink

Bashing all Supplements

But the authors caution that the results may not apply to 
the population at large because the high-dose trials were 
small and their participants tended to have chronic health 
problems such as heart disease. And because most of the 
studies did not note the cause of death, the authors say 
they cannot conclude anything about the underlying mechanism.

Beware the meta-study. They can be manipulated and very misleading. There should be other corroborative and specific studies in order to draw any conclusions. I like this quote from Dr. Cordain's recent news letter regarding epidemiological studies:

In New York City, there are always more fire
trucks at bigger fires.  Hence, more fire trucks
are associated with bigger fires, but more fire
trucks do not cause bigger fires.

Here are some links for your consideration:
Dr. Andrew Saul's testimony before Canadian Parliament on Vitamin safety.
I have published a couple of Dr. Saul's interviews with accomplished nutrition researches. These came from the Doctor Yourself newsletters. Here's some links in case you missed them in the past:

• Dr. Bruce Ames. He is specifically asked about vitamin E supplements in this interview and supplements in general.
• Dr. Michael Holick. Probably the most accomplished vitamin D researcher in the world. He is also asked about vitamin D safety and vitamin supplement safety in general.

Update

[/health/vitamins]     0 comments     permalink

Vitamin E and C Warnings

[/health/vitamins]     1 comment     permalink

New Edition of Pauling's Book

Well, I am glad that I haven't gotten this book yet. It is a classic that I have mentioned before and has inspired many people in the various natural health movements over the years. More info...

[/health/vitamins]     0 comments     permalink

Contact Me:
bobber at kc0dxf dot net

Music Sites

Guitar Builders and Luthiers

Running

Frequented National Blogs

Internal

Columnists (political)

Columnists (technical)

Health and Nutrition

Big Shark Team Cyclists

Other Cyclists

Health Care Reform

Paleo (Hunter Gatherer) Diet (and related diets)

Christianity

Historic Christian Confessions

Classical Education

Routed Slot Car Tracks

Training With Power

Cycling

Ultrafit

Digital Cameras

Sporting Goods and Bike Shops

Technical

Transcendent Music

Utilities