[Medicine-for-people] Supplements: Beware the Lowest Bidder

Douwe Rienstra medical at olympus.net
Sat Mar 24 16:52:17 PDT 2007


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Medicine for People!

April 2007
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Contents
Supplements: Beware the Lowest Bidder
 - What's in the Capsule?
 - How Do You Know the Pill is Any Good?
 - Testing Supplements
 - Investigating Supplement Companies
 - Why Care About Quality?
 - What are the High-Cost Options?
Semi-annual Non-Profit Dispensary Report
Medical School in Port Townsend

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Beware the Lowest Bidder:  Choosing Supplements for Health
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== What's in the Capsule ==
One of the more trenchant comments about the 1960's space program came from
astronaut John Glenn:  "As I hurtled through space, one thought kept
crossing my mind:  Every part of this capsule was supplied by the lowest
bidder."   While he returned safely, we can't say that for every astronaut.

Last month we published our recommendations for supplements to maintain a
healthy brain as we age.  We gave a low-cost and a high-cost option (along
with news of a significant discount on the high-cost option.)  This month I
look closely at the difference between supplements and explain why buying
at the low end may not be most economical choice.

== How Do You Know the Pill is Any Good? ==
Medications and supplements are a bit like a meal in a restaurant.  The
higher priced meal is most likely to be tasty every time, while the
hamburger in the greasy spoon will have its good days and its bad days.
Sometimes patients find that the generic drug, the low-bid drug, is not as
effective as the brand name.  This happens often enough that doctors have a
couple of abbreviations to use on the prescription to tell the pharmacist
not to substitute a generic.  DAW means "dispense as written" and DNS means
"do not substitute."

The situation is similar with nutritional supplements; the low-cost option
may do the job, or it may not.  How do you know?  Your joints feel better
or they don't.  You tolerate the supplement or you become nauseous.

It's more difficult to judge supplements used for prevention, which is why
this topic follows our series on brain aging.  The noggin takes years to
wear out; how can you be sure those supplements are doing their job of
prevention?

== Testing Supplements ==
One way to measure supplement quality is in a laboratory.  I paid for part
of my medical school costs by working in the laboratory at the Veteran's
Hospital in Durham, North Carolina.  In exchange for room and board, nine
of us medical students (and one physiology graduate student, Bill Matthews,
now a marine biology consultant here in Port Townsend) ran the hospital
laboratory at night.  One man on duty, one in reserve, eight sleeping.
We'd had a brief course and relied on a three ring binder of protocols to
help us through the procedures.  For blood transfusions, we'd spend half an
hour setting up a series of test tubes containing mixtures of the patient's
blood and a sample from the donated blood.  We'd look under the microscope
to be sure the cells weren't clumping, then call our back-up to confirm.
We both had to sign or the blood wasn't released.  Each of us can remember
occasions in the wee hours when the number one guy would be badgering
number two to agree that the cells weren't clumping, and number two, who
could go back to bed as soon as he declined to sign off, would say "no,
they're clumping." "Well, it's just a few clumps." "No."

Today hospital laboratory workers are much better trained then we were.
Even then, the daytime lab crews would calibrate the equipment and run
blind test samples to test their accuracy.  Then and now, credentialing
agencies give unknown samples to the labs to be sure they come up with a
number that is close to correct.  It isn't easy.  There can be other
substances in the blood, sometimes prescription drugs, that interfere with
the analysis.  Blood levels of anything we measure are always approximate.
 We can only work to be sure our errors are small and close to the correct
answer.

That's why our office occasionally tests the laboratories we use.  For
example, a couple of years ago we had put considerable time into a new
service, a preventive evaluation involving laboratory testing for adequacy
of certain nutrients in your system.  I sent off two samples to the company
without telling them that they came from the same individual.  They sent
back completely different answers.  End of that particular project!

Similar problems plague testing of nutritional supplements.  When I started
our nutritional dispensary, I'd ask vendors for a product analyses from an
independent laboratory.   I'd assume the assay was in the ballpark of the
correct answer.  I don't any more.  In 2004, Al Czap from Thorne Research
"tested" a laboratory that "analyzes" vitamin tablets for manufacturers
(http://thorne.com/media/editorial9-4.pdf).  Two bottles, two different
claims on the label, same capsules inside.  The lab conveniently found that
the capsules contained vitamin levels close to what the label clamed.  When
the label read 18 milligrams of vitamin B6, they reported a lab result of
19 milligrams.  When the same capsule was packaged in a bottle that carried
a label of 36 milligrams, they reported a lab result of 36.5 milligrams.
Now, probably the manufacturers that use this lab are making an effort to
get the correct amount into the capsule, but obviously they've not tested
the laboratory.  They are happy to find their assumptions are supported by
the lab result and go on their merry way.

== Investigating Supplement Companies ==
A few months ago, I spent some time  investigating the products I recommend
for brain health.  I called a major online supplement distributor,
hereinafter called BigEasy.  This company had received a passing grade from
an online rating service. Even after identifying myself as a physician, the
most knowledgeable person they could find to answer my questions was
someone (I'll call her Sue) who obtained her information from a computer
screen.  Sue told me that BigEasy buys their phosphatidylserine from Aceto
Corporation, a large chemical substance jobber which buys it from someone
else.

While BigEasy does not say so on their website, Sue noted that their
phosphatidylserine product incorporates gelatin, sorbitol, coloring,
caramel, glycerin, and titanium dioxide.  Now, most people can consume
those things without harm, but an honest label would include them.  While
Sue did not mention magnesium stearate, almost all encapsulated supplements
contain it.  Magnesium stearate is a fatty substance present in most
commercial supplements that reduces the cost of manufacture but can combine
with active ingredients and upset the stomach when many capsules are taken.
 Most manufacturers leave this off the label.

Sue didn't know and could find no information that heavy metal testing was
standard for their incoming raw materials.  When asked how they handled
quality control, she clicked a few times and read me a statement that
BigEasy "subscribes to Good Manufacturing Practices."  (These are in 2007
the lowest common denominator of product quality control in the United
States.)

I checked up on similar products from Thorne Research, a company that sells
only through health care providers.  When I quizzed Thorne Research, my
questions were answered by a PhD biochemist on one occasion and a
naturopathic physician on another.  Dr Roxas told me that Thorne buys
phosphatidylserine from Fidia Research Foundation, the company in Italy
that originally developed phosphatidylserine for medical use.  When
researchers study phosphatidylserine, they buy it from Fidia.  When you see
a study showing the PS is helpful, that study was on Fidia PS. There is
nothing in the capsule except what is on the label, nor is there gelatin.
There is no magnesium stearate, which means that Thorne can't run their
encapsulating machines at the extremely high speed possible when that
slippery substance is added to the fill material.  Fewer capsules per day
out of each expensive encapsulating machine means higher costs.

In contrast to most other companies, Thorne representatives will talk all
day about how they maintain product quality
(http://www.thorne.com/quality_control_at_Thorne.wss).

While Thorne is not shy about selling products that cost more than the
competition, I was surprised recently when choosing an L-tryptophan
product, to see how close their price was to a competitor who seemed also
to be making efforts to produce a quality product.

== Why Care About Quality? ==
The "Odd Couple" entertained us with the interactions of Felix Ungar, the
perfectionist nerd, and his roommate Oscar Madison, the easy-going
sportswriter.

There is no law saying that only Felix Ungar types can start a supplement
company.  Oscar Madison types can, too.  Usually there is little risk;
these companies aren't making chemotherapeutic agents, but on occasion, the
consequences can be severe.  In the 1980s, one Japanese company produced
all the L-tryptophan for the world market.  They developed a new method of
genetic engineering to produce it. What they didn't know was that sometimes
this process resulted in an impurity in the L-tryptophan.  When the
low-cost manufacturers received their fifty-five gallon drums of the
contaminated L-tryptophan, they just ran it though their capsule machine.
As a result, over thirty people died from eosinophilia-myalgia syndrome due
to the impurity (http://en.wikipedia.org/wiki/Eosinophilia-myalgia_syndrome).

Again, this is unusual, and you are as unlikely to die from a nutritional
supplement as you are to become ill from eating hamburger or spinach.  But
if you wish to be sure there are no surprises in that hamburger or spinach
or vitamin C, be careful where you buy it.  The lowest bidder has other
concerns than product quality.

== What are the High-Cost Options? ==
There are a number of high bidders in the supplement industry.  Some of
those high-bidders sell multi-level marketed vitamins
(http://www.rienstraclinic.com/newsletter/2002/2002Nov.html).  Everyone on
the pyramid takes a bit of profit, and that's what you're paying for.
Others behave like Felix Ungar.  They fuss.  They put their money into
their product.

How do you find those careful companies?   My advice is to look on our
shelves; we are very careful about what we put on them.  Jonathan Wright,
MD, is a perfectionist; look at his dispensary
(http://www.tahoma-clinic.com/shop/default.php).

While there are a number of competent supplement manufacturers, Thorne
Research is the only one as of this writing to be certified by the
Australian Therapeutic Goods Administration
(http://www.tga.gov.au/cm/cm.htm).  The Australian TGA sets the bar for
nutritional supplements higher than most other countries, so that Thorne's
TGA certified products qualify for sale in the international market.

When you are taking supplements for prevention, you can't rely on your
joints or blood pressure to tell you whether or not that supplement is
effective.  You can only rely on the integrity of whoever manufactured that
supplement.  Making a conscious and informed choice, you may have a little
more relaxing time than John Glenn in orbit.

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== Semi-annual Non-Profit Dispensary Report ==
Here is accounting for our nutritional dispensary for the second half of 2006.

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Income from product sales...................25,956.73

Cost of goods ........................................19,548.48
Labor costs	..........................................6,314.22
Rent, utilities, accounting, VISA charges,
taxes, licenses, and a small fraction of
office operating expenses.....................3,961.60

Net.........................................................(3,867.57)

Error finance charge 1st half..................376.00

Corrected net........................................(3,491.57)
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I inadvertently overstated the inventory financing costs for the first half
of 2006, and subtracted that from this semiannual statement.  That gives us
a $444 profit for the first half of 2006, and a $3492 loss for the second
half.

If you wonder how we can lose on this, I have to tell you I sometimes
wonder, too. The factors are:

 -- Our low volume operation has no economies of scale such as bar codes,
scanners, etc.
 -- We give a discount on most everything we sell.
 -- We have high labor costs per unit sold
 -- We don't qualify for volume discounts from vendors

Which is why Walmart isn't snooping around to learn our secrets!

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Monre Street Clinic News
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Dr Rienstra is offering a series of four classes to help you understand
important issues important to health and longevity.  Learn more at
www.RienstraClinic.com.

=====================

=== Recent issues of Medicine for People! ===
Brain Health as We Age Part 12 - The Final Chapter
http://www.rienstraclinic.com/newsletter/2007/2007Mar.html
Brain Health as We Age Part 11 - Reason for Hope:  Nutrients to Preserve
Memory and Sharp Thinking  February, 2007
http://www.rienstraclinic.com/newsletter/2007/2007Feb.html
Janaury, 2007  Brain Health As We Age Part 10 - The Hippocampus, Seat of
Memory http://rienstraclinic.com/newsletter/2007/2007Jan.html
December, 2006  The Shingles Vaccine: is it Right for You?
http://www.rienstraclinic.com/newsletter/2006/2006Dec.html
November, 2006 Brain Health As We Age Part 9 - Dementia - Know Thy Enemy
http://www.rienstraclinic.com/newsletter/2006/2006Nov.html
October, 2006  Brain Health As We Age Part 8 - Phosphatidylserine Preserves
Brain Function thru Membrane Support; Not-For-Profit Nutritional Dispensary
http://www.rienstraclinic.com/newsletter/2006/2006Oct.html
Septermber 2006 Brain Health as We Age Part 7 - Homocysteine, Folic Acid
and Vitamin B-12 http://www.rienstraclinic.com/newsletter/2006/2006Sep.html
August, 2006 Health Care Finance Reform: Small Changes; Big Results
http://www.rienstraclinic.com/newsletter/2006/2006Aug.html
July, 2006 Brain Health as We Age Part 6 - Microinflammation and the Brain
http://www.rienstraclinic.com/newsletter/2006/2006Jul.html


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Medicine for People! is written by Douwe Rienstra MD, edited by Carolyn
Latteier, and published at Port Townsend, Washington. Copyright April, 2007.

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