Medicine For People!
- 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
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.
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?
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 (PDF) that "analyzes" vitamin tablets for manufacturers. 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.
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.
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.
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.
There are a number of high bidders in the supplement industry. Some of those high-bidders sell multi-level marketed vitamins. 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.
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. 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.
Here is accounting for our nutritional dispensary for the second half of 2006.
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
Error finance charge 1st half.......................376.00
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!
Medicine for People! is published by Douwe Rienstra, MD at Port Townsend, Washington. Edited by Carolyn Latteier.