Quality Manufacturing: Establish Rules

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Last week’s Memos were about supplements that were tainted with pharmaceuticals. What can manufacturers do to insure their products are not tainted? Mistakes can always happen, but what can be done to get those errors as close to zero as possible? That’s what we’ll cover this week.

Let’s begin with this premise: no manufacturer of dietary supplements grows every plant they use or makes every vitamin in their supplements. There’s nothing wrong with that because the growth and production of supplements is so complex. However, there are two things that a manufacturer can require from their vendors.

First, that they follow specific guidelines in the growth of plants: what type of seeds, what type of organic herbicides, how the plants must be harvested, and on and on. Following guidelines would also be required of outside companies who make vitamins and process minerals.

Second, all vendors’ products would be tested for contaminants upon arrival before any final products are made. If they do not meet the guidelines, the shipment is rejected.

Monitoring the quality of ingredients is the first step in making sure a dietary supplement contains untainted ingredients. I’ll cover another in Thursday’s Memo.

What are you prepared to do today?

Dr. Chet

 

Tainted Supplements: Buyer Beware

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There was a big problem with the papers that were published in JAMA and the resultant media headlines: the authors and commentator lumped the tainted products into a single category of dietary supplements and categorized these questionable manufacturers and their tainted products with all manufacturers of dietary supplements. That was simply wrong, and people in health news know better. There will always be unscrupulous companies out to make a quick buck and laughing all the way to the bank.

Some of the tainted products are still on the market today. Most are available only online, and their websites contain no information about the company who makes them or how they were made. They might simply be the same product sold under different names; there’s no way to tell.

The everyone-in-the-pool approach used by the authors reflects an underlying belief that the FDA should give approval to every dietary supplement. There are healthcare professionals who don’t like supplements of any kind. With this kind of news, they make the leap that all supplements are equal, and thus all require more restrictive oversight to stem the tide of tainted supplements. That’s just foolish. Quality manufacturers that want to continue to be in business follow the rules set out by the FDA for dietary supplements. Fly-by-night companies won’t, no matter what the laws say.

Buyer Beware

The articles do raise an important concern: how do you know whether the products you’re buying are made by a reputable manufacturer or not? After all, you’re going to be putting them in your body. Do your homework, just as you might do with any other consumable product. Check out the company online to the extent you can. The more information you can find, the better. If there’s not much info, consider that a red flag.

But how do you know what to look for? I’ll cover that in next week’s Memos, so make sure you don’t miss them.

What are you prepared to do today?

Dr. Chet

 

References:
1. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3337.
2. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3329.
3. FDA Database: http://bit.ly/2Pyq0B3

 

Which Products Were Tainted?

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The logical concern is this: what products were on the list of supplements that made up all those headlines? There were over 700 products on the FDA list of tainted products, so I think there’s a better way to ask the question: what were the categories of products?

1. Sexual performance was the overwhelming leader.
2. Weight loss was second.
3. Muscle building also made the list.

The problem with the sexual performance products was that they contained actual Viagra, Cialis, or one of the other medications used for erectile dysfunction. The weight loss products contained a pharmaceutical that has been taken off the market because of side effects. Most of the problematic muscle-building products contained anabolic steroids. When people take these types of medications pitched as dietary supplements without knowing what’s in the product, the potential for unexpected consequences is substantial and could threaten their health.

I reviewed the entire list of supplements on the FDA list and found no products—not one—offered by a reputable company. No multivitamins. No antioxidants. No herbals such as echinacea.

Here’s the bottom line: these were not dietary supplements, they were pharmaceuticals that skirted the FDA regulations for pharmaceutical and over-the-counter drugs and the FTC rules for honesty in advertising. But that’s not what the paper’s authors and the commentator said. We’ll finish this on Saturday.

What are you prepared to do today?

Dr. Chet

 

References:
1. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3337.
2. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3329.
3. FDA Database: http://bit.ly/2Pyq0B3

 

Tainted-Supplement Headlines

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I’d like you to read these three headlines, stop, and identify the first thought that comes to your mind:

“Hundreds of Supplements Are Tainted With Hidden Pharmaceutical Drugs”

“Hidden Drugs and Danger Lurk in Over-the-Counter Supplements, Study Finds”

“Supplements Often Tainted by Hidden Drugs”

No matter what supplements you’re taking, the thought “I wonder what’s really in my supplements?” must have passed through your mind, even just for a second. I know my readers were thinking that. Should you be concerned? Will that multivitamin or B complex you’re taking contain something dangerous?

That’s the takeaway from these headlines about a paper published in the JAMA Network Open journal (1). The article had a corresponding commentary criticizing the FDA for dereliction of duty in not seeing that these products were removed from the marketplace. (2).

There are some important lessons here and this is the first one: while numerous publications called this a study, it was not. A few scientists reviewed the FDA website that listed tainted products marketed as dietary supplements; the FDA had sent warning letters to the manufacturers to stop selling the products. The authors grouped them by category of product type and then spent eight pages talking about them. According to the paper, they did nothing else—no other investigation or analysis.

The type of products that made the tainted products list wasn’t surprising if you closely follow health news. I’ll tell you what they are on Thursday.

What are you prepared to do today?

Dr. Chet

 

References:
1. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3337.
2. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3329.
3. FDA Database: http://bit.ly/2Pyq0B3

 

Vitamin D: Stay the Course

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Let’s finish this look at the recent paper on vitamin D (1). As you could read in Thursday’s Memo, they included some curious studies in their review. Let’s take a look.

Mixed-Purpose Studies

Have you ever eaten leftovers? Sure. Did you take all the different leftovers—the spaghetti, the fried rice, the mashed potatoes and gravy—mix them together in a stew or smoothie, and eat them? Probably not. And that’s the primary problem with this review paper: too many different types of studies.

There were enough papers using very high doses of vitamin D administered orally to the elderly that could have been combined. There certainly were enough studies to use only 800 or 1,000 IUs that could have been combined.

It is not the statistics; it’s the physiology and biochemistry. There’s going to be a difference in how the body utilizes 100,000 IUs at one time versus 1,000 IU every day for 100 days. That has to be acknowledged as a possibility. That it wasn’t illustrates a typical problem in these types of studies.

The Pharmaceutical Model

The real weakness of the studies that were included in this review was that the vitamin D was used as a treatment for a disease rather than as a nutritional supplement. What gets lost in translation is that in several studies where vitamin D was used to address low vitamin D levels in the elderly with and without fractures, there was actual improvement in bone-mineral density.

It begs the question: why would you give astronomical doses to healthy people? That’s what they did in communities of elderly residents. Their intentions were good (they wanted to try to prevent fractures and falls), but it’s a lousy approach. Would you give someone a one-month dose of a blood pressure medication? You could kill them. If you’re going to use a vitamin that has robust uses in the body, you have to respect it. They considered it a nutrient, but used it as a drug.

The only issue that I could find with the high doses of vitamin D is that for some reason, they were associated with an increase in falls. That seems inexplicable to me, but it was a consistent observation at high doses of vitamin D. The only reason I would consider it suspect was that in most studies included in the review paper, people self-reported falls. Still, it was there.

The Bottom Line

The overall problem with this review of vitamin D is that the authors considered only a single factor; bone building is dependent on a variety of nutritional factors that were never considered. Most of all, the great majority of the studies didn’t consider the role of exercise: fewer than five of the 81 studies gave any mention to exercise. In order for bones to grow and recover, they must be stressed on a regular basis. There’s no way to come to the conclusions the authors did without that data.

While researchers looked at only a single factor involving the musculoskeletal system, the immune and nervous systems can still benefit from vitamin D even if bones don’t benefit as much as some supplements promise. Vitamin D has also been shown to help mental health and depression. Some day nutrition research will be done correctly, but it wasn’t served very well by this paper or the studies that were included. I found no reason to stop taking vitamin D as a supplement. In fact, it’s time to increase your dosage as the days get shorter and your sunlight exposure decreases.

What are you prepared to do today?

Dr. Chet

 

Reference: DOI:https://doi.org/10.1016/S2213-8587(18)30265-1.

 

A Potpourri of Research on Vitamin D

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Scientists try to follow some strict guidelines when they select studies to be included in a meta-analysis. With that in mind, here’s some of what I found in reviewing the studies. Remember, they were looking at fractures, falls, and bone-mineral densities.

  • The length of the studies ranged from as short as eight weeks to as long as seven years. The most popular study length was one year, second was two years.
  • Most of the studies focused on the elderly. Falling and fractures are obvious concerns for that population. But they also included papers on post-parathyroidectomy patients of all ages, renal transplant patients, and young patients that were HIV positive where falling and fractures were not obvious consequences of the age group.
  • For the most part, they selected studies with vitamin D taken via oral supplements. But they also used cod liver oil, with and without vitamin D, as well as intramuscular injections.
  • This one was just simply puzzling. The range of vitamin D administered to the subjects was as low as 400 IU and as high as 600,000 IU in a single dose. Some gave oral vitamin D at 100,000 IUs four times per year, injections of 300,000 IU and 600,000 IU, and one study administered 300,000 IU in a single oral dose.

You don’t have to have any type of scientific degree to see the problem with the apples-and-oranges selection of the studies. Competent scientists may be able to account for differences statistically to do the analysis, but they can’t account for the varying physiological impacts on the subjects.

I’ll finish this up on Saturday.

What are you prepared to do today?

Dr. Chet

 

Reference: DOI:https://doi.org/10.1016/S2213-8587(18)30265-1.

Update: Vitamin D’s Health Effects

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With all the political headlines last week, an important health headline could have been overlooked. A group of scientists published a paper suggesting vitamin D doesn’t prevent fractures and falls or help increase bone-mineral density, and they recommended that it not be used for that purpose. I’m a strong believer that vitamin D is one of the fundamental supplements we should take, so I took a close look at this paper.

Typically I call this a Research Update, but I’m intentionally not calling it that this time because there’s no new research in this paper. This was a research review paper that included a re-analysis of prior research, some 81 studies. That’s a meta-analysis, a statistical technique that has risen in popularity in the past 10 years. In fact, it really only included research published since 2014, the last time some of these authors did the exact same analysis. Based on the prior research of the statistician involved who was the lead author, I have to believe the math is correct.

The problem is in the selection of the studies. I did something I don’t always do. I examined almost all of the abstracts of the 81 papers that were used in the meta-analysis. It was tedious to say the least. To be blunt, I don’t understand how some of the papers were selected. On Thursday, I’ll give you the run down on the research review part of the paper.

What are you prepared to do today?

Dr. Chet

 

Reference: DOI:https://doi.org/10.1016/S2213-8587(18)30265-1.

 

Absolutely True, Relatively Meaningless

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In this final Memo about the retraction of several of Dr. Brian Wansink’s publications, there are several important questions that need to be addressed. What do the errors mean? Did Dr. Wansink intend to deceive? Finally, who was making the accusations?
 

Publication Errors and What They Mean

Let’s take a look at the errors I mentioned on Thursday. The first was continually analyzing the data to come up with new hypotheses—that’s not the way research is supposed to be done. In this case, the data were collected via questionnaires after eating at a buffet in a small town restaurant. The purpose was to see if the price of the buffet influenced whether people felt better or worse about their food choices. This wasn’t the best study idea Wansink ever dreamed up; I don’t see the results of this study impacting the obesity epidemic in any way, even if the data were pristine and analyzed precisely without the data churn that came afterward.

The second error pointed out by the post-article reviewers all related to statistical errors. They questioned the data being carried out to the hundredths of a point and stated that there were errors in calculating the means. These were survey results using a Likert scale and should never have been presented other than in whole numbers or at best, to half a point; going to the hundredths just makes no sense. It would have been better to recommend that to the authors than make a big deal about deceptive statistical errors. They also found that the number of subjects continually changed in some analyses: one test said 122 subjects while another said 124. There may have been a degree of ineptitude but again, no attempt to overtly deceive.

Finally, regarding the plagiarism accusation. Wansink did what many authors do: he used prior text taken from his own prior publications and inserted them into articles as appropriate. They should have been cited, but when you re-use what you’ve already written that’s not plagiarism, that’s an oversight or a bone-headed error.
 

Did Dr. Wansink Attempt To Deceive?

I read Dr. Wansink’s blog post that started this whole mess. What he attempted to do was illustrate how new researchers can get published. He had no attempt to deceive anyone. As the blog got more play in the scientific universe, he took some pretty big hits and not in a nice way. He answered every one with respect, including several from one of the accusers.

I came away thinking that Dr. Wansink didn’t understand the ramifications of continually analyzing data with changing hypotheses. In addition, he was not the best statistician and would have been helped tremendously by help from someone who really understood numbers.
 

Who Were His Accusers?

I checked out three of the primary accusers, two of whom had published the article mentioned in Thursday’s Memo (1). They all seem to be fascinated with numbers and scientific purity.

One was a retired physics professor; in his entire academic career, he published two research papers and that was over 30 years ago. He was primarily a physics teacher and retired 19 years ago. My problem isn’t his age, it’s that he hadn’t done much in his own field, let alone Wansink’s.

A second is a PhD candidate in the social sciences. If anyone understands the mess the use of observation and questionnaire testing can present in behavioral research, it would be him. It’s curious that he wouldn’t make that a key element of his paper.

The final accuser was a PhD/MD candidate who was kicked out of his program by his advisors, according to his blog. That gave him plenty of time to do the most in-depth and longest review of Wansink’s papers.

This may sound cruel but what we have is a never-was, a wannabee with very limited experience, and a never-will-be. Not exactly a stellar cast of accusers. They were absolutely correct, but what they showed is relatively meaningless.

What I didn’t see was a review of Wansink’s paper on the never-ending soup bowl (2), maybe because it was based on actual numbers because the amounts of soup were measured. They also failed to mention that another study was replicated and confirmed by another lab (3); it was on how the names of food influences whether children and young adults will eat more vegetables.
 

The Bottom Line

In spite of the publications being retracted, and with that, the forced retirement of Dr. Wansink from his Lab, there’s still value in the research that he’s published. He seemed to be more an idea guy than a bench scientist. Makes sense: his PhD was in marketing so he tried to research people’s attitudes about food. He just didn’t know how to do it very well from a science perspective.

If you want to control your eating, use a smaller plate, plate your food away from the table and don’t add any more, and keep all snacks out of sight. Proof or no proof, those are still good recommendations.

What are you prepared to do today?

Dr. Chet

 

References:
1. BMC Nutrition. doi.org/10.1186/s40795-017-0167-x.
2. Obes Res. 2005 Jan;13(1):93-100.
3. AMA Intern Med. 2017;177(8):1216-1218. doi:10.1001/jamainternmed.2017.1637

 

The Reasons for Retraction

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Publications related to food habits are important if you’re in the weight loss field; I rely on them to help people achieve their weight loss goals. If the studies were poorly done, that’s unfortunate but behavioral science is an inexact science anyway. But if someone intentionally manipulated the data to get a specific outcome, that’s just not right. Let’s see what several scientists found when they examined Dr. Wansink’s data more closely. What were the problems?

It seems there were three. First, as I mentioned on Tuesday, he had a graduate volunteer continue to examine the data to come up with hypotheses that were significant. That means they organized the data differently and kept running statistical analyses until they came up with something that was statistically significant. As I said, that’s a no-no because of the potential of finding something by chance; you get the best answers to the questions you actually ask, so finding something by accident is not as valid among scientists.

Second, there were errors in the way data were displayed. The reviewers made a very big deal of granularity and how the means displayed weren’t possible. I’ll leave that to the people who specialize in statistics.

Finally, they accused him and his colleagues of plagiarism. If there were an absolute violation of science, that would be it.

But as you might expect, not everything is always as clear as people make it out to be, and I’ll explain that on Saturday. Until then, I would still keep the snacks out of sight and continue using that salad plate instead of a dinner plate in order to eat less.

What are you prepared to do today?

Dr. Chet

 

Reference: BMC Nutrition. doi.org/10.1186/s40795-017-0167-x.

 

Scientific Retractions

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One of my favorite observational scientists has been Dr. Brian Wansink, former Director of the Food and Brand Lab at Cornell University. I’ve written about his research and used it in presentations several times over the years. One of my favorite tips came from one of his studies: use a salad plate instead of a dinner plate. It cuts down on the food you take at one plate-full by about 25%.

That’s why I was dismayed when I read that several of his papers have been retracted from JAMA and other publications. There are many reasons why a paper can be retracted: problems with data and statistics, questionable research techniques, or unsubstantiated conclusions. Evidently, there was some of all of those accusations, which resulted in the papers being retracted.

Of course I had to check this out. What did he do? How did his papers become suspect to begin with? Who was involved in this process? I’ll answer part of the who right now. It was Wansink himself with a blog post talking about collecting data and then using multiple statistical analyses to get to a hypothesis in a couple of studies. That’s a very big no-no in science.

But due to the nature of his observational research, does it mean all of his work on relationships between habits and food is worthless? We’ll find out this week.

What are you prepared to do today?

Dr. Chet