Tag Archive for: FDA

Dietary Supplements: Certified

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Recently I watched a webinar on mitochondrial health and athletic performance co-sponsored by the American College of Sports Medicine and a nutritional company. The speakers were a clinical researcher and a PhD dietitian for a professional basketball team. I’m going to review what the clinical researcher talked about on Saturday.

Today I’m going to focus on a comment by the dietary specialist. She believes as I do that supplements complement a good diet, but when she started talking about dietary supplements, she said they aren’t regulated by the Food and Drug Administration. At that point, I would typically stop listening because she’s incorrect; both the FDA and the FTC regulate dietary supplements; it’s just done in a different way than over-the-counter medications and pharmaceuticals.

Then she said that whatever supplements she recommends to her players, she looks for products that are certified by NSF or the United States Pharmacopeia (USP). I agree. These are not easy certifications to obtain. It isn’t just that the supplement is tested once and it’s over—it’s an ongoing process that costs a lot of money for the company, but they’re industry standards. Certification is something you should consider when you purchase dietary supplements of any type but especially related to sport performance.

What are you prepared to do today?

        Dr. Chet

Teaching Doctors About Supplements, But Not Really

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If you haven’t watched the videos that I talked about Tuesday, please take the time to watch them, preferably before you continue reading—I’d like you to form your own opinion about the videos before you get my perspective. I came away with three opinions about the videos, other than they really focused on dietary supplements not being approved by the FDA. Of course, no legitimate healthcare professional or supplement manufacturer ever said they were; consumers may not know that, but I would hope doctors did.

First, the second video discussed potential drug-supplement interactions. There have been few direct studies on those interactions; most are case studies involving the use of herbs such as St. John’s wort and ginkgo biloba that have been published in peer-reviewed journals. What they don’t say is that very few studies have examined drug-drug interactions either. How do they find out about them? Trial and error from reports to the FDA’s adverse effects reporting system.

That addresses my second opinion. There was a strong focus on reporting adverse events from dietary supplements to the FDA. One would think that’s a good thing, but the list of adverse events they listed included every system in the body. I get reporting an allergic reaction, but how would a physician attribute gastrointestinal or cardiovascular issues to a dietary supplement after putting the person on a new medication? It’s just as likely to be due to the medication. Seems to me like an open door to lots of irrelevant reports.

Finally, they spoke about some supplements interacting with blood tests. The only one I’m aware of is excessive biotin intake affecting the troponin test for potential cardiac events. One would expect an extensive list would be provided; the problem is none exists because that’s the only known interaction.

The Bottom Line

There are 13 vitamins. There are dozens of minerals, most found in trace amounts. There are hundreds of herbs, plus nutrients that don’t fall into any of those categories. All can be found in dietary supplements. If I were a physician who spent time watching the videos, I really wouldn’t know more about those nutrients in supplements than I did before I watched. I would have learned only two things:

  • The FDA does not have the authority to approve dietary supplements.
  • If a patient takes dietary supplements, anything bad that happens in the body should be reported as an adverse event.

A lot of red flags were waved when the issues deserved a yellow flag at most. I can think of only one word: sad. With the lack of training and knowledge about supplements among doctors, I think those two organizations could have spent their money better and created videos that would have really helped doctors and their patients.

What are you prepared to do today?

        Dr. Chet

References:
1. https://www.youtube.com/watch?v=GYJYPCJmspE
2. https://www.youtube.com/watch?v=qqyP-vbtlZY

Teaching Doctors About Supplements

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In late May, the Food and Drug Administration (FDA) in partnership with the American Medical Association (AMA) released two short videos to teach physicians about dietary supplements, plus a third aimed at consumers.

The first video spent time defining and explaining what a dietary supplement is, the delivery systems companies use such as tablets,  gummies, bars, etc., and the role the FDA plays in the process. The second video focused on adverse events, how to report them, and a sample conversation between a doctor and patient. I encourage you to watch the videos at the links below.

I think there are two important points of the videos. First, the FDA does not approve dietary supplements in the same way that they approve pharmaceuticals—obviously their main point because it was repeated several times. In exchange for allowing supplements to be introduced quickly, companies do not have to prove safety or effectiveness. However, if they make any health claim, they must report that to the FDA within 30 days of making the claim. Those claims are restrictive; a company can’t say on the bottle or promotional materials “cures heart disease” but can say “contributes to a healthy heart.”

Second, you should always discuss the supplements you take with your physician, especially if you take medications. It can be a pain if you take a lot of supplements, but you must do it because there can be interactions. For example, calcium, whether from food or a supplement, interferes with the absorption of thyroid medications. They should not be taken together (which is tricky because it’s recommended thyroid meds be taken at bedtime when you may be taking a calcium-magnesium supplement to aid sleep).

Those are what I see as the positives of these videos that cover supplement companies and patients; there’s no information about how supplements work or which supplements do what. I’ll cover that aspect of the videos on Saturday. In the meantime, take the time to watch both 10-minute videos.

What are you prepared to do today?

        Dr. Chet

References:
1. https://www.youtube.com/watch?v=GYJYPCJmspE
2. https://www.youtube.com/watch?v=qqyP-vbtlZY

It’s Official: Prescription Fish Oil

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The U.S. Food and Drug Administration approved the prescription fish oil Vascepa for expanded use on Friday, December 13. The approval for the medication is for the secondary prevention of cardiovascular disease in patients under the following conditions:

  • Triglycerides above 150 mg/dl for everyone with diagnosed CVD and taking a statin medication.
  • Diabetes and two or more additional risk factors for CVD along with taking a statin medication.

The modifiable risk factors for CVD include smoking, obesity, high cholesterol, hypertension, and sedentary living. Remember from our prior series, secondary prevention may help reduce the risk of CVD symptoms developing.

My concerns are the same as they were before. Triglycerides less than 250 mg/dl can be resolved by diet and exercise in most people. Because the mechanism of action is unknown as to how the prescription works, there’s no reason to think that reducing triglycerides by lifestyle change won’t work as well as the prescription; the clinical trial didn’t track this data.

Speaking of lifestyle change, keep in mind the website specials on the Optimal Performance program as we get ready for the New Year. The Basic Meal Plan will teach you how to change your diet to reduce triglyceride levels if your levels are too high.

What are you prepared to do today?

        Dr. Chet

References:
1. http://bit.ly/36EbsYK
2. N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Primary vs. Secondary Meds

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One of the key questions for the FDA advisory panel to consider was whether the prescription fish oil was a primary preventer of cardiovascular disease or a secondary preventer. What’s the difference? Primary prevention of CVD would impact the disease and stop events before they occurred in the subjects taking the fish-oil medication. Secondary prevention would prevent additional CVD events from happening in those with established CVD.

If you were a type 2 diabetic with an additional risk for CVD such as obesity or being a smoker, taking the prescription fish oil with a statin would prevent a heart attack or stroke from happening; that’s primary prevention. Based on the Reduction of Cardiovascular Events with Icosa-pent Ethyl–Intervention Trial (REDUCE-IT) that didn’t happen, but it did prove to be a secondary preventer of additional cardiac events in those subjects in the study with established disease.

The question is whether the FDA will approve the prescription fish oil as a primary prevention or a secondary prevention pharmaceutical. The advisory panel seemed split on that count. The assumption by some was that there was disease present even though the event had yet to occur. Others said “prove it” by doing an actual clinical trial to examine that question. We’ll find out how the FDA decides later this year. As I mentioned yesterday, the financial implications are huge.

There are still some things to consider with the clinical trial, and I’ll cover that on Saturday.

What are you prepared to do today?

        Dr. Chet

Reference: N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Prescription Fish Oil Update

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“This Fish-Oil Heart Drug Could Be Big, Could Be Huge.” That was the headline in a well-known financial report after a Food and Drug Administration panel unanimously voted in favor of an expanded use for the prescription fish-oil drug. I mentioned this was a possibility when I first talked about Vascepa in October. The FDA is expected to make a final decision by the end of the year.

What is the expanded use? The medication could be prescribed to those who have established heart disease or type 2 diabetes with another CVD risk factor and are already taking statin medications to lower cholesterol. The advisory panel approved the use because research showed that when combined with statins, it could reduce CVD endpoints such as death, heart attacks, and strokes by an additional 4.8% when compared to a placebo over a 4.9 year follow-up period, 17.2% versus 22%.

One more thing. The medication could be prescribed to those with triglycerides as low as 150 mg/dl. That would include millions more potential users in the U.S. and Canada alone. You can see why the headline was in the financial news; the potential profit for investors could be huge. A lot is riding on what the FDA decides. I’ll explain that on Thursday.

What are you prepared to do today?

        Dr. Chet

Reference: Bloomberg Online. Max Nisen. Posted 11-15-2019.

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

 

The Bottom Line on E-Cigarettes

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Vaping e-cigarettes is supposed to be better than smoking cigarettes because the toxic chemicals will be gone. That may be true for the chemicals released from tobacco and paper, but the third area of concern is the e-liquids that make up the flavor component of e-cigarettes. The marketing tactic often focuses on the variety of flavors available. The question is this: are they safe or do they contain chemicals that could negatively impact the lungs?

Researchers obtained a random sample of e-cigarette liquids from the most popular brands on sale in Greece, Spain, Germany, the Netherlands, the UK, Hungary, Romania, Poland, and France. The samples included a variety of different flavors and nicotine strengths. They analyzed each sample to find out exactly which chemicals were present and in what quantities.

Every liquid container that they tested contained at least one substance that has some level of health risk according to the United Nations classification system. The chemicals, with long complex names, can cause respiratory irritation, allergy or asthma symptoms, or breathing difficulties if inhaled. What they might do when heated is still to be determined.

There were several more research papers presented that also illustrated that e-cigarettes are not problem free. The belief is that they are not as harmful as conventional cigarettes, but the fact is we really don’t know because the components haven’t been tested.
 

Meanwhile There’s the FDA

And they probably never will be tested, at least in the U.S. This past July, the new head of the FDA Dr. Scott Gottlieb announced that he was suspending laws that govern e-cigarettes for five years. In the last administration, the governance over e-cigarettes was turned over to the FDA where they enacted restrictions that insisted the products be tested for safety before being brought to market. Those rules have been suspended so the industry could have time to set standards and comply with tobacco regulations.

I read Dr. Gottlieb’s ruling. As a physician who has treated cancer patients, he has seen what cigarettes do first hand. His belief is that nicotine addiction is the primary issue and that vaping, while not as good as not smoking, may help people quit smoking by using these products to help reduce reliance on nicotine. Gottlieb seems to believe that nicotine, while still addictive, does not kill people; it’s the 5,000 other chemicals in cigarettes that do.

I simply do not understand his reasoning. There are hazards to nicotine, as the research this week has shown. There are chemicals in the e-liquids that have not been identified, have not been tested, and we have no history with their use to investigate. How do we know what health issues we’re facing without finding answers to those questions?

One more thing. Dr. Gottlieb is an investor in a vaping products company called Kure. He has said that he will divest his interest and recuse himself from decisions on vaping for one year. I guess physician years are like dog years; he seems to have made a big decision on vaping after being in office just a few months.
 

The Bottom Line

As a former smoker, I understand the addiction. If vaping products had been available when I quit, maybe I would have used them. As a healthcare professional today, there is not a chance. We’re talking about inhaling substances that have never been subjected to any form of safety or toxicity testing. It’s unreasonable to do that. The studies I reviewed this week clearly show there is doubt. We know how long it took the tobacco industry to finally admit that tobacco was addictive when they had the data all along. The e-cigarette industry has no data at all.

You are a free-living human being. It’s your body, and what you choose to put in it is your choice. I just hope none of it comes from tobacco or e-cigarette products.

What are you prepared to do today?

Dr. Chet

 

Reference: European Respiratory Society. 2017. Abstract OA1978.