Vitamins and Supplements: Magic Pills - the fifth estateMay 29, 2022
component of that is that to reach an optimal blood level, that's the best available evidence showing that 10,000 is what you would need. Gillian: First of all, you didn't take my blood level, I did all this on the computer so you don't know what my blood level is. However, you recommend that I need that kind of -- As a Canadian in the winter, if you're not already taking
supplements, that's -- Gillian: That's your best guess. -- what you require, yes. Gillian: But it's a guess. Oh no, it's definitely an assumption. Everyone has a different response to vitamin D.
When I hear various groups recommend 10,000 IU a day or even 5,000 IU a day on a routine basis, I really want to say show me the data, show me the evidence . Gillian: The evidence is what Dr. Joann Manson is piling up here. The Brigham and Women's Hospital researcher has collected blood samples from 25,000 people, making her study of vitamin D one of the largest in the world. She is comparing disease rates between those who take vitamin D
supplementsand those who don't. The final results will not be known for another two years, but already, Manson has concerns. Many people take too much vitamin D.
The Institute of Medicine also recommended avoiding more than 4,000 IU a day because that could be associated with adverse events. Calcium in the urine which can be associated with kidney stones, high blood calcium, calcium from the arteries, vascular calcification and soft tissue calcification and now there are studies showing a U-shaped curve that those who have high and low blood Vitamin D levels have an increased risk of cardiovascular disease, as well as all-cause mortality. So we can't assume that more is necessarily better. (♪♪) Gillian: Then there's the fish oil. The third most used supplement in North America. Many believe that the Omega 3 contained in the oil is essential for good health.
DHA Omega 3 in particular is extremely important. Gillian: Adam Ismail is CEO of one of the largest fish oil trade associations in the world. There's certainly ample evidence that it helps things like lower blood pressure, lower risk of coronary death, lower triglyceride levels, lower heart rate. Gillian: But the science behind fish oil is a bit more complicated. So these are two capsules. This is an FDA approved product, this is a very commonly sold supplement. Gillian: Preston Mason is a researcher at Harvard University. And give it a smell. Gillian: Smells a little fishy but not bad. Right. So you will always have some smell.
Gillian: One of the problems with fish oil is that it's delicate. It is extracted as a by-product of oily fish such as anchovies. As the fish is ground, the oil is exposed to oxygen and it doesn't take a lot of oxygen to turn it rancid. This is a common supplement for fish oil. Look what that smells like. Gillian: Oh. what? Gillian: That doesn't smell good. That smells like it's going bad. Yeah, sure, yeah. It's a very strong fishy smell. Gillian: If it was just a smell problem, that would be one thing. But oxidized oil contains oxidized lipids, lipids are one of the building blocks of cells.
Scientists have known for a long time that lipids, when oxidized, can cause damage. So oxidized lipids trigger inflammatory responses within our body, particularly in our cells, and if we ingest oxidized lipids, we can trigger these inflammatory changes that can lead to cardiovascular disease. Gillian: No one yet knows at what point oxidized lipids can become dangerous, but over the years, studies have shown that Omega 3 supplements contain high levels of them. In 2002, the industry set a maximum oxidation standard, a voluntary one. And yet, just this year in New Zealand, a study found that 83% of fish oil supplements did not meet the industry standard.
It was shocking to see such a high proportion of products that had high levels of oxidation, so we bought 47 products in the New Zealand market and tested them. Gillian: What was the percentage that you found that didn't meet your standards? It was about 20 percent. Gillian: Would you agree that 20 percent is still problematic? Well -- Gillian: From a consumer standpoint? If it's really 20 percent, then yeah, we'd like to see that 20 percent improved. But even if the industry improves the quality of fish oil, it won't address the other problem of omega 3 supplements and that's the growing evidence that they don't live up to their claims, that they don't help prevent disease.
Two years ago, endocrinologist Dr. Andrew Gray compiled the best studies on fish oil as reported in the world's most prestigious scientific journals. The vast majority agreed. I think cardiovascular disease, one has to say that there's no convincing evidence that taking fish oils protects against first heart attack or second heart attack, so people who are advised to do it or are doing they are wasting time and money. Gillian: But the fish oil industry continues to insist that the benefits are real. We asked the industry association to send us their best evidence which, strangely enough, turned out to include some of the very studies Gray cited and didn't seem to help the case Adam Ismail was trying to make.
He says that it does not seem to reduce sudden cardiac death. Next up, insufficient evidence. JAMA 2012, overall, Omega 3 supplementation was not associated with a lower risk of all-cause mortality. Another diary from 2012, the evidence is not clear that the benefits are almost certainly not as great as previously believed. So that doesn't seem to be suggesting that there is an overwhelming amount of evidence. Yeah, well, I think what you're looking at are the abstracts, and I brought the studies with me so I can show the actual data inside the full articles. Gillian: But the conclusions are the conclusions.
Well, but again, those papers are looking at very broad areas of cardiovascular disease, and, you know, I think it's hard to argue that omega-3s aren't important for heart function. Gillian: It could be true, if you get your Omega 3s from eating real fish. The problem is that science has yet to prove that the same is true for supplements. We would think that something that is natural, that is essential for the normal function of cells and the body, would have clinical benefits. You just have to prove it. There is a lot of major noise or promotion, but we still need robust clinical trials to validate those hypotheses.
Gillian: So, in the absence of scientific evidence for so many supplements, why are regulators so eager to approve them? When we'll return. This tells us that they know the products are of low quality. (♪♪) Gillian: North America's love affair with dietary supplements came of age in the '80s. Everyone, it seemed, was on the quest for better health. That's an antioxidant, synergistic with "E." Gillian: Fed up with a traditional medical system that too often seemed cold and impersonal, people were embracing alternatives. Science was out, nature was in. And an industry was poised to take advantage. Back then, in Canada, most natural health products were regulated as food.
There were no requirements for testing, manufacturers were not required to prove their products were safe or effective before putting them on the market. But some people got sick and that put pressure on the government to do something. It would lead to a battle. Manufacturers and believers against scientists and regulators. Those who have the responsibility to protect public health. The battle first broke out in Washington. Flashback to the turn of the century when snake oil vendors could hawk their potions with promises they couldn't keep. Gillian: In the early '90s, David Kessler went to the US Food and Drug Administration promising stricter regulations for supplements.
In particular, discerning manufacturers back up health claims with evidence. The industry went crazy. I've handled some of the toughest regulatory issues. I made tobacco. Tobacco seemed easy compared to dietary supplements. What happened was that the dietary supplement industry recognized that the standard we set, meaningful scientific agreement, would require that before they could make a claim to have a scientific basis, and they just couldn't make any claims. And they saw literally billions of dollars at stake, and unleashed a lobbying campaign second to none. Gillian: The campaign was as dramatic as it was effective. Framed by the industry as an attack on fundamental freedom.
It even got Hollywood involved. Vitamin C, you know, like in oranges. Gillian: The letter request produced millions, more mail than Congress received on the Vietnam War. And it worked. 784, a bill to amend the Federal Food, Drug, and Cosmetic Act to establish standards regarding dietary supplements and for other purposes. Gillian: The law that passed was a victory for the industry. In the United States, there would be no requirement to prove that supplements are safe or effective before allowing them on the market. In Canada a few years later, the same battle would unfold when the industry and its supporters targeted Health Canada's crackdown plan.
Among the proposals, regulate natural health products as pharmaceuticals, subjecting them to the same scientific standard as prescription drugs. Dr. Stuart MacLeod was part of a Health Canada advisory board that recommended just that. That we should have a single standard of evidence, and we shouldn't endorse any product that doesn't meet that standard, and we were actually talking about efficacy standards, the kind of thing that comes from a randomized control trial. . Gillian: Just like in the United States, the pushback was intense. It's about control and a lot of money. Why, after centuries of successful use of these herbs and plants around the world, would the government now intrude to tell you that you cannot make decisions for your own health or the health of yourself and your family?
Gillian: There were letters and petitions and in the end the campaign worked here too. Then Health Minister Allan Rock backed down. We must respect and allow space for Canadians' freedom of choice when it comes to natural health products. Government should not be in the business of micromanaging people's lives. Gillian: But unlike in the US, in Canada there would be some rules. If Canadian manufacturers wanted to make health claims, they would have to provide some evidence that the claims were true. They also pledged to follow good manufacturing practices. It was a deal that the industry still upholds as a guarantee to consumers.
Health Canada has provided us with one of the strongest regulatory frameworks in the world. Gillian: Helen Long runs the Canadian Health Food Association. Before a product goes on sale, you have to prove that your product works, that it has quality ingredients, that it's effective, that it does what it says on the bottle. Gillian: But what constitutes proof? In 2001, Wayne Friesen of Winnipeg entered the supplement manufacturing business. Today, his company, Innotech, markets 16 products. Your biggest salesperson? A powdered vitamin called Cardioflex. Basically, it's an amino acid formula. You're raising your essential amino acids like lysine, you're raising it from whatever you're eating in your daily routine with your diet.
Well, that's not going to work very well unless you have adequate levels of vitamin C, so we have three types of vitamin C. Gillian: Who formulated this? Well, we work with a chiropractor and we challenge the formula, do we want this in her, do we want that in, how, is it going to taste good? Gillian: What experience does a chiropractor have when it comes to cardiovascular health? Well, just... there are a lot of chiropractors who believe in Linus Pauling's theory about the nutrients that are missing from the western diet. Gillian: Linus Pauling was once a giant in the world of science.
A double Nobel Prize winner in chemistry and peace who became even more famous for his theories about high doses of vitamin C that he claimed could cure everything from the common cold to cancer. he was a hero scientist who was making that claim and that changed things. Gillian: A hero that Dr. Paul Offit has called possibly the world's greatest charlatan. I think when he made those statements in the late '60s and early '70s, mega
vitaminswell above the recommended daily amounts, became something that people thought was a goodidea. Gillian: Was there science at the time to suggest that he was right?
There was not one shred of science to suggest that he was right. In fact, some of the first studies done in the early 1970s showed just the opposite. Gillian: Over the decades, study after study disproved Pauling's theories, and yet 40 years later, it's still hard to disabuse believers. Wayne Friesen sells a product based on Pauling's ideas, all of which are endorsed by Health Canada. You know that Dr. Linus Pauling's science on this has been discredited for many years, that the scientific community has essentially written off Dr. Linus Pauling when it comes to vitamin C in these types of formulations and disease prevention.
Yeah, there's some pressure on that with some doctors and stuff, but not among the health industry, the natural health industry has embraced it. Gillian: In the early days of the regulations, Health Canada seemed to be proceeding cautiously, rejecting more applications than it was approving. But that created a delay, and it wasn't long before the government was under political pressure from an industry eager to get the system moving again. In 2012, Health Canada toured the country to hear directly from the industry. So this was a PowerPoint presentation given by Health Canada. Gillian: Michael Kruse of the Bad Science Watch watchdog group attended some of the sessions and kept the handouts.
Health Canada promised a new approach. But the slides reveal problems that Health Canada was aware of. For example, 40 percent of the complaints received referred to natural health products, 40 percent of them to quality. They say contamination, they say intentional adulteration. Yeah, those are certainly things that we mentioned as well. And backed by a ton of evidence. This tells us that they know that the products that are reaching the market are of low quality. Gillian: And yet the solution seemed to be to trust the industry even more. According to this slide, it was up to the licensee, not Health Canada, to ensure quality.
For many claims, Health Canada would accept what it recognized as weak evidence. It was all part of their effort to make the approval process faster and clearer. Kruse couldn't believe what he was hearing. One of the results of that was that he was able to get his product approved in as little as ten days. Now, I thought ten days? How is that possible? But there was a small manufacturer who stood up and said that ten days is too long. We want to be able to respond to what's called the Dr. Oz effect, what Dr. Oz has, raspberry ketones for example, on his show and he says these are the new miracle product, we want those products on our shelves within a couple days and I thought, well, this is the problem.
Gillian: In the end, the industry got what it wanted. Rejecting more than half of the applications, Health Canada today approves more than 90 percent of them. It retains the right to conduct spot inspections, but employs just ten inspectors for an industry that now has nearly 800 licensees. Which brings us back to the manufacturers. Wayne Friesen says that Health Canada has inspected his factory. No one has ever suggested that his Cardioflex caused any harm. But given its roots in the now discredited science of vitamin C, on what basis was it approved? Health Canada tells us that the ingredients in Cardioflex meet established standards for the promotion of good cardiovascular and general health.
And yet, at $49 a bottle, Innotech's claims about Cardioflex go much further. I looked at some of his ads and these are some of the claims he makes: that this product lowers cholesterol, increases energy, lowers high blood pressure, improves HDL cholesterol, the good kind, relieves chest pains, improves circulation, and makes you feel younger. So what evidence do you have to support any of those claims? Those are, not necessarily the claims, but those are some of the things that our customers who have used it over the last 12, 13 years are reporting. Gillian: But I'm trying to get to if there's any science that you've done or anyone has done that backs up those claims that you make in your marketing.
With this product? Gillian: Yeah. Well, we're about to do a study with -- Gillian: You haven't done one up to this point. Right, nobody has. Gillian: How do you know it's really effective? Guess what I'm asking. Well, we wouldn't put it on the market unless it was cash. Gillian: We have repeatedly asked Health Canada for an interview to discuss all of these issues. Repeatedly, they refused. For critics, it begs the question, given the weaknesses of the Canadian system, is it really better than the unregulated US system? There's really nothing different, you know, in the bottom line between the two systems and that's what we're concerned about.
Gillian: We have beautiful rules on paper, but in practice -- They're not being enforced, yeah. Gillian: When we come back, what can happen when there are no regulations? We found the results were shocking, we found DNA from asparagus, DNA from houseplants, rice and other things, but not the product that was on the label. (♪♪) (♪♪) Right here I have our Liposomal D -- This is our bacopa. This is an herb that would be great for older people that -- Essential nutrients like chromium. Gillian: For as long as supplements have been around, there have been concerns about contamination, adulteration, and even fraud.
But few studies have had more impact than the 2013 study led by Steven Newmaster of the University of Guelph. 60 percent of the products he tested had ingredients that shouldn't have been there. One in three were fake. When we got the results, I remember saying to my colleagues, this is very, very important information, and the public will be very concerned. Gillian: It wasn't just the audience. After the study appeared in a scientific journal, it was picked up by the New York Times and read by the New York attorney general. Last December, my office purchased a variety of private label herbal supplements from stores in different parts of New York State.
Gillian: Eric Schneiderman ordered his own herbal supplement tests that produced even worse results. We found that only 21 percent of the products we tested had DNA evidence that they contained the product on the label. We found the results were impressive. We found DNA from asparagus, DNA from houseplants, rice and other things, but not the product that was on the label, so there were people selling what was reported to be ginseng that clearly did not contain ginseng and this is an industry billionaire a year and it seemed like there was just massive fraud going on. Gillian: Schneiderman began by ordering retailers to stop carrying the products in question.
Then he went looking for political support. Today, the attorneys general of 14 states are calling on the US Congress and the FDA to finally get serious about regulating supplements. But the Canadian equivalent of the FDA has been strangely unconcerned. Since the publication of his study, Steve Newmaster has heard from regulators and industry players around the world, but has yet to hear from Health Canada. No, I don't remember an email from them, a phone call. We haven't crossed paths at the meetings we go to. Gillian: So this has been published in a major scientific journal -- I'm looking forward to and would love to work with them and I'm not sure how this fits with their mandates and how they might move it.
Go ahead, technology. Gillian: We asked Health Canada why they didn't act on Newmaster's work, especially since the Americans did. In a written response, they said they reviewed the study, but because Newmaster did not list all the ingredients and brands he tested, Health Canada decided no action was necessary. So what about the industry? One in three products tested were counterfeits? Aren't you worried? Helen Long from the Canadian Health Food Association... Well, I think it's important to remember that there are varieties of tests. I'm not a scientist, so I can't talk about the details of the tests, but I think it's important to remember that there are several methods.
Gillian: You don't accept the method that was done here, the DNA -- I'm not suggesting that, but I'm not a scientist. Health Canada has not yet approved that testing method. Gillian: Health Canada may not have approved it, but some in the industry are beginning to embrace it. Take a little bit of the sample and just - Gillian: Since the publication of his study, Newmaster has refined their DNA barcoding technology. He made it more portable and cheaper to use. Load it into the machine. Press "Go". Gillian: Supplement retail giant GNC has now agreed to start using DNA barcoding, Walmart has also expressed interest.
And North America's largest manufacturer, Nature's Way, recently formed a partnership with Guelph scientists in a renewed effort to put quality first. Travis Borchardt is Vice President of Nature's Way. It's a game changer, right? We began working with Dr. Newmaster and began a relationship that included testing the identity of many of our herbal dietary ingredients. Gillian: If Newmaster has his way, supplement manufacturers will soon be able to test ingredients back to source. Easy - it can be tested all the time and I think it's a proper way to solve a problem. Gillian: But that still leaves the question of what, if any, of this stuff actually works.
We're using the herb combined with the standardized extract -- Containing perna-- Gillian: In the absence of science, in the absence of meaningful regulation, what is a consumer supposed to believe? The whole problem can be encapsulated in this. Every natural health product approved for sale in Canada is assigned a number, right there in the fine print. It is Health Canada's guarantee that the product is safe and effective. But critics say it doesn't make sense. I think the government is misleading the public and suggesting that they have validated the efficacy and quality of natural health products. People spend millions of dollars on these products every year.
And most of them have no evidence of efficacy. So they are being deceived by a manufacturing lobby group that really focuses on profit and not the health of the person. Gillian: And yet people buy and still believe. Perhaps there are some things that science will never change. We love the notion of the
magicpill, we do. Something that makes everything better. It's too seductive. (♪♪) (♪♪) (♪♪) (♪♪)
If you have any copyright issue, please Contact