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No Compliments for ‘Supplements’

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On Jan. 19, the PBS flagship investigative series, Frontline, broadcast an in-depth look at the vitamins and supplements industry in this country and, it said, found some “hidden dangers.”

In announcing the program, titled "Supplements and Safety," Frontline said, “It's estimated that half of all Americans take a health supplement every day, from fish oil to multivitamins to diet pills. The booming 30-billion-dollar-plus vitamins and supplements industry says these products can make consumers healthier — but a new FRONTLINE investigation with The New York Times and the Canadian Broadcasting Corporation raises troubling questions” and explores how these substances are marketed and “how it’s often hard to know what’s really in the bottles you buy.”

“The FDA [Food and Drug Administration] does not do any review of dietary supplements before they come onto the market, and I think that all consumers need to understand this,” Stephen Ostroff, M.D., acting commissioner of the FDA, tells FRONTLINE.

I got about three dozen emails, plus some phone calls, about this program. All of them were critical, some sharply. Many of the emails were very long—as is this posting; very long. So I’m including a representative sampling of the critical comments sent my way, followed by a response from Frontline, with my thoughts in a couple of places.

I should say at the outset that I am not one of the critics. I felt this was a valuable and cautionary presentation and public service; better to know than not to know and that—in the absence of regulation—common sense, consumer diligence and your doctor’s advice is a reasonable way to proceed. I do feel, however, that, given the enormity of routine use of vitamins and supplements by perhaps 100 million or more Americans—and the degree of mistrust by many of the pharmaceutical industry—greater context should have been provided that made clear that, despite some serious examples of bad outcomes on the program, this is not a public health calamity.

A number of those who wrote to me mentioned an online article by Dr. Joseph Mercola, an osteopath who operates an extensive and heavily-trafficked website, Mercola.com, and who markets an extensive array of “premium supplements” under his name.

Mercola takes a hard shot at the Frontline “hit piece.” He says: “The one thing that can be conclusively said about supplements is that they may be the safest category for any consumable product, regardless of the specific cases highlighted by Frontline. On the whole, junk food and drugs are FAR more likely to harm or kill you.”

He also reports that Frontline’s “supposed consumer assistance program begins with a recipe ad for ‘Cheez-it cheesy chicken bites’ and Dr. Pepper. For an investigative journalism piece supposedly concerned about the health and well-being of consumers, this strikes me as irrational, unless PBS and Frontline were shilling for the Junk Food and Big Pharma industry.”

Here Are Some of the Letters

I was deeply disappointed by this week's Frontline story on Supplements. Don't get me wrong, I appreciated that you tried to cover the topic. I'm glad you raised the question in the public mind, but that is the most positive thing I can say about the story. If the story had been done better it could have sparked meaningful debate for weeks to come, but it was shoddy reporting with overt attempts at sensationalism. The low quality of the program didn't invite debate, it invited polarizing opinions. That is unusual for Frontline, and not appreciated (at least by me).

There were many factual errors some that are completely indefensible (basic scientific errors.) I think the most embarrassing moment for the show was when the author was forced to admit that she only read the first paragraph of the 10 page research paper and from one sentence refused to consider any of the rest of the information in that article as evidence contrary to her opinion. The fact that you included that moment in the final cut shows the ignorance of the production crew.

Allentown, PA

(Ombudsman’s Note: This is presumably a reference to correspondent Gillian Findlay and to a trade association official, Adam Ismail, who, in response to Findlay’s points in various journals, said: “Yeah, well, I think what you’re looking at are the abstracts.”)

~ ~ ~

I am a fan of Frontline; I find the journalism exceptional and the topics interesting. It is a program I make note of and make an effort to watch in the wasteland of television. However, the most recent program on supplements was biased. I do understand the limited regulation on supplements. I do understand the concern for safety. I do know how the alternative community has limited resources for research and studies. However, the pharmaceutical companies have a vested interest…money…to keep people fearful of alternatives. Did the producers make any attempt to contact the reputable supplement manufacturers? Examples would be Metagenics, Pure Encapsulations, Nordic Naturals…brands that are well-known in the complementary community as having quality products? The truth is always in the middle, I say; this program presented only one side.

AZ

A Long Letter

The program was clearly intended to leave viewers with the one-sided impression that dietary supplements are unregulated, unsafe—and that ultimately you, the consumer, should not have the right to stay healthy in a manner of your choosing. The overarching narrative of one especially egregious segment was that supplementation of any sort is unnecessary and does not impart any benefits—and worse, that it may even be dangerous.

For example, the documentary has longtime natural health foe and vaccine millionaire Dr. Paul Offit explaining that one 1000 milligram tablet of vitamin C is equivalent to eating “seven or eight entire cantaloupes,” and that this is bad because the body was not meant to eat so much. Never mind that this says nothing about how many milligrams might be required for certain individuals to achieve optimal nutrition, nor that a growing body of scientific evidence suggests that food alone does not provide enough nutrients to the human body! Considering also that 93% of Americans are nutrient deficient, how does Dr. Offit propose we correct nutrient imbalances?

With respect to C, he also skips over the abundant scientific evidence that early humans, when everyone lived in a tropical environment, consumed much more C than we do today (which means our bodies evolved to handle C in abundance). We need to consume our vitamin C, unlike most animals whose bodies simply make it as needed, often in very large quantities.

As for vitamin D, other “experts” were lined up to argue that any dose higher than the antiquated, absurdly low 600 IU recommendation from the ponderously conservative Institute of Medicine (IOM) is not only “not beneficial,” it may even be harmful—a claim that is patently bogus.

Fish oil was specifically targeted, with claims that almost no clinical studies have shown a benefit to consuming fish oil supplements—an astoundingly false claim, considering the vast preponderance of scientific evidence to the contrary. Fish oil has been found to be so beneficial, in fact, that Big Pharma has patented expensive fish oil-derived drugs.

The pretext for all of this, of course, is to undermine the credibility of supplements and to make the case that more regulation and oversight is required—ostensibly, a pre-approval system similar to the one suggested by supplement foes Sens. Durbin (D-IL) and Blumenthal (D-CT). What is not mentioned in the Frontline piece is how profoundly such a system would infringe upon the rights of millions of Americans who rely on dietary supplements to maintain and optimize their health. It would drive the cost of supplements through the roof, which would then sweep them off the shelves and into the hands of drug companies… As we’ve argued time and time again, the FDA has the authority to remove dangerous and illegal products from the market—and actually did so in each instance cited in the documentary, proving once again that the current system works when the FDA enforces the law.

All of this comes into focus, however, in a segment in which fish oil supplements were attacked as being inferior to their pharmaceutical counterparts. To substantiate these claims, the documentary’s primary expert, Preston Mason, PhD, cuts open fish oil supplements and points out how different they are from a pharmaceutical fish oil drug.

As it turns out, Dr. Mason is very familiar with that particular drug. It’s called Vascepa, and for the past several years he has worked as an advocate for the drug. He even lobbied the FDA on behalf of Amarin Pharma, the drug’s manufacturer, to broaden the uses it was originally approved for. Apparently the producers of the Frontline piece did not think viewers needed to be informed of this conflict of interest. It gets worse. Immediately following the broadcast, Amarin was ready with a website that highlights the documentary, as well as a media campaign (sponsored by Amarin) that features Dr. Mason and a fellow Vascepa advocate, Eliot Brinton, MD. According to OpenPayments.cms.gov, Dr. Brinton earned $366,698.68 from pharmaceutical companies. Dr. Mason is not a medical doctor, so he is not required, under the Sunshine Act, to make his compensation public.

Anita Baxas, MD, Miami, FL

A Response From R. Preston Mason:

(Ombudsman’s Note: Shortly after posting, the following response to the above letter from Anita Baxas was sent to Frontline by R. Preston Mason.)

“You can be assured that I self-funded the research related to the fish oil supplements that was discussed on Frontline. This was done to avoid any perception of bias. The results of our study were presented at a national meeting and received special recognition as reported also by my university. They awarded this research for its scientific value and importance for patient care. The truth is that the widely used fish oil supplements that we independently tested contain many ingredients that are not advisable for people at risk for heart disease (e.g., various saturated fats, oxidized lipids). The fish oil supplement industry should spend more of their time and money making a quality product rather than attacking scientists and independent journalists. A review of their expenditures would show an alarming disproportion of funds going to marketing rather than research.

“The claims made in the letter are untrue. The FDA has approved omega-3 fatty acids for patients with very high triglycerides (>500 mg). This is a relatively small but important group of patients who need a  quality omega-3 fatty acid product. Such products require rigorous clinical testing and oversight by the FDA. Contrary to what was said in the letter, I’ve never advocated to the FDA that any prescription product should be expanded beyond its approved use for patients. Moreover, any consulting fees I receive from industry are donated entirely to charity. Rather than making unsubstantiated false claims, physicians like the writer of the letter should be encouraging scientists like myself to continue such independent investigations into the quality and integrity of supplements. The public deserves to know what they’re consuming.

“It may also be mentioned that the last time I presented to the FDA was to provide data critical of a major prescription pain medication Vioxx produced by the giant pharmaceutical company Merck. Based on our research and the results of clinical trial analyses, the drug was eventually removed from the market. I can hardly be accused of favoring one industry over another based on my record. It is a matter of letting the science do the talking in these types of investigations. Before publishing personal accusations, why not check the facts? This work was done in the public interest so we should keep our focus on the data and the need for greater transparency in the supplement industry. ”

R. Preston Mason, PhD

More Letters...

Your piece on supplements was very narrow in scope. You did not interview people who are being helped by good supplements, and the depth of content was not sufficient, misleading the public with what was written. Next time hire someone to look objectively and deeply in to supplement industry. Terrible Story, an injustice to those who would otherwise benefit from supplements. I am a user of supplements and without them, I would be most likely be dead.....

Carrie Gordon, Charlotte, NC

~ ~ ~

My entire family uses naturopathic medicine, which is primarily non-drug treatments including supplements and nutrition. We choose this specifically to STAY OUT of hospitals and to stay healthy by NOT using toxic (often lethal) drugs. PBS's smear campaign against the entire supplement industry was unconscionable AND it turns out to be based on FALSE data!! What, PBS didn't check facts first? I have my supplements approved by my naturopath every single time I have an appointment. I don't trust the pharmaceutical industry with my life and well-being. And I don't trust doctors who only want to prescribe drugs or surgery for every ailment, rather than nutritional counseling and common sense simple treatments that have been effective for hundreds of years...and aren't creating huge profits for the industry. It is clear that you have lost all common sense and are fighting against American's right to access to supplements, which offers a less expensive and much safer alternative to the drugs that PBS apparently prefers…I am literally embarrassed that PBS has buddied up with Dr. Offit, a well-known front man for Big Pharma.

A. Adams, Renton, WA

Frontline Responds

Millions of Americans use health supplements every day and swear by the benefits. Our documentary, Supplements and Safety, takes a hard look at this multi-billion dollar industry – specifically examining the risks and consequences associated with supplements’ limited regulation and oversight. It was done in partnership with The New York Times and the CBC news program, Fifth Estate.

Early in the film, the acting FDA commissioner offers this warning: “The FDA does not do any review of dietary supplements before they come to market, and I think that all consumers need to understand this.” With this lack of regulation as the backdrop, the film reported on cases of contamination and serious health problems, and the many credible calls for more rigorous testing and standards on what is actually in supplements, and how they are labeled and advertised. It also examined the health risks associated with taking high doses of vitamins, heavily marketed by the industry and its gurus but contested by many doctors.

Following the broadcast we heard from viewers thanking us for focusing on this aspect of the industry; many told us they were taking steps to get more information about the supplements they take. As expected, we also received criticisms, much of it either referring to or repeating a critique from Dr. Joseph Mercola, a popular supplement advocate and retailer, who would not speak to our reporters and producers.

Critiquing the Critique

Dr. Mercola labeled the film a “Hit Piece on Vitamins and Supplements.” Under that headline, much of the rest is a pile-up of innuendo with a decidedly conspiratorial tone.

The overarching allegation is that FRONTLINE, the CBC and The New York Times are all doing the bidding of nefarious forces – Big Pharma, Big Food, or some other hidden power pulling our strings. What nonsense. Aside from the fact that pharmaceutical companies are also involved in the supplement business, we have a long track record of examining industries, including prescription drugs, meat and poultry, and whatever the value of supplements, why would that sector be off limits – especially considering the ongoing and important public policy debate over regulating the industry?

Repeatedly, the Mercola article and some viewers seized on corporate spots that ran before some versions of the film streaming online – not the television broadcast.  “PBS Frontline Goes to Bat Against the Supplement Industry While Promoting Junk Food,” was their attack. FRONTLINE was not involved in any aspect of the selection or placement of these spots, which were sold by PBS and run across PBS.org through automated process. (Further, to be clear, FRONTLINE does not have any sponsorship from a pharmaceutical company, as some viewers erroneously alleged.) But these complaints, or the real concerns about “junk food,” are obviously designed to divert attention from our specific investigation of the supplement industry.

Frontline Continues…

Another one of these diversions was the attempt to tarnish our work by erroneously linking it to an entirely different program at the CBC [mentioned by Mercola and some other letter writers] that had to retract a supplement-related story. That had nothing to do with us, and any effort to try to draw us into someone else’s issue is unfair.

Likewise, one viewer claimed we deleted his critical post of the program from our Facebook page. Again, that is just not so. A few critics took another equally dubious tact: suggesting the film was produced by a bunch of “amateurs” who know nothing about nutrition or science. Our team included a veteran FRONTLINE filmmaker and a New York Times science writer who has covered the field for years. And the film relied on the work of public health officials, voices from the industry itself, and numerous bona fide scientists, most considered leading experts in their field, as well as peer-reviewed studies in publications such as the “Annals of Internal Medicine,” “The New England Journal of Medicine,“ “The British Journal of Medicine” and others.

 While three of the most celebrated names in supplements, including Dr. Mercola, would not speak to us, the critics went on to attack those who did participate in the film. Dr. Paul Offit, author of the book on supplements, “Do you Believe in Magic,” was dismissed as in the pocket of Big Pharma (just like FRONTLINE).  And Dr. Preston Mason, Ph.D., whose study on over the counter fish oil was cited in the film, was accused of having a conflict of interest - which we think he is on very solid ground rejecting. His study showed that some fish oil was oxidized, very much in line with other peer-reviewed, published studies. These are ad hominem attacks, and suffice to say, we feel these experts have a valid and important place in the story.

Overall, whether on the issue of the proper way to regulate and oversee the huge supplement industry, or the appropriate dosage of vitamins, Mercola and others want to see our tough examination as a total rejection of the industry.  That is untrue and unfortunate.  

There are many places and ways to hear the promises of supplements and testimonials to their value. But as our film pointed out, the supplement industry was behind the passage of a bill that foreclosed most forms of regulation. Under the circumstances, the millions of supplement consumers surely have an interest in an examination of whether that policy choice has served the public well.

Some Further Thoughts of Mine

While Mercola’s column and all the letter-writers were very critical, one online assessment that I found to be both broadly positive, but balanced, critical in places, and informative, was provided by a public health research group called “the 2x2 project,” which says it is “supported generously by the Department of Epidemiology at Columbia University’s Mailman School of Public Health.”

Here, for example, is a small part of their assessment:

“FRONTLINE’s portrayal of the FDA stems from its focus on narrative arc. They need a villain, and Power Elites are always a safe bet. To its credit, the documentary succeeds in keeping the narrative captivating, and leaves the viewer with a visceral distaste for the corrupted supplement industry. FRONTLINE would fail in its mission if their report read like an academic abstract. But this comes at a cost: at times, the report is heavy on anecdotes, and light on data. According to the claims of FRONTLINE itself, half of all Americans take dietary supplements – or roughly 160 million people. If they were as dangerous as FRONTLINE suggests, the casualty count would be astronomical. While we cannot ignore the suffering of 20 B-50 patients, or 70 OxyElite Pro patients, this is hardly the public health disaster that an exposure of 160 million typically produces. If the scale of the problem is as big as has been suggested, where are the victims?

“While FRONTLINE’s anecdotes oversell how dramatically devastating supplements can be, the report does look to experts to provide data backing other important claims. The key to FRONTLINE’s story is that dietary supplement manufacturers are not required to prove the efficacy or even the safety of their products, and the industry has lobbied hard to prevent that requirement. Supplements use is on the rise, even while evidence increasingly indicates that they have no clear benefits: pooling data from 78 randomized trials including 296,707 patients shows that there is no benefit to taking beta-carotene, vitamin A, vitamin C, vitamin E, or selenium. Moreover, Beta-carotene, vitamin E, and high-dose vitamin A actually increase your risk of mortality. While this effect is small, and not nearly as dramatic as liver disease from OxyElite Pro, the damage is an enormous public health menace when spread over 160 million Americans.”

Posted on Feb. 4, 2016 at 3:10 p.m.