February 23, 2016
PBS’ Frontline recently did a hit piece on the supplement industry (see above video if you haven’t already), and your response to them about my Frontline article had a dramatic impact. You clearly have made a difference by pointing out their glaring bias!
PBS Ombudsman Michael Getler — whose job it is to review criticism from viewers and “ensure that PBS upholds its own standards of editorial integrity” — received dozens of emails, plus a number of phone calls.
In his words: “All of them were critical, some sharply.”
On February 5, Getler published a long, detailed review of the critique received, Frontline’s responses, and his own findings. If you have the time it would be worth reading Getler’s article as you can see how many people felt this was a shoddy piece of journalism.1
While I extend my gratitude to Getler for his common sense admission that vitamin supplements do not pose “a public health calamity” as the show unfairly insinuated, I simply must set the record straight yet again, on the issue of regulation, since he and PBS continue to portray a seriously distorted and inaccurate narrative.
Dietary Supplements Are Fully Regulated by FDA Under DSHEA
While supplements are not regulated as drugs, they are fully regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). As the name reveals, supplements have been subject to their own specific set of regulations since 1994. As stated on the FDA’s website:2
“FDA regulates both finished dietary supplement products and dietary ingredients … Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
- Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.
That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
- FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.”
Which part of “FDA regulates both finished dietary supplements products and dietary ingredients” is confusing enough for anyone to conclude that regulation is absent, missing, or otherwise nonexistent?
More to the point, how can any competent investigative journalist make such a blunder as to misrepresent supplements as unregulated when the law has been in force for more than two decades? Is it ignorance? Is it negligence? Or is it agenda-driven obscuration?
Pre-Marketing FDA Review of Supplements Versus Drugs
Getler reiterates a quote by the acting FDA commissioner, who during the PBS program said that the FDA “does not do any review of dietary supplements before they come onto the market.”
While this is true, appropriate context is needed. The implication is that, were supplements regulated as drugs, they would undergo FDA review prior to marketing and would, therefore, be safer.
On the face of it, that seems to make sense, but the reason why this logic is fatally flawed is that the FDA’s pre-market review for drugs simply involves reviewing the manufacturers own tests.
The FDA does not perform ANY — yes, you read that correctly, ANY — independent testing to verify the manufacturer’s results before approving a drug. They merely rely on the submissions of an industry that has consistently and repeatedly been found guilty of nefarious behavior in this area.
The classic example is Merck withholding studies they performed on Vioxx prior to its release that the drug had cardiac toxicity. They voluntarily removed the drug about five years after its FDA approval, but not before the drug killed 60,000 people.
Contrary to Popular Belief the FDA Does NOT Independently Evaluate Drugs
Contrary to what Getler and PBS would have you and the public believe — the idea that the FDA does independent objective premarket evaluations — the “FDA does not develop or test products; FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers” only.3
The lack of independent verification of drug companies’ claims is a major problem, as fudging and manipulating research has become commonplace. Investigations have shown that most of the scientific misconduct occur in the drug literature (compared to general biomedical literature).
Nearly 75 percent of retracted drug studies are attributed to scientific misconduct such as data falsification and fabrication. Imagine the potential for tragedy when a drug is based largely on pure fantasy or wishful thinking!
So exactly how would the FDA’s review of manufacturers’ studies make nutritional supplements any safer than they already are?
Legally Prescribed Drugs Kill Hundreds of Thousands Annually
When taken as prescribed, drugs of any category kill more than 106,000 people per year, and 2 million Americans become seriously ill every year because of toxic reactions to drugs.4
So the notion that regulating supplements as drugs would make them safer is not based in reality. Current drug regulations allow very dangerous drugs to be marketed, and action is only taken AFTER problems become apparent and severe.
Tens of thousands need to die before a drug is finally removed from the market. It should be a great comfort to everyone to know that the FDA does not drag its feet when it comes to taking dangerous supplements off the market, though.
The idea that supplements are harmful is not supported by the data. Quite the contrary, yet investigative journalists, like Frontline and CBC, consistently fail to mention statistics that put things into proper perspective. For example, a 2012 report7by the U.K.-based Alliance for Natural Health International showed that adverse reactions to pharmaceutical drugs are 62,000 times more likely to kill you than food supplements.
According to the annual report8,9 from the American Association of Poison Control Centers, there were zero deaths from vitamins, minerals, or any other dietary supplement in 2014. Meanwhile, Tylenol is linked to about 500 deaths annually. The idea that supplements should be regulated as drugs is rooted in financial interests. The supplement industry impinges on drug industry profits, and that’s the only rationale for this campaign to impose drug regulations on supplements.
Supplements Are the Safest Category of Consumable Products — Even Safer Than Food
Supplements are the most regulated food. They ARE NOT drugs. Supplements are consumed by the majority of Americans and Canadians, and statistically, it’s quite clear they are by far the safest consumable product there is, and least likely to hurt or kill you.In fact, most junk food is FORTIFIED with vitamins. Modern agriculture has favored yield over nutrition, causing poor soil conditions, disease outbreaks, and a less nutrient-dense food supply. If one is to avoid vitamin fortified junk foods, doesn’t it make sense to eat real food and intelligently use supplements to create a balanced diet?
Food sickens 48 million Americans each year; 128,000 of them severely enough to require hospitalization, and 3,000 die from food poisoning – and tens of thousands die from antibiotic-resistant infections that are primarily caused by our CAFO produced meats.10
Meanwhile, there were 3,249 adverse event reports for dietary supplements11 in 2012. The No.1 adverse event from supplements was choking, primarily in the elderly. Unsupervised children swallowing pills and heart palpitations due to the ingestion of too many diet pills, libido enhancing supplements, and energy drinks were also among the top problems reported. Again there were no deaths.
Choking is hardly an adverse effect warranting increased regulation, as it is a hazard that goes along with swallowing any food, drug or supplement. As for experiencing side effects from taking too many pills, let me remind you that prescription painkillers are the No. 1 cause of overdose deaths in the U.S., killing approximately 16,600 people each year.
Yes, people don’t always follow dosing instructions, but when it comes to supplements, it’s exceptionally rare to incur serious, permanent harm or death when taking too much. If any value is given to statistics, supplements set the bar for safety that all other consumable products, including drugs, should be measured by.
Supplements Are Also Regulated by the FTC
Supplements are also regulated by the Federal Trade Commission (FTC).12 This agency regulates the advertising of supplements, but it has a close working relationship with the FDA. Aspects of advertising covered by this regulation include but are not limited to:
- Express and implied claims
- Clear and prominent disclosures
- Amount, type, and quality of evidence, and the relevance of the evidence to the specific claim
- Claims based on traditional use
- Use of DSHEA disclaimer
As explained on the FTC’s website, it “enforces laws outlawing ‘unfair or deceptive acts or practices’ to ensure that consumers get accurate information about dietary supplements so that they can make informed decisions about these products.” Any and all advertising “must be truthful, not misleading, and substantiated.”
Given the fact that supplements are regulated both by the FDA under DSHEA and the FTC, it is wildly irrational to state that supplements are unregulated unless one is lying. Frontline and CBC are not saying supplements could be regulated better. They imply supplements are marketed like Snake Oil and Magic Unicorn pills in some Wild West era of lawlessness!
In addition to the FDA regulating both ingredients and final products, supplements must also follow Current Good Manufacturing Processes (CGMP),13 which also falls under FDA jurisdiction.
It appears it’s up to informed readers and viewers to educate journalists (and health professionals) of their error, and to set the record straight whenever this fallacy is presented as fact. So, if you ever see supplements presented as “unregulated” again, I hope you step up to the plate and let them know that misrepresenting LAW is simply not acceptable by any journalistic standard.
Deceptions occur in all categories of commerce, and the supplement industry is no exception. But, when the government has to choose where it applies its limited resources for enforcement – shouldn’t it start where you find the highest body counts? That would be the logical priority, but not when you have the best government money can buy. If the policies don’t favor Big Pharma, Big Bank, Big Ag, Big Oil, Big Military, you can bet those resources will be applied elsewhere.
If you want to avoid unsafe supplements, the best way to do so is to stay away from the ‘gas station’ varieties. Those categories are typically focused on weight-loss, sexual performance, muscle growth & energy boosters. These categories have a history of being illegally spiked with pharmaceutical ingredients, so please think twice before purchasing these substances.
Do You Believe the Media Is Providing You With Fair and Balanced Journalism?
Frontline responded to the critique in my first article, saying:14 “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.” Is it really nonsense to believe the media is manipulated by financial contributors with very big pocketbooks?
“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.),” Frontline writes.
As I pointed out in my first article, the sponsor list for PBS15,16,17 includes drug companies, junk food companies, and pesticide producers. Are we really to believe that PBS is just the middle-man, accepting funds from all of these industries, yet have NO influence over the programming? Just how much money is PBS getting from these companies?
If they want to disguise themselves as the “Public” Broadcasting Company, they should prominently disclose their corporate funders when they provide reports that have clear conflicts of interest. Moreover, while initially I did not delve into Frontline-specific sponsors since Frontline wants to make it “clear” that they do not have any pharmaceutical sponsorship, I will address it now.
Frontline Sponsors Include Several Foundations With Drug Ties
Frontline is produced by WGBH Boston and is broadcast nationwide on PBS. Information about Frontline, including its sponsors, can be found in WGBH’s Sharing The Vision member’s guide, and on Frontline’s FAQ page. Frontline is funded through the support of PBS viewers and the Corporation for Public Broadcasting. They also receive “major” funding from:
- John D. and Catherine T. MacArthur Foundation,18 which provides financial. support to the Human Vaccines Project;19the CDC Foundation20 (which “works closely with foundations to build programs that address specific health threats”); and the Harvard T.H. Chan School of Public Health21 (which promotes “solutions to four major global health threats” and has worked to develop various vaccines)
- Reva and David Logan, founders of the Reva & David Logan Foundation for Social Justice, Scholarship, the Arts and Investigative Journalism, which has co-funded drug research with Solvay Pharmaceuticals22 —a company that manufactures more than 30 drugs in the U.S. including Norlac RX, Zenate, Zenate Advanced Formula and Zenate Prenatal, all of which are prescription multivitamins
- Jon and Jo Ann Hagler23 on behalf of the Jon L. Hagler Foundation. Jon Hagler served on both the World Bank’s Pension-Finance Committee and on the Finance Committee of the Rockefeller Family Fund. The World Bank helps fund vaccines and partners with vaccine and other drug companies. The Rockefeller Foundation helps fund the “Golden Rice” project with Gates to develop GMO rice with beta carotene genetically engineered into it.
Jon and Jo Ann Hagler established two endowed chairs in hematology and oncology at Massachusetts General Hospital,24 which partners with “pharmaceutical, biotech, venture capital and philanthropic communities.”
- The Ford Foundation,25 which in June 2014 made a two-year, $800,000 grant toward a new cross-platform Enterprise Journalism Group within Frontline “that will deepen the series’ in-house investigative bench.” By 2014, the Ford Foundation had given nearly $20 million to WGBH (PBS) over a 55-year period. The Ford Foundation has a long history of funding global projects that include vaccines.
More Frontline Funders With Drug and Vaccine Ties
Frontline also receives funding from:
- The Park Foundation:26 “a longstanding series funder.” In 2004, the Park Foundation also funded the Pan American Health Organization book project: “Vaccines: Preventing Diseases and Protecting Health.”
- The Bill & Melinda Gates Foundation has funded Frontline in the past, especially “major funding” for the 2010 to 2011 broadcast season.27 In 2014, Gates was taken to task for its massive funding of NPR, Frontline, PBS NewsHour and Teaching Channel.28 Questions were raised as to whether impartial reporting was really possible in light of Gates’ massive influence. In 2012, Frontline again announced that it is partially funded by the Gates Foundation.29
- The Tow Foundation,30 which co-funded a joint three-year fellowship program between Frontline and Columbia University Graduate School of Journalism.31 Columbia University receives a lot of money for drug research. The Tow Foundation was recently recognized by Inside Philanthropy for making “very large contributions” to various “pet projects of the TOW family,” including medical research.32
All of these groups have links, both major and minor, to drug companies and vaccine research and support. So how can Frontline claim non-biased, non-slanted, independent journalism when their bread is being buttered by a list of foundations that have a history of funding and supporting the drug paradigm?
Like It or Not, PBS, Frontline and CBC Are Bedfellows in This Debacle
Moreover, no matter how “accidental” or “random” the junk food ad featuring Cheez-Its (made with vitamin enriched flour) and Dr. Pepper (soda is a major cause of our obesity epidemic) right before the show might have been, the show featured a food ad that is harmful to health. And I don’t think it’s “nonsense” to point out just how hypocritical that came across.33 The effect was quite striking!
It’s impossible to view it without getting the idea that Cheez-Its and soda are good while supplements are bad. And I question whether that combination was entirely accidental.
Frontline also complained that it was “unfair” to link their show to the CBC’s shoddy hit piece on supplements, calling it an “attempt to tarnish our work by erroneously linking it to an entirely different program at the CBC.” Any rational viewer will clearly see this link is not in error. PBS partnered with CBC to create this Frontline program.
All three are linked through this partnership. Frontline wants you to believe it is an independent agent, with no financial ties to anyone, not even PBS. This simply fails to line up with reality, especially when the program fails to prominently disclose its funding sources. This atrocious lack of transparency leaves no other rational conclusion other than it’s a massive conflict of interest that endangers the “public” while accepting money from some of the worst multinational corporations on the planet.
You CAN Make a Difference! Write Your Local PBS Station Now
Since PBS is a public broadcasting station, they should publicly disclose their financing. PBS and Frontline, which have had an exemplary track record of providing fair and balanced reporting in the past, utterly failed to do so in this instance. For some reason, they partnered with CBC, which for the past year has been running an organized campaign against supplements, and this bias was clearly revealed in this “Supplements and Safety” episode.
This kind of biased (and inaccurate) reporting is unacceptable. If you agree, I urge you to write your local PBS station with a strong message of your dissatisfaction with their programming and clear collusion with industry.
You can also contact PBS Ombudsman Michael Getler, whose job it is to perform independent reviews of PBS programming to ensure it stands up to journalistic standards and integrity. You can contact him by clicking the “Send an E-mail” on the PBS Ombudsman’s webpage, or call him at (703)-739-5290.
Following are some suggested talking points:
- Any and all potential conflicts of interest of experts interviewed should be disclosed
- PBS corporate funding for programming should be publicly disclosed
- Supplements cannot be accurately portrayed as “unregulated,” since they are regulated by the FDA under DSHEA, the FTC, and Current Best Manufacturing Processes. This is grossly negligent and endangers the public into further vitamin deficiencies (at least two out of every three people are deficient in vitamin D alone)
CBD Now Considered an Unapproved New Drug
The drug industry wants supplements to be regulated as drugs, and this is why such efforts are put into making you think the supplement industry is unregulated, even though it’s not true. Here’s an interesting example of what happens when a simple plant extract becomes a drug.
According to the FDA, once a drug company files an Investigational New Drug (IND) application34 for a supplement, it suddenly becomes a drug, and no one can market it as a supplement going forward — unless the substance has a history of being marketed as a supplement that precedes the IND. In the case of cannabidiol (CBD), the FDA claims a drug company was first on the scene.
British drug company GW Pharmaceuticals gained IND status on a CBD product in 2007, and eight CBD supplement manufacturers were recently issued warning letters35,36 from the FDA for marketing “unapproved new drugs.”
CBD shows massive potential in the treatment of seizures, and you can be assured the price difference to families for the same product — a CBD supplement versus a CBD drug — will be exorbitant. It’s going to be a boondoggle for big pharma that might even make Martin Shrekli37 proud!