First Do No Harm

A Response to John Oliver’s Story on Dr Oz and Supplements

Editor's Note: To view the portion of the show this piece references, go here: https://www.youtube.com/watch?v=WA0wKeokWUU

I was about to mention in one of our newsletters the story of Dr Oz going up before congress to address his hyperbolic language while discussing a variety of weight loss supplements, when I caught John Oliver's Last Week Tonight on HBO.

Oz doesn’t sell the things he talks about, but he is constantly selling his show. The more hype, the greater the audience.

John Oliver tore into Dr Oz with his usual aplomb and then quickly went after supplements in general (a few specific) and the FDA’s oversight/regulation, or lack thereof, of the industry.

Regulation, at first glance, especially given Oliver’s presentation of a few “facts,” seems logical and good for the consumer. However, allowing a regulatory agency that is in bed with the pharmaceutical industry to regulate their competition would be a bit like allowing players from the Yankees to referee their home games.

Oliver’s writers did their homework and easily dug into the crap that Oz had hyped on his show, but facts have context and what many have accepted as facts over the years are not at all facts but simply BS that has become “fact” for those who have heard it over and over and over. But first let's take a look at the supplements they focused on.

Oliver jumped on the green coffee supplement with a study found here: Supplementation of a High-Fat Diet with Chlorogenic Acid Is Associated with Insulin Resistance and Hepatic Lipid Accumulation in Mice

The abstract starts off with a mention of previous studies showing that coffee consumption prevents metabolic syndrome (type two diabetes). It then discusses the methodology of the study by describing the three groups of mice, what they were fed, and the amount of CGA (chlorogenic acid) the mice received.

At the end of 12 weeks, the study concluded that the CGA-fed mice had increased their insulin resistance compared to the others.

This conclusion, of course, is totally contrary to this study: Randomized, double-blind, placebo-controlled, linear dose, crossover study to evaluate the efficacy and safety of a green coffee bean extract in overweight subjects, published at PubMed.

The difference between the two studies comes down to methodology.

The first study used mice; the second study used human beings. The first study used an amount of CGA based upon the weight of the food received, while the human study used varying amounts of the CGA.

The human study used a product from a nutraceutical company approved by the FDA. Where the mouse study got their product is not mentioned in the abstract.

The mouse study results are not only contrary to the human study presented here, but contrary to a meta-analysis of previous studies (results grouped together).

Then there is the study on Svetol® in particular that we published at this site:

In a study published in Phytotherapy ... "researchers used 400 mgs of Svetol brand green coffee bean extract with 50 participants aged 19-75 during the course of a 60 day placebo controlled study. Interestingly, in this study scientist tried to mimic what happens when people diet by asking participants to reduce their daily caloric intake by 500 calories. Both groups lost weight, however those on Svetol green coffee bean extract lost considerably more. The group on placebo lost 5 lbs. while the group on Svetol lost 11 lbs. In addition the BMI of the group on Svetol green coffee bean extract went down by 5.7% and the ratio of lean (muscle) mass to fat mass increased by 4%. This shows that the green coffee bean extract caused participants to lose weight by increasing fat burning while sparing muscle tissue (exactly what you want when losing weight). The participants took 1 capsule containing 200mgs of Svetol green coffee bean extract with each of their 2 biggest meals."
[
https://www.drneillevin.com/ordereze/Content/PageDetails.aspx?PageID=99]

Svetol® is not just CGA, but that and other phytochemicals found in green coffee.

The question is: why the contrary results in all these human studies compared to the mouse study?

It boils down to methodology. Something in the mouse study made the results contrary. In human studies, the substance is taken before meals, but it "seems" like, in the mouse studies, it was mixed in with the food. Additionally, we don’t know the quality of both the food and the substance given to the mice. But obviously, since this is the only study contrary to the rest, something in the study was vastly different from all the rest.

The main difference between the human studies and the mouse study is that one study was done on mice. The results from mouse studies cannot always be transferred onto humans. If you've read much of our site or newsletter, you know how we often reference mouse studies tongue-in-cheek. I've even read about testing of Alzheimer's drugs on mice. Really? What's a mouse have to remember in the first place?

The simple fact that Oliver (his research people) jumped on this study while ignoring all the others tells us that his report had a bias.

When I published our story on Svetol®, I had known about the mouse study. Because it was contrary to all the other studies, I ignored it. It’s like any study in that oftentimes, to do a statistical analysis, we toss out the results that are "off the scale" to either side of the mean, especially if they are much greater or much less than all other responses. Those particular responses tend to “skew” the results.

Next Oliver jumped on ephedra, and personally I’ve had the ephedra story up to here. We have some 30 references to ephedra at this site. I disliked the story from the start and Oliver’s facts were questionable.

First, let’s talk about the widely covered story of the Baltimore Orioles pitching prospect Steve Bechler, brought up by Oliver.

  • Belcher did NOT use ephedra. He used ephedrine (the active ingredient in ephedra, in concentrated form) which is not an herb, but is classified as a drug.

  • Belcher had an enlarged heart and a history of heart disease with borderline hypertension and liver abnormalities.

  • He was dieting heavily and had eaten very little for at least three days, possibly more.

  • He was overly dressed (his internal temperature when he was found was 106 degrees).

  • All products containing Ephedra or Ephedrine specifically warn you that if you have a heart condition, you should not be taking this product.

Belcher was, in point of fact, abusing the product and abusing his body.

The news story on Belcher and ephedra that Oliver played for his audience next brought up the number of deaths due to “ephedra.” I put that inside quotation marks because every death that was "reported to be" due to ephedra was not due to ephedra, at least those we’ve been able to research; those news stories that reported the actual product the deceased had used. In every case we found that the deceased had used ephedrine. In every case we found that the deceased had abused ephedrine.

The claim was 155 deaths. One health-conscious site found only 81 deaths due to ephedrine while I found another source that reported the number at 110. But let’s go with the number 155.

Those 155 deaths occurred over a TEN year period. Tylenol now kills, on the average, around 130 people a year; people who use it according to the instructions on the label.

Of those "ephedra" deaths, the research I did some 10 years ago (because of all the hoopla in the news then over ephedra) came up with ZERO deaths due to ephedra being used according to the instructions, within the guidelines set by herbalists.

I repeat again: it is ephedrine that caused those deaths and in every case I was able to chase down, the victim had been abusing the product.

The focal point of Oliver’s story (the irony) is “if only there was a regulatory agency to oversee these supplements,” with the punch line being: Duh…the FTC and FDA.

But let’s jump into one more supplement brought up by Oliver: L-tryptophan. You'll see where I'm going with this.

In the late nineties, a very bad batch (from Japan) of L-tryptophan killed 37 people and caused injuries to 1500 people. Some injuries were permanent .

This was a horrible disaster. Few stories in our media, however, were thorough enough to point out that the batch had come from genetically engineered bacteria. The company, Showa Denko, upon discovering what they’d produced, immediately destroyed all bacteria used in the production of the product, thus scotching investigators’ ability to determine what went wrong.

This was, admittedly, a horrible situation which brought up a cry for regulations in the supplement industry.

However, when the FDA is called upon to “regulate” the vitamin and supplement industry, they don’t just regulate, they start to “eliminate.”

Ephedrine was abused and caused 155 deaths. Solution: Eliminate ephedra.

One bad batch of L-tryptophan from Japan caused 37 deaths and injured 1500 people. Solution: Eliminate L-tryptophan.

And what about stevia? No deaths. No injuries. Impinges on the profits of Aspartame®. Solution: Eliminate stevia.

Let’s hear from Dr Linda Page, ND, PhD:

I am continually distressed about ephedra's misuse and abuse, most importantly the isolated component of ephedra, ephedrine. If herbalists and formulators lose the ability to use ephedra, we are losing one of the best broncho-dilators from the plant kingdom that is extremely valuable when used for asthma and allergies. What then would people have to choose from to alleviate their symptoms? Drugs of course.

As for the ban on L-tryptophan, here is what Dean Wolfe Manders, PhD has to say on that subject:

In the fall of 1989, the FDA recalled L-Tryptophan, an amino acid nutritional supplement, stating that it caused a rare and deadly flu-like condition (Eosinophilia-Myalgia Syndrome — EMS). On March 22, 1990, the FDA banned the public sale dietary of L-Tryptophan completely. This ban continues today. On March 26, 1990, Newsweek featured a lead article praising the virtues of the anti-depressant drug Prozac. Its multi-color cover displayed a floating, gigantic green and white capsule of Prozac with the caption: “Prozac: A Breakthrough Drug for Depression.”

The fact that the FDA ban of L-Tryptophan and the Newsweek Prozac cover story occurred within four days of each other went unnoticed by both the media and the public. Yet, to those who understand the effective properties of L-Tryptophan and Prozac, the concurrence seems “unbelievably coincidental.” The link here is the brain neurotransmitter serotonin — a biochemical nerve signal conductor. The action of Prozac and L-Tryptophan are both involved with serotonin, but in totally different ways. [http://ceri.com/trypto.htm

When Aspartame® was finally okayed by the FDA, Japan was not very hot on it. Diet Coke all over the world contained Aspartame®. In Japan, however, it contained stevia. People kept using stevia.

Not one death; not one injury, but suddenly it’s banned.

I’m not big on trusting Wikipedia, but this time they got it right. You really should read this:

In 1991, after receiving an anonymous industry complaint, the United States Food and Drug Administration (FDA) labeled stevia as an "unsafe food additive" and restricted its import.[31][54][55] The FDA's stated reason was "toxicological information on stevia is inadequate to demonstrate its safety."[56]

Since the import ban in 1991, marketers and consumers of stevia have shared a belief that the FDA acted in response to industry pressure.[31] Arizona congressman Jon Kyl, for example, called the FDA action against stevia "a restraint of trade to benefit the artificial sweetener industry".[57] To protect the complainant, the FDA deleted names in the original complaint in its responses to requests filed under the Freedom of Information Act.[31]

Stevia remained banned until after the 1994 Dietary Supplement Health and Education Act forced the FDA in 1995 to revise its stance to permit stevia to be used as a dietary supplement, although not as a food additive – a position that stevia proponents regarded as contradictory because it simultaneously labels stevia as safe and unsafe, depending on how it is sold.[6]

Early studies prompted the European Commission in 1999 to ban stevia's use in food in the European Union pending further research.[58] In 2006, research data compiled in the safety evaluation released by the World Health Organization found no adverse effects.[44 Since 2008, the Russian Federation has allowed stevioside as a food additive "in the minimal dosage required".[22]

In December 2008, the FDA gave a "no objection" approval for GRAS status to Truvia (developed by Cargill and The Coca-Cola Company) and PureVia (developed by PepsiCo and the Whole Earth Sweetener Company, a subsidiary of Merisant), both of which use rebaudioside A derived from the Stevia plant.[59] However, FDA said that these products are not Stevia, but a highly purified product.[60] In 2012, FDA posted a note on their website regarding crude Stevia plant: "FDA has not permitted the use of whole-leaf Stevia or crude Stevia extracts because these substances have not been approved for use as a food additive. FDA does not consider their use in food to be GRAS in light of reports in the literature that raise concerns about the use of these substances. Among these concerns are control of blood sugar and effects on the reproductive, cardiovascular, and renal systems."[61]

The argument here is this: The FDA does not regulate supplements; it bans supplements.

John Oliver and anyone else who wants to, can scream to the high heavens complaining about the movement that sent people’s money to Washington and into the coffers of Senators Hatch and Harkin all he wants, because nobody in America wants the FDA to take away our right to use vitamins, minerals, supplements, and natural products (except the pharmaceutical industry and its friends).

This is what the battle boils down to: a battle between the people who want to use diet, vitamins, herbs, and supplements to maintain their health versus a pharmaceutical industry using the FDA to protect their profits by maintaining a tight squeeze on the smaller industries. The pharmaceutical industry's goal is to make every person in America (and beyond) a "patient."

This is a classic David v Goliath story. In 2013, the nutritional and dietary supplement industry sent $1,635,000 to congress (in lobbying). The pharmaceutical industry sent $226,114,456. [www.opensecrets.org]

Exactly how many drugs have the FDA banned?

Tylenol: 130 average deaths yearly (of people who used it according to the label instructions). Still available.

Vioxx: Over 60,000 deaths. The FDA did not ban Vioxx, but Merck & Co. voluntarily removed it from the market.

Coumadin: Over 12,000 deaths each year. Still approved and on the market.

Birth control pills Yaz and Yasmin, released in 2006, are responsible for at least 100 deaths and over 10,000 injuries. Still available.

Actos, Avandia, Paxil, Prozac, Effexor, Zoloft, Lexapro, Depakote, Testosterone, Accutane, Crestor, Pradaxa, Xarelto, Fosomax, and Reglan, all of these responsible for deaths and injuries numbering in the thousands, yet still on the market. Over the counter NSAIDS (non steroidal anti-inflammatory drugs) send nearly 30,000 - 50,000 people to the hospitals yearly. Still on the market.

The “FDA Drug Review: Postapproval Risks 1976-1985” found the following annual deaths from:

Approved Drugs ................60,000 - 140,000

Food Contamination ..............................9,100

Aspirin ..........................................................90

Compared To:

All vitamins ...................................................0

Uncontaminated amino acids ......................0

Commercial herbs ........................................0

And yet, just one problem with a supplement pops up or someone abuses a supplement and the FDA removes the product from the market.

Today, it is estimated that over 200,000 people die from prescription drugs, though you will see “official” numbers a lot lower, mainly because the industry does not “snitch” on itself and tends to “under-report.”

Is the FDA complicit?

You bet  it is. A recent report that the blood pressure drug Benicar had caused 23 serious cases of late-onset diarrhea associated with significant weight loss sent those terrible trial attorneys into action.

Twenty-three serious cases? The attorneys found thousands of cases, many of whom had died from either the drug or while being treated for serious intestinal distress. And they discovered that the FDA had known about the problem for quite a long time but covered that up.

Is the FDA complicit? That’s kind of what “cover-up” means.

A Very Shorth History of the FDA

With the passage of the Federal Food and Drug act, Harvey W Wiley, MD headed up the Bureau of Chemistry which would one day become our modern FDA. In 1912 Wiley resigned in disgust, “because the fundamental principles of the Pure Food Law have been strangled; because he has been powerless to punish the manufacturers of misbranded and adulterated drugs." [Rocky Mountain News, March 21, 1912]

In 1929, Wiley wrote a book entitled, The History of a Crime Against the Food Law: The Amazing Story of the National Food and Drugs Law Intended to Protect the Health of the People, Perverted to Protect Adulteration of Foods and Drugs. In it he wrote: "If the Bureau of Chemistry had been permitted to enforce the law as it was written and as it tried to do, what would have been the condition now (1929)? No food product in our country would have any trace of benzoic acid, sulphurous acid or sulphites...no soft drink would contain caffeine...no bleached flour would enter interstate commerce...Our food and drugs would be wholly without any form of adulteration. The health of our people would be vastly improved and their life greatly extended...The manufacturers of our food supply would (provide) whole ground, unrefined cereal flours and meals. The resistance of our people to infectious diseases would be greatly increased by a vastly improved and more wholesome diet...The cause of a wholesome diet would not have been put back for fifty or a hundred years...and this History of a Crime would never have been written."

Skip ahead to January 2, 197 and Dr Herbert Ley, Commissioner of the FDA has this to say:

The FDA 'protects' the big drug companies and are subsequently rewarded, and using the government's police powers they attack those who threaten the big drug companies. People think that the FDA is protecting them.

It isn't.

What the FDA is doing and what the public thinks it is doing are as different as night and day.

In 1993, Federal Judge Lowell Jensen was quoted saying, "It apparently is FDA's view that if a company makes a claim that milk helps prevent rickets, milk suddenly becomes a drug."

As to the companies they’re supposed to oversee, in testimony before the House Subcommittee on Intergovernmental Relations, 1970, FDA Commissioner Charles C. Edwards testified: "(It is) not our policy to jeopardize the financial interests of the pharmaceutical companies.”

Later Senator William Proxmire was quoted saying: "The FDA...(is) actively hostile against the manufacture, sale and distribution of vitamins and mineral as food or food supplements. They are out to get the health food industry and drive the health food stores out of business. And they are trying to do this out of active hostility and prejudice."

Regulation? Really?

While Oliver cries out for “regulation” of supplements, regulation isn’t even on the list of things the FDA has in store for vitamins and supplements. In order to protect the profits of the pharmaceutical industry, their main goal is to destroy the vitamin and supplement industry, and that, ladies and gentlemen, is exactly why people like you and me sent money to Senators Hatch and Harkin.

We wanted to rein in the FDA and keep their hands off of our supplements.

And yes, we will honestly admit that there will be a lot of crap on the market, especially when Dr Oz sings out “miraculous” and “magical.” But this is why we have organizations like Consumer Labs that will review the literature on a specific supplement and then test the leading brands.

Sure, some supplements will not have in them what they claim to have in them. This is fraud, and the supplement industry is rife with fraud at times. But again, this is why we have Consumer Labs; this is why we, at this site, and many others write exposes on fraudulent products; why we read Mercola, Jason Kennedy, Dr. Ray Sahelian, MD, and Dr Alan Sears; and why we receive newsletters and do our own thorough research. This is why we shop for trusted brands, like Swanson's, NOW Foods, Nature Made, and many, many more.

The simple fact is: people who are concerned with their health are the most informed buyers in America. And when some clown like Dr Oz spouts off about miracles and the clowns in his audience take him up on it and order fraudulent products, their behaviors are injurious to the rest of us who know what the FDA is up to and who carefully pick and choose our nutrition and nutritional products to maintain good health.

When Dr Oz spouts off about the miracle named “garcinia cambogia,” we the buyer can go to a good number of trusted sites to learn that it’s really “garbagea.”

Yes, we who want good health, who are interested in our good health, and are doing things to maintain our good health; we are the overseers of vitamins and supplements.

Do we really need the crooked FDA, daily complicitly foisting off on the public dangerous drugs while trying to outlaw berries and raw milk?

I don’t think so.

Further Reading

FDA Complicit in Pushing Prescription Drugs

Senate Report Claims GSK Hid Avandia Risks, FDA May Be Complicit

The Vioxx scandal: damning Senate testimony reveals drug company, government complicity

FDA DRUG APPROVAL PROCESS IS WORRYINGLY FLEXIBLE AND RIFE WITH ERRORS, NEW STUDIES FIND

Indicting Big Pharma

NSAID Pain Killers Linked to Irregular Heartbeat

Dangerous Prescription Drugs

 


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