Archive for the ‘Healthfraud’ Category

Dannon Takes a $21 Million Dollar Hit for Bogus Health Claims………

Dannon, the makers of Activia yogurt and DanActive drinks, has been fined $21 million dollars by the FTC for deceptive advertisements involving specific health claims. Specifically, they claim that their products can make you poop and keep you from catching a cold or the flu. Not smart. Really not smart. But it doesn’t matter because they will still come out on top.

The FTC has been trying (bless their little hearts) to crack down on misleading claims in advertisements, and I appreciate the effort. Thanks to the emasculation of the FDA by the 1994 Dietary Supplement and Health Education Act (DSHEA), the FTC is the only governmental regulatory body that can put a stop to them. In this case, as the linked article explains, it is likely too little and too late. Dannon has been pushing their products with these bogus claims for years and they are widely accepted by the public. $21 million dollars is a minor slap on the wrist and just the cost of doing business these days.

To catch any readers not familiar with DSHEA up to speed, it fundamentally changed the way that supplements and herbal remedies are regulated, making us all a lot less safe as a result. Post-DSHEA, regulation of the supplement industry, and even the more mainstream over-the-counter medicine industry (they are actually pretty much all the same thing these days), essentially works like old wild west law enforcement. Manufacturers can pretty much do as they please as long as they don’t make specific disease claims, such as that their product cures asthma, and as long as they don’t kill anybody. Well, as long as they don’t kill too many people.

Under DSHEA, the burden of proof for safety, efficacy and label accuracy belongs to the FDA. That may not sound bad but trust me, it is. There are hundreds of new products in this category that come out yearly and the FDA does not have the resources to investigate all of them. So there has to be some kind of triage system in place. A company can package a product, such as a so-called herbal remedy, and as long as they stick to what have come to be known as structure and function claims (“immune support” or “cardiac health”) they won’t be noticed by the FDA. They don’t need any evidence that their product is safe or that it is effective in any way. They don’t have to be honest about what is on the label in regards to ingredients. Nobody is checking on these things. It is an honor system and it has killed people.

Take ephedra for example. Ephedra is an herb that has been used traditionally for things like colds and asthma, as well as for increasing energy and for weight loss. It is understandable that pre-scientific cultures came to associate ephedra with these conditions because it is a potent stimulant. It constricts blood vessels, increases the heart rate and blood pressure, and it opens up airways in the lungs. Because of this effect it was investigated as a potentially beneficial medicine but the side effect profile was rough and better medications were developed. Science-based medical practice had no place for ephedra but it became an increasingly popular component in supplements taken by people desiring improved athletic performance or weight loss. It still isn’t clear whether or not it actually has much of an effect, if any, in regards to those desired outcomes, but it quickly became very clear that it was dangerous.

For years, thousands reports of adverse events came in to the manufacturers of products containing ephedra. These reports included deaths from strokes and heart attacks. These adverse events, including deaths, occurred not only in unhealthy people with risk factors for such outcomes but also in healthy young adults. Finally the FDA decided to step in, and in the late 90’s proposed label warnings. This was met with a campaign by the supplement industry and their lobbyists, as well as the two senators (Hatch and Harkin) responsible for DSHEA in the first place, to put a stop to this. They succeeded and unsuspecting consumers continued to suffer.

Then the tide turned. Additional evidence supporting the FDA concerns about ephedra came along, and public awareness of these concerns and calls for action increased. But it wasn’t until 2004 that the sale of ephedra was made illegal, after many thousands of serious adverse events were uncovered that had been purposefully kept from the FDA by a supplement manufacturer and after a large and expensive meta-analysis was conducted that clearly showed just how dangerous ephedra was. Even this was bitterly contested by the supplement industry but appeals were denied and ephedra remains banned in America.

DSHEA allowed this to happen. If supplements and herbal remedies were regulated like the sloppy drugs that they are, manufacturers of products with ephedra would have needed to provide appropriate evidence that they were safe. The tale of ephedra puts the lie to the fallacy that natural equals safe and should have served as a cautionary tale and impetus to improve the system. It didn’t, so you the consumer must be weary.

This came out today. I’ve read about many cases of adulterated herbs and supplements, usually Viagra spiked male “enhancement” pills, but things are much worse than I thought. Warfarin? Benzos? Damn. And that’s here in America folks.

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The Truth Behind Herbs and Supplements…..

For a few years during my high school and college days, I was into supplements. I was also into country music, but nobody is perfect. I took vitamin C to ward off colds, B vitamins for increased energy and ephedrine for weight loss to name just a few. My excuse? Like the ancient Chinese who supposedly used acupuncture 5,000 years ago*, or the 18th century American physicians who bled their patients to remove excess bodily humors, I was prescientific.

In contrast to those dark days, as a result of my discovery of the work of James Randi and the modern skeptical movement I spent the early years of my pediatric residency developing an interest in so-called alternative medicine. My eyes were opened as I learned about the reality behind the substances I ingested with the fearlessness of ignorance and I became embarrassingly aware of the simple fact that science just doesn’t support the near entirety of claims made by the manufacturers of herbs and supplements**. Despite this, these products can be found on the shelves of thousands of stores across this country and they rake in billions of dollars annually. Unfortunately, consumers are generally unaware of the science, or rather the lack of it, behind these products, and of the risk that they take each time they head down to the GNC or Rite-Aid. 

If I were to walk out my back door and take a random sampling of the available plant life, place those clippings of various flowers, weeds and grasses in my blender, and press liquefy, the end result would have the potential to make me a very rich man. To the untrained eye it would appear to be merely a glass full of grass juice, and to the naive mind a nasty and useless concoction. But to an individual initiated in the unethical reality of herbs and supplements, it might just be a gold mine. You see, all it would take to turn green grass into green cash is the current state of regulation of herbs and supplements in the United States and a vague structure/function claim. 

Here’s how it works. Since the early 90’s, 1994 to be exact, with the passage of the Dietary Supplement Health and Education Act, the supplement industry has essentially existed as if stuck in the days of the American Old West. The Law of the day, much like our current Food and Drug Administration, served as a means of maintaining a somewhat controlled chaos. Try this excerpt on for size, podnuh. 

“Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.” 

Now just let that sink in for a moment. Wait for it. Wait for it. Has it hit yet? Has that feeling of emptiness and despair that I experience on a near daily basis during my frequent adventures in the Land O’Woo settled in yet? Allow me to break this down for you. Since 1994, when the FDA was sent outside to fetch its own switch so that Congress could more effectively tan its hide, manufacturers have had no oversight whatsoever when it comes to determining whether or not their herb or supplement is safe. My fictional grass juice, which I’ll have you know has been used by Native Americans to cure teeth itch and hair pain for thousands of years, could contain iocane powder*** and kill several consumers before the FDA would be able shut down my operation. In fact, as I am writing this there are herbs and supplements sitting on store shelves which contain toxic levels of heavy metals such as lead or mercury and which are adulterated with pharmaceuticals****. When enough people are harmed by an herb or supplement, such as in the infamous case of ephedrine a few years ago, the FDA investigates and the product is pulled. There are thousands of new supplements that go on the market each year and the emergence of the next Ephedra is only a matter of time. 

But what about effectiveness? Unfortunately, DSHEA rains on that parade as well. There is no requirement under the law for an herb or supplement to be proven effective by the company selling it as long as the claims made fit certain criteria. If claims of positive impact on a specific disease are made, then the FDA has the power to make sure that the evidence supports those claims. If vague claims involving support of structures or bodily functions are made, then the FDA is impotent. So if I attempted to market my backyard grass juice to cure epilepsy, I wouldn’t get very far. But if my infomercial talks about supporting brain health (wink wink, nudge nudge) or improving neurological function, I’ll be opening my Swiss bank account in no time. 

The dangers of DSHEA and the herb and supplement racket actually go much deeper than this brief discussion goes into. I’ll devote additional posts to these issues but I encourage my readers to take the next step and investigate for themselves. A great place to start, as it is with any healthfraud or alternative medicine related topic, is Science-Based Medicine

*The Chinese weren’t using acupuncture 5,000 years ago despite what numerous news reports and press releases claim. What is known today as acupuncture has only existed for the past several decades and has failed the test of science. 

**These manufacturers are typically subsidiaries of the mammoth pharmaceutical companies so reviled by the alt med crowd. Awareness of this fact has forced many a believer to erect additional impenetrable walls of cerebral compartmentalization to avoid the coma inducing cognitive dissonance. 

***Iocane powder is a deadly poison that is odorless, tasteless and highly soluble. It is only available in powder form and was once popular for use during battles of wits when death was on the line, particularly with Sicilians. Although it takes a few years, determined individuals are capable of developing immunity to the poison. 

****Actual Viagra has been found in supplements bearing claims of male enhancement!

Fear, False Hope and Irregular Medicine…..

One of the most pernicious, and most universal, aspects of so-called alternative medicine is the offering up of false hope. This often occurs in the setting of benign conditions such as lower back pain (benign only when you aren’t suffering from it) or self-limited viral infections, where time alone is usually sufficient to bring about resolution of symptoms. So the unproven remedy being offered, as long as it isn’t dangerous in itself, may lead to a perception of benefit due to various placebo effects. A very different scenario tends to play out in the setting of more serious illness, such as cancer or HIV. Every day, victims of false hope based on unscientific ramblings waste time and money on cures that have no basis in reality.

This phenomenon certainly isn’t unique to the United States, where chiropractors treat infants with asthma, homeopaths tout 90-year-old anecdotes as proof of effectiveness against the flu and droves of us cross the border into Mexico to seek out bogus stem cell treatments and various other claims of miracle cures. Every country has more than their fair share. Two weeks ago, an online New York Times article discussed the growing (sorry, had to be done) trend of concerned South Korean parents bringing their children to “growth clinics” in order to add inches to their height.

These clinics, one of which has 50 branches operating across South Korea, prey upon the popular bias against short people in a country of, well, short people. But not that short. Data from 2006 reveals that the average height of 18-year-old men and women in South Korea were 5 ft 8.5 inches and 5 ft 3.5 inches respectively. The average height of American men is only about two inches higher. But according to the article there is a commonly held belief that taller people are more successful and find better husbands or wives. Because of this belief, parents are subjecting their little little ones to a variety of unproven, and potentially harmful, methods of increasing the length of their limbs. These methods appear to be primarily traditional in nature, including acupuncture, herbal tonics containing deer antler of course (sympathetic magic is at the root of much of alternative medicine) and aromatherapy. These, which are likely safe if not environmentally sound depending on just what animal parts are being used, are balanced with a version of a torture rack for toddlers and growth hormone injections.

These clinics appear to also focus on good nutrition, something which has been proven to help maximize the genetic potential for height in an individual, but what they consider good nutrition is left up to the imagination. But considering the cost of these clinics, which according to the article can cost nearly $400 dollars a month for one child, I don’t think that lack of access to food is a problem in these families. And as for the other offered therapies, there simply isn’t any evidence that they are effective. They are, in fact, with the exception of growth hormone injections, based on pre-scientific and highly implausible notions such as the stagnation of mystical and undetectable “human energies”.

The ultimate height achieved by any individual is based on  multiple variables, with genetics being the largest determinant. Short parents don’t often have tall kids, regardless of how many times they crank the ratchet on their basement Rackomatic Jr. 3000. Human growth hormone, which regulates bone lengthening and stimulates release of another important growth factor by the liver, can be given to children via injections in order to increase growth. Unfortunately, it only helps in deficiency states and it doesn’t work very well. But I guess if parents think that their child will magically by transformed from pauper to prince by going from 5-2 to 5-3.5, they might be more willing to accept the risk.

I would love to know what kind of informed consent goes on in these clinics. I doubt very much that the proprietors give a guarantee of success without an escape clause. That isn’t how these things typically work. There is usually something added to the mix that is effort dependent, such as a strict exercise regimen or hard to follow diet. That way when the child doesn’t grow to the expectations of their parents, the clinic can blame their not following the recommendations perfectly. Or, if all else fails, they can simply express regret that the child wasn’t brought in sooner, when the treatments would have been sure to work. Either way, the parents are left with the burden of guilt and the pusher of false hope, even if a well-intentioned true believer, merely calls out next.