Dietary Supplements & Pharmaceuticals | Natural Health Newsletter

Date: 05/25/2009    Written by: Jon Barron

Glaxo, Rumsfeld, the FDA, and Dan Brown

Angels and Demons, the film based on Dan Brown's book of the same name, has just been released. The plot is simple and is essentially a redo of his last book, The Da Vinci Code, with the names of the villains changed to spread the guilt. The premise is simple -- track a series of seemingly unrelated clues back to their primal source of spawning evil and criminal malfeasance. Since this format has worked so well for Dan Brown, I figured it might be a great way to get to the root of three recent announcements in the news.

With that in mind, I've decided to develop three treatments to present to Hollywood studios using Dan Brown's clue chasing format, but focusing on natural health and nutrition instead of religion. That means that instead of having to distort history and cast Opus Dei and the Iluiminati as villains, I get to populate my movies with real villains such as the FDA, the Center for Science in the Public Interest, GlaxoSmithKlein, Donald Rumsfeld, and the U.S, Senate. In real life, they have all been involved in some very nasty, behind-the-scenes activities that are likely to have profound adverse effects on your health.

angels and demons image

So without further delay.

Thriller/Mystery -- FDA warns consumers to stop using Hydroxycut products

Hydroxycut is a dietary supplement that, according to company literature, works by mimicking and intensifying the adrenergic hormones (adrenaline and its variants). Adrenergic hormones are the modulators that mobilize fatty acids from triglyceride stores and force the skeletal muscles to use more fatty acids for heat production. Thus, either mimicing them or stimulating their production in the body can help you lose weight.

Does/did it work?

The answer appears to be yes, it worked at least as well as a any of the other stimulant/fat burning pills on the market that have been designed to replace ephedra since it was pulled from the market six years ago. On the other hand, Hydroxycut was considerably overpriced in that it offered nothing more than a dozen other similar far less expensive formulas on the market (formulas, by the way, still on the market). Perhaps the extra money was required to pay for the product's rather expensive television advertising. But all of that is irrelevant to the issue at hand, which is why the FDA chose to go after Hydroxycut in the first place. And to get that answer let's act like Dan Brown's hero, Robert Langdon, and follow the clues back to the source.

On Friday, May 1st, the U.S. Food and Drug Administration warned consumers to immediately stop using Hydroxycut products developed by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. According to the FDA, some Hydroxycut products are associated with a number of serious liver injuries. In response, Iovate agreed to recall Hydroxycut products from the market. The "number" the FDA is talking about is 23 "reports" (not actually proven that Hydroxycut is actually responsible) over seven years and many millions of users.

hydroxycut imageSo what' s the problem? If Hydroxycut is causing liver damage, even if the numbers are small, shouldn't it be pulled from the market? Let's hold off on answering that question for the moment and keep following the clues.

As the Nutrition Business Journal said in their May 5th article on the subject, "This is a big deal for the dietary supplement industry because it will inevitably invite comparison to the ephedra AER [adverse event reporting] episode, and critics of the industry will no doubt call for some review of DSHEA [the Dietary Supplement Health and Education Act] as a result." The NBJ article also quotes an attorney who has worked with dietary supplement companies for many years as saying, "I predict we will see hearings. I don't know if it will be the FDA that initiates things. It probably will be an oversight committee in Congress" that moves to better fund the FDA so that it can fully enforce DSHEA.

And in fact, we are already seeing movement in that direction. An editorial published in the online edition of the Star Tribune on May 5th calls for action to "tighten up laws on diet supplements." As a case in point, the editorial cites a letter to the editor of the World Journal of Gastroenterology that points out with a strong sense of outrage that "Ingredients do not need to be considered ‘generally regarded as safe' as pharmaceuticals or food additives do, and the FDA must prove that a supplement is harmful before taking regulatory action. This means consumers, in effect, become unwitting subjects in a large scale post-marketing trial of a product's safety.''

Yes, the attacks have begun, but that's just the surface story. Like Robert Langdon in Angels and Demons (and no, I haven't seen it), we need to dig deeper to uncover the conspiracy rotting away at the core.

Our next clue takes us to a May 4th press release issued by the Reality Coalition. Who is the Reality Coalition, you might ask? As stated in their release, they are "a group of experts and organizations on overweight and obesity." Well, they certainly sound respectable, but what did they say in their release? In fact, they applauded "the U.S. Food and Drug Administration's (FDA) swift action warning consumers about the serious health risks associated with the use of 14 dietary supplements sold under the Hydroxycut brand name."

They further explained:

"The FDA's action aligns with the Reality Coalition's position that consumers should avoid unregulated dietary weight loss products that promise quick fix weight loss, but lack the scientific rigor to support these claims.

"'This action by the FDA draws even further attention to the serious public health threat posed by unregulated dietary supplements,' said Reality Coalition co-chair George L. Blackburn, MD, Ph.D. ‘Consumers must be educated and continuously made aware that over-the-counter weight loss supplements are not FDA approved.'

"'We have always argued that manufacturers of these products be held accountable to the same scientific standards as pharmaceutical drugs,' said Louis J. Aronne, M.D. ‘Now, is the ideal time for Congress to protect consumers by taking a closer look at the current Dietary Supplement Health and Education Act, raising the regulatory bar for weight loss supplement manufacturers to be accountable for the safety and efficacy of their products. At this point, the FDA has approved one product for weight loss for over-the-counter sale, but that's not enough. We firmly believe that there needs to be an FDA review process for all OTC weight loss products, otherwise tragedies like this will continue to occur.'"

Well, that all sounds reasonable. Who could object? But let's follow the demon's trail a little further. Perhaps the Reality Coalition, like the Illuminati cited in Dan Brown's book has a more sinister background than merely being "a group of experts and organizations on overweight and obesity."  As it turns out, a May 11th article in Food Navigator.com contains a revealing clue. "The Reality Coalition was set up in 2006, supported by a grant from the drug firm GlaxoSmithKline (GSK)."

gsk glaxo smith klineVery interesting, but why would a major pharmaceutical company like GSK be interested in funding a mouthpiece organization devoted to overweight and obesity? Because, as it turns out, GSK currently sells that lone FDA-approved, over-the-counter, weight-loss drug sold in the US market, as cited above in the Reality Coalition press release. And it gets even better. As it turns out, this is not the first time GSK has tried to capture the weight-loss market for itself. Last year GSK submitted a citizen petition to the Food and Drug Administration asking them to prohibit all weight-loss claims made by any supplement manufacturer unless their supplement was pre-approved by the FDA. Again, considering that GSK had a lock on that spot, that would be tantamount to asking the FDA to grant them a monopoly. Can you imagine how much it would be worth to have the only weight loss product in the world that could be legally sold? By the way, the name of that sole FDA approved weight-loss product is alli, a product that has proven to be only marginally effective and that produces side effects such as loose stools and "oily spotting." (You don't want to know what oily spotting is.)

Incidentally, consumers spend on average about $33 billion a year in the US alone on weight-loss supplements. Now that's a market worth GSK's efforts to get the FDA to ban all competitive products from the market, or at least force them to remove all references to weight-loss from their labels and literature. When you think about it, though, that's pretty much the same as a ban. For example, who would buy a product named "Fluffy Be Gone" that was unable to even hint at any ability to help you lose weight? Why Fluffy? Because using a name that even implied weight loss would be illegal; so fluffy, the new on-the-street euphemism for being over-weight would be about as close you could get.

But can you see the movie? Gestapo coated agents from the FDA hunting down alternative health freedom fighters. The nighttime meeting of the Reality Coalition cabal around the large wooden table as they discuss their plans to crush the alternative health industry -- guided by a mysterious voice on the phone that turns out to belong to the president of GSK...with only Robert Langdon and Fluffy the dog to save us. I mean, are we talking blockbuster thriller or what?

Okay, but like any good producer going in to pitch a studio, we need a backup plan -- another idea to pitch in case our primary idea doesn't fly.

Conspiracy/Heist -- Tamiflu, Donald Rumsfeld, and Dick Cheney

Okay, this movie begins with a flashback to the avian flu scare of 2005. Now keep in mind that as early as August of that year, I was telling readers not to panic, that although there was reason to be concerned about avian flu, pandemic conditions were far from imminent. Nevertheless, the press and the government seemed intent on whipping the world into a frenzy over the next couple of months. And on November 1st of that year, even as the threat seemed to be waning, President Bush addressed the nation. In summary, he said that the United States must be prepared to detect bird flu outbreaks anywhere in the world, that we needed to create and stockpile vaccines to protect us from any potential outbreak, that we needed to fine tune our plans to respond to any pandemic at the federal, state, and local levels, and we needed to stockpile the anti-viral drugs that would protect us against bird flu. Specifically, he said:

"We're also increasing stockpiles of antiviral drugs, such as Tamiflu and Relenza. Antiviral drugs cannot prevent people from contracting the flu, but they can reduce the severity of the illness when taken within 48 hours of getting sick. So in addition to vaccines, which are the foundation of our pandemic response, I'm asking Congress for $1 billion to stockpile additional antiviral medications so that we have enough on hand to help treat first responders and those on the front lines as well as populations most at risk in the first stages of a pandemic."

tamiflu packagingNeedless to say, with the President's endorsement, not to mention direct government purchases of a billion dollars, Tamiflu sales reached $1 billion in 2005, and climbed an astounding 37% more in 2006. And sales of Tamiflu still topped $1 billion in 2007 even as the threat of an avian flu pandemic largely receded. It turns out governments continued to stockpile in preparation of an ever less likely avian flu outbreak, even as reports of viral resistance to Tamiflu continued to surface at an ever accelerating rate. At the worst this sounds like fortuitous good luck for Roche, the manufacturer of Tamiflu. After all, what did they have to do with the outbreak of avian flu or the government's decision to stockpile their drug? Obviously, nothing…at least at first glance. But we need to do a Robert Langdon and follow the trail of clues deeper to reach the corrupt center of the conspiracy. Was there a hidden Roche/White House connection? Was there someone else who could benefit from the increased sales of Tamiflu?

As it turns out, Roche merely distributes Tamiflu. They didn't create it. That honor goes to a company based in Foster City, California, called Gilead Sciences, and they get paid a royalty on every Tamiflu pill sold anywhere in the world. So what has all this been worth to Gilead -- with sales of Tamiflu actually topping $5 billion a year? Well in early 2005, Gilead's stock price sat at $17 a share. By mid 2008, its stock had climbed to over $56 a share. This would obviously be worth a fortune to any of their large shareholders. So the question we might be inclined to ask at this point in our investigation is, "Are there any shareholders of note who would have benefitted from the huge stock price increase triggered by the billions of dollars in government purchases of Tamiflu, a product that is only marginally effective at best?" And the answer is yes; there's Donald Rumsfeld.

Tamiflu was developed and patented by Gilead in 1996. According to a January 3rd 1997 press release, Donald Rumsfeld was appointed to Gilead's board directors in 1988 and named Chairman of the Board in 1997. Undoubtedly, he got the appointment based in large part on work he had done earlier in his career as CEO, President, and Chairman of the Board of G.D. Searle, a worldwide pharmaceutical company. His chief accomplishment at Searle was to use the political connections that he had acquired while serving in the Reagan Administration to gain approval for the controversial sweetener aspartame over the objections of FDA review committees and the Public Board of Inquiry. In any case, he served as Gilead's Chairman until 2001 when he was appointed Secretary of Defense in the Bush Administration. At that point, although he gave up his position with Gilead, he did not give up his stock. In fact, instead of selling off his shares to avoid any potential conflicts of interest as might be expected from someone taking a cabinet position, he instead opted to buy another $18 million worth of stock upon joining the cabinet. The bottom line is that Rummy's Gilead stock has shown a 720% profit since he first went to Washington, with 56% of that increase coming as a result of sales related to government bird flu purchases alone.

But it was not just Tamiflu that represented a conflict of interest. Also while Secretary of Defense, Donald Rumsfeld personally signed off on orders to inoculate all US soldiers with Vistide, an anti smallpox drug also made by Gilead as part of George Bush's multi-billion dollar "Project Bio-Shield." Of course, smallpox was never an issue in Iraq, and Vistide carries a whole range of side effects, including renal toxicity, neutropenia, fever, anemia, headache, hair loss, uveitis and/or iritis, and abdominal pain. But it sure did produce a lot of money for Gilead…and Donald Rumsfeld.

Note: Rumsfeld resigned his cabinet position in November 2006, but continues to make money from all his fine efforts in the White House.

image of rumsfeld and cheney

It should probably also be mentioned that Donald Rumsfeld's best friend in the White House was Dick Cheney. They had worked together on the Armageddon Plan during the 1980's -- one of the most highly classified programs of the Reagan Administration. Then later, it was Rummy who hired Dick to work in the Ford administration. Does this matter? Yes, when you consider that they completely supported each other's efforts to steer business to their former companies while working together in the Bush Administration. Cheney supported Rumsfeld's government purchase of Gilead products as part of Homeland Security as discussed above. In return, Rumsfeld supported Cheney's use of Hailiburton, the company where Cheney served as CEO until joining the administration. What was this worth to Haliburton (and Cheney)? While Mr. Cheney was with Halliburton, he used his government contacts to finagle almost $2 billion in taxpayer-insured loans from the U.S. Export-Import Bank and the Overseas Private Investment Corp. In the five years before Mr. Cheney joined the company, it got only $100 million in government loans. (Those are some mighty fine contacts!) Also , in the 5 years Cheney served as CEO of Haliburton, he managed to arrange $2.3 billion in government contracts, compared with $1.2 billion in the five years before he took over.

But that was just the tip of the iceberg. Cheney's real work for Haliburton began after he left the company. While in the White House, in concert with his friend Donald Rumsfeld, the Secretary of Defense, he managed to steer an astounding $6 billion (and some say it's as high as $18 billion) in additional contracts to Haliburton. (Amazingly, accounting on these contracts is very vague and records not readily available.) Then again, this might be considered a small reward for a company that has provided Dick Cheney with a net worth estimated to be between $19 million and $86 million.

Although nothing Haliburton did had anything to do with alternative health, the key point here is the tit-for-tat exchange between old friends that ultimately allowed Gilead and Rumsfeld to pocket hundreds of millions of dollars of your money while making the entire country less healthy.

I have to admit that like the previous plot line, this thriller leaves a lot to be desired when it comes to its ending. The good guys lose. The bad guys get away with everything! That doesn't play well with audiences and the studio execs who cater to them. This may present a problem for the studios.

Perhaps I'm going about this all wrong. Perhaps what I need is a comedy. In fact, what's really hot right now is taking old dumb TV shows like The Brady Bunch, The Flinstones, and Land of the Lost and turning them into big budget movies. Perhaps there's something I can do along those lines as my final fall back pitch to the studios.

Slapstick Comedy -- Soda Tax weighed to pay for health care

land of the lost actorsThe old silly TV show in this case is actually a plan proposed earlier this year by Governor David Paterson of New York to raise money for the state by taxing non-diet drinks. Specifically, Gov. Paterson, as part of a $121 billion budget, proposed an "obesity tax" of about 15-18% on non-diet drinks. Although, triggered by a budgetary shortfall, the obesity tax in truth represents nothing less than a blatant attempt by big government to control what you eat and what foods you have access to. It should be noted that since Gov. Paterson's proposal did not tax diet sodas, it represented an attempt to steer millions of people away from sugar towards artificial sweeteners. Incidentally, the health consequences of using artificial sweeteners is well documented, as is their role in promoting obesity. You read that correctly, "promoting obesity." If Gov. Paterson had been playing fair, then he would have proposed a tumor tax and an even larger obesity tax on diet sodas -- but then again, big government (in all countries) is clueless. In the end, it was shot down in a storm of protest.

As it turns out, New Yorkers were not amused by this proposed obesity tax on sodas and other non-nutritional drinks. Polls taken shortly after the Gov. announced his proposal showed that 60% of those surveyed opposed the proposed 18% tax, with just 37% supporting it. Even those who prefer diet soft drinks, which would not be subject to the tax, said "nyet" to the proposal by a 58% to 39% margin. And the opposition ran across the political spectrum. Then again, bad comedies never seem to go away. That's right. New York legislators are back at. On May 19th, they announced their intention to try again with a proposed one cent excise tax on non-diet sodas.

Which brings us to the big budget movie version of the story.

According to the Wall Street Journal, it seems that leaders in the US Senate found Gov. Paterson's idea amusing enough that they think it should play not just in New York, but play in theaters across the entire country. They are actually considering new federal taxes on soda and other sugary drinks to help pay for an overhaul of the nation's health-care system. The Journal reports that The Center for Science in the Public Interest, a Washington-based public advocacy action center that pressures food companies to make healthier products (at least as they define them), plans to propose a federal excise tax on soda, certain fruit drinks, energy drinks, sports drinks and ready-to-drink teas. Again, as with Gov. Paterson's proposal, the tax would not include most diet beverages. In fact, yet again, it is designed to promote their use. Think about that for a moment. If you're increasing the cost of sugared sodas, but not diet sodas, what are you deliberately encouraging people to buy? You always have the option of just increasing the tax on all sodas, which would be consumption neutral. But no! Which brings up the question: why does everyone in government seem to want us to consume mass quantities of artificial sweeteners? But that's a different movie.

As it turns out, the proposal has reached sympathetic ears among senior staff members of several Democratic senators. In truth, the agenda for most of the Senate staff probably has far less to do with health, and much more to do with money -- to at least make a show of offsetting some of the massive deficits the government is accruing this year. It is estimated that adding a tax of three cents per 12-ounce serving to these types of sweetened drinks would generate $24 billion over the next four years.

All in all, a very funny idea!

Conclusion - Hydroxycut, Tamiflu, soda tax

So what do you think about my three treatments? Do you think the real life villains I've exposed match the fictional characterizations of Opus Dei and the Illuminati in Dan Brown's books? Are the stories intricate enough with twists and turns, and plans within plans? Have I exposed the raw nerve of human greed and corruption? Have I shown that there's no limit to stupidity -- that if an idea is truly bad and comical enough, it can be resurrected at ever higher levels of government? Have I proven that there are powerful forces aligned against you trying to get you to fund multi-billion dollar health schemes that do little to support your health, and that government is even looking to use your money to force feed toxins (artificial sweeteners) to you and all your loved ones?

If so, then come see my movies -- all playing now in real life near you…whether you want them to or not.

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