Senate Legislation May Increase FDA Persecution of Americans and Violations of First Amendment Rights

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September 22nd, 2010 Leave a comment Go to comments

The US Senate is at its typical deceitful antics again. Senators are once again debating more repressive legislation, this time in the form of the Food Safety Accountability Act of 2010. This legislation is designed in part to silence those who cite research on foods and supplements that have beneficial effects to health. The main sponsor of the legislation, Senator Patrick Leahy (Democrat from Vermont), claims he’s trying to protect Americans from unsafe contaminants in foods and supplements. But the legislation is so defective that, if passed, it will almost certainly be used by the FDA to continue to attack, persecute, and shut down companies and organizations that publish citations of scientific research that shows their food and supplement products are beneficial.

If after reading this article you are persuaded that this new legislation has some problems and should not pass in its present form, please take action by contacting your Senators to oppose the bill. It takes just a couple of minutes to do this.

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FDA Happy to Sacrifice Your Health, Life, and Freedom for Its Money and Power

Why does the FDA want to silence these people? Simple, they are a threat to its income and influence.

Innovative food and supplement companies sell a wide variety of highly beneficial products that often out-perform expensive and side-effect laden drugs at a fraction of the cost. The FDA would rather have you buying the latest and greatest statin drug to lower your LDL cholesterol, not eating healthy foods and taking cheap and effective supplements like niacin, plant sterols, red yeast rice, and fiber supplements that all have scientific backing for lowering LDL cholesterol without the dangerous side effects of statins.

Why does the FDA prefer statins? Again, follow the money. Statin makers are big pharmaceutical companies. They pay billions in fees to the FDA to approve these drugs. The FDA is addicted to these fees. While the drug companies “complain” about the high fees, they are actually very happy to participate in this plot because it enables them to introduce pricey new products every year, many of which work not much differently from the dozens of similar products already on the market, and keep smaller competitors from cutting into their markets. The FDA is a very good business partner in that it helps create drug monopolies and destroy any competition that may arrive before it can take too big a cut out of big pharma and FDA profits.

Small companies can’t afford $1 billion plus drug approval processes that take several years, even more than a decade, to get a drug approved. So many small companies that want to offer consumers products to help solve their health problems have turned to foods and supplements as the only route available to them.

Drug Ingredients Often Derived from Nature

One little secret that many do not know is that many popular and effective drugs are derived from foods and plants. Consider statin drugs yet again. They are based upon a chemical compound called monacolin K produced by the Aspergillus mold. Yet this is not the only source for this compound. The identical compound was isolated from a supplement called red yeast rice that has been used as a food and food coloring agent in China for thousands of years. The patent application process for the Aspergillus derived lovastatin was a few months ahead of those working on similar drugs derived from red yeast rice, so red yeast rice was relegated to a less profitable status.

As you might expect given the presence of an identical chemical compound, red yeast rice can lower LDL cholesterol much like statins. There is plentiful scientific research underscoring this point. But big pharma could not make a big profit on that generic natural compound without patents, so they spent many years and much money turning it into a patentable drug and then more to get the FDA to help enforce monopoly pricing and engage in persecution of any competitors that point out their far cheaper natural products have many similar benefits.

The FDA, of course, was intent on shutting down the cheap sources for red yeast rice for its own reasons of money and power. They classified red yeast rice as a drug unless vendors could show it contains none of the chemical compound approved by the FDA as a drug, even though that compound is a natural result of a bacterial fermentation process that has been used for thousands of years before anybody ever dreamed up the ideas of patents or the FDA. The FDA has a vested interest in ensuring that drugs remain expensive and profitable and that competition is shut down as quickly as possible. After all, this is what enables big pharma companies to pillage the finances of consumers and insurance companies alike to hand over massive fees to the FDA.

(from Wikipedia: red yeast rice)

The Food and Drug Administration (FDA) position is that red yeast rice products that contain monacolin K, i.e., lovastatin, are identical to a drug and thus subject to regulation as a drug. In 1998, the FDA initiated action to ban a product (Cholestin) containing red yeast rice extract. The U.S. district court in Utah allowed the product to be sold without restriction. This decision was reversed on appeal to the U.S. District Court. (Moore, 2001) (see Further Reading: PDRhealth). Shortly thereafter the FDA sent warning Letters to companies selling red yeast rice. The product disappeared from the market for a few years.

In 2003 red yeast rice products began to reappear in the U.S. market. As of 2010 there are at least 30 brands available. Many of these avoid the FDA restriction by not having any appreciable monacolin content. Their labels and websites say no more than “fermented according to traditional Asian methods” or “similar to that used in culinary applications.” The labeling on these products often says nothing about cholesterol. If they do not contain lovastatin, do not claim to contain lovastatin, and do not make a claim to lower cholesterol they are not subject to FDA action (no function, no foul). Two reviews confirm that the monacolin content of red yeast rice dietary supplements can vary over a wide range, with some containing negligible monacolins.[5][6] In 2007 the FDA sent Warning Letters to two dietary supplement companies. One was making a monacolin content claim about its RYR product and the other was not, but the FDA noted that both products contained monacolins. Both products were withdrawn.[7][8] The FDA also issued a warning press release (see Further Reading; FDA 2007). The crux of the release was that consumers should “…not buy or eat red yeast rice products…may contain an unauthorized drug that could be harmful to health.” The rationale for “…harmful to health…” was that consumers might not understand that the dangers of monacolin-containing red yeast rice might be the same as those of prescription statin drugs.

Supplements May Be Superior to Drugs

Statins and red yeast rice shared the monacolin K compound, at least until the FDA forced red yeast rice makers selling in the US to remove it. But it turns out that some of the other similar chemical compounds found in red yeast rice may also be helpful for lowering cholesterol and may explain why red yeast rice, even with lower levels of the statin compound, can reduce cholesterol significantly and do so without the severe level of statin side effects such as CoQ10 enzyme depletion that leads to chronic pain, depression, and even suicidality in some statin users.

The Wikipedia article on red yeast rice explains this in much more detail and specifically points out that some of the research on red yeast rice shows it is even more effective than many statin drugs without such severe side effects.

(from Wikipedia: red yeast rice)

The amount typically used in clinical trials is 1200-2400 mg/day of red yeast rice containing approximately 10 mg total monacolins of which half are monacolin K. This does raise a question about the function of the other monacolins and non-monacolin compounds in the products, as the monacolin K content is lower than what is usually considered effective for lovastatin (20-80 mg/dy). In 2006 Liu et al. published a meta-analysis of clinical trials. The article cited 93 published, controlled clinical trials (91 published in Chinese). Total cholesterol decreased by 35 mg/dl, LDL-cholesterol by 28 mg/dl, triglycerides by 35 mg/dl, and HDL-cholesterol increased by 6 mg/dl. The incidence of reported adverse effects ranged from 1.3% to 36%.[9] Of the clinical trials reviewed in the meta-analysis, the only study conducted in the United States reported a 22% reduction of LDL-cholesterol after 12 weeks.[10]

Subsequent to the 2006 meta-analysis there are a number of articles reporting on a massive trial conducted in China: the China Coronary Secondary Prevention Study (CCSPS). Close to 5000 post-heart attack patients were enrolled for an average of 4.5 years to either receive a placebo or a RYR product named Xuezhikang (血脂康). This is a patented-process (U.S. patent #6,046,022), ethanol extract of red yeast rice, with a total monacolins content of approx. 0.8%. It is also sold as Lipascor. Key CCSPS results: in the treated group risk of subsequent heart attacks was reduced by 45%, cardio deaths by 31%, and all-cause deaths by 33%. Some of the articles report on subsets of the population, i.e., just diabetics or just hypertensives.[11][12][13][14][15][16]

These heart attack and cardiovascular death outcomes appear to be better than what has been reported for prescription drugs. A 2008 review pointed out that the cardioprotective effects of statins in Japanese populations occur at lower doses than are needed in Western populations, and theorized that the low amount of monacolins found in Xuezhikang may be more effectively athero-protective than expected in the Chinese population in the CCSPS study for the same reason. Others have speculated that phytosterols or unknown substances in Xuezhikang also contribute to the benefits.[17]

Using Scare Tactics To Suppress Freedom and Maximize Power and Profits

The government is trying to use recent scares about food contamination in eggs, peanut butter, and other products to ram through legislation that will enable big pharma to continue to pad the pockets of legislators with campaign contributions and keep FDA employees whirring away to victimize and profit from making as many American sick and dependent upon pricey drugs as possible.

FDA and USDA have shown they are entirely unable to protect much of anybody from problems in products used by nearly all Americans. Whether it is poisonous Tylenol or contaminated foods such as soda, eggs, peanut butter, and tomatoes, these agencies don’t protect much of anybody. But they are happy to point out how they failed and then beg for more money, more laws, and more employees to fix their problems. This has been going on for decades. Face it, they will never fix the problems because doing so would mean they can’t keep going back to the politicians begging for more, more, more.

(from Senate Bill on Food Safety Is Stalled)

Dr. Margaret Hamburg, commissioner of food and drugs, said in an interview that she was still confident the legislation would pass, although she confessed to being bewildered by the lengthy battle to schedule a vote.

“This is a historic opportunity,” Dr. Hamburg said. “This legislation would provide F.D.A. with important resources and authorities that we really need to be able to do our important job.”

It’s clear the FDA always wants more — more power, more money, more employees, and more tyranny.

Yet the FDA can’t even bother to do its job even when its existing resources are adequate. Below, we provide a couple of examples of this in the areas of new drug approvals and food contamination that affect hundreds of millions of Americans.

FDA Delays Approval of Effective Drugs

The FDA habitually delays the approval of well-substantiated drugs that are intended to treat seriously ill people, often many of whom became ill years after the drugs were discovered but will likely die long before the drugs are stamped “FDA Approved”. Cancer drugs are a common example of how the FDA’s processes cause many unnecessary deaths via delays and by making drugs so expensive that few can afford them.

Take for instance the prostate cancer drug Provenge®. This is a somewhat unusual drug in that it is derived from a patient’s own immune system cells and therefore is custom-made for each patient. The first phase III clinical study showing this drug was effective was completed in 2001. But the FDA forced the maker to jump through all sorts of regulatory rules, more trials, and more delays. All of this greatly increased the cost of bringing the drug to market while ensuring that many men who failed other prostate cancer treatments could not try this one. It took until April 29, 2010, for the FDA to approve this drug, even though the studies from nearly a decade earlier were clear it worked in sick patients who failed other treatments. Even the Wall Street Journal was pleading with the FDA to approve it in 2004. The result is that thousands of people died unnecessarily. Thousands more will die, too, because the regulatory overhead imposed on the drug company has caused the treatment to cost $93,000 per patient and delayed the build-out of special manufacturing labs needed to produce this custom-made drug that is tuned for each patient. For these reasons, it is estimated that only 8% of the 27,000 men who will die from prostate cancer in the next year will have access to Provenge®.

This is not an isolated incident. Delaying and driving up the cost of cancer drugs is routine practice for the FDA.

Why would the FDA do this? Once again, money and power. They benefit from creating tremendous cost for big pharma companies, and big pharma companies benefit from the FDA causing long delays in drug approvals that allow them to milk existing drugs that don’t work as well for as long as they can before their patents expire.

(from FDA Delay of One Drug Causes 82,000 Lost Life-Years)

What the public does not understand is that when a new therapy like Provenge® is being considered for approval, companies selling older (less effective) drugs have a tremendous incentive to block the better medicine. It can be quite cost-effective to persuade the FDA to erect barriers against newer therapies that compete with highly profitable existing drugs. Allegations ran rampant that the FDA delayed Provenge® because large pharmaceutical companies did not want to lose revenue from toxic chemotherapy drugs that advanced prostate cancer patients were forced to use in lieu of Provenge®.

Bureaucratic ineptitude has been highlighted by the failures of the Securities and Exchange Commission (SEC) to prevent widespread financial fraud.14 As you may know, even when outsiders conducted meticulous investigations and handed cases like that of Ponzi schemer Bernie Madoff to the SEC on a silver platter, the SEC did nothing to stop Madoff from defrauding more victims.

When complaints are made about FDA drug delays, a kneejerk response from some in Congress is “we need to give the FDA more money.” It is regrettable that politicians can’t see past the simple fact that providing more money and power to incompetent and corrupt agencies results in more incompetence and corruption.

FDA Ensures Food Contamination Will Continue

The FDA argues that it need more power to stop food contamination. Yet when it has in the past learned about such contamination, it chose to bury it to protect the culprits. It has done this even when virtually every American is affected and the fix for the problems is relatively inexpensive and could be easily born by private companies that need to modernize processing plants that are the cause of mercury contamination throughout the US food supply.

(from Teach Your Children: Government is Dangerous to Their Lives)

US FDA Covered Up Massive Mercury Contamination of US Food Supply

You might point out that determining drug safety is not an easy thing to do. But consider that the FDA is also responsible for hiding clearly evident safety hazards from the public such as heavy metal contamination of food supplies. It is incontrovertible that the FDA covered up widespread mercury poisoning of the American food supply as we discussed in January 2009 in the article High Fructose Corn Syrup is Dangerous for Many Reasons.

It also appears that they focused the public’s attention on the peanut bacterial contamination scare of early 2009 just as the news about the mercury food supply poisoning cover-up was coming out. The government and media have continued to harp on the peanut scare while burying the bigger story about mercury contamination in virtually every food product that uses the common sweetener High Fructose Corn Syrup.

Given how ruthless and immoral the FDA is, it seems at a minimum plausible that they and/or others working with them manufactured or hyped the peanut contamination scare to draw attention away from the poisoning of Americans on a massive scale due to pervasive contamination of High Fructose Corn Syrup with mercury. The FDA’s own scientists had been trying to force the agency to do something about the widespread mercury contamination since discovering the problem in 2005. It took the agency’s lead researcher on the problem retiring from her government job to break the story three years later, in January 2009:

(from High Fructose Corn Syrup is Dangerous for Many Reasons)

However, much more alarming news about HFCS has been announced this month. Recent studies of samples of HFCS and food products containing it in the United States conducted via two studies found that between 31% and 45% of the samples contained mercury. Mercury is toxic in even small quantities. For years, there have been suspicions that mercury used in vaccines may be related to the rise in autism in the United States. But this mercury contamination issue is much bigger and affects common foods widespread throughout the nation’s food supply. Products tested from big-name manufacturers such as Minute Maid, Coca-Cola, Hershey’s, Quaker, Hunt’s, Manwich, Smucker’s, Kraft, Nutri-Grain, and Yoplait had detectable levels of mercury.

Even more alarming, the US Food and Drug Administration (FDA) knew about this mercury contamination problem since 2005 but suppressed the information. The 2005 study which found 45% of the samples had mercury contamination was conducted by the FDA. But the agency kept it quiet and did nothing to correct the situation even behind the scenes! In March 2008, former FDA scientist Renee Dufault retired. As a researcher on that study, she was later able to go public with the news of the HFCS mercury contamination.

FDA Kills More Americans Than Terrorists Do

The examples above are just a few of hundreds of similar ones that have likely killed or harmed millions of Americans. When you add up all that the FDA is doing to hurt Americans, it is clear that the agency kills and injures more Americans every year with its corruption and inefficiency than were killed or injured by the Al Qaeda terror attacks on September 11, 2001.

Putting it simply, the FDA is a more deadly enemy of Americans than Al Qaeda is.

So why hasn’t the government declared war on the FDA and shut down the agency? Again, money and power. Politicians get both from big pharma. Big pharma benefits enough from the FDA machinations that it would prefer them to continue and is cheerfully paying off politicians by various means to ensure they will.

What You Can Do

In addition to contacting your Senators to oppose the Food Safety Accountability Act bill, you can also help push through pending legislation that will provide very sick people access to drugs that the FDA hasn’t yet approved.

This legislation is due in large part thanks to the efforts of the family of a teenager who died after being denied access to drugs that might have saved her. Abigail Burroughs was a teenage cancer patient who was told by her doctors that experimental drugs might save her life but without them she would die. But no matter what she and her family did, they could not get access to the drugs because of FDA roadblocks. The girl died before the drug was approved.

Abigail’s family set up the Abigail Alliance to lobby for improved access to life saving drugs. This has resulted in the Compassionate Access Act of 2010 aims to keep the FDA out of the way of patients who are going to die without experimental drugs. If this act were to be approved, many lives would be saved and valuable data on drug usage could be gained years earlier than FDA-styled clinical trials allow. If you’re interested in supporting access to life-saving drugs to people who will die without them, please contact your representatives to support the Compassionate Access Act of 2010. This legislation isn’t a full cure for the problems of the FDA, but it is a step in the right direction, unlike the Food Safety and Accountability Act of 2010.

Further Reading

FDA Abuse Reminiscent of Family Court Abuse

Reject US Government Attempt to Ban Nutritional Supplements

Teach Your Children: Government is Dangerous to Their Lives

Health Risks from Tylenol, Acetaminophen, and Paracetamol

High Fructose Corn Syrup is Dangerous for Many Reasons

Congress Seeks to put Dietary Supplement Makers in Jail for Ten Years!

FDA Delay of One Drug Causes 82,000 Lost Life-Years

Life-Saving Cancer Drugs Not Approved by the FDA

Breaking News: NEW “Food Safety” Threat—Urgent Action Alert!

Why Patrick Leahy’s Food Safety Accountability Act of 2010 Must Be Stopped

For Dendreon, It’s 500 Prescriptions for Provenge and Counting

Novel Cancer Treatment Cleared: Dendreon’s ‘Therapeutic Vaccine’ Prompts Body to Attack Prostate Tumors; High Cost Is a Hurdle

  1. gaius gracchus
    November 21st, 2010 at 02:21 | #1

    The FDA are nothing but a bunch of whores to the pharmaceutical industry. This is a fact that is easily illustrated by the numbers of FDA officials who take turns as CEO’s and board members of the large pharmaceutical companies whose interests they seek to protect. It is utter HYPOCRISY for them to say they are trying to protect consumer health and safety!

    Aside from preventing people from accessing things like red yeast rice which has been used for centuries in Asia, they also approve things that have turned out to be very harmful. It is all about money. The FDA is a perverse, self-aggrandizing organization that should be abolished.

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