Wednesday 27 January 2010

When supplements that are statistically safer than almost anything are banned and drugs that kill more of our citizens than an invading army aren't, we have good reason to be suspicious of the bureaucracy that purports to guard our interests. When such a situation endures uncorrected for decades, we are right to suspect the allegiances of our own government.

We can all agree that it is important to ensure consumers have safe products. And we also tend to believe that our government, acting in our interests, has in place legislation, standards and bodies that guarantee such safety.

Unfortunately, when you look closely at the status quo, you discover that this is not so. Government is certainly protecting someone's interests but that someone is not the consumer and very often governmental action or inaction in this regard directly strikes against the well being of the consumer.

It is my contention that we will continue to be in grave jeopardy and freedom will continue to elude us so long as we cling, all the evidence to the contrary, to the belief that our government is on our side or will do anything about certain large corporations that do not actually give a damn whether we live or die.

To get an idea of how insidious this is, it is worth taking a look at how differently dietary supplements are treated, compared to pharmaceutical drugs.

For instance, let's compare the way the FDA treated a supplement called "ephedrine" with the way it treats prescription drugs.

Ten years ago, in 1999, an estimated 12 million Americans were using the supplement, ephedra. In 2003 ephedra was banned as an "unsafe risk". It is not the only supplement to have been thus unjustly banned and to justify and enforce the ban, the FDA announced, "No dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the United States is illegal and subject to FDA enforcement action."
Sounds pretty grim doesn't it? Now the links between the FDA and the pharmaceutical cartels should make one immediately dubious as to its impartiality but let us ask first "What is ephedra?"

"Ephedra" is also known as "epitonin, "Ma huang," and "Chinese Ephedra." It is actually one of the oldest medicines known to Man and was first used in China some 5,000 years ago.

Research has revealed that ephedra "increases metabolism and helps promote weight loss, relaxes the air passages in the lungs to help treat asthma and cough, promotes perspiration to help a person recover from a minor cold and helps promote urination to help relieve edema." According to the website "ephedra."
It is known that historically the Native Americans and the early Mormon pioneers drank a tea called "Mormon tea" that was brewed from ephedra.

After 5000 years of usage it is somewhat odd that only now has anyone "discovered" that ephedra is unsafe for consumption. By a bizarre coincidence this comes at the very time when there exist organizations dedicated to the sale of drug remedies for many of the things with which ephedra is known to help and whose sales the popularity of a cheap, safe, natural remedy places in jeopardy.

Public Citizen, a well-known consumer advocacy group, reports more than 150 deaths occurred between 1995 and 2004 that were "linked" to ephedra. Now as we saw above, some 12 million people were using ephedra in 1999, which means that many MORE than 12 million people would have used it in the nine years between 1995 and 2004.

In excess of twelve million people using a product over a nine year period and it is linked with 150 deaths? (that's 16 to 17 a year!). That is a very low risk factor! When you factor in that "linked" is a very imprecise term and therefore it is highly likely that some or many of the deaths "linked" to ephedra may well have had other causes, you begin to see that ephedra is actually safer than virtually all pharmaceutical drugs, swine flu and other flu vaccines, eating peanuts, riding a bike, inhaling city air, drinking alcohol, smoking, eating processed foods; almost anything you care to think of. The FDA decision to ban it therefore is self evidently not and cannot be based on concerns about it being dangerous: because it isn't!

Now compare ephedra's stats with just one class of drugs, known as NSAIDs (Non-steriodal anti-inflammatory drug). Between 1999 and 2006 in the U.S., as many as 60,000 deaths were linked with either Vioxx or Bextra, just two of the NSAIDs. There are many NSAIDs as well as these two: ibuprofen and aspirin for instance, but just the two mentioned were linked with four hundred times as many deaths as those linked with ephedra! The difference in risk is so vast you might as well compare the risks associated with swimming the Atlantic to the risks of crossing it in an ocean liner.

NSAIDs are drugs with antipyretic, analgesic, and anti-inflammatory effects - they reduce fever, pain, and inflammation and are used for a variety of ailments. Some, including ibuprofen and aspirin, are regarded as relatively safe and are available without prescription.

Whether one is reassured by the term "relatively safe" depends on how one defines "safe," I suppose because, there were 25 deaths due to Ibuprofen alone in 2005 (according to the database of the AAPCC (the American Association of Poison Control Centers). This compares with just ONE (yes, one!) death linked with to all dietary supplements combined (of which there are hundreds in total) for that year.

Those twenty five deaths from Ibruprofen in 2005, would average out to around 200 deaths over an 8 year period. This is not to say that Ibruprofen is lethal because the death rate looks fairly low when you consider how many people actually take the drug. Like any drug, if you take it on a regular basis, it is going to do damage to your biological systems to one degree or another but it does not appear to be an outright killer. The point being made here is that ephedra is banned, while drugs linked to more deaths - and often many more deaths, are not.

60,000 people died over a seven year period, during which NSAIDs are not found by the FDA to be "unsafe at any dosage" and banned.

Only after an awful lot of people died were Vioxx and Bextra eventually withdrawn from the market because of major heart attack risks. Vioxx was withdrawn in 2004 and Bextra in 2005. Another NSAID, Celebrex, is still available by prescription.
60 000 deaths occurred because the FDA failed in its duty to protect the public and did not apply to these drugs anything remotely approaching the "concern" it applied to the much safer product ephedra.

Clinical trials of Vioxx began in 1998 and one study conducted by the pharmaceutical manufacturer Merck revealed serious cardiovascular problems. Unfortunately this study was never published. It might have saved a lot of lives if it had been but Merck claimed that it was "not large enough" to provide definitive data. Yet how much less extensive was the "definitive data" that led to the ban of ephedra? The FDA approved Vioxx in 1999.
Another pharmaceutical giant, Pfizer, first admitted there were cardiovascular risks associated with its NSAID, Bextra, in October of 2004. Around the same time, the American Heart Association (AHA) received a report indicating patients using Bextra while recovering from heart surgery were more than twice as likely to suffer a stroke or heart attack than those taking placebos.

In April, 2005, Pfizer eventually withdrew Bextra from the US market on recommendation (not a ban you understand, a recommendation) by the FDA, which cited the increased risks of heart attack and stroke and also of a serious, sometimes fatal, skin reaction.

To summarize, dietary supplements have managed to grow in popularity despite their manufacturers operating in a playing field about as level as the deck of the Titanic.

Ephedra, a typical example of a dietary supplement had been around for 5000 years before it was suddenly "linked" to 150 deaths in an 8 year period and was banned.

On the other hand, manufactured drugs, known as NSAIDs, which managed to cause 60,000 deaths in just 7 years are not.

Clearly then we are being "protected" from dietary supplements that hardly kill anybody and not protected from pharmaceutical products that systematically take out a sizable portion of the citizenry year in and year out.

Overseeing this lunacy is the FDA. As I pointed out earlier, the links between the FDA and the drugs manufacturers might well explain the hugeness of this discrepancy and give us a clue as to the reasons for its dereliction.

The odd thing is, this problem with the FDA has been known, reported on, complained about and made the subject of innumerable books and articles for many years and through that time countless people have died or been made unwell as a consequence of this negligence.

Yet once again the people are simply ignored and nothing is done to correct this clear and present danger to their lives and well being.

How much longer are we going to put up with this betrayal?


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