Should the FDA Control Supplements?

The FDA, as a leading protector of the public health, has plenty on its plate right now. We have had recalls and investigations of meat, spinach, pet food, lead-painted toys, Heparin, and an unknown number of things that never made the nightly news. In addition to the reported alerts, likely hundreds if not thousands of things we should have been worrying about never even warranted an investigation. Recent reports state that the FDA has inspected many facilities in this country as much as two years late. Others, including the Chinese factory that shipped adulterated heparin ingredients, have never been inspected at all.

Since the FDA obviously cannot do the job it is charged with doing currently, it seems ridiculous to add even more responsibilities to their list of duties. In recent congressional hearings after the threat posed by poisoned pet food and lead toxicity in toys, the message was clear that the FDA is seriously under-funded and there is no relief in sight in FY2009. In fact, Congress has been reducing the funding for the FDA for nearly twenty years and actually changed their funding methods to a "pay-per-use" system where pharmaceutical companies pay a hefty fee to have drugs approved. This has resulted in the insane policy of drug companies paying for approval of their products and FDA employees depending on these fees for a paycheck. It is not a distant stretch to a situation in which the FDA becomes employed at the whim of the very industry it is mandated to monitor.

Cozy relationships between the FDA and the pharmaceutical industry are nothing new: some top level officials have moved back and forth between positions at Big Pharma and the FDA with increasing regularity. When conflict of interest questions are raised, these same officials always swear it doesn't happen . These cozy relationships have definitely had a relationship to the kinds of rule changes and regulations passed-usually in Big Pharma's favor. The entire "pay-per-use" policy is just what the pharmaceutical industry wants-it ensures that they hold the purse strings for the functioning of the entire agency. Hefty fees for approval ensure that only the largest players can enter the game as they have the money to participate where smaller firms do not. In essence, Big Pharma has paid to have competition removed from the field, to the detriment of the consumer. It is no surprise that so many high-profile drug recalls have occurred after this funding model was put in place. The pharmaceutical industry no longer concerns itself with well-documented trials and testing as their employees at the FDA aren't likely to question them too closely and only issue a recall after there is over-whelming evidence of harm to the public.

Large pharmaceutical interests, one of the richest lobbying groups in Washington has ever been eager to eliminate competition between not only themselves and other drug producers, but between themselves and natural health products that they see as competing. If green tea, garlic capsules and DHEA lower your cholesterol, you wont be buying Lipitor or other statins. So, natural health supplements are a real threat to their profits. The fact that they see them as a threat lends much credence to the fact that these natural health aids actually work-and they don't like that! However, people tend to use traditional forms of healing, particularly among populations without much money or access to doctors and they have been unable to break this habit that impacts their profits so severely. In fact, there is much evidence that these natural practices are growing among higher-income groups as more knowledge regarding nutrients, plant alkaloids, minerals, amino acids, natural hormones, oxygen, magnetics and light is gained. As newer, more expensive and more toxic drugs are rushed to market with inadequate testing, more and more adverse reactions and deaths occur. Many people are simply afraid of these drugs-with good reason.

A compilation study published in 1998 estimated both serious adverse reactions and deaths among several studied groups of hospitalized patients and estimated from the evidence complied that there were 2216000 serious adverse reactions and 106000 fatal adverse reactions in 1994, making adverse drug reactions between the 4^th and 6^th leading cause of death. Conclusion? They found that serious and fatal adverse drug reactions in US hospitals were "extremely high'.

In contrast, the FDA itself noted 184 deaths and 2621 adverse drug reactions from herbs, mostly used in weight-loss formulas, over a 5-year period (1993-1998). In 1998, the American Association of Poison Control Centers Toxic Surveillance System reported less than one death per year from supplements, with vitamins with iron as being the most toxic to children. In comparison, we recently experienced 81 deaths from Heparin in a four month period. Does it sound like we should panic over non-supervision of supplements by the FDA?

Attempts to control supplements by Big Pharma are nothing new; the fight has been going on for years. So intense was citizen reaction to industry efforts to regulate natural herbs and supplements that overwhelming public pressure forced Congress to pass the Dietary Supplement Health and Education Act ("DSHEA") in October 1994. Not that the global pharmaceutical industry was about to let citizen outcry and political common sense beat them at the game, supplement control became a part of the free trade agreements and was written into United Nations plans in the Codex Alimentarius. The European Union is currently having some success in outlawing natural medicine in Europe and the Codex movers and shakers have redoubled their efforts to make the bans worldwide. Currently, Canada is considering C-51, a law that will outright outlaw 60% of natural Health products. This authoritarian effort will make it illegal to even grow some common herbs in one's own garden for personal or family use. Under C-51, it appears one would be breaking the law if one were to harvest and prepare such timeless country delicacies as dandelion greens.

All of these facts add up to the inescapable truth that the efforts to control natural supplements and herbs cannot possibly be motivated out of concern for our health. However, the deep pockets of Big Pharma extend to the news media and infiltrate professional groups: the outlawing of Ephedra a few years ago was one such disinformation campaign where high dollar reporting was most evident.

Ephedra, used for centuries in it's natural state as a remedy for Asthma and breathing problems, was summarily outlawed based on flawed reporting and studies performed and promoted by groups funded by our friends in the pharmaceutical industry. There were deaths, true, but these deaths weren't caused by Ephedra but by ephedrine, the pharmaceutical industry's own derivative of the active ingredient in Ephedra. This was the weight-loss product responsible for injury and deaths, not Ephedra. Plenty of dangerous reactions had already been reported for years regarding ephedrine and pharmacia had recently begun to produce pseudoephedrine to take the alerted public eye off their product. Both ephedrine and pseudoephedrine are closely related to amphetamines and methamphetamines-a fact the pharmaceutical companies will continue to smokescreen as long as possible. Pseudoephedrine is one of the most common ingredients in the production of methamphetamine and more recent legislation has restricted most over-the-counter cold remedies containing it to behind-the glass, see-the-pharmacist, fill-out-the-form hassles every spring and fall for seasonal allergy sufferers. The result is that more sufferers are forced to visit a doctor for a prescription medication at considerable expense to their pocketbook. Now, this is the kind of legislation Big Pharma likes to see!

Given all of the evidence of the safety of herbs and natural supplements, the dangers of pharmaceutical drug reactions and the distortion, underhanded dealing and communal connivance of Big Pharma and the FDA, I find it difficult to understand why an informed consumer with no axe to grind would wish to allow the FDA to regulate natural therapies. For those feeling somewhat uninformed, there is a considerable list of websites attached where one may study the subject and develop their own informed opinion. In addition to those below, there are other imformative links in the sidebar.

Major drug maker recalls entire inventory
http://www.msnbc.msn.com/id/8050556/

Philip Rudnick, PhD Professor Emeritus, Chemistry,West Chester University of Pennsylvania
Comparative Safety of Drugs and Supplements/Herbs May 19, 2004
http://www.thenhf.com/articles_27.htm

Pushing for Supplement Restrictions - Again!
http://www.newmediaexplorer.org/chris/2004/11/05/p ushing_for_supplement_restrictions_again.htm

Orthomolecular Medicine News Service, February 23, 2007
NO DEATHS FROM VITAMINS: Poison Control Statistics Prove Supplements' Safety
http://www.orthomolecular.org/resources/omns/v03n0 3.shtml

List of recent FDA recalls:
http://www.healthatoz.com/healthatoz/Atoz/drugdb/d rugGuideRecallList.jsp