Saturday, March 13, 2010

On Nutritional Supplements, FDA Regulation, and Pharmaceuticals' Free Pass

In February Senator John McCain sponsored a bill to regulate nutritional supplements and the companies who manufacture them (The Dietary Supplement Safety Act of 2010, S3002), purporting that greater FDA oversight of the manufacture of supplements was necessary in order to prevent the injury and death of American citizens.  In particular, McCain is on the record stating that his goal with this bill was to protect athletes from tainted supplements, especially those laced with anabolic steroids. 

This bill is now dead in the water as McCain withdrew his support when Senator Orrin Hatch expressed his concern that the bill would negatively impact the nutritional supplement industry. 

Even though this bill now won’t be pushed through the legislative process, it appears that we can expect a continuing dialogue over nutritional supplement safety and regulation among members of Congress. 

Along with millions of other Americans, I am relieved that the McCain bill is no longer a threat but am concerned about future developments in this arena.  The thought of the FDA having any more oversight than it already does over natural products makes my stomach turn for a number of reasons.

Here are a couple --

First, there is a track record of overreaction to the dangers of nutritional supplements (supposed or real) in the media and among policy-makers. 

Let’s take the example of ephedra.  Ephedra is an herbal stimulant and thermogenic agent (increases body temperature) that people used for weight loss, sometimes with or without caffeine, and it was banned in 2004 because of a number of reported side effects, including hypertension, irritability, nervousness, hyperthermia, heart palpitations, seizures, and even a handful of deaths (1).

I am not defending ephedra as a supplement that is safe for all people under every condition, and I definitely believe it’s possible that it has caused problems for some people, fatalities including.  After all, if an herb or nutritional supplement has any sort of biological impact on the body at all, there are bound to be people who will have a negative reaction to it!

But let’s look at the media frenzy that surrounded the deaths of 3 athletes in the last decade, purportedly due to their use of ephedra. 

In 2001, Korey Stringer participated in a Minnesota Vikings training camp and died of heat stroke.  Even though his autopsy showed no traces of ephedra in his system at the time of death, the herb was widely blamed for killing the young athlete (2).

Professional baseball player Steve Bechler died on the field due to heat stroke in 2003.  Ephedra was blamed for causing his death, and indeed the toxicology report showed ephedra derivatives in his blood.  He also had a history of heat stroke, was overweight, was on some sort of liquid diet, and was at a practice in South Florida with brutal heat and humidity, which he was unaccustomed to, when he collapsed on the field and tragically passed away (3). 

The third high-profile death blamed on ephedra was that of college football player Rashidi Wheeler, who in 2001 collapsed during training exercises designed to push the athletes to the edge and died of exercise-induced bronchial asthma, which he had had problems with in the past.  Even though the coroner found ephedra in his system, it was deemed not to be a causative factor in his death (4).

The death of anyone, particularly someone as young as each of these three men were, truly is a tragedy.  I don’t have enough information to judge if ephedra caused any of their deaths, though ephedra’s role in killing two of them appears dubious.  Either way, the both the media and the FDA jumped on the anti-ephedra bandwagon and today it is considered an illegal substance.

A handful of possible death implications and a few thousand complaints of negative reactions -- that is reason for concern, to be sure!  Which is why the media and FDA's handling of a group of substances that kill between 100,000-200,000 people each year in our nation, and cause complications for far more, is puzzling.

Why is ephedra demonized and banned and herbs/nutritional supplements viewed as such a threat while young (and old) people all around us on prescription or over-the-counter drugs seem to be dropping like flies?  All the while, the very agencies and organizations crying foul on supplements are silent by comparison on the pharmaceutical issue!

Why have pharmaceuticals, including many of the pain killers, antidepressants, and anti-anxiety meds found in the bloodstream of young, dead actors (and many others who were less famous), been given a free pass?

The Emperor is naked, and few seem to care . . .

28-year-old Heath Ledger was found dead in his apartment in January 2008, and his death was found to have been caused by “an accidental overdose of prescription medications including painkillers, anti-anxiety drugs and sleeping pills . . . ‘Mr. Heath Ledger died as the result of acute intoxication by the combined effects of oxycodone, hydrocodone, diazepam, temazepam, alprazolam, and doxylamine,’" (5)

Another young actor, Brittany Murphy, shocked the Hollywood scene when she suffered cardiac arrest and  passed away in her home in December 2009.  Her toxicology report states the following:  “Multiple medications were present in the blood, with elevated levels of hydrocodone, acetaminophen [Tylenol], and chlorpheniramine. L-methamphetamine was also present.  It should be noted that the pattern of use of these medications suggest treatment of symptoms of a cold or other respiratory infection. Acetaminophen and hydrocodone are components of Vicodin. Chlorpheniramine is the active ingredient in some over-the-counter medications. L-methamphetamine is a component of some inhalers.” (6)

Most recently, of course, is the tragic death of 80’s teen actor Corey Haim at age 38.  Haim collapsed and passed away at his mother’s home just a few days ago.  While no toxicology report will be available for a few weeks, bottles of prescription drugs (and no illegal drugs) were found in his home, making it at least possible that he just became the next high-profile death by prescription medication.(7)

When compared with the public cry against ephedra and any other herbal or nutritional supplement accused of injuring people, I have to wonder -- where is the outrage against these pharmaceuticals??  These few examples of famous people dying in their homes on legal drugs are just the high-profile, proverbial tip of an enormous iceburg.

When taking pharmaceutical drugs as prescribed is attributed to at least 106,000 death per year in America alone (and possibly as many as 200,000) (8) and the total number of deaths attributed to nutritional supplements since 1989 is 230 (9), why would anyone in their right mind want to waste our government’s time and resources on regulating nutritional supplements when the pharmaceutical industry is clearly in much, much worse shape?

Let me repeat -- there are a minimum of 106,000 deaths per year in America due to prescription drugs, and there have been 230 deaths due to nutritional supplements since 1989.  1989 was 21 years ago (we won't count 2010 in these figures since the year just began).  That means in the past 20 years there have been approximately 2.1 million deaths because of prescription drugs, and only 230 because of nutritional supplements, or 9,217 times more deaths due to drugs.  But there is not 9,217 times more outrage.  Somehow, much of the public has allowed its outrage to be focused on the 230 deaths instead of the 2.1 million!

Clearly, something isn't right here.

Even supposing there truly is a need for oversight and regulation in the nutritional supplement industry, why would we hand such a job over to the FDA when they’ve done such a poor job regulating drugs, allowing 2.1 million Americans in the last 20 years to die because of them?

Lastly, I am absolutely in support of companies who manufacture drugs, supplements, vaccines, and even food additives being required to be up front about injuries that they have been purported or proved to have caused (such as aspartame, or NutraSweet, which has over 10,000 complaints against it – more than complaints of all other substances combined) (10).  That aside, I have to wonder where the government derives the authority to tell us which substances we can and cannot take into our bodies. 

What it comes down to for me is this -- Washington, please leave me alone and let me take my herbs and supplements that healed me of Chronic Fatigue Syndrome in 2005, kidney stones in 2008, swine flu and a mumps-like illness in 2009, chronic problems with headaches and skin, too many cold and flu-like illnesses to name just in the few years alone.  I don't want to worry about limited access or increasing prices that would be sure to come with greater regulation.  

And in return, let those who desire substances that are associated with well over 100,000 deaths per year in America have their pills.

(As a side note -- I am not implying that all pharmaceuticals carry the same level of risk.  I am of the opinion that in some circumstances a drug may be the most appropriate solution.  Even when it is not the solution I would choose for myself, I support peoples' freedom to choose how to take care of their own health.  But as with anything you put in your mouth -- a food, a supplement, or a drug -- it is always a good idea to do your research first and use wisdom.)  

Final comment -- allow me to briefly share my own personal experience with anti-anxiety and sleep medications.  When I was ill with Chronic Fatigue Syndrome/fibromyalgia, I didn't sleep deeply for an entire year.  My doctor prescribed small doses of 3 drugs that seemed to do the trick for me (clonazepam, Neurontin, and Elavil/doxepin elixir) .  The problem was, I kept needing more (a common problem).  If I forgot to take the drugs with me on a trip, I would lie in bed all night with my heart racing, aware of every passing minute.  After being on these drugs for a few years, I actually began reading about them.  I discovered that 2 of the drugs had created a lot of problems for people, were highly addictive (in fact there are clinics to help people try to get off of clonazepam and other benzodiazapenes), and if I ever wanted to have kids I would have to go off of them first.  When I got married in 2004 I decided it was time to get off the drugs.  I planned on taking 3-4 months to wean off of them.  What I experienced during these 3-4 months (the first few months of my marriage -- happy happy joy joy) was withdrawal symptoms including altered perception as if I was tripping on drugs, mood swings and crying spells, and a returned inability to sleep.  When the prescription for these medications was handed to me 5 years earlier, I had NO IDEA what I was getting myself into!  And because they seemed to work, I just went with it.

Thankfully, after my months of drug trips and emotional roller-coasters in 2005, I began to seek out natural solutions and found a nutritional supplement that INSTANTLY took away the bad withdrawal symptoms, but I still wasn't able to get off all of the drugs.  Months later, I came across some therapeutic-quality essential oils that healed my severe insomnia (meaning, after a period of time, I stopped needing ANYTHING for sleep), and I haven't had any problems since.  So you can see why I'm such a huge proponent of seeking out natural solutions instead of blindly trusting a doctor, even if he/she is well-intentioned.


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