Saturday, May 2, 2009

Hydroxycut recall and my response

I wanted to post this note to remind everyone of our personal responsibility to our bodies. This is in response to the recent news of Hydroxycut's recall.

For the past two years, I have learned an extensive amount about clinical trials (I hope so, being a clinical research coordinator and all!!) and the stages in which medications need to go through in order to get the stamp of approval from the Food and Drug Administration (FDA) to be marketed.

Yes yes yes, I know that there are many faults in the system, but there are many more benefits in the system.

Let me just explain:
When the pharmaceutical companies create a compound, they do know a bit from the door about what part of the body it will affect, what part of the brain it will work on (I work in the field specifically of anti-depressants, anxiolitics aka anti-anxiety meds, and anti-psychotics). They know which organ will be metabolizing the medication, and thus, what organ the medication will be hardest on (I.e. a drug called depakote, a mood stabilizer, is metabolized by the liver....it's potentially hardest on the liver if it's not monitored with simple routine bloodwork to track the liver enzymes.)
Phase 1 trials are where the drug is tested on people that don't have whatever diagnoses it's targeted to treat. This is very important so that they learn the 'pharmacology' of the drug--how long it takes to peak in someone's system after it's taken. Some medications (xanax and ativan) are insanely quick acting but wash out very quickly. Some medications take longer to peak and stay in the system longer (prozac). This is also where they learn about the amount of medication someone should take for the best effect, pharmacologically.
Phase 2 and 3 trials are where they study if the medication works (this means that the people with the diagnosis take it and see if it relieves the symptoms of the diagnosis, treat the diagnosis, etc). Also in these two phases, they continue to learn about the safety of the medications.

My company does phase 2 and 3 trials. Through those trials, we do many many many blood draws and ecgs. We learn MUCH about the medication by what it could effect....not just the routine blood sugar and cholesterol. Some studies have pages and pages of labwork results that we compare to the person's 'baseline' labwork and evaluate any changes.....liver tests, complete blood count, urinalysis. It's extensive. The ecgs tell us the way that the person's electricity is flowing through their heart (I think!! Hey I'm a coordinator not a cardiologist!!) We do multiple rounds of blood work and multiple ecgs to make sure that the person is still safe on the medications. If anything goes out of range and is clinically significant, often the person is taken off the new medication, that is monitored and treated.

For things like Hydroxycut that are never tested, the answer of what it effects in the body remains unknown. At least to us.....the companies may know, but if it's bad news, do you think they'll tell us?? If it effects the liver negatively (to the point of death or need of a liver transplant) do you really think that the creating company will reveal that willingly?!?!?!

Clinical trials cost millions of dollars. It *is* in the best interest of the pharmaceutical company to push their compounds through to be approved so that they can make the money back. Pharmaceutical companies lose alot of money for a compound being 'canned', not ever getting approved. This remains a drive in the faulty side of things....but the clinical trials are where it is learned what the full effect (or mostly full effect) of the compound has on the human body.

I type all that so that you can think long and hard about what you put in your bodies. The things like Hydroxycut, NO explode, vitamins, even our beloved Shakeology don't go through clinical trials. It's not required for them to (still haven't figured out why)....but I urge you to do your homework before you take something that you read about and hear great stories about. It could be doing something to any one of your organs that you don't feel at first and you have no idea about. Do your homework.

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