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Rodents Rank! 

 If I had a nickel for every time someone said to me, “I don’t want to be a guinea pig!”, I could probably  finance that dream trip to Tahiti. My usual response is to borrow from my wise colleague Lisa, and say “Well, you know that guinea pigs don’t get to choose, and in our clinical trials you always have that option….”.  This retort isn’t always persuasive, however, part of our mission and vision is to educate the community about the process of clinical trial participation. If this encourages one person to view research a bit differently, then maybe that is enough.

The irony of the whole “guinea pig” discussion to me is that Americans spend between 30 and 40 BILLION dollars a year on dietary supplements – more than 4 billion on weight loss supplements alone. Although dietary supplement manufacturers must register their facilities with the FDA, they are not required to get FDA approval before producing or selling dietary supplements, and they do not have to prove safety or effectiveness of their products. I heard a recent news story on yet another round of FDA efforts to police the manufacture and distribution of weight loss supplements containing the banned and harmful ingredient sibutramine. Sibutramine has been prohibited for use in the United States since October of 2010 because it is known to pose health risks to individuals who have history of cardiovascular disease.

Many of the supplements currently on the market and readily available – sexual enhancement, weight loss, body building, etc. – advertise to be “all natural”. Well, so are Botulinum toxin and cyanide……

By contrast, ALL of the clinical trial programs here at JCCR are FDA-monitored and evaluated for both safety and effectiveness. In fact, this industry is highly regulated as can be attested to by anyone who has taken part in a trial with us and slogged through a twenty page consent form. We mean business when it comes to participant safety. As a result, JCCR is recognized by the industry as a premier clinical research company.

So, as far as I’m concerned, rodents rank! The mere mention of those little mammals gives me an opportunity to set the record straight on the reality of clinical trials. Go guinea pigs!!!

Posted by Amy Autry Bush Wednesday, November 19, 2014 12:20:00 PM Categories: Musings

Days of old..... 

a message from Susan N. Greco, MD

A little snake oil, anyone?  There was a time, not too long ago, that hucksters sold all sorts of concoctions aimed at fixing whatever ailed you.  In the early 1900’s there were no regulations governing medications sold in the U. S., and these pills and potions were often made of toxic substances that were both unsafe and ineffective.  In 1906, the Pure Food and Drug Law was passed requiring an accurate list of ingredients, but drugs still didn’t have to be safe or effective.  It was another 50 years before all the rules were in place requiring that drugs marketed in the U.S. be proven both safe and effective.

As the clinical trials scene has evolved, a number of additional safeguards have also been instituted.  We have Institutional Review Boards (IRB) looking out for research subjects’ rights in all clinical trials.  Many long studies have an independent group of scientists – a Data Safety Monitoring Board (DSMB) – reviewing results throughout the trial to promote patient safety.  And all of us doctors who oversee clinical trials are extensively trained in research and good clinical practices.

While many of us would like to see fewer government regulations in other areas of our lives, I do appreciate the layers of oversight in the development and marketing of drugs in the United States.  The system may be far from perfect, but between the FDA, the IRB, the DSMB, and the dedication of clinical research investigators, there are a lot of smart people looking out for us.  I’m thankful that our system provides the knowledge that allows us to make educated, evidence-based decisions.  I extend a heartfelt thank you to all of our wonderful research participants – the world of clinical trials depends on people like you!

Posted by Amy Autry Bush Wednesday, November 19, 2014 12:18:00 PM Categories: Insider Corner