Red Yeast Rice, thanks FDA (not really)

[Gonad the Barbarian]

So there's Red Yeast Rice, a food source supplement that contains natural substances that lower cholesterol. But then there's Mevacor, a drug patented and marketed by Merck that is one of those very same substances. So what does the FDA do? Perhaps invalidate Merck's patent and status as a drug because it's an existing natural subtance? Think again.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108962.htm
More info here:
http://heartdisease.about.com/cs/cholesterol/a/Nrxcol_rry.htm
and here:
http://www.all-about-lowering-cholesterol.com/fda-red-yeast-rice.html
Aww hell, just google "red yeast rice fda." It's OFN, but I don't think it's widely known about and pretty screwed up.

Edited for clarity.

 

[MrMatt]

are you saying this is bad or good? Sounds like the FDA prevented a company from commercializing a common natural compound and possibly wreaking havoc on that market...

 

[Gonad the Barbarian]

Clicky the linkies.

 

[edcarman]

As far as I can tell, the Merck patent for lovastatin and its production via fermentation was filed in June 1979. It would have expired in the middle of 1999.
It seems the FDA began procedures to ban RYR in 1998 and that ban came into effect in 1999. Merck's patent was months away from expiring at that time.

According to the FDA, RYR contains enough lovastatin that there is significant risk it could have adverse reactions with other medication or side effects similar to those that would be experienced with Mevacor.
As a regulated drug, Mevacor can only be sold with a prescription from a healthcare professional who should have knowledge of these side effects and interactions and should advise the patient accordingly.
As an unregulated supplement, RYR could be sold over the counter by an assistant who is not required to have any knowledge of these risks and it is up to the end consumer to find out about them.

The FDA's reason for prohibiting the unregulated sale of RYR is that, since it contains a certain amount of lovastatins, it poses similar risks to drugs like Mevacor and should, thus, be subject to the same degree of regulation.

I doubt that RYR would be very popular with supplement providers if it had to go through the same clinical trials as regulated drugs and could only be sold with a prescription. The requirement for it to be regulated if it contains lovastatin is thus, effectively, a total ban.

 

[eits]

um... that's actually pretty awesome of the fda to do.

fuck merck in the ass with a pine cone.

 

[Ancalagon44]

Thanks edcarman for bringing some sense into this, that sounds totally reasonable. Why should the "alternative health" industry not be required to pass clinical trials like all other medicine? Oh right, because then it will be obvious its no better than the placebo effect.

 

[Gonad the Barbarian]

I guess I shouldn't be surprised pharma defenders and natural remedy poopoo-ers show up.

 

[Ancalagon44]

Oh I'm under no illusions about the pharma industry, they can be just as misleading.

But natural remedies are just that - poo poo. Why use a 2000 year old remedy when science has improved upon that remedy for 2000 years?

 

[Gonad the Barbarian]

Why don't you ask Merck since that's clearly exactly what they did here?

 

[eits]

Oh I'm under no illusions about the pharma industry, they can be just as misleading.

But natural remedies are just that - poo poo. Why use a 2000 year old remedy when science has improved upon that remedy for 2000 years?

lol where the shit do you think medications came from? what do you think people took before these medications were invented? there are natural remedies for things out there that work... that's where pharmaceuticals came from.

open up any pharmacology textbook and you read for yourself that modern pharmacology was borne of the fact that many natural remedies worked throughout the centuries. there are certain agents in various plants, etc. that have an effect in the way the brain and/or body works.

 

[Kipper]

Thanks edcarman for bringing some sense into this, that sounds totally reasonable. Why should the "alternative health" industry not be required to pass clinical trials like all other medicine? Oh right, because then it will be obvious its no better than the placebo effect.

You have Clinton and the Dietary Supplement Health and Education Act of 1994 to thank for that one. Combined with subsequent Congressional action that has cut the USDA's funding for inspections, enforcement, and its actual lack of teeth, manufacturers can do whatever they want. I've seen anecdotal reports of off-the-shelf supplements containing controlled anabolic steroids.

...Not to mention the ghastly status of our food safety system, which the FDA is also a principal regulator in. On a related note, the dimer of pantothenic acid, pantethine, has been found to have a pharmaceutical effect on lowering cholesterol. It's regulated as such in Europe. I can buy it OTC here in the states.

 

[Gonad the Barbarian]

The DSHEA has been about the only thing protecting supplements from being completely taken over/eradicated by Pharma. And don't just blame Clinton, it passed a R controlled house and congress unanimously. I don't see how what the FDA did here isn't in direct conflict with the DSHEA. It strikes me as insane that so many think anything deemed effective needs to be controlled and regulated by Pharma and government, especially with the barrage of "There's a drug for that" prescription ad campaign that's been going on for the past 15 years or so. There's something to blame R controlled house and congress for, I think Clinton even tried to veto it.

 

[Kipper]

The DSHEA has been about the only thing protecting supplements from being completely taken over/eradicated by Pharma. And don't just blame Clinton, it passed a R controlled house and congress unanimously. I don't see how what the FDA did here isn't in direct conflict with the DSHEA. It strikes me as insane that so many think anything deemed effective needs to be controlled and regulated by Pharma and government, especially with the barrage of "There's a drug for that" prescription ad campaign that's been going on for the past 15 years or so. There's something to blame R controlled house and congress for, I think Clinton even tried to veto it.

The entire rationale behind regulating supplements is that makers can make any claims for any product and pretty much sell anything regardless of whether it works, or more importantly, whether or not it is safe. The onus is on the FDA to prove that things are unsafe, and with a shoestring budget it doesn't have the resources to do that. The result is that the public serves as a large, paying guinea pigs for an industry that is selling products that by in large, have unproven efficacy AND safety.

The line between some supplements and pharmaceuticals is a thin one, at best. The FDA should hold supplement makers to task and force them to PROVE some of their claims, not to mention the safety of their products. But as previous posters said, that would basically gut the industry.

I believe the FDA's alluding to the fact these pills are marketed as a treatment for high cholesterol. That would cross the line where you are making explicit claims about being able to treat a condition, which brings whatever product under the FDA's jurisdiction. A lot of supplements give vague benefits like "promotes elevated metabolism" or "organ health" instead of directly stating "This cures cancer" or "prevents liver disease," whereby they would be making pharmaceutical claims.

 

[Gonad the Barbarian]

The DSHEA pretty much prevents supplement makers from making specific treatment claims, and mostly covers substances that have been in the food chain for about forever. And I think the FDA's "reasoning" for going after RYR is blatantly apparent. Maybe they will find another amino acid to protect us from soon too.