Hello again Enzyme Enthusiasts!

Happy Holidays from everyone at Enzymes, Inc. – thanks again for taking the time to visit our blog and a special thanks to everyone who stops by on a regular basis.

Quite a lot has happened recently in the world of enzymes and nutraceuticals. I’ll hit some of the high points…

Serious adverse event reporting legislation

The serious adverse event reporting bill - S. 3546 - passed the Senate and the House, and is waiting to be signed by the President. It will go into effect a year after, and makes it mandatory for companies to report serious adverse events resulting from their products through MedWatch. A “serious adverse event” is defined as: death, life threatening, requires hospitalization, results in a disability, or causes a congenital anomaly.

Not only will nutraceutical companies be required to report, but so will those producing over the counter medications. As I have mentioned before, it will be interesting to compare the data collected on the two. I believe mandatory reporting of these adverse events will result in establishing the safety of nutritional supplements.

Do you drive tired?

It was recently discovered that the levels of the enzyme Amylase present in saliva can determine how much sleep, or lack thereof, you have been getting. They refer to lack of sleep as incurring “sleep debt”.

The study was done at Washington University in St. Louis, and was conducted on fruit flies – which apparently can go for fairly long periods without sleep. The technology may one day be implemented to increase safety on roadways, and will definitely be used to study the effects of sleep depravation and effectiveness of treatments.

Pharmaceutical study on digestive enzymes

Altus Pharmaceutical has presented results of a phase II clinical trial of a microbial enzyme based digestive enzyme supplement for the treatment of pancreatic insufficiencies in patients with Cystic Fibrosis. Using amylase, protease, and lipase from a microbial source to increase the nutritional absorption of food – what a novel idea!

Well, kudos to them for conducting a study proving the efficacy of digestive enzymes – and for having the big bucks to make it happen.

Studies on HDL drug stopped by Pfizer due to excessive deaths

Sad news from other side of pharmaceutical research - 82 subjects of a study involving a drug intended to raise the level of the “healthy cholesterol” HDL are dead and the study has been halted. Additionally, it was mentioned that others involved in the study experienced “cardiovascular problems”.

Acceptable mortality rate is such a strange thing. Why did it take 82 people dying to clue the researchers something was wrong? It seems to me that if one person dies the study should come to a screeching halt until cause is determined.

Well, that’s it for now – thanks again for your support, and stay tuned for more information!  And don’t forget - if you have a blog or other site, and you visit our blog, link to us!  Thanks.

This entry was posted on Thursday, December 14th, 2006 at 6:22 pm and is filed under Enzymes Inc..

Tags: enzyme supplements, digestive enzymes, nutritional supplements,