Drug Manufacturing

 

Q: Most of the big drug companies are international corporations. Are the brand name products they sell in the U.S. all produced in the U.S.? Or are they currently using manufacturing facilities in other countries for at least some of the products on the market in the U.S.?

A: Often, drug companies will manufacture the same drug in a U.S. facility that they sell a lot less expensively in other countries. In other cases, the drugs are manufactured in other countries at FDA-approved labs and shipped to the U.S. for sale. It is up to the companies as to which FDA-approved facility makes their drugs. The big savings occur when generics made in other countries at FDA-approved facilities are available to Americans.

Q: If bill H.R. 3240 introduced by congressman Gil Gutknecht should pass, how do you propose that the FDA should go about to approve and monitor drug manufacturing facilities in foreign countries? I cannot see a lot of enthusiasm by foreign countries or companies to have the FDA interfere in their business abroad, especially if it also cuts into profit.

A: The FDA already monitors drug manufacturing facilities in other countries who want to make products destined for the U.S. There would be no change in this, other than more companies wanting the FDA to inspect their facilities to tap the lucrative U.S. market.

Q: My saliva test showed my estradiol to be <0.5 and my progesterone to be 57.0. I am a 72 year-old, post-menopausal woman who has undergone no surgeries and takes no drugs. If I take Natural Estrogen, should I also be using a progesterone creme?

A: We do recommend the use of a prog esterone cream together with Natural Estrogen. Such a recommendation is based on the assumption that one does not have an estrogen or other hormone positive cancer. Also, this recommendation is made with the understanding that blood testing must be performed initially in order for anyone to arrive at the best combination of hormone replacement therapy. Progesterone levels play an integral role in obtaining a healthy hormonal balance in the quest for longevity and youthful aging. Refer to "Treating Osteoporosis, The Youth Hormone" (Life Extension magazine, March 1999).

Q:Your information about vitamin K's role in inhibiting blood clots appears to be supported by only one publication (Blackwell, Thromb Res, 1985), and that study was done with vitamin K analogues rather than vitamin K itself. Could you please comment?

A: We cited two other studies as well: Furie, et al. and Ronden, et al. Analogues are not necessarily synthetic. Natural analogues of compounds (such as vitamins) occur. Such is the case with the vitamin K study you refer to. It involved three analogs of vitamin K-K3, K4 and K7. Vitamin K3 is a synthetic form of vitamin K, but vitamins K4 and K7 are naturally occurring analogues.

Our enthusiasm for the anti-clot forming potential of vitamin K is based on its role in the activation of proteins S and C, which are anticoagulant proteins; published studies showing that people with deficiencies of protein S are prone to blood clots; and vitamin K's role in controlling calcium. Platelet aggregation, a phenomenon that contributes to blood clots, involves the control of calcium. Blood coagulation is an extremely complex area of biochemistry involving at least 13 separate factors in addition to vitamin K. Much more work needs to be done in this area.

Q:How is Enhanced Life Extension Protein different from other whey products on the market? Are they equivalent?

A: Most whey products on the market are made of a simple and cheap concentrate with a smidgen of isolate. Enhanced Life Extension Protein, on the other hand, contains 100% whey isolates-made by employing the low temperature, cross flow microfiltration (CFM) technique. It is very expensive to make, so much so that most other companies have been unwilling to offer the very same CFM whey isolate. Furthermore, it contains additional lactoferrin, which boosts immune function, has anti-microbial and antioxidant properties, scavenges free iron in the body and protects certain cells from lipid peroxidation. Enhanced Life Extension Protein also does not contain synthetic sweeteners. See www.lifeextension.com for more information on whey protein.