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I work in the blood/plasma industry. I have for 16 years. We are considered Phase 1 in drug manufaturing so I am very clear on the Code of Federal Regulations regarding drug manufacturing. We are closely monitored by FDA as well as other organizations.
I know enough about profit and the need for quality control and Good Manufacturing Processes to keep drugs safe. There is plenty of room for error that can lower the quality of medications all along the line, not just within the company that pours the powder in the capsule. I also know the dilemma many drug manufacturers would face in buying their supplies to make the drugs if they did not know anything about the plant in which they were purchasing this from unless they also were inspected by a common system. As an FDA regulated drug manufacturer, I am required to keep a paper trail of where any supplies came from that were used in the manufacturing process. We keep so much documentation that you would all be asleep if I wrote it all down. To sum it up, I was told by a co-worker when I was first hired, "If you pick your nose, you better initial for it." I know the FDA is not perfect. They have a limited budget to operate on but the investigators I have worked with do the best they can. As for Vioxx, they can only clear the medications that they have seen clean research on. They cannot always tell what a drug will do after long term use. I've seen much hard work go up for review by the FDA, and it is no easy process. My company had one medication go for approval and we literally sent a vanload of research. It was sent back for 6 more months of research because there was one aspect of the documentation that was not clear. Instead of criticizing the FDA for Vioxx being pulled, we should be grateful that they did find thousands of other drugs that DID show they were unsafe. They don't have a crystal ball, but they do have a strict manufacturing policy and for that I am thankful. |
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I am also in the research field of pharmaceutics. People just don't understand how difficult it is to get a successful drug, from the early stages of just finding the compound all the way to human trials. The only way to truly know the results of a drug is to take it through animal and clinical trials, but even then, you just never know until its on the market for a few years. What scares me is the vitamin and herb industry, these are not regulated. Have you noticed that only recently they are putting expiration dates on vitamins....hmmmmm. Vitamins- In October of 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA). The DSHEA was written to help empower American consumers to make choices about their own preventative healthcare strategies, and hopefully this would reduce the country's health care expenses. Under the DSHEA it was decided that nutritional supplements would continue to be regulated as a food product rather than the more restrictive regulations that drugs fall under. While this made multi vitamin and nutritional supplements widely available it also allowed nutritional supplement manufacturers to practically regulate themselves, since there was no agreed upon standard of good manufacturing practice and no government pressure to be true to the label on their products. It was't until March of 2003, nine years after the DSHEA became law, that the FDA proposed new regulations to require current good manufacturing practices (CGMPs) in the manufacturing, packing, and holding of multi vitamin and dietary supplements. But thats JMHO ;) |
Thanks for posting the letter, Meg!
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As far as comparing the health of Asian countries to that of the Western world - I'm inclined to say that MOST of that is due to lifestyle - i.e. diet and exercise - until recently the majority of the population in Asia lived in rural areas, mostly with no automobiles and raising much of their own food - vegetables, grains, lean meat, fish and poultry with very little sugar. However, this is now changing for much of the population as they become more 'civilized' and accustomed to driving or taking public transportation and eating fatty, sugary fast food. In fact, last year one of my coworkers went to China on a three-week tour - commented that especially in Taiwan and Bejing she saw quite a few overweight/obese people, especially children - however in the rural areas it was quite different, although they are rapidly becoming more 'civilized' there as well. And of course, it's been shown in numerous studies that once many Asians emigrate to the US, they start becoming much less active and eat a LOT more calories, more sugar, fat, etc. and become overweight and/or obese as a result... |
I can't speak for Asian immigration, but my husband is from Holland and when he moved here, he started gaining weight and becoming a couch potato. Where we live, he can't walk to the grocery store, or to any other shopping for that matter. He walked and rode a bike on a daily basis in Holland, and here he goes from the house to the car. Restaurant visits are much more uncommon there, and they have much less additives in the foods. He thought all American bread was sweet and was overwhelmed by the size of the grocery stores and the large portions in restaurants in the US. Free refills also don't happen in Europe, so they don't drink 48 ounces of Pepsi with each meal. It all adds up.
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