Domain: fda.gov
Stories and comments across the archive that link to fda.gov.
Comments · 713
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botox
CNN has a story about botulinum toxin being used to treat back pain. Has anyone ever been treated with this stuff? I've heard it being used for people with twitchy eyelids and other spasms, numbing (read: killing) specific nerve endings. The toxin itself is one of the nastiest neurotoxins around, and sometimes pops up in canned foods. Another article.
Jeff
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GENE interactions are the future of MEDICINE?
Medicine Interaction related deaths are caused by either incompetent doctors, patients not disclosing medications fully, or foolish patients not reading warning labels. It's basically idiocy and carelessnes that causes this. When taking medication, remember that you are putting a chemical into your body, and we have a pretty good idea as to how they interact with other ones clinically, if not molecularly (experimenting with that's probably unethical anyhow). Medical interaction research isn't neglected, but is a standard and critical part of getting a drug approved for use. If you want to know more, go to www.fda.gov and look at their massive database on drugs. They've got info on interactions aplenty, particularly their medwatch database.
And as for why gene interaction is so hot, is that it's the real key to a lot problems. You thought that the human genome was it? No no no... that was only the beginning... it was the map for gene interactions. The genes are worthless if we can't figure out what they do and how they interact. I mean, we can't even tell you how an E. coli works even though we've got the genome. There will be a lot of profit out of finding protein interactions, sure, but it'll be to find cures. I work in a lab that's trying to figure out gene therapy in prostate cancer. We need to know the genetic mechanisms for therapy to be effective. Or don't you want cancer cured?
"I may not have morals, but I have standards." -
GENE interactions are the future of MEDICINE?
Medicine Interaction related deaths are caused by either incompetent doctors, patients not disclosing medications fully, or foolish patients not reading warning labels. It's basically idiocy and carelessnes that causes this. When taking medication, remember that you are putting a chemical into your body, and we have a pretty good idea as to how they interact with other ones clinically, if not molecularly (experimenting with that's probably unethical anyhow). Medical interaction research isn't neglected, but is a standard and critical part of getting a drug approved for use. If you want to know more, go to www.fda.gov and look at their massive database on drugs. They've got info on interactions aplenty, particularly their medwatch database.
And as for why gene interaction is so hot, is that it's the real key to a lot problems. You thought that the human genome was it? No no no... that was only the beginning... it was the map for gene interactions. The genes are worthless if we can't figure out what they do and how they interact. I mean, we can't even tell you how an E. coli works even though we've got the genome. There will be a lot of profit out of finding protein interactions, sure, but it'll be to find cures. I work in a lab that's trying to figure out gene therapy in prostate cancer. We need to know the genetic mechanisms for therapy to be effective. Or don't you want cancer cured?
"I may not have morals, but I have standards." -
Dangerous to get too fancy with editorial notes[Editorial note: Federal laws concerning research on human subjects requires that data about such studies be stored securely, with a number of explicit security requirements. If Clemson faculty have no expectation of privacy when using Clemson computers, Clemson is breaking those laws if it conducts any research on human subjects (which it does) and stores the data on Clemson machines.]
Well, not quite, actually. Clemson would be breaking those laws if it's demanding to have write access to the clinical data or actively circumventing the security and tampering with data. The leaps in logic you'd have to make here to break the law -- from "no expectation of privacy" to "university must be sniffing passwords" to "clinical computer systems therefore aren't secure" to "fraudulent data!" -- are pretty tenuous. Just saying there's no expectation of privacy doesn't equal a law violation here. Also, it's not likely that a lot of raw electronic data on human subjects actually is captured and stored on Clemson machines under the rules spelled out by the federal regulations, even if trials are being conducted there. Data being stored securely at a research site usually just means that the case report forms (paper) are kept in a locked cabinet by the principal investigators office. Electronic data in clinical trials is a huge world of pain, extremely expensive because you have to be compliant with 21 CFR Part 11. So usually the data, in the form of a lot of paper, is sent to either the big pharma companies or specialists called CROs (contract research organizations), to be made electronic and locked.
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Re:spam = pornography?> BTW, why do they usually put V----- in the email instead of the word? Do some mail servers filter email like browser censorware filters web pages?
Because Viagra is a trademark of Pfizer, and they don't wanna get nailed for infringement.
Because Viagra is a prescription drug, and they don't wanna get nailed for practicing medicine without a license.
Each of these excuses is about as good as the nonexistent "S.1618" law spammers like to cite. (Rule #1: Spammers lie.)
Feel free to forward all such spam to the FDA. The reporting address is available a few pages into http://www.fda.gov
(And is it just me, or is about half the spam I get from Florida, and about half of that from dialups in Pompano Beach? Judging from the spam I get from Florida, I'm really not surprised at how many Floridans are too dumb to figure out how to punch a hole in a card...)
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Re:Crippled for a reason
I'm curious if any of our neo-luddite friends out there are aware of the approval process any food must go through before being labeled fit for human consumption, both in Europe and the U.S.
Biafrans act as if it were software going from the first development build that ran to a final release in one step. News flash for those who would prefer to be scared than informed: If Microsoft went through a software development process similar to the food-approval process, we'd be bitching about the fact that, while Windows 2001 is supremely stable, it would be nice not to have to be limited to the 8.3 filename limitation. It's actually quite slow but with an emphasis on safety.
Any food, GM or not, has to go through an arduous, expensive, long approval process that addresses the very concerns the Know-Nothings bleat about. In fact, it checks for things they have never publicly considered.
Maybe we should make sure this stuff isn't going to kill millions before we unload tons of it on a third world country?
Maybe you should actually read what happens before whimpering in fear. From Are Bioengineered Foods Safe? from the U.S. Food and Drug Administration:
No matter how a new crop is created--using traditional methods or biotechnology tools--breeders are required by our colleagues at the U.S. Department of Agriculture to conduct field testing for several seasons to make sure only desirable changes have been made. They must check to make sure the plant looks right, grows right, and produces food that tastes right. They also must perform analytical tests to see whether the levels of nutrients have changed and whether the food is still safe to eat.
There are areas where they could be improved in terms of safety (but Biafrans choke at additional animal testing), and other areas where they could improve time-to-market and affordability of the process to increase the number of innovations made, make them cheaper (and thus available to people other than First World consumers). I'd be the last to say that governments are immune to criticism. But for Pete's sake please RTFM and get informed to what the real issues are instead of reading a headline and spewing off based on something you saw in a 1950's Sci-Fi flick whose science was written by English Lit majors. -
Re:Crippled for a reason
I'm curious if any of our neo-luddite friends out there are aware of the approval process any food must go through before being labeled fit for human consumption, both in Europe and the U.S.
Biafrans act as if it were software going from the first development build that ran to a final release in one step. News flash for those who would prefer to be scared than informed: If Microsoft went through a software development process similar to the food-approval process, we'd be bitching about the fact that, while Windows 2001 is supremely stable, it would be nice not to have to be limited to the 8.3 filename limitation. It's actually quite slow but with an emphasis on safety.
Any food, GM or not, has to go through an arduous, expensive, long approval process that addresses the very concerns the Know-Nothings bleat about. In fact, it checks for things they have never publicly considered.
Maybe we should make sure this stuff isn't going to kill millions before we unload tons of it on a third world country?
Maybe you should actually read what happens before whimpering in fear. From Are Bioengineered Foods Safe? from the U.S. Food and Drug Administration:
No matter how a new crop is created--using traditional methods or biotechnology tools--breeders are required by our colleagues at the U.S. Department of Agriculture to conduct field testing for several seasons to make sure only desirable changes have been made. They must check to make sure the plant looks right, grows right, and produces food that tastes right. They also must perform analytical tests to see whether the levels of nutrients have changed and whether the food is still safe to eat.
There are areas where they could be improved in terms of safety (but Biafrans choke at additional animal testing), and other areas where they could improve time-to-market and affordability of the process to increase the number of innovations made, make them cheaper (and thus available to people other than First World consumers). I'd be the last to say that governments are immune to criticism. But for Pete's sake please RTFM and get informed to what the real issues are instead of reading a headline and spewing off based on something you saw in a 1950's Sci-Fi flick whose science was written by English Lit majors. -
Error in original post!
Once again, the Slashdot moderators have messed up the facts again. As stated (url: http://www.mars.com/facts.asp?op=milkyway ) here, the center of the MilkyWay is not a black hole.
THE FACTS: The MilkyWay is often consumed into what may be considered a black hole. However, if this were indeed a black hole, the black hole would not appear to gain mass.
For instance, one 40-year-old male who had taken part in the study, funded by the United States Food and Drug Administration. Where a black hole would compress the matter to a mere geometric point, the black hole referred to in the study actually appeared to expand when the chocolate-malt product was consumed. When enough MilkyWay are regularly consumed, the subject will experience an increased capacity to eat; the capacity increasing with each sitting.
More concerned are the exercise professionals. "Those who consume too much of the product will put personal trainers out of business," suggests Jed Smith, Editor, American Human Body Focus. "People," he adds, "will no longer see a need to keep their bodies fit. Consumers are putting millions of professional trainers at risk of losing their job."
Cynthia Lamon, of the Maximum Performance Association of Athletic trainers (MPAA), has vowed to encourage US Congressional support of the Diet Manipulation Consumption Act (DMCA), currently a bill which was introduced and passed by the House. Pending the approval of the Senate, the President would then be asked for his approval.
The DMCA, if passed, require the millions who consume the MilkyWay chocolate-malt bar to accept the planned licensing agreement displayed on the outside of the packaging. Additionally, if the licensing provisions state so, those who wish to consume the sacred bar will be required to slice the bars only with Mars-KitchenWare utensils. Such sets of tools are alleged to offer technological advantages over traditional fork and knife sets.
The food items will also contain Crafted Structured Starch (CSS) technology, which would make splitting the food fibers impossible without the KitchenWare tools, which are able to unbind the additives which ensure the foods are sanitized.
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ColorblindnessFor one of the better descriptions for a normal sighted person on what color-blindness is to most people, check out this page. Any time one of my friends starts pestering me about what this color, or that color, looks like, I send them here, it generally answers their questions.
And finally, for anyone that had their hopes up like me, it seems the friendly people at ColorMax were lying about what their glasses could do (iirc, they basically claimed to have a [very expensive] cure for colorblindness)
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Cell Phones (may) have positive effectsAccording to the FDA: "the risk (for one type of brain cancer) actually decrease[s] with cumulative hours of mobile phone use" and human lab subjects "were able to make choices more quickly in one visual test when they were exposed to simulated mobile phone signals."
See FDA Consumer Update on Mobile Phones (October 1999).
San Jose Mercury News has a storyMy personal observation is that mobile-phone-dependent people tend to have a very short attention span. I don't know which causes which, though. Maybe the FDA will test that in lab.
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Re:quality control
And this one will help answer your question.
;=)
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thoughtsSince the U.S. Government (what? We're not the entire world?) is only dealing with Internet sales, I don't see the state governments getting in an uproar. Your local supplier won't change.
On the other hand, this simply gives the FDA some new powers. Since traditionally, the FDA doesn't do a lot, it really doesn't change much. For example, anything your local GNC probably sells, the FDA can't and won't investigate. (It's not a medicine or a food.) For example, here's their stance on homeopathic medicines: "FDA regulates homeopathic drugs in several significantly different ways from other drugs. Manufacturers of homeopathic drugs are deferred from submitting new drug applications to FDA. Their products are exempt from good manufacturing practice requirements related to expiration dating and from finished product testing for identity and strength. Homeopathic drugs in solid oral dosage form must have an imprint that identifies the manufacturer and indicates that the drug is homeopathic. The imprint on conventional products, unless specifically exempt, must identify the active ingredient and dosage strength as well as the manufacturer."
In short, they don't care unless it's a food, cosmetic, or medicine.
Now personally, when I order a few grams of coke, I want coke, not baking soda. At least now I have the FDA to complain to!(Think about it. If they sent you Premarin instead of antibiotics you'd want someone to complain to.)
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LASIK vs. PRK
In America, there are 160 million people wearing either glasses or contacts. (TIME, 1999) There are two different forms of laser surgery. One is called "PRK", which stands for "photorefractive keratectomy", and the other is called "LASIK", which stands for "laser in situ Keratomileusis". There are some fundamental differences between these two procedures. Basically, the PRK method is used most often on smaller, less drastic eye corrections. It has virtually no human involvement (there are no cuts made by a doctor because only a machine does any slicing) but it has a longer recovery period. LASIK is used for more drastic changes in vision quality and has a faster recovery period. This procedure depends more on the doctor making cuts, so there is more need to be absolutely sure that the doctor is experienced with this particular treatment. A basic thing to be concerned about is actually, it turns out, the software used for the laser path. Depending who you go to, newer software will be available for better vision. This cost is, of course, passed on to the patient which is something else to consider. If you are interested in seeing a photo essay example of LASIK surgery, that is available here. And for those squeamish folks out there, these are illustrations. No blood, no gore. Check it out.