Domain: fda.gov
Stories and comments across the archive that link to fda.gov.
Comments · 713
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fear isn't necessarily bad...
It's not "my" hypothesized link between thimerosal-preserved vaccinations and autism. Despite the flames I've received from WarCraft addicts on
/. tonight, and lots of folks putting words in my mouth, or misquoting me (for example, you yourself quoted me as having written "all vaccinations", which I did not write) there are many, many people - some of them probably smarter than both of us - who suggest links between thimerosal-preserved vaccinations and autism. Proof? No. Suggestion? You bet. Any other competing theories that make more sense? Sure, there are other theories, but at best they're only as provable or sensible as thimerosal-autism causation is.
I don't see what's so difficult for people to accept: mercury is toxic; toxic things should not go inside your body; if they do, bad things might happen to you. If, as some people suggest, thimerosal (which is ~%50 mercury) causes no health risks to children, why is the FDA working to remove thimerosal from all vaccines? http://www.fda.gov/cber/vaccine/thimfaq.htm#q3 As an aside, I just spent a few minutes reading the answers to other questions on the FAQ, and I'll be damned if that wasn't written by a team of lawyers. Several of those questions do not have answers, but rather a barf of text that - if you can limp through reading all of it - will probably only confuse you.
Here's something from The Boston Globe (http://www.boston.com/news/globe/editorial_opinio n/oped/articles/2005/07/01/autism_mercury_and_poli tics/):
"Numerous animal, DNA, epidemiological, and other studies point to Thimerosal as a culprit in America's epidemic of neurological disorders. Autistic children have been shown to have higher mercury loads than nonautistics, and there have been reports of significant improvements in some brain-injured children by removing mercury from their brains. Most of the symptoms of autism are similar to the symptoms of mercury poisoning. Scientists have been able to induce autism-like symptoms in mice by exposing them to Thimerosal. A recent study by an FDA scientist, Dr. Jill James, found that many autistic children are genetically deficient in their capacity to produce glutathione, an antioxidant generated in the brain that helps remove mercury from the body."
So the FDA scientist found that some kids can't flush mercury from their bodies as well as others. Why would this matter if mercury weren't a poison that was introduced into their bodies? Of course it matters, which is why the FDA wants thimerosal usage to stop. Most kids get tons of shots and flush the excess mercury without problems, but some of the kids do not flush it and they are negatively affected.
To recap, pharmacos use thimerosal, thimerosal is %50 mercury, mercury is toxic, some kids cannot flush mercury like others, mercury lingers in the body, mercury poisoning is similar in characteristics to autism, and the whole chain started from the shot. Seriously, you think this sounds like a conspiracy theory? -
Re:Autism ratesWe'll know for sure very soon, one way or another. Thimerosal has disappeared from the (minority) of vaccines that had them in the first place. Table of mercury in childhood vaccines
So- of those few vaccines that still contain thimerosal, such as Fluzone (the most I can find in the tables, at 25 micrograms mercury for a 0.5 mL injection), how does that compare with what you eat?
You get twice that much by ingestion from a single gram of chunk white tuna. Or, from the Mercury Calculator, two ounces of canned albacore is 180% of what a 40-pound child should eat in a day.
Of course, injection is very different from ingestion- but the example I give is extreme. After the influenza vaccines, thimerosal levels drop off dramatically- and virtually all use of thimerosal was discontinued years ago.
So stop whining about vaccinating your kids. There are low- and no-thimerosal options for everything but straight TT (tetanus toxin), and you can get your kid stuck for tetanus without thimerosal by using Tdap or another vaccine with a tetanus component. And in another 5 years or so, we'll know for sure if the thimerosal was responsible. Until then, your kids get way more exposure from food, water, and air than vaccines.
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Re:Autism rates
The FDA says that most children's vaccines -- and all vaccines for children under 6 -- haven't had more than a trace amount of mercury, if anything, for years. Critically thinking under your assumptions about mercury, one would expect that when the amount of mercury in vaccines dropped to little or nothing several years ago, the incidence rate of autism would have dropped. But they haven't.
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Re:All patents are bad
No, they don't have to be identical. From the FDA website:
http://www.fda.gov/cder/drugsatfda/glossary.htm#TE
"By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product."
How that active ingredient is made up or processed does not have to be the same. The test is whether the generic is "therapeutically equivalent" which means:
"Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product."
The definition goes on to what the minimum standards are. However, this leaves leeway as to how the generic is processed and manufactured. And, it does vary from company to company. -
Quality is Not the Same
Brand name drugs don't advertise after a drug goes off patent and all major costs have already been recouped. The only expense left is manufacturing.
If you think there has not been a problem about generic quality control check out this statement from the Commissioner of Food and Drugs a few years back:
"Finally, FDA has also uncovered evidence that some generic drug firms have
violated the good manufacturing practice regulations that govern overall
production procedures and techniques that help guarantee the safety and
effectiveness of drug products."
http://www.fda.gov/bbs/topics/CONSUMER/CN00080b.ht ml -
Re:500 is a pretty low figure
No photos, but there is a bit more technical info at the official FDA announcement at:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01559.h tml
"The device works by connecting together the ends of a severed blood vessel, providing a bridge or shunt around the damaged area and restoring blood flow to the injured limb. It can be implanted on the battlefield and other remote areas to bypass damaged blood vessels and temporarily maintain blood flow to the injured limb until the patient can be transported to a surgical facility.
The TLSS is a tube formed from two layers of plastic. The device has several features that optimize its use in a trauma situation, including a self-sealing elastomer membrane that permits drugs to be injected directly into the shunt without loss of blood; beveled ends that facilitate quick and effective placement of the device within the severed blood vessel; graduated markings that provide visual confirmation of proper device placement; and extra reinforcement in the center of the device so it can be cut to a shorter length if needed." -
Re:The gambling goes both ways
"Since there is no such thing as a 100% safe vaccine, and this vaccine is relatively new, a person would be gambling with their daughter's life either way."
Really? This vaccine hasn't killed any of the 11,000 women involved in testing. Cervical cancer kills one woman for every five who die in automobile accidents in the United States. Where, exactly, is this "gamble?"
"Of course, we could just educate the girls and parents and let them make the decision as to yes/no and if yes, when, themselves."
Or we could just, you know, eradicate the disease from the population as quickly as possible. What exactly is your point? -
Re:Patentless?
You hit on the one thing I think our doctors are good at: critical care. If you have a broken something or a leaking something they can fix you up amazingly. I know there are good doctors, I just think they are rare and subject to burnout. It's the little things that leave me feeling cheated. I shouldn't have to explain how the common cold works to a doctor.
You're wrong about the error rate. According to the FDA medical errors in hospitals kill 50k-100k Americans per year, and are the 8th largest cause of death. Not all of these errors are caused by doctors, but I think it's fair to mix doctors and the health care system up. This doesn't even begin to cover the millions of less critical errors made on an outpatient, office, or long term care facility. The linked document (from 2000) outlines an ambitious program to reduce medical errors. The results so far are hardly impressive.
I don't think minimizing the error rate and huge financial and human cost are helpful. I have respect for people in the health care field, but we need to be honest about the problems. -
Oh, good, markets!
BY the way, there is an ancient market-based solution to this conundrum where a socially good activity is not perused because of insufficient profit margin. Rather than revert to socialized, state sponsorship which is paid from the people's existing wealth, the state can instead create new wealth by granting a monopoly on the activity. In this case, granting a limited term monopoly, perhaps with second source requirements, to the high bidder drug company, will ensure that the drug is studied sufficiently and brought to market.
Whew! For a minute there I thought that there was no way we could funnel money to pharma companies from this discovery. Now that you're proved me wrong, we can all hold hands, jump up and down and shout "The Magic of the Market! The Magic of the Market!" I think I feel the Imaginary Hand fondling my giblets right now.
But more seriously, this is the central problem of capitalism. It's very, very good at optimizing corporate profits. Unfortunately, there's a circular-definition problem where "good" is defined as "corporate profits" and vice versa. In many cases, they coincide--if you consider cheap consumer goods to be a social good, then capitalism happens to be working well. On the other hand, when you find yourself making ridiculous contortions in order to pretend that corporate profit is equivalent to social good, you might want to consider that this is why we have regulation; this is why we have what you feh-feh as "socialized state sponsorship." Note that one of these "socialized state sponsorship" programs originally developed DCA, the FDA's Office of Orphan Products Development.
You get yourself into the most ridiculous twists. Are you seriously claiming that handing money to a state employee is simply "paid from peoples' existing wealth", but handing twice as much money to a corporate employee is "creating wealth"? -
Way off base, dude. Think of herd immunity.
1. Merck and GlaxoSmithKline are right now lobbying for laws to
You know, you have a legitimate axe to grind, about big pharma being set up to maximize profits, which doesn't always maximize social good. That's a problem in any capitalist system, and it's why we have regulation, and publically-funded research to fill in the gaps. (Like the FDA's Office of Orphan Products Development, where much of the initial DCA research was performed.)
_FORCE_ innoculation of girls in school from 6-11 mandatory with
their vaccine against a sexually transmitted disease virus.
However, your kvetching about the HPV vaccine (I see you're referring to a "sexually transmitted disease virus" instead of a "cancer virus" there) shows an ignorance of the concept of herd immunity. The point of mandatory vaccinations is that they can't reach everyone, but if they reach a critical mass of people, the disease can be eradicated, like smallpox or polio have been eradicated. Vaccines don't do their public-health work unless nearly everyone gets them; if not, the disease hangs around in unvaccinated people.
Did you think it was a mistake for the government to FORCE people to be vaccinated against polio? Against smallpox? Against measles? Mumps? Rubella? Meningococcal disease (for college students)? Diphtheria? Plenty of these other vaccines make money for pharmaceutical companies; why aren't you complaining that we're FORCEd to take them? Except we're not actually forced, because parents who want their kids to get cervical cancer when they grow up can leave them vulnerable to it, which I suppose is their own business. -
Re:Patentless
Wrong.
FDA doesn't approve a Brand, per se, but they approve a drug, period. What protects that manufacturer is the fact, that mostly, a new drug is protected by a patent. Once that patent expires, that drug is then open to development by other companies as generic drugs, and it this process that is easier as you noted.
A company can apply to FDA and receive approval to sell a drug as a generic drug. That application does not carry with it the same requirements of clinical trials, but simply to prove to FDA that the manufacture of that drug will result in the same identical drug. FDA will inspect the facility where the drug is to be sold, to ensure that the facility adheres to FDA standards in that manufacturing process. FDA also looks at that manufacturing process to ensure that it will result in the same identical chemical structure, at the applied for strength and dosage.
A FAQ about generic drugs can be found here: http://www.fda.gov/cder/consumerinfo/generics_q&a. htm -
Re:Noticed in your sig you like Bill Hicks
So, do you think that if doctors don't know the alternatives, we should advertise to the patients?
Sometimes, yes. Not every appropriate customer is going to visit the doctor in the first place. They may have a chronic condition, but not visit the doctor because they don't feel that there is an appropriate treatment. Statins, for instance, have historically been way underprescribed despite tremendous evidence of their huge health benefits. It's fine and good to tell people that they need to lose weight/eat better/exercise more, but the fact remains that statins work and patients are far more likely to take them than change their lifestyle, i.e., it empirically saves lives both with and without lifestyle changes.
Another relevant articleWhat exactly does a "pharmaceutical consulting group" do, anyway? Something good, like "Facilitate open communication between drug companies and doctors?" Or something bad like "Figure out how to push more drugs whether people need them or not?"
Why don't you listen to what doctors have to say? 41% of doctors surveyed said they thought it had benefits... Some doctors (just 18%) also see some harm (their biggest complaint: time spent correcting misperceptions), but to say that it's simply a matter of DTC ads being "bad" is too simplistic and wrong.
The fact is that virtually every industry, except for perhaps commodity industries, engages in some form of marketing that targets buyers, decisions makers, and their end-users. Even good and very important products need marketing (I say this with experience, having worked for many years for a medical devices company and with many connections in the med-tech area). While I agree, in principle, that prescribing drugs inappropriately is bad and is sometimes a real problem, the solution is not simple. The under-prescription of drugs not only harms those patients who are not prescribed the drugs, they drastically reduce the market for the drug companies and thus the incentive and the ability for the drug companies to recoup their costs (which are necessary to ensure the production of drugs in the first place). I won't say everything is peachy in the drug industry, but misguided attempts to regulate it are equally dangerous.
Also, as to your specific question about what pharma. consulting groups do, they can certainly play an important and beneficial role (one of my siblings worked for one for several years). A lot of what they do involves talking to doctors, managed care, hospitals, and sometimes patients to figure out what their problems and concerns area. There is often a lack of basic knowledge about drugs and/or misperceptions their side-effects. They are also frequently called upon to study uses for new drugs or new uses for existing drugs. By identifying what these are, the drug companies can then figure out how best to address them. Information is rarely so perfectly distributed on both sides that there can't be any benefits from further study. I won't say that they can't do anything harmful for society, but this is true for virtually everything under the sun. -
Re:So we should trust Microsoft?
The statistics in the IOM report, which were based on two large studies, suggest that medical errors are the eighth leading cause of death among Americans, with error-caused deaths each year in hospitals alone exceeding those from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516). http://www.fda.gov/fdac/features/2000/500_err.htm
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Maybe they can't multi-task quite as well as they think. -
Indeed we do, and it shows.
The efficacy of dichloroacetate was studied in the FDA's orphan product research program. Two clinical trials were performed on the drug; here's the complete list. The Canadians did a good thing, but they are standing on the Americans' shoulders.
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Indeed we do, and it shows.
The efficacy of dichloroacetate was studied in the FDA's orphan product research program. Two clinical trials were performed on the drug; here's the complete list. The Canadians did a good thing, but they are standing on the Americans' shoulders.
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They do that.
The FDA has an orphan products grant program, which conducts clinical trials on drugs which would be overlooked by for-profit companies. Interestingly, two grants were given for researching dichloroacetate (see the "Previous Grants" page).
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Programs like that exist.
The FDA awards grants for "Orphan Product Research", research on "drugs and devices for small patient populations". Dichloroacetate was one of the drugs thus studied, in this case for congenital lactic acidosis, which while I'm sure it's unpleasant, isn't the sort of thing major pharma companies throw heaps of money after. Thanks for this development should also go to P.W. Stacpoole, who (according the the bibliography in the Cancer Cell article) has been publishing papers on the pharmacology, safety and effectiveness of DCA since 1988.
The Orphan Product Research Program has, according to the website, approved 40 new products for rare diseases. It's sponsored a staggering list of clinical trials, on an annual budget of around $13 million.
So, the system, in this instance, worked. Should anyone ever consider dissolving the program, you can roll up a copy of that list and bash them over the head with it like a naughty puppy. -
Programs like that exist.
The FDA awards grants for "Orphan Product Research", research on "drugs and devices for small patient populations". Dichloroacetate was one of the drugs thus studied, in this case for congenital lactic acidosis, which while I'm sure it's unpleasant, isn't the sort of thing major pharma companies throw heaps of money after. Thanks for this development should also go to P.W. Stacpoole, who (according the the bibliography in the Cancer Cell article) has been publishing papers on the pharmacology, safety and effectiveness of DCA since 1988.
The Orphan Product Research Program has, according to the website, approved 40 new products for rare diseases. It's sponsored a staggering list of clinical trials, on an annual budget of around $13 million.
So, the system, in this instance, worked. Should anyone ever consider dissolving the program, you can roll up a copy of that list and bash them over the head with it like a naughty puppy. -
Programs like that exist.
The FDA awards grants for "Orphan Product Research", research on "drugs and devices for small patient populations". Dichloroacetate was one of the drugs thus studied, in this case for congenital lactic acidosis, which while I'm sure it's unpleasant, isn't the sort of thing major pharma companies throw heaps of money after. Thanks for this development should also go to P.W. Stacpoole, who (according the the bibliography in the Cancer Cell article) has been publishing papers on the pharmacology, safety and effectiveness of DCA since 1988.
The Orphan Product Research Program has, according to the website, approved 40 new products for rare diseases. It's sponsored a staggering list of clinical trials, on an annual budget of around $13 million.
So, the system, in this instance, worked. Should anyone ever consider dissolving the program, you can roll up a copy of that list and bash them over the head with it like a naughty puppy. -
Not unreasonable
The Dietary Supplement Health and Education Act (DSHEA) of 1994 allows companies to sell such a substance after proving only that it has no "significant or unreasonable risk of illness or injury." If they sell it in the indication that it be used in 10 mg pills, and then a study indicates that 100mg is the best dose, then people can just take 10 pills. You don't need a patent to sell something. In other news, thousands of people die from aspirin and acetaminophen misuse each year, but they aren't illegal.
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Software validation.
The answer is simple.
Proprietary closed source software cannot be validated. You cannot trust that it will always work properly, because the source is not available for validation.
http://www.fda.gov/cdrh/comp/guidance/938.html
http://standards.ieee.org/catalog/olis/se.html
http://hissa.nist.gov/HHRFdata/Artifacts/ITLdoc/23 4/val-proc.html#233_SEC
http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi? title=200621
Software pricing has nothing to do with it. The validation process in regulated environments will cost many times more than the actual value of the software itself. The cost of the actual software is trivial.
Closed source software has no future in regulated, mission-critical applications.
Belief and faith are irrelevant. -
Re:I hate to say this...
The drug was called Iressa. Here's the final FDA statement from two years ago. I recall my mom glumly stating that Christmas "two more people living would have changed the statistics - it was that close".
Sad, as there were definitely people that benefited from the drug - we saw some of these cases firsthand, and of course saw huge amounts of data. However, the final trial failed to show statistical significance. -
Re:yes, you are
"Are the drug companies spending money on advertising for fun, or is it with the aim of producing a return? Presumably, they are aware of the economics of their field and know the balance for return on R + D, and return on advertising. Also, genuine question, do you have the figures to verify this statement? I have an interest in this anyway, so i'm not just trying to undermine your argument."
http://www.newstarget.com/010315.html
Also, several studies on direct-to-consumer prescription drug advertising have been published in JAMA of which I've read some abstracts, but I don't have an online JAMA subscription so I can't read 'em unless I go to the library.
Also some good stuff here:
http://www.fda.gov/cder/ddmac/globalsummit2003/
http://www.fda.gov/fdac/features/2003/203_dtc.html
All these from this google search:
http://www.google.com/search?client=safari&rls=en& q=direct+to+consumer+prescription+drug+advertising &ie=UTF-8&oe=UTF-8 -
Re:yes, you are
"Are the drug companies spending money on advertising for fun, or is it with the aim of producing a return? Presumably, they are aware of the economics of their field and know the balance for return on R + D, and return on advertising. Also, genuine question, do you have the figures to verify this statement? I have an interest in this anyway, so i'm not just trying to undermine your argument."
http://www.newstarget.com/010315.html
Also, several studies on direct-to-consumer prescription drug advertising have been published in JAMA of which I've read some abstracts, but I don't have an online JAMA subscription so I can't read 'em unless I go to the library.
Also some good stuff here:
http://www.fda.gov/cder/ddmac/globalsummit2003/
http://www.fda.gov/fdac/features/2003/203_dtc.html
All these from this google search:
http://www.google.com/search?client=safari&rls=en& q=direct+to+consumer+prescription+drug+advertising &ie=UTF-8&oe=UTF-8 -
Re:Order yours hereOk, here's one. Mushroom Amatoxin Poisoning. From the link:
Poisoning by the amanitins is characterized by a long latent period (range 6-48 hours, average 6-15 hours) during which the patient shows no symptoms. Symptoms appear at the end of the latent period in the form of sudden, severe seizures of abdominal pain, persistent vomiting and watery diarrhea, extreme thirst, and lack of urine production. If this early phase is survived, the patient may appear to recover for a short time, but this period will generally be followed by a rapid and severe loss of strength, prostration, and pain-caused restlessness. Death in 50-90% of the cases from progressive and irreversible liver, kidney, cardiac, and skeletal muscle damage may follow within 48 hours (large dose), but the disease more typically lasts 6 to 8 days in adults and 4 to 6 days in children. Two or three days after the onset of the later phase, jaundice, cyanosis, and coldness of the skin occur. Death usually follows a period of coma and occasionally convulsions.
Additionally, orellanine poisoning has a longer latent period, but would require a larger dose.
The final type of protoplasmic poisoning is caused by the Sorrel Webcap mushroom (Cortinarius orellanus) and some of its relatives. This mushroom produces orellanine, which causes a type of poisoning characterized by an extremely long asymptomatic latent period of 3 to 14 days. An intense, burning thirst (polydipsia) and excessive urination (polyuria) are the first symptoms. This may be followed by nausea, headache, muscular pains, chills, spasms, and loss of consciousness. In severe cases, severe renal tubular necrosis and kidney failure may result in death (15%) several weeks after the poisoning. Fatty degeneration of the liver and severe inflammatory changes in the intestine accompany the renal damage, and recovery in less severe cases may require several months.
The disulfiram-like toxins are nasty. Drink, and you go into organ failure.
Mushrooms in this last category are generally nontoxic and produce no symptoms unless alcohol is consumed within 72 hours after eating them, in which case a short-lived acute toxic syndrome is produced.
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Re:Then so is the FDA...
"Then so is the FDA.....You're a friggin idiot"
Hey, I wasn't the one who used the FDA as an example of a non-government agency. Hello? knock knock. Does the top-level domain .gov mean anything to you? -
Re:The Battle of the Sexes
Dear coward:
I hope that you read this. You are going to get into trouble.
Condoms do not work as well as The Pill. That is quite incorrect and a common misconception. Each method of birth control has a percentage chance of failure based on complexity, user requirements, and type of barrier. The Pill has a very small percentage of failure - something like 1%. Condoms have an 11% failure rate. Check out the FDA's list:
http://www.fda.gov/fdac/features/1997/babytabl.htm l -
Re:I'm excited.
Your first two examples are bogus.
The reason for #3 is pretty obvious: If all macaroni is FAT FREE, then saying that your Kraft Macaroni is FAT FREE is confusing consumers. They are allowed to say "macaroni is a fat free food," and even allowed to tout this as a key selling point. What they can't do is try to use this information to differentiate themselves from other macaroni on the market.
For #4, you suggest the solution yourself: Have the extra information in a separate location on the package. You'll be hard-pressed to convince me that the FDA's demand for a certain amount of packaging space is a big deal. I do think you're right about them needing to switch to a "meets or exceeds" mode, even though there might be abuses.
You're also right that there aren't sufficient allowances for small farms and producers, and for setups that don't meet the FDA's expectations (The Omnivore's Dilemma has an interesting example there, with an organic farm that did its slaughtering outdoors. Since they couldn't get the FDA to sign off on a seemingly safe and healthy practice, they were limited to selling meat directly to consumers.) -
Re:I'm excited.
Forcing companies to label properly does NOT work.
Shady processors adulterated fertilizers, deodorized rotten eggs, revived rancid butter, substituted glucose for honey. Farmers began to learn about such deceptions from a new breed of agriculture chemists, often trained in Germany, located in State officialdom and helped by Federal funds. These chemists could apply their scientific skills to expose the work of chemists employed by industry to depreciate food products, as the Senate Report put it, in "a greed for gain."
Anyone who is interested in the mundane world of fact, rather than fanciful flights of political ideology, knows that prior to regulation and inspection, the quality of food was much lower than it is today. The quote above describes the situation in the mid-1800's, prior the the first national pure food act in the U.S. in 1906.
The law is a powerful instrument, and it has proven to be more effective than anything else in forcing people who are selling things to not lie about what they are selling.
The issue with food labelling has nothing to do with any rational concerns about food quality, however. The only issue is that consumers have a right to know what they are buying. In practice, the only way of ensuring that right is honoured is to have legal sanctions against lieing about what is being sold, and uniform labelling standards are by far the most efficient way of doing this.
Personally, I'm not at all keen on supporting an even more uniform agricultural monoculture than we have now, so if meat from cloned animals was labelled I would tend to avoid it. -
Re:I'm excited.
I agree a few more details on the labeling. The requirement to use "0 trans fat" or "fat free" is that there is only 0.5g PER SERVING. So it doesn't even have to be significantly below the 1g level. From http://www.fda.gov/opacom/backgrounders/foodlabel
/ newlabel.html Free. This term means that a product contains no amount of, or only trivial or "physiologically inconsequential" amounts of, one or more of these components: fat, saturated fat, cholesterol, sodium, sugars, and calories. For example, "calorie-free" means fewer than 5 calories per serving, and "sugar-free" and "fat-free" both mean less than 0.5 g per serving. Synonyms for "free" include "without," "no" and "zero." A synonym for fat-free milk is "skim". There are also many other defenitions for "low", "lean", "high".... -
Re:Focus on what has actually occurred!
I think the parent poster brings up a good point here, in that many of the comments on this article so far that have been in opposition to GM foods have failed to cite any specific examples
If you have to cite a specific problem, it's too late.
If you're going to talk about some mysterious bad voodoo that GM foods have perpetrated on the unsuspecting populace, at least take the 5 minutes required to google it and provide some citations. Just saying "oh well, you know, GM foods are pretty bad and can do some nasty stuff" isn't going to convince anyone or make for a constructive debate.
Uncontrolled introduction of GM product into the food supply - http://vm.cfsan.fda.gov/~dms/starguid.html
Allergic reaction caused by GM food - http://www.newscientist.com/article.ns?id=dn8347
It's not about GM being bad, its about having proper controls in place. -
Please, please read this.
Potassium Iodide will save your life in the event of a nuclear incident. This includes dirty bombs as well as fission bombs. Here is the fda's view:
http://www.fda.gov/cder/drugprepare/KI_Q&A.htm
KI is available from several sources. Please get it right now. It will save your life. The government may not have enough for you. -
Re:Productivity?Tackhead wrote:
This is government work. Nothing's being produced, only consumed.
Not all government work is non-productive. Most government agencies have some hand in assisting citizens and businesses in their productive endeavors, either by providing regulatory and legal infrastructure (the Dept. of Agriculture and the FDA inspect for food safety, the NIST provides consistant weights and measures for use in all sorts of commercial transactions, the judiciary provides the means of enforcing contracts, etc.) or by producing actual goods and services (the Library of Congress publishes books on tape and in braile for the deaf and the blind, the Army Corps of Engineers builds all sorts of public works and many agencies perform a fair amount of basic research that, eventually, winds up in the public sector via technology transfer).
I know that the Libertarian party-line, so popular on slashdot and with technologists in general, is that government is nothing but a leech on the ass of an otherwise productive capitalist society and should be restricted to funding a militia, but the facts simply don't bear this out. Any large organization will have an alarming amount of bureaucratic waste, and most governments may have a little more than most private sector entities, but governemnts can, and in some cases do, do more than generate paper and hot air. -
Re:Open source use not prohibited for FDA approved
I fully agree with the parent comment.
And quoting from the document 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff' at http://www.fda.gov/cdrh/comp/guidance/938.html#_To c517237928
The Scope section of the document refers to just this type of situation:-
'Where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) the software developer may not be directly responsible for compliance with FDA regulations. In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developer's activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturer's intended use.'
So - it is clear what the FDA wants - it clearly does NOT stop you from using Free/Open Source Software, it just requires you to use quality processes to ensure the software is verified / tested for your intended use - which you SHOULD anyway do, if want to develop INDUSTRIAL STRENGTH software.
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venu -
Re:Someone remind me...
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Re:Someone remind me...
GE foods available for purchace are never harmful to humans. They are tested extensivly before release.
The FDA considers them GRAS (generally recognized as safe), for being "substantially equivalent" to the non-GE counterparts.
That said, we almost lost the Monarch butterfly because of GE wheat a few years ago (I can't remember what exactly it was, something missing in the wheat... I dunno).
Bt corn? herbicide-tolerant soybeans? Lots of GE crops have been blamed. Seems a tad suspicious.
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Re:You can tell something about these people
The drug industry has a Congress-approved methodfor extending patents past 20 years, and the issue keeps popping up.
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Re:NNNnnnnggghhhhahhyyyyyaaahh!!!
(in my best Gilbert Gottfried voice): Drinkypoo, YER an idiot!
The fact that you would invite comparison to Gottfried indicates that you revel in being annoying.
Youth diabetes was basically unheard of in this country before the advent of the food pyramid
That is categorically bullshit. Diabetes is caused in two ways. One of which is overindulgence combined with underexercise. The other is damage to the pancreas.
Yes. And research has indicated that damage to the pancreas very likely can be caused by overtaxing it, such as by regularly consuming large quantities of "ready" carbohydrates, those which are most easily broken down. Sucrose is at the top of the list, and somewhere near the bottom is stuff like white bread (or most wheat bread, which is only brown because they color it, not because it's substantially different.) This is why, for example, brown rice is better for you than white rice.
Diabetes has been known of for over 2,000 years, and it is not caused by some sinister fucking food pyramid conspiracy.
Not all of it, just some of it, and in particular youth diabetes, which has been nearly nonexistent in every country in which the primary foodstuff is not comprised of carbohydrates.
More importantly, SUGAR IS NOT A FUCKING DRUG! You are intentionally misunderstanding the definition of a "drug." "Drugs" are substances not necessary for nutrition which cause chemical changes in the way the human body works. Sugar is a natural nutrient and has been part of the human diet in one form or another since we were human.
That's funny, because only one definition of "drug" agrees with you. Most of them make no restriction on whether the substance is a nutrient or no, and in fact the one that does takes that description directly from the Food, Drug, and Cosmetic Act:
SEC. 201. [21 U.S.C. 321](g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.
What you are arguing is that a legal definition provided solely for the purpose of clarifying a legal act is to be considered the definitive word on the subject. I personally do not enshrine the law above knowledge.
A more reasonable description of the word "drug", and the one that has persisted since time immemorial, is A chemical substance, such as a narcotic or hallucinogen, that affects the central nervous system, causing changes in behavior and often addiction. (The American Heritage® Dictionary of the English Language, Fourth Edition, drug, noun, sense 2.) By this measure, sugar more than qualifies; it is definitely a chemical (A substance with a distinct molecular composition that is produced by or used in a ch
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Re:Hmm
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Re:How about eliminating patentsI would encourage you to try to visit a lab sometime. As a seasonal employee of a Fortune 1000 Pharmaceutical company, I can tell you that there is a huge amount of original research that goes into everything that the FDA approves. They use supercomputers, computing clusters, and many many PHDs all working for many years just to make a promising drug candidate that will probably never make it to market. After developing a substance and testing it in the lab and on animals, it enters the arduous FDA approval process, complete with three phases of human clinical trials. Modern pharmaceuticals are a high tech and very competitive business that needs patent protection for the good of humanity.
You might be thinking about dietary supplements, which have been unregulated since 1994 thanks to the DSHEA. Those are often folklore remedies quickly packaged into pill form without any requirements for testing or proven safety. -
Re:Come on guys..
Even with the posted IRC logs, this may not be the entire story. I haven't scrolled through enough of the 600+ comments yet, and I can't verify the legitimacy of the quotation. But let's assume it's valid. The guy is supposed to be in Afghanistan right now. That means he is taking preventative medication for malaria. At least one of the anti-malarial drugs typically administered by the U.S. military in Afghanistan, mefloquine (a.k.a. Lariam), occasionally causes mental problems. It's rare - usually, mefloquine just causes an upset stomach or insomnia - but it's possible that the degree of this fellow's reaction is induced by the medication. If he lost close friends in the attack, it's also conceivable that he was so overcome that his comments on IRC were made in the heat of the moment, especially given the following (very low-key) email. It's probably better to give the fellow the benefit of the doubt, concentrate on his positive contributions, and move on.
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Gov asks about ANY charges
If you're getting hired by the US Federal Government, and are going to have *any* kind of security clearance (and sometimes even when you won't), you'll have to fill out a form called an SF-86.
This document asks (in addition to a lot of very personal info) if you have ever been charged with ANY crime (except traffic tickets/moving violations with fines of less than $150), and if so you have to list the charges, the results of the charges, and the contact information for the court/jurisdiction the charges were brought. Even if you get supervision of something similar, you have to report it, even if it was expunged (except in a very specific circumstance).
And if you lie on the form, it's a Federal crime (18 USC 1001). -
Re:PRK
No, the flap never fully bonds with the eye again. You are always at risk from one 3 Stooges re-enactment from having her flap hang-out. What we have reached here however is the crossroads of long-term gain for short-term pain.
You have a reference for that?
My eye doctor said they could peel back the flap up to around a year after surgery (for corrections). After that it would have healed and they'd need to do the intralasik procedure again (If you use the blades to cut the flap instead of a laser, it heals even faster).
The FDA webside for lasik states you should wait 4 weeks before entering "strenous" contact sports such as boxing, football, karate, etc. This is probably for the blade cut flap, though.
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Re:Grinding your eyeball?
From the article you cite: 12,000 ulcers / 24 million wearers = 1 per 2000
Lasik has several risks, but just counting flap complication rates = (0.1-0.5%) = 1 per 200-1000, which doesn't include some of the other side effects mentioned by the FDA. -
Re:Be careful!
ok
.. i started looking under "bullshit"
this is great.. i would have loved to been there when this was created
http://www.fda.gov/ohrms/dockets/dockets/05n0345/0 5N-0345-EC872.htm -
Re:I'm a college student AND work in a pharmacy21 USC 13. Controlled Substances Act.
Section 812(b). Schedules of Controlled Substances.
Except where control is required by United States obligations under an international treaty, convention, or protocol, in effect on October 27, 1970, and except in the case of an immediate precursor, a drug or other substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such drug or other substance. The findings required for each of the schedules are as follows:
(2) Schedule II. -
* (A) The drug or other substance has a high potential for abuse.
* (B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
* (C) Abuse of the drug or other substances may lead to severe psychological or physical dependence.
Source: http://www.fda.gov/opacom/laws/cntrlsub/ctlsbtoc.h tm
Actually, the only mention of "Narcotic Drug" is under the definition of Schedule III. Oh, and anabolic steroids are scheduled, under Schedule III.
I'm a Human Development and Family Studies major. A bachelor's degree lands me a job in social work, but that's not why I'm in the major. I'm doing it for pre-law. My parents both work in the same field. You should know this, but the people who make laws don't know shit when it comes to the not-so-well-off in society. And when it comes to drug laws, the entire system was built on racism and is perpetuated on moneymaking. I firmly agree with you, these drugs, especially ones like Adderall, are very addictive, and very, very dangerous, and should not be taken without perscription - and trust me, I've seen first hand how drug addicts turn out, but whoever told you that these were /narcotics/ is just perpetuating the drug war, and trying to undo the lies is something I'm rather passionate about. -
Even better than the real thing?
[F]rom the look of the videos these things are too scary to ever be allowed into hospitals.
Yeah, cause robot worms are way scarier than these things. -
Re:Unexplained phenomenons
While you happily play with words like parent poster were a paranoid, anybody else can read interesting stuff like:
However, nearly all fish and shellfish contain traces of mercury. For most people, the risk from mercury by eating fish and shellfish is not a health concern. Yet, some fish and shellfish contain higher levels of mercury that may harm an unborn baby or young child's developing nervous system. The risks from mercury in fish and shellfish depend on the amount of fish and shellfish eaten and the levels of mercury in the fish and shellfish. Therefore, the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) are advising women who may become pregnant, pregnant women, nursing mothers, and young children to avoid some types of fish and eat fish and shellfish that are lower in mercury.
(source) -
Re:Are they kidding?
What logical relationship exists between a giant, inept and incompetent beaurocracy that tries to regulate foods and drugs, and nano-tech, which is mostly tech related?
The FDA regulates (see their homepage) things marketted to treat and to prevent disease, generally, including both drugs and (though its not part of the name) non-drug biological products and medical devices (they also regulate food -- obviously -- cosmetics, animal feed and veterinary drugs, and radiation-emitting devices.) Nanotech is sometimes currently and quite likely more in the future applied to prevent and treat disease, and to that extent comes under the FDA's scope of responsibility, as either a "drug" or a "medical device", depending on how you look at it. Expanding their brief to explicitly include nanotechnology designed for use on or in the human body would make a lot of sense even if it isn't, per se, a "drug" or "medical device". -
Re:Cause and Effect?