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The social concious thing may still be somethign they're doing, but the dedication to putting out the most "healthy" (in terms of lack of artificial additives and ingredients) ice cream around has definitely dropped off. Every single B&J pint used to have All Natural printed on it, and it was true. Now, some of the flavors include partially hydrogenated vegetable oils and high fructose corn syrup (i'm thinking of "Makin' Whoopie Pie" in particular, though other examples exist) and have lost the All Natural label.

Somewhat ironic, given Ben and Jerry's removal of paper bleeched with Dioxins(one of the most dangerous-to-your-health chemicals currently produced, if you believe the hype) from from their products, that they would chose to include chemicals that have been strongly linked to health problems.

Also somewhat ironic: Bryers ice cream, which is also owned by Unilever but not known for it's humanitarian efforts, produces (as far as i have seen) only all natural ice cream.

Don't put too much stock into the socially conscious stuff, it's still about making money.

• Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling
• Gender, Ethnicity, and Clinical Trials.

• Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling
• Gender, Ethnicity, and Clinical Trials.

• Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling
• Gender, Ethnicity, and Clinical Trials.

This link was commented out of the article. It may be interesting to /. readers. It's about the FDA of 1906.

Be careful trying to use what you design in the USA. Some software is classified as a medical device in the US and needs FDA approval before it can be used. Outside USA, other countries have their own approval procedures.

No, it [nuclear power] is not safe

Nothing is completely safe. Thing is, the alternatives - the real, viable alternatives -- to nuclear power are even less safe.

You may recall the recent FDA advisory warning pregnant women and children to limit their intake of several types of fish because of mercury contamination in those fish.

The FDA guidelines call for children and pregnant women -- and women who "may become pregnant" to abstain completely from shark, swordfish, king mackerel, or tilefish, and to limit intake to six onces of albacore tuna a week.

What you might not have heard is that the panel that made the recommendation contained two members who were former lobbyists for the fishing industry -- or that another member, a scientist, not a lobbyist, resigned in protest because he believes that even six onces a week of albacore tuna is dangerous, and that that recommendation was only made because of industry lobbying.

What you also might not have heard is that the primary source of mercury in fish is from "mercury rain" -- and the primary source of mercury rain is from coal fired power plants .

As it happens, the EPA is retreating from plans to more closely regulate mercury pollution from power plants, and "just coincidently" some of the language justifying that retreat is word-for-word the same as language in utility company memos.

So on the one hand, the fishing industry influences the FDA to soft-pedal its warnings to children and pregnant women, and on the other hand the power industry gets the EPA to continue to allow pollution.

And this is not to mention the other dangers of coal: despoiling the environment by digging it up, despoiling the air with smog when it's burnt, giving miners black-lung, etc.

I grew up a few miles from Three Mile Island, and I was still there when the accident happened, and I'll take clean nuclear power any day. Even in the worst case, we can contain a nuclear plant accident -- but we can't contain an ocean of mercury contaminated fish.

Antibiotics are being over-used in home products (and also in factory farm livestock feed). The problem is that the antibiotics in, say, hand soap, really don't do anything to further protect you from germs. In fact, then tend to breed germs populations that become resistant from exposure. If this is kept up, we might face 'super germs' in the future that are resistant to all of our antibiotics.

Of course, I'm not blaming you personally. The industry needs to stop adding antibiotics to household soaps.

Exactly - except it's not should, it's must. 21 CFR Part 11.10 mandates this.

What you can (and probably should) do is to regulate its use in any of these fields as that field seees fit (or not regulate at all, as the case may be). When it is to be used in medicine, regulate it as a medical technology.

What you can (and probably should) do is to regulate its use in any of these fields as that field seees fit (or not regulate at all, as the case may be). When it is to be used in medicine, regulate it as a medical technology.

As many of you know cellphones, and other wireless handheld hardware emits RF radiation at low levels. Since I am considering using a cellphone as my primary phone line (as in not paying for a land line), I realised that the use of cellphones in this manner is quite new (within the last 10 years lets say). I can't help but wonder if this will pose a health risk in the long term.

A recent study just published by Popular Science magazine found a "link between microwave radiation emitted by GSM mobile phones (the most common type worldwide) and brain damage in rats". Even "hands free" sets that you can buy for cellphones are believed to worsen the levels of cell phone radiation in the brain. Even the FDA website says that "There is no proof that wireless phones are absolutely safe". Most people ignore these risks because nobody is dying from cell phone use today, but could this cause a health disaster in the future? I am sure many slashdotters are quite attached to their cellphones, what do you think about this risk?

A counterindication for having a MRI scan done is having a tattoo. Obviously, people with tattoos are more likely to be of a subversive persuasion so it makes good sense for the government to infiltrate tattoo parlors... ...or could it just be that magnetic dye particles are conductive and therefore heat in a rapidly varying magnetic field?

Advanced Botanicals Inc's contact page can be found here. They're listed on this page as having different products refused entry to the US for false labelling.

Advanced Botanicals Inc's contact page can be found here. They're listed on this page as having different products refused entry to the US for false labelling.

I am very sensitive to aspartame, if I absentmindedly accept a sugarless mint or gum from someone, I'll suffer a severe migraine wich renders me totally incapable of doing anything for hours. Safe my ass...

i'd be pissed that the supermarket didn't bother to do some basic research on the whole bse thang.

it's all in the fda faq on bse. especially these gems:

all the organs in which infectious prions occur were removed at slaughter and did not enter the food supply. Muscle meat is not a source of infectious prions....None of this material left the control of the companies and entered commercial distribution.

you know how many cases of bse have been identified in humans? 155. worldwide. you know how many of those were in the united states? one. and you know how that woman got vcjd (human bse)? by eating organ meat... in britain.

we'd save more lives if the ama decided to call everyone on their membership list to tell them not to drive.

can you believe that me, the raging vegan, is saying this? what's this world coming to...

Thimerosal was proven safe *before* it was approved for use in vaccines. In multiple studies.

Studies on the Safety and Effectiveness of Thimerosal

Oh, and, what money? The whole reason pharma companies don't like making vaccines (besides getting sued for bogus reasons) is that vaccines don't make money. By definition they have to be cheap, or else they won't be used. By preference, pharma would rather specialize in chronic diseases of rich people.

by stating the drug's name but not what it was used for, the ads were exempt from a Food and Drug Administration regulation that generally requires prescription drug advertisements to disclose the risks of the medication as well as its benefits. From the drug companies' perspective, it was impractical to include detailed risk information in a 30- or 60-second TV spot.

by stating the drug's name but not what it was used for, the ads were exempt from a Food and Drug Administration regulation that generally requires prescription drug advertisements to disclose the risks of the medication as well as its benefits. From the drug companies' perspective, it was impractical to include detailed risk information in a 30- or 60-second TV spot.

Actually, drinking water is regulated by the EPA, not the FDA as you stated. And indeed, bottled water companies are required to submit to FDA regulations.

Of course, what do you expect from an Anonymous Coward? :)

FYI: Bottled Water Regulation and the FDA

I don't understand why I should have the right to be not knowable if my DNA shows up at a crime scene unless I have been previously *convicted* of a felony. By this argument, we want to make sure that those who are committing their first felony cannot be found via DNA. What is the advantage to society that we be unable to find first-time felons, or tenth-time felons who managed to plea bargain down to a non-felony each time they commit a felony?

The answer is easy to understand, but so much easier to overlook. If your DNA is in the database, then anyone who wants to commit a crime against any of your acquaintances, or frame you for whatever reason, has only to obtain the smallest sample of your DNA (e.g. from a kleenex or napkin in your trash), use an easily available PCR kit to amplify it, add the DNA to some of your type of whole blood with leukocytes removed, sprinkle a few drops at the crime scene, and presto! you're in jail on incontrovertable evidence.

But it's not incontrovertable if the process of faking your blood with PCRed DNA is so easy, is it? Well, that's missing the point. The likelyhood that anyone would actually do this sort of thing (if they haven't already) is strongly correlated with the proportion of the population cataloged in a database. If everyone is cataloged, then everyone's friend is cataloged, and everyone's enemy is cataloged. So no criminal is then precluded from establishing this nearly perfect diversion.

In short, the larger proportion of people in the cops database, the more useless the database becomes. As soon as one DNA forgery is discovered, there goes the "beyond a reasonable doubt" standard in every subsequent case.

asbestos manufacturers who made products prior to the research on its link to lung cancer should not have been responsible beyond product recalls. Thalidomide and phen/fen were obviously intended for ingestion and in fact they made it through FDA trials so you can't say the blame lies solely at the feet of their inventors. In the case of Phen/fen it was not the manufacturers fault at all but the physicians who wrote prescriptions for their combined long term use despite the fact that one of the drugs was labeled and tested as a short term solution. For more info see This FDA link.

Because tropical aquarium fish are not used for food purposes...

is strictly regulated by the FDA. Not only is a software company required by law to obtain premarket approval 510(k) from the FDA before marketing certain types of medical software in the US, but it is also required by law to document and follow a very thorough software development and validation process.

Although this kind of software is usually not sold to the general public, it is used every day in hospitals and clinics to do everything from analyzing bacterial infections to robotic surgery to radiation oncology treatment planning.

I have worked for several software companies, developing software that is considered a class II medical device. Not only did we have to completely document everything from requirements to validation testing, but we had to keep the documents themselves under version control! Knowing that your software could mean life or death to someone, really puts the software engineering process into perspective.

is strictly regulated by the FDA. Not only is a software company required by law to obtain premarket approval 510(k) from the FDA before marketing certain types of medical software in the US, but it is also required by law to document and follow a very thorough software development and validation process.

Although this kind of software is usually not sold to the general public, it is used every day in hospitals and clinics to do everything from analyzing bacterial infections to robotic surgery to radiation oncology treatment planning.

I have worked for several software companies, developing software that is considered a class II medical device. Not only did we have to completely document everything from requirements to validation testing, but we had to keep the documents themselves under version control! Knowing that your software could mean life or death to someone, really puts the software engineering process into perspective.

is strictly regulated by the FDA. Not only is a software company required by law to obtain premarket approval 510(k) from the FDA before marketing certain types of medical software in the US, but it is also required by law to document and follow a very thorough software development and validation process.

Although this kind of software is usually not sold to the general public, it is used every day in hospitals and clinics to do everything from analyzing bacterial infections to robotic surgery to radiation oncology treatment planning.

I have worked for several software companies, developing software that is considered a class II medical device. Not only did we have to completely document everything from requirements to validation testing, but we had to keep the documents themselves under version control! Knowing that your software could mean life or death to someone, really puts the software engineering process into perspective.

is strictly regulated by the FDA. Not only is a software company required by law to obtain premarket approval 510(k) from the FDA before marketing certain types of medical software in the US, but it is also required by law to document and follow a very thorough software development and validation process.

Although this kind of software is usually not sold to the general public, it is used every day in hospitals and clinics to do everything from analyzing bacterial infections to robotic surgery to radiation oncology treatment planning.

I have worked for several software companies, developing software that is considered a class II medical device. Not only did we have to completely document everything from requirements to validation testing, but we had to keep the documents themselves under version control! Knowing that your software could mean life or death to someone, really puts the software engineering process into perspective.

Anyhow, tetrodotoxin fascinated me then, and it does now. Maybe someday I'll be in Japan and actually get to try Fugu and have a first hand experience with a light consumption of tetrodotoxin.

It's a neurotoxin, just like Asparthame (Nutra-Sweet), only more people are affected by MSG than Asparthame.

I call Shenannigans! Shenannigans!

The whole bit about Aspartame being a neurotoxin is an internet urban legend. It has absolutely no basis in science. In particular, the claim about methanol poisoning from digesting the stuff is just wrongheaded since you get far more from drinking an equivalent amount of fruit juice or beer.

Furthermore, the G in MSG is glutamate, an amino acid and is pretty safe. This is the component that people claim is a neurotoxin. It is true that glutamate can do nerve damage in high doses, but consuming MSG in food will not bring blood glutamate levels that high. You get a good amount of the amino acid from just breaking down proteins from plant and animal sources in the body. By the way, the reason that MSG works as a "flavor enhancer" is because the tongue actually has a fifth chemical receptor beyond those of salty, sweet, sour, and bitter -- one that bonds to glutamate.

it's not necessarily different by country... it even varies by state. My state, for instance, just passed malpractice caps on noneconomic damages... and even despite that, I'm in the process of losing my malpractice insurance (despite having NO claims against me). They are dropping me like a bad habit, and if I want to stayed insured, it's going to cost me double what it was before (that's if I can even get insured).

Most of these unlabeled uses of drugs/viruses/devices are done under compassionate use protocols of one type or another. There is also "emergency use," which can even be done before clinical trials... try this link for some more info.

Even so, you should read the fine print. Even for emergency use, you still have to consult your IRB (that's "institutional review board" for you non-medical folks... they can veto what you want to do), and at least one other physician before submitting the paperwork... and who knows how long before your approval comes back? I've not personally submitted one of these (I am not an oncologist), so I won't speculate on the time frame, though I'd hope they would bypass the usual beauracratic delays.

Adherence was poor and attrition was high in both groups

This seems to be the biggest problem to me, besides the "long term studies are required" bit. Most popular diet plans will lose you weight if you stick with them -- the trouble is hardly anyone does (95% failure rate, according to the FDA). They're not ineffective; they're just really unpleasant and difficult to be on.

So if you're feeling lucky, and don't really like food (though I'm not sure how you got fat then), give one of these a shot. Otherwise you might want to try a system that acknowledges this grim statistic and targets the real culprit: not your belly, but your mind.

"we will have cameras in our breakfast cereals before long"

That Has already been done.

So why won't doctor's help short people grow?

They do. The US FDA has just approved a big expansion of the range of heights considered appropriate for growth hormone prescriptions.

Well, actually, Micro$oft wouldn't exactly cure cancer, they'd put it into remission for two or three years. You'd have to purchase new and "improved" treatments each time it came out of remission, in order to live for a few more years.

Well, actually, Micro$oft wouldn't exactly cure cancer, they'd put it into remission for two or three years. You'd have to purchase new and "improved" treatments each time it came out of remission, in order to live for a few more years.

Regulate food? Like in the former USSR and Eastern Bloc countries?

Now say employee John Foofxr decides he wants someone to pay him some serious moolah to have this drug approved.

That's awfully blatent, and would get old John a long vacation at club fed. That kind of thing just isn't going to happen.

THIS is how the ``bribes'' happen. If you are a high-level bureaucrat, you can have a little talk with the executives at a company whose new drug you are tasked with approving. You mention that you'll be retiring soon, perhaps in a year or so after you've concluded their case. They reply that they really need someone who's experienced with dealing with FDA bureaucrats, to act as liasion with the agency (or experienced at dealing with Congress, to lobby for them, or ...), and would be interested in hiring you. You reply that you will certainly contact them when you retire. No money ever changes hands, but if you really want that cushy job, you make sure their drug gets approved.

There are some very real problems, with the FDA and government agencies in general, and you've missed them all. Two examples:

A real problem is that the FDA bureaucrats have nothing to gain by approving a drug, but a great deal to lose. If an FDA bureaucrat approves a drug and it turns out to be another thalidomide, he's in BIG trouble. If he approves a drug, and it turns out to be a side-effect-free cure for cancer and the common cold, he gets absolutely nothing. Thus, the bureaucrats always want one more round of tests, and people die waiting for safe, effective medicines.

Another big problem is regulatory capture, a natural process in which the regulated and the regulator talk only to each other, and the regulator eventually winds up siding with the regulated. We see this in action in US government when industry insiders are appointed to head the watchdog agencies for their industries, and when upper-level bureaucrats retire from Civil Service to take very high paying, low stress jobs in the industry they regulated. The result is that the FDA protects the pharmacutical industry at least as effectively as it protects us.

One example of how the FDA protects the industry is their enforcement of monopolies. No drug can go to market unless it is patented, because no drug can go to market unless someone has spent tens of millions getting the FDA's blessing. If someone were to find that an unpatentable combination of eye of newt, hair of bat and toe of frog cured cancer, the FDA would never approve it, since no company would fund the tests. Doctors would never hear about it from the drug company salesmen, so most of them would continue prescribing the current slash-and-burn therapies, which are sometimes worse than the disease. This hypothetical free, safe and effective therapy would never become available to most Americans, even if the research were published in JAMA and Lancet.

With respect to such products, protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labeled, and; public health and safety are protected from electronic product radiation.

Perhaps the real question should be: why is the agency named the FDA instead of being given a broader name that more accurately reflects its mission?

No, it is not "hard" per se, if we're talking about devices. There may be a million and one requirements your device have to comply with, but there isn't much red tape.

Howto:

1. Go to the FDA and download the requirement specs for your device. Sometimes the specs point to other standards, e.g ISO standards, which you will have to find elsewhere.

2. Test your device according to the specs.

If you're to lazy or too much in a hurry to do 1 and 2, talk to an independent testing lab and they will help you from start to finish, for lots of $$$.

3 When you see that your device passes all requirements, send the results (aka premarket notification) to the FDA and 90 days later you can start marketing.

Muscat, J.E., et al., "Handheld cellular telephone use and risk of brain cancer", Journal of the American Medical Association, vol. 284, pp. 3001-7, 2000.

Inskip, P.D., et al., "Cellular-telephone use and brain tumors", New England Journal of Medecine, vol. 344, pp 79-86, 2001.

Johansen, C., et al., "Cellular telephones and cancer", Journal of the National Cancer Institute, vol. 93, pp 203-7, 2001.

There is a whole market niche in medicine for location tracking, which includes beds, patients, and equipment. If seen products based on RF, and the RFID things are just starting to influence these products.

I've also seen products based on IR, where there are sensors along the ceilings and the IR transmitters are on the tops of devices to be tracked.

FDA Guidlines

A Vendor group here

One vendor's explanation here

Or "Multidata"!

Deaths in Panama

Disclosure: I work for a manufacturer of treatment plan verification devices. It never hurts to actually ~check~ to see that the software is working as spec'ed.

You also can't buy a lot of other things in the USA. Granted, some of them I do not ever want.

What's really funny is that some standards for tap water are actually higher than those for bottled water. A different government agency (the FDA) oversees standards for bottled water than the one (the EPA) for tap water.

Very often bottled water is really just tap water, or worse. Just look at this article. Some bottled water is actually from very dangerous sources near industrial waste sites, and the FDA requires significantly less frequent testing for bottled water sources than does the EPA for tap water.

Some standards, though, like the maximum permissible amount of lead, are actually lower for tap water, but only by a miniscule amount: a difference of 10 parts per billion. If you're really nervous about that insignificant amount of lead, though, you can always get a Brita or Pür water filter to remove it, which is a hell of a lot cheaper than buying water by the bottle (refer again to FDA article for that).

There is also the consideration, though, that the minerals in mineral water make it taste better, not to mention make it possibly better for you, than probably the tap water of your region. But a lot of bottled water, like the Coca-cola company's Dasani, ain't mineral water ("Ingredients: water, magnesium sulfate, potassium chloride, salt"). Be sure about the significance, or lack thereof, to your health of what you're buying. I think that for most intents and purposes bottled waters by varying degrees are scams, and for that matter so are sodas, at the prices we get charged.

Imagine, there was a time in the USA before the FDA even existed (1930 to be exact). More recently, there was a time when medicine was a private industry in the USA, and people didn't give a rats ass about getting the government's approval for medical devices (1966).

Somehow, in 37 years out of the 227 years this country has existed, the nation now thinks that medical advances can only exist after a lengthy approval process, complete with beurocratic red tape, medicare approval, and gov overhead.

Yes, the government oversees the distribution and purity of drugs, the quality of foodstuffs, and qualifications of our doctors. All that is fine and good. But why have we let ourselves be roped into holding back life-altering discoveries that work just because it doesn't have some commission's stamp on it?

Your information would be more credible if you knew how to spell the word site.

Perhaps.
However, my error makes the statement no less true.
To make up for my apparent lack of credibility, let me refer you to the following for more information: http://www.fda.gov/cdrh/devadvice/3122.html

Also, as a side note, I work for a very large medical diagnostics company.

-jerdenn

I know it's a troll but...

Unless, of course, the aforesaid activist would like to volunteer for stage 1 drug testing... no? Didn't think so.

A bit of a straw man argument against human trials. Plenty of sick people volunteer to test potential cures.

At any rate, animal testing is far from perfect. Animal testing didn't reveal any negative side effects in the case of thalidomide, so the real testing happened on the human consumer. The kicker was that the pharmaceutical company was able to avoid paying damages, on the grounds that their product had been animal tested.

Regardless of what you think of the morality of animal testing, animals are not biochemically identical to humans (which is why you can't feed a dog chocolate but you can feed a goat arsenic). Animal testing of itself is no substitute for a human clinical trial.

(As a bizarre aside to all this, the fda has approved thalidomide as a tretment for leprosy.)

Am I the only person who doesn't use a Cell Phone these days? Would you hold the back of a TV set to the side of your head?

Not unless you are into radiation therapy.

Granted X-rays are higher energy waves than cell phones, but that stuff adds up.

Anyways, incidences of CJD are 1 in 1 million, so don't worry about it anyways. You're much more likely to die from exiting your home. :)

That and I do still think that by being selective about your meat you can avoid mad cow disease or anything similar. Up to now the FDA hasn't found a single case of Mad Cow Disease in any tested cows in the US (AFAIK).