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I wasn't trying to trap you, but by your response maybe I did?

Since we're trading silly insults, I've heard some surgeons don't really like any hint they might be wrong, about anything, even if its just a silly mistake or outside their field of expertise.

For your information (or rather for someone else reading this who is actually interested), Da Vinci appears to be fully FDA certified, NOT as a research device, for some procedures since 2000 or 2001. I believe they have been certified for some endoscopic cardiac procedures as well. Yes, here's an FDA press release about approval of the device for coronary artery bypass surgery: http://www.fda.gov/bbs/topics/answers/2004/ANS01298.html. (from 2004)

501(k) applications and decisions are here.

From the company's site, listing procedures for which the robot is certified: http://www.intuitivesurgical.com/products/fdaclearance/index.aspx.

The problem is the mercury -- enough in one bulb to contaminate 1,000 gallons of water, even in newer low-mercury bulbs.

The number on another scaremongering article was 6,000.

Either way...

There's a gaping flaw in the logic that if you count PPM for a safe dose, look at the volume, then multiply up. It assumes the mercury is even close to equally disolved in that water.

If a drop, the volume of which is found in a typical CFL, dropped in to a thousand gallons of water and sank to the bottom, whilst I wouldn't happily do so, I'd still be willing to drink a glass from off to the side of where that drop went in. A little more nervously, I'd still be willing to do so a few weeks later, assuming the drop was still largely intact at the bottom.

On the flip side, let that drop sink in to a million gallons of water, thus apparently a thousand times under the "safe dose"... and I challenge anyone to be willing to drink the cupfull taken from where the drop sank, original drop included.

Yes, mercury is bad for you. It turns you in to a character in Alice In Wonderland.

On the other hand, we're druming up fear by pointing to a perfect distribution and the safe level (accepting that safe levels are usually many times lower than the point at which harm is a likelihood that's why they're called "safe" not "minimal risk" levels).

If you're going to get your panties in a bunch about that, you'd better not each fish (particularly swordfish, shark, smallmouth bass and pickerel). With an FDA "safe for human consumption" of 1ppm, shark ranged 0.30-3.53ppm in samples tested, averaging 0.88ppm and swordfish at 0.36-1.68ppm, averaging at 0.88 (FDA).

By comparison, the mercury maybe getting out of a bulb, disolved properly in to ground water, getting in to the water supply and failing to get filtered past the safe level is somewhat less of a risk than the statistical variance that means you'll almost certainly clear the safe levels in at least one case if you have a nice swordfish steak half a dozen times at your favorite restaurant.

Neither is likely to do you much harm. In both cases, getting in to your car and driving to work is a vastly greater risk, yet it puts the silliness of the debate in context when simply eating fish is far worse for you (on that one very limited axis).

This may be a more common problem than you suspect, and not merely as the result of mutation (most mutations kill or otherwise negatively affect the mutated organism).

http://www.fda.gov/Fdac/features/2000/500_gene.html

What's the relevance? The article is about virus therapy, the FDA link is about gene therapy? Gene therapy is generally delivered through the use of modified viruses. (Virii? A pox on you, I say!)

I remember hearing about the Pennsylvania case when it happened, as it sent shockwaves through medical research in the US, whether or not you were involved in gene therapy, or even human trials at all.
Apparently what happened to this particular boy was that they attempted to introduce corrected genes to overwrite his own mutation. They chose a human cold virus as the vector, and injected it into his liver. The result? Acute liver failure. The researcher in charge had been underreporting adverse events. I believe 6 other medical centers had their research closely scrutinized, as they were part of his study. I don't recall any pertinent details though.

That said, one of the things about medical research, or medical treatments in general, is to weigh the benefits of therapy to the risks. For research in particular, the research subject generally bears much more risk, and society stands to benefit more from the research than the subject does.

I echo your sentiments. In the case of aggressive, inoperable brain cancer, I suspect that high risk procedures such as this may be worth pursuing. (With proper informed consent, and proper human research safeguards in place of course!)

This may be a more common problem than you suspect, and not merely as the result of mutation (most mutations kill or otherwise negatively affect the mutated organism).

http://www.fda.gov/Fdac/features/2000/500_gene.html

What's the relevance? The article is about virus therapy, the FDA link is about gene therapy? Gene therapy is generally delivered through the use of modified viruses. (Virii? A pox on you, I say!)

I remember hearing about the Pennsylvania case when it happened, as it sent shockwaves through medical research in the US, whether or not you were involved in gene therapy, or even human trials at all.
Apparently what happened to this particular boy was that they attempted to introduce corrected genes to overwrite his own mutation. They chose a human cold virus as the vector, and injected it into his liver. The result? Acute liver failure. The researcher in charge had been underreporting adverse events. I believe 6 other medical centers had their research closely scrutinized, as they were part of his study. I don't recall any pertinent details though.

That said, one of the things about medical research, or medical treatments in general, is to weigh the benefits of therapy to the risks. For research in particular, the research subject generally bears much more risk, and society stands to benefit more from the research than the subject does.

I echo your sentiments. In the case of aggressive, inoperable brain cancer, I suspect that high risk procedures such as this may be worth pursuing. (With proper informed consent, and proper human research safeguards in place of course!)

16. What about a sample size package containing only 1-2 pills of pseudoephedrine like those often sold at gas stations or grocery stores?

The Act exempts the requirements of a "logbook" to any purchase by an individual of a single sales package if that package contains not more than 60 milligrams of pseudoephedrine. These single dose packages have to remain behind the counter.

Even in the case where the dosage forms are the same, the vet ones are often quite a bit more. As for drug prices, while the expensive drugs (say, $100/mo) are a lot cheaper in Canada, the generics usually aren't less expensive. This FDA paper claims that they're much higher, then conveniently omits that most of them are pretty cheap either way.

Yes, he is. Read your link. It may be on the FDA's web site, but it lists the responsibilities and powers granted to the Secretary of Agriculture, who is the head of the Department of Agriculture, not the Food and Drug Administration (which is an agency in the Department of Health and Human Services, led by the Secretary of Health and Human Services).

No, I have no idea why the FDA has law that doesn't concern them on their web site.

No he isn't.

http://www.pharmalot.com/2007/11/chantix-and-suicidal-behavior-the-numbers-please/
http://www.fda.gov/cder/drug/early_comm/varenicline.htm

Medical Device manufacturers, or their proxy, DO fully validate closed source software that is used in critical medical devices.

Well, you have failed to come up with any reasonable argument for why that should be cheaper for COTS than for open source software. The only reason it would be cheaper is if COTS is audited less thoroughly.

Just because random joe blow on the Internet doesn't get to browse through a codebase doesn't render it automatically suspect.

Of course, I'm assuming that the people doing the validation have access to the COTS code under NDAs. That's not the point. In fact, source code access, while necessary, is essentially meaningless by itself for validation. Do you seriously think that looking at a few million lines of production C code lets you say anything about whether the software is suitable for use in critical environments?

What renders COTS automatically suspect is that you don't get access to all the development metadata. In fact, in many cases, you can't even control or even verify whether the software you are running is the software you audited.

You're also misrepresenting the FDA software validation guidelines by trying to pretend that FDA software validation amounts to an analysis of the source code; that is not what the guidelines require.

There's nothing at all fraudulent about any of it.

There is something fraudulent about deliberately choosing a category of software that companies know that they have less information on and thereby lets them save money on the validation process. And hopefully, sooner or later, some smart lawyers are going to get big settlements against companies that do that.

I work for a manufacturer in the pharmaceutical industry and I hear people say things like Linux and/or Open Source is a problem with the FDA, but I haven't seen anything yet to back that up. Period.

To "validate" software with the FDA, you really only need to do three things:

1) Make your software/system/device secure
2) Have control over the system
3) Document #1 and #2

There are people who come from an old guard that have all sorts of misconceptions about what can and can't pass FDA regulations. It seems to stem from a gross misunderstanding of what the regulations actually say.

I've read the portions that deal with computers and electronic information. There is absolutely nothing in it to suggest open source even remotely is an issue. I suspect this is an urban legend started by companies selling proprietary software.

Regardless, the regulations (Part 11) are the FDA Bible and so long as you can satisfy the requirements in them which basically boil down to the three I listed above, then you are in compliance.

To convince yourself this is true, read this.

Hello,

I've been involved in the design and implementation of a few medical and bio-medical instruments.

All software used in medical instruments submitted to the FDA, whether commercial-off-the-shelf (COTS), OSS, proprietary or otherwise must be validated for use in the instrument. This usually includes extensive documented testing.

COTS software is usually considered easier to validate for a variety of reasons : if it is a largely used piece of software (say Excel), it is likely its usage in other medical instruments has been validated before. This validation procedure can ususally be reused. Also third party companies or entities can provide the validation. It comes out cheaper for integrators to pay a relatively cheap validation fee to such companies rather than go through the validating themselves. As well, COTS software does not change too often, and integrators are not desktop users: they are happy to use an old, validated piece of software for a long time. Finally, only black-box testing is sufficient, since FDA understands that, say Microsoft, will not as a rule divulge trade secrets like source code to mere medical instruments companies.

In contrast, OSS varies a lot and often. Each version is different for the FDA, and must be validated separately. Since the source is available, black-box testing may not be seen as sufficient by the FDA. OSS is often seen the same as in-house developed software. When used, OSS comes in often in the shape of libraries and very tightly integrated to the rest of the special-purpose software. Indeed FDA does not have a special category for OSS, whereas it does for COTS.

The killer is that while it is possible for a medical instrument company to set up its software development business so that it can meet FDA standards, it has no power over third party OSS. As a result, OSS is used extremely sparingly, if at all. So it's not prejudice against OSS, it's history. FDA has to be somewhat lenient with respect to COTS, because otherwise instruments would cost too much do design if everyone had to reinvent the spreadsheet and validate it.

Many more details here.

How does 118 parts per billion relate to .2mg/kg?

I think you're mistaken about the 5mw limit. Lasers more powerful than IIIa are indeed available for sale. AFAICT, they just have more strongly worded warning labels on them.
I didn't say they weren't available for sale. I just said they weren't available for unrestricted over the counter sale. "Class IIIb and class IV laser light show projectors may be sold only by or to individuals or firms that have obtained approval from the FDA." Anything over 5 mW is IIIb or higher. Protective eyewear is typically required where direct viewing of a class 3B laser beam may occur. Class-3B lasers must be equipped with a key switch and a safety interlock.

May I direct you to g oo g l e. Or even checking thinkgeek which was discussed earlier in the thread.
Note that the links google turns up for 100 W lasers are not things you can just buy by mail order. It is interesting that ThinkGeek is selling 10 mW lasers, which presumably would be IIIb, to individuals who don't have any special FDA approval. Unless the regulations have changed since the FDA put up that web page in 2005, I don't see how that can be legal.

... and when they did so, the FDA didn't much approve of their over-the-top marketing (for Cocaine.) I wonder if they can get them riled up twice in a row?

http://www.fda.gov/foi/warning_letters/b6312d.htm

I'm reading the FDA's Article on Thimerosal and it's a little mixed.

"Thimerosal is a preservative that has been used in some vaccines since the 1930's, when it was first introduced by Eli Lilly Company. It is 49.6% mercury by weight and is metabolized or degraded into ethylmercury and thiosalicylate."

"Methylmercury is a neurotoxin."

"As part of the FDAMA review, the FDA evaluated the amount of mercury an infant might receive in the form of ethylmercury from vaccines under the U.S. recommended childhood immunization schedule and compared these levels with existing guidelines for exposure to methylmercury, as there are no existing guidelines for ethylmercury, the metabolite of thimerosal. At the time of this review in 1999, the maximum cumulative exposure to mercury from vaccines in the recommended childhood immunization schedule was within acceptable limits for the methylmercury exposure guidelines set by FDA, ATSDR, and WHO. However, depending on the vaccine formulations used and the weight of the infant, some infants could have been exposed to cumulative levels of mercury during the first six months of life that exceeded EPA recommended guidelines for safe intake of methylmercury."

They think ethylmercury is likely safer than methylmercury.

"Infants excreted significant amounts of mercury in stool after thimerosal exposure, thus removing mercury from their bodies."

"FDA is continuing its efforts toward reducing or removing thimerosal from all existing vaccines."

So, mercury is bad, but they think people are OK with this level of mercury exposure. They believe it's enough of a risk that removing mercury from vaccines is a good idea.

Given that, I don't think it's fair to paint the anti-vaccination crowd

Not like you couldn't have done it. That's the entire point of an encyclopedia than anyone can edit.

That, or someone could add references between the time he complained about it and the time I read it ;) For instance, pacemakers: http://www.fda.gov/ora/inspect_ref/itg/itg42.html

Um, you're incorrect about this. RU-486 has been accepted in the U.S. since 2000.

One important feature of the FDA's policy is that we will regulate proteins (or other added substances such as fatty acids and carbohydrates) produced by genes, that have been intentionally added to food crops, as new food additives

and

In December, Monsanto Corp. applied to the U.S. Environmental Protection Agency (EPA) for approval to field-test and sell a new line of modified corn.

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.

It takes about 10 years to get FDA approval for a new drug. You have to do all this, complete with the appropriate complement of reports, lobbyists, and lawyers, before you can even start to sell your drug.

Indeed, if only the FDA had some sort of accelerated approval method...

Acually, if you actually RTFA, it raises exactly the same problems you write about, so I'm curious how you could call it moronic without, you know, calling yourself a moron ;)

That said, I still have to wonder about some tradeoffs. Essentially, the way I read the article:

1. A lot (if not most) of the increasing risk was in the name of cutting costs as such, or cost per capacity. E.g., the original Cobalt, which was expensive but apparently safe, got then replaced with Nickel, then with even cheaper Nickel-Manganese alloy. I'm not sure how that can be a problem, but _something_ (this or something else) along the way apparently turned a safe battery design into a potential time bomb.

2. (Or maybe 1a.) They seem to be blaming the factory in China where everyone outsourced the actual manufacturing to. Again in the name of cutting costs. Maybe it's just blame-shifting and finger pointing, but it raises a valid theoretical concern. It's not easy to know, once a battery is assembled and sealed, what really is inside. If, theoretically, they shafted you for an extra buck, how would you know? You can put all sorts of checks in place in your own factory, but once you've outsourced it, it's out of your control.

It even gives you an example of what can go wrong in that scenario. If the separating membrane doesn't soften and collapse at a given temperature, the battery essentially just lost the designed protection against catching fire. What if someone replaces that foil with something cheaper, but which doesn't work that way?

3. (Or maybe 1b.) Apparently at least one batch is suspected to have been manufactured with counterfeit materials. I have to wonder if this wasn't just because they were cheaper. I.e., cost cutting again.

4. Not cost cutting, but competitive advantage again, apparently some laptop manufacturers recharge their batteries more "aggressively" (read: exceed the rated recharge current) so they can get a minor competitive edge there. It apparently (according to TFA) causes the battery to vibrate, and might cause particles to impale the membrane and shortcircuit the battery.

So while I'm not against capitalism or anything, it makes me, you know, wonder. Maybe the drive to cut costs can be taken to dangerous extremes? Just a thought.

Yes, it should fix itself, companies would in an ideal world avoid loss of reputation due to faulty products, etc. But sometimes it's too late. E.g., it's already suspected that a plane crash was due to a laptop igniting in the hold. E.g, an even worse case was when in 1937 a pharma company offered a liquid antibiotic where the actual antibiotic wasn't solluble in water, but someone found out it was solluble in diethylene glycol, a deadly poison. It was what prompted the FDA to mandate extensive testing for medicine. (And speaking of diethylene glycol, it seems to keep reappearing recently in Chinese-manufactured toothpaste. No doubt because it's cheaper than something less toxic.) Etc.

Do I have a solution? Nope. It makes me wonder, though.

At least it would help revent the spread of ignorance and superstition ...

While it is true that some viruses can pass through latex condoms (and a LOT can pass through "natural skin" condoms), a condom does help prevent the spread of AIDS, etc.

http://www.fda.gov/oashi/aids/condom.html

Condoms are not 100% safe, but if used properly, will reduce the risk of sexually transmitted diseases, including AIDS. Protecting yourself against the AIDS virus is of special concern becuase this disease is fatal and has no cure.

About two-thirds of the people with AIDS in the United States got the disease during sexual intercourse with an infected partner. Experts believe that many of these people could have avoided the disease by using condoms.

Condoms are used for both birth control and reducing the risk of disease. That's why some people think that other forms of birth control -- such as the IUD, diaphragm, cervical cap or pill -- will protect them against diseases, too. But that's not true. So if you use any other form of birth control, you still need a condom in addition to reduce the risk of getting sexually transmitted diseases.

A condom is especially important when an uninfected pregnant woman has sex, because it can also help protect her and her unborn child from a sexually transmitted disease.

Note well: Condoms are not 100% safe, but if used properly, will reduce the risk of sexually transmitted diseases, including AIDS.

"I don't disagree with you about the concept of screening healthy people, in most cases, it's a bad idea."

"But don't tell me somebody have been using CT for screening - was that in the US ?"

"I live in Denmark where there was a minor debate a couple of years ago regarding screening mid-aged women for brest cancer. Your exact argument was the primary reason a lot of doctors opposed the idea. But even if they use X-ray for screening it's nowhere near as risky as doing full body CT. And the primary proponent of the screening was suggesting Ultrasound as the screening technique - which makes sense since modern ultrasound is almost as accurate , and in some cases more accurate, than X-ray mammography."

Actual term is "substantially equivalent" when compared to a medical device that has been previously cleared for market. In this case there are two predicate devices, the Meditron Stethoscope System and the STG Monitor Multichannel Lung Sound Analysis System. FDA's 510(k)summary page is here - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfPMN/pmn.cfm?ID=21693 PDF of the summary is here - http://www.fda.gov/cdrh/pdf6/K061495.pdf

Actual term is "substantially equivalent" when compared to a medical device that has been previously cleared for market. In this case there are two predicate devices, the Meditron Stethoscope System and the STG Monitor Multichannel Lung Sound Analysis System. FDA's 510(k)summary page is here - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfPMN/pmn.cfm?ID=21693 PDF of the summary is here - http://www.fda.gov/cdrh/pdf6/K061495.pdf

Pharmaceuticals should be developed by government grants and the IP turned over to Public Domain. A list of the 20 worst ailments that *could* be treated with drugs should be created. Then, funding would go from the Federal Government to Universities willing to work on those problems.

This is already done to some extent. Universities receive grants from the NIH (as well as quite a bit from pharmaceutical companies) for basic research. However, this IP doesn't typically end up in the public domain. Also, there's the Orphan Drug Act in which the government funds pay for the development of drugs for unprofitable ailments (although, again, the IP doesn't end up in the public domain).

That said, I think your proposal is a good idea, whether the IP ends up in the public domain, or becomes patented by the Government and licensed to manufacturers for a reasonable fee (to at least partially offset the price to the taxpayer). There's no reason a more enlightened country couldn't take this approach and set up some sort of Crown corporation.

In fact, as an example of this, Cuba developed an anti-meningitis vaccine some time ago, and the US saw fit to overlook its little embargo thing to allow its use. Cuba's pharmaceutical industry has been quite successful, especially considering both the embargo and the relative funding to which they have access.

Of course, the original topic of the article was patent concerns, which is why I made my original comment. It's probably not the ideal situation to have untrained individuals manufacturing untested pharmaceuticals in their basements, but the statement was based on the current situation in which both patents and outrageous prices on pharmaceuticals are required to offset their development and regulatory costs.

It is really quite simiilar really, to software - the cost is all in development (although, these costs are much larger in pharmaceuticals), and the manufacturing cost is marginal (although somewhat higher in the case of synthetic pharmaceuticals, or much higher in the case of isolated agents like interferon). However, the type of work covered under software patents (algorithms) usually involves minimal development, the work that requires significant development (complete works) is covered under copyright. If the purpose of patents is to provide sufficient protection for the research to be profitable (and thus justify its occurrence), then it should be limited in scope to provide a reasonable return on investment for the type of patent being issued - perhaps a solution would be to issue patents for different times based on the invention being considered.

The UN Human Rights Declaration (UDHR) may be Western biased, but that's what we've got, even if it is somewhat toothless. As a reference point, it's better than nothing.

I see the merit in your point on democracy, yet I'd choose American style democracy over any flavour of monarchy from the Middle East on any day of the week (and I'm not American).

Is China 'Evil'? I don't know, but it does seem to be run by a bunch of assholes, IMHO. The Basic Law in Hong Kong is a joke. The Chinese government routinely tortures and imprisons people for their beliefs. Corruption is a way of life. Censorship is way over the top. Last year there was that video of Chinese army soldiers shooting Tibetan refugees in Nepal.

I recognize that I may be biased since the bastards tried to poison us the other month.

from 1990 until as recently as 2006. Here's a link This has to do with benzene formation in the actual can of soda from ascorbic acid and benz. acid reacting due to heat/light. They decided the amount was too small to cause harm. The importance of the finding is that it seems to imply that benzoic acid/benzene are BOTH safe in small amounts. Or if you want, that only benzene in small amounts is safe. This argument altogether skips a little known property of molecules such as benzene known as "nonpolarity". The nonpolar benzene in soft drinks may enter gastrointestinal cells, but won't get very far since it is not soluble in water/blood. The benzoic acid is very much like certain pharmaceutical drugs in that it can be delivered as a "prodrug" (a pre-drug before the cell converts it to the actual drug). Basically my point is that this issue can be skirted by industry who claim the benzene/benz acid health effect was already dealt with, when it has not.

Why does everyone assume that anything with the term plastic in it is non-degradable? Besides, it's not like doctors are allowed to just stick things in a person's body on a whim.

Take a step back from the knee-jerk, luddite reaction to technology and think for a second about what the article is talking about here: an emergency supply of blood that is easier to store, transport, and perhaps even acquire (cheaper than drawing blood?). Complications from a foreign substance in your body are pretty minor compared to dying from blood loss, and the kinds of places where transfusions are needed are not always well-suited to the storage of spare blood (like in a medic's fieldpack in 100+ degree heat in Falluja).

</rant>

It's likely they've thought of this and chosen their materials accordingly. Even if the body isn't able to dispose of the artificial hemoglobules itself, it's likely that they could be transfused out (or possibly simply bled out, since you noted that these probably don't denature and clot like platelets). Furthermore, adding stuff to the blood stream does not necessarily stop the body's natural blood production, and it's not like they're claiming their artificial blood is ready for use yet, anyway.

stated in the article, or any reference to this issue that I can find. Can you provide a cite to back that up? If it were true, the the title would be even more misleading, since it's not all iPods, but is all harddrives.

The article is misleading, yes, but it is not the magnet that's doing the interference. In 1995 cell phones were also found to interfere with pacemakers at the same range. This is not news, there are a number of devices that can interfere with pacemakers -- all patients with pacemakers already know this.

The danger of drugs, and the reason the FDA exists, is that nobody knows what new chemicals will do inside the human body until they've been tested. The most spectacular medical disasters aren't usually the result of malice, but ignorance -- insufficient testing. Clinical trials are the reason drugs cost insane amounts of money, and there's no other acceptable way to judge a drug's safety and efficacy than to actually use it in a controlled experiment with a large sample size.

The U.S. legislature was strongly opposed to regulating industry until the Elixir Sulfanilimide tragedy forced the issue. Sulfanilamide was a popular drug used to streptococcal infections in the first half of the 20th century. It worked, but it originally came as a pill or powder, which was distasteful to children. A well-respected drug company, S.E. Massengill, determined that a liquid form would be a popular with kids and southerners, so they tasked a chemist with creating the Elixir. The chemist, Harold Cole Watkins, dissolved the drug in diethylene glycol (normally an antifreeze), did some quick tests for aesthetics, including small amounts for taste, and sent the result straight to manufacturing. The time from concept to market was about 3 months.

Diethylene glycol is deadly poison in the amounts prescribed for the Elixir, and this detail wasn't noticed until the product had already been purchased, prescribed, and used by over a hundred people across the country. Massengill Inc. sent out letters to the various drug stores asking for the product to be returned, and then another round of letters specifying that the recall was urgent, at the FDA's behest. It was essentially the FDA's work to ensure that 100% of the product was recalled from stores.

Since the product was designed to be kid-friendly, most of the deaths were, of course, children. There was one more death, too: the chemist who had designed the Elixir committed suicide. Massengill Inc. asserted that they had followed regulations throughout the incident, and though the results were regrettable, Massengill could not be blamed for the disaster.

Two decades later, a German drug company created a sedative called Thalidomide. The FDA allowed a small clinical trial in the U.S. but never approved the drug for sale; however, the drug was approved in many other countries and was marketed to pregnant women for morning sickness, and of course we have the right to travel to other countries and take advantage of the "miracle drugs" they have that we don't -- anyway, the drug generally causes flipper babies when taken by pregnant women, and affected about 10,000 children, mostly in Europe, between 1956 and 1962.

So, what was that about "free and responsible"? It is impossible to overestimate the unscrupulousness of commercial manufacturers. If they don't know something about a product, then we certainly can't, and so we're forced to rely on reputation. The only way to be responsible in the face of that is to avoid the products altogether, and that doesn't sound like a great solution either.

By the way, the USPTO also reserves the right to void a patent for the public good -- if there was an AIDS epidemic in the US the way there is in Brazil, India, South Africa, and so on, the U.S. could easily exercise that right. Is it legit for the Brazilian government to do the same for their own country? Yes, it just cheeses off the U.S. drug manufacturers.

Here is the FDA's chart on mercury concentrations for various kinds of fish. The lowest tuna concentration is canned "Tuna Light" with 118 PPB. However, there are 6 other listed can tunas on the list hat are above the 300 PPB max exposure limit listed in the article.

article tagged as FUD

a 170 gram can of tuna containst aboul half the mercury as a CF bulb, and YOU EAT THE TUNA. this is either a scam or a fake article.

Despite the moderators who think that this is informative, it's false. According to http://www.cfsan.fda.gov/~frf/sea-mehg.html, canned albacore tuna has a mercury concentration of about 0.353 ppm. The "canned, light" tuna is listed as being about a third of that, but I'll go with the higher number to give you the benefit of the doubt. Working it out, that means that 170 grams of canned tuna has about 60 micrograms of mercury. That is about 1.2% as much as the 5 milligrams of mercury in a typical CF bulb -- nowhere close to 50%

I've seldom seen such a failure to get the point. Here, I'll recap the thread for your convenience:

Bloke down the pub: Government research programs are inherently wasteful, and would never work.
Me: Actually, a government program discovered the drug we're discussing--but the patent was essentially handed to BMS, and they're gouging patients.
You: Drug companies have to charge a lot for drugs because of the R&D costs. Government-funded research programs would never work.
Me: But BMS didn't bear the R&D costs in this case. The government did. Weren't you reading?
You: I said, drug companies need the high profits because of R&D costs!
Me: I told you, BMS didn't pay for the R&D costs! You can say that they need the money, but you haven't explained why they actually deserve it in this case, since they didn't do the basic R&D on the drug any more than I did.
You: But drug companies need to charge high prices because of R&D costs.

Quoting directly, you said: Do you think all the employees work for free? I'm certainly not advocating that the government fund private research. The drug companies are making good profits for the risks they are taking, and thus need no subsidies.

If you'd been reading instead of mindlessly repeating yourself, you'd have noticed that (a) the government turned over its research to a private concern for commercialization, (b) the "risk", in this instance, was subsidized, while the profits were privatized. Whether or not BMS "need[s] no subsidies", they certainly got them.

Also, the government already does fund private research directly; see, for instance, the FDA's OOPD Grant Program, for just one example.

I am afraid MSBLACK has got his/her facts wrong.

The FDA Standards of Identity for chocolate are set out in Title 21 - Part 163 - Subpart B "Requirements for Specific Standardized Cacao Products" which can be found at the following URL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/CFRSearch.cfm?CFRPart=163.

There are standards of identity (SOIs) for different types of chocolate, including white, milk, and sweet (which covers both semisweet and bittersweet although there is no legal distinction between the two). The minimum COCOA CONTENT in sweet chocolate is specified as "15 percent by weight of chocolate liquor" and for semi and bittersweet as "not less than 35 percent by weight of chocolate liquor." Chocolate liquor is ground up cocoa beans whose fat content is between 45-55% depending on the species of bean and where the bean is grown.

Cocoa content is NEVER specified in terms of solids (cocoa powder) content -- which is where the original poster got his/her facts wrong (this is a very common misunderstanding). Cocoa content refers to the total amount of cocoa solids and cocoa butter in a chocolate product. If you look closely at the ingredients label you'll see that most chocolates have cocoa liquor (or chocolate liquor or cocoa mass) plus added cocoa butter. Cocoa content is expressed as a percentage, by weight, of the combination of those two ingredients.

The FDA SOIs for all chocolates (white, milk, sweet, and liquor) allow manufacturers to include dairy fats and other milk ingredients (including whey) in their products. This is done to reduce the cost of manufacturing (which is what the FDA petition is ** really ** all about) as well as stabilize the cocoa butter crystals to extend the shelf life of the chocolate without adding preservatives.

There are a number of profound ironies here. Irrespective of the subjective taste impressions of American vs European chocolate, the fact is that American standards for what manufacturers can put in chocolate -- and still call it chocolate -- are stricter here than in the EU. The EU SOIs for chocolate allow manufacturers to replace up to 5% of the cocoa butter in chocolate with 'cocoa butter equivalent' and/or 'cocoa butter replacement' fats and still call it chocolate.

Manufacturers can't do that in the US but that is what the CMA and its fellow lobbying organizations are petitioning the FDA to do -- but they want to go much, much, further. They want the ability to replace 100% of the cocoa butter with other fats and still call it chocolate.

It is also important to recognize the difference, in this debate, between chocolate manufacturers and chocolatiers and candy makers. A chocolate manufacturers makes chocolate products (chocolate liquor, cocoa powder, cocoa butter, and finished chocolate) by processing cocoa beans. Chocolatiers buy chocolate from chocolate manufacturers and melt it down to make their finished products. There are relatively few companies in the world that both manufacture chocolate and are also chocolatiers though there are more chocolate manufacturers that also make candy.

If you look at the ingredients on a candy bar or on a box of truffles you'll see that chocolate is listed as an ingredient and -- if it's "good" (or "pure" or "real") chocolate, the only fat in the chocolate will be cocoa butter. All those other ingredients are not in the chocolate -- they're what's inside the outer chocolate coating.

Clay Gordon
Editor and publisher
www.chocophile.com
Author Discover Chocolate (Gotham Books, October 2007)

I read with great interest the "Citizen Petition to modernize Food Standards" ( http://www.fda.gov/ohrms/dockets/dockets/07p0085/0 7p-0085-cp00001-02-vol1.pdf ). I am wondering why this "Citizen Petition" is signed by only a group of industry groups, representing the producers rather than the "Citizen". I do not think that the industry groups represent the consumers or the citizen: quite naturally, they only represent their constituants, which are industry companies. The reasonable aim of those companies is to maximize profits, which is a not a goal shared by the citizens, or the general public. Thus, I do not think that this "Citizen petition" is receiveable as is. It should be modified to be called "Industry petition", and should be completed by a document representing the consumer, for example through consumer unions.

On an unrelated note, I have been trying to copy (using the "copy/paste" functionality of my computer) from the PDF document, but could not, because I was asked for a password. I discovered I could also not print this document, being also asked for a password. I would like to keep a written copy of this document, so please provide me with this password, or please give me the reference of the regulation that requires password protection for public documents. Please contact me at my email address: XXX@XXX.com . Thank you.

There is a reason the FDA's summary is so vague---the proposal isn't about chocolate. Well, not just about chocolate. The proposal is supported by a substantial range of food manufacturer's and distributors, touching on chocolate, meat, poultry, frozen food, and more.

The proposed changes affect divergences from standard labeling guidelines for a lot of reasons, including things like "improvements in nutritional properties", "use of safe suitable flavors and flavor enhancers", "alternate manufacturing processes", etc.

You can read the whole thing yourself (pdf warning) here. See especially the last 4 pages or so.

Is the change in guidelines a good thing for consumers? I don't know. I don't know enough about food manufacturing to judge.

...depending on how old you are. I think the concern was associated more with X-ray radiation emissions from CRT televisions, and older ones at that (prior to the introduction of the Radiation Control for Health and Safety Act of 1968). I would fathom to say that most of us on this site are too young to have been plopped in front of a TV that old for large amounts of time.

No, you're wrong. The FDA has *very specific and stringent* laws about what certain words mean on packaging, as one example, look at this.

http://www.cfsan.fda.gov/~lrd/fr070206.html

Just one of thousands of examples like this...

The amount of stuff being produced these days for a consumer would easily overwhelm a consumer with even above-average patience and attention span. This is true in not just music, but in many other sectors/industries (cars, home electronics are other examples).

So, somebody needs to be the "gatekeepers" — we are happy to employ them to avoid missing on the good new stuff while not spending all our time weeding out the bad new stuff. The question is only, who should that be.

In medicines, which we deemed to be too important, we have FDA — a government agency. In everything else there are competing outlets, some of them commercial (think CNet), some not (think Consumer Reports).

The following is a simple truism, but it is needed to counter the article's implicit disapproval: Apple got there, because consumers of music like the work, Apple's experts are doing.

Maybe, it is the dissatisfaction with radio jockeys (think "Payola"), or with MTV, who, presumably, are losing their music gatekeeping role to Apple — I don't know. But should Apple become thought of as abusive of its position, people will switch to others — competition, as is often said, is only a click away.

No, we pretty much have the same rule as you do but since it's rarely enforced, people like Kevin Trudeau can continue to peddle crap which claims to 'cure' dieting even though by claiming such, he is required to submit his products for testing to verify their claims. Since you're not from the U.S., any product which claims to cure an affliction must be tested by the FDA to prove it's claims. If, however, you say that the product helps to relieve the symptoms of X, then it's not subject to medical scrutiny. See this FDA page on how things are supposed to work.

Which he hasn't and never will. The only time the FTC stepped in on his lame ass was when he sold the products themselves. The FTC shut him down based on his infomercials so he adjusted his snakeoil salesmanship to only sell the books which tell you what products to buy. Since his books are protected Free Speech, PROFIT!

See this link and this link for what a con artist this guy is and how he's endangering peoples lives with his lies as well an analysis by a doctor about his claims.

A few more interesting tidbits:

-- At least 80% of women will have been infected by at least one strain of genital HPV by the time they reach 50 years of age.

-- Condoms are only about 70% effective at preventing HPV transmission

-- In 2007, approximately 11,150 cases of invasive cervical cancer will be diagnosed in the United States, and about 3,670 women will die from the disease. For comparison, seatbelts saved 13,274 lives in 2001 in the US.

-- Somewhere near 10% of people have had visible genital warts. These people may still be able to transmit the virus after the warts are gone.

-- HPV can be transmitted from a mother to her baby during birth, so it is even possible to get HPV from a virgin.

-- The HPV vaccine does not contain thimerosal/mercury.

A few more interesting tidbits:

-- At least 80% of women will have been infected by at least one strain of genital HPV by the time they reach 50 years of age.

-- Condoms are only about 70% effective at preventing HPV transmission

-- In 2007, approximately 11,150 cases of invasive cervical cancer will be diagnosed in the United States, and about 3,670 women will die from the disease. For comparison, seatbelts saved 13,274 lives in 2001 in the US.

-- Somewhere near 10% of people have had visible genital warts. These people may still be able to transmit the virus after the warts are gone.

-- HPV can be transmitted from a mother to baby during birth, so it is even possible to get HPV from a virgin.

-- The HPV vaccine does not contain thimerosal/mercury.

Hey, that's not cool. Lead poisoning is a very serious. It's not the kid's fault they are exposed to it, but they get to deal with the damage for the rest of their life.

Some links for your educational pleasure:

http://www.todaysparent.com/healthsafety/allages/a rticle.jsp?content=20040206_103527_3540&page=4
http://www.fda.gov/fdac/features/1998/198_lead.htm l
http://www.niehs.nih.gov/oc/factsheets/lyh/govtdo. htm
http://www.atsdr.cdc.gov/HEC/CSEM/lead/biologic_fa te.html
http://oldweb.uwp.edu/academic/geology/lead/
http://www.cfc-efc.ca/docs/ldac/00000367.htm
http://www.nsc.org/library/facts/lead.htm

feel free to mod this up, mods, lead poisoning is underrecognised.