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I provided a link to the Gardasil issue which are admitted to. From this page the reports are roughly 25,000 reported serious problems from the vaccine. Looking at the total of 600,000 vaccines given that is a 4% chance that a person can have a serious side effect. The numbers I provided were actually being extremely kind to Gardasil.

OK, let's look at the data carefully. Start with the CDC summary: 57 milion doses, 22,000 reports to VAERS. Of those, 8% were serious. That works out to about 3.5 in 10,000. Given that VAERS is self-reported and doesn't require an actual diagnosis or necessarily any evidence that the issue was vaccine related, even that data is pretty overstated. Hopefully, we're using the same definition for "serious" (which for these purposes is typically "hospitalization, chronic injury, or death"). I suspect we're not, because anything with a 4% chance of serious side effects would be considered straight up poison and ripped from the shelves.

On to the NHS site. It gives no numbers for such "serious" side effects, but does gives other stats:

>10% for redness at the injection site or headaches.
>1% for fever, nausea, painful limbs.
~0.01% for hives

Self reported and without statistics (more like VAERS) are a series of disorders, most of which are not especially serious, but a couple of which are moderate to severely serious (Guillain Barré syndrome). Of course, the HuffPo site you linked notes that the statistics thus far have shown that those serious disorders appear to occur in the HPV vaccinated population at the same rate as the population at large, so it's rather hard to claim that the vaccine was the cause.

It's amazing to me that we're using the same sites and you're coming up with numbers that don't appear to be anywhere in those sites. The best I can come up with is that your methodology takes all possible reactions including "redness at the injection site", takes the 10% probability of that, notes that there was an unconfirmed case of Dutch elm disease in there, and says "Dutch elm disease (or similar) in 10% of cases!"

It's really not difficult to Google "gardasil vaccine harm" to find all kinds of reports on the vaccine.

Here is a link to the Google search results of alien abduction cases. You'll note a variety of sources with a lot of different anecdotes, as well as more serious academic sources. Depending on which site you go to, you get very different results. My concern here is that your idea of "education" is reading all of the sites and averaging what you read.

And as mentioned before, we don't know that the vaccine is truly effective.

From the FDA in 2013: The vaccine is effective against HPV types 16 and 18 which cause approximately 70% of cervical cancers, and against HPV types 6 and 11 which cause approximately 90% of genital warts.. Maybe there's some cutting edge research (or web site rumor mills) that indicates otherwise. Maybe those unnamed sources are even right. But they're usually not.

Or did you not know about these [therefusers.com]?

200 cases out of ~60 million doses? I'm definitely willing to believe that. But not 4%. I'd say that's an excellent result and that compensating the rare problem case is perfectly reasonable. I mean, giving peanuts to 60,000,000 people is likely to cause adverse reaction

Does FDA have a mandatory limit on the power emitted by laser pointers?
Yes. Laser products promoted for pointing and demonstration purposes are limited to hazard Class IIIa by FDA regulation.

21 CFR 1040.11(b) and 1040.11(c), limit surveying, leveling, and alignment, and demonstration laser products to Class IIIa. This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers. There are also limits for any invisible wavelengths and for short pulses. Pointers may not exceed the accessible emission limits of CDRH Class IIIa or IEC1 Class 3R.

http://www.fda.gov/Radiation-E...

so yes, if you are employing a mounted laser in a scientific or industrial setting, no problem. if you bought a handheld 2w laser from wickedlasers.com and are storing it at your home and you have no reason to own such a device other than "hobby", that's illegal to own.

p.s., wickedlasers.com is out oh HK, so they can ship whatever they want. you can also buy a cell signal scrambler online, and guess what those aren't legal either.

Does FDA have a mandatory limit on the power emitted by laser pointers?
Yes. Laser products promoted for pointing and demonstration purposes are limited to hazard Class IIIa by FDA regulation.

21 CFR 1040.11(b) and 1040.11(c), limit surveying, leveling, and alignment, and demonstration laser products to Class IIIa. This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers. There are also limits for any invisible wavelengths and for short pulses. Pointers may not exceed the accessible emission limits of CDRH Class IIIa or IEC1 Class 3R.

http://www.fda.gov/Radiation-E...

so yeah, if you own an industrial factory that contains cutting lasers, you are fine. if you have a 2w handheld laser in your home, not so much. the kind that wickedlasers.com (for example) sell are clearly *not* for industrial or scientific use.

You think this matters? We should have real concerns. In late October Resers had a listeria recall on a lot of products produced at one assembly plant for lots of sub-companies. There has been no followup in the news (post november) detailing any further testing by them or the FDA. That original recall was initiated due to testing done in Canada. Should there be any consumer confidence by the American public that we can trust a factory like this to produce safe food? Look at their recall window on those products, it has been expanded now and includes 2014 products. How often do they test!? Why are they still shipping this food if its being recalled? This problem was first exposed in October. How often do they do a thorough cleaning!? I have tried to followup and have not been told of _any_ routine testing done on American soil by either the FDA or the company in question. The Reser consumer rep literally told me consumers do not care about their quality practices and that she did not have any information for me on how often they test for this. I have tried to find out more and all I have to go on is public information in the news. All consumers have are gems like this and more questions:

The problem was discovered through microbiological testing by the Canadian Food Inspection Agency. A traceback investigation and follow-up testing by FDA at the facility determined there was potential cross contamination of products with Listeria monocytogenes from product contact surfaces.

You're an idiot of the Prosthetic arm from Joes RepRap in his garage doesn't concern you. That doesn't mean its 'bad', but you're an idiot for not being concerned about the possible unforeseen effects.

I posted this in a previous /. story about printed limbs, so I'll just do a quick copy and paste:
Prostheses are more or less exempt from any FDA regulation that would make them expensive.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.3420 [fda.gov]

Sec. 890.3420 External limb prosthetic component.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.9 [fda.gov]

Sec. 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. [...]

[A list of reasons when your product is not exempt]

There's someone, somewhere, who had to spend money for the FDA to approve the first [artificial limb], but after that, everyone gets a free ride.

You're an idiot of the Prosthetic arm from Joes RepRap in his garage doesn't concern you. That doesn't mean its 'bad', but you're an idiot for not being concerned about the possible unforeseen effects.

I posted this in a previous /. story about printed limbs, so I'll just do a quick copy and paste:
Prostheses are more or less exempt from any FDA regulation that would make them expensive.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.3420 [fda.gov]

Sec. 890.3420 External limb prosthetic component.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.9 [fda.gov]

Sec. 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. [...]

[A list of reasons when your product is not exempt]

There's someone, somewhere, who had to spend money for the FDA to approve the first [artificial limb], but after that, everyone gets a free ride.

The irony here is that the FDA itself conducts no scientific review.

As reported last October: (emphasis added)

Q: Does the FDA test these foods before they're allowed on the market?

A: No. Instead there is a voluntary consultation process. Genetically engineered foods are overseen by the FDA, but there is no approval process. Foods are presumed to be safe unless the FDA has evidence to the contrary, Jaffe says. The FDA "has to show that there may be a problem with the food, as opposed to the company needing to prove it's safe to FDA's satisfaction before it can get on the market," he says.

And from the horse's mouth itself: (emphasis added)

[Section V B] It is the responsibility of the producer of a new food to evaluate the safety of the food and assure that the safety requirement of section 402(a)(1) of the act is met. In section VII., FDA provides guidance to the industry regarding prudent, scientific approaches to evaluating the safety of foods derived from new plant varieties, including the safety of the added substances that are subject to section 402(a)(1) of the act. FDA encourages informal consultation between producers and FDA scientists to ensure that safety concerns are resolved. However, producers remain legally responsible for satisfying section 402(a)(1) of the act, and they will continue to be held accountable by FDA through application of the agency's enforcement powers.

Also, the basis for the fallacious assumption that genes introduced from other species are not worth rigorous testing: (emphasis added)

[excerpted Section V C] With respect to transferred genetic material (nucleic acids), generally FDA does not anticipate that transferred genetic material would itself be subject to food additive regulation. Nucleic acids are present in the cells of every living organism, including every plant and animal used for food by humans or animals, and do not raise a safety concern as a component of food. In regulatory terms, such material is presumed to be GRAS. Although the guidance provided in section VII. calls for a good understanding of the identity of the genetic material being transferred through genetic modification techniques, FDA does not expect that there will be any serious question about the GRAS status of transferred genetic material.

"Obviously GMO organisms are safe because we have no expectations they won't be safe." Most people would call BS on that kind of self-fulfilling prophecy. Does the FDA really not understand it's how those nucleic acids are arranged, not just what nucleic acids are present?

23AndMe received a warning letter from FDA because they are marketing a medical device without a determination of substantial equivalence - http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm

Don't blame the FDA...
Due to the structure of the 1938 Food Drug and Cosmetic act which established the FDA, it is not permitted to regulate homeopathic drugs in the same way as "normal" drugs. This is a registry of homeopathic drugs and if a drug is on there but is not a "normal" drug, the FDA can only regulate that it is manufactured safely, similar to food, not whether it is effective at treating disease. That is why you see this kind of labeling on such products:

A product's compliance with requirements of the HPUS, USP, or NF does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.

All the FDA can do is go after companies that market non-homeopathic drugs (i.e. "normal" drugs) as homeopathic, like HCG.

Don't blame the FDA...
Due to the structure of the 1938 Food Drug and Cosmetic act which established the FDA, it is not permitted to regulate homeopathic drugs in the same way as "normal" drugs. This is a registry of homeopathic drugs and if a drug is on there but is not a "normal" drug, the FDA can only regulate that it is manufactured safely, similar to food, not whether it is effective at treating disease. That is why you see this kind of labeling on such products:

A product's compliance with requirements of the HPUS, USP, or NF does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.

All the FDA can do is go after companies that market non-homeopathic drugs (i.e. "normal" drugs) as homeopathic, like HCG.

There are no childhood vaccines that are not available without thimerosol, including the MMR vaccines that are the subject of this article.

And for full appreciation of the massive fail that the "EEP!!! thimerosol in MMR!" position represents: not only has thimerosol been removed from childhood vaccines in the USA, but (pay attention now) MMR never had thimerosol in the first place!

There are no childhood vaccines that are not available without thimerosol, including the MMR vaccines that are the subject of this article. Even flu vaccines are available thimerosol free.

First link: "Despite this vaccine being hugely effective against B. pertussis, which was once the primary childhood killer, these data suggest that the vaccine may be contributing to the observed rise in whooping cough incidence over the last decade by promoting B. parapertussis infection." In other words, whooping cough vaccine against whooping virus (for which it was designed) may actually promote infection of a related but not identical virus. This does not say the vaccine promotes sickness.

Second link: "Despite widespread childhood vaccination against Bordetella pertussis, disease remains prevalent. It has been suggested that acellular vaccine may be less effective than previously believed. During a large outbreak, we examined the incidence of pertussis and effectiveness of vaccination in a well-vaccinated, well-defined community." In other words, the whooping cough vaccine may not last as long as thought. More boosters may be needed or a different vaccine may need to be developed. It says nothing about spreading sickness.

Third link: "Safety and shedding data from four clinical studies were included in the BLA supplement. Additionally, a publication with associated electronic datasets was submitted in support of a label claim regarding shedding in HIV positive subjects." In other words, it is shows the shedding rates of HIV infected subjects whose immune system is somewhat compromised, not the general population.

Fourth link: "RotaTeq rotavirus vaccine and vaccine-derived strains were detected actively in stool samples from 13 out of 61 (21.3%) infants having diarrhea within 2 weeks of rotavirus vaccination, and among three out of 460 (0.7%) cases with acute gastroenteritis captured via the Australian Rotavirus Surveillance Program. Six (37.5%) of these 16 vaccine-derived viral specimens were associated with a G1P[8] strain thought to be the result of genetic reassortment between two component RotaTeq strains. Although nearly half of these reassortant-associated cases had underlying medical conditions, such as severe combined immunodeficiency disorder, further study is needed to understand the relationship between shedding, viral reassortants and underlying medical conditions." So a sample size of 61 in which half the infants had other medical issues had samples of rotavirus. Again, the vaccine does not spread sickness.

Those were just the first four links. All of them say the same thing: vaccines are not 100% effective. But no scientists have ever claimed them to be. Each of the first three showed that in certain circumstances, the vaccine is not effective. In fact, the first link says that the Pertussis vaccine is not effective against another disease. Excuse for not being panicked about that.

Nixon first used the phrase, "War on Drugs". According to wikipedia, "The CSA did not only combine existing federal drug laws but it also changed the nature of federal drug law policies, expanded the scope of federal drug laws and expanded Federal law enforcement as pertaining to controlled substances."

Consider Paragraph 811 "Authority and criteria for classification of substances" of the Controlled Substances Act, written by Nixon's Attorney General, which says, in part:

(d) International treaties, conventions, and protocols requiring control; procedures respecting changes in drug schedules of Convention on Psychotropic Substances
(1) If control is required by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by subsection (a) of this section or section 812(b) of this title and without regard to the procedures prescribed by subsections (a) and (b) of this section.

Thus, US law is subservient to UN drug policies.

"Among the possible uses for Google Glass that early adopters are dreaming up, you can now add 'surgical assistance' to the list. With approval from the institutional review board, a UCSF cardiothoracic surgeon recently utilized Glass during procedures ..."

I have been involved with getting electronics into operating rooms, and it is an expensive, complicated and time consuming process. FDA requirements apply to all medical devices; with RFI being a big problem, especially in an OR environment (which is full of "mission critical" electronic gear). To be blunt, if Google glass interferes with the electronics already in the OR, patients could die, and everyone involved with getting it there would be directly responsible.

From my perspective, the note-worthy thing about this story would be getting the certification needed to take Google Glass into the OR, as that would probably be the hardest thing to do, much harder than some trivial HIPAA scrubbing, and it puzzles me that that is not mentioned in the article. So, I have to wonder, did they actually do this, or is Google and UCSF just winging it and hoping no one dies during their trials?

There's actually a list of GRAS (Generally Recognized as Safe) at the FDA Website. To my knowledge, GM foods fall under this listing.
http://en.wikipedia.org/wiki/GRAS
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing

and here's a short listing for GM items listed under GRAS.
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?filter=genetically+modified&sortColumn=&rpt=grasListing

There's actually a list of GRAS (Generally Recognized as Safe) at the FDA Website. To my knowledge, GM foods fall under this listing.
http://en.wikipedia.org/wiki/GRAS
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing

and here's a short listing for GM items listed under GRAS.
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?filter=genetically+modified&sortColumn=&rpt=grasListing

Why isn't acetaminophen also used in combination with asprin, naproxin, or ibuprofen in a single pill? Does it do no good with used with those non-opiate pain medications? See: http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm239874.htm

When acetaminophen is combined with aspirin and caffeine, it's called "Excedrin," and is sold over-the-counter in the US. I have no idea if acetaminophen has synergistic effects with other pain relievers. Try google, maybe.

If even half of the FDA's letter is correct (and I see no reason to doubt it), they've been bending over backwards to work with 23andMe for years. The company made a deliberate decision to both ignore the regulators and (more damningly) fail to study the effectiveness of their own product, and now they're paying for it. Here's the relevant section of the letter:

Your company submitted 510(k)s for PGS on July 2, 2012 and September 4, 2012, for several of these indications for use. However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter for (b)(4), as required under 21 CFR 807.87(1). Consequently, the 510(k)s are considered withdrawn, see 21 C.F.R. 807.87(1), as we explained in our letters to you on March 12, 2013 and May 21, 2013. To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the Act, 21 U.S.C. 360(k).

The Office of In Vitro Diagnostics and Radiological Health (OIR) has a long history of working with companies to help them come into compliance with the FD&C Act. Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device. FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Further, we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS. As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.

However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has n

It was not written by a lawyer. Or someone who knows business.

The first sentence is suspect "MobilECG is an USB-based open source 12-lead clinical electrocardiograph"

In the US, it is not a "clinical" electrocardiograph without FDA clearance to market (which is what you are doing), yet it is stated to be one. IANAL, but I recommend you get one. Now. Some people have an obligation to report this website to the FDA. If you're not in the US, fine, but statements like this will prevent you from ever getting clearance.

Citation: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073942.htm
Experience: Clinical portion of submission of several Class II and on Class III radiology and cardiac devices for FDA 510(k) and PMA.

Oh, and lastly, FDA "approval" (you would really be seeking clearance) does not come in for $230K. For this device, you are looking at $5MM minimum. And that does not count the attorney you're going to need to bail you out of the stupidly naive comments on your website.

One doesn't need to be an "expert" in order to apply logic and statistics; wood burning stoves are a negligible contribution to particulate pollution in most locations.

Citation needed, my friend.

Because we do not have as a principle of government "government should make all things illegal that cause early deaths for people around them"

Actually: yes, you do. That is one of the key things a government of the people does. It uses collective resources to acquire information on matters individuals are not or badly capable of acquiring the same sort of information on (like testing all the food they buy for harmful substances). It then makes democratically supported decisions most individuals would or could not make (like black- or white-listing certain food additives).
Think about this one: do you think it should be illegal to sell your kidney? Why?
It's your body, right?

Such combinations not only are legal, they are commonly sold

You're doing it again. You're being intentionally obtuse and making irrelevant statements. You knew damn well I was talking about baby milk with rat poison, sold as food, which would be illegal. Here, have fun: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
I repeat: why outlaw the addition of rat poison to baby milk in [state X], but not in [state Y]?

Your rhetorical question of "You're the expert on this, right?" is an ad hominem

Yes, it is. Considering the total lack of evidence provided for your statements and the irrelevance of those statements, it seemed like the proper response.

"You're an idiot" is merely name calling.

Except that is not what you said. Let me refresh your memory: "It matters because it shows that you don't know the fuck what you're talking about and obviously don't care."

I should also mention that, yes, Plasma is one of those loop-hole cases, where most donors get a tiny amount of cash for their time. But any number of other factors can disqualify anyone from doing that.

And there's a good FDA write-up quite intelligently explaining the policy:

http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/ucm108186.htm

The FDA tried to ban saccharin and an act of Congress stopped them (food lobby at work)

http://www.fda.gov/AboutFDA/WhatWeDo/History/ThisWeek/ucm117882.htm

http://enhs.umn.edu/current/saccharin/fda.html

The fact is, a lot of research shows that saccharin is bad, yet the lobbies that support it spend a lot of money to keep it on the market.

The FDA has what they call "ADI", acceptable daily intake. In other words, you can eat a little bit of poison and that is ok, just don't eat too much because we're paid to not ban it.

Well, I guess it works for tobacco, that should be banned as well, but it remains legal because of lobbies.

The fact is, lots of stuff is bad for us, but because there is enough money in it, it remains on the market.

That's because the dosage makes the poison. Nothing "is a poison." Everything is a poison at certain doses. Water, oxygen, carbohydrates, anti-oxidents, etc.
All of them lethal at some level but quite necessary for survival.

That is why the FDA has a much better standard of "acceptable daily intake" rather than your over-reactionary stance. It turns out that saccharine was bad for rats (which, btw, are not people and do not always react the same as people) at very high doses. But quite safe for humans at "normal" doses. That does not make it a "poison."

http://www.fda.gov/AboutFDA/WhatWeDo/History/ThisWeek/ucm117882.htm

http://enhs.umn.edu/current/saccharin/fda.html

The fact is, a lot of research shows that saccharin is bad, yet the lobbies that support it spend a lot of money to keep it on the market.

The FDA has what they call "ADI", acceptable daily intake. In other words, you can eat a little bit of poison and that is ok, just don't eat too much because we're paid to not ban it.

Well, I guess it works for tobacco, that should be banned as well, but it remains legal because of lobbies.

The fact is, lots of stuff is bad for us, but because there is enough money in it, it remains on the market.

Oops, forgot the link.

I suspect that you could do it (if nothing else, cheat: anti-drug vaccines are a big area of research, so you can probably find somebody to sell you antibodies targeted at any of the major ones, at which point you smear it on a slide and work out a means of detecting antibody/antigen binding...); but that would probably be a good way to discover the other major virtue of animal olfactory systems:

With rather limited exceptions (certain contact anesthetics will temporarily knock the sense of smell offline, cocaine included if memory serves, and contact with something nasty enough to physically damage the sensory cells: eg. occupational ammonia exposure, squirting zinc solutions up your nose, will eventually toast the sense of smell entirely), organisms are pretty good at self-cleaning. Once exposure to a scent stops, the olfactory system is back and ready for action in short order. Whether this is because it employs some fancy non-binding mechanism, or because 'cells' are the closest things to sci-fi nanites that we know of, I don't know; but it works.

Antibody or chemical-reaction based systems are inherently consumable, and such specialized electronic gas sensors as do exist can be vulnerable to 'poisoning' by environmental contaminants. (Among the more obnoxious, catalytic methane sensors are poisoned by silicone vapors, as found in about a zillion elastomers, lubricants, and all sorts of other things. Just something to keep in mind if you ever find yourself in a coal mine... A poisoned methane sensor is indistinguishable from a methane sensor that just isn't detecting any methane, so replace regularly and avoid sparks and open flames.)

The FDA allows some insects to be in food with in limits.

Example:

CORNMEAL Insects
(AOAC 981.19) Average of 1 or more whole insects (or equivalent) per 50 grams

Just search 'Insects" and see that all foods allow for some bugs to be in there.

DISCLAIMER: I am, (among other hats) a software developer for a medical device manufacturer in the United States.

Seriously, people. The FDA's stance has *ALWAYS* been that if something has a medical purpose or is an accessory to a medical device, then it *IS* a medical device, even with software. See: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated 2005.

For the purposes of this document, we refer to devices that contain one or more software components, parts, or accessories, or are composed solely of software as “software devices,” including:

• firmware and other means for software-based control of medical devices
• stand-alone software applications
• software intended for installation in general-purpose computers
• dedicated hardware/software medical devices.
• accessories to medical devices when those accessories contain or are composed of software.

This guidance applies to software devices regardless of the means by which the software is delivered to the end user, whether factory-installed, installed by a third-party vendor, or field-installed or -upgraded.

So, yes, apps with a medical purpose are medical devices, just like any other piece of software.

Which means they *ARE* subject to the "Obamacare Tax" -- Which is *NOT* a "sales tax" to be paid by the consumer. It's an "income tax" to be paid by the manufacturer / developer.

This also means that if your app is categorized as a medical device, you (the developer) have to register with the FDA as a device manufacturer, which costs a couple thousand dollars a year, and means that every few years, the FDA sends someone out to review your quality control system, which includes your testing methodologies, what complaints you've received and how you've handled them, how you document your development process, etc.

AND what your software does determines what kind of medical device the FDA calls it. And the kind of medical device determines whether you are required to get the FDA's permission before you distribute it. (even if you distribute it for free) And yes, applying for that permission costs money, whether it's approved or not.

And, by the way: Each country makes its own rules about what makes a medical device and what you're required to do to be able to legally distribute it in that country. And in most countries that includes software.

Right. But since being overweight has just been re-classified as a disease, any app that lets you track you weight can be interpreted as being one that is involved in the "treatment or prevention of disease." Don't you think they won't.

The other thing I like about this is that they have a scheme for registering and tracking these devices. See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm for details.

This is the Globally Unique Device Identifier (GUDID), which they are pronouncing "Good ID". Who says that the government can't market its stuff.

with all kinds of regulations and safety cases that have to be complied with... things they can cope with because they're so large, but little upstart companies can't afford to comply with...

You have no idea WTF you're talking about.
Generic "zomg too much regulation comments" almost always get upmodded and are almost always full of shit.
Prostheses are more or less exempt from any FDA regulation that would make them expensive.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.3420

Sec. 890.3420 External limb prosthetic component.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.9

Sec. 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. [...]

[A list of reasons when your product is not exempt]

There's someone, somewhere, who had to spend money for the FDA to approve the first brain--computer--limb interface, but after that, everyone gets a free ride.

with all kinds of regulations and safety cases that have to be complied with... things they can cope with because they're so large, but little upstart companies can't afford to comply with...

You have no idea WTF you're talking about.
Generic "zomg too much regulation comments" almost always get upmodded and are almost always full of shit.
Prostheses are more or less exempt from any FDA regulation that would make them expensive.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.3420

Sec. 890.3420 External limb prosthetic component.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.9

Sec. 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. [...]

[A list of reasons when your product is not exempt]

There's someone, somewhere, who had to spend money for the FDA to approve the first brain--computer--limb interface, but after that, everyone gets a free ride.

No matter how much I'm trying to train my brain it still thinks that insects and their larval forms are absolutely repulsive. You can't defeat that unless you have grown up eating those things and then it's the norm.

You have grown up eating insects. They're everywhere, so it's impossible to avoid them in mass food production. The FDA has guidelines for how much is allowable in food that's sold for consumption.

It's all in your head. Youtube is full of videos of people trying "sushi" for the first time, and gagging while eating California rolls. California rolls don't have any raw fish. It's (cooked) imitation crab meat, cucumber, avocado, seaweed, and rice.

Maybe not.

Does Fluoride Make Your Kids Dumb?
Dr. Mercola: Visionary or Quack?
FDA Orders Dr. Joseph Mercola to Stop Illegal Claims
Inspections, Compliance, Enforcement, and Criminal Investigations - 2011
Inspections, Compliance, Enforcement, and Criminal Investigations - 2006
Joe Mercola: 15 years of promoting quackery
The New PuritansWhen did liberals become so uptight?

Maybe not.

Does Fluoride Make Your Kids Dumb?
Dr. Mercola: Visionary or Quack?
FDA Orders Dr. Joseph Mercola to Stop Illegal Claims
Inspections, Compliance, Enforcement, and Criminal Investigations - 2011
Inspections, Compliance, Enforcement, and Criminal Investigations - 2006
Joe Mercola: 15 years of promoting quackery
The New PuritansWhen did liberals become so uptight?

'[Processed foods are bad]'? Really?? What the fuck is 'processed food' even?
Next you're going to say that 'additives' and 'chemicals' are 'bad for you'.

when you have to break down and reassemble a food to make it similar to the food it was before processing( like enriched flour, modified milk ingredients) then yes that stuff is bad for you, replacing sucrose(glucose, fructose) with HFCS frankenfood is not the best thing to be eating...additives and chemicals are bad for you if they are the wrong ones....melamine is a terrible thing to feed babies and pets, GRAS http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ does not mean its been tested or even evaluated in any sort of way....like BPA and slew of other food additives(also does not mean they are bad like Xantham gum)

I know what your point is, but ignorance is not a defense...we're not here to educate you...you are responsible for that...your hyperbole is noted...and dismissed.

If your oxygen concentrator doesn't run for 9 hours

There are other reasons that solar flares that cause power outages. If one's life depends on concentrated oxygen one should have a backup supply to last a few days.

you can't keep your insulin cold for 9 hours

According to the FDA insulin will last quite a while without refrigeration.

Insulin products contained in vials or cartridges supplied by the manufacturers (opened or unopened) may be left unrefrigerated at a temperature between 59F and 86F for up to 28 days and continue to work. However, an insulin product that has been altered for the purpose of dilution or by removal from the manufacturer’s original vial should be discarded within two weeks.

There are many reasons power can be out for quite a while; weather, earthquake, equipment failure, etc. The point is that short term, less than a few days, without power should be able to be handled by individuals. If a catastrophe is going to happen if the power goes out for a few days there is a much bigger issue than space weather.

PS. I see this as another misuse of a word to sensationalize a story. Space weather may cause local problems but not catastrophes.

"Importantly, the IOM report concluded that there was no evidence that silicone breast implants caused systemic health effects such as cancer or autoimmune disease."

So says the FDA...

Hmm. Wikipedia says that the government did answer the open letter:

http://en.wikipedia.org/wiki/Backscatter_X-ray#Health_effects

Here's the citation:

http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/SecuritySystems/ucm231857.htm

I still want to minimize my exposure to ionizing radiation.

I can't stand the pillar the medical profession puts itself on. Let's run down the list of examples for how the medical profession doesn't give a shit about patients, shall we?

• We're forced to be seen by inexperienced, sleep-deprived, overburdened, overworked trainees. We don't allow truckers to drive more than X hours in Y days and the medical profession has proven lack of sleep impacts mental abilities. But med student hours? Sky's the limit, and it's common knowledge that you're supposed to fake your timesheets now that hospitals "track" this and have "policies."
• Medication errors cause 1.3 million injuries a year. Let's be clear here: Dr. I-Swore-An-Oath apparently can't be bothered to slow down and PRINT CLEARLY on your prescription form.
• Surgeons routinely fuck up "which leg" or "which eye." They're taught all sorts of anatomy, except they can't seem to figure out "left" versus "right"
• Despite the fact that hospitals are increasingly a cesspool of MRSA and other diseases, we continue to cling to the idea that we should treat people with transmissible diseases in close proximity to others, instead of having doctors travel to the sick patients, treat them, disinfect, and move on to the next patient. Gee, what could possibly go wrong with concentrating sick and weak people in one area?

As a physician I'm quite interested in the subject. :-) Things have been bad in the past, but is getting better on all fronts. Let's take your issues one at a time:

There's a cap placed on residency hours per week and hours in a row, now. Yes, it's sometimes broken, but it's a lot better than 20 years ago. And, no, it's not routine practice to fake your timesheets. Or at least where I trained ~15 years ago, and not in the training program I assist overseeing. That being said, in some subspecialty fellowships I wouldn't doubt that it's more common to do this -- But they do this to gain more experience as you may only get a once in a decade experience if you stay on call and extra 2 hours. Who would deprive themselves that?

Penmanship is not taught in medical school. But electronic perscriptions are becoming more commonplace in the last few years (both on the outpatient and inpatient sides). And the last couple decades have brought on more responsibility of the patient to know what they are taking. The outpatient medication errors are the combined fault of the physician, the pharmacist, and the patient.

I wouldn't say that anyone routinely operates on the wrong body part. But mistakes do happen. It's now standard of care to do a "time out" with the patient, nurse, and physician all in the operating room to agree on the patient's name, date of birth, and procedure to be performed before any sedation is administered or incisions are performed. But I once had a patient respond to a different name who expected to have the same procedure performed. Fortunately he was tripped up by the date of birth.

As for washing hands, that's a culture change. My hospital has random people anonymously assigned to watch people enter and leave patient rooms to make sure we always wash in and out. (The people are people that work on the floors anyway.) A couple verbal warnings and suddenly everyone's compliant. No need for technology.

And the younger generation of physicians are more humble. But that's also because they tread medicine as more of a job and less of a calling. I guess you can't get everything. :-(

I can't stand the pillar the medical profession puts itself on. Let's run down the list of examples for how the medical profession doesn't give a shit about patients, shall we?

• We're forced to be seen by inexperienced, sleep-deprived, overburdened, overworked trainees. We don't allow truckers to drive more than X hours in Y days and the medical profession has proven lack of sleep impacts mental abilities. But med student hours? Sky's the limit, and it's common knowledge that you're supposed to fake your timesheets now that hospitals "track" this and have "policies."
• Medication errors cause 1.3 million injuries a year. Let's be clear here: Dr. I-Swore-An-Oath apparently can't be bothered to slow down and PRINT CLEARLY on your prescription form.
• Surgeons routinely fuck up "which leg" or "which eye." They're taught all sorts of anatomy, except they can't seem to figure out "left" versus "right"
• Despite the fact that hospitals are increasingly a cesspool of MRSA and other diseases, we continue to cling to the idea that we should treat people with transmissible diseases in close proximity to others, instead of having doctors travel to the sick patients, treat them, disinfect, and move on to the next patient. Gee, what could possibly go wrong with concentrating sick and weak people in one area?

If you live in the United States, you likely already engage in accidental entomophagy. Allow me to introduce you to the USDA's guide to what are the acceptable levels of insects in your food. Go head and CTRL+F on that page for 'insects.'

And if you just live, you already engage in regular accidental autocannibalism. But there's still a long way for ordinary people to chop up their neighbors and keep their body parts in fridge for Friday night barbecue.

Allow me to introduce you to the USDA's guide to what are the acceptable levels of insects in your food.

And if that doesn't gross you out, go ahead and google around for the acceptable upper limit of faeces. There is one, and it's not zero.

I say "Because OMFG, gross!!!"

If you live in the United States, you likely already engage in accidental entomophagy. Allow me to introduce you to the USDA's guide to what are the acceptable levels of insects in your food. Go head and CTRL+F on that page for 'insects.'

Having particularly good eyesight, I don't think I've ever eaten a blackberry that didn't have thrips or aphids on it. Guess what? They're delicious on blackberries!

Of course, getting my Wilderness Survival merit badge on my way to Eagle Scout gave me the opportunity to forage for edible insects and I would actually recommend the fly larvae that attach to grassland stalks and form 'bulbs' around them. Taste like walnuts! Too bad it takes forever to harvest them or I'd make a product out of that for the granola-brains community.

Well, even the FDA reckons this and a draft proposal has been out since October 2011, to be finalized this October: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/ucm255978.htm

You can contact the FDA here to file a complaint in regards to this racist decision.

Every once in a while, you hear of some local government or some NGO sponsoring an expensive piece of equipment for a hospital, then even with judicious use the hospital runs out of the yearly cap by May, making that equipment gather dust.

While here in good ol free market USA, virtually all our major equipment in our small rural hospital has been purchased by funds from various NGOs because we don't have the right mix of patients to make money off the bizarre US system. To add insult to injury to 'the best medical system in the world', we have increasing problems with drug unavailability. Nothing like a lack of sterile saline solution to kick your medicine back a couple hundred years.

The US system is failing on so many levels that it's pretty embarrassing.

Don't forget the mercury.
http://www.fda.gov/food/foodsafety/product-specificinformation/seafood/foodbornepathogenscontaminants/methylmercury/ucm115662.htm
http://en.wikipedia.org/wiki/Mercury_in_fish

the amount of mercury in this year's flu shot is about the amount in 1/1000th of a tuna sandwich, 12.5 micrograms (source: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228#thi) (25ug thimerosal, which is 50% ethylmercury, which has none of the dangerous properties of mercury).

There is no formaldehyde in vaccines.

There certainly isn't MSG in vaccines; you may be thinking about chinese food.

I don't know what's wrong with the brains of the anti-vaccine crowd, but science has shown again and again that they are incorrect as a simple matter of fact.

It's not just oxetetracycline, I'm afraid.

Unfortunately, the FDA only inspects a tiny fraction of what's out there.

As for heavy metals, Chinese apiaries too often use lead soldered frames. Honey reacts with metals, unfortunately.

They still make "Ice Cream" and if you read through the FDA definition of ice cream, it is more about the percentages of milk solids and milk fat and not about the non traditional additional additives like corn syrup etc..

FDA definition of ice cream:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=135.110

From the Breyers FAQ

4) What is a Frozen Dairy Dessert?

Frozen Dairy Dessert products are made with many of the same high-quality ingredients that are commonly found in Ice Cream â" like fresh milk, cream and sugar â" and offer a great taste and even smoother texture. These products do not fall within the current FDA definition of standardized Ice Cream, so we call them Frozen Dairy Dessert.

5) Does Frozen Dairy Dessert taste different than Ice Cream? Are there nutritional benefits to Frozen Dairy Dessert when compared to Ice Cream?

In a national side-by-side taste test, our fans tell us they like the new recipe just as much as the original. Weâ(TM)re confident these new products deliver the great taste Ice Cream fans expect but with any product change itâ(TM)s always possible that you may notice a difference. Frozen Dairy Dessert tends to have less fat than ice cream.

6) Are there Breyers flavors that are not Frozen Dairy Dessert?

Many flavors â" which are based off the original recipes that William Breyer himself created 140 years ago â" are Ice Cream, including: Natural Vanilla, Natural Strawberry, Chocolate, French Vanilla, Vanilla/Chocolate/Strawberry, Mint Chocolate Chip, Homemade Vanilla, Coffee, Vanilla/Chocolate, Lactose-Free Vanilla, Triple Chocolate and NASCAR® Checkered Flag.

7) What is the packaging difference between Ice Cream and Frozen Dairy Dessert? Does the price of Frozen Dairy Dessert products differ from that of Ice Cream?

All products are clearly labeled as either Ice Cream or Frozen Dairy Dessert. The ingredient and nutritional information may have changed. The suggested retail price for Frozen Dairy Dessert varieties is consistent with the current Ice Cream products.

8) Why did Breyers make the change to Frozen Dairy Dessert?

Since 1866, Breyers products have consistently delivered high-quality ingredients, great flavors and smooth creaminess that our fans love, and we remain committed to that Pledge. Our Ice Cream and new Frozen Dairy Dessert varieties continue to use fresh milk, cream and sugar. What distinguishes our Frozen Dairy Dessert from our Ice Cream is that itâ(TM)s blended in a whole new way to create a smoother texture.