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Well, selling what you design might be a little tough.
First off, like cell phones, these things are going to be tied up in all sorts of patents (sure, not as many, but yes, there's going to be license fees).
Second, and the biggie, depending on the type of hearing aid, it requires either a simple 510K filing or a whole Premarket Authorization (PMA), which means clinical trials, proof of efficacy, etc. These are medical devices, and subject to regulation. It's what stops people from selling snake-oil medicines and smartphone apps that cure acne.

Read the FDA regulations: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm127086.htm
It's not cheap to get those done -- there are user fees of $500K and higher for FDA filings.

In the US at least, this is largely a moot point. Lasers of this power are typically used for medical technologies, and can result in health issues (as pointed out throughout the page.) For these reasons, the FDA has the authority to regulate the import of lasers - and they're not too happy with Wicked Lasers (for good reasons, imo).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm234938.htm
I'm having a hard enough time getting a 40lb dye laser through for my research lab (missing line on some paperwork, nearly solved I hope), so the FDA _is_ checking on this stuff. Not saying that none will slip through, but as a matter of course WL's products are now sort of like powdered rhino tusk - illegal to import, pointless to pay for, and sent in hunted shipments.

Or they could just tell the FDA using MedWatch as is noted in every prescription drug fact sheet provided by a pharmacy when filling your prescription.

I really hope that FBers are not so stupid that if they're having an MI or something of a similar caliber they 1) Post on facebook how drug X caused it and then 2) Go to the ER. At least they could do it the other way around - and hopefully throw in 3) report it to the FDA & their doctor in parallel.

There is a recent case that shows the opposite. The FDA wanted to revoke the approval for Avastin for use in metastatic breast cancer threapy due to the severe side effects and almost no measurable benefits, not to mention the expense. But some people went hysterical claiming that the FDA is taking away a valuable drug (lot of name calling and mud slinging there) despite that fact that the drug only made you more miserable while the prognosis did not change. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000352/ http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm193900.htm

Yes, that is the argument the pharmaceutical companies make, for sure. But first, the costs they quote are largely bunk. They say they spend $50M bringing a drug to market, but it doesn't cost $50M to do a clinical trial. It costs $50M to do their massive advertising campaign, political bribery, and to pay for their lawyers.

No, the trials still cost $50M. They spend $500M on the other things (and they only spend it on the compounds that actually work out - the problem with the $50M bit is that it has to get spent many times on compounds that don't work out). However, even if you somehow eliminated the advertising/etc, you still have to pay for all the trials, and that won't happen without either public funding or patents. Suppose a single clinical trial has 10k patients. Suppose they each see a doctor 10 times, with lab tests each time. You're probably going to pay on the order of $100 per patient just for routine labs, and probably $1k per patient to their doctor for their time. That's $11M right there. Clinical trials involve doctors, and very few doctors do anything without getting paid for it (quite a bit). In fact, one of the biggest areas of fraud in the clinical trial industry is doctors signing up inappropriate patients to collect more money - more than a few but not nearly enough doctors have gotten banned from having anything to do with the Drug Industry as a result of this (and they're usually caught and turned in by companies - inappropriate patients just adds cost and noise to the data)..

Learning how to approach treatments differently requires risk and investment in basic research that drug companies increasingly don't want to do. So here we are, perpetuating a broken system and paying through the nose for it instead of trying to come up with a better way.

I'm sure quite a bit of effort goes into this, and I'm all for public spending to improve the situation. However, this is a bit like pointing to fusion as the solution for the world's energy needs. Sure, it is better than what we have, but we don't have it yet. We need a solution for the future, but we need solutions for the present as well. While we're at it, I'm sure that most diseases are better-treated by just fixing their root causes (bad genes or gene regulation) instead of pumping people full of chemicals that have a myriad of side-effects. Again, it isn't this isn't obvious to everybody - but we work with the tools we have.

My personal feeling is that we should leave the industry alone (well, of course with oversight as it already has), and start funding full end-to-end drug development out of the NIH. Anything the NIH comes up with will be licensed royalty-free to any manufacturer (with manufacturers being not held responsible for problems with the drug itself - only with manufacturing issues), which means the pills will be as cheap as aspirin. The NIH could even outsource some of the effort to the drug industry, but this would be a pure fee-for-service model and the NIH would retain patent rights. We can then let this model run for a while and look at the ultimate costs to society. If in the end it turns out to be cheaper to run the NIH than it costs for everybody to pay for the pills, then we just expand the effort and private industry would gradually transform into a government contracting effort (patents wouldn't be abolished, but it will be very hard to sell pills for $5 when the NIH is coming out with them for $0.05 left and right). If the NIH model doesn't work out, well, we're no worse-off than we are now and we haven't gutted the drug industry in the process.

The problem I have with just banning patents/etc is that the likely industry reaction will be to stop developing drugs almost entirely, aside from low-risk lower-cost things like marketing-driven new formulations, combination pills, etc. Maybe the labs will switch to doing other things, bu

Because oranges aren't always orange and they have imperfections. Shipping and storing only exacerbates this. But suppliers noticed that people bought more oranges when they looked "pure" orange. And the FDA allowed it (for whatever reason). Go to an organic food store sometime and look at the produce. You'll think it looks like shit. But it's really just not coated in dye.

Oh, but if the big bad evil government stopped oranges getting coated with food dye then everyone would complain that the nanny state is killing capitalism. So vote with your dollar and be lost in the sea of people who put perception above knowledge.

Why is it that slashdot is all about crowd sourcing things and peer-to-peer distributing the load until it comes to government? Then, suddenly, there's all kind of trust and faith in consolidation of power, authority, (re)distribution of resources, etc..

The fact that there are stores that openly and proudly sells uncolored produce tells me that many consumers know the difference and make a strong choice based upon those differences.

As a person who believes that going against capitalism often has unintended negative consequences, all I really ask to be mandated by government in this kind of case is truth in labeling.

Citrus Red No. 2 which is used to color the oranges you buy in supermarkets.

Why the fuck do oranges have to be coloured? Are oranges not sufficiently orange?

Because oranges aren't always orange and they have imperfections. Shipping and storing only exacerbates this. But suppliers noticed that people bought more oranges when they looked "pure" orange. And the FDA allowed it (for whatever reason). Go to an organic food store sometime and look at the produce. You'll think it looks like shit. But it's really just not coated in dye.

Oh, but if the big bad evil government stopped oranges getting coated with food dye then everyone would complain that the nanny state is killing capitalism. So vote with your dollar and be lost in the sea of people who put perception above knowledge.

you are missing the whole point of slashdot. but for your infornography enjoyment here goes

yes virginia sugar is a Generally Recognized As Safe substance, but it does have drug combination issues. there are a number of drugs and illnesses where sugar is unsafe in combinations. anti-biotics and sugar as well as antihistamines and sugar have drug interaction issues. don't forget diabetics either, they have natural sugar interaction issues.

so if you don't want sugar just say you have medications that interact, or happily find that you are diabetic, your choice. oh and here is how to make sugar more poisons, combine it with bacteria! still GRAS though http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm153929.htm

Your use of the word "generally" means that it isn't always given out. What should those patients do?

I use the word 'generally' only because it is possible the pharmacist could fail to perform their duties properly. If the patient does not receive the pertinent information, then FDA regulations are being violated. The FDA publishes the information as well, and the patient could visit the proper government website on their own; or google search the medicine, and find things like the Slashdot article.

Specifically CFR21:

(a)Highlights of prescribing information . The following information must appear in all prescription drug labeling: [...]
(10)Warnings and precautions . A concise summary of the most clinically significant information required under paragraph (c)(6) of this section, with any appropriate subheadings, including information that would affect decisions about whether to prescribe a drug, recommendations for patient monitoring that are critical to safe use of the drug, and measures that can be taken to prevent or mitigate harm. [...]
(11)Adverse reactions . (i) A list of the most frequently occurring adverse reactions, as described in paragraph (c)(7) of this section, along with the criteria used to determine inclusion (e.g., incidence rate). Adverse reactions important for other reasons (e.g., because they are serious or frequently lead to discontinuation or dosage adjustment) must not be repeated under this heading in Highlights if they are included elsewhere in Highlights (e.g., Warnings and Precautions, Contraindications).

I remember buying a TGI Friday's back of chips from a vending machine. The ingredients claimed it contained 6 servings. Why are they allowed to get away with shit like this? If the fat / sugar / calories sounds too high they increase the number of servings in a packet.

If retailers were forced to separately package each serving (or perhaps be liable for a serving tax), it might make them think a bit harder about the packet size and calorie content in the first place.

The serving size listed on packaging is supposed to be an estimate of how much the person will consume in a single sitting, as defined by the FDA:
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074948.htm#Serving%20Size
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114097.htm
Chips recommended serving size is 30grams. Since the TGI Friday's chips come in 6oz sizes (thats 180g), that is 6 servings.

Did you eat the whole bag fatty?

I remember buying a TGI Friday's back of chips from a vending machine. The ingredients claimed it contained 6 servings. Why are they allowed to get away with shit like this? If the fat / sugar / calories sounds too high they increase the number of servings in a packet.

If retailers were forced to separately package each serving (or perhaps be liable for a serving tax), it might make them think a bit harder about the packet size and calorie content in the first place.

The serving size listed on packaging is supposed to be an estimate of how much the person will consume in a single sitting, as defined by the FDA:
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074948.htm#Serving%20Size
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114097.htm
Chips recommended serving size is 30grams. Since the TGI Friday's chips come in 6oz sizes (thats 180g), that is 6 servings.

Did you eat the whole bag fatty?

http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/SecuritySystems/ucm227201.htm

http://www.tsa.gov/research/reading/index.shtm

Look at, in particular, the radiation safety engineering assessments.

I think we should secure our food from people who might poison it

Don't we already do that? Or is there a whoosh I'm missing?

It's the "logical next step" in all the "break this sticker with a screw hidden underneath and void your warranty" crap.

And of course, it's got 90% of the consumer population so fucking scared that they won't break that sticker even when they need to repair a device that's 5 years old and 4 years, 9 months out of the stupidly short 90-day warranty.

It's the same kind of brainwashing crap you get with expiration dates on bottled water (also found on non-expiring foods/spices such as honey and salt) and stupidly short expiration dates on medicines.

Pop Sci still runs a great "void your warranty" column. I recommend reading it on a regular basis and learning to say "fuck it, void the warranty, I'm going to improve/repair my own fucking property" whenever possible!

Consider, there is no educational or professional certification required to write and sell software that controls an infant incubator used in an NICU

But you do need FDA approval to be allowed to sell the software, which is actually a pretty darned hard hoop to jump through, and it gets harder as it gets more critical to patient safety.

So, there isn't any thimerosal in flu shots? Yes, in all but one (even the one labeled preservative free)
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228#t3

Of course, that's not the pediatric list. This is...and it still contains some thimerosal
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228#t1

The salt analogy is bad, look at my other comments to see why.

So, there isn't any thimerosal in flu shots? Yes, in all but one (even the one labeled preservative free)
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228#t3

Of course, that's not the pediatric list. This is...and it still contains some thimerosal
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228#t1

The salt analogy is bad, look at my other comments to see why.

heres the direct link to the FDA page on Thimerosol:

You get more mercury from a tuna sandwich than you do from vaccines.

Injecting something in a few seconds is quite different from ingesting and digesting over more than a few minutes.

People don't normally inject tuna sandwiches into their bodies. So even if there are 85 micrograms of mercury in the sandwich it's not the same as 25 micrograms of mercury in a vaccine ( http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228 ). And that's assuming a tuna sandwich with 100 grams of tuna at the max mercury levels stated in: http://www.fda.gov/food/foodsafety/product-specificinformation/seafood/foodbornepathogenscontaminants/methylmercury/ucm115644.htm
Note: I'm assuming that a PPM value of 0.118 (the average level) would mean that 100g of tuna will contain 11.8 micrograms of mercury.

The other difference between mass vaccines and most "normal" drugs is, these vaccines are given to very large numbers of people who aren't sick.

So even if the vaccine (whether the preservatives, fillers, active ingredients or contaminants) only harms a tiny proportion of people who somehow don't deal with it well, and so doesn't show up in tests of say 1000 subjects, it can still cause problems when millions get it.

If you inject something into millions of people, why should we be surprised if some people actually have a bad reaction to it, or even deny the possibility of it?

But if the affected are few then it can be considered "collateral damage". It's only not collateral damage if the numbers harmed are greater than the numbers harmed by the disease itself - in which case it becomes a self-inflicted "pandemic".

Basically the safety standards for mass vaccines have to be higher than for "normal" drugs.

You get more mercury from a tuna sandwich than you do from vaccines.

Injecting something in a few seconds is quite different from ingesting and digesting over more than a few minutes.

People don't normally inject tuna sandwiches into their bodies. So even if there are 85 micrograms of mercury in the sandwich it's not the same as 25 micrograms of mercury in a vaccine ( http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228 ). And that's assuming a tuna sandwich with 100 grams of tuna at the max mercury levels stated in: http://www.fda.gov/food/foodsafety/product-specificinformation/seafood/foodbornepathogenscontaminants/methylmercury/ucm115644.htm
Note: I'm assuming that a PPM value of 0.118 (the average level) would mean that 100g of tuna will contain 11.8 micrograms of mercury.

The other difference between mass vaccines and most "normal" drugs is, these vaccines are given to very large numbers of people who aren't sick.

So even if the vaccine (whether the preservatives, fillers, active ingredients or contaminants) only harms a tiny proportion of people who somehow don't deal with it well, and so doesn't show up in tests of say 1000 subjects, it can still cause problems when millions get it.

If you inject something into millions of people, why should we be surprised if some people actually have a bad reaction to it, or even deny the possibility of it?

But if the affected are few then it can be considered "collateral damage". It's only not collateral damage if the numbers harmed are greater than the numbers harmed by the disease itself - in which case it becomes a self-inflicted "pandemic".

Basically the safety standards for mass vaccines have to be higher than for "normal" drugs.

clicked too fast.
Not OSHA, How about the FDA?. Or are they in on the big conspiracy?

The FDA is not a trustworthy organization.

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228

this is a site for adults with a brain.

Since when?

clicked too fast.
Not OSHA, How about the FDA?. Or are they in on the big conspiracy?

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228
Thanks for playing, now go spread your anti-science derp elsewhere, this is a site for adults with a brain.

The simple truth is that people who want to criticize Wikileaks will find justification to do so. The (ostensible) truth is that Assange has not released "everything"; otherwise he wouldn't have a doomsday file. That means that there HAS been some selection, thus there is clearly bias of some kind.

However, under this story I have seen Assange damned both for bias and for not having enough bias, so why even bother to defend him on this basis? You must go another direction, and argue that there is always bias, it is fucking impossible to avoid, and the best situation is when you simply know what it is, which enables you to make an informed reading on a piece of data.

Assange has shown himself to be anti-authority through his actions, and let me say, thank goodness. We need less big authority running around telling people what to do. Government's role should not be to force but to enable. That means making it possible for people to make informed decisions. Unfortunately, the government actively works in the other direction, routinely using government secrecy to hide wrongdoing of the actual constituents, the corporations. Look at the situation regarding milk labeling and rBGH, which has been outright proven to produce inferior product which is substantially, measurably different from milk not produced using the hormones. Yet the FDA continues to be its champion in spite of diehard evidence that it is harmful! Government actively works to hide evidence of wrongdoing that citizens have the right to know about, and it is only through eternal vigilance by people like Julian Assange that we are even able to find out about it at all.

Here is the FDA's response to the letter. http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/SecuritySystems/ucm231857.htm

It seems to me that the organizers of such a system could look for precedent in the medical device industry. There is a central repository for medical device problems, the MAUDE database, that keeps track of adverse events, and is searchable by anyone. Any respectable medical device manufacturer will consult that database to make sure that their new wiz-bang product isn't susceptible to the same failings as existing products, and you can bet the FDA will do the same before approving a new device. Practitioners and users can search the database to see if there are issues with a particular device (or class of devices).

It doesn't mean that problems with medical devices don't still exist, but at least there is mandated uniform reporting.

Another key issue here is that the FDA is empowered to take devices off the market if enough serious problems come up. As far as I know, there is nothing like that in voting systems (but damn well should be).

The difference between Libertarians and anarchists in general is that Libertarians want the government to protect people from other people, with no artificial limits on liability.

Here is an idea that I think we all need to embrace. In fact, I would even extend this to a more aggressive stance, that says that the government should hold companies accountable for all the indirect costs of what they do.

Of course, to play devil's advocate, I can easily imagine that companies will find ways around these kinds of policies. For example, if a mining company wanted to do a very dirty (and cheap) extraction that would poison a nearby stream, which resulted in severe health issues for those downstream, they could potentially establish some kind of temporary company which assumes all liability. Then, when the shit comes crashing down on their heads, they could just fold up the small company, declaring bankruptcy and walking away.

Yes, it may be possible to track down the responsible people and prosecute them, but that would take (potentially) years and years of lawsuits and legal wrangling. Furthermore, in cases like this, the wealthy parent company would be capable of spending a lot more resources in court than would any of the (presumably) less well off people that would be harmed by the mining, which may practically prevent any accountability.

In the end, wouldn't it just be simpler (and prevent less suffering) if there was (in addition to the unlimited liability) a set of rules (ie, regulations) that could prevent this whole ugly situation in the first place?

...but it's not like the government does anything to help this now anyway.

What about the regulations on food package labeling? Isn't that a big help? What about all of the regulations on food safety?

I think it is very disingenuous of you to claim that government does nothing to help you here. Look at all the issues of food safety in China absent any regulations.

Generally speaking, we enjoy a very safe food supply, thanks in large part to the government regulations. If you chucked out all those regulations, the system of checks and balances may kick in to eventually reach some kind of stable equilibrium, but in the meantime, a lot of people will get sick and die from bad food.

Isn't it simpler to try to prevent this in the first place?

Dietary supplements like Herbs are covered under the DSHEA and that changes the rules. Essentially the roles are reversed and the burden falls on the FDA to disprove any claims being made rather than the manufacturer to prove any claims.

http://health.howstuffworks.com/wellness/food-nutrition/vitamin-supplements/fda-regulate-herbal-supplements2.htm

"Herbs' classification as dietary supplements comes from the Dietary Supplement Health and Education Act of 1994 (DSHEA). The act essentially ties the regulatory hands of the FDA. Producers of pharmaceutical and over-the-counter (OTC) drugs alike must first demonstrate that their products are effective and safe. After an average of 8.5 years' worth of tests, conducted first in labs and then in clinical trials at universities, drug producers file an appeal for FDA approval. The FDA then reviews the claims and either approves the drug, classifying it as an OTC or prescription drug. If the FDA doesn't approve the drug, it cannot be sold in the United States. Only about 0.1 percent of the compounds first tested in labs ever receive FDA approval [source: FDA].

There is no similar process for herbs. Under the DSHEA, the burden of proof to demonstrate an herbal supplement or its ingredients are unsafe is transferred from the producer to the FDA [source: Doogan]. Essentially, anyone who can package, market and distribute supplements with herbal ingredients can do so with no oversight by the FDA. As such, herbal supplement manufacturers can make wide claims concerning the benefits their products provide people who pop them. Only after a drug has been proven an "unreasonable" health risk or "imminent hazard to public safety" can the FDA compile a complaint, file it and hope for the best [source: Doogan]."

http://www.fda.gov/food/dietarysupplements/consumerinformation/ucm110417.htm

"Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace."

New dietary supplements still need a sign off from the FDA even if they have no burden to prove their claims. However, the GRAS or "generally recognized as safe" clause exempts supplements with a long history of safe use from even these requirements.

And yes, according to these rules whole marijuana clearly falls into the GRAS food additive category and should be completely unregulated by the FDA. It is improperly classified as schedule I by the FDA in contradiction to their own rules. Even so I believe there are other federal prohibiting marijuana and I know there are treaties we've agreed to requiring such laws.

The bottom line is, if a health benefit is claimed, the FDA classifies it as a drug and regulates it.

Last time I looked, lemons prevent scurvy. Are you telling me vegetables are regulated by the FDA?

First, vegetables are regulated by the FDA. They're regulated as foods. They're not regulated as drugs because they're not drugs. They're foods that happen to contain beneficial chemicals. If you make claims about treating preventing, or curing any disease with a product, the FDA does consider that a drug.

Here you can see an example of a product for which specific claims were made to cure a disease:

Redco Foods: Salada Naturally Decaffeinated Green Tea (promoted for conditions that cause the product to be a drug; unapproved nutrient claim; unapproved health claim); [Emphasis added.]

Foods are not drugs, and if you make treatment claims on a food, it's going to be regulated as a drug (or you'd better remove the claim.

Now, you're free to say, in the abstract, "Lemons prevent scurvy", but if you try to sell lemons with that claim, the FDA will get involved.

That's simply false. Here is the FDA's own definition of a drug:

How does the law define a drug?

The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]. [Emphasis added]

That's why when you see a neutriceutical advertised, they're careful about what claims they make (or, more accurately, what they disclaim). If the compound in question is actually touted as doing something for your health, it has to come under the FDA regulations concerning trials. This commercial is typical of how the companies skirt the issue of effects.

Until last year tobacco was not regulated by the FDA, and I'm pretty sure the active ingredient in it was known to be "potent enough to have an effect on your health" even way back in the dark ages of 2008.

Of course, that's why treatments based on nicotine (and there certainly are some) are classified as drugs, and have been regulated by the FDA for some time now. (Nicotinic agonists are being investigated for things like asthma.

The issue with tobacco is that it's been a long time since cigarette makers have made any claims about the health benefits of smoking. The cigarette companies are now regulated to the extent that they're not allowed to say "light" or "low tar" in their marketing, they have to have larger warning labels, etc. That's quite different from the regulations the FDA puts on other drugs, because the claims are different.

Caffeine, your other example, is also subject to FDA regulation, when it's claimed to actually do something.

To say nothing of caffeine, which is not regulated by the FDA as a drug but as a food ingredient or dietary supplement... like an "herbal".

Caffeine absolutely is regulated as a drug by the FDA, when it's added to a product. There are levels of caffeine recognized as safe by the FDA, and those levels are adhered to. Caffeine drinks (e.g., Red Bull) carefully avoid making health claims, which is why they're not subject to the same testing, but instead are only subject to the regulation about caffeine content. Coffee, as one example, isn't subject to FDA regulation because it's not added, but naturally occurring. This is why the FDA is stepping in with alcoholic drinks that contain caffeine.

The bottom line is, if a health benefit is claimed, the FDA classifies it as a drug and regulates it. If it's not regulated by the FDA, it can't make any health claims (legitimately), and you might as well be eating PEZ.

Until last year tobacco was not regulated by the FDA, and I'm pretty sure the active ingredient in it was known to be "potent enough to have an effect on your health" even way back in the dark ages of 2008.

Of course, that's why treatments based on nicotine (and there certainly are some) are classified as drugs, and have been regulated by the FDA for some time now. (Nicotinic agonists are being investigated for things like asthma.

The issue with tobacco is that it's been a long time since cigarette makers have made any claims about the health benefits of smoking. The cigarette companies are now regulated to the extent that they're not allowed to say "light" or "low tar" in their marketing, they have to have larger warning labels, etc. That's quite different from the regulations the FDA puts on other drugs, because the claims are different.

Caffeine, your other example, is also subject to FDA regulation, when it's claimed to actually do something.

To say nothing of caffeine, which is not regulated by the FDA as a drug but as a food ingredient or dietary supplement... like an "herbal".

Caffeine absolutely is regulated as a drug by the FDA, when it's added to a product. There are levels of caffeine recognized as safe by the FDA, and those levels are adhered to. Caffeine drinks (e.g., Red Bull) carefully avoid making health claims, which is why they're not subject to the same testing, but instead are only subject to the regulation about caffeine content. Coffee, as one example, isn't subject to FDA regulation because it's not added, but naturally occurring. This is why the FDA is stepping in with alcoholic drinks that contain caffeine.

The bottom line is, if a health benefit is claimed, the FDA classifies it as a drug and regulates it. If it's not regulated by the FDA, it can't make any health claims (legitimately), and you might as well be eating PEZ.

Counter to what you say, I would venture to say caffeine is better regulated than most the herbal garbage out there. The Dietary Supplement Health and Education Act of 1994 limits the authority of the FDA in regards to dietary supplements. Its scary but they have more authority over your chocolate milk than your multivitamin. And if for some reason one of these supplements turn out to actually have efficacy then chances are they will be locked down just look at ephedra. From: http://www.fda.gov/food/dietarysupplements/default.htm FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.

It has similar benefits in men (with regards to certain colon and rectal cancers), but since those aren't marketable diseases, they can't be bothered to fucking get the drug approved for use in males.

Your information is out of date. Gardasil was approved for use on men almost a year ago.

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm186991.htm

New laws aren't really necessary, as the existing ones can be used to force additional improvements in this area. The manufacturers of the tubes are already held to FDA 820 for design and development, 21 CFR 820, of which section 820.30 (g) calls out risk analysis during validation. All the FDA has to do is indicate that the risk analysis includes foreseeable misuse which includes incorrect tubing connections, and all manufacturers will have to be able to demonstrate that their device is incompatible with a (justifiable) subset of existing similar tubes.

The FDA is already aware of the adverse events (21 CFR 820.198), and may even see trends. Some of these cases are the result of overstressed individuals, for which better staffing is the best answer. But for some of these cases I'll borrow from Forrest Gump, "How do you fix stupid?"

Moreover, would you want the government backing a specific industry standard for tubing? I can foresee many ways in which that system could be abused. The FDA is hoping someone else steps up and makes it easy for the different manufacturers to cooperate on this.

A really efficient mixed system would be a socialist political system

How wrong can a person be? Socialism is an economic system of state ownership of industry and the political system advocating such an economic system.

Privatization of common goods such as water and health care is a recipe for disaster.

Partially wrong, yes water is a common good but health care and medicine are not. They may be good for the public but they are not common goods. As for privatized medicine being a disaster? HAHA! Take one example, LASIK Surgery. About 10 years ago, in 1999 when this surgery started, LASIK surgery on 1 eye cost about $10,000 but today a good surgeon will perform it for $2000. Prices of $1000 or less can be found too, but I wouldn't trust one without some good and credible references first.

What you have in the US is not a mixed system, it is a corrupted capitalist system.

No, what we have in the US is a mixed system, it's corrupted but it's also mixed. I know, I'm in that system. Because I was disabled in an accident I now collect Social Security Income, a government insurance program. When I worked I had no choice but to pay into Social Security, employers deduct it then give the government the money. Because I am disabled my health insurance is Medicare, another government insurance program. And like Social Security I had no choice but to pay into it, like SS employers deduct money from employees' pay and gives it to the government. Even now I pay into Medicare, again the government deducts some of my SSI as a premium for Medicare.

And don't try to tell me that that is not socialized medicine. If it were capitalist then it would be in private hands.

Now for when I had the accident which caused my disability. At the tyme I was a college student and I was riding my bike after class when I was hit by someone who should not have been driving. After the accident I was medivaced by helicopter to the hospital. After I came out of the coma I was in I was transferred to a rehab house, I survived a TBI, Traumatic Brain Injury. There I went through several weeks of therapy before I was allowed to move into my mother's house. While living with her I went through more therapy. Altogether my medical bills came to more than $120,000. As a student and not working I didn't have insurance and I was not wealthy, but I got all that medical care anyway.

So even those who can not afford medical care still get it in the US. Either government pays or the costs are passed on to those who can afford it or to insurance. Most Americans aren't willing to have someone die just because the person can't pay for medical care. For proof look at 2 examples, St. Jude Children's Research Hospital, started in 1962 by the actor and comedian Danny Thomas. Thinking "no child should die in the dawn of life" he started the hospital which treats children from around the world without asking parents to pay. Then the Ancient Arabic Order of the Nobles of the Mystic Shrine, Shriners for short, operates the Shriners Hos

Perhaps you have magic eyes that can look at a piece of fish and see the mercury in it. Do you have any useful advice (i.e. not platitudes) for those of us with normal vision?

The cocksucking regulators do. As do a large number of medical, consumer, and environmental advocacy groups.

Perhaps this chart helpfully provided by the cocksucking regulators with data going back as far as 1978 would have saved you some grief. Or perhaps the very notion of "I'm going to eat only one thing" might have encouraged a normal person to do some research beyond reading the label on the damn can.

What part of "consult with your doctor before starting any program of diet or exercise" didn't you understand?

And then seriously? Your reaction to your own gobsmackingly foolhardy ignorance about what you put into your body results in you trusting nobody but yourself to supervise your water quality?

Why not simply let it be sold like any other product? I really don't see what the difference is between tobacco/pot compared to corn, beans and other foodstuffs. Alcohol is slightly different because if you screw it up it can have toxic side effects

Poison peanuts, Poison wheat, poison corn. I, for one, am glad there's an FDA. There can be toxic side effects with foodstuffs, too. But IMO there shouldn't be an ATF, the FDA should regulate alcohol products, as well as tobacco and marijuana.

If you'd ever smoked pot laced with jimson weed or animal tranquilizer, you'd see why I'd like it to be legalized and regulated. You can't regulate an illegal product, or control it in any way. The term "controlled substance" is an extreme oxymoron.

Why not simply let it be sold like any other product? I really don't see what the difference is between tobacco/pot compared to corn, beans and other foodstuffs. Alcohol is slightly different because if you screw it up it can have toxic side effects

Poison peanuts, Poison wheat, poison corn. I, for one, am glad there's an FDA. There can be toxic side effects with foodstuffs, too. But IMO there shouldn't be an ATF, the FDA should regulate alcohol products, as well as tobacco and marijuana.

If you'd ever smoked pot laced with jimson weed or animal tranquilizer, you'd see why I'd like it to be legalized and regulated. You can't regulate an illegal product, or control it in any way. The term "controlled substance" is an extreme oxymoron.

New GE plants are tested by the FDA, the NIH, and the EPA.

I got this from "Whole Earth Discipline" by Stewart Brand, page 127. http://books.google.com/books?ct=result&id=1tTtAAAAMAAJ&dq=stewart+brand+whole+earth&q=national+institutes

He seems to be wrong. The NIH has no direct responsibility or authority over foodstuffs. They do regulate gene therapy for humans, but that's completely different thing.

Gene therapy is one area I fully support genetic engineering research, and application.

Here's the real story:
http://www.fda.gov/food/biotechnology/default.htm

The FDA considers GM foods basically safe, and looks over safety tests performed by the company selling the product to ensure they have not overlooked potential dangers. In cases that new proteins or pesticide resistance the burden of proof is much higher then swapping genes already in foodstuff.

Is that the same FDA that approved drugs that were later found to be bad?

I disagree with him on the things that fall outside his expertise of biology and ecology.

I don't see what his qualifications or expertize is on the Google or on the Amazon page. His wiki entry has some info but it doesn't say what those qualifications are either. It says he studied design at an art institute but doesn't say what degree he got if any.

Having said that I like that he worked with The Whole Earth Catalog and started the WELL (which I wanted to join). I wonder what he thinks of (Sittin' On) The Dock of the Bay, I love that song.

For instance, I'm not as convinced nuclear power is our only hope.

I'm a long way from being convinced nuclear power is any hope for energy, instead I believe the oppose and believe that the money used in it's research can better be used in other research. As it is the nuclear power industry is Hooked on Subsidies. The SciAm article A Solar Grand Plan says "A massive switch from coal, oil, natural gas and nuclear power plants to solar power plants could supply 69 percent of the U.S.'s electricity and 35 percent of its total energy by 2050." And the NREL's Wind Energy Resource Atlas of the United States details the wind potential of different regions of the US. One analysis I read of it concluded the Rockies have enough potential to supply the 48 contiguous states with electricity.

The video you link to brought up one problem with alternative energy, the lack of a reliable baseload. However geothermal energy can supply some. And until storage technology is developed that is large scale, natural gas fired and nuclear power plants can be kept online. However which ever way it goes I want to see an end to subsidies whether it's the billion dollars alternative energy gets or the billions more coal, natural gas, nuclear power, and petroleum get. And that includes external costs such as pollution.

Falcon

Oh, on the FDA, I want it abolished. The NIH, which I'd like privatized, can take over some of what the FDA does. As for drug approvals, I believe people should be able to take whatever drug they want without a prescription.

Ah, finally, someone with some sort data to back up their rhetoric. I think yours is the 20th response to what I've posted here, and the previous 19 had no basis for their assertions. Reasonable debate at last ;-)

New GE plants are tested by the FDA, the NIH, and the EPA.

I got this from "Whole Earth Discipline" by Stewart Brand, page 127. http://books.google.com/books?ct=result&id=1tTtAAAAMAAJ&dq=stewart+brand+whole+earth&q=national+institutes

He seems to be wrong. The NIH has no direct responsibility or authority over foodstuffs. They do regulate gene therapy for humans, but that's completely different thing.

Here's the real story:
http://www.fda.gov/food/biotechnology/default.htm

The FDA considers GM foods basically safe, and looks over safety tests performed by the company selling the product to ensure they have not overlooked potential dangers. In cases that new proteins or pesticide resistance the burden of proof is much higher then swapping genes already in foodstuff.
The FDA compliance seems to be optional for plants. There was a proposed law to make it mandatory in 2001, but it never went through as far as I can tell. I guess the "war on terror" and economic downturn did it in. It is mandatory for animals however, and companies usually do submit to the FDA, if only for legal protection of following "best practices" if something does go wrong down the road.

The USDA/APHIS regulates new species, and participates in the process from the first stages of testing. Their primary concern is keeping a "superweed" from being created, and their tests and inspections reflect primarily that. Most notably for consumers, they requires data that

A detailed description of the differences in genotype between the regulated article and the nonmodified recipient organism. Include all scientific, common, or trade names, and all designations necessary to identify: the donor organism(s), the nature of the transformation system (vector or vector agent(s)), the inserted genetic material and its product(s), and the regulated article. ...Describe known and potential differences from the unmodified recipient organism that would substantiate that the regulated article is unlikely to pose a greater plant pest risk than the unmodified organism from which it was derived, including but not limited to: Plant pest risk
characteristics, disease and pest susceptibilities, expression of the gene product, new enzymes, or changes to plant metabolism, weediness of the regulated article, impact on the weediness of any other plant with which it can interbreed, agricultural or cultivation practices, effects of the regulated article on nontarget organisms, indirect plant pest effects on other agricultural products, transfer of genetic information to organisms with which it cannot interbreed, and
any other information which the Administrator believes to be relevant to a determination.

Both safety of the plant and transfer of genetic material are important.
http://edocket.access.gpo.gov/cfr_2008/janqtr/7cfr340.6.htm

The EPA regulates any bioengineered plant that has pesticide like properties. They regulate genes/proteins, and not on the individual plant level.

So there you go. In practice, companies do test bioengineered produce more then traditionally engineered produce, but the human health is the least regulated part of the deal. I would be in favor of all new produce lines, no matter the technique in creating them, be required to have basic testing for nutrition and toxicity. The FDA rejects this, saying it is cost prohibitive.

If his expertise is "spot on" why don't yo

If you're a nerd you've presumably read the FDA's advice on tattoos.. There's no controlled clinical data on the inks or their systemic effects.

You might think that there's good de facto trial data simply because hundreds of millions of tattoos have been given and many of the recipients have lived to ripe old ages. Sounds OK...but since the pigments are unregulated it's not like there's really large populations of known users. And the huge explosion of tattooing over the last few years, and the concomitant arrival of new inks, makes the longitudinal data less relevant.

Plus your skin is designed to keep stuff out. Do you really want to circumvent that? Once it's inside...well read the part about the dyes showing up in the lymph nodes. Who knows what the toxic doses are?

If you're a nerd you've presumably read the FDA's advice on tattoos.. There's no controlled clinical data on the inks or their systemic effects.

You might think that there's good de facto trial data simply because hundreds of millions of tattoos have been given and many of the recipients have lived to ripe old ages. Sounds OK...but since the pigments are unregulated it's not like there's really large populations of known users. And the huge explosion of tattooing over the last few years, and the concomitant arrival of new inks, makes the longitudinal data less relevant.

Plus your skin is designed to keep stuff out. Do you really want to circumvent that? Once it's inside...well read the part about the dyes showing up in the lymph nodes. Who knows what the toxic doses are?

There is a high power laser pointer ban, but the ban is on marketing terms only. Only class 3a or lower lasers (0-5mW) may be marketed as laser pointers. Class 3b and higher lasers (5-500mW) may be sold in a hand-held form, but not marketed as pointers or amusement devices.

More to the point, there are regulatory requirements for features in high power laser devices that are often ignored.
All types of laser devices of any power must be registered with the FDA prior to sale in the US. Note this is registration per product type, not per sale. Class 3b and higher lasers must have a key based lockout, a remote interlock connector, and a warning label affixed to the product. Most importers of cheap chinese lasers of class 3b (>5mW) fall afoul of all of these requirements, and they are often confiscated in shipping with no recourse for the buyer.

http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/LaserProductsandInstruments/ucm116373.htm
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=1040.10

The only class 3b hand-held lasers I've seen recently which meet all the requirements above are sold by wickedlasers.com. In the past year they have added a safety "key" and interlock connector to their class 3b laser products, and they now meet all the legal requirements. Other vendors might also meet the legal requirements, but I have not personally seen any.

There is a high power laser pointer ban, but the ban is on marketing terms only. Only class 3a or lower lasers (0-5mW) may be marketed as laser pointers. Class 3b and higher lasers (5-500mW) may be sold in a hand-held form, but not marketed as pointers or amusement devices.

More to the point, there are regulatory requirements for features in high power laser devices that are often ignored.
All types of laser devices of any power must be registered with the FDA prior to sale in the US. Note this is registration per product type, not per sale. Class 3b and higher lasers must have a key based lockout, a remote interlock connector, and a warning label affixed to the product. Most importers of cheap chinese lasers of class 3b (>5mW) fall afoul of all of these requirements, and they are often confiscated in shipping with no recourse for the buyer.

http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/LaserProductsandInstruments/ucm116373.htm
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=1040.10

The only class 3b hand-held lasers I've seen recently which meet all the requirements above are sold by wickedlasers.com. In the past year they have added a safety "key" and interlock connector to their class 3b laser products, and they now meet all the legal requirements. Other vendors might also meet the legal requirements, but I have not personally seen any.

Yup - clinical trials cost a fortune. Most of the costs of developing a drug are in the trials - tens of millions of dollars each and hundreds of millions of dollars in total (and that is when they're run assembly-line style by organizations that do nothing but run and supply trials 24x7).

I think half of it is essentially corporate welfare for doctors and hospitals. The costs you point out are very real of course. You also need to factor in that if you pay a doctor $100 per visit per subject and somebody else offers $150 per visit per subject then you won't get any subjects. There seems to be a lot more demand for subjects than supply. Of course, the actual volunteers don't see a dime of this money, and chances are their doctor doesn't mention to them that they are recommending experimental treatment A over experimental treatment B because they get more money out of it. Not that doctors would actually do anything like base treatment decisions on their financial interests...

Actually, if you look at the FDA's debarment list (a list of people forbidden to work on pharmaceuticals or trials), you'll find most are doctors. The most typical offense is signing up people for trials who shouldn't be in the trials so that they can get paid all the associated fees. This is bad for everybody. The patient gets experimental drugs that may not help them, or might even hurt them. The pharmaceutical company gets clinical trial data that contains more noise, which means they have to subject even more people to experimental medication to find out if it works or not, and pay more money as a result. The public ends up with less accurate clinical trial data, which might mean that a drug that actually works doesn't get approved (which means people don't benefit from it, or maybe they keep taking inferior drugs that are actually less safe even though the trial data suggests otherwise).

Human clinical trials are a mess. Their ability to generate meaningful data is also very weak compared to things like animal testing. The problem is that they're all we have, so we need to make the most of them.

The GP is right that the only way we can see independent trials happen is if the government funds them - or maybe VERY LARGE charities. I'm all for it - if an independent trial might benefit the public by showing benefit from a cheap "new" drug, or nail the coffin in a bad drug, then let's have it. And I'm generally in favor of drug patents. Competition is always good for consumers and it keeps private companies more honest.

The stem cell transplants currently used for leukemias and lymphomas involves completely eradicating the host immune system through chemotherapy and/or radiation therapy. Then a donor stem cell is implanted and is used to replace the host immune system (which will hopefully be completely eradicated and not pumping out cancer cells). Dr Cui's research is a little different. He is keeping the host immune system intact, but is taking sample immune cells from donors with cancer resistance and injecting them into the host. The goal is that the donor cells will kill the cancer but not the rest of the host's cells which leads to GVHD. This seems to work for solid tumours in rats. A good summary of is research is here.
In the US, the usual FDA process for drug approval is to go through 3 phases of human trials (then a mandatory phase 4 during which adverse event data from the wild is gathered and analyzed). There is a Fast Track program at the FDA for serious diseases where there is a need for treatment options. This allows drugs to get approved faster by skipping steps and using surrogate end points instead of proving complete efficacy and safety.
I'd be interested to hear the reasons that grants were not given to continue this research. It might have something to do with there not being a specific mechanism of action identifiable in his experiments. In his interview he admits that he has no idea why it works, but it seems to work. Sciency people don't like things like that. They probably have a better reason than "it seems a little hokey", though.

If only there were some sort of program to fast track the process through...

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm