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Here's a fun fact to contemplate. The version wandering the US right now is H3N2. The prevalent strain making the rounds in China is H1N1. How long before it crosses the pacific and starts round two of the process. Folks if you haven't gotten vaccinated against this yet. DO IT NOW! These strains are no fun and the current vaccine is supposedly a good match against the strains most prevalent.

Which strains were in this year's vaccine?

Oops, answered my own question:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm315365.htm

Based on that information and the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the strains selected for inclusion in the 2012-2013 flu vaccines are:
A/California/7/2009 (H1N1)-like virus
A/Victoria/361/2011 (H3N2)-like virus
B/Wisconsin/1/2010-like virus.

Horse's Mouth: http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm

Better?

The biggest concern people have is with the thimerosol in the vaccines, which is 50% mercury. They banned thimerosol from contact lens solutions and other products - isn't there some other preservative they could put in vaccines? You have to admit, it's a bit disconcerting to be injecting your newborn with mercury.

Done, with the possible exception of some varieties of the optional seasonal flu shot. The anti-vaccine conspiracy theorists don't care. They've just moved on.

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228#t1

(Strangely, there has not been any corresponding drop in autism diagnoses, although there has been more than enough time for such a trend to become obvious.)

False! why do you spread an urban legend, a rumor, just because you feel it makes you part of the "right" side of an argument?

Get the facts, right from the US government, mercury is STILL USED and is LEGAL in many vaccines

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228#t2

This particular patent fight is also occurring in other places. In the US, there was a decision last year between Pfizer and Teva that was ruled the opposite way, and if no other challenge is successful, I believe Viagra will continue to exist under patent for Pfizer until 2019. At issue is that Viagra really has two patents- one for sildenafil and its formulation into a drug and one for the use of sildenafil to treat erectile dysfunction. Sildenafil was originally developed for blood pressure and cardiovascular disease, so the application for the ED indication patent trailed the formulation patent by several years. The formulation patent expired this year, but the indication patent lasts until 2019. In the US, a regulatory framework known as a Paragraph IV challenge exists for generic drug manufacturers to either argue that their proposed generic does not violate the existing patents, or that the patents themselves are invalid. This potentially allows them to open up the generic market years before the patent was originally set to expire, so this sort of legal action is not uncommon, particularly for blockbuster drugs.

I don't see any mention in the article that having the device connected to IP is causing the issue. Sounds like a touchscreen / code issue. The FDA's article also doesn't specify anything other than that.
Hospira has completed an investigation into customer reports and has found the major contributor to be software related. Other contributing root causes that have been identified include damaged connections, physical damage and other touch screen defects.

It would be nice if the article would stick to the point and not confuse issues.

The problem is people using statistics to lie. I'm helping fix that. There's another problem of having harmful side effects, but I'm not involved with that problem any more.

If so many people died, and those drugs could affect their health, it means drugs could have deteriorated health at most that much. The system is intentionally designed to collect every possible side effect incident, so doctors know what to look out for. It is not designed to tell doctors "this is exactly how bad this drug is" (that is, in fact, one goal of the project I used to work on).

As someone else mentioned, many of the people whose deaths are recorded as being related to drugs are already in a hospital to begin with. There is no sure-fire way to know whether a particular drug caused their death, or simply didn't do enough to keep them alive.

Yes, we would rather have inflated numbers, but only with the full knowledge that those numbers are inflated, and how they're inflated. As an example of how these numbers should be quoted, look at their source. Refer to the FAERS data. Note the description right up top:

Documenting one or more of these outcomes in a report does not necessarily mean that the suspect product(s) named in the report was the cause of these outcomes.

Pepper spray is regulated.

Not in most states in the US.

Meanwhile, lasers really /are/ regulated:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=1040.10

Thus making you, once again, the idiot.

While a ph of 2.5 in Coke Classic is a little on the high(or low if you are so inclined) side for most canned foods, Cola is not cooked and processed inside of the cans and at most gets heated to only environmental temps during shipping...that being said most canned vegetables, sauces and fruits are usually at a ph of 4.6 or less and then pressure cooked with at least 1 bar(15 psi) which raises the temp to a little over 250 F from anywhere between 5-90 mins depending on the contents....BPA leaches better at low ph and high heat...

The problem is two fold 1] the BPA lining until about 2 years ago was the only lining approved to be used for human consumption by the FDA and the new BPA free liners were only used in very few products( Muir Glen, Eden Foods, and small seafood operations)...withe addition of Cambell's and a large portion of Conagra foods making the switch the industry is making strides to improve the situation. 2] the FDA still says that BPA is generally recognized as safe (GRAS) But until the FDA stops talking out of both sides of its mouth then they can get down to make the industry fix this idiocy. As it stands the FDA's official position as stated by its regulations the BPA containing polymers and the leeching into the food supply is still GRAS

here is the FDA in April saying BPA is bad m'kay http://www.fda.gov/newsevents/publichealthfocus/ucm064437.htm

here just a month earlier BPA is A OK http://www.fda.gov/Food/FoodIngredientsPackaging/ucm166145.htm

and now in July https://www.federalregister.gov/articles/2012/07/17/2012-17366/indirect-food-additives-polymers BAN it!!!(but only for babies and toddlers)

While a ph of 2.5 in Coke Classic is a little on the high(or low if you are so inclined) side for most canned foods, Cola is not cooked and processed inside of the cans and at most gets heated to only environmental temps during shipping...that being said most canned vegetables, sauces and fruits are usually at a ph of 4.6 or less and then pressure cooked with at least 1 bar(15 psi) which raises the temp to a little over 250 F from anywhere between 5-90 mins depending on the contents....BPA leaches better at low ph and high heat...

The problem is two fold 1] the BPA lining until about 2 years ago was the only lining approved to be used for human consumption by the FDA and the new BPA free liners were only used in very few products( Muir Glen, Eden Foods, and small seafood operations)...withe addition of Cambell's and a large portion of Conagra foods making the switch the industry is making strides to improve the situation. 2] the FDA still says that BPA is generally recognized as safe (GRAS) But until the FDA stops talking out of both sides of its mouth then they can get down to make the industry fix this idiocy. As it stands the FDA's official position as stated by its regulations the BPA containing polymers and the leeching into the food supply is still GRAS

here is the FDA in April saying BPA is bad m'kay http://www.fda.gov/newsevents/publichealthfocus/ucm064437.htm

here just a month earlier BPA is A OK http://www.fda.gov/Food/FoodIngredientsPackaging/ucm166145.htm

and now in July https://www.federalregister.gov/articles/2012/07/17/2012-17366/indirect-food-additives-polymers BAN it!!!(but only for babies and toddlers)

And it is not used in US vaccines for some time now.

Thimerosal is in flu shots. We can get them at the drug store (which is also the pharmacist) or the supermarket. Thimerosal is only used for multi-use vials here. "all vaccines routinely recommended for children 6 years of age or younger and marketed in the U.S. contain no thimerosal or only trace amounts (1 microgram or less mercury per dose), with the exception of inactivated influenza vaccine, which was first recommended by the Advisory Committee on Immunization Practices in 2004 for routine use in children 6 to 23 months of age." So there you have it...

And it is not used in US vaccines for some time now.

Thimerosal is in flu shots. We can get them at the drug store (which is also the pharmacist) or the supermarket. Thimerosal is only used for multi-use vials here. "all vaccines routinely recommended for children 6 years of age or younger and marketed in the U.S. contain no thimerosal or only trace amounts (1 microgram or less mercury per dose), with the exception of inactivated influenza vaccine, which was first recommended by the Advisory Committee on Immunization Practices in 2004 for routine use in children 6 to 23 months of age." So there you have it...

Too Late

The issues with antidepressants aren't just hypothetical. The FDA found reports of suicide associated with antidepressant use serious enough to include a "black box" warning to the effect that antidepressants can cause an increase in suicidal thinking.

I was talking about the book he mentioned (Anatomy of an Epidemic). Note that the black box warning only applies to people under 24 years of age.

Another issue- when given to people with bipolar disorder, antidepressants can actually cause mania, and some researchers believe this can cause the disorder to actually get worse over time ... Another issue is that antidepressants can cause what they call discontinuation syndrome- that is, withdrawal effects.

To add to this, if you go on medication it is very important to follow up with your psychiatrist regularly. In particular, do not abruptly stop taking your meds. Call your doctor first. This applies to any prescription drug, not just antidepressants.

I'm not saying you should never take antidepressants, but these are very powerful chemicals we're talking about, so you really need to be careful. That means be sure you're working with a good psychiatrist, not your primary care physician, who simply does not have the know-how to diagnose and treat serious mental illnesses. That means doing a lot of reading as well- educate yourself about what you're up against and what the treatments are.

I agree with this 100%. You are responsible for your own health. Only you can decide what risks and side effects are acceptable. Personally, I find years or decades of misery to be a much worse option, but everyone has to make that choice for themselves.

And it's a good idea to consider the various alternative/complementary treatments ... the evidence for these things isn't fantastic (although that could be because there's not a multibillion dollar fish-oil industry sponsoring clinical research)

Actually, there is a multi-billion dollar industry. There are a lot of alt medicine journals popping up (mostly because the research didn't pass muster at real journals). They even have federal research grants. Again, it's a personal choice, but I'd say if you're worried about vitamin levels go get your blood tested.

Please don't spread stupidities like these. Fibromyalgia may not be a disease, but that doesn't mean it's automatically a "psychiatric problem".

Disclaimer: I'm a software architect, not a doctor, and have never had a passing grade in biology.

My mother was diagnosed with fibromyalgia roughly 15 years ago. I may not like the woman, but I have to speak up for people who suffer from this syndrome; because whether or not it is related to some "psychiatric problem", these patients suffer tremendously. This is only worsened by the fact that a great number of doctors and institutions not only "don't believe" in the syndrome, they won't even acknowledge it, or attempt to help.

My understanding is that we don't have a fucking clue where it's coming from. Some people believe it's purely psychiatric (exhibit A, parent post), others believe it's purely physical (problem in the muscles and soft tissues themselves), others believe it's a nervous system problem (aka "Central Sensitisation Syndrome"), and others believe it may come from the way the brain interprets the signals coming from the nervous system. The FDA writes on its website it may be caused by "injury, emotional distress, or viruses that change the way the brain perceives pain". Which is the bureaucratic equivalent of "Fuck, if I know!"

The problem, for the patients, is that when they go to their GP, he will recommend some drugs. In my mother's case, I've seen *a lot* of anti-depressants (tricyclics, SSRIS and SNRIs, sometimes combinations of these), anti-convulsants (Lyrica, some forms of gabapentin, Rivotril (clonazepam)...) in *massive quantities*, and painkillers, in even greater quantities (Morphine patches, codeine, paracetamol and coproxamol tabs by the bucket).

There is no supervision, control nor regulation as to how much the patient takes, because doctors have no clue what to do. Her GP, for a long time, was a "pain management" aficionado, which basically meant "just tell me what you need, and I'll write it down on the prescription pad"; not because he was an incompetent idiot, but he was simply at a loss as to what to do.

What do I mean by "no supervision nor regulation"? Patients are routinely indicated to "take as many as you need". My mother has been *addicted* to Rivotril for nearly a decade, where instead of the 45 drops a day she was supposed to take, she would drink from the little bottle directly. Rivotril was banned in the country she resides a few months ago, for non-epilepsy cases. I don't know whether it's physically possible to be addicted to clonazepam, but that one was a tough habit to kick.

As for her GP, when he asked for help from colleagues, they would get a copy of the medical file, and _refuse_ consults. Then comes the referral game. GP sends patient to a rheumatologist, great. He takes a couple of scans, notices some bone decay, arthritis, and whatnot, and sends her off with another bag of drugs. Because the patient is high on meds 24/7 (and hence, can suffer from a lot of side effects, such as memory loss, speech impairment, etc), they get sent to a neurologist, to see if he can figure something out, who then prescribes something else. The neurologist then decides to test her levels of substance P, because not being a "believer in fibromyalgia", the pain has to "come from somewhere". The levels fluctuate, but not in sync with the pain crises that most fibromyalgia patients experience, which discredits the patient even further.

It is true that a great number of fibromyalgia patients suffer from depression, anxiety or even PTSD, but considering these are people who feel pain every second of every day and night, that's not something I'm very surprised about. The pain and sleep disturbance make it very difficult for fibromyalgia patients to behave normally in society, and function correctly with the rest of the working crowd (going out for drinks, inviting people

Nope. There's a third option.

Most drugs aren't life-saving. Even a successful cancer drug like bevacizumab (Avastin) extends life in metastatic colorectal cancer by about 3 months, as I recall. (It costs $100,000 for that treatment, so you're buying life at $400,000 a year.) It's very frustrating to read the New England Journal of Medicine about a successful new drug that only extends median survival from, say, 12 months to 16 months. So people with metastatic colon cancer haven't been dying over 7.3 years for lack of a new drug. They've lost (at best) 3 months.

A lot of the new drugs (like Avastin) have life-threatening adverse affects. For example, there are anti-immune drugs that are used to prevent rejection in kidney transplants. If you don't give enough, the kidney is rejected. If you give too much, the patient can't fight off infections and dies. There's an anti-immune drug for multiple sclerosis that is very effective against multiple sclerosis, but frequently allows a normally dormant virus to activate with an incurable fatal brain infection.

After the Food and Drug Administration Safety and Innovation Act was passed, which allowed pharmaceutical companies to pay user fees to get their drugs approved more quickly, the FDA did approve drugs much faster. However, they also approved a lot of drugs that turned out to kill more people than they saved, like Rosiglitazone and Vioxx.

Most of the doctors who follow this issue, who made FOIA requests and read the internal FDA debates, believe that the FDA approved these dangerous drugs because they were under more pressure to approve new drugs faster. Vioxx is a good example. It wasn't a life-saving drug; it was a treatment for the pain of arthritis, and wasn't any better than competing drugs. They got it to market faster and it killed people.

When we loosen regulations, and pressure the FDA to approve drugs faster, we get more drugs that kill people and we don't get any miracle drugs that save lives.

(Can't blame the Republicans for this. The SIA was a bipartisan bill, BTW, and some Republicans actually opposed it.)

This isn't a randomized controlled trial, It's more like a historical control. But it's the best evidence we've got. And it's better evidence than Peltzman had.

And besides, when we do get a new drug that's really promising, the FDA puts it on a fast track and approves it as quickly as possible -- consistent with careful science. Their average approval time is under 7 months. http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm (And I don't know where you got that 7.3 years from. This table says it took 1 year in 1998. You may be counting the entire development time from patent to FDA approval.)

I think economists like Peltzman get things completely wrong because they create a free-market economic model for widgets and plug drugs into their model. I once read a book called Structure of the Chemical Processing Industry. They made the point that products aren't widgets. The pharmaceutical industry has a different structure than the automobile industry. Significantly, most customers don't have enough information to know whether a drug is effective. Significantly, the human (or mouse) body is much more complicated than cars, and there's no predictable way to find new drugs. Significantly, you can spend billions of dollars (as we did with the AIDS vaccine), and get nothing. Significantly, most pharmaceuticals depend on basic research by scientists who usually don't profit directly from the final drug. Significantly, most of that basic research is funded by the government.

Peltzman's theories about how the free market works don't correspond to reality. That's the point in science. You do need specific examples -- empirical evidence.

Speaking for Krugman, he never said, "the government is so wonderful"

With regards to regulatory bodies such as the FDA and FCC, his general philosophy is to look at the good they do versus the harm. The FCC and FDA certainly have done some good things (such as stopping a few instances of mouse poop in your food) but there is a huge heaping mound of harm they have done. Milton Friedman lays out a good case against those regulatory bodies and details some of the harm they have brought about. This includes sentencing people to death by not approving medication because their disease was too rare to deserve a cure because someone without the disease might accidentally take the medicine and be harmed by it. Spending $100 million (due to FDA regulations) to approve medicine to cure a disease only thousands suffer from isn't worth the risk to the FDA. They likely have saved hundreds or thousands of peoples lives by forcing stricter testing standards but they have likely killed or harmed millions, if not more, by preventing some safe and effective treatments from coming to market.
The FDA has tried to be better in this area (most of Milton's criticisms were from the 70's on back): http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
but is still a good illustration of the types of serious problems these regulatory bodies create. Could you argue against all of this and disagree with it? Certainly. Is it nutty, unfounded, and/or irrational? Hardly.

Luddites?

http://www.huffingtonpost.com/2010/01/19/monsanto-gm-corn-causing_n_425195.html

http://www.huffingtonpost.com/jeffrey-smith/genetically-modified-soy_b_544575.html

http://www.mindfully.org/GE/2005/Modified-Soya-Rats10oct05.htm

basically, no one does ANY testing, they just trust that Monsanto says that it is safe,

http://www.fda.gov/Food/Biotechnology/Submissions/ucm161107.htm

And please, don't get me started about "nature does it for millennia" bullshit. Nature does not insert random genes from some weird funguses or fish into corn (or other plants).

The natural world will have NO PROBLEMS paying the price in working around these new toxins in the plants. It will take a few years and hundreds of generations of critters, but they will adapt. Are we willing to pay the same price too? Sooner or later, we may just find our that our improved food is killing us and we don't know why.

We have evolved to eat the food we have available, not the other way around. We are FAR away from an understanding how our body works completely. We know the big picture, but that's it. So please, don't call people that question our "perfect understanding of nature" into question. You just sound like those stupid people,

http://science.slashdot.org/story/12/06/12/2148229/why-smart-people-are-stupid

I don't want to get gangrene from my prescription obtained from Finland.

Don't worry, you can still get gangrene from your prescription obtained in the good old USA. There are over two million adverse drug reactions to FDA approved drugs per year.

Class I is as easy as it gets, considerably cheaper to paper up for the FDA than Class III stuff like cochlear implants. Thermometers and blood pressure cuffs are Class I.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm127086.htm

The regulatory definition of a class I hearing aid is codified as follows:

21 CFR 874.3300 Hearing Aid
(a)Identification. A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400).
(b)Classification. (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9.
(2) Class II for the bone-conduction hearing aid.
The regulatory definition of a class II air-conduction system is as follows:
21 CFR 874.3950 Transcutaneous air conduction hearing aid system.
(a)Identification. A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal.
(b)Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled "Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA." See 874.1 for the availability of this guidance document.

How do I know you didn't just fake your data completely? Or the analysis? The average researcher who doesn't know how to do multiple comparison correction properly doesn't just publish their significant result, they publish everything they tried, in a great big table, and it's blindingly obvious what they did. There probably is some fraud going on, but it's in the same category with outright fakery - either it gets uncovered over time or everybody publishes all their data.

The FDA modernization act of 1997 requires that all trials of interventions to treat life threatening diseases be registered no later than 21 days after a trial is opened for enrolment. For other agents, even though the trial might not be required to be registered, it's unlikely either the FDA or an ethics review board would accept a major trial that had not been registered. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126838.pdf

Even without trial registration, a (blinded) randomized clinical trial is the best source of evidence. These by definition are planned in advance, including a hypothesis and a planned analysis. Yes, inconclusive results (NOT negative results) might not be published. But in any other form of scientific study, inconclusive results are unlikely to be published, hypotheses are frequently made up after the fact, AND the analysis is often ad hoc.

I'd love to see those regulations. As far as I know, the FDA basically said said that they frowned on those labels, because the term GMO indicated modification (which describes everything) not engineering (in the case where the term GMO or genetically modified is used), and also because they don't like labels that have the implication that something is superior when in fact there is no difference, and a few other reasons that the label can be misleading (like if a bottle of pure orange juice said it was non-GMO, when there are no GE oranges). However, they have not banned it, merely expressed disapproval. I agree it would not be justified, just as I do not feel going the other way and forcing labeling of either containing or not containing GE ingredients is justified.

I don't get how so many people can keep making that claim. Have you been to a grocery store at all? there's plenty of products that say 'contains no GMOs' or 'Contains no genetically engineered ingredients.' There's also the organic label, which is a bit different in that it also covers cultivation practices, but it guarantees that the crops are not GE. If I would have known so few people paid attention to this I would have bought a few and uploaded pictures to link to.

You could at least link the FDA's guidelines instead of a summary of an article about why they suck.

Turns out:
* FDA opposes GMO for most food, because most food doesn't contain any organisms, only parts of them.
* FDA opposes GM/GMO because it's an acronym, and we must coddle the dumb people. (Which I generally hate, but for food labeling, I'm almost sympathetic...)
* And the big one, FDA opposes "genetically modified" because "modification" literally includes hybridization and selective breeding as well as direct modification, and suggests terms like "genetically engineered", "developed using biotechnology".

Since anti-GMO folks hate it when proponents go for the semantic win to point out that crops have been genetically modified for millennia instead of arguing the substance, you'd think they'd have dropped that losing name in favor of "genetically engineered" years ago. Now the FDA is making them, and... all they wanna do is bitch.

About the only things that deserve patents are fundamental discoveries and drugs that are unique and cost hundreds of millions to develop and test. And even then, just provide some kind of "formula patent" that only lasts 5-6 years.

Abolish patents entirely and replace private research with publically funded research. The hard work (discovering new drug targets) is done by the NIH anyway. All pharma does are the clinical studies which are pretty much rote. They could easly be done by the public as well. And if we take the profit motive out of the situation, maybe we won't see 100,000 annual deaths due to adverse drug reactions.

Patents exit to encourage private investors to invest in research. But if we directly fund research, we need no patents. The best part is that when the public does all the work, we'll get to keep all the profits too.

If you're going to stick it in your coronary artery, your cardiologist probably wants to know that people smarter than him have spent a lot of time asking a lot of hard questions about it.

We are talking about a government agency here... Or were you going for the +5 funny?

Last time I checked neither x-ray machines nor CT scanners are considered food or drug so why is the FDA involved? I could see the FCC or OSHA but not FDA.

In addition to drugs, the FDA is also responsible for clearing medical products and devices.

Here's this year's list of newly-approved devices so far. If you're going to stick it in your coronary artery, your cardiologist probably wants to know that people smarter than him have spent a lot of time asking a lot of hard questions about it.

Not every device gets the full treatment. But even if you're coming up with a minor tweak to something that's comparatively low risk, it must be cleared under section 510(k): last month's cleared devices. The paperwork's simple compared to a new device approval, but even the 510(k) clearance process means that something as simple as "STERILE LUBRICATING JELLY" is sterile, biocompatible, made in a factory that follows good manufacturing processes, etc.

If it sounds like a horrendous amount of paperwork, well, it is. But the alternative - random uncleared devices without even the practicioner knowing what's in them - is far, far worse. There's a reason that both prescription and over-the-counter medications have standard packaging and labeling requirements, undergo multiyear-long clinical studies, and take the better part of a billion dollars and a decade to bring to market, and why quack 'supplements' advertised on TV and in your email's spam filter have a big disclaimer that "this product is not intended for the diagnosis and treatment of any disease".

If it sounds like TSA used the loophole of "these backscatter X-ray machines aren't intended for the diagnosis and treatment of any disease" in order to circumvent FDA scrutiny, well, I'd have to agree with you there, too. But what's more important: the health of the traveling public, or securing cushy careers for HomeSec bureaucrats?

Last time I checked neither x-ray machines nor CT scanners are considered food or drug so why is the FDA involved? I could see the FCC or OSHA but not FDA.

In addition to drugs, the FDA is also responsible for clearing medical products and devices.

Here's this year's list of newly-approved devices so far. If you're going to stick it in your coronary artery, your cardiologist probably wants to know that people smarter than him have spent a lot of time asking a lot of hard questions about it.

Not every device gets the full treatment. But even if you're coming up with a minor tweak to something that's comparatively low risk, it must be cleared under section 510(k): last month's cleared devices. The paperwork's simple compared to a new device approval, but even the 510(k) clearance process means that something as simple as "STERILE LUBRICATING JELLY" is sterile, biocompatible, made in a factory that follows good manufacturing processes, etc.

If it sounds like a horrendous amount of paperwork, well, it is. But the alternative - random uncleared devices without even the practicioner knowing what's in them - is far, far worse. There's a reason that both prescription and over-the-counter medications have standard packaging and labeling requirements, undergo multiyear-long clinical studies, and take the better part of a billion dollars and a decade to bring to market, and why quack 'supplements' advertised on TV and in your email's spam filter have a big disclaimer that "this product is not intended for the diagnosis and treatment of any disease".

If it sounds like TSA used the loophole of "these backscatter X-ray machines aren't intended for the diagnosis and treatment of any disease" in order to circumvent FDA scrutiny, well, I'd have to agree with you there, too. But what's more important: the health of the traveling public, or securing cushy careers for HomeSec bureaucrats?

Last time I checked neither x-ray machines nor CT scanners are considered food or drug so why is the FDA involved? I could see the FCC or OSHA but not FDA.

In addition to drugs, the FDA is also responsible for clearing medical products and devices.

Here's this year's list of newly-approved devices so far. If you're going to stick it in your coronary artery, your cardiologist probably wants to know that people smarter than him have spent a lot of time asking a lot of hard questions about it.

Not every device gets the full treatment. But even if you're coming up with a minor tweak to something that's comparatively low risk, it must be cleared under section 510(k): last month's cleared devices. The paperwork's simple compared to a new device approval, but even the 510(k) clearance process means that something as simple as "STERILE LUBRICATING JELLY" is sterile, biocompatible, made in a factory that follows good manufacturing processes, etc.

If it sounds like a horrendous amount of paperwork, well, it is. But the alternative - random uncleared devices without even the practicioner knowing what's in them - is far, far worse. There's a reason that both prescription and over-the-counter medications have standard packaging and labeling requirements, undergo multiyear-long clinical studies, and take the better part of a billion dollars and a decade to bring to market, and why quack 'supplements' advertised on TV and in your email's spam filter have a big disclaimer that "this product is not intended for the diagnosis and treatment of any disease".

If it sounds like TSA used the loophole of "these backscatter X-ray machines aren't intended for the diagnosis and treatment of any disease" in order to circumvent FDA scrutiny, well, I'd have to agree with you there, too. But what's more important: the health of the traveling public, or securing cushy careers for HomeSec bureaucrats?

Last time I checked neither x-ray machines nor CT scanners are considered food or drug so why is the FDA involved? I could see the FCC or OSHA but not FDA.

In addition to drugs, the FDA is also responsible for clearing medical products and devices.

Here's this year's list of newly-approved devices so far. If you're going to stick it in your coronary artery, your cardiologist probably wants to know that people smarter than him have spent a lot of time asking a lot of hard questions about it.

Not every device gets the full treatment. But even if you're coming up with a minor tweak to something that's comparatively low risk, it must be cleared under section 510(k): last month's cleared devices. The paperwork's simple compared to a new device approval, but even the 510(k) clearance process means that something as simple as "STERILE LUBRICATING JELLY" is sterile, biocompatible, made in a factory that follows good manufacturing processes, etc.

If it sounds like a horrendous amount of paperwork, well, it is. But the alternative - random uncleared devices without even the practicioner knowing what's in them - is far, far worse. There's a reason that both prescription and over-the-counter medications have standard packaging and labeling requirements, undergo multiyear-long clinical studies, and take the better part of a billion dollars and a decade to bring to market, and why quack 'supplements' advertised on TV and in your email's spam filter have a big disclaimer that "this product is not intended for the diagnosis and treatment of any disease".

If it sounds like TSA used the loophole of "these backscatter X-ray machines aren't intended for the diagnosis and treatment of any disease" in order to circumvent FDA scrutiny, well, I'd have to agree with you there, too. But what's more important: the health of the traveling public, or securing cushy careers for HomeSec bureaucrats?

Let me guess... you're not a chemist. Because, if you were, you would know that the hydrogenation process converts unsaturated fats into saturated fats. "Trans fats" are unsaturated fats (seriously, even if you knew nothing about "trans fats", it's clearly on the first paragraph of the wikipedia article).

The problem is not "hydrogenation", it's "partial hydrogenation".

Lucky guess! I am indeed not a chemist!

The very first section of the Wikipedia article on Hydrogenation states:

Hydrogenation of unsaturated fats produces saturated fats and, in some cases, trans fats.

Surely a professional chemist like yourself can fix the Wikipedia article to make it less ambiguous. And there are plenty of other references around that say that transfats from from a Hydrogenation process.

While it may be true, if somewhat pedantic, to claim that only "partially hydrogenation" creates trans fats, it seems that I'm not alone in using "hydrogenation" as a generic term to describe the process.,

And, in the end, the problem is neither "trans fats" nor saturated fats... the problem is that people have no restraint. Our bodies are made to tolerate saturated fats, because we've been having saturated fats for thousands of years (see "butter"). Of couse, if your idea of a nice afternoon is stuffing your face with fatty food, you're bound to get health problems, even if you're having fully-cis unsaturated fats. Both trans fats and saturated fats (like cholesterol) are REQUIRED for normal functioning of your cells: the problem is, again, that people have no fucking restraint.

Wait a second - you say that trans fats are REQUIRED, yet the very Wikipedia article that you told me I'm too lazy to read says "Their recommendations are based on two key facts. First, "trans fatty acids are not essential and provide no known benefit to human health",[1] whether of animal or plant origin". Did you even read the shit that you told me to read? That particular quote came from the National Academy of Sciences.

I went to the paper, expecting to find a fairly high powered laser that is not a pointer, and expecting to call someone out on calling them pointers. However, they're only 5 mW, which is indeed a pointer. Cool that they can use such low powered lasers for this.

The FDA has regulations in the U.S. saying that no laser products over 5 mW may be marketed as "pointers":

Class IIIb lasers cannot legally be promoted as laser pointers or demonstration laser products.

Not according to the FDA page on it.

...because of the increased number of thimerosal containing vaccines that had been added to the infant immunization schedule, concerns about the use of thimerosal in vaccines and other products have been raised ... Thimerosal has been removed from or reduced to trace amounts in all vaccines routinely recommended for children 6 years of age and younger, with the exception of inactivated influenza vaccine

So it is rarer, and in lower amounts, but it is still present. And that only applies to "routinely recommended" vaccines but not all childhood vaccinations. Sorry if it sounds like I am nitpicking, but I don't want people to believe that it is totally gone.

Now, I understand the science behind vaccination, and am actually PRO vaccine, but when you can the ingredients to a box of cereal, but NOT the ingredients to a shot your a directly injecting into your infant, and more importantly a giant mega-corporation's shot with a proven track record of including known toxins like mercury.....

Sure, there is ignorance out there, but blaming parents who want to protect their children is stupid. Blame the giant corporations who included mercury in the shots in the first place.

According to the FDA and Wikipedia the only commonly recommended vaccination for children under 7 years of age that still contains Thiomersal is an Influenza vaccination for children over 2 years of age.
That suggests that those parents were not only panicky and over-reacting, but also over-generalizing and uninformed.

Also, I am pretty sure that manufacturers are not allowed to put inactivated viruses inside a box of cereal they intend to sell in stores, but that inactivated virus is the entire point of a vaccine, making your box of cereal example less than useful.

Finally, the reason that those Evil Giant Corporations put it in those vaccines in the first place might not be quite so evil...

Thiomersal's main use is as an antiseptic and antifungal agent. In multidose injectable drug delivery systems, it prevents serious adverse effects such as the Staphylococcus infection that, in one 1928 incident, killed 12 of 21 children inoculated with a diphtheria vaccine that lacked a preservative.[4] Unlike other vaccine preservatives used at the time, thiomersal does not reduce the potency of the vaccines that it protects.

(this is the first three sentences of the Use section of the Wikipedia Thiomersal article)

References:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228
http://en.wikipedia.org/wiki/Thiomersal

There are three types of drug ads in the US - http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/default.htm

The ones that mention both the drug and what it is indicated for are called Product Claim Ads and must enumerate the benefits and the risks including potential side effects. Reminder Ads give the drug's name but not what it is indicated for and Help-Seeking ads describe a condition does not recommend or suggest a specific drug or drugs.

inertia.

No - cost.

Hospitals have strict budgets and have to penny pinch. The software vendors charge a ludicrous amount for their software - so much that the hospital admins cringe and have a very hard time finding the money. And with these hard times, hospital revenues are in a huge slump - all those unemployed people have lost their health insurance and therefore can't pay their hospital bills - which the hospitals eat much of it. (COBRA is obscenely expensive and if you have a "preexisting" condition, you can't get cheaper insurance or any insurance for that matter; so millions of people go without even when they can afford health insurance.)

To head off the "software vendors have to worry about lawsuits and that's why they charge so much!"

No they don't. They have no more product liability costs than any other company and as far as FDA requirements, they've actually reduced some of the regulation.

If the product is being sold in the US, at least, there may be quite specific reasons why it is 'homeopathic' and why it is sold as such.

Under the Federal Food, Drug, and Cosmetic Act, which established the FDA and its regulatory authority, Homeopathic drugs are a distinct regulatory class. Further(presumably because so much homeopathy is conducted with concentrations indistinguishable from water) the regulations are significantly looser than for conventional drugs. You have to follow some basic accuracy in labelling stuff, and meet strength and purity standards(though per "Section 211.165 (Testing and release for distribution): In the Federal Register of April 1, 1983 (48 FR 14003), the Agency proposed to amend 21 CFR 211.165 to exempt homeopathic drug products from the requirement for laboratory determination of identity and strength of each active ingredient prior to release for distribution.Pending a final rule on this exemption, this testing requirement will not be enforced for homeopathic drug products." you don't actually have to verify the strength and purity before sale).

For this reason, if you want to sell something that is listed in the Homeopathic Pharmacopeia of the United States and its supplements(there are lots of things listed in here...), at a concentration that can be expressed in one of the traditional homeopathic dilution levels(nX, nD, nC, nM, etc.) you can more or less knock yourself out with only the slightest of scrutiny.

In many cases, this does result in the classic overpriced distilled water scenario. It doesn't take many 1:100 or 1:1000 dilutions before even an analytical chemist with an unlimited budget would despair of determining what you were originally diluting(in the case of things like homeopathic plutonium, this is good.) However, "1X", a fairly stiff 10%, is also a perfectly legitimate homeopathic dilution, albeit not one that true homeopathy enthusiasts would tend to view as potent.

The most notorious case of this being Bad is probably 'Zicam', where intranasal administration of 10% zinc gluconate turned out to occassionally destroy the unlucky user's sense of smell. Oops.

In this case, stripped of the 'homeopathic' wording, the spray looks like a fairly plausible, and likely safe, mixture of dilute capsaicin and Eucalyptol in an isotonic carrier. Sensible enough. Whether the function of the 'homeopathic' label is regulatory exclusively or also for marketing purposes is harder to say; but it may be some of both.

This means that the people with no other protection but herd immunity are being compromised by utter stupidity

So where's the outrage from (a) you, (b) the doctors cited in TFA or (c) the media about the multiple orders of magnitude larger numbers of teenagers and adults who have not had their MMR, DTaP, etc. booster shots?

Over the last 20-plus years there have been e.g. Pertussis outbreaks roughly every 4-5 years and it's known to be caused, at least in part, by teenagers or adults whose vaccine-given immunity has worn off. Heck it wasn't until 2005 that the FDA even approved http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm142787.htm a Pertussis booster shot for adults even though it's been used in Europe for much longer (and it wasn't until last year that the FDA approved one for the over-65 set).

So why aren't you, those doctors and the media clamoring to prohibit adults from entering pediatrician offices without proof of up-to-date vaccinations of the adult?

As someone who had all their vaccines and still suffered through a bout of Pertussis as an adult (complete with signature please-save-me-from-drowning "whoop"), I still think you and TFA's doctors are complete idiots. A primary-care physician's office is going to be a soup of infectious germs and going to any pediatrician's office is pretty much always going to be comparable to connecting a computer with a freshly-installed copy of Windows 95 on the Internet.

It's called software validation and it's a pain in the ass. It's such a pain for medical devices that everyone avoids it unless absolutely needed. Which is why medicine is 10 years behind when it comes to electronics.

For a "quick" overview, here's a start: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126954.htm

I always thought AAMI 62304 summed it up better... but, either way you look at it, the main effect of the regulations is to slow things down, make them more costly, and therefore less subject to rapid reinvention.

Along about 1978, new medical devices were coming out so quickly that doctors and regulators couldn't keep up, so we got the 510(k) regulations. Then about 1990 or so they realized that they had to do something about software and the design process, too, so the "design controls" regulations rolled in in the mid 1990s. There's some minimal merit in the formalization of the product and software development process, but the real desired (and achieved) effect in the marketplace is to throttle the number of new types of devices coming to market so that only the best, and best understood, make it over the initial cost to market hurdle. I think the regulation also serves to stifle improvement of the devices that have made it to market, since the investment to get there is so great, business leaders are very wary about doing anything that might put a successful device "at risk," such as pointing out a flaw by improving it.

It's called software validation and it's a pain in the ass. It's such a pain for medical devices that everyone avoids it unless absolutely needed. Which is why medicine is 10 years behind when it comes to electronics.

For a "quick" overview, here's a start: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126954.htm

FDA continues to admit it's useless and just likes to thrash its arms about in a non threatening manner.

Yeah? The guy that owned this peanut processing facility went to prison. Useless and non-threatening? Hardly.

FDA seeks to invest in foodborne illness prevention, medical product safety and countermeasures $4.3 billion request reflects a 33 percent increase from FY 2010 enacted budget

The U.S. Food and Drug Administration is requesting a budget of $4.3 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2012 budget — a 33 percent increase over the FDA enacted budget for FY 2010. The FY 2012 request covers the period of Oct. 1, 2011, through Sept. 30, 2012.

“FDA protects and promotes the health of all Americans through every stage of life,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “The breadth of this mandate means that FDA responsibilities continue to grow. The new budget contains new resources so that FDA can fulfill its growing responsibilities to the American public.” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm243354.htm

It is a supreme falsehood that a government's responsibilities and resources must grow. Bureaucracies like the FDA may be immune to democracy, but the politicians who seek to grow them are not.

Mother's refusal to accept SIDS diagnosis leads to discovery of metabolic issue with regards to cough medicines
http://articles.cnn.com/2007-10-17/health/cough.syrup.deaths_1_cold-medicines-cough-medicines-child-deaths?_s=PM:HEALTH

Just a list of pulled meds...
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm

At one time X-rays were used with pregnancies the way we use ultrasounds. It was claimed to be totally safe. Until it was later determined that unborn infants suffered greater risks from X-rays, including higher cancer rates.

***

Also, excuse me if I am a tad suspect whenever millions of $$$ are involved in an industry. And a government that has repeatedly made mistakes and hid them.

That said, I still believe that generally vaccines are safe, and that they are beneficially for society. But should not be required unless highly communicable.

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/ucm064880.htm#descend

There must be some Federal Bureau Against Quacks, or something.

There is.

See Lengthy Jail Sentence for Vendor of Laetrile -- A Quack Medication to Treat Cancer Patients. They finally nailed Jason Vale, the guy behind Laetrile, the apricot-pit "cancer cure". He did over 5 years in a Federal pen as prisoner #09073-067.

It's already patented, so I can't make any money off of it. Gardasil can cause sterilization with just one shot, though it's not 100%. I have no doubt it can be refined to do so.

Here's the answer you are looking for:

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm179225.htm

Beer is not regulated by the FDA, but rather ATF, and they do not have labeling laws.

Saying anyone who questions this vaccination is a moron without studying the facts is stupid. Many vaccines are important, others carry untold risks. The discussion of this issue has been beaten back by people worshiping at the church or big pharma and various political and media forces, but never addressing the research. It is important to understand the issue and not just read what talking heads and politicians have to say.

The vaccine in question is primarily used prevent a virus that can cause rare cancers 70% of the time [1]. The death rate of cervical cancer is quite low, 4,021 (0.1660% of total deaths) in 2007 [2]. The risks of death from the cancers in question are are similar dying of gallbladder disorders [2]. As for the laundry list of other rare cancers it is linked to preventing, they are dramatically rarer then cervical cancer, data is to support this is readily found for those that are curious.

The CDC data [3] shows some serious concerns, 20,096 reaction reports including 71 verified deaths over 40 million doses. Of the 20,096 reports, 1,607 (8%) are considered serious. A serious reaction is defines by the CDC as a "report that indicated hospitalization, permanent disability, life-threatening illness, congenital anomaly or death". There is no way to determine that these reactions are not linked to the vaccine without much more study.

I am not convinced that they are being honest about the risks and benefit of this drug. The number of lives it is supposed to save, 2,815 per year (70% of cervical cancer deaths are linked to viruses the vaccine prevents [1]), does not appear to outweigh the risks of a serious reaction. The benefit looks in the margin of error. Stop believing talking heads and politicians, do your own research, we are nerds after all. I have far more faith in medicine to treat me for a condition in the future then to take a risky medication to prevent a virus I will never get because I made it to the the age of 26 without it [1]. Never expect the talking heads or even your doctor to actually understand the research, few doctors are trained in research, they are practitioners fueled by money and boredom.

I may be completely wrong and totally misunderstand the data I see published, this will not stop me from actually performing my own review of the research in an effort to actually understand the issues rather then accept biased claims from everyone.

[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116945.htm
[2] http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html
[3] http://www.cdc.gov/NCHS/data/nvsr/nvsr58/nvsr58_19.pdf, Table 10

Thimerosal is pretty rare in vaccines. First, it's only used in vials with multiple-doses in it, so that eliminates a fair chunk already. DTaP & Tdap, polio, MMR, Hep A, Hep B, rabies, smallpox... No Thimerosal. The only vaccine that you're likely to come in to contact that MAY have some of the preservative is some seasonal influenza vaccines. Even then, a Thimerosal-free version is often available.

Find a list of vaccines and their Thimerosal content and history here: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/UCM096228

I'm assuming the case is similar in the EU. As previously stated by others, the concern shouldn't be over vaccines but just about everything else. There're so many Hg sources and uses that a total ban is bullshit.

True, though those devs were slapped down because they were stupid enough to overtly claim specific medical benefits. The FDA can, and sometimes will, slap you down for doing that. However, if your product falls under the DHSEA, you can get away with practically anything, so long as you make your claims in slightly oblique language and don't kill too many people. If it is a food item, you can get away with a similarly broad collection of "Qualified Health Claims".

In the case of a game, which definitely isn't going to be killing anybody, and probably isn't at the top of the list of the dwindling population of FDA inspectors, you could almost certainly run into no trouble so long as you kept your statements of the form "$GAME$ engages player's short-term memory and executive function" rather than "$GAME$ improves player's short-term memory and executive function". At that point, you'd just need a promising preliminary study or two, or some positive word-of-mouth, and there would be absolutely no legal obstacle to selling it, and tacitly promoting it for use in environments where patients with schizophrenic symptoms are treated...

If you make direct, overt, health claims, or try to market a drug that isn't either grandfathered or approved, the law is not your friend; but there are a number of ways around that, most being actively exploited.

This has NOTHING TO DO with Pharma. moron.

well then they will get them for 10 bucks at wal-mart.

Wasn't this done in 2008?

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048235.htm