NIH Confirms Protocol To Reverse Type 1 Diabetes

FiReaNGeL writes "In 2001, researchers at Massachusetts General Hospital demonstrated the efficacy of a protocol to reverse type 1 diabetes in diabetic mice. New data from a study performed at the National Institutes of Health provides additional confirmation of the ability to reverse type 1 diabetes and on the role of spleen cells in islet regeneration. Spleen cells appear to contribute to islet recovery more in mice who are older and with more advanced diabetes compared with younger mice with less advanced diabetes, in which regeneration of remaining islets may be the dominant mechanism."

Missing something?

[Salvance (1014001)]

I must be missing something ... if the technique was first described and shown in 2001, then reaffirmed in 2003, why haven't they moved forward with trying to treat humans with severe/end-stage diabetes? In fact, they don't even discuss the possibility, which makes me wonder if there is something else in play (bad side effects for example). This sounds like a MAJOR medical breakthrough, and typically breakthroughs like this are pushed into more expanded trials and even human tests faster than the researchers at MGH are moving forward.

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[lpret (570480)]

I'm diabetic, and while I'm hopeful that someday there will be some great breakthroughs, I'm convinced that Big Pharma won't let it happen. Case in point, my hospital has a fairly large diabetes cure research group. However, in the past three years, every single doctor has gone to work for a pharmaceutical company to develop ways to "help survive cancer." Oh, and they doubled their income in the process. It's a multibillion dollar growing industry filled with hypochondriac baby boomers that could disapp

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[Runefox (905204)]

It's probably true; Think of how much money they make on cancer treatments and AIDS treatments, and then you'd realize that it's not economical to release a cure, unless that 'cure' needed to be administered on a regular basis. Same with diabetes, MS, and other diseases that are currently incurable-but-slightly-treatable.

My grandfather, who is a type-I diabetic (I'm a type-II myself), staunchly believes that there are cures for AIDS, cancer, diabetes, etc, but the pharmacies are making too much money on the

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[Rich0 (548339)]

Uh, do you know how many people would need to be in on such a conspiracy? The folks who came up with the concept, the folks who developed some molecules that might work, tons of people involved in clinical trials, etc. It would probably be just as easy to fake the Apollo landings.

Now, if you think that cancer has been cured in mice - sure, but that is old news. Cancer has probably been cured in mice a thousand times, but until we can start breeding and treating people like mice it will probably take a li

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[mcrbids (148650)]

Uh, do you know how many people would need to be in on such a conspiracy? The folks who came up with the concept, the folks who developed some molecules that might work, tons of people involved in clinical trials, etc. It would probably be just as easy to fake the Apollo landings.

Uhm... hello????

Everybody knows that the Apollo missions were faked!

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[Woldry (928749)]

... there are cures for AIDS, cancer, diabetes, etc, but the pharmacies are making too much money on the treatments to release them.

AIDS is a viral disease. So are many cancers -- more and more are being identified as such every year. No one has yet figured out a way to cure any viral disease; partly because of the very nature of the beast, it's a nastily difficult problem to solve. Even if the paranoid theory is correct about other diseases, I can't believe that anyone has solved the viral-disease hu

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[jrp2 (458093)]

What surprises me is the lack of active participation by the insurance industry in the search for a cure for Diabetes. These are the commercial entities most likely to benefit financially by a "cure".

As several have pointed out, the commercial entities most likely to benefit from from treating, rather than curing, are the pharmaceutical and, to a lesser degree, the food industries (diet foods). It is no surprise they are not interested in a cure, but the health insurance industry would benefit directly in

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[Rich0 (548339)]

Uh, could it perhaps just be that the group had a good reputation and the leader got scooped up for a big price, and then quickly afterwards he recruited his former team? And the fact that they're making twice as much isn't that big a deal - everybody knows that you make more in industry than in academia.

What happens whenever a big-shot researcher moves from one university to another...the same thing!

No doubt that Pharma is generally more interested in treatments than cures, but I doubt there in some kind

may nytimes article on this

[theskeptic (699213)]

An article about this was published in may in the nytimes [nytimes.com]

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[q2k (67077)]

Dr. Faustman just got her funding earlier this year to proceed with the BCG Human Clinical Trial. She is being funded by The Iococca Foundation. The Foundation is funding another human trial at UVA. However, it's all in the very early stages. I think actual human trials are at least 3 years away.

It is a promising and comparatively cheap cure if it works the same way in people. There are about 10,000 things that could go wrong between here and there though.

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[Tsu Dho Nimh (663417)]

... if the technique was first described and shown in 2001, then reaffirmed in 2003, why haven't they moved forward with trying to treat humans with severe/end-stage diabetes? In fact, they don't even discuss the possibility, which makes me wonder if there is something else in play (bad side effects for example).

Look up "Complete Freund's Adjuvant" ... the stuff induces a massive immune inflammatory response, and is illegal to use in humans. The study has to be replicated, not ONCE, but several times, unt

Re:Missing something?

[Andy Dodd (701)]

"I must be missing something ... if the technique was first described and shown in 2001, then reaffirmed in 2003, why haven't they moved forward with trying to treat humans with severe/end-stage diabetes? In fact, they don't even discuss the possibility, which makes me wonder if there is something else in play (bad side effects for example). This sounds like a MAJOR medical breakthrough, and typically breakthroughs like this are pushed into more expanded trials and even human tests faster than the researchers at MGH are moving forward."

There is no such thing as severe/end-stage type I diabetes. Usually by the time you are diagnosed, you are at the "severe/end stage" - Your pancreatic beta cells are gone or nearly so. Insulin can prolong your life for decades, and if your bloodsugars are carefully controlled (via aggressive and careful diet, insulin dosing, and glucose monitoring), you will live just as long a life as a normal person.

If you're talking about severe diabetes complications (Kidney damage, retina damage, etc.)- By the time those present themselves, the cumulative damage of years of abnormal bloodsugars is done and curing the underlying diabetes isn't going to help.

Last but not least, you clearly missed the "In the 2001 and 2003 studies, Faustman and colleagues treated end-stage nonobese diabetic (NOD) mice with Freund's complete adjuvant, a substance that suppresses the activity of the immune cells that destroy islets in type 1 diabetes." line. Immunosuppressants are scary shit, and usually considered an absolute last-resort treatment when the other choice is death. Admittedly, it sounds like this MIGHT be a rather targeted immunosuppressant with fewer side effects than most, but still, it's an immunosuppressant.

I've been a type I diabetic for over a decade and have been looking forward to a cure for years. While this article gave me a lot of hope, the mention of immunosuppressants took a lot of it away. There are already quite a few treatments for Type I diabetes that are proven to work, but generally are only given to those who are already on immunosuppressants for another reason. (For example, pancreas or pancreatic beta cell transplants are only given to patients already receiving another transplant who will be on antirejection drugs and immunosuppressants anyway.)

That said, it sounds like there are fewer side effects than other immunosuppressants, as I have heard that there are plans for human trials starting in 2007 or 2008. Six years from the first results in mice to the first human trials is actually quite quick. There are plenty of examples of cases where botched human trials nearly killed the test cases. (Remember that incident a year or two in London where 6-8 test patients basically swelled up like balloons and found that six months later most of them had trashed immune systems and the beginnings of cancer?) People are REALLY, REALLY careful with human trials.

It sounds like they are conducting one more large-scale study in mice before beginning human trials. They didn't have money for it before, but they received a large amount from one of Lee Iacocca's charities to fund further studies.

Given the involvement of immunosuppressants, I hope they are extra careful with human trials. I can wait another decade if it means I won't be developing cancer or a few years after treatment.

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[Andy Dodd (701)]

Interestingly enough, the drug mentioned is usually used as an immune booster, although its tendency to suppress autoresponsive T-cells is an unusual side effect.

http://en.wikipedia.org/wiki/Freund's_adjuvant [wikipedia.org] - One of the core aspects of this treatment. Note that it appears to be a REALLY nasty drug with a lot of side effects, and is in fact currently forbidden for use in humans. (So I have no clue how they are using it in a human trial...)

http://en.wikipedia.org/wiki/Denise_Faustman [wikipedia.org] - There's a lot of co

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[jesup (8690)]

There is no such thing as severe/end-stage type I diabetes. Usually by the time you are diagnosed, you are at the "severe/end stage" - Your pancreatic beta cells are gone or nearly so. Insulin can prolong your life for decades, and if your bloodsugars are carefully controlled (via aggressive and careful diet, insulin dosing, and glucose monitoring), you will live just as long a life as a normal person.

If you're talking about severe diabetes complications (Kidney damage, retina damage, etc.)- By the time t

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[Andy Dodd (701)]

"However, an effective cure would help him a lot, even at this late date. It becomes increasingly hard to control blood sugar levels, and he doesn't notice when levels wander into dangerous levels anymore. While it wouldn't reverse the damage to the kidneys, vision, etc, it would remove a major cause of further damage and life-threatening blood sugar swings. Even a partial reversal would help a lot."

The issue is whether the risks of the treatment outweigh the benefits of partial/complete reversal.

My opinion

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[The Step Child (216708)]

Immunosuppressants are scary shit, and usually considered an absolute last-resort treatment when the other choice is death. Admittedly, it sounds like this MIGHT be a rather targeted immunosuppressant with fewer side effects than most, but still, it's an immunosuppressant.

Because of the nature of type I diabetes, the only way to cure it is *some* form of immunosuppression. The ideal solution would be to specifically suppress the T cells which are responsible for destroying islet cells. This in itself is t

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[jesup (8690)]

Read the Nov 12th Scientific American article on this release (http://sciam.com/print_version.cfm?articleID=CE7 B B73A-E7F2-99DF-3069CE90D77629FB [sciam.com]). According to Wikipedia, Freund's adjuvant is highly toxic (http://en.wikipedia.org/wiki/Freund's_adjuvant [wikipedia.org]).

Also, some very early experiments in humans have been done in Israel, using a less-toxic immune-suppressive (which doesn't suppress as much). No success, but there may be some data from it that it was heading in the right direction (see SciAm article).

This

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[Dunbal (464142)]

if the technique was first described and shown in 2001, then reaffirmed in 2003, why haven't they moved forward with trying to treat humans with severe/end-stage diabetes?

First you test it in vitro, in a test tube.
Then you test it in animals, starting with mice, and eventually working your way up to dogs, pigs, monkeys, etc.
Then you test it in a few HEALTHY human volunteers, looking for possible side effects.
Then you tes

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[bsane (148894)]

Then you test it in a few HEALTHY human volunteers, looking for possible side effects.
Then you test it in sick people, to see if it actually works on humans.

In some cases healthy people may not be tested first- they may try especially risky procedures only on people who very likely to die if left untreated.

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[Salvance (1014001)]

Oh, I didn't see that in the article. Are you saying it causes cancer because you have read about this potential diabetes treatment on another site or journal, or just because (in general) stem cells have been shown to become cancerous more readily than researchers had hoped [slashdot.org]? If the former, I'd love to read the article if you have a link.

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[iawia (9172)]

Actually, the research mentioned in the article is not introducing any stem cells, so if that's the source, it doesn't apply to this research. The idea here is that the spleen actually contains 'adult stemcells' that can differentiate into insulin producing cells.

The research in question is done by Faustman financed (at least partly) by the Iococca Foundation. ( http://www.iacoccafoundation.org/grants_diabetes_r esearch.html [iacoccafoundation.org] )
They're preparing for human trials of at least part of this protocol, but it seems

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[Andy Dodd (701)]

Stem cells or no stem cells, cancer is a known side effect of nearly any immunosuppressant, which happens to be a fundamental part of this protocol.

Oblig /.

[Anonymous Coward]

Who cares about NIH - does Netcraft confirm it?

You know...

[PreacherTom (1000306)]

It gets me sometimes when comments I see in medical threads are just plain ignorant. Yes, this is only in stage 1 trials. Still, promising results *are* the therapies of the future, and they are relevant and interesting. They are especially relevant when speaking of treating something so widespread and degenerative as diabetes. This already has been an age of miracles, folks. Enjoy what the next 10 years will bring.

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[Dunbal (464142)]

They are especially relevant when speaking of treating something so widespread and degenerative as diabetes.

      Although type II diabetes is by far more prevalent than type I. Still an effective cure would be a major breakthrough for these people.

Type I, not Type II

[necro81 (917438)]

It is very important to note that this is a treatment for reversing Type I diabetes, not Type II.

Type I diabetes [wikipedia.org] comes from an autoimmune reaction against the insulin-producing cells. It is more common in children, and accounts for about 10% of all insulin cases.

Type II diabetes [wikipedia.org] tends to be caused by an insulin insensitivity - the insulin receptor in cells looses its effectiveness. The complications from Type II diabetes tend to be worse, and none of them are pleasant. There are many risk factors for Type II diabetes, some of which a person can't do anything about (i.e., genetic predisposition), but the primary risk factor is obesity and inactivity. So, for the foreseeable future, doctors will no doubt continue to caution people to be vigilant about their weight and, for those under treatment for diabetes, to still be especially vigilant about monitoring their blood sugar levels.

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[retrosteve (77918)]

Ah, but there's another consideration --

Type 2 diabetes deteriorates if not kept well-controlled. In advanced stages, the hyperglycemia oxidizes proteins and kills off pancreatic islets, until the pancreas is unable to produce insulin, just as in Type 1.

So if an advanced type-2 diabetic fixed up their insulin resistance, they might still be unable to produce insulin. And the therapy in the article might then be helpful to them too!

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[Boghog (910236)]

the hyperglycemia oxidizes proteins and kills off pancreatic islets, until the pancreas is unable to produce insulin, just as in Type 1.

You are right on the result (pancreas no longer able to produce insulin), but your mechanism (oxidative stress) is at best only part of the picture. If oxidized proteins induced by hyperglycemia were cytotoxic, a lot more cell types in addition to pancreatic islets would be killed off.

The exact mechanism of beta cell burn out in advanced type II diabetes is unclea

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[retrosteve (77918)]

Point taken. I was, as you note, simplifying the mechanism. There are several others, including amyloidosis brought on by oxidation of amylin normally found in the islets.

Point is still that the pancreas needs new islets, which this therapy may be able to provide. Meaning that advanced type-2's might find this therapy useful just as type-1's do.

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[sessamoid (165542)]

From a societal standpoint, Type I DM is much worse than Type II simply from the fact that Type I kills children and young adults in the prime of life. Type II is largely a disease of the middle-aged and elderly who have far fewer working years ahead of them.

Not as simple

[DebateG (1001165)]

Calm down people. They haven't cured diabetes; in fact, this cure for diabetes (in mice) isn't new at all. This isn't a phase I clinical trial. They haven't tried it on people, and I really doubt the FDA will approve any such trials in the next few years.

The controversy is over the role of stem cells. No one disputes that adding Freund's adjuvant to the NOD mice can cure their diabetes, and it seems to work through a hazily-understood modulation of the immune system. That has been established for 15 years.

Re:itll be years

[Loconut1389 (455297)]

better than never, and diabetes, though the complications can be gruesome, if managed well is more of a nuisance than a terror. For many, diabetes is a very manageable problem, but instances do occur with circulation problems to the limbs that require amputation. It'll be great when this cure hits the streets, and as with anything, the sooner the better, but rather than complaining that it'll take years before being available to humans, why don't we celebrate the fact that a cure is officially in sight?

Re:itll be years

[billybob_jcv (967047)]

Do you understand the difference between Type 1 & Type 2 diabetes? I do not consider needing to give insulin shots 4 times per day to my 21 month old daughter "manageable". She is now 9 and wearing an insulin pump, which means we change her infusion set (a fairly large needle inserted under the skin on her stomach or back) every three days. Type 1 diabetes cannot be managed by diet, exercise & pills!!!
   

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[autophile (640621)]

which means we change her infusion set (a fairly large needle inserted under the skin on her stomach or back)

Fairly large? My infusion set has a catheter that's a quarter inch?

--Rob

Re:itll be years

[Loconut1389 (455297)]

For young children, its burdensome, sure but everybody that has to do it gets used to it, just like anyone who has to take any kind of medicine- regardless whether its IM, IV or PO. I wasn't saying that what people go through isn't troublesome, and everyone needs shots at different intervals- everyone is different. There are exceptions to everything. Anyway, my overall point was that rather than saying, well geeze, it'll be 4-6 years before its available, waah- we should be saying Thank Someone that there's even a chance of a cure, otherwise you and your daughter are guaranteed to be doing those shots for a long time to come- now you may only have to do it a few more years- if even that. Insulin pumps have come a long way and are better than giving shots- maybe something better (transdermal patch?) will come along between now and when the 'cure' is available. I happen to know a relative who is Type 1 diabetic and has received awards for having the disease for longer than the vast majority of people (I think he's around 80 and has had it since he was young)- but he's been giving himself shots several times a day his whole life and still manages to have a pretty good existence- he used to run even up to a few years ago, still walks a lot, etc. Its a part of his life and it doesn't slow him down. On the same token, I know another friend and her husband who are in their late 50's and have nearly had to have legs amputated. There's someone on every end of the spectrum, as I said originally- but just be thankful you can look forward to the day you don't have to give those shots anymore, or she may never have to do it herself.

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[ScrewMaster (602015)]

I'm not a diabetic myself (so far, anyway) but I've had several relatives that were Type II, and I knew a girl who was a Type I that died at thirty from complications from it. And this was an individual that exercised, kept her weight down, monitored her glucose level constantly and took care of herself way better than most. She said once evening, rather sadly, "Diabetes really sucks." My father also died of complications due to his diabetes mellitus, and I took care of him the last three years of his life

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[Slippy. (42536)]

Type 1 takes over your life. It's horrible for kids. Steals much joy from being young.

You *must* watch your diet all the time or risk coma/death very quickly in the short term, or bad side effects (blindness, loss of limbs, organ failure) in the long term. Getting drunk can get a person in trouble fast, especially if vomitting occurs.

First time your friends see you get sugar low, you'll get looked on as a freak by many people. A sugar low means you'll lose thinking ability (you look dumb) and won't real

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[witekr (971989)]

Thank you for the insightful post. I'm a 19 y/o Type 1 Diabetic, and have had to deal with many of the situations you wrote about in your post.

Type 1 Diabetes is not fun to have, and it's not something to be shrugged off. I'm sure that some diabetics experience less problems than others, but it's not a disease to be shrugged off as if talking about a wart or a cold. My life is a bit more complex now than my pre-diabetic life; Every day I must constantly keep track of my insulin, food, and exercise, and t

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[FallLine (12211)]

For young children, its burdensome, sure but everybody that has to do it gets used to it, just like anyone who has to take any kind of medicine- regardless whether its IM, IV or PO. I wasn't saying that what people go through isn't troublesome, and everyone needs shots at different intervals- everyone is different.

I respectfully disagree. Having worked for an insulin pump manufacturer and having spoken with hundreds of doctors, patients, and educators, I can tell you that managing diabetes is fundamental

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[Dunbal (464142)]

Type 1 diabetes cannot be managed by diet, exercise & pills!!!

      Insulin pumps can be pretty darned dangerous, too. Over 25% of diabetes related deaths are actually due to (accidental or intentional) insulin overdose. At least it's nice to know that people are working on the problem though.

Re:itll be years

[LiquidCoooled (634315)]

That just shows, if the protocol had been released under the BSD or even GPL license, we could have ported it to humans by now.

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[Loconut1389 (455297)]

sarcasm aside, I often wonder why people can't voluntarily submit themselves to whatever they want. All these laws we have are designed in large part to prevent involuntary testing- but if someone like Jonas Salk is willing to die to test a vaccine or treatment, why stop them? I'm not a big fan of animal testing as it is- though I accept it as somewhat of a necessary evil- but I really don't see why if we want to have a limb taken off, added on, grow boobs, have them taken off, whatever, that we can't just

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[Dunbal (464142)]

I often wonder why people can't voluntarily submit themselves to whatever they want.

      OK, look at it the other way. Just because you're prepared to die to test out a new treatment doesn't mean that I'm prepared to kill you with it. We usually have to be pretty darned sure that something won't be harmful before starting testing on humans.

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[bigpat (158134)]

OK, look at it the other way. Just because you're prepared to die to test out a new treatment doesn't mean that I'm prepared to kill you with it. We usually have to be pretty darned sure that something won't be harmful before starting testing on humans.

Who is this "we" you keep talking about?

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[Gription (1006467)]

Uh, gee, could we make sure we have it right first? This isn't a light switch that they are flipping here. We are trudging about in areas that we don't understand yet. They are still making guesses about the mechanism by which it works!

In 2001 one researcher managed to come up with a repair in mice and published. Then other scientists couldn't repeat the findings. Now a few years later we have scientists who can repeat the findings. Sounds like it is progressing very well and at a pace that you would expe

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[MECC (8478)]

Then other scientists couldn't repeat the findings.

Which other scientists (just curious)? What's suspicious about all this is that JRDF, which will throw money at everything from new implantable device research to stem cell research won't fund [jillstanek.com] research into Denise Faustman's legitimate breakthrough discovery [massgeneral.org]. Could it be because her discovery involve a cheap drug whose patent has expired? [washtimes.com]

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[fyngyrz (762201)]

Did you ever consider that there are cases with some disease processes where people might be very pleased to consider becoming a "guinea pig"?

Not everyone thinks the government should be their mommy. If you need a mommy, then by all means, have some old lady adopt you. For those adults capable of making informed decisions for themselves, why not stay the heck out of their lives? I know, it is just such a radical idea, but even so... adults, making decisions about their own bodies, for themselves... it a

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[WilliamSChips (793741)]

We're talking about advertizers here, making provably false claims. Yes, I want the government to prevent companies with good advertizing from killing people.

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[fyngyrz (762201)]

The fact that there are risks and unknowns do not in any way reduce your ability to make an informed choice. An intelligent adult understands that there are risks and unknowns. You can't be protected from everything, including people who might not care about your particular situation or outcome.

None of that serves as "good reason" to take the right to choose from adults.

As for your outlook on drug companies, fine, whatever. You're entitled to your outlook. That still doesn't give you the right to tel

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[Dunbal (464142)]

the TCO is cheaper if you just go to the pet store and buy another mouse.

      I did that. For some reason these damned mice just won't sit still when I plug them into the USB slots. I have to use duct tape to hold their tails in place. And I have been bitten about 30 times. I think I'll give up and go back to my trackball, they're just not worth the effort.