The Problems With Drug Testing 166
gallifreyan99 writes: Every drug you take will have been tested on people before it—but that testing process is meant to be tightly controlled, for the safety of everyone involved. Two investigations document the questionable methods used in many studies, and the lack of oversight the FDA seems to have over the process. First, drugs are increasingly being tested on homeless, destitute and mentally ill people. Second, it turns out many human trials are being run by doctors who have had their licenses revoked for drug addiction, malpractice and worse.
Lab conversation (Score:4, Funny)
Unlicensed doc: "The police called about a murderous drug-fueled rampage. Who did you say that test subject #37 was?"
Assistant: "Abby someone."
Doc: "Abby who?"
Assistant: "Abby... Normal."
An outrage! (Score:2, Flamebait)
This is an outrage and a waste. We must switch to testing on the successful and the smart, who have nothing else to contribute anyway!
Sure, malpractice, drug addiction and, especially, the unspecified "worse" are known to cause people to quickly forget all the training they've ever receiv
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I had a problem with worse once.
It was worse than expected.
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Instead, I recommend that drugs be tested on Pharmaceutical company CEOs. I liked it so much, I bought the company. Or the farm.
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Exactly! Because — unlike the homeless — the CEOs aren't good for anything else, are they?
Nonsense (Score:2, Interesting)
Look, none of this is common place. It's very rare. Why? Because if this happens, then the multi-million dollar trial you paid for is worthless and would have to be redone. I'm working on setup of the data handling for a phase 1 clinical trial right now and there is no way in hell we would let a doctor with issues (ethical or otherwise) anywhere near the trial. Any data they collect would be suspect and could not be used. Homeless person that is taking a lot of meds already? I don't think so. I don
Liars (Score:2)
Look, none of this is common place. It's very rare. Why? Because if this happens, then the multi-million dollar trial you paid for is worthless and would have to be redone.
That's why they'll tell you that they aren't doing any drugs and this is the only clinical trial they're participating in, and maybe throw in a fake name for good measure.
... or outsourced to Eastern Europe (Score:3)
My dad almost lost both of his legs because his doctor insisted that his condition is so severe that he needs experimental medication. The 1st round of medication did nothing to make him better. After he started the 2nd round of medications i got hold of the paperwork that he fscking doctor had my dad to sign. She was doing experiments on him on behalf of a US company and had my dad fooled that it's the only way. So after years of my dad lining in excruciating pain i dragged him to another doctor, at another hospital, who applied a standard medical procedure and he was fixed in 2 months.
The murderous doctor (while my dad was in the hospital, there were at least 2 other patients on experimental medication who died) was sporting a nice new BMW high-end car when i got my dad out of there. Way more expensive that she could have afforded from her salary + standard bribes extorted from the patients.
True (Score:5, Interesting)
So my mother has a Ph.D in experimental psychology and knows a thing or two about how to design experiments, how to avoid systematic bias, how to distinguish that from random error, and in the admittedly non-objective opinion of her son, is quite sharp about identifying sources of those in methodologies. After raising three children she tries to restart her career. At first the only work she could find was a lowly temp job entering survey responses from a drug trial into a database. Turns out that the forms completed by the doctors and patients surveyed left answers to many questions blank. So how is she instructed by those managing the data entry to handle those cases? She is told to systematically select particular answers to particular questions. And which answers? The answers consistent with the drug being effective and harmless.
Now you do not have to be a Ph.D. to spot a problem with that. Hell, my German Shepherd could probably do that. But maybe as a scientist herself the violation of scientific integrity stung too strongly and my mother insistently raised complaints within the company. And how far did those go to correct the "mistaken" guidelines for data entry? Absolutely nowhere.
Ten Million (Score:4, Insightful)
That's how many people (mostly children) have died of malaria since the investigators knew they had a working vaccine in the mid-90's.
That vaccine might actually see the light of day this year, but the regulators are hinting that they might deny approval because it's not tremendously effective in infants.
Because, you know, IN FUCKING THEORY, somebody might get injured from the vaccine.
I'm sorry, the blood of ten million mostly-children on the hands of regulators gets me a bit worked up. And now they're staring at their naval because an investigator might also have a drinking problem? Oh, man, I better hit submit before I say something I might regret.
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Sometimes things that are "known to be safe and effective" end up killing people or having nasty side-effects, or preventing people from receiving proper treatment. Didn't cigarettes used to be a safe and effective way to lose weight?
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Extraordinary claims require extraordinary evidence.
An extraordinary claim would be that people didn't die because of delays to market of drugs that save lives.
Since its you that seems to be making that claim, it is also you that needs to provide evidence that people do not die while the FDA delays the availability of life saving drugs.
(we know you cannot do that, but maybe not everyone knew that you were the one with the extraordinary claim, not the guy you accused of having an extraordinary claim)
Revoked license (Score:2)
Now who's crazy? (Score:2)
Where's all the pro-science crowd who keeps telling us to blindly trust medical science when the stories of people (mistakenly) avoiding certain well-tested drugs come up?
The rhetoric does nothing but defeat their actual viewpoint and this is why -- bad science is being done, and it needs to be accounted for to the sceptics, no matter who insane they may seem. Bad science is the enemy of good science because it undermines trust in the system.
Re:Er, that's a bit confusing (Score:5, Insightful)
Re:Er, that's a bit confusing (Score:5, Insightful)
From a humanitarian perspective, the quandary is "Do we want to allow the weakest among us to make decisions they are unqualified to properly weigh?"
I will leave the ethics to others, but ultimately, as future consumers of these tested pharmaceuticals, do we want to rely on results that are likely skewed because the test subjects were also taking heroin, methamphetamine, and cocaine?
Re:Er, that's a bit confusing (Score:5, Insightful)
Hear hear!
We should remove other decisions from the weakest among us. Why let them enter into legal contracts regarding their own health and finance when we're certainly more capable of doing it for them. We're just protecting them, after all.
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> We should remove other decisions from the weakest among us.
It is not about removing decisions from the weakest among us.
It is about limiting the power of the most powerful among us.
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It is not about removing decisions from the weakest among us.
It is about limiting the power of the most powerful among us.
Is there something I am not understanding here? Looks to me like your second statement is the excuse to implement the first.
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What decision for fuck's sake? "Allow them to stick needles in me or starve?"
That is no decision. That's like me offering you the decision to dance for my amusement or end up with a bullet in your head, and then me claiming that dancing like an idiot was your own free will.
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which is why we need to make sure the Shelter Network can actually handle the number of Homeless in a given area.
Its common for a Shelter to have a time at night you have to check in by so you have at least one time in 24 hours you know where a person is.
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...provided it ain't Summer. Have you ever been in such a place? Trust me, in a warm summer night, anywhere else is nicer.
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Oh yeah, like they have a choice. A decision entails that there is a viable alternative. And I kinda doubt they go "hmm... become a human guinea pig or pursue my career in advertising...".
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Whoa, step back from that slope man, it's slippery.
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"You're coming across as stupid, like you're a teenager or an arrested-development libertarian type."
Mother. Fucking. WOOSH.
Summer needs to hurry up and end so idiots like you can get the fuck back to school. Not like it's going to do your slave ass any good.
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They'll just advocate "take a pill" like a car salesman advocates buying a car..
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Missing modpoints again so quoting the AC +1 informative:
Speaking as a university researcher ...
I'm not disagreeing with the sentiment of your post, but in research ethics the concept of coercion is often taken much more broadly than it might be in typical parlance.
The idea is that if the incentives for research participation become too large, someone might not be able to rationally turn down an offer, and might be compelled to do something they do not want to do. I.e., you can coerce someone with rewards that are too large, just as you can coerce them with punishments that are too large. The idea is to prevent people from feeling like they sold their soul to the devil.
Where this gets complicated is that what is considered to be a coercive incentive depends on the potential participant's circumstances. So if you're homeless, you might feel compelled to do something you wouldn't otherwise do because you're desperate. I've been on research proposals where $35 or so USD was considered coercive because that amount of money was so large for the area of the world that they were recruiting from at the time.
I'm not sure how this intersects with this story--I agree that in itself, there's nothing wrong with recruiting homeless individuals. You also don't want to deny them opportunities that others have. But by the same token, you don't want to take advantage of their circumstances to make an undignified proposal something they can't refuse (not saying it is undignified, just that it probably needs more scrutiny, which it may or may not have had).
Re:Er, that's a bit confusing (Score:4, Insightful)
If I was homeless and had a crack at suing a big pharma company for millions with absolutely nothing to lose, I think I'd take a shot at it.
It's not like they could sue me back. Just need to find a lawyer who wants a 50% take of the damages.
What? (Score:3)
You do realize that it takes money to sue someone correct? Well, technically you could file yourself but you will quickly lose because a laymen is not going to understand the required procedures even assuming they could figure out the correct paperwork to file to get the case started.
Very few lawyers work pro bono. If any risk at all existed in the case (including to their reputation) lawyers can and often do refuse cases.
No, it's not practical for a homeless person to sue anyone. In a criminal case a la
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So those "No win, No fee" lawyers don't exist?
I fail to see where you got pro bono from "find a lawyer who wants a 50% take of the damages"
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Have you ever thought about why they have such wide nets cast to get clients? TV ads, billboards, newspaper ads.... they're just trying to get people who have damages claims that are legitiimate enough that it's reasonable to win.
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I haven't noticed, I don't live in an ass-backwards country where everyone sues everyone else for no good reason.
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If you had a crack at suing a big pharma company then you'd have money and therefore probably wouldn't be homeless. Your premise is flawed.
Unless, of course, you think that there are lawyers willing to take on a case against big pharma for no money up front? In which case, your premise is also flawed.
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TV and radio and even billboards around me are full of ads from lawyers who are eager to sue for anything related to medical liability. What color is the sky on your planet?
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Unless he had been drinking methylated spirits while reading and signing the disclaimer
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From what friends in biology tell me, I gather that the reviewers would spit on you if you tried
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They may not be in good physical health. They may have substance abuse issuse (alcohol or other drugs). They may have mental health issues. This makes me wonder if the myriad of side effects we see for drugs are related to the poor quality of test subjects.
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From a humanitarian perspective, the quandary is "Do we want to allow the weakest among us to make decisions they are unqualified to properly weigh?"
Alternatively we could choose not to treat them like a helpless puppy or small child and accept that their decisions are as valid as yours and mine.
Honestly judging someone's qualifications to make decisions based on their financial state is pretty condescending.
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From Big Pharma's perspective, with the involuntary testing of prison inmates off the table in most Western countries, the homeless population presents a viable alternative who are statistically unlikely to pursue litigation.
From a humanitarian perspective, the quandary is "Do we want to allow the weakest among us to make decisions they are unqualified to properly weigh?"
I will leave the ethics to others, but ultimately, as future consumers of these tested pharmaceuticals, do we want to rely on results that are likely skewed because the test subjects were also taking heroin, methamphetamine, and cocaine?
It's not the companies sponsoring the test that somehow try to pick this demographic. It's the people themselves. Most of the tests pay the panelists, but it's not all that much. For someone with a stable job, the small amount usually isn't worth the hassle (have to be at the test location during business hours several times a week sometimes, keeping logs, or whatever). Not to mention not worth the possible health risks. For homeless/unemployed/etc., that's their electric bill for this month. It's enough mo
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, do we want to rely on results that are likely skewed because the test subjects were also taking heroin, methamphetamine, and cocaine?
Are they testing on Wall Street traders now?
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You do realize that homelessness and drug additions do not go hand-in-hand, right?
You should get to know some actual homeless people. I have worked with quite a few through my mother-in-law's church. I would estimate that more than 90% of them have serious substance abuse problems.
Re:Er, that's a bit confusing (Score:5, Informative)
I'd be willing to bet that better than 50% of that 90% are mentally ill and self medicating with street drugs and alcohol. And though they may be addicts they are addicts because of the mental illness not necessarily because they like doing the drugs.
See when Reagan gutted the mental health system in this country so he could funnel the money to the defense industry (Gotta fund that Star Wars Defense Initiative) most of the mentally ill ended up homeless as states lost federal funding for mental health. There was a dramatic spike in the number of homeless in the 1980's and most of them were the mentally ill that were discharged from state hospitals for budget reasons. Don't get me wrong, the involuntary commitment thing we were doing to the mentally ill up to that point was all kinds of evil but the loss of funding did as much damage as wrongs it prevented. There are many many mentally ill that would voluntarily submit to treatment if it didn't cost anything because they don't have money and we've got a lot better drugs these days to treat things like schizophrenia than we did in the 80's.
I'd also like to point out that many of the homeless addicts that aren't mentally ill and not addicted to alcohol could be productive citizens if the war on drugs ended. They end up homeless because their addiction inevitably ends up giving them a criminal record that prevents employment. Combine the lack of employment because of a criminal record with the addiction and you end up with a homeless person. Unfortunately an alcohol addiction makes people pretty much unemployable due to the impairment and the massive health problems it causes.
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See when Reagan gutted the mental health system in this country
In fairness to Reagan, 'gutting' the mental health system was a fairly popular idea at the time because psychiatrists couldn't distinguish between sane people and insane people, [wikipedia.org] and were imprisoning sane people.
Re:Er, that's a bit confusing (Score:4, Insightful)
Your sampling is skewed towards the homeless population that is willing to go to a church.
You should get to know some other homeless people.
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Your sampling is skewed towards the homeless population that is willing to go to a church.
They don't go to church. The church goes to them. My wife's mother works through her church to reach out to homeless people, give them food and blankets, and help them find day labor so they can earn both money and self-respect. She often asks me and my kids to go with her. We find people living in parks or under bridges, etc. My experience is that nearly all of the homeless have deep interrelated problems, including substance abuse, mental illness, alienation from family and friends, mistrust of autho
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Well, putting aside the question of whether or not this practice is exploitative, I see a greater concern in
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Or, much worse for us (but probably to the delight of the pharmaceutical industry), the terrible side effects will be masked by the symptoms of exposure, malnutrition and chronic alcohol abuse.
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Because they're not just homeless. They're poor, likely have no family support, little edgucation and are not generally equipped to be make that sort of decision. And if something does go wrong they likely have no insurance they can use to seek help. Sure, if they find out its related to the testing the drug company might have to pay. But if it gives them cancer 5yrs later?
I'm all for adults making their own choices. But some people that appear to be adults, are not, for a variety of reasons. We should not
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We're still talking abusing the plight of a person. I don't know about you, but in my books that's kinda immoral. According to our law books, that's even illegal under certain conditions.
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That far already? Not just considering them a "lower class" but already a "lower being"?
Just so I can confirm my prejudice: Democrat or Republican?
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Where did I claim that homeless person are 'lower beings'? Please speak for your self and refrain from that dick-headed prejudice.
You have to look at it from a purely biological standpoint. Completely different living and sleeping habits, food intake, body temperature control, and continuous exposure to the outside all result in different metabolism from the general population. That alone will not produce correct results when testing drugs targeted to the general population. Besides, having test subjects wh
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You really don't notice how condescending and patronizing you sound? Really?
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From over here D or R looks like a silly question, considering they're so indistinguishable. Maybe I'm spoiled by having parties that are actually different in their opinions and positions on the political spectrum.
And, bluntly, replace "homeless" with "black" in the statement you quoted and tell me you wouldn't see anything wrong with this either.
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His intent is pretty obvious, but you must have some axe to grind. Someone who is homeless is obviously not living anything remotely resembling the life that the general population lives. Differing metabolism is just one of the myriad of factors that differentiates the homeless from the general population. This would be like using mensa members to determine if a test for the general population is too easy.
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It's alright this is how Obama-care works. If we got rid of the questionable doctors doing it, they would be replaced by illegal Mexican aliens. So relax and take another pill. The government wouldn't allow anything to harm you, would they? Of course your medicine is safe and we have more medicine to treat the side effects of the medicine, and more medicine to treat the side effects of that medicine. Just think of Obamacare as a subscription service for the latest, greatest pharmaceuticals that Big Medicine
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FTFY:
"What in the Wide World of Sports is a-going on here!? I hired you people to get a little track laid, not to jump around like a bunch of Kansas City faggots! " - Slim Pickens as Taggart in "Blazing Saddles"
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Be glad that you are, for the moment, healthy enough to maintain that attitude. When you develop something that your lifestyle says you should never get, I hope the rest of us have figured out the problem for you already.
And when we let you die anyway because in 2014 you called our concern "Wackadoodle", well you can be sure I voted "abstain" so you have other people to blame.
To be more specific, homeless, destitute, and mentally ill people are not necessarily genotypically representative, and dangerous re
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And, more importantly, probably incapable of actually making informed consent to be guinea pigs.
And, quite possibly massive ethi
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Dude, they're not talking about drug tests where your employer wants to check if you're high on crack cocaine.
They're talking about drug tests where a new experimental drug needs to be tested, first on mice and then humans, to see if it's safe enough for FDA approval.
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To be fair, he was only confused about this because the summary was complete and utter crap.
Yeah, the summary is shit. Maybe we should have it tested.
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...actually to be completely accurate: TFT was crap. TFS had plenty to tell you which kind of drug testing this was about. SO our wonderful OC couldn't bring himself to get past TFT before commenting... pretty much average for /.
Personally I kind of wanted to rant after reading TFT and was severely disappointed when I read TFS to find nothing new or of interest so didn't bother to go anywhere near TFA but did scan TFC to find if anyone decided to stick to TFT's subject anyway!
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You can acronym like a MFer.
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To be fair, he was only confused about this because the summary was complete and utter crap.
Yea, but if you READ the article, it's pretty clear what the summary means..
Lesson learned? Yep, READ the article before posting comments.....
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nah its easier to just shrug it off when I get one wrong. As far as off topic comments go, it hardly even registers compared to the gay nigger brigade still trying to cover natilie portmans hot grits in pants; so overall.... could be worst.
Fair? (Score:2)
life ain't, wasn't, and won't be.
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It's pretty clear that Slashdot summaries are only tested on the incompetents and mentally ill. (Alternately, those are the people writing them.)
Re:not true because... (Score:4, Insightful)
Right there with you, but that isn't the kind of drug testing TFA is talking about. This is referring to "clinical trial" tests as part of the approval process for new-to-market pharmaceuticals.
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Most jobs I've had to have a test before I could show up the first day. The past two not so much, with the current job, and I quote HR "Whatever drug you were taking in the interview, we really want you to keep taking it".
So basically, leave it to HR to always adopt a position that is not usually in your best interests.
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So basically, leave it to HR to always adopt a position that is not usually in your best interests.
So, HR isn't looking out for my best interest? Shocker! (not!)
Just in case you don't already know, HR is NOT there to protect you, they are there to protect the company. So be VERY careful when you take a "problem" to them to solve, because you can bet they won't be looking out for your interests.
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I don't have my people tested for drugs. For more than one reason. First and foremost, I fear they could find something. Actually, I'm pretty sure they'd find something with one or two of the guys.
Then, why the fuck should I care what they do in their spare time? I'm neither their mommy nor their nanny. I care about them coming to work sober and being able to do their job. That they do. So where's my interest in anything beyond that?
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I have never, and will never, submit to a drug test.
While I am in favor of voting with my feet (so to speak), most of us can't afford to remain steadfast in our convictions when it comes to keeping our mortgage paid and our kids fed.
I had a drug test in 1996, and again in 2001, and a pair of them in 2013. I'm now subject to random testing, which irks me to no end. Unfortunately, there's no other game in town that wants to pay me six figures and not test me -- at least not one I've found yet.
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Construction companies drug screen at employment inception and when there's an accident.
It's unlawful search (and seizure of your body fluids), but hell, it's a free country... you can work for yourself.
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Really? because its been my experience that most of the people subjected to employment drug testing are the lower salary employees. Then again, I work in IT where most companies don't drug test because they know what the results will be.
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My particular niche of IT centers around healthcare, which includes insurers, which pretty much mandates preemployment screening at a minimum.
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Um.... me too, and still never been even asked. In fact my last employer was basically a hospital (or rather if them and the hospital were facebook friends, their relationship status would be 'its complicated'). Now the actual insurance industry, that I could understand....they seem more um.... uptight.
Hospitals themselves I am pretty sure have the same issue as IT given what I have heard from the horses mouthes about doctors and drug habbits
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..but, but, (failed) f1r$t p0$+!
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just pull a hobby lobby and say I'm on a drug that is part of my religion and you can't test me for it.
It is really hard to imagine how that is related to the Hobby Lobby case which was about GOVERNMENT requirements being levied on a company and not drug tests as a condition of employment. I think the law is pretty clear, companies can do drug testing and refuse to employ those who fail said tests.
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Satanists Craft Religious Exemption Plan to Help Women Skirt Abortion Laws — and Here’s How They’re Using Hobby Lobby to Make Their Case
http://www.theblaze.com/storie... [theblaze.com]
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They are trying to cash in on public ignorance and the hype surrounding the Hobby Lobby ruling, for their own purposes (fund raising and PR). There is no legal precedent established by Hobby Lobby that they can use to make their case, but there are people who will swallow their story They won't get anywhere with this.
So this is WAY off topic.... So I'm done on this sub-thread...
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That's swell. Abusing religious laws to fight religious bullshit.
Would it make me the devil if I can't help but giggle?
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That's what I love about sane countries. Your religion means fuck if it conflicts with laws, first you have to obey the real laws, then the ones of your imaginary friend.
If your imaginary friend conflicts with the law, he can take a hike.
Re:Huh (Score:4, Informative)
People with chronic conditions that might be helped by it. My sister has MS and was part of a clinical study of a new treatment. I have Type II diabetes and just finished a clinical trial of a new form of mealtime insulin. Neither of us is homeless, destitute or mentally ill.
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assuming you weren't the control!
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That's the "risk" (among others). But at least you'd test it on a group of people where you can actually see more than just whether the crap kills them.
Then again, it could have the unwanted side effect to unveil prematurely that the crap doesn't do jack but line the pockets of its maker...
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Hadn't thought of that group, good for you! Hope it worked for you and your sister.
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... And don't have other options. Many drugs currently developed help a very specific part of the population. A lot of drugs now have something like this in their "approved uses" list: "... and who do not respond to current treatments..."
By studying the chemical bases for drug efficacy, we are developing highly personalized drugs that work in well under 50% of the target audience. No one really knows why something *doesn't* work for a good part of the population - it could be other drug interactions, or
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In my case, Glypizide, Metformin (pills) and Lantus (injected) was doing a good job. However, there was always the possibility that mealtime insulin (instead of Glypizide) could be better. Alas, it wasn't, but at least none of the problems were catastrophic, and now I know.
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The problem is that this doesn't offer them a "way out", that whole shit ensures they stay down in the gutter. 'cause, well, you don't think they get paid according to the risk to their health, do you? They get paid just enough for them to get by and keep them dependent. It's drug pushers we're talking about. Legal drug pushers, but why does anyone think they're in any way morally better than the average drug cartel. Paying the bums more than absolutely necessary not only costs more than it has to, but it a
Re:theres no money in procedural rigour. (Score:5, Informative)
FDA does actually require testing of the efficacy (in phase 2) as well as safety (phase 1) so you are wrong there. Testing drugs in the US is nothing but thorough. It takes on average 12 years and $350 million dollars to test a new drug and in some cases even longer and over a billion. After the 12 years of testing, the application for final approval (100,000+ pages) takes the FDA on average another 2.5 years to process.
The reasons for this excruciating process are obvious: approve an unsafe drug and your ass is on the line. Delay a life saving drug by years and you are just ensuring safety. People die in both cases but one is a lot more career threatening to than the other.
I'm not saying that testing drugs is not necessary but you have to look at both side of equation. Excessive requirements for testing and bureaucracy involved mean:
1, more expensive drugs
2. fewer drugs brought to market as many are not worth the expense
3. more people dying while waiting 15 years or more for a life saving drug to be approved
4. drug research is cost prohibitive for smaller companies leading to less competition
etc.
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Not really. They need only prove to be slightly better than placebo in a flawed study.
For example, in the SSRI studies, the side effects of the drugs effectively unblinded all of them.
That's why we see expensive new drugs get to the market when less expensive drugs with equal or better effectiveness and a better history of safety already exist.
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Sometimes the manufacture is trying to devolep a new drug with less side effects than those currently avalable. My wife participated in a study of an anti ADD drug. She didn't get any better so either it was ineffective or she was getting the placebo. For participating in the study she was given prescription to an already approved drug.
For her this drug is almost perfect. She can stick to her diet and has lost 50 lbs. She no longer spaces out, has more energy and can study for hours at a time, (she is pre
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When I saw Brave New World, I thought I might never again hear someone speak so chreerfully about death as the teacher conditioning the children. Then I heard the voiceover disclaimer lady in drug ads...
But seriously... (Score:2)
What does this story have to do with Linux?
I assume you were going for "funny".
But on the off chance you (or some reader) is asking this seriously...
Slashdot is about things that are of interest to nerds. The approval process for new drugs (which might save, enhance, damage, or end their lives) is one of those subjects.