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The Problems With Drug Testing

Soulskill posted about 4 months ago | from the inject-directly-into-eyeball-six-times-daily dept.

Medicine 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.

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Er, that's a bit confusing (-1)

Anonymous Coward | about 4 months ago | (#47570007)

I don't mind non-invasive drug tests being done by non licensed doctors, but testing drugs should definitely handled by licensed docs.

Re:Er, that's a bit confusing (5, Insightful)

saloomy (2817221) | about 4 months ago | (#47570119)

Not to be seen as a classist biggot, but if someone homeless or destitute, but understand the nature of the proposition, why shouldn't they be able to enter an agreement to test drugs that 1) might help whatever the condition being treated is and 2) render them with some income? The same opportunities should be afforded them as others. You can't exclude someone because they are homeless or destitute. I would argue that Mentally-Ill persons can not enter into such an agreement knowingly (without the consent of a care giver), and unless the drug was treating for that ailment, any mental side-effects would be difficult to discern from the original mental illness, and render the result suspect anyways.... just by $0.02

Re:Er, that's a bit confusing (4, Insightful)

rmdingler (1955220) | about 4 months ago | (#47570267)

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?

Re:Er, that's a bit confusing (4, Insightful)

mythosaz (572040) | about 4 months ago | (#47570319)

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.

Re:Er, that's a bit confusing (0, Flamebait)

Anonymous Coward | about 4 months ago | (#47570855)

You're coming across as stupid, like you're a teenager or an arrested-development libertarian type. Of course we should help the less capable and less informed make better choices. That's what patient advocates are for. Taking advantage of people's desperation to make them lab rats is obviously evil.

Re:Er, that's a bit confusing (2, Informative)

Anonymous Coward | about 4 months ago | (#47570889)

> 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.

Re:Er, that's a bit confusing (2)

Rockoon (1252108) | about 4 months ago | (#47572087)

It is not about removing decisions from the weakest among us.
It is about limiting the power of the most powerful among us.

..by removing decisions from the weakest among us.

Is there something I am not understanding here? Looks to me like your second statement is the excuse to implement the first.

Re:Er, that's a bit confusing (3, Insightful)

viperidaenz (2515578) | about 4 months ago | (#47570397)

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.

Re:Er, that's a bit confusing (0)

rmdingler (1955220) | about 4 months ago | (#47570583)

No good attorney would agree to take the 50% first rattle out of the box.

A competent barrister would agree to 40% and accrue the remaining ten in interest from the client's draws prior to settlement.

What? (2)

s.petry (762400) | about 4 months ago | (#47571233)

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 lawyer must be provided if the person can not afford one, but that is not true with civil cases.

Re:What? (1)

viperidaenz (2515578) | about 4 months ago | (#47572047)

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"

Re:Er, that's a bit confusing (1)

Mr. Freeman (933986) | about 4 months ago | (#47571477)

>If I was homeless and had a crack at suing a big pharma company for millions

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.

Re:Er, that's a bit confusing (0)

Anonymous Coward | about 4 months ago | (#47571663)

If the case is good, there's definitely some lawyer who will take it for a 30% cut of the winnings. There is or at least was recently a pretty serious glut of lawyers on the market.

Re:Er, that's a bit confusing (2)

lgw (121541) | about 4 months ago | (#47572073)

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?

Re:Er, that's a bit confusing (1)

Anonymous Coward | about 4 months ago | (#47570415)

do we want to rely on results that are likely skewed because the test subjects were also taking heroin, methamphetamine, and cocaine?

Wow... at first I was gonna respond with something about how I don't ever want the right to make decisions about my own body to be taken away from me, but then I noticed that little tidbit at the very end.

You do realize that homelessness and drug additions do not go hand-in-hand, right?

Re:Er, that's a bit confusing (2, Informative)

ShanghaiBill (739463) | about 4 months ago | (#47570863)

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 (4, Informative)

rahvin112 (446269) | about 4 months ago | (#47571507)

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.

Re:Er, that's a bit confusing (3, Insightful)

conureman (748753) | about 4 months ago | (#47571693)

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.

Re:Er, that's a bit confusing (2)

ShanghaiBill (739463) | about 4 months ago | (#47571923)

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 authority (including people like me that are offering to help), etc. I can think of only two or three people where our efforts have made any lasting difference, but hey, even turning two or three lives around is an accomplishment, and I would rather be out with my kids and their grandmother doing that, than sitting at home watching TV.

Re:Er, that's a bit confusing (-1)

Anonymous Coward | about 4 months ago | (#47572035)

(including people like me that are offering to help)

They are right to mistrust you. You're in a cult that worships a telepathic invisible space monkey. Seems like you have your own issues with mental illness to worry about.

Re:Er, that's a bit confusing (1)

fuzzyfuzzyfungus (1223518) | about 4 months ago | (#47570597)

Honestly, that's the bit that surprised me. If the payoff exceeded the potential legal exposure I don't doubt that you'd be able to find contractors willing to vivisect the homeless; but I am surprised that 'studies' on such a population(heavily weighted as it is with potentially confounding mental and physical morbidity, difficult to track over anything but the short term, etc.) would be treated as adequate.

From what friends in biology tell me, I gather that the reviewers would spit on you if you tried to do a rodent study by 'eh, we set out a nonlethal trap in the basement of the building and used whatever mice wandered in'. Obviously you can't order custom humans the way you can standardized mouse strains; but impoverished homeless people seem like about the least desireable study population you could imagine, except for the cheap and highly unlikely to sue you bit.

Re:Er, that's a bit confusing (1)

LordLimecat (1103839) | about 4 months ago | (#47571667)

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.

Re:Er, that's a bit confusing (1)

Anonymous Coward | about 4 months ago | (#47570281)

not all mentally ill people require a caregiver... in fact I'd imagine a lot of people fall into the "mentally ill" and are of perfectly sound mind and judgement. mild depression is a mental illness, some people just call that "being sad" other Mentally ill. General anxiety disorder, alcoholism, Narcissistic Personality Disorder, Borderline Personality Disorder. all are entirely possible to have and be perfectly sound mind. but anyone who's dealt with them (or the people suffering from them in the case of NPD and BPD) know it's a mental illness. But they do not need a caregiver to enter into agreements like this.

Now seriouslly mentally ill that require a caregiver... yes. but the vast majority of mentally ill do not need a caregiver.

Re:Er, that's a bit confusing (1)

Anonymous Coward | about 4 months ago | (#47570805)

not all mentally ill people require a caregiver... in fact I'd imagine a lot of people fall into the "mentally ill" and are of perfectly sound mind and judgement

Mr. Lebowski is disabled.

Re:Er, that's a bit confusing (0)

sosume (680416) | about 4 months ago | (#47570465)

Actually, I would expect a homeless person to have a completely different metabolism. So yes, that would make them unfit for testing drugs for the general population.

Re:Er, that's a bit confusing (2)

QRDeNameland (873957) | about 4 months ago | (#47570519)

Not to be seen as a classist biggot, but if someone homeless or destitute, but understand the nature of the proposition, why shouldn't they be able to enter an agreement to test drugs that 1) might help whatever the condition being treated is and 2) render them with some income? The same opportunities should be afforded them as others. You can't exclude someone because they are homeless or destitute.

Well, putting aside the question of whether or not this practice is exploitative, I see a greater concern in the fact that they are testing on a group that may not be representative of the general population. If, for example, the people you are testing on are disproportionately severe alcoholics or drug addicts, you might get a disproportional incidence of side effects that will skew your results. Ethics aside, it seems like bad scientific practice to me.

Re:Er, that's a bit confusing (0)

Anonymous Coward | about 4 months ago | (#47570571)

Not all drug trials are efficacy trials.

Re:Er, that's a bit confusing (0)

Anonymous Coward | about 4 months ago | (#47570659)

Of course not. Before you get to see if the drug works in people strung out on meth (efficacy), you have to see if the drug is safe for people strung out on meth (Phase 1 tests).

How many drugs cure cancer and are safe for patients not strung out on meth that get thrown out?

Re:Er, that's a bit confusing (1)

QRDeNameland (873957) | about 4 months ago | (#47570697)

I have no idea how that is relevant to anything I said.

Re:Er, that's a bit confusing (1)

sjames (1099) | about 4 months ago | (#47571157)

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.

Re:Er, that's a bit confusing (1)

Anonymous Coward | about 4 months ago | (#47571417)

It's a good (and challenging) question.
The argument about whether results could be generalized has already been made.
The other argument I've come across is one about the extent to which people are free when they are desperate.

Basically, the argument (and it is made for a whole range of things, not just drug testing) is that if someone is sufficiently desperate then their freedom to choose not to do something for money is compromised (because it may be a choice between doing that thing and starving, although in that case you could argue that the not-starving-but-doing-something-awful option is better).
It is kind of like (but by no means the same as) the idea that a person's freedom to choose is compromised if they are having a gun pointed at their head. You could argue that they are 'free' to refuse whatever they are being directed to do, but (from the above perspective) the likelihood of getting their head blown off compromises their freedom to choose. Obviously this latter case is a a bit more overt, and people would generally agree that the person with a gun pointed at their head is not really free than they would for the destitute-and-drug-testing thing.

(That's my understanding of the freedom argument, anyway. It is a bit simplistic, though.)

Re:Er, that's a bit confusing (1)

Charliemopps (1157495) | about 4 months ago | (#47571737)

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 be exploiting their sad lot in life to spare ourselves some discomfort. Pay more for testing, attract regular people. If you care about the homeless make community service part of the testing gig.

Wackadoodle (-1, Troll)

Russ1642 (1087959) | about 4 months ago | (#47570035)

This whackadoodle crap is the quality reporting we now get on Slashdot.

Re:Wackadoodle (1, Funny)

Virtucon (127420) | about 4 months ago | (#47570121)

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"

Wackadoodle (0)

Anonymous Coward | about 4 months ago | (#47570809)

If you have insights to share about the quality of reporting at Medium.com, you've failed to convey them, so your post just reads as "Derp."

Re:Wackadoodle (1)

Bite The Pillow (3087109) | about 4 months ago | (#47570969)

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 reactions may not be found when they should have been. Doctors with their licenses revoked isn't on the surface as big of a deal, other than the inability to be certain the study studied what it intended to, let alone having any confidence in the results.

But I'm sure you have 100% confidence in your genetics and lifestyle, and have no reason to expect to be taking anything that had to pass human trials. I suppose you could get hit by a meteor and bypass the whole aging thing completely.

I suppose I could go on preemptively admonishing your short-sightedness, but I suppose you could claim you don't need glasses.

Simple Drug Test (1)

Anonymous Coward | about 4 months ago | (#47570045)

Have the test subject read a Slashdot summary. If it makes sense, the subject is on drugs!

i don't like you so i need you drug-tested (0)

Anonymous Coward | about 4 months ago | (#47570057)

Well, you passed the drug test, but I'm going to fire you anyway. Reason for firing is...you took a drug test.

Wait, I'm Confused (1)

Anonymous Coward | about 4 months ago | (#47570071)

What does this story have to do with Linux?

Re:Wait, I'm Confused (0)

Anonymous Coward | about 4 months ago | (#47570097)

Linus is on drugs.

Re:Wait, I'm Confused (0)

Anonymous Coward | about 4 months ago | (#47570387)

With more H1Bs you'll soon be homeless and destitue and let's face it - you're still reading slashdot so you must be mentally ill.

But seriously... (1)

Ungrounded Lightning (62228) | about 4 months ago | (#47571239)

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.

not true because... (-1, Offtopic)

TheCarp (96830) | about 4 months ago | (#47570079)

I have never, and will never, submit to a drug test. In fact, in the past decade, every single time I have been on the hunt for a new job and on the phone with an HR person, I have been silently practicing my vitriolic rant should they ask.

As of yet, nobody has asked, so nobody has gotten my rant.

People who get paid to piss in a cup for someone elses amusement are called prostitutes, and honstly, I have nothing against honest prostitutes; its only the ones who delude themselves into thinking they are something else that I take issue with.

Re:not true because... (1)

Anonymous Coward | about 4 months ago | (#47570107)

I went in for a drug test one time. All they wanted was some piss. They didn't have any drugs for me to test, at all!

just pull a hobby lobby and say I'm on a drug (0)

Anonymous Coward | about 4 months ago | (#47570113)

I have never, and will never, submit to a drug test. In fact, in the past decade, every single time I have been on the hunt for a new job and on the phone with an HR person, I have been silently practicing my vitriolic rant should they ask.

As of yet, nobody has asked, so nobody has gotten my rant.

People who get paid to piss in a cup for someone elses amusement are called prostitutes, and honstly, I have nothing against honest prostitutes; its only the ones who delude themselves into thinking they are something else that I take issue with.

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.

Re:just pull a hobby lobby and say I'm on a drug (0)

Anonymous Coward | about 4 months ago | (#47570335)

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.

Then you don't get hired.

The problem solves itself!

Re:just pull a hobby lobby and say I'm on a drug (0)

Anonymous Coward | about 4 months ago | (#47570861)

and then I sue for religion discrimination

Re:just pull a hobby lobby and say I'm on a drug (1)

bobbied (2522392) | about 4 months ago | (#47570677)

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.

Re:just pull a hobby lobby and say I'm on a drug (2)

Joe_Dragon (2206452) | about 4 months ago | (#47570865)

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]

Re:just pull a hobby lobby and say I'm on a drug (1)

bobbied (2522392) | about 4 months ago | (#47570973)

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...

Re:not true because... (2)

Spy Handler (822350) | about 4 months ago | (#47570131)

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.

Re:not true because... (0)

Anonymous Coward | about 4 months ago | (#47570219)

To be fair, he was only confused about this because the summary was complete and utter crap.

Re:not true because... (1)

istartedi (132515) | about 4 months ago | (#47570369)

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.

Re:not true because... (1)

Matheus (586080) | about 4 months ago | (#47570539)

...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!

Re:not true because... (2)

rmdingler (1955220) | about 4 months ago | (#47571011)

Dude.

You can acronym like a MFer.

Re:not true because... (1)

bobbied (2522392) | about 4 months ago | (#47570689)

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.....

Fair? (1)

rmdingler (1955220) | about 4 months ago | (#47571001)

If today's little lesson proves any single thing at all,

life ain't, wasn't, and won't be.

Re:not true because... (3, Insightful)

CelticWhisper (601755) | about 4 months ago | (#47570133)

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.

Re:not true because... (2)

Austerity Empowers (669817) | about 4 months ago | (#47570251)

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.

Re:not true because... (1)

bobbied (2522392) | about 4 months ago | (#47570759)

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.

Re:not true because... (1)

l0n3s0m3phr34k (2613107) | about 4 months ago | (#47571225)

I try to tell people that's basically the same outcome as "praying to God"...you might get some response, but it's just as often a plague instead of "help"

Re:not true because... (-1)

Anonymous Coward | about 4 months ago | (#47570331)

You didn't even read the summary of the article, let alone the article did you? This has ZERO to do with employer drug testing. I would love to read your rant though, please share!

Re:not true because... (1)

mythosaz (572040) | about 4 months ago | (#47570417)

..but, but, (failed) f1r$t p0$+!

Re:not true because... (1)

mythosaz (572040) | about 4 months ago | (#47570359)

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.

Re:not true because... (0)

Anonymous Coward | about 4 months ago | (#47571017)

So, for people like you who feel they can not afford to put their money where their mouths are it is vitally important to use your mouth to support anyone who does take that risk. You must adopt a policy of publicly supporting anyone who refuses drug testing for any reason at all. For you, those people must get a reflexive benefit of the doubt. It is the least you can do.

FYI, some states forbid random testing as a condition of continued employment. California and Massachusetts come to mind. Some let employers do whatever they want, for example Nevada.

Re:not true because... (1)

rmdingler (1955220) | about 4 months ago | (#47571083)

Most of the companies who can afford to pay a wage that allows for few comforts do business with the government, or do business with a company that does business with the government.... short story: there will be drug screening.

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.

Re:not true because... (0)

Anonymous Coward | about 4 months ago | (#47570955)

> I have never, and will never, submit to a drug test.

And it shows. Because only someone totally stoned out of their gourd would think this story has anything to do with drug screening.

Huh (0)

Virtucon (127420) | about 4 months ago | (#47570093)

First, drugs are increasingly being tested on homeless, destitute and mentally ill people.

Name another group of the population willing to be guinea pigs for experimental medication? Prison inmates also comes to mind but not much else.

Second, it turns out many human trials are being run by doctors who have had their licenses revoked for drug addiction, malpractice and worse.

It's the American Dream to have made mistakes but to venture out into new avenues. Is one condemned for life not to at least use some of the talents acquired through years of school and experience just because they fell down! If not we're condemning people to a life of servitude at Walmart or 7-11 when they could be serving a useful purpose like pushing through drug test results.

Re:Huh (0)

Anonymous Coward | about 4 months ago | (#47570201)

Name another group of the population willing to be guinea pigs for experimental medication?

University students. Well, at least the ones who don't have mommy and daddy to pay for everything for them.

Re:Huh (3, Informative)

techno-vampire (666512) | about 4 months ago | (#47570381)

Name another group of the population willing to be guinea pigs for experimental medication?

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.

Re:Huh (1)

geekoid (135745) | about 4 months ago | (#47570489)

assuming you weren't the control!

Re:Huh (2)

techno-vampire (666512) | about 4 months ago | (#47570921)

Shrug! Even if I were part of the control, I'd still be doing something to help.

Re:Huh (1)

Virtucon (127420) | about 4 months ago | (#47570491)

Hadn't thought of that group, good for you! Hope it worked for you and your sister.

Re:Huh (1)

techno-vampire (666512) | about 4 months ago | (#47570949)

I'm not sure how well it worked for her, but I'm glad that my trial's over and I'm back on my old treatment. Not only did I find myself obsessing over how much and when I was eating, I had vastly more hypoglycemic episodes than normal. (Of course, at least half of them had no symptoms other than a low reading, so I can't be sure.) I know that mealtime insulin works for many people; now I know that I'm not one of them.

Re:Huh (1)

Bite The Pillow (3087109) | about 4 months ago | (#47571007)

... 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 diet, or microbiota, or epigenomic changes. But in many cases they do have a good model of why it *does* work when it does, because that's where they got the idea to use this formula or this drug.

I have X disease, I take all the treatments, nothing works. So I sign up for a trial and hope that a) I am in the control group and provide meaningful data to establish both efficacy and safety or b) that it works for me when nothing else will.

I can already see the replies. Please note that most of these types of issues will happen after procreation, meaning the treatment will improve quality of life for a parent and probably a child, but will not do much to change inheritance of whatever defect is present. So we aren't helping people who should otherwise die, unless after procreation people are considered disposable. In which case I'm glad to make a list of disposable people.

Re:Huh (1)

techno-vampire (666512) | about 4 months ago | (#47571173)

... And don't have other options.

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.

sometimes... (-1)

Anonymous Coward | about 4 months ago | (#47570129)

You gotta break a few eggs. And this doesn't sound like computer stuff. Fuck you slashdot.

Lab conversation (3, Funny)

Waffle Iron (339739) | about 4 months ago | (#47570143)

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! (1, Flamebait)

mi (197448) | about 4 months ago | (#47570255)

drugs are increasingly being tested on homeless, destitute and mentally ill people

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!

Second, it turns out many human trials are being run by doctors who have had their licenses revoked for drug addiction, malpractice and worse

Sure, malpractice, drug addiction and, especially, the unspecified "worse" are known to cause people to quickly forget all the training they've ever received in the medical school, and all the practice they got before losing their license.

Re:An outrage! (1)

mythosaz (572040) | about 4 months ago | (#47570365)

I had a problem with worse once.

It was worse than expected.

Re:An outrage! (1)

jsepeta (412566) | about 4 months ago | (#47570567)

Instead, I recommend that drugs be tested on Pharmaceutical company CEOs. I liked it so much, I bought the company. Or the farm.

Re:An outrage! (0)

Bite The Pillow (3087109) | about 4 months ago | (#47571081)

You are a stupid person. If you are simply ignorant and chose not to read a little more, you are stupid for making that choice.

We have to have a representative sample in order to test both safety and efficacy. We have to include the successful, unsuccessful, and mediocre, in order to have a result.

The second part is really easy to dismiss on its surface. if you assume that every revoked doctor is completely sober for every drug trial. A bad reaction in one patient that leads to severe health issues is not acceptable, if it could have been prevented by insisting on licensed doctors only.

And then there's this quote: "Karns canâ(TM)t remember the companies he worked for". If I ran a one-month study, I'd be able to tell you who I worked for. If I consulted for one month, I'd be able to tell you who paid my check. Perhaps I misread your statement as sarcasm, but it is at least in some cases fact.

One of the studies mentioned is taking stem cells and transplanting them. Anyone who lost their license, I would not allow them to do this to me. Feel free to volunteer as a mentally ill person, which you clearly are based on this single comment, to have non-doctors implant things that may or may not be stem cells into places that you may or may not want things transplanted.

That was sarcasm, btw, don't actually do that.

Nonsense (2, Interesting)

Anonymous Coward | about 4 months ago | (#47570339)

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't want to deal with trying to figure out which drug was doing what. Ideally, they would only be on our drug or a placebo (sugar pill), nothing else. Bottom Line: There is just too much money tied up in an already risky clinical trial to not do it right.

Re:Nonsense (0)

Anonymous Coward | about 4 months ago | (#47570997)

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't want to deal with trying to figure out which drug was doing what.

I agree with what you're saying - but the question is, what happens if you make it to Phase 3? Right now you have at most a handful of patients. When you hire a CRO (contract research organization) to find 5000 patients, that's where the trouble starts. When you hire a CRO for another 10000 patients two years down the road to repeat the same fucking phase 3 study because the FDA threw your first phase 3 study out anyways - probably because your potential-acquirer chaired the AdCom and they'd rather see you bankrupt so they can pick you up for ten cents on the dollar - then it really gets ugly.

theres no money in procedural rigour. (0)

nimbius (983462) | about 4 months ago | (#47570411)

testing drugs is monotonous, time consuming work normally outsourced to college grad students. When these arent available, or are unwilling to accept such a droll assignment as part of their education, the task can and certainly is reassigned to members of the medical community desparate to regain good standing. Test subjects are often compensated at a level only seen as commensurate to an audience of the destitute. $250 to test a drug that at its worst can kill you, is quite a bargain for someone who hasnt seen shelter or a hot meal in a month. Finally, the nature of the drug generally has to be questioned.

In many countries Americas "breakthrough" drugs are categorically refused on the ground that they do no more than placebo, and are sometimes just too god damn dangerous. In the united states, all a pharmaceutical company needs to do is essentially demonstrate an overall level of safety, not the effectiveness of a given prescription drug to ensure its acceptance in the market. That drug is then paradoxically marketed directly to the public. Everything from asthma medication to narcotics for chronic pain and insomnia are presented to the end user and the question duly raised to them, "Ask your doctor is $DRUG is right/ok/good for you." The commercial is then interlaced with a laundry list of side-effects and dangerous if not outright fatal complications that can develop as a result of using the particular drug being marketed. Results from drug tests and studies are sometimes mentioned, but are always downplayed as "a small number of" or "users may rarely" in describing what exactly could come about as a negative consequence of using a particular drug. We dont test drugs to make sure theyre safe. We test them to make sure their safe enough not to damage the ROI and marketability of a drug by introducing too many outright fatal or debilitating side effects.

Re:theres no money in procedural rigour. (4, Informative)

clarkkent09 (1104833) | about 4 months ago | (#47570561)

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.

Re:theres no money in procedural rigour. (1, Insightful)

sjames (1099) | about 4 months ago | (#47571249)

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.

Re:theres no money in procedural rigour. (1)

Anonymous Coward | about 4 months ago | (#47571399)

Wow, someone laid out an obviously informed post about how the FDA requires efficacy studies in one phase of trials, but not others and you responded with "Not really." And then proceeded to question the ethics of an entire field of science as well as a large government agency based on one case you don't actually understand.

What an asshole.

Re:theres no money in procedural rigour. (1)

sjames (1099) | about 4 months ago | (#47571227)

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...

People like danger (1)

0xdeaddead (797696) | about 4 months ago | (#47571985)

the 'death' is what attracts people to the drugs.

... or outsourced to Eastern Europe (2)

psergiu (67614) | about 4 months ago | (#47570423)

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 (4, Interesting)

Jodka (520060) | about 4 months ago | (#47570535)

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 (3, Insightful)

bill_mcgonigle (4333) | about 4 months ago | (#47570857)

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.

Re:Ten Million (1, Informative)

Anonymous Coward | about 4 months ago | (#47570913)

Extraordinary claims require extraordinary evidence. You've provided none.
Because of that, I don't even have to go looking to know that your version of events is misleading at best.

Re:Ten Million (2)

Rockoon (1252108) | about 4 months ago | (#47572119)

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 (1)

manu0601 (2221348) | about 4 months ago | (#47571501)

The easy way for a doctor to have his license revoked it going outside of mainstream medicine. Reading too much medicine research papers can lead to such situation, and it seems a perfect fit to run human drug trials.

Ran into this recently (1)

fightermagethief (3645291) | about 4 months ago | (#47571555)

As a representative of the homeless community, I was recently offered a drug testing trial that paid 1000 USD. I had to come in and piss positive for heroin, but nothing else. Then I was to be subjected to experimental tapering-off drugs for heroin addicts. 1000 bucks for a small dose of heroin sounds about right, considering I could probably just lick a pharmaceutical like oxycontin and still test positve, but I would rather eat with the bums at the chow line than be a lab rat for experimental pills. The only person that I know that said yes was already a heroin addict and actually wanted to get off the stuff. The homeless are subject to much more than drug trials though, have you ever seen 'Surviving the Game' with Ice-T?

Let me get this right: (0)

Anonymous Coward | about 4 months ago | (#47571563)

The author is surprised and outraged that in order to develop drugs for mental illness, those drugs are being tested on the mentally ill?

Now who's crazy? (1)

MikeBabcock (65886) | about 4 months ago | (#47571573)

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.

So you live in a police state (1)

0xdeaddead (797696) | about 4 months ago | (#47571981)

Honestly it's more of a joke looking from the outside, enjoy your 'freedom'.

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