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The Problems With Drug Testing
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.
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
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.
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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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."
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.
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?
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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.
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.
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.
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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.
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.
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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.
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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.
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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.
Negative moral value of force outweighs the positive value of good intentions.
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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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.
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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.
Shrug! Even if I were part of the control, I'd still be doing something to help.
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Happiness in intelligent people is the rarest thing I know.
Ernest Hemingway
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.
-The wise argue that there are few absolutes, the fool argues that there are no probabilities.
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.
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.
The cost of that cleanup, of course, will be borne by taxpayers, not industry.
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.
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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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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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, and were imprisoning sane people.
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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.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
That's swell. Abusing religious laws to fight religious bullshit.
Would it make me the devil if I can't help but giggle?
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
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?
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
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).
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