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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
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?
Happiness in intelligent people is the rarest thing I know.
Ernest Hemingway
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.
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.
Ceci n'est pas une signature.
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.
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.