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.
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.
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.
Re:Er, that's a bit confusing (Score:2, Informative)
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:2, Informative)
> 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:Ten Million (Score:1, Informative)
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: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.