The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
The inspector general of the U.S. Department of Health and Human Services, Daniel Levinson, said federal health officials do not know how many clinical trials are being conducted, audit less than 1 percent of the nation’s testing sites and, on the rare occasions when inspectors do appear, generally show up long after the tests are completed.
“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur Caplan, chairman of the department of medical ethics at the University of Pennsylvania.
Do we need something like People for the Ethical Treatment of People?
Animal research facilities must register with the federal government, keep track of subject numbers, get unannounced spot inspections and address problems speedily or risk closure, none of which is true in human research, Caplan said.
The report concluded that the FDA’s oversight of clinical trials is disorganized and underfinanced. Just like its oversight of imported food, foreign drug manufacturers, animal food, and the safety of over the counter medicines.
Having been involved in clinical trials supervised by the VA Hospital system, my tendency is to agree with #1. At least, subjectively, responsibility was well delegated.
However, the report came from the IG of the DHHS. Not someone with a political interest in looking for unnecessary problems. If accountability is absent, we’re still relying exclusively – for 99% worth – on those who might benefit from the trials to provide oversight.
Total nonsense. Trials are always conducted according to strict protocols that can be defended if the medicine moves forward for approval. Additionally, medical institutions have a review committee who approves the protocol according to local standards. Surprise inspections are not uncommon. I’ve been involved in clinical testing since the early 80s never saw a patient mistreated. It may happen but it is rare. In fact, if the trial looks very good, it may be stopped early and the medicine made more widely available because it is felt to be unethical for some patients not to receive the treatment.
>>my tendency is to agree with #1.
Ditto.
And if we want tighter controls on American-grown E. coli vegetables, kiddie cold medicines, cures for cancer, and lead-painted toys, we are going to have to PAY for it. That means either higher taxes, or taking some of the hundreds of billions of dollars we waste every year and redirecting them to programs that actually benefit Americans. Those are the only two options.
Although clinical trials are officially pretty well controlled in the USA, we have no idea what may be done under-wraps in terms of “unofficial” clinical trials.
Watch the movie “The Constant Gardener” for an idea of what could actually be happening in the name of research.
A person in a closed environment, tends to see What is there. AND ONLY there.. NOTHING in the next location, or the next.
you cant see past your own Limits..
And unless you were involved..as in checking ALL the facilities, WORKING at ALOT of facilities, or Suppling the durg/material/treatments… You cant see what WAS/IS happening.
I think the previous posters are assuming the reporter played it straight.
Call Ripley’s if he did. I’ve never known it to happen with anything I was familiar with, aside from some specialty press.
Journalists are experts at writing articles that grab the attention. Seldom anything else.
To #1:
The joke is on anyone that actually believes in the benevolent “institutional review board”. Usually an elite set of university medical and research oriented individuals all drooling at the prospect of another “wonder drug” that could net the university millions in their ‘cut’, and by the way the ONE individual who is put on the board who isnt a member of the professional community is ‘appointed’ by the President of sponsoring organization. What a schill!!!
Nothing’s perfect and there are always the unethical, as we are well aware of. The reporter is making his story as *wnd of the world as we know it* as he can, but that dosen’t mean there are not problems.
The FDA, I think does a pretty decent job considering how much their budget has been cut over the years. In many goverments, reducing funding, as has been done at the FDA, of a department with such a huge mandate would totally cripple it, but all in all the FDA still manages to keep the human existance ending plagues to a minimum.
I’m really begining to agree with the isolantionists a bit, after Bush is gone and we end our envolvement in Iraq and Afganistan, we should pull back into ourselves, it would give the world what it claims to want and allow us to concentrate on making this country viable again, in health care, education, infrastructure, science and maths.
Departments like the FDA and others are struggling to keep their heads above water and thats wrong.
Oh…and Ed, thats one of my favorite Twilight Zone episodes……lol ;0
12,
That is one UGLY lady under all those bandages..
I still like the one about the Rich guy that TRIES to make it look Asif’ the world is ending to others…Then has a mental breka down, and All he see’s is the End of the world, even tho it didnt.
#1, #2, & #3
I guess you guys can’t see the forest for the trees. The review panels and oversight committees are all on the same side. That is not the same as an independent oversight from a disinterested party such as the FDA. Your oversight has a lot of bias and conflict of interest involved.
That is not to say or even suggest that the results are routinely doctored. But I will say that because we never know, it is possible.
>>The joke is on anyone that actually believes in the
>>benevolent “institutional review board”.
Obviously, you have no first hand (or even second hand) experience with IRBs. Or clinical trials, or the FDA, or much of anything else related to this post.
>>That is not to say or even suggest that the results are
>>routinely doctored. But I will say that because we never
>>know, it is possible.
See above. I think all that radiation is getting to you Isotopic One. The IRB has nothing whatsoever to do with the “results” of a clinical trial. None. They review protocols and monitor safety issues. And in doing that, they are even more stringent than the FDA. The notion that an IRB somehow “doctors up” the results of a clinical trial is so laughable I’m ashamed of you for even bringing it up.
#16, MM
The notion that an IRB somehow “doctors up” the results of a clinical trial is so laughable I’m ashamed of you for even bringing it up.
And how do we know that? Because the people doing the experiments say so? Would I be allowed to verify a trial first hand? Plus, it is not the Review Board that would doctor the results, more probably the actual trial administrators.
History has repeatedly shown us that organizations can not be trusted to police themselves. Although I have no specific knowledge of any malfeasance here, neither would I put a blanket trust on any “Review Board” that is tied to the trial or even industry itself.
#17 – Nookyular One
Why would the trial administrators give a shit how the trial came out? They’re being paid by the drug companies, and they get the same amount of money if the drug works or doesn’t work. And virtually all phase 3 clinical trials are multi-center, so if they doctor up the results to make it looks like the drug works at THEIR institution, but it doesn’t work at others: Automatic Red Flag.
Besides, the trials are virtually all double-blind, and if the blind is broken before the trial is over, it leaves a paper trail.
What you are suggesting is a pervasive corruption that permeates the regulatory agencies, the drug companies, the medical community, and the government, all working in concert to sell you a drug that is dangerous or does not work.
I hope you’ve still got that tin-foil hat.
In the future, it might be good if you restricted your comments to something you know about.
Is that a snap from Metallica’s video “ONE”?