Medical Experimentation - What are the Legal/Ethical Limits?

[NeoN]

From everything I've read of various patient's outcomes, it seems to me that surgeons occasionally take great leeway with the device labeling and indications.

But, that begs the question for patients: How do YOU know what the limitations are, indications, generally accepted practices?  Are you to just 'trust your doctor?'.   Sure, that's fine for those who have excellent outcomes, but for others, wherein it is patently obvious that the surgeon has pushed the limits, if not exceeded them, how do you know what is normal and acceptable?

Go ask another surgeon?  Well, that doesnt work very well, especially if they wont implicate a colleague - for fear of retribution.

Here's a post by Dr. Peloza on Spine Universe which will, just by the nature of the questions being asked, give you goose-bumps:

http://www.spineuniverse.com/debate/index.php/topic,11.0.html

"Regarding whether or not sham surgery as a control is ethical... First off I understand the reason for a sham surgery control but you can get data that proves the point without doing a sham surgery. I was part of the IDET study, but that was just putting a needle next to the disc, not actually cutting into the patient. If doing a randomized trial involves sham surgery and if this means we have to do a surgical approach, then I think that is very problematic, especially in the U.S. I can’t imagine patients who have free access to healthcare would randomize to this and agree to be part of the randomized group. Secondly, no hospital IRB would approve and I don’t think any surgeon or patient would agree to be part of it. I think it is an ethical challenge and would face all kinds of legal hurdles."

For example: In the FUSION VS. ADR debate, we hear variably that less than 5% and greater than 90% of fusion patients are candidates for ADR. They cant both be right. 

This thread will focus further on sources and means to discover these bounds.

[NeoN]

This is the ONLY way to accurately define indications and methods to optimize medical treatment.

http://ebm.bmj.com/

Unfortunately, the articles are not accessible to the general patient.

[NeoN]

http://www.naturalnews.com/019187.html

(1988 - 2001) The New York City Administration for Children's Services begins allowing foster care children living in about two dozen children's homes to be used in National Institutes of Health-sponsored (NIH) experimental AIDS drug trials. These children -- totaling 465 by the program's end -- experience serious side effects, including inability to walk, diarrhea, vomiting, swollen joints and cramps. Children's home employees are unaware that they are giving the HIV-infected children experimental drugs, rather than standard AIDS treatments

========================================

As a reminder to everyone: There are people out there (doctors) who think they have the right to experiment without disclosure ... because its for the 'greater good of humanity' (which often includes their bank account, since most of them are invested in the devices they are implanting). 

That, by the way, is a primary motivator of this site - to collect and disseminate information on spine procedures, which the average, desperate and tormented spine patient, does not have the capacity or time to accomplish alone.

-N

[PAG]

NeoN,

     Thanks for your warm welcome and replies. Here is a group that we may be interested in supporting. Alliance For Human Research Protection. Here is the link to this worthwhile group. http://www.ahrp.org/cms/content/view/18/87/.

     If I knew then (2008) what I know now about the hidden machinations and corruption that is systemic with the medical community, I would have preferred to suffer than to be in the physical and emotional trauma I am now experiencing post surgery as a clinical trial subject. When one either volunteers or is recruited into a trial, one no longer is a patient who will be treated with some dignity and ethical standard of care. This has to be done by the physician, otherwise he can be quickly and openly prosecuted for medical malpractice. Not so with the clinical trial subject. The secrecy and exploitation that goes on behind the scenes while involved in a clinical trial is parallel to the way doctors treated subjects in Nazi Germany when they were performing medical experimentations on the persons who were detained in camps or swifted away into Nazi doctor controlled institutions. It is pretty much the same with clinical trial subjects worldwide. The US is no different. I have learned that there are no laws that protect the clinical trial subject once one signs the consent form. It is understood that the consent form was approved by an institutional review board or IRB. Most IRBs have financial and professional connections to the hospitals and research centers that they have oversight over. For the most part, they are volunteers and few are trained in the field of medicine which they give their approval for the materials and consent forms that are passed to the subject. Most IRBs are overseeing so many clinical trials that they do not have the time to inspect or monitor the trial, except for the data that they are given by the priniciple investigator or physcian. It is set up as a layed bureauracy, and corruption is rampant. Lawyers do not have a clue how to advocate for the clinical trial subject, since the word trial implies risk. And to investigate medical malpractice is next to impossible, because the medical records for a trial are sealed from the public. One also needs experts to point out where the principle investigator screwed up -- and with a trial, it is usually the PI who is the only "expert" in this area, locally. You will not find another PI who will contradict a doctor who is during a clinical trial in the same area of medicine -- because both are probably working for the same corporation or research institute.
the window is starting to wiggle again...so I will jhave to stop typing.. PAG