I am not talking about pharmaceutical drug trials (which are generally paid for by the drug companies), I am talking about tests of things like stem cell transplantation.
My wife has been diagnosed with scleroderma, a degenerative immune system disorder, for which there is no cure. There is a large study being conducted to determine if adult stem cell transplantation is effective as a treatment. We are trying to get approval for her to become a test subject, but it is contingent on her insurance company picking up the tab for the transplant, an experimental treatment. It was just declined, but the doctors said they will appeal.
My question is this: how can a major medical study, costing tens of millions of dollars and the commitment of seven regional test centers, depend on the largess of insurance companies for their test subjects? We have very good insurance, but they rarely approve experimental treatments. So how can you conduct a clinical trial if few of your potential test subjects can get approval?
Another question is the screening process; how can they approve any subjects when the screening process takes six months or more, during which time no chemotherapy can be received? By the time the insurance company gives its approval, patients that initially met the criteria have deteriorated and no longer meet the standards. Doesn’t this call into question the validity of the study, since the bureaucracy of the selection process screens out those patients with faster developing or more virulent cases of the disease?
We just don’t understand, and my wife works in the medical research establishment.
If there are no test subjects, there is no study. And if a patient isn’t getting treatment while waiting for approval, they will die sooner, and pay fewer premiums.
I had never heard of this until my dad was diagnosed about 3 years ago. His kidneys shut down, but was a good candidate for transplant. Fortunately, my mom was a perfect match, and he’s doing awesome now! A little trouble with his hands in the cold, but otherwise just as ornery as before.
The studies are often funded by large grants from either the government, corporations (who might want to to develop the treatment that’s being studied and slap their brand name on it,) or donors that for whatever reason feel their money should be spent in medical research.
No, not experimental at all, it was a very routine kidney transplant operation. Insurance handled the bulk of it, and social security covered alot, too. I think SS only kicked in because the scleroderma rendered him disabled, so he isn’t able to work anymore.
I realize I didn’t answer the OP, but just wanted to share my lovely story.