Log In

Home
    - Create Journal
    - Update
    - Download

LiveJournal
    - News
    - Paid Accounts
    - Contributors

Customize
    - Customize Journal
    - Create Style
    - Edit Style

Find Users
    - Random!
    - By Region
    - By Interest
    - Search

Edit ...
    - Personal Info &
      Settings
    - Your Friends
    - Old Entries
    - Your Pictures
    - Your Password

Developer Area

Need Help?
    - Lost Password?
    - Freq. Asked
      Questions
    - Support Area



Whatever gooses your gander ([info]khym_chanur) wrote in [info]unfunnybusiness,
@ 2009-07-02 15:46:00


Previous Entry  Add to memories!  Tell a Friend!  Next Entry
Bad alt-med study back on track, funded by tax money
So, the NCCAM (National Center for Complementary and Alternative Medicine) portion of NIH (the U.S.'s National Institute of Health) was funding a study on the use of chelation therapy (injecting special chemical in order to remove metals from the body) to treat heart disease.

The whole thing has oodles of problems:
  1. NCCAM's scientific advisory board initially voted against funding the study, but then alt-med supporter Representative Dan Burton applied some pressure and NCCAM suddenly coughed up $30 million to fund the study.
  2. The study, a phase 3 clinical trial, was done even though no phase 1 or phase 2 trials had been done, or even an animal study, contrary to the usual rules for a phase 3 study.
  3. The IRBs (Institutional Review Boards) which approved the project weren't provided with accurate scientific information and risk estimates by those performing the project.
  4. Many of the clinics where the study was being conducted had a financial interest in promoting chelation therapy, and the blinding protocol used was flawed in a way which let the investigators know which injections were the drug and which were the placebo.
  5. "Several site co-investigators have been disciplined for substandard practices by state medical boards, several have been involved in insurance fraud, and at least three are convicted felons." [From the NIH's response to a complaint about the study]
  6. "Since the mid-1970's court documents and newspapers have reported at least 30 deaths associated with intravenous disodium EDTA." [Also quoted from the NIH's response]
  7. The informed consent forms given to the study volunteers left out important risks.
#3 to #7 (plus other things left out of this summary) were enough to get the study halted, and combined with #1 and #2 you'd think that it would stay halted. But nope, the study is back on track. The NIH basically:
  1. Told the people performing the study to inform the volunteers of the risks they'd left off of the consent forms.
  2. Told the IRBs to clean up their acts so that they'd catch similar problems in the future.
  3. Gave those performing the study a slap on the wrist.
  4. Otherwise carry on as they had before.


(Read comments) - (Post a new comment)


[info]lil_miss_stfu
2009-07-03 01:03 am UTC (link)
The thing that boggles my brain is that Disodium EDTA is one of the anticoagulants available for our haematology tubes. I know that doesn't mean its not safe for use on humans, but it still makes me twitch :p

(Reply to this)


(Read comments) -

 
   
Privacy Policy - COPPA
Legal Disclaimer - Site Map