A HIPAA-SIzed Problem With Patient Reported Outcomes

  • by: |
  • 11/15/2007
Ed Silverman, the brains behind pharmalot ( www.pharmalot.com) has written a great piece on the trend towards patient reported outcomes in clinical trials. Must reading on this subject for anyone interested in personalized medicine and understanding how and why FDA yanked the QOL indications from Amgen's anemia drugs.

http://www.the-scientist.com/article/home/53617/

Now it seems that accessing this data can often be a problem for the researchers who want to use this research to find out what works. An editorial in JAMA by Norman Frost of the Univ of Wisc. Medical School writes that application of HIPAA rules has shut down research or scared off otherwise important studies in the name of privacy:

"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation."

http://www.sciencedaily.com/releases/2007/11/071113165648.htm
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog