NEWSLETTER 3: HOW SAFE IS PLACEBO?

Withdrawing or withholding a treatment in a control group to “wash-out” the current medication along with use of a placebo is associated with a risk of an adverse advent and as such should be evaluated as one would evaluate any other risk in the process of practicing medicine.

That means, one should move past any buzz-words and ask the usual questions that apply to any experimental protocol including:

1. How likely is harm?
2. How great is the harm?
3. How durable is the harm?
4. What's the character of the harm?
5. Is the risk necessary for the success of the research?
6. Is the research important enough and high-quality enough to make the risk appropriate?
7. Are there ways the risk could be lessened?
8. Is the risk (probability/magnitude/duration) within the range for which it is ordinarily acceptable to invite subjects to bear it, or is it in some way an extraordinary risk?
9. Can the subjects understand and appreciate proper informed consent?
10. Is the informed consent process adequate?
11. Are there adequate additional safeguards if the consent process is compromised?

The investigator should be able to provide answers to the above questions that satisfy the IRB of the propriety of the research, and the research should not be approved if the investigator cannot do so. This doesn't mean that research involving drug-free intervals can never be conducted; it just means that it takes a lot of thought and care to do them properly.

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCTI, CCRC, CCRP
Expert Medical Witness, ExpertMD
PI (Principal Investigator), DSI (Drug Study Institute)
Board Certified Internist, JPMC (Jupiter Preventive Medicine Center)
DABIM (Diplomat American Board of Internal Medicine)
FACP (Fellow American College of Physicians)
CPI (Certified Physician Investigator) by the AAPP (American Academy of Pharmaceutical Physicians)
CCTI (Certified Clinical Trial Investigator) by the ACRP (Association of Clinical Research Professionals)
CCI (Certified Clinical Investigator) by the DIA (Drug Information Association)
CCRC (Certified Clinical Research Coordinator) by the ACRP (Association of Clinical Research Professionals)
CCRP (Certified Clinical Research Professional) by SoCRA (Society of Clinical Research Associates)
Member, SIMPD (Society for Innovative Medical Practice Design)
Member, ACPM (American College Preventive Medicine)
Ethics Committee Member, Jupiter Medical Center
IRB Member, Jupiter Medical Center
Founder, CertifiedResearchers.com