IND, Compassionate, Off-label-use + CAM Flashcards
What is IND?
Investigational new drug. An IND designation is necessary to be allowed to test drugs on subjects, it comes from the FDA. The admission is based on pre-clinical data. Patients can request a special permission - only in life-threatening situations.
What means compassionate use?
When patients with life-threatening diseases would like to get access to a drug, that is being tested, but they don’t want to be part of the trial, they could get the placebo instead. They go to the doc - get IND permission - get compassionate use. It takes place at the phase 3b. Who pays? sponsor of the patient, charity organization, rarely the health insurance. If nobody pays, the patient might go to court - a lot of hassle.
What is off-label use?
drug prescription for a non-approved indication, population, in a non- approved dose or form.
marketing of the drug only under that label.
usually used on children, orphan diseases, or small subgroups.
What is the problem with off-label use?
it is very common, it is nice that people get access to anything they want, but scientifically it is a disaster. we can’t conclude based on knowledge. patients might not even be informed they are getting off-label drugs.
What is the indication creep?
off-label promotion of drugs and medical devices mostly by profit-driven industries. –>
- reducing thresholds for diagnosis
- relying on surrogate end points
- exaggerating efficacy and safety claims
- disease mongering
- attempt to tailor research evidence to individual patients.
What is CAM?
Complementary and Alternative Medicine
Complementary:
used together with conventional medicine
Alternative:
used in place of conventional medicine
Vitamins, minerals, herbs and other dietary supplements DON’t have to undergo trials for safety and efficacy as long as the supplier makes no claims in linking the supplements to a specific disease.
:-)
FDA regulation of homeopathy
required: quality, purity, packaging and labelling standards- limitation about alcohol content, need: no active ingredients! then it is safe! (almost like OTC drugs)
CAM regulation in CH:
approval based on simplified procedure or via registration/notice.
no efficacy, no safety testing necessary (they cycle for a while, therefore usually safety not necessary)
efficacy only required when application for medical indication
CAM in the EU
more restricted!
What is CAM? according to Mr. Gemperli :-)
a remedy is claimed, hence it is alternative medicine, then it is assessed by people, science and the public - it’s found beneficial - it becomes mainstream - no longer alternative
Remarks on Clinical Trials and CAM:
- scientific plausibility does not matter - the only thing that matters is the clinical trial
- system based on trial and error
- many drugs detected by chance
- CAM does not play by any rules
