Unethical practices - drug industry

MAIKAI maikai at aol.com
Wed Aug 16 20:48:51 EST 1995

>>As an aside here, I understand what decongestants can do to people.  
My mother (who is 57) a few years ago had a very bad cold, so stopped at
the pharmacy for a decongestant.  They gave her a sustained release 
tab that was 240mg (it has since been taken off the market, as too 
many people were having adverse reactions).<<

 Interesting about your mother's reaction.....I live in another state from
my mom---we talked at least once a week.  About a week before when I
talked to her, she was talking a mile a minute----don't think I said more
than a few words every so often.....I kind of wondered then what was going
on....it was almost like she was on speed.  I saw a letter to the editor
in the May '95 edition of Family Practice that talked about a patient the
doc had that had taken 240 mgs. of Edifac(sp?) sustained release.  He was
a young, healthy male.  Four hours after the first one he was feeling
uncomfortable and his pulse went up to l30 (normal about 70).  The same
thing happened the second day.  The doc wasn't sure what happened......but
noted docs should continue to use caution in prescribing or recommending
the higher dose of sustained release decongestants, until proven safe. 
The letter was written in response to a study published in the Jan. '95
edition re:  a study on  hypertensive patients of 60 mgs. of the stuff,
taken four times a day.  The sample was small---and I believe the average
age was only 50.  Every other study I've found has been on small samples
of either young healthy males, or a younger population, for short
durations (ie:  72 hours).  
I've been told the chemical composition is similar to amphetamines.
I've sent 6 capsules to the drug company who is interested in testing for
dissolution, etc. (I had them tested for quantity, and that at least was
OK) and outlined my mom's medical history.  I don't blame the drug
company, since the literature has warnings----but they didn't list the
"fatal" warnings, like comparable drugs do (if one has certain
conditions).  They've been cooperative.  Wonder if they'll tell me the
truth if something is wrong with them. (doubt it).  
OBRA '90 and the state Pharmacy Act puts a lot of responsibility on the
pharmacist------the laws are quite specific.  Prior to OBRA the
pharmacists got away with saying it wasn't there job to question the
docs---they weren't licensed to practice medicine.  Not so with the
passage of OBRA.  At the very least my mom should have been warned of side
effects and symptoms to be aware of.  Problem in the states, is that the
State's licensing boards oversees pharmacists, docs, etc. and for the most
part they consist of peers.  Many states have not had a good track record
of taking disciplinary action (the ol' protect your own syndrome).....but
I'll play the process out.  If I don't get satisfaction, I'll hire my own
experts, and publish their opinions in the local newspaper, along with
what happened.  I have a business degree---not medical----and with a
little research at NIH, found out the pills were relatively
contraindicated.  I believe they keep pharmacy records for 6 years.....I
agree as to hypertension and hyperthyroidism-----warnings and cautions are
very specific, as well as use in the elderly (over 60).  Glad your
relatives survived their encounters with the stuff!  I'm awaiting a copy
of a GAO report released last week----talks about the "drug crisis" in the
elderly---they estimate over 5 million in the US have adverse effects. 

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