August 1, 2003

Karen M. Templeton-Somers

Center For Drug Evaluation and Research (HFD 21)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Re: Docket number 03N-0143

Syrup of Ipecac

Dear Ms Templeton-Somers:

My name is William O Robertson MD; as you may recall I was invited to
testify at the public hearing on Syrup of Ipecac (SOI) held on 12 June
2003 - and will try to refrain from repeating what I said there.
Nonetheless I would like to add several points for consideration by the
FDA as it ponders how to respond to the Advisory Committee\'s 6-4 vote.

1\. As promised when I left, enclosed is an abstract from J.Tox-Clin Tox
(2001 39:233) and the second an article from Vet and Human Tox (1999
41:97-8) with both alluding to clinical practice behaviors. As is
apparent, at the time of both surveys, a number of our nation\'s Poison
Centers and their Medical Directors continued to recommend use of SOI on
specific occasions.

2\. Both Drs Managuerra and Tennenbein alluded to the purported \"fact\"
that if SOI is administered within 5 minutes of an ingestion, it removes
\"\...a mean of 25-30%\...\" of the ingested substance. Quite clearly,
that figure is based on several carefully selected and clearly biased
studies. In support of that contention, check Vasquez et al (Clin Nucl
Med 1988 13:638-9) where 83% of a radioactive label was recovered at the
5 minute time interval; Bond, R. et al (Ann Emerg Med 1993 22:1403-07)
where APAP blood levels among SOI treated children were only 50% of
controls who had not been treated; and Amitai et al (Peds 1987 80:364-7)
who also showed rapid SOI treatment to reduce APAP levels to some 50% of
controls. And this was not their only \"exaggeration\".

3\. While FDA\'s focus is understandably on SOI, the real topic is
actually \"emesis\" - as it is able to be induced by a wide variety of
substances - including apomorphine, liquid detergents, hydrogen
peroxide, copper sulfate, etc. As of today, SOI has a remarkable
track-record of safety - its use in an alcohol detox unit saw \>300,000
uses transpire without a single serious consequence. In contrast,
apomorphine has had its problems - and, currently, involves an
injection, copper sulfate was abandoned because of the ensuing
complications and hydrogen peroxide - which comes in a variety of
concentrations - poses recognized risks at the higher levels - and both
the professional public and general public are not informed about that
issue. The point is that eliminating a \"safe alternative\" (SOI) but
leaving available a group of non-safe ones to induce emesis appears to
me to be a less than appropriate move. And rest assured that those
anorectics and bulimics who might have their supply of SOI emetic cut
off would very quickly find another even less safe alternative using
\"too much\" table salt (NaCl) or baking soda (NaHCO~3~) - and end up
with hypernatremia that has caused and will again cause death.

4\. Over the past week, I\'ve heard several radio interviews with Dr. A.
Wood - a member of FDA\'s OTC Advisory Committee; in the most recent
discussion, he boasted that neither he nor his wife (also a physician)
had ever permitted Ipecac to be in their house- having clearly made up
his mind about the matter sometime before he was appointed to the
Committee. And he reiterated from the Committee meeting itself that
emesis was the most reprehensible of all bodily functions and, although
he was \"over-ruled\" - quite convincingly - by a grandmother member of
the Committee, I can only wonder about his \"scientific objectivity\"
With that pre-existing bias, would he have recognized that both Dr
Tennenbein and Dr. Managuerra -- despite clearly minimizing the mean %
returns after Ipecac-induced emesis and, thus, being\" scientifically
inaccurate\" were, in fact \"scientifically accurate\" when they found
induction of emesis to have very few adverse effects. Then, Dr Wood
stressed that vomiting itself was \"an adverse effect of the drug\" with
everyone else seeing it as an \"intended effect of Ipecac\".

5\. Should other members of the FDA worry about the side effects - and I
had stressed how more than 300,000 doses were given in a Pavlovian
conditioning program directed at keeping alcoholics off the booze here
in Seattle - where do those individuals stand with reference to Tylenol?
Well over 100 U.S. citizens \"abuse\" Tylenol every year to such an
extent that they end up dying. While it is understandable that FDA and
the manufacturer are trying to improve the labeling to avoid errors,
that won\'t do away with purposeful abuse. And I would doubt that the
answer would be \"banning its use\". The relative benefits are simply so
much more significant than the risks that Tylenol\'s use will continue -
and Ipecac\'s use should also. Banning ipecac for such a reason would -
in my opinion - be total nonsense and certainly not justified.

6\. Finally, earlier this week, we got a call from the Olympic Peninsula
where a mother had awakened from her 10 minute nap only to discover that
her 2 year old had gotten into her medicine bottles - and, that among
other items, more than 10 Effexors (a muscle-relaxant) were missing. We
urged making him vomit - but the mother couldn\'t find her ipecac - so
she asked 911 to drop by - but they had just taken ipecac off the rig
and replaced it with charcoal. Naturally, the kid wouldn\'t touch it -
so it was a joy-ride to an \"urgent care\" unit. Unfortunately, it was
short of nursing staff to administer the charcoal by lavage so a second
ambulance came by and transported him to hospital. The time lapse was so
long that they did nothing but observe him. After several hours of
\"unusual sleepiness\" - but no EKG problems, he was able to go home
about midnight with his mother having gotten several very healthy bills
along the way. It all could have been avoided had emesis been induced at
home!

Thanks much for your attention; if you should have any questions or seek
clarification of any of the above, please don\'t hesitate to ask -
206-517-2356 or FAX 206-526-8490 or e-mail
[robertso@wapc.org]{.underline}

Sincerely yours,

William O. Robertson MD

Medical Director, Washington Poison Center

Professor Pediatrics, University of Washington

CC: Curtis Rosebraugh

Food & Drug Administration