TY - JOUR
T1 - Oral immunotherapy in food allergy: how difficult to weigh its risks and benefits?
AU - Calvani, Mauro
AU - Miceli Sopo, Stefano
AU - Giorgio, Valentina
PY - 2011
Y1 - 2011
N2 - To the Editor:
The editorial by Thyagarajan et al1 entitled ‘‘Peanut oral immunotherapy
is not ready for clinical use’’ and published in the July
2010 issue of the Journal argued for limiting the clinical practice
of oral immunotherapy (OIT) by underlining that several important
questions about OITare still unanswered. Quoting the Hippocratic
Oath, ‘‘never do harm to anyone,’’ they also underlined that
OIT seemed to be generally safe but not without risks.
Wasserman et al2 replied to this editorial, stating that OIT for
food allergy is safe and effective. Paradoxically, those same authors
also reported the death of a child that happened during an
OIT formal trial performed in a tertiary pediatric center, adding
that it was due to a dosing error. Unfortunately, Wasserman
et al did not report any bibliography for that clinical case. They
did not give further details about the tertiary center involved or
about the trial in which the child took part.
Until now, no OIT-related death has been reported in the
literature. Thyagarajan et al replied back, apparently denying the
occurrence of such a death, and stated that ‘‘it is correct that there
have been no fatalities in the studies of OIT up to the present
time.’’3
We have recently published a systematic review about OIT,4
and we also have not found any deaths among all the trials published
up to now. In fact, OIT in food allergy has been used in Italy
for many years,5-7 and several adverse events have been described,
8 but a death caused by OIT has never been signaled. Nevertheless,
the letters quoted above put us in doubt: Did the child
die, or did he not?We really think it is important to know whether
a life-threatening event has happened because of a dosing mistake
while performing OIT. Mistakes are common in medical clinical
practice, and to knowhow it happened and which type of food was
the trigger would be useful.
Indeed, if that death happened in a tertiary center, how many
errors could happen if OIT comes into routine practice and starts
to be performed also in less experienced centers? We agree with
Thyagarajan et al1 that OIT can begin to be recommended only
after demonstrating that it is ‘‘superior to nonaction (or the current
standard of care).’’ For this reason, we believe that it is necessary
to know whether any life-threatening event has happened while
performing OIT because we are certain that it will help in carefully
and safely weighing the risks and benefits of OIT.
AB - To the Editor:
The editorial by Thyagarajan et al1 entitled ‘‘Peanut oral immunotherapy
is not ready for clinical use’’ and published in the July
2010 issue of the Journal argued for limiting the clinical practice
of oral immunotherapy (OIT) by underlining that several important
questions about OITare still unanswered. Quoting the Hippocratic
Oath, ‘‘never do harm to anyone,’’ they also underlined that
OIT seemed to be generally safe but not without risks.
Wasserman et al2 replied to this editorial, stating that OIT for
food allergy is safe and effective. Paradoxically, those same authors
also reported the death of a child that happened during an
OIT formal trial performed in a tertiary pediatric center, adding
that it was due to a dosing error. Unfortunately, Wasserman
et al did not report any bibliography for that clinical case. They
did not give further details about the tertiary center involved or
about the trial in which the child took part.
Until now, no OIT-related death has been reported in the
literature. Thyagarajan et al replied back, apparently denying the
occurrence of such a death, and stated that ‘‘it is correct that there
have been no fatalities in the studies of OIT up to the present
time.’’3
We have recently published a systematic review about OIT,4
and we also have not found any deaths among all the trials published
up to now. In fact, OIT in food allergy has been used in Italy
for many years,5-7 and several adverse events have been described,
8 but a death caused by OIT has never been signaled. Nevertheless,
the letters quoted above put us in doubt: Did the child
die, or did he not?We really think it is important to know whether
a life-threatening event has happened because of a dosing mistake
while performing OIT. Mistakes are common in medical clinical
practice, and to knowhow it happened and which type of food was
the trigger would be useful.
Indeed, if that death happened in a tertiary center, how many
errors could happen if OIT comes into routine practice and starts
to be performed also in less experienced centers? We agree with
Thyagarajan et al1 that OIT can begin to be recommended only
after demonstrating that it is ‘‘superior to nonaction (or the current
standard of care).’’ For this reason, we believe that it is necessary
to know whether any life-threatening event has happened while
performing OIT because we are certain that it will help in carefully
and safely weighing the risks and benefits of OIT.
KW - Administration, Oral
KW - Clinical Trials as Topic
KW - Desensitization, Immunologic
KW - Food Hypersensitivity
KW - Humans
KW - Administration, Oral
KW - Clinical Trials as Topic
KW - Desensitization, Immunologic
KW - Food Hypersensitivity
KW - Humans
UR - http://hdl.handle.net/10807/3753
U2 - 10.1016/j.jaci.2011.03.037
DO - 10.1016/j.jaci.2011.03.037
M3 - Article
SN - 0091-6749
VL - 128
SP - 250
EP - 251
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
ER -