Re: Going, going, gone?
From: Richard Chudacoff, MD (rchudacoff@mylinuxisp.com)
Thu Sep 21 14:27:06 2000
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Luis
I forwarded your letter to Ralph Hale. Here is his reply.
Rick
-----Original Message-----
From: Ralph Hale [mailto:RHale@acog.org]
Sent: Thursday, September 21, 2000 2:14 PM
To: rchudacoff@mylinuxisp.com
Cc: SZinberg@acog.org
Subject: Re: Cytotec
What you state is probably true but what we have been told during our
investigations is that it is due to brazilian studies yet to be published
where it was used in patients with previous c-sections and they had a high
incidence of uterine rupture. The reason for their using this data may be
due to the Seattle lawsuit but they are not giving out this information as
the basis for the alert nor is the FDA recognizing this as the reason.
-----Original Message-----
From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net]On Behalf Of Luis
Sanchez-Ramos, MD
Sent: Thursday, September 21, 2000 9:55 AM
To: Multiple recipients of list OB-GYN-L
Subject: Re: Going, going, gone?
I don't believe that the letter is due to two studies from Brazil. There
are no studies as yet published from that country which report serious
adverse events when used for cervical ripening and labor induction.
There are studies from Brazil which suggest that if used for abortion in
large doses, misoprostol may cause some congenital anomalies (Mobiu's
syndrome). These data have been refuted by other authors. The
"Searle"letter was written a couple of months ago and it was planned
even prior to that time. Wouldn't that be enough time for the "two
Brazilian" studies to have been published by now?
The main reason for the Searle letter is a lawsuit in which Searle was
named as a defendant in a wrongful death case due to amniotic fluid
embolism. The plaintiffs claim that Searle was liable because they had
not warned the obstetrical community of the potential adverse effects of
the drug.
Luis Sanchez-Ramos, MD
At Thu, 21 Sep 2000, Richard Chudacoff, MD wrote:
>
>Ralph Hale's reply to my letter writing campaign:
>
>Your concern has been echoed from many of our members. We have
investigated
>the origin of this letter. It is a Searle letter based upon two studies
>that took place in Brazil. We have been unable to get copies of the studies
>but reviews of the reports raise many questions as to there validity. Once
>we get the reports we will be in a better position to evaluate the
>scientific validity. In the meantime, our OB committee is working on an
>ACOG statement that should be available very shortly. We were not aware of
>the Searle letter until, like you, we received a copy in the mail. They
>have done a real disservice to the patients and physicians. However at
this
>time we do recommend that it not be used in VBAC patients as that seems to
>be the main issue. More later.
>
>--
>Richard Chudacoff, MD
>Chudacoff Obstetrics & Gynecology, PLLC
>
>15200 Southwest Freeway, #270
>Sugar Land, TX 77478
>Tel: 281-277-3900
>Fax: 281-277-3901
>
>rchudacoff@mylinuxisp.com <mailto:rchudacoff@mylinuxisp.com>
>Richard.Chudacoff@obgyn.net
>**********************************************************************
>Neither the confidentiality nor the integrity of this message
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>can be guaranteed following transmission on the Internet.
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>
>**********************************************************************
>-----Original Message-----
>From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net]On Behalf Of Richard
>Chudacoff, MD
>Sent: Wednesday, September 20, 2000 5:22 PM
>To: Multiple recipients of list OB-GYN-L
>Subject: Re: Going, going, gone?
>
>I have sent the following letter to Dr. Blythe, the District VII Chair:
>
>James G. Blythe, M.D.
>Chairman, ACOG District VII
>1200 Pleasant Suite, #403
>Des Moines, IA 50309
>
>Dear Dr. Blythe
>
>By now you have read, like thousands of other Obstetricians and
>Gynecologists in our country, the letter from Searle regarding the use of
>Cytotec (Misoprostol) for induction of labor. Never before has a drug
>company come out with such a negative letter against a medication that,
>while being used off label, has such overwhelming evidence for its safety
>and effectiveness. Even our own American College of Obstetricians and
>Gynecologists endorsed its use in both a Committee Opinion and Practice
>Bulletin in the November 1999 green journal.
>
>Today the Risk Management Department and the Perinatal Division at the main
>hospital I deliver have placed a moratorium on the use of this cost
>effective and therapeutically effective medication, until further notice,
>forcing me to abandon a method of induction I feel comfortable with, and
>will result in increasing my cesarean section rate.
>
>As District Chairman I plead with you to contact ACOG, that they may issue
a
>rebuttal letter to Searle, advocating the continued use of Cytotec for
labor
>inductions, for the benefit of our patients. If not, this therapeutic
option
>will go the way of Bendictin, where we saw a dramatic increase in
>hospitalizations for hyperemesis once it was wrongly pulled from the
market.
>We still do not have as safe and as effective medication for hyperemesis as
>we did in that safe, Category A medication. If we lose this battle, what
>will we lose next? Terbutaline and Indomethacin for preterm labor? Nitrates
>for uterine tetany?
>
>Now is the time to take a stand for our patients, rather than cower in the
>shadow of legal manipulation. At some point we physicians need to stand up
>for ourselves; to do what is right by and for our patients; and not recoil
>under another rock by the 'cover-your-ass' fervor that overwhelms our
>practices today. Again, I plead with you to help us clinicians recover our
>right to use Cytotec for induction of labor.
>
>If there is anything I can do to facilitate this request to the leadership
>at ACOG, please do not hesitate to contact me without delay.
>
>Respectfully yours.
>
>Please feel free to use all or part of this letter in your correspondence.
>
>Rick
>
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