Re: Going, going, gone?
From: Joanne Bulley (islesannie@yahoo.com)
Thu Sep 21 21:24:16 2000
LUIS -
Since you know so much about this drug, you should PERSONALLY write
Ralph Hale - help them document the truth (as far as is currently known)
in order to speed along the refutation of the Searle letter and promote
a safety of use letter. You could probably WRITE the thing for Ralph
Hale!
Joanne
At Thu, 21 Sep 2000, Luis Sanchez-Ramos, MD wrote:
>
>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.
>>**********************************************************************
>>
>>**********************************************************************
>>-----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
>>
--
Joanne Bulley, MD, FACOG
Keene, NH, USA
All decisions are made with insufficient data.
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