Re: Going, going, gone?
From: Luis Sanchez-Ramos, MD (luis.sanchez@jax.ufl.edu)
Thu Sep 21 16:07:20 2000
First of all, the lawsuit was not in Seattle. I have a copy of the
complaint (allegations)against Searle and the letter is a perfect (word
by word) answer to those allegations. Sadly, the cause of the AFE could
be more easily attributed to the oxytocin infusion.
Brazil has the highest cesarean delivery rate in the world and one of
the lowest VBAC rates. I find it unusual that two large studies from
that country deal with the use of misoprostol for labor induction in
patients with previous cesarean attempting VBACs.
How likely is it for Searle to obtain copy of studies from Brazil which
have not yet been published and use this information to put out their
letter? Let's get real! How can they place so much value on studies
performed in Brazil and extrapolate the results to those obtained in the
USA. Searle has had a lot of problems with misoprostol in Brazil,
mostly due to the illegal use for abortions.
Why is there such an uproar with this letter? No one stopped using
terbutaline for preterm labor after receiving the FDA letter warning of
the dangers of this off-label use.
I have heard many rumors through e-mails I have received: the latest
states that Forest Labs (Cervidil) bought out Searle (misoprostol) and
since the former shows a better profit margin..thus the letter. We are
still using it and will continue to use it until it becomes illegal!
--
Luis Sanchez-Ramos MD
At Thu, 21 Sep 2000, Richard Chudacoff, MD wrote:
>
>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
>>**********************************************************************
>>**********************************************************************
>>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
>>
