Re: Going, going, gone?
From: Jim Connerth (babydoc@apex.net)
Thu Sep 21 22:16:59 2000
ACOG has today come out with a rather prompt response on their web page-referred
to in an earlier post this pm;thanks to all involved on this list for their not
insignificant efforts on our part!!
Joanne Bulley wrote:
> Luis - again - you are an EXPERT in this subject - get 1 on 1 contact
> with Ralph Hale and make your knowledge etc known to those writing the
> statements - write the statements your self - fight junk medicine when
> you know the facts and background!
>
> Joanne
>
> At Thu, 21 Sep 2000, Luis Sanchez-Ramos, MD wrote:
> >
> >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
> >>>
>
> --
> Joanne Bulley, MD, FACOG
> Keene, NH, USA
>
> All decisions are made with insufficient data.
|
|
