Re: Going, going, gone?
From: Joanne Bulley (islesannie@yahoo.com)
Thu Sep 21 21:42:45 2000
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.
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