Bendectin And Birth Defects (Page 17)

I took this drug in the 1970's while pregnant. Am looking for the side effects to the babies. Drug has been off the market for many years. Not sure on correct spelling. Used for nausea and vomiting during pregnancy. Thank you for any help you can send me. Sincerely, Dana.

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REPORT

i would also like some help. my brother was born in 1980 just a year before me and my mother took debenox as a anti-sickess pill, my brother was born with water on the brain and a hole in the spine (spinabifida) he died 8 days after he was born! my mother told me that while in the hospital she was asked about compensation as oviously she said to go away and they said(whoever they were) that the company was a american company and that there was a bad batch of pills made. they would be in touch with her and shes has never recived anything!! my mum feels that there isnt a price that can be put on my brothers head and i agree but shurly this comany has to pay!! please please help

xx thank you xx

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My daughter was discovered to have a bicornate uterus as well as some other issues too. They gave me huge doses of benedictin in 1979/80. The thing that enrages me even more is that it didn't even work for the vomiting!

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Uterine malformation including bicornate uterus is a fairly common occurance. There is no relationship demonstrated with bendictin use.
Similarly spina bifida has an incidence of roughly 2 per 1000 live births, and no demonstrated relationship with bendictin use. Of note, you mention your brother was born in 1980, which was before the association of spina bifida with folic acid deficits was appreciated. And it wasn't until the 90's that legislation was passed to fortify foods with folic acid to reduce the incidince of spina bifida.

Vivian, if you're still following this thread I'd be interested in the study you state links bendictine with congenital malformations. One study is just that, and as I've noted the scientific community has pretty solidly concluded that there is no association, but I would like to read the study. Thanks.

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I don't have a brother born in 1980; you are mixing me up with someone else. The study was by Dr., Paterson of Sorrento BC. I have a hard copy (35 years old) buried somewhere in a cubby hole. He still lives in Sorrento, BC if you want to call him.

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Not mixing you up, just responding to 3 posts simultaneously. Sorry for any confusion that might have caused. I probably should have addressed names.
In any event, I will look for that study, but do you happen to know what journal it was published in?

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No, sorry it was a long time ago. You could probably just call him or google him.

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I tried googling. Do you know his first name? No studies popped up, initially, but more info might help.

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Paterson Donald Dr
1223 Trans-Canada Hwy, Sorrento, BC V0E 2W0

250-675-2322

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emtridoc, have you found any studies by Dr Paterson yet? A Dr Donald Patterson(sic) is mentioned in "Birth Defect For Children, Inc". You'll find it in "Part Two" (paragraph 11) [there's "Part One" & a "Judicial Opinion" page also], which reads verbatim as:

- "In 1969, Dr Donald Patterson stirred up a new flurry of concern about Bendectin's safety. He wrote a letter to the Canadian Medical Journal reporting several cases of limb defects in children whose mothers had taken Bendectin.36 That same year the German government held hearings on the safety of Bendectin, but the company was able to convince the authorities that there was no problem.37" -

Only two paragraphs later, and further on, Dr William McBride is mentioned.

A most interesting paragraph on the same page[about halfway down] is the one immediately following the list of "Bendectin Epidemiological Studies", which reads verbatim as:

- Most human teratogens were not discovered through animal studies or epidemiology. The disastrous effects of the rubella virus, thalidomide, anti-convulsive medications and excessive alcohol consumption during pregnancy were first reported by alert practioners[should be practitioners]. Physicians noted a pattern of malformations occuring in their patients and searched for a common etiological factor" -

Drs Patterson and McBride are also mentioned in the footnotes, numbered as 35 and 47 respectively.

Debendox, which my mother took whilst pregnant with me, is suspected of causing, inter alia, malformations of the external ear and heart defects. I have a quite malformed pinna and no aperture to the inner ear on my right hand side only. Mum told me that I was born with an 'exhausted heart'. Whether this was caused solely by a difficult delivery or an improperly developed heart I don't know, but it's not really given me any grief since then, apart from being broken several times whilst a teenager that is!

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ILP, Nice job locating that reference, but I'm sure you know that a letter to the editor does not constitute a study. While it is certainly true that many significant findings are first noted by observation (Galileo observed the tides and thus postulated that the earth rotated on an axis and around the sun, but then had to prove it), such observation must be corroborated by study. Was the observation of two patients? Twenty? Two hundred? Did Dr. Patterson evaluate for other confounding factors? For instance I presume he was practicing in such a way that most of his patients were from the same area. Was there a water contaminant? Because the preponderance of evidence gleaned from scientific study of various formats has not demonstrated a link between bendictin and birth defects. The opinion piece on "Birth Defect Research For Children, Inc" lists many footnotes, but most are on other medications, or are newspaper articles, and memos, not peer reviewed research.

As for microtia (the unique ear feature you possess), the prevalence in the U.S. in 2006 was 0.22-10.28 per 10,000 live births. Pretty rare, but not zero, and of course debendox not being prescribed. Many factors have been investigated (maternal age, diabetes, hypoxia (from living at altitude), number of previous children born to the mother, etc, but none have really stood up well to further study from what I've read, as of yet.

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Emtridoc, thanks for your response and information. I'm still unaware as to whether or not you've yet managed to winkle out any substantive work that Dr Paterson may have undertaken regarding suspect teratogens. Maybe it's still a work in progress[on your part...and his!]. We live in hope.

I'm so glad you mentioned Galileo because he rates more than scant mention in - "Daubert: The Most Influential Supreme Court Ruling You've Never Heard Of". - I wonder if you've read it? It doesn't augur well at all for plaintiffs for any credence being given to case studies, peer reviews etc... What was that someone said about a Dr's letter to an editor doesn't *constitute*[more later] a study, pray tell?

"Galileo's Revenge", a book written by Peter Huber, became so widely recognized it was frequently cited by lawyers, lobbyists, former Vice President Dan Quayle and - most crucially - Judge Alex Kozinski, who used Huber's definition of "good science" as "the main explication of the scientific method" when writing his opinion in Daubert for the U.S. Court of Appeals for the Ninth Circuit, where the case was remanded by the U.S. Supreme Court.

*Constitute*: The Seventh Amendment, though only an amendment, is still part of the Constitution, and it reads as: "Provides for the right to trial by jury in certain civil cases, according to common law." - For me, the cited "civil cases" are "certainly" that, i.e., "certain"[but perhaps some of them should be tried as being criminal instead]. Several U.S. Supreme Court Judges and other legal professionals have voiced their concerns that too much power is given to Judges to play a "gatekeeping" role in cases where it's clearly evident that, in many cases, negligence[read as: injustice] evinces that it's an "open and shut" case[pun unintended]!

Even if Dr Paterson hasn't done any more to date, concerning Bendectin, than write that letter years ago, it may be enough. From little things, big things grow.

"They also serve who only stand and wait." - It's the last line of the great English poet John Milton's sonnet. After going blind, Milton wrote the poem "On His Blindness". Though blind, methinks he was well-able to ever see and proclaim things evident. On this score[of Milton's], the Daubert "Stand"ard ["wait"ing in the wings...of the Eagle] would certainly never even get a look-in for one moment!

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Dr. Paterson published the results of his findings on the relationship between the drug and congenital malformations. The study was found by someone involved in a law suit against the drug company. Dr. Paterson was the main medical expert in the trial. I personally have spoken to him about this. He was flown down for the trial. It was NOT just a letter to the editor. Dr Paterson had two babies born in his practice that had the same malformations. Statistically he should never see two in such a small practice. So he did the research and found a statistically significant link between bendictine and these malformations. As a result of his paper the medical community accepted a link between bendictine and these congenital malformations. You can't find it on the internet as it was pre-internet. We are talking over thirty years ago. How do I know all this? Dr. Paterson lives 20 minutes from my house and practices medicine in our local hospital. A year after he published his paper I was proscribed bendictine and gave birth to a daughter with deformed eyes (not the malformation he found). The irony of the situation did not escape me. A fellow doctor had not read his paper.

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Vivian, thanks for your information. I'm sorry to hear of your daughter's eye deformity. Does the deformity have its own own medical name like my 'microtia/aural atresia'? Do you know what the same malformations of the two babies in Dr Paterson's practice was? I'm sure there's a lot of skeletons still hiding in drug companies' and governments' copious cupboards.

When you say that Dr Paterson was flown down for the trial, do you mean down to the U.S. or somewhere else in Canada, and do you know if the trial went the full distance or was it aborted/truncated due to some legal technicality as many cases have been, and will probably continue to be?

It would be good if someone could ask Dr Paterson if he'd consider uploading his research onto the internet if he hasn't already done so in some way. Someone else might like to take up the cudgels.

Emtridoc, re your "...and of course Debendox not being prescribed" [in your #332 post], it may well be true that many deformities in many different countries did occur without a "personally-prescribed" drug's involvement but that's not to say that Debendox/Bendectin/Diclectin wasn't taken by some of the expectant mothers who weren't actually prescribed the drug but took some of their pregnant friend's supply. We all know how patients just relish having to wait in a Dr's waiting room, especially when they're feeling terribly ill, and perhaps feeling that they look like something that the cat just dragged in, when it could so easily be obviated by just asking a pregnant friend -- who's known to have a supply of the prescribed dru -- if they'd dispense some as a stop gap. Especially if the friend is told that you'll replace their deficit when the Dr gives you a prescription for the same drug. It's not much different to a person popping next door to a neighbour to borrow a cup of sugar when you think about it. I'll wager that many unprescribed[borrowed] contraceptive drugs have been taken in such fashion around the world. Sometimes it's felt just too precarious to wait that bit of extra time - by seeing a Dr - until a person is able to get their own prescription filled. So how confident can we be that the records of "all"[read as:prescribed/unprescribed Debendox/Bendectin/Diclectin ingestion is reliable? My very own dear departed mother told me that she only took a few doses of Debendox then returned the remainder to the chemist as she didn't like them, but what if she'd just given them to a nauseous pregnant friend instead? In the poorer third world countries I just can't see people not sharing their medicines to friends' needs in an emergency. And how many records have drug companies admitted to destroying or altering over the years, especially when they feel a likely lawsuit looming?

In my #320 post I accidently left out a very important word in the 2nd sentence of the 2nd paragraph. It should read as: Not all mothers who took Bendectin, Debendox or Diclectin had babies with *obvious* abnormalities. It's quite possible that many babies were born with some type of internal abnormality which, whilst it may not cause sufficient angst such as to warrant investigation by a Dr, still exists as a veritable abnormality, not unlike a surgical team leaving a swab or small surgical instrument inside a patient's suture. If the foreign object causes no angst it could stay there undiscovered for years, if not forever.

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Dr Paterson was flown to the states. It was a major law suit. I can't remember the outcome other than the drug eventually being pulled off the market. It was over 30 years ago. I can't remember the name of my daughter's eye deformity. She has tear dropped shaped eyes. Thirty years is a long time. If someone wants Dr Paterson to upload his research they should call him. I don't see the point.

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ILP, Not only not prescribed, but not available for decades in the U.S (though some people may know that Vitamin B6 and Unisom are the essential ingredients) . So unless there have been people hoarding it then handing it out in large numbers I think we can say with confidence that the prevelance in 2006 is unrelated to bendictin.

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Emtridoc, my comment about Debendox/Bendectin/Diclectin not being prescribed but perhaps still ingested was meant to be taken in general, i.e., since from the time of Debendox's inception and not specifically aimed at only microtia or only U.S. 2006 data. That's what I meant by "...many deformities in many different countries". Perhaps I should have said "...many *different types* of deformities in many different countries". Mea culpa. It's so easy to talk at crossed purposes unless one leaves absolutely no room for ambiguity to rear its ugly head. There may well have been a hoarding and mass dispensation of not only Bendectin, but many another drug too, without any prudent prescription being involved. We mustn't forget that drug companies themselves must have a huge hoarding in hand before they can adequately -- but not necessarily prudently[like with thalidomide] -- supply a mass marketing of it. Plus, I wonder if any country ever copied[pirated] these anti-emetic drugs' constituents exactly, or closely, and then dispensed such with much or total abandon? We know of Chinese companies being found guilty of fortifying babies' formula powder with melamine resulting in many a fatality and physical/psychological trauma. There's no lengths that some folk won't go to to make an easy $hekel or two.

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There's a very interesting article -- "Debendox and congenital malformations in Northern Ireland" -- in the British Medical Journal, 10 January 1981, Volume 282, pages 148 &149.

Never a truer sentence was written than that of the above article's finale which reads as: "...It would be unfortunate if studies such as this one diverted attention away from the need for more information on Debendox."

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ILP, the good news is that Letter to the Editor was hardly the end of research (and to be clear, that was an opinion letter referencing a previously published study that concluded no teratogenic effect, but was not itself a study or article).
Here's an abstract from Reproductive Toxicology, July-Aug 1995:
Abstract
Objective: to review the extensive literature pertaining to the reproductive and teratogenic effects of Bendectin and the opinions of the scientific experts for the defense and plaintiff. These data were evaluated with regard to the reproductive risks of Bendectin providing a scientific framework for evaluating the views of the experts in the Bendectin litigation. Design: the Bendectin literature was primarily obtained from articles cited in Research Alert of the Institute for Science Information. Other articles were obtained from Medline, review articles, and colleagues. An attempt was made to be all-inclusive, citing and reviewing all articles related to each subject being discussed. The literature includes epidemiologic studies, animal studies, in vitro studies, and basic science articles related to the principles of teratology and reproductive toxicology. Review articles, meta analyses, editorials, commentaries, articles in the press, and case reports were also included. Methodology: the methodology utilized for the evaluation of Bendectin teratogenicity was presented. It consists of a five-part analysis of epidemiologic studies, secular trend analysis, animal studies, dose-response relationships, and biologic plausibility. Conclusion: the five-part analysis of Bendectin reproductive effects indicates that therapeutic use of Bendectin has no measurable teratogenic effects. Presentations by many of the plantiff's experts failed to meet the scientific standards that should be expected of knowledgeable scientists and contributed to the persistence of Bendectin litigation.

And there has been more research since, with the preponderance coming to similar conclusions.

More research to come?

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Emtridoc, thanks for that. Now I can stop thinking that you were holding out on us. Due to my being 'ever-the-contrarian', I must again point out that just because "...therapeutic use of Bendectin has *no measurable* teratogenic effects" doesn't mean with absolute certitude than none exists. Whenever discussion focuses on measuring things, and nothing's more important than that involving human beings' metric[so I'm told], I'm forever mindful of that perpetual anomaly called the "Heisenberg Uncertainty Principle". If we consider that the etiology of pregnancy nausea is largely, if not entirely, idiopathic, and of course not all women suffer from it, then how certain can we -- as mere mortals -- be of treating it without causing, inter alia, any teratogenic result? Perhaps it won't be until we are completely au fait with the cause[s] of pregnancy nausea that we become a full benign bottle on myriad things with a teratogenic bent...and head 'em all off at the pass_ivity.

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In the most comprehensive study of its kind in the world, the University of Adelaide, South Australia has identified the higher risk of major birth defects from Assisted Reproduction. The results are being published May 5 in the New England Journal of Medicine, and presented in Barcelona, Spain, at the World Congress on Building Consensus in Gynecology, Infertility and Perinatology.

An article, in "ScienceDaily", mentions that there is much concern with women using "clomiphene citrate"[now very widely available at low cost] to stimulate ovulation as its use -- outside of a closely supervised clinical setting -- is said to triple the risk of fetal malformations.

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