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Are GMOs bad for you?
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When I read CSARdiver's comments, I read it that one form of thalidomide would not have the adverse effect on fetal development. It does not follow that thalidomide would then be approved for pregnant women.
https://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm107296.htm
It is approved for use for people with leprosy and multiple myeloma.0 -
lemurcat12 wrote: »Monsanto secretly runs the world (although their secrecy apparently isn't that good -- get better, Monsanto!). I believe that all Monsanto officers and directors also were members of Skull and Bones and, of course, are Masons.
They are Lizard People too!1 -
suzannesimmons3 wrote: »When I read CSARdiver's comments, I read it that one form of thalidomide would not have the adverse effect on fetal development. It does not follow that thalidomide would then be approved for pregnant women.
https://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm107296.htm
It is approved for use for people with leprosy and multiple myeloma.
But If it didn't affect a foetus why wouldn't it be prescribed for pregnant women/women of childbearing years with those conditions? Just think of the money it would rake in for the pharmaceutical company.
There are plenty of reasons. How could the company possibly market such a product, with its history, to pregnant women?0 -
suzannesimmons3 wrote: »Not being argumentative just wondering in what world a pregnant woman would be given thalidomide.
Thalidomide is an angiogenesis inhibitor (inhibits growth of new blood vessels) and indicated for use in the treatment/prevention of erythema nodosum leprosum. It is also be used in conjunction with dexamethasone for the treatment of multiple myelomas.
Actually fewer risks in comparison to ACE inhibitors, but lacking the media hyperbole.
The disastrous teratogenic effects of thalidomide were not known until the drug was used in off label indications for "morning sickness".
But is it now safe in any form for pregnant women? Because that is what I was questioning Northcascades about. You then posted a meme implying I was wrong. So where is the study showing it's safe in any form for pregnant women?
Repeat: The R variant has a very safe pharmacovigilance profile.
You are welcome to review the pharmacovigilance profile on the FDA site which comprises every reported adverse drug experience.0 -
suzannesimmons3 wrote: »Not being argumentative just wondering in what world a pregnant woman would be given thalidomide.
Thalidomide is an angiogenesis inhibitor (inhibits growth of new blood vessels) and indicated for use in the treatment/prevention of erythema nodosum leprosum. It is also be used in conjunction with dexamethasone for the treatment of multiple myelomas.
Actually fewer risks in comparison to ACE inhibitors, but lacking the media hyperbole.
The disastrous teratogenic effects of thalidomide were not known until the drug was used in off label indications for "morning sickness".
But is it now safe in any form for pregnant women? Because that is what I was questioning Northcascades about. You then posted a meme implying I was wrong. So where is the study showing it's safe in any form for pregnant women?
Repeat: The R variant has a very safe pharmacovigilance profile.
Two can play at that game.
Repeat: But is it now safe in any form for pregnant women? Because that is what I was questioning Northcascades about. You then posted a meme implying I was wrong. So where is the study showing it's safe in any form for pregnant women?You are welcome to review the pharmacovigilance profile on the FDA site which comprises every reported adverse drug experience.
I did just that. Going to the links on Thalidomide on the website you posted brought me to this:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2eda833b-1357-4ed4-a093-194524fcb061
Well gee, look what it says:EMBRYO-FETAL TOXICITY
If thalidomide is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females who are pregnant or who could become pregnant while taking the drug. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects.
Because of this toxicity and in an effort to make the chance of embryo-fetal exposure to THALOMID® (thalidomide) as negligible as possible, THALOMID® (thalidomide) is approved for marketing only through a special restricted distribution program: THALOMID REMS® program, approved by the Food and Drug Administration.
You can get the information about THALOMID and the THALOMID REMS program on the Internet at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436.
So it looks like you are the one who is
2 -
R....variant....
"Thalidomide is an immunomodulatory agent with a spectrum of activity that is not fully characterized. Thalidomide is racemic — it contains both left and right handed isomers in equal amounts: one enantiomer is effective against morning sickness, and the other is teratogenic. The enantiomers are converted to each other in vivo. That is, if a human is given D-thalidomide or L-thalidomide, both isomers can be found in the serum. Hence, administering only one enantiomer will not prevent the teratogenic effect in humans."
https://pubchem.ncbi.nlm.nih.gov/compound/thalidomide#section=Pharmacology-and-Biochemistry
I take this to mean that if a person takes one form of thalidomide the body still ends up with both in their blood stream. Is one of these forms referring to the R variant?1 -
The "organic" labelled ruby red grapefruit is a GMO food, the technique used was blasting a tonne of grapefruit seeds with radiation forcing mutation, planting them and seeing what grew, and if it tasted good and added a new twist sell it.
No stringent safety testing was ever demanded or done.
On the other hand, foods currently called GMO are only a subset of foods modified using 3 out of the 5 methods and are the MOST TESTED CONSUMER PRODUCTS EVER.
For someone to convince me GM makes food less safe, they would have to explain to me how transplanting on to five genes is somehow more dangerous then say hybridization which essentially mixes 30+ million genes from two separate subspecies.
In the first case, we can pinpoint only the feature we want, in the latter we just hope for the best. In the first case the end product is rigorously tested, in the later its a total free for all.
Not to mention some GM foods do not actually add genes, they simply turn off a gene, such as the new arctic apple, which prevents it from rotting so soon like regular apples.
The only arguments I have ever seen against GMO are the typical antigovernment, anti agri, anti pharma conspiracy theories and selected examples numbering in the single digits pulled from the millions of safe useful products we all enjoy.
Or conflation with other conspiracy theories about Monsanta etc... Meanwhile there are metastudy reviews compiling research from 10s of thousands of studies that show with perfect consistently GM technology is safe.
What really gets under my skin about all this GMO fear mongering and LIES out of either ignorance or malice is that GM technology is our VERY BEST hope to cure many diseases including cancer, and our very best hope to create transplant-able human organs, directly saving lives.
Yes "science" sometimes, occasionally, gets things wrong, but conspiracy theories are wrong a good 99.5% of the time, and the .05% of the time they are right is pretty much equal to a broken clock being right twice a day.9 -
We know so much more about genetics compared to when I was a girl. Now we know that we share nearly all the same genetic encoding as the mouse. Who knew?
https://www.genome.gov/10001345/importance-of-mouse-genome/0 -
'You are to keep My statutes. You shall not breed together two kinds of your cattle; you shall not sow your field with two kinds of seed, nor wear a garment upon you of two kinds of material mixed together. - Leviticus 19:19 (NASB)
"You shall not sow your vineyard with two kinds of seed, or all the produce of the seed which you have sown and the increase of the vineyard will become defiled." - Deuteronomy 22:9 (NASB)
I am convinced that at least some of the resistance is from the religious right, which uses selected Old Testament verses to condemn the practice.
These verses however, condemn all hybridization. Do they know how many of their fruits, vegetables, and flowers these days are hybrids? (Hint, it's a lot)1 -
suzannesimmons3 wrote: »Not being argumentative just wondering in what world a pregnant woman would be given thalidomide.
Thalidomide is an angiogenesis inhibitor (inhibits growth of new blood vessels) and indicated for use in the treatment/prevention of erythema nodosum leprosum. It is also be used in conjunction with dexamethasone for the treatment of multiple myelomas.
Actually fewer risks in comparison to ACE inhibitors, but lacking the media hyperbole.
The disastrous teratogenic effects of thalidomide were not known until the drug was used in off label indications for "morning sickness".
But is it now safe in any form for pregnant women? Because that is what I was questioning Northcascades about. You then posted a meme implying I was wrong. So where is the study showing it's safe in any form for pregnant women?
Repeat: The R variant has a very safe pharmacovigilance profile.
Two can play at that game.
Repeat: But is it now safe in any form for pregnant women? Because that is what I was questioning Northcascades about. You then posted a meme implying I was wrong. So where is the study showing it's safe in any form for pregnant women?You are welcome to review the pharmacovigilance profile on the FDA site which comprises every reported adverse drug experience.
I did just that. Going to the links on Thalidomide on the website you posted brought me to this:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2eda833b-1357-4ed4-a093-194524fcb061
Well gee, look what it says:EMBRYO-FETAL TOXICITY
If thalidomide is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females who are pregnant or who could become pregnant while taking the drug. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects.
Because of this toxicity and in an effort to make the chance of embryo-fetal exposure to THALOMID® (thalidomide) as negligible as possible, THALOMID® (thalidomide) is approved for marketing only through a special restricted distribution program: THALOMID REMS® program, approved by the Food and Drug Administration.
You can get the information about THALOMID and the THALOMID REMS program on the Internet at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436.
So it looks like you are the one who is
What am I wrong about?
You are missing the point. Are you attempting to learn something or just trying to be right? The statement you provided lacks necessary detail.
Start by looking up chirality.
Birth defects are caused by the S - enantiomer of thalidomide. The R - enantiomer is safe. The revised manufacturing process contains multiple steps to eliminate the S - enantiomer. Note that when originally launched the teratagenic effects of the S - enantiomer were not detected until thalidomide was used off-label as a anti-nausea medication for "morning sickness".
1 -
"As mentioned above, there are two conformations of thalidomide (the safe R+ form and the unsafe S- form). The obvious answer to change thalidomide into a safe drug would be to only administer the safe R+ conformation to the patients, but this is not what happens in vivo as the liver metabolizes thalidomide with enzymes that turn the R+ into S- spontaneously using hydrolysis (#Franks, et al, 2004) and (#Stephens, 2000). In the effort to try to separate the two forms, the idea would backfire, because the teratogenic form of the drug is most likely to develop."
http://www.toxipedia.org/display/toxipedia/Thalidomide1 -
The statement I provided was directly from the website you directed me to. If it lacks details then find another website to link to.suzannesimmons3 wrote: »Not being argumentative just wondering in what world a pregnant woman would be given thalidomide.
Thalidomide is an angiogenesis inhibitor (inhibits growth of new blood vessels) and indicated for use in the treatment/prevention of erythema nodosum leprosum. It is also be used in conjunction with dexamethasone for the treatment of multiple myelomas.
Actually fewer risks in comparison to ACE inhibitors, but lacking the media hyperbole.
The disastrous teratogenic effects of thalidomide were not known until the drug was used in off label indications for "morning sickness".
But is it now safe in any form for pregnant women? Because that is what I was questioning Northcascades about. You then posted a meme implying I was wrong. So where is the study showing it's safe in any form for pregnant women?
Repeat: The R variant has a very safe pharmacovigilance profile.
Two can play at that game.
Repeat: But is it now safe in any form for pregnant women? Because that is what I was questioning Northcascades about. You then posted a meme implying I was wrong. So where is the study showing it's safe in any form for pregnant women?You are welcome to review the pharmacovigilance profile on the FDA site which comprises every reported adverse drug experience.
I did just that. Going to the links on Thalidomide on the website you posted brought me to this:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2eda833b-1357-4ed4-a093-194524fcb061
Well gee, look what it says:EMBRYO-FETAL TOXICITY
If thalidomide is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females who are pregnant or who could become pregnant while taking the drug. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects.
Because of this toxicity and in an effort to make the chance of embryo-fetal exposure to THALOMID® (thalidomide) as negligible as possible, THALOMID® (thalidomide) is approved for marketing only through a special restricted distribution program: THALOMID REMS® program, approved by the Food and Drug Administration.
You can get the information about THALOMID and the THALOMID REMS program on the Internet at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436.
So it looks like you are the one who is
What am I wrong about?
You are missing the point. Are you attempting to learn something or just trying to be right? The statement you provided lacks necessary detail.Start by looking up chirality.
Birth defects are caused by the S - enantiomer of thalidomide. The R - enantiomer is safe. The revised manufacturing process contains multiple steps to eliminate the S - enantiomer. Note that when originally launched the teratagenic effects of the S - enantiomer were not detected until thalidomide was used off-label as a anti-nausea medication for "morning sickness".
Not according to this:
https://academic.oup.com/toxsci/article/1668162/ChiralThalidomide
Thalidomide apparently works by tumor necrosis factor-alpha inhibition, inhibition of angiogenesis, and other mechanisms. R(+)-thalidomide was reported to be responsible for sedative effects (Eriksson et al., 2000; Hoglund et al., 1998), whereas S(−)-thalidomide and its derivatives were reported to be teratogenic (Fig. 7B) (Blaschke et al., 1979; Heger et al., 1994). It was further proposed that the thalidomide tragedy could have been avoided if the single R(+)-enantiomer had been used. Irrespective of the fact that an earlier study in an appropriate animal model demonstrated equivalent teratogenic potential of both isomers, which was greater than the racemate (Fabro et al., 1967), chiral inversion occurs with thalidomide (Reist et al., 1998). Humans interconvert (S)- and (R)-thalidomide enantiomers (Fig. 7B) rapidly with both oral and intravenous dosing (Eriksson et al., 2001). Albumin, hydroxyl ions, phosphate, and amino acids appear to mediate this effect (Reist et al., 1998). Therefore, even if single enantiomers of thalidomide were provided, the ensuing enantiomeric mixture could contribute to toxicity (Agranat et al., 2002). Similar inter-conversion has been demonstrated for thalidomide analogues (e.g., lenalidomide, EM 12, CC-4047), although certain substitutions can confer optical stability (Schmahl et al., 1988; Teo et al., 2003; U.S. Food and Drug Administration, 2005; Yamada et al., 2006). On the basis of the animal study demonstrating teratogenicity of both thalidomide isomers and evidence of human chiral inversion, exposure to either thalidomide enantiomer or unstable thalidomide derivatives during the period of sensitivity (days 20–36 after conception; Dencker and Eriksson, 1998) would risk fetal harm. Susceptibility might additionally be influenced by genetic polymorphisms which alter thalidomide metabolism (Ando et al., 2002) in the maternal/fetal unit.
Is there any data to support that (R)-thalidomide is safe in pregnant women?0 -
Y'all realize that this entire discussion about thalidomide has literally nothing at all whatsoever to do with the topic of this thread, right?4
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The common denominator being "bad pharma" right?2
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suzannesimmons3 wrote: »suzannesimmons3 wrote: »Not being argumentative just wondering in what world a pregnant woman would be given thalidomide.
Thalidomide is an angiogenesis inhibitor (inhibits growth of new blood vessels) and indicated for use in the treatment/prevention of erythema nodosum leprosum. It is also be used in conjunction with dexamethasone for the treatment of multiple myelomas.
Actually fewer risks in comparison to ACE inhibitors, but lacking the media hyperbole.
The disastrous teratogenic effects of thalidomide were not known until the drug was used in off label indications for "morning sickness".
But is it now safe in any form for pregnant women? Because that is what I was questioning Northcascades about. You then posted a meme implying I was wrong. So where is the study showing it's safe in any form for pregnant women?
Repeat: The R variant has a very safe pharmacovigilance profile.
Two can play at that game.
Repeat: But is it now safe in any form for pregnant women? Because that is what I was questioning Northcascades about. You then posted a meme implying I was wrong. So where is the study showing it's safe in any form for pregnant women?You are welcome to review the pharmacovigilance profile on the FDA site which comprises every reported adverse drug experience.
I did just that. Going to the links on Thalidomide on the website you posted brought me to this:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2eda833b-1357-4ed4-a093-194524fcb061
Well gee, look what it says:EMBRYO-FETAL TOXICITY
If thalidomide is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. Thalidomide should never be used by females who are pregnant or who could become pregnant while taking the drug. Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects.
Because of this toxicity and in an effort to make the chance of embryo-fetal exposure to THALOMID® (thalidomide) as negligible as possible, THALOMID® (thalidomide) is approved for marketing only through a special restricted distribution program: THALOMID REMS® program, approved by the Food and Drug Administration.
You can get the information about THALOMID and the THALOMID REMS program on the Internet at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436.
So it looks like you are the one who is
What am I wrong about?
You are missing the point. Are you attempting to learn something or just trying to be right? The statement you provided lacks necessary detail.
Start by looking up chirality.
Birth defects are caused by the S - enantiomer of thalidomide. The R - enantiomer is safe. The revised manufacturing process contains multiple steps to eliminate the S - enantiomer. Note that when originally launched the teratagenic effects of the S - enantiomer were not detected until thalidomide was used off-label as a anti-nausea medication for "morning sickness".
Then how come they don't sell the R version and then they wouldn't have to force women to sign disclaimers and put themselves on double birth control because of birth defects.
Manufacturers only sell the R enantiomer. The S enantiomer is not manufactured and eliminated from the process.
Due to the history of this product and the increased sensitivity FDA regulates this under the REMS program.
It's part and parcel to the bureaucracy - little to no science behind it, but fear is a powerful motivator and CYA rules the day.1
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