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Are GMOs bad for you?
Replies
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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 -
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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
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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".
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"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 -
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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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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.
Not according to Celgene:
https://media.celgene.com/content/uploads/thalomid-pi.pdfThalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25C in dimethyl sulfoxide and sparingly soluble in water and
ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated
S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero
Oh, and there seems to be science behind the fact that the R form is not safe in pregnant women as I and others have posted above.1 -
'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)
Yes, this is definitely being debated vigorously by Kosher-observing Jews, if that is what you mean by the "religious right" (although probably most would take that phrase to describe conservative Christians). There are probably all kinds of fascinating articles you could read citing Nachmanides and other medieval and ancient philosophers, but suffice to say, they are not prohibiting intra-species hybrids, or even, to my knowledge, interspecies hybrids like Granny Smith apples which were hybridized in nature (and then grafted when discovered).
I would not enjoy debating a rabbi on this topic.
Interestingly, since all my Jewish friends happily wear shatnez, eat cheeseburgers, and don't maintain separate sets of cookware, the only people on my Facebook feeds loudly fulminating against GMOs (and definitely not citing scripture) are primarily atheists, witches, Wiccans, and pagans. (Gardening makes for strange bedfellows).0 -
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suzannesimmons3 wrote: »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.
Not according to Celgene:
https://media.celgene.com/content/uploads/thalomid-pi.pdfThalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25C in dimethyl sulfoxide and sparingly soluble in water and
ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated
S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero
Oh, and there seems to be science behind the fact that the R form is not safe in pregnant women as I and others have posted above.
Like the serious increase in thalidomide babies in developing countries due to drug sharing....so surely if they only sold the R varient because that's "safe" there wouldn't be any defects.or the need for women to double protect themselves against accidental pregnancy.
True, but what do we know, we lack scientific understanding.1 -
Shawshankcan wrote: »dmelvin3737 wrote: »Humans have been selectively breeding traits what we found increased yield or resistance to certain disease or allowed for less water for hundreds of years.
GMO's are nothing more than selective breeding 2.0
Personally, I try to eat organic as much as possible and avoid pesticides and GMOs.
If you think organic means pesticide free, you are delusional or seriously mislead. Many organic approved pesticides are more harmful towards humans, less effective for their goal and require multiple sprayings.
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The only thing about GMO that we can be absolutely sure about is that we just don't know enough about it yet. That doesn't make it good or bad. It doesn't mean it hasn't been strenuously tested. But DDT was strenuously tested. The list of things we once believed to be perfectly safe that turned out to be hideously dangerous is long and varied.
As a farmer, I'd be concerned about my neighbor planting GMO that might impact my crop in any way. Because let's face it, the controlled release of GMO crops in the early days went pretty badly. *(Starlink) And as a consumer, I wish simply for clear, honest and accurate labeling. So I can make informed choices based on my research, whim or preference. In a very broad sense, I would feel better about GMO if it had a bit more time in circulation. And I'm more than happy for monsters like Monsanto to test it on other people in far away lands.
On the side topic of organics that has popped up a few times, In my humble opinion as an organic certified farmer. The whole organic industry badly requires reassessment. Most certifications trace their origin back to a document written well before many modern farming techniques were even imagined, let alone viable. As a result, the criteria is full of hard rules that are frustratingly irrelevant. And as people have mentioned in previous posts, all the while some things you would think were important to control or exclude are not even monitored. Different governments from one country and state to the next have taken different directions and the whole thing is a mess. Ultimately, Organic does not mean what most consumers think it means..6 -
The only thing about GMO that we can be absolutely sure about is that we just don't know enough about it yet. That doesn't make it good or bad. It doesn't mean it hasn't been strenuously tested. But DDT was strenuously tested. The list of things we once believed to be perfectly safe that turned out to be hideously dangerous is long and varied.
Don't remember if it was earlier in this thread or another thread, but the decision to ban DDT was not made based on science - it was a political decision made by the head of the EPA based on complaints from the Audubon Society (which the EPA head just happened to be a board member of) and on wild conjecture based from the sensationalist book title 'Silent Spring'. Even the head of the EPA admitted publicly that the decision to ban DDT based on politics over-ruled all of the EPA scientists who concluded that there was no link to be found between DDT and environmental issues.3 -
The only thing about GMO that we can be absolutely sure about is that we just don't know enough about it yet. That doesn't make it good or bad. It doesn't mean it hasn't been strenuously tested. But DDT was strenuously tested. The list of things we once believed to be perfectly safe that turned out to be hideously dangerous is long and varied.
Don't remember if it was earlier in this thread or another thread, but the decision to ban DDT was not made based on science - it was a political decision made by the head of the EPA based on complaints from the Audubon Society (which the EPA head just happened to be a board member of) and on wild conjecture based from the sensationalist book title 'Silent Spring'. Even the head of the EPA admitted publicly that the decision to ban DDT based on politics over-ruled all of the EPA scientists who concluded that there was no link to be found between DDT and environmental issues.
Quite true, even today it's only listed as mildly toxic and probably carcinogenic. But it was banned because of it's impact on natural ecosystems. Killing mosquito's is one thing, but it's widespread use was killing insects indiscriminately. And over time speculation grew as to further environmental impacts. Some suggest the near extinction of the Bald Eagle amongst other birds of prey. All the while mosquitos were getting more resistant to it.
Australia has a similar tale.. The canetoad. Some of our brightest minds, seeking a way to control the cane beetle that ravaged the Australian sugar cane industry. After extensive studies, decided it would be a good idea to introduce cane toads from Sth Africa. The problem was as soon as they got to Aus, they went nuts and started eating just about anything but cane beetles. And of course with no natural predators, their numbers swelled to billions and now we have a cane toad plague we will never likely get rid of. The scope of the environmental impact is incalculable.
My point wasn't about any one thing. It was simply that science is not perfect. It is just a study. You test and test until you discover something and some of our most world changing scientific discoveries have been totally unplanned. I have the same reservations about GMO as I do any new groundbreaking field of scientific endeavor. GMO will be part of our future.. But for now it's a field that is barely in it's infancy.0 -
The only thing about GMO that we can be absolutely sure about is that we just don't know enough about it yet. That doesn't make it good or bad. It doesn't mean it hasn't been strenuously tested. But DDT was strenuously tested. The list of things we once believed to be perfectly safe that turned out to be hideously dangerous is long and varied.
Don't remember if it was earlier in this thread or another thread, but the decision to ban DDT was not made based on science - it was a political decision made by the head of the EPA based on complaints from the Audubon Society (which the EPA head just happened to be a board member of) and on wild conjecture based from the sensationalist book title 'Silent Spring'. Even the head of the EPA admitted publicly that the decision to ban DDT based on politics over-ruled all of the EPA scientists who concluded that there was no link to be found between DDT and environmental issues.
Quite true, even today it's only listed as mildly toxic and probably carcinogenic. But it was banned because of it's impact on natural ecosystems. Killing mosquito's is one thing, but it's widespread use was killing insects indiscriminately. And over time speculation grew as to further environmental impacts. Some suggest the near extinction of the Bald Eagle amongst other birds of prey. All the while mosquitos were getting more resistant to it.
Australia has a similar tale.. The canetoad. Some of our brightest minds, seeking a way to control the cane beetle that ravaged the Australian sugar cane industry. After extensive studies, decided it would be a good idea to introduce cane toads from Sth Africa. The problem was as soon as they got to Aus, they went nuts and started eating just about anything but cane beetles. And of course with no natural predators, their numbers swelled to billions and now we have a cane toad plague we will never likely get rid of. The scope of the environmental impact is incalculable.
My point wasn't about any one thing. It was simply that science is not perfect. It is just a study. You test and test until you discover something and some of our most world changing scientific discoveries have been totally unplanned. I have the same reservations about GMO as I do any new groundbreaking field of scientific endeavor. GMO will be part of our future.. But for now it's a field that is barely in it's infancy.
Opinion piece on DDT and malaria and Rachel Carson: https://www.thedailybeast.com/how-rachel-carson-cost-millions-of-people-their-lives
I haven't researched it enough to have an opinion, but I do know some who have and agree with the author, so it's a view I give some credibility (with the understanding that I would need to look into it more).2
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