Why does an injection need to be kosher?
Here’s the latest news from the OU Kashrut Division:
“May 14, 2014
Pfizer Inc. (NYSE:PFE) today announced that the Orthodox Union (OU) has granted kosher certification to ELELYSO™ (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is the first prescription medication to be certified kosher by the OU, a milestone for the brand which was approved by the U.S. Food and Drug Administration (FDA) in May 2012.”
“May 14, 2014
Pfizer Inc. (NYSE:PFE) today announced that the Orthodox Union (OU) has granted kosher certification to ELELYSO™ (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is the first prescription medication to be certified kosher by the OU, a milestone for the brand which was approved by the U.S. Food and Drug Administration (FDA) in May 2012.”
I honestly cannot understand why an item that cannot be eaten or drunk and is not for use in food preparation, serving, or clean-up needs to have a hechsher (rabbinic seal certifying that it’s kosher). If someone would kindly explain this to me, I’d appreciate it.
posted by Shira Salamone at 11:41 AM
39 Comments:
The OU has said for years that they will certify products that do not need a hecksher. They say that when they accept money for this they do make plant trips and confirm that there are no unexpected kashrut concerns.
Ah, so this isn't a halachic matter, it's just a business decision.
I worry about this. Given the standard religious slippery slope, once something CAN be done, it tends to become something that SHOULD be done and then something that MUST be done.
The OU just started the boulder rolling down the hill on medical injections needing halachic oversight. I do not want to hear about how people are dying of X because the injection for it isn't kosher when there is no reason for this to be an issue in the first place.
The OU certifies all sorts of nonsensical projects. Aluminum foil, plastic bags, etc. Lots of things not relevant.
Maybe so, Miami Al, but I'm inclined to think that the Physicist may have a point. Is it possible that the same folks who insist on a hechsher for products that don't need one might do the same with medications?
Sure. But the OU is a business that happens to have a non-profit synagogue group attached to it for tax reasons. They aren't your doctor.
If you take medical advice from a Rabbi you've never met, you deserve what you have coming to you.
Now people feeling disempowered to do anything but what the people around them are doing is another problem, and is that social/peer pressure a problem, but none of that is a reason for OU not to take the contract.
" . . . the OU is a business that happens to have a non-profit synagogue group attached to it for tax reasons."
Miami Al, I can only repeat what I said to Larry Lennhoff above: " . . . this isn't a halachic matter, it's just a business decision."
Which is to say that the OU Kashrut Division is exploiting halachah to make money. . .
. . . and is violating the traditional prohibition against leading people astray--lifnei iver lo titen michshol--in the process.
[Shira opens umbrella in anticipation of incoming volley(s) of rotten tomatoes.]
As long as I have my umbrella open already anyway, I'll say that, in my opinion, " . . . people feeling disempowered to do anything but what the people around them are doing . . ." *is* a reason for OU not to take the contract. I agree with The Physicist that this a slippery-slope decision, and am concerned there *will* be people afraid to make medical decisions without rabbinic permission. I think this decision sets a terrible, and possibly dangerous, precedent.
I will go further and note that "one who profits from the crown loses his place in the world to come," and also "do not use your Torah as a spade to dig with."
The OU's inability to say to company that comes to them want a hechsher "no, it doesn't need it" is a blatant exploitation of Keter Torah for wealth, and the ensuing creation of the perception that things that are not subject to the laws of Kashrut need a hechsher is precisely using the Torah as a spade to dig with.
I have never been able to grant the OU any moral standing, and yet I find its hechsher on a product comforting, as an indicator that the manufacturer is not hostile to Jews. OTOH a few years of dealing with the OU could change that.
"The OU's inability to say to company that comes to them want a hechsher "no, it doesn't need it" is a blatant exploitation of Keter Torah for wealth, and the ensuing creation of the perception that things that are not subject to the laws of Kashrut need a hechsher is precisely using the Torah as a spade to dig with."
Well said, Reform BT. I agree.
The OU replies to my inquiry:
The Orthodox recently granted kosher certification to Pfizer’s medication, ELELYSO™ (taliglucerase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher’s disease. ELELYSO™ is administered as an injection, and we have received many inquiries asking why did the OU certify an injection which does not require supervision.
Indeed, injectable medicines do not require kosher certification, and this was communicated to Pfizer on a number of occasions. Nonetheless, Pfizer specifically requested that the OU certify ELELYSO™ and allow the OU logo to appear on the product label because it is intended primarily for a Jewish audience. Gaucher's disease is a genetic disorder with a very high incidence among Ashkenazic Jews. The OU agreed to grant kosher certification at Pfizer’s request to show support for this endeavor. The market for this product is relatively small (approximately 10,000 people worldwide are afflicted with Gaucher's disease), and the OU appreciates Pfizer’s sensitivity to the needs of the Jewish community.
In addition, many people are unaware that they are afflicted by Gaucher’s, and standard blood tests do not check for this disease. Pfizer was hopeful that OU certification on this medication would provide significant exposure via OU press releases and notifications, and this would heighten public awareness of this disorder.
In general, the OU has attempted to make inroads in certification of oral medications. Liquid medications and chewable tablets may have serious kashrus concerns, and even inedible tablets which may contain non-kosher ingredients should not be taken if a kosher alternative is available (See Shulchan Aruch, Yoreh Deah 155:3). Because many medications are essential for one’s health, any decision about taking or discontinuing medication should be made in consultation with one’s doctor and Rabbi.
"Pfizer was hopeful that OU certification on this medication would provide significant exposure via OU press releases and notifications, and this would heighten public awareness of this disorder."
That's the best explanation I've heard. But I'm still concerned about people avoiding taking un-hechshered medications even though the medications don't need a hechsher. I agree with The Physicist that people's lives could be endangered.
The explanation is unsatisfactory. To paraphrase a famous American philosopher, no one will go bankrupt overestimating the intelligence of the modern Jew.
The OU and Pzifer may have the best of intentions but it'll still turn into "You used injectable insulin without a hashgacha? I'm not sure I want my daughter dating your son..."
"Because many medications are essential for one’s health, any decision about taking or discontinuing medication should be made in consultation with one’s doctor and Rabbi."
That is downright terrifying.
The bigger issue is not a direct backdoor, it's the fact that plenty of products that never needed supervision now seem to because "well if a supervised version is available."
I do disagree with this:
"Which is to say that the OU Kashrut Division is exploiting halachah to make money."
It's not halachah, it's renting out their trademark.
I like most of the the reasoning, but the same end could have been achieved by charging Pfizer less to put out a press release stating that there is this treatment for this disease that affects lots of Jews, so Pfizer came to us for a hechsher, we notified them, and are notifiying you that injected medications do not require a hechsher, and are perfectly halachically acceptable without. If you are experiencing any of the following symptoms . . . please consult a doctor.
As I said, Pfizer should get charged for the use of the OU's marketing channels, but not for the use of the trademark.
Garnel, I agree. As the Phyicist commented above, "Given the standard religious slippery slope, once something CAN be done, it tends to become something that SHOULD be done and then something that MUST be done." I can easily see this turning into a shidduch (marital match) issue in addition to a serious health issue.
Many thanks to Larry Lennhoff for posting the OU's reply to his inquiry, which Miami Al quoted:
" Miami Al said...
"Because many medications are essential for one’s health, any decision about taking or discontinuing medication should be made in consultation with one’s doctor and Rabbi."
That is downright terrifying."
Yes, it certainly is. It seems to me that a statement such as this may signal the beginnings of an OU version of Daat Torah, the belief, held by some Chareidim (religious-right-wing Orthodox Jews) that any decision must be vette by their Rebbe.)
"It's not halachah, it's renting out their trademark."
Miami Al, if a halachic issue, namely, kashrut, is their stock in trade, how can "renting out their trademark" not be a use--or, in this case, a misuse, in my opinion--of halachic authority?
" . . . the same end could have been achieved by charging Pfizer less to put out a press release stating that there is this treatment for this disease that affects lots of Jews, so Pfizer came to us for a hechsher, we notified them, and are notifiying you that injected medications do not require a hechsher, and are perfectly halachically acceptable without. If you are experiencing any of the following symptoms . . . please consult a doctor."
Reform BT nails it.
"it seems to me that a statement such as this may signal the beginnings of an OU version of Daat Torah, the belief, held by some Chareidim (religious-right-wing Orthodox Jews) that any decision must be vette by their Rebbe.)"
Again, if you actually knew modern orthodox Jews, you'd realize how fundamentally stupid that is. Not to mention it's not a "rebbe". That's chasidism. It would be the rosh yeshiva. If you're going to malign Orthodox jews, at least get the terminology right. Or, better yet, keep your opinions to yourself.
I wasn't maligning Modern Orthodox Jews as a group, I was maligning the Orthodox Union specifically, because the OU seems to be encouraging that attitude, which has, for the record, been rejected by all the Modern Orthodox Jews posting in the comments here and/or by e-mail.
I apologize for my terminology only--yes, I should have referred to "their Rosh Yeshiva" rather than "their Rebbe" when writing about Modern Orthodox Jews.
As for your suggestion that I keep my opinions to myself, why should I? I've made every effort to maintain a civil blog (both in the posts and in the comments), and to be diplomatic in my writing to the best of my ability. That said, there's an old song, ”It’s my party and I’ll cry if I want to.” Well, it's my blog, and I'll write what I want to.
you make ludicrous leaps in logic (or illogic). That the OU is willing to accept payment when Pfizer is doing something silly has nothing to do with daat torah. and suggesting that someone check with their doctor and rabbi as to whether to take medicine is not at all illogical. Every rabbi I know (and unlike you, I actually am orthodox and know real live orthodox people) would say "what does your doctor say to do" and then they tell people to listen to their doctor. My point is, all you do is complain. And you complain about stuff you know nothing about. In your recent post, learning in a beit midrash has nothing to do with people talking in shul. You draw links that are just silly.
You miss the point, Anon (and by the way, I would appreciate it if you would pick a name).
The OU said ""Because many medications are essential for one’s health, any decision about taking or discontinuing medication should be made in consultation with one’s doctor and Rabbi."
What Miami Al--a Modern Orthodox Jew, for the record--found "downright terrifying" about this is the very notion that one should consult a Rabbi in addition to one's doctor when deciding whether to take or discontinue a medication. You said, "Every rabbi I know (and unlike you, I actually am orthodox and know real live orthodox people) would say "what does your doctor say to do" and then they tell people to listen to their doctor." The question is, why would a Modern Orthodox Jew consult a *rabbi* about medication in the first place? Since when is a rabbi an expert in medical matters? My understanding is that the insistence that one consult a rabbi even in regard to matters in which he has neither training nor expertise is exactly what Daat Torah is all about. And I am under the impression that Daat Torah is a hallmark of Chareidi Orthodoxy, but that Modern Orthodox Jews don't follow that practice. Feel free to correct me if I'm wrong.
As for your complaint about my Good practice post, you missed the point there, too--they're not talking while *they're* praying, they're talking while *someone else* is, on the assumption that everyone else is as good at ignoring other people's conversations as they are. I don't see anything silly about the link between studying bet-midrah-style and being able to ignore distractions.
And I'll return the "compliment"--all *you* do is complain, too.
your blog used to be interesting. now it sucks. goodbye.
Fine. If you'd rather pack your bags and leave rather than address my response, be my guest.
And take your rude language with you. As I said, I try to run a *civil* blog, and I expect my commenters to avoid using vulgar words.
"My understanding is that the insistence that one consult a rabbi even in regard to matters in which he has neither training nor expertise is exactly what Daat Torah is all about."
Wrong. Thank you for playing. Daas Torah (nobody says Daat Torah) is the idea that because of a rosh yeshiva's learning, he possesses some special skills or sense that comes from being immersed in Torah. Daas Torah comes into play with questions like "should I marry this girl" "where should I send my kid to school."
Questions about medications -- for which there are legitimate questions, such as whether one can take medications on Shabbat or Yom Tov, or whether they might contain kitniyot on Pesach or whether they are potentially treif and shouldn't be taken are squarely within the wheelhouse of a modern Orthodox rabbi.
For example, Armour Pharmaceuticals makes a thyroid medicine that is made from pig thyroid glands. It's an oral product. Should one take it? that's a halachic question, particularly since there are non-porcine derived products (Synthroid being the biggest).
So, Miami Al might think it's terrifying, but I think it's not unreasonable in that situation to talk to my doctor (why not give me the chemically derived one?) and then ones rabbi. And believe me, I'm as Mod Orth as they come.
It's the fact that you make some ridiculous leaps, not to mention complain about everything, that has transformed your blog from an interesting place about the struggles of being an observant conservative Jew to being nothing more than the rants of a cranky person. The shul, food, your shul, Orthodox people, etc. I bet you sit on your front porch and tell kids to get off your damn lawn.
"Nobody says Daat Torah."
Insofar as I speak Hebrew, which is debatable, the Hebrew that I speak is with something at least remotely resembling Israeli pronunciation. So *I* say Daat Torah. Others are free to pronounce it in whichever way they prefer.
"Questions about medications -- for which there are legitimate questions, such as whether one can take medications on Shabbat or Yom Tov, or whether they might contain kitniyot on Pesach or whether they are potentially treif and shouldn't be taken are squarely within the wheelhouse of a modern Orthodox rabbi."
No, I'd ask my *doctor* whether my health condition necessitates my use of medication on Shabbat or Yom Tov. Regarding treif or chametz medication, I'd ask whether there are medications that I could take that would be equally effective that don't contain chametz and/or aren't treif, and would turn to a rabbi only if the doctor couldn't answer the question. Even then, I'd seek a rabbi with some medical knowledge, and not just my local rabbi. If the only treatment for a medical condition, or the only one that my body could tolerate, were treif, I would not ask anyone's permission to take it. On the other hand, I would ask a rabbi how I might protect the kashrut of my kitchen while taking treif and/or chametz medication.
You raise the legitimate question of pig-derived medications. But you ignore what I, personally, think is an equal consideration, namely, the question of whether one should take a lab-derived medicine when a medicine from a natural source is available. How would my body handle a lab-derived chemical, and/or would the lab-derived chemical be more likely to pollute?
Okay, so I'm a kvetch (complainer). Guilty as charged. I'm workin' on it.
You aren't orthodox. Res ipsa loquitur.
I haven't noticed that folks who *are* Orthodox refrain from criticizing the *non*-Orthodox.
Shira, please stop engaging your anonymous poster. Arguing with people like that is like trying to teach a pig to sing; it wastes your time and annoys the pig.
Oh, and captcha! seems awfully interested in House Numbers lately. . .
Reform BTs' comment makes me wish blogger had a 'like' button.
Reform BT, thanks for the advice. Sometimes I don't know when to leave bad enough alone. I second Larry's "like."
You may be amused to know that Ms. Low-Tech here had to do an internet search for "captcha!" I think I've see it on other blogs, but I'm afraid to fiddle with my own blog, less I mess it up and can't figure out how to fix it.
In an attempt to find out how a more religiously-right-wing Orthodox community reacted to this OU decision, I did an internet search. I think it was "kosher injection" that brought up this one: Yes, even some folks from the Lakewood Kollel crowd question this OU decision.
Oops, sorry--didn't mean to keep my readers in the dark: Kollel, explained.
your 3 readers know what kollel is.
See here.
You're concerned about porcine derived oral medications? Does it require an inquiry with your Rabbi to know that pork is a Kashrut problem? My Catholic friends all know that.
Is it reasonable to ask your doctor about a synthetic alternative? Absolutely. Do you expect your Rabbi to have an insight as to the proper thyroid medication?
However, re-reading the OU statement, it says that "discontinuing a medication" should be done in consultation with your doctor and Rabbi. Ready literally, it suggests that if the doctor wants you to stop, you need to check with your Rav.
I think what they mean is, before you stop taking a medication for religious reasons, check with your doctor (that it's safe) and your Rav (that you actually should stop). That's two failsafes to stop people from doing dumb stuff.
However, the suggestion that TAKING the medicine should be done in consultation with the Rav... I have never checked with my Rabbi on matters of medication (doctor), litigations (lawyer), or taxes (accountant). I have discussed matters of Eruv, Kashrut, and family friends weddings with by Rav, and for none of those did I consult my doctor, lawyer, or accountant.
I find the suggestion that your Rabbi should be involved in areas way outside their training to be terrifying and the risk of "Daas Toirah" magical thinking slipping in there. However, the statement on it's own, read as, "before you stop for religious reasons, check with your Rav" sounds reasonable.
I don't speak for Modern Orthodox Jews. I don't think you should seek medical advice from your Rabbi (unless he's also an MD). YMMV
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