Wednesday, February 12, 2014

Slick Marketing, Free Market Forces and the Future of B12


[NOTE: An earlier version of this was posted, admittedly in somewhat of a fit of rage. I have since corrected some errors and hopefully presented a more sound argument.  - Teresa]

It is said that every person reacts differently and recovers differently after having a total gastrectomy (TG). Something that we all have in common is malabsorption of vitamins and minerals, which people experience to varying degrees. But one problem that is persistent in every TG patient is deficiency in the vitamin B12.

B12 is a vitamin essential to the healthy functioning of nerve cells and blood cells. It is found readily in animal meats and products such as milk and eggs, so anyone who eats a non-vegan diet is likely getting plenty of B12 through the foods they consume. It is even commonly added to fortified cereals and other similar products.


Unique to B12 is how it is made usable by the body. According to a fact sheet from the National Institutes of Health, "Two steps are required for the body to absorb vitamin B12 from food. First, hydrochloric acid in the stomach separates vitamin B12 from the protein to which vitamin B12 is attached in food. After this, vitamin B12 combines with a protein made by the stomach called intrinsic factor and is absorbed by the body."


Now if you were paying attention there, you surely noticed that in order to process and absorb B12 from food, you need to have a stomach. Those who have had TG and even some who have had gastric bypass rely on not just supplementation of B12, but specifically the injectable Cyanocobalamin form of B12. Because without the intrinsic factor in the stomach, the body suffers what is called pernicious anemia and is unable to convert oral vitamin B12 to a usable form, so one can pop all the pills they can swallow and it will likely do no good. 





Pernicious anemia causes the body to slow production of red blood cells and according to the above-linked article, "Without enough red blood cells to carry oxygen to your body, you may feel tired and weak. Severe or long-lasting pernicious anemia can damage the heart, brain, and other organs in the body. Pernicious anemia also can cause other problems, such as nerve damage, neurological problems (such as memory loss), and digestive tract problems."


I got my first shot at the doctor's office in September 2010 and took home a prescription for a 30mL bottle (@1mL per dose is 30 doses). I had a friend who is an RN come over and give me my next shot a month later. After that, I made Dan watch a YouTube video showing how to give a subcutaneous injection and he gave me shots for several months before I could muster the courage to do them myself. The general rule of thumb is to take a shot a month, so a 30mL bottle is basically a 2 1/2 year supply. 


I think it was within the first six months of my surgery I started hearing a little buzz about a shortage of B12 but didn't think too much of it at the time. I guess I felt that I would be okay as I basically had a 2+ year supply, drug shortages happen here and there in the pharma business and it would likely be resolved by the time I needed more.


Last February, I had to see the doctor for a new prescription. This time the pharmacy was unable to provide me with a 30mL bottle due to the shortage and I had to resort to using 1mL bottles of which they could only provide me with 12. (I am currently holding on to my used ones because I fear that one day I will have to pop them all open for the small remainder still inside and combine them just to get a few much needed doses).





Looking into the shortage I discovered that it was ongoing, it hadn't been temporary as I had previously thought. A few months ago I emailed one of only two FDA approved manufacturers of injectable Cyanocobalamin about the shortage. [I think now I had heard on a discussion forum that manufacturers are having trouble sourcing the raw materials to make it and mistakenly attributed that information to the company representative in my previous version]. In reviewing his response he simply said, "What I can report is that we are not manufacturing cyanocobalamin presently but hope to place this product  onto manufacturing schedule very soon. The decision to place a product back onto manufacturing schedule is not a simple process and involves several internal departments and regulatory agencies." Which I take to be a sincere and professional way of saying, "I have no idea when we are making more."

But the halt in production of injectable cyanocobalamin is only a small piece in the puzzle of why the shortage is so alarming. Because the main reason for the shortage, the reason the manufacturers have been unable keep up with demand is because it has become fashionable to get B12 shots. That's right, it's all the rage these days in the health clubs and the "medical" spas. It's being touted as a weight loss miracle.


The problem with this is there is absolutely zero evidence that injectable B12 is any more effective than taking oral supplements in healthy individuals. None. The only reason it "gives you energy" and "makes you feel revived" is because some copywriter in a marketing department somewhere is telling you that it does. Medical professionals and journalists alike have found that selling B12 injections as energy builders and an aid in weight loss is just a snake oil ruse. There is no evidence that B12 aids in weight loss according to the mayo clinic.

The fact is that normal, healthy individuals will get the same result taking oral B12 supplements as they get with a shot. Vegans who do not get enough through their diet will also be just fine with oral supplements. But as I explained above, TG patients, gastric bypass patients and others with various stomach/intestinal disorders, including the elderly, are increasingly missing out on these MEDICALLY NECESSARY injections because people like Madonna and Justin Timberlake want to have more pep in their step.


Last summer, this doctor lamented the B12 shortage and explains it's the placebo effect that makes people think they are getting "results" from the shots. I can attest to the placebo effect at work here because I would tell my doctors how I felt it working immediately and they would smile at me the way one would smile at a child that has just told the most unbelievable, fantastic tale.


Another blogging physician likens the current B12 shot craze to a "fetish" and calls out it's overuse. 

He does not mention though, that there are some people for which oral supplements do not work, and they are the ones most harmed by this increasingly popular practice.


And a television station in Salt Lake City, Utah (video seen here) investigated the use of B12 injections for non-medical reasons and did a good job in pointing out that people are basically wasting their money. What it failed to do is bring to light how this recreational use of injectable B12 is actually harming people who need it, because it is making it very hard to find and also causing the costs to skyrocket.

The increasing cost brings up another point: if you are getting B12 injections at the gym or the spa, man are you getting ripped off. Oh. My. Word. Are you ever getting ripped off! Even with the rising costs, people are paying too much for these shots. This alone should enrage current proponents of the "needle-fed B12 fad" and send them right to the vitamin aisle for a $5 jar of oral supplements.

I called a local "medspa" and inquired about their B12 injections. I was told that it would be $100 for a month long treatment.  Upon further inquiry she explained that it would be one 1mL injection per week for four weeks. So that's $25 for a 1mL shot. The journalist from KSL TV in Salt Lake City reported that people are paying up to $80-90 a shot. No wonder so many outlets are offering these "miracle" shots. It's all about the money.

I dug up receipts and can report the following: 
September 2010 paid $31.90 for a 30mL bottle and 30 syringes = $1.06 per 1mL dose. 
February 2013 paid $42.90 for 12 1mL bottles and syringes = $4.40 per dose
February 2014 paid 61.95 for only 9 1mL bottles and syringes = $6.88 per dose.

And those are retail prices. You know these health clubs and spas aren't paying retail, they're paying much less than that. Basically, if you are paying more than about $10 for a 1mL injection, you're being bamboozled. And it seems a lot of people are paying 5-10 times more than that.

Then there is the dosage to consider. People who need injectable B12 because they cannot absorb it from food or oral supplements are prescribed about a 1mL injection every month. I know of some who get one every two weeks and others who get one every 2-3 months, but once a month seems to be the average. Getting the shots once a week is just overkill for healthy people who have their stomachs intact. And I've even seen references in weightlifting forums to getting them every 3-4 days. That's literally pissing money away because your body is not storing all that. You're getting too much, paying too much, and it's being excreted through your urine.

I'm not against people who strive for a healthy lifestyle and choose B12 supplementation as a way to maintain that health and well-being. I just ask that people reconsider their use of the injectable form. Most people simply don't need it. And they are causing a shortage for others who can suffer severe effects, including death, if they have to go without for too long.



Looking on the bright side, there is some indication that the sublingual and nasal spray forms of B12 are absorbed directly into the bloodstream, through the mouth or sinus cavity respectively, circumventing intestinal absorption and the need for intrinsic factor. It is also speculated that the methylcobalamin form of B12, while more expensive, is better absorbed by the body and shows promise that the above delivery methods, rather than injection, may prove to be beneficial to those who cannot absorb it through the intestine.

So if it turns out that I can dissolve a few sublingual tabs under my tongue every day and still get a decent amount of B12 to keep my body healthy, I will surely ditch the needles. Then all the fad dieters and body builders can continue to pay ridiculous amounts of money for injections that do very little for them. After all, this is America, and people have every right to be swindled by charlatans.





9 comments:

  1. Thank you, Teresa!

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  2. I can't argue with a single point you have made...which is saying a lot as I have a website that sells injectable B12. It has been an odd ride providing a product with clients that are spas AND clients that are doctors. Still stunned when I do google searches on B12 shortage (how I found your post) and some of the results are YEARS old. The shortage must ultimately come down to not be able to patent and profit.

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    1. Thanks for your comment Stephen. This shortage continues to baffle me. I would think that such a sharp increase in demand in the past five or so years would be enough to maintain decent profitability of a product. But the fact that no one can patent a vitamin in and of itself is surely something to consider. I catch myself often wondering if the shortage isn't being created intentionally, as we all know what happens to price as demand increases and supply drops on the curve, right?

      Since writing this, I've begun to kick around another theory as to why manufacturers are cutting back on production. I'm finding more evidence, both anecdotal and scientific, that the sublingual B12 that dissolves in the mouth is actually sufficient in maintaining healthy levels even in people who have had gastrectomy. Previously, medical professionals said this was not possible. So I wonder if the manufacturers aren't considering the possibility that injectable B12 may be on its way to becoming obsolete?

      Though given the current demand for injectable B12 in the spa/health club markets I would think that money is still to be made manufacturing it. People who NEED it will get it as cheaply and efficiently as they can. But spa/health club clients prefer the injectable form either alone or as part of a "cocktail" so how can something really become obsolete when so many still demand it?

      Please post here as a comment if you ever find out anything insightful; I will do the same. Best of luck to you in all this.

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    2. I haven't really considered the supply side and manufacturing in depth. At a guess I wouldn't think the real issue is not whether injectable B12 is profitable, but whether it is more profitable than something else they could be making instead. Is the limiting factor available vats for production, or available financing to pay for production? I doubt we will ever know.

      It is a certainty that many of our clients either do not need B12 at all or could just take a vitamin pill - or sublingual, oil on skin, etc etc. Packaging is part of marketing and a prescription injection seems a lot more powerful than an over the counter pill. In asia where our B12 is coming from it is common to get a B12 shot when you visit the doctor ... kind of like getting anti-biotics in north america I think. You have to leave with something or you did not get your moneys worth. Que mention of placebo effect...

      (disclaimer - vitaminB12direct.com)

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  3. Thank you, Teresa, for the most complete account of what's going on with the B-12 shortage that I have found so far. I really do appreciate it.

    I had bariatric surgery with stomach stapling and a 6-foot colon bypass quite a few years ago and thus I have a nutritional malabsorption problem. I was malnourished before my surgery, and am still malnourished. I am less obese than before . . . but still overweight. I've always been a big woman, but I definitely put my body into "starvation mode" when I served as a U.S. Marine. Quite frankly, the USMC hates fat, and they won't put up with it - so I starved myself and overexercised to satisfy their weight requirement. Eventually, I was given an official waiver to weigh 31 lbs. more than 'the book' allowed, and for the last couple years of my enlistment, the Corps got off my back about what the scale said. I was finally given a waiver because my body fat percentage was below the maximum allowed - but my weight was still 31 lbs. over! I am one of those rare females with a verifiably large bone structure. When I was in, the USMC didn't want to recognize that. The 'spread' of allowable weight for men from minimum to maximum was quite broad. Not so much for females. In my opinion, they would rather believe that all women have an average bone structure. Unfortunately, we don't. I'm built like a discus thrower, not a long-distance runner. And the Corps likes Marines who look good in uniform (in fact, I had to have an official portrait taken in a certain uniform to submit with my waiver request - so they could see that I didn't look horrible in that uniform although I was TECHNICALLY overweight. *sigh*.)

    Like so many others, I NEED my B-12. I am suffering from all the classic side effects of a B-12 shortage; fatique, a low RBC count, etc. I'm also 50 years old, and I don't suppose that helps. I take 4 multivitamins a day, but as your blog explained so well - doing so doesn't address my B-12 problem.

    Today (7-7-14) my pharmacy has 4 2-mg vials of B-12 on the shelf. I'm desperate to get my hands on them, but my doctor wrote the prescription incorrectly and isn't in the office today. (He seems to be turning into a 'part-time' physician - but that's another story.) I actually need a vial every week. Yes, it seems like a lot, but again - I'm not your physically average female.

    The only question I have about this B-12 shortage, is what exactly are the "raw resources" required to synthesize B-12? You mentioned "raw resources" in your blog entry, but didn't specify what those are. I suppose it's a difficult question to answer unless one is in the pharmaceutical industry and/or has a chemistry degree.

    Anyway, thank you again for the excellent write-up!

    S. Hubbell
    Missouri

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  4. Thanks for you comment Ms. Hubbel. I'm sorry to hear of your struggles both pre and post- surgery. I'm sorry about seeming so vague about the "raw materials" issue but the fact is I am somewhat fuzzy about it myself. I thought it had been something a pharmaceutical rep had said, but in retrospect, I think that was something I heard in an online forum. I honestly don't know what the "raw materials" are. I would suspect some form of cobalt is a main component. I am not even sure that that a problem with obtaining any sources is truly a cause of the production shortage. As far as getting what you need, my non-medical professional advise would be to ask your physician about supplementing with sublingual B12 tabs. These are the ones that dissolve under the tongue. Best of luck to you.

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  5. I was diagnosed with pernicious anemia by an endocrinologist due to serious symptoms I was experiencing. I need the injections every two weeks or at the very least monthly. I haven't had any since March. I no longer have insurance nor am able to pay "spa " prices. As you have written, the symptoms can be quite severe. I am usually very good typist and this has been very difficult to write. I have no choice now but to source it out of the US. Do you know of anyone that has done this? I need a safe supplier.

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  6. Anonymous,

    1) If you currently have a script for injectable B12, call every pharmacy to see if they are able to fill it at least partially. American Regent, one of the North American manufacturers, has recently released B12 in 1mL, 10mL and 30mL in limited supply, at least according to the FDA website. That means that a pharmacy that told you in April or May that they could not get it might be able to get some know. Tell them this, they might not even be aware. Ask them to try.

    2) As far as trying to get some outside the US, understand that the shortage affects Canada as well, (likely all of North America). That means you'll be looking in Europe or Asia. I personally think that getting medicine outside the US, particularly something injectable, is a sketchy prospect and likely wouldn't consider it. I think you may have better options ...

    3) I AM NOT A MEDICAL PROFESSIONAL. NOTHING THAT I SAY IN THIS COMMENT OR ANYWHERE ON MY BLOG IS INTENDED NO BE TAKEN AS MEDICAL ADVICE. PLEASE SEEK THE OPINION OF A QUALIFIED MEDICAL PROFESSIONAL. Get your hands on sublingual B12 tabs that dissolve under the tongue, preferably the methylcobalamin form as opposed to cyanocobalamin. You can find them readily on the internet and most drug stores. "Natural" health stores are more apt to carry the methyl- form, and it's a little more expensive.

    I KNOW you have been told that nothing but the injectable will work for you. I've been told the same thing. But I have come across both anecdotal evidence and a scientific study done in South Korea that indicates that the sublingual tabs (not just regular pills) deliver adequate B12 to those who take them regularly, at least in the short term. My understanding is that it is believed that the vitamin is absorbed directly into the bloodstream through the mouth, bypassing the need for absorption in the intestines and the need for intrinsic factor to do so.

    I should also note that there is a nasal spray on the market as well that likely works via a similar mechanism (absorption into the body through sinus cavity). Don't know much about it other than it's pricey. But judging by the rising cost of injectable, it may prove to be a better option.

    I am working on an update to this post. I am trying to get info from the FDA, more info from manufacturers and find more studies. It will be chock ful o links for everyone.

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  7. I just want to thank you for diligent work compiling the information you have. It's the best I have found.

    Yes, I have a script and have been using the injectable for more than five years. I had a small stockpile but had I known there would be a shortage, it would have been much greater. (sidenote - I was told by my pharmacist that the large bottles became unstable after a month once opened and any remaining should not be used) I did however carry on using them past the one month mark out of neccesity without adverse effects although I am in no way advocating it.
    I will try the sublingual. I have been sceptical because tablets by the handfull have obviously never done anything for me and I was tired of throwing money away. Will look into the nasal spray as well. I realize everyone has a different set of circumstances but I can report back on my experiences with the efficacy of what I find.
    Thanks also for the heads up on the limited release of the injectable. I will start hitting all the pharmacies to find a possible source.
    I experience MS like symptoms without it and it so frustrating that the recreational use has potentially caused a shortage for those who have a genuine medical need.
    Thanks again for your great work.

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