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Summary
Quick summary of the For My Tummy position:
Probiotics in pills or capsules that protect against stomach acid, GOOD.
Probiotics in food, exposed to digestive juices all the way to the gut, BAD.
Types of Probiotics
That is to say that probiotics such as Digestive Advantage-IBS ™ and Align ™, both reviewed on this blog, are helpful forms of probiotics, and the strains seem to help more than Acidophilus or the multiple strains in the Neutraceuticals products. Both Digestive Advantage-IBS ™ and Align ™ are encapsulated in such a way that they do not need to be refrigerated, as some probiotics do. They also seem to reach the gut and then have the intended effect of improving gut (large intestine) response in the digestion of foods on an IBS diet, and perhaps extend the range and types of foods that can be eaten.
Probiotics in Food
Probiotics as food additives are unlikely to produce such help, because they are unlikely to reach the gut with their probiotic bacteria intact. Dannon’s web site section for health professionals summarizes a study that says that indeed their probiotic travels the entire digestive tract and emerges in the same strength–and then omits all the details that help to judge a study’s validity. Not to mention that people with some digestive problems have lactose intolerance, strong enough that they cannot eat yogurt. The encapsulated pill/capsule form of probiotic stays together and protects the contents, the millions of “colony-forming” GOOD bacteria that will change the digestive activity in the gut in a good way.
Immune System Probiotics
This–the unlikeliness to be helpful–also goes for DanActive, ™ which contains “l-casei immunitas” ™ as its resident strain of bacteria. In contrast, if increased immune function is what you want, search here for the Ganeden Biotech product Sustenex ™. Sustenex provides an encapsulated form of patented probiotics that are designed to bypass digestive juices in the upper digestive tract. I’m holding off on a wholehearted endorsement, just because I haven’t investigated the research, and only know that Dr. Mehmet Oz is a fan.
Further Information
See the many posts here; search on “probiotics” and on “Dannon,” or select the category “Probiotics.”
Feel Welcome to Comment
Thanks for visiting; please leave a comment below, by clicking the “Comments” link.
January 25th, 2008
Posted by
tummyblogger |
Probiotics, Align, NSI Probiotics, Digesting Information, Dannon Activia Yogurt, Digestive Advantage - IBS, Sustenex |
17 comments
Background
As I’ve mentioned before, I received free samples of Digestive Advantage-IBS (DA-IBS) ™ from Ganeden Biotech. The understanding with them was that I would write weekly reviews, in similar fashion to those I’ve written while sampling Align. They would not, and Procter & Gamble, who makes Align, did not, have any say over what I might write.
The Wrinkle
The complicating factor is that Ganeden Biotech makes two versions of Digestive Advantage-IBS. ™ I started with the form that is in a tiny caplet for swallowing. Then, after four weeks, I switched to the form of DA-IBS ™ that comes in chewable tablets. The reason for putting the chewable tablets second was that they contain a tiny amount of sucralose, the ingredient name for Splenda ™. Sucralose “works for me,” as one of the IBS triggers. It turned out that taking only that small amount of sucralose every day was no problem.
Report
I have already reported, after four weeks of taking the caplets, that Digestive Advantage-IBS ™ is my choice for probiotic. See this post.
BUT
After a couple of weeks taking the chewable tablets, I felt that they weren’t as strong or effective as the caplets. I often wound up taking two chewables a day. Then I would take one DA-IBS chewable in the morning, and “cheat” and take one DA-IBS caplet in the evening.
Then I just thought–this is not a clinical trial, after all. What I want is the caplets, not this solution that doesn’t quite work for me. So I stopped taking the chewable form of Digestive Advantage-IBS ™ completely.
Now I take one, or occasionally two, DA-IBS caplets every day. I think the difference is not the sucralose content. My theory is that the chewables are far less likely to deliver the probiotic ingredients–yes, the good bacteria–to the large intestine, which is where I need them. This is the criticism often made of products such as DanActive ™ and Activia ™, and it may work equally well for Digestive Advantage-IBS ™ Chewables.
Availability
If the form of Digestive Advantage-IBS ™ that is available at your pharmacy/ drugstore/ apothecary is the chewable form, and you would like to try the caplet, either ask the pharmacist to order the caplets or order DA-IBS ™ caplets online from Amazon.com. It’s shipped directly from Amazon.com, not from an allied store, so should be available and fast.
November 9th, 2007
Posted by
tummyblogger |
Probiotics, IBS Triggers, Align, Dannon Activia Yogurt, Digestive Advantage - IBS |
one comment
Reviewing Digestive Advantage-IBS and Align
After approximately ten weeks of using Align ™ probiotic caplets, and filing my objective reports of the experience, I thought it was a pretty good product with some real problems in pricing and supply. {See my Align reviews}
Four weeks ago this past Monday, I started Digestive Advantage-IBS ™ (DA) in caplet form. {See my earlier DA reviews.}At that time, and for a year at least before then, the caplets were readily available through Amazon.com and other online sources, and the chewable tablets could be purchased at the CVS across the street. The price of DA was about half that of Align ™. I knew that DA had the problems of pricing and supply licked.
Problems with GERD on Align
What I didn’t report, in the ten weeks or so that I took Align ™, was that I had ever increasing (and recurring) problems with GERD. After all, Align was a probiotic aimed at affecting digestion in the large intestine. Toward the end of the time on Align, I was taking Prilosec ™ OTC as well as Ranitidine 150 mg. on a daily basis to control GERD.
Prilosec ™ is only supposed to be taken for two weeks, and I had just started DA when the two weeks were up. My GERD was under control for the moment, so I thought, I’ll continue with the Ranitidine and wait and see on the Prilosec, expecting that “any day now” I would need Prilosec again.
IBS and GERD All Clear, on Digestive Advantage-IBS
The “WOW!” in the title is that during the four weeks on Digestive Advantage-IBS ™ I have never needed to go back on Prilosec ™. Align ™ gave me ever-increasing problems with GERD; the NSI probiotic 15-35 that I took before beginning Align also gave me problems with GERD. I thought it went with the territory. Four weeks plus without GERD is amazing to me.
Otherwise, Digestive Advantage-IBS ™ (plus diet, exercise, all that good stuff) has controlled my IBS tummy very well. I have begun to add fruits and vegetables–sometimes cautiously, sometimes not,. When I’ve added a fruit or vegetable that doesn’t work too well for me, and have an evening of a slightly rocky tummy, I take a second DA caplet. Generally in a half hour, and certainly by morning, I’m fine.
Subjective vs. Objective
My report is only subjective, and certainly not a scientific study. In spite of reports to the contrary, Digestive Advantage-IBS does have adequately controlled scientific studies that show significant results for IBS pain and bloating. In addition, my comparison of Align ™ with DA indicates that, while both are a little bit constipating to my system (with IBS-C), DA is slightly more so, making it potentially better for people with IBS-D. The constipating effect can be countered, if desired, by half a teaspoon more of Heather’s Organic Acacia Tummy Fiber ™ or Fibersure ™ or a guar gum Soluble Fiber Supplement.
Summary: A Probiotic for IBS *and* GERD
So, for the purpose of taking a probiotic, and for taking a probiotic that is easily available, and for taking a probiotic that is cheaper than most others on the market, I have a summary comment below.
Bottom Line
Not only a Digestive Advantage, but also a competitive advantage.
October 19th, 2007
Posted by
tummyblogger |
Probiotics, Align, NSI Probiotics, Digestive Advantage - IBS |
6 comments
An Eventful Week
The first week of Ganeden’s Digestive Advantage-IBS (DA-IBS) has been eventful, including the frantic repair of this web site, so this post is a bit late in coming.
On one day, I wound up at the end of the day with a classic upset stomach. From something I ate? I’m not sure. I didn’t have anything else on hand, the stores were all closed, and I was curious about how it would work, so I took an extra caplet. I was very surprised that within forty-five minutes my tummy was feeling mellow once more.
Overall Impressions
Overall, the two days of more gas when starting DA-IBS were shorter than adapting to Align. The tummy-mellowing effect of DA-IBS seems, subjectively, to be stronger. That is, as I got more DA-IBS in my system over the week, my tummy felt better than it has for a long long time. I call that feeling “mellow.”
I do have enough gas that I am reminding myself to have some of Heather’s Organic Tummy Tea ™ - Fennel, which has always seemed to me to break up gas into smaller, quieter bits than simethicone capsules or drops or chewable tablets.
September 27th, 2007
Posted by
tummyblogger |
Probiotics, IBS, Align, Digestive Advantage - IBS |
no comments
For some time there has been a Page Title — in the upper right hand corner of the header menu — called “Window Shopping.” If you clicked on it, you would see a browser window that goes directly to the Best Life International website, and their “Soy Amazing” ™ Meal Replacement shake.
That was it. No blurb, no explanation, just the browser window.
I have now added several more browser windows, for products mentioned here that are not available at Amazon.com. The full list of products:
Two soy shakes mentioned here:
-
Soy Amazing Meal Replacement Shake, ™ from BestLife International–high soluble fiber content, high protein
- Revival Soy ™ Chocolate Daydream Shake — no fiber content, high protein.
Two probiotics for IBS reviewed here–windows to their web sites.
- Ganeden Digestive Advantage - IBS ™: currently serializing a review.
- Align. ™ Series of reviews, completed.
Use the Google site search, or the Category listings, for more information.
September 25th, 2007
Posted by
tummyblogger |
Breakfast, fiber, Chocolate, Revival Soy, Probiotics, Food for IBS, Irritable Bowel Syndrome, IBS food, Align, Soy Products, Soy Amazing, Online sources, BestLifeInternational, Digestive Advantage - IBS, IBS Diet |
2 comments
Agony of August–NOT
I finished the month of August without my annual bout of extreme IBS, either D or C, and credit the combination of IBS diet and the fact that I was taking the probiotic Align ™ for this amazing difference from the past “agony of August.”
Then, in the beginning of September, I had some C, the result of missing a dose of Heather’s Organic Acacia Tummy Fiber ™. Just goes to show you that all elements need to be in place for your tummy or mine to be on its best behavior.
Elements of IBS Therapy
So, to remind readers of these reviews, to use a probiotic for best effect on IBS, you also need the following daily elements:
For me, a year ago in July and August 2006 those things were not in place yet, and the probiotics I tried did not work for me. This year, I had both elements in place, and the Align ™ probiotic I reviewed worked great throughout August.
Conclusion of Align ™ Review
Align works as promised, at least on a well-prepared tummy. During the period I took Align ™ I also began to sample some fruits and vegetables, with good success except for broccoli.
The distribution system for Align ™ does not appear to be in place yet, and that affects the credibility of the main source of information, the Align ™web site. For example, the web site has a “sticker” update that says “Now available in pharmacies,” which is not true. There *may* be limited availability in warehouses, if a pharmacist knows to ask and is willing to order it. There is no distribution that has hit the shelves of a large chain pharmacy near me (CVS), in contrast to Digestive Advantage - IBS ™.
Promo Code for Align ™
The promo code to use for a $5 discount when ordering Align from the aligngi.com web site is AlignWOM. Look for a place on the web site called “promo code” and enter it there.
September 6th, 2007
Posted by
tummyblogger |
Probiotics, IBS, IBS therapy, IBS Triggers, Align, Heather's Organic Acacia Tummy Fiber (tm), Adjuncts, Digestive Advantage - IBS |
2 comments
This recent post about IBS probiotic Align has a comment from David at Ganeden Biotech, makers of Digestive Advantage ™IBS. They would like me to repeat the review process that I did with Align, using their product for IBS. Their product is widely available in stores, and has one good clinical test of its efficacy.
I am going to respond and thank them. I will have to suggest that I do the review month with their product for Constipation, rather than the one labeled IBS. DA-IBS contains sucralose (Splenda), one of the IBS triggers — at least one of my triggers. Their http://www.ganedenbiotech.com/prod_constipation.html is labeled as using sugar, rather than sucralose.
So, we’ll see. Again, the only compensation is two months of free product. I will also ask for a discount specifically for readers of this blog. They already offer free samples on their web site, although I don’t know how many that would be sent to each customer.
There are some interesting and good reviews of Digestive Advantage ™- IBS on ePinions, which will server for starters.
September 1st, 2007
Posted by
tummyblogger |
Probiotics, IBS, Irritable Bowel Syndrome, IBS-C, IBS-D, Align, Digestive Advantage - IBS, Digestive Advantage - Constipation, IBS Symptoms |
2 comments
Last week, on Wednesday August 22, 2007, I opened the 7-day pack of Align ™ for my last two weeks of reviewing the patented probiotic product. On that day I also ordered the next month of Align ™ from their web site. The day of the week was Wednesday. While I have a note of the order and the date and the confirmation code, I do not remember what time it was, though I think it was on the East Coast during the day.
In any case, there were two days left in the work week to ship out the Align ™ probiotic that I take for Irritable Bowel Syndrome (IBS). That did not happen, as I learned today with some dismay. Here is the actual email I received, with some editing to remove identifying details.
Reply
P&G to Contacts list Show original Message text
from P&G eStore Support hide details 3:00 pm (15 minutes ago) [that’s 3:00 p.m. EST]
to personlinks@gmail.com
date Aug 27, 2007 3:00 PM
subject Your Align Order Confirmation
mailed-by softcoin.com
Dear Customer,
We wanted to let you know that we just shipped your Align order number# 865697
The shipment went out via USPS and should arrive within one to two weeks.
If we can be of further service, please let us know. Customer Service can be reached by email at support@softcoin.com or by toll-free phone at 1-800-451-8904.
Thank you for purchasing Align.
Order 865697 Summary
To be shipped to:
The credit card name
The street address
The apt. number
The city and state
The phone number
Item: Align 28-Day Supply
Qty: 1
For additional order details, please log into your Align E-store account and click on ‘Account History’ then ‘Order Details’.
Thanks again for ordering from Align.
Reading this:
For additional order details, please log into your Align E-store account and click on ‘Account History’ then ‘Order Details’.
I logged in and viewed my order on their web site. All that was there was the amount of the purchase, my address, which I happen to remember, and the date and confirmation number for the order.
No tracking code, nothing that tells me when the Align ™ order will arrive, other than the alarming “one to two weeks” and the news that it was shipped USPS. Apparently shipping was not USPS Priority Mail, which comes in two days across country from Heather’s Products.
I am alarmed. Because of the delay in processing my order, five days out of 14 have been lost. If the order takes two weeks to reach me, I will have been out of Align ™ probiotic for between four and five days. Since, as I’ve noted before on this blog, missing a dose makes a noticeable difference, that is a dilemma. Much of the benefit of taking Align ™ for my Irritable Bowel Syndrome (IBS) may be gone; much of the original discomfort in starting Align may return. Do I wait out the time until Align ™ arrives, or do I shift back to my supply of the NSI 15-35 probiotic, or do I try another probiotic marketed for IBS, though perhaps not as well researched as Align ™?
A call to customer service reveals the following information:
- There is no other faster way to ship Align ™, even if the order is placed by telephone.
- In other words, all orders go out by USPS First Class Mail.
- US Mail, unlike FedEx or UPS, works on Saturdays and delivers on Saturdays
-
The shipping point (warehouse, I guess) is in southern Ohio, clear of the flooding.
That information reduces my sense of panic; this is an illustration of what I said a few days ago about Irritable Bowel Syndrome (IBS) and repression-sensitization. (Yes, I know “represser” is misspelled; it should be “repressor.”) I wasn’t worried about the order being fulfilled when I sent it last Wednesday, because there was still plenty of time left. I “repressed” any worry. Then I got the notice five days later that the fulfillment people for Align ™ were only now getting around to sending out the order. I immediately “sensitized;” taking care of this / blogging about it shifted to the highest priority.
So as not simply to rant, I would like to offer several recommendations in the distribution of Align ™:
- Provide several possibilities for online and telephone ordering, such as
-
shipping alternatives
- standard
- express, with tracking number
- purchase alternatives
- online and telephone from website
- in stores
- Provide for standing orders on a repeat basis, although a monthly, rather than 28-day, supply would be essential for this to be workable in many budgets.
- Create an adequate supply chain before marketing to create demand!
The last, of course, is a “change the past” request, which is unfair–or a “bring on the future really quickly” request, which might be doable.
======================
PS Just called my local CVS Pharmacy. The pharmacist there says that the name and description of Align ™ Probiotic rings a bell, that another pharmacist was just asking about it, but he doesn’t have it; he’ll call me back when he knows more. He did call back; four other pharmacists in the chain don’t know any more than he does; they have no product information, and no sources. He’s going to read this blog to find out about Align ™.
Thanks to this particular CVS pharmacist, and the others I have known, who are really as great as their ads.
======================
Did you know that my compensation for writing so much about Align ™ is a two-months free supply, and the ability to offer readers a promotional code for a $5 discount on the $29.99 price of an online order (shipping is free). To get the code, please write a comment to any article on this blog, and request the code. I’ll send you an email with the code, and will ordinarily publish your comment and my response, without the promo code.
So, do you have any thoughts on this post, or others? An experience with Align ™?
August 27th, 2007
Posted by
tummyblogger |
Probiotics, general, Irritable Bowel Syndrome, Align |
18 comments
Missing the Pill
This week would have been a very boring, more-of-the-same, post about Align. ™ It would have been, except that on Friday I forgot to take the day’s tablet of Align. It was my second week of taking Align using the 7-day blister packs that come in the new packaging.
Because I had, during this second week, gotten the days on the blister pack properly aligned (I couldn’t resist) with the actual days of the week, I discovered that I had missed a day on Saturday morning, when I still had a caplet marked “Friday,” in my blister pack. “Oh, well,” I thought, it won’t make a noticeable difference. Didn’t I just write a post that said so?”
The Effect of Missing the Pill
I was surprised that I did notice a difference, a distinctive sense of something missing. It’s not that anything terrible happened, or that I had more pain, or anything obvious. Just 15% more sense, for three days, that my tummy was back to struggling for equilibrium. The feeling was really very hard to put a finger on, and nothing I’d go to a doctor about, yet definitely a noticeable feeling.
That barely definable feeling did convince me that Align was actually doing something good for me, that the smooth and mellow tummy I had reported was smooth and mellow, and not imaginary. When I took Friday’s Align caplet on Saturday, I didn’t expect to notice the missed day–it wasn’t a case of a self-fulfilling prophecy.
Serving up Subjective Proof
In one kind of clinical trial, the subjects are rotated on and then off — or counterbalanced off and then on — the investigational drug to see whether the same people report different effects for placebo vs. drug.
This was my own small trial along the same lines, and I am, on admittedly small evidence, convinced of the efficacy of Align–and of the irritating quality of those Sunday through Saturday blister packs!
August 23rd, 2007
Posted by
tummyblogger |
Probiotics, IBS, Irritable Bowel Syndrome, IBS therapy, Align |
no comments
Fifth Week–Packaging Issues
I’m into the second four-week sample of Align, the probiotic from Procter & Gamble that has a patented new strain of the “good bacteria.” The big news is that I can’t cope with the “days of the week” blister packaging! I just grabbed one and tore it open at the regular time in my day. It was a Wednesday, and I grabbed a Sunday or a Friday, so of course I couldn’t keep count of how many I had taken. If I had a choice, I would use the vial of capsules.
What this kind of packaging does, though, is underline that Align is something to be taken every single day. It is definitely NOT a medicine that you take when you feel bad and have symptoms. Instead, it is a supplement, to add something that your body needs. In order to be work, you need a constant supply, every day. Okay, so you don’t suddenly feel sick if you miss a day–should I try that experiment, just so I can report on it? If you go away for a weekend and leave your Align (or other PRObiotic) at home, and you have been taking it for a while, it’s no big deal to miss a couple of days.
Stop for Antibiotics?
Taking antibiotics for any reason does kill the bacteria. The jury is still out on whether you take both, or stop the probiotic. This isn’t covered in the FAQ at aligngi.com, the–now slick and glossy and attractive–Align probiotic website. I will look for more information and report back.
Good Week
Otherwise, my tummy has had a good week. So have I. They do seem to go together a lot of the time, don’t they? There is a problem with–take your pick–acid reflux, GERD, heartburn, or erosive esophagitis. This problem is NOT different from taking the NSI PRObiotic. I am now taking both Prilosec and Zantac 150mg tablets twice a day, to manage the whatever-it-is-going-to-be-called.
Coupon Code
Reminder: For commenters on any article who do request it, the promoters of Align have given me a $5 coupon code to distribute. I’m giving it out to blog readers who write in with comments on any post, and let me know that they want the promotional coupon code.
August 16th, 2007
Posted by
tummyblogger |
Probiotics, Irritable Bowel Syndrome, IBS therapy, Align |
5 comments
Today
Today, I took the 28th Align, of the allotment for my first month on Align.
Today I was late for an appointment. I ate a hasty meal including kiwi fruit, and my ride was late, besides. I rushed into the building where we would meet,and into the slow-as-molasses elevator. As I fretted, I noticed that I expected, as all my life I have expected, that my tummy would feel knotted and painful. However fretful I felt, though, that the world wouldn’t move fast enough to take away the shame of being late, my tummy was calm and unknotted.
Tonight
Tonight a friend came over and brought fried chicken and buffalo wings. I tore the fried coating off the chicken and ate some white meat, and then ate two buffalo wings. My tummy now, as I write, is still smooth and mellow.
Tomorrow
I am not going to do either of the above tomorrow, though. Maybe have another kiwi fruit, but that’s about all.
The Past Week
As the past week began, I was still coming out of a strong GERD (reflux, heartburn) outburst, and wasn’t sure whether Align was implicated. I did start taking Prilosec OTC, as well as Ranitidine (Zantac) 150 Mg. For the past five days or so, my tummy has been calm, and I’m nearly predictable and not constipated.
The Next Not-Quite-Month
For the next 28 days I’ll take the second free sample of Align. Unless there’s a problem with C, I will not be taking any other probiotic. I will write weekly reports on how it goes.
I hope that others will comment here about their experience with probiotics or Align. In addition to the free samples for blogging about Align, I’ve been given a discount code that I’m offering to anyone who writes in with a comment, on this article, or something else on the blog, and asks for the code as part of writing in.
Let us hear from you!
August 7th, 2007
Posted by
tummyblogger |
Probiotics, IBS, Irritable Bowel Syndrome, IBS therapy, IBS Triggers, Align |
2 comments
For My Tummy’s IBS-News
If you have been checking the IBS news, on this blog you will see that the top items (in today’s news, July 31, 2007) are about Zelnorm.
FDA Approves Investigational New Drug Status for Zelnorm
The FDA has approved the very strictly controlled and limited use of Zelnorm for women (not men) under 55, who constipation which in the past responded to Zelnorm, or who haven’t tried Zelnorm but for whom other therapies have been inadequate. See the Medical News Article, (http://www.medicalnewstoday.com/articles/78120.php ).
The Marketing of Zelnorm for IBS-C
Novartis, the makers of Zelnorm, as well as other remedies, has been aggressive in defining the population it serves. They are creating a need for their product where there was no apparent need before. I think that worked for the automobile, too! (;-)) The ethical question is about creating a wide pool of people who think they have Irritable Bowel Syndrome (IBS) as the result of a television ad, and therefore need Zelnorm to treat this illness they hadn’t known they had. When does occasional constipation rise to the level of gastrointestinal disorder?
When Marketing Creates the Market
Let me quote (with permission) a good part of the article, and then give you a link to the whole thing:
Zelnorm, a drug that was approved in 2002 for short-term treatment of women with “irritable bowel syndrome” and in 2004 for chronic constipation for men and women under age 65, was withdrawn from the market in March 2007 after studies showed an increased risk of heart attacks and heart problems.
Zelnorm was also very aggressively advertised and promoted, particularly through infamous TV ads showing people with wavy lines and messages written on their stomachs. These ads, and the overall promotional campaign of which they were a part, didn’t just market Zelnorm — they also marketed “Irritable Bowel Syndrome” (IBS) as a condition, working to convince millions of viewers that they have “IBS,” rather than more conventional occasional and symptomatic digestive problems.
By the time Novartis voluntarily withdrew Zelnorm from the market in March 2007, millions of people had taken it, and certainly many who did not truly have IBS or chronic constipation. Novartis racked up $560 million in Zelnorm U.S. sales in 2006 - not technically a “blockbuster” (a term reserved for drugs with at least $1 billion in annual sales), but not too shabby either. As Ed Silverman at Pharmalot pointed out back in March:
The review showed that only 0.1 percent of 11,600 Zelnorm patients, or 13 people, experienced serious heart problems; one died. Of 7,000 placebo patients, 0.01 percent of the patients, or just one person, reported cardiovascular problems. In medical terms, the absolute risk of a serious problem was small, but the relative risk was high.
More than 2.6 million prescriptions were written for Zelnorm in 2006. If the 0.1 percent rate of patients holds true, that would mean that 2,600 of those 2.6 million had heart problems. It’s likely that, due to the aggressive advertising, a significant portion of those 2.6 million did not in fact have IBS. These patients were thus unnecessarily exposed to this heart attack risk - a risk that may be small, but even a small unnecessary risk is still unnecessary. This week, the FDA permitted Zelnorm to return to the market under a very restricted program. The FDA’s press release described it:
The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.
In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.
For this population, the benefits of Zelnorm may outweigh the risks. But the aggressive ad campaign resulted in millions of people taking it for whom the benefits most certainly did not outweigh the risks.
And therein lies one of the main problems with Direct to Consumer Advertising of drugs: Drugs that may be important for a small subset of patients are instead marketed to all consumers, causing many people who don’t need the drug to ask their doctors for prescriptions for it, and for their doctors to prescribe them. By the time side effects that only surface after the drug has been on the market for several years have finally surfaced, millions of people who didn’t need the drug have taken it, and been exposed to that unnecessary risk (not to mention expense).
Vioxx is the most famous example of this. More than 20 million people took it, despite the fact that only 1-2% were actually at risk of the ulcers and gastric complications that Vioxx was designed to prevent. Vioxx was never any better at pain relief than pennies-a-pill over-the-counter ibuprofen. Its only advantage was a (somewhat) lower risk of gastrointestinal problems. But the majority of the 20 million people who took it did so not because they had ulcers, but because they saw the ads featuring Dorothy Hammill skating again after taking Vioxx.
. . .
Comment
The author of the blogpost goes on to suggest that there be a lengthy moratorium on direct to consumer advertising (DTCA) when a new drug is introduced, to allow for a sensible time frame for doctors to learn about the new drug and who will benefit.
The author concludes that:
Delays and moratoria might reduce the number of people who are exposed to such side effects, but they don’t address the core problems of DTCA in encouraging people who don’t need expensive and potentially hazardous brand-name prescription drugs to take them. Every other country [but] the U.S. and New Zealand has concluded that advertising prescription drugs directly to the public just doesn’t make sense, and thus [doesn’t] allow them. There’s no doubt that in the more than 50 other countries where Zelnorm is or was sold but without advertising, the number of people who took it, and who had heart problems as a result, was much lower.
The Link is here: the URI written out is http://prescriptionaccess.org/blog/?p=53.
The Problem for People with Irritable Bowel Syndrome (IBS)
Many of us who have IBS take charge of our medical lives and find out what works for us. It seems to me that for society as a whole there would be a benefit in delaying the introduction of new drugs until doctors are more familiar with them. On the other hand, in the subpopulation with Irritable Bowel Syndrome (IBS), if we heard there was a new drug that the FDA had approved, and we couldn’t have because there was a moratorium, we would set the internet on fire - at least metaphorically.
The Question
So there’s a question: could you wait for a new drug to go through the limited use period when it wasn’t advertised or distributed widely? It would be much like the preliminary marketing of Align, although Align is not a drug, but a supplement that does have FDA approval. Some of us would have it, and some would not, and access would be well controlled.
Is that fair for a new drug? What do you think?
Related Posts
FDA Pulls Zelnorm
After Zelnorm
July 31st, 2007
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tummyblogger |
Medical, Probiotics, IBS, Irritable Bowel Syndrome, IBS therapy, IBS-C, Align, Digesting Information, Zelnorm |
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