Saturday, April 20, 2013

Food Additive, Carrageenan, May Be Linked To Gastrointestinal Problems - RT Please


Carrageenan?  I've never heard of it.  Just something else to look out for in the ingredients.  
Doubts surface about common food additive's safety

CHICAGO — Sara Baker says the light went on in her head after a cup of hot cocoa set off a storm in her stomach.
"I went back and looked at the package and there it was: carrageenan," said Baker, a career services coordinator from Bloomington in central Illinois.
Baker been taking medication for ulcerative colitis for years but still suffered debilitating digestive flare-ups without warning. She had read warnings about carrageenan in a natural health newsletter but didn't take them seriously.
This time, though, "it really clicked," she said of the ingredient, which researchers say has not been conclusively linked to gastrointestinal problems in humans. "It took awhile to learn just how many things it's in, but now that know, I can avoid it and I no longer have the problems."
Experiences like Baker's have led some people with gastrointestinal problems to sidestep mainstream medical advice and avoid carrageenan, a seaweed-derived texturizer found in meat, dairy and other processed foods — including some organic products.
For scientists, however, these are just anecdotes. Though studies on lab animals and human cells have suggested that carrageenan can cause gastrointestinal inflammation, many researchers and physicians say it's unclear whether it has the same impact on people who consume it.
Scientists at the University of Illinois at Chicago and University of Chicago are seeking to address that question with a controlled clinical trial that Baker is participating in.
"I believe it's worth investigating and doing the science to find out," said Dr. Stephen Hanauer, a medical professor and chief of gastroenterology and nutrition at University of Chicago Medicine.
His co-researcher, UIC physician and professor Joanne Tobacman, has been looking at the health effects of carrageenan for more than a decade and is concerned enough to have petitioned the U.S. Food and Drug Administration in 2008 to prohibit the use of carrageenan in food.
Her petition cited decades of science, including her own, on carrageenan-induced inflammation in animals and cells. In June, the FDA responded with a letter of denial.
"It was disappointing that with such clear evidence about the effects of carrageenan on inflammation, the FDA did not restrict the use of carrageenan, particularly in infant formula," Tobacman said.
The additive, which lends a uniform, creamy texture to food, can be found in soy milk, yogurt, ice cream, cheeses, some meats, diet soft drinks and even toothpaste.
Michael Adams, deputy director of the FDA's Office of Food Additive Safety, said the petition did not make a compelling case to re-examine the safety of carrageenan. "It has been reviewed repeatedly by FDA scientists and other international organizations, and in the judgment of those experts there hasn't been a problem," he said.
Adams called a rat study from 2006 "the gold standard for us because it exactly mimics the exposure consumers are going to get when they eat these carrageenan-containing foods."
That study was funded and performed by a manufacturer of carrageenan.
Adams said he didn't know that but added: "If you look at the science and you believe it's well done it doesn't matter where the money comes from."
The Cornucopia Institute, a Wisconsin-based organic industry watchdog group, on released a report on carrageenan called "How a Natural Food Additive Is Making Us Sick."
Charlotte Vallaeys, Cornucopia's director of food policy, said the group felt "an ethical obligation" to raise awareness. "If government agencies weren't going to protect consumers, then it seemed we needed to let consumers know about this so they could protect themselves."
The institute also is challenging the FDA's denial of Tobacman's petition. Among other objections, Cornucopia's letter to the agency asks why officials did not consider any studies on carrageenan published in the last four years.
Adams said the FDA's scientific evaluation in response to the petition was finished in May 2009, after which it spent more than three years in what he calls the "administrative chain."
Regarding infant formula, Adams said Europe takes a different approach to food additives than the U.S., sometimes banning a substance when toxicity studies raise concerns but are not conclusive.
"The Europeans do their business that way but we don't," he said. "We would base it more on the science we have rather than waiting for science to be developed."
While the Chicago researchers proceed with their work and advocates seek federal action, some consumers and activists have made an impact on their own by lobbying manufacturers directly to phase out the ingredient.
Last month Stonyfield joined a number of manufacturers who have removed or have pledged to remove carrageenan from their organic products. Organic Valley says it has removed the ingredient from most food items but is still working on reformulations for soy milk, chocolate milk and one version of its whipping cream.
A representative of the organic dairy company Horizon Organic and soy milk maker Silk (each majority owned by Dean Foods) said both view carrageenan as safe and would not comment on any plans to remove it.
The U.S. National Organic Standards Board reapproved the use of carrageenan in most organic foods last year but decided to prohibit its use in organic infant formula. (WHAT????
Carrageenan manufacturers, the FDA, the United Nations food additives committee and some scientists say it is safe, as evidenced by centuries of use.
Still, many gastroenterologists are not convinced carrageenan is dangerous.
"There are some studies in rats and mice showing that carrageenan exposure can lead to GI inflammation that mimics things like Crohn's" disease, said Dr. Sunanda Kane, a Mayo Clinic physician and medical adviser to the Crohn's and Colitis Foundation of America. "But it's never been shown on human tissue in humans walking around."
Over the last 50 years, incidence of inflammatory bowel disease has risen as people eat more processed food, Kane said. "But is it carrageenan or that we don't exercise or have lots of other additives and preservatives or fructose in our food supply?"
In Hanauer and Tobacman's study, people whose ulcerative colitis is in remission are being put on a carrageenan-free diet, then given either a controlled dose of carrageenan or a placebo.
So far, the research has been hampered by low volunteer rates — currently, fewer than 20 subjects. Hanauer notes that the prospect of re-inflaming one's inactive ulcerative colitis is not particularly attractive.
But Baker, who was one of more than 120 people who responded when Cornucopia asked to hear from those with carrageenan-related digestive problems, said she was willing to go through it to help establish human science on the topic.
"I believe there are people who are as sick as I was, or even worse, who need this information," she said.

Doubts surface about common food additive's safety | SouthCoastToday.com:

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Friday, April 19, 2013

Patient Taking Adalimumab (Humira) - Questioning Why Makers of The Drug Are Preventing Disclosure of Trial Data.

......He isn't the only one wondering what in the hell is up AbbVie's sleeve.  

I don't even take the drug, I never will, but what's the deal with withholding data like this.  Let's see it, AbbVie!  Shouldn't trial information be available to the general public in order for people to make informed decisions regarding the best treatment choice? How can people do that, when the information isn't there!?  
I visualize a bunch of robots.. The robots are the patients, they take what they are given and do as they are told.  God forbid people ask questions and want the answers and demand them.  People have the right to know this information... right?  For the people that take this stuff, they put the chemical into their body everyday and they aren't allowed to know everything there is to know about the stuff?  That just doesn't sit well with me and it shouldn't sit well with you either.  
It's sketchy.. The whole drug/medicine/medical industry can't be trusted.  They really are starting to show their faces by trying to put a curtain in front of them.  When people are told "No" to something that is usually otherwise available, it just holds a red flag to it and makes people wonder things, speculate what the reasons may be for withholding.  AbbVie is making it quite clear that they have something to hide.  Logically, what reason would they have for wanting to hold back trial data... unless the data shows something that could result in an unfavorable response.  It might make people requestion if Humira is for them or not.  Now if the data were positive, wouldn't the company want to display it for the world to see?  It would lead to more sales and continued use of the treatment.
Let's face it, your doctor isn't running down the whole list of possibly negative consequences of taking the drug before you start it.  He/she just isn't and that's that. They shine a positive outlook on the drug because they want you to take it.  In addition, THEY don't even know the ins and outs of the drug.  That's really our job and our responsibility as patients to do our homework.  Some people do their research and some  people don't, but for the ones who do, not having this information easily available or just not showing "all" of the information is just giving people a false/skewed view of what the drug really is.  
Not cool!


A patient with Crohn's disease is concerned about the attempt by the makers of adalimumab to prevent disclosure of trial data submitted during the drug's approval process, according to a personal view piece published online April 16 in BMJ.
THURSDAY, April 18 (HealthDay News) -- A patient with Crohn's disease is concerned about the attempt by the makers of adalimumab to prevent disclosure of trial data submitted during the drug's approval process, according to a personal view piece published online April 16 in BMJ.
Alex Lomas, a patient with Crohn's disease from London who has been taking adalimumab for three years with beneficial results discusses the lack of trial data available on biologicals.
Noting that part of the National Institute for Health and Care Excellence's approval for use of adalimumab for Crohn's disease was the recommendation to set up a registry to track long-term outcomes and relapse rates after treatment withdrawal, Lomas reports that registries are fragmented or are still at pilot stage. He adds that the attempt by AbbVie, the maker of adalimumab, to prevent the European Medicines Agency from disclosing recent trial data submitted during the drug's approval process is cause for concern and is preventing patients and health care providers from making informed decisions about the use of this treatment.
"As the drug industry and medical profession as a whole move towards the registration of all trials, and the publication of all trial data -- in no small way thanks to the All Trials initiative (www.alltrials.net) -- this decision by AbbVie is a backwards step and is offensive to trial participants, patients, and the wider public who ultimately pick up the tab," Lomas writes.

Health News Copyright © 2013 HealthDay. All rights reserved.

The patient Alex Lomas is taking a biological drug for Crohn’s disease, and he wants to know why the maker is trying to prevent disclosure of trial data that may well affect him
I have an obsession with data. I have instruments in my house so I know how hot each room is and to warn me if the fridge door has been open for too long. I record my weight and blood pressure using devices connected to the internet so that I can monitor long term trends. I use my smartphone to track how much walking and exercise I do.
I was diagnosed with Crohn’s disease about 20 years ago, when awareness of inflammatory bowel diseases was not as high as it is today.1 The treatment decisions made at the time of my diagnosis had unfortunate side effects for me as a teenager. High doses of prednisolone led to Cushing’s syndrome, and I was mercilessly teased about my appearance at school. With time came a reduction in the dose of steroids required, but I had to take them throughout my 20s, and control of my symptoms was still inadequate.
As a patient with Crohn’s disease, I take an active interest in my day-to-day health, but I also routinely scan news media and journal sites for new treatments and for changes to current best practice in the management of my condition. I often arrive at appointments with my consultant armed with PDFs printed from the BMJ, the Cochrane Collaboration, and the National Institute for Health and Care Excellence (NICE) to discuss the latest trials and treatment options. Yes, I’m afraid I’m one of those patients.
Three years ago my consultant suggested a new course of treatment with adalimumab (Humira), an anti-TNF╬▒ monoclonal antibody. My local primary care trust approved this new drug, which costs £352 per injection, and which I administer myself by injection each fortnight.2 Since I started taking adalimumab I have the least symptoms since diagnosis. I am no longer taking steroids; I have started to recover from 15 years of side effects; and I spend less time in clinical care and off work on sick leave.
However, anecdotes are not the foundation of evidence based medicine, and nor are they a rational basis for evaluating the cost of a treatment. On 1 April 2013 responsibility for commissioning transferred from my primary care trust to the local clinical commissioning group, bringing into sharp focus the question of whether the NHS is getting value for money in continuing my treatment.
Equally importantly, I want to be able to evaluate the benefits and risks of these costly pharmaceuticals with which I inject myself regularly. Biologicals are relatively new, and have failed spectacularly in clinical trials.3 Who knows what 20 or 30 years of data from clinical use might bring? The most recent Cochrane review of biologicals looked at nine studies, and, although it found that they were effective, it noted that none of the trials allowed for an assessment of long term adverse events nor had any trials been undertaken that compared efficacy among the available biologicals.4 My consultant recently told me that no trials had been done to determine what the minimum effective dose of adalimumab was, nor would there likely ever be; a drug company has no interest in showing you can take less of something.
Part of NICE’s approval for the use of adalimumab in treating Crohn’s disease was the recommendation that a register of patients being treated with biologicals be set up to track long term outcomes and relapse rates after withdrawal of treatment, something patient groups welcomed.5 Unfortunately it seems that such registers are fragmented, with registers of patients with rheumatoid arthritis held independently from registers of patients with inflammatory bowel disease, or are still at pilot stage.6
As a patient, I need clinicians to interpret trial data and systematic reviews of new and existing treatments so we can come to appropriate decisions about my treatment, but what if even experts don’t get to see the whole picture? How can we even know what trials are being run?
I was therefore dismayed to learn that Abbvie, the maker of adalimumab, are seeking a legal injunction to prevent the European Medicines Agency from disclosing trial data submitted during the drug’s approval process.7 With such a new drug, it is vital that all data, whether it’s good news or bad, are made available so that I, my consultant, and the care commissioning group can make informed decisions about the efficacy and cost effectiveness of treatments.
As the drug industry and medical profession as a whole move towards the registration of all trials, and the publication of all trial data—in no small way thanks to the All Trials initiative (www.alltrials.net)—this decision by Abbvie is a backwards step and is offensive to trial participants, patients, and the wider public who ultimately pick up the tab.

Notes

Cite this as: BMJ 2013;346:f2336

Footnotes

  • Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.
  • Provenance and peer review: Not commissioned; not externally peer reviewed.

References



I’m a patient: show me the trial data | BMJ:

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