Mention celiac disease these days and lots of industry people get dollar signs in their eyes. As we have long hoped they would, food manufacturers are finally starting to realize the potential of the gluten-free market. (There was an interesting article on this topic in The Wall Street Journal a few days ago: For General Mills, Wheat-Free Items Are Tricky to Make, Cheap to Market.)

But did you realize that the pharmaceutical industry has its hungry eyes trained on celiac disease patients, too? For $3,800, drug company executives can buy a market research report from DataMonitor that summarizes their potential opportunities in the celiac disease market. Some of the highlights are available for free:

• Celiac disease medications will be available sometime within the next 5 years, and drug sales could reach $8 billion by 2019.
• Continued efforts to increase awareness, especially once a drug comes to market, will drive celiac disease diagnosis rates up to 50%-60% by 2019, which will expand the overall patient population.
• Right now, most of the research and development is being done by small companies backed by venture capital, but there are big licensing opportunities available for larger companies.

Also according to the this report, among the drugs that are farthest along in the “research pipeline” (i.e., the research process) are:

• AT-1001 (larazotide acetate), being developed by Alba Therapeutics.
  Alba values its drug’s US market value at over half a billion dollars. Shire Pharmaceuticals Group has agreed to pay Alba $325 million for worldwide rights for all potential uses, except in the U.S. and Japan. (From the Shire press release about the agreement: “Should the product reach blockbuster status, Shire will also pay royalties on net sales of the product, with tiered, single or double digit royalty rates.”)
• CCX-282, being developed by ChemoCentryx.
  GlaxoSmithKline has bought an option to sell this drug (and other drugs being developed by ChemoCentryx) worldwide.

I have very mixed feelings about all this. On one hand, I personally would rather follow a gluten-free diet and not have to take any medications. On the other hand, I know that some people have a lot of trouble staying gluten-free. Furthermore, gluten-free food costs so much more than “regular” food, and these medicines might make it possible for people to eat regular, cheaper food. Isn’t it a shame, though, that insurance companies (and taxpayers) in the United States will probably pay for these medications but are unwilling to reimburse for the extra costs of gluten-free food? (It shouldn’t surprise you to know that something I wrote on this topic a while back generated some controversy.)

What’s your opinion?

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This past week, Mayo Clinic researchers reported that the prevalence of celiac disease has been increasing significantly over the past 50 years. (I posted information on the Mayo Clinic study a few days ago.) Theirs wasn’t the only announcement last week about the prevalence of celiac disease, however. In Finland, Dr. Pekka Collin of the University of Tampere and colleagues have discovered that there’s also an increasing prevalence of celiac disease in elderly patients. Their report was published online June 29 in BMC Gastroenterology.

In 2002, the Finnish research team studied nearly 3000 randomly selected individuals over the age of 50 to see how many of them had celiac disease. The prevalence of celiac disease turned out to be 2.45%. Three years later, the researchers re-studied roughly two-thirds of that same group of people and discovered that “the frequency of celiac disease was indeed increasing” among these older people. Five new cases had developed since the start of the study in 2002, increasing the prevalence in this population to 2.70% in 2005.

“Undiagnosed celiac disease may generate significant problems in the elderly,” the researchers warn. Also, they caution that a single negative blood test result does not mean celiac disease will never develop – “the disease may also appear later in life.”

To learn more about celiac disease in older individuals, read Celiac Disease in the Elderly.

_Source:

Vilppula A et al. Increasing prevalence and high incidence of celiac disease in elderly people: a population-based study. BMC Gastroenterology 2009;9:49

Read about other recent advances in celiac disease research.

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The prevalence of celiac disease has been rising – it’s 4 times more common now than in the 1950’s – and researchers at the Mayo Clinic in Rochester, Minnesota suspect the rise is due to an environmental factor, such as “a change in quantity, quality, or processing of cereal.”

In an article in the July issue of the medical journal Gastroenterology, Dr. Alberto Rubio-Tapia and his colleagues describe a research study in which they analyzed blood samples from three distinct groups:

• Group 1: 9133 healthy young adults who gave blood samples between 1948 and 1954 (these blood samples had been frozen and were still available for analysis)
• Group 2: 5558 present-day elderly residents of Minnesota who were born in the same years as the volunteers in Group 1
• Group 3: 7210 present-day Minnesota residents who are the same age now as Group 1 subjects were when they gave blood samples in 1948-1954.

Using modern tests to detect celiac disease autoantibodies (tissue transglutaminase and endomyseal antibodies), the researchers found that 14, or 0.2%, of the subjects in Group 1 (who had given blood roughly 60 years ago) had undiagnosed celiac disease. When they compared the older samples with the recently obtained samples, they discovered that the rate of undiagnosed celiac disease was 4.0 times higher in modern-day Group 2 (46 elderly people, or 0.8%) and 4.5 times higher in modern-day Group 3 (68 young adults, or 0.9%).

In other words, “the prevalence of celiac disease has dramatically increased more than four-fold in the United States during the past 50 years,” the researchers said. Similar increases have been reported in Europe, they added.

Dr. Rubio-Tapia’s team also compared survival rates in the 1948-1954 study participants with and without undiagnosed celiac disease. During the 45 years after the blood samples were collected, the risk of death was four times higher for people with undiagnosed celiac disease.

In a press release issued by the Mayo Clinic, Dr. Rubio-Tapia’s colleague Dr. Joseph Murray commented, “Some studies have suggested that for every person who has been diagnosed with celiac disease, there are likely 30 more who have it but are not diagnosed. And given the nearly quadrupled mortality risk for silent celiac disease we have shown in our study, getting more patients and health professionals to consider the possibility of celiac disease is important.”

“Moreover,” the research team concludes, “our finding that the prevalence of celiac disease seems to have increased dramatically during the past 50 years suggests that celiac disease is emerging as a substantial public health concern in the United States.”

Special note: On the Mayo Clinic website, you can watch a video of Dr. Murray explaining the research.

_Source:

Rubio-Tapia A et al. Increased prevalence and mortality in undiagnosed celiac disease. Gastroenterology 2009;137:88-93.

Correction (July 6, 2009): The original version of this blog post had the results in groups 2 and 3 reversed. The text as it appears now is correct.

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You can now use a saliva sample to find out whether you have the genes for celiac disease. Yesterday, Prometheus Laboratories, Inc. began selling MyCeliacID, which the company says is the first saliva-based genetic test for celiac disease. Until now, genetic tests for celiac disease required blood samples or cheek swabs. According to Prometheus, saliva-based genetic testing provides more DNA for evaluation, and samples are less likely to get contaminated in the process of collection.

The test can be ordered online at www.MyCeliacID.com. After you make the request online, a licensed physician reviews and places the order in accordance with state and federal law. The company then sends you a tube in which you collect some saliva. When you return the tube to them (shipping is prepaid), they analyze your saliva for the presence of the HLA-DQ2 and HLADQ8 genes (both alpha and beta subunits), and the physician reviews and releases the result. You’ll be notified by email (usually within 7 days, according to their site), and you can access your test results online via a secure link. You’ll have a chance to make an appointment with a genetic counsellor if you wish.

As of now, MyCeliacID is available only to residents of the U.S. (except New York), Canada and Mexico. Residents of New York (and everyone else) can still arrange for celiac gene tests using blood samples or cheek swabs through Kimball Genetics.

Remember: Genetic tests do not diagnose celiac disease. As I’ve explained in Genetic Testing for Celiac Disease, in general there are two possible outcomes of testing for celiac disease genes:

• You don’t have the genes. This means you are very, very unlikely to ever develop celiac disease.
• You do have the genes. This doesn’t mean you have celiac disease. It means there’s a chance you might develop celiac disease at some point in your life, or you might not. If you do have the genes, you should definitely share the results with your doctor so you can be monitored.

MyCeliacID costs $329. Your insurance company will probably not reimburse you for it.

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