By Mike Arsenault (bio below) Ten years ago my daughter Emily was born with eczema. Being an acupuncturist, I knew that using steroids on her tiny, infant body could be a very slippery slope, so I used my herbal training to make a simple herbal balm for her. It worked so well that I used […]
It’s an Itchy Little World
Tag Archives: Research
Supreme Court gene patent decision means little for eczema research
Following last week’s decision by the US Supreme Court that human genes cannot be patented, I’d say nothing has changed for eczema patients.
What I mean is that it makes little difference to eczema therapies now or in the future whether companies can obtain US patents on human genes.
I see two major issues: moral and commercial. Morally, I feel it’s a great triumph that even the famously conservative justices of the Supreme Court—who we really expected to side with big bucks, as they seem reliably to do—unanimously affirmed that nobody can own naturally-occurring human DNA. No company can own a piece of my genetic heritage.
Commercially, the issue is intellectual property. I work in biotech, and every day I hear about how it’s crucial for companies to control their IP. No investor is going to back a company that can obviously be sued in the future or that is developing a product that could instantly be copied by a competitor without penalty.
The loser in the decision was Myriad Genetics, which owned the US patent on BRCA1 and BRCA2, two human genes in which mutations increase one’s chances of getting breast cancer. (From what I can tell, Myriad had patents on the normal genes as well as common cancer-linked mutations.) Myriad had exclusive rights to DNA tests that could determine whether patients had mutations. Now many other companies are developing similar tests, and the competition will drive down the price of the tests.
That’s great if you want to get tested for breast cancer. But what does it mean for companies that are developing diagnostic tests for other conditions? These companies may abandon their efforts. Or the companies may never get started.
At least that is what one commercially-minded person whose views I respect tells me.
The Faster Cures blog, conversely, makes the point that patenting DNA could, and has, led to R&D on diseases being blocked by legal obstruction. Lilly, apparently, spent eight years fighting Harvard, MIT and others over the rights to one particular gene, NF-kB. Presumably lots of money got spent that might have gone to actual research instead of lawyers.
But for a gene patent to be useful, there must first of all be a strong link between genetics and disease. Eczema, despite being known to have a strong genetic component, has not been definitively linked to genes except in the case of filaggrin. There are a few mutations that seem to correspond to particularly severe eczema but they don’t occur in many people.
In any case, the sequence of filaggrin was made public in 2006 so the point is moot—once made public, an invention can’t be patented. (I searched the US Patent and Trademark Office database and didn’t see anything.)
Also a diagnostic test is only useful if it gives you information you can act on. There’s no point telling an adult that they have severe eczema, because they already know that. And if parents learn that their child is at risk—not guaranteed—of developing eczema, what can they do to prevent it?
Not much that I know of.
Diagnostics aside, how might a gene patent be useful?
Many drugs or biotherapies being developed affect how genes are regulated—how the process of turning their information into protein is amplified or damped. Perhaps owning a gene patent would let you control work that other people are doing to regulate that gene. We’ll never know now! What is certain, though, is that if you had a gene patent and lots of money, you could probably intimidate other companies by threatening them with expensive legal action.
I don’t think enough is known about eczema at this point that a gene patent would have been a factor. Look at the existing therapies and the few in the pipeline (such as Anacor’s). They are all either anti-inflammatories or calcineurin inhibitors. They don’t affect genes directly.
Researchers are starting to put together useful models of how itch signals get transmitted from the skin to the brain. For itch, we wouldn’t be interested in a diagnostic, but we would like to have a therapy. It’s conceivable that one or two genes may turn out to be key, and we might want drugs to regulate them. But gene patents would not be necessary for scientists or companies to do that work.
In short: last week’s Supreme Court decision, while morally important and laudable, will have little effect on the field of eczema research and therapy.
End Eczema
Three years in: what has the $42M Atopic Dermatitis Research Network produced?
In July it will be three years since the NIH awarded National Jewish Health in Denver, CO $ 31 million to create and administer the Atopic Dermatitis Research Network, a consortium of five academic sites across the US. A contractor, Rho Federal Systems of Chapel Hill, NC, won an $ 11 million contract to operate a center to coordinate statistics and clinical trials for the project.
That makes $ 42 million—spread over five years—which puts the project on the large end of NIH funding for individual biomedical efforts. The typical NIH research grant ranges from $ 100 thousand to $ 2 million, and anything bigger is fodder for university news releases. Which raises the question: what have US taxpayers gotten in return?
I ask this as a patient who is grateful that these scientists are working to understand a disease that affects me, my family, and millions in the US and worldwide.
The answer is not obvious, since the publications page on the ADRN website hasn’t been updated since July 2011.
According to the website:
The Atopic Dermatitis Research Network (ADRN) is a consortium of academic medical centers that will conduct clinical research studies in an attempt to learn more about skin infections associated with atopic dermatitis (AD). The studies will focus on antibiotic-resistant Staphylococcus aureus infections and widespread viral infections of the skin, both of which are more prevalent among AD patients. The ADRN will build on the work of the Atopic Dermatitis and Vaccinia Network (ADVN) which conducted clinical studies focused on making smallpox vaccinations safer for people with AD.
This research will lead to a greater understanding of the immune system in AD patients and may lead to novel therapeutic strategies to manage or prevent infectious complications associated with this disease.
The ADRN will conduct a number of clinical studies over the next five years and will be enrolling large numbers of people with AD.
A search on clinicaltrials.gov returns two entries for the ADRN: one (open) to create a database of patients for the study of genetic markers connected to susceptibility to infections, and one (completed) to look into how AD patients respond to a new flu vaccine.
The ADRN’s NIH contract number is HHSN272201000020C. A search in the NIH’s PubMed database returns 12 papers that acknowledge funding by that contract number. Three of those are review papers (which did not involve new research).
So that makes two clinical trials and nine research papers, three years into a five-year $ 42 million project.
Should US taxpayers expect more; be satisfied; or be impressed?
The answer is probably that we will have to wait to find out.
In each year, a typical top university research lab operates on about $ 2-3M a year and publishes somewhere around ten papers. That’s roughly $ 200k a paper.
Three of the five years in the ADRN contract are up; three-fifths of $ 42M is around $ 24M. We might therefore naively estimate that we should have seen upwards of 100 papers produced so far.
Most likely the reasons there are only 12 at the moment are that you don’t start publishing papers right at the outset of a project. The research must be done first and then written up; and the process of getting accepted to a journal takes months. And the ADRN appears largely to rely on clinical trials–which take time to set up.
So why do we only see two trials listed on clinicaltrials.gov?
I’ve never had anything to do with a clinical trial, but when I was a researcher, I conducted animal experiments, and there were formidable administrative hurdles to get over before I could start work. I imagine that trials with human subjects are heavily regulated by the government, and for good reason. So the apparently small output of the ADRN to date is, I’m guessing, because it takes a long time to plan trials, get approval, and conduct them, before you can begin analyzing data and reporting it.
Still, let’s keep in mind that the ADRN is an extension of the ADVN. It’s not like the ADRN began from scratch—the scientists had the momentum of existing expertise and administration and research aims.
Looking at the titles of the published papers, I can’t immediately judge which are the most important. So I emailed Donald Leung, the principal investigator for the ADRN (he’s a professor and head of the Division of Pediatric Allergy and Immunology at National Jewish Health), and asked him whether he could summarize the consortium’s findings so far and highlight key points. I hope to hear back from him soon and perhaps to interview him on the phone.
I’d like to know what ADRN scientists have found that surprises them. What have they learned that is truly new?
And what is going to be truly useful to patients in the end? Publishing papers should not be the be-all and end-all of scientific research. What about patents? I’d like to know whether anyone in the ADRN has thought about controlling intellectual property and commercialization. While it’s true that clinical studies may highlight the ideal dosing amount or schedule for existing therapies, and this does not involve creating a new commercial enterprise, most medical technology must pass through the marketplace before it can benefit the consumer/patient.
Someone has to do the dirty work of developing scientific discovery into therapy, and it’s not academic scientists.
More to come.
End Eczema
Fishy research for eczema sufferers
Eating fish has long been associated with healthy skin but is fish good for eczema? Researchers from Sweden found that the early introduction of fish into a child’s diet reduces the risk of eczema and asthma.
How soon can you introduce fish into a child’s diet?
Norwegian researchers found that frequent fish consumption before age 1 is associated with a reduced risk of allergic disease for toddlers. In this study, the average age infants began eating fish was 9 months of age (another study suggested 8 months of age was ideal and it reduced the risk of allergy). The Norwegian researchers concluded that fish consumption in infancy was more important than maternal fish intake during pregnancy in preventing childhood eczema.
Eczema Diet readers: check out pages 78 to 80 for safe seafood and fish to avoid.
You can read more on the eczema fish studies here:
http://jech.bmj.com/content/64/2/124.short
http://onlinelibrary.wiley.com/doi/10.1111/j.1398-9995.2006.01115.x/full
http://www.ncbi.nlm.nih.gov/pubmed/20670305
FYI: Keep in mind that fish allergy is possible so avoid fish if your child is allergic to fish or seafood.
New NEA post: Atopic Dermatitis Research Network needs trial participants
This week you’ll find me blogging over at the National Eczema Association website. I interviewed Donald Leung of National Jewish Health about the Atopic Dermatitis Research Network. Three years in to a $ 42M program to investigate the links between genetics and our susceptibility to skin infections, the ADRN is registering patients with the NIH before proceeding with clinical trials.
They still need black and Hispanic patients to sign up–eczema, genetics, and skin pathogens are different for different ethnic groups. The better your demographic is represented in the trials, the more that scientists will learn that applies to you.
The ADRN has centers in Boston, Chicago, Denver, Los Angeles, Portland OR, and Rochester NY.
If you’re interested in participating, email Judy Lairsmith at National Jewish or call 1-888-413-5852.
End Eczema
Natural Remedies For Eczema – You Still Need to Research Them
Natural remedies for eczema – there are many available, including natural oils and herbs. Eczema is really hard to deal with – the itch – it can actually take over your whole life. It can really over-shadow things. Anyone who has eczema will know that the prescribed medication is steroid cream. There are drawbacks to using steroid cream which you may have experienced or have discovered. A major drawback is that steroid cream can actually thin the skin. Another drawback is that it does not work! It covers the problem – it creates a film over the top of the eczema. You will notice if you use steroid cream that as soon as you stop the eczema actually comes back worse than before you started.
When searching for natural remedies for eczema unfortunately you will still have to look into the product. You need to still check the ingredients. I realised this on my searches. I was constantly on the internet looking for an eczema natural cure. Within my hours spent, I came across one that claimed to be natural – the results looked great and so did the testimonials. Then I scrolled down to the ingredients and sure enough it had Hydrocortisone in it.
Different people experience eczema in different forms, such as, cracked skin, tiny bumps, inflamed or weeping. Whichever of these relates to your eczema I know that night time sleeping will be unbearable for you. If you have a young child with eczema the fact they are not a good nights sleep can actually make the whole thing worse.
Eczema is particularly hard to cope with in young children and unfortunately that is where it usually begins – in children under 5. I have had first hand experience with this. My sons eczema began on his first Christmas. The time we spent trying to rid him of eczema after this was not a pleasant journey and one that I would not wish on any parent.
For more information on eczema and to see how our eczema nightmare came to an end visit my blog or Squidoo.
For more information on eczema and to see how our eczema nightmare came to an end for us visit my eczema natural remedies blog or my eczema Squidoo lens