Re: [GRG] 23andMe ordered to stop selling saliva collection kit – White House Petititon

Brody,

I largely agree with your assessment, except for the intolerance for erroneous information. In this case and others like it, the need outweighs the risks such that any data is likely to be better than none. Unfortunately misinformation in healthcare is just part of the game. This at least begins to give everyone the chance to focus on more relevant things than the Obamacare website or some other hokum cooked up to distract us from the economy, such as your individual genetic material, what it says to a first order approximation, what you can do with it  (put it on the Personal Genome Project), and what you can do about it–take responsibility for your healthcare in a way that nobody else will.

If the FDA were to air a technical concern publicly, such as the test run once instead of triplicate as opposed to explaining in verbose detail that this is their jurisdiction and they are the authority on the matter, I might be tempted to listen. But for the time being, all I have heard is the legal posturing which I could personally care less about.

Show me the data (or lack thereof). To that end at least, I hope we can all agree. =)

Cheers,

Joe

On Tue, Nov 26, 2013 at 2:58 PM, Brody Holohan wrote:

  Not to rain on the FDA hate parade too much here, but I think the point is that the FDA has been abundantly clear to the company about the regulatory requirements, and that the recent decision was a result of the company ignoring them, not a blanket condemnation of personalized genetics.  The fact that they have been working with 23andme since 2009, during which the company has been marketing and selling its test, just underscores how lenient the FDA has been.  It’s the FDA putting its foot down and insisting that the company acknowledge that we demand evidence-based medicine in this country, and you can’t just ignore health standards and get away with it.
  The other thing is that this test comes with a message– it comes with canned analysis that puts things in a medical/therapeutic context.  I don’t think the FDA would have a problem with the test if, instead of saying things like “your genome increases your risk for Celiac disease, talk to your doctor about gluten sensitivity”, it told you what alleles you had and linked to relevant scientific literature (or even summarized it) and didn’t say a word about things you should do with your doctor.  Then it should be regulated more like a scale or a blood pressure cuff– you just have to demonstrate that it’s accurate and using it isn’t harmful.  When you start talking about things to do based on that information, you’ve entered different regulatory territory, which comes with things like false positive rates, multiple testing corrections, prospective clinical trials, etc.  It’s worth mentioning that any assay worth it’s salt should have gone through those quality control steps before it entered the market, or even hit the published literature, because they’re the sort of thing usually addressed in peer review if they’re missing (and if the lab in question is halfway competent, they should have been addressed prior to submission, as part of the “not fooling yourself” component of research).  Skipping those quality control steps smacks of amateurism or undue haste.
  It’s also worth mentioning that, at least in academic labs, array-based, high-throughput information isn’t taken at face value.  If I were to screen cell lines for a specific allele with a SNP array (and the 23andme assay is a SNP array), for example, and I found one line that had the trait I was looking for, I would be a fool to go ahead with the experiment without verifying the result by PCR or a western blot first, because arrays are notoriously prone to false positives and negatives.  The fact that the 23andme system goes ahead with medical analysis based on what is probably a single run of a SNP array (they don’t mention if they run it in triplicate, which is a bare minimum in a lab setting) is a bit disturbing.  The chip they use can handle 24 samples per run, and chip cost is hard to estimate (it will vary depending on how well they negotiated with Illumina), but an academic lab doing lots of arrays could expect chip costs in the neighborhood of a couple hundred dollars per chip, and it is typically more expensive for commercial entities, so I doubt they are running things multiple times.  That may be the main point the FDA is trying to make, that the company is doing too much analysis off of too little information.
  Many of these alleles have only been looked at individually, not in the context of a known genetic background, and so it actually is an open question as to what it means when you take relative risk numbers derived from population studies and apply them to single individuals.  Applying that sort of data to individuals is something that requires science, and it’s a cheap shortcut to try and sell a product without doing that science.  Yes, sometimes the regulatory system slows down medical applications’ journey to market.  However, it also stops a heck of a lot of BS from harming patients, stops fad treatments from going mainstream, and increases the quality of the science we do before things hit the market; the FDA isn’t perfect, but it’s better than nothing.
Brody Holohan

About Johnny Adams

My full-time commitment is to slow and ultimately reverse biological aging and age related decline for more years of healthy living. I’ve been active in this area since the 1970s, steadily building skills and accomplishments. I have a good basic understanding of the science of aging, and have many skills that complement those of scientists so they can focus on science to advance our shared mission. Broad experience Top skills: administration, management, information technology (data and programming), communications, writing, marketing, market research and analysis, public speaking, forging ethical win-win outcomes among stakeholders (i.e. high level "selling"). Knowledge in grant writing, fundraising, finance. Like most skilled professionals, I’m best described as a guy who defines an end point, then figures out how to get there. I enjoy the conception, design, execution and successful completion of a grand plan. Executive Director Gerontology Research Group (GRG). Manages Email discussion forum, web site, meetings and oversees supercentenarian (oldest humans, 110+ years) research. CEO / Executive Director Aging Intervention Foundation (dba for Carl I. Bourhenne Medical Research Foundation), an IRS approved 501(c)(3) nonprofit. http://www.AgingIntervention.org Early contributor to Supercentenarian Research Foundation. Co-Founder Geroscience Healthspan Forum. Active contributor to numerous initiatives to increase healthy years of life. Co-authored book on conventional, practical methods available today to slow the processes of aging – nutrition, exercise, behavior modification and motivation, stress reduction, proper supplementation, damage caused by improper programs, risk reduction and others. Fundamental understanding of, and experience in the genomics of longevity (internship analyzing and curating longevity gene papers). Biological and technical includes information technology, software development and computer programming, bioinformatics and protein informatics, online education, training programs, regulatory, clinical trials software, medical devices (CAT scanners and related), hospital electrical equipment testing program. Interpersonal skills – good communication, honest, well liked, works well in teams or alone. Real world experience collaborating in interdisciplinary teams in fast paced organizations. Uses technology to advance our shared mission. Education: MBA 1985 University of Southern California -- Deans List, Albert Quon Community Service Award (for volunteering with the American Longevity Association and helping an elderly lady every other week), George S. May Scholarship, CA State Fellowship. BA psychology, psychobiology emphasis 1983 California State University Fullerton Physiological courses as well as core courses (developmental, abnormal etc). UCLA Psychobiology 1978, one brief but fast moving and fulfilling quarter. Main interest was the electrochemical basis of consciousness. Also seminars at the NeuroPsychiatric Institute. Other: Ongoing conferences, meetings and continuing education. Aging, computer software and information technology. Some molecular biology, biotech, bio and protein informatics, computer aided drug design, clinical medical devices, electronics, HIPAA, fundraising through the Assoc. of Fundraising Professionals. Previous careers include: Marketing Increasing skill set and successes in virtually all phases, with valuable experience in locating people and companies with the greatest need and interest in a product or service, and sitting across the table with decision makers and working out agreements favorable to all. Information Technology: Management, data analysis and programming in commercial and clinical trials systems, and bioinformatics and protein informatics. As IT Director at Newport Beach, CA based technology organization Success Family of Continuing Education Companies, provided online software solutions for insurance and financial professionals in small to Fortune 500 size companies. We were successful with lean team organization (the slower moving competition was unable to create similar software systems). Medical devices: At Omnimedical in Paramount CA developed and managed quality assurance dept. and training depts. for engineers, physicians and technicians. Designed hospital equipment testing program for hospital services division. In my early 20’s I was a musician, and studied psychology and music. Interned with the intention of becoming a music therapist. These experiences helped develop valuable skills used today to advance our shared mission of creating aging solutions.
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