Google-backed genetic-testing firm ordered by FDA to freeze sales
By Toni Clarke and Sharon Begley REUTERS
The Food and Drug Administration has warned 23andMe, a company backed by Google Inc., to halt sales of its genetic tests because they have not received regulatory clearance.
23andMe, which was founded in 2006 by Anne Wojcicki, sells a $99 DNA test that the company says can detect a range of genetic variants and provide information about a person’s health risks. Wojcicki recently separated from her husband, Sergey Brin, co-founder of Google.
- In a warning letter dated Nov. 22 and released yesterday, the agency said products that are designed to diagnose, mitigate or prevent disease are medical devices that require regulatory clearance or approval, “as FDA has explained to you on numerous occasions.”
The privately held, Mountain View, Calif.-based company acknowledged receipt of the letter and said in a statement, “We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission.”
- The agency said some of the intended uses of the company’s Saliva Collection Kit and Personal Genome Service are particularly concerning, including risk assessments for certain cancers.
The agency said false positive tests for certain breast or ovarian cancers could lead a patient to undergo preventive surgery including mastectomy, intensive screening or other potentially risky procedures. A false negative could result in a failure to recognize and act on an actual risk.
- 23andMe will not be able to sell its tests for medical purposes until it submits the necessary data.
The FDA has not cleared any genetic tests that are offered directly to consumers.
Kathy Hudson, deputy director for science, outreach and policy at the National Institutes of Health, said the FDA’s action clarifies its expectations for direct-to-consumer genetic testing.
“NIH believes genetic information has a great potential to improve human health, but there needs to be reliable,validated tests,” she said.
One concern is that the results of genetics research, especially linking a DNA variant to the risk of a particular disease, might apply to some ethnic groups but not to others. As a result, a consumer might think she has an elevated risk of some illness when in fact she does not.”
Science is something I deeply appreciate; greatly dislike the “ostrich effect” which can be seen as disregarding ‘what is’ or science. Especially irritated when the Corporate complex selects or isolates certain aspects of an item or product and distorts through magnification or avoidance for the purpose of enhancing sales. One wonders why this so often happens. Could it be because of insatiable greed and disregard for the common good? It seems this kind of thinking flows fluidly from the capitalistic desire to enhance the bottom line.
So this is the basis from which I posit that services such as 23 and Me should have strong oversight or regulation because of the issues of ‘certainty’ surrounding a worried, stressed population where in longevity is seriously threatened by obvious medical forecasts which suggest dire odds against one’s chances for good health and freedom from early demise from such as cancer and heart disease, and so on.
Many prominent, beautiful, healthy women of late have ‘chosen’ preemptive double mastectomy to insure their survival after finding that they indeed have a particular gene isolated in their genome which is frequently present with those women who do succumb to radical stage-4 breast cancer. It is their right and choice (rightly or wrongly) and must be honored. Their decision is to enhance health and survival for all the right reasons and is based on current medical information. They are entitled to this advantage, if indeed it is this.
My mind suggests the playing field isn’t fair. This is not an imaginary projection, for a sizable segment of society presently understands that most common health factors and indeed — most chronic diseases are nutrient oriented or dietary. In other words, they can be cleared, cured, headed off at the pass or prevented in the first place through nutritional correction. That and careful diligence in lifestyle choices, guarding against toxic threats from all our environmental assaults in our food, air and water plus the electromagnetic miasma we are eternally bombarded with (electronic gadgets, microwaves, cell phone, gaming boards, computers and so on.) Pooh, you think? Well think again. It isn’t just eating good stuff, but it’s guarding against all the toxins we innocently ingest and surround ourselves with 24-7. Think about it — seriously.
Anyway, when I spoke of the fair playing field . . . one should be able to get all this important and relevant guidance from one’s doctor, but it’s not happening because none of this is part of their background — their medical school training has none of it; some have a cursory few hours in ‘all those years’. Their domain is the care of your body, i.e. health, but they don’t study health in school — they study disease and know what that looks like. So this is their focus, and how to treat those symptoms of disease.
One should not have to be cutting important, healthy parts of him/herself out in order to be secure. How much better to learn how to prevent all these things. This is where personal responsibility comes in. One must want to do this, give it the time to learn and do. Go online for sites of many of the famous, respected nutritional doctors. There are books galore written by many of them. Among current doctors we find Russell Blaylock, Jonathan Wright, Steven Sinatra, Joel Fuhrman, Mark Hyman, John McDougall, Dr Saul of Orthomolecular Medicine, and many of the best who have passed on, but have left books still as relevant as ever — like Hulda Clark, Ann Wigmore, Max Gerson (whose daughter Charlotte has carried on at the helm carrying on with his therapy). There are brilliant scientists like Drs. Loren Cordain of Paleo Diet, Raymond Francis of Beyond Health.
There are many others whom we turn to because of their special fields of expertise like Donna Gates of BED (Body Ecology) who is so expert with probiotics and enzymes and so on. We have David Wolfe and his new-age thinking, always leading the way – stretching the boundaries. And last but not least – “energy medicine” like Gary Craig’s EFT and Donna Eden’s Energy Medicine, both of which I personally use and love and would be lost without.
Both Dr Max Gerson and daughter Charlotte’s books are worthy for the tell it all details of how to help oneself with the treatment at home or on your own. Ditto with Dr Hulda Clark’s “Cure for all Disease” LOVE IT. Also at the top of my list is Donna Eden’s Energy Medicine which is so broad and insightful and possibly the best book around to introduce the whole concept of energy Medicine and how and why it works so well. All blessings! And all these have been highlighted here at smokinchoices, plus many more professional, distinguished scientists sharing their piece of the pie which is in fact — highly interesting, enthralling and amazing. We are blessed. Jan)