The Attempted 23andMe Shutdown:
The FDA Has Again Betrayed the Core Values of the United States
by Jerry Emanuelson
On November, 22, 2013, The United States Food and Drug Administration ordered DNA testing services company 23andMe to stop marketing the health risk aspects of its DNA testing services, claiming that the service is an adulterated and misbranded medical device. This situation was finally modified in October of 2015. By that time, however, a lot of damage had been done by depriving consumers of valuable information about their personal health risks.
I am one of the more than a million 23andMe customers. I used the DNA information obtained from 23andMe and DeCodeMe to reverse my spinal osteoporosis, something that my father died of (in a very slow and agonizing manner) as his spine slowly crumbled away, finally leaving him bedridden for nearly all of the last 14 months of his life.
All of the techniques that I successfully used to reverse my spinal osteoporosis were not approved by the FDA, and were generally not known by doctors. FDA-approved osteoporosis treatments and conventional osteoporosis testing are both mostly aimed at females, and I am a male.
My father was not treated for osteoporosis until it was much too late to save him; and he died a slow and agonizing death as his spine gradually crumbled away. He never really received any effective treatment, only palliative care.
Unfortunately for him, my father (like many of his generation) was overly trusting of federal agencies like the FDA that displayed a benevolent mask to the world. He was not as eager as I have always been to inquire deeply and to look behind that deceptive benevolent mask to see, and then try to escape, the crushing control that the FDA exerts over the United States medical system. All too often, the FDA is not the proper guardian of public health and pure foods and medicines, but instead an agency that simply obstructs the free flow of information.
It is an unfortunate truth that seeing through the benevolent mask of the FDA requires an effort that most are unwilling to make.
I have solid personal medical data, as well as many peer-reviewed scientific studies, to show that the tests and techniques that I used actually work. Unfortunately, our federal government thinks that we lack sufficient intelligence to be entrusted with information about our own DNA. The FDA also thinks that ordinary people are too uneducated to be entrusted with any appreciable control over their own medical care.
The FDA believes that, because some people may make mistakes in managing their own medical care, that medical freedom should to prohibited to all.
Supporters of the FDA obstruction of information ignore the fact that when the FDA makes mistakes, as it frequently does, everyone suffers.
Much of the problem with the FDA regulating 23andMe stems from the glacial pace of government approvals as compared to the extremely rapid pace of advances in DNA technology (as well as other medical technologies). One of the main things that the FDA is demanding is data on accuracy.
I received my 23andMe results from their DNA microarray Version 2. In 2013, 23andMe was been using Version 3, and they were about to start using Version 4. Each version is a great leap forward in technology. So what year's data does the FDA want?
Judging from the past performance of the FDA, any FDA approval would likely be long obsolete before the FDA could ever get around to issuing such an approval. FDA approval has always been a long and ponderous process. It has historically also been a "one size fits all" process. This stands in stark opposition to the new and rapidly advancing field of personalized medicine. The FDA finally got around to issuing some limited approvals of the free flow of genetic information in late 2015. It is inevitable, though, that such approvals will always be too little and too late.
The situation that 23andMe is was in for nearly two years was much like the situation that the Ford Motor Company would face if the federal government demanded that Ford immediately cease operations today because they had found a possible starting problem with the Model T, or had a question about a possible brake problem with the 1959 Edsel, or that they needed more safety data on the 1970 Ford Fairlane. DNA technology is just moving far too rapidly for outmoded forms of government regulation based upon the ancient FDA model.
23andMe tests several hundred thousand different SNPs. So should 23andMe submit an request for approval for each of them to the FDA? Each SNP is at a different location on human DNA, and each one results in a different outcome. At the normal rate of FDA approvals, their approval for the full potential of the 23andMe service would take many centuries.
In a few years, it is likely that, if any direct-to-consumer personal genome services, are allowed by government agencies to exist, then they will be decoding all of the known SNPs. According to the United States National Library of Medicine, there are 62,676,337 SNPs in humans known as of late 2013. That number has been growing recently at the rate of about 10 million per year.
Is the FDA really ready to process tens of millions of applications, and to return approvals in a timely manner? Even if they only want to approve each individual health risk or pharmaceutical effect, then each of these reports will change as additional SNPs are added or additional medical journal reports are made. If 23andMe were to fully comply with any conceivable approval mandate, 23andMe could very quickly have the FDA backlogged for centuries.
The FDA too often uses a quiet, but brutal, heavy-handedness -- rather than science -- to determine what individuals are allowed to do with their own bodies and with their own DNA. All this is done while the FDA continues to smile down upon us, using that same, increasingly deceptive, mask of benevolence.
My battle to reverse my own spinal osteoporosis is not the first time that I have had to work around FDA interference in order to maintain my own health.
The FDA has become the most dangerous of all government entities, and (because of the economic influence of the United States and the expansive ambition of the FDA enforcement officials) its nearly invisible tentacles extend throughout the entire world.
The FDA role in medicine needs to be reduced to a role of medical manufacturing plant inspection and safety testing, and to acting in an advisory capacity in the drug approval process. They have repeatedly proven themselves to be both too arrogant and too incompetent at managing the medical system because of the great extent to which they aspire to control it. The glacial pace with which the FDA bestows its blessings retards medical progress in a great many areas, especially those areas related to personalized medicine.
This quiet and deceptive control over what we do with our own bodies and our own information about our DNA, while hiding behind this mask of benevolence, stands in stark opposition to the longstanding values of the United States.
The FDA must be totally revamped at all levels. There are scientists at the FDA who are sincerely trying to do good things. Unfortunately, much of the enforcement arm of the FDA is stuck in a mode of hushed oppression that stands in opposition to the long-held core values of the people in whose name they act.
Far too many people still believe that the FDA is protecting them. (In limited ways, it is. I rely heavily on FDA-mandated food labeling myself.) Most people, though, will never learn the truth about this problematic agency, even in cases where the FDA was responsible for the premature suffering and deaths of their loved ones.
Many others will realize the facts much too late, as they personally become the indirect victims of FDA enforcement actions that wear the deceptive mask of the benevolent agency that it was originally intended to be.
The millions of victims of the United States Food and Drug Administration die quietly, long before their time, in hospitals and nursing homes. And these innocent and trusting victims of the FDA are buried just as quietly, but all too soon, in cemeteries spread all across the country.
Most of us will just have to hope that 23andMe prevails in its legal battles with the FDA. The FDA has suffered major legal defeats before.
Since questions of accuracy seem to be at the root of the FDA letters to 23andMe, it is only fair that I should include here some data regarding the accuracy of my own DNA testing. There are no perfect standards to measure any one DNA test against. I can only show the concordance of two different DNA scans that I had.  They were done in 2008 by two different companies in two different countries using two completely different DNA microarrays. One DNA scan was done in Iceland, and the other in the United States (in California).
The DeCodeMe test from Iceland report covered 1,013,349 SNPs (DNA variants at specific DNA locations).
The 23andMe test from California report covered 579,751 SNPs.
The overlap was approximately 551,000 SNPs that were common between the two tests.
There were 8 conflicts between the two tests. This results in a concordance (or agreement) of 99.998 percent between the two tests performed in two different countries.
There were an additional 43 SNPs that were unreported by one company or the other. If we define the absence of a report on a specific SNP as a disagreement, then the concordance is reduced to only 99.991 percent.
The larger "error rate" (or discrepancy between the two companies) is still more than 100 times less than the historic error rate of FDA drug approvals. The exact error rate of FDA drug approvals is quite controversial. (Among other things, it depends upon how one would measure this error rate.) Many people would put the FDA drug approval error rate at much higher than what I am giving them credit for here.
The DNA scanning companies must strive for 100 percent accuracy. Still, the level of accuracy is quite remarkable considering that no one in the world could have done these tests at any price just a decade earlier. The comparative accuracy of 23andMe and the FDA, and the comparative speed with which these two organizations operate, speaks volumes about the relative abilities of each organization.
For those who would like additional technical details about the conflicts between the two tests, the specific conflicts on my tests are shown below. At least 4 of these 8 conflicts are known to be problem areas for these scans.
rs1344694 reported as (G;G), (G;T)
rs9576827 reported as (G;G), (A;A)
rs754499 reported as (G;G), (G;T)
rs4705038 reported as (C;C), (A;C)
rs501192 reported as (A;G), (G;G)
rs4458717 reported as (C;T), (T;T)
rs4660646 reported as (A;G), (G;G)
rs11149566 reported as (A;G), (A;A)
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