Is the recent FDA action blocking access to the personal gene analysis services of the company 23andMe really about health and safety? This controversy may instead be more about fear of the future and protecting special interests. What we could be seeing is the usual Luddite paranoia arising at every historic advance in technology, but this time it seems, fear is being exploited by the powerful establishment who may see their dominion at risk. For many, this is fundamentally an issue of civil rights.
The argument being made by the FDA is that people who receive the results are not equipped to interpret the medical implications of the data. By law, analysis of health data is something that only a medical doctor can do, and the FDA enforces that system. Secondly, anyone dispensing medical advice without a doctor’s license must be stopped. On that point, there is no disagreement, but is this what 23andMe is doing?
23andMe provides customers not only their personal gene analysis; they also distill and organize the data according to the known functions of the relevant gene variants published in the scientific literature. What does the scientific literature say about a particular cholesterol gene, for example, and how do combinations of genes having similar biological effects alter the mathematical odds of acquiring a certain biological result? These biological results range broadly from tracing a person’s ancestry back 5 generations, to predicting your ability to taste certain flavors, to indicating how efficiently certain drugs–caffeine or Plavix–for example, will be broken down in your body, to isolating how much of your genome retains traces of DNA inherited from Neanderthals. This is fascinating stuff and very useful. If you are not interested in any of these things, you will not want to use the services of 23andMe, but if you are interested, why should the government prevent you from having it?
Analysis of genetic data is an enormous undertaking, and this is very well done at 23andMe from what I have seen–even providing hotlinks directly to the scientific papers on the gene in question. The company distills the data so that the individual can take the results and any concerns they may have to their personal physicians to use in managing their health. Simply giving a person a list of hundreds or thousands of genes would be useless for most people. The data analysis that 23andMe provides their customers is vital. If that’s practicing medicine, arrest my librarian. (Note to FDA: Don’t mess with librarians. They are smart, organized, and know where things are.)
The second argument the FDA makes is that ordinary citizens do not have the ability to interpret the results and a person might act inappropriately on the basis of the information. Someone might panic if informed that they carry a gene variation with a propensity for a deadly disease, for example.
But this is nothing new. The same argument could be made with respect to a high cholesterol reading or an HIV test. Having a genetic risk does not mean that you will get the disease, just as having high cholesterol does not diagnose that you will have a heart attack or stroke. People understand this and they manage to cope with having access to their cholesterol readings or HIV test result by acting in any way they see fit to do.
The technology being used is well established and reliable–I use it in my own laboratory research and have done so for over a decade. Of course there will be errors–false positives and false negatives in any genetic screen. Name a test (medical or otherwise) that does not have these. Most of us can handle the befuddlement of the engine warning light flashing on in our car. Often it is a false signal, but that’s fine. It is important for the driver to have the information to decide what to do. An essential distinction between genomic analysis and the engine light on your dashboard is that if the warning light stresses you, there is little you can do to avoid it, but 23andMe customers requested the information. They understand that with thousands of genes being assayed, the result of any genomic analysis is not a diagnosis; it is a screen.
In effect, the argument the FDA makes is that people are too ignorant or irresponsible to have access to information about their own body. This is the heart of the issue, and it is a troubling argument. The underlying question that people should be asking is why should the FDA be taking this patronizing view?
As citizens of a free society all of us must be concerned anytime the government acts to withhold information from its citizens. When government censorship concerns information about one’s own body, the abridgment of freedom is even more alarming, because the information is personal and vital to an individual’s right to pursue life and happiness:
We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness. –That to secure these rights, Governments are instituted among Men, delivering their just powers from the consent of the governed.–That whenever any Form of Government becomes destructive of these ends, it is the Right of the People to alter or to abolish it.
Those are revolutionary remarks of a bunch of radicals. Today we are much more enlightened. We understand that the government knows what is best for us. The role of government is to protect us from our own bad judgments.
“No, you may not have a large soda.”
The revolutionary genetic pioneers paying 23andMe for genetic screening refuse to acquiesce to this well-intentioned government censorship. They cannot seem to understand that government’s role is to know what is best for us, and to regulate what personal information about ourselves we should have. In their distorted zeal to embrace the future, these people see the FDA action as fundamentally at odds with the founding principles of our society. As these wackos would have it, the role of a free government is to serve the people and secure personal liberty. These fanatics eschew the rightful relationship of dominion and subservience citizens should have to government and the power establishment. In their radical view, the FDA action is government censorship of information that concerns personal information that an individual desires to have, is willing to pay their money to obtain, and to use it for their own personal benefit. We simply can’t have that–right?
People are naturally wary of anything new and so they more likely to swallow any argument maintaining the status quo. 23andMe breaks the corporate/government establishment in health care by giving individuals direct access to information about their own body. The issues about security of the genetic data, misuse of it, and whether or not a person can utilize it appropriately in their own health, are not new. The same arguments apply to any of the current types of medical laboratory analyses and records. By that logic, a person should not get an HIV test because, my God! What if that information were to become public?
Scientific progress has already undermined the strangle hold on direct access to personal health data, and the FDA and medical industry are having a difficult time keeping pace with the advances. The FDA’s action in approving home pregnancy tests or glucose monitors, for example, invalidates their argument about people being able to understand and utilize personal genome analysis responsibly.
Those arguing against 23andMe are using fear mongering tactics. They suggest hidden and subversive motives, and damn the company by association with the likes of Google. “They are mining my personal data!” Google is scary. Try searching the internet for “baldness” or “PMS” and see what pop-ups sprout at the edge of your screen. You understand how this works–right? Data mining is what fuels the internet, which has propelled a revolution that has changed in the world, and it has only gotten started. Are you worried about the Safeway grocer analyzing your shopping list to get the low-down-and-dirty on you? Some folks are, but they are not going to be the ones using 23andMe anyway. Change and the unknown–whether radiation, genetic engineering, or almost anything new–is what gives some people goose bumps.
That mad man, Henry Ford, proposes to replace the normal means of transportation with a “horseless carriage.” What few people realize is that the hazardous contraption carries up to 20 gallons of a highly explosive mixture of hexane and octane on board! Even breathing the smoke out of the engine’s smokestack will kill you. That’s a fact. Do you want something like that in your corral! This thing is dangerous, and who needs it anyway? Is there any place you cannot go on your horse?
Yes, looking back we can see the quaint phobias of those who came before us. We are smarter today, though.
I hear tell one of them ‘lectric vehicles ran over a hunk of metal and burnt up! I hope they put them Tesla guys out of bidness!
But this time, it appears to many, that the fear mongering is being exploited by the powerful establishment. The 23andMe debate has exposed the extent to which personal access to one’s data about their own health is blocked by government regulation. If you wanted to know your cholesterol level, for example, you cannot obtain it directly. You would have to call and make an appointment with a doctor. Wait until he could see you. Tell him in person you want the test and pay the doctor to write you a prescription authorizing you to go to a laboratory to have the analysis done. You need to make an appointment at the laboratory and go there to have the test performed. The lab sends the results–not back to you–they send it to your doctor. In a few weeks you can go back for your follow-up appointment and the doctor will read you the cholesterol concentration from the lab report. That’s how the health industry works in this country today. The very expensive and inefficient process fuels an enormous industry of insurance, real estate, doctor office staff, and the pharmaceutical industry. The results of tests go to the doctor, not to you, and that’s the way “they” like it. Even though you may simply want to know the HDL and LDL cholesterol readings in your own blood, you cannot have the information without paying a doctor as the middleman. This is the issue.
Hey! It’s my cholesterol. I made it. I only what to know how much I made. My genes are no different. Who has the right to tell me I can’t look at my genes? There’s no problem with a fortune teller measuring your lifeline. Walk into any drugstore and there are tons of health supplements and vitamins to treat everything from dementia to impotence–almost none of it backed by clinical studies showing that they work. But we cannot have access to the latest in scientific technology for our own personal use. Smoking, gun control, immunization, however you feel about it, do have consequences for society at large. There is a necessary balance between personal choice and public good, but looking at your own genes is personal. What justifies the government extending its reach into a persons genes?
At one time anyone in this country could purchase cocaine and opiates legally. But then at one time it was illegal to purchase alcohol. The pendulum swings, and it is pretty clear which way it is swooshing these days.
Bill Gates, who is devoting his philanthropic activities to improving health in the developing world, has a broader view of health care from his global perspective. “By far, most people on the planet are born, live their entire lives and die without ever seeing a doctor,” he said last week in a speech at the NIH. This perspective shows how extreme healthcare has become as a business in the United States. If you want to see your own body, you need the government’s permission. Then if access is granted, you will be permitted to see it only through the eyes of a doctor who will describe it to you. The great irony is that people in the underdeveloped world lack access to the most modern medical science because of poverty, whereas people in the developed world lack access to it because of politics.
Imagine! What if a person could know what genes they have that could affect their health. It’s not science fiction. It is political fiction.
This has been modified from an earlier publication on Huffington Post: