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Ed Hudgins

FDA Stopping the Genetics Revolution

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FDA Stopping the Genetics Revolution

By Edward Hudgins

December 11, 2013 — Entrepreneurs look to limitless possibilities while government regulators look to limit possibilities.

That’s the stark contrast we see between 23andMe, a company that makes and markets genetic test marker kits, and the Food and Drug Administration, which has forced them to stop selling their potentially life-saving product.

In your genes

Since 2006, 23andMe has been selling $99 kits that allow individuals to send a saliva sample to company labs. 23andMe analyzes the sample to find out whether individuals are predisposed to several forms of cancers and other diseases, to determine possible responses to certain types of drug treatments, and to glean other information about individuals from their genetic material.

The FDA was established to certify the safety, efficacy, and health claims of medicines and medical devices. And the FDA’s authority is broad. It covers not only what is considered a “device”—everything from heart valves to tongue depressors—but also how “efficacy” is defined.

23andMe does not claim that the results of their analyses are accurate 100 percent of the time. Few medical tests are. And to be sure, 23andMe has not jumped through all the time-consuming FDA hoops that might secure for their product the government seal of approval. But the key reasons that the FDA gives for being concerned are also key reasons why the FDA has outlived any usefulness it might ever have had.

You’re too stupid

In its “cease selling” letter to 23andMe, the FDA asserted that if an “assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery … or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.” Similarly, “assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies…”

In other words, individuals are just too stupid and irresponsible to handle information about their own bodies and health.

In point of fact, were 23andMe to make a positive finding for cancer risk, the individual would do like every single individual does now in such cases: go for a second opinion and more tests. In the case of a false negative, this is not a negative for having the ailment—which many FDA-approved tests can fail to find in the early stages. It's a failure to find the genetic propensity for the ailment. Vigilance is always advised. Similarly, a finding that suggests better treatments for some condition would certainly lead a patient to inquire further into the best way to ensure their health.

It’s your life!

And the FDA’s concern that individuals might “self-manage” treatment reveals an issue in its war on 23andMe that’s so fundamental that it’s missed my many. Your life is your life! Your body is your body! You have a right to “self-manage” yourself! The benefit of living in society with others is that through the production and voluntary exchange of goods with others you can better preserve and improve your own life.

Politicians and government bureaucrats don’t own you. You are not a child to be abused by these negligent paternalists.

To be fair, the FDA was started earlier in the last century in reaction to concerns about hucksters pushing phony snake oil “cures” to an uneducated and uninformed population. But if there ever was a problem, the communications and information revolution obviated it. Adults can and should be allowed to make their own decisions about their own lives. As to fraud, that's what we have law courts for.

Life-extension revolution

The other big issue that many are missing is that 23andMe and companies like them are the vanguard of a revolution in medical treatments and life extension similar to the revolution in communications and information made by companies like Apple and Microsoft. The latter revolution was made by entrepreneurs, operating in a free market with virtually no government regulation, producing undreamt-of goods and services.

Genetic science offers the possibility of tailored therapies for individuals. It offers a future from which Alzheimer’s, Parkinson’s, and so many other afflictions will have been banished.

Some people might fear a dystopian “Brave New World” and, thus, want the FDA and, more generally, government oversight of this emerging revolution. That guarantees that the revolution will be smothered in the crib. By attacking 23andMe, the government has shown that it is a roadblock to progress in this field. Imagine if Apple had received a “cease and desist” letter for creating the iPhone. That's how medical advances are being treated today.

Those who fear the future should get out of the way of those who embrace it. And this means getting the FDA out of the way of the entrepreneurs who will help give us all longer, healthier tomorrows.
-------
Hudgins is director of advocacy and a senior scholar at The Atlas Society.

For further information:

*Edward Hudgins, “It’s Getting Better All the Time: Reviews of Abundance and Merchants of Despair.” April 24, 2013.

*Edward Hudgins, “Government Medicine's Prejudice Against Innovation.” October 20, 2004.

*William Thomas, “Transhumanism: How Does It Relate to Objectivism?”

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How is the quality of the genetic tests assured or at least rated?

If some schlock outfit is returning results with false negatives that can be life threatening. False positives are just scary and one can go to a medical person and get a verification or corroboration of the positive. It is the false negatives that would worry me.

The issue of quality would exist whether or not the FDA existed.

Ba'al Chatzaf

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Baal -

The company can only continue to profit by convincing customers to purchase their services. Especially in the internet age, negative reviews will quickly doom 12andme.

I rather like the Swiss approach to certifying medicines and medical devices. Competing independent labs, like competing Underwriters Lab, do the certification.

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Baal -

The company can only continue to profit by convincing customers to purchase their services. Especially in the internet age, negative reviews will quickly doom 12andme.

I rather like the Swiss approach to certifying medicines and medical devices. Competing independent labs, like competing Underwriters Lab, do the certification.

I favor any method of honest certification. I simply point out that some caution must be taken to lessen the ocurrance of bogus false negatives.

Ba'al Chatzaf

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Whatever the FDA approves, avoid it. The Fraud and Deception Administration approves only bad things, never good things.

In marketing scientific research, it is important to fudge the data so it favors the product. In order to assure that the data is fudged correctly (to sell the product), there is a process called peer review.

If you look into the details of the research on msg, aspartame, fluoride, etc., you will find deliberate dishonesty, not merely honest mistakes. The FDA is not your friend.

This should not come as a surprise. The FDA, as an extension of government, was destined to become corrupt.

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Whatever the FDA approves, avoid it. The Fraud and Deception Administration approves only bad things, never good things.

In marketing scientific research, it is important to fudge the data so it favors the product. In order to assure that the data is fudged correctly (to sell the product), there is a process called peer review.

If you look into the details of the research on msg, aspartame, fluoride, etc., you will find deliberate dishonesty, not merely honest mistakes. The FDA is not your friend.

This should not come as a surprise. The FDA, as an extension of government, was destined to become corrupt.

The FDA approved the amoxicilin that I use as an anti-biotic now and then. It works just fine.

You generalize too much.

Ba'al Chatzaf

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Whatever the FDA approves, avoid it. The Fraud and Deception Administration approves only bad things, never good things.

In marketing scientific research, it is important to fudge the data so it favors the product. In order to assure that the data is fudged correctly (to sell the product), there is a process called peer review.

If you look into the details of the research on msg, aspartame, fluoride, etc., you will find deliberate dishonesty, not merely honest mistakes. The FDA is not your friend.

This should not come as a surprise. The FDA, as an extension of government, was destined to become corrupt.

The FDA approved the amoxicilin that I use as an anti-biotic now and then. It works just fine.

You generalize too much.

Ba'al Chatzaf

anti means against. biotic means life. Antibiotics are poisons. It is not possible to take an antibiotic without to some degree poisoning yourself.

I am puzzled. You claim to be healthy and fit. Why would you need an antibiotic now and then? As unhealthy as I am, I seem to be immune to infections.

Did the FDA ever approve anything that is not a poison?

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JTS - This sounds like anti-scientific nonsense. Antibiotis "kill" germs that sicken us. Chemotherapy, for example, "kills" cancer cells that are killing us. If you're suggesting that good diets and exercise along and banish all diseases or illnesses, you're into deep, deep, nut-ball territory.

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anti means against. biotic means life. Antibiotics are poisons. It is not possible to take an antibiotic without to some degree poisoning yourself.

I am puzzled. You claim to be healthy and fit. Why would you need an antibiotic now and then? As unhealthy as I am, I seem to be immune to infections.

Did the FDA ever approve anything that is not a poison?

Some poisons are good for us. If the thing they kill is better off gone than the side effect, we are getting a benefit.

By the way do you know any science or mathematics at all? Are you familiar the the rules of logical reasoning?

Ba'al Chatzaf

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JTS - This sounds like anti-scientific nonsense. Antibiotis "kill" germs that sicken us. Chemotherapy, for example, "kills" cancer cells that are killing us. If you're suggesting that good diets and exercise along and banish all diseases or illnesses, you're into deep, deep, nut-ball territory.

A healthy body is deadly to disease causing germs. Also I'm not convinced that stopping an infection by a poison is a good thing. What if the infection is a healing process that should be allowed to run its course?

About chemotherapy: The latest news about chemotherapy (poison therapy) is by the admission of the doctors themselves, it has an extremely low rate of success. And what do they mean by success? The cancer comes back stronger. It also makes nutrition therapy more difficult to be successful, because it must overcome the poison therapy.

About banishing all diseases: I didn't say that. Some people are permanently damaged before birth. Also I didn't say health is only about diet and exercise.

Speaking of nut-ball territory: Government is supposed to protect rights. But in the USA, poison therapy for cancer is enforced by law on children and nutrition therapy for cancer is illegal.

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JTS - This sounds like anti-scientific nonsense. Antibiotis "kill" germs that sicken us. Chemotherapy, for example, "kills" cancer cells that are killing us. If you're suggesting that good diets and exercise along and banish all diseases or illnesses, you're into deep, deep, nut-ball territory.

A healthy body is deadly to disease causing germs. Also I'm not convinced that stopping an infection by a poison is a good thing. What if the infection is a healing process that should be allowed to run its course?

Oh dear God, save me from this bullshit! Naturalistic dreck and crap. Why did so many otherwise healthy people die during the Spanish Flu epidemic. There are pathogens out there for which we have no natural defense. That is a FACT. That is why most of the Aztecs were wiped out when they came into contact with Spaniards with small pox. Since the Spaniard grew up mostly covered with shit the develop partial immune responses (the ones the survived that is) to diseases. The Aztecs living in another hemisphere had no natural defense against he small pox virus.

Ba'al Chatzaf

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Some poisons are good for us. If the thing they kill is better off gone than the side effect, we are getting a benefit.

What if the thing they kill can be gotten rid of or avoided without the side effect?

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Oh dear God, save me from this bullshit! Naturalistic dreck and crap. Why did so many otherwise healthy people die during the Spanish Flu epidemic. There are pathogens out there for which we have no natural defense. That is a FACT. That is why most of the Aztecs were wiped out when they came into contact with Spaniards with small pox. Since the Spaniard grew up mostly covered with shit the develop partial immune responses (the ones the survived that is) to diseases. The Aztecs living in another hemisphere had no natural defense against he small pox virus.

Ba'al Chatzaf

Read the writings of NH doctors who had first hand experience with smallpox. They say smallpox is over-rated. There is also such a thing as dying of the remedy for the disease.

The Aztecs died of multiple causes, including mass famine and malnutrition and other diseases. I would want to know what weakened them.

I have no fear of germs and viruses. Wish me bad luck.

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Ba’al –

The problem with folks who hold nutty, insane opinions like this guy is not that the opinions are wrong. It’s that they reject a rational approach for determining truth.

For nearly a century and a half, thousands of individuals have devoted time and energy in the scientific process to understand the plethora of health problems that plague humanity and do discover ways to cure or deal with those problems. So many of my family and loved ones wouldn’t be alive today without those discoveries. And some died decades ago who, with access new discoveries that came too late, would have been alive today.

So when someone as unserious as this guy starts spouting off, best thing to do is not waste your valuable time debating him because you don’t have a common standard—reason—by which to determine the truth.

Stay healthy!

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So when someone as unserious as this guy starts spouting off, best thing to do is not waste your valuable time debating him because you don’t have a common standard—reason—by which to determine the truth.

Stay healthy!

Thank you for your good wishes. The prior poster -was- serious. There are million of people in the country that really and truly subscribe to such unscientific notions and no amount of clinical evidence will dislodge them. The are tens of millions in America he believe in homeopathic medicine or who believe that the body will naturally and successful fight off -every- infection. It just ain't so. During the Spanish Flu epidemic people who per perfectly healthy in the morning were dead by evening. It was a horror show. Some people have no natural defense against certain viruses or have an insufficient immune reaction. The lucky ones have by good fortune inherited a genome that produces natural immunity but this happens to the few, not the many.

After the Spaniards inadvertently introduced small-pox to the land of the Aztecs, there were a few Aztecs that were able to survive and they acquired a life long immunity to any further small-pox infection. I have read historians who estimated the death rate among the Aztecs from small pox at between 30 to 60 percent of the population. Since the Spanish had no idea how disease spread we cannot call the small pox scourge genocide but it had nearly the same effect as deliberate infection of the population.

Ba'al Chatzaf

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Ba'al - Yes, I understand that people do really believe a lot of complete bunk; homeopathic medicine is a good example. In that sense they're "serious." But they're not serious in the sense of seriously seeking the truth. For whatever reason--laziness, religious dogma--they refuse to exercise their critical thinking capacity. Much misery results.

Cheers!

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Ba'al - Yes, I understand that people do really believe a lot of complete bunk; homeopathic medicine is a good example.

I for one do not believe in homeopathic medicine. Homeopathy means remedying a disease by a small amount of the same disease. Vaccination is an example. Allopathy means remedying a disease by a different or opposite disease. I don't believe in that either.

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Ba'al - Yes, I understand that people do really believe a lot of complete bunk; homeopathic medicine is a good example.

I for one do not believe in homeopathic medicine. Homeopathy means remedying a disease by a small amount of the same disease. Vaccination is an example. Allopathy means remedying a disease by a different or opposite disease. I don't believe in that either.

You also do not believe in statistically rigorous double blind clinical trials either. I would make a bet at 8 to 5 odds that you believe in Vital Essence and Wholeness and Woderfulness as well.

Ba'al Chatzaf

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I for one do not believe in homeopathic medicine. Homeopathy means remedying a disease by a small amount of the same disease. Vaccination is an example. Allopathy means remedying a disease by a different or opposite disease. I don't believe in that either.

You also do not believe in statistically rigorous double blind clinical trials either. I would make a bet at 8 to 5 odds that you believe in Vital Essence and Wholeness and Woderfulness as well.

Ba'al Chatzaf

You would lose that bet.

How would you do a double blind study on fasting? That would require putting people on a fast and they don't know they are on a fast. Impossible. Also it would be difficult for an experienced doctor who pays any attention (tests and stuff) to not know whether the patient is on a fast. So even single blind probably would be impossible.

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Dr. John H. Tilden had experience with smallpox, late 1800s and early 1900s. He says aboriginals are specially susceptible to smallpox. Among aboriginals he included Indians, Mexicans, Negroes. He says the reason why is they lived in filth. He says smallpox is a disease of filth. How did Indians living in a teepee go have a shit? What did they use for toilet paper? How did they take a bath or a shower?

So I get this picture. Imagine a field of dry grass. Someone lights a match. The next thing is a raging unstoppable prairie fire. The match is the virus (or whatever). The dry grass is the filth.

There is a graph that clearly shows that smallpox was well on its way down long before the smallpox vaccine was introduced and the same graph shows that the vaccine did not make any difference. Probably in The Poisoned Needle. Get rid of the dry grass; no more out of control prairie fires.

During the Dark Ages, Western man ceased to bathe. In America, up to the time of Graham, people did not take baths. They had no bath tubs and did not regard bodily cleanliness as a necessity of life. Graham and the other Hygienists taught Americans to bathe and in this work they had the active opposition of the medical profession.

Natural Hygiene Chapter XII.html 30

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