FDA halts sale of 23andMe DNA tests | UTSanDiego.com

According to this Union Tribune article: FDA halts sale of 23andMe DNA tests | UTSanDiego.com, (and NBC News)  the FDA has stopped 23andMe from selling their personal DNA analysis "kits." (FDA Letter Posted on Internet)  In this case, 23andMe could simply not report on some of the controversial findings and continue to do business.  I'd bet that's what they'll do, until the more controversial findings are resolved.  However, I think this is a major issue,and it is sort of at the center of a major junction of issues involving DNA testing.  Issues may need to be resolved by legislation or court decisions.  Those issues include moral, ethical, financial, and personal rights.  The decision is also fascinating because it involves investments made by Google, and a recently highly successful San Diego company Illumina. Illumina makes the "chips" that are used in DNA testing, and the company's stock has had an immense run-up recently.  23AndMe was founded in 2006 in San Diego by Anne Wojcicki, Linda Avey, and Paul Cusenza.  Wojciki married Google co-founder Sergey Brin, which is probably why Google has investment in the company.  In 2008 Time magazine identified 23AndMe's testing as the best invention of the year.

When 23AndMe first started out, the FDA wasn't really interested.  All of the sudden in 2010 they wanted definitive proof that all of the DNA testing is accurate.  Why the sudden "change of heart?"    Should the FDA even be involved with DNA testing?  DNA testing could be considered to be similar to fortune telling.  You give the fortune teller a lock of hair, and are told what might happen to you in the future.  In this case, you spit in a bottle, send it in and are told the probabilities that you might be diagnosed with different diseases.  Fortune telling isn't regulated by the FDA -- why should this?  There is also some belief that there are rivalry between various doctors, jealousy, and issues of competition from other start-up companies who would like to throw stumbling blocks in front of the leader (23 and Me) so they can catch up. Should 23 and Me be forced to make public all of their DNA work and analysis that they use in making their assessments?  If so, that gives away all of their expensive research, so that other companies can use it to compete directly with 23 And Me.  Much of that sort of information is also complicated by the lack of ability to patent information about DNA markers, and the recent US Supreme Court decision.

Just a few years ago, the company charged about $400 and evaluated about 90 medical conditions.  Now it only costs $99 and does many more (250) conditions.  I'm sure the FDA expects the number of genetic markers evaluated to continue to increase, and the cost may even continue to fall.  Possibly other companies, and companies in other countries will also begin to do genetic testing.  At a $100 price, it would seem that it's within the price range that everyone would want to know.  If the price continued to drop, I would think for sure that everyone would have DNA testing done for themselves and their children.

The FDA is apparently concerned about affects on "public health" -- which seems rather vague.  I speculate that could mean:
1. FDA is concerned that people who are told they might be susceptible to certain diseases could request treatments or medications based upon that information, which could overload the US public health "system."
2. Some percentage of those treatments or medications may be unnecessary or harmful to patients
3. Patients who have knowledge gained from DNA testing will have an unfair advantage in buying life and health insurance.  If a patient knows they have a high probability of being diagnosed with an "expensive" or fatal disease, they would, in effect, be cheating when they bought expensive insurance policies.  Should they be required to disclose to insurance providers?  Should insurance providers do their own testing?
4. There are also moral & ethical issues related to DNA testing.  For example: Should a person disclose to a potential spouse their DNA test results if they know they are likely to encounter a serious medical condition?

A Scientific American Forum Blog by Charles Seife says:  "The genetic-testing company’s real goal is to hoard your personal data."  He believes that the ultimate purpose of 23andMe is to collect the genetic information for a database.  That database could become extremely valuable for genetic research, similar to Google's search database.  From a public health perspective, I think the optimum situation would be to have a massive global database that contains everyone's family history of diseases, and everyone's DNA evaluations.  That extremely valuable database could then be "mined" to determine the effect of the many DNA markers on disease, and most likely help in preventing the diseases.  However, there would be major issues of privacy and security involved in such a database.  Also, since the DNA testing is just in its infancy, there are probably lots of errors.  So any such database would be "contaminated" by the errors.  

I think it will be very interesting to see how these issues are resolved in the future.  I wonder how other countries will react to the same situation.  Could US Citizens go to another country to have their DNA tested?  Could we send a bottle of spit to another country to have it tested outside of the FDA authority?

'Poop Pills' Could Replace Fecal Transplants of Gut Bacteria - D-brief | DiscoverMagazine.com

I always wondered if this would work --and much easier than the other "methods" of transplanting.

'Poop Pills' Could Replace Fecal Transplants of Gut Bacteria - D-brief | DiscoverMagazine.com:

Drugmakers And Pharmacists Sue Maine Over Importation Law | Pharmalot

I have had investments in drug manufacturers for decades, and I truly believe that we need to do everything we can to encourage research and development of new medicine.  Simple drug or immunization breakthroughs have saved millions of lives and have saved billions, or maybe even trillions of dollars in medical care.
However there are inefficiencies and perverse, sub-optimal incentives built into our pharmaceutical industry that allows tremendous waste of effort and increases the cost unnecessarily.  When "big pharma" is unable to develop truly new drugs, they get involved in developing and marketing "me too" drugs which are just knock-offs of original drugs.  That helps promote competition, but creates a lot of extra expense in getting them approved.  The advertising and marketing cost, in some ways gets passed on to consumers as well.
I'm also critical of the restrictions on import of medicines into the US.  This is another example of big pharma trying to "game the system" so that they can raise the price they charge consumers in the US while still compete on a world market, with lower prices elsewhere.  Maine is trying to allow residents to import drugs from Canada, UK, Australia etc.  However big pharma wants to stop it.  See this article:
Drugmakers And Pharmacists Sue Maine Over Importation Law | Pharmalot:
Are we to assume that the drugs sold in those countries are "less pure" than the ones sold in the US?  Most of them are made by the exact same multinational company -and sometimes to even tighter standards.  Yes, they love to pull out some examples of situations where problems occurred.  However there have been recalls of drugs all over the world -- including many within the US.
I think the Government should not stand in the way of competition --and at some point has to allow the buyer to take responsibility for verifying the drugs they receive are OK.  Big pharma could also facilitate that with better serial number barcoding on all bottles that could be scanned to verify --not a huge technological task.  However they don't want to do that, because it would actually increase competitive pressure on their bottom line.

Gene transfer by viruses treats patients in clinical trials

I've read for years about the possibility of using a virus to implant genes into organisms.  It sounds like they are now figuring out how to do it.  This article almost sounds like a miracle --particularly for the children and their parents who were treated.

Gene transfer by viruses treats patients in clinical trials | BLOUIN BEAT: Science & Health:

I hope this technique will continue to evolve and improve to resolve other diseases that are clearly genetic based.

http://www.cancer.gov/cancertopics/research-updates/2013/CAR-T-Cells

Opening Up the Market for Health Care

I think it's pretty clear that one of the best ways to reduce our cost of medical care is to help the "free market" system work more efficiently.  To do that, we need to open up pricing for health care and services, as well as provide consumers with the capability of evaluating alternative providers and medications.

30 years ago, it was impossible for a patient to be able to find out costs for services or prescriptions.  We didn't have access to the information, nor did we have the pricing.    Now, with the internet, and powerful search systems, it is possible for us to find out the details about our ailment, determine the best treatment, search for the best price on a pharmaceutical.  In some cases, we may need a blood or urine test or some other type of laboratory evaluation.  We may need an x-ray, CAT scan, or MRI also.  Why do we always have to go to a doctor BEFORE we can get those tests?  It's simple, we need a gateway to keep us from spending unnecessarily on those services.  Why can't we set up our pricing scheme so that patients could do those things in advance of seeing the doctor -- but at their own risk or expense?

Also we need better on-line comparisons of drug prices.  It's clear that patients can do this in other countries, but within the US, there are apparently restrictions on price comparison of prescription drugs.  Most likely this is because of pressure from big pharma..We can easily compare prices of drugs in other countries using the internet.  However within the US it is very difficult.  Obviously no pharmaceutical company wants to be the first or only company to do this.  However if legislation were passed requiring everyone to post their prices, everyone will be playing by the same rules -- totally fair!   It would also facilitate competition, which the companies don't want, because it would likely reduce the overall revenue received for drugs.  

NitroMemantine Reverses the Loss of Brain Connections in Alzheimer’s Disease | Alzheimer's Reading Room

NitroMemantine Reverses the Loss of Brain Connections in Alzheimer’s Disease | Alzheimer's Reading Room:

Another article in SciTech describing the new breakthrough

You Tube Video: http://www.youtube.com/watch?v=TZPRXhkhFqA

Common Nutrient Keeps Flies Sharp into Old Age: Scientific American

Here is another clue to a diet change that could improve memory and longevity.  Polyamines -- which include putrescine, cadaverine, and spermidine (doesn't that sound gross) are chemicals found in wheatgerm and fermented soya beans.

Common Nutrient Keeps Flies Sharp into Old Age: Scientific American:

Apparently natto, a Japanese product increases the amount of polyamines in human blood.  Natto, according to Wikipedia:

 Nattō is a traditional Japanese food made from soybeans fermented with Bacillus subtilis. It is popular especially as a breakfast food. Nattō may be an acquired taste because of its powerful smell, strong flavor, and slimy texture

Could this actually work for humans?  If so, it would be an amazing breakthrough!

A Homely Rodent May Hold Cancer-Fighting Clues - NYTimes.com

Another day, another breakthrough in cancer research:.  Interesting how the study of other organisms has resulted in so many medical findings.
A Homely Rodent May Hold Cancer-Fighting Clues - NYTimes.com:  Naked Mole Rats produce a compound, called hyaluronan,  that appears to prevent them from getting cancer.
Could this be the cancer cure we've been looking for?  I hope so!

If nothing else, it will possibly guide studies into other methods of preventing or curing cancer by employing similar mechanisms that hyaluronan uses. 

Alzheimer’s drug candidate reverses disease in mice Page 1 of 2 | UTSanDiego.com

This "J147" drug being developed and tested by the Salk Institute could be an extremely important breakthrough.  According to a recent RAND study, Alzheimer's disease is already one of the most expensive diseases,(See this article). With the upcoming aging baby boomers (us), the disease could bankrupt our medical care system.  If a simple drug could help reverse brain damage due to Alzheimer's disease, it could help mitigate that impact. The J147 drug is an extract of curcumin -- the spice in curry.   See this article Alzheimer’s drug candidate reverses disease in mice Page 1 of 2 | UTSanDiego.com:

The drug has already been in development for 6 years of preclinical studies at Salk.  The lead author of the study is Marguerite Prior, a research associate in Dave Schubert's laboratory.  Schubert is the head of Salk's cellular neurobiology laboratory.

David Schubert has apparently talked to drug companies and they are not interested in pursuing further development of the drug, and right now he needs only $1.5M to start the initial human trials -- and apparently can't get the funding.  I can see why the big pharmaceuticals might not be interested since it would be difficult to patent a naturally occurring spice, so there would not be much profit margin in producing the drug.  http://www.utsandiego.com/news/2013/may/15/tp-potential-alzheimers-drug-reverses-disease-in/

Since currently there really is no real cure, and the drugs that are prescribed only slow down the process slightly, it reduces the value of even screening for the disease.  Why find out if you've got it, if there's nothing that can be done about it?  http://www.utsandiego.com/news/2012/dec/03/alzheimers-dilemma/

Article in Science2.0 
Alzheimer's Research Journal about J147

Make your own J147:

The synthesis of J147 has been carried out using simple chemistry as described in our
previous paper by condensation of 3-methoxybenzaldehyde and (2, 4-dimethylphenyl)
hydrazine hydrochloride in EtOH at room temperature, followed by acetylation using
trifluoroacetic anhydride and triethylamine in CH2Cl2 gave J147 (Scheme 1). Donepezil has
been synthesized with 99% purity according to the literature procedure published in Organic
Process Research & Development 2008, 12:731-735 (Scheme 2).
Synthesis of (E)-N-(2,4-dimethylphenyl)-2,2,2-trifluoro-N'-(3methoxybenzyli-dene)
acetohydrazide (J147) {2nd Level Heading}
A mixture of 3-methoxybenzaldehyde (50 g, 367.64 mmol) and (2, 4-dimethylphenyl)
hydrazine hydrochloride (63.23 g, 367.64 mmol) in EtOH (50 mL) was stirred at room
temperature for 1 h, the obtained solid was filtered off, washed with ethanol and dried under
vacuum to afford hydrazone hydrochloride 1 (95.94 g) in 90% yield as a light brown solid.
This unstable hydrazone (50 g, 172.41 mmol) was dissolved in CH2Cl2 (50 ml), Et3N (57.56
mL, 413.79 mmol) followed by (CF3CO)2O (28.77 mL, 206.89 mmol), was added at 0°C and
the mixture was stirred at room temperature for 1 h. Reaction mixture was diluted with aq.
sat. NaHCO3 solution (500 mL), extracted with CH2Cl2 (2 x 500 mL), dried (Na2SO4) and
evaporated, resulting solid was recrystalized from ethanol to give J147 (49.11 g, 81%) as a
white solid: mp 70 to 72°C; LCMS purity 98%; 1H NMR (CDCl3, 500 MHz) δ ppm 2.10 (s,
3H), 2.42 (s, 3H), 3.82 (s, 3H), 6.98 (dd, J = 8.5, 2.0 Hz, 1H), 7.07 (d, J = 7.5 Hz, 1H), 7.14
(d, J = 8.0 Hz, 1H), 7.28 (m, 3H). MS (ESI): m/z calcd for C18H17F3N2O2 ((M + H) +)
351.1314; found 351.1366 ((M + H) +).

Americans Face Shorter Life Span, Life Expectancy Suggests NIH Study - AARP

The AARP reported on an NIH study that shows that the US is at the bottom of the list of longevity among the 17 advanced nations including Europe and Australia.    This is a very embarrassing situation for our country -- especially when we spend far mor per capita on medical care than any other nation.

Americans Face Shorter Life Span, Life Expectancy Suggests NIH Study - AARP:
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UCSD RESEARCH CLAIMS NEW CANCER WEAPON | UTSanDiego.com

This could be the long-awaited break-through in the "war on cancer" that was initiated by Richard Nixon when he was president:

UCSD RESEARCH CLAIMS NEW CANCER WEAPON | UTSanDiego.com: