General Government & Technology Medical Technology

If Theranos can do this, why not 23andme?

theranos walgreens

Theranos opens in Maryland, and 23andme is still chatting with the left in last century organization , FDA, which is always busy with its special interest groups. (United Healthcare on speed dial?) See our first post on Theranos – An Almost Great Start Up

I find it odd that Walgreens in Maryland can give blood tests to anyone over 18, you don’t need an Rx, and it comes with a consult with a pharmacist.

Yet, 23andme can’t read your genes and tell you what the published literature says about it.

Walgreens says: Test results are not for diagnostic or treatment purposes and are not conclusive as to the absence or presence of any health condition.

So why does a consultation with a pharmacist come with the blood test that is not for diagnostic purposes? To discuss the weather? This is BS. Of course the tests are going to be used for diagnostic purposes and I bet these stores s will show increased statin sales to go with the pharmacist being asked, “Is my cholesterol high?” Oh, how I would love to see a brochure from Stephen Sinatra, MD, FACC right there telling people that the current cholesterol levels are a scam.

Here’s the PR from Walgreens:

Walgreens (NYSE: WAG) (NASDAQ: WAG) is now offering daily testing for cholesterol, blood glucose and body composition at more than 60 stores in Maryland. Each test also includes a free blood pressure reading and personal consultation with a Walgreens pharmacist.

“Providing convenient, affordable access to health testing services is an important part of our commitment to disease prevention and chronic care management,” said Jon Reitz, market pharmacy director, Walgreens. “As the most accessible health care providers, our pharmacists are spending more time with patients through consultations, immunizations, medication questions or concerns, health testing and other important services to help our customers get, stay and live well.”

Tests are available to those ages 18 and over at most stores during pharmacy hours daily with no appointment necessary. Walgreens offers health testing daily at more than 4,100 stores in 41 states. To find the nearest Walgreens offering these testing services, visit the store locator at www.walgreens.com/findahealthtest, or call 1-877-W-and-YOU (1-877-926-3968).

Walgreens pharmacists administer tests by fingerstick. Cost for testing is:

— Total Cholesterol – $35

— Blood Glucose – $20

— Body Composition – $15

— Wellness Pack: Cholesterol, Blood Glucose and Body Composition – $65

— Blood pressure – free with every health test

Test results are not for diagnostic or treatment purposes and are not conclusive as to the absence or presence of any health condition. Customers are encouraged to share test results with their primary care physician.

General

Bitcoins Are Here, Thank you Coinbase

bitcoin silicon valley

We decided to accept bitcoins. (Our favorite cafes like Coupa Cafe and Cafe Venetia accept them.) Our product is this site but you could help us keep going if you have some extra bitcoins in the electrons to share. We sure do appreciate it.

Donate Bitcoins

Will bitcoins be THE most disruptive innovation? Maybe. Will they crash and burn? Maybe.

I don’t know but we like to be where new, new things are because the old, the current and the near future aren’t looking so great.

There’s action:

From Techcrunch

Coinbase has raised $25 million in a Series B round led by Andreessen Horowitz in the largest funding to date for a company focused on the Bitcoin digital currency. Existing investors Union Square Ventures and Ribbit Capital also participated.

The round brings the total raised by Coinbase up to $31 million.

Coming out of Y Combinator last year, Coinbase provides a wallet and payment processor for merchants, analogous to what PayPal created a decade ago to provide a simple online means for transactions.

Coinbase now has around 600,000 consumer wallets, according to co-founders Fred Ehrsam and Brian Armstrong. That’s up from 130,000 it announced in May alongside its first venture round of $5 million from Union Square Ventures.

 

READ OUR BITCOIN MYSTERY PAGE: MYSTERY

General

What’s New in Palo Alto

A visual look around town while we recuperate from cold weather.

We find: IDEO puts up directions to find its new home; Philz Coffee gives love and good vibes; City Hall does an LED tree as we import Arctic temps; Good Vibrations come also from Good Vibrations (18 and older to enter, on Ramona next to Coupa) and we welcome PowerSite (High St.) and S. Graf (Hamilton Ave)

Government & Technology Medical Technology Voices

The FDA, Irate Customers and 23andMe again

23andme fda

23andme and the FDA

A recap of the past day: 23andme has stopped including the health reports section of the test because apparently people are not smart enough to understand the results as presented: High, Low, and Typical risk category. The FDA is worried people will be rash based on what they read.

Agreed – people don’t understand risk. Over the past three years I’ve watched many 23 consumers begin a thread on the forum with: “23andme got it wrong! I don’t have arthritis or (fill in the blank) – melanoma, blue eyes, gout, etc. They thought high risk meant: YOU HAVE IT! If they were placed in high risk that’s how the results were interpreted, similar for low risk: “23andme got it wrong! I have breast cancer, (curly hair, psoriasis, etc) and they say I don’t.”

No, they never said that at all. They associated your genetic output with published studies. They did a literature search for us.

No matter how many responded to explain the word ‘risk’ and what the numbers meant, the problem continued. I wonder why 23 didn’t explain this issue more clearly before giving the results in the same manner they make people jump through hoops to learn the most serious breast cancer or Alzheimers risk (are you sure? really sure you want the results?) This was a perfect place to have a few slides that must be read before results are given. I also think the LOW RISK category should have been first. I suspect low risk calms the mind enough to deal high risk with a better frame of mind leading to a less dramatic (and incorrect) reading

What People Are Saying Now

Furious, angry, so upset. Those are word used by 23andme customers against 23andme. I’m in shock and awe. 23andme would LOVE to give results for those who bought after November 22nd. The FDA is responsible for the current hold from Nov 22 on. But anger is directed at 23andme. Lesson here: to some, they bought a product from a corporation and want what was promised. The reason it can’t be is not understood or appreciated. These may be the same people who fail to understand RISK as in 23andme is at greater risk in giving the health reports than not doing so. RISK – a word people need to understand.

The best analysis of the situation I have currently seen is here at the Law and Science Blog from Stanford.

General

We Found IDEO

IDEO

Breathe again.

In the cosmic lost and found, I lost IDEO and they found us. Thank you.

Here they are:

Across from the old entrance on 100 there is a sign that says ‘Welcome to IDEO, right this way’ which redirects people to our front entrance which has been temporarily moved as we undergo a campus redesign. We are rethinking our Palo Alto space to better meet the needs of our people, our work and our clients.

IDEO’s reception will be temporarily located on the rear side of 715 Alma. Our front doors can be accessed by walking down the alley from Forest Avenue between Alma and High Street. We will no longer be in 100 Forest Ave but IDEO will continue to have a presence in Palo Alto and will remain headquartered in the location.

General Government & Technology Medical Technology

23andme and you and the FDA

23andme.com logo

More thinking on this subject.

Over on The Economist website someone wrote in that United Healthcare is behind the FDA’s attack on 23andme. Apparently they have a long history of complaints about 23. And they have friends at the FDA. United Healthcare, like many, are worried they are not getting their slice of the huge pie that is genetics testing. The market is estimated at 25 billion over the next decade.

Insert here one issue raising its head in the conversation – privacy and piracy. Some are saying genetic info can be used against you. Anything can be used against you: your name, social security number, cc info, DOB…but they also are quite useful to you to live a functional life today. The same is true of genetic information. Being a chicken little is only first stage resistance to something new. People used to argue whether we should “allow” couples to know the gender of the unborn baby when that issue first arose. We allowed it and we survived. Same again here. To function in the medical world of the future we need to have our DNA decoded.

It will be either at birth or through 23andme or maybe it will be both. Insurance companies will demand the info – it benefits everyone to know, e.g. that you don’t respond to Prozac. They won’t pay for it and you don’t have to be called noncompliant when you stop taking the stuff. It will be cost effective to have genes tested.

This is all going to work out: the quacks in the middle are demanding their cut and they will get it. Genetics will be Rx and you have to have a “consultation” pre and post. The issue isn’t IF genetics will be corporate info, it is WHEN.

Anne Wojcicki isn’t going anywhere. 23andme is here to stay. Stanford, NIH, Johnson and Johnson, are all involved. And Google is embedded. I suspect this is a changing point and one that puts 23andme on the map and in the chips quickly. Need an Rx? Fine..send them to 23andme.

Everyone is going to slice this pie and in the end, medicine/health will be genetically based. It has to be – we know it, we have medicalized and monetized it and what remains is full scale deployment.

But we also need to educate people that they are in charge of their DNA and health – that if you are high risk, you CAN make a genetic difference by lifestyle. Stress, soda, and sourdough bread can make you diabetic, especially if you have a pre-disposition genetically. Enter epigenetics: environment interacting with your genes. This is so exciting – we can be in charge, more so than ever before. Our DNA, our lifestyle, our choice. No Rx needed to stop eating red meat and potato chips. That mammogram? Radiation causes mutations – maybe you don’t want one every other Friday.

We have a chance to mold the future. Let’s do it. Torpedo the old paternalistic system, take charge of your genes, get them to express or not. Live long and thrive 🙂

Government & Technology Medical Technology

FREE THE 23! FDA Halts 23andme Genetic Tests

23andme.com logo

People have a right to all information about their bodies and health.  Real stats, genetics, risks, things that can be done that don’t require paying someone in a white coat to do.  It belongs to us.  “They” can medicalize and monetize it and they have and will, but it is always ours.

The FDA  had to be sued before they would inform the public that trans fats are bad. Yes, that’s how that came to be. They were sued so they (legally) had to respond with the facts (evidence) that they are indeed a toxin to the body.

Now, this icon of quackery, fraud, greed, and well, you get the picture…has told Anne Wojcicki’s 23andme.com that it has to stop marketing the genetic test they sell for $99.00 You don’t need an Rx to take your temperature (yet) but we need permission to find out if we are high or low risk for heart disease? Cancers? If warfarin dose should be reduced in certain populations? Oh spare me the paternalization of the already deathly medicalization of the body.

The FDA might have some value but when their own researchers out the place for systemic fraud, it’s time to step back, stop bowing, and ask some hard questions.   Too many people think a double blind, peer reviewed study given a blessing by the FDA means “all is well”.  These are just the asleep at the wheel consumers the drug companies like to have.

The FDA isolated 23andme and the drug warfarin (rat poison) as problematic saying only an FDA approved test can let people know if they are unduly sensitive to this drug. I happen to be one of the sensitive ones – meaning if you give me warfarin, I need less than most because of my genetic makeup. This isn’t a maybe. This are my genes, IRL, and would be the same no matter where I get the test.

Speaking of warfarin, here is what 23andme says about it in their blog and you may find a hint of why the FDA targeted this result:

The mostly commonly used blood thinner, warfarin (Coumadin®) has proven to be a godsend for millions of people at risk, but this study suggests that as many as half of those who use the drug do not benefit from it because of challenges related to finding the proper dose.

Calibrating the right prescription of warfarin is notoriously difficult because the right amount depends not just on such things as a person’s size, their diet and age, but also, importantly, their genes.

The new study isn’t about genetics. It’s by researchers at Duke Medical Center, who suggest that the new blood thinner apixaban is safer than warfarin and more effective at preventing strokes in people who have atrial fibrillation, a common heart rhythm disorder.

Apixaban hasn’t yet received FDA approval. That may soon change, but the study reminds us of all the challenges with current drugs and the tremendous amount of resources invested into finding drugs that are safe and effective for more people. Another complementary way to achieve that goal is by learning more about how individual patients may respond to specific drugs. Your genetics are a big part of that equation.

In the case of warfarin, a person’s genetics directly impacts how sensitive they are to the drug. Although there are a number of factors that influence a person’s optimal dose of warfarin, genetic variations in the CYP2C9 and the VKORC1 genes play an important role in how the body responds to the drug. More than two years ago the FDA updated the labeling on warfarin to make note of this genetic influence but genetic testing is not req

Some think the insurance companies are behind this step. Maybe. If it benefits them, sure. One might think (hope) that the insurance companies should be delighted with genetic testing. Your genes say you don’t respond well to a drug such as a certain SSRI? – then your insurance company will not be paying for drugs that don’t work.

And if we got the important information out such as – if you do have Jolie’s genes, the last thing you want to start doing is radiating those breasts. Radiation is carcinogenic. Every exposure damages DNA. When the DNA repairs, there is the possibility it repairs incorrectly with mutations. Radiate those possibly cancerous breasts and you turn on the gene and make the possibility a probability. See what Lawrence Berkeley Lab scientists have to say about radiation and cancer .

High risk for colorectal cancer? Start with what you can control epigenetically – stop eating red meat. That alone saves lives. If I were insurance companies I’d get the word out on the number of deaths each year from colonoscopy and tell people to make an INFORMED decision before rushing to get scoped. I’d also show the evidence that polyps can go away and how slow growing they are. It is important that every data point gets out as well as those from people saying, “Colonoscopy saved me!!!!!”

Don’t forget DNA is ME (get your flipboard app to appreciate this. It is www.thesiliconvalleystory.com ‘s magazine on genetics.

General

Lean In @Dreamforce with Sheryl Sandberg

Great talk by Sheryl Sandberg. What took this issue so long to be addressed?

I am reminded of a story that happened to me my first day at work at a  small tech company. The President comes to my desk and welcomes me. He says. “I’m always glad to have another woman. They work twice as hard for half as much.”

I kept my mouth shut and thought to myself, “I’ve just been granted the best information I could have. The game is rigged and now you know it.”

Fast forward. The President is fired.  The company is bought. I get fired. The next day I get a call from my boss and he says, “It was a mistake to fire you. The new owners say you have to be a part of the package. They want you.” I said, “Fine.  I’ll come back and this is how much I want.” Boss: “You wouldn’t do this to me!” Me: “Yes.”

I get the raise. I return,  I get 2 more promotions with raises over the next two years before I leave.

Sheryl: Thank you for calling out the gender issue.  This time, it will stick.

 

 

 

 

 

 

General

Music In Palo Alto

silicon valley story

Jerry Garcia is gone.  St. Michael’s Alley isn’t what it used to be. But every once in a while we are reminded that music is still alive and important here in Palo Alto.

I’m sorry that the video didn’t turn out so well due to lighting conditions but thanks for a nice interlude as tech takes a back seat for a minute in Silicon Valley.

A shout out to James and Daniel…small world!