Thursday, October 22, 2015

23andMe Launches New Health Tests, Navigates FDA Regulations - iHealthBeat

Consumer driven genomic testing joins consumer driven laboratory testing.

Both promise to reduce health care costs. But, will established laboratories oppose these efforts. The disruption will be massive.  The key issue is FDA approval and reliability of results.

The development pipeline may be altererd forever.

Elizabeth Holmes, CEO and owner of Theranos states that publishing basic research in peer reviewed journals takes too much  time and expensive delays.  She prefers subitting to the FDA directly.  But does the FDA have the manpower to establish reliability and repeatability of that data ?

Background on 23andMe

On Wednesday, genetic testing company 23andMe announced that it will provide customers with health information again, but in a more limited capacity because of continuing regulatory involvement from FDA, the New York Times reports.

23andMe Co-Founder and CEO Anne Wojcicki launched the company with investments from her then-husband Google Co-Founder Sergey Brin (Pollack,New York Times, 10/21). 23andMe launched its first genetic test, the Personal Genome Service, in 2007 (Humer/Steenhuysen, Reuters, 10/21). The company said its original $99 test could predict a likelihood of developing conditions such as:
  • Alzheimer's disease (Perrone, AP/Sacramento Bee, 10/21);
  • Breast and ovarian cancer;
  • Certain heart conditions (Reuters, 10/21); and
  • Parkinson's disease (AP/Sacramento Bee, 10/21).
However, FDA in 2013 ordered 23andMe to halt sales of the service because the tests had not received FDA approval (Reuters, 10/21). Since then, the company has used the genetic data it collected to fuel drug research and has focused on analyzing family history and ancestry, which is not FDA-regulated. More than one million people have used 23andMe's saliva-based test to learn about their genetic code (AP/Sacramento Bee, 10/21).

Details of 23andMe's New Testing Service

About eight months ago, FDA approved 23andMe's carrier screening test for Bloom Syndrome, a disorder that causes short stature and a predisposition to cancer. FDA then reclassified such carrier screening tests as Class II medical devices, meaning they no longer require premarket approval, which involves clinical trials. 
On Wednesday, 23andMe debuted a new $199 carrier screening test that can predict whether a person will pass on one of 36 conditions to a child, including:
  • Beta thalassemia;
  • Cystic fibrosis;
  • Sickle cell anemia; and
  • Tay-Sachs disease (Reuters, 10/21).
In addition, the test can predict non-medical traits, including:
  • Eye color;
  • Earwax composition (New York Times, 10/21);
  • Freckles;
  • Hair curliness; and
  • Lactose intolerance (Reuters, 10/21).
In addition, 23andMe still is working toward gaining FDA approval for personal tests predicting an individual's likelihood of developing specific diseases and how that individual might respond to specific drugs

23andMe Launches New Health Tests, Navigates FDA Regulations - iHealthBeat

More on the Theranos WSJ Interview--It's All About the Nanotube !

Friday, October 16, 2015

Theranos, one of the hottest new biotech startups, has a huge credibility problem - Vox



The Wall Street Journal and VOX Updated by  

According to Theranos founder Elizabeth Holmes, her technology amounts to nothing less than a health-care revolution: a disruptive and lifesaving innovation that delivers cheaper, earlier, and less painful results.



But Theranos, and Holmes, has also been surrounded by a dark cloud of suspicion. Critics have asked for proof that the company's technology actually works, and that its results are accurate. Holmes — the world's youngest self-made woman billionaire at 31 — and her PR team have mainly responded by citing intellectual property concerns and suggesting that the seeds of doubt have been sown by incumbent laboratory companies such as Quest and Laboratory Corporation.



Elizabeth Holmes talks with Matthew Herper at the 
2015 Forbes Under 30 Summit. (Image: Glenn Davis)


Some are questioning the accuracy and reliability of the results of their testing. Theranos offer a menu of tests, however only one test, HIV, has been approved by the FDA. And there have been some 'insider' employees who question the accuracy of the "Edison machine". These claims are refuted by it's founder, Elizabeth Holmes in a one thousand page rebuttal presented those claims to investigative reporter Matthew Herper of Forbes magazine  

In a series of tweets Elizabeth Holmes also counters Mr Herper's report.

There were other bizarre revelations in the Journal piece. Some parts of the Theranos website, which carried claims Carreyrou was probing, disappeared during his investigation. One former employee, Dr. Ian Gibbons, killed himself, and after the reporter spoke to his widow, "a lawyer representing Theranos sent her a letter threatening to sue her if she continued to make 'false statements' about Ms. Holmes and disclose confidential information."
The story goes on like this: Theranos repeatedly swings back at the Journal, even sending representatives to the homes of some of Carreyrou's sources to ask them to sign statements saying the newspaper "mischaracterized their comments."
Unsurprisingly, almost as soon as the story went up, the company published a statement denying many of the facts in the piece: Theranos' website elaborated their rebuttal statements.
Elizabeth Homes states;
“We’re under real attack from the lab industry which is seeding all sorts of stuff about us into the press,” Holmes told me, as you can see in the video above. Wait, I said to her. A lot of the people with questions Theranos are good, thoughtful people who are not in anybody’s pocket. She doubled down: “To be clear, the commentary in the press is 100% instigated by the lab industry and it showed up in the press about us last year and it’s just been repeated. What I would say is that we’re the only laboratory company that is really focused on transparency.”
According to Wikipedia, Elizabeth Holmes excelled early in life and later at Stanford University, where her original idea was developed.
Holmes proposed establishing a company to Professor Robertson in the fall of 2003, while she was a 19-year-old sophomore at Stanford. She used money that her parents had saved for her education to establish Real-Time Cures in Palo Alto. Later, she changed the company's name to Theranos (an amalgam of "therapy" and "diagnosis"),[9] because she believed that many people had a cynical reaction to the word "cure."[6] Holmes initially worked out of a basement of a group college house.[3] She dropped out a semester later to pursue her business career full-time. Professor Robertson served as a director of the company.
The company grew gradually over the next decade, raising $400 million from Draper Fisher JurvetsonLarry Ellison, and others. Theranos operated in "stealth mode" during this period, remaining highly secretive to avoid potential competitors and investors who could fund a competitor. The company took three former employees to court in 2007, accusing them of misappropriating trade secrets.[12]
By 2014 the company offered 200 tests and was licensed to run in every state of the US.[6] It had 500 employees and was valued at more than $9 billion. Holmes retained control of more than 50% of the company's equity.[13]
As of 2014 Holmes has 18 US patents and 66 non-US patents in her name and is listed as a co-inventor on over one hundred patent applications.[6] Holmes is the youngest self-made female billionaire on the Forbes 400 list at #111, with an estimated net worth of $4.6 billion.[2]
Arguments that dominant laboratory companies such as Quest and Labcorp have much to lose if Holmes innovative testing proves reliable and accurate. She argues they are behind much of the controversy.
Elizabeth Holmes idea is to allow patients to order their own laborataory blood tests, walking into a Walgreens and ordering the test for themselves.
One other component for success  will be if health plans will reimburse for a Theranos test ordered by a patient or a physician. Bloomberg reports a Theranos-- Capital Blue Cross agreement for reimbursements.
Theranos may be a disruptive technology for the clinical laboratory world. It's progress will be measured ultimately by individual decisions regarding specific test by FDA and/or CLIA wavers. Ultimately consumer acceptance as well as physician endorsement will predict success or failure for Holmes.
Health Train Express supports her efforts despite doubts by her competitors and others. Large and established companies have much to  lose and/or learn from her creative efforts.


Theranos, one of the hottest new biotech startups, has a huge credibility problem - Vox

Thursday, October 15, 2015

This study is forcing economists to rethink high-deductible health insurance - Vox

Americans aren't used to shopping for health care — and maybe we don't want to start


In 2006, about one in 10 employees had a health insurance deductible over $1,000. Today? About half do.
To health economists, this sounded like good news; they've long theorized that higher deductibles would force down health-care costs. The idea was that higher deductibles would make patients become smarter shoppers: If they had to pay more of the cost, they'd likely choose something closer to the $1,529 appendectomy than the $186,955 appendectomy (yes, some hospitals really do charge that much). This would push the really expensive doctors to lower their prices so cheaper physicians didn't steal their business.
This was, however, just a theory. And a massive new study suggests it might have been all wrong.
Economists Zarek Brot-Goldberg, Amitabh Chandra, Benjamin Handel, and Jonathan Kolstad studied a firm that, in 2013, shifted tens of thousands of workers into high-deductible insurance plans. This was a perfect moment to look at how their patterns of care changed — whether they did, in fact, use the new shopping tools their employer gave them to compare prices.
Turns out they didn't. The new paper shows that when faced with a higher deductible, patients did not price shop for a better deal. Instead, both healthy and sick patients simply used way less health care.
"I am a little bit surprised at just how poorly patients were able to do when looking at very similar products, like MRI scans, and with a shopping tool," says Kolstad, an economist at University of California Berkeley and one of the study's co-author. "Two years in, and there's still no evidence they're price shopping."
This raises a scary possibility: Perhaps higher deductibles don't lead to smarter shoppers but rather, in the long run, sicker patients.


This study is forcing economists to rethink high-deductible health insurance - Vox

Government: No benefit hike for Social Security next year - AOL

Government: No benefit hike for Social Security next year 

Thanks to decreasing gas costs, the annual cost of living adjustment (COLA) in 2016 will be zero. However this may be even worse for some Medicare beneficiaries. A little known exemption (waiver) means  current medicare recipients will not have any increase.  The waiver also extends to several other groups. The impact will affect those who begin receiving Medicare benefits in 2016. The monthly premium increase will be about $ 60.00.  This increase occurs despite the fact that Medicare's reimbursements have decreased over the past several years due to many factors.

Normally the COLA offsets any Medicare premium increases annually.

Since 2010 there have been three years where there was no COLA.

Social Security benefits are complex. The age at which you apply, your marriage status and  other factors will affect your monthly benefits.

Some seniors may benefit from applying for  Medicare early, before January 2016.  Advice from Health Train Express   "Check with your  social security office.

Tuesday, October 13, 2015

400,000 Citizens To Lose Health Insurance (Again) Because Of Obamacare Co-Op Failures | Galen Institute

400,000 Citizens To Lose Health Insurance (Again) Because Of Obamacare Co-Op Failures | Galen Institute



CMS Undermines Real Cost Savings for Consumers



The Obama administration is proposing a Medicare payment rule that would have the effect of clamping price controls on biosimilar drugs, extending destructive pricing policies to a potentially vibrant 21st century life sciences industry.
The Centers for Medicare and Medicaid Services (CMS) has proposed a rule that would guide how Medicare pays for a new class of medicines used in physicians’ offices and hospitals. The new medicines are designed to imitate the therapeutic effect of biologics—medicines created in the laboratory but derived from living organisms that lock into the body’s own biological processes to treat cancer, diabetes, rheumatoid arthritis, and other diseases

Her proposals to rein in prescription drug costs involve forcing pharmaceutical companies to meet a government quota for investing in research, denying companies tax breaks for consumer advertising, and capping out-of-pocket expenses for individuals with chronic health problems. Those are the new ideas.
Clinton also is recycling ideas to allow Americans to import cheaper drugs from abroad, allow Medicare to “negotiate” prescription drug prices, and reduce the patent life for innovative drugs—stale old ideas that have failed to gain bipartisan traction.
Her government-centric solutions would impede creation of new treatments and cures, restrict access to medicines for patients, and, by distorting markets and treatment decisions, ultimately drive up health costs. The dangers are addressed here, here, and here.

A  Bad Actor, Not A Pharmaceutical Innovator Causes Outrage over Drug Prices.
A profiteer masquerading as a pharmaceutical company executive has set the Internet afire with his 5,000% price increase for a rare but important drug used by AIDS and some cancer patients.
Martin Shkreli, a 32-year-old former hedge fund manager, cornered the market on Daraprim, a drug used to treat a life-threatening parasitic infection. His start-up company, Turing Pharmaceuticals, bought rights to this old but effective generic drug and used his temporary monopoly power to dramatically jack up prices.
Shkreli is by no stretch of the imagination a pharmaceutical innovator, yet The Washington Postused the news to implicitly indict the industry in a front-page article, “Pricey pill is rare case of transparency in health care.”
“Shkreli’s actions were shocking for a simple reason: It was an unusual moment of complete transparency in health care, where motives, prices and how the system works are rarely ever talked about so nakedly,” Post reporter Carolyn V. Johnson wrote.  “Shkreli’s company, Turing Pharmaceuticals, raised the price of Daraprim from $18 to $750 per pill because he could.”
The article implies that these actions are a windowinto the pricing practices of other pharmaceutical companies.  Nothing could be further from the truth.
Established pharmaceutical companies invest billions of dollars in research over more than a decade to bring a single new drug to market.  Companies must recoup their investment if they are to continue to invest in research for new treatments and cures.
Comparing Turing Pharmaceuticals to established pharmaceutical companies does not have legs. Turing did not invest in creating this drug. It bought rights to a drug approved 62 years ago and which has sold for as little as $1 a pill by previous licensers.  Recouping years of investment in research was not Shkreli’s agenda.
Still, even someone as arrogant as Shkreli responds to public outrage over his outrageous price hike for Daraprim. After the public outcry, Shkreli said he would lower the price by a yet-undisclosed amount.  It is hard to see any justification for anything remotely close to the $750 price. He was taking advantage of a temporary monopoly on this drug to, in turn, take advantage of patients with cancer and AIDS. How much worse does it get?
What Shkreli needs is not only public pressure but genuine competition

 By Grace-Marie Turner 56 Changes so far to ObamaCare(PDF) By our count at the Galen Institute, more than 56 significant changes have been made to the Patient Protection and Affordable Care Act, at least 35 that the Obama administration has…