Thursday, April 21, 2016

La$t Drop of Blood

What more do you want?

"Startup Theranos faces federal sanctions" by Caroline Chen and Zachary Tracer Bloomberg News  April 14, 2016

SAN FRANCISCO — US regulators have proposed sanctions that would ban Theranos Inc. founder and chief executive Elizabeth Holmes from the diagnostics business and bar the blood-testing startup from receiving payments from Medicare, according to a report in the Wall Street Journal.

The proposed sanctions would prohibit Holmes or Theranos president Sunny Balwani from owning or running a lab for two years, according to a March 18 letter to the company from the Centers for Medicare and Medicaid Services, or CMS, posted by the Journal. The letter gives Theranos 10 days to respond.

Lauren Shaham, a CMS spokeswoman, declined to comment or confirm the authenticity of the letter.

“The whole thing is hypothetical; if sanctions are imposed, we could appeal and the process could take months,” Brooke Buchanan, a Theranos spokeswoman, said by phone. “The fact is we have not received sanctions.”

She said Theranos had responded to the agency and was in discussions with it.

The letter posted by the Journal contains a list of proposed sanctions, including fines, revocation of Theranos’s ability to take payments, and a threat to ban company executives from the industry for two years.


A redacted inspection report of Theranos released in March by CMS detailed a long list of shortcomings at the company’s Newark, Calif., laboratory, including failures to meet quality-control standards, such as not keeping freezers at the temperatures required by manufacturers; lack of proper documentation and missing signatures on paperwork; and unqualified personnel. CMS said in late January that faults at the lab were so severe that they jeopardized patients’ health.

The company’s Arizona lab wasn’t part of the CMS report and has continued to operate, with the majority of patients coming through its outlets at Walgreens Boots Alliance Inc. stores.

Walgreens spokesman Jim Cohn declined to comment.


Do you see fraud in that face?

"Theranos under investigation by SEC, US Attorney’s Office" by Sheelah Kolhatkar and Caroline Chen Bloomberg News  April 19, 2016

Theranos Inc. said it is under investigation by the US Securities and Exchange Commission and the US Attorney’s Office for the Northern District of California, after the blood-testing startup has come under scrutiny by federal and state health regulators.

The criminal and civil investigations are among several probes described in a company memo provided to Bloomberg on Monday by closely held Theranos. The memo was sent to Theranos’s “partners,” which include Walgreens Boots Alliance Inc. and others.

“The company continues to work closely with regulators and is cooperating fully with all investigations,” Theranos said. It has also been investigated by the Food and Drug Administration, the Centers for Medicare and Medicaid Services, or CMS, and state health departments in Pennsylvania and California. Theranos said the FDA and state inquiries are closed.

The revelation is the latest in a stunning fall from grace for the company, which at one time commanded a $9 billion private valuation. Chief executive Elizabeth Holmes was profiled as a wunderkind after dropping out of Stanford University to found the company, attracting glowing media profiles that described promises to upend the medical diagnostics business with inexpensive tests using just a few drops of blood. Since then, the firm has been investigated by multiple health authorities and forced to defend itself against reports that its technology may not work.

In an interview broadcast on NBC’s “Today” show Monday before the investigations were announced, Holmes said she was “devastated” that her company didn’t catch the lab problems. She vowed to fix the problems and said the company would survive.

“We’ve taken the approach of saying, ‘Let’s rebuild this entire laboratory from scratch so that we can ensure it never happens again,’ ” Holmes said on the show. “I feel devastated that we did not catch and fix these issues faster.”

Theranos said some of the regulatory probes came after news reports published by the Wall Street Journal. The inquiries are focused on asking for documents and are ongoing, the Palo Alto, Calif.-based company said.

Walgreens spokesman Jim Cohn declined to comment. The pharmacy chain has about 40 stores in Arizona with Theranos “Wellness Centers” on site.


Is there not one drug store you can trust?

"Sean Parker’s put up big bucks for cancer. We’ve got questions" by Sharon Begley, April 13, 2016

Tech entrepreneur Sean Parker is just the latest big name to put up big money to fight cancer.

Parker, who helped found Facebook and Napster, plans to spend $250 million to build teams of researchers who aim to harness the immune system to attack cancer.

That’s on top of the $100 million for cancer immunotherapy research put up by former New York City Mayor Michael Bloomberg and clothing magnate Sidney Kimmel. Biotech billionaire Patrick Soon-Shiong has also assembled a coalition of rival drug companies to focus on immunotherapy. And the White House is proposing spending $755 million on a cancer “moonshot” led by Vice President Joe Biden.

So, will all that effort amount to anything?

Here are [some] questions to keep in mind:

Will the money make much difference?

If money could cure cancer, we’d be home free.

Still, extra funding is always welcome.

Are these new initiatives trying a new approach?


Is too much money chasing too few ideas?

This has happened before, such as when the federal government decided to make a big push for solar energy....

It's the billionaires who will save us.


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