Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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It's Official. Califf Abandons Pharma & Sides With Silicon Valley to Solve Inequities in Healthcare

It's Official. Califf Abandons Pharma & Sides With Silicon Valley to Solve Inequities in Healthcare | Pharmaguy's Insights Into Drug Industry News | Scoop.it

My hope is that Silicon Valley and entrepreneurs nationwide will collaborate on building an environment capable of linking the more than 300 million people in the U.S. to information that helps them live healthy, productive lives. Within this broad mission, I’m particularly focused on bridging a growing divide that has led to unprecedented health disparities as functions of income, education, race, and geography. But as increasingly ubiquitous smartphones and other electronic devices allow more and more people to access amazing sources of information and knowledge, we have the essential means to reverse these trends.


Both giant information companies and our country’s universities—particularly those with large health systems—have critical roles to play in ensuring that all Americans, and ultimately the entire world, benefit from new knowledge and technological capabilities. Generating and analyzing information are not enough—we must overcome barriers to using data to improve health and healthcare. I have no illusion that I have the solutions to these problems, but I am grateful for the opportunity to work with a company and a university that are letting me give it a shot!

 

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The Valley vs. the FDA: Kleiner's Beth Seidenberg on Getting Along With the Agency Tech Loves to Hate

The Valley vs. the FDA: Kleiner's Beth Seidenberg on Getting Along With the Agency Tech Loves to Hate | Pharmaguy's Insights Into Drug Industry News | Scoop.it
She says the FDA's "breakthrough therapy" designation has accelerated approvals, but more reform is required.


While health is suddenly a hot topic in the region, a handful of venture capitalists have said they simply won’t invest in companies that require FDA approval — opting for the relative safety (or more obvious exits) of health apps and infrastructure plays over drugs and diagnostics. Others are looking for end runs around the system altogether.


In large part it’s a cultural clash. The ask-forgiveness-not-permission ethos of an Uber or Airbnb, which counts on consumer sentiment to swing policy, doesn’t play with the FDA. You’re not allowed to move fast and break things when it comes to people’s health. And the agency doesn’t take kindly to companies that violate its rules while ignoring repeated requests for information.


But some in Silicon Valley, particularly those who have no choice but to work with the FDA, are striving to locate what is ultimately some obvious middle ground: Yes, the FDA is slow, underfunded and understaffed. But beyond the invisible hand fringes, few are eager for a return to the days when the free market decided what was medicine and what was snake oil (or worse).


I caught Dr. Beth Seidenberg, a partner in the life sciences group at Kleiner Perkins Caufield & Byers and a physician who trained at Johns Hopkins University, sounding utterly constructive on the issue during a conference earlier this summer.


Seidenberg is the former chairperson and co-founder of the National Venture Capital Association’s Medical Innovation and Competitiveness Coalition, created in 2010 specifically to push for FDA reform. Before joining Kleiner, she was the chief medical officer at Amgen and a senior executive in research and development at Bristol-Myers Squibb.

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But have U.S. patients paid the price? Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month.

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Not Only Investors, Patients Also Were Hurt by Criminal Theranos. Lock HER Up!

Not Only Investors, Patients Also Were Hurt by Criminal Theranos. Lock HER Up! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A review of regulatory records and interviews with patients shows that Theranos, a Palo Alto, Calif., company didn’t just burn investors who bought into its promise to revolutionize the world of blood testing. It also left a trail of agonized patients who had been drawn to Theranos by its claims of convenience, low cost and reliability.

 

While inaccurate tests can occur at any laboratory, Theranos failed to maintain basic safeguards to ensure consistent results, according to regulators, independent lab directors and quality-control experts.

 

Questionable test results from Theranos caused some patients to become alarmed and others to adjust the amount of medicine they were taking. Rattled patients who told The Wall Street Journal they sought more information about their results said they got no response, and weeks or months passed before Theranos told many patients that their results were unreliable.

 

In all, Theranos said it issued “tens of thousands” of voided or revised test results to doctors or patients.

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Related story: “Will Silicon Valley Startups & Empowered Patients Replace #BigPharma?”; http://sco.lt/9FmPDN

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