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Thursday, May 4, 2017

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

On that upcoming biotech pow wow in the White House

Donald Trump, along with top White House players like Ivanka and Jared Kushner, will meet with a cadre of biotech researchers, industry execs, and investors on Monday. Among the attendees, according to Bloomberg, are Regeneron CEO Len Schleifer (so we know pricing will be high up on the agenda), Stanford University President Marc Tessier-Lavigne, and Cori Bargmann of the Chan-Zuckerberg Initiative.

So we wanted to ask you: How do you think this whole shindig will go? What will they talk about? What do you want the biopharma execs to to convey to the leader of the free world? 

Let us know here. We may print your answers in an upcoming Readout.

A biotech brouhaha worthy of Beckett

Amid the tooth-gnashing and garment-rending around Neurotrope’s failed Alzheimer’s disease trial this week, there was one gleamingly positive voice: An article, written for Seeking Alpha, that mysteriously found its way onto a press release wire.

That seemed odd to TheStreet’s Adam Feuerstein, who, mindful of that recent Seeking Alpha-related biotech scandal, did some digging and got a hold of the author.

What ensues is a surreal dialectic about micro-cap research, public relations, and inscrutable acronyms that is very much worth your time.

Approving drugs that don’t work is both bad and expensive

So say a trio of doctors writing in the New England Journal of Medicine, pointing to Eli Lilly’s failed Alzheimer’s disease treatment solanezumab and concluding that the “FDA saved taxpayers billions.”

Not because the agency rejected solanezumab — the FDA never actually reviewed it — but because it asked Lilly to carry out the large, rigorous trial that eventually damned the drug. That’s usually standard procedure after Phase 2, but the authors warn that 21st Century Cures could portend a world where drugs can win approval on mid-stage data — a world in which millions of Alzheimer’s sufferers pay big money for a drug that doesn’t work.

Even in the pre-Cures world, approval standards were already plenty lax, according to a coincidentally published paper in BMJ. The authors looked at 117 drugs approved either on a single pivotal study or effects on surrogate endpoints and found that very few ever went through the sort of rigorous trial that kept solanezumab off the market.

Califf goes rogue!(ish)

Now that Dr. Robert Califf’s bureaucratic chains have been reft, the former FDA head is pulling no punches on health care: 

“We know that so much of what we do is practically worthless,” he said yesterday at the World Medical Innovation Forum in Boston, “and the incentives for payment right now often reinforce things that don’t have much value.” 

The conference focused heavily on value-based care — and Califf pointed out that how effective a drug is often bears little relation to how much it costs.

“The reimbursement system, I think, is really messed up,” Califf said. “If you just compare lives saved, life years saved, quality of life — drugs in different areas of medicine that have equal effects have very different reimbursement schemes. I think that’s having a huge effect.”

Read more on STAT Plus.

More reads

  • A year after approval, GlaxoSmithKline has treated its first patient with a gene therapy. (MIT Technology Review)
  • High stakes in Big Pharma's latest cancer race. (Wall Street Journal)
  • Imaging technology could help doctors identify which prostate cancers truly need treatment, saving thousands of men a year from unnecessary treatment. (STAT

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Thanks for reading! Until tomorrow,

Damian & Meghana

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