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Hillary Clinton’s War on Pharma II; A call for common sense reporting on Alzheimer’s R&D

Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry.

thumb down Hillary Clinton wanted that war with pharma, badly

For all the backlash around Martin Shkreli’s brief, disastrous turn as CEO of Turing, the Tweet from Hillary Clinton condemning his price gouging stands out for the widespread damage it did to biotech stocks. There are lots of reasons why the biotech stock indexes have tanked over the past year. And it’s easy to see why that may have been overdue. But having a presidential candidate use Shkreli to declare a “war on pharma” sets the stage for the battle to continue in DC after the votes are counted. Trying to score cheap points with voters in a primary is a bad way to establish policy. Yet that is what we are looking at if Clinton is elected. The US — and the badly fractured health system that needs reforming — deserve better. And biotech has enough problems right now without getting caught up in the war. Let’s urge Clinton to take a more responsible stand if she wins the big election Tuesday.

thumb The SEC sends an important message on who biotech accountants are working for

We reported this week that the SEC wants to sanction the PwC accountant who let Steven Burrill go his merry way for years before he was caught – by other means – looting the biotech fund he managed. The SEC has already dealt with Burrill, who was forced to reimburse funds used for personal expenses, but enforcers want to send a message here to other accountants doing the books for biotechs and all companies. You have a professional responsibility to check out why execs are, say, advancing bigger and bigger sums for work not yet done. Sums that may never have been warranted under any circumstances. And you can’t be waved away by the same execs who may have something to hide. Burrill’s investors deserved better. Whatever the individual merits of these charges, let’s hope that message comes through loud and clear.

thumb down New internal FDA documents underscore Woodcock’s uninformed decision to back Sarepta drug

As I’ve said before, there’s no reason to expect the Sarepta controversy to go away anytime soon. The latest document drop from the FDA on the internal war over Janet Woodcock’s insistence on an approval now includes accusations that she ignored internal assessments on its Duchenne drug Exondys 51 from senior officials. This was nothing more than a gut-level decision which clearly deviated from agency standards for an approval. And FDA Commissioner Robert Califf unwisely decided to let her have her way, opening up a new and dangerous path for others to follow. Let’s all continue to hope this drug is as safe and efficacious as the company and patients advocates insist it is. But approving an experimental drug like this was worse than a mistake. It was bad policy making at its worse.

thumb down Let’s remain professionally skeptical about Alzheimer’s drug research

Looking over all the ways mainstream media fawns over early-stage Alzheimer’s drug research has become something of a hobby of mine. And this week we were treated to the full smorgasbord of gullibility with a string of unreserved reviews for the early animal and human data that’s become available for Merck’s late-stage BACE drug. Some of the UK papers (hello Daily Mail) have a tendency to jump from the slightest indication of efficacy in small groups to wondering when the new cure will be approved. We saw the same thing recently when Biogen touted its early data on aducanumab. But it’s a cruel hoax on the patients and their families. There are good reasons why Alzheimer’s has been an R&D disaster zone for more than a decade. Let’s wait for some convincing data before heralding the next big breakthrough. We’re a long way from a cure. And that’s a hard truth. Alzheimer’s development has a long, long way to go, under the best of circumstances.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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