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The Readout Damian Garde

Pick a side in the Biogen debate

On the subject of Biogen and its much-discussed treatment for Alzheimer’s disease, SVB Leerink analyst Geoffrey Porges contends that “the probability of [FDA] approval is high.” Baird’s Brian Skorney, by contrast, says Biogen’s drug “is not getting approved absent a deus ex machina.”

And the consensus, to the extent there is one, is somewhere in between, judging by Biogen’s stock price. That could change on Thursday, when the company will present detailed data on aducanumab, its once-waylaid Alzheimer’s drug. As STAT's Rebecca Robbins reports, experts will be looking for evidence that Biogen’s declaration of clinical victory is more than a matter of chance and small populations. She has four key questions.

Meanwhile, Biogen’s confidence hasn’t wavered. “Here’s the decision that FDA is going to have to make,” Chief Medical Officer Dr. Al Sandrock said at last month’s STAT Summit. “Do we believe there is enough evidence to approve it now? Or do we ask the company to do another trial, wait five years, and how many people have to get demented in that time period?”

You can watch a video of the full session with Sandrock here.

In Huntington's, hope meets the hurdle of clinical trials

When an experimental therapy for a currently untreatable disease reaches clinical trials, there's excitement and hope. But there's also desperation among patients who don't meet the criteria to enroll.

Such is the case with a clinical trial now underway to test a Roche treatment for Huntington's disease. The drug, called RG6042, is aimed at the genetic roots of the disease, and if it's successful, it could be life-changing for those affected by the genetic disorder. As with all trials, though, Roche's can only include so many people. So some Huntington's patients — those who are too old, too young, have other health conditions, or just couldn't get a spot — have been turned away from participating.

STAT's Andrew Joseph has the story of a trial that for now looks like the best, and really the only, option available to these patients, with multimedia from Matthew Orr and Dom Smith.

Read more.

Gilead’s awkward relationship with the feds

Yesterday, the Trump administration said it would provide HIV prevention drugs for free to people who should be taking them but don’t have prescription drug insurance coverage. What’s not mentioned in the Department of Health and Human Services’ 654-word press release is that the pills in question result from a donation from Gilead Sciences.

That’s perhaps because Gilead and HHS are in a strange legal situation. The government claims Truvada, an HIV-prevention pill that brings in more than $2 billion a year for Gilead, infringes federal patents. Gilead disagrees, and the two parties are fighting in court.

The new HHS program exists because Gilead decided to donate enough Truvada to cover as many as 200,000 patients over 11 years, and yet the company gets no mention, let alone official thanks. But one can imagine the government’s thinking on the matter: You don’t want to appear too grateful when your stated position is that Truvada isn’t Gilead’s to donate in the first place.

No one knows how many drugs $500 billion buys

There’s a bill in the House that would rein in the cost of drugs, which would in turn cut into pharmaceutical revenues and, according to the Congressional Budget Office, result in between eight and 15 fewer new treatments over the course of a decade.

Or maybe it’s 56 fewer treatments over a decade. That was the conclusion of a study, sponsored by PhRMA and BIO, released last month. But maybe instead it’s 100 new treatments, as the White House Council of Economic Advisers said yesterday. That analysis claims that the federal savings brought from cheaper medicines might actually be negated by the cost of sick people not getting novel therapies.

It’s worth noting that, of the three analyses, only the CBO’s is nonpartisan and not funded by the drug industry. But the roughly tenfold discrepancy in predicting the effects of pricing controls underlines a longstanding problem in this debate: No one can agree on the premise, let alone the conclusion.

More reads

  • Merck cyberattack’s $1.3 billion question: Was it an act of war? (Bloomberg)
  • As Trump looks overseas for drug pricing ideas, one expert says France has some useful approaches. (STAT Plus)
  • FDA nominee clears Senate panel (New York Times)
  • China’s CRISPR babies: Read exclusive excerpts from the unseen original research. (MIT Technology Review)

Thanks for reading! Until tomorrow,

Wednesday, December 4, 2019

STAT

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