Wednesday, October 26, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we bring you the latest in biotech. Follow us on Twitter: @damiangarde@megkesh, and @statnews.

How Purdue Pharma bought its way out of an OxyContin roadblock

Back in 2001, West Virginia officials, hoping to stem the spread of fatal OxyContin overdoses, came up with a plan: requiring prior authorization before allowing the powerful painkiller to be prescribed.

But unbeknownst to them, Purdue Pharma, the drug's manufacturer, had a deal with a middleman in which it traded rebates in exchange for a guarantee that OxyContin remained available. Years later, in the midst of an opioid overdose epidemic, local officials recall "screaming at a wall" as the seeds of crisis were planted in their community.

STAT's David Armstrong has the story.

Ask anyone: The pricing issue isn’t going anywhere

Public furor over the escalating cost of medicines isn’t constrained to a single tweet or congressional scolding session. And, as mounting evidence suggests, it’s not going to go away on Nov. 9.

Just ask famed short-seller Andrew Left, who made his name betting against Enron and was largely proven right when he recently came after Valeant Pharmaceuticals. Yesterday, Business Insider asked him about promising short opportunities coming out of the election. He’s wagering that drug companies will take a hit on pricing. 

“The only idea short term is to see if the government is serious about regulating pricing on prescription pharmaceuticals and what companies are levered up and who can be vulnerable,” Left said.

Meanwhile, PhRMA is raising annual membership dues by 50 percent. That'll give it a $300 million war chest to defend the drug industry post-election and prepare for legislative fights around the country. The industry is already fighting “tooth and nail,” as Eli Lilly CEO John Lechleiter put it, to defeat a California proposition that would constrain pricing in the state.

"We expect pricing to become more difficult in the US over the next three to five years," Novartis CEO Joe Jimenez told investors on Tuesday. He is not alone.

Pfizer CEO Ian Read: Perhaps not a scofflaw, but scoffing at law

Pfizer CEO Ian Read has ample reason to be disgruntled with The Man: That Pfizer-Allergan mega-deal was, after all, axed earlier this year by the US government.

But his distaste with regulatory bodies stretches deeper still. Yesterday, at the Cleveland Clinic Medical Innovation Summit, Read took to the stage and spoke plainly of the failings in the US healthcare system, including his frustrations with regulatory policy — ranging from the Sunshine Act to generic drug oversight at the FDA. Some excerpts:

On research and development
One big reason that drug development timelines are so long? Red tape. Or, as Read put it: “Most of the time is wasted in interaction with the FDA.” 

From the earliest investigative stage, “there are long discussions about meeting regulators' needs, which may or may not be valid,” he said. He is more inclined to trust the drug developers to do what's right: “Good scientific organizations... [will want to] bring forward good trials," he said.

On the EpiPen
The costliness of the EpiPen, too, is a “failure of regulation,” Read said.

One reason the EpiPen (which is manufactured by Pfizer) is so costly is that the FDA has laws in place that standardize how these life-saving devices work. That's meant to ensure reliability, but it also makes it tough for competitors to jump in and create alternatives. 

“You want an FDA that’s strong. You want them to bring safe medicines to you,” Read said. “And right now, the fallout of that is — you have to pay more for generic products, because you were so focused on having this pristine, totally independent, totally-focused-on-safety FDA that you don’t get the regulations right.”

On medication non-adherence
Even issues like medication adherence are out of the hands of drugmakers, Read said — because kickback laws limit the amount of contact between pharma and physicians. So while helping patients regularly take their meds would certainly help Pfizer's bottom line, and presumably help patients, too, the company can't do much about it.

“The kickback provisions stop us from working with [physicians] on that,” Read said. “Basically it’s the laws that stop us.”

‘Druggable’ is a relative term

Identifying genes with ties to Alzheimer’s disease is a good thing. So, too, is keeping in mind that decades of such discoveries are yet to lead to drugs that could arrest the disorder’s effects on the brain. A new study seems to accomplish the first good thing but fall a bit short of the second.

Researchers from the Boston University School of Medicine compared genomic data from African-Americans with and without Alzheimer’s, homing in on a group at higher risk of developing the disease. Writing in the journal Alzheimer's and Dementia, the researchers report that two genes — COBL and SLC10A2 — were particularly associated with the disease.

The study “identifies two potentially druggable targets,” one of the researchers said in an accompanying press release, which touted the discovery’s potential to “lead to the development of new therapies.”

That is, of course, not impossible. But it’s worth noting that APOE and LRRK2 — two genes that have been associated with Alzheimer’s for decades — remain decidedly undrugged. As biochemist Derek Lowe wrote last week, “there is no genetic smoking gun for Alzheimer’s, because it would have been found by now.” And thus each incremental discovery must be taken with a grain of salt.

The FDA has thoughts on the female libido

While Addyi may have proven a touch anticlimactic, there’s hope for a new generation of drugs that might increase a woman’s libido.

The FDA yesterday released a draft guidance that outlines what it’s looking for in developing the 2.0 version of a "female Viagra." The guidance alone seems to validate the need for this class of drugs.

“Sexual dysfunction can adversely affect various aspects of life for a women, including her relationship with her partner,” FDA writes. “There is a medical need for development of drugs with a favorable benefit-risk profile to treat women with sexual dysfunction.”

More reads

  • Ireland has joined the growing queue of countries lining up to host the European Medicines Agency if it ditches the UK in a post-Brexit world. (Reuters)
  • The Bill and Melinda Gates Foundation is donating $210 million to the University of Washington to support healthcare research. (AP)
  • Vertex is taking its next-generation cystic fibrosis combo into mid-stage trials this year. (TheStreet)
  • How the fleece vest became the unofficial uniform of Silicon Valley investors. (Business Insider)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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