OxyContin, Abbott, and the 'King of Pain'

Purdue Pharma has been pilloried for its marketing practices with OxyContin, which made the drug a blockbuster and helped plant the seeds of the opioid crisis. All the while, Abbott Laboratories, Purdue's marketing partner, stayed out of the headlines.

But internal documents obtained by STAT's David Armstrong show that Abbott gleefully pushed OxyContin with aggressive marketing techniques (including plying one reluctant doctor with his favorite donuts and accosting others in their local bookstores). The sales reps, led by a manager who called himself the "King of Pain," were instructed to downplay the threat of addiction and make other claims that had no scientific basis.

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Silicon Valley's bold new biotech foray

Mark zuckerberg and priscilla chan think a few billion dollars will help answer that question in the affirmative.(Jeff Chiu / AP)

Silicon Valley’s betting big again on biotech, and it’s a moonshot of a goal: Facebook CEO Mark Zuckerberg and his wife, Dr. Priscilla Chan, announced yesterday that they'd commit $3 billion over the next decade to try “to cure, prevent or manage all diseases within our children’s lifetime.”

Part of this philanthropic effort includes building a “cell atlas,” which looks like a boon to biotechers — it’s meant to catalogue all cell types in the human body to more deeply understand the progression of disease.

One thing that biopharma might not love quite so much? A commitment to open sourcing all the data.

Zuckerberg and Chan will funnel $600 million into building a cooperative called the Biohub, which will bring together researchers from Stanford, UCSF, and Berkeley. They’ll get plenty of funding to do basic science research — with 5-year grants doled out to “early investigators” with “bold, innovative, risky ideas,” said Cori Bargmann, a Rockefeller University neuroscientist who is leading the effort.

Personalized cancer vaccines are more and more likely to be a thing

Genentech is the latest major drug maker to buy into the concept of personalized cancer vaccines, signing a $310 million deal with a German biotech company called BioNTech.

The idea is to use messenger RNA, or mRNA, to help the body detect tumors. In theory, mRNA can compel cells to produce any protein, and BioNTech believes it can force tumors to express proteins that sound alarms within the immune system. Genentech already makes drugs that help the body’s natural defenses attack cancer; it's interested in pairing the two technologies to craft a tumor-killing combination.

The deal falls right in line with a pair of other mRNA partnerships: Moderna Therapeutics’ agreement with Merck, and CureVac’s deal with Boehringer Ingelheim. (For what it’s worth, BioNTech, which has been working in the field for years, might bristle at being compared with Moderna and its year-old cancer vaccine program.)

There are a great many unanswered questions about mRNA, but even skeptics agree the platform has potential in the world of vaccines. And Genentech, in writing such a big check, would seem to agree.

Gilead hits a snag outside of hep C

For the past year or so, the back and forth with Gilead Sciences has gone like this: Investors worry the company will sink if it doesn’t make a big acquisition. Management insists it's got great products on the way and complains that it's pipeline is undervalued.

That latter case took a minor blow on Wednesday as Gilead conceded that its in-development treatment for ulcerative colitis doesn’t really work. The company terminated a late-stage study of an antibody called GS-5745 after its independent advisers noticed that the treatment had little chance of meeting its goals.

It’s not a major setback for Gilead, as GS-5745 is still in development for gastric cancer and autoimmune disease. But it won’t help placate the anxious investors checking their watches as Gilead’s colossal hepatitis C revenues slink back to earth.

A senator takes the FDA to task for a power grab

Senator Lamar Alexander is not happy about the FDA's proposal to regulate all laboratory-developed tests.

“The biggest loser, it seems to me, would be Americans who stand to benefit from the rapid pace of science and discovery,” he said this week in a Senate health committee hearing.

Alexander estimated that Vanderbilt University Medical Center in his home state of Tennessee would have to shell out $30 million to $75 million to get a single laboratory test through the FDA regulatory process.

That seems a little steep. Alexander said he based his estimate on how much one company spent a few years back to get approval of a high-risk medical device. But most lab tests are way simpler and less risky, and the regulatory process is unlikely to cost anywhere near as much.

Alexander also argued that FDA regulation is unnecessary, since the Centers for Medicare & Medicaid Services already oversees lab-developed tests. That's true. But this report from the FDA offers pretty solid justification for imposing more stringent oversight.

Thursday, September 22, 2016