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PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty.

I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else.

However, the really interesting part of this week’s meeting of an FDA joint Advisory Committee to discuss the controversial diabetes drug Avandia – at least in the sense of likely long-term impact – is not the scientific question under discussion, but the surfacing and handling of the raging interpersonal battle going on right now inside the Division of Cardiovascular and Renal Products. So I'll have to swallow my distaste and follow along with the drama.

Two words that make us mistrust Duke:  Anil Potti Christian Laettner

Not that the scientific question at hand – does Avandia pose significant heart risks? – isn't interesting. It is. But if there’s one thing that everyone seems to agree on, it’s that we don’t have good data on the topic. Despite the re-adjudication of RECORD, no one trusts its design (and, ironically, the one trial with a design to rigorously answer the question was halted after intense pressure, despite an AdComm recommendation that it continue).  And no one seems particularly enthused about changing the current status of Avandia: in all likelihood it will continue to be permitted to be marketed under heavy restrictions. Rather than changing the future of diabetes, I suspect the committee will be content to let us slog along the same mucky trail.

The really interesting question, that will potentially impact CDER for years to come, is how it can function with frothing, open dissent among its staffers. As has been widely reported, FDA reviewer Tom Marciniak has written a rather wild and vitriolic assessment of the RECORD trial, excoriating most everyone involved. In a particularly stunning passage, Marciniak appears to claim that the entire output of anyone working at Duke University cannot be trusted because of the fraud committed by Duke cancer researcher Anil Potti:

I would have thought that the two words “Anil Potti” are sufficient for convincing anyone that Duke University is a poor choice for a contractor whose task it is to confirm the integrity of scientific research. 

(One wonders how far Marciniak is willing to take his guilt-by-association theme. Are the words “Cheng Yi Liang” sufficient to convince us that all FDA employees, including Marciniak, are poor choices for deciding matter relating to publicly-traded companies? Should I not comment on government activities because I’m a resident of Illinois (my two words: “Rod Blagojevich”)?)

Rather than censoring or reprimanding Marciniak, his supervisors have taken the extraordinary step of letting him publicly air his criticisms, and then they have in turn publicly criticized his methods and approach.

I have been unable to think of a similar situation at any regulatory agency. The tolerance for dissent being displayed by FDA is, I believe, completely unprecedented.

And that’s the cliffhanger for me: can the FDA’s commitment to transparency extend so far as to accommodate public disagreements about its own approval decisions? Can it do so even when the disagreements take an extremely nasty and inappropriate tone?

• Rather than considering that open debate is a good thing, will journalists jump on the drama and portray agency leadership as weak and indecisive?
• Will the usual suspects in Congress be able to exploit this disagreement for their own political gain? How many House subcommittees will be summoning Janet Woodcock in the coming weeks?

I think what Bob Temple and Norman Stockbridge are doing is a tremendous experiment in open government. If they can pull it off, it could force other agencies to radically rethink how they go about crafting and implementing regulations. However, I also worry that it is politically simply not a viable approach, and that the agency will ultimately be seriously hurt by attacks from the media and legislators.

Where is this coming from?

As part of its recent PDUFA V commitment, the FDA put out a fascinating draft document, Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. It didn't get a lot of attention when first published back in February (few FDA documents do). However, it lays out a rather bold vision for how the FDA can acknowledge the existence of uncertainty in its evaluation of new drugs. Its proposed structure even envisions an open and honest accounting of divergent interpretations of data:

When they're frothing at the mouth, even Atticus doesn't let them publish a review

A framework for benefit-risk decision-making that summarizes the relevant facts, uncertainties, and key areas of judgment, and clearly explains how these factors influence a regulatory decision, can greatly inform and clarify the regulatory discussion. Such a framework can provide transparency regarding the basis of conflicting recommendations made by different parties using the same information.

(Emphasis mine.)

Of course, the structured framework here is designed to reflect rational disagreement. Marciniak’s scattershot insults are in many ways a terrible first case for trying out a new level of transparency.

The draft framework notes that safety issues, like Avandia, are some of the major areas of uncertainty in the regulatory process. Contrast this vision of coolly and systematically addressing uncertainties with the sad reality of Marciniak’s attack:

In contrast to the prospective and highly planned studies of effectiveness, safety findings emerge from a wide range of sources, including spontaneous adverse event reports, epidemiology studies, meta-analyses of controlled trials, or in some cases from randomized, controlled trials. However, even controlled trials, where the evidence of an effect is generally most persuasive, can sometimes provide contradictory and inconsistent findings on safety as the analyses are in many cases not planned and often reflect multiple testing. A systematic approach that specifies the sources of evidence, the strength of each piece of evidence, and draws conclusions that explain how the uncertainty weighed on the decision, can lead to more explicit communication of regulatory decisions. We anticipate that this work will continue beyond FY 2013.

I hope that work will continue beyond 2013. Thoughtful, open discussions of real uncertainties are one of the most worthwhile goals FDA can aspire to, even if it means having to learn how to do so without letting the Marciniaks of the world scuttle the whole endeavor.

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Opah fish are hauled onto a dock for sale last week in San Diego. Fishermen coming home to California after weeks at sea are finding strict anti-coronavirus measures, and nowhere to sell their catch.; Credit: Gregory Bull/AP

Hannah Hagemann | NPR

Commercial fishermen in the U.S. who have already faced challenges in recent years to make it in an increasingly globalized and regulated industry, are now struggling to find customers during the coronavirus crisis.

"This is totally unprecedented. This is the biggest crisis to hit the fishing industry ever, no question about that," Noah Oppenheim, executive director of The Pacific Coast Federation of Fishermen's Associations told NPR in a phone interview. The federation is a trade association representing commercial fishermen along the West Coast.

On Tuesday, seafood industry leaders, processors and fishermen sent a letter to House and Senate leaders requesting $4 billion in aid for the industry.

The closings of restaurants due to the coronavirus pandemic has hit commercial fishermen particularly hard.

An estimated 50% to 60% of wild seafood caught in the U.S. is exported, says Oppenheim. Those international markets have dried up. He says, of the seafood that's not exported, around 80% of that is sold to restaurants.

"Both of those sectors of the seafood economy are largely nonfunctional at the moment, so we're going to have to make up for approximately 90% of our markets ... through either new supply pipelines or new sets of customers."

Jerid Rold, a fishermen in Moss Landing, Calif., tells NPR, he's been out of work for a month, since South Korea stopped taking imports of hagfish. Further damaging profits, Dungeness crab prices on the West Coast have fallen from up to $7 dollars a pound to $2, says Oppenheim.

In Eureka, Calif., "there are no buyers purchasing products at the harbor there. You can't move the Dungeness crab out of the Humboldt bay," Oppenheim said. "It's actually extraordinary how similar these impacts are playing out across the country. They are palpable, they are profound and they are severe."

On the North Atlantic coast, Sam Rosen, a 30-year-old lobsterman based in Vinalhaven, Maine, said he and others are "selling lobster for amounts they shouldn't be sold for."

That's been close to $2.50 a pound, compared to a usual $10 a pound this time of year, Rosen said.

"It's definitely a shock to the system," Rosen said. "This is uncharted territory right now. I don't think anyone thought it was going to be as bad as it's getting."

If aid isn't provided to fishermen soon, "I think we could see hundreds to thousands of fishermen leave the industry nationwide," Oppenheim said.

Copyright 2020 NPR. To see more, visit https://www.npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.

An international team of scientists has described a rare fossil site that is believed to be among the earliest evidence of different fish species using a common nursery -- much like ones utilized by some fish today.

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