Category Archives: Follies of the Human Condition

The FDA is not holding back effective drugs

It’s going unnoticed amidst the news of the rolling disaster that is the incoming Trump administration, but our lame duck Congress has just passed a major piece of legislation called the 21st century cures act. Scientists are happy about the extra $5 billion this bill gives to the NIH – sort of. That money has to go to specific programs, like the Precision Medicine Initiative and Biden’s Moonshot program, rather than being put into the general funds of the NIH, meaning that Congress, and not the NIH, is deciding what specific research to fund. That’s generally not a good idea, but more money toward broad research and translational initiatives like cancer and precision medicine is still a net win.

More controversial are the FDA provisions of this bill. The bill pushes the FDA to take into account other, often less rigorous types of clinical studies when it decides whether or not to approve a new drug. Some worry that this means drug companies will have more leeway to push unsafe or ineffective drugs on the market. I’m more ambivalent – there are cases (drugs for rare diseases) when double blind randomized clinical trials may not be right, and the FDA should have the flexibility to demand the best evidence appropriate to each case. If – and this is a big if as we look ahead – we trust that the FDA can stand up to industry pressure, than giving them more flexibility to follow best scientific practices is the way to go.

My bigger problem with the FDA provisions are that the premise is flawed. As I write in Pacific Standard this week, the bill’s sponsors argue that, by cutting regulations and red tape at the FDA, we’ll free new cures that are just waiting to be put into the hands of patients. That’s wrong – the FDA is not the rate limiting step here. There is no backlog of effective new drugs just waiting to be approved.

Go check out my piece for the details. The rate limiting step is the science. Medical science is hard, and diseases are understood imperfectly. If you want more effective drugs faster, we need to invest more in research.

Trusted Sources

Zach Weinersmith’s Saturday Morning Breakfast Cereal reminds us that the public at large believes in the results of science based on their trust in scientists and, quite often, those that communicate the science.

The comic also shows how hazardous it can be to abuse that trust. This is why efforts to hold the institutions through which we do science accountable – like Retraction Watch, Rep. Speier’s HR6161, SAFE, critiquing of the publish-or-perish system, p-hacking, journal profiteering, and embargo abuse – are vital. It needs to be clear in public forums that we take that trust seriously and are more committed to protecting the integrity of the practice of science than to protecting individuals who violate that trust to maintain an illusion.

Apocalypse 1913: Adrift In A Hostile Cosmos

Arthur Conan Doyle’s The Poison Belt (1913)

415px-Strandus-1913-05End of the world narratives are typically about a fight for survival – people fight for food, shelter, and safety as the asteroid, pandemic plague, or zombie hordes threaten to wipe out human life. This was just as true of SF a century ago as it is today: In 1912, Jack London’s The Scarlet Plague featured armed Berkeley professors, holed up in the chemistry building as a plague swept away civilization; while Garrett Serviss’ The Second Deluge tells of a thousand lucky survivors who, in a modern ark, escape a world-wide flood.

The next year, Arthur Conan Doyle also published a novel about a group of hardy survivors. But the terms of survival in The Poison Belt are much more ironic: Professor Challenger and his fellow adventurers, who had fought off dinosaurs and ape-men on a remote South American plateau in Doyle’s 1912 The Lost World, now confront the extinction of human life as passive observers, watching the destruction of humanity from the window of the “charmingly feminine sitting room” of Professor Challenger’s wife. Continue reading

Sunday Science Poem: Darwin and Happy Endings

Wisława Szymborska’s “Consolation” (2002)
henri_rousseau_-_fight_between_a_tiger_and_a_buffaloEvolution has always been more controversial socially than scientifically. After Darwin published the Origin, the idea that all species descended from common ancestors was quickly accepted by most biologists (though his proposed mechanism of evolution, natural selection, remained controversial until the 20th century). Socially, however, evolution was and remains difficult for many people to swallow. The literalist beliefs of religious fundamentalists of course conflict with evolution. But even among those who don’t have a particular religious axe to grind, discomfort is not uncommon. Evolution in practice is brutal: we posses our unique adaptations – our brains, our opposable thumbs, our ability to talk, to socialize, to feel, see, and touch – thanks to the selective death of billions of organism over eons.

In her hilarious poem “Consolation”, the late Nobel-winning Polish poet Wisława Szymborska ironically contrasts the brutality of the real world in which evolution plays out, with the romantic world we construct for ourselves. She portrays Darwin, the great thinker who first grasped the harsh reality of evolution, as someone who escapes by reading novels with only happy endings.
Consolation

Darwin.
Supposedly for relaxation he read novels.
But he had a requirement:
they couldn't end sadly.
If he happened on one,
he flung it furiously in the fire.

True or not –
I gladly believe it.

Roaming in his mind over so many times and places
looking back on all the extinct species,
such triumphs of strong over weak,
so many tests of survival,
sooner or later all in vain,
that at least in fiction
and its micro-scale
he had a right to expect a happy ending.

And so necessarily: sunrays behind a cloud,
lovers together again, kin reconciled,
doubts dissolved, faith rewarded,
fortunes recovered, treasures dug up,
neighbors regret their mulishness,
good names restored, greed put to shame,
old maids married to respectable ministers,
schemers expelled to the other hemisphere,
forgers of documents cast down the stairs,
seducers of virgins hurrying to altars
orphans taken in, widows embraced,
pride humbled, wounds mended,
prodigal sons invited to the table,
the cup of bitterness poured into the sea,
tissues wet with tears of reconciliation,
universal singing and music-making,
and the puppy Fido,
lost already in the first chapter,
let him run home again
and bark joyfully.

Translation from the Polish by Michael A. White (2016)
Image: “Fight Between a Tiger and a Buffalo”, Henri Rousseau (1908), via Wikimedia Commons.

I dare you to convince me this isn’t decent science journalism

Comedian Nikki Glaser has a new show on Comedy Central, Not Safe, focused on sex in pop culture. The second episode contained a segment called “Studies Show” which invited panelists to riff off the results of sex research. At the end, Glaser provided a stingingly accurate commentary on the way journalists the media apply the results of individual studies on hot button topics too broadly and which aligns well with Mike’s analysis of the challenges of scientific research:

I hope you learned something, but, if not, no big deal. They’ll be contradicted by new studies next week. – Nikki Glaser