Category Archives: Uncategorized

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.

The Legacy of Slavery in African American DNA

This week at Pacific Standard,  I discuss a recent study that examines the influence of slavery and its discriminatory aftermath in the genetic diversity in over 4,000 African American genomes. One of the most striking results of the study is probably the most obvious: On average, about 15% of the DNA of African Americans is of European origin – and, according the researchers’ best statistical model, that European DNA largely dates back to before the Civil War. That was a time when interracial sexual relations overwhelmingly took the form of whites raping black slaves. After the Civil War, according to the model, admixture between blacks and whites dropped off sharply.

Like I said, it’s not particularly surprising, but the breadth of the genetic legacy of slavery is striking.

The study makes some other intriguing suggestions about African American genetic history, especially regarding the enormous demographic shift of the Great Migration (~1915-1970), when 6 million African Americans left the South and settled in other parts of the country. The big takeaway from this study is that African American genetic history is one of coercion: coerced migration and coerced sex over a relatively short period of time, which left strong signals in the genetic diversity of present day African Americans.

Aside from the historical aspect, studies like this matter if African Americans are going to participate in the ongoing development of personalized genomic medicine. Because the genetic structure of the African American population differs from that of whites, African Americans have different genetic risk factors for disease – and even different risk variants for the same diseases. Studies like this lay the groundwork for an inclusive practice of genomic medicine.

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.

Science for the People: Medical Marijuana

sftpThis week, Science for the People is taking a closer look at the medical marijuana controversy. How effective is medical marijuana and for what conditions is it a suitable treatment? In our attempt to separate evidence from anecdote we’re joined by a panel of three: Dr. David Casarett, a palliative care physician and author of the book Stoned: A Doctor’s Case for Medical Marijuana; Dr. Robert Wolff, a systematic reviewer for Kleijnen Systematic Reviews and coauthor of a recent systematic review to assess benefits and harms of cannabis for medical use; and Dr. Marcel Bonn-Miller, assistant professor in the Department of Psychiatry at the University of Pennsylvania Perelman School of Medicine, who has dedicated his career to understanding the relationship between cannabis use and PTSD.

Science for the People is now part of the Skepchick Network.

Don’t forget to support the Science for the People on Patreon to keep the sciencey goodness flowing toward your ear holes.

*Josh provides research help to Science for the People and is, therefore, completely biased.

Revisting the blink comparator and The Rural Alberta Advantage

Today is the anniversary of the discovery of our sentimental favourite dwarf planet, Pluto. On February 18, 1930 Clyde Tombaugh, working at the Lowell Observatory in Flagstaff, found the first evidence of a planet beyond Neptune. This seems like the perfect day to revisit an old post about a song that reminded me of the equipment he used. This is an edited and updated version of a Finch and Pea post from February 11, 2012.

With rich dark wooden curio cabinets and a narrow book-filled balcony accessed by a steep staircase, the Rotunda at the Lowell Observatory in Flagstaff feels like a natural home for the distinguished scientist. I visited the Lowell in 2011 for the National Association of Science Writers meeting, and it was everything that I had always imagined being a scientist would be when I was a kid. Feeling the warm glow of scientific discoveries past, there was one thing in the room I couldn’t take my eyes off: the glass plates and elegant brass eyepiece of the blink comparator used to discover Pluto. Continue reading