Newspapers and Laptop.

AI, Copyright, and Open Science: Health Implications of the New York Times/OpenAI Lawsuit

By Adithi Iyer

The legal world is atwitter with the developing artificial intelligence (“AI”) copyright cage match between The New York Times and OpenAI. The Times filed its complaint in Manhattan Federal District Court on December 27 accusing OpenAI of unlawfully using its (copyrighted and paywalled) articles to train ChatGPT. OpenAI, in turn, published a sharply-worded response on January 8, claiming that its incorporation of the material for training purposes squarely constitutes fair use. This follows ongoing suits by authors against OpenAI on similar grounds, but the titanic scale of the Times-OpenAI dispute and its application of these issues to media in federal litigation makes it one to watch. While much of the buzz around the case has centered on its intellectual property and First Amendment implications, there may be implications for the health and biotech industries. Here’s a rundown of the major legal questions at play and the health-related stakes for a future decision.

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Washington, DC – September 23, 2021: A person walks among the over 681,000 memorial white flags dedicated to each of the COVID Pandemic victims at the National Mall.

Running Cover for Death: Pandemic Minimizers Normalize an Inhumane Baseline

­­By Nate Holdren

Last week, David Leonhardt took to the pages of the New York Times to celebrate the latest COVID death figures, which he claims mean the U.S. is no longer in a pandemic, because there are no more “excess deaths.”

The hunger for good news is, of course, understandable amid this ongoing nightmare. But to respond to death with “smile everyone, it could have been more deaths!” is grotesque because of the disrespect to the dead and those most affected by the deaths.

It also lets the powerful off the hook, which is Leonhardt’s primary motivation, I assume. In other words, looking for good news is a political position.

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Irresponsible Health Reporting? The N.Y. Times and the Perpetuation of Chemophobia

By Patrick O’Leary

When I read Susannah Meadows’s article in last week’s New York Times Magazine, The Boy with a Thorn in His Joints, I was at a bit of a loss how to respond. The article is Meadows’s account of dealing with her son’s juvenile idiopathic arthritis, and describes how, wary of the side effects of the treatment recommended by two well-regarded pediatric rheumatologists, she put her son on an alternative-medicine regime instead. Meadows relates how, on a regimen of probiotics, sour Montmorency cherry juice, fish oil, and something called four-marvels powder, her son underwent a near total recovery.

It should be noted, to her credit, that Meadows goes out of her way to acknowledge the anecdotal character of her experience. And, likewise to her credit, Meadows continued to work with her son’s doctors and take their concerns seriously throughout her son’s experiment with alternative medicine. But in spite of Meadows best journalistic instincts and her thorough reporting, her article perpetuates a dangerous misunderstanding. Throughout her article, Meadows makes an implicit distinction between pharmaceuticals and the substances (cherry juice, fish oil, four marvels powder) she was putting in her son’s body. But here’s the thing: the single most important distinction between the methotrexate her doctors recommended and the four marvels powder she chose to administer to her son is that the former has been proven safe and effective in “adequate and well-controlled investigations,” while the latter is essentially unregulated. The active ingredients in both substances are chemicals with hard-to-pronounce Latin names, the difference is just how much we know about these chemicals.

And that’s the point that Michelle M. Francl, a professor of chemistry at Bryn Mawr College, articulates far more eloquently and forcefully than I possibly could in her recent Slate article: Don’t Take Medical Advice From the New York Times Magazine: The dangerous chemophobia behind its popular story about childhood arthritis. Francl’s article is a must-read, and makes several extremely valuable points, but I particularly want to highlight just one of these. Susannah Meadows is an intelligent and experienced journalist, a wonderful commentator on politics and publishing, and clearly a mother whose love for her children is boundless. But she is not a doctor or a scientist, nor is she even a health or science reporter. Yet her anecdotal account of her own child’s illness is now probably the most widely disseminated article about treating juvenile arthritis ever, and it is one that perpetuates a basic and dangerous misunderstanding about the nature of medicine.

Regulatory Concepts in the News, Part I: FDA Efficacy Standards for Old Drugs

By Patrick O’Leary

While reading some of the great articles from the health section of the New York Times over the holidays it struck me that such articles, in their need to be concise and accessible, often give only passing treatment to regulatory concepts that can be fundamental to the story. Accordingly, I thought it might be useful to write a series of posts digging down a bit deeper into some of the regulatory foundations of health stories that percolate up to public attention through the news. In this post I’ll begin by looking at an interesting point relating to drug efficacy standards raised by an article about a newly expensive (but decades-old) drug.

In Andrew Pollack’s “Questcor Finds Profits, at $28,000 a Vial” we read that a drug called Acthar, first approved by the FDA in 1952 and used primarily to treat rare infantile spasms, has in recent years become a very expensive and (for it’s maker) lucrative treatment for conditions ranging from multiple sclerosis to rheumatologic conditions. The article is worth a read for its thoughtful discussion of drug pricing, but it also makes passing reference to a some important regulatory concepts that bear further examination. One issue that particularly stood out to me was Pollack’s statement that Questcor, Acthar’s manufacturer, has been able to market the drug for a variety of uses “without being required to prove that the drug actually works” because it was “essentially grandfathered” into an anachronistic efficacy standard by being “approved for use in 1952, before the [FDA] required clinical trials . . . .” On first read, that sounds fairly alarming, so I thought it might be worthwhile to unpack the law around such “grandfathered” drugs a little. While it is true that FDA did not require proof of effectiveness for new drugs until lawmakers included this requirement in the Drug Amendments of 1962, it isn’t the case that pre-1962 drugs simply get a free pass on proving effectiveness. The truth, as one might expect, is somewhat more complicated. Read More