Category: Patrick O’Leary

Does FDA Need a Dietary Supplement User Fee Act?

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By Elizabeth Guo

Dietary supplements are dominating headlines these days – and not in a good way. Last Wednesday, Nevada officials found basketball star Lamar Odom unconscious at a brothel after taking cocaine along , a sexual enhancement dietary supplement. That same week, the New England Journal of Medicine released an article finding that dietary supplements lead to roughly 23,000 emergency visits a year. Following these events, some officials have called on the Food and Drug Administration (FDA) to take a stronger role in regulating the dietary supplement industry.

Dietary supplements have had a long and storied past. As early as 1973, FDA tried to regulate dietary supplements regarding vitamin and mineral potency. The dietary supplement industry responded by challenging FDA in court, and Congress subsequently enacted the Proxmire Amendment, limiting FDA’s authority to regulate dietary supplements. However, by the 1990s, as consumers increasingly began to rely on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994, expanding FDA’s authority to regulate supplements by enacting special rules related to dietary supplement labeling and manufacturing.

Currently, FDA regulates dietary supplements as a special category of foods. Unlike manufacturers of over-the-counter drugs, dietary supplement manufacturers do not need to be registered with FDA and do not need list possible adverse events on supplement labeling. As Joanna Sax points out, this is a major problem because not all dietary supplements are the same. For example, certain weight loss or sexual enhancement supplements often contain chemicals associated with potentially serious side effects while other supplements containing chemicals such as Vitamin C pose less serious safety concerns.

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TOMORROW: Second Annual Health Law Year in P/Review

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Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Read More

1/31: Second Annual Health Law Year in P/Review

The Petrie-Flom Center Staff Leave a comment

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Read More

1/31: Second Annual Health Law Year in P/Review conference

The Petrie-Flom Center Staff Leave a comment

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Read More

On Scientific Journals as a Bulwark Against Research Misconduct

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By Patrick O’Leary

I’ve been thinking a lot lately about how our society regulates the integrity of scientific research in an era of fierce competition for diminishing grants and ultracompetitive academic appointments. When I shared a draft paper on this topic a few weeks ago, several colleagues urged me to think more about the role played by academic journals, so I was interested to see this article in Nature last week about a recently uncovered criminal scam defrauding two European science journals and countless would-be authors. It caught my attention because it seems to belie the notion that the journals and the honest scientific community are sophisticated enough actors to be trusted to root out the fabrication, falsification, and plagiarism that constitute “research misconduct” under Federal law. Needless to say, it takes a different kind of expertise to discern scientific misconduct than to uncover a more mundane phishing scam like the one these cons were running, but the anecdote stands as a nice reminder of the fallibility even of great minds.

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Time Magazine on Solving Health Care’s #1 Problem: “All the Prices Are Too Damn High”

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By Patrick O’Leary

The cover story of the March 4, 2013 issue of Time Magazine is a piece by Steven Brill titled Bitter Pill: Why Medical Bills Are Killing Us. The article has apparently made a pretty big splash: in an interview (Part 2, Part 3) with Brill last week, Jon Stewart of Comedy Central’s The Daily Show told his audience that the article was so good that it “should be required reading for . . . not only every individual in this country, but lawmaker in this country.”

What most seems to fascinate Stewart, and what Brill emphasizes, is an insight that is old hat to health law types: the market for health care is just plain screwy. Brill explains that health care consumers “have no choice in what you’re buying, you have no idea what you’re buying, you have no idea what the price is, even when you get the bill you have no idea what it says.” The starting point for the article was Brill’s observation that in all the debate over the last few years about health care, “we seem to jump right to the issue of who should pay the bills, blowing right past what should be the first question: Why exactly are the bills so high?” Read More

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

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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.

Two Reflections on Health Law Scholarship

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By Patrick O’Leary

Last spring I had the chance to work as a research assistant for Marc Rodwin, a Lab Fellow at Harvard’s Edmond J. Safra Center for Ethics, reading through hundreds (perhaps thousands) of pages of Congressional hearing transcripts from the 1960s and 1970s relating to the federal regulation of drugs. In reading the final version of the article that I helped to research, Independent Clinical Trials to Test Drugs: The Neglected Reform, forthcoming in Volume 6 of the Saint Louis University Journal of Health Law & Policy (also available online), two things occurred to me about the way academics and to some extent policymakers approach regulatory law, especially in the life sciences.

First, it struck me that in the general discourse about health policy, we are often surprisingly oblivious to history. Although the first U.S. law requiring safety or efficacy testing for new drugs was passed a mere 75 years ago, the intervening decades have been prolific when it comes to proposals and debate. What Rodwin’s article does, and I think is valuable both to support his own proposition and to advance the scholarship of others, is to frame his contemporary proposal with a close historical look at similar proposals and the debate surrounding them. What becomes clear, whether the topic is independent clinical testing, the “drug lag,” or the scope of patent protection and marketing exclusivity, is that our “new” ideas about how to improve the system are often anything but. The idea that we ought to know the history of our subject is not particularly groundbreaking, of course, but it’s plain we could be doing more. I’ve found that even the little history I’ve read–all those hearings, of course, but also wonderful books like Daniel Carpenter’s Reputation and Power and Philip J. Hilts’s Protecting America’s Health, and under-utilized resources like FDA’s Oral History Transcripts–has proved endlessly valuable even in thinking about cutting edge ideas like those I’m privileged to be exposed to as a participant in the Petrie-Flom Center’s Health Law Policy and Bioethics Workshop.

Second, it occurred to me that when we think and write about health policy, we might benefit from distinguishing–at least for ourselves–between two distinct projects: the practical endeavor of proposing “realistic” policy changes that take account of and purport to improve on our imperfect and historically contingent regulatory regime, on the one hand, and the more theoretical work of contemplating an ideal system, a “castle in the sky.” Folks who think deeply and write about these issues obviously engage in both: Rodwin’s article, for example, plainly takes the present framework as its starting point, but does so with the larger theoretical question in mind.  I just wonder if we might be more explicit in articulating how proposed incremental changes fit into a broader project of making the regulatory scheme look more like our hypothetical ideal. The history of regulatory law is so littered with incremental changes that have had unanticipated consequences elsewhere in the system that I would love to see more authors lay out explicitly what they hope the system will look like, and justify their incremental proposals as part of that broader vision.

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

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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

The Future of Biomedical Research Funding

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By Patrick O’Leary

As I’ve written about previously on this blog, the consequences for the FDA of budget sequestration under the Budget Control Act of 2011 could be fairly severe (as well as raise some interesting legal questions). In a recent Online First piece for the Journal of the American Medical Association (JAMA), Hamilton Moses and E. Ray Dorsey note that sequestration would also have a serious impact–to the tune of $2.5 billion–on the National Institutes of Health (NIH), the primary source of public funding for biomedical research in the United States.

While Doctors Moses and Dorsey acknowledge that the immediate consequences of such a cut would primarily affect young researchers and new applicants for funding, “exacerbat[ing] tensions between large infrastructure projects . . . and small investigator-initiated grants, which historically have been the primary source of new clinical insights,” they also argue that sequestration presents an opportunity to reevaluate our emphasis on publicly funded biomedical research. In their telling, sequestration would be just the most recent step in a nearly decade-long trend of reducing federal funding, a trend that “presents an opportunity to reshape biomedical research.” Moses and Dorsey call for new private sources of research support, ranging from specialized financial instruments like Biomedical Research Bonds to an increased role for public charities and private foundations. The future of biomedical research, they argue, will be built on the private sector, not the federal government.

The challenges of shifting the burden of funding research to the private sector are many, of course. One particularly challenging question is whether private funds could effectively replace NIH’s significant role in funding “basic” research. Bhaven N. Sampat’s new article “Mission-Oriented Biomedical Research at the NIH” in Research Policy provides some context for the scale of the problem. Citing a 2010 study by Dr. Dorsey himself, Sampat notes that although NIH funding accounts for only about a third of U.S. biomedical research funding, “there is a sharp division of labor, with NIH funding concentrated further upstream, on ‘basic’ research than private sector funding” from private sector pharmaceutical, biotechnology, and medical device firms. Although the role of private foundations has grown in recent years, Sampat notes that NIH funding continues to exceed all such funding “by a factor of six . . . .” Assuming we continue to value basic research, the capacity and willingness of private actors to fund such research thus remains a major question mark.