https://streaming.biocom.arizona.edu/event/index.cfm?id=26074
Participants in the live webcast will have the opportunity submit questions and comments. Please do!
This week, my colleague Derek Bambauer will speak as part of the Regulatory Science series at the University of Arizona. Free CLE attendance form and readings are available.
Tune in at 12:00pm (Pacific) / 3:00pm (Eastern) on Wed Sept 16.
https://streaming.biocom.arizona.edu/event/?id=26071
The talk will also be archived at the same link.
Bill of Health contributor Christopher T. Robertson has a new Op-Ed out in the New England Journal of Medicine:
As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn’t mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product’s risks as well. Since it’s not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a printed magazine ad. Companies have tended to comply with this requirement by supplementing colorful, persuasive ads with one or two pages of dry text providing the required disclosures, often simply using language that the FDA has approved for other purposes, such as package inserts for prescribers. But research shows that most patients who attempt to read these disclosures find them difficult to understand, and many don’t even try to make sense of them.1 Now, the FDA is in the process of adjusting its DTCA rules, aiming to provide greater assurance that patients receive due warning of the most significant risks — but its tweaks probably don’t go far enough to really empower consumers to make smart decisions about the drugs they put into their bodies. […]
Read the full article here.
Co-blogged with University of Arizona Fellow, Jonathan Loe
Breathlessly, many news outlets reported yesterday that Kim Kardashian West was in trouble with the FDA for misleading social media advertising of the drug Diclegis. For example, the reliably hyperbolic Daily Mail led with “Kim Kardashian slammed by FDA.”
As followers of this blog may not know, Mrs. Kardashian West is pregnant with her second child. Following on the disappointing news that the soon-to-be sibling of baby “North West” will not be named South, the celebrity-for-celebrity’s-sake shared a post on Instagram (and Facebook, and linked to from Twitter, naturally). The post announced for the world that “OMG” her “#morningsickness” had benefited from a prescription of Diclegis—with “no increased risk to the baby.” The FDA issued a warning letter, because the social media post failed to communicate any risk information.
But is the FDA really concerned with people, however famous, commenting on their personal experiences with drugs?
The answer is…
By: Christine Baugh
A new Google Chrome extension puts the spotlight on conflicts of interest. The browser app, available for free download here, was created at the Hacking iCorruption hackathon event held March 27-29 in Cambridge, MA. The event, co-sponsored by the Edmond J. Safra Center for Ethics at Harvard University and the MIT Center for Civic Media (hosted at the MIT Media Lab) brought together individuals with a variety of backgrounds and skills to work toward the common mission of fighting institutional corruption, in this case by creating practical tools. This project was one of several exciting tools created at the hackathon (information about other projects available here), and it won first prize among the projects.
The Chrome extension, called Unearth, puts funding and conflict of interest information on the abstract page of PubMed research articles. Christopher Robertson, Associate Professor of Law at the University of Arizona James E. Rodgers College of Law and Edmond J. Safra Center Fellow who was a member of the Unearth team, explains the rationale for the browser extension in this Youtube video. In short, conflict of interest and funding disclosures are often placed at the end of a research article and are generally unavailable on the abstract page. This makes it impractical for physicians and other research scientists to pay appropriate attention to this important information. Research from the Cochrane Collaboration has demonstrated that research studies funded by industry generally describe “greater benefits and fewer harmful side effects” than their non-industry funded counterparts. Thus, taking the source of research funding into account when reading a new research study is critical. Although the extension currently only works for open access articles from PubMed Central, this includes several million research articles for which funding and conflict of interest information was previously much more difficult to obtain. Additionally, the developers plan on expanding the breadth of coverage in the coming weeks. Read More
This new post by Tony Caldwell and Christopher Robertson appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.
The Physician Payments Sunshine Act, a provision in the Affordable Care Act, seeks to increase the transparency of the financial relationships between medical device and drug manufacturers, physicians, and teaching hospitals. Launched on September 30, 2014 by the Centers for Medicare & Medicaid Services (CMS), the Open Payments database collects information about these financial relationships and makes that information available to the public.
As of early February, the Open Payments database includes documentation of 4.45 million payments valued at nearly $3.7 billion made from medical device and pharmaceutical manufacturers to 546,000 doctors and 1,360 teaching hospitals between August 2013 and December 2013. This included 1.7 million records (totaling $2.2 billion) without the names of physicians or teaching hospitals who received the payments.
These records were intentionally de-identified by CMS because the records had not been available for review and dispute for 45 days, or because the records were not matched by CMS to a single physician or teaching hospital due to missing or inconsistent information within the submitted records. Future reports will be published annually and will include data collections from a full 12 month period. […]
Continue reading here.
Do you know of a doctoral student or scholar who finished his or her last degree in 2009 or later, and who has produced excellent empirical research on the relation of law or legal practices to population health? If so, please consider submitting a nomination by December 10. It’s quick and easy.
Over at our sister blog for the Safra Center’s Institutional Corruption Lab, Paul Thacker has a great post about how the Physician’s Payments Sunshine Act came to exist. The new database created by the Act is just now going live, and its a good time to reflect on how we got here. Thacker was a staffer for Senator Chuck Grassley, and from that vantage, has rare insight into how the bill was conceived and how initial objections of Big Pharma were overcome. Thacker also outlines several complementary efforts, including pressure to reform NIH policies around conflicts of interest. That proposal went all the way to the White House, where it was gutted. Worth reading.
This single webpage (Vox) covers about 80% of what I try to convey during the first day of my health law class. And the page does it with some nice graphics, which are worth stealing (ahem, “fair using” for educational purposes). While nothing will be new to health policy scholars, it is a nice synthesis. Highly recommended.
Many health law profs have wondered about how state officials can turn down bucketloads of federal money, without suffering the ire of their local constituents. In states like Arizona, that frustration was spoken most vocally by the local healthcare industry and their employees, who have the most to gain from the expansion of coverage, even if the Medicaid beneficiaries are unlikely to themselves have political clout.
Well, over at the New Yorker, Sam Wang has now compiled the polling data for the gubernatorial races to ask whether “In Swing States, Is Obamacare an Asset?” This graphic tells the whole story, focusing on states where Republican incumbents who made Medicaid-expansion decisions are now up for re-election:
![Chart09-09-updated[1]](https://i0.wp.com/petrieflom.wpengine.com/wp-content/uploads/2014/08/Chart09-09-updated1.jpg?ssl=1)
Although voters respond to a mix of positions and personalities, and these are only nine states, it is striking that the governors who declined federal money to cover their most vulnerable are also the most vulnerable at the polls.
By
You must be logged in to post a comment.