Month: October 2014

The inadequacy of voluntary measures to reduce the use of antimicrobials in animal feed

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By Diana R. H. Winters
[Cross-posted at HealthLawProf Blog.]

On Thursday, October 2, 2014, FDA released its “Summary Report on Antimicrobials Sold or Distributed in Food-Producing Animals” for 2012. The Report contains the depressing news that “domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals increased by 16%,” between 2009 and 2012, though the percentage of those labeled solely for therapeutic use rose from 28% to 32%. The other 68% are labeled for just production (growth promotion) or production and therapeutic uses.

But why is that depressing, you may ask. Isn’t this exactly why FDA issued a final-guidance document and a draft rule in December 2013, both addressing its voluntary program with drug sponsors to decrease, and eventually end, the use of medically important antimicrobials for growth promotion in animal feed? Problem identified, solution initiated—right? If only it were that simple.

FDA has a long history of delay and intransigence on this issue. I have written about that history in the past, and do so again in this forthcoming article. In 2011, FDA was sued by a group of public interest organizations for its unwarranted delay, and a federal district court ordered the agency to begin proceedings to hold withdrawal of approval hearings for certain medically important antibiotics, hearings that it had originally called for in 1977. The Second Circuit reversed this decision in July of this year (NRDC v. FDA, 760 F.3d 151).  Read More

Expelling Immigrants from the Exchanges

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By Wendy Parmet

[Cross-posted from HealthLawProf Blog.]

The warning by the Centers for Medicare and Medicaid Services (CMS) last month that up to 115,000 people might lose their health insurance under the Affordable Care Act (ACA) unless they can send proof of their citizenship or immigration status was more than a bit ironic. After spending much of the year and millions of dollars trying to boost participation in the exchanges, CMS is now trying to reduce participation. In so doing, it will likely exclude many young, healthy adults, just the type of people that the exchanges need to succeed

The reason for the exclusion lies with the heated politics of immigration, and our ambivalent approach to providing immigrants with health care. Although the ACA’s critics have lambasted the law on many accounts, when the Act was first debated in Congress no charge – not even death panels! — was made more heatedly or drew more attention than the claim that the Act would cover illegal immigrants. It was that charge, after all, that Representative Joe Wilson referred to when he shouted “You lie!” during the President’s speech to a joint session of Congress.

Obama, however, didn’t lie when he promised that the Act would not cover illegal immigrants. The ACA bars from the exchanges immigrants who are “not lawfully present,” a category that includes the so-called Dreamers, the young immigrants who by virtue of an executive order have a right to live and work in the country. It also requires exchange applicants to provide their Social Security number and, in the case of non-citizens, information about their immigration status, which must be verified by the Department of Homeland Security. These are the requirements that CMS is now enforcing.  Read More

Facebook Announces New Research Policies

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By Michelle Meyer

A WSJ reporter just tipped me off to this news release by Facebook regarding the changes it has made in its research practices in response to public outrage about its emotional contagion experiment, published in PNAS. I had a brief window of time in which to respond with my comments, so these are rushed and a first reaction, but for what they’re worth, here’s what I told her (plus links and less a couple of typos):

There’s a lot to like in this announcement. I’m delighted that, despite the backlash it received, Facebook will continue to publish at least some of their research in peer-reviewed journals and to post reprints of that research on their website, where everyone can benefit from it. It’s also encouraging that the company acknowledges the importance of user trust and that it has expressed a commitment to better communicate its research goals and results.

As for Facebook’s promise to subject future research to more extensive review by a wider and more senior group of people within the company, with an enhanced review process for research that concerns, say, minors or sensitive topics, it’s impossible to assess whether this is ethically good or bad without knowing a lot more about both the people who comprise the panel and their review process (including but not limited to Facebook’s policy on when, if ever, the default requirements of informed consent may be modified or waived). It’s tempting to conclude that more review is always better. But research ethics committees (IRBs) can and do make mistakes in both directions – by approving research that should not have gone forward and by unreasonably thwarting important research. Do Facebook’s law, privacy, and policy people have any training in research ethics? Is there any sort of appeal process for Facebook’s data scientists if the panel arbitrarily rejects their proposal? These are the tip of the iceberg of challenges that the academic IRBs continue to face, and I fear that we are unthinkingly exporting an unhealthy system into the corporate world. Discussion is just beginning among academic scientists, corporate data scientists, and ethicists about the ethics of mass-scale digital experimentation (see, ahem, here and here). It’s theoretically possible, but unlikely, that in its new, but unclear, guidelines and review process Facebook has struck the optimal balance among the competing values and interests that this work involves.  Read More

What’s Next If the FDA Holds the Line on Social Media?

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By Kate Greenwood
[Cross-posted at Health Reform Watch]

Earlier this week, the Food and Drug Administration announced that it was reopening the comment periods for the two draft guidances on the use of social media to promote prescription drugs and medical devices that it released in June:  Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Both guidances have drawn criticism from industry and observers, with the FDA being charged with, in the words of Pharmaguy at the Pharma Marketing Blog, “not being technically savvy enough to understand the nuances of social media and search engine advertising.”

In the draft guidance on social media platforms with character space limitations, such as Twitter and sponsored links on Google and Yahoo, the FDA states that “if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication.” The draft guidance would allow companies to limit the risks that are presented within a character-and-space-limited communication to those that are the most serious, as long as the communication also includes a direct hyperlink to a destination (for example, a landing page) that is devoted exclusively to a complete discussion of the product’s risks. The FDA emphasizes in the draft guidance that “[i]f an accurate and balanced presentation of both risks and benefits is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion).”  In the first round of comments, PhRMA commented that the amount of information that companies are required to include in a single communication “would make the use of Twitter and comparable platforms impossible in all but the rarest cases.” With regard to sponsored links, PhRMA also noted that the guidance assumes that advertisers have more control than they in fact do over “the appearance – and order of appearance – of information on such platforms.”

It will be interesting to see whether and how the FDA responds to these comments, as well as to any additional comments filed during the period that comments are reopened, which ends on October 29th. If the agency holds the line (as I think it should) and continues to require that companies provide at least some balance between risks and benefits in all advertising and labeling, regardless of platform, companies will no doubt (continue) to look for alternatives.  Read More

A Situational Definition of Sex

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By Vadim Shteyler

In a previous blog post, I introduced Dutee Chand, a world-class sprinter suspended from national and international competitions by the International Olympic Committee (IOC) and the International Association of Athletics Federations (IAAF). According to the policies of these organizations, an athlete with testosterone levels in the male range cannot compete in the female category. As I discuss in my previous post, by creating a definition of sex that is meant to only be applicable in sports, the IOC and IAAF effectively created a situational definition of sex.

Sex is poorly defined.

From the debate that arose after Dutee Chand’s suspension—as well as from other recent controversies surrounding sex-segregation in bathrooms, prisons, the military, and many other settings—it is evident that people cannot agree on a definition of sex. In the United States, sex is defined differently in different contexts. At birth, it is defined by external genitalia. In genetic testing, it is defined by chromosomal makeup. In everyday life situations, it is defined by clothes, hair, and other select physical features.  Read More

Ebola in the United States—Some Resources for the Law School Curriculum

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By Jennifer Bard
[Cross-post (with some updates) from Prawfsblawg.]

Law students have lots of things competing for their attention, but one topic I’ve found of general interest this fall is Ebola. Although the topic is obvious low-hanging fruit for those of us in the health law crowd, I’d suggest there’s plenty to keep Constitutional Law, Torts (information is coming out that the patient was sent home from the emergency room, even though he said he had been to Liberia and that his contacts are being monitored including five school children), Commercial Law, International Law, immigration, etc. going as well. An infectious disease like Ebola triggers concerns about shipping, air travel, and, of course, quarantine, search, and seizure.

Today’s news that a Texas hospital has diagnosed a patient already in the United States was inevitable-and provides an opportunity to throw a legal spotlight on the laws of quarantine and isolation.   As a matter of Constitutional Law, the President of the United States can take any measure necessary to protect the nation’s security, remember President Bush’s plan to use the military to control pandemic flu (see an overview from the CRS or the plan itself), or interstate commerce, but only individual states have the power to take action addressing health issues that do not threaten the safety of the country as a whole.   That’s because individual states, but not the federal government, retain “police power” to promote the health of their citizens even in the absence of a threat to others. Here’s a helpful article. This overview of emergency legal powers, specific to Ebola, comes from the Robert Wood Johnson foundation supported Network for Public Health. Here is some more general information comparing state and federal authority from the CDC and a great overview from the Congressional Research Service. While Ebola itself is low on the list of the scariest diseases we in the U.S. risk catching (here’s a list from for those who don’t have enough to worry about), it is interesting to see how quickly it happened given that estimates of only a few weeks ago were that the probability was no more than 25%. Here’s how Vox explained it using visuals.  This is an on-going story-and should test the resources and skills of the Dallas County Health Department–and provide a live public health lesson to the country.

De-Prioritizing Treatment for Mental Illness May be Due to Flaws in Reasoning

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By Kelsey Berry

In a recent article in Science Translational Medicine, former NIMH Director Steve Hyman explores possible reasons for the policy failure to prioritize treatment of mental disorders worldwide, even when evidence and cost-effective interventions are available and validated.

Hyman notes a number of potential factors, loosely falling into four categories.

  1. Stigmatization challenges;
    • Fear of the severely mentally ill
    • Superstitions about the causes of mental illness
    • Attribution of imagined moral flaws or weaknesses to sufferers or their families
    • Belief that mental health professionals are in the profession because they are similarly troubled
  2. Scientific challenges;
    • Relatively slow scientific progress and translation of discoveries into clinically useful diagnostics and therapeutics
  3. Advocacy challenges;
    • Diminished ability of the mentally ill to advocate effectively for themselves
    • Low commercial advocacy due to difficultly in discovering marketable treatments
  4. Flaws in reasoning;
    • A tendency to focus on saving lives versus improving them – a problem that puts most non-lethal disabilities at a disadvantage in priority setting
    • A tendency to distinguish mental disorders from other “biologically based” disorders that we do not control, due to the subjective experience of one’s own (healthy) mind

Though none of the categories above are without normative dimensions, the last category raises two clear points worth mentioning just now.  Read More