Happy National Health Observances!

By Emily Largent

Perhaps you already knew that October is National Breast Cancer Awareness Month. Did you also know that it is:

  • Domestic Violence Awareness Month,
  • Eye Injury Prevention Month,
  • Health Literacy Month,
  • Home Eye Safety Month,
  • National Bullying Prevention Month,
  • National Down Syndrome Awareness Month,
  • National Medical Librarians Month,
  • National Physical Therapy Month, and
  • Sudden Infant Death Syndrome (SIDS) Awareness Month?

On top of that, we have (just to name a few): Mental Illness Awareness Week (Oct. 6-10); National Depression Screening Day (Oct. 9); Bone and Joint Health National Awareness Week (Oct. 12-20); World Pediatric Bone and Joint Day (Oct. 19); and World Psoriasis Day (Oct. 29).  Background on what it takes to make it onto the H.H.S. Office of Disease Prevention and Health Promotion’s national health observances (NHOs) calendar can be found here.

These campaigns can have different goals: raising general awareness of a health need; changing behavior–for example, convincing individuals to change risky behaviors or to take steps toward disease prevention; soliciting donations for research;  increasing early detection; enabling patient support groups; or influencing legislators and policy.  It appears that NHOs can make a difference.  They are not, however, free of controversy.

For example, a primary goal of National Breast Cancer Awareness Month (NBCAM) is to encourage regular breast examination so that cancer can be diagnosed at an early stage.  It has been found that the NBCAM campaign was initially effective in increasing diagnoses, but the effect has diminished over time as the movement has matured, and it seems that the benefits of mammography screening programs have been overestimated.  Unsurprisingly, it has been suggested that it is time for NBCAM to shift focus.  Additionally, many have been critical of the commercialization of NBCAM (see, e.g., the NFL’s “A Crucial Catch” campaign).

What do you think of NBCAM?  Of NHOs more broadly?  Personally, I was surprised at how few of the October NHOs I was aware of, even though medical charity is a topic of  personal and academic interest for me.

Worth Reading This Week

By Nicolas Terry

10/22/14: “Human Subjects Research Regulation” Book Launch

Human_Subjects_Research_slide

Book Launch: “Human Subjects Research Regulation: Perspectives on the Future”

Wednesday, October 22, 2014 12:00 PM – 1:00 PM

Harvard Law School Library Langdell Hall 4th Floor, Caspersen Room, 1557 Massachusetts Ave.

This event is free and open to the public. Lunch will be served. For a list of our panelists, please visit our website.

MIT Press recently published Human Subjects Research Regulation: Perspectives on the Future (2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch. This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

Please join us for a discussion of the book, pending efforts to amend federal research regulations, and some of the biggest unresolved questions in this space.

This event is co-sponsored with the Harvard Law School Library

Facebook Rumored To Be Planning Foray Into the Online Health Space

Reuters broke the story on Friday, citing anonymous sources:

The company is exploring creating online “support communities” that would connect Facebook users suffering from various ailments. . . . Recently, Facebook executives have come to realize that healthcare might work as a tool to increase engagement with the site. One catalyst: the unexpected success of Facebook’s “organ-donor status initiative,” introduced in 2012. The day that Facebook altered profile pages to allow members to specify their organ donor-status, 13,054 people registered to be organ donors online in the United States, a 21 fold increase over the daily average of 616 registrations . . . . Separately, Facebook product teams noticed that people with chronic ailments such as diabetes would search the social networking site for advice, said one former Facebook insider. In addition, the proliferation of patient networks such as PatientsLikeMe demonstrate that people are increasingly comfortable sharing symptoms and treatment experiences online. . . . Facebook may already have a few ideas to alleviate privacy concerns around its health initiatives. The company is considering rolling out its first health application quietly and under a different name, a source said.

I’m quoted in this International Business Times article about Facebook’s rumored plans. After the jump is the full statement I provided to the reporter (links added).  Continue reading

Rapid Rise in IND’s for Biosimilars

By Bob Bohrer
[Cross-posted on Pharmaceutical Policy.]

According to a story by Bronwyn Mixter in Bloomberg’s BNA BIOTECH WATCH, the FDA has received at least twenty-five IND’s for biosimilar development programs. Some quick perspective on that is appropriate. Twenty-five initial IND’s for the development of new small molecule drugs for cancer or autoimmune disease would face many years of clinical trials and long odds against approval (DiMasi et al estimated the approval rate at sixteen percent to nineteen percent). However in this “a little brave” and “a little new” world of biosimilar development, clinical development programs are likely to be much shorter in duration than development programs for new drugs or innovator biologics, and the success rates are likely to be very high, as I indicated in a pharmaceuticalpolicy.blogspot.com post of May 19th, 2014. The DiMasi study referenced above estimated the large molecule success rate at thirty-two percent; and, biosimilars are not only within that large molecule category, they are copies of drugs that have already been shown to be reasonably safe and effective. So it is very likely that we will see filings for the approval of more than twenty biosimilars in the next three years.

It will be very interesting to watch the rapidly developing biosimilar marketplace.

Congressmen Express Concern About Proposed Changes to Generic Drug Labeling Rules

By Bob Bohrer

I have previously posted on pharmaceuticalpolicy.blogspot.com about the FDA’s proposed change to the rules for generic drug labels and an estimate of the liability costs that might be incurred by the generic drug industry as a result of the proposed change.  The Generic Pharmaceutical Manufactuer’s Association lobbying efforts appear to have motivated Congressmen Steve Israel (D-NY) and Timothy Bishop (D-NY) to draft a letter to the FDA requesting changes to the proposed rule.  A copy of the Congressmen’s letter to the FDA can be downloaded through this link.

Inaugural SG Global Chat: Harvard Effective Altruism Expanding to HSPH

SG Global Chat
Harvard Effective Altruism — Using Evidence and Reason to Maximize the Impact of Efforts to Make the World Better

October 8, 2014 12:30-1:20pm, Kresge G-2

Harvard Effective Altruism (HEA) is a student group at Harvard College and Harvard Business School. The group is dedicated to spreading the ideas of effective altruism to better the global community. Previous HEA speakers include Peter Singer, Nick Bostrom, Max Tegmark and Thomas Pogge. This year, HEA plans to became a Harvard University-wide student organization. Come to the first SG Global Chat of the year to hear more about HEA, the events the group has planned, and ways to get involved. Presented by Anders Huitfeldt (ScD Candidate in Epidemiology) and Eric Gastfriend (Student at Harvard Business School).

Light lunch provided. Any questions email studentgov at hsph.harvard.edu.

Dov Fox on Racial Sorting in Family Formation

Check out Dov Fox‘s new op-ed on racial sorting in family formation over at Huffington Post: Reproducing Race.

The piece was prompted by this week’s news of the white lesbian mother who sued a sperm bank for mixing up the sample she ordered with that from a black donor. The impulse to call one’s mixed-race child a “wrongful birth” gives reason, Dov argues, to rethink the racial preferences that we tend to accept without question; race-matching should be resisted for expressing the divisive notion that single-race families should be preferred to multiracial ones and that families should be set apart by race.

Exploring the Brain in Pain: An Applied Neuroscience & Law Initiative

Amanda C. Pustilnik

I am excited to join the Petrie-Flom Center as the first Senior Fellow in Law & Applied Neuroscience. This fellowship is the product of an innovative partnership between the Petrie-Flom Center and the Center for Law, Brain and Behavior (CLBB) at Massachusetts General Hospital. This partnership aims to translate developments in neuroscience into legal applications, remaining sensitive to the normative dimensions of many – if not all – legal questions. The field of law & neuroscience is large and growing, addressing questions that intersect with nearly every area of law and a huge range of social and human concerns. CLBB is bringing together scientists, bioethicists, and legal scholars to look at questions ranging from criminal responsibility and addiction, to mind-reading and brain-based lie detection, to how the brain’s changes over our lifecourse affect our capacities to make decisions.

In the first year of this joint venture, we will be focusing on a set of issues with potentially huge implications for the law: The problem of pain. Pain is pervasive in law, from tort to torture, from ERISA to expert evidence. Pain and suffering damages in tort add up to billions of dollars per year; disability benefits, often awarded to people who suffer or claim to have chronic pain, amount to over one hundred billion annually. Yet legal doctrines and decision-makers often understand pain poorly, relying on concepts that are out of date and that can cast suspicion on pain sufferers as having a problem that is “all in their heads.”

Now, brain imaging technologies are allowing scientists to see the brain in pain – and to reconceive of many types of pain as diseases of the central nervous system. Brain imaging shows that, in many cases, the problem is literally in sufferers’ heads: Long-term pain changes the structure and function of the brain, perpetuating non-adaptive pain and interfering with cognitive and emotional function. Continue reading

Upcoming Event: Emerging Issues and New Frontiers in FDA Regulation

lab_colored_beakers_slideEmerging Issues and New Frontiers for FDA Regulation

October 20, 2014 8:00 AM – 5:00 PM

Alston & Bird, The Atlantic Building, 950 F Street, NW, Washington, DC 20004-1404

Registration is now open online. A limited number of free seats are available to Harvard affiliates. For more information or to request a seat, please email us at petrie-flom@law.harvard.edu by October 7th.

Please join the Food and Drug Law Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School for an academic symposium on cutting-edge legal and regulatory issues facing FDA.  Leading academics will present papers on mobile health, stem cells, personalized medicine, and other novel medical product issues, as well as food regulation.  Papers will be available to registered attendees in advance, and will be published in an upcoming issue of the Food and Drug Law Journal.

Continue reading

Tomorrow: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Harvard Law School
LOCATION CHANGE: Wasserstein Hall, Milstein West AB
1585 Massachusetts Ave.
Cambridge, MA 02138

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

This event is supported by the Oswald DeN. Cammann Fund.

Tomorrow: Petrie-Flom Center Annual Open House

PFC_Logo_300x300Petrie-Flom Center Annual Open House

October 6, 2014, 5:30 PM – 7:00 PM

Harvard Law School
LOCATION CHANGE: Wasserstein Hall, Milstein West AB
1585 Massachusetts Ave, 2nd Floor, Cambridge, MA [Map]

Come learn more about what the Petrie-Flom Center does and how you can get involved at this gathering for faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics.  We will review our sponsored research portfolio, introduce our staff and fellows, describe various opportunities for students and others, and demonstrate key features on our website.  And of course, we’ll eat, drink, and be merry.  Hope to see you there!

The Open House reception will immediately follow the Legal and Ethical Issues in Healthcare Start-Ups Panel.

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

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).  Continue reading

Expelling Immigrants from the Exchanges

[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.  Continue reading

Facebook Announces New Research Policies

6856181503_8d8e73208b_zA 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.  Continue reading

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

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.  Continue reading