TOMORROW: Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

The Petrie-Flom Center Staff Leave a comment

Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

April 2, 2014, 12:00 PM

Langdell, Vorenberg Classroom – North (225), Harvard Law School, Cambridge, MA

Please join us for this esteemed panel of leading patent experts, including members of the European Patent Office. Discussion will address U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.

Panelists:

  • Aliki Nichogiannopoulou, Director, Biotechnology, EPO
  • Anja Schmitt, Examiner, EPO
  • Maaike van der Kooij, Examiner, EPO
  • Tom Kowalski, US Patent Attorney
  • Moderator: Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute

This event is free and open to the public, but space is limited and registration is required. Register here.

Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

Cosponsored by the Broad Institute of MIT and Harvard.

A Case Against the “Noncompliant” Patient

dcho 1 Comment

By Deborah Cho

In recent years, providers have attempted to shift how health care is delivered so as to include the patient in the decision-making process.  This concept of shared decision-making was most memorably relayed to me in medical school through a critical lesson during which we were instructed to replace the word “noncompliant” with “non-adherent” when describing patients who were unwilling or unable to stick with treatment regimens.    Noncompliance painted a picture of a paternalistic provider mandating the rules of play, while the patient cowered below as a disobedient subordinate.  It also implied that the patient did something wrong by breaking the rules and that the actions of the patient ought to be modified to fit the rules, rather than the other way around.  On the other hand, non-adherence signified that the patient was a contributing partner in the development of the treatment plan and, further, that he may be justified for not abiding by the terms of his plan.

There were two overarching reasons for the shift to the shared decision-making model: first, that this would produce better overall clinical results and second, that this view shows more respect for patient autonomy.  Providers were learning and accepting that treatment plans prescribed within their vacuums could fail to be affordable, intelligible, or even realistic given a patient’s life circumstances.

So how does this relate to law students and lawyers?

Read More

Is Finding Malaysia Airlines Flight MH370 Worth 52,192 years of children’s lives?

I. Glenn Cohen 3 Comments

[Note: This post is meant to be provocative and press a public policy question in the most thought-provoking way possible. Losing a loved one is among the most heart-wrenching experiences in a life time and my heart goes out to all those with loved ones on the flight waiting for answers. But one of the major points of this post is to highlight our tendency to spend more on identified lives not statistical ones for just these kinds of reasons and ask if it is justified.]

The search for Malaysia Airlines Flight MH370 is likely run to “Hundreds of Millions of Dollars” according to the most recent estimate from ABC News. This is based on extrapolation of the difficulties involved and the experience of searching for Air France 447 which cost 50 million USD. Let’s take a conservative estimate of 100 million USD to find the plane, probably on the low end. Let us put aside the possibility that even with that expenditure the plane will never be found, again an assumption that counts against the argument I will be making. This is 100 million dollars spent, roughly speaking, on “helping.” It is very unlikely that there are any survivors, so I don’t think this can reasonably be thought of as “life-saving” (I will assume it is not, but if it were  that wouldn’t make that much of a difference in the argument I will offer though it will require confronting the question of Should the Numbers Count for life saving?).

Instead the money is being spent (1) to satisfy the somewhat diffuse curiosity/grief of those who have watched this in the media, (2) to give answers to the very deep need for closure of the loved ones of those flying on these planes, and (3) to learn about what went wrong and potentially determine whether there is a systemic problem with these planes that might affect other planes.

All of those are worthy goals. But are they worth 100 million USD? In the category of “helping” or “life-saving” what else could we do with the money? Let me draw on one estimate mentioned by Ezra Klein in the WaPo and Don Taylor at the Incidental Economist from a paper by Tammy Tengs “Five Hundred Life Saving Interventions and Their Cost Effectiveness“

I chose the cheapest intervention, influenza vaccines for children age 5+ which is estimated to cost $1,300/life year saved in 1993 dollars. I then updated that to 2013 dollars with a conversion calculator to generate a cost of 1915.89 USD per life year saved (it may also be that this intervention is now cheaper than it was at the time of Teng’s paper). I then divided 100 million dollars by that number to get my 52,192 life years saved for children estimate. That is fairly back of the envelope and there are lots of tweaks you would do to get a more exact figure, but it is close enough to make the point: Why are we spending so much on Malaysia Airlines search when we could be saving so many lives?

Read More

Genetic Mugshots

Dov Fox Leave a comment

By Dov Fox

New technologies can put pressure on the logic of the law. Consider the well-settled legal conclusion that equal protection rights don’t apply when police use race-based descriptions to look for suspects. An emerging forensic technique called DNA phenotyping makes it hard to defend this reliance on racial proxies–rather than appearance itself–in the investigation of crime.

Phenotyping promises to use a piece of hair or skin left at a crime scene to infer an unknown person’s physical characteristics like eye color, nose shape, and cheekbone width. A groundbreaking new study — featured in last week’s Nature, New Scientist, and Time Magazine — used high-resolution 3D images and facial recognition software to approximate the facial features of almost 600 people of mixed ancestry from their DNA.

I consider the scientific, constitutional, and criminological implications of this technology in The Second Generation of Racial Profiling. I argue that reliable DNA phenotyping would force us to rethink whether race-based suspect descriptions are the kind of racially classifying state action subject to strict scrutiny–and it would lean on the narrow tailoring requirement that the state use race-neutral alternatives when possible. I summarized my replies to the best policy objections in a short piece on The Future of Genetic Privacy:

Critics of the forensic technique argue that its adoption would imperil individual privacy and facilitate racial profiling. These objections are important, but they’re overstated. What “a person knowingly exposes to the public,” the Supreme Court has held, “is not a subject of Fourth Amendment protection” against unreasonable searches and seizures. And statutory safeguards could be afforded for sensitive external traits about whether a suspect has changed genders, for example, or had plastic surgery.

Racial profiling is another concern. That the technology could be used to target minorities at disproportionate rates, however, gives no reason to think that such misuse is probable or any more likely than DNA dragnets or stop-and-question sweeps based on race-based suspect descriptions. The adoption of more precise physical markers in place of notoriously unreliable eyewitness observation would improve arrest accuracy and enhance police legitimacy.

The more serious worry is that DNA phenotyping might resurrect discredited conceptions of racial biology. If the [National Institute of Justice-funded] technology works as well as the government is banking it will, however, then replacing race-based suspect designations with the colors and shapes of facial features could, to the contrary, loosen the hold that race has on the way that people think about crime. Today’s all-points-bulletin for a “black man” could give way to tomorrow’s search for a suspect with dimples, copper complexion, and green eyes.

Wouldn’t police just filter these markers into racial terms? Maybe not, if they’re trained like clerks at a makeup counter are to trade in racial identifiers for face shapes and color tones. Besides, measures short of prohibition would likely soften whatever risk the adoption of DNA phenotyping would pose to egalitarian norms — for example, requiring higher burdens for investigatory use, or racial impact assessments of the kind that gained national prominence after the Supreme Court struck down a key provision of the Voting Rights Act.

Antibiotics, Farm Animals, and the FDA

jskopek Leave a comment

On Wednesday, the Food and Drug Administration announced that 25 pharmaceutical companies that manufacture animal drugs will participate in voluntarily phasing-out the use of antibiotics for growth promotion purposes in farm animals.

The companies are acting in response to voluntary guidelines that the FDA issued in December, requesting that the companies change their labeling of “medically important” antibiotics in two ways: (1) removing production uses (e.g., animal growth promotion) from the approved indications for the drugs; and (2) requiring veterinary oversight, rather than allowing over-the-counter distribution, for the remaining therapeutic uses.

Of the 26 companies targeted by these guidelines, 25 have agreed to comply by either revising their labels or withdrawing the drugs from animal use completely.   The FDA did not name the one company that has not agreed to comply.

While this is undoubtedly an important step forward in the FDA’s efforts to reduce non-necessary uses of antibiotics in livestock production—and hopefully slow the evolution of drug-resistant bacteria—it is important to note that there are potential loopholes in the FDA’s approach, as I have previously discussed. Read More

Doc Fix Likely to Delay Review of Inpatient Hospital Admissions

mlawrence Leave a comment

Every year, in order to prevent a statutorily-triggered decrease in physician reimbursements under Medicare, Congress must adjust the statutorily-prescribed fee schedule.  This is known as the “doc fix.”  The American Medical Association, for what it is worth, has lobbied for a permanent doc fix, but that has not happened yet.

This year’s automatic pay cut was going to be 24%, and for a moment a temporary fix was in doubt because of bipartisan support for a permanent fix.  But thanks to some procedural maneuvering yesterday, it looks like a temporary doc fix is through the house, at least.  (See coverage in Politico here and Washington Post here.  And just for fun, see a show about getting things through the house with procedural maneuvering here.)

In addition to the doc fix, a provision included in the House bill would forbid the Department of Health and Human Services from conducting post-payment review through Recovery Audit Contractors of inpatient hospital admission until March 31, 2015.  This will stop for at least a year a review program that, in its last full year of operation, returned to the Medicare trust fund (and took away from hospitals) billions of dollars.  (See commentary condemning the delay here and commentary criticizing the Recovery Audit Contractor program here.) It’s a notable development and if passed will kick the can down the road a short ways for Medicare to decide how it wants to handle utilization review in this area.

Petrie-Flom Intern’s Weekly Round-Up, 3/21-3/28

The Petrie-Flom Center Staff Leave a comment

By Chloe Reichel

The Hobby Lobby case that is currently before the Supreme Court may have effects far beyond the contraceptives mandate stemming from the Affordable Care Act. Other health care services and non-discrimination provisions may also be at stake.

Deadlines will be extended for people who need more time to complete their enrollment in insurance plans through HealthCare.gov. Those who apply will be given until mid-April to complete their applications.

Social media efforts led to the provision of an experimental drug to treat a young boy’s life-threatening infection. Bioethicists are now debating the ethics of this case and its implications for future social media interactions.

Due to stringent approval processes, researchers interested in studying marijuana face difficulty in attempting to do so. Despite growing interest in researching the substance, it can take years for researchers to begin their studies on marijuana.

Enrollment in health insurance policies through the Affordable Care Act reflect vast differences in the legislation’s implementation across the country. State-by-state enrollment data varies widely, and overall enrollment statistics neglect this important variation.

Tanning salons in New York are now forbidden from making claims about the health effects of their services. Previously, tanning salons in New York suggested that “sunlight prevents cancer,” a misleading statement considering the negative health effects of tanning.

Changes to Medicare’s policy manual have shifted the agency’s policies on paying for care used to maintain, rather than improve, patients’ health. Medicare will now pay for physical therapy, nursing care, and services for patients with chronic diseases.

Responding to a statewide public health crisis, Governor Deval Patrick has proposed a ban on the the opiate Zohydro. He has also suggested designating $20 million in funds for the purpose of bolstering treatment and recovery programs.

RESCHEDULED: 4/11, Hot Topics at Presidential Commission on Bioethics

The Petrie-Flom Center Staff Leave a comment

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

This event is free and open to the public. Lunch will be served.

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

Saturday, April 5th: Aid Grade! (from Harvard Effective Altruism)

Nir Eyal Leave a comment

A communication from Harvard Effective Altruism:

 

Hi altruists,

Saturday, April 5th is a big day for EA at Harvard: we have three different awesome events for you! Our guest for the day, flying up from DC for the occasion, will be Dr. Eva Vivalt, the founder of AidGrade. AidGrade helps figure out what works in international development by doing rigorous and engaging analyses of different interventions to find out their effects. They’re also looking for interns and full-time hires for this work, so please visit if you’re interested!

We’ll be having a talk on AidGrade’s research from 1-2pm, followed by a research-a-thon from 2-6 where we help AidGrade do some meta-analysis. The day will be topped off by a Boston-area effective altruism meetup at Clover–with another special guest, Jacob Trefethen of 80,000 Hours Cambridge UK, and many awesome local effective altruists.

Read More

It’s Doctors’ Duty to Promote Gun Safety With Patients

acaplan 2 Comments

Art Caplan has a new opinion piece up at Medscape: “It’s Doctors’ Duty to Promote Gun Safety With Patients.” From the article:

There is a huge problem with guns in the United States, and there are many things that public health can do, and many things that doctors should do to try to minimize the threats that guns pose to children, families, and all of us. One of the leading problems with guns is that we don’t educate children to know what to do when they find a gun or see a gun. So, if a 5- or 6-year-old sees a gun, we need a program that teaches that child that if you see a gun, walk away, get out of the area, and then tell an adult. That is a public health program. It’s something that school nurses could do. It’s something that pediatricians should talk about with their child patients. It’s something that families should hear about. We need a campaign. Vivek Murthy, the Surgeon General candidate, thinks that it is an appropriate thing to do. Apparently, the NRA doesn’t.

You can watch or read the full piece on the Medscape website (access requires a login and password, but registration is free).