Author Archives: petrieflom

Caplan: Stop Critiquing the DSM 5

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Art Caplan has a new column out in Time that takes a different stance on the DSM-V, compared to all the criticism the revisions have recently received:

The critics are going way too far. The DSM is often described as “the bible of the mental health field”—an unfortunate misnomer that leaves it open to attack. It should really be called “The best we know so far about mental disorders” or perhaps “Our best effort to properly classify complicated human behavior.”

But a bigger problem is that the editors don’t know how to defend against the attacks.

Read the full column here.  And some competing commentary here and here.

Caplan on Cloning Human Embryos

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Art Caplan has a new column out spurred by the announcement that researchers at Oregon Health Sciences University have successfully cloned human embryos.  Recognizing the possible ethical concerns and calling for immediate bans on human reproductive cloning (not cloning for stem cell research), Caplan hopefully notes: “Through cloning you can take a disabled or sick person’s DNA from one of their body cells, insert it into a human egg from which the DNA has been removed, fuse the cell electrically (the technique used in Oregon) and create an embryo from which cells can be grown that are identical matches to what the sick or disabled person needs.”

Take a look at the full column here.

Introducing New Blogger Leslie Francis

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We’re pleased to introduce Leslie P. Francis as a regular contributor to Bill of Health.

Professor Francis holds joint appointments at the University of Utah as Alfred C. Emery distinguished professor of law and distinguished professor of philosophy, and adjunct appointments in Family and Preventive Medicine (in the Division of Public Health), Internal Medicine (in the Division of Medical Ethics), and Political Science. Since 2012, she has also served the College of Law as Associate Dean for Faculty Research and Development. Professor Francis received a B.A. from Wellesley College, where she graduated with high honors in philosophy and was a member of Phi Beta Kappa. She received a Ph.D. in philosophy (1974) from the University of Michigan. After joining Utah’s philosophy faculty, she received her J.D. from the University of Utah (1981) and served as a law clerk to Judge Abner Mikva on the United States Court of Appeals for the District of Columbia Circuit. Appointed to the law faculty in 1982, she teaches and writes extensively in the areas of health law, bioethics, and disability. Professor Francis currently serves as a member of the National Committee on Vital and Health Statistics, where she co-chairs the subcommittee on Privacy, Confidentiality, and Security; and as a member of the Executive Committee of the International Association for Philosophy of Law and Social Philosophy (IVR). Professor Francis also has been a member of the Medicare Coverage Advisory Committee and of the American Bar Association’s Commission on Law and Aging.

Representative Publications:

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Introducing New Blogger Nicholson Price

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W. Nicholson Price II is an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School.  He holds a J.D. from Columbia Law School, a Ph.D. in Biological Sciences from Columbia University, and an A.B. from Harvard College.  After law school, he clerked for Judge Carlos T. Bea of the U.S. Court of Appeals for the Ninth Circuit and was a Visiting Consortium Scholar at the UCSF/UC Hastings Consortium on Law, Science and Health Policy.  His current research interests include innovation in pharmaceutical manufacturing, genetic testing, and personalized medicine.

Some of Nicholson’s recent publications include:

Does Whole-Genome Sequencing Circumvent Gene Patents?  Bio-IT World (December 10, 2012).

Unblocked Future: Why Gene Patents Won’t Hinder Whole-Genome Sequencing and Personalized Medicine. 33 Cardozo L. Rev. 1601 (2012).

Price, W.N. et al. Large-scale experimental studies show unexpected amino acid effects on protein expression and solubility in vivo in E. coli. 1 Microbial Informatics and Experimentation 6 (2011).

Neuner, L.K. & Price, W.N. The Deepwater Horizon Oil Spill: Potential Insurance Coverage Implications. Ins. Law Coverage Bulletin (Sep. 2010).

Am I My Son? Clones and the Modern Family. 11 Colum. Sci. Tech. L. Rev. 118 (2010). Winner, Julius Silver Notes Competition 2009.

Price, W.N. et al. Understanding the physical properties that control protein crystallization by analysis of large-scale experimental data. 27 Nat. Biotechnol. 51 (2009).

Patenting Race: The Problems of Ethnic Genetic Testing of Patents.
8 Colum. Sci. Tech. L. Rev. 119 (2007). Winner, Julius Silver Notes Competition 2006.

Petrie-Flom Student Fellowship Applications Due in One Week!

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[Note: This Student Fellowship program is different from the Petrie-Flom Center Academic Fellowship, applications for which will open again in the Fall.]

The Center and Student Fellowship.  The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas.  For more information on our current fellows and their work, see our website. 

Eligibility. The student fellowship program is open to Harvard Law School students and students in other Harvard graduate programs who are committed to undertaking a significant research project during the year of their fellowship. 

Keep reading for additional information on fellowship requirements and applications…

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Privacy and Progress and the Deidentification of Whole Genome Sequence Data

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[Posted on behalf of Elizabeth Pike and Kayte Spector-Bagdady from the Presidential Commission for the Study of Bioethical Issues - and cross-posted here.]

In the most recent issue of the Hastings Center Report, Drs. Amy Gutmann and James Wagner of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), contributed to the lively debate surrounding the identifiability of genetic data. In Found Your DNA on the Web: Reconciling Privacy and Progress, Gutmann and Wagner, Chair and Vice-chair respectively, argue that the paradigm of identifiability has become less relevant to individual privacy protections than restrictions on access and use.

In their commentary, Gutmann and Wagner continue the public deliberation of the Bioethics Commission’s report, Privacy and Progress in Whole Genome Sequencing, in which the Bioethics Commission took a forward-looking approach to the privacy concerns raised by whole genome sequencing—issues that have come to the forefront of this important science.

Under current law, health information that is deidentified—information for which there is “no reasonable basis” to believe it can identify an individual or that has been stripped of traditional identifiers—is afforded different legal protections than identifiable health information. However, whole genome sequence data are unique to only one person, making them more vulnerable to reidentification.

Recent articles have cast doubt on the extent to which whole genome sequence data can be deidentified. For example, in Identifying Personal Genomes by Surname Inference, published in Science in January, Melissa Gymrek, et. al. successfully uncovered full identities of 50 individuals.

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PFC Student Intern Applications Due Soon!

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The Petrie-Flom Center for Health Law Policy,
Biotechnology, and Bioethics at Harvard Law School
 
Call for Applications
Student Internship Program

 

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the upcoming academic year beginning in September 2013.   Full-year availability is preferred, but single-term internships will be considered on an individual basis; please indicate your preference in your application materials. We are not currently accepting applications for Summer 2013, but may consider extension through Summer 2014 if there is mutual interest.

Who is eligible?

Harvard undergraduate and graduate students with an interest in the Center’s work are eligible to apply. More information about the Center is available here. The internship is open to students in all disciplines, but we particularly welcome applications from students studying health policy, philosophy, bioethics, law, medicine, business economics, and the sciences.  We are also interested in receiving applications from students interested in technology and communications, as we plan to substantially update and expand our Internet presence and social media strategy.

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Fox on DNA Forensic Error and the Execution of Innocents

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Willie Jerome Manning, a 44-year-old black man, is scheduled to die by lethal injection on Tuesday for the 1992 kidnapping and murder of white college students Jon Steckler and Tiffany Miller in Mississippi. No physical evidence has ever linked Manning to the crime. And the Justice Department has just come clean that the forensic science used to prosecute Manning was fundamentally flawed.

A jury convicted Manning almost 20 years ago based on three kinds of circumstantial evidence. First was the testimony of his cousin and a jailhouse informant who claimed that he confessed the crime to them. The cousin had accused two other men before Manning, however, and the informant has since recanted altogether. Second were Steckler’s jacket, ring, and CD player from his car that Manning was arrested for trying to sell. Manning told police from the beginning that he had acquired the stolen property from someone he didn’t know.

Critical to the prosecution’s case was the last piece of evidence against Manning: expert testimony by an FBI agent that African American hair fragments were found in Miller’s car. Not only did DNA and fingerprints found at the crime scene never incriminate Manning himself, however. Two days ago, the Justice Department notified Manning’s lawyer and the County District Attorney that “testimony containing erroneous statements regarding microscopic hair comparison analysis was used in this case.” Federal officials have yet to detail the precise errors involved, but made clear in their letter that the FBI’s forensic evidence was unsound not least because it “exceeded the limits of science” at the time.

Keep reading… 

Live Blogging FDA in the 21st Century Conference, Plenary 3: Susan Winckler, President and CEO of FDLI

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[Posted on behalf of Holly Fernandez Lynch, Executive Director, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]

For the last plenary session of the conference, we heard from Susan Winckler, President and CEO of the Food and Drug Law Institute, who discussed “Other Influencers of Food and Drug Law” – namely the media and Congress.

Susan began by contrasting media past and present – from newspapers, radios, and TV news, today the agency has to contend with the range of issues and challenges associated with social media.  There has been a shift from dealing with a defined press corps focused (and expert) on FDA to a “media of the masses,” which requires some level of training and background on the agency’s mission and intricacies.  The agency can now also speak directly to the public, and be more proactive, without the filter of reporters and news media editors.

Associated with this media shift, Susan identified several new realities and challenges:

  • How to explain complex scientific and legal issues in 140 character tweets?
  • How to speak with “one voice” despite the fact that every agency employee now has a media outlet?
  • How to address the expectation that FDA make declarations in real time, giving immediate responses to new developments? 
Susan then moved on to discuss the various ways in which congress engages with and influences the agency, beyond amending the FDCA:

Live Blogging from FDA in the 21st Century Conference, Panel 7: Major Issues in Device Regulation

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[Posted on behalf of Jeffrey Skopek, Academic Fellow, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]

Jeffrey Shapiro (Hyman, Phelps, McNamara PC), Why the 510(k) Pathway is the Right Approach for Most Medical Devices

Jeff Shapiro began with an introduction to FDA approval processes for medical devices.   He explained that all devices reach the marked based on a finding of  reasonable assurance of safety and efficacy, whether it is through the PMA or 510(k) process. 

His focus was on the 510(k) clearance process for Class I/II devices, which is based upon FDA’s finding of substantial equivalence to a “predicate device.”    This predicate device is another Class I/II device that (1) has the same intended use and (2) has the same technological characteristic, or has difference characteristics but does not raise new questions of safety.   He explained that this review process creates a chain of linked comparisons through which the FDA allows advances only far enough that likely clinical impact can be predicted.   Novel devices are shifted to PMA process. 

He argued that the 510(k) approach has many benefits.    Like common law, it is precedent driven.   It provides an open regulatory architecture.  It allows leapfrogging within industry sectors, avoiding re-inventing the wheel.  It is efficient, focusing on modifications, rather than complete evaluation.    Each clearance adds richness to the body of potential baseline technology, allowing fine comparisons in a wide variety of device types.    The PMA approval, by contrast, has closed regulatory architecture.  Each iteration must re-invent the wheel, and thus is only practical for a small number of high risk devices.    

He closed by suggesting that the 510(k) process can be improved in ways discussed in his paper, but that it works well for most medical devices and should thus be around for a long time.

Kayte Spector-Bagdady/Elizabeth Pike (Presidential Commission for the Study of Bioethical Issues), Device-ive Manuevers: FDA Regulation of the Bifurcation of Direct-to-Consumer Genomic Data and Information

Live Blogging from FDA in the 21st Century Conference, Panel 6: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars

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[Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging - see posts below)] 

The first panel of today is on regulatory exclusivity and generic drugs, moderated by Ben Roin at the Petrie-Flom Center.

Leading off was Kate Greenwood, discussing orphan drug development and recycled molecules.  She started off with Makena, known as 17-P,  first approved in 1976 as Delalutin.  In 1996 FDA withdrew its approval at the manufacturer’s request, as it hadn’t been marketing it.  A few years later, a study showed that the molecule, 17-P, helped prevent premature birth.  Compounding pharmacies started making it, and in 2006, CustoPharm filed a Citizen’s Petition asking whether the way was clear for a generic; FDA said yes, though the route might be challenging.  But in May 2006, a different company filed for a NDA for this new use; it was approved as Makena in January 2007; the company (KV Pharmaceuticals) priced it at $30,000 for a course of treatment (vs. $300 for the compounded version, still available pre-approval).  Responding to criticism, FDA stated that Makena’s reliance on government funding did not prevent Orphan Drug application.  But a few months later, FDA stated that compounding pharmacies could still make 17-P for patients; KV declared bankruptcy and blamed FDA’s decision not to discretionarily enforce Orphan Drug exclusivity.  KV has since sued FDA and HHS, and the case is pending.

Kate moved on to discuss ways to adjust the innovation/access balance, including shortening the exclusivity period, allowing limited competition, or capping or controlling drug prices.  There are concerns, however, that after Makena payers won’t really allow any monopoly price period.

Next up was Kevin Outterson, talking about opacity of R&D information; all we see are the shadows of data.  There are $250 billion of branded drug sales, with something like $200 billion in patent rents in the U.S. alone (twice that globally).  Patent theory describes this as the engine behind development in drugs – but it’s not free; we pay in higher drug prices.  We’re paying for R&D, not the pills themselves, which would be priced at the generics’ cost.  There’s no industry that celebrates inefficiency the way drugs do, touting the $1.2 billion figure for drug development.  Don’t blame patent law, though!  They require up-front disclosure.  But that doesn’t apply to clinical data, which is kept locked away, only accessible to FDA.  This process, which society pays for, is anathema to the scientific process.

Live Blogging from FDA in the 21st Century Conference, Panel 3: Protecting the Public within Constitutional Limits

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[Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging - see posts below)]

The third panel at the conference covered commercial speech protection and off-label drug promotion, in reaction to the Second Circuit’s December 12 case, United States v. Caronia.  Caronia was promoting Xyrem, approved for narcolepsy, for off-label uses, which is prohibited by FDA.  He was criminally charged and convicted, but the Second Circuit held this prohibition constitutionally suspect.

Leading off was Aaron Kesselheim.  Aaron started off describing the FDA’s prohibition on off-label promotion.  Off-label promotion prohibition is based on the requirement of substantial evidence for efficacy.  There are some safe-harbors, like distributing papers, but generally off-label promotion is prohibited because promotion drives prescription patterns, and off-label promotion for unapproved uses can have significant negative consequences.  FDA has negotiated many major settlements, totaling billions of dollars in recent years.  In this context, the Caronia decision is troubling from a public health point of view, even if not particularly surprising given the history of commercial free speech doctrine.

Aaron described four ways forward for the FDA after Caronia.  First, the government could rely more heavily on written materials as evidence, arguing that it is part of the label.  Second, the government could change the prosecutorial language, using speech as evidence of an attempt to misbrand, rather than prosecuting for speech; this might not be enough to fix the problem.  Third, the government could prosecute off-label promotion as false and misleading speech, but that requires hard case-by-case evaluations.  Fourth, the government could better argue that the Central Hudson test for commercial free speech is met.

Next, Chris Robertson also took Caronia as a jumping-off point, noting that Caronia was actually convicted of conspiracy to introduce a misbranded drug into interstate commerce – though the Second Circuit held he was actually convicted for his speech.  Caronia comes in the wake of robust First Amendment jurisprudence from the Supreme Court, including Citizens United, Sorrell, Stevens, Alvarez, and Fox v. FCC, and thus might be a harbinger of this reasoning spreading across the country.  In addition, the reasoning of Caronia could potentially apply equally to drugs with no approved use, and thus undermine the entire FDCA (since what is defined as a drug is determined by label claims).

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Live Blogging from FDA in the 21st Century Conference, Keynote: Deborah Autor

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[Posted on behalf of Jeffrey Skopek, Academic Fellow, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]

Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, U.S. Food and Drug Administration (for now – and soon headed off to Mylan), gave a keynote address exploring the ways in which the FDA’s mandate is increasingly difficult to achieve in an era of globalization.

In the first  part of the talk, she provided an overview of the FDA, discussing the extent to which FDA-regulated products infuse nearly every aspect of life.   For example, 20 cents of every consumer dollar spend in the US is on a good that is regulated by the FDA (for a total of over 2 trillion dollars).   Further, the FDA must achieve this monumental task at very lost cost to the public – just 8 dollars per person per year.

The second part of the talk identified various ways in which modernization (e.g., the speed of technology, communications, and commerce) and globalization (e.g., the complex global regulatory landscape) is making the FDA’s mandate more difficult.   Just as disease knows no borders, product safety and quality no longer know any borders.  For example, FDA regulated products originate from more than 150 countries, 130,000 importers, and 300, 000 foreign facilities.   And the number of FDA regulated shipments at over 300 ports has skyrocketed.  For example, 10-15% of food products are imported, 50% of medical devices are imported, and 40% of drugs are imported.  Further, the global supply chains are complex and hard to oversee, in part because the increased number of individuals, producers, and companies are geographically dispersed; and also because the new and hard to regulate distribution channel for products, such as the internet.

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Art Caplan on Plan B and Kermit Gosnell

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Art Caplan has a new Viewpoint article out in Time discussing Plan B’s impact on late trimester abortion:

Gosnell was a stop of last resort for woman late in their pregnancies. They sought an abortion past the point of fetal viability — a choice illegal in Pennsylvania and throughout the United States. For these women, Gosnell and his ilk are their only option.

But regardless of the outcome of Gosnell’s trial, the need for late trimester abortion is going to disappear. Even surgical abortion will be a thing of the past, as the abortion clinic slowly gives way to pharmaceutical abortion.

More and more women will be using cheap and readily available emergency contraception, not abortion. The FDA just announced that Plan B can be sold over-the-counter to buyers as young as 15. Other women will use mifepristone when they choose to end a pregnancy within the first seven weeks. They won’t be faced with the choice of a third trimester abortion because they will be able to easily access pharmaceutical options. The awful horror of Gosnell will disappear not as a result of legislation or protests or even trials but as a result of affordable pills that are easy to use.

Take a look here.

Post-doc/Instructor Positions in Medical Ethics at NYULMC

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The Division of Medical Ethics at the NYU Langone medical Center seeks to recruit two persons either as post-docs or instructors.

Applicants must demonstrate an excellent record of quality scholarship and teaching, and must have a PhD, JD, or MD. Successful applicants will be expected to demonstrate a strong scholarly career track in a sub-field of medical ethics/bioethics. The Division is especially interested in persons with research interests in neuroethics, reproductive technologies and ethics, public health ethics, transplantation ethics and mental health ethics. Continue reading →