5/20 conference: “Biostatistics & FDA Regulation: The Convergence of Science & Law”

Biostatistics and FDA Regulation: The Convergence of Science and Law

Tuesday, May 20, 2014, 8:00am – 5:00pm

Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation. The full conference agenda is available on the website.

Registration is required in order to attend this event. Please register here.

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    Research Round-Up: New Publications from the PHLR SciVal Experts Community

    In honor of last week’s National Public Health Week, we have a lot of fresh, new PHLR. The latest crop of papers from public health law researchers touch on a number of important points and issues including transportation safety, implementation, tobacco control, and media presentation of public health law. Check out Scott Burris’s brief summaries after the jump!

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      CONFERENCE – CLASHING RIGHTS & REPRODUCTIVE AUTONOMY

      Join us at Northeastern University School of Law at 1 p.m. on April 25, 2014 as leading academics and practitioners discuss the tensions between free speech and reproductive rights.

      For more information, see http://www.northeastern.edu/law/academics/institutes/health-law/events/clashing-rights/

        You can’t put a price tag on Sovalid (unless it’s over $84K)

        Gilead Sciences has developed a new drug (Sovaldi) that cures hepatitis C.

        This is a huge deal: about 150 million people world wide are chronically infected with the hepatitis C virus (HCV); according to the CDC 60-70% of people with chronic HCV will go on to develop chronic liver disease, 5-20% will develop cirrhosis over 20-30 years, and 1-5% will eventually die from the direct consequences of chronic infection (liver cancer or cirrhosis).

        Sovaldi, which cures patients about 90% of the time with minimal side effects, could change all of this. John Castellani, President of Pharmaceutical Research and Manufacturers of America says that this breakthrough is so valuable, that “you just can’t put a price tag on it.”

        But of course, a price tag has been put on it: $84,000 for the 12-week course of treatment (or $1,000) per day.

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          Petrie-Flom Intern’s Weekly Round-Up, 4/4-4/11

          By Chloe Reichel

          Following the release of information on Medicare billing practices, it was revealed that approximately 4,000 physicians each billed over $1 million in 2012. This data may shed light on medical billing procedures.

          Despite a proposed 1.9 percent cut to the Medicare Advantage program, these cuts will not be implemented. On Monday the Centers for Medicare and Medicaid Services announced that funding to Medicare Advantage will increase by an average of .4 percent in 2015.

          Though genetic testing is becoming cheaper and more accessible, many Americans refrain from getting tested. This is because the Genetic Information Nondiscrimination Act does not protect consumers from discrimination for life, disability, and long-term care insurance plans.

          On Friday, Kathleen Sebelius, current Secretary of Health and Human Services, will resign from her role. Sebelius oversaw the oft-criticized implementation of the Affordable Care Act. Sylvia Mathews Burwell, director of the White House Office of Management and Budget, has been selected by President Obama to fill the role. Burwell served in the Clinton administration, and was president of the Walmart Foundation, prior to her work with the Obama administration.

          This Thursday the European Parliament debated a petition that would prevent the allocation of EU funds for research, aid, and public health programs that involve the destruction of human embryos. The petition had 1.8 million signatures, and is seen as a sign of popular support for social conservatism.

          Hawaii’s extensive health system has led to excellent health outcomes for the state’s residents and the state’s budget, since the state has some of the lowest healthcare costs in the nation. Hawaii has near-universal health insurance coverage, and starting forty years ago, has required employers to provide health benefits to their employees.

          On Saturday, Maryland legislators voted to decriminalize possession of small amounts of marijuana. Those found in possession of less than 10 grams of marijuana will now be charged with civil fines, as opposed to criminal penalties.

            Worth Reading This Week

            By Nicolas Terry

              FOR HARVARD STUDENTS: 4/16: Dallas Buyers Club: Free Film Screening and Discussion

              Image by christian razukas from Wikimedia Commons.

              Dallas Buyers Club: Free Film Screening and Panel Discussion

              April 16, 2014 6:00 PM
              Wasserstein Hall 1010, 1585 Massachusetts Ave.

              Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

              • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
              • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
              • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

              This event is open to students from all Harvard schools.  No pre-registration is required.

              This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

                Messing with the data, law school edition

                (cross-posted from TIE)

                One important outcome measure for law schools is employment of their graduates, especially jobs for which bar passage is required and are long-term, full-time jobs (BPRFTLT). If a law school can boost that number, it will appear to be better than its rivals. A job is “long-term” if it is expected to last at least a year. Can you guess what many law schools have done? Hired dozens of their grads for a little more than a year:

                  FBPRFTLT2012 / 2013 2012 % of EBPRFTLT 2013 % of EBPRFTLT
                GEORGE WASHINGTON 119 / 88 25.5% 20.7%
                WILLIAM AND MARY 35 / 43 23.3% 25.9%
                UMASS DARTMOUTH 3 / 3 23.1% 10.3%
                VIRGINIA 54 / 58 15.7% 16.7%
                NYU 58 / 42 13.2% 8.3%
                GEORGETOWN 41 / 73 8.9% 13.5%
                EMORY 17 / 64 8.7% 26.0%
                COLUMBIA 38 / 29 8.7% 7.0%
                CHICAGO 17 / 13 8.3% 6.5%
                YALE 11 / 9 6.0% 5.6%
                ILLINOIS 7 / 20 5.3% 11.9%
                MINNESOTA 7 / 5 4.5% 2.6%
                HARVARD 16 / 11 3.1% 2.2%
                UCLA 7 / 25 2.9% 9.6%
                PENN 7 / 13 2.7% 5.5%
                STANFORD 4 / 5 2.4% 2.9%
                WASHINGTON UNIVERSITY 4 / 4 2.0% 2.0%

                (First column is the law school; second is the number of law-school funded jobs that the law school described as bar passage required, full-time, long-term (BPRFTLT) to the ABA for the classes of 2012 and 2013; third and fourth columns are the % of BPRFTLT jobs funded by the school for the classes of 2012 and 2013, respectively. The chart includes all schools in the ABA data set who reported more than 2% BPRLTFT funded jobs for the class of 2012. Schools are ordered descending by column 3. The class of 2013 data was released by the ABA this week.)

                Some comments:  Continue reading

                  TOMORROW: Hot Topics at Presidential Commission on Bioethics

                  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.

                    Massachusetts’ Ban on “Prescribing and Dispensing” Zohydro: The Arguments For and Against Preemption

                    By Kate Greenwood

                    Cross-Posted at Health Reform Watch

                    As Kurt Karst reported at FDA Law Blog, here, drug maker Zogenix has filed a Motion for Temporary Restraining Order and Preliminary Injunction challenging Massachusetts’ decision to “prohibit the prescribing and dispensing” of the company’s extended-release hydrocodone capsule, Zohydro ER. At a hearing on Tuesday, Judge Rya Zobel told the parties that she is likely to decide in the company’s favor. While Zogenix argues that Massachusetts’ action is unconstitutional for a number of reasons, including that it violates the dormant Commerce Clause and the Contracts Clause, Karst predicts that Judge Zobel will grant Zogenix’ motion on preemption grounds.

                    Zogenix argues in its Memorandum that “[t]he emergency declaration issued by Governor Patrick, and related order by the Commissioner of the Department of Public Health (DPH), purported to ban Zohydro™ ER based on safety concerns that squarely conflict with – and are therefore preempted by – FDA’s determination that Zohydro ER® is safe and effective and may be marketed and sold in the United States.”  Zogenix notes that the reason Massachusetts gave for banning Zohydro—that the drug lacks abuse-deterrence features—was expressly considered by the Food and Drug Administration during the course of the approval process.  FDA concluded that Zohydro’s benefits, in particular the fact that it contains no acetaminophen, outweighed the risks posed by its lack of such features.

                    Zogenix acknowledges that the Supreme Court’s decision in Wyeth v. Levine stands for the proposition that when the FDA approves the contents of a drug’s label, the agency merely establishes “a ‘floor’ upon which state tort requirements may build.” But, the company argues, “this is not a labeling case; it is a case about the safety and efficacy vel non of a drug already found to be safe and effective.”  If Massachusetts’ ban is upheld, Zogenix concludes, “Congress’s objectives to promote the public health through FDA drug approvals could be directly contravened by a potential flood of state policy disagreements.”

                    While Massachusetts has not yet filed papers in opposition to Zogenix motion, there are a number of strong counter arguments it could make. Continue reading

                      Killing for Species Health

                      In the past few months, the Copenhagen Zoo has killed a giraffe and four lions in order to protect the genetic health of their breeding populations, generating significant international backlash and highlighting difficult questions about the value of species preservation.

                      The international controversy surrounding the zoo’s actions began in February, when it killed a healthy 18-month old giraffe with a bolt pistol, performed a public autopsy on his body (video), and then fed his remains to the zoo’s lions and other big cats in front of the public (video).  A bolt pistol was used, rather than an injection, so that his meat would be safe to eat.  A statement from the zoo explained that it had decided to kill this giraffe because his genes were “well represented in the breeding programme,” such that allowing him to grow into an adult and breed was “unwanted.”  Zoo officials turned down adoption offers from other zoos on the grounds that this would have left open the door to inbreeding and potentially removed a place for a giraffe whose genetic makeup was more valuable in terms of future offspring in captive breeding programs.  (The statement also addresses a variety of other interesting “health law” questions, such as “Why are the giraffes not given contraceptives?”).

                      The controversy gained further momentum two weeks ago, when the zoo announced that it had killed four lions—a 16 year-old male lion, a 14 year-old lioness, and their cubs—to clear the path for a newly arrived young male lion.  (It is unclear whether these specific lions were among those who had previously eaten the giraffe).   A statement from the zoo explained that it had decided to kill these lions based on several population-level concerns, including that the 16 year-old male might have someday mated with his female offspring creating a problem of inbreeding, or that the new young male might have mated with the 14 year-old lioness instead of younger females with greater reproductive fitness.

                      While the idea that these types of killings can be justified on the grounds that they protect the health of the genetic populations of which the individual animals are a part is fairly common, it is unclear whether “health” is actually an appropriate concept to apply to an entity such as an animal’s species.    Continue reading

                        The Future of “Country of Origin” Labeling Regulations

                        By Ching-Fu Lin

                        The U.S. Court of Appeals for the District Columbia Circuit recently ruled against the meat industry’s challenge to stop the United States Department of Agriculture’s (USDA) implementation of the amended Country of Origin Labeling (COOL) rules.  The current COOL regulations (amended in May 2013) require retailers to identify several types of information on beef, pork, and poultry products that were previously not required.  It now requires labeling of the country where the animals were born, raised, and slaughtered along with the prohibition of the commingling of meat muscle cuts from different origins.

                        The old and less stringent version of the COOL regulations was published in 2009 by the USDA’s Agricultural Marketing Service (AMS) based on the 2008 Farm Bill (Food, Conservation, and Energy Act of 2008) amending the Agricultural Marketing Act of 1946.  In the same year, Canada and Mexico brought a case in front of the World Trade Organization (WTO) Dispute Settlement Body (DSB), arguing that the old COOL requirements violated relevant WTO rules.  The WTO DSB found that the old COOL requirements were inconsistent with the US’s obligations under Article 2.1 (national treatment principle) of the WTO Agreement on Technical Barriers to Trade (TBT Agreement) as well as Article X:3(a) (uniform, impartial, and reasonable administration) of the General Agreement on Tariffs and Trade (GATT 1994).

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                          Repealing the ACA. Will the debate ever end?

                          Last week the President celebrated the enrollment of 7.1 million Americans in health insurance with the words “The debate over repealing this law is over… The Affordable Care Act is here to stay,” here. Indeed, as the number of insured under the Act has grown, Medicaid has gained another 3 million enrollees, here, and other ACA provisions have kicked in so the conventional wisdom has emerged that while a political turn in favor of Republicans would lead to some important “tweaks,” the so-called “popular parts” such as guaranteed issue would survive. This world view seemed confirmed when Senators Burr, Coburn and Hatch introduced the first true Republican alternative to the ACA, here. Tim Jost commended that effort for going beyond the rhetoric of repeal noting, here, ”Republicans seem to be coming to terms with the fact that the ACA has permanently changed the health policy landscape.” However, House Budget Committee Chairman Paul Ryan seems to be having none of this suggesting, here, that total reform remains the objective and that “We can have in this country universal access to affordable health insurance for everybody, including people with preexisting conditions without a costly government takeover of one-sixth of our economy.” It’s going to be a long election season.

                            Introducing New Contributor Joel Lexchin

                            Joel Lexchin received his MD from the University of Toronto in 1977 and for the past 27 years has been an emergency physician at the University Health Network. He is currently a Professor in the School of Health Policy and Management at York University and an Associate Professor in the Department of Family and Community Medicine at the University of Toronto. From 1992-94 he was a member of the Ontario Drug Quality and Therapeutics Committee and he was the chair of the Drugs and Pharmacotherapy Committee of the Ontario Medical Association from 1997-99. He has been a consultant for the province of Ontario, various arms of the Canadian federal government, the World Health Organization, the government of New Zealand and the Australian National Prescribing Service. He is the author or co-author of over 140 peer-reviewed articles on topics such as physician prescribing behaviour, pharmaceutical patent issues, the drug approval process and prescription drug promotion.

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                              Generics, Bioequivalence, and Justice

                              By Matthew L Baum

                              I have written previously on this blog about morally modifying technologies (here and here), which by definition work no better than existing technologies but enable the side-stepping of a moral tension associated with the first technology. Generic pharmaceuticals are a particularly well-known and widely endorsed form of morally modifying technology: they have no therapeutic advantage over name-brand drugs, but by costing less enable the sidestepping of some of the difficult moral issues involved in rationing healthcare.   With the current public focus on limiting the rising cost of healthcare, moreover, there is increasing emphasis on the development and use of generics as a cost-saving measure. Jonathan J. Darrow has already written on this blog questioning whether we should celebrate increasing public endorsement of the development of these drugs that bring with them no new therapeutic benefit. But I would like to highlight in this post a different challenge to the responsible pursuit of a golden age of generics: bioequivalence.

                              Helping the development costs of generics to stay low, the FDA has an abbreviated approvals process that hinges on the generic being shown ‘bioequivalent’ to the name-brand drug (on top of requiring the generic to contain the same active chemical and be taken by the same route and dosage form) [See here and here]. Bioequivalence may sound reasonable, but many would be surprised to learn that it does not mean therapeutic equivalence.

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                                Implications of the NAF Fiasco for Nursing Home Agreements

                                By Alex Stein

                                Until recently, the National Arbitration Forum (NAF) was a designated arbitrator in thousands of nursing home agreements. When a nursing home resident complained about medical malpractice or other mistreatment, her complaint had to be arbitrated before NAF and according to NAF’s rules. If the resident or her successors were to sue the nursing home in court, the court would have to stay the proceeding and compel arbitration, as mandated by Section 2 of the Federal Arbitration Act (FAA) that deems written arbitration agreements “valid, irrevocable, and enforceable.”

                                Five years ago, things have changed dramatically. Continue reading

                                  Petrie-Flom Intern’s Weekly Round-Up, 3/28-4/4

                                  By Chloe Reichel

                                  In an attempt to increase transparency and accountability of Medicare, the Obama administration will release data about the services provided as a part of this program. The information will focus on the number and kind of services provided.

                                  In the six months following the implementation of the Affordable Care Act, over seven million Americans signed up for insurance plans. These figures are in accordance with those estimated by congressional budget analysts.

                                  Teva Pharmaceutical Industries has appealed a case to the Supreme Court about a generic form of its drug Copaxone. Teva is trying to keep their patent on the drug to prevent the manufacture of generics.

                                  Judge David C. Bury, a federal judge in Tucson, will not stop the implementation of rules that restrict the usage of the abortion drug mifepristone in the state of Arizona. The legislation that restricted the usage of this drug went into effect on Tuesday.

                                  On Monday, the last day for sign ups for health insurance plans under the Affordable Care Act, hundreds of thousands attempted to register for policies. The website HealthCare.gov had some glitches on this day, including a period of a few hours in which the site failed to accept applications.

                                  The Affordable Care Act has allowed many Americans who were previously uninsured to sign up for health insurance, leading to increased usage of health services. This is creating new stresses for small health clinics, but also providing additional funds that allow these clinics to operate.

                                  On Thursday the FDA approved a handheld antidote for painkiller overdoses. The naloxone device, made by kaleo Inc., is called Evzio.

                                  An ethics report was recently released on the risks of long-term space travel. The report addresses physical and psychological risks associated with space travel.

                                    Whose Business Is It If You Want To Induce a Bee To Sting Your Penis?

                                    Photo source: WikiMedia Commons

                                    You might think that the answer to this question is obvious. Clearly, it’s your business, and yours alone, right? I mean, sure, maybe it would be considerate to discuss the potential ramifications of this activity with your partner. And you might want to consider the welfare of the bee. But other than that, whose business could it possibly be?

                                    Well, as academic empiricists know, what others can do freely, they often require permission to do. Journalists, for instance, can ask potentially traumatizing questions to children without having to ask whether the risk to these children of interviewing them is justified by the expected knowledge to be gained; academics, by contrast, have to get permission from their institution’s IRB first (and often that permission never comes).

                                    So, too, with potentially traumatizing yourself — at least if you’re an academic who’s trying to induce a bee to sting your penis in order to produce generalizable knowledge, rather than for some, um, other purpose.

                                    Yesterday, science writer Ed Yong reported a fascinating self-experiment conducted by Michael Smith, a Cornell graduate student in the Department of Neurobiology and Behavior who studies the behavior and evolution of honeybees. As Ed explains, when, while doing his other research, a honeybee flew up Smith’s shorts and stung his testicles, Smith was surprised to find that it didn’t hurt as much as he expected. He began to wonder which body parts would really smart if they were stung by a bee and was again surprised to learn that there was a gap in the literature on this point. So he decided to conduct an experiment on himself. (In addition to writing about the science of bee stings to the human penis, Ed is also your go-to guy for bat fellatio and cunnilingus, the spiky penises of beetles and spiders, and coral orgies.)

                                    As Ed notes, Smith explains in his recently published paper reporting the results of his experiment, Honey bee sting pain index by body location, that

                                    Cornell University’s Human Research Protection Program does not have a policy regarding researcher self-experimentation, so this research was not subject to review from their offices. The methods do not conflict with the Helsinki Declaration of 1975, revised in 1983. The author was the only person stung, was aware of all associated risks therein, gave his consent, and is aware that these results will be made public.

                                    As Ed says, Smith’s paper is “deadpan gold.” But on this point, it’s also wrong. Continue reading