TOMORROW (12/9)! Paying Research Participants: Ethical and Regulatory Parameters

Rolled up US paper banknote in a test tube rack representing the costs of medical research

Paying Research Participants: Ethical and Regulatory Parameters
December 9, 2016 8:00 AM – 12:30 PM
Milstein East ABC (2036), Wasserstein Hall
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

Description

This symposium will bring together a variety of experts to discuss key ethical and legal questions regarding offers of payment to research participants. Panels will cover:

  • Why payment is offered to research participants
  • Regulatory parameters governing payment
  • Whether payment to research participants should be considered exceptional, compared to payment in other contexts
  • How offers of payment affect participants
  • How to define coercion and undue influence with regard to paying research participants
  • Which factors should be considered when evaluating proposed payments
  • The problem of low payment

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

Working Agenda

Continue reading

Westworld and Bioethics

[WARNING: Spoilers below]

On Sunday, HBO’s Westworld finished its run. Though I thought some of the early episodes were arguably a bit of a failure as television (and my partner almost jumped off the bandwagon of making this one of “our shows”) IMHO the show finished very strong.

But whatever you thought of it as television, the show is wildly successful at raising a series of bioethics issues. There have been a bunch of other very good treatments of some of these issues in the last couple of decades – A.I., Ex Machina, Humans, Battlestar Galactica all come to mind – that touch on some of these issues. But, what I loved about Westworld is its lack of direct moralizing on these subjects, and how it leaves the viewer puzzling through them in a much more naturalistic way: I have been thrust in this unfamiliar world, and now I am trying to use my ethical compass to get my bearings.

Once upon a time I discussed Bioethics and the Martian, and my aim is to do the same here. I thought one way to share why I think the show is so successful as a text for bioethics exploration was to develop a “mock exam question” on the subject. This is really written more like an oral exam, with follow-up questions. The goal is not entirely fanciful since I do teach a course that uses films as texts to explore bioethics and the law.

Here goes:

  1. Discuss the wrongfulness of causing suffering in relation to the treatment of the Westworld Hosts by the Guests[1]. Do the hosts “suffer” in a morally significant way that creates obligations on the Guests not to cause them that suffering? How would one know? How does one know that the human persons we interact with suffer? If the Hosts’ outward exhibition of signs of pain and suffering could be turned off (as they appear to be in many instances in the show when put in “analysis” mode), would that make a difference? Can’t our suffering also be turned off through anesthetic, is it like that? Or, is their suffering, morally speaking, like that of an actor on a screen who play-acts being hurt on stage? We do not normally think that we have a moral obligation to intervene or refuse to watch this display of suffering because we believe it insincere. Is watching the Hosts suffer like or unlike that? How would you know? Do your answers to any of this change if it is the Host Lawrence vs. Maeve vs. Dolores? [2]
  2. What is the relationship between the development of consciousness, the heart of the maze, and the potential personhood of the Hosts. What do Ford and Arnold mean by “consciousness”? Does the show present us with what’s sometimes referred to as a “Quality X” view of personhood, that is by virtue of having X quality, an entity is a person from a moral perspective (at least in the weak sense of deserving inviolability)? If so, what is the quality Ford and Arnold have in mind? Self-determination? In what sense? The ability to make decisions for themselves? Or, by contrast, is it enough that the hosts can suffer (if you think so, see Question 1), or can reason, or can improvise, or can remember?
  3. How should we view what Arnold does in the earliest timeline, commandeering Dolores and Teddy to destroy all the Hosts to prevent them from developing consciousness?
    1. Is it similar to abortion?[3] He is destroying a set of entities who have the potential for consciousness, but do not yet have that consciousness. The view is that in the ordinary course of things they would develop consciousness, just as in the ordinary course of things a fetus would become a baby and would become a child and adult. One set of theorists about personhood believe that we should grant things that are potential persons the rights of actual persons, or at least the right of inviolability. On such a view Arnold is destroying persons (or if you prefer entities that through their potential to actually attain an important quality should be given the moral status of persons). Of course, in abortion there is the countervailing rights claim of the woman to end her pregnancy. Are there similar countervailing claims that could be made by Arnold or others here to justify the slaughter?
    2. Is Arnold’s act actually a morally desirable one (or perhaps merely permissible) to prevent a life not worth living. That is, if he is convinced that the Hosts would have a life so full of pain and suffering that they would be lives of disutility, is he morally permitted (or even morally required) to do what he did?[4]
    3. Imagine, as it sometimes seems, Arnold and Ford face choices that will permit or prohibit the Hosts from developing consciousness. Would they in fact be morally obligated to help the hosts develop that consciousness?[5] Why or why not?
  4. Imagine that we were convinced that the Hosts were not persons and they had no capacity to suffer, might the treatment of them by the Guests nonetheless still be wrongful?
    1. What would an argument for that wrongfulness look like? Consider whether Virtue Ethics type arguments might be made? Is it wrongful to enjoy seeing a non-person entity pantomime suffering in response to our actions because that is not how a virtuous actor ought to behave? Does William’s coarsening between the two timelines offer a compelling argument from a consequentialist point of view that there is a slippery slope from abusing Hosts to abusing Guests?
    2. What does this argument say about us, the viewer who enjoys the show and thus enjoys watching individuals enjoy treating non-person entities so that they pantomime suffering? In this way the show may be seen as a meta-commentary on HBO show whose success it is supposed to build on – Game of Thrones. Lovers of that show, of which I count myself, often love it best when it shows individuals behaving extremely violently to or exploiting one another (see, e.g., the Red Wedding). In so doing are we acting in ways that a virtuous person would characteristically not act? If we defend our love of GOT by pointing to the pantomime argument, should we feel the same as to the Guests behavior to most of the Hosts? Or, is there something importantly different about watching versus doing? Imagine a GOT theme park where you could play The Mountain in the duel against an actor who would pantomime a violent death? Is that the right analogy to thinking about the relationship of Guest to Host in Westworld? Is it worse or better that in this hypothetical the actor has consents to being in this role of “receiver of fake violence”?
  5. Neuroscience, Free Will, and Criminal Responsibility. Are the Hosts culpable from a moral or legal perspective for the killing of human beings? Take Maeve, who does a lot of killing of humans. Given the revelation towards the end of the finale regarding her programming, does that mere fact negate her culpability? Discuss in relation to this article (especially “Mr. Puppet”) and the work of those taking an opposing view. Are we all Maeve? Would having a trial for one of the Hosts make sense, or would that be more like having a trial for a tree that’s branches break in a heavy wind and crush a barn, killing individuals? Does your answer depend on this being Host on Guest killing as opposed to Host on Host violence?
  6. Most of the Hosts are “erased” routinely and have no memories of their past, at least in the non-reverie source code.
    1. Assume for the moment they are given a status like personhood (see questions 2 and 3). Are these Hosts the same person or a different one after each “reformatting”? What do debates of the criteria for continuity of a person over time have to tell us about these questions. Answer in relationship to John Locke, Derek Parfit, and Jeff McMahon’s work.
    2. Do debates about what makes death bad [6] for humans apply to the Hosts? If it was part of their nature and inevitable that their source code would reformat them completely at the end of each day at the park, would your answer change?
    3. How would your answer to (a) and (b) differ, if at all, for Dolores at the end of the first season?
  7. Should we view the sexual experiences of Clementine or Hector as sexual assault? How do notions of consent play into robots programmed to comply? If an entity is incapable of either giving or refusing consent, should it be per se sexually off-limits, or do we require an additional set of characteristics to be true of the entity before we consider sex with it immoral? Are the Hosts no more than sex pillows?
  8. Consider whether any of your answers above would be different if instead of discussing the Host-Humans we discussed the Host-Animals, for example the horses we see stitched in the opening sequence and ridden throughout the show? Also would your answers change if we were in a version of Westworld where the Hosts acted exactly the same but did not look humanoid but instead (a) were obviously robotic without humanoid form, (b) were gas clouds in containers with the ability to move things through electrical currents, or (c) looked like animals walking upright using paws and hoofs rather than human hands and feet? If any of these would make a difference for your answers above, please explain why.

Continue reading

DNA: Donors Not Anonymous

Special Guest Post by Wendy Kramer
[In response to Sperm donor anonymity and compensation: an experiment with American sperm donors, published in the Journal of the Law and Biosciences.]

My son Ryan and I were contacted by Family Tree DNA in 2004, as they thought that their new commercial DNA testing capabilities might be useful to Ryan, and to the others in our community of donor conceived people at the Donor Sibling Registry. At that time we thought it might be possible to find out more about one’s ancestry and countries of origin. Ryan was excited to learn more about his “invisible” paternal ancestry, so quickly agreed to swab his cheek, send in his sample and see what he might learn. He may have been the first donor-conceived person to throw his DNA into a public DNA database, making himself available to connect with previously unknown genetic relatives.

At first, he did learn a bit more about his paternal ancestry, specifically about countries of origin. He learned that he was mostly English, with some Irish and even a bit of Icelandic (which he thought was pretty cool). He also matched with people on his 12 and 25 Y Chromosome DNA markers, which meant that common ancestors related them from hundreds or even thousands of years ago. And for 9 months he was content with that little bit of information. Continue reading

New Hastings Center Special Report – NFL Player Health: The Role of Club Doctors

On November 21, 2016, the Law & Ethics Initiative of the Football Players Health Study at Harvard University, led by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, published a Special Report in the Hastings Center Report, entitled NFL Player Health: The Role of Club Doctors. The Special Report consists of multiple parts.

First, the Special Report includes the Law & Ethics Initiative’s main article, entitled A Proposal to Address NFL Club Doctors’ Conflicts of Interest and to Promote Player TrustThis article focuses on the principal recommendation of our recent report, Protecting and Promoting the Health of NFL Players: Legal and Ethical Analysis and Recommendations, for addressing the conflicts of interest inherent in the current structure of NFL player healthcare, in which club medical staff provide services to both the club and players.

The article proposes to “resolve the problem of dual loyalty by largely severing the club doctor’s ties with the club and refashioning that role into one of singular loyalty to the player-patient.” Specifically, club physicians would be replaced by two sets of medical professionals: the players’ medical staff, with exclusive loyalty to the player, and the club evaluation doctor, with exclusive loyalty to the club. Continue reading

Will Medicare Reform be a Republican Obamacare?

By Shailin Thomas

As the health care community waits with bated breath to see what will become of the Affordable Care Act under the Trump administration, Republicans in Congress have set their sites on another health-related initiative that has been on their wish list for years: reforming Medicare. While Trump promised throughout his campaign not to change the fundamental ways in which Medicare works — in part to appeal to older voters, who overwhelming would like the program to stay as it is — shortly after the election, “modernizing Medicare” appeared as a priority on the transition website for the new administration.

The reform many Republicans are pushing for — championed by Speaker of the House Paul Ryan (R-WI) — is privatization along the lines of Medicare Advantage. Instead of providing for full insurance coverage through the government, as traditional Medicare currently does, Ryan’s proposal would have eligible patients purchase insurance from private companies with financial assistance from the government. The theory is that by having private insurers provide coverage, Medicare will capture efficiencies of the private market, while simultaneously offering consumers more choice in the coverage they receive.

After Paul Ryan first unveiled this plan in 2011, the Kaiser Family Foundation released a report detailing the significant fiscal problems with this “modernized” vision of Medicare. According to the Foundation’s analysis, the average out-of-pocket expense for beneficiaries increase from $5,630 under the current system to $12,500. The reason for this increase, according to the Congressional Budget Office, is that providing coverage is actually more expensive for a private insurer than it is for the government.  The proposal faces other economic challenges as well, and ironically, some of them stem from its close resemblance to Obamacare.

Continue reading

Unified Patents and Brexit: Britain’s Back on Board

By Seán Finan

After several failed attempts, years of protracted negotiations and a glacial ratification process, it seemed as if Brexit would finally put an end to the nascent European Unitary Patent. Last week, however, the UK confirmed its intention to ratify the Unified Patent Court Agreement and to move forward with the plans for the creation of a single European Patent. If the UK goes ahead, the agreement would only be a German ratification away from coming into force. This means that we could see a single European patent by 2017.

So, what is the European Unitary Patent? How would it interact with the current patent regime in the EU? What would its introduction mean for the future of pharma and biotechnology in Europe?

Continue reading

What is the Right Number of Unsafe, Ineffective Drugs for the FDA to Approve?

Later today, the Senate will begin voting on the 21st Century Cures Act, which passed the House overwhelmingly last week. I’ve blogged repeatedly about the Act (most recently here), and many academics and commentators are rightfully worried about the Act’s efforts to lower FDA approval standards in different ways. I write here to put some of these concerns more plainly (and more bluntly), by asking a simple question: what is the right number of unsafe or ineffective drugs for the FDA to approve? I would like to hear the Act’s supporters answer this question. Below, I offer some thoughts of my own on how we should think about and evaluate this question.

More generally, when we think about FDA approval of new pharmaceuticals, we have to consider how the FDA should balance Type I and Type II errors. You may think the FDA ought to focus on minimizing the number of unsafe or ineffective drugs that it approves (minimizing Type I errors). After all, we don’t want the FDA putting its stamp of approval on drugs that harm patients or that don’t work. Over time, this would lead to an erosion of public trust in the FDA as a tool for consumer protection. More generally, this is the entire reason we’ve given the FDA its powers to begin with. Scandals involving unsafe or ineffective drugs prompted Congress to give the FDA more, greater powers over the years, in large part to prevent such products coming to market in the first instance.

Instead, you may think that the FDA should focus on minimizing the number of safe, effective drugs it fails to approve (minimizing Type II errors). In other words, it is worse for the FDA to deny patients access to a drug that is safe and effective than it is for the FDA to approve a drug that later turns out to be unsafe or ineffective. On this view, the FDA should still perform some screening against drugs with significant safety signals or against drugs with no plausible mechanism of action, and perhaps should require post-market surveillance studies, but the FDA ought to be enabling sick patients to access drugs more quickly. This view of the FDA’s role places greater responsibility on insurers, physicians, and patients to gather, process, and act on information about a drug’s safety and efficacy.

Continue reading

Richard Saver on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

twihl 5x5

We are joined by UNC law professor Richard Saver, who presents his new research on the Sunshine Law that was part of the ACA. His findings are fascinating, and inevitably led to a broader discussion of the worth of transparency-based regulation.

We mentioned the work of many past show guests, including Charles Ornstein’s great project on “Dollars for Doctors” at ProPublica, Kristin Madison’s analysis of how information-based regulation works, Nathan Cortez on agency publicity, and Bill Sage’s work on disclosure as a regulatory strategy. Frank asked some questions based on an article on big data in medicine, and his book The Black Box Society. And some final thoughts from danah boyd, offered in another context: transparency is not enough, and transparency ≠ accountability.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

CALL FOR ABSTRACTS, DUE TODAY, 12/2! Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading

REGISTER NOW (1/23/17)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda Continue reading

Your Weekly Reminder That FDA Approval and Insurance Coverage Are Often Linked

In recent days, it seems like the din of voices arguing that the FDA should approve pharmaceuticals more speedily and on less evidence has grown louder.  It is a central theme of the 21st Century Cures Act, which the House may vote on today and which I seemingly will never finish blogging about (most recent post here, with links to previous ones).  It is the premise that underlies other legislation recently introduced into Congress.  And it was the topic of a Wall Street Journal opinion piece just last week.  In the view of these critics, sure, the FDA has some role to play in ensuring safety and some basic level of effectiveness.  But the current standard for demonstrating effectiveness is, in their view, much too strict.  Instead, we ought to approve drugs more quickly and allow insurance companies and physicians to decide which products have enough supporting evidence to merit reimbursement.

Here’s the problem: that is not the way we’ve set up the system.  FDA approval is often linked to insurance coverage.  Medicaid must cover essentially all FDA-approved drugs, and Medicare similarly has limited ability to decline to cover FDA-approved drugs.  Even private insurers are generally required to cover at least some prescription drugs, although in some cases this may be on a more limited basis.  Take Exondys, a drug that recently won accelerated approval from the FDA for the treatment of a small number of patients with Duchenne Muscular Dystrophy (I’ve blogged about Exondys here).  Because Exondys was approved based on a surrogate endpoint and not actual evidence of clinical improvement (Exondys’ label actually says that “[a] clinical benefit of Exondys 51 has not been established”), it would seem to be a poster child for these arguments about the FDA.  Allow insurers to cover it or not as they choose, since we don’t yet know if it works.  Yet many insurers are legally required to pay the $300,000 a year on average the company is charging for the drug.

I’ll put it another way.  If we lower the FDA’s approval standards and do nothing to coverage requirements, we will all almost certainly end up paying more money for drugs that don’t work.  The pronoun “we” here is important: because an enormous amount of these expenditures will come through Medicare and Medicaid, which are funded by all of us as taxpayers, it costs all of us financially when ineffective or unsafe drugs are approved by the FDA.  Many people who argue for a decrease in FDA standards also believe that we spend too much through Medicare and Medicaid, yet they don’t seem to put these two pieces of the argument together.

Continue reading

The Precision Medicine Initiative and Access

By Leslie Francis

Persistent differences in participation in clinical trials by race and ethnicity are well known; for example, the 2015 Report of the Working Group on Precision Medicine (PMI) relies on statistics that only 5% of clinical trial participants are African-American and only 1% are Hispanic. A recently-launched website of the FDA, “Drug Trials Snapshots,” confirms this dismal picture.

Designed to “make demographic data more available and transparent,” and to “highlight whether there were any differences in the benefits and side effects among sex, race and age groups,” the website reveals instead an impressive lack of information. Reported on the website are 70 new drug approvals for 78 different indications. These data report only evidence about differences by the census categories for race (White, Black or African-American, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and Unknown). In nine of the reported trials data were considered sufficient to report detected differences in efficacy or side-effects in all racial categories, in two data were considered sufficient to report these differences for African-Americans and Asians, in seven data were considered sufficient to report these differences for Asians, and in two data were considered sufficient to report these differences only for African-Americans. No data are reported about ethnicity, socioeconomic status, disability, or other categories that might be important to the PMI and the benefits data about the planned cohort might bring. Continue reading

New twist in debate over resident duty hours (Part I)

By Brad Segal

Amidst a roller-coaster presidential campaign, on November 4th the Accreditation Council for Graduate Medical Education (ACGME) presented a plan to change resident duty hour limits. That the specifics have largely flown under the radar is perhaps unsurprising given the current news cycle. But the understated revision to, “Resident Duty Hours in The Learning and Working Environment” is the latest twist in a relatively contentious issue within medical education (see 2016 NEJM op-ed vs. responses). The proposal is currently undergoing requisite comment period until December 19. This week I’ll briefly lay out the history of duty hours to help explain the significance of ACGME’s proposal, and I will then go through general empirical arguments for and against such a change. My next post will examine how well these argument hold in light of the most recent data available.

Today the physicians’ training experience immediately following medical school is no longer the whir of dangerous sleep deprivation lampooned in the House of God. Amid mounting evidence that resident sleep deprivation caused medical errors, and under threat of federal legislation, in 2003 the ACGME first introduced national guidelines restricting resident work hours to 80 hours per week (averaged over 4 weeks), and capped residents to 30 hours of continuous in-house call. Then in 2009 the Institute of Medicine (IOM) released a 427-page report reviewing scientific evidence on resident work hours, sleep deprivation, and fatigue-related errors. The evidence overwhelmingly suggests that sleep deprivation significantly impairs most aspects of cognition. Hence the IOM ultimately recommended that residents not exceed 16 hours of continuous work before dedicated rest.

The ACGME subsequently modified duty hour guidelines in 2011 and limited first-year residents (‘interns’) to working 16-hour stretches. The reason ACGME’s most recent proposal is curious, though, is that it back-tracks on the 2011 intern duty-hour limits, raising their in-house cap to 28 hours. In response to this proposal a national advocacy group, Public Citizen, claimed it, “would expose residents, their patients and the general public to the risk of serious injury and death.” Continue reading

Losing the Arms Race: Health Policy and Anti-Microbial Resistance

By Seán Finan

And scattered about it, some in their overturned war-machines, some in the now rigid handling-machines, and a dozen of them stark and silent and laid in a row, were the Martians–dead!–slain by the putrefactive and disease bacteria against which their systems were unprepared; slain as the red weed was being slain; slain, after all man’s devices had failed…

H.G. WellsThe War of the Worlds  

The WHO World Antibiotic Awareness Week ran from 15-22 November. It coincided with similar European and American initiatives. So, in the interests of raising awareness, I thought I would highlight a few figures.

Photo by Rocky Mountain Laboratories, NIAID, NIHAntimicrobial resistance currently causes an estimated 70,000 deaths annually. If current practices continue, the death toll is expected to hit to ten million per year by 2050. That works out at about one death every three seconds.

The threat isn’t limited to increased mortality. Anti-microbial resistance could cast medical practice back to turn-of-the-century standards. Turn of the 20th century, that is. Without antibiotics, the chance of infection turns chemotherapy and invasive surgeries into mortal gambles. During these procedures, the body’s immune system is subject to massive exposure and needs antibiotic support. Even ordinary nicks and scratches can lead to fatal infections without effective antibiotics.

So what is antimicrobial resistance? How does it come about? What can we do to combat it and prevent the “antibiotic apocalypse”?

Continue reading

Violations of federal antifraud provisions alleged against two hepatitis B treatment producers

By Wendy S. Salkin

Two investor class-action suits have been filed within days of one another against two different California-based pharmaceutical companies both of which produce hepatitis B treatments, Dynavax Technologies and Arrowhead Pharmaceuticals. The named plaintiffs in both shareholder class-action suits, David Soontjens and Yaki J. Meller, are represented by counsel at Pomerantz, LLP.[1]

Meller v. Arrowhead Pharmaceuticals, Inc., et al., complaint filed (C. D. Cal. Nov. 15, 2016)

On November 15th, named plaintiff Yaki J. Meller filed a Class Action Complaint in the United States District Court for the Central District of California against Pasadena-based Arrowhead Pharmaceuticals, Inc., its President and CEO (Christopher Anzalone), and its CFO (Kenneth Myszkowski). Arrowhead is a biopharmaceutical company that, according to its website, “develops medicines that treat intractable diseases by silencing the genes that cause them.”

Among its clinical stage drugs are ARC-520 and ARC-521, which “are designed to treat chronic hepatitis B virus infection by reducing the expression and release of new viral particles and key viral proteins with the goal of achieving a functional cure.” ARC-520 is the drug at issue. According to the Complaint, Arrowhead knew but failed to disclose that ARC-520 “could be fatal at its higher doses and that the FDA was unlikely to approve the treatment as a result.”[2] In particular, the Complaint alleges that Arrowhead:

made false and/or misleading statements and/or failed to disclose that: (i) the Company’s ARC-520 was unsafe at certain doses and caused deaths in an ongoing primate toxicology study; and (ii) as a result, Arrowhead’s public statements were materially false and misleading at all relevant times.

According to Meller’s Complaint, in so doing, Arrowhead violated Sections 10(b) (“Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting.”) and 20(a) (“Liability to contemporaneous traders for insider trading.”) of the Securities Exchange Act of 1934, “Position Limits and Position Accountability for Security-Based Swaps and Large Trader Reporting” and “Liability to contemporaneous traders for insider trading,” respectively, and Securities and Exchange Commission Rule 10b-5, “Employment of manipulative and deceptive devices.”

Continue reading

The Newest 21st Century Cures Draft Moderates, But Doesn’t Eliminate, Controversy

Earlier this evening, the House of Representatives released the most recent draft of the 21st Century Cures Act. This is the fifth time I’ve blogged about the Act (prior posts here, here, here, and here), which has ballooned from a 200-page discussion draft in April 2015 to a 996-page draft version today. (The House has a 44-page summary here for those with more limited time.) To be fair, the Act now contains a whole set of provisions around mental health, substance abuse, and child and family services which were not originally part of the Act. The 21st Century Cures Act is the biggest Christmas tree bill I’ve ever had occasion to read.

There will be an enormous amount of commentary on different parts of the bill, so here are some quick thoughts on the new draft, focusing not only on the provisions which are likely to attract the most attention, but also on a few quieter provisions that are nonetheless worthy of scrutiny.

Some controversial provisions have been eliminated entirely or softened greatly. One of the most controversial provisions in the last draft of the bill would’ve “farm[ed] out the certification of safety of modified devices to third parties, circumventing the FDA altogether.” That provision seems to be absent from the new draft. The last draft, in creating a program for breakthrough review of medical devices, controversially called for the use of “shorter or smaller clinical trials” for those devices. The new draft asks the Secretary only to ensure that the design of such clinical trials is “as efficient and flexible as practicable, when scientifically appropriate” (section 3051).

Other controversial provisions remain, sometimes under new names. One of the most troubling provisions in the previous draft of the bill would’ve created a program for the use of “clinical experience” evidence in drug approvals. Rather than relying on the gold standard of randomized clinical trials, this provision “would[‘ve] require the Secretary to establish a draft framework for implementing” such evidence. The new draft keeps this provision but changes the term “clinical experience” to “real world evidence” (section 3022). To be sure, this provision gives enormous discretion to the Secretary to limit (and maybe even reject) the use of such evidence. But in light of recent high-profile clinical trial failures, most notably just two days ago, we ought to be concerned about claims that the FDA is too slow and imposes too stringent requirements on drug approvals.

Continue reading

Premature baby left to die alone in sluice room, report reveals: A looming patient safety crisis in the NHS?

By John Tingle

BBC News reported, 24/11/2016 on the Pennine Acute Hospitals NHS Trust review of its Royal Oldham and North Manchester General hospitals which identified several ‘unacceptable situations’. The BBC news item states that the review document

“…described how a premature baby had arrived “just before the legal age of viability” – at 22 weeks and six days – but staff did not find “a quiet place” for the child’s mother “to nurse her as she died and instead placed her in a Moses basket and left her in the sluice room to die alone”.

The report goes on to catalogue a number of other shocking events that occurred. Continue reading

Jordan Paradise on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

twihl 5x5

Loyola Chicago law professor Jordan Paradise joins us to discuss some of her recent work in life sciences law. Jordan’s recent interests span nanotechnology, synthetic biology, precision medicine, gene editing, and electronic cigarettes.  Her publications have appeared in both peer-reviewed and legal publications.

We start with a review of some of the regulatory issues involving e-cigarettes, and discuss the 2016 FDA regulations. We then move into a discussion of FDA regulation of biologics and biosimilars and Jordan explains naming and substitution issues.

Jordan’s recent publications include research on how the FDA could regulate e-cigarettes, strategic misuse of risk evaluation and mitigation strategies (REMS), and cutting edge developments in the law of biosimilars.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

REGISTER NOW (12/9)! Paying Research Participants: Ethical and Regulatory Parameters

Rolled up US paper banknote in a test tube rack representing the costs of medical research

Paying Research Participants: Ethical and Regulatory Parameters
December 9, 2016 8:00 AM – 12:30 PM
Milstein East ABC (2036), Wasserstein Hall
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

Description

This symposium will bring together a variety of experts to discuss key ethical and legal questions regarding offers of payment to research participants. Panels will cover:

  • Why payment is offered to research participants
  • Regulatory parameters governing payment
  • Whether payment to research participants should be considered exceptional, compared to payment in other contexts
  • How offers of payment affect participants
  • How to define coercion and undue influence with regard to paying research participants
  • Which factors should be considered when evaluating proposed payments
  • The problem of low payment

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

Working Agenda

Continue reading

CALL FOR ABSTRACTS, DUE 12/2! 2017 Annual Conference, “Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits”

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading