Kevin Outterson appeared on NPR’s “Here & Now” to discuss the growing problem of antibiotic resistance and possible ways to incentivize development of new antibiotics. From the interview:
On the misuse of antibiotics
“We should think of this as a global resource that needs to be conserved and taken care of. So antibiotics should never be used inappropriately. In the country right now, we have something on the order of 23 million people who are getting antibiotics for ear aches. Most of those situations would resolve on their own in a couple of days. We also give antibiotics many times for people just because they have some sort of a common cold — it’s estimated 18 million prescriptions a year — doesn’t help anyone who has the common cold. It’s a complete waste.”
On the rise of antibiotic-resistant bacteria
“It’s frightened people for more than a decade. You mentioned at the top the 23,000 Americans who are dying from resistant infections. The CDC said on top of that, there’s another 14,000 dying from a horrible disease, intestinal disease, called Clostridium difficile [C-diff] in the United States. Together, that’s larger than the number of people who die in this country each year from AIDS. And we’re not — as bad as things are now, the more troubling aspects, or what might happen in five or 10 years if some sort of a pathogen was resistant to everything we had got out to the population. It sounds like a Hollywood movie.”
Kevin Outterson will join us on Monday, February 3, for the first spring meeting of the Petrie-Flom Center’s Health Law Policy Workshop. He is a Professor of Law and Professor of Health Law, Bioethics, and Human Rights at Boston University. Professor Outterson teaches health law and corporate law, and his interests include global pharmaceutical markets, finance and organization of health care systems, antimicrobial resistance, poverty tourism, and health disparities. He serves as the editor-in-chief of the Journal of Law, Medicine & Ethics, the faculty co-advisor to the American Journal of Law & Medicine, the immediate past chair of the Section on Law, Medicine & Health Care of the AALS, and a member of the Board of the American Society of Law, Medicine & Ethics. Before teaching, Professor Outterson was a partner at two major U.S. law firms.
His research work focuses on the organization and finance of the health sector. Areas of specialization include global pharmaceutical markets, particularly antibiotics and other antimicrobials that can degrade in usefulness over time through resistance.
On Monday, Professor Outterson will discuss his paper “New Business Models for Sustainable Antiobiotics.” For more information on the Health Law Workshop, including meeting time and location, and to download the paper, please visit our website.
The Gilardi v. HHS decision is out today (on scribd), blocking the PPACA contraception mandate for the plaintiffs. Two brothers own Freshway Foods and a related company that offer a self-insured health plan to their 400 employees. For non-grandfathered plans with an annual enrollment period starting on or after September 23, 2010, PPACA required zero deductibles and cost sharing for a package of preventative services. One component of that package includes FDA-approved contraception. The Gilardi brothers claimed this requirement violates the Religious Freedom Restoration Act (RFFA). A majority of the Court agreed, sending the case back to the District Court for a reconsideration of the injunction.
This case raises an interesting point about pluralism in our society. When do we get to abstain from generally-applicable laws that violate our moral beliefs? Even more attenuated, when do we get to opt out because other people’s actions violate our beliefs? Can the Freshway companies decide to drop hospice care for their employees as violating their Catholic beliefs? Could a Muslim employer prevent employees from bringing home the bacon with their paychecks? Could a Baptist employer fire employees for watching porn at home on HBO?
I hear complaints from time to time about the complexity of health care law. Now we have some evidence.
Katz and Bommarito (gated, free registration) at Michigan State analyzed the US Code for complexity using a variety of big data techniques. The most complex area of US statutory law? Our friend, Title 42, home to Medicare, Medicaid, and the Social Security Act. Title 42 beat (lost?) to tax law by a substantial margin (tax was #2, noted Paul Caron).
But according to Katz (by email), the underlying data is from 2010, before PPACA was codified into Title 42. So health law is in no danger of losing the lead.
In secret, during “trade” negotiations. Just one example: the 12 years of data exclusivity for biologics is currently US law, but that may get carved into stone in the new Trans-Atlantic Trade and Investment Partnership (TIIP). Once enshrined in a trade agreement, this rule and thousands more will be immune to change by any national democratic process.
Who participates in this process? Generally, only “cleared advisors” from the Fortune 500.
A partial (leaked) list of the initial bargaining positions for the EU are downloadable here. In the Initial Positions Papers, the EU notes that they have approved 16 biosimilars which have not yet been recognized as such in the US. Other topics include generic approvals, GMP inspections, and regulatory science for drug approvals.
All of decisions have immense potential impact for consumer welfare. My concern is the undemocratic lack of transparency for the entire process.
Some SCOTUS opinions stir up politics and legislation (think: Roe v Wade). Others tend to end the process. When the Court is interpreting a federal statute, if they get it “wrong” it is of course possible for the elected branches to reverse them. But for some of these issues, political stalemate in Congress gives the Justices the last word, perhaps for decades.
Which makes the Roberts Court both activist and powerful.
If you couldn’t make it to our inaugural session on Health Law Year in P/Review, co-hosted by the Petrie-Flom Center and the New England Journal of Medicine, you’re in luck! You can watch the video here:
Even the surprisingly resurrected Richard III (on the Twitter-sphere, anyway) appreciates bioethics concerns. Read on to find out more about Richard III’s eagerness for patient confidentiality and other updates in this week’s (extended) Twitter round-up:
Stephen Latham (@StephenLatham) included a link to his blog post challenging Andrew Francis’ recent claim that penicillin was the central drug spawning the sexual revolution of the 1960s. While penicillin may have facilitated the widespread acceptance of pre-marital relations, it was The Pill that “translat[ed] that newfound sexual freedom into sexual equality.” (1/28)
Dan Vorhaus (@genomicslawyer) posted a summary video regarding the Neanderthal baby story that rocked the internet in the past few weeks, as reported by Taiwan’s Next Media animation. (1/28)
Michelle Meyer (@MichelleNMeyer) shared a news report on Israel’s recent admittance to giving birth control to Ethiopian Jewish immigrants, frequently without either consent or knowledge. Concerns first arose after an investigative journalist began to explore why birth rates in the community had fallen so drastically and seemingly inexplicably. (1/28)
Arthur Caplan (@ArthurCaplan) linked to a piece explaining the future implications and consequences of the guidance requiring schools to make “reasonable modifications” in order to include students with disabilities in either general athletic programs or provide them with parallel opportunities. The guidance, while a potential huge move forward for individuals with disabilities, nonetheless will be nothing without “tough and honest conversation about financing and revenue – and soon.” (1/28)
Michelle Meyer (@MichelleNMeyer) retweeted an article showing the return of the “invisible gorilla” from the 2010 book, but this time in the fake CT scans shown to both expert radiologists and volunteers alike. The gorilla was large in size compared to the typically indicative nodules, and was unmistakably a gorilla, but yet 20 out of the 24 radiologists failed to see the gorilla. It’s a frightening real-life example of what the original study’s jargon terms as “inattentional blindness.” (1/29)
Kevin Outterson (@koutterson) live tweeted the Pew meeting concerning new antibiotic development pathways for limited populations. See the string of tweets on his Twitter page for further details of how the meeting proceeded. (1/31)
Daniel Goldberg (@prof_goldberg) shared a link describing the first scientific evidence suggesting that doctors can “truly feel” their patients’ pain. The study, done by Harvard researchers, used brain scans to indicate activated regions of physicians’ brains during a simulated interaction with patients. (2/1)
Frank Pasquale (@FrankPasquale) linked to a story on the problems associated with over-prescribing amphetamine-based medications, particularly to teenagers and young adults. While focusing on the individual story of an aspiring medical student named Richard Fee, the author delves into the underexposed side effects of often overzealous prescribing and the surprisingly casual attitude that most Americans hold towards this medication. (2/3)
Frank Pasquale (@FrankPasquale) also posted a piece inspired by the talk surrounding World Cancer Day on the problems related to cancer treatment in developing countries. Contrary to being solely a problem of so-called developed nations, cancer remains an issue globally – including such cancers that are caused by an infectious agent. Fighting the false notions – that cancer in developing nations is minimal, that it is always not “catchable,” and that enough care (particularly vaccines) is being delivered – is essential to reducing the global inequity in cancer treatment. (2/4)
Michelle Meyer (@MichelleNMeyer) retweeted the (supposedly resurrected and technologically adept) Richard III’s tweet regarding publication of details surrounding his newly-identified bones: “Hmmm not so happy about my physical attributes being discussed in public. What happened to patient confidentiality ???” (2/4)
Daniel Goldberg (@prof_goldberg) shared a report on a new study that found a correlation between low self-esteem and female body representation and obsession in “chick lit.” The report noted that the results suggested a possible “intervention tool” by having characters seek support from friends and family for such body concerns. (2/5)
Michelle Meyer (@MichelleNMeyer) retweeted a graphic eloquently summarizing one of the simplest and most potent arguments in favor of vaccination, and arguably the greater biopharmaceutical industry. (2/6)
Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.
After the NFIB decision in June, Maine tried to expand Justice Roberts’ remedy to also make the “maintenance of effort” provision optional for states. Maine was unsuccessful in the First Circuit with the argument, for procedural reasons. Prior coverage here.
The Obama Administration is sticking to the letter of the law, and announced Tuesday that it is refusing to allow cuts for Medicaid beneficiaries at or below 133% (138% after the 5% income disregard) of FPL in Maine.
Maine has not yet announced whether it will take the case back to the First Circuit. With Huberfeld & Leonard, we’ve argued at length (see esp. pp. 75-83) that Maine does not have the winning argument, in an article to be published in the BU Law Review later this month. SSRN version here. The short version is that MOE is a common tool to lock-in states during transition to a new program, was discussed in the briefing, but was not part of the coercion analysis in Justice Roberts’ plurality. The key provision was 42 USC 1396c, the Secretary’s authority to reduce some or all of the funding to non-compliant states. But we will see if Maine wants to argue the substance of this point at the First Circuit.
Boston is a great city for health policy. On Jan. 25, BU Law hosts a conference on New Legal Challenges to Global Tobacco Control. Just a month later, Harvard hosts its own conference on the Global Governance of Tobacco (details here).
The BU Law conference (announcement here; detailed schedule here) will focus on challenges rooted in constitutional law (First Amendment litigation in the US attacking FDA-required graphic images on tobacco packs); trade mark law (plain packaging in Australia); and global trade and investment treaties such as the Hong Kong-Australia Bilateral Investment Treaty and the WTO Agreements. Speakers include some of the world’s leading public health experts on this topic:
Matthew Allen, Allen + Clarke Policy and Regulatory Specialists
Micah Berman, New England School of Law
Scott Burris, Temple University Beasley School of Law
Julien Chaisse, The Chinese University of Hong Kong
Richard Daynard, Northeastern University School of Law
Samantha Graff, NPLAN
Jane Kelsey, University of Auckland Faculty of Law
Lara Khoury, McGill University Faculty of Law
Mark Levin, University of Hawai’i at Manoa William S. Richardson School of Law
Jonathan Liberman, Cancer Council Victoria
Benn McGrady, Georgetown University Law Center
Ted Mermin, Public Good Law Center
Kevin Outterson, BU School of Law
Robert Stumberg, Georgetown University Law Center
Allyn Taylor, Georgetown University
Tania Voon, University of Melbourne Law School
George Annas, BU School of Law and BU School of Public Health
Leonard Glantz, BU School of Law and BU School of Public Health
Wendy Mariner, BU School of Law and BU School of Public Health
Alexandra Roberts, BU School of Law
Keynote Speaker: Dr. Michael Siegel, BU School of Public Health
The conference is open to everyone; see the schedule for details. The conference papers will be published in the American Journal of Law & Medicine.
After what we hope was a hearty meal (or at least a restful, happy holiday) this past Thanksgiving for all of our readers, we are back with this week’s Twitter round-up – just a few days behind schedule.
Daniel Goldberg(@prof_goldberg) tweeted an article by Stefan Fatsis on the different perspectives regarding child participation in tackle football. As Goldberg noted in his tweet, from the perspective of neuroethics, the choice is clear: tackle football (or American football) is harmful for kids. (11/19)
Frank Pasquale(@FrankPasquale) included a link to a piece describing why data from all clinical trials should be readily accessible to doctors, or the origins of the BMJ Open Data Campaign. The article used the case of the Tamiflu anti-flu drug as an example, where the article authors described their hurdles in communicating with the drug’s producers concerning drug test results while trying to review the efficacy of the drug through Cochrane Collaboration. (11/21)
Kevin Outterson (@koutterson) posted his article, published in the New England Journal of Medicine, concerning the path for new federal regulations for compounding pharmacies in the wake of the meningitis outbreak and the New England Compounding Center (NECC). (11/23)
Arthur Caplan(@ArthurCaplan) brought up a recent post concerning the American College of Obstetricians and Gynecologists (ACOG) and their declaration that making birth control pills over-the-counter (OTC), rather than prescription, could reduce the rate of unplanned pregnancies in the United States (which has not changed in 20 years). While the change would not occur overnight, there are many consequences that remain unclear – including changes in price and insurance coverage. (11/23)
Michelle Meyer (@MichelleNMeyer) retweeted a link to David Shaywitz’s article, which noted the increased criticism and distrust facing industry studies as compared to those of university scientists. Shaywitz encouraged contextualization of industry criticism to recognize that such critiques often plague medical science in general, not just industry. (11/24)
Note: As a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet.
I wrote last week (at TIE) that corporations might have First Amendment or RFRA religious rights to object to contraception coverage. Now we have a second federal judge agreeing, this time on behalf of Tyndale Bible Publishers (complaint here; preliminary injunction here). The short answer:
The plaintiffs have therefore shown that the contraceptive coverage mandate substantially burdens their religious exercise.
The Tyndale opinion again focuses on the rights of the owners of the company (here, a family foundation) rather than the company itself:
This Court, like others before it, declines to address the unresolved question of whether for-profit corporations can exercise religion within the meaning of the RFRA and the Free Exercise Clause. See, e.g., First Nat’l Bank v. Bellotti, 435 U.S. 765, 777–78 n.14 (1978) (recognizing that corporations have First Amendment speech rights, but declining to “address the abstract question whether corporations have the full measure of rights that individuals enjoy under the First Amendment”); Stormans, Inc. v. Selecky, 586 F.3d 1109, 1119 (9th Cir.2009) (“We decline to decide whether a for-profit corporation can assert its own rights under the Free Exercise Clause …”); Church of Scientology of Cal. v. Cazares, 638 F.2d 1272, 1280 n.7 (5th Cir.1981) (same). Instead, the Court will assess whether Tyndale has standing to assert the free exercise rights of its owners…
Viewing the rights of Tyndale’s owners (in particular, those of the Foundation) as the basis for its RFRA claim, the Court finds that Tyndale has made a satisfactory showing of Article III standing.
The court also found “third party standing”
It bears emphasizing that if the Court accepted the defendants’ position, no Tyndale entity would have standing to challenge the contraceptive coverage mandate—not even the Foundation. This is because, in the defendants’ view, Tyndale—though directly injured by the regulation—cannot exercise religion, and the Foundation—though capable of exercising religion—is not directly injured by the regulation. The third-party standing doctrine serves to avoid such conundrums.
These cases are serious, but the threat is to mandatory contraception coverage, not the entire ACA.
Don’t just read the summaries – check out the tweets themselves! From now on, links to the original tweets will be included in our round-up. Additionally, as a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet. With that, read on for this week’s round-up…
Arthur Caplan (@ArthurCaplan) posted an article about the growing trend of paying for convenience in healthcare with privacy, sometimes without formal consent. The latest example (and the subject of this article) is palm-scanning at New York University Langone Medical Center. (11/11) [Note: Dan Vorhaus also tweeted this the next day.]
Frank Pasquale (@FrankPasquale) linked to a post on the potential valuables (medicines, solvents, chemical treatments) hidden amongst newly-discovered marine micro-organisms. With regulations hefty on land but largely non-existent for water, there are concerns that damage from harvesting could result in ecosystem damage or exploitation of water resource-rich developing nations. (11/11)
Dan Vorhaus(@genomics lawyer) brought up a link describing the “particularized consent approach” of the website my46, meant to facilitate the process of helping people decide what results of genetic testing to see and when to see such results. Combining this with his post about the direct-to-consumer genomics of 23andMe, it is clear that this is an area to watch. (11/12)
Daniel Goldberg(@prof_goldberg) exclaims his love for the term “empathotoxin” in conjunction with the link for this blog post. The post talks about the declining sense of empathy correlated with medical training as according to a research review by American Medicine, with results based on self-reporting. (11/12)
Kevin Outterson(@koutterson) tweeted an article about the oncoming scrutiny likely to hit Congress in the throngs of the current meningitis outbreak. While state boards and the F.D.A. are receiving much of the onslaught as a result of their lax oversight, Congress has hindered stronger regulation for drug compounders particularly in regards to defining the F.D.A.’s policing authority – and thus, say some, is partly deserving of blame. (11/14)
Daniel Goldberg(@prof_goldberg) also linked to an article that talked of lessening the gaps between the mainstream views concerning disability (the “outside” view) and those within the disability community (the “inside” view) when considering law. By proposing a certain set of “framing rules” facilitated by input from the inside view, nondisabled people can make more informed decisions regarding the relationship to disability. (11/14)
Dan Vorhaus(@genomicslawyer) posted an article that followed up on an earlier tweet from our weekly round-ups detailing China’s new draft regulation for human genetic materials, including but not limited to organs. (11/15)
Frank Pasquale (@FrankPasquale) included a link to the The New York Times piece on the massive drug shortages plaguing the nation’s healthcare system. Pasquale noted in his tweet that organizations which purchase on behalf of groups, often for hospitals, may be contributing to this shortage. (11/17)