NPRM Symposium: How Should We Think About Whether To Donate Our Leftover, Non-Identified Tissue to Research?

By Michelle Meyer

Proposed changes to the federal Common Rule would ask patients for the first time to decide whether to allow their non-identified, leftover tissue to be used for research or thrown away. For that choice to be meaningful, the public needs to be aware of the nature, risks, and benefits of biospecimens research, and of what the proposed changes will—and will not—do. In my latest Forbes essay, “No, Donating Your Leftover Tissue To Research Is Not Like Letting Someone Rifle Through Your Phone,” I consider the power of analogies and other reflections on Rebecca Skloot’s recent New York Times op-ed on the NPRM.

Peeling the Onion: How to Promote Pharmaceutical Innovation and Access to Medicine

By Timo Minssen

As mentioned in my earlier blog post, I decided to conclude this year by publishing a introductory speech that I gave on April 14th, 2015 at the 2015 Broad Institute Innovation & Intellectual Property Symposium. The speech was part of the session “Bringing Therapies to the Patients” and introduced a panel-discussion with Entrepreneur and Professors of Law and Business about the failures of the patent system to support new therapeutics. The text is below:

Peeling the Onion:
How to Promote Pharmaceutical Innovation and Access to Medicine

Speaking about frustrations over the IP system in pharmaceutical innovation, sometimes feels like – to lend the words of the late German Nobel Prize winner Günter Grass – “peeling an onion:” Continue reading

Happy New Year: From “Weltschmerz” to Pharmaceutical Innovation

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By Timo Minssen Dear readers and colleagues, I would like to take this opportunity to wish you all a very happy, healthy and peaceful year 2016. Reaching the end of 2015, I cannot stop thinking about the year that has passed. Being … Continue reading

Bioethicist Art Caplan – About Time: FDA Overturns Ban On Gay Men Donating Blood

A new piece by Bill of Health contributor Art Caplan on Forbes:

In 2001 one of my goals as the chair of the Federal government’s Advisory Committee on Blood Safety and Availability was to get the ban on gay men donating blood overturned. The ban made no sense ethically or scientifically. The ban stigmatized gay men, and insisting on a lifetime prohibition for even one sexual encounter, condom or no condom, made no scientific sense. Finally, almost 15 years later, the FDA has joined the rest of the Western world and dropped the lifetime prohibition.

The FDA still insists on a one-year ban on having sex with another man even though today’s testing is very reliable for detecting HIV and other diseases at six months. Still, at a time when blood donations are falling and demand is rising, getting more donors into the supply side is a very good thing. […]

Read the full article here.

Cost Control’s Growing Complexity

By Zack Buck

A paper entitled “The Price Ain’t Right? Hospital Prices and Health Spending on the Privately Insured” has a number of health policy experts talking this week. Authors Zack Cooper, Stuart Craig, Martin Gaynor, and John Van Reenen—as part of the Health Care Pricing Project—present new findings demonstrating that geographic areas with low Medicare costs and geographic areas with low private insurance costs are nearly completely unrelated. That is, locales with comparatively low Medicare costs are not necessarily areas with comparatively low costs for care paid for by private insurers. Though stunning, this lack of relation between the two metrics does make sense; the report notes that Medicare’s costs are largely driven by the amount of provided care and services, whereas care paid for by private insurance is largely affected by the price at which the care is set by each hospital. (Kevin Quealy and Margot Sanger-Katz of the New York Times have a number of interesting graphs and charts that reflect the study’s findings here.)

Indeed, before the study, and because of a dearth of private insurance pricing data, many simply believed that locales that were cheaper for Medicare were cheaper for private insurance—that is, areas that were great stewards of Medicare funds were likely efficient for private insurers as well. But this new paper demonstrates that this is not true. The two metrics are completely separate.

At the risk of overstating it, this finding could drastically change the paradigm for controlling health care costs going forward. The paper got the attention of Atul Gawande, who noted its importance in an article for The New Yorker. There, Gawande revisits the story of McAllen, Texas, which focused on exploding Medicare costs largely driven by large volume. (I even look at the McAllen story in a forthcoming article here because of its fascinating impact on cost control for Medicare.)

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Bioethicist Art Caplan: Shkreli Isn’t to Blame For High Drug Prices in U.S.

A new piece by Bill of Health contributor Art Caplan on NBC News:

Should we care about Martin Shkreli, the man I call the “Wolf of Pharma Street”? His hoodie-wearing perp walk sparks outrage, but he is diverting attention from far bigger and more important systemic problems regarding the cost of drugs for all Americans.

Shkreli, the former Turing Pharmaceuticals CEO, has been indicted by the feds for allegedly running a Ponzi scheme to keep his various drug company investments afloat.

Before the feds came calling to charge him with securities fraud, Shkreli had secured the manufacturing license for Daraprim which is used to treat nasty, often fatal protozoal infections in, among others, those with AIDS. Shkreli, grinned, flipped the rest of humanity the bird, and raised the 62 year-old drug’s price by 5,500 percent; from $13.50 to $750 per tablet overnight — thus retiring the “Biggest Jerk in Health Care Award” forever. […]

Read the full article here.

Bioethicist Art Caplan: Cruz or FDA – Who do you trust with your health?

Bill of Health contributor Arthur Caplan and his colleagues have a new piece up on The Hill Blog:

Sen. Ted Cruz (R-Texas) not only wants to be your president; he wants to decide what medicines you can get. On Dec. 10, Cruz and Sen. Mike Lee (R-Utah) introduced legislation intended to speed up Food and Drug Administration review of drugs and devices that have been approved in certain foreign countries. The Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act would require FDA to approve or reject within 30 days of application any drug or device that has been approved in a “trusted” foreign country — specifically, Canada, Australia, Israel, Japan, and the European Union members. Should the FDA reject an application, Congress can override the agency. […]

Read the full post here.

Senator Cruz’s RESULT Act Contains a Particular View of the FDA’s Role – But What About CMS?

By Rachel Sachs

Last week, I blogged here about the introduction of the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text) by Senators Ted Cruz and Mike Lee. As I noted, the Act would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a particular list of countries, including EU member countries, Japan, and Canada. If the FDA declines to grant reciprocal marketing approval, the Act would permit Congress to override the FDA’s decision through a majority vote via a joint resolution.

My post, and additional commentary from numerous other outlets (including RAPS, Vox, and Marginal Revolution) largely focused on the Act itself – on the merits of the various provisions, and on whether those provisions would be effective at accomplishing the Act’s stated goals. But each commentator’s view of the situation depends in large part on their priors about what the purpose of the FDA is, and relatedly, how it should behave to achieve those purposes. In this post, I want to first briefly explain these different views about the purpose of the FDA before explaining the ways in which our views about pharmaceutical regulators are often tied to our views about public health insurers – a point which has largely gone unmentioned in the debate about the RESULT Act.

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“Naughty or Nice?’ A Special ‘The Week in Health Law’ Podcast Review of the Year in Health Law & Policy

By Nicolas Terry

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In a special Holiday-themed show reviewing the year in Health Law & Policy Nic welcomed Nicole Huberfeld, the Ashland-Spears Distinguished Research Professor of Law at the University of Kentucky College of Law, Nicholas Bagley, Professor of Law at the University of Michigan, and honorary ‘Nic’ Elizabeth Weeks Leonard, J. Alton Hosch Professor of Law at the University of Georgia.

The ‘naughty or nice’ round included discussion of the declining numbers of the uninsuredKing v. BurwellArmstrong v. Exceptional Child CenterGobeille v. Liberty Mutual Insurance CompanyChief Justice RobertsSenator Marco Rubio, and FTC cases LabMDPOM WonderfulWyndham & North Carolina Board of Dental Examiners.

Our ‘Happy New Year’ round included the House of Representatives ACA lawsuitUniversal Health Services v. United States ex rel. Escobar, the MMA 2003 non-interference clausehealth care prices, and Whole Woman’s Health v. Cole.

Finally, our ‘carolers-of-choice’ were Justice ScaliaDonald TrumpJimmy Fallon and the FLOTUS with the MOSTEST.

We’ll be back in the New Year. Happy Holidays. Thanks for your support Dear Listeners!

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 RadioTunein 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

New Developments in the Guatemala STD Experiments Case

In the late 1940s, US government scientists, in collaboration with Guatemalan counterparts, were involved in a horrible array of experiments on human subjects in which a variety of vulnerable groups in Guatemala were intentionally infected with syphilis, gonorrhea, and chancroid and left without treatment. [For more on how they ended up in Guatemala and the ethics of intentional infection studies, see my work here and here.] The experiments were done without consent and without scientific rigor, violating both contemporaneous and modern ethical standards.  They were not uncovered, however, until a few years ago when a historian discovered the files in the midst of doing archival research on one of the scientists, who had also been involved in the Tuskegee syphilis study in the US.

Since her discovery, the US and Guatemalan governments have both issued apologies and reports condemning the studies (here and here), and the US pledged a relatively small amount of money to support the Guatemalan government’s efforts to improve surveillance and control of H.I.V. and other sexually transmitted diseases in that country. However, individual compensation to the victims of the experiments and their families has not been forthcoming; the victims calls for a voluntary compensation program to be established have gone unheeded, and they have also been unable to prevail in court, for a variety of jurisdictional and technical reasons.

As Glenn Cohen and I argued following the victims’ first court loss in 2012, compensation is a moral imperative.  We expressed support for a voluntary compensation program, but in its absence, alternative mechanisms of justice are essential.  Therefore, we were heartened to hear that a petition for the victims was just filed in the Inter-American Commission on Human Rights in Washington, D.C., by the Office of Human Rights for the Archdiocese of Guatemala, represented by the UC Irvine School of Law International Human Rights Clinic and The City Project of Los Angeles.  The petition claims violations of the rights to life, health, freedom from torture, and crimes against humanity under both the American Declaration of the Rights and Duties of Man, and the American Convention on Human Rights, as well as the denial of a right to a remedy for human rights violations.

There are still a number of hurdles ahead, not the least of which is determining which individuals would actually be entitled to compensation, as the record keeping in the initial experiments was so poor and so much time has passed.  But we are heartened that advocates are still pressing forward for these victims and hope that justice, though certainly delayed, will not continue to be denied.

More information on the petition is available here.

“Crisis Pregnancy Center Fighting for Right to Create More Crisis Pregnancies”

IUD in hand

Flickr/Creative Commons—+mara

By Gregory M. Lipper

That’s how Tara Murtha describes the lawsuit brought by Real Alternatives and its three (male) employees seeking to enjoin application of the Affordable Care Act’s contraceptive-coverage regulations. This lawsuit is different than the ones currently before the Supreme Court: Real Alternatives is not a religious organization, and its employees argue that the mere availability of contraceptive coverage in their own plans violates their rights under RFRA—even though nobody is making them use that coverage.

The plaintiffs are represented by Alliance Defending Freedom, a Religious Right legal organization that has also represented many of the for-profit corporations and nonprofit religious organizations bringing free-exercise challenges to the coverage regulations and accommodation. Unlike most of ADF’s other clients in these cases, Real Alternatives acknowledges that its opposition to the coverage regulations arises purely from its opposition to the use of birth control; there is no claimed religious basis for this opposition.

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The “Ashley Treatment” – Thoughts about Avoiding Sexualization

Ashley is young woman who was born in 1997 with a severe mental and physical disability that prevented her from ever eating, walking or talking by herself. Her mental capacity was also not expected to develop further than that of an infant. In 2004, When she was six and a half years old, Ashley‘s parents and the Seattle Children’s hospital physicians who had been treating her sought to perform on Ashley a novel medical intervention that would include hormonal treatment for growth attenuation, surgical removal of her breast buds, and a hysterectomy. This surgical intervention was presented as beneficial to Ashley by allowing her parents to take care of her longer and postpone institutionalization. The removal of breast buds and hysterectomy were meant to spare Ashley the pain and discomfort of menstruation and the development of fully-developed breasts, and also to “avoid sexualization” in order to make her less vulnerable to sexual abuse when she was ultimately institutionalized. Continue reading

Senator Cruz’s RESULT Act Unlikely to Achieve Results

By Rachel Sachs

On Thursday, Senators Ted Cruz and Mike Lee introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text), which would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a particular list of countries, including EU member countries, Japan, and Canada. The Act would require the FDA to grant such “reciprocal marketing approval” within 30 days, unless the FDA makes affirmative determinations about the drug or device’s lack of safety and efficacy. If the FDA declines to grant reciprocal marketing approval, the Act would also permit Congress to override the FDA’s decision through a majority vote via a joint resolution.

Zachary Brennan at RAPS has already provided a helpful explanation of the problems with this proposal, and in particular the problems created if Congress were permitted to override FDA denials of approval. In this post, I want to focus primarily on the Act’s premise. Senators Cruz and Lee argue that this bill would speed approval of drugs and devices “which are currently saving lives in other developed countries, but have not been approved in the U.S. because of FDA red tape.” The implication is two-fold: 1) that drugs are often left languishing at the FDA while they enjoy approval in other countries, and 2) that the FDA has no grounds for failing to approve these drugs. The first argument, about the speed of FDA approval, is made quite frequently by legislators who seek to weaken the FDA’s gatekeeping authority over new drugs and devices in the United States. Unfortunately, it hasn’t really been true for decades. The second argument ignores the historical context of the FDA’s decision-making authority.

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Bioethicist Art Caplan: Engineering the Better Baby

Bill of Health Contributor Arthur Caplan has a new article in Project Syndicate:

There should no longer be any doubt about whether humans will one day be genetically modified. A new tool – called CRISPR – is already being used to edit the genomes of insects and animals. Essentially a very sharp molecular knife, CRISPR allows scientists to carve out and insert genes precisely and inexpensively. It is only a matter of time before it will be used to engineer our descendants – eliminating many dangerous hereditary diseases in the process.

To be sure, this eventuality is being hotly debated. The main arguments against genetic modification of human embryos are that it would be unsafe and unfair, and that modification would quickly go beyond efforts to reduce the incidence of inherited maladies. But, ultimately, none of these reasons is likely to be persuasive enough to stop the technology from being widely used. […]

Read the full article here.

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‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we talked with Robert I. Field, Professor of Law at Drexel University. Robert is also a professor of health management and policy at Drexel’s Dornsife School of Public Health, a lecturer in health care management at the Wharton School of the University of Pennsylvania, and a senior fellow of Penn’s Leonard Davis Institute of Health Economics. He is the author of “Mother of Invention: How the Government Created ‘Free-Market’ Health Care,” which presents a historical overview of government programs in creating and maintaining the health care system and places health reform in the context of an ongoing evolutionary process. He is also the author of “Health Care Regulation in America: Complexity, Confrontation and Compromise,” a comprehensive overview of health care regulation.

We discussed a number of recent developments surrounding the ACA, including the most recent judicial challenges (and their potential to congeal into an emerging ACA SCOTUS jurisprudence) and legislative attacks. We discussed mainstream health economists’ zeal for the Cadillac tax, despite such thin evidence it will actually raise wages. We closed with a discussion of one theme from Robert’s book: what the US health care sector would look like if there were dramatic reductions in government support and regulation.

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 RadioTunein 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

Changing How We Think (and Talk) About Public Health Law

By Scott Burris, JD

Marice Ashe, Donna Levin, Matthew Penn, Michelle Larkin and I have a new piece in the Annual Review of Public Health (also available on SSRN). We set out a “transdisciplinary model of public health law” that encompasses within the core of the field both the traditional public health law practice of lawyers and what we call “legal epidemiology” — all the important public health law functions (from policy design to evaluation) that are typically carried out by people without legal training. I hope you will take a look.

Why this article and a transdisciplinary model? The idea comes out of the experience that the authors have all had trying to promote public health law practice and research. We realized that in spite of the success of the field and its importance to public health, a lot of non-lawyers in public health training, practice and research were uncomfortable with law — even when their work had to do with enforcing it or evaluating its impact.

We realized that we as lawyers were making things worse, by adhering to a traditional view of public health law as purely a practice of lawyers. We found that acknowledging the work of non-lawyers in public health law, conceptualizing key public health law activities in scientific terms, and even borrowing some scientific practices for legal work, were effective ways to change attitudes and improve our impact. Many of us have articles in the pipeline on legal epidemiology, policy surveillance and “the five essential public health law services” that will show the model in action.

I don’t have to tell readers of this blog that public health law is a great field. I hope the concept of transdisciplinary model will help make it a truly integral part of public health.

Read the full article here.