April, 2015 - Bill of Health

To Spur Medical Innovation, Make Corporate Cheaters Pay

April 30, 2015April 30, 2015 Ameet Sarpatwari 3 Comments

By Aaron S. Kesselheim and Ameet Sarpatwari

The past decade has seen a relatively constant rate of newly approved drugs every year. The number has even jumped in the past few years. Yet, despite such encouraging trends, we are actually facing a crisis in drug innovation today. That is because many of these new products do not offer substantial improvements over already available alternatives.

At the same time, novel and effective treatments for many diseases—both rare and common—remain elusive. For example, there is widespread concern over the lack of development of new antibiotics aimed at multidrug-resistant infections. Therapeutic innovation for central nervous system disorders such as dementia and psychoses, which affect almost 100 million Americans, has likewise stagnated.

In this climate, pharmaceutical manufacturers have nonetheless continued to thrive. The top eleven drug manufacturers made $711 billion from 2003 to 2012, including $68 billion in 2012 alone, translating to an industry profit margin on par with the banking sector.

New Discussion Draft of 21st Century Cures Act Released

April 30, 2015April 30, 2015 rachelsachs Leave a comment

By Rachel Sachs

Yesterday, a new discussion draft of the 21^st Century Cures Act was released, just in time for today’s hearing on the draft before the House Energy and Commerce Committee. At just 200 pages (although with some sections still “to be supplied”), this version is just half the size of the previous draft. As such, it is perhaps more notable for what it took out of the original draft than for what it added in. I haven’t had time to digest fully all of the cuts just yet, but in advance of the hearing this morning I wanted to highlight two significant deletions from the first draft and one potentially significant addition.

First, when I blogged in February about the first draft of the Act, I expressed excitement over the idea of a Medical Product Innovation Advisory Commission. The Commission would have had the ability to oversee the way in which agencies like the NIH, FDA, and CMS all interact with each other to affect the development and dissemination of medical products. A significant portion of my scholarship focuses on precisely these ideas, and I was hopeful that the Commission would make it into the second draft. Alas, it did not.

Second, the first draft of the Act contained a series of very controversial exclusivity provisions. Chief among them may have been the draft provision giving “dormant therapies” (essentially, new drugs for unmet medical needs) the option of 15 years of exclusivity. Alexander Gaffney’s Regulatory Explainer on the first draft provides a helpful overview, for those who are interested in learning more about this provision. But interestingly, this and other provisions relating to increased exclusivity are gone from the new draft. Now, it is possible that some of this language will reappear later, especially as the section of the draft relating to “Repurposing Drugs for Serious and Life-Threatening Diseases and Conditions” has yet to be supplied. But in the first draft of the document, the sections for “Repurposing Drugs” and “Dormant Therapies” were separate, so it is not clear that this is likely to happen.

Exploring The Significant State-To-State Variation In Marketplace Enrollment

April 29, 2015April 29, 2015 The Petrie-Flom Center Staff Leave a comment

This new post by the Petrie-Flom Center’s Academic Fellow Matthew J. B. Lawrence appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

What role did geography, advertising, community, Navigators, and the controversy surrounding the Affordable Care Act (ACA) play in consumers’ decisions whether to purchase health insurance in the individual marketplaces? The percentage of potential exchange marketplace enrollees who actually made use of the marketplace to purchase insurance varied widely from state to state for 2014 and 2015.

As of February 22, 2015, for example, there were eight states with enrollment at 50 percent or greater and eight states with enrollment at 25 percent or lower. (Per the Kaiser Family Foundation, the top eight were Vermont, Florida, Maine, DC, Delaware, Pennsylvania, New Hampshire, and North Carolina. The bottom eight were Colorado, Ohio, Alaska, Hawaii, North Dakota, Minnesota, South Dakota, and Iowa).

It would be an interesting and challenging task to explain this variation empirically. Generating reliable statistical inferences from inter-state comparisons is notoriously difficult, and the variables at play here range from the easily measured (percent of population eligible for subsidies, navigator grant amounts, number of participating insurers, premiums) to the not-so-easily measured (enthusiasm for Obamacare, efficacy of state or federal outreach efforts, geography, education, availability and usefulness of charity care and emergency Medicaid, functionality of state exchange website, population health, availability of health services). […]

Read the full post here.

‘The Week in Health Law’ Podcast

April 29, 2015April 29, 2015 Nicolas P. Terry Leave a comment

By Nicolas Terry

This week we are joined by Nathan Cortez, Associate Dean for Research and the Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies at SMU-Dedman School of Law. We discuss wearables & mHealth and their regulation by FDA, FTC, & HHS-OCR.

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 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: Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics & Tobacco Products

April 28, 2015April 28, 2015 mmeyer Leave a comment

The Food and Drug Law Journal is pleased to announce a forthcoming symposium—Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics, and Tobacco Products—to be held at the Georgetown University Law Center (GULC) on Friday, October 30, 2015, and co-sponsored by the Food and Drug Law Institute and GULC’s O’Neill Institute for National and Global Health Law.

The deadline for submitting abstracts is June 1, 2015. Download more information about the symposium here.

Athlete concussion under-reporting and pressure from stakeholders

April 27, 2015April 27, 2015 christinebaugh Leave a comment

By: Christine Baugh

As concussions are increasingly seen as a public health problem, under-reporting and under-diagnosis of concussion is recognized as one barrier to improving the safety of sports participation. A number of studies have previously characterized the extent of under-reporting of concussions among athletes, particularly at the collegiate level. Furthermore, existing research has examined the applicability of theories of behavior change to concussion reporting and created relevant frameworks for examination. Although a growing body of evidence suggests that reporting (or not reporting) a concussion is a decision actively made by the athlete weighing relevant factors, the extent to which interpersonal, intrapersonal, environmental, or policy factors influence athletes’ decisions about whether or not to report a concussion is not fully understood.

A recent study, on which I am a co-author, titled “Concussion under-reporting and pressure from coaches, teammates, fans, and parents,” published in Social Science and Medicine aimed to understand one possible contributory factor to athlete under-report of concussion: pressure on athletes from relevant stakeholders. (Abstract available here.) The survey-based study queried a sample of 328 athletes from 19 contact or collision sports teams (notably excluding football and hockey teams) at 4 colleges in the northeast region of the United States. Among other things, the study asked athletes whether they experienced pressure to return to play after a head impact, specifically asking about pressure from coaches, teammates, parents, and fans. Read More

Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?

April 27, 2015April 27, 2015 I. Glenn Cohen Leave a comment

Given that it was the subject of my first ever blog post on Bill of Health, I am very pleased to share my new paper: “Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?” which has just been published in the Journal of Law, Medicine, and Ethics (it is behind a paywall, but there is a version they have allowed me to post on SSRN that has all the text but not the formatting that can be freely downloaded).

This paper is likely to piss off people both on the Left and the Right of the abortion issue, which I think of as a feature not a bug ;), but in any event I hope will prompt a good conversation. Here is the abstract:

There was a moment in the 2012 campaign, when Mitt Romney attempted to “pivot” to the center and get away from the statements of those like Todd Akin who made comments about how in cases of “legitimate rape,” the victims’ bodies “have ways to try and shut that whole thing down.” The way Romney did his pivot was to make clear that while he was against abortion, he would, of course, make an exception for women who had been raped or whose pregnancy was the result of incest. This has become something of a moderate orthodoxy among those who oppose abortion. Read More

Bioethicist Art Caplan: Chinese Scientists Try To Alter Genomes In Human Embryos

April 27, 2015April 27, 2015 acaplan Leave a comment

A new piece by contributor Art Caplan in Forbes:

Bet you did not know that today is National DNA Day. It is. But before we all begin to party over our biological programming, remember this is also the day when the world is trying to figure out how to respond to a paper from a team of scientists in China stating that they tried to alter the genomes of human embryos using a new technique known as CRISPR.

Without getting bogged down in the details, CRISPR it is a new powerful tool that permits editing or clipping out segments of DNA and inserting novel genetic material. The Chinese group used it for the first time in human embryos, thereby taking a baby step across the line to trying out a technology that someday could be used to change the DNA of our descendants to repair genetic diseases, get rid of traits we don’t like or to try and build better, improved babies. Yes, that is the low moan of eugenics you hear in the background of this CRISPR experiment. Happy National DNA Day to you, too. […]

Read the full article here.

No Jab, No Pay: Australia’s Misguided Approach to Vaccine Refusal

April 25, 2015April 25, 2015 wparmet Leave a comment

By Wendy Parmet

Australia’s recently announced “no jab, no pay” policy offers a potent reminder of the all-too-common tendency to penalize vulnerable populations for public health problems. Like many other countries, Australia has experienced a worrisome increase in the number of families deciding not to vaccinate their children. In response, the government of Prime Minister Tony Abbott has announced a program of carrots and sticks. The carrots include increased payments to physicians to incentivize them to urge families to vaccinate their children. The sticks include tightening the religious exemption (Australia does not provide an exemption for personal belief) and the “no jab, no policy” which will deny families whose children aren’t vaccinated certain income-based childcare and family tax benefits.

Governments have long used the denial of public benefits – traditionally public education – to push parents to vaccinate their children. Studies have shown that laws conditioning attendance in schools and daycares on vaccination can increase vaccination rates, although the particular formulation of the law (especially how difficult it is to receive an exemption) matters.

To be sure, laws that require children to be vaccinated to attend schools or daycare impose heavier burdens on poor families who are more apt to need daycare and are less able to homeschool their children. Still, these laws reach broadly, especially when they apply to private schools. Homeschooling remains relatively rare. Significantly, school-based vaccine laws do not single out low-income families. Read More

Month: April 2015