The Globalization of Infectious Diseases

The recent arrival of Ebola in the United States has captured the attention of both the public and the media for many reasons.  One key reason is that Ebola is making many people realize for the first time that serious diseases which were formerly confined largely to developing countries have the potential to spread more widely across the globe.  But Ebola is not the first infectious disease to spread in this way, and it’s valuable for Americans to realize that many diseases which are often viewed as existing only in developing countries are already present in the developed world, due to a complex set of factors including migration and climate change.

Specifically, serious diseases transmitted by insects like chikungunya, dengue fever, and Chagas disease are already here in the United States.  I blogged here in August about DARPA’s prize to predict the spread of chikungunya, and the CDC’s estimates suggest that the disease may be finding a foothold in this country, with 11 locally-transmitted cases in addition to the more than 1500 travel-associated cases confirmed so far in 2014.  Compared to an average of just 28 cases per year since 2006, the spread is concerning.  Scientists also contend that dengue fever, a disease with similarly debilitating symptoms, is now endemic to Florida.

The case of Chagas is even more dramatic.  Categorized by the CDC as a “neglected parasitic infection,” it is estimated that 300,000 infected people live in the United States.  That’s ten times as many people as are diagnosed with ALS, a disease which has made much more of a mark on the public consciousness.  Chagas’ impact (both human and economic) on the United States’ health system is and will continue to be extremely costly, with one study estimating the economic cost to the United States at roughly $900 million annually.  Some of these costs are indirect — for instance, donated blood must now be screened for the presence of the parasite, to prevent its transmission.  But most are direct.  Over the long term, Chagas can cause severe, even fatal damage to the heart and gastrointestinal tract.

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The Medical Liability Climate: The Calm Between Storms Is the Time For Reforms

By: Michelle Mello, JD, PhD

Standard Law School and Stanford University School of Medicine

On November 4, Californians will vote on Proposition 46, a ballot initiative to adjust the $250,000 state’s noneconomic damages cap in medical malpractice cases for inflation, raising it to $1.1 million virtually overnight.  It’s a long overdue move – California has one of the most stringent damages caps in the country, and the cap really affects access to the legal system.  Now is the perfect time to do it, because after years of turbulence, the medical liability environment has calmed.

In an analysis published October 30 in the Journal of the American Medical Association (JAMA), David Studdert, Allen Kachalia and I report that data from the National Practitioner Data Bank show that the frequency and average cost of paid malpractice claims have been declining.  The rate of paid claims against physicians decreased from 18.6 to 9.9 paid claims per 1,000 physicians between 2002 and 2013, with an estimated annual average decrease of 6.3% for MDs and a 5.3% decrease for DOs. Among claims that resulted in some payment, the median amount paid increased from $133,799 in 1994 to $218,400 in 2007, an average annual increase of 5%. Since 2007 the median payment has declined, reaching $195,000 in 2013, an average annual decrease of 1.1%.

Trends in insurance premiums vary more according to which market you’re looking at, according to data from the Medical Liability Monitor’s Annual Rate Survey, but also look pretty favorable overall. None of the locations we examined showed large increases over the last 10 years, and most showed flat or declining premiums. Continue reading

Above the (Public Health) Law: Healthcare Worker Deception and Disobedience in a Time of Distrust

[Author's Note: Addendum and updates (latest: 4  pm, 10/31) added below.]

A physician shall… be honest in all professional interactions, and strive to report physicians… engaging in fraud or deception, to appropriate entities.
AMA Principles of Medical Ethics

This is a troubling series of news reports about deception and defiance on the part of some healthcare workers (HCWs) in response to what they believe to be unscientific, unfair, and/or unconstitutional public health measures (to be clear, the text is not mine (until after the jump); it’s cut and pasted, in relevant part, from the linked sources):

(1) Ebola Aide Doc: I’m Not Telling My Team To Tell The Truth

Gavin Macgregor-Skinner, an epidemiologist and Global Projects Manager for the Elizabeth R. Griffin Foundation, who has led teams of doctors to treat Ebola in West Africa, reported that he “can’t tell them [his doctors] to tell the truth [to U.S. officials]” on Monday’s “CNN Newsroom.”

“At the moment these people are so valuable . . . I have to ensure they come back here, they get the rest needed. I can’t tell them to tell the truth at the moment because we’re seeing so much irrational behavior,” he stated. “I’ve come back numerous times between the U.S. and West Africa. If I come back now and say ‘I’ve been in contact with Ebola patients,’ I’m going to be locked in my house for 21 days,” Macgregor-Skinner said as his reason for not being truthful with officials, he added, “when I’m back here in the US, I am visiting US hospitals everyday helping them get prepared for Ebola. You take me out for three weeks, who’s going to replace me and help now US hospitals get ready? Those gaps can’t be filled.

He argued that teams of doctors and nurses could be trusted with the responsibility of monitoring themselves, stating, “When I bring my team back we are talking each day on video conferencing, FaceTime, Skype, text messaging, supporting each other. As soon as I feel sick I’m going to stay at home and call for help, but I’m not going to go to a Redskins game here in Washington D.C. That’s irresponsible, but I need to get back to these hospitals and help them be prepared.

UPDATE: Here is the CNN video of his remarks.

(2) Ebola Doctor ‘Lied’ About NYC Travels

The city’s first Ebola patient initially lied to authorities about his travels around the city following his return from treating disease victims in Africa, law-enforcement sources said. Dr. Craig Spencer at first told officials that he isolated himself in his Harlem apartment — and didn’t admit he rode the subways, dined out and went bowling until cops looked at his MetroCard the sources said. “He told the authorities that he self-quarantined. Detectives then reviewed his credit-card statement and MetroCard and found that he went over here, over there, up and down and all around,” a source said. Spencer finally ’fessed up when a cop “got on the phone and had to relay questions to him through the Health Department,” a source said. Officials then retraced Spencer’s steps, which included dining at The Meatball Shop in Greenwich Village and bowling at The Gutter in Brooklyn.

Update 11PM, 10/30: A spokesperson for the NYC healh department has now disputed the above story, which cites anonymous police officer sources, in a statement provided to CNBC. The spokesperson said: “Dr. Spencer cooperated fully with the Health Department to establish a timeline of his movements in the days following his return to New York from Guinea, providing his MetroCard, credit cards and cellphone.” . . . When CNBC asked again if Spencer had at first lied to authorities or otherwise mislead them about his movements in the city, Lewin replied: “Please refer to the statement I just sent. As this states, Dr. Spencer cooperated fully with the Health Department.”

(3) Ebola nurse in Maine rejects home quarantine rules [the WaPo headline better captures the gist: After fight with Chris Christie, nurse Kaci Hickox will defy Ebola quarantine in Maine]

Kaci Hickox, the Ebola nurse who was forcibly held in an isolation tent in New Jersey for three days, says she will not obey instructions to remain at home in Maine for 21 days. “I don’t plan on sticking to the guidelines,” Hickox tells TODAY’s Matt Lauer. “I am not going to sit around and be bullied by politicians and forced to stay in my home when I am not a risk to the American public.”

Maine health officials have said they expect her to agree to be quarantined at her home for a 21-day period. The Bangor Daily News reports. But Hickox, who agreed to stay home for two days, tells TODAY she will pursue legal action if Maine forces her into continued isolation. “If the restrictions placed on me by the state of Maine are not lifted by Thursday morning, I will go to court to fight for my freedom,” she says.

Some thoughts on these reports, after the jump.  Continue reading

Ebola: A Problem of Poverty Rather than Health

By David Orentlicher
[Cross-posted at Health Law Profs and PrawfsBlawg.]

Undoubtedly, the death toll in West Africa would be much lower if Guinea, Liberia, and Sierra Leone had better health care systems or if an Ebola vaccine had been developed already. But as Fran Quigley has observed, Ebola is much more a problem of poverty than of health. Ebola has caused so much devastation because it emerged in countries ravaged by civil wars that disrupted economies and ecosystems.

Ultimately, this Ebola epidemic will be contained, and a vaccination will be developed to limit future outbreaks. But there are other lethal viruses in Africa, and more will emerge in the coming years. If we want to protect ourselves against the threat of deadly disease, we need to ensure that the international community builds functioning economies in the countries that lack them.

Our humanitarian impulses in the past have not been strong enough to provide for the needs of the impoverished across the globe. Perhaps now that our self-interest is at stake, we will do more to meet the challenge.

Art Caplan on Ebola Quarantines

Over at his NBC News column, Art Caplan proposes a different approach to quarantining ebola “heroes.”

How to combat fear? Honor these heroes by giving them paid R &R, with their partner if they so choose, for 21 days. Give them a vacation in the guise of quarantine. Give them a reason to want to go back to fight Ebola. Give other doctors and nurses a reason to emulate them. Build or buy a nice hotel for these heroes.

And more, on why a general quarantine is a bad idea:

When officials respond to panic with quarantine they basically say they can’t trust public health officials, science and the ethics of doctors and nurses. There is no substitute for that trust. None. If state and city officials undermine trust out of panic or politics, then they destroy the best weapon we have to control Ebola — good science implemented by heroes.

The Ebola “Czar”

By David Orentlicher
[Cross-posted at Health Law Profs and PrawfsBlawg.]

In the wake of Craig Spencer’s decision to go bowling in Brooklyn, governors of three major states—Illinois, New Jersey, and New York—have imposed new Ebola quarantine rules that are inconsistent with national public health policy, are not likely to protect Americans from Ebola, and may compromise the response to Ebola in Africa, as health care providers may find it too burdensome to volunteer where they are needed overseas. Don’t we have an Ebola czar who is supposed to ensure that our country has a coherent and coordinated response to the threat from Ebola?

Of course, the term “czar” was poorly chosen precisely because Ron Klain does not have the powers of a czar. He will oversee the federal response to Ebola, but he cannot control the Ebola policies of each state. Unfortunately, on an issue that demands a clear national policy that reflects medical understanding, public anxieties will give us something much less desirable.

Is Corruption Partly Responsible for the Ebola Crisis?

Guest post by Matthew Stephenson
[Cross-posted from The Global Anticorruption Blog.]

There’s been an interesting mini-debate over at the FCPA Blog about whether, or to what extent, corruption is partly responsible for the severity of the Ebola crisis in West Africa. Richard Cassin, the publisher and editor of the FCPA Blog, argued that it is. He made this argument initially in a post from this past August entitled “Ebola tragedy is also a story of graft.” He offered as evidence the following observations: (1) the WHO and other observers estimate that a very high percentage–perhaps up to 25%–of global spending on public health is lost to corruption; (2) the very high Ebola fatality rates in West Africa have been attributed in part to the lack of adequate intensive care facilities to administer the treatments; and (3) the countries hardest hit by the Ebola outbreak–Guinea, Liberia, Sierra Leone, and Nigeria–are reputed to be highly corrupt, as indicated by their very poor scores on Transparency International’s Corruption Perceptions Index.

Many critics who commented on Cassin’s initial post complained that the evidence offered did not in fact support the strong claim in the title that corruption has contributed significantly to the Ebola outbreak. In particular, the critics pointed out that: (1) the fact that a great deal of public health spendinggenerally is lost to corruption does not actually tell us whether corruption was a major factor in the particular case of the Ebola outbreak, and (2) the low ranking of the affected countries on the CPI likewise–even if we concede that the CPI is a decent measure of actual corruption–does not indicate that corruption caused (in any significant way) the Ebola outbreak to be as lethal as it has been; at most it shows a correlation that might be explained by any number of other factors.

Cassin responded with a second post last month in which he rebutted the critics. He acknowledged that while one can never establish with “scientific certainty” that corruption has a causal effect on the severity of the Ebola outbreak, there is powerful circumstantial evidence that corruption is a “gateway” to this and other public health crises (as well as other problems like terrorism and crime), because it siphons off public resources. Cassin cites to a couple of research papers that purport to show that corruption in general has adverse impacts on public health, in particular because it adversely affects access to clean water and sanitation.

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Tomorrow: A Conversation with Jim Doyle

A Conversation with Jim Doyle
October 15, 2014 12:00 PM – 1:00 PM
Wasserstein Hall, Room 1019, 1585 Massachusetts Ave.

JimDoyleJoin the Harvard Health Law Society for a lunch talk with former Attorney General and Governor of Wisconsin Jim Doyle. Come hear about the former governor’s experiences tackling public health issues through state politics and join us for a Q&A session about health policy, health law careers, and politics. Governor Jim Doyle served as the 44th governor of Wisconsin and is recognized as a national leader in health care, energy, biotechnology, and many other areas. He has worked closely with the White House, high-ranking officials, and other governors. He currently serves as counsel for Foley & Lardner and is teaching a class at the Harvard School of Public Health this fall entitled “Health Policy, Leadership, and Politics at the State.”

Co-sponsored by the Center for Health Law Policy and Innovation and the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics.

State Concussion Legislation: Variable Implementation

By Christine Baugh

The most recent issue of the Journal of Law Medicine and Ethics (generously made available for free by the American Society of Law Medicine and Ethics) included several articles examining state concussion laws. One theme that arose across the articles is that although concussion-related legislation is on the books in all 50 states and the District of Columbia, the extent to which it is creating an improvement in youth and adolescent athlete health outcomes is unclear.

In their article titled “State experiences implementing youth sports concussion laws: challenges, successes, and lessons for evaluating impact” Kerri McGowan Lowrey and Stephanie Morain interviewed stakeholders (e.g., officials at state departments of public health, state athletic associations) at a majority of states with concussion laws in order to understand how the laws had been implemented. Although previous research in the area (see, for example: Hosea Harvey’s piece in the American Journal of Public Health) presented concussion legislation as relatively homogenous, McGowan Lowrey and Morain’s approach provided critical insight. They found that while the state laws are relatively uniform in their construction, there is substantial variation in their implementation. In particular, McGowan Lowrey and Morain reported variation in compliance with the statutes, variation in how much stakeholders were included during formative stages in the legislation’s composition, and variation in what constituted concussion education.

In another article in the issue, my colleagues Emily Kroshus, Alexandra Bourlas, Kaitlyn Perry, and I specifically examined the concussion education and acknowledgement provisions of state concussion laws. This investigation was conducted in two parts: first we examined what the statute mandated and then we examined what the high school athletic association and/or department of education in that state actually provided for education. Similar to McGowan Lowrey and Morain, we found that implementation did not always match statute. In some promising cases the education provided exceeded the information minimally required by statute. In other situations, the concussion information was provided in such a way that it was required to be returned with a parent signature. In cases like this, compliance with one part of the statute (mandating acknowledgement of receipt of information) may have been compromising another (providing concussion education). Although the education and acknowledgement tenets were relatively similar across states, more heterogeneity was found in the implementation of these aspects of the statutes.

In general, these two studies suggest that the approach for examining statute, and particularly its efficacy, needs to be designed to address implementation stage information. Strict examination of the statutory language obscures critical implementation-level differences. These concussion-related statutes, enacted now in every state, are ostensibly supposed to reduce risk and improve athlete health outcomes. The extent to which they are reliably accomplishing this goal is unclear. What is clear is that implementation of the laws, and enforcement in cases where schools do not abide by statute, are necessary precursors to consistent efficacy. Although it is important that all states have taken steps toward protecting the health and safety of youth and adolescent athletes, approving a statute is not the final step toward this aim. Further research is needed to understand what health effects the current laws are having and critically where improvements can be made in this important area of public health law.

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Ebola, Flight Bans, and Politics

By Zachary Shapiro

It seems like the debate over banning flights from West African Ebola stricken countries has become instantly political, with many Conservatives calling for a flight ban. See here. One author, in response to these calls, points to the history of Liberia’s relationship with the United States as a reason that the US should not consider a flight ban. Arguments against a flight ban that are not based on public health principles provide fodder for the talking heads and individuals who want to see this as a political issue.

The real question should be how much good a flight ban would do to halt the spread of Ebola to the United States. Many public health experts, from the CDC to the WHO, do not think a ban would make us safer.

Ebola is only contagious when the patient is symptomatic, and the first symptom is almost always a fever. If a patient does not have a fever, and is asymptomatic, they are not contagious. Thus they do not provide a serious risk of infecting other people, even in the confined quarters of an airplane. This makes temperature screening especially important. This easy screening tool is already in use at airports in Ebola affected Countries.  Continue reading

Caplan on Ebola and Quarantine

Art Caplan and his colleague Alison Bateman-House have a new post in Time about government authority to quarantine individuals who pose a risk of infecting others, and the practical logistics of carrying out a quarantine.  Take a look here:

Ebola in America: Government Can Lock Us Up for Weeks at a Time

Ebola Update: Why Don’t We Seem to Care?

By Deborah Cho

It’s been over half a year since the beginning of the current Ebola outbreak in West Africa, yet the number of cases and deaths from the disease continue to rise.  The total case count as of September 29, 2014 is 6,574 and total deaths are at 3,091.  Even so, the international response, as a whole, seems to be lacking.  As I lived near the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia this past summer, I was acutely aware of the Ebola epidemic’s magnitude while it had the media’s attention.  The attention given was similar to that given to a car accident on the side of a road as onlookers drive on by without stopping to offer help.  Unfortunately, it was quite clear that aid efforts were woefully inadequate and that the disease would continue to spread rapidly without a stronger response.  It seemed that though our curiosity about this virus was at an all-time high, our national concern for the epidemic and its casualties were extremely minimal other than in the brief moments when we were faced with prospect of flying in two of our own infected citizens.  Continue reading

Are we appropriately framing the risks of brain trauma in contact sports?

By Christine Baugh

The recent concussion and sport special issue of the Journal of Law Medicine and Ethics (generously made available free by the American Society of Law Medicine and Ethics: HERE), edited by new Bill of Health contributor David Orentlichter,  includes a number of important works discussing legal and ethical issues related to mild traumatic brain injury sustained through sport. One of the most thought provoking articles in the issue is a piece by Kathleen Bachynski and Daniel Goldberg titled Youth Sports & Public Health: Framing Risks of Mild Traumatic Brain Injury in American Football and Ice Hockey. This piece delves into the important issues of cultural and normative influences on the framing (and thus public understanding) of the risk of brain injury in sport. At the heart of the paper is the assertion that, “The framing of risk is not a neutral, apolitical enterprise,” and that in the United States and Canada highly influential institutional actors such as football and ice hockey leagues have played a formative role in the cultural valuation of the risks inherent in these activities.

Bachynski and Goldberg provide a variety of examples where the overarching questions such as “Are contact sports too risky?” or “What is an appropriate level of risk?” are deferred for easier alternatives. Addressing more focal issues are: State concussion laws which mandate secondary prevention measures, advancement in protective equipment which promises to mitigate risk of injury, rule changes made by sports leagues which aim to make inherently dangerous activities somewhat less dangerous. Rather than addressing the broader risk questions, the implicit assumption in these more focused efforts is that risks are acceptable as long as they are managed. Through what Bachynski and Goldberg assert are concerted efforts on behalf of major stakeholders (e.g., major sports leagues), this has been the predominant frame for risk assessment in contact sports.

Unfortunately, this method of framing risks is not without consequences. Bachynski and Goldberg argue that this framing may alter our understanding of the scope of the problem as well as the most appropriate interventions or solutions. This frame may also inappropriately downplay the need to address the broader moral, social, and political questions that arise from concussions in contact sports. For example, the authors pose the following question, “At what age can players consent to risks of head trauma and associated elevated risks of chronic degenerative neurological disease?”

Answering this question could require a complex weighing of the scientific evidence of the long-term risk of neurodegeneration and balancing it against a variety of factors such as the paternalistic desire to control the population’s ability to partake in self-injurious behavior and the need to protect an individual’s autonomy. (We do, after all, regularly let individuals partake in other dangerous activities—e.g., downhill skiing or driving a car.) We would need to think about questions such as: Should we treat the risk of brain injury differently than bodily injury? Should the risk of delayed or chronic injury be weighed differently given humans’ known difficulty in assessing risk in the distant future? What does scientific evidence have to say about the nature of the risk across age ranges? However, under the current framing these questions are not the ones being addressed. Bachynski and Goldberg’s article elucidates the first step toward addressing concussions from sport: appropriately framing the problem.

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Vaccination Policy and Public Trust

By Kelsey Berry

The conflict between a physician’s dual roles as an agent of population health and an agent of his or her patient is exemplified in the classical debate about ethical vaccination policy. Whereas studies have demonstrated the role of vaccination in protecting public health at negligible risk to individuals, “vaccine hesitancy” and non-acceptance among parents has increasingly contributed to vaccination delay and refusal. Recent domestic measles outbreaks and increased numbers of reported infections in 2011 and 2013 gesture to the public health impacts of even small decrements in uptake, especially in a globalized setting where the infection can travel easily.[1]

The FORUM at Harvard School of Public Health recently hosted an event on vaccination, exploring through an expert panel the drivers of public perception about vaccination and ways of restoring public trust in vaccination. Panelists discussed the need for research into the values and concerns of those who exhibit vaccine hesitancy, and development of effective modes of communication, tailored to individuals’ concerns, that will allow trained physicians to effectively guide choice. Notably, the clinical encounter was brought up several times as fertile ground for both reestablishing trust and promoting vaccine uptake effectively.

Reestablishing public trust in public health interventions may be key to avoiding conflicts between physicians’ duties to both population health and patients/guardians. If the patient/guardian ultimately expresses support for vaccination, as a result of persuasive information supplied by the physician, the conflict seems to disappear. However, what about the case in which a patient expresses support for vaccination as a policy, but does not support the use of vaccination in the case of his or her own child (assuming for simplicity that there are no medical contraindications to vaccination in this child’s case)? This scenario brings out a possible duality in the held views of patient/guardians. There seem to be two competing views within one patient/guardian: first, the view that we as a society should promote population health through vaccination, and second the view that one’s own person/child should be exempt from vaccination. Continue reading

A Lack of Pep for PrEP

By Emily Largent

The Kaiser Family Foundation (KFF) recently conducted a survey of gay and bisexual men in the U.S. focusing on attitudes, knowledge, and experiences with HIV/AIDS.  The survey results, released Thursday, can be found here.  I was most interested in the finding that only a quarter of those surveyed know about PrEP (pre-exposure prophylaxis).

PrEP (brand name Truvada) is a combination of two medicines (tenofovir and emtricitabine) that has, if taken consistently, been shown to reduce the risk of HIV infection in people who are high risk by up to 92%.  The FDA approved an indication for the use of Truvada “in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk” in 2012.  The U.S. Public Health Service released the first comprehensive clinical practice guidelines in May of this year. Continue reading

How much promise do safety-net ACOs really hold?

The Health Affairs blog recently published an important write-up of the status of safety net ACOs. Therein, authors James Maxwell, Michael Bailit, Rachel Toby and Christine Barron offer five “key observations regarding emerging safety-net ACOs and suggest broad policy implications” which are drawn from what appears to be a fairly extensive research project including “site visits and telephone interviews with 66 safety-net ACO leaders and state officials conducted over the last two years in 14 states.” Generally, they leave the reader with an optimistic impression of safety-net ACOs efforts to achieve population health – which contrasts with my previous post on Bill of Health.

In short, the authors offer the following observations:

  1. State policy is a key factor in the formation of safety-net ACOs.
  2. Both health policy experts and those involved in forming ACOs consider health homes, high-cost case management, and integrated behavioral health to be priority delivery system transformations for ACOs in the safety-net.
  3. It takes money to save money: upfront capital and financial flexibility are required for investment in delivery system transformations.
  4. Safety-net ACOs are adopting payment and delivery system transformations incrementally.
  5. Building on a long-standing recognition of how non-medical factors impact health outcomes and utilization, safety-net ACOs are addressing social determinants of health through community partnerships.

The entirety of the post is well-written and I encourage folks to check it out for themselves. My concerns about the ACO model do still largely hold, however. While the authors of this blog highlight four states (MA, OR, AL and MN) with policies on the books to encourage creativity in safety-net ACO design, that leaves 46 others without such supportive legislation. In short, I think we are still working at the margins here. Moreover, I worry that the authors have chosen a definition of ACO that goes well beyond what CMS considers to be an ACO and in so doing have spotlighted “bright lights” of the health care delivery landscape that may not have the metrics and results to support their claims at innovation. The authors offer us little information about what kind of improvements either in quality of care or health outcomes these safety-net ACOs have been able to achieve. (Meanwhile, CMS recently released the latest quality metrics on the Pioneer and Shared Savings ACOs they sanction and monitor.)

The bottom line is this: safety-net ACOs, like all ACOs, certainly hold promise. The question is whether we will translate this promise into systems-level change.

Live Blogging: Post-Trial Responsibilities Conference, Session 2

By Zachary Shapiro

Hello from the Post-Trial Responsibilities conference! I will be live blogging session 2: where speakers will be providing important perspectives on PTA. Barbra Bierer is monitoring the discussion.

We started with Richard Klein calling in from FDA:

Richard is talking about post-trial responsibilities. He points out that there is a justice issue here with ensuring access to health care and up to date interventions. He points out that while the FDA can encourage Post-Trial Access (PTA), it has no authority to require or ensure it. He points to moral authority, rather than legal. Foreign trials, however, are a different story, as the FDA has sway over protocol applications that are submitted in the US. Richard begins highlighting some specific considerations for protocol drafters and IRBs: particularly focusing on determining monitoring plans, as well as figuring out financial responsibilities for the provision of PTA.

He moves on to highlight that there is more of a moral obligation than a legal obligation. FDA is supportive of the provision of PTA. He believes that enthusiasm must be tempered, as there are situations when PTA is not appropriate. These include studies that have significant safety concerns, studies of bio-markers as well as validation studies that do not specifically examine safety and effectiveness. There are also situations where PTA is simply not feasible, particularly if additional drugs do not exist (one thinks of the recent Ebola treatment), if there is insufficient safety data, or if there is no practical capacity or resources to provide safety monitoring. We must also be aware of financial limitations, especially for start-up biotech firms that might not have deep pockets. Continue reading