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.

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Defining Public Health Emergencies

[Cross-posted from HealthLawProf Blog.]

What makes a public health threat an emergency? In this week’s New England Journal of Medicine, Rebecca Haffajee, Michelle M. Mello and I ask this question in connection with Massachusetts Governor Deval Patrick’s decision last spring to declare the opioid-addiction epidemic a “public health emergency.”  In our Perspective we do not question the seriousness of the opioid-addiction problem; or the specific policies Patrick implemented. Rather, we ask whether the epidemic warranted the invocation of emergency powers.

In the years since 9/11, in the name of public health legal preparedness, public health officials and scholars have focused much attention on the need for so-called emergency laws to strengthen the response to a public health emergency. Although the exact parameters of emergency laws vary, they typically allow for the suspension of some or most ordinary legal procedures and protections. Thus when an emergency is declared, the rules of the legal system are suspended. Executives can take action without awaiting legislative approval, or following the typical administrative process. Judicial review may also be significantly curtailed. As my co-authors and I discuss, this has enormous costs, not only on the individuals and entities whose interests are affected, but on the credibility of public health officials who must ultimately depend on the public’s trust. If the public comes to believe that declarations are issued too easily, its support for public health may diminish. In addition, in the absence of legislative and judicial checks, executive powers may easily be turned against vulnerable populations, as they have been too often in history.

Yes precisely because emergency laws are designed to give officials flexibility to respond to unexpected crises, for which existing policies are insufficient, public health emergency laws grant officials extremely broad, usually unreviewable, discretion to decide what constitutes a “public health emergency.” For example, the Massachusetts law that Governor Patrick invoked provides no definition of a public health emergency whatsoever, leaving its determination solely to the Governor’s judgment. Likewise no definition appears in the 2005 federal Public Readiness and Emergency Preparedness Act (PREPA), which preempts most state tort claims against and a vaccines and countermeasures once the Secretary of Health and Human Services declares an emergency.  Continue reading

What Is (or Isn’t) a Public Health “Emergency”?

In this week’s issue of New England Journal of Medicine, Michelle Mello, Wendy Parmet, and I write about what constitutes — or should constitute — a “public health emergency”. The law provides for emergency declarations, which suspend ordinary legal standards and processes in order to avoid catastrophe, on many levels (international, federal, state, local) and in public health or more general contexts. We focus our discussion at the state level, using Governor Deval Patrick’s declaration of the opioid-addiction crisis as a public health emergency as an opportunity to explore the appropriate parameters of these powers. My co-authors and I don’t debate the public health significance of opioid addiction in the Commonwealth, nor the specific measures ordered pursuant to this declaration. We do question the expanding use of public health emergency powers beyond the traditional arenas of infectious disease outbreaks, natural disasters, and acts of bioterrorism into new territories, such as injuries and chronic disease.

State laws provide governors and their top health officers with considerable latitude in declaring public health emergencies. But the powers available upon such declarations are extraordinary and should be wielded with care. My co-authors and I identify three key criteria that seem to be enshrined in the spirit of public health emergency laws: “the situation is exigent, the anticipated or potential harm is calamitous, and the harm cannot be avoided through ordinary procedures.” In the absence of these criteria, the invocation of such emergencies may raise heightened concerns — for instance, if ensuing orders involve serious infringements on individual and private business rights — and could result in a loss of public trust in health officials and legitimacy in public health laws. We caution against setting such troubling precedent.

Read more in our Perspective, entitled “What Is a Public Health “Emergency”?“.

What’s to become of population health?

When the accountable care organization (ACO) model was initially conceptualized, many in the health policy world hoped it could provide a platform for real transformation of US health care.

Among the ACO model’s most promising innovations was its explicit orientation towards achieving “the Triple Aim.” First articulated by Don Berwick and the Institute for Healthcare Improvement (IHI), the Triple Aim is a strategy for optimizing the health care delivery system and achieving the best of all worlds. It outlines three goals: high quality health care, lower costs, and population health. The Center for Medicare and Medicaid Services adopted this goal and still describes a version of the Triple Aim on its webpage titled “Innovation.”

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Asking the Right Right Question About Football – Why do Some NFL Players Abuse Their Partners?

The national press is buzzing after TMZ released a video of Baltimore Ravens running back Ray Rice’s barbaric assault of his then-fiancee, Janay Rice.  Much of the spotlight of the coverage shined on the NFL’s handling of the abuse, and perhaps even more time was spent yesterday questioning Ms. Rice’s decision to stay in her relationship with her husband.  These are certainly valid questions to ask, and there is something to be said about the raised “awareness” of domestic violence in the aftermath of its players deplorable acts of violence.  I would argue the discussion has been more valuable than any awareness raised by NFL teams wearing pink during breast cancer awareness month.

If we want to best-capitalize on the awareness raised by these acts of violence, however, the conversation needs to shift from harm reduction (“why did she stay?”) to harm prevention.  To illustrate: when faced with the prevalence of lung cancer, do we ask “Why does the cancer patient continue to smoke?”  Yes, to some extent, we do, but we first addressed the causal inquiry, “What causes cancer?”, and in order to prevent the next generation from becoming addicted to nicotine, millions have been invested and continue to be invested in educating the public (and particularly youth) about the harms of tobacco use, and legislative action has been taken to prevent the harms caused by tobacco use.

Domestic violence (or intimate partner violence), like lung cancer, is a public health issue.  This is not a novel or controversial statement.  According to a 2010 CDC report, one in four women and one in seven men have experienced severe physical violence by an intimate partner, and according to a 2003 report, the national costs of health services for intimate partner rape, physical assault, and stalking is nearly $4.1 billion.  The CDC’s website states:  “The goal is to stop IPV [intimate partner violence] before it begins. There is a lot to learn about how to prevent IPV.”

It is time that the health care community take the CDC’s statement seriously and work collaboratively across law, public health, and medicine to research, propose, and implement innovative solutions to this perpetual epidemic, that costs thousands of lives in the United States each year.  Unlike some other organizations aimed at addressing public health issues, organizations whose goal is to prevent domestic violence are often grossly under-funded.  Perhaps the most apropos inquiry or statement to put to the NFL, the NFL Player’s Union, or other public health institutions that agree that domestic violence prevention is important is one capture by a classic football film: “SHOW ME THE MONEY.”

[Ed. Note: This post reflects the author's views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

To Watch: Rural Enrollment on Exchanges

As we gear up for a second year of exchange marketplace enrollment, one issue to keep an eye on is the success we have at getting people who live in rural areas onto the healthcare rolls.  As pointed out in today’s Kaiser Health News write-up (here), there is potential for the ACA to increase rural health disparities, even while it gets more people insured, because many of the efforts to encourage enrollment–think navigators, enrollment centers, advertising, and outreach–just work better in urban areas.  For some reading on this issue, see the Kaiser Family Foundation’s posting here, the HHS’s Health Resources and Services Administration’s report here, and the Rural Health Foundation’s roundup here.

Ebola and the Return of Quarantine

[Ed. Note: Cross-posted from HealthLawProf Blog.]

Last month’s riots in an Ebola-infected slum in Monrovia, Liberia demonstrated anew the perils of relying on quarantine, and similar highly coercive public health laws, to contain highly contagious diseases.

At first blush, Ebola viral disease (EVD) is exactly the type of disease for which broad quarantines (more precisely, sanitary cordons) would seem appropriate. Transmitted through direct contact with the bodily fluids of an infected person, EVD can spread rapidly through a community, as it has done in several West African nations. Although experimental treatments and vaccines offer promise for the future, they have not yet been shown to be effective in humans; nor are they readily available. As a result, health officials are forced to rely on tried and true public health strategies, such as identifying cases, isolating and treating them with strict infection control measures, and monitoring their contacts. Needless to say, doing so is very challenging and very expensive, especially in highly urbanized areas, with weak health systems.

Given the challenges, health officials and government leaders are often tempted to call in the troops, and rely on more heavy-handed measures, such as imposing sanitary cordons around whole towns or neighborhoods, quarantining those who have had contact with patients, and restricting travel into and out of affected regions. Although the impetus for these measures is understandable given the magnitude of the EVD threat, history suggests that such highly coercive tactics frequently backfire. Like the military-style show of force employed by the police department in Ferguson, Missouri earlier this summer, highly coercive public health measures can undermine the public’s trust in authorities. Thus, rather than reduce travel, identify contacts, and come forward if they show symptoms, individuals are more apt to try to leave affected areas and avoid the health care system. Or they riot, as they did in Monrovia and China during the SARS outbreak. In any case, the problem is made worse not better. Continue reading

The Expressive Dimension of Donor Deferral

By Dov Fox

The Guardian and L.A. Times are the latest major news organizations to decry trans-Atlantic restrictions on blood donation by men who have sex with men (MSM). The case against such categorical bans has been reignited by an influential piece that Bill of Health editor Glenn Cohen recently published with co-authors Jeremy Feigenbaum and Eli Adashi in the Journal of the American Medical Association. Cohen, Feigenbaum, and Adashi make a powerful case why sexual orientation should be just one component among others used to assess the risk that blood donors might spread HIV.[i]

But their argument elides exactly what is—and isn’t—wrong with excluding men who have sex with men from donating blood. At times they suggest the longstanding U.S. ban reflects “outdated homophobic perceptions.” Yet they acknowledge that it was “well-intentioned and guided by a need to protect the integrity of the national blood supply.” Indeed, the Food and Drug Administration that enacted the lifetime MSM ban solicited guidance from the National Gay Task Force whose recommendations were adopted into Red Cross blood collection procedures.[ii] It’s unlikely the policy was motivated by animus as opposed to concern for public health.

Elsewhere, the authors imply the policy’s chief offense is that it deprives MSM of a crucial “civic opportunity.” But giving blood, even if it shares the life-saving potential of military service and registration as an organ donor, is not typically regarded as a duty of citizenship tantamount to voting or jury service.[iii] So it’s not its effects on those it excludes that makes the donor ban so bad.

The best reason to let low-risk gay men give blood lies in the demeaning message that excluding them expresses, what I’ve called the expressive dimension of donor deferralContinue reading

Parental Consent for Youth Contact Sports Participation

As we enter into the fall sports season, it’s unlikely that a week will go by where we don’t hear the current buzzword in sports community: concussion. Whether in reference to an acute player injury, an untimely death, new or ongoing litigation, or rule changes in sport, the athletic community and the public are increasingly aware of the impacts of these brain injuries. Although much of the media attention is directed toward college and professional athletes, youth and high school athletes significantly outnumber their older counterparts and it is thought that they take longer to recover from these injuries.

A recent publication by Mannings and colleagues surveyed 369 parents of 5-15 year old full-contact football players in order to assess the parents’ understanding of concussion (1). Although the study does have limitations, its finding could have important implications. The parents surveyed were often missing critical information about concussions. For example, less than half of parents correctly identified that concussion is a mild traumatic brain injury. Additionally, none of the parents surveyed correctly identified all of the symptoms of concussion queried in the study. Although it is mandated by statute in the majority of states (2) that parents and/or athletes are provided with information about concussions prior to sports participation, the extent to which the information provided (normally in the form of an information sheet) is read, understood, or retained is not well understood.

Sports participation is associated with a myriad of positive physical, psychological, and social outcomes. However, it also comes with the risk of injury, including concussion. For youth and adolescents, parents play a critical role. Most often, children and adolescents rely on parental consent to participate in sports. Given parents’ role as decision-makers, and the finding of Mannings and colleagues, an important ethical issue that needs to be addressed is what level of knowledge should be required for parents to provide informed consent for their child to participate in inherently risky activities such as contact sports?

[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.]

Art Caplan: Is It Fair That Americans Received the Ebola Treatment?

Art Caplan has a new video on Medscape laying out the principles behind rationing limited supplies of experimental ebola treatments. As he explains:

I believe the answer to the question of who should receive the drug is: people we can both learn from and potentially help the most. I believe those are the 2 values we use when trying to ration access to an experimental drug. If we do not learn whether something is safe and effective, then we have missed an opportunity, even in the middle of an epidemic, to find out whether it is worth giving out drugs that are new, untested, and unapproved. People who should be included are those who can be observed and kept under surveillance — not for a day or a week but probably for months and years. That favors people who are not in rural villages. That favors people who will have access to hospital facilities. Those criteria will drive the selection of who receives a new, unapproved drug.

Click here to see the video and read more.

DARPA Announces Disease Forecasting Prize

On Friday, the Defense Advanced Research Projects Agency (DARPA) announced a challenge to the public: provide the most accurate forecast of the spread of chikungunya virus in each of the countries in the Pan American Health Organization, win $150,000. Innovation prizes like DARPA’s are increasing in popularity, with public and private entities alike issuing challenges across a variety of subjects and methodologies. DARPA isn’t the first to announce a disease forecasting prize, either – the Centers for Disease Control (CDC) recently awarded a prize for predicting the timing and intensity of last winter’s flu season. But the choices both to focus on chikungunya and to do so using a prize fund are interesting ones that deserve further discussion.

Chikungunya is a viral disease spread by infected mosquitoes, much like the better-known malaria and dengue fever. Its symptoms often resemble those of dengue, whose other common name – breakbone fever – is telling. Chikungunya is rarely fatal, but it is often temporarily disabling, until the disease has run its course. And unfortunately, also like dengue, there is no specific treatment for chikungunya, although recent Phase I trials of a candidate vaccine appear to have been successful. But perhaps most importantly for DARPA’s purposes, chikungunya is also experiencing a resurgence in the Americas, including in the United States.

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Art Caplan: WHO Ethics Committee on Ebola Just a Start

Art Caplan has a series of new opinion pieces out on the WHO ethics advisory committee meeting that approved the use of experimental drugs to treat patients ill with Ebola.

He suggests deeper exploration of issues of informed consent, corporate responsibility, and resource allocation in this blog post for The Health Care Blog. As he writes in his piece in NBC News Health:

It is important that the WHO committee affirmed the morality of compassionate use. This addresses the concern that any use of unapproved drugs is inherently exploitative. But there are huge ethical issues that still remain unaddressed and unanswered regarding experimental interventions.

In the wake of the Canadian government’s offering 1,000 doses of an experimental Ebola vaccine to the stricken nations, he also extends the argument from allocation of treatment to allocation of prophylaxis in this opinion piece in NBC News Health:

It is ethically appropriate in the midst of a deadly contagious epidemic to try both untested treatments and experimental preventative vaccines that have shown some promise in animals and no safety issues. But with only 1,000 doses of vaccine available, who should get them? And what do they need to be told?

The most ethical way to distribute limited experimental vaccine, is, as the WHO ethics group noted, with an eye toward collecting information on safety and efficacy. Rather than just handing out vaccine to a small group of people in countries that have seen Ebola outbreaks, it is important to learn as much as possible about whether the vaccine has any efficacy in humans and is safe.

You can read more at the links above.

Art Caplan: Ebola Treatment Distribution is Troubling

Amidst news from Spain that a 75-year-old Catholic priest has received the experimental treatment ZMapp for Ebola, Art Caplan critiques what he describes as the “bad science” behind choosing its recipients:

ZMapp is not the answer to the Ebola epidemic ravaging West Africa. There is no chance of getting a significant amount of this drug made for many months. Deploying more health care workers, face guards, moon suits, gloves and antiseptic, along with restrictions on travel and burying the dead, is the only way to get the epidemic under control. [...]

The fact that a 75-year-old has been given the scarce drug is especially disturbing, not because he is 75 but because 75-year-olds do not have strong immune systems — something very important in battling a virus like Ebola. Moreover 75-year-olds often have other medical problems that complicate the ability of scientists to figure out if the drug is safe and if it is really working.

In testing unapproved, highly risky drugs like ZMapp, it is crucial that recipients not be so sick that they may well die regardless of whether they get the drug or not. Indeed, the recipients ought not be very sick so that side-effects can be seen and efficacy determined. To do that, doctors need to be able to monitor experimental subjects for months to make sure the drug does not damage their livers or cause any other fatal side-effect. So not every person infected with Ebola makes for the best recipient — younger, those more recently infected and those who can be closely monitored are among the “best” candidates.

You can read more of Art Caplan’s perspective on NBC News Health here.

Ebola, Ethics, and the WHO Getting to Yes

Earlier this week, the World Health Organization, responding both to the international outcry over the rapidly rising number of Ebola cases and deaths across sub-Saharan Africa (and critiques of the speed of their action), and the news that western health care workers and ministry had found ways to get access to the untested-in-humans Ebola drug ZMapp, convened a panel of ethicists to offer recommendations on more widespread use of experimental Ebola treatments.

The issues considered by the ethicists included:

1) Whether it is ethical to use unregistered interventions with unknown adverse effects for possible treatment or prophylaxis. If it is, what criteria and conditions need to be satisfied before they can be used?

2) If it is ethical to use these unregistered interventions in the circumstances mentioned above, then what criteria should guide the choice of the intervention and who should receive priority for treatment or prevention?

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Art Caplan: Why do two white Americans get the Ebola serum while hundreds of Africans die?

As the WHO announced today that medical ethicists will convene next week in New York to discuss the use of experimental medicines in the West African Ebola outbreak, Art Caplan has a timely new opinion piece in the Washington Post asking why only white American victims of the Ebola outbreak have been treated with an experimental serum. Caplan argues that the decision was a question of economics:

The reasons for different treatment are partly about logistics, partly about economics and, partly about a lack of any standard policy for giving out untested drugs in emergencies. Before this outbreak, ZMapp had only been tested on monkeys. Mapp, the tiny, San Diego based pharmaceutical company that makes the drug stated two years ago: “When administered one hour after infection [with Ebola], all animals survived…Two-thirds of the animals were protected even when the treatment, known as Zmapp, was administered 48 hours after infection.”

But privileged humans were always going to be the first ones to try it. ZMapp requires a lot of refrigeration and careful handling, plus close monitoring by experienced doctors and scientists—better to try it at a big urban hospital than in rural West Africa, where no such infrastructure exists. [...]

But it’s about more than logistics. Drugs based on monoclonal antibodies usually cost a lot—at least tens of thousands of dollars. This is obviously far more than poor people in poor nations can afford to pay; and a tiny company won’t enthusiastically give away its small supply of drug for free. It is likely that if they were going to donate drugs, it would be to people who would command a lot of press attention and, thus, investors and government money for further research—which is to say, not to poor Liberians, Nigerians or Guineans. [...]

To get Caplan’s full perspective, read the full article.

The Revival of Phage Therapy to Fight Antimicrobial Resistance (AMR) – Part III: What about patent protection and alternative incentives?

In Part II of this blog on legal issues relating to the revival of phage therapy I discussed the US Supreme Court’s decisions in Myriad and Prometheus, which might present major obstacles to the patentability of phage-related technology (a more detailed analysis of the Myriad and Prometheus decisions is available here).

Yet, all is not lost. As indicated in Part II, Myriad does not directly affect the patentability of synthetically modified biological compounds and Prometheus would still allow patents on inventive applications of natural processes and correlations that add new features to “natural laws”. Thus there still seems to be considerable leeway for patenting within the area of page therapy.

One example, mentioned in a recent Nature article, could be the skillful selection and precise combination of different phages in order to attack one specific type of bacteria. Such selections, however, would face a tough battle to overcome the “additional features that add significantly more” and “not identical” thresholds set by Prometheus and Myriad. Another example with even better prospects for patentability relates to genetically modified phages that are – due to human intervention – enabled to target only specific bacteria. This technology was recently presented by MIT researchers at the 2014 American Society for Microbiology Meeting. The researchers led by Timothy Lu had genetically engineered phages that use a DNA-editing system called CRISPR to target and kill only antibiotic-resistant bacteria while leaving other susceptible cells untouched. The significant engineering and alteration of natural products and processes involved in such inventions would most likely meet both the Myriad and Prometheus standards.

Yet, while the USPTO has recently issued new patent eligibility guidance and the CAFC has begun to directly apply Prometheus and Myriad to reject patent claims in biotech cases (e.g. In re Roslin), many questions remain unsolved. In particular, it is still not sufficiently clear exactly how much modification is required to render a molecule or method sufficiently distinct from naturally occurring product and processes. And even if the patent-eligibility threshold could be met in extraordinarily circumstances, the claimed invention would still have to fulfil other patentability requirements such as novelty, non-obviousness and the written description-requirements. The threshold for these requirements, however, have been heightened in recent years (see e.g. KSR v. Teleflex (2007) , Nautilus (2014) etc.). Considering that phage therapy is almost a century old with a substantial common general knowledge and a state of the art employing routine methods, these crucial requirements might still prevent the patentability of many useful applications.

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The Revival of Phage Therapy to Fight Antimicrobial Resistance – Part II: What about patent protection and alternative incentives?

Three days ago I commented on a couple of legal issues raised in the recent Nature report “Phage therapy gets revitalized”  by Sara Reardon. One challenge concerns the reluctance of pharma companies to broadly invest in the development of phage therapies. As pointed out in the report, this does of course very much (but not only) relate to the question of patentability. Various aspects might present obstacles to the patentability of technology relating to phage therapy. To not complicate the discussion and considering recent developments I decided to focus on some of aspects under US patent law.

Like in Europe, the first door to patentability that phage-related technology would need to pass concerns patent eligibility. In the last years the US Supreme Court has rendered an astonishing number of fundamental patent-decisions, including not less than four (!) landmark judgments on patent eligibility, i.e. Bilski v. Kappos (2010), Mayo v. Prometheus (2012) , AMP v. Myriad (2013)  and Alice v. CLS (2014). Most relevant in this context are the decisions in Prometheus and Myriad.

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Art Caplan: The Real Reasons for Worrying About Ebola

Art Caplan has a new opinion piece on NBC News responding to the recent media coverage of Ebola. He makes the case that although this has been the worst recorded outbreak of the disease, citizens of developed countries have little reason to panic:

Ebola is not going to run amok in downtown Boston, Cape May or Myrtle Beach or anywhere else in the U.S. It is running amok in poor African nations because local authorities did not have the will or the resources to respond quickly, because no one confronted local funeral customs that expose people to Ebola, mainly because the world did not care much if hundreds died in poor, politically insignificant nations.

The harsh ethical truth is the Ebola epidemic happened because few people in the wealthy nations of the world cared enough to do anything about it.

Read the full article.

The Fight Against Antimicrobial Resistance: Important recent publications

One of my previous blogs discussed the growing threat of antimicrobial resistance (AMR). I concluded that antimicrobial resistance is a growing and complex threat involving multifaceted legal, socio-economic and scientific aspects. This requires sustained and coordinated action on both global and local levels.

A recent medical review on drug resistant tuberculosis supports these findings and provides further fodder to the debate. In their study, which was published in April 2014 in The Lancet – Respiratory Medicine, the authors analyzed the epidemiology, pathogenesis, diagnosis, management, implications for health-care workers, and ethical and medico-legal aspects of extensively drug-resistant tuberculosis and other resistant strains. In particular, the authors discussed the increasing threat of functionally untreatable tuberculosis, and the problems that it creates for public health and clinical practice. The paper concludes that the growth of highly resistant strains of tuberculosis make the development of new drugs and rapid diagnostics for tuberculosis—and increased funding to strengthen global control efforts, research, and advocacy—even more pressing.

This was also recognized in the recent WHO’s Global Surveillance Report on AMR, which was published this April. It is the first WHO report that studied the problem of AMR on a global level. Noting that resistance is occurring across many different infectious agents, the report concentrates on antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results demonstrate a wide-spread growth of resistance to antibiotics, especially “last resort” antibiotics. In particular the report reveals that this serious threat is no longer a mere forecast for the future. AMR is a contemporary problem in every region of the world and has the potential to affect anyone, of any age, in any country. Consequently the WHO report concludes that antibiotic resistance is now a major threat to public health that needs to be tackled on a global level.

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