How does the FDA regulate mobile medical apps?

healthkit

Last month, the FDA released new guidance regarding the regulation of mobile medical apps, to replace its earlier version from 2011. Since that time, the amount of health and medical apps on the market has exploded, with the release of Apple’s Health app with iOS 8 cementing mobile health as ‘a thing’. Needless to say, it is about time for a regulatory update.

The FDA defines a ‘mobile medical app’ as a mobile app that is intended to either (1):

–       Be used as an accessory to a regulated medical device; or

–       Transform a mobile platform into a regulated medical device.

What is a regulated medical device? The FDA guidance states that (1):

When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.

Leaving the sexist nature of this terminology aside, we can see that the FDA takes a very clinical perspective on what types of apps they consider as falling in their domain. This approach is practical. It means that they a priori alleviate themselves of responsibility for the numerous health apps continually being produced, which allows them to focus on those apps posing the greatest risks to users. An app which intends ‘to affect the structure or any function of the body of man’ is potentially much more impactful than a simple diet tracking app. Or is it? And is it debatable whether diet and fitness apps intend to alter the structure or function of man?

Apps, which the FDA will not regulate, but will ‘exercise enforcement discretion’ over, are those that help users to self-manage their disease or conditions without providing specific treatment or treatment suggestions, help users track or manage their health (e.g. trackers for diet, exercise, sleep, mood), apps that provide access to electronic health records, apps that help patients communicate with doctors (e.g. by providing videoconference portals or allowing patients to take snapshots of their symptoms), or those that perform calculation for things like body mass index or pregnancy due date (1).

Apps that are regulated are those that, for example, turn the mobile into a control for a medical device such as a blood pressure cuff or insulin pump, or transform the mobile into a medical device such as an electronic stethoscope or a blood glucose reader (1). The rationale for regulation of these latter uses is that these types devices are already FDA-regulated, and would pose a risk to patients if improperly functioning (1).

Does this mean there is no risk associated with the ‘softer’ uses of medical apps, which are not regulated? Of course not. The risk is lower, perhaps, but apps may contain false or misleading health and medical information, which could be improperly used if taken uncritically. The growing knowledge economy of our society means that education and literacy are far more important than ever before, and this is true down to such a small issue as using health apps on a mobile phone to gain a real personal benefit.

Recently, we have seen the FTC fine the makers of apps that purported to aid in detecting malignant melanoma, which would qualify as being a medical device (2). It will be interesting to see how the regulatory landscape evolves in the future, which will depend on whether there is real transformative power of these non-medical device health apps to influence people’s behaviour and health decisions.

 

References

1. U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Mobile medical applications: Guidance for Industry and Food and Drug Administration Staff. U.S. Department of Health and Human Services Food and Drug Administration. 2015.

2. Dredge S. FTC fines app firms for claiming their technology could detect melanoma. The Guardian. Wednesday Feb 25 2015. http://www.theguardian.com/technology/2015/feb/25/ftc-fines-apps-detect-melanoma (accessed 02 March 2015).

Category: Uncategorized | 2 Comments

The dangers of doing nothing: What pregnant women need to know about clinical trials

KaitlinB9_9.jpgPlease welcome a guest post by Kaitlin Bell Barnett, who writes about health and medicine for various print and online outlets. She’s at work on a book about medications and medical care in pregnancy. Her first child is due in July.

 

pregnant-woman-researcher.jpg

Photo Credit: edoctorvn

New FDA guidelines say that clinical trial participants should know not just the risks and benefits of the study they’re enrolling in, but how those risks and benefits compare to the typical care they’d get at the doctor’s office. These recommendations, which are expected to be finalized later this year, seem reasonable enough at first glance. But, they’re likely to further hamper research in a population that’s already badly underrepresented in clinical studies: pregnant women.

Researchers already avoid conducting studies on pregnant women because of concerns about risks to the fetus. In clinical practice, this lack of research often translates into women foregoing care, since doctors know very little about how certain drugs could affect the developing fetus. Better safe than sorry, they reason.

Pregnant women’s lack of inclusion in formal studies doesn’t mean they’re not being experimented on. They are – just not in a systematic way that would help clarify how helpful or harmful medications and other interventions actually are. The average expectant woman takes three to five prescription drugs during her pregnancy, not to mention many over-the-counter herbs and supplements.

“It’s really problematic that we don’t know even the basic pharmacokinetics of how certain medications work in pregnant women,” says Miriam Kuppermann, head of the clinical research program for the University of California, San Francisco’s maternal-fetal medicine program. “There’s good reason to believe that those will be different in pregnant women because of all the pregnancy hormones.”

When it comes to disclosing the risks and benefits of the typical “standard of care”, as the proposed FDA guidelines recommend, researchers face a catch-22: How can they inform pregnant participants – or participants who may become pregnant during the course of the trial – about risks and benefits that simply aren’t known?

The key lies in how they communicate risks, and how they present the “standard of care” for pregnant women.

Pregnancy and Depression

Take the case of depression, which affects 12 to 15 percent of pregnant women.

Some recent studies suggest that SSRI antidepressants may increase the risk of first-trimester miscarriage, preterm birth, minor complications after birth, and that one drug, Paxil, increases the risk of cardiac defects. Other studies, though, have found no increased risk. And a substantial body of evidence shows that mothers who are depressed while pregnant have a higher risk of preterm labor, low birthweight babies and other pregnancy complications that can hurt the baby, especially if the mothers are too depressed to eat properly, exercise, go to prenatal checkups, and otherwise adequately care for themselves.

Clearly, more research is needed on the most effective ways to treat prenatal depression. Informed consent materials and procedures for a study of a drug or therapy should explain the reasonably foreseeable risks and benefits of that intervention – both to mother and fetus – based on any previous data.

Because there is no single, accepted standard of care for prenatal depression, informing women about their alternatives if they were to seek treatment at the doctors should cover all the major options: the effectiveness and risks of antidepressants, different modes of therapy – and of untreated prenatal depression.

Too Much Information

It’s easy to see how all this talk of risks and benefits, most of them still ill-defined, could overwhelm prospective subjects.

“If you don’t know the risks and benefits, then telling pregnant women that they need to weigh them is just a way of making them feel stressed out,” says Georgetown bioethicist Rebecca Kukla, who has sat on IRBs, the governing bodies for universities and hospitals that handle informed consent procedures. “It’s literally an impossible burden to follow.”

Doctors, researchers and bioethicists have already voiced concerns that the requirements to disclose yet more risks will trip up research, not just involving pregnant subjects (a public comment period on the guidelines ended last month).That situation is likely to be even worse when it comes to pregnant women, since the quality of data for commonly-used medications that constitute the standard of care are is of such poor quality, and because the risks and benefits for both the mother and fetus must be weighed.

“If it were to have a general chilling effect I could definitely imagine that it would it would have an even greater chilling effect on pregnancy, because everything does,” says Margaret Little, who runs Georgetown’s Kennedy Institute of Ethics and has written extensively about pregnant women’s participation in clinical research. “There’s such an aversion to doing [this research] anyway that it adds one more stone to the big pile of rocks that are keeping people from doing this.”

Indeed, research shows more information is not always more helpful when it comes to informed consent, says Kuppermann, who studies methods of presenting risks and benefits to trial participants. Sometimes, simpler is better.

The number needed to treat and number needed to harm

To avoid drowning subjects in a sea of statistics, researchers should more widely employ two easy-to-understand measures of risk and benefit: the Number Needed to Treat (NNT) and the Number Needed to Harm (NNH). The NNT captures how many people would have to take a drug or receive the treatment in order for at least one person to benefit. Its twin, the NNH, calculates how many people must be treated in order for one additional person to be harmed

One study showed, for example, one additional miscarriage for every 26 women treated with antidepressants (the NNH), while another review of multiple studies showed 1 additional person saw improvement in depression symptoms for every 5 people receiving antidepressants, compared to one person in seven for placebo. By providing both statistics, researchers can more clearly communicate how the benefits of treatment stack up against the risks.

Including the NNT and NNH stats along with succinct summaries of research findings regarding the effects on both mother and fetus would help pregnant women evaluate the risks and benefits of enrolling in the trial – and of the treatments they would likely receive (or not receive) in ordinary medical care.

Then and only then can pregnant women truly know what they’re getting themselves into – whether they choose to enroll in the study or go to the doctor.

 

Category: Uncategorized | Tagged , , , , | Leave a comment

Will Google’s new health search function change the way we manage health?

 

Google

Google says that one in twenty searches is for health information (1). For many people, the Internet has become the first port of call when a strange symptom, the common cold, or morbid curiosity in the ‘Google Images’ bar strikes. However, the ‘armchair medicine’ often doled out by the Internet, along with the unscientific popular health discourse introduced by the likes of Dr Oz, has made for murky waters of health information seeking (2).

How are we to find relevant, high-quality, and evidence-based health advice when the trillions of gigabytes of Internet space are loaded with misinformation?

Enter the brilliance of Google’s search algorithm. Google has just announced that they will now be adding health information directly into search results. It will be included in the Knowledge Graph – the little box that often appears in the upper right-hand corner, showing basic statistics and information about a subject. The health information will be sourced from a database fact-checked by physicians at the Mayo Clinic, adding credibility, quality, and a sound evidence base (1). That is, if it done properly, although there is no reason why it should not be.

This new search addition could be revolutionary, in terms of providing accurate health information to people who need it. In 2008, the U.S. Health Information and National Trends Survey (HINTS) found that while over half of the adult American population turns to the Internet first when searching for health information, trust in the Internet as a reliable source of information was low and had declined over the first decade of this century (3). People often leave Internet health searches feeling frustrated, confused, and likely no closer to the answers they are seeking (4). Given the major shift we are experiencing in online communication technologies and health information technologies – we may not be far off from being able to access our own electronic health records – information must be available in an appropriate and equitable way so that all people can use the power of technology to better learn about and manage their health.

Last year, the Pew Research Center found that 87% of all Americans now use the Internet (5). Ninety percent of them say that the Internet has been a good thing for them personally, and three-quarters say that the Internet has been a good thing for society (5). It seems as though Google’s new health search addition will contribute to this positive attitude – and to the ubiquity of this company in the digital information industry. The transformative power of Internet searching on people’s behaviour and health management is yet to be determined.

References

  1. Ramaswami P. A remedy for your health-related questions: health info in the Knowledge Graph.Weblog. http://googleblog.blogspot.co.uk/2015/02/health-info-knowledge-graph.html (accessed 18 Feb 2015).
  2. Korownyk C, Kolber MR, McCormack J, Lam V, Overbo K, Cotton C, et al. Televised medical talk shows – what they recommend and the evidence to support their recommendations: a prospective observational study. BMJ 2014;349:g7346.
  3. Health Information National Trends Survey. Brief 16: Trends in cancer information seeking. http://hints.cancer.gov/brief_16.aspx (accessed 18 Feb 2015).
  4. Arora NK, Hesse BW, Rimer BK, Viswanath K, Clayman ML, Croyle RT. Frustrated and confused: the American public rates its cancer-related information-seeking experiences. J Gen Intern Med 2007;23(3):223-8.
  5. Fox S, Rainie L. The Web at 25 in the U.S. http://www.pewinternet.org/2014/02/27/the-web-at-25-in-the-u-s/ (accessed 18 Feb 2015).

Image: “Google” by Google Inc. Public domain.

Category: Industry, Social Media | Tagged , , , , | 3 Comments

Let’s stop playing politics with vaccines

Sriram Ramgopal (guest poster)Please welcome a guest post from Sriram Ramgopal, a resident physician in the Department of Pediatrics, Children’s Hospital of Pittsburgh. He is interested in pediatric advocacy and is pursuing a career in Pediatric Emergency Medicine. 

Politically motivated fearmongering about vaccination is putting children in our community in danger. During the Republican presidential primaries leading up to the 2012 election, former representative Michelle Bachmann criticized Governor Rick Perry’s mandate for the HPV vaccine, which protects against a cancer-causing virus. She claimed at the time that she had met parents who believed that the vaccine gave their daughters “mental retardation.” These statements introduced a new precedent of injecting issues of vaccine safety into presidential politics. The American Academy of Pediatrics made emphatic statements at the time to clarify that the HPV vaccine does not cause mental retardation, but by this point the damage had been done: fear had taken hold in parents’ minds.

In 2015, with the presidential election around the corner and a widespread measles outbreak on our minds, the dangerous mix of immunization paranoia and politics continues. Senator Rand Paul, physician and presidential hopeful, claims to have met “many tragic cases of walking, talking normal children who wound up with profound mental disorders after vaccines,” a statement that is dubious at best. His words are grounded in a fraudulent study that has long since been retracted and its author now discredited. Governor Chris Christie has also entered into the debate by stating, “parents need to have some measure of choice in things as well, so that’s the balance that the government has to decide.” By employing the rhetoric of individual rights and a fear of big government, those in public office often attempt to score cheap political points and win public acceptance. Politicians like Senator Paul and Governor Christie are brandishing discredited ideas as tenable arguments against clear evidence-based recommendations to vaccinate, sowing confusion amongst parents.

According to the World Health Organization, measles is a leading cause of death worldwide, despite the universal availability of a widely researched and safe vaccine against it. The disease killed over 145,000 individuals, most of them children under 5 years of age, in 2013. Immunization against diseases like measles not only protects those that receive the vaccines but also helps to protect those who are not eligible to receive them, such as young infants and children with deficient immune systems. It is these children who are also at the highest risk of grave complications ranging from encephalitis to pneumonia, and depend on the rest of us to protect them.

It is no secret that vaccination rates across the country are falling. Based on CDC data, the nationwide measles, mumps and rubella vaccination rate among 19-35 month-olds is 91.9%, down from a rate of 92.3% in 2006. Rates are falling most in Ohio, Missouri, West Virginia, Connecticut and Virginia. It is very possible that more and more parents will choose to opt out of immunizing their children for fear of side effects, thanks to the dissemination of groundless claims. In response to the current epidemic, the American Academy of Pediatrics has released a recent statement once again exhorting parents to vaccinate their children, reiterating what they have said for decades: the measles vaccine is safe and effective.

We are already burdened with a wide number of celebrities, discredited researchers, and physicians relying on anecdotes and hearsay who are more than willing to use the vaccine controversy to gain quick publicity. Politicians should be clear to the public on the proven science of vaccines and should avoid muddying the waters further. It would be better for the candidates, too: it is widely believed that Michelle Bachman lost credibility because of her statements on vaccines in 2008. Senator Paul and Governor Christie should learn a lesson from her failure and be willing to communicate a clear message to the public: vaccines are safe and are effective at protecting against dangerous diseases. Unnecessary vaccine exemptions put our greatest asset – our children – at risk.

The views expressed in this article are those of the author and do not necessarily represent the views of, and should not be attributed to, the Children’s Hospital of Pittsburgh or the University of Pittsburgh.

Category: Uncategorized | Tagged , , , | Leave a comment

What I use the scientific literature for

Paris_-_Arc_de_Triomphe_du_Carrousel_-_PA00085992_-_034

Spandrels in the Arc de Triomphe | Wikimedia Commons CC BY-SA 3.0 Thesupermat

As a PhD student, it is fully accepted by myself and by society at large that I have a nerdy side. My dream job is to while away hours in front of my computer, thinking, analysing data, writing, re-writing, writing some more, and of course, reading academic literature.

The PLOS Integrative Paleontology blog recently discussed what the scientific literature is used for, and called for others to weigh in. Although the main metrics we use to gauge the consumption of academic literature are citations and article downloads, it’s difficult to truly discern the tangible impacts of scientific articles on the individual lives of those who consume it.

As a soon to be fully-fledged population health scientist, with toes dipping in the pools of health psychology and social epidemiology, I read and use scientific literature on a daily basis. Although I draw inspiration from many areas outside of science, the scientific literature is my bread and butter.

So here is what I use it for:

  •  My PhD research. This is the most obvious one. My research is on the changes to health literacy skills during ageing among the older population of England, and on the relationship between health literacy and health behaviours. I read and cite relevant articles for my work.
  • Side projects. Although I’m doing my PhD, I have several research projects on the side with other people in my research group. Although most are unpublished at the moment, they relate to my PhD research and to the type of work I want to do in the future.
  • Blogging. This third usage is less common for academics, but for me it’s a bit self-explanatory given this blog. I generally do two types of posts. The first is discussing any new public health research that is interesting, relevant and/or is making news headlines. The second type is a more in-depth piece on a general public health topic that draws from several evidence sources.
  • Figuring out what to do with my academic life. This point is only slightly tongue in cheek. As I prepare to move beyond my PhD, I’m constantly brainstorming research ideas in the back of my mind. Reading what others have done is always helpful and every now and then I read a gem of inspiration. Keeping on top of the literature is always important in the life of an academic, but it feels especially important now. I do my best to read from outside of my field to stretch the way I think about things.
  • Passion. Lateral thinking, discovery, and making a useful contribution to human knowledge are all reasons why we do we what do. I have a folder marked ‘interesting articles’ that have been influential on my thinking. I would recommend any of these articles to any population health science researcher with similar and especially to those with dissimilar inclinations to myself (apologies as some of these are not open access):

Who and what is a ‘population’? Historical debates, current controversies, and implications for understanding ‘population health’ and rectifying health inequalities” – Nancy Krieger. Emphasising the subjective, fluid, and sometimes arbitrary way in which populations are defined, and the resulting implications for the meaningfulness of population means, this review article should be required reading for any population health researcher.

The communications revolution and health inequalities in the 21st century: implications for cancer control” – K Viswanath et al. Just as the title says, this paper discusses how the ‘communications revolution’ that we are currently living through, with widespread and immediate access to people and information through mobile internet may have negative consequences for social equity in cancer control.

Fair society, healthy lives” – The Marmot Review. A landmark public health document detailing the link between health inequalities and social inequalities, and arguing for the reduction of health inequalities as an issue of social justice. The report delivers quantitative statistics and six actionable policy objectives to reduce health inequalities.

An anthropology of structural violence” – Paul Farmer. A physician and medical anthropologist, Paul Farmer argues how disease outbreaks, inadequate health systems, and health inequalities in present day cannot be understood without knowledge of the historical and political circumstances through which they arise. He focuses on Haiti, where the racist history and political economy of the country create public health problems that are a form of structural violence against vulnerable peoples.

The Spandrels of San Marco and the Panglossian Paradigm: a critique of the adaptationist programme” – Stephen Jay Gould and Richard C Lewontin. An exemplary piece of engaging scientific writing, metaphor, and an exercise in causal yet non-deterministic thinking, this paper introduces the biological ‘spandrel’ into Darwinian theory.

What do you use the scientific literature for?

Category: Uncategorized | Leave a comment

Why Measles Isn’t Just An Anti-Vaxxer Problem

like a present

Photo by Caselet, CC BY-ND 2.0

I have a little metaphor I use with my kid. When he asks why we get shots at the doctor, I remind him of all the super powers he has.

One day he got super powers against whooping cough and tetanus. Another time I explained that his baby brother just got super powers against rotavirus. I tell him about what these diseases are.

I told him about how I got chicken pox as a kid, just a few years before the vaccine came out, and how I was itchy and miserable for two weeks. He said, in a moment of reflection, that he was glad he got the shot that just hurts for a minute, and won’t have to get chicken pox for two weeks.

Super powers make a great metaphor, and I’ll keep using it, but it’s got a major flaw.

This post is dedicated to all the anti-vaxxers, vaccine choice proponents, and curious people everywhere who have wondered why parents who vaccinate are threatened by those who don’t.

It’s also dedicated to the anti-anti-vaxxers, people who think that those who skip vaccines are weeding themselves out of the population. (Anti-anti-vaxxers, while I admit to laughing at some of your memes–OK maybe a lot of them–you’ll catch more flies with honey and understanding.)

Three reasons disease outbreaks are not just a problem for anti-vaxxers

1. For a first look at why this situation isn’t so simple, check out this humor post about Why We Didn’t Vaccinate Our Child. It’s not what you think! The author writes that he is forgoing the Yellow Fever vaccine because yellow fever isn’t endemic to their area, the Andromeda Strain vaccine because it’s a fictional disease, and the pertussis vaccine because his child isn’t old enough for it yet.

A child has to be a minimum of 12 months old to get the Measles/Mumps/Rubella vaccine. If you show up at the doctor’s office the day before your kid’s first birthday, they’ll ask you to come back later. So kids are 12 months, maybe 13 or 14 before they get the shot. That’s a long time. Your one month old, your two month old, your six month old, your eleven month old, are all vulnerable.

(There is a measles-only vaccine that kids can receive at 6 months. If you spend time around Disneyland regulars, or if you’re traveling to countries where measles is common, ask your doctor about this shot.)

2.There are also people who have medical reasons why they can’t get vaccinated, or why they may be more susceptible to the disease even with vaccination. The last time I wrote about the flu vaccine, this was one of the comments:

I have a low immune system due to another illness and I appreciate it when others get the flu shot. My doctor recommends that all my family members get it for my protection.

And that’s good. I like it when others help to not kill me.

People who can’t get the vaccine rely on others’ immunity. Think of how many people are between you and the nearest measles spreader. Louise coughs on Jim who coughs on Agnes, who coughs on you. If they’re immune, you’re pretty well protected. If they’re all susceptible to the disease, that’s a measles highway.

(There are, of course, multiple pathways between Louise and you. If you’d like to play with scenarios, try the Vax game where you try to separate social networks to prevent the spread of disease. It’s quick and fun.)

3.And the third problem relates to that flaw in the super power story. In comic books, a super hero’s powers Just Work. They might be taken away by a bizarre accident or by the work of some villain, but Superman doesn’t bounce 95 bullets off his chest while, oops, five others get through.

But that’s how the measles vaccine works. The MMR protects 95% of people from measles, and 88% from mumps. For comparison, the flu vaccine is some 70% effective most years (less this season).

We know that five of the Disneyland cases occurred in people who has been fully vaccinated. That means that probably 95 other vaccinated folks were exposed but didn’t come down with the disease. Likewise, although many fully vaccinated hockey players got the mumps this season, they probably only made up 12% of the vaccinated players that were exposed. The other 88% can thank the nurses who brandished scary needles at them twenty years earlier.

People who are not fully vaccinated, or in whom the vaccine isn’t effective, are not only at risk themselves, they are also a stepping stone between someone with the disease and someone vulnerable. Your co-worker who skips the flu shot because he’s young and healthy and says he never gets sick? He might be fine, but could pass it on to his grandma who has lowered immunity, or to the pregnant woman in the next cubicle, or to the baby or the cancer patient he passes on the street mid-sneeze.

Vaccines are important because, with good coverage rates, the vulnerable folks are only the ones in those groups I mentioned: people who are too young for the vaccine, who can’t have it for medical reasons, and whose bodies failed to develop the super powers they was supposed to.

There’s no way around those numbers. But without knowledge and understanding of the risks, other people may opt out of vaccines, deepening the pool of susceptibles in the population.

And I mean we need to understand the risks of both the shot and the disease. No vaccine is 100% safe, but vaccines are far safer than the diseases they prevent. Measles kills 1 in 1000 children who get it. The MMR vaccine has nowhere near that level of risk.

So, anti-vaxxers, your children don’t catch measles and then take it home like a jar of fireflies to enjoy alone or with a few close friends. Instead, they may unwittingly spread it to babies, people with certain medical issues, and a small percentage of the people who have done all they can to try to protect themselves but in whom the vaccine doesn’t work.

And fully vaccinated fans of super powers, 5% of you are vulnerable to the next measles-toting kid who comes along, and you too might pass it to your baby or your immunosuppressed buddy.

Personal vaccination choices have a huge impact on public health, especially for measles where the average infected person spreads it to 12-18 others. Please choose responsibly.

Category: Uncategorized | Tagged , , , | Leave a comment

Why a new antibiotic won’t help diseases of poverty

tumblr-petri-dish

Image by Klari Reis at The Daily Dish

Today we warmly welcome Alexander Chaitoff and Joshua Niforatos to the blog. They are medical students at the Cleveland Clinic Lerner College of Medicine with interests in social justice and health equity. See the end of this post for their full biographies.

Just earlier this month, news broke that one of the first new classes of antibiotics in quite some time was discovered. Understandably, the news was met with jubilation. But while many are celebrating this breakthrough, some within the public health community are tempering their excitement.

These news reports generally highlight pharmaceutical and technological developments, yet fail to remind the public that infectious diseases are largely considered diseases of the poor. After all, it is easier to rally behind a “miracle” technology than it is to rally behind a restructuring of society that prevents multi-drug resistant diseases in the first place.

The discovery of a new class of antibiotics does as much to highlight the many economic and social issues in our world as it does to kill deadly pathogens.

Skimming through the pages of the history of medicine, the same infectious diseases that once killed the Romans of antiquity were the same infections that killed poor Americans until the early 1900s. Only one hundred years ago, Americans were more likely to die from infectious diseases, tuberculosis and the flu, than they were to die from the chronic diseases that now afflict the country.

However, with the serendipitous discovery of penicillin by Alexander Fleming in 1928, many felt infectious disease would become a thing of the past. As new classes of antibiotics seemed to be in endless supply, the nation’s brightest minds, and biggest wallets, turned their attention towards new health challenges.

Unfortunately, the antibiotic pipeline has dried up and dangerously resistant organisms have started to emerge. Health leaders are again recognizing infectious diseases as a leading problem, which explains the excitement that has surrounded the recent discovery.

Drug development has major limitations for curing infections of poverty. 

Consider first that this new drug that has garnered so much excitement has not yet been put through rigorous clinical trials. These trials can cost well over 100 million dollars, and less than 8% of drugs that begin trials are brought to market. This means that unless there is the potential for a hefty profit, pharmaceutical companies steer clear of testing many drugs in development.

Herein lies the problem. It is harder for pharmaceutical companies to recoup an investment in treatments for infectious disease. In this case, it also means that there is still a low likelihood that the antibiotic that made the news last week will be available anytime in the near future.

Just as disconcerting, we’ve seen what happens when a pharmaceutical company decides to get behind a cure for an infectious disease. In 2014, Gilead received approval for the first cure for Hepatitis C, a disease that largely impacts those with less education and living in poverty. However, when Gilead priced their drug regiment at over $80,000, they effectively limited access for the patients with real need.

Even if this new wonder-antibiotic is made available, why should anything different be expected?

The problem goes beyond the economics of drug development. Effective treatment of infectious diseases ranging from Ebola to chikungunya does require an understanding of the science behind new antibiotics. However, and equally important, effective treatment also requires an understanding of what it means for an infection to be a disease of poverty.

povertydivide

The north-south continental poverty divide in the United States.
Holt JB, 2007. Data Source: Community Health Status Indicators.

A 2011 Institute of Medicine report revealed alarming data that the poorest of the poor in the United States are disproportionally affected by a host of infectious diseases that preferentially infect those in low-income and middle-income countries. The groups most likely to be afflicted by neglected infections of poverty include minorities; single-family, low-income households; racially segmented cities; the American South; and other groups that live along the fault lines of society. These fault lines within society have deep historical roots in the power relations of class, gender, and race. Our social institutions – political, economic, cultural, religious, and legal – reinforce these unequal power relations.

“Of all the forms of inequality, injustice in health care is the most shocking and inhumane,”

Martin Luther King, Jr. once noted. Health disparities are also one of the most lethal forms of inequity.

As money is filtered into efforts to create antibiotics for infectious diseases, it is astonishing that money is not equally as filtered into resources dedicated to building a more “just” society. These resources would result in society where diseases of poverty do not disproportionately affect the poor. In commenting on how to treat and prevent the spread of Ebola, for example, infectious disease specialist Paul Farmer notes that,

“the only formula we’ve come up with is the following: you can’t stop Ebola without staff, stuff, space and systems.”

A new class of antibiotics is exciting news, but that feeling must be tempered. Unless the world stumbles upon another golden age of antibiotic discovery, one new antibiotic will only buy us time in the fight against the ever-evolving microbes that surround us.

At this point in history, scientific advancement, while very important, is not the real issue in this fight for health. The real issue is that infectious diseases are diseases of poverty. The real issue is that new antibiotics alone will not save us from these diseases, but social solutions just might.

It is far easier and less expensive to fund research into novel drug discovery than it is to develop a society in which everyone has equal and affordable access to quality care. Perverse incentives can inhibit the organization and funding of a public health system that is able to educate, prevent, and treat infectious diseases that primarily infect the marginalized of society. Such excitement concerning the discovery of a single drug without a willingness to make more difficult investments reveals our failure to truly understand how bacteria and viruses actually work.

 

Alexander Chaitoff studied microbiology and political science at The Ohio State University before receiving his MPH as a 2013 Marshall Scholar. Interested in the nexus of scientific and social determinants of health, he has worked and researched for a variety of organizations including the Department of Health and Human Services, the National Health Service, and in 2010 co-founded the 501(c)3 nonprofit research organization the Pure Water Access Project, Inc. He is currently a medical student at the Cleveland Clinic Lerner College of Medicine.

Joshua Niforatos is a medical student at Cleveland Clinic Lerner College of Medicine. Prior to attending medical school, he earned bachelor degrees in both cultural anthropology and biology at University of New Mexico. He then went on to earn a Master of Theological Studies at Boston University School of Theology where he studied theology, anthropology, and ritual. Interested in the intersection of liberation theology and social determinants of health, and reflecting on his public health experience working with immigrants at risk for Type II diabetes in New Mexico, he is a co-founder of a student chapter of Physicians for a National Health Program at Case Western Reserve University. 

 

Image source: Holt JB. The topography of poverty in the United States: a spatial analysis using county-level data from the Community Health Status Indicators project. Prev Chronic Dis 2007;4(4). http://www.cdc.gov/pcd/issues/2007/
oct/07_0091.htm
. Accessed 21 January, 2015.

Category: Uncategorized | Leave a comment

How often should you shower?

-It's_an_Old_American_Custom,_Keep_Clean._Take_a_Bath_Every_Day_You_Can._-_NARA_-_514650

U.S. National Archives and Records Administration. Public domain.

At first glance, a silly question. Have you ever questioned your showering practices?

A shower is taken for granted, a daily or near-daily practice that begins or ends our days. It can be soothing, warm, and pleasurable, or a minor annoyance that must be worked into a busy schedule.

The practice of bathing has a long history. Ancient Rome was famous for its baths, or thermae, which played a culturally significant role as community centres focused around the act of bathing. Bathing has long been a communal act in many societies, and still is today in many places, such as in Morocco, where public hammams are visited once weekly by men, women, and children.

Volubilis_bassins

Ancient Roman bath in Morocco.
“Volubilis bassins” by M. Benoist.
Licensed under CC BY-SA 3.0 via Wikimedia Commons

In the Western world, showering or bathing daily is typically the accepted practice. The daily shower is associated with modernity, simply because we live in a modern society (whatever that means) and showering daily is what we do. However, understanding that bathing practices are socially influenced brings about the question – health-wise, is the daily shower necessary? Put simply, the answer is no.

Showering gets rid of the good bacteria

Showering increases the amount of skin bacteria dispersed into the air (1-2). Icky-factor aside, this actually doesn’t make a difference to your personal risk of infection (3). But, it does mean that good bacteria, which are naturally present on your skin and are important for health immune function, are stripped away. They will come back, but there’s no need to get rid of them on a daily basis.

Showering dries out your skin and hair

It depends partly on the climate you live in and whether you naturally have dry or oily skin, but soaps and shampoos strip away natural, healthy skin oils. Over time, especially in a dry climate, this can lead to irritated and cracked dry skin. Lotion helps, as applying it your skin reduces the shedding of skin scales and bacteria post-shower (2).

Showering uses a ton of water 

It is a luxury to have a hot shower every day.  An American taking a 5-minute shower uses more water than the average person in a developing country slum uses in an entire day (4). While rich people using less water won’t help poor people get the water they need, it is important to respect this resource. Be aware of your consumption. Environmentally, this is also important.

Chemical by-products from soaps get into the water system 

Detergents like soaps and shampoos are bad for freshwater systems. They are poisonous to fish, as they damage their mucus membranes and gills (5). While fertilizers and pesticides are the worst pollutants, detergents also pollute the Canadian and American Great Lakes (6). Microbeads from body scrubs and face washes also pollute waterways because they don’t break down (7).

Of course, there are important reasons to shower. Sanitation is a cornerstone of human development. Regular bathing is essential to health. Psychologically, a shower is really nice. Once every two or three days though is plenty.

References

  1. Speers R, Bernard H, O’Grady F, Shooter RA. Increased dispersal of skin bacteria into the air after shower-baths. Lancet 1965;1:478-83.
  2. Hall GS, Mackintosh CA, Hoffman PN. The dispersal of bacteria and skin scales from the body after showering and after application of a skin lotion. Journal of Hygiene (Cambridge) 1986;97;289-98.
  3. Larson E. Hygiene of the skin: when is clean too clean? Emerging Infectious Diseases 2001;7(2):225-30.
  4. Watkins K. Human development report 2006, beyond scarcity: power, poverty, and the global water crisis. United Nations Development Program (UNDP).  2006.
  5. Abel PD. Toxicity of synthetic detergents to fish and aquatic invertebrates. Journal of Fish Biology 1974;6(3):279-98.
  6. Bennett ER, Metcalfe CD. Distribution of alkylphenol compounds in great lakes sediments, United States and Canada. Environmental Toxicology and Chemistry 1998;17(7):1230-5.
  7. Eriksen M, Mason S, Wilson S, Box C, Zellars A, Edwards W, et al. Microplastic pollution in the surface waters of the Laurentian Great Lakes. Marine Pollution Bulletin 2013;77(1-2):177-82.
Category: Uncategorized | Leave a comment

Could the Ebola epidemic end this year?

Although the Ebola epidemic is still raging in west Africa, US and European buzz about the disease spiked briefly and then all but disappeared, according to Google search data published in Vox’s in-depth report.

Liberia’s situation is the most promising, compared to the other two countries involved, writes Julia Belluz at Vox. Experts say that Guinea has “no discernible upward or downward trend” of cases, Sierra Leone is “the most challenging front,” and Liberia is the country closest to having the outbreak under control.

Ebola eradication is probably impossible, because the disease seems to simmer in wildlife populations, including bats, making occasional jumps into humans. Until recently, the outbreaks only killed dozens or hundreds of people before fizzling out, sometimes without another recorded case for years. The current outbreak, on the other hand, has been going on for over a year, with an official death toll of, at this writing, over 8,000.

Now, a new model of the epidemic suggests that it may be under control, at least in Liberia, by summer of this year.

I spoke with John Drake, whose team at the University of Georgia studies the dynamics of groups of living things, from wildlife populations to disease epidemics. They have a paper out in PLOS Biology today describing their prediction.

What’s the best case scenario and the worst case scenario here?

The worst case is that it could be quite terrible. If the current vigilance and investment and public buy-in isn’t maintained, it could take a turn for the worse.

I don’t think the worst case scenario is a very likely outcome, because I think that the public, the community, the politicians, the health community have all been galvanized by their battle with Ebola over the summer and fall of 2014. And they’ve made tremendous gains, and I think that they’re going to maintain that vigilance. And I’m optimistic that the great majority of transmission could be eliminated by the late spring, maybe even slightly earlier.

A lot of previous models focused on R0 [the number of new infections that each infected person can cause], but yours takes other factors into account.

A lot of models are based on an ‘if everything remains the same’ kind of assumption, and all that’s changing is the number of susceptible and infectious persons in the population.

But we said, well, no! The baseline is not staying the same, because they’re building Ebola treatment units. So hospital capacity is increasing. And what effect does that have on containing the outbreak? We included that trajectory, that sequence of Ebola treatment units being constructed in the development of our model.

Another important difference is that we focused on the different sites at which persons would acquire infection, whether that was in the hospital, at a funeral, or in the community, and how that would feed back into transmission. If a person acquires the infection in the hospital, then they’re very likely to be treated in the hospital, and the contact rate would be low.

On the other hand, a person who contracted the infection in the community might go to the hospital and effectively be isolated from the susceptible population. But they might be treated in the community, which means a larger number of persons might be exposed. And so this places an emphasis on the willingness of potentially infected persons to seek care and be treated, and allows us to explore better what’s the possible range of outcomes based on the frequency with which patients are isolated.

Another difference is in order to make our work tractable, we took a shortcut. We said, we don’t suspect that what epidemiologists call susceptible depletion, the extent to which previously infected individuals are removed from the population and therefore causing the epidemic to be self limiting—we don’t think we’re in that situation yet. And by making the approximation that susceptible depletion was negligible, that allowed us to make further progress on emphasizing the sorts of things we thought were important.

Your predictions are focused on Liberia, but the epidemic is also raging in Guinea and Sierra Leone. Do you think all three can contain it by this summer?

Our model is Liberia specific. There are differences among these countries; we don’t fully understand what those differences are.

My group decided to focus on Liberia because at the time we began this work, it’s where the epidemic was most out of control, it’s where we thought we could make the greatest contribution, and it’s where we had the best information. And we knew of other folks working particularly on Sierra Leone and Guinea.

Epidemiologically I think Sierra Leone is probably fairly similar. Transmission in Guinea seems to be a little bit different, and I think people are scratching their heads to understand first of all how is it different, and secondly what are the consequences of those differences.

I wouldn’t say the whole thing is coming to a close yet. I think that if Liberia is able to maintain their current level of response, and if they are able to prevent reinfection, reignition of the epidemic within Liberia, then I think we’re on a downward trend for Liberia. But it’s in a context in which there’s going to be interaction with neighboring countries, and there’s a possibility for subsequent flare-ups, so it requires vigilance and rapid response.

I think that the response in Sierra Leone and Guinea will ultimately contain those epidemics. I think that they are working very hard to accomplish that, and eventually that will happen in those places as well. But there needs to be continued investment in those places.

What do people need to know about Ebola now?

I do think the public’s been well informed about this particular epidemic, and I think that people understand that there’s not any reason for hysteria in western Europe or in the United States or places that are contributing health professionals to try and contain this epidemic.

I think that we are learning things about how collectively the world can respond to emerging infectious diseases like this that really pose a threat not just in one region or in a particular country or in the developing world, but that actually expose us all to some level of risk. And how to mobilize our scientists and medics and policy makers in a coordinated way.

Category: Uncategorized | Tagged , | Leave a comment

Black lives must matter more in health research

Anyone who thinks America is a ‘post-racial’ society is delusional. ‘Post-racial’ is political discourse that aims to deny any presence of racism or racial inequality in modern society. Racism is visible everyday. From visible neighbourhood segregation to everyday instances of white privilege to population-level statistics, it can be seen and felt (1-7). For example, in 2013, the average white family had a net worth 13 times greater than the average black family ($141,900 vs. $11,000), a gap twice the size it was prior to the Great Recession (1).

PewWealthGap

Why does racism matter for public health?

Racism is not only a social, cultural, political, and legal issue; it is also a health issue. Across history, racism has consistently been manifested in terms of the ultimate health outcome: death. When Europeans colonised the Americas hundreds of years ago, the aboriginal populations perished in scores. America’s legacy of slavery almost goes without mentioning. Still today, the life expectancy of American Indians and Alaska Natives is, on average, 4.2 years lower than all races and origins in the U.S. population combined (6).  Black men are more likely to die than non-black men, with a life expectancy 5 years lower than white men in America (see graph below) (7).

 lifeexpectancy

Recently, we’ve seen the ultimate outcome of racism dramatically played out in the streets of America. This form of overt violence, where unarmed yet ‘suspicious-looking’ black men are shot down by officers of the law is nothing new, yet requires contextualisation. Let’s not forget that while African Americans have been living in the United States for over 400 years, they have only had legal rights for about a tenth of that time. Let’s not forget how recent the civil rights movement was. It will take more than a couple of generations to repair the legacy of slavery, if it ever can be repaired.

The effects of racism on health, while undoubtedly negative, are not well understood. Racism is a personal experience, the manifestation of which is politically and socially situated in specific places and times. It is institutional, interpersonal, overt, covert, and violent.

The field of epidemiology and public health has only accumulated a small body of inquiry into racism and health, and most of it deals with the social experience of racial discrimination in people’s daily lives. As of 5 January 2015, a PubMed search of the term ‘racism’ returns 2,263 articles from all medical disciplines. By contrast, a search for the term ‘obesity’ returns 210,214 articles, about ten times more. This quick example is not meant to imply that obesity is not an important and urgent research topic (it is), or that these are even comparable topics, but rather to demonstrate the relative dearth of knowledge on racism in the quantitative health sciences.

Without empirical research we cannot record the effects of racism on population health and inequalities, we cannot transcribe the embodiment of discrimination in marginalised groups on a large scale.  By ‘embodiment’, I mean the literal embodying of social and ecological environments in terms of their biological effects in and on our bodies (8,9). A useful framework for quantitative health scientists wishing to investigate the effects of race and racism is ecosocial theory (8,9). The ecosocial theory of disease distribution concerns who and what drive social inequalities in health (8). I’ll leave the juicy bits to the paper and book referenced above, but will briefly describe what the theory posits with respect to racism:

Inequitable race relations simultaneously – and not sequentially

1)   Benefit the groups who claim racial superiority at the expense of those whom they deem intrinsically inferior,

2)   Racialize biology to produce and justify the very categories used to demarcate racial/ethnic groups, and

3)   Generate inequitable living and working conditions that, via embodiment, result in the biological expression of racism – and hence racial/ethnic health inequalities. (9)

These ideas are nothing new to those familiar with critical race theory, social constructionism, or intersectionality theory. However, they are often foreign to quantitative health scientists. We are taught how to count, classify, and categorise people in order to fit them into complex statistical models not designed to account for the social construction of biology. So, how do we move forward? We need to ground our work in theory (epidemiology, as a field, is notoriously atheoretical, although that’s a subject for another day), which means looking outside of our discipline to the social sciences. We need to collaborate with other fields and explore mixed methods. As epidemiology evolves, theories like the ecosocial theory may become entrenched in our discipline.

This is important because research is a key piece in the patchwork of knowledge, activism, policy, and public will that is required to make the world a more just place. The media attention and public demonstrations that have occurred in aftermath of Ferguson and other recent incidents of racialized violence perhaps signal a change in the public consciousness. Let’s keep moving in this direction.

 

 

Note: Although I refer to ‘black lives’ in this title, it not to privilege any minority group over any other. Linking to current public discourse and providing a focus for this article, the intent is purely demonstrative. The ecosocial framework can be applied to many inequitable social relations across place and time.

References

1)   Kochhar R, Fry R. Wealth inequality has widened along racial, ethnic lines since end of Great Recession. http://www.pewresearch.org/fact-tank/2014/12/12/racial-wealth-gaps-great-recession/ (accessed 1 January 2014).

2)   Nico Lang. It’s time to wake up from the myth of a ‘post-racial America’. Daily Dot. 25 November 2014. http://www.dailydot.com/opinion/ferguson-michael-brown-post-racial-myth/ (accessed 3 January 2015).

3)   McIntosh P. White privilege: unpacking the invisible backpack. Independent School, Winter, 1990, pp. 31-6.

4)   Vanhemert K. The best map ever made of America’s racial segregation. Wired. 26 August 2013. http://www.wired.com/2013/08/how-segregated-is-your-city-this-eye-opening-map-shows-you/ (accessed 3 January 2015).

5)   Baird-Remba R, Lubin G. 21 maps of highly segregated cities in America. Business Insider. http://www.businessinsider.com/most-segregated-cities-census-maps-2013-4?op=1&IR=T (accessed 3 January 2015).

6)   Indian Health Service: The Federal Health Program for American Indians and Alaska Natives. Disparities. http://www.ihs.gov/newsroom/factsheets/disparities/ (accessed 3 January 2015).

7)   Centers for Disease Control and Prevention. NCHS Data Brief: Death in the United States, 2010. http://www.cdc.gov/nchs/data/databriefs/db99.htm (accessed 3 January 2015).

8)   Krieger N. Methods for the scientific study of discrimination and health: an ecosocial approach. Am J Public Health 2012;102(5):936-45.

9)   Krieger N. Epidemiology and the people’s health: theory and context. New York: Oxford University Press; 2011.

Category: Determinants of health, Epidemiology, Health systems, Preventable Deaths | Tagged , , , , , , , , | Leave a comment