Friday Round-Up

Image from: survivingtheworld.net

First, congratulations to FlyGal, who's farewell post So long and thanks for all the fish was published in the June Scientiae blog carnival. The theme this month was moving forward and we've heard rumors that FlyGal is indeed moving forward the way she hoped. Stop by the carnival to read other inspirational stories as well.

Some other interesting reads for you this weekend include:

• A New England Journal of Medicine piece on the FDA as a public health agency written by the new FDA director, Margaret Hamburg and Joshua Sharfstein, the principal deputy commissioner.
• The WSJ Health Blog is live blogging details about the H1N1 virus and Ed Yong over at Not Exactly Rocket Science has a good breakdown on the origins of the now pandemic swine flu.
• El Nino may be upon us again.
  
• If your pocket periodic table is wearing around the edges (you know you have one), it may be time for an upgrade. Welcome super-heavy element 112.

Have a great weekend everyone and we'll see you next week!

CER's definitive maybe

Comparative Effectiveness Research. CER. It’s coming soon and to believe some of the things that have been written about it, one would expect it to loom on the horizon like a dark storm cloud, spitting lightning and damaging medical care wherever it goes.

Some hate its impact on the growth of personalized medicine and some think it represents the first step to an invasive and paternalistic regulatory system in which the government controls every doctor’s decision. Being the die hard skeptic that I am, hearing this kind of wailing tends to lead towards asking the question of whether any of this is true. In the case of CER I can answer with a definitive… it depends.

I say "it depends" because CER is not attatched to any policy platform yet. Right now, it's a study to see what kind of data we can get. It isn't definitely one thing or the other until we see what the government chooses to do with that data. The concerns being expressed are policy problems based on what might be done with the CER data.

Personalized Medicine
When people look at CER they see a world in which studies determine what the best mode of care for 51% of the people and apply it to 100% of the population. This would appear to be a rollback of all of the gains made in individualized care. However, this fear makes strong assumptions about what the goals and means of CER.

Rather than assuming CER is a monolithic study designed to produce only one “effective” treatment, it is also possible to view CER as being a large scale work of clinical epidemiology. It can be used as a way to determine which of the myriad personalized medicine options are going to be more effective. Viewed in this light, CER becomes a tool that would allow physicians to spend less time on unproductive treatments. It COULD be a monolithic means of determining best care, but it hardly has to be.

Dr. Big Brother
The idea that CER will be used to dictate medical care is based on a similarly unfounded assumption. It assumes that the data from CER studies will be used by both the government and private insurers to dictate an exact plan of care by reimbursing patients only for CER rated “best” treatments.

This fear again assumes that CER will be used to rate “best” treatments and also makes some assumptions about the present and the future. It assumes that in the present these health entities don’t already make reimbursement decisions based on effectiveness data and assumes that there would be no protection of personalized medicine in the future.

For the present, given that insurance entities are already making these same determinations, it seems possible that their information would be better with a comprehensive CER regime. The concern for the future is a valid one and does require that, if CER expands in the future, there will be some necessary protections based on the data that comes out, but to assume that it will be used in the most underhanded manner has no basis in the current legislation.

Conclusions
So that’s a very clear maybe. My point in this is not suggest that those people concerned about CER have no point, but rather to show that it’s based on sizeable assumptions about a program that hasn’t even gotten off the ground yet. It’s this indeterminacy which suggests that, rather than fight against CER, these groups should be active in shaping the future of it. Yes, it could be disastrous for American health care, but it doesn’t have to be. CER is coming, but what it does depends on what we do… maybe.


This is Part 2 in the New Voices discussion of comparative effectiveness research (CER).
Part 1 - What is Comparative Effectiveness Research?

Experiences with H1N1 in China

Chronicles of a Science Policy Intern
Shortly before starting my summer in Washington DC, I traveled to the People’s Republic of China for 2 weeks to complete a course in international entrepreneurship. All in all, it was a great trip. I learned a lot and would highly recommend a visit to China for anyone interested in learning more about this developing country.

Arriving in China by plane revealed the first of the unexpected experiences. The H1N1 virus (swine flu) is still a very real concern in China. Upon landing in Shanghai, the entire plane was considered to be “in quarantine.” Chinese health officials boarded the plane wearing complete biohazard suits including goggles and respirators. Each passenger was individually screened for fever or other signs of the H1N1 virus. The Chinese health officials walked up and down each row and took the temperature of every passenger by holding a thermal imaging scanner to our foreheads. This went one-by-one in an A330 with almost 300 people on board. Someone several rows behind me apparently did not pass the quarantine exam, because all the health officials gathered around this unfortunate soul. Soon, several seats in the near vicinity had large red stickers on them and those people didn’t get off the plane when the rest of the passengers were allowed to deplane over 60 minutes later. Luckily, no one in my group was quarantined.

While this was an interesting experience, it raised a larger question: is this really the most effective way to prevent a public health crisis? Considering the fact that there is rarely antibacterial soap in any restroom in China, hand sanitizer is not provided in public areas, and many Chinese citizens readily spit in public, I question whether the resources spent to screen an entire plane could be spent more wisely on public health initiatives to prevent the spread of disease. Before I arrived in China there had only been a few documented cases of H1N1, so apparently the Chinese method of keeping H1N1 from entering the country has been effective so far. This seemed like a “wall” approach. If the country could keep H1N1 out, there wouldn’t be a problem. But what happens if the “wall” develops a crack? Without the internal infrastructure (antibacterial soap, hand sanitizer, hygiene) in place, China is taking a huge gamble with the health of its citizens. I’d argue that in addition to keeping H1N1 out of China, the government should also work to develop internal measures to prevent the spread of the virus in the event that H1N1 or a mutated form does enter the country.

I’m curious about the differences in public health initiatives between the United States, China, and the rest of the world. What experiences with public health and H1N1 have you had? Does anyone have experiences with the public health responses of other countries to H1N1?

Science in Film

We’ve all had the experience. You’re sitting watching an otherwise entertaining movie or TV show and all of a sudden it happens. The Terrible Science Moment. It could be anything from a discovery to the way a hospital or a lab is presented. Or it could be CSI. The point is that we’ve all experienced that moment where our natural suspension of disbelief is shattered and we’re left with no choice but to change the channel and watch something else. Maybe The Simpsons is on.

So, what characterizes the best science films? A question that anyone associated with the sciences will answer differently. We all have our own personal things that we’re willing to suspend disbelief for just as we all have our personal views that, when violated by movie science cause us to howl out cries of “I can’t BELIEVE they got it so WROOOOOONG”.

For me, I don’t ask that everything be accurate. Partially because accuracy is rarely if ever dramatic, and partially because I, like many people, live in the real “accurate” world and it is not especially exciting. What I do ask, is that films approach science honestly and with some respect. I can live with dramatic choices as long as science isn’t used as the equivalent of magic. A generic example of the difference…

Film 1. The protagonist has been attacked by the villain with a poison for which there is no known cure. They seek out the eccentric scientist who has an untested potentially lethal cure that she’s been working on for years. The protagonist demands the cure regardless of the risk. The scientist injects him with it and there is a dramatic scene as the protagonist hovers near death and screams and thrashes around a lot. Then he opens his eyes and slowly reaches out a hand to his true love. The cure has worked. He is saved.

Film 2. Same scenario as above. Except now the protagonist rushes to a lab to INVENT the cure. She is seen pouring various oddly colored liquids into oddly shaped plastic tubes until days (or hours) later there is a single test tube of “cure” that is an even stranger color, which she then drinks. The same painful curing scene as above with the same ending.

Film 1 is moderately absurd but within the realm of possibility. I have met many eccentric scientists and I like to think that many of them have strange labs and are working on unusual projects. Film 2 makes me insane. I think the process of discovery is amazing and yet I’m quite certain you would be hard pressed to cure disease with a couple of days in a generic lab with no lab techs and absolutely no testing. Both of these films are ridiculous but at least one acknowledges some reality of science.

It’s a question of respect and it’s also the difference between a good science film like Gattaca and The Worst Science Film Ever In History… The Core. I don’t know how accurate Gattaca is, but I know it aspires to be realistic and it has a respect for both the process of science and the ethical dilemmas that it creates.


Contrast this with TWSFEIH The Core, where science is like magic… only dumber. I could go on about the differences, but instead I think it’s best to give examples. So tune in next Tuesday to see what I think a good science film looks like and watch me yell, scream and wave my arms over the worst science films I have ever seen. Including TWSFEIH The Core.

What is Comparative Effectiveness Research?

One of the fascinating (and much debated) new programs contained within ARRA (American Recovery and Reinvestment Act) is 1.1 billion dollars to be spent on comparative effectiveness research (CER). CER immediately became a much debated topic with government supporters strongly in favor of it and many coming out just as strongly against it. Naturally, like most controversial topics, there has been minimal discussion of what it is. According to the department of health and human services CER is:

“Comparative effectiveness research is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions.”

Right, so in lay speak, that means that CER will evaluate procedures and medicines and see which ones are going to have the most value to patients. It is a program that is designed to cut waste from the process of patient care.

HHS also lists the criteria on which medicines and treatments will compared...

1. Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, and costs of care).
2. Potential to evaluate comparative effectiveness in diverse populations and patient sub-populations.
3. Uncertainty within the clinical and public health communities regarding management decisions.
4. Addresses need or gap unlikely to be addressed through other funding mechanisms.
5. Potential for multiplicative effect (e.g. lays foundation for future CER or generates additional investment outside government).
   

Or to put it into simpler terms...

1. Will this significantly help a serious problem?
2. Will this have an impact across a broad range of population?
3. Will this make treatment decisions easier?
4. Will this help where no one else is helping?
5. Will this help future research on CER?
   

So why do we need this? Well, in traditional clinical trials medicines are compared only against placebos (a.k.a. nothing). The idea behind CER is that we'll be able to make better decisions if these medicines are tested against each other. In theory, we will be able to determine which medicines and treatments are most effective and we will be able to determine if specific medicines should be targeted for specific patients. The goals of CER are to provide better care at a lower price. Whether it can do that is up for significant debate.

Why do we need the government to do this? One of the primary reasons why the government would be involved in this is because the private sector lacks sufficient incentive to engage in this research. Any discoveries regarding the comparative effectiveness of medicines could have unpredictable benefits and costs across industry. It's difficult to incentivize a business to do research which could show their product is the least effective one on the market. This leaves the government, in its role as representative of the public interest, as the most neutral entity to do the research.

But what does this all mean in the end? One major concern is that each party in the health care field is going to have a very different definition of what constitutes waste; and the costs and benefits of an expanded CER program are going to depend entirely on which definition of waste you use.

There is the potential for very real problems with CER. It has the potential to be as wasteful and bureaucratic as any of the worst government programs (Medicare I'm looking at you...). Also, HOW you run the program (and not the program itself) is going to determine whether CER is a miracle or a monster.

We'll examine these key criticisms - and any others you suggest in the comments section - on Thursday.

Welcome Two New Voices

Here at New Voices, we're excited to announce that we have two new regular bloggers joining us for the summer, Takao Yamada and Matt Hanzlik.

Name: Takao Yamada
Position: Research!America Science Policy Intern
Education: Georgetown University Law Center c/o 2010
BA in Political Science & English, Hobart College
Previous experience: Takao has worked in industry and been an entrepreneuring restaurateur. Aside from all those college English papers, he has writing experience as a freelance sports reporter.
Fun fact: If the picture doesn't give it away, Takao likes food. He even won a pie eating contest when he was eight.

Some posts you may have seen by Takao so far include: Soda as Sin and Sensationalizing Science Journalism.

Name: Matt Hanzlik
Position: Research!America Science Policy Intern
Education: University of Minnesota c/o 2010
Studying: Public/Non-Profit Management & Entrepreneurial Management
Previous experience: Matt has a strong advocacy background having served as the National Advocacy & Government Affairs Coordinator for the Student Society for Stem Cell Research and as a business and outreach intern at the American Parkinson Disease Association of Minnesota.
Fun fact: Even though he's from a land-locked state (minus all those lakes), Matt wants to learn to barefoot water-ski before the end of the summer.

Matt previously joined New Voices as a guest blogger in January to discuss President Obama's executive order on stem cells.

We're looking forward to Takao and Matt's perspectives and hope you'll welcome them to the New Voices community!

Climate Change and Health: Extreme Weather Events

Image from: www.climatechangeconnection.org

Throughout this series we've talked about a number of ways that climate change effects human health. Anyone familiar with the topic of climate change has heard the horror stories about the catastrophic events that are in store for out planet if we don't curb carbon emissions. Today we're going to look at how those extreme weather events could alter human health.

A few recent examples of extreme weather events include the tornadoes in Oklahoma in February - outside of regular tornado season - and the floods in North Dakota in March, caused by heavy rains and blizzards, which President Obama cited as an example of the need to act on global warming. Additionally, we are likely to see more intense and frequent hurricanes, windstorms, and mudslides.

A particularly horrific example of how climate change can intensify natural disasters is the wildfires in Australia. Though the fires were caused by arson, they were spurred on – at least in part – by global warming, which had caused excessive drought and heat in the region.

The NASA map below shows land surface temperature across Australia from January 25 to February 1, 2009 compared to the average mid-summer temperatures the continent experienced between 2000-2008. During this time period, temperatures differed up to 10 degrees Celsius: cooler in blue regions, normal temperatures in white regions, and hotter temperatures in red regions.


As we approach hurricane season (Cyclone Aila has already made landfall) and the dog days of summer more and more people will be talking about climate change. The question is, what changes will we fight for to help save our planet and our health?


For more on this topic, check out these Science Progress resources: Global Ailing, The Human Toll of Climate Change, and this map.


This is Part 7 of 7 in our Climate Change and Health series.
Part 1 - Climate Change and Health
Part 2 - Heat-Related Issues
Part 3 - Malaria
Part 4 - Lyme Disease
Part 5 - Mental Health
Part 6 - Water-borne Disease
Part 7 - Extreme Weather Events

Sensationalizing Science Journalism

Say it with me people… “Correlation is NOT causation”

Frequent Moves Increase Suicide Risk in Teens

This was from the New York Times health section on June 1st and I can’t tell if it offends me more from a scientific or a journalistic standpoint. The article details a Danish study examining the links between teenage suicide and moving. A fine study that could yield some interesting results with the potential to give us an indicator of when parents should be concerned. But, given the research on suicide to date, it would be somewhat ridiculous to suggest that moving has clear, causal links to suicide.

To her credit the author of the study Dr. Ping Qin of the Centre for Register-Based Research at Aarhus University in Denmark points at that nothing in the study suggests whether moving is a causal risk factor or an intermediate variable, but the article then drops this quote from a professor not involved with the study….

“The evidence is becoming quite compelling that there is a causal effect of children’s residential mobility on a variety of negative behavioral outcomes…”

Now, it’s possible that there is some link between moving and teenage suicide, but the evidence in this study doesn’t suggest it. This quote is particularly problematic because the study did not control for poverty, family instability or distance moved. So an impoverished child who has to move across the country following the divorce of his parents is treated the same as a wealthy child whose whole family moves across town. I cannot speak for everyone, but that strikes me as a serious problem with anyone claiming that there is a causal link between suicide and moving.

Suicide is an incredibly serious problem in this country with 1.3 million deaths annually. It’s the third leading cause of death among Americans age 15-24. Articles like this is they continue to promote magic bullet theories to teen suicide instead of a thorough examination of all the causes of suicide. When you see that 90% of people who die by suicide have a treatable mental illness or a substance abuse disorder and then imagine the claim that it’s really about moving, you can understand why this article upset me.

It’s Dr. Qin's fault that her study was used in this manner (although the adjustment failures within it are), and I hope that science journalists will keep their focus on the details rather than sensationalism (which isn't selling papers anyway). Perhaps I’m overreacting, but I find it frustrating when things like this are promoted in the stead of research into depression and social anxiety disorder that actually helps save lives.

For some real details about suicide check out the following resources:

• National Institute of Mental Health
• Suicide fact sheet
  

Flowing Scientific Knowledge

Victoria Falls, Zimbabwe by only_point_five

"Advances in science when put to practical use mean more jobs, higher wages, shorter hours, more abundant crops, more leisure for recreation, for study, for learning how to live without the deadening drudgery which has been the burden of the common man for ages past. Advances in science will also bring higher standards of living, will lead to the prevention or cure of diseases, will promote conservation of our limited national resources, and will assure means of defense against aggression.But to achieve these objectives - to secure a high level of employment, to maintain a position of world leadership - the flow of new scientific knowledge must be both continuous and substantial. "

from Science the Endless Frontier by Vannevar Bush

How can we assure that "the flow of new scientific knowledge" is both "continuous and substantial"? The discussion is open in the comments section ...


This is Part 2 in our ongoing discussion of Science the Endless Frontier.
Part 1 - Introduction
Part 2 - Flowing Scientific Knowledge
Part 3 - The Importance of Basic Research
Part 4 - The Need for Federal Support for Research

TV Science is Not Real Science

(Click here for full strip) Credit: PhD comics

I don't watch a lot of popular shows, but after some prodding by a colleague here at New Voices, I watched an episode of House. I know it's TV. I know the show is only an hour long and I know they have to take some artistic liberties, but two things bothered me:

1. The smart guy in the show was neurotic, anti-social, white and male (which does nothing to stop the already popular misconception that scientists are largely Caucasian males who are weird and socially awkward creatures).

2. The time line for solving the medical mystery was completely unrealistic, since right now, the time line for going from basic research breakthroughs to applied therapies/pills is about 10-15 years.

It made me think,

"No wonder people are mad that we still don't have a cure for cancer or whatever other disease. If people think that breakthroughs in medicine and science can be achieved just like that - hey presto- then we are in real trouble."

In some ways I am happy that TV and mass media is showing images of scientists- at least we have a presence out there. But, it would be nice for people to know how real scientists operate in the real world.

I wish there was a reality show that followed grad-students and post-docs around to show people what really happens. The slow grind of grant proposals, experiments (most of them failing, or worse, a positive result that can't be reproduced), Internal Review Boards (IRBs), manuscript submissions, the review process etc. And then , if you are lucky enough to be in translational medicine or manage to collaborate with folks over in clinical/translational medicine, maybe the product goes into clinical trials, FDA approval, marketing....

What do you think? Would you watch a show like that?


Related resources:

• Naturally Obsessed: The making of a scientist- a documentary about life in a molecular biology lab.
• Post about Grey's Anatomy's misleading finale at Framing Science
• Post about Science on TV at Science Progress