Bioethics/Policy Discussion: 23andMe vs. FDA

On Wednesday, members of the Penn Science Policy Group met to discuss the current regulatory friction between the FDA and the genetic testing company 23andMe.

23andMe provides personalized DNA results that are interpreted to provide information about ancestry and health risks for various diseases. Because the results provided by 23andMe border on medical information, the FDA has been working closely with the company since 2009 to ensure that their marketing and analysis were accurate and in accordance with federal regulations. However, in May of 2013 23andMe ceased communications with the FDA and simultaneously ramped up marketing of their Personal Genome Service (PGS) for providing “health reports on 254 diseases and conditions.” In retaliation, the FDA sent a letter to 23andMe on Nov 22 warning them to stop marketing their PGS without approval or face harsh regulatory actions. This letter sparked a public debate about how much regulation should be imposed on this new technology, which was the focus of our discussion on Wednesday.

The question at the heart of the debate is: do individuals have the right to access their own genetic information (and interpretations of it) without medical (and hence FDA) oversight?



The laissez-faire argument is that individuals have the right to know their genetics, and governmental paternalism should not restrict that access over fears that certain individuals might react negatively to their DNA interpretations. For instance, a woman might find out she is slightly predisposed to breast cancer and get an unnecessary radical mastectomy (for which it might be challenging to find a doctor that would perform this procedure solely based on the 23andMe PGS, anyways). These scenarios shouldn’t prevent more responsible people from obtaining it. To their credit, 23andMe is very open about allowing people to access more information regarding their personalized interpretations. Curious users can find detailed explanations and links to scientific studies if they care to investigate.

Those in favor of regulation argue that the accuracy of the PGS needs to be verified. They caution that faulty tests could cause unnecessary worry and lead to increased healthcare expenditure to verify or refute the result. The FDA states that most of the intended uses for PGS are consistent with uses that regularly require approval by the FDA. The rationale in favor of regulation is that a company marketing its genetic test as health information should be required to demonstrate the information is correct and reliable. More debates arise from this point about what is correct and reliable and who should determine it. 23andMe insists that the FDA needs to set clear guidelines on this technology before it is feasible for them to comply.

That, in essence, was the purpose of the ongoing communication between the FDA and 23andMe. To many people, it appeared strange that 23andMe all of a sudden ceased talks with the FDA. Some have hypothesized that it was a marketing ploy, and one that seems to have worked thanks to extensive media coverage. While it is too soon to determine their motive for severing communication, currently 23andMe has resumed talks with the FDA and halted their health-related genetic reports (ancestry is still available). The CEO Anne Wojcicki commented that their “goal is to work cooperatively with the FDA... to make sure consumers have direct access to health information in the near future.”

It will be interesting to watch this process unfold. In the future personal genetic tests will become more popular as our knowledge of human genetic variation and disease grows, so the regulation of 23andMe will be crucial to set the standard for other companies offering this service. 

What do you think about the FDA regulating 23andMe? Comments are welcome.

For additional reading, see:

 http://www.usatoday.com/story/opinion/2014/01/08/23andme-genetic-testing-fda-column/4373339/

http://blog.23andme.com/news/23andme-provides-an-update-regarding-fdas-review/

http://www.slate.com/blogs/future_tense/2013/12/13/_23andme_vs_the_fda_both_are_wrong.html



Mike Allegrezza 

Image: © Rodolfoclix | Dreamstime Stock Photos & Stock Free Images

Richard Calderone and Science Advocacy at Georgetown

Dr. Richard Calderone stopped by PSPG last week to talk about the masters program in Science Policy and Advocacy at Georgetown University. Dr. Calderone is a microbiologist with an active laboratory but he also advises lawmakers on public health issues, especially those involving infectious diseases. A few years ago Dr. Calderone started the science policy masters program which was modeled after an undergraduate certificate program in policy that already existed at Georgetown. Students in this interdisciplinary masters program take courses not only on government and policy but also science classes such as microbiology, immunology and pharmacology. About 40% of graduates are currently in policy positions at places like the EPA and Research!America while many others go on to professional school (medical, dental, law). So if you're thinking about a career in science policy you might want to check out the program!

Dr. Calderone (from Georgetown University Faculty website)

Recap: Adam Katz of Research!America- How (and why) to engage Congress as a research scientist

Adam is the Policy and Advocacy Specialist at Research!America, where he leads a variety of advocacy initiatives to make science and medical research a higher national priority. When he visited PSPG on Nov. 12th he spoke about how and why scientists, especially those in academia, should engage in the political system. Academic scientists in particular are heavily supported by federal funding and taxpayers, so it is important to initiate and maintain a dialog between researchers, politicians and the American people. Research!America has conducted numerous polls to understand the relationship between these three groups, and they have found that while Americans believe scientific research should be a top priority, the public does not have a clear understanding of how this research is funded (only a small fraction of those polled identified the NIH as the main source of basic biomedical research funding). Therefore it is important that we as scientists, taxpayers and constituents take it upon ourselves to stress to our politicians the importance of the NIH and its integral role in supporting basic science research. There are many ways to make your voice heard: through email, phone calls and even in person, as PSPG has done twice this year. Mr. Katz gave excellent tips on how to address a congressperson and their staff: thank them for past support, keep it concise, lay out your concerns and follow it with a personal story, ask their opinion and reiterate the action you'd like taken. If this type of science policy work sounds like a potential career path to you, we encourage you to attend our next speaker event on Wednesday Dec. 4th at 12pm featuring Dr. Richard Calderone, director of the M.S. program in Biomedical Science Policy & Advocacy at Georgetown University.


Penn Science Spotlight: Manipulating gene expression in single cells


One goal of PSPG is to make science more accessible to the general public. Our first science spotlight features work by Matt Churgin and the Fang-Yen lab.

Scientists who want to understand how specific genes function in specific cells need the ability to manipulate gene expression, but there are few tools that allow us to ask questions at the single cell level. At best these tools can target populations of cells, but that’s not good enough for the developmental biologist who wants to know the fate of a particular cell within an embryo. A recent study out of Penn (Churgin et al. Genes Genomes Genetics, 2013) addresses these limitations by improving on a method that relies on heat-inducible gene expression and a continuous wave laser. This type of laser constantly bombards the specimen with heat and tends to warm up not just the target cell but the cells around it, causing the gene of interest to be expressed in the wrong place. To address this problem the authors used a pulsed infrared laser that heats up only the target cell, setting the stage for single cell experiments. The authors then demonstrated that they could use this to temporarily induce the expression of green fluorescent protein (GFP) in one specific cell. They then took it a step further and showed that they could induce permanent expression of GFP that could be passed down to daughter cells. This new technique will allow scientists to have greater spatial (which cell?) and temporal (when and how long?) control over gene expression. This will help answer questions such as how the fate of cells is genetically controlled during development.

Efficient Single-Cell Transgene Induction in Caenorhabditis elegans Using a Pulsed Infrared Laser
Matthew A. Churgin, Liping He, John I. Murray, and Christopher Fang-Yen
Genes Genomes Genetics October 2013

If you are a student or postdoc at Penn and have published recently, we would love to highlight your important contributions to the scientific community on our blog. Please contact our communications coordinator.

An informal discussion with Dr. Paul Offit: recap

Dr. Paul Offit stopped by PSPG to lead a discussion on snake oil and pseudoscience and how scientists can combat misinformation. An excellent example of this issue is the ubiquitous use of dietary supplements to treat everything from colds to weight loss to depression. Dietary supplements are not regulated by the FDA and are not rigorously tested for safety and efficacy and yet millions of Americans believe that multi-vitamins and supplements keep them healthy. These daily supplement capsules are packed with more vitamins than a person could possibly get from a normal diet, and yet there is no evidence that more is better. Because supplements are unregulated, what you see on the bottle is not necessarily what you get: there have been instances in which the supplement was actually 30x more concentrated than what the label claimed, and there have been cases of contaminated supplements causing death. So why is the general public so easily fooled? Because they believe they're ingesting "natural" alternative homeopathic remedies, rather than drugs which could have side effects, when in reality these supplements are drugs themselves made by the very pharmaceutical companies people are sticking it to. How can we as scientists combat this false narrative? Dr. Offit suggests to first use evidence-based science, and if all else fails appeal to emotion. In an ideal world, facts, evidence and reason would be enough to convince people, but unfortunately that is not the world we live in.

Dr. Offit is the author of numerous books his latest being Deadly Choices: How the Anti-Vaccine Movement Threatens Us All and Do You Believe in Magic?: The Sense and Nonsense of Alternative Medicine.

 Check out Dr. Offit on the Colbert Report in 2011!

Guest post: Congress shuts down America’s young scientists



 How is the government shutdown affecting me? Well, it hasn’t… yet. But even if this shutdown is over in the next few days, its impacts will ripple through American scientific research and our innovation-dependent economy for years to come.
     No, I have not been furloughed. I am free to keep doing my research since I work in a university lab which are usually state or private institutions. However I, like the vast majority of American scientists (and for that matter most scientists world-wide), work with federal grant money. We scientists have to compete incredibly hard to get those grants, and the process is long and arduous. On October 1st, the main grant funding departments were shut down including the National Institute of Health (NIH) and National Science Foundation (NSF). It takes a lot of work for them to sift through the thousands of brilliant grant applications to find the absolutely most brilliant and promising ones. Since many steps of this process need to be planned months in advance, and are not easily rescheduled, their operations will be severely delayed.
     My advisor (my boss, the head of the lab) is a new professor, and she trying to get her first major grant. You basically can’t keep running a lab without one. Just before the shutdown she was told by the NIH that her application scored exceptionally well, and will most likely get funded. However, I’ve chatted with others, one of whom was in the exact same situation during the previous shutdown back in the 90’s, which only lasted 3 weeks. Yes, they were finally awarded the promised funding, but it was 16 months late. Also, on a more personal level, I have no idea what will happen with the one small grant I was planning to apply to as a PhD student. I’ll still apply, but those kind of delays could mean that I graduate too soon to use the funding, even if they awarded it to me. This spotty funding is problematic when you want to, say, plan and then actually accomplish interesting experiments. In short, it makes it very hard to do our jobs.
     Therein lies the biggest problem--the uncertainty. We just don’t know what will happen in the near or distant future, so we don’t know how we should be using our funds most effectively. For some scientists, the consequences of the shutdown are immediate. NIH scientists are now indefinitely barred from entering their laboratories while field researchers may be forced to delay or even skip their next data gathering expeditions. There are already hundreds of personal accounts of how the shutdown will affect scientists and their work1.
     Even worse is the fact that science in America is actually taking a double-hit: the effects of the shutdown will occur on top of the fact that members of congress have successfully pushed to slash funding for the NIH and NSA, which directly translates fewer and smaller grants given to researchers. These budgets used to grow a little every year, or at least track inflation, helping America stay on top of health technology and innovation. But the budget was recently reduced this year by 5%, and some members of congress are proposing for a further 10% cut. It is scary times to be a scientist in training. I have no idea where funding levels will be when I try to start my own lab in a few years. It is already competitive out there, but the number of positions will probably shrink even further.
     I just want to get everyones’ head on straight about this; the political games congress is playing will affect us all for years to come, from stunting the careers of young scientists, to dulling America’s scientific, technological and economic edge.

So, how is the government shutdown affecting you?

TL/DR: The shutdown is blowing it for American science for years to come.

-Ryan G. Natan, 4th year PhD candidate in the Neuroscience Graduate Group
                 
      Ryan works in UPenn’s Laboratory of Auditory Coding studying how the auditory cortex helps us notice changes in sounds we hear and how we get used to repetitive sounds. 
     1) http://www.reddit.com/r/askscience/comments/1nikj/scientists_please_discuss_how_the_government/

Invited Speaker Dr. Harvey Rubin on "A Proposal for a Global Governance System for Infectious Diseases”

Michael Allegrezza

It’s easy to forget about infectious disease when one has access to quality healthcare that includes vaccines and antibiotics for most major pathogens. But infections still account for 22% of all deaths worldwide. In the developing world, it is far worse. For instance, over half of all deaths in sub-Saharan Africa are from infectious diseases. While many researchers are using science and technology to combat this problem, others have noticed that creating international policies for monitoring and controlling infectious disease would also greatly decrease mortality and minimize global outbreaks. 

In June, Dr. Harvey Rubin gave a talk entitled “A Proposal for a Global Governance System for Infectious Diseases” to members of the Penn Science Policy Group. In addition running a research lab, Dr. Rubin has established himself as a critical intellect on the topic of global disease and acts as the Director of Penn's Institute for Strategic Threat Analysis and Response. His publications and testimonies to various bureaucracies offer credibility to his opinions, but it is the real-world application of his insight into vaccine distribution that gives him the most authority.

Vaccines are an enormously effective way to prevent infectious disease. Unfortunately, access to vaccines is limited in certain areas of the globe, specifically places that don’t have a power grid, as vaccines need to be kept refrigerated. Powering the refrigerator requires access to electricity, which is unreliable in remote or under-developed areas. Dr. Rubin’s solution: use the excess energy generated by cell-phone towers, which basically cover the globe (as he puts it, “there are more cell phones in the world than there are toilet bowls”), to power vaccine refrigerators. This simple solution could save 5 million lives annually. After working with local governments, non-profits, and commercial organizations, Dr. Rubin and his team have established a pilot program in Zimbabwe and hope to begin another soon in India. You can check it out here: http://www.energizethechain.org/

Dr. Rubin explained that there is also a challenge ahead to monitor and control global outbreaks of disease.  Even with the recent scares of influenza and SARS outbreaks, there are still no international treaties related to infectious disease. Problems such as the rise in antibiotic resistant pathogens, unsafe and poorly secured containment facilities, political instability, and minimal drug development incentives are creating a climate for global disease outbreak. But these problems present opportunity: each problem has policy-oriented solutions that could be used to minimize the risk of such an outbreak. Towards that end, in 2009 Dr. Rubin published a proposal in Current Science detailing four interconnected components where policy could help shape global disease monitoring and control, which he discussed with us during his presentation.

To wrap up the discussion, Dr. Rubin shared sage advice for those interested in making a career out of this work: “Don’t do what I did.” The demands of academic research will quell this type of branching out until tenure is obtained. He mentioned that good places to develop a career in international health policy can be found outside academia in government and NGOs. Most importantly though, “be an expert in something; then people will believe that you know what you are talking about.”



Whole genome sequencing - a policy discussion

Whole genome sequencing and the future of medicine: A discussion of policy implications ranging from genome privacy to designer babies.

Michael Allegrezza

The presidential race of 2016 was tight. That is, until information was leaked that Hillary Clinton has a genetic predisposition to early onset Alzheimer’s disease. How her genetic info was obtained is unknown; her campaign staff followed strict protocols to collect and destroy everything she touched – toothbrushes, bed sheets, cups. It may be that years before she was a candidate, a cunning opponent attended her book signings and patiently preserved the pages she penned until the moment was ripe. But the method and legality of the leak is irrelevant. Unlike in a jury case, one can’t instruct an entire electorate to ignore information that may have been illegally obtained. Thus began a new era of American politics: no longer was it simply video or written evidence of your past that was under scrutiny. Now, the DNA code prophesizing your future was also campaign material.

Presently, the above scenario might sound like science fiction. But an emerging technology called whole genome sequencing (WGS) is poised to blur the distinction between imagination and reality. WGS is the ability to decode the entire DNA sequence that makes an individual unique. While this technology is still too expensive and cumbersome to be applied on a population scale, the cost-per-genome is dropping at an astounding rate, much faster than has occurred with computing power.  WGS is beginning to enter the clinic as more physicians use it to help with diagnosis and treatment determination, but policies related to WGS are still in their infancy. In May, the Penn Science Policy Group gathered to discuss the emerging use of WGS and the implications it will have for medicine and society.

Privacy is a huge concern. One’s genome is like their medicine cabinet, except it reaches both backward into the past and forward into the future. The opening scenario might seem a little dramatic and highly specific, but there are already indications showing that government officials take measure to protect the President’s DNA and collect DNA samples from foreign leaders. Scenarios can be envisioned within the lives of civilians, too. Imagine a child custody case in which WGS showing a parent’s predisposition for cancer or neurological disease is used as evidence against their fitness for parenting.  The Genetic Information Nondiscrimination Act of 2008 (Pub.L. 110–233, 122 Stat. 881, enacted May 21, 2008, GINA) was enacted to prohibit the use of genetic information in employment and health insurance situations.  However, it does not cover life insurance or long-term care insurance, which is already proving problematic for some. How this law would apply to genetic sequencing obtained covertly or used for persuasion in civil courts or the public sphere is unknown.

Even consenting to undergo WGS has some privacy risks. A study published this year re-identified 50 individuals from de-identified genetic sequences using public access information like age and surname. Although the group of samples used represents a low hanging fruit for such hacking, it demonstrates the need for more focus on protecting anonymity of sequencing information.

A 2012 report to the President indicated that stronger baselines for privacy of WGS data are needed. Privacy protections at the state level are inconsistent. And although samples collected through federal agencies like the NIH and CDC have federal laws mandating confidentiality, privacy, and security, “currently, there are no overarching federal or industry guidelines indicating how commercial genetic testing companies should operate, what privacy controls they should implement, or what limits they should put on the use of genetic data and information.”

One hotly debated topic is the ethics of incidental findings from WGS. When a physician orders WGS because it may help explain a patient’s particular medical condition, they are “looking” for relevant information. However, many more things may be found in the genome that are not relevant to the original reason it was ordered, but may have health consequences for the patient or their family members. These consequential discoveries are known as incidental findings.

What happens when results incidentally find that a patient carries the gene for Huntington’s disease? Or a gene that predisposes them to colon cancer? Or for adverse reactions to certain anesthetics? Recently the American College of Medical Geneticists published recommendations urging that every WGS result be analyzed for the presence of mutations in 57 genes that are highly predictive of diseases with actionable interventions. ACMG recommends these findings be reported to the patient regardless of consent and age (includes children), and the patient’s only chance to not receive this information is to decline sequencing. Opponents argue that this practice goes against patients’ right to refuse unwanted medical tests and information, even if it might be beneficial. Opinions on this topic among PSPG members were diverse and conflicted, which showcases the need for thorough public discourse on this issue.

Additionally, there are applications of WGS that warrant discussion. Even seemingly benevolent intentions, such as preventing genetic disorders, can conjure up fears of a deterministic society rife with prejudices based upon genetic identity. The 1997 movie Gattaca portrays a grim vision of the future where fertilized embryos are screened to deliver babies with desirable qualities like a certain gender, perfect vision, and resistance to addiction. Children born naturally are considered invalids and forced into a working class that supports the more glamorous careers of those with superior genes. 

But this scenario is pretty far-fetched, right? Actually, not quite. A technique called preimplantation genetic diagnosis (PGD) already exists to enable carriers of certain genetic disorders to have healthy babies – the first child born from this procedure is now 23 years old. The real concern is that this technology will be used beyond preventing terrible diseases to selecting merely preferential traits. Some countries have enacted laws to prevent this application, such as the UK and Canada, but in the US there is no federal regulation of PGD. In fact, some parents have even purposely selected for children that are deaf. The two largest obstacles for widespread use of PGD are the cost (it must be combined with in vitro fertilization) and our lack of knowledge about the complex genotypes that determine many of the desirable qualities depicted in Gattaca. However, given the pace at which science and technology move, these possibilities should not be underestimated when considering policies for the future.

When the first human genome was sequenced, a wave of excitement rushed through the media as it anticipated a new era of medicine, one that was tailored to the uniqueness of our individual genetic identities. In a word: “personal.”  Personalized medicine has thus far been a disappointment, but that should have been anticipated. Only when the cost of genome sequencing and analysis drops to a point where it can become commonplace can we expect to benefit from its potential. 

Will WGS reach the tipping point soon and become a standard part of medical practice? It seems that although the cost is dropping, other limitations exist that will limit widespread integration of WGS in the near future. Many of the biologists in our group identified the bottleneck of WGS as the analysis and interpretation of genomic data. Trained professionals that can interpret and communicate this massively complex information are at a premium, and the clinical interpretation is still mostly meaningless. Nearly every genetic association identified with common diseases is too insignificant to be clinically useful. As a result, right now genomic data is more confirmatory than predictive. That is, knowing a patient’s DNA sequence is useful in diagnosing the cause of a disease, but rather useless in predicting whether or not it will develop. WGS on a newborn is not a crystal ball, yet still this information could assist in medical care throughout a person’s lifetime, making it an attractive companion to a patient’s medical record that will become more valuable as science progresses.

Although maybe not for another decade, we will eventually see the tools, professions, and knowledge of WGS progress to the point where it transforms medicine and everyday life. Current policies regarding WGS are lacking, varied, or incomplete. Federal regulations are needed that ensure security, privacy, and informed consent of WGS and restrict its malicious use while protecting the liberty of individuals and the benefits obtained from it. A future of personalized genetics is inevitable; it is our duty now to ensure we enter a future that uses WGS for minimal harm and maximal gain.

Next Penn Science Group meeting will be on Tuesday, April 30th from 5:30-7pm in 1412 BRB.
Come hear about all the recent advocacy efforts by the Advocacy Subgroup!

Penn Science Policy Group at the Symposium!


For this year's Penn Science Research Symposium, the Penn Science Policy group decided to have an active presence at the event. With the help of Sima Patel and Mike Allegrezza, a poster was quickly constructed to highlight the group's activities along with the recent DC Advocacy Day.  Folks like Chris Yarosh (pictured), were generous enough to man the poster during the poster session and field questions.

Mike also played a pivotal role in introducing the poster to staffers from Sen. Toomey and Sen. Casey's office. This was done so these staffers would now be aware of the  group's presence on campus and to help set up networking events in the future.  Mike also showcased some of the other posters to the staffers to help demonstrate how NIH dollars are being used for the development of new treatments such diseases like Alzheimer's and cancer.

Another highlight of the Symposium was  having House Rep. Chaka Fattah deliver closing remarks. Rep. Fattah really urged the crowd to get the word out about the latest in scientific progress at Penn-and that type of information would be sure to hit the walls of Congress. Pictured below is House Rep. Fattah at the conclusion of his speech, shaking hands with Shaun.

Rally for Medical Research


Check out our group at the Rally for Medical Research! (L-R), Mahlet Abera, Unknown, Mike Askenase, Mat Wimmer, David Reiner, Wade Hayes, Jenessa Smyth, Lindsay Foresee, Mike Convente, Joe Jordan, Chris Yarosh, Erika Hendel, Skye Geherin, Kevin Yu, Serena Dollive, Shaun O'Brien and Julie Crudele

The DP has a great recap of the latest Rally for Medical Research Hill Day which occurred in late September. UPenn students and postdocs made the trip down to DC to make the case for biomedical research funding to Congress and their staff. We were joined by other scientists, physicians, patients and patient advocates who helped get the message out that deep arbitrary cuts to basic scientific research funding is a short-sighted and ineffectual solution to the country's fiscal problems.

The Daily Pennsylvanian :: Students lobby legislators for science funding

PSPG looking snazzy on the bus to DC

Recap of visit with Rep. Charles Dent (R-15 PA) by Jenessa Smith


Charles Dent (R)
15th District PA Congressman

The meeting with Representative Dent’s staffer Lauren Kent –Stevens went very well. She was receptive to our messages of urging Rep. Dent to continue his commitment to prioritizing the NIH. She reiterated that Rep. Dent is a member of the appropriation committee that allocates funding for agencies such as the NIH and that although he cannot sign HR1301 to send to himself, he would respond favorably to the measure once it reaches his committee. In addition, Ms. Kent informed us that Rep. Dent co-chairs the House ethics committee, which informs a bipartisan group of representatives about novel and exciting research by inviting scientists and innovators to speak at meetings. Ms. Kent was interested in our research and about the grant finding and application process. Finally, Ms. Kent urged us to reach out to state legislators that do not see the importance of NIH funding in their states, simply because they may not receive NIH funding to institutions or companies in their respective states or districts. She wanted us to inform people that NIH funding has provided us with many life-saving treatments and techniques that would not be available today with support from the NIH. In all, it was a productive meeting and we left our message to reverse the sequester-enforced NIH budget cuts and that NIH budget must increase in the future.    


Robbing Peter to Pay Paul-How the Federal Sequester will damage our National Role as Medical Innovator

by: Nicole Aiello, Penn Biomedical Graduate Student

The United States federal government is poised to impose arbitrary cuts on the National Institutes of Health (NIH) budget, as a part of a series of global budget reductions termed “sequestration.” These cuts will stifle medical progress, kill research jobs, and fail to reduce the national deficit in a meaningful way. Sequestration will trickle down to negatively impact thousands of research facilities across the country that rely heavily on federally funded grants to address the fundamental scientific questions that drive medical breakthroughs. Although the University of Pennsylvania is a private institution, biomedical research labs here operate almost exclusively on grants awarded by the NIH, which is poised to endure a $1.6 billion reduction in funding on March 1st if Congress fails to act on the looming sequestration.

The NIH distributes more than 80% of its funding to researchers at universities and other institutions all over the country to support biomedical research. Its budget has been flat for the last ten years, and as inflation continues to climb each year the NIH can do less and less with its money. If the sequestration is allowed to occur, the NIH will lose 5.1% of its already stagnant budget, which means that significantly fewer scientific projects will be funded. These are projects that address fundamental questions about how diseases like cancer, Alzheimer’s and diabetes arise and how they might be targeted for treatment.  Importantly, these proposals often would not go forward without federal funding, because profit-driven private sector companies do not consider them a cost-effective investment.

The competition surrounding NIH funds is already at an all-time high and will only become more cut-throat if the sequestration is allowed to occur. Labs in academia, even though they operate within a university, rely almost entirely on grants. The loss of financial support would force some labs to shut their doors, halt critical biomedical research, and deter young scientists from pursuing careers in academia. Job prospects for science PhD holders have been grim in recent years, with a steady flow of incoming graduate students and dwindling opportunities for traditional academic positions, and the situation will become even more dire if the NIH budget is cut. As a graduate student waiting to hear back about a federal grant application, I can attest to the uncertainty surrounding the current funding situation. Because Congress has pushed the decision on sequestration to March 1st, my application exists in a state of limbo until the NIH receives its budget for 2013. There are tens of thousands of researchers in the same position all over the country, many of whom desperately need these grants to carry on with, or even begin, their research projects.

Cuts to the NIH budget will have an obvious negative impact on the scientific community, but they will also indirectly hurt the economy, especially here in Philadelphia. Federal investment in research is a large source of support for academic universities, which rank among the top employers in the Philadelphia region. For instance the University of Pennsylvania, which received $472 million in NIH awards in 2011, is the 2nd largest employer in the region, with Temple and Drexel also falling in the top 50. These universities drive the local economy, and they all directly benefit from publicly funded research. This means that the less support the NIH can give to our universities, the less support they can give to the Philadelphia community.

Unfortunately, deep cuts to the NIH budget will not only hinder medical progress but will only amount to a mere 0.04% in savings on the national budget. To put that into perspective, it’s like saving a nickel on a $100 purchase. Politicians have been throwing around the buzzwords of “shared sacrifice,” but we as a people should not have to forfeit the future of medical research in a desperate attempt to balance the budget. Indiscriminately slashing research funding is a bad short-term solution for reducing the national deficit, with even worse long-term repercussions for the economy and the health of our nation.

Time to politicize Science Research?

By: Alana Sharp, Penn Biomedical Graduate Student

There has perhaps always been a bizarre disconnect between scientific research, the general public, and politics.  The story of measles is a fitting example.  A highly contagious viral infection first described as early as 68 AD, measles was once “as inevitable as death and taxes” (Babbott Am J Med Sci 1954).  In the 1971, Merck & Co. began marketing Maurice Hilleman’s combined vaccine for measles, mumps, and rubella; today, MMRV is a CDC-recommended vaccination, and measles is no longer considered endemic in the United States.  However, due to the reverberations of a now-retracted study linking childhood vaccinations with developmental disorders, an obstinate anti-vaccination movement persists in the United States.  In the past twenty years, enclaves of children unvaccinated due to parental refusal have permitted sporadic outbreaks of the disease.  Such outbreaks have been thus far contained by surrounding vaccination-compliant communities; however, the growth of this anti-vaccination movement bodes ill for the future eradication of measles.  In this way, one of our greatest medical advances has thus been sullied and distorted, to the detriment of both childhood health and the reputation of the scientific community.

Another illustration of the divide between science and politics is that of anthropomorphic climate change.  The now renowned assessment by the Intergovernmental Panel on Climate Change (IPCC) in 2007 predicted significant changes to global temperatures, weather patterns, sea levels and acidification, and losses to biodiversity.  This report has repeatedly been shown to be overly conservative, as new data suggest faster Arctic ice melting and temperature rises, and reveal broader detrimental impacts to ecosystems, food safety, and political stability.  In the realm of American politics, these warnings are generally unheeded.  With the exception of occasional head nods by Barack Obama and the political left, the impetus to shift toward renewable energy sources and green infrastructure has been weak and unsustained.  Indeed, a significant contingent of our political system and mainstream media maintains that global climate change is a hoax, and an untold network of unreported funding continues to nurture anti-science organizations and promulgate propaganda and misinformation.

The risks in politicizing science are significant.  To the researcher, they may be personal and severe, as demonstrated by the ‘Climategate’ attacks of 2009 and the firing of the NWS scientist last month.  Some believe that the politicizing of scientific discovery will tarnish the reputation of scientists as unbiased purveyors of truth.  Furthermore, bringing research to the general public is a time-consuming pursuit, made worse by an educational climate in which politicians threaten to ban critical thinking and wherein sensitive scientific topics are altogether ignored.  In contrast, it is much easier to research tissue engineering without delving into the controversies over human embryonic stem cell research.  It may seem nobler to publish on the therapeutic benefits of entheogenic compounds without delving into drug policy reform.  The scientist may feel better trained to produce data on climate change, or to develop cancer treatments, than to contribute a voice to the politics of carbon taxes and Medicare reform.  I argue, however, that this reluctance by scientists to address the political ramifications of their research, and confront those that would usurp and pervert it, is at best an act of self-preservation and at worst an act of cowardice.  

This issue will come to a head March 1, when Congress must cut $85 billion in federal spending.  This spending ‘sequestration’ will produce lasting effects to federal funding of scientific research, with cuts of 5.0-8.2% to funding agencies including the NSF, NIH, FDA, NWS, DOE, NASA, and more.  Superimposed on a largely stagnant funding climate, these cuts will produce significant changes to research funding.  The NSF is expecting to award fewer new grants, and the NIH will reduce the size of existing research grants; furthermore, the funding of large projects may be rejected in favor of safer, incremental proposals.  We can expect the career trajectory of young scientists to suffer and for graduating PhD students to struggle to find employment.  Academic institutions with meager endowments will suffer, and the United States will continue to drop in international rankings of education and scientific productivity.  

If there was ever a time for the scientific community to speak up, the time is now.  Congress will not make our case for us.  The public will not make our case for us.  It is for us to contribute to the dialogue and remind the country that science is valuable and inextricably linked to American progress.  We must explain that many of our great intellectual steps forward were initially preliminary projects nurtured by federal grants, most of which were deemed too risky to fund by private corporations.  We must explain the relationship between the scientist in the lab and treatments for cancer, diabetes, and heart disease; we must demonstrate the link between the technologies of our future and the funding that will make them realities; and we must elucidate the economic, intellectual, medical, political, and security payoffs of research.  In the days to come, we must make our voices heard.




The Sequester and its impact on Medical Breakthroughs

I believe that we are entering a new era of hope in medical research.  Seemingly every day we hear about new and exotic therapies that read more like science fiction than scientific reporting: immune cells are removed from our bodies and re-engineered to destroy cancer; patients are cured of AIDS by receiving bone marrow transplants; children are given vaccinations to prevent the development of cancers when they become adults; and massive genetic analyses are providing insight into the causes of disease and directions for developing the therapies of the future. 
It is therefore deeply concerning that in the midst of such promise and growth, we stand at the edge of a deep precipice of cuts to research funding.  The United State’s federal debt has ballooned into a number that is increasingly difficult to look at, and en lieu of rational fiscal policies and bipartisan compromise, Congress has instead backed itself into a corner called “sequestration.” 
Beginning in 1917, as part of a rarely discussed operational formality, federal budgets were limited by a pseudo-arbitrary debt ceiling.  Without much discussion, this limit has every year since been reached and subsequently raised.  In 2011, however, an impasse was reached wherein the national debt was suddenly decried as a threat to the nation’s future.  At the hand of overzealous small government advocates and divisive partisanship, the Budget Control Act was enacted, resulting in immediate federal budget cuts totaling $900 billion.  In conjunction, a “super committee” of congressional representatives was assembled and assigned the task of cutting $1.2 trillion from the national budget.  This exercise ended in failure.   
In the wake of this disappointment, the task of making the $1.2 trillion spending cuts has fallen to Congress.  In what has been termed the ‘nuclear option,’ failure to institute these cuts will result in sequestration, wherein draconian across-the-board cuts will be instituted automatically.  Sequestration is currently slated to go into effect March 1.
The primary medical research funding agency, the National Institutes of Health (NIH), risks disproportionate funding cuts if sequestration is permitted to occur.  The NIH’s budget has been neither adjusted for inflation nor increased in the last decade, an oversight unseemly in light of the increasing prevalence of preventable disease, the emergence of novel infectious disease, and the need for improved therapeutics for undertreated disorders.  To compound this flat-lined funding with budget cuts is shortsighted and reprehensible.  Furthermore, it is inefficient: the proposed 8% cut in NIH funding constitutes an inconsequential 0.08% of the federal budget.  The NIH funds our medical institutions, pays for our medical research, and supports graduate education for the future leaders in basic and clinical sciences.  To decry the failings of our educational system and urge for a larger, more competitive scientific workforce, while simultaneously gutting the NIH’s funding, is simply senseless.
Furthermore, the economic payoff from investment in scientific funding is disproportionately high.  Investment in biomedical research pays off in many ways: in many states, research facilities are a significant employer, which is invaluable in periods of high unemployment.  Development of new and improved medical therapies generates savings in the providing of medical care, a worthwhile aim when healthcare costs threaten many families’ savings.  Many pharmaceutical and private medical corporations, economic drivers and major employers themselves, received public funding in their nascent development.  The preparation of vaccines and treatments for emerging diseases is essential for guarding our national security against bioterrorism.  And, really, who wants to lose a loved one because the medication that could have treated them was halted mid-development due to lack of funding?
I urge everyone in America to stand up and demand that medical research not be subjected to these budget cuts.  To allow sequestration to proceed would be a thoughtless step backward, but it is within our power to demand of our elected officials that these cuts not be made.  Perhaps Barack Obama said it best, in 2009: “At such a difficult moment, there are those who say we cannot afford to invest in science, that support for research is somehow a luxury at moments defined by necessities.  I fundamentally disagree.  Science is more essential for our prosperity, our security, our health, our environment, and our quality of life than it has ever been before.” 

by: Alana Sharp, Penn Biomedical Graduate Student


Save the NIH from the Sequester!
On March 1st, sequestration will eliminate $1.6 billion from the National Institutes of Health (NIH) budget. The deadline is fast approaching, and Congress has failed to put forth any alternative plans for avoiding the drastic cuts sequestration would entail. As a biomedical graduate student, whose research and training are supported by the federally funded NIH, these cuts deeply concern me. Although many argue that spending cuts are necessary in an era when the country has amassed trillions of dollars in debt, austerity does not translate well to medical research nor to the well being of the general public. The amount cut from the NIH would save the federal government 0.042% of the national budget, but would have devastating effects on the economy, medical research, and the training of a new generation of scientists and medical doctors. Is the paltry amount of money saved really worth all that will be lost?
It is impossible to estimate how a loss of $1.6 billion would affect our lifespan, health, or quality of living. This money funds research that develops treatments for cancer, diabetes, and countless other diseases. Since 1962, NIH-funded research has played a role in the development of 153 FDA-approved drugs, vaccines, and new indications for currently approved medication. Furthermore, without the NIH, basic scientific discoveries that fuel new treatments will not happen. The basic research funded by the NIH is essential to designing the best drug treatments and therapies, but because they are long-term investments and do not guarantee a high profit margin, private industry is wary of investing its time and money in these projects. Thus, sequestration would both harm the NIH’s ability to promote new areas of discovery-based research and indirectly impact the NIH-dependent pharmaceutical industry.
Under sequestration, the NIH is slated to lose 5.1% of its annual $31 billion budget, a sum of $1.6 billion. This loss would have a devastating impact on the nation’s economy, as the NIH is a major source of employment and expenditures, and essentially acts as the base for the U.S. medical innovation sector. In 2011, the NIH contributed $61 billion to the U.S. economy, and supported over 432,000 jobs. In spite of the fact that government funding for health research and development has been stagnant over the past decade, the NIH has proven that the returns it generates are well worth the investment.
If the sequester takes effect, a substantial number of important research projects will be rejected simply due to lack of funding. Only the top 18% of research projects in the country acquire coveted NIH funds, which means that many worthwhile projects are already being cast aside. Under sequestration, the grant success rate would drop to 14%, at least 20,000 jobs would be lost, and 3 billion fewer dollars would be funneled into the economy. To put the $1.6 billion figure into even sharper perspective, this is double the amount currently invested in training grants and fellowships. Consequentially, many of our most talented young scientists will take their skills to other fields, or leave the country altogether, creating a lost generation of trained biomedical researchers and doctors.
Congress seems inclined to let the sequester pass, as a means to score political points for each party. Congress needs to be reminded that biomedical research is largely a non-partisan issue, and historically has been supported by both Republicans and Democrats. Both parties understand how biomedical research can reduce the cost of healthcare, and representatives from each political party have indicated that the NIH plays a crucial role in such endeavors. House Majority Leader Eric Cantor (R-VA) has said, “Doing what we can to facilitate medical breakthroughs . . . should be a priority. We can and must do better.” If Congress truly believes that federally funded advances in medical research are worthwhile, they should act quickly to ensure that the NIH is spared the results of sequestration. 
Spending cuts for federally funded medical research affect everyone to some extent, as most individuals have experience with a family member that has a chronic disease or illness. The most recent statistics collected by Research!America found that nearly 50% of Americans think the government isn’t investing enough resources in medical research, and 54% would be willing to pay slightly more in taxes provided their money went directly to medical research. I urge you to take this same passion and contact your congressmen about sequestration. The future of the NIH, the healthcare driven economy, and medical research in the U.S. depends on your support.


 By Ellen Elliot, Penn Biomedical Graduate Student

Check out our first op-ed piece! (Originally published at the Daily Pennsylvanian http://goo.gl/cZpwk)

HOW YOU CAN SAVE SCIENCE!!!


Two weeks is all that remains before the largest automatic federal budget cuts take place, which could have devastating affects for the Penn Community. If these automatic budgets cuts occur, expect Penn’s ability as a science innovator to be hampered as the sequester would slash billions from the National Institutes of Health (NIH), the National Science Foundation (NSF) and Graduate Medical Education (GME) programs-all programs that fund science research at Penn.

How could Congress and the President allow this to occur? The sequester was born out of two years of political fights over the national debt and federal spending habits. These automatic cuts were constructed as a nuclear option to force both parties into negotiations over federal spending, by having severe financial consequences if it was ever triggered. However the sequester mechanism was triggered in the fall of the 2011, as a bipartisan budget committee failed to compromise on how to rein in federal spending.

These automatic cuts call for equal across the board cuts to military and non-military agencies. With the recent Taxpayer Relief Act of 2012, the automatic sequester was delayed till March 1st, 2013, with the hope that a polarized Congress could figure out a solution.  At this point in time, non-military agencies are slated to lose $42.5 billion in funding, or roughly 5-6% of their budgets this year. Additional reports are now suggesting that Congress is also content to let sequester occur, which could have dire circumstances at Penn.

Penn biomedical research labs depend on funding from the NIH, which is slated to lose at least $1.6 billion this year-a savings of less than 1% of the federal budget! This would severely hamper the discovery of advances in basic and clinical science. Penn is a leader for cancer immunotherapies, thanks, in part, to Dr. Carl June’s Phase I clinical trial (NIH funded) that resulted in amazing regression of lymphoma in pediatric patients. Without the initial NIH investment, this trial would have been nearly impossible to conduct, as pharma companies deemed it too risky to invest in.  Breakthrough vaccine development has also occurred at Penn, as exemplified by Dr. Paul Offit’s pediatric vaccine to rotavirus, another example of research that would not have been possible without NIH funds. Thanks to the sequester, reduced NIH funding will have a chilling effect on new therapeutic development at Penn and possibly drive away talented individuals from scientific careers.

Reduction in NIH funding would severely impact the training of the next generation of biomedical scientists and could impact the U.S.’s position as a leader in innovation in the coming decades. In addition, Graduate Medical Education, or residency training, would also be hampered due to a 2% cut in Medicare and thus is a real concern for Penn Medical Students and Residents. This would also undercut the mission of the nation’s #1 Children’s Hospital. The National Science Foundation (NSF), which funds researchers in the Engineering Program and the School of Arts and Sciences, would also lose $300-500 million (5-6%) this year.   Collectively, these cuts have the potential to create a lost generation of newly trained scientists, engineers and clinicians.

In light of this information, the Penn community needs to tell Congress and President Obama how important this funding is to the viability of this institution and to Pennsylvania as a whole. Pennsylvania is one of the top 5 recipients of federal research dollars. The biomedical industry alone creates millions of dollars of revenue in the state and more than 350,000 jobs including those due to the ripple effect. Continued support of research is good for the university and it is a smart investment for the economy.  Obviously the sequester will be a job killer in this struggling economy.

We need you to act, in order to avoid the full severity of these automatic budget cuts. You can e-mail your Congressperson through this link- http://goo.gl/to9Pv

We also welcome to you to join the newly formed Penn Science Policy Group, to learn more about this issue.  This coalition of science graduate students and post-docs are contacting our Congressional leaders to promote the necessity of continuing to invest in American innovation. To learn about this group, email at penn.science.policy-at-gmail.com.