Tag Archives: science policy

Now what? Science Activism Beyond the March

The effects of the March and the outpouring of support for scientific research and evidence-based policymaking are already showing, as exemplified by the increase in NIH funding approved by the Congress instead of the Trump administration’s proposed cuts. However, this should not make us complacent in our demands. The EPA’s scientific advisory board is being replaced by representatives of agencies it is meant to regulate, climate change action is still being hindered and the environment is increasingly threatened, and the anti-vaxxers just succeeded in invoking an outbreak of measles in Minnesota. As Dr. Harris Berman, along with the deans of other medical schools in Boston, recently wroteWe must harness this energy and ensure that the March for Science on Saturday marks the beginning of closing the rift that got us here in the first place”, we should also ensure that this march becomes the global movement it is meant to be. The enthusiasm & sense of urgency that brought out the scientists out on the streets on April 22 should be harnessed to battle the anti-science hysteria currently spreading across the nation. The only way to do it would be to not isolate, but engage the public, to whom we have a responsibility for putting their faith in us, in meaningful ways to improve science literacy through relevant communication. Here we present some additional resources for you to get engaged in science activism after the March:

  • Communicate Your Science – Increasing visibility of scientists and science among the general public would help to shore popular support for scientific research. The #ActualLivingScientist campaign on social media helped dispel the alienation between the scientific community and the people who support their work. Share the importance of your work by writing or speaking about it online or offline. For example, check out The People’s Science’s new initiative, The Field Project, where researchers are encouraged to write a brief summary of their work for the “broadest possible audience”. Talk about your work and how you got into scientific research through our “Humans of Sackler”. Or even better, write for us if you want to practice your writing and communicating skills. Visibility Matters!
  • Volunteer in Science Outreach – The greater Boston area provides ample opportunities for science outreach programs, especially with large-scale events like Cambridge Science Festival. On a smaller scale, you can volunteer for the BIOBUGS, the Brain Bee, the annual mentoring opportunity at Josiah Quincy Upper School and more. Keep an eye out for emails re: these events & more from the Sackler Graduate Student Council.
  • Engage in Policy Action – Since the election, scientists have started to take on political action themselves. One such group is 314 action, who seeks to elect “more leaders to the U.S. Senate, House, State Executive & Legislative offices who come from STEM backgrounds”. The Union of Concerned Scientists, who have been fighting for evidence-based policy to solve social & environmental problems since 1969, hosts an advocacy resource where you can learn how to take action with or without getting involved with the organization. If you would like to write about policy, this writing program by Rescuing Biomedical Research can be your first foray into that world. You can also get involved with the new student organization at Sackler, Scientists Promoting INclusive Excellence #@ Sackler (SPINES), which seeks to increase visibility of minority scientists among other goals.
  • Educate Yourself – If you are not sure on how best to participate in science activism, you can start by learning. Follow the official March for Science blog to learn how the movement is advancing. Check out this online class being offered by faculty from University of Michigan on how to “more effectively discuss knowledge”. Get involved with the Emerson Science Communication Collaborative between Emerson media students and Sackler students. For an even extensive gamut of resources, the American Association for the Advancement of Science (AAAS) has an online toolkit for you to start getting involved!

If you know of any other organizations or groups involved in science literacy, education, outreach & communication, please leave us a comment below!

Reflections from AAAS 2017 – Research During the Trump Administration

The theme of this year’s American Association for the Advancement of Science (AAAS) meeting in Boston was “Serving Society through Science Policy.” As we move through the first few months of a new administration, this gathering could not have been more timely. While this conference is diverse with topics ranging from gene editing to criminology, the undercurrent of the meeting was anxiety over what will happen to research under the Trump administration.

What is science policy even? Most in this audience probably think of it as how much money research gets budgeted and occasional rule changes on whether fetal stem cell research can occur. Generally, science policy is the set of federal rules and policies that guide how research is done. Science policy can be split into two general frameworks: policy for science and science for policy. These can often feed into each other. For example, policy for science provides funds for climate research. The data and conclusions derived from that research could then inform new climate related policies. That would be science for policy. While science itself is an important input into the whole process, other considerations such as economics, ethics, budgets and public opinion are also inputs. As a scientist who considers science as a method of interpreting the world, my biases had not let me consider non-science inputs for science policy decision-making. It may seem obvious to some, but it was illuminating to realize that other concerns can be just as valuable and legitimate.

As funding is a major reason scientists are concerned, I was happy to learn a lot about the place of research in the federal budget. There are some out there who believe that research in Boston will be fine no matter who is in charge because of all the industry science in the area. It’s true; around two-thirds of research and development is funded by industry. However, industry is mostly concerned with development. Basic research is primarily funded by federal money. The federal budget is divided into mandatory spending and discretionary spending. Mandatory spending does not require congress to act for programs in it to be funded. These include the entitlement programs such as Social Security, Medicare and Medicaid. Dr. Josh Shiode, a Senior Government Relations Officer from AAAS, informed us that entitlement programs are considered “third-rail” discussions by lawmakers, meaning if you touch them, you die (an electoral death). In contrast, discretionary spending requires Congress to actively fund. Most of research and development spending falls into this category.



Due to changing (aging) demographics, the percentage of the budget that goes towards mandatory spending has been steadily increasing. 50 years ago, we spent around 30% of the federal budget on mandatory spending and now we are up to 70% and increasing. Research and development generally gets around 10-12% of the remaining budget left for discretionary spending. Traditionally, increases in discretionary defense spending will correspond with a parallel increase in nondefense discretionary spending. The Trump administration has proposed increases in military spending. Given likely tax cuts and reluctance to make changes to entitlement programs, it is unlikely nondefense discretionary funding will fare well. The good news is major research programs like the BRAIN Initiative, Precision Medicine Initiative and the Cancer Moonshot were funded through the bipartisan 21st Century Cures act during the lame-duck session. While NIH and biomedical research will likely have diminished profiles during this administration, both parties are against Alzheimer’s, diabetes and cancer. What is less clear is how research performed by the EPA and Department of Agriculture will fare although initial reports are grim. Finally, repeal of the Affordable Care Act will have rippling effects, as many research universities are also providers of healthcare. It is clear that there will be a shift in culture. Under President Obama, science was elevated and scientists were regularly consulted. As former senior science adviser to President Obama John Holdren said: “Trump resists facts he doesn’t like”.

There is reluctance for some scientists to get involved in the political theater, as some believe science should be apolitical. I would argue that science is already political as science can dictate policy and policy can dictate science. What science is and should be is nonpartisan. No party has an inherent monopoly on being allies of science and scientific thinking. So what can scientists do? All politics is local and personal. The majority of Americans say they don’t know a scientist. This is an easy thing to work on. Make sure you introduce yourself to others! Visit your lawmakers and let them know that you are funded by federal money. Politicians are most concerned about their own districts and so if you’re a transplant, you likely have connections to more than one district. Try to build a relationship with him or her by seeing if you could help with anything. Figure out if you can help your local community with anything by serving on committees. Speaking of committees, know what committees your representatives are on. When communicating, think carefully about what words you use. Former U.S. Congressman Bart Gordon opined that he never called it climate  change. Instead, he called it energy independence. While branding may sound like a trivial thing to worry about, targeted story telling is extremely important. We would love for our data to speak for itself but people connect best to stories, especially ones concerning things they can relate to or care about.

If you’re interested in science policy, there are a number of good resources available to get better acquainted. The Engaging Scientists & Engineers in Policy (ESEP) Coalition has a wealth of information and resources on their website (http://science-engage.org/). In fact, they host a local monthly science policy happy hour to network and engage those interested in science policy. If you are interested in learning more about the R&D budget, AAAS has an excellent resource with analyses of federal research and development funding (https://www.aaas.org/program/rd-budget-and-policy-program). There you can also find their data dashboard to look at funding for specific agencies for different periods of time.


21st Century Cures Act: Boosting biomedical research, but at what cost?

Co-authored by Andrew Hooper & Nafis Hasan

In a remarkable display of bipartisanship, the Senate passed HR 34 and President Obama signed the 21st Century Cures Act into law on Dec. 13, 2016. The original bill was introduced and sponsored by Rep. Suzanne Bonamici (D-OR) on Jan 2015 and garnered co-sponsors from both sides of the aisle, including the support of Rep. Lamar Smith (R-TX), Chairman of the House Committee on Space, Science and Technology. The House approved the original bill in Oct 2015 and after a year on the Senate floor where the bill underwent several amendments proposed by both Democrats and Republicans, the Senate approved the bill on Dec 6 2016 and passed the bill on to President Obama to be signed into law.

This law is meant to accelerate drug development and bring cutting edge treatment to patients, revise the current status of mental health research and treatment for disorders, with a strong focus on the current opioid crisis sweeping across the nation. The law is also of significant importance to biomedical scientists as it will expand funding  for certain fields, keeping in line with the Precision Medicine Initiative launched in 2015. More specifically, the Cures act will provide funding for specific NIH innovation projects such as the Precision Medicine Initiative ($4.5 billion through FY 2026), the BRAIN initiative ($1.51 billion through FY 2026), the Cancer Moonshot project ($1.8 billion through FY 2023) and the Regenerative Medicine (stem cells) program (30$ mn through FY 2026). In addition, this law will stimulate innovative research by awarding investigators with the Eureka Prize for “significant advances” or “improving health outcomes”. The law also seeks to promote new researchers through its Next Generation of Researchers Initiative, an attempt to solve the postdoc crisis in academia. As a response to the lack of women and underrepresented minorities in STEM fields, the law also contains provisions that will attract and retain such scientists in “priority research areas”.  Finally, to further encourage early-stage researchers, the law authorizes the establishment of programs to help in the repayment of student loans and raises the cap on the repayment assistance available to the researchers.

Besides ensuring funding for biomedical research, this law aims to address privacy concerns brought up by experts regarding patient information in the era of precision medicine (for more details, check out our analysis of the precision medicine initiative). Under this law, certificates of confidentiality will be provided to all NIH-funded researchers whose studies involve collection of sensitive patient information. This information will be withheld by the NIH, but can be accessed upon requests filed under the Freedom of Information Act. On the other hand, in order to make sure data sharing is made easier for scientists, this law will allow NIH to break out of red tape and regulations that obstruct scientists from attending scientific meetings and sharing data.

Despite the generally positive reception of the Cures Act by NIH officials and research scientists, the bill was not without its critics. The principal criticism of the final product is that it constitutes a handout to pharmaceutical and medical device companies by substantially weakening the FDA’s regulatory check on bringing new treatments into the clinic.

For example, Sydney Lupkin and Steven Findlay point to the $192 million worth of lobbying collectively expended by over a hundred pharmaceutical, medical device, and biotech companies on this and related pieces of legislation. The goal of this lobbying, Lupkin and Findlay assert, was to give the FDA “more discretion” in deciding how new drugs and other treatments gain approval for clinical use – presumably saving a great deal of money for the companies that develop them. Adding weight to their assertion is the fact that President Trump is reportedly considering venture capitalist Jim O’Neill for FDA commissioner. Mr. O’Neill is strongly supported by libertarian conservatives who see FDA regulations as inordinately expensive and cumbersome, so it seems reasonable to worry about how Mr. O’Neill would weigh safety against profit in applying his “discretion” as head of the FDA. On the other hand, under a wise and appropriately cautious commissioner with a healthy respect for scientific evidence, we might hope that maintaining high safety standards and reducing the current staggering cost of drug development are not mutually exclusive.

Additionally, Dr. David Gorski writes of one provision of the Cures Act that appears to specifically benefit a stem-cell entrepreneur who invested significantly in a lobbying firm pushing for looser approval standards at the FDA. Once again, it is not unreasonable to suspect that there is room to reduce cost and bureaucratic red tape without adversely impacting safety. And in fairness to the eventual nominee for FDA commissioners, previous commissioners have not been universally praised for their alacrity in getting promising treatments approved efficiently… at least, not within the financial sector. Still, the concerns expressed by medical professionals and regulatory experts over the FDA’s continued intellectual autonomy and ability to uphold rigorous safety standards are quite understandable, given the new administration’s enthusiasm for deregulation.

It appears that this law will also allow pharmaceutical companies to promote off-label use of their products to insurance companies without holding clinical trials. Additionally, pharma companies can utilize “data summaries” instead of detailed clinical trial data for using products for “new avenues”. It is possible that these provisions were created with the NIH basket trials in mind (details here). However, as Dr. Gorski argues, without clinical trial data, off label use of drugs will be based on “uncontrolled observational studies”, which, while beneficial for pharma companies, are risky for patients from the perspective of patient advocacy groups. These fears are not without evidence – a recent article from STAT describes how the off-label use of Lupron, a sex hormone suppressor used to treat endometriosis in women and prostate cancer in men, is resulting in a diverse array of health problems in 20-year olds who received the drug in their puberty.

Another “Easter egg”, albeit unpleasant, awaits scientists and policy-makers alike. Buried in Title V of the law is a $3.5 bn cut on Human and Health Services’ Prevention and Public Health fund, without a proper explanation added to such an act. Given the outcry on the lack of public health initiatives in the Precision Medicine Initiative, one is again left to wonder why 21st century cures are focusing only on treatment and drug development and not on policies directed towards promoting public health and prevention of diseases.

In conclusion, the implementation of this law will largely depend on the current administration. With the NIH budget for FY2017 still up in the air, the confirmation of nominees still hanging in balance, this law is far from being implemented. Based on the provisions, it appears that overall biomedical funding will be boosted in particular fields, designated “priority research areas”. However, it shouldn’t fail an observant reader that this bill also seems to allow pharma companies a higher chance to exploit the consumers. It, therefore, still remains a question of whose priorities (consumers/patients vs. investors/corporations) are being put forward first and the answer, in our humble opinion, will be determined by a dialogue between the people and the government.

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