Back in 2010, the Canadian government opted to make the long form portion of its 2011 census voluntary. Researchers who use the data in their work, and policymakers who use the data to make decisions were concerned about how a voluntary survey would impact the resulting data.
As expected, the early analysis suggests that the lower quality data will lead to higher spending. Those costs might not be borne by the national government, but the provinces, local authorities and other parties that have used this data to track changes in their jurisdictions. Without this data, they must pay to replace it, and due to the lower quality, they are paying more for less. Smaller jurisdictions have been harder hit from this change, as response rates have been lower in rural jurisdictions, and smaller governments are less likely to have the resources to fill those data gaps.
The Canadian Chamber of Commerce has called for the long form to be mandatory in the next census (2016), and a bill was introduced in Parliament to that effect last week. With the Conservatives still in majority, it seems likely to fail. Those in the United States may not find themselves concerned, as we still have 5 years to the next census. However, the Census Bureau administers the American Community Survey, and there have been efforts to curtail that in the past. It may happen again.
On Friday the White House formally launched the Precision Medicine Initiative. I mused about it shortly after it was mentioned in the President’s State of the Union address. While that post covered the why, the announcement on Friday also covered the how this Initiative might move forward.
While the National Institutes of Health (NIH) would receive the bulk of the $215 million (with much of its share going to the National Cancer Institute), the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC) would also contribute to the Precision Medicine Initiative. The NIH and National Cancer Institute projects are focused on clinical research on individualized treatments and the FDA and ONC are focused on updating technical and regulatory infrastructure to better handle the kinds of data sets and data sharing expected to come from a project that burrows done to individual treatments.
A lot of this data will come from a voluntary research cohort, a group who agree to contribute their medical data (including genetics, lifestyle, metabolites, personal sensors and environmental information) to the effort and would help design the initiative. This cohort would be one million strong. Thankfully the Administration recognizes the privacy impact of making detailed medical information about that many people available for research access. How effective they will be in assuring the privacy of this information remains to be seen.
While I recognize the impact of cancer, and how genetic markers for cancer can help in treatment, I’m a bit skeptical of how broadly focused a Precision Medicine Initiative can be when roughly one third of its budget targets cancer. Yes, cancer takes many forms, and targeting individual treatments could benefit a lot of people suffering from rare forms of the disease – forms that don’t respond well to currently available treatments. I’d rather this not become the Precision Cancer Initiative, at least not when it was first called something else.
The White House has been playing offense on policy, making several announcements before, during and after last week’s State of the Union address. Unless the initiatives are heavy on executive branch action, I’m not especially optimistic about their success.
But this announcement from the White House has me in a slightly more positive frame of mind. It would nearly double Federal funding for fighting antibiotic resistance in the fiscal year 2016 budget. It’s follow-through on the 2014 Executive Order related to antibiotic resistance and other government actions since the President made this an area of focus back in 2013.
Most of the requested increase would go to the Department of Health and Human Services (which covers the National Institutes of Health, the Centers for Disease Control and the Food and Drug Administration), but funding on antibiotic resistance would also grow at the Departments of Agriculture, Veterans Affairs and Defense. The fact sheet outlines a long list of programs that this money will help support, as well as some aggressive potential outcomes
- Reduce the incidence of carbapenem-resistant Enterobacteriaceae (CRE) infections by 60 percent.
- Reduce the incidence of Clostridium difficile infection (CDI) and methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections by 50 percent.
- Reduce the incidence of multidrug-resistant Pseudomonas infections acquired during hospitalization by 35 percent.
- Spur at least a 25 percent reduction in the rate of multi-drug resistant Salmonella infections and pediatric and geriatric antibiotic-resistant invasive pneumococcal disease.
According to Senator Elizabeth Warren of Massachusetts, pharmaceutical companies paid more than $13 billion in fines and/or settlements for violations of federal law. The Senator would like to use some of that money to boost the budget of the National Institutes of Health.
The Medical Innovation Act (not yet introduced) would require large pharmaceutical companies that enter into settlement agreements with the government to contribute money to the National Institutes of Health budget. It would be one percent of the annual profits for each ‘blockbuster drug’ that can be connected to federal research support. The contributions to the so-called ‘swear jar’ would take place for five years – often the term of the settlement agreement entered into by the company.
There is no legislative language available just yet, so analysis based on a speech has its limitations. The terms of the proposed legislation feed into Senator Warren’s role as a populist champion – someone targeting big companies for behavior she (and others) consider contrary to the interests of the non-rich. That it would boost medical research is a bonus, but not really the major political motivation for the Senator.
While the additional money would be nice, it is dependent on what would be an irregular funding stream. It would be hard to plan well for the use of the ‘swear jar’ proceeds without some kind of mechanism to provide some funding stability. Senator Warren estimates that her legislation would have provided the NIH an additional six billion dollars per year over the last five years. But its unrealistic to expect that the same amount of money would be available each year over the next five.
The biomedical research community is arguably still recovering from the end of the dramatic NIH budget increases around the turn of the century. While the community would certainly welcome more money, I’m concerned that a stretch of good behavior by pharmaceutical companies would lead to halted grants and/or construction projects because this income dried up.
I like the idea – it’s an acknowledgement of how some profits from scientific and technical companies can be traced back to federal support of the underlying research. But without a meaningful plan to properly manage this income stream, it could cause more problems than it solves.
Amidst the laundry list that is the State of the Union was the Precision Medicine Initiative. In short, it’s a program geared toward expanding treatments crafted to address patients that don’t respond to treatments targeted to an ‘average patient.’ The initiative was announced with Bill Elder in the audience. Elder benefited from a ‘precision’ treatment for his cystic fibrosis. The cause of his disease is shared by only 4 percent of cystic fibrosis patients.
Details at the moment are scarce. The Federal budget may give additional details once it’s released next month. The program would likely be led by the National Institutes of Health, though the focus of the Initiative would not necessarily be restricted to medicines, wider use of DNA testing to help craft cures or similar clinical treatments. Refinements in medical imaging can be helpful in this area and health information technology may also be leveraged to develop new cures that can assist those not helped by treatments geared toward the ‘average’ patient.
Setting aside the usual concerns about getting approval for new initiatives in a tight budgetary environment, it remains to be seen if this program can successfully be sold to the general public. If the focus is on treatments focusing on the margins, it could be hard to sell the benefits to a broader public. Of course, if there are members of Congress with direct experience benefiting from targeted treatment, then the acceptance of this program might be easier to get. Unlike the BRAIN Initiative, focused on better understanding of something we all have, the Precision Medicine Initiative runs the risk of being a niche program, not likely to get the large investments it might need. If it follows the organization of the BRAIN Initiative, including several agencies and a few public-private partnerships, the total investment might be spread around sufficiently to mitigate the political challenges of getting lots of money.
The recent thawing of U.S.-Cuba relations may be chilled by the incoming Congress, but researchers are encouraged.
Since 2009 the Treasury Department has allowed U.S. scientists to conduct research visits to Cuba. But the changes announced by the Obama Administration should make it easier to conduct research in Cuba and collaborate with Cuban scientists. Once the country is removed from the list of state sponsors of terrorism, it will no longer be necessary to obtain an export license to bring scientific equipment to Cuba. Travel licenses for scientists should become easier to obtain, meaning it should be easier for American scientists to attend scientific meetings in Cuba and vice versa. AAAS is quite pleased with the development, in part due to its efforts over the last several years to strengthen collaborative opportunities between the two countries.
Perhaps the most widespread scientific impact of this thaw in relations could come from infectious disease research. With Cuba’s proximity to Florida, tracking infectious tropical disease is of great interest to both countries, especially with the recent spread of dengue and chikungunya to both the U.S. and Cuba.
(January 8 – I’ve linked to the meeting agenda)
The first 2015 meeting of the President’s Council of Advisers on Science and Technology (PCAST) takes place on January 9th in Washington, D.C. Unfortunately, no agenda is presently available, so all we have to go on are the brief items in the Federal Register notice. (Should an agenda become available before the 9th, I’ll link to it here.)
As usual, you can attend in person (registration is online), and a webcast will be available (it should be available shortly after the meeting).
According to the Federal Register, the public portion of the meeting will cover technology development and the aging population (I presume these are separate panels and separate topics, but I could be wrong). There will be the opportunity for public comment, and if there are reports in progress, there may be status updates on them as well.