Last week the Food and Drug Administration (FDA) announced that it would examine the trend of food products that included caffeine. This has already prompted one company to pause production on a caffeinated gum. The announcement follows action in 2010 to withdraw caffeinated alcoholic beverages from the market. Part of the rationale behind that effort was that the addition of caffeine masked the usual cues people receive from alcohol consumption. (So those arguing the latest action marks a new intrusion aren’t paying close attention.)
Currently FDA regulations allow the addition of caffeine to products if it meets safety standards and gets included in the ingredients list. It has only approved the addition of caffeine to products once – for colas in the 1950s (perhaps because it was a replacement for coca).
James Hamblin and others at The Atlantic has been studying the effects of caffeine and its regulatory history. It would appear that the FDA is focused in part on caffeine in products that are or could be marketed to children. Michael Taylor, the FDA deputy commissioner that was interviewed for the announcement, appears to suggest that things like energy drinks and breakfast foods with caffeine are the kinds of things the agency is particularly concerned about. The FDA hasn’t set a level for children, but it recommends a maximum of 400 milligrams for healthy adults.
While it is possible that the recent announcement would be enough to cut back on the number of caffeinated food products, I suspect the FDA will pursue further study. Whether that ultimately leads to regulation is uncertain, in part because it would not likely be a blanket prohibition. While implementation of any kind of caffeine regulation will be problematic, focusing on certain products and a specific audience will require more time to develop.
The recent judicial rebuke over emergency contraception is just the latest example of the challenges the Food and Drug Administration (FDA) has had in getting its scientific and regulatory houses in order. The kerfuffle over Plan B is different (but not an isolated incident) in that the interference in agency processes came from outside the FDA, rather than from within. But the agency has a lot of work to do to deal with the conflicts, delays and struggles over drug and device approvals. The agency is trying (the Commissioner did publicly disagree with the Secretary over Plan B), but it has a long way to go.
This week’s reporting by ProPublica (H/T Scientific American) focuses on the FDA’s relationships with contract drug testing companies. The reporters recount how two companies were found to have conducted years of tests that were either unreliable or fraudulent. As a result over 300 drugs needed to be retested, with at least 140 of those drugs already approved for sale.
None of the drugs were pulled from the shelves, even temporarily. No public statements were made by the FDA about the retesting, even though the European Medicines Agency pulled seven drugs tested by one of the labs. The FDA remains tight-lipped on the matter, and ProPublica has been able to identify only five drugs that were approved at least in part due to suspect tests of one of the two companies, Cetero (the other company is MDS Pharma Services).
(ProPublica has a number of other investigations worth looking into, many of which focus on medical and/or scientific topics.)
Clearly the FDA still has many challenges to tackle before it can effectively fulfill its regulatory obligations. The bigger problem, as I see it, is an institutional culture that accepts glacially-paced efforts to correct errors, coupled with a complete lack of interest in informing the public. I don’t envy Commissioner Hamburg’s task in trying to tame the agency. I wish her the best of luck.
Last weekend I made mention of a release of new guidelines for biological research that may involve things like dangerous viral DNA (H/T ScienceInsider). Here are the details.
About three weeks ago the Office of Science and Technology Policy (OSTP) released a proposed policy on “Institutional Oversight of Life Sciences Dual Use Research of Concern.” Comments are due on April 23, and you can read the proposed policy online. The institutions in question are non-governmental, and the proposed policy closely resembles the March 2012 policy that controls U.S. government funded and/or performed research. As OSTP noted, the internal policy on such dual use research was established roughly a year ago, in connection with some research papers that Science and Nature delayed publishing.
Under the proposed policy, universities and other research institutions that receive federal funding would be required to review life science research conducted under their roof to see if they fit under the specific definitions of research of concern. For the moment, that refers to a list of 15 particular toxins, and a few kinds of experiments with those toxins. The intent is to expand these policies as needed in the future.
In a sense life science fields are treading a similar path to other fields where there is dual use research of concern. Some of these efforts are tied to policies like export controls, which seek to contain the spread of technology that could be used for nuclear weapons or other nasty bits of business. While it is difficult to contain the spread of technology and/or scientific research, these policies can help decisionmakers better understand the consequences of research, and I think that’s beneficial.
The pending budget cuts for scientific research and development are likely to land on research communities at least as hard as the biomedical research community landed after the National Institutes of Health budget stopped its doubling. But there may be just a little cushion for that fall.
Early in February the Office of Management and Budget issued proposed guidance for revised rules on reimbursing universities for administrative costs (H/T ScienceInsider). You may be more familiar with the phrase indirect costs, which is now called ‘facilities and administration’ costs. The guidance is open for public comment until May 2, 2013. If you look deep into the document, it becomes clear that the administration of research can get caught up in something as mundane as the utility bill. So streamlining or otherwise simplifying the processes involved can help a great deal. Even if many of the specific suggestions from the research community have not made it into the proposed guidance, the consolidation of eight federal circulars on the subject into one could be a massive time saver. The same can be said for the standardization of language and reporting requirements across categories of grants and contracts.
I found it difficult not to get lost in the discussions of finance, auditing and accounting. I suspect many other researchers may have a similar experience. It makes me appreciate research administrators all the more. Hopefully these changes can help them do their jobs more efficiently, saving us all some money and getting a bit more research out of the budgetary turnip. We’re going to need it.
A little over a year ago I speculated as to when the Supreme Court would hear the lawsuit over the Obama Administration policy allowing federal funds to be used to support embryonic stem cell research. While my prediction of early 2013 may seem accurate based on last week’s action, in truth the Court had to have the case since last fall in order to review the matter and decide whether to hear the case. The petition was filed by plaintiffs in October.
According to SCOTUSBlog, the Court gave no comment when it denied the petition to hear the case. While the issue of NIH stem cell research policy could still be opposed, those not in favor will need to pursue their case through either Congress or the Executive Branch. The latter is not happening during the current administration, and the former seems unlikely given the inability of Congress to pass much of anything.
Of course, the injunction that plaintiffs sough after filing the lawsuit back in 2009 didn’t last long in court. While the resolution of this case reduces the uncertainty involved in pursuing federal money for embryonic stem cell research, I’m not sure that was much of a problem for researchers.
As I suggested last week, now is traditionally the time (between the re-election of a President and the second inauguration) where many senior officials leave. Attention has been focused on two Cabinet secretaries, but the list of science and technology positions to replace has grown by one.
Environmental Protection Agency Administrator Lisa Jackson announced earlier today that she will depart her post after the President’s State of the Union address early next year. Jackson and the EPA have often caught flack from all sides, which suggests to me that the Obama Administration will have a tough time finding a replacement. It wouldn’t surprise me if Jackson’s deputy, Robert Perciasepe, was eventually nominated after some indeterminate time as Acting Administrator.
I expect more senior science and technology appointees to announce departures over the next several weeks. I’d rather not guess who the departing will be. However, I am expecting it to take time for their replacements to be named. It seems as though the Administration had a good list to work from when they started, and weren’t able to keep it stocked as openings emerge. It’s too bad, given all the praise of a ‘scientific dream team’ to see it fall back to earth.
ScienceInsider is reporting that a voluntarily imposed moratorium on research involving the H5N1 flu virus may be lifted soon. (This should be distinguished from the discussions around publishing articles based on this kind of research, which seemed to be resolved in March.)
A meeting is currently underway, including the researchers involved in establishing the moratorium, to work through a draft policy on reviewing studies on gain-of-function research in this area (gain-of-function meaning using gene engineering or other techniques to make naturally occurring viruses more lethal or able to jump to new hosts). The working through also involves applying the draft policy to four hypothetical studies.
Any final policy will be binding on National Institutes of Health (NIH) funded studies. But it strikes me as likely that other countries may find the policy instructive for their own regulatory interests. At a minimum, NIH will be reviewing more H5N1 studies than it currently does under whatever final policy emerges.
As other viruses become the focus of gain-of-function studies, and synthetic biology becomes less and less novel, I think the kinds of review discussed now could become more common. What’s happening now is worth noting for future reference.
There’s a proposition on the California ballot (37 for those keeping score) that would require the labeling of food from plants or animals that contain genetic material changed in specified ways (two kinds of method are listed in the measure – cell fusion and in vitro nucleic acid techniques). Many countries require labeling of food containing genetically modified organisms, so for once California will not be legislating new science-oriented public policy if the measure passes (not a likely outcome at the moment, but there’s still a week until the election).
The Board of Directors for AAAS has weighed in with a statement (H/T The Scientist) that emphasizes the advocacy in its mission and I think downplays the scientific ethos it claims to support. It starts with how the Board characterizes the initiative, and similar labeling efforts – as a means of demonstrating foods with genetically modified organisms to be unsafe or untested. This notion is strenuously rebuffed in the statement, and I’m not interested in debating the point. Personally, I don’t object to eating genetically modified food.
But I would love to know when I’m eating it and when I’m not.
Much in the same way that I’d like to avoid certain nuts, flavors, or other ingredients that have little or no connection to the potential health impacts. Come on, I want to know when I’m having the donuts fried in lard rather than those fried in canola oil (it matters, seriously).
The notion of other, reasonable justifications for labeling the constituent parts of food is not considered or addressed by AAAS. To their narrow point of view, labeling is only done for purposes of safety, and since safety has been definitively proven, genetically modified food doesn’t need to be labelled.
Frankly, I think a lot of agitation over this issue could be effectively quelled by being in favor of transparency, and open information. I was under the impression this was a good scientific practice. Continue reading
Yesterday (October 11) the Presidential Commission for the Study of Bioethical Issues released its latest report, Privacy and Progress in Genetic Testing. It concludes a roughly 18-month project by the Commission on the collection, use and governance of genetic information. The commission held four public meetings, consulted with several government agencies on their genetic information policies, and solicited public comment. (Coverage in Nature and ScienceInsider)
In the eyes of the Commission, this is currently a period of transition, where a lot of genetic information is going to become commonplace in clinical settings and applications. Many more people are going to have access, so the security and privacy afforded this information by the difficulty in accessing it is dissipating. But the increased use of data requires an increase in the amount of data available. The Commission recognizes this, at least implicitly, the need for greater public trust in the use of genetic information in order for the benefits of that information to be fully realized. (Not to mention the increased possibility for abuses of that information; something roughly half of U.S. states have laws against.) To that end, the report makes several recommendations under the following themes:
- Strong Baseline Protections While Promoting Data Access and Sharing
- Data Security and Access to Databases
- Facilitating Progress in Whole Genome Sequencing
- Public Benefit
One of the goals of these recommendations is to make sure that any person’s genetic information receives a minimum level of privacy and security – regardless of how it is collected or who does the collecting. Another is to make it easier to exchange and share information across fields and sectors of activity. A minimum floor of privacy and security guarantees is critical to this, and will need to be augmented by other common standards for information collection, use, and management. There’s a lot of daylight between where various players in genetic testing are and where the Commission would like them to be.
It’s hard to tell how much teeth these recommendations will have. The nature of the commission is such that their recommendations are at best suggestive. They do not have the force of law or regulation, unless Congress or an executive branch agency opts to implement them. Given the delicate balancing act required by these recommendations, I suspect some agency or agencies will need to champion these recommendations for them to take hold in the United States.
I-Corps, the National Science Foundation (NSF) program to help researchers get assistance for commercializing their research, recently turned one. You can watch the webcast of the anniversary event. According to the latest program solicitation, NSF is interested in growing regional nodes (new teaching sites for its commercialization curriculum) for a national network for research commercialization assistance. They are looking to double the number of three-person research teams split between industry and universities.
Over on the other side of the Atlantic, the European Commission has issued draft revised legislation for its sponsored clinical trials. The 2004 rules, which the proposed legislation would revise, were intended to harmonize practices across the European Union, but led to an overall decline in registered trials and an increase in costs. There is an attempt with this proposed legislation to streamline the administrative requirements for the trials, with a particular focus on making it easier to register and administer trials taking place in more than one member state. This is similar to a major thrust of the U.S. efforts to update its federal guidance for human subjects research. (The next steps in that effort have yet to be made public.)