Filed under: Food and Drug Administration (FDA), Public Health
The Food and Drug Administration (FDA) has decisively entered the debate regarding the health risks of artificial trans fatty acids in foods. On November 8, the FDA announced its “tentative” determination that partially hydrogenated oils (PHOs), also known as trans fatty acids, are no longer generally recognized as safe for human consumption. The FDA cited research by the American Heart Association (AHA), the World Health Organization, the American Dietetic Association, the Institute of Medicine, and the FDA Food Advisory Committee Nutrition Subcommittee demonstrating that trans fats increase the risk of coronary heart disease. Trans fats simultaneously raise levels of bad cholesterol and lower good cholesterol, among other adverse negative health effects. In the FDA Press Release, Dr. Margaret Hamburg, Commissioner of the FDA, stated that reduction in trans fat intake “could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year – a critical step in the protection of Americans’ health.”
This is not the first move by the FDA to address the heavily documented health risks of trans fats. Ten years ago, the FDA implemented regulations that required information about the trans fatty acid content in foods and dietary supplements to be declared on the Nutrition Facts label. As a result, the label now identifies the total fat, saturated fat, and trans fat content. While not directly reducing or eliminating trans fats from American diets, the label requirement forced transparency on the part of food manufacturers and provided consumers with information on which to base purchasing decisions. It also incentivized manufacturers to scale down on the use trans fat in food production.
If the FDA determination is finalized, PHOs would no longer be permissible ingredients in food products without prior approval by the FDA as a safe food additive. Food additives, by statutory definition include substances that “result or may reasonably be expected to result, directly, or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use).” The definition excludes several types of substances that are regulated under separate provisions, including pesticide chemicals, pesticide chemical residues, and color additives. All food additives that are not generally recognized by qualified scientific experts to be safe under the conditions of use are thus classified as not safe for market entry. Only after a generally recognized as safe (GRAS) determination by the FDA may a food additive enter the market as an ingredient in any given food product.
The FDA has a well-established regulatory process for determining whether a food additive is GRAS. The FDA maintains GRAS listings in the Code of Federal Regulations that act as a sort of recipe for food manufacturers. These complete listings are available here, here, and here. Generally, if a food additive conforms to that published GRAS listing, including the specific amount, intended use, good manufacturing practices, and any limitations, it may be used as an ingredient without prior FDA assessment. For example, caffeine is a GRAS listed substance for use in cola-type beverages. When added to other food products, however, caffeine is no longer considered GRAS and the FDA can institute an enforcement action against those products where there is a concern about public safety. This scenario played out several years ago with regard to drinks combining alcohol and caffeine.
The announcement is seen by those in the health and nutrition fields as an energizing sign of life in a recently limp FDA. Marion Nestle, a professor at New York University, proclaimed in an interview with the New York Times “[t]he FDA is back!” Likewise, organizations such as the AHA and the Center for Science in the Public Interest (CSPI) that have been advocating for increased regulation over trans fats praise the FDA’s move, though they emphasize that action is long overdue. CSPI originally petitioned the FDA for inclusion of trans fat information on the label in 1994 and subsequently in 2003 to prohibit use of PHO as a food ingredient.
It appears that the FDA anticipates phasing-in of the GRAS requirements, and has solicited the public for feedback on several aspects of scope and implementation. Specifically, the FDA asks for data supporting other approaches, input on the estimated timeframe to reformulate products to bring them into conformance, special considerations for small business, and any other foreseen challenges to such an approach. The comment period is open until January 7, 2014.
Filed under: Children's Issues, Proposed Legislation, Public Health, State Initiatives
I was stunned to learn recently that female lacrosse players, at least in my town in New Jersey, may not wear hard helmets even though male lacrosse players must wear them. This struck me as ludicrous and unfair. Both sports involve athletes running around with long sticks, hurling dense rubber balls at high speeds. It seemed to me that balls and sticks can strike players in the head and players can collide in either sport. How could we care more about preventing traumatic brain injury (TBI) in boys than in girls? I was outraged. But as it turned out, I also was a bit uninformed. It is not as clear as I thought it would be that we should require girls to wear helmets.
A common objection is that female and male lacrosse are very different sports subject to different rules and requiring different skills. Male lacrosse involves much more brute physical contact, whereas female lacrosse does not permit body checking and demands finesse. As a female senior lacrosse player explains, because girls’ lacrosse sticks have shallower pockets, girls “’have to be more skilled with our cradling, . . . [so our] game is more graceful.’” A male senior midfielder acknowledged that the girls’ “’stick skills are unbelievable’” and that “’the girls’ version is more pure.’” Some believe there is less need for helmets in girls’ lacrosse because of these differences. Moreover, there is concern that requiring girls to wear helmets will encourage girls to play more like boys, which would risk losing the valuable uniqueness of girls’ lacrosse.
As much as I want to honor female players’ pride in their skills and finesse, science should drive the policy decision whether to require girls to wear helmets. Research by Nationwide Children’s Hospital in Columbus, Ohio reveals that girls’ lacrosse has the third-highest rate of concussion among female sports, after soccer and basketball, and “its in-game rate is only about 15 percent less than the rougher male version.” But what do we know about whether helmets can reduce that risk? Not enough. Read more
Navigating the New Field of International Health Law, Featuring Gian Luca Burci, Legal Counsel for WHO
Filed under: Global Health, Health Law, Public Health
This lecture, “Navigating the New Field of International Health Law,” will explore the intersection of health and international law and the emergence of International Health Law as a practice area. Featuring Gian Luca Burci, Legal Counsel for the World Health Organization, this program will focus on the growing interactions between health policy and various areas of international law, including international business transactions, intellectual property, international security, and human rights law. The program is sponsored by the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and the International Law program at Seton Hall Law.
The event will take place at Seton Hall Law, Newark, NJ, on Wednesday, February 22, 6 to 7 p.m. There is no charge. 1 New Jersey CLE credit will be available. Click here to make your reservation or for more information, please contact Sara Simon, Director, Healthcare Compliance Certification Program, at firstname.lastname@example.org or call 973-642-8190.
In their zeal to keep us all alive, it seems fair to say that public health officials love bioterrorism preparedness measures. In fact, the only thing they might love planning for more is pandemics. So last month, when researchers at two different facilities revealed they were able to mutate the virulent H5N1 avian flu strain to pass between mammals simply through the air, the NIH was highly concerned.
The discovery is alarming because avian flu is considered one of the world’s deadliest pathogens, with a 60% mortality rate. But while avian flu viruses have infected humans in the past, those infections have come directly from birds. If the virus can be mutated into an airborne pathogen, the consequences can be catastrophic.
Two research teams (one led by Ron Fouchier of Erasmus Medical Center in the Netherlands, and the other by Yoshihiro Kawaoka of the University of Wisconsin) engineered the new bird flu strains. After growing the H5N1 strain for several generations, the scientists discovered the exact genetic mutations that allowed the virus to be transmitted by air between ferrets. The results could be easily duplicated if the teams publish their studies with full details.
The National Science Advisory Board for Biosecurity (NSABB), a U.S. government advisory panel that is run out of the NIH, asked the journals Science and Nature to delay publication of the research. The NIH released the following details in a press release:
Due to the importance of the findings to the public health and research communities, the NSABB recommended that the general conclusions highlighting the novel outcome be published, but that the manuscripts not include the methodological and other details that could enable replication of the experiments by those who would seek to do harm. The NSABB also recommended that language be added to the manuscripts to explain better the goals and potential public health benefits of the research, and to detail the extensive safety and security measures taken to protect laboratory workers and the public.
The request has sparked a debate about if and when it is appropriate to have oversight of dual-use research. As defined by the NSABB, dual-use research of concern is research that is “reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or materiel.” A good synopsis of the bioethical implications of such research is considered by Alan Rozenshtein on lawfareblog.com.
One of the research team leaders, Ron Fouchier, responded that the NSABB’s advice amounted to one-country domination of a discussion with worldwide impact. At the same time, he conceded that the mutant strain is “probably one of the most dangerous viruses you can make.” The professor who oversees biosafety for University of Wisconsin, William Mellon, responded that the research is “society’s best defense against a pathogen that has shown time and time again that, in nature, it can adapt to human hosts with dire consequences for global public health.”
Science and Nature were slower to respond. Last month, Science Editor-in-Chief Bruce Alberts noted the journal’s initial hesitation to acquiesce to the NSABB recommendation-
“We strongly support the work of the NSABB and the importance of its mission for advancing science to serve society…At the same time, however, Science has concerns about withholding potentially important public-health information from responsible influenza researchers. Many scientists within the influenza community have a bona fide need to know the details of this research in order to protect the public, especially if they currently are working with related strains of the virus.”
Nature‘s Editor-in-Chief Philip Campbell replied along the same lines:
“We have noted the unprecedented NSABB recommendations that would restrict public access to data and methods and recognise the motivation behind them. It is essential for public health that the full details of any scientific analysis of flu viruses be available to researchers. We are discussing with interested parties how, within the scenario recommended by NSABB, appropriate access to the scientific methods and data could be enabled.”
The issue at hand is as one scientist, Peter Palese, opined in Nature: “We need more people to study this potentially dangerous pathogen, but who will want to enter a field in which you can’t publish your most scientifically interesting results?”
Just last week, both teams of researchers announced in an open letter published in Science and Nature that they agreed to pause their work for 60 days. In the meantime, the teams propose to discuss the benefits and safety measures of their work in an international forum for discussion and debate within the scientific community. The researchers stated in the open letter,
“We realize that organizations and governments around the world need time to find the best solutions for opportunities and challenges that stem from the work. To provide time for these discussions, we have agreed on a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals.”
Where, when and how these discussions will take place on an international level remains to be seen, but the NSABB appears to have made its point.
An unintended effect of the recommendations is that they have called into question the role and purpose of the NSABB. The NSABB was created in 2004, as a response to the 2001 anthrax attacks and the subsequent public outcry for regulation of research with implications for bioterrorism. As past president of the American Society for Microbiology, Ronald Atlas, put it, “[t]here was a sense, whether right or wrong, that if the community did not act to protect the integrity of science, government would overreach and there would be censorship.” Instead of regulating scientific research directly, the NSABB panel of scientists was given the role of offering advisory opinions on sensitive issues.
Since 2004, the NSABB has only been asked to review six papers. Two of those papers, released in 2005, described the reconstruction of the deadly 1918 influenza virus. The NSABB recommended that the papers clearly define the public-health benefits of the research, but no other advice was given. This is partly why the NSABB’s current recommendation is unprecedented.
According to Amy Patterson, director of the NIH, a draft policy for dual-use research should be presented by the U.S. government this spring. The draft should present a comprehensive framework for the oversight of such research, and create a local review component. As she states it,
“Whatever system is put in place needs to have both aspects: some consideration up front when the work is funded, but also a component of local oversight and review. It starts with the investigator — he or she knows best what is emerging out of their work. But we also need a level of institutional review to provide a second set of eyes taking a fresh look. The earlier something is recognized, the more options for management you have.”
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, stated that the draft plan may require scientists to apply online for access to critical information, after explaining their need for details on dual-use research. As of right now, it is unclear who would judge the validity of such requests. It is worth noting that at least one other institution, the University of Maryland’s Center for International and Security Studies, has outlined potential oversight systems already.
The dilemma of dual-use research is already a global problem, and therefore requires a global solution. The World Health Organization commented after the H5N1 mutations, stating a deep concern about the possible misuses of the research. The WHO was quick to note the critical need for such scientific knowledge, but concluded that “such research should be done only after all important public health risks and benefits have been identified and reviewed, and it is certain that the necessary protections to minimize the potential for negative consequences are in place.”
As Laurie Garrett, senior fellow for global health at the Council on Foreign Relations, notes in a thorough review of international mechanisms for oversight of dual-use research, the first problem is that there are “no consistent, internationally agreed-upon regulations governing synthetic biology.” The only review that does currently exist is the “toothless” Biological Weapons Convention(BWC) from 1975, to which 165 states are party.
Last month, U.S. Secretary of State Hillary Clinton attended a BWC summit, and stated-
“The nature of the problem [dual-use research] is evolving. The advances in science and technology make it possible to both prevent and cure more diseases, but also easier for states and nonstate actors to develop biological weapons. A crude, but effective, terrorist weapon can be made by using a small sample of any number of widely available pathogens, inexpensive equipment, and college-level chemistry and biology. Even as it becomes easier to develop these weapons, it remains extremely difficult . . . to detect them, because almost any biological research can serve dual purposes. The same equipment and technical knowledge used for legitimate research to save lives can also be used to manufacture deadly diseases.”
The need for global cooperation on this issue is crucial.
In truth, it seems that pandemics fascinate most of society, and not just public health professionals. Last year saw the release of the movie Contagion, with a plot line appealing enough to enlist the acting talents of Gwyneth Paltrow and Matt Damon (for a great comparison of the movie to real-world issues, see W. Ian Lipkin’s op-ed for the New York Times). Further, avian flu remains a present threat. Just this month, Chinese health authorities confirmed a bird-flu-related death, Indonesia reported the third death related to bird flu in three months, and there are reports of avian flu among birds in India. Given that H5N1 remains such a threat without the consideration of bioterrorism, the need for regulations on dual-use research is seemingly more apparent than ever.
As those nationwide prepared for their holiday gift exchange, American lawmakers inexplicably put an end to a different type of exchange: a life-saving and successful public health tool called needle exchange.
House Republicans fought for, and won, a ban on federal funding for needle exchange programs in a massive spending bill passed in December that will fund the federal government until the fall of 2012. The ban prevents the federal government from spending money funding needle exchange programs not only in the United States, but also restricts the State Department from funding syringe programs internationally. Providing federal funding to such programs had been banned from 1988 to 2009, until finally the ban was ended after the election of Barack Obama. Now it’s back.
These programs focus on high drug-use neighborhoods, providing free clean needles to intravenous drug users in an effort to prevent the spread of blood-borne diseases, including HIV/AIDS. They are often accompanied by HIV counseling and testing, and typically also provide referrals to drug users for treatment. After much debate about their effectiveness, data have shown that the programs drastically reduce infection rates and do not increase illegal drug use. Further, the programs, which currently exist in 33 states, are widely supported by the scientific and public health community, from the CDC to the AMA to the National Academy of Sciences. When the Washington, D.C. Department of Health looked at the efficaciousness of its needle exchange programs, 800,000 needles had been exchanged, 5000 HIV tests had been offered, and 900 people had been referred to drug treatment. Unsurprisingly, the number of new HIV/AIDS infections dropped 60 percent in Washington, a city devastated by the HIV/AIDS epidemic. In New York, the numbers of intravenous drug users with HIV have dropped from 50 percent in the 1980s to 16 percent today, following the implementation of a needle exchange program.
Not only do they make scientific sense, but they also make fiscal sense: needle exchange programs reduce health spending in the long run. According to a 2002 report by the Institute of Medicine, needle exchange programs save between $3,000 and $50,000 for each infection prevented.
But the news was not all baffling over the holidays. In New Jersey, state lawmakers approved a bill allowing pharmacists to sell needles and syringes without a prescription, and it now awaits Governor Chris Christie’s signature. Although previously against needle exchanges, Christie has said he has an open mind and will carefully review the bill. And unsurprisingly, according to the New Jersey State Health Department, more than 40 percent of the state’s HIV or AIDS cases were a result of intravenous drug users’ use of contaminated needles.
When it comes to such common sense policy that is effective in reducing new infections, provides support and outreach to those struggling with addiction, is supported by data and the scientific community, and provides smart savings on health care costs in the long run, the ban on such a policy is not only confounding and irresponsible, but dangerous to us all.
Clean Needles in New Jersey, N.Y. Times Editorial, Dec. 14, 2011, available at http://www.nytimes.com/2011/12/15/opinion/clean-needles-in-new-jersey.html?_r=1 (last accessed Jan. 3, 2012).
Emily Badger, Feds Poke Hole in Needle Exchange Funding, Miller-McCune, Dec. 20, 2011, available at http://www.miller-mccune.com/health/feds-poke-hole-in-needle-exchange-funding-38518/ (last accessed Jan. 3, 2012).
Kristen Gwynne, Risking Lives: In 2012 Spending Deal, House GOP Slaps Ban on Federally Funded Syringe Exchange Programs, AlterNet, Dec. 16, 2011, available at http://www.alternet.org/newsandviews/article/749233/risking_lives%3A_in_2012_spending_deal,_house_gop_slaps_ban_on_federally_funded_syringe_exchange_programs/ (last accessed Jan. 3, 2012).
N.J. Lawmakers Approve Sales of Needles, Action News, Dec. 5, 2011, available at http://abclocal.go.com/wpvi/story?section=news/local&id=8455789 (last accessed Jan. 3, 2012).
Sarah Barr, Needle-Exchange Programs Face New Federal Funding Ban, Kaiser Health News, Dec. 21, 2011, available at http://www.kaiserhealthnews.org/Stories/2011/December/21/needle-exchange-federal-funding.aspx (last accessed Jan. 3, 2012).