Research, the Avian Flu and Bioterrorism

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.

Are Fat Taxes All the New Rage?

The world’s first fat tax is finally here. Well, it’s not actually here (New Jersey’s Star Ledger Newspaper took the time to say “fat chance” to such a plan working in the U.S.), but it has been officially enacted in Denmark.

The tax applies to all foods that have a saturated fat content greater than 2.3%. The tax rate is 16 Danish kroner per kilogram of saturated fat (roughly $1.29 per pound). Danish officials expect the tax to generate somewhere between 1.5  billion and 2.75 billion Danish kroner annually. According to the Danish Agriculture and Food Council, a family with two adults and two children that does not change their eating habits can expect to pay an extra 1000 kroner a year (a little less than $200).

Interestingly enough, the goal of the tax is not to target obesity. The obesity rate in Denmark is 13.4%, which is 2.1% less than the European average. The last time the U.S. had obesity rates as low as Demark was in the 1970s. Instead, the fat tax is aimed at increasing the Danish life expectancy of 79 by three years over the next decade.

This type of legislation is not new for Danes. Denmark was actually the first country to institute a ban on trans fats in 2003, and last year the country instituted a 25% tax on sugary items like ice cream, chocolate and sweets. Sin taxes for soda, alcohol and cigarettes also exist. Advocates of these taxes note the benefit to preventative health and also the advantage of filling the government’s coffers. According to the secretary general of the European Public Health Alliance, Monika Kosinska,

“Denmark will not only increase general health amongst the population but will also ease the burden on the public health care system and increase its resources at a time of recession when [European] Member States are cutting public expenditure.”

Benefits aside, the criticisms of the new tax are numerous. In an article for The Atlantic, Edward Tenner notes the rich irony that Denmark, one of the world’s foremost producers of butter, cheese and bacon, is the first country to implement a tax on fat. Critics include, of course, the numerous producers of affected foods like butter, milk, cheese, meat and oil. One CEO of a Danish meat manufacturing company called the tax a bureaucratic nightmare.

Producers are required to pay the tax, and these costs will be passed on to consumers, suggesting that more Danes will shop abroad. Denmark’s central association of margarine producers (MIFU), has already filed a complaint with the European Union (EU) Commission arguing that the tax is noncompliant with EU free trade rules.

Other critics note that the tax may not be high enough to actually change behavior.

Given the similarity to soda taxes (previously discussed on this blog), it’s worth referring to a 2009 article published in the New England Journal of Medicine by Kelly Brownell and his team. They considered the public health and economic benefits of taxing high-sugar beverages and found that the 5% soda taxes that many U.S. states have enacted are too small to affect consumption. Their team proposed that a sugar tax on beverages would have to be much higher to lower soda consumption, at around 1 cent per ounce of beverage.

A 2007 study by the Forum for Health Economics and Policy focused on the ability of a fat tax to change behavior and found that a 10% fat tax on dairy would not reduce consumption by even one percent. The authors suggest that the tax rate would have to be much higher, but even a 50% tax may only reduce fat intake by 3%.

Some critics have offered suggestions on how to better address the problem both of obesity and shortened life-spans. Dr. Mike Rayner, Director of Oxford University’s Health Promotion Research Group, argues that Danes may switch from high fat foods to other unhealthy foods. He proposes that the overall unhealthiness of food should be taxed instead, not just a single nutrient. Simultaneously lowering taxes on fruits and vegetables could promote a healthier behavior change.

Dr. Yoni Freedhoff, medical director of the Bariatric Medical Institute in Ottawa, points to the public health issue of obesity as a societal problem. He notes,

“If we want to have legislation that deals with this problem, perhaps legislation that would deal with advertisement to children and zoning laws for fast foods around school would be a better place to start than a tax that is simply going to raise money and will not, in fact, change anything.”

NYU professor Marion Nestle finds the fat tax to be troubling for a different reason. To see individual behavior change, she argues that we must change the behavior of corporations “that make and market unhealthful products, spending vast fortunes to make them available, desirable and socially acceptable.” She cites a recent Lancet article on food environment factors that sees food processing, cost and marketing as drivers of consumption. She concludes, “[G]overnments seriously concerned about reducing rates of chronic disease should also consider ways to regulate production of unhealthy products, along with the ways they are marketed.”

Despite the multitude of criticisms, several other European countries have expressed a desire to follow suit– including France, Finland, Romania, Sweden, Norway, and even Britain. Americans should also be watching this social health experiment. But given that our country’s favorite condiment is mayonnaise, maybe the Star Ledger is right– it may not be time for a U.S. fat tax just yet.

FDA’s ‘Bad Ad’ Program is in Full Effect

Last spring, the Food and Drug Administration (FDA) launched the Truthful Prescription Drug Advertising and Promotion Program (known more accessibly as the “Bad Ad Program“). The goal of the program is to enlist the help of health care professionals, consumers, and industry representatives in noting FDA violations and reporting activities and messages that are false or misleading. Common drug marketing violations include omitting or downplaying risk, overstating effectiveness, promoting off-label uses and making misleading drug comparisons. The program is run by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), which is responsible for “ensuring truthful advertising and promotion of prescription drugs.”

The FDA published a year-end report in May noting that the program has been successful in raising awareness. DDMAC received 328 reports of potentially untruthful or misleading promotions in one year, with the majority of those submitted by health care professionals (188 reports) and consumers (116 reports). The report notes that prior to the Bad Ad program, the FDA received an average of about 104 reports per year.

And the Bad Ad tips are still coming in. Just at the end of last month, DDMAC issued a reprimand letter to Pfizer’s Vice President of US Regulatory Affairs regarding misleading advertising of drugs on the company’s Lipitor website. A complaint to the Bad Ad program observed that the links from the Lipitor site led to pages for the drugs Caduet (for high cholesterol and blood pressure), Norvasc (for high blood pressure), and Chantix (for smoking cessation). But each of those pages failed to note any of the risk information associated with the drugs, which is a violation of the Federal Food, Drug, and Cosmetic Act.

The FDA states that “by omitting the most serious and frequently occurring risks associated with Caduet, Chantix, and Norvasc, the webpage misleadingly suggests that these drugs are safer than have been demonstrated.” The letter ends with a request that Pfizer immediately stop the dissemination of violative promotional materials for the drugs. The company was to have submitted a written response to the complaint by September 14^th that states how they will comply with the request.

While the Bad Ad program may be working to raise awareness among health professionals and consumers, one violation may not be enough to induce compliance from pharmaceutical companies. In fact, DDMAC already chided Pfizer in March of 2009 for omitting risk information for Caduet and Chantix. In that case, Pfizer sponsored links for the drugs on Internet search engines. The sites linked to did not mention any risk information and therefore, presumably,  can be said to have also represented the products in a manner which, as above, suggests that these drugs are safer than have been demonstrated.” The most recent letter states that “DDMAC is concerned that Pfizer is continuing to promote its products in a similarly violative manner.” A citizen’s task force is a good way for the FDA to multiply their eyes and ears to keep tabs on misleading and/or violative advertisement. We’ll see what further successes the next year-end report for the Bad Ad program can show. Or, perhaps, success might also be measured in the absence of violations.

FDA Drafts Guidance on Mobile Medical Apps

In an effort to keep up with advancing technology, the Food and Drug Administration (FDA) has proposed new regulations to monitor medical smartphone applications (apps). The draft proposal states that any mobile app that is intended for use in performing a medical device function meets the definition of a medical device under the Federal Food, Drug, and Cosmetic Act. Specifically, these mobile medical apps must be either used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device.

To further clarify what apps will be regulated, the document notes that a mobile app is a device “when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man.” The guidance document explains how the intended use of mobile apps can be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives.

The goal of the regulations is to protect patient safety, though to date there have been no adverse events reported to the FDA. The proposal seems to be forward looking in creating a framework for mobile app manufacturers. According to the Associated Press, there are already more than 17,000 medical applications currently available.

Physicians can use mobile phones to calculate prescription dosages, review disease treatment guidelines, and explain diagnoses and procedures to patients. The FDA expects that by 2015, 500 million smartphone users will rely on health care apps.

Two medical apps have already received FDA approval for use by physicians. The first is a prenatal care app called AirStrip OB. Cleared in 2009, the app allows obstetricians to use their phones to remotely access real-time data for mothers and babies. The second app, approved earlier this year, is Mobile MIM. This app allows hospitals and doctors offices to send images to physicians’ mobile devices. The FDA noted that the software should not be used to replace radiology workstations as the primary way to view medical images, but is useful when a physician has limited access.

Opinions from within the industry vary on the new guidelines. Some feel that the regulation is both necessary and welcome. By regulating the medical app industry, the FDA is offering market players clear guidelines for continued development. Others argue that the regulations may be too far reaching. For example, medical apps to calculate prescription dosages for patients are not new and are based on accepted formulas. Smartphone apps that achieve the same goal increase efficiency and do not put patients at risk, and therefore do not merit differential treatment.

The proposed regulations raise two main concerns for patients and physicians. The first is a privacy concern, similar to the drawbacks considered for other forms of Electronic Health Records. Transferring data between hospital systems and physician smartphones will increase confidentiality and security concerns. Once patient data is accessed on a smartphone, privacy may be easily breached should the phone be used by another person, lost or stolen. The second concern is that these proposed rules could increase the purchase price for medical apps. App developers will likely have increased costs for filing applications and seeking legal counsel, and those costs will be passed to end users.

The draft proposal is currently in an open comment period, and the FDA will amend the regulations after the comment period closes.

Sunscreen Labeling Rules Revamped

Last month, the Food and Drug Administration (FDA) released new regulations for sunscreen manufacturers to update rules from over 30 years ago. The new regulations, which will take effect in 2012, require that sunscreen manufacturers prove certain labeling claims before they can be used on packaging. In an effort to avoid consumer confusion, the FDA is regulating when sunscreens can claim broad-spectrum protection or water resistance and is also setting a sun protection factor (SPF) cap at 50.

According to the new rules, only sunscreens that block both ultraviolet A (UVA) and ultraviolet B (UVB) rays can be labeled to have broad spectrum protection. While UVB rays are the primary cause of sunburn, UVA rays contribute to skin cancer risk and premature aging. Sunscreens that are not broad spectrum or with SPF values less than 15 will be given the following warning label:

Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

In addition, sunscreens can no longer be labeled as waterproof or sweatproof, and manufacturers cannot use the term “sunblock” on their packaging. The FDA remains concerned with exaggerated claims, as no sunscreen can block the sun entirely, nor are any of them completely waterproof. Instead, sunscreens can be called “water resistant” and must be marked as either 40 or 80 minutes, depending on how long the SPF protection will last. Finally, the FDA is requiring any sunscreens with rates above SPF 50 be labeled as “SPF 50+”, given that data suggest no additional protection above that level.

In issuing these new regulations, the FDA is targeting rising skin cancer rates among Americans. The Centers for Disease Control and Prevention (CDC) reports that skin cancer is the most common form of cancer in the United States with 58,000 new cases diagnosed and around 8,000 deaths per year. The hope is that the new regulations will make it easier for consumers to choose the best sun protection and that this will help decrease the incidence of skin cancer.

As welcome as these new regulations are, they are subject to two major criticisms. The first is that the amount of sunscreen used by manufacturers to determine SPF values is not consistent with actual use by consumers. In testing, two milligrams of lotion are used for every square centimeter of skin. Scientific American reports that most people use only one fifth to one half of that quantity, meaning that their skin is not fully protected at the labeled SPF level. Secondly, the FDA assumes for designation purposes that consumers will always follow the directions on their sunscreen products. In practice, sunscreen users fail to reapply as often as directed (which is at least every two hours during sun exposure).

Even with these limitations, the new system is a marked improvement to the 1978 regulations. Consumers can protect themselves even before the new regulations take effect in 2012– the FDA recommends that individuals use sunscreen with an SPF of at least 15 and a broad spectrum rating to protect from the full range of sunlight. In addition to purchasing the right sunscreen products and following directions, the FDA encourages that people wear proper clothing and limit sun exposure to help protect skin from UV rays.

The Right to Life, Liberty… and the Internet?

This month, the United Nations (UN) Human Rights Council recognized access to the Internet as a human right. The report was written by UN Special Rapporteur on the Promotion and Protection of the Right to Freedom of Opinion and Expression, Frank La Rue, and it separately considers access to Internet content and access to the infrastructure required for Internet access. The report cites over 2 billion Internet users worldwide and notes that the Internet has becomes a key means through which individuals can exercise their right to freedom of opinion and expression. La Rue concludes that “there should be as little restriction as possible to the flow of information via the Internet, except in few, exceptional, and limited circumstances prescribed by international human rights law.”

The report seems motivated by recent episodes of political unrest such as the Arab Spring uprisings. La Rue states that the Internet is “one of the most powerful instruments of the 21st century for increasing transparency in the conduct of the powerful, access to information, and for facilitating active citizen participation in building democratic societies.” He notes that countries have been increasingly censoring online information through 1) arbitrary blocking or filtering of content, 2) criminalization of legitimate expression, 3) imposition of intermediary liability, 4) disconnecting users from Internet access, and 5) inadequate protection of the right to privacy and data protection. La Rue recognizes some legitimate reasons to restrict Internet access, like in the case of cyber- attacks, but focuses on how countries often abuse their power and infringe on the rights of their citizens:

In many instances, States restrict, control, manipulate and censor content disseminated via the Internet without any legal basis, or on the basis of broad and ambiguous laws, without justifying the purpose of such actions… Such actions are clearly incompatible with States’ obligations under international human rights law, and often create a broader “chilling effect” on the right to freedom of opinion and expression.

La Rue specifically notes his concern with the “three- strikes-law” in France and the UK’s Digital Economy Act of 2010. Both of these proposals are anti-piracy measures that would impose penalties against Internet users for illegal file sharing and violation of intellectual property rights. The end result could be suspension of Internet service if copyright infringers disregard warnings. La Rue considers that

Cutting off users from Internet access, regardless of the justification provided, including on the grounds of violating intellectual property rights law, to be disproportionate and thus a violation of article 19, paragraph 3, of the International Covenant on Civil and Political Rights.

Article 19 of the ICCPR concerns the right to freedom of expression.

The fundamental human rights doctrine, the Universal Declaration of Human Rights (UDHR), was penned in 1948 just after the end of WWII. In part based on Franklin Delano Roosevelt’s Four Freedoms, the document was largely a response to the atrocities seen in the war. Article 19 of the UDHR states that

“Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.”

The drafters left the definition of ‘media’ open in anticipation of new technologies, and the Internet and its extraordinary proliferation in recent years is the most relevant form of media in our time.

La Rue, however, does not just depend on this as a basis for his claim that removing Internet access is a deprivation of the basic human right of freedom of expression. He elaborates on how the Internet facilitates the realization of other human rights-

The right to freedom of opinion and expression is as much a fundamental right on its own accord as it is an “enabler” of other rights, including economic, social and cultural rights, such as the right to education and the right to take part in cultural life and to enjoy the benefits of scientific progress and its applications, as well as civil and political rights, such as the rights to freedom of association and assembly. Thus, by acting as a catalyst for individuals to exercise their right to freedom of opinion and expression, the Internet also facilitates the realization of a range of other human rights.

But even if Internet access constitutes a human right, many countries lack access to basic commodities such as electricity, let alone the necessary infrastructure and technologies to access the Internet. La Rue rests on the positive obligation of countries to work towards promoting or facilitating freedom of expression. He encourages countries to develop a “concrete and effective policy… to make the Internet widely available, accessible and affordable to all segments of population.”

La Rue’s report remains the first recommendation in a series of negotiations on how to adopt access to the Internet as a fundamental right. As La Rue concludes, “given that the Internet has become an indispensable tool for realizing a range of human rights, combating inequality, and accelerating development and human progress, ensuring universal access to the Internet should be a priority for all States.”

La Rue is right to understand the internet as a means to effectuate development. The implications for healthcare can, of course, be staggering. An internet connection is no substitute for bread or medicine but that connection  makes widely available medical techniques and public health information and makes “remoteness” a somewhat antiquated concept. If global health is to substantially  improve, internet access will ultimately be key.

Functional Foods: What Happens When Advertising Misleads Consumers?

An article recently published in the New York Times focuses on the complexities of modern-day food labeling. It seems that almost every product in the grocery store touts a label boasting of some health benefits, from supporting heart health to lowering cholesterol levels. These items are referred to as functional foods or nutraceuticals, and they are foods that claim to provide health benefits beyond the traditional nutrients they contain. Functional foods are one of the fastest growing areas in the food industry.

While companies cannot claim that functional foods actually prevent or cure diseases, they can market foods with having health-promoting or wellness-maintaining properties. The article explains how economists refer to items like functional foods as credence goods. For these foods, most consumers are unable to assess the utility of health claims and therefore rely on advertisements to be true. Misleading marketing and advertising can leave consumers confused about what they are buying and about just how helpful some products are in maintaining overall health.

The Federal Trade Commission (FTC) oversees food advertising and has filed recent complaints of deceptive marketing against Kellogg and Dannon. Frosted Mini-Wheats can no longer claim that they are clinically shown to improve children’s attentiveness by nearly 20 percent, and boxes of Rice Krispies are no longer emblazoned with a claim that they support children’s immunity. Dannon was forced to remove claims that its Activia yogurt improves intestinal transit time, as the FTC found no scientific proof for such a claim.

The Food and Drug Administration (FDA), which oversees food labeling, has also noted the problems with false or misleading claims on functional foods. Commissioner Margaret Hamburg wrote an open letter to the industry urging them to examine product labels to avoid violating established labeling standards. But the issue seems too complicated for an open letter to solve. As the FDA’s deputy commissioner for foods Michael Taylor wrote last year,

“Going after [misleading marketers] one-by-one with the legal and resource restraints we work under is a little like playing Whac-a-Mole, with one hand tied behind your back.”

The Deputy Commissioner appears to be right, and not all food companies are willing to give up false or misleading claims or labeling without a fight. In 2010, the FDA found that the makers of POM Wonderful pomegranate juice had violated the Federal Food, Drug, and Cosmetic Act by making therapeutic claims that “establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.” When POM did not retract its claims, the FTC filed a complaint against the maker for deceptive advertising based on unsubstantiated scientific claims. POM was initially defiant (calling the FTC complaint unwarranted), but eventually settled and changed their advertising.

The company did, however, file a federal lawsuit against the FTC for acting outside its authority and violating the right to free commercial speech. As NYU Professor Marion Nestle pointed out in an article, POM’s suit is being brought “not because they are claiming they have science on their side, but because they think their health claims, believable or not, are protected by the First Amendment.”

There are other ways to confront misleading ‘healthy’ claims before they are printed on products and sold to consumers. The article notes the approach of the European Food Safety Authority, an independent panel of experts to whom food makers submit applications of scientific evidence backing their desired claims. The panel reviews each case and issues an opinion on the evidence, and will create a list of approved health claims for companies to use in the future.

The FDA’s approach is focused on the other end of the product line, and encourages consumers to learn to read nutrition labels and make wise purchasing decisions. This includes updating the Nutrition Facts Panel printed on the back of food packages, adding calorie counts to restaurant menus, and pushing the Let’s Move initiative to combat childhood obesity. A smarter consumer is an admirable and essential goal, but with the amount of money put into advertising on a global scale, the FDA must issue stricter guidelines for food companies. Hopefully, the outcome of the POM lawsuit will help empower the FDA to do just that.

The FDA’s Move to Combat Prescription Drug Abuse: Educating Patients and Physicians

The Food and Drug Administration (FDA) announced a new risk-reduction program this month to help curb abuse of prescription painkillers. The program, called the Risk Evaluation and Mitigation Strategy (REMS), is targeted at manufacturers of long-acting and extended-release opioids. It requires that these manufacturers develop new medication guides for patients and educational materials for prescribing physicians. Each company has 120 days to submit materials to the FDA for review.

According to the FDA, the focus of the REMS plan is to educate doctors about proper pain management and patient selection, and to improve patient awareness about how to use these drugs safely. The medication guides for patients should include consumer friendly language that explains safe use and disposal. The drugs targeted by the REMS plan include oxycodone, methadone and morphine.

As the plan stands now, physicians are not required to review the educational materials. To help generate interest, the FDA plans to offer continuing education credits for physicians who receive the education. The ultimate goal is to make this training mandatory through congressional approval that would link the training to licensing for physicians who prescribe controlled substances.

The FDA hopes that REMS education will cut down the misuse of prescription painkillers without restricting access. There are an estimated one million emergency room visits a year as a result of prescription drug abuse, and the FDA estimates that more than 33 million Americans misused opioids during 2007. That same year, deaths from drug overdose were second only to motor vehicle crashes among leading causes of unintentional injury death in the U.S.

Encouraging safe disposal of medications is key. Over half of all nonmedical painkiller users get their pills “from a friend or relative for free.” Doctors have also been found to prescribe more doses of painkillers than patients actually use, and patients don’t always dispose of unused medications properly.

What can you do to help combat prescription drug abuse? The Drug Enforcement Administration is sponsoring the second National Prescription Drug Take-Back Day this Saturday. You can find a collection site near you by clicking here. Last year, more than 121 tons of prescription drugs were collected at nearly 4,100 locations. It’s a good reason to extend that spring cleaning to your medicine cabinet!

Medicaid Incentives for Healthy Behavior: Turning That Cigarette Back Into Cold Hard Cash

The Centers for Medicare and Medicaid Services (CMS) recently announced a $100 million program through which states can reward Medicaid enrollees who adopt healthy behaviors. The grant program is part of the Patient Protection and Affordable Care Act and allows states to offer incentives for tobacco cessation, controlling or reducing weight, lowering cholesterol or blood pressure, and avoiding the onset of diabetes or improving management of the condition. The goal of the program is prevention, as spending on chronic conditions is said to account for more than 75 percent of annual healthcare expenditures in the U.S.

According to CMS Administrator Dr. Donald Berwick,

With the right incentives, we believe that people can change their behaviors and stop smoking or lose weight. Not only can preventive programs help to improve individuals’ health, by keeping people healthy we can also lower the nation’s overall health care costs.

States are not limited to direct cash incentives– proposed plans could include waiving premiums, deductibles and coinsurance payments, or offering coupons or gift certificates for weight management classes or tobacco cessation counseling.

CMS has based the program on data suggesting a short-term change in behavior when people are offered monetary incentives. Current research shows that while people may be internally motivated to make healthier decisions because of future consequences, they don’t often weigh those delayed outcomes with the immediate reward of engaging in the behavior. For example, knowing that smoking increases lung cancer risk 20 years from now isn’t always going to stop someone from smoking a cigarette. The benefit of monetary incentives is therefore their immediacy– they replace one unhealthy reward with another less harmful one. In short, CMS is betting that someone would put down that cigarette right now if you just paid them to.

But the experience of making healthy decisions seems to align more with what Mark Twain opined in Following the Equator,

He had had much experience of physicians, and said “the only way to keep your health is to eat what you don’t want, drink what you don’t like, and do what you’d druther not.

Though an individual may make a healthy choice now because they would prefer a cash incentive, that doesn’t automatically change their instinctual behavior. Someone could theoretically be convinced to take a grocery store gift card instead of buying a fast food dinner, but that does not change how much they enjoy the taste of a cheeseburger. In many circumstances, people engage in certain behaviors simply because they like to. For this very reason, critics are quick to point out that monetary incentives are unlikely to spur long-term changes in unhealthy habits. Critics also note that there is little research on whether these incentives will be successful in the Medicaid beneficiary population.

What may redeem the initiative from these criticisms is that CMS is candidly calling it a  ”demonstration program,” designed to figure out which strategies produce long-term behavioral changes. By allowing states to develop their own programs and keep data on the experience, CMS seems to be hedging its bets, wagering that at least one program will provide a successful model. Further, CMS can use the data to evaluate other factors such as the administrative costs incurred by states in rendering the programs.

Could $100 million federal grant dollars be used to support preventative health in a different way? Of course. But as long as this money is being set aside to incentivize healthy behavior, we may get an answer to whether external motivators spur long term behavior change. I, for one, would love to know just how much money it costs to convince someone to stop smoking, or to consistently trade in that Big Mac for some broccoli. It almost has to be cheaper than what we’re doing right now.

Childhood Obesity: A Problem Worth Solving

[Ed note: We are pleased to welcome Regina Ram to Health Reform Watch. Regina is finishing her first year as a law student at Seton Hall. She graduated from Drexel University with a B.S. in Biological Sciences and minors in Psychology and Anthropology. She completed a Masters in Public Health from Boston University in 2010 with a focus on Health Law, Bioethics and Human Rights. As a graduate student, Regina worked as a legislative advocate for Dana-Farber Cancer Institute and also supported a SAMHSA funded research program to integrate substance abuse treatment into primary care settings. As an undergraduate, she worked as a healthcare writer and authored emerging technology evidence reports on health devices and procedures.]

Just recently, the New York Times published an article describing the attempt of parents in Philadelphia to change the poor eating habits of the city’s children. A concerned group of parents in a North Philadelphia neighborhood takes turns standing outside of corner stores near a K-8 school in the mornings. They don safety vests and walkie-talkies, and their goal is to discourage kids from stopping at corner stores to buy snacks like soda and candy before school. The article likens the parents to foot soldiers fighting in a national battle over the diets of children.

As dramatic as that may sound, statistics from the Centers for Disease Control and Prevention (CDC) support the metaphor. Nationwide, obesity rates have more than tripled over the past 30 years in both children and adolescents. Long-term consequences include higher risk for heart disease, type 2 diabetes, stroke, several types of cancer, and osteoarthritis in adulthood. More immediate effects include social and psychological problems like stigmatization and poor self-esteem. Further, caring for these health conditions has significant economic effects on the U.S. health care system. All of these statistics portray a battle well worth waging.

But is a group of parents patrolling a convenience store at 8:00 A.M. going to stop childhood obesity? Probably not. Even if the program dissuades kids from buying morning snacks, that behavior is unlikely to continue once parents are gone. Is it a step in the right direction? Certainly. The Surgeon General’s report on overweight and obesity notes that “families and communities lie at the foundation of the solution to the problem.”

However, any successful solution to decrease childhood obesity rates has to involve parents and communities as components of more comprehensive interventions. The causes of obesity in children are multi-factorial, ranging from diet and exercise to genetic and social factors including socioeconomic status and the built environment. The wide array of contributing factors points to the need for an interplay between public and private action to address childhood obesity.

Outside of the home, schools are a key setting for public health efforts to reduce childhood obesity rates. In particular, the National School Lunch Program can be an effective tool in improving the diets of school-age children. Just this year, the U.S. Department of Agriculture announced recommendations to overhaul the nutrition criteria of food programs for the first time in 15 years. The recommendations include limiting salt intake and the use of starchy vegetables, offering only reduced fat milk and using whole grains. Introducing children to healthier foods can help them understand what to eat and why, and that goes much further towards changing future patterns of behavior.

External factors like marketing and advertising also weigh on children’s decisions to eat certain foods. Recent litigation cases (one noted by Jennifer Jascoll here on the HRW website) have focused on the effectiveness of this advertising on children, as well as the disproportionate impact of such advertising on children of lower socioeconomic status. A New York City Councilman recently proposed a bill to ban fast food toys for meals over 500 calories. Children are generally more vulnerable to social messages, and restricting marketing is a case where benefits clearly outweigh the costs.

While involved parents and communities like the one in Philadelphia are undoubtedly an asset, it is going to take a more orchestrated effort to decrease rates of childhood obesity. Parents need to be empowered to make healthy choices and encourage healthier lifestyles for their children. At the same time, schools need to be working hand in hand with the community to ensure that the messages given at school correspond with the messages children hear outside. However unwieldy the issue seems, any action is to be applauded as preferable to no action at all.

(Note: for a more in-depth discussion of the economic consequences of obesity, see Michael Ricciardelli’s article here on HRW)