Can the FDA Ban Cupcakes?

By Katie Booth

In the spirit of Valentine’s Day, I wanted to discuss an important issue: Can the FDA ban cupcakes? While this may seem like a silly question, the Center for Science in the Public Interest (“CSPI”) has filed a petition with the FDA urging the agency to regulate the amount of sugar (including high fructose corn syrup) in soft drinks. According to the executive director of CSPI, sugar is a “slow-acting but ruthlessly efficient bioweapon” that causes “obesity, diabetes, and heart disease.”

If soft drinks are a problem, surely cupcakes are too. A twelve-ounce can of Coca-Cola contains 39 grams of sugar. A seasonally-appropriate red velvet cupcake from Sprinkles contains 45 grams of sugar—and who can eat just one? National cupcake consumption increased 52% between 2010 and 2011, and U.S. consumers ate over 770 million cupcakes last year. Sugary soft drink consumption, on the other hand, is down 23% since 1998 and 37% since 2000.

While the FDA can’t regulate sugar as a bioweapon, it probably could regulate sugar as a food additive. Under the Food, Drug, and Cosmetic Act, a food additive is “any substance the intended use of which results or may reasonably be expected to result—directly or indirectly—in its becoming a component or otherwise affecting the characteristics of any food.” This broad definition would include sugar. The FDA does not, however, regulate food additives that are “generally recognized as safe” (“GRAS”). Presumably the FDA considers sugar to be GRAS—for now.

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Twitter Round-Up (1/27-2/7)

By Casey Thomson

Even the surprisingly resurrected Richard III (on the Twitter-sphere, anyway) appreciates bioethics concerns. Read on to find out more about Richard III’s eagerness for patient confidentiality and other updates in this week’s (extended) Twitter round-up:

  • Stephen Latham (@StephenLatham) included a link to his blog post challenging Andrew Francis’ recent claim that penicillin was the central drug spawning the sexual revolution of the 1960s. While penicillin may have facilitated the widespread acceptance of pre-marital relations, it was The Pill that “translat[ed] that newfound sexual freedom into sexual equality.” (1/28)
  • Dan Vorhaus (@genomicslawyer) posted a summary video regarding the Neanderthal baby story that rocked the internet in the past few weeks, as reported by Taiwan’s Next Media animation. (1/28)
  • Michelle Meyer (@MichelleNMeyer) shared a news report on Israel’s recent admittance to giving birth control to Ethiopian Jewish immigrants, frequently without either consent or knowledge. Concerns first arose after an investigative journalist began to explore why birth rates in the community had fallen so drastically and seemingly inexplicably. (1/28)
  • Arthur Caplan (@ArthurCaplan) linked to a piece explaining the future implications and consequences of the guidance requiring schools to make “reasonable modifications” in order to include students with disabilities in either general athletic programs or provide them with parallel opportunities. The guidance, while a potential huge move forward for individuals with disabilities, nonetheless will be nothing without “tough and honest conversation about financing and revenue – and soon.” (1/28)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article showing the return of the “invisible gorilla” from the 2010 book, but this time in the fake CT scans shown to both expert radiologists and volunteers alike. The gorilla was large in size compared to the typically indicative nodules, and was unmistakably a gorilla, but yet 20 out of the 24 radiologists failed to see the gorilla. It’s a frightening real-life example of what the original study’s jargon terms as “inattentional blindness.” (1/29)
  • Kevin Outterson (@koutterson) live tweeted the Pew meeting concerning new antibiotic development pathways for limited populations. See the string of tweets on his Twitter page for further details of how the meeting proceeded. (1/31)
  • Daniel Goldberg (@prof_goldberg) shared a link describing the first scientific evidence suggesting that doctors can “truly feel” their patients’ pain. The study, done by Harvard researchers, used brain scans to indicate activated regions of physicians’ brains during a simulated interaction with patients. (2/1)
  • Frank Pasquale (@FrankPasquale) linked to a story on the problems associated with over-prescribing amphetamine-based medications, particularly to teenagers and young adults. While focusing on the individual story of an aspiring medical student named Richard Fee, the author delves into the underexposed side effects of often overzealous prescribing and the surprisingly casual attitude that most Americans hold towards this medication. (2/3)
  • Frank Pasquale (@FrankPasquale) also posted a piece inspired by the talk surrounding World Cancer Day on the problems related to cancer treatment in developing countries. Contrary to being solely a problem of so-called developed nations, cancer remains an issue globally – including such cancers that are caused by an infectious agent. Fighting the false notions – that cancer in developing nations is minimal, that it is always not “catchable,” and that enough care (particularly vaccines) is being delivered – is essential to reducing the global inequity in cancer treatment. (2/4)
  • Michelle Meyer (@MichelleNMeyer) retweeted the (supposedly resurrected and technologically adept) Richard III’s tweet regarding publication of details surrounding his newly-identified bones: “Hmmm not so happy about my physical attributes being discussed in public. What happened to patient confidentiality ???” (2/4)
  • Daniel Goldberg (@prof_goldberg) shared a report on a new study that found a correlation between low self-esteem and female body representation and obsession in “chick lit.” The report noted that the results suggested a possible “intervention tool” by having characters seek support from friends and family for such body concerns. (2/5)
  • Michelle Meyer (@MichelleNMeyer) retweeted a graphic eloquently summarizing one of the simplest and most potent arguments in favor of vaccination, and arguably the greater biopharmaceutical industry. (2/6)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Twitter Round-Up (1/20-1/26)

By Casey Thomson

Though simply the consequence of bad translation, the story of the Harvard geneticist George Church looking for a woman to act as surrogate for a Neanderthal clone shocked the internet bioethics world. A look at the problems with this hypothetical situation is just one of the components of this week’s Twitter Round-Up.

  • Frank Pasquale (@FrankPasquale) linked to an opinion piece discussing the reasoning behind the United States’ place in the world rankings of life expectancy at different stages of life. The news is a big hit to ideas of American exceptionalism: according to a report by the National Research Council and the Institute of Medicine, Americans have a substantially higher death rate for those younger than 50 as compared to Western Europeans, Canadians, Japanese, and Australians, but once they reach the age of 80, they have some of the longest life expectancies globally. (1/20)
  • Arthur Caplan (@ArthurCaplan) shared his article on why Neanderthal cloning is a bad idea, both in terms of safety and in terms of avoiding cruelty. (1/22)
  • Arthur Caplan (@ArthurCaplan) posted a news story on the reopening of bird flu experimental procedures for vaccine creation. Caplan was quoted in the article as stating: “I have no issue with restarting the research but some issue with where they are going to publish it and where they present it because bad guys can use it too.” (1/23)
  • Daniel Goldberg (@prof_goldberg) included an evaluation as to the medical disparities occurring in Colorado, particularly between races. The article emphasized in its conclusion that the existence of the disparities themselves is quite clear, but discussion on how to erase such differences is noticeably absent. (1/23)
  • Michelle Meyer (@MichelleNMeyer) retweeted a post that attempted to quantifiably compare the quality of care in Medicare options, namely whether Medicare Advantage plans 1) will eventually shortchange patients by skipping out on care quality because of profit motive or 2) have incentives to improve care quality because of the newly implemented systematic quality monitoring, where poor ratings impact them financially. The author found that most existing data makes the second theory more compelling, though the amount of data regarding the subject in general is largely lacking. (1/24)
  • Michelle Meyer (@MichelleNMeyer) also shared a link to an explanation of the intricacies of “personalized regulation” in medicine, which aims to preserve patient choice in an era leaning more and more towards paternalistic medical oversight. Understanding that patients may choose to make rational decisions that diverge from the community or committee consensus is key towards improving medical care to better reflect patient wants, and rights. (1/24)
  • Arthur Caplan (@ArthurCaplan) included a story on the large imbalance in misconduct reports in research between the genders. Men overwhelmingly led the charge, with only nine women out of the 72 faculty members who committed research misconduct. (1/24)
  • Michelle Meyer (@MichelleNMeyer) additionally shared a letter written by the Editor of The Hastings Center’s Bioethics Forum on the reasoning behind publication of a controversial article on the social pressures leading to obesity. The letter calls for the importance of recognizing that publication means that an article contributes to the larger debate on an issue, though does not affirm that the publication medium agrees with the views espoused within; it also encouraged responses to the ideas of the article. (1/25)
  • Stephen Latham (@StephenLatham) posted a video link from Comedy Central on the perils of WebMD and vegetarianism. (1/25)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Twitter Round-Up 1/1-1/13

By Casey Thomson

Due to the string of December holidays and some traveling by the round-up author, this post belatedly summarizes tweets from the end of 2012 to the beginning days of the new year. The round-up will resume a regular schedule following the conclusion of this week. Read below for this (extended) round-up:

  • Frank Pasquale (@FrankPasquale) posted an article about China’s growing obesity problem, one that shocks those who remember the Great Famine of 1958-61 and which is still largely minimized by government officials. The total number of obese individuals in China has risen from 25% in 2002 to 38.5% in 2010, according to the World Health Organization. (1/1)
  • Frank Pasquale (@FrankPasquale) also tweeted this blog post on the possibilities of cyborgs, a potential reality that a recent BBC article notes may not be too distant. Such an invention could potentially result in direct mental control of machines, augmented intelligence, augmented learning, and mood modification, among other benefits, postulates the article author. (1/1)
  • Frank Pasquale (@FrankPasquale) additionally posted a piece addressing the idea of love between humans and robots. (1/3)
  • Alex Smith (@AlexSmithMD) announced the release of PREPARE, an online advanced care planning tool meant for individuals to foster communication skills and prepare for decision-making rather than make premature plans. The project in part is meant to help empower individuals rather than have them tied to the medical establishment. (1/4)
  • Dan Vorhaus (@genomicslawyer) included a blog post on crowd-funding personalized bioscience, particularly summarizing companies aiming to contribute outside the genetics realm. This includes sequencing the gut microbiome and noting biomarker concentrations through the blood. (1/7)
  • Michelle Meyer (@MichelleNMeyer) posted an article decrying the paternalistic attitudes surrounding the release of genetic information to patients. Not only does this article claim that “People are smarter & more resilient [re #genetic info] than ethic debates give them credit for”, as Meyer references from the article, but it also recognizes that the complexities of the genome do not make it less necessary for doctors to figure out how to discuss it with the public. (1/7)
  • Michelle Meyer (@MichelleNMeyer) also posted about the Supreme Court’s decision regarding a case on government funding of embryonic stem cell research. SCOTUS declined to hear an appeal to stop the research, which opponents claimed was in violation of the 1996 Dickey-Wicker law. (1/7)
  • Daniel Goldberg (@prof_goldberg) posted about a recent study on the influence of body weight and gender on courtroom judgments. The Yale Rudd Center for Food Policy and Obesity found that only an obese female was punished when in consideration along with a lean male, an obese male, and a lean female. Goldberg notes in his tweet that the results are “unreal but sadly [unsurprising]”. (1/8)
  • Alex Smith (@AlexSmithMD) retweeted an article lamenting the continued fall of fellowship trained geriatricians, which noted that the decrease in numbers is surprising considering that a boost from the Affordable Care Act raises a geriatrician’s annual salary by 12 percent through 2015. (1/9)
  • Arthur Caplan (@ArthurCaplan) shared a link on a sperm donor custody case in Kansas where the sperm provider thought he had absolved any connection to the child that his sperm would create, but is now being called upon to pay child support. While similar cases have not received as much media attention, the concept – being responsible financially as a result of having genetic ties to a child – has come up in cases involving fathers who were deceased yet were called to pay through their estate, and even in a similar sperm donor case in Pennsylvania in 2011. (1/10)
  • Frank Pasquale (@FrankPasquale) posted an article discussing the recent move by  various healthcare centers requiring their health practitioners (doctors and nurses alike) to get a flu vaccine – possibly at the risk of their job. Should this be grounds for termination, or should the healthcare providers have the same choice to abstain from vaccination as does a patient? (1/13)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Where Are We Now: Post 4, Looking in the Mirror, or 3 Games in Public Health

By Scott Burris

In a well-known exchange, Richard Epstein argued that modern public health had strayed far outside its traditional and proper work of preventing epidemics and injuries into a realm of social engineering in which it lacked both competence and legitimacy. William Novak, the historian, disagreed, emphasizing the continuity of our public quest for well-ordered, salubrious (and virtuous) communities. Deciding whether public health is winning or losing in the legal arena – and figuring out how we win more often — depends to some degree on what game it is we think we are playing – that is, on whether Epstein or Novak is right.

I think they both are, and it is worth considering how. I suspect that most of us think, without going too deeply, that we’re doing pretty much the same thing that Lemuel Shattuck was doing at the dawn of modern American public health: marshaling collective resources to use data to diagnose, treat and prevent harm to public health.  And if that’s what you think you’re doing, his report is still an excellent guide to making the case for legal action: evidence shows that we can prevent morbidity and mortality in a cost-effective way that does not significantly interfere with anyone’s rights and makes our society stronger and more competitive.

But law, at least, is a very good area for asking whether we are doing something quite different than our grandmother’s public health.  The use of law as a tool of intervention in public health – as a way of creating safer products and environments and incentivizing healthier behavior — has exploded since the 1960s. Yes, you can find public health law at work in the early 17th century, but when I was born in 1956, there was no OSHA, no EPA, no NHTSA. No warning labels on dangerous products. No safety belt standards or laws. Minimal limits on drinking and driving. No federal clean water or air standards. An unrecognizable FDA. And so on it goes.  In the great Novak-Epstein debate, Novak is right that we have a rich tradition of public health regulation, and plenty of paternalism and interference with individual rights based on epidemiological evidence of preventable harms. This is public health as sic utere, then and now largely a matter of showing how someone is doing something that demonstrably imposes costs on others. That’s why the debate Shattuck was waging sounds so familiar to contemporary ears. (And, by the way, that extends to the moralism implicit in our “scientific” recommendations about healthy lifestyles.)

But Epstein is right, too, I think, to observe that something is different. Public health is now a pillar of the regulatory state and the risk society, deeply enmeshed in the project of defining and minimizing risks great and, let’s face it, small.  We deploy complex regulatory systems, some of which work and some of which we continue to defend anyway, in spite of our own commitments to evidence. As matters like obesity and inequality take intervention further and further from proximate to distal links in the causal chain, our ability to back our proposals with evidence, and evidence that speaks to an everyday sense of causality, becomes severely attenuated. Much of what we propose rests on a vision of the good – salus populi – that is as much a matter of values as it is of evidence.  Failing to own that, we fool ourselves without winning over our audience.

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‘Frankenfish’ far less scary than fast food

By Art Caplan [cross-posted from his NBCNews Vitals column]

Two big events recently took place in the world of food: The Food and Drug Administration decreed that genetically engineered salmon wouldn’t harm the environment and McDonald’s announced that its McRib sandwich is back on the menu.

The FDA’s announcement paves the way for the first approval of a genetically engineered animal for humans to eat – and it was met with a good deal of highly critical wailing and groaning by Consumer’s Union, National Geographic and many other advocacy groups who are wary of genetically engineered food.

The McRib’s return was greeted with a few snickers by late night comedians and overwhelmingly happy faces on the millions of Americans who eat at one of the 13,000 McDonald’s restaurants from Maine to Hawaii every day. This, as my grandmother would have said in Yiddish, is “fakakta”—completely screwy.

If you like salmon, and I do, should you worry much about the safety of eating genetically engineered salmon?  No. The FDA said it could not find any valid scientific reason to prohibit the sale of the fish.

If you like the McRib, and I do, should you worry a lot about eating it?  Oh yeah.

Keep reading…

The Ethics of Bike Shares: Some Tough Distributive Justice Questions about Helmets, Fatalities, and Obesity/Heart Disease

Boston recently followed many other world cities in implementing a bike share program. As the New York Times recently reported, North American cities face a dilemma: if the European experience is any guide, for bike shares to take off the city must do away with the helmet requirement. That turns out to be not a health versus leisure trade-off, but a complex health vs. health trade-off. As the New York Times puts it:

In the United States the notion that bike helmets promote health and safety by preventing head injuries is taken as pretty near God’s truth. Un-helmeted cyclists are regarded as irresponsible, like people who smoke. Cities are aggressive in helmet promotion. But many European health experts have taken a very different view: Yes, there are studies that show that if you fall off a bicycle at a certain speed and hit your head, a helmet can reduce your risk of serious head injury. But such falls off bikes are rare — exceedingly so in mature urban cycling systems. On the other hand, many researchers say, if you force or pressure people to wear helmets, you discourage them from riding bicycles. That means more obesity, heart disease and diabetes. And — Catch-22 — a result is fewer ordinary cyclists on the road, which makes it harder to develop a safe bicycling network.

Suppose hypothetically we came to the conclusion that more life years would be lost to obesity/heart disease related injuries from forbidding helmet laws than would be saved from putting helmets in place, would that justify doing away with our helmet laws? Does it matter that the injuries cause immediate death/injury in the un-helmeted case but are gradual to accumulate as to obesity and heart disease in the helmet case? That might in turn depend on whether we believe in the “rule of rescue” and whether we think of it as merely a rule about allocating aid versus preventing harm in the first place. If most bicyclists who are injured are younger, given the typical profile of the city biker, is there a dimension of age-weighting that might be relevant. Or, in fact, given that those who do not use bikes now due to the helmet laws will be older when they suffer from obesity/heart disease give us a reason to think age-weighting is inappropriate in this domain. This is somewhat similar to the arguments offered in the Age Discrimination in Employment Act (ADEA) context, that unlike Title VII or the ADA we will ALL (if things go well) eventually be old, so protection for the old benefits everyone. However, those who get hit by cars without helmets will likely die young. Finally, what role for choice, responsibility, resistance to the nanny state, etc?