You are here: Home / Archives for Legal / Federal Regulation

What is the Army Doing with your Baby’s Blood?

April 19, 2011 By Leave a Comment

Like many, I used to love watching The X-Files. The appeal of the show was not just the intricacy of the plot, which had seemingly endless layers of conspiracy, but was also because of the clever way in which factual information was interleaved with fiction, almost making me “want to believe.” One of the most memorable scenes occurs in the show’s third season in an episode titled “Paper Clip,” an obvious reference to the post- World War II “Operation Paper Clip” program by the Office of Strategic Services to sanitize the histories of Nazi scientists so that they could obtain security clearances in the United States. Mulder and Scully find themselves in an abandoned mine in West Virginia. The cavern is filled with filing cabinets, housing “lots and lots of files,” as Scully so artfully described it. Inside the cabinets are smallpox vaccination records and tissue samples collected as part of the Smallpox Eradication Program, creating a comprehensive genetic database for every man, woman, and child born since the 1950’s.

It was creepy. And it made me think about the scar I have on my left shoulder from my own smallpox vaccination.

It is hard not to be reminded of that X-Files episode when reading the complaint in the case of Jeffrey Higgins v. Texas Department of State Health Services. Filed at the end of 2010, the case relates not to smallpox vaccination but to newborn blood screening. In an effort to aid parents in the identification of genetic disease of their newborn child, every state in the United States operates a newborn screening program, and many other countries have similar programs. Such programs began in the late 1960’s and have been expanded over the decades so that virtually all of the 4,000,000 infants born in the United States each year have their heel pricked to collect a few drops of blood around the second or third day of life. Exceptions are rare.

The screening is valuable and provides parents with important medical information that may allow infants born with genetic conditions to have those conditions addressed right from the beginning of their lives. But it is not much of a stretch to understand why medical researchers might have a broader interest in the collection of these samples. Rather than being concerned with a single infant’s condition, the availability of a comprehensive database of newborn blood samples would allow a wide variety of studies to be conducted, looking at patterns of disease that could have profound implications for addressing public-health objectives.

Indeed, in a report published this week in the journal Pediatrics, a copy of which can be found here (subscription required), the authors note the increasing research interest in newborn blood samples. A contract awarded by the National Institutes of Health in 2009 was specifically to develop a “repository of dried bloodspots that is either virtual or physical and comprised of those stored by state newborn screening programs and other resources.” There are certainly positive objectives that could only be reached with access to such blood databases. But the problem is that, in the same way that I found Mulder and Scully’s discovery creepy, many people are uncomfortable having their children’s blood stored in a government database.

This discomfort is justified. There are currently few laws that limit the type of research that may be conducted and most states have no requirement to notify parents that the blood samples may be retained and used for other purposes than the screening of their newborn children. It’s probably fair to say that most never even considered what happened to the blood after collection.

The Higgins case has its origins in an earlier case filed in 2009 when five families sued the Texas Department of State Health Services for the unauthorized storage and use of newborn blood spots. A settlement was negotiated in which Texas agreed to destroy some 5,000,000 newborn blood samples that had been collected and retained since 2002. The Texas legislature also acted — not to limit retention of samples but to provide express government authorization for future samples to be retained. Higgins was filed when it was later revealed that about 8800 samples had been turned over to an Armed Forces laboratory as part of an effort to build a national mitochondrial DNA registry. The stated purpose of the database is forensic, namely to provide a tool by which missing persons may be identified and to aid in the resolution of other difficult cases.

The complaint in Higgins, a copy of which can be found here, alleges that Texas has acted deceptively: “Defendants have knowingly, deceptively, routinely, unlawfully and without the knowledge or consent of the infants’ parents, sold, traded, bartered, and distributed blood samples … to private research companies, government agencies, and other third parties.” A report published by The Texas Tribune that can be found here seems to confirm that records now released by the state “show an effort to limit the public’s knowledge of aspects of the newborn blood program, and to manage the debate around it.” The Tribune skeptically describes “oversights” in response to its requests for information, a pattern of suppressing disclosure about activities related to the blood program, and efforts to “plant” information with sympathetic lawmakers.

I have no doubt that blood databases such as are envisaged have the potential for enormous public good by allowing researchers access to a body of information that is nowhere else available. But the privacy concerns are obvious. Of course people weigh these countervailing issues differently, but the only way to settle the tension between them is by discussing them openly and candidly. One benefit of cases like the one in Texas (and a similar one that failed in Minnesota in 2009) is that public visibility over blood programs is increasing so that that discussion can take place.

Filed Under: Federal Regulation, Legal, Local Regulations, Medical science, Scientific

Of Hares and Lions

March 23, 2011 By 1 Comment

Alarmed at sound of fallen fruit
A hare once ran away
The other beasts all followed suit
Moved by that hare’s dismay.

They hastened not to view the scene,
But lent a willing ear
To idle gossip, and were clean
Distraught with foolish fear.

The quotation is a translation from The Jataka, a body of Indian literature that relates to previous births of the Buddha, and dates to somewhere around the third or fourth century BC.  The story is perhaps the origin of the more modern story of Chicken Little, and tells the parable of a hare that lived at the base of a vilva tree.  While idly wondering what would become of him should the earth be destroyed, a vilva fruit made a sound when it fell on a palm leaf, causing the hare to conclude that the earth was collapsing.  He spread his worry to other hares, then to larger mammals, all of them fleeing in panic that the Earth was coming to an end. 

When radiation is discussed in the news, I often think of the story of the hare and vilva tree.  It seems that we are perpetually confronted with calls to overregulate radiation based on irrational fears of its effects on the human body.  Here I mentioned the persistent fears about radiation from cell phones and the passing of legislation in San Francisco last year requiring that retailers display radiation-level information when selling such devices, but there are many others that appear repeatedly in the news:  radiation from power lines, from computer screens, from cell-phone towers, and from any number of common household devices have at times been alleged to be responsible for causing cancer.  All of these allegations have uniformly been discredited in thousands of scientific publications over the last decades because they do not produce radiation at energies sufficient to break chemical bonds, a factor that is critical in the mechanism by which cancer is caused. 

Most recently, of course, there have been widespread reports of radiation being emitted from the damaged Fukushima Dai-ichi power plants.  There have been demands for governments to suspend the use of nuclear reactors in generating power and at least the German government appears to be acceding, with Chancellor Angela Merkel using absurd hyperbole in characterizing what is happening in Fukushima as a “catastrophe of apocalyptic dimensions.” 

There are legitimate concerns about radiation.  It does cause cancer in human beings.  Regulating our exposure to harmful radiation is an important and necessary role for governments.  But at the same time, rationality must surely prevail based on accurate scientific understanding of the mechanisms by which radiation causes cancer. 

There are a number of simple facts relevant to the debate. 

First, human beings have evolved in an environment in which we are continually exposed to radiation  — from cosmic rays, the Sun, and the ground all around us — and our bodies are adapted to exist with certain levels of radiation.  Indeed, the biological mechanisms by which we evolved as human beings are intimately related to that radiation exposure.  A wonderful graphic produced by Randall Munroe at xkcd illustrates different exposure levels and can be seen here.  One amusing fact shown in the chart is that consumption of a banana exposes a person to more radiation than living within fifty miles of a nuclear power plant for a year — and is dramatically less than the exposure from the natural potassium that exists in the human body. 

Second, there are only a limited number of viable options to produce energy at the levels demanded by modern society.  These are basically through the use of coal power generation and the use of nuclear power generation.  Other “clean” technologies that are frequently pointed to, such as wind and solar power generation, are wonderful technologies that are worth pursuing and which may one day be efficient enough to provide adequate levels of energy to replace coal and nuclear methods.  But that day is not here yet.  Those technologies are simply incapable of producing energy at the levels needed to support modern society and, in any event, have their own environmental concerns that need to be considered and addressed.  I commented, for example, on some environmental concerns associated with wind power generation here. 

Third, with the particular safety mechanisms that are in place, nuclear power generation is safer than coal generation, its only realistically viable alternative.  The xkcd chart cited above notes, for instance, that there is greater radiation exposure from living within 50 miles of a coal power plant for a year than living within the same distance from a nuclear power plant for a year.  The Clear Air Task Force, an organization that has been monitoring the health effects of energy sources since 1996, released a report last year finding that pollution from existing coal plants is expected to cause about 13,200 deaths per year, in addition to about 9700 hospitalizations and 20,000 heart attacks.  A copy of the report can be read here.  Nuclear power generation is also more environmentally responsible since it does not release climate-changing greenhouse gases in the way that coal power generation does.  When considering policy to reduce or eliminate the use of nuclear power — driven largely because the smaller number of deaths from nuclear power result from isolated high-profile events instead of the greater number of deaths that result from the persistent low-level effects of coal power generation — it is important to take these comparisons into account. 

I want to offer a final comment about radiation hormesis, which was recently raised most prominently by political commentator Ann Coulter in the context of the Fukushima event, although it has also been raised by other, more scientifically reliable, sources.  For example, Bob Park, a respected physicist who comments regularly on science and government policy, raised it in the context of a recent study that he interprets as showing that “Chernobyl survivors today suffer cancer at about the same rate as others their age [and that t]he same is true of Hiroshima survivors.”  His remarks can be found here.   Radiation hormesis is an effect in which low-level exposure to radiation produces beneficial effects and that has apparently been observed in laboratory settings.  It has not been convincingly confirmed in human beings and the exposure rates to produce the effect are, in any event, low.  My own view is that pointing to radiation hormesis as a positive argument for the use of nuclear power is counterproductive.  The effect is too speculative and there are too many other — stronger — arguments in its favor. 

The Jataka tells us that when the panicked masses led by the timid hare met a lion, it was he who restored their sensibility.  He brought them to their senses by looking coldly at the facts and determining that the earth was not breaking apart; it was only the misunderstood sound of a vilva fruit.  Let’s be lions, not hares. 

Filed Under: Environment, Environmental Law, Federal Regulation, Legal, Physics, Scientific

Just Plain Nuts

February 6, 2011 By Leave a Comment

Perhaps you have seen the movie.  You know, the one where someone decides to eat only food served over the counter at McDonald’s for a period of time, with a requirement that every item on the McDonald’s menu be tried at least once.  The result was astonishing and you may well remember the shock you felt when you saw what happened.  Eighteen pounds lost and a drop in cholesterol level of 40 points, as well as reports of feeling “excellent” and “energized” as a result. 

What’s that?  That’s not how you remember the movie turning out? 

Oh.  I know.  You’re thinking of that other movie. 

When Morgan Spurlock released his film Super Size Me in 2004, it followed less than two years after Surgeon General David Satcher issued a warning that obesity was a major threat to life in the United States and called for a “national attack” on obesity.  Spurlock’s film recounted an experiment in which he decided to eat only food served by McDonald’s for a period of thirty days.  The results shown in the film were dramatic.  Spurlock went from a healthy weight of 184 pounds for his 6’2″ frame to a heavy 210 pounds in the thirty days.  His total cholesterol increased from a healthy 168 to 230, and he experienced mood swings, lethargy, depression, and sexual dysfunction. 

The film was nominated for an Academy Award for Documentary feature and as a result was widely seen, grossing some $20 million.  But there was also considerable criticism of the film that was less widely publicized.  Critics contend that the exercise was unfair because of the quantity of McDonald’s food consumed by Spurlock.  It is estimated that his average consumption during the thirty-day period was about 5000 calories.  In addition, he limited his physical activity during the period.  He explained that he was attempting to imitate the average diet for a regular McDonald’s eater.  But neither he nor anyone else ever identified a person who regularly consumes that much food from McDonald’s. 

Much of the criticism directed at Super Size Me has appeared in other, less-well-known films.  The one referred to at the beginning of this post is Me and Mickey D, which recounts the experience of Soso Whaley, who ate only food from McDonald’s for a period of sixty days — twice as long as Spurlock.  By limiting her total caloric intake to somewhere between 1800 and 3000 calories per day and by continuing with an “occasional” exercise regimen, she lost significant weight and reduced her total cholesterol substantially. 

The point made by Whaley in her film is that what we ingest as individuals is a matter of personal responsibility and that it is too easy to point the finger at producers of certain types of food for the consequences when we choose to eat them.  Similar points have been made in other films like Portion Size Me by James Painter, which tracked two individuals who ate only fast food for a month but at consumption levels appropriate for their body types.  The prevailing view among nutritionists reflects the conclusions of nutrition science — namely that most fast food is too high in salt, sugar, and saturated fat for it to be a major part of a healthy diet but that it is not unduly harmful to include such food occasionally. 

Although they have received considerable notoriety, there have, in fact, been relatively few cases brought against fast-food companies seeking compensation for obesity.  The most publicized is certainly Pelman v. McDonald’s Corp., which has persisted in litigation for years since it was first filed on August 22, 2002, with the plaintiffs asserting that consumption of McDonald’s products caused them to become overweight and to develop diabetes, coronary heart disease, high blood pressure, and elevated cholesterol.  While the complaint filed in 2002 asserted a full palette of legal theories for liability, hoping that at least one of them would stick and result in a legally actionable wrong, the only theories that remain viable are those based on the Consumer Protection Act of New York.  The plaintiffs assert that McDonald’s engaged in a number of deceptive practices that misled the plaintiffs into thinking its foods could form part of a healthy and nutritionally beneficial diet.  The history of the case is perhaps best summarized in the most recent ruling denying class certification, which can be read here.  

To me, it strains credulity to think anyone could really believe that McDonald’s products are particularly healthy, and to be so naive as to be deceived by the kinds of assertions that McDonald’s has admittedly made to present its products in the best light possible.  “Puffery” — the exaggeration about products made by salesmen — is as old as the concept of sales itself and is not actionable; we are expected to have some basic understanding of the give and take that occurs in sales.  Indeed, the phrase caveat emptor has been used for centuries in British and American jurisprudence. 

Last week, though, a new case was filed involving the Nutella® hazelnut spread.  The allegations are essentially familiar.  The case is filed as a class action with a class representative who asserts that she was searching for healthy foods to serve her family for breakfast, and relied on advertisements for Nutella® in making her selection.  Nutella®, of course, is not a particularly nutritious food, and people can decide for themselves whether having a small amount of it with breakfast is consistent with how they choose to structure their own diets.  But the class representative was apparently “shocked to learn that Nutella® was in fact not a ‘healthy’ ‘nutritious’ food but instead was the next best thing to a candy bar” after friends told her what it contained.  The lawsuit attacks such things as images of mother feeding the spread to “happy, healthy children” and words suggesting that Nutella® can be part of a “tasty yet balanced breakfast” when eaten with whole wheat bread, orange juice, and a glass of skim milk.  A copy of the complaint can be read here.  

Filed Under: Biology, Federal Regulation, Legal, Scientific

Its Truth Only Partially Known

January 17, 2011 By Leave a Comment

It was while Samuel Hahnemann was translating a book by William Cullen in 1789 that he encountered a description of how Peruvian bark could be used in treating malaria.  In his book, Cullen attributed the effectiveness of the bark to its bitter and astringent properties.  Only 24 years old at the time, Hahnemann impetuously added a footnote to the translation disagreeing with the explanation and noting that there were other substances even more bitter and astringent that Peruvian bark that were were ineffective against malaria.  Instead, Hahnemann drew from his own experience taking toxic doses of the herb, conscious of how his body responded with fever and chills that he found similar to the symptoms of malaria. 

It was thus that Hahnemann developed the “law of similars” that is embraced by homeopaths, the word “homeopathy” being a combination of the Greek words “homoios” (“similar”) and “pathos” (“suffering”).  The idea was that disease could be prevented by using a substance to cause the body to react in a way that was similar to its reaction to disease.  While homeopathy is not accepted by modern medical science, the idea was not particularly outlandish considering the state of medical understanding at the time.  It was, after all, around the same time that Edward Jenner discovered that smallpox could be prevented by deliberating infecting people with small doses of cowpox to produce symptoms similar to those of smallpox.  I described some of the history of that development of vaccination here. 

Because the substances used to induce certain conditions were toxic and potentially dangerous, Hahnemann proposed to use extreme dilutions, so much so that none of the original substance would remain.  He proposed dilutions of 30C, meaning that the substances were to be diluted by a factor of 100, with the dilution repeated 30 times.  His proposed dilution is accordingly 10-60, a dilution so severe that it would be necessary to consume a liquid remedy that is roughly 10 billion times the volume of the Earth in order to consume a single molecule of the substance.  The dilution is so great that the effectiveness of homeopathic remedies is often attributed to the placebo effect. 

While homeopathic medicine had a considerable following through much of the 19th century, it was ultimately displaced by the development of modern medicine around the beginning of the 20th century.  Prompted primarily by concerns about the potential toxicity and side effects of now-conventional medicines, homeopathy began a resurgence sometime in the late 1970’s or early 1980’s.  There are virtually no adverse side effects with homeopathic treatments because the active ingredients have been so diluted as not even to be present, and this is one of its main attractions.

But some companies have wished to have their cake and to eat it to.  The cold remedy Zicam, taken as a nasal spray, is a notable case in point.  Marketed as a homeopathic remedy, it is prepared with highly diluted galphimia glauca, histamine dihydrochloride, luffa operculata, and sulfur.  It also includes only modestly diluted zinc acetate at a dilution of 2X, i.e. 1/100th dilution, and zinc gluconate at a dilution of 1X, i.e. 1/10th dilution.  These zinc compounds are at a level where they may still be biologically active, suggesting that the remedy is intentionally prepared so that it may be marketed as a safe homeopathic remedy while also including a biologically effective solution of 10% zinc gluconate. 

In 1999, a small number of physicians began noting that some of their patients developed anosmia — loss of the sense of smell — after consuming Zicam.  Familiar with studies dating from at least the 1930’s associating intranasal application of zinc sulfate with anosmia, those physicians questioned whether there was sufficient zinc compound in the remedy to be causing anosmia in patients.  There have been a number of reports suggesting an association, but the numbers are small — small enough that the manufacturer maintains they are not statistically significant while noting that there are many causes for anosmia.  It is fair to say that it remains unclear whether the zinc compounds in Zicam are responsible. 

Last week, the Supreme Court of the United States heard oral arguments in the case of Matrixx Initiatives v. Siracusano.  At issue is whether Matrixx, the manufacturer of Zicam, had a duty to report the concerns over a causal relationship between Zicam use and anosmia to investors.  Even if public response is based on an unsubstantiated link, there is still an impact on sales of the product and on the value of an investment in the company. 

The issue is not an easy one, but it is easy to see both sides of the argument.  On the one hand, a company should not need to respond to every unsubstantiated allegation, rushing to inform investors that it has irrationally been accused of something.  But conversely, this is a case where the concerns — even if perhaps not well nailed down statistically — are being raised by legitimate physicians on the basis of past, relevant research.  A transcript of the entire oral argument can be read here.

How the Court will ultimately decide the case is unclear because the facts are not clear-cut.  But the principles it will use are well-defined.  Companies are liable if they fail to disclose information that is considered “material” in that it will affect the value of the product and if they have failed to disclose that information with an intent to mislead.  Regardless whether the value that many consumers find in homeopathic remedies is substantiated, they deserve, as always, to have accurate information about what they are consuming.

Filed Under: Federal Regulation, Legal, Medical science, Scientific

The Labor of Bees

January 3, 2011 By Leave a Comment

In October last year, an elderly man in Dougherty County, Georgia was operating a bulldozer when he accidentally disturbed a bee colony.  He died after being stung more than 100 times, and investigations into his death confirmed that africanized honey bees have now taken up residence in the state of Georgia.  At least two other hives of africanized bees have since been discovered within the state. 

The first that many heard of africanized bees was seeing The Swarm sometime in the 70’s, an overly sensationalist movie in a decade that saw far too many melodramatic disaster films.  But the underlying premise of the movie — that africanized bees are more aggressive than the strains of honeybees introduced into North America by Europeans in 1691— was essentially accurate.  It was in 1957 that 26 Tanzanian queen bees were accidentally released into Brazil by a beekeeper who was attempting to breed a strain of bees that would have greater honey production than local bees, while also being better adapted to a tropical climate than European bees.  The africanized honey bees that have steadily been expanding their territory into the southern United States are directly descended from those Tanzanian queens. 

The concern to humans and animals over the encroachment of africanized honey bees is surely overblown; since their initial colonization in Texas in 1990, they have been responsible for fewer than 20 human deaths.  The greater concern is with their displacement of the European bee population because of a fundamental difference in their behavior traits.  Africanized bees put greater effort into colony reproduction than do European bees, who instead spend more time on the collection and storage of food, resulting in their critical role of pollenizing roughly 35% of the food supply. 

It seems, though, that the africanized bee is not even the greatest concern facing the European bee population.  In 2006, large-scale losses of managed honeybee colonies were noted in the United States and in parts of Europe.  The impact is perhaps felt nowhere more sadly than West Virginia where, in 2002, the honeybee was named the state’s official state insect.

While similar bee declines have been documented since as early as 1869, the recent reduction was considerably more severe, leading to its characterization as “colony collapse disorder.”  While some speculative ideas have been put forward as possible explanations, including the effects of mobile-telephone radiation (one begins to wonder what cell-phone radiation is not blamed for these days), genetically modified crops, or the effects of global climate change, there is little if any evidence for these mechanisms having an impact on bee colonies.  The reality is likely much more prosaic, with insect diseases and pesticides being the two causes that have received the most study.  Indeed, in October, a paper was published suggesting that the disorder was due to a combination of a virus and fungus that were found in every killed colony that was studied, leading some to claim that the mystery had been “solved.”  Time will tell, but a copy of the paper can be found here.  

What is interesting about the disorder from a legal perspective are the Pollinator Protection Act and the Pollinator Habitat Protection Act, both of which were introduced in Congress in 2007 to provide mechanisms through the Farm Bill to fund a number of programs to research and develop potential solutions.  These programs include the surveillance of pests and pathogens that affect honeybees as well as research into the biology of honeybees so that causes of the disorder can be better understood. 

Last month, the second annual report — also mandated by the bills — was released and can be found here.  It is fair to say that the reported results so far remain inconclusive.  The best hypothesis appears to be that the disorder is a result of multiple factors that may at times act in combination, making the problem a difficult one to solve. 

There is no question about the importance of honeybees to pollination, but the lack of a clear understanding of the population decline has begun to increase interest in promoting alternative pollinators.  While the European honeybee is undoubtedly the most important, it is estimated that there are about 4000 species of bee native to the United States.  Changes in farming practices to promote the activities of these other bee species might help to accommodate the decline.  But one is left with the obvious question:  If the mechanism that is affecting honeybees remains poorly understood, what is the chance that it will eventually spread to other bee species?

Filed Under: Biology, Federal Regulation, Legal, Scientific
« Older Posts
Newer Posts »