Poisoned Needles

One of the most impressive stories of global human cooperation began in 1796 with a young dairymaid named Sarah Nelms.  The stories had been apocryphal, mere legends whose truth was suspect:  dairymaids did not get smallpox. 

Smallpox, of course, was one of the great scourges mankind has faced.  Evidence has been found for the disease in Egyptian mummies who died at least three thousand years ago.  Human history is rife with descriptions of smallpox decimating local populations when it was introduced to areas where it was previously unknown.  Smallpox epidemics in North America after introduction of the disease by settlers at Plymouth in 1633 are estimated to have had 80% fatality rates among the native population.  Similar results occurred later in Australia with aborigines.  Numerous isolated island settlements in both the Pacific and Atlantic had almost all of their native populations wiped out by the disease. 

The fact that dairymaids seemed to have a peculiar immunity to smallpox was remarkable, a consequence of the fact that they had frequently suffered from cowpox, a much less fatal disease.  It was Edward Jenner who recognized that deliberate infection with cowpox could serve as a way to protect against smallpox.  On May 14, 1796, he obtain matter from fresh cowpox lesions on the hands and arms of Sarah Nelms, using it to infect James Phipps, an eight-year old boy.  James developed fever, loss of appetite, and discomfort in his armpits — symptoms of cowpox — and recovered about a week and a half after being infected.  A couple of months later, Jenner infected him again, but this time with matter obtained from smallpox lesions, and no disease developed. 

It would take Jenner some years to persuade scientific colleagues that “vaccination” in this way — the word being derived from the latin “vacca” for cow and “vaccinia” for cowpox — could prevent the spread of smallpox.  He was ultimately vindicated.  The end result of his campaign came on December 9, 1979 (and endorsed by the World Health Assembly on May 8, 1980) with a certification that smallpox had been eradicated from the planet except for some small stores maintained for research purposes. 

On October 12, the Supreme Court of the United States will consider oral arguments in what is likely to be a pivotal vaccination case.  At issue is a portion of the National Childhood Vaccine Injury Act, originally passed in 1986 (42 U.S.C. §§ 300aa-1 – 300aa-34).  Aside from its independent relevance, the Vaccine Act is interesting because it can be seen as a case study for many current efforts to introduce broader tort reform prompted by the concern, popular in some circles, that compensation awarded in tort cases is excessive and that litigation is generally an ineffective mechanism for giving compensation. 

Vaccine cases have traditionally been handled under state law, particularly conventional products-liability law.  The Vaccine Act was intended to provide a substitute mechanism for compensating those who may have been injured by vaccines that they received.  At the time, there was active protest by the manufacturers of vaccines, who complained that the cost associated with lawsuit threats was too high and who threatened to cease production of vaccines because the economic risk was too great.  At the same time, those who were injured by vaccines were generally dissatisfied — the time taken to litigate claims and engage in settlement negotiations was long and the entire process was costly, still sometimes resulting in no compensation at all.  These are all arguments that are still currently made more broadly by advocates of broader tort reform. 

Congress created an administrative program that focuses on compensation to the victims of vaccine-related harms.  If a victim can demonstrate receiving a vaccination of a particular type listed in a special Vaccine Injury Table, he or she is awarded compensation, without regard to either fault or causation.  This takes place in the Office of Special Masters of the U.S. Court of Federal Claims, commonly called the “Vaccine Court.”  If the compensation is unsatisfactory or if no award is made, the possibility still exists to bring a tort claim.  The program thus attempts to strike a balance between allowing claims to be brought in the traditional manner, while at the same time offering an alternative that results in faster and more predictable claims being paid.  How much the program is used thus offers an interesting perspective on the success of such a tort alternative. 

In exchange for the essentially automatic awarding of claims, the Vaccine Act preempts tort claims arising from “unavoidable” injuries: 

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine … if the injury or death resulted from side effects that were unavoidable …

It is this provision that is at issue in the case being heard by the Supreme Court.

The fact that an injury is “unavoidable” from use of a product does not normally insulate the manufacturer of the product from having to pay damages when it injures someone.  Indeed, “design defects” of products frequently give rise to damages — it does not matter that the product was flawlessly produced in precise accordance with specifications and with extreme care; if it has a faulty design that injures people, there is still liability for the injuries. 

In 2008, the Georgia Supreme Court held that the Vaccine Act does not preempt all design defect claims — only those where the injurious side effects were unpreventable.  That decision can be read here.  In 2009, a federal appeals court ruled that all design-defect claims are preempted, i.e. even if it were possible to prepare a safer form of the vaccine, there is still no permissible state tort claim arising from use of the more harmful design. That opinion can be read here

While the issue the Supreme Court will consider appears at some level to be a narrow one in that it is a matter of resolving a disagreement over statutory interpretation, it has broader importance.  In the quarter century since it was passed, about two thirds of those applying for federal injury compensation have been turned away empty-handed.  The program was sold as one in which the adversarial nature of litigation claims was to be avoided, but critics suggest that proceedings before the Vaccine Court have turned out to be nearly as time-consuming, expensive, and contentious as traditional litigation.  Many thus consider this experiment in tort reform to have been a failure, and a decision on one of the Vaccine Act’s more important provisions by the nation’s highest court will help determine whether such a view is warranted.

Over a Barrel of Oil

There is a singular moment in the novel Dune when Paul Atreides mounts and controls a sandworm, one of the enormous creatures that tunnel through the sand of the desert world Arrakis.  It is an image that has been repeated numerous times in novels and on film — perhaps notably in Avatar when Jake Sully successfully tames the enormous flying beast Toruk — and which has been used countless times before Dune as a defining symbol.  The outsider tames what only those who are members of an inner circle have any hope of controlling, and he thereby becomes part of the group, perhaps even its leader. 

Dune was published in 1965 at a time when nations were coming to a full understanding of the role that oil had taken in the world’s economies in the time since Henry Ford built the first gasoline-powered automobile in 1896.  In Dune, the economy of the entire galaxy is reliant on melange or “spice,” a substance whose existence is directly linked with the sandworms over which Paul achieves dominion.  Until Paul disrupts what has become the natural order of things, access to the spice is controlled by the Combine Honnete Ober Advancer Mercantiles (“CHOAM”).  In an interview in 1980, the author Frank Herbert acknowledged that the spice was a metaphor for oil and that CHOAM was a metaphor for the Organization of the Petroleum Exporting Countries (“OPEC”), the cartel whose infamous imposition of oil embargoes during the Yom Kippur War in 1973 still echoes today. 

Limiting access to foreign sources of oil precipitated rationing measures in the United States as lines of cars snaked over streets waiting for access to gasoline pumps:  an extension of Daylight Savings Time, a ban on gasoline sales on Sundays, calls for homeowners to turn down their thermostats and for companies to trim their work hours.  The nation looked inwards, hating that it could be crippled by such foreign dependence.  Congress approved construction of the Trans-Alaskan oil pipeline, which was completed in 1977, the same year that the still-ongoing debate over whether to drill for oil in the Arctic National Wildlife Refuge began. 

In 1975, Congress introduced the Corporate Average Fuel Economy (“CAFE”) standards as a measure to improve the average fuel economy of vehicles in the United States.  Between 1975 and 1988, the fuel economy of new cars and trucks inceased by 70%.  Since that time, there has been relative stagnation in fuel economy even as there have continued to be scientific and technological advances that allow its improvement.  Rather than increase the overall fuel economy of vehicles, the gains in efficiency extracting energy from gasoline have been used instead to produce larger and more powerful vehicles. 

That may be about to change. 

On May 21, 2010, President Obama issued a Presidential Memorandum calling for “steps [to] be taken to produce a new generation of clean vehicles.”  A copy of the memorandum can be found here.  Last week, the Environmental Protection Agency (“EPA”) and the National Highway Traffic Safety Administration (“NHTSA”) together responded to that memorandum by issuing a Notice of Intent to develop new standards for both greenhouse-gas emissions and fuel economy for light vehicles for the years 2017 – 2025.  The current standards that cover model years 2012 – 2016 require average emission levels to be less than 250 g of CO2 per mile with a fuel efficiency of 35.5 miles per gallon.  A copy of the Notice of Intent can be read here

The Notice provides an overview of standards that might be considered, considers the technologies that would be needed to meet those goals, and calls for feedback from the public.  The current deadline for public comment is the end of this month, with plans to issue a second notice on November 30 that includes an updated analysis of the potential efficiency targets. 

While no actual standards have yet been developed, the outline of possible standards in the Notice is informative, providing scenarios that range from a fuel efficiency of 47 mpg to as high as 62 mpg.  Already, some environmental groups have indicated an intention to press for the highest standards, but many think this is unrealistic in light of the realities of consumer demands for vehicle size and performance.  Nevertheless, the Governors of eight states have sent a letter to the President calling for standards of 60 mpg by 2025.  A copy the letter from the New York Governor can be read here

Putting increased pressure on vehicle manufacturers to meet higher fuel economy standards is generally welcome news, and the new standards could provide a measure of time in which those standards catch up with technical advances that have been made over the last fifteen years.  It is one part of what could be a comprehensive strategy to develop independence from foreign oil sources, a strategy that includes not only conservation efforts but also more aggressive pursuit of other sources of energy such as through nuclear power generation.  Despite efforts to avoid the consequences of a similar reduction in access to foreign oil since the embargo of 1973, U.S. reliance on imported petroleum has nonetheless increased since then so that 57% of the oil currently used in the United States is imported. 

It is unrealistic to expect draconian reductions in living standards to be readily accepted.  But at the same time, it is foolish not to be ambitious in insisting that we take advantage of technological developments that allow us to make the best use that we can of our resources.

WARNING: THIS BLOG MAY BE ADDICTIVE

Well, I have to confess that there is a part of me that hopes so! But my title today is, at least to me, very obviously a spoof.

People need to be careful about spoofs though. Sometimes they take on a life of their own.

Consider Ivan Goldberg, a respected physician who specializes in treating individuals with mood disorders. He fabricated the term “Internet Addiction Disorder” in 1995. It was intended to be satirical, and he patterned his list of diagnostic criteria for the disorder after the entry for pathological gambling in the Diagnostic and Statistical Manual of Mental Disorders (“DSM”) — the authoritative work on psychiatric disorders published by the American Psychiatric Association. A copy of Goldberg’s parody can be found here.

Perhaps it was the technical way it was written, or perhaps it was because it struck a nerve among those who sometimes feel widowed as a result of significant Internet use by loved ones, but the parody caught on. Some thought it was real — even a few serious and respected publications were fooled — and many people began to accept that Internet Addiction Disorder was legitimately recognized.

In the fifteen years since Goldberg’s spoof, there has been increasing research on the effect of a variety of modern forms of technology on the human brain. One of the more interesting is the Starcraft study. Starcraft is a military science-fiction strategy game that has received enthusiastic accolades from those in the video-game industry, who have praised it as one of the best video games ever. The multiplayer version of it has gained particular popularity in South Korea.

Because it is so good, a lot of people want to play it. And some of them spend a lot of time playing it. Of the eleven participants in a the study, six had dropped out of school for two months because of the amount of time they were playing Starcraft and two were divorced by their spouses as a direct result of the time they put into the game. Psychiatrists at the Chung Ang University in South Korea tested a treatment of this group by prescribing the antidepressant Bupropion for six weeks, resulting in their playing time decreasing by about a third. MRI studies of their brains by the Brain Institute at the University of Utah showed increased brain activity in three areas that was not present in a control group when shown images from the game.

Many people remain dismissive of the idea that there can be such a disorder as Internet Addiction, and suggest that the treatment with an antidepressant works because those individuals were depressed — under that view, the excessive time playing Starcraft is a sympton of depression, not of a new type of disorder. They perhaps spend so much time playing in an effort to escape from the sadness that their depression causes. Known psychiatric disorders of obsession and compulsion are other likely candidates for disorders that are sometimes manifested by excessive Internet usage and game playing.

The game Lineage II is another multiplayer online game, also extremely popular in South Korea. Instead of the science-fiction theme of Starcraft, though, Lineage II has a fantasy theme. The makers of the game, NCsoft Corporation and NC Interactive, Inc., were sued about a year ago by Craig Smallwood, a 51-year-old resident of Hawaii who claims that he became addicted to the game. His complaint asserts that over the period of 2004-2009, he played the game some 20,000 hours — that comes out to an average of 11 hours a day, every day of the year, for five years. When his access to the game was cut off, he claims to have “suffered extreme and serious emotional distress and depression,… been unable to function independently,… suffered psychological trauma,… was hospitalized, and … requires treatment and therapy three times a week.”

In a decision in August of this year, the judge in the case, Alan C. Kay, dismissed some of the causes of action but declined to dismiss them all. The causes of action that remain, and which Smallwood presumably will now attempt to prove, include defamation, negligence, gross negligence, and negligent infliction of emotional distress. The full opinion (which considers a number of procedural issues at some length) can be read here.

Although some commentators have ridiculed the decision, finding it stretches credibility to allow a cause of action to proceed on the basis of Internet addiction, it is worth noting that this ruling is still at a very early stage of the litigation. This was a ruling on a motion brought by the defendants, meaning that the plaintiff’s assertions were necessarily considered in their most favorable light and assumed to be true. Those claims that were dismissed — misrepresentation, unfair trade practices, intentional infliction of emotional distress, and assessment of punitive damages — were found by the court to have no merit even if all of the assertions were true and construed in that most favorable way.

It is likely to be an arduous and uphill battle now to prove his assertions and to prevail on the surviving causes of action. Currently, Internet addiction is not a disorder recognized by the DSM and this is likely to be an important factor in the remainder of the litigation. It is also true, though, that some serious researchers advocate including Internet addiction in the next edition of the DSM, currently scheduled for release in 2013. This advocacy has been formal, appearing in prestigious peer-reviewed journals such as the American Journal of Psychiatry, but it still appears that those in the psychiatric-research community who advocate including it currently remain in the minority.

The ultimate decision of the American Psychiatric Association will likely have a strong impact on litigation. Courts will take notice of such an expert assessment, whichever way it goes. If the next edition of the DSM includes Internet addiction as a disorder, expect to see many more lawsuits like those brought by Smallwood, and expect them to have a greater chance of success than currently seems likely. Also expect the producers of Internet content to respond and seek ways to avoid any liability.

I’m putting myself out ahead of the curve. You’ve been warned.

Pursuing Nature to Her Hiding Places

“Tomatoes May Be Dangerous to Your Health” was the headline of an opinion piece published on June 1, 1992 by the New York Times.  In it, Sheldon Krimsky criticized the exemption of genetically engineered crops from certain levels of review by the Food and Drug Administration (“FDA”).    He was referring to the Flavr Savr’ Tomato, the first genetically engineered food later to be granted a license for human consumption by the FDA.  That species of tomato included engineered genes that were to slow the natural softening process that accompanies ripening.  The idea was that the tomatoes could spend more time on the vine than other tomato species, producing more flavor, but still remaining firm enough to ship. 

In response to Krimsky’s article, Paul Lewis wrote a Letter to the Editor in which he coined the term Frankenfood to refer to food derived from genetically engineered crops: 

Ever since Mary Shelley’s baron rolled his improved human out of the lab, scientists have been bringing just such good things to life.  If they want to sell us Frankenfood, perhaps it’s time to gather the villagers, light some torches and head to the castle. 

The term caught on and many still continue to use it in referring to food produced from genetically engineered crops. 

The reality is that humanity has been engaging in a form of genetic manipulation of crops even since the earliest days of agriculture, but such processes were a result of selective breeding rather than through direct manipulation of genes.  Consider the case of milk production, for example.  As a result of identifying bulls who have highly desirable genes, the number of bulls that are used to sire dairy cows is astonishingly small, resulting in a very narrow range of genetic diversity among cattle in the dairy industry.  At the time of his death in 1997, for example, the Dutch Holstein Friesian bull named Sunny Boy had sired some two million calves.  The impact on the genetic origin of dairy products throughout the world was a direct result of human intervention in natural processes.  Or consider the production of soybeans.  In the 1990’s, the entire soybean crop in the United States — some 60 million tons — was descended from a mere dozen soybean strains that had been collected in northeastern China.  

Since the FDA approved human consumption of the Flavr Savr’ Tomato in 1994, there has been a huge infiltration of genetically modified crops into the food supply, especially in the United States where more than 90% of the soybean, cotton, and canola markets are supplied by genetically modified crops.  Byproducts of those crops — notably soy lecithin — are found in thousands of processed-food products:  chocolate bars, baby foods, margarine, breakfast cereals, and many others. 

This week, the FDA is conducting hearings as part of its consideration whether to allow human consumption of AquAdvantage, a genetically modified species of Atlantic salmon that some are — inevitably — calling a frankenfish.  The application was submitted to the FDA in 1995, but the agency has so far never approved any genetically modified animal for human consumption.  AquAdvantage has been modified so that it grows twice as fast as its natural counterpart.  Critics have expressed two concerns:  that the effect on people who consume the fish is unknown and that if the genetically engineered fish escapes, it may have a negative impact on the natural salmon population.  These concerns are not frivolous ones:  salmon populations are already depleted because of overfishing, and if the genetically modified fish grows at twice the speed as naturally occurring salmon, there is a possibility of disrupting the food supply for natural salmon populations. 

It can be difficult to predict all of the effects of genetic modification of organisms.  For example, there is a known history of genetically modified plants producing substances they hadn’t produced before or of repressing the production of substances they normally produce:  transgenic potatoes that were supposed to make more starch and less sugar did the opposite; transgenic tomatoes that were made to produce excess carotene became unexpectedly smaller; and perhaps most notably, reproduction mechanisms of some plants changed so that inserted genes unexpectedly started appearing in other plant species. 

Surveys confirm that there is generally a strong desire by people in the United States to have food labeled as arising from genetically modified organisms, something that the FDA has never required.  Industry interests in the United States generally oppose labeling — jurisdictions elsewhere in the world where labeling is required, notably the European Union and Japan, find almost no one willing to buy food derived from genetically modified organisms. 

The FDA has taken the position, however, that federal law, when properly construed, actually prohibits the agency from requiring labeling of food derived from genetically modified plants.  The relevant law that the FDA cites is found in the Food, Drug, and Cosmetic Act (21 U.S.C. §343) and prohibits a variety of food labeling that is “false” or “misleading.”  The FDA has concluded that because it has generally found food derived from genetically modified sources not to be “materially different” than food derived from natural sources, it cannot require labeling, and this position has been upheld in court:  Alliance for Bio-Integrity v. Shalala, 116 F.Supp.2d 166 (D.D.C. 2000).  Producers of genetically modified food are permitted to add labels if they wish, but none do. 

It seems likely that AquAdvantage will be approved for human consumption in due course.  One of the objectives of the hearings is to determine whether the FDA’s position on labeling should be different because this is an animal to be consumed rather than a plant.  Some background material on the labeling issue prepared by the FDA can be read here

It was only three years after the release of the Flavr Savr’ Tomato that its producer Calgene needed to withdraw it from the market.  They were sold under the brand name MacGregor’s in California and a few places in the Midwest of the United States.  But they turned out to be more delicate than expected, bruising easily so that special trucks were needed for transportation.  Delivery of the tomatoes to grocery stores became prohibitively expensive.  Perhaps AquAdvantage will be no more successful in the end.  But whether it is approved soon by the FDA or not, it is clear that consumption of such animals is a genie that will soon be out of the bottle and very unwilling to get back in.

Grousing About Politics and Science

When the United States and France completed the Louisiana Purchase in 1803, it was unclear exactly how much land was being exchanged.  President Thomas Jefferson accordingly commissioned the Corps of Discovery to explore the territory, choosing his friend Meriwether Lewis to lead the expedition.  Over a period of some two and half years, Lewis and his partner William Clark were to conduct the first overland expedition of North America to the Pacific coast and back. 

During their travels, they established relationships with some of the native peoples, notably eliciting the aide of the Shoshone woman Sacagawea to act as a guide and interpreter.  They were to provide a significantly improved understanding of the geography of the northwestern United States and to document 122 previously unknown species of animals and 178 new plants and trees. 

It was at the mouth of the Marias River in what is now Chouteau County, Montana that Lewis and Clark encountered the sage grouse on June 6, 1805.  Their native-american companions told them it was a common bird, and indeed their journals record further encounters throughout much of the region.  Estimates are that sage grouse numbered somewhere around 16 million in population around the time of their documentation by Lewis and Clark.  Today, it has only a fraction of that population — somewhere about 250,000 — and efforts to include it on the Endangered Species List have become emblematic of what many scientists see as political encroachment on scientific independence. 

Earlier this year, Secretary of the Interior Ken Salazar announced that the sage grouse “warrants” inclusion on the List but that it was “precluded by the need to address higher priority species first.”  A very different decision was made under the Bush administration in 2005 when Deputy Assistant Secretary Julie MacDonald ruled against its listing.  That decision was one that highlighted some of the most egregious interference with science for political reasons in recent memory.  In Western Watersheds Project v. United States Forest Service, the Idaho District Court described the conduct of the Deputy Assistant Secretary as “inexcusable,” finding that “[h]er tactics included everything from editing scientific conclusions to intimidating [Freedom and Wildlife Service] staffers.”  The court’s ruling, which can be found here, documents repeated and persistent “attempts to improperly alter the ‘best science’ findings” as part of a campaign to achieve “preordained” political objectives.  Similar allegations have been leveled against her by scientists in numerous other cases involving decisions not to list certain species. 

It is perhaps no surprise then that the release of a draft policy on scientific integrity by the Interior Department is being viewed with considerable skepticism by scientists.  Those scientists remember well when President Obama issued his Memorandum on Scientific Integrity on March 9, 2009 calling for the development of “recommendations for Presidential action designed to guarantee scientific integrity throughout the executive branch” within 120 days.  A copy of his Memorandum can be found here.  It was still the honeymoon period for the new administration and at the time, the apparent commitment was heralded by many scientists as a welcome change from perceived attempts by the prior administration to suppress scientific knowledge and conclusions for political purposes.  But that enthusiasm has steadily given way to frustration and disappointment as time still continues to pass more than a year after the President’s deadline without any recommendations or plan being developed. 

The release of the Interior Department’s draft policy a couple of weeks ago is the first real manifestation of the executive branch’s implementation of policy directed to scientific integrity.  Most scientists who have read it believe it falls short.  Of particular concern is language that appears still to allow political appointees to alter scientific documents, exactly what was happening in considering additions to the Endangered Species List by the prior administration:  “During the conduct of Departmental business, decision makers may be involved in editing of documents for clarification of major points to aid decision making.”  But more broadly, the policy is seen as having insufficient provisions for preventing other types of political interference in science.  Another provision, for example, warns that “[p]ublic release of a scientific product without the required level of review or without appropriate disclaimers could be considered misconduct.”  There is concern that the normal circulation of material by scientists among their peers for scientific evaluation could be considered misconduct, particularly since little guidance is given by the policy as to when dissemination is “premature.” 

A copy of the draft policy can be read here

To be fair, the policy has been released in draft form as part of the normal rule-making procedure that is followed by Executive agencies so that comments can be collected from the public and considered prior to its actual implementation; the comment period is set to expire on September 20, 2010.  That procedure is an important part of the process, allowing the public at large to identify and articulate deficiencies in proposed policies or rules.  Proposals can sometimes be modified significantly in light of the comments that are provided, and the hope is that that will happen in this instance.  But even if the major concerns are addressed, scientists will still eagerly await the more broadly applicable recommendations promised by the President in the ambitious early days of his tenure.