“Shift work refers to work that takes place outside of traditional 9-to-5 daytime hours. If you work nights or rotating shifts, you are a shift worker. Many people who work shifts are at risk for developing shift work disorder (SWD) and may experience excessive sleepiness (ES) on the job.” So says the website designed to market the drug known as Nuvigil, sold by Cephalon, a subsidiary of Teva Pharmaceutical Industries, Ltd. Approved by the US Food and Drug Administration (FDA) in 2007 to treat narcolepsy and obstructive sleep apnea and the excessive sleepiness that may come with working a night shift, sales of Nuvigil grew by about 20 percent between 2013 and 2014, bringing in $189 million in the first six months of this year. The company’s online advertising suggests that that “1 in 4” of the approximately 15 million Americans who work outside 9 to 5 hours “may have SWD” and that shift workers may include factory workers, security guards, retail workers, fire fighters, doctors, nurses and other hospital workers, hotel and restaurant employees along with accountants, stockbrokers and “other people with corporate jobs.”
“The main symptoms of SWD are excessive sleepiness (ES) during a work shift and trouble sleeping (insomnia) during sleeping hours,” says the Nuvigil marketing copy. Curious about both the drug and the number of US workers the company might have in its sights as a potential market, I went to see what I could discover.
Working outside daylight hours
When it comes to Americans who are on the job outside of daytime hours, most reports cite 15 million US workers – as do the Nuvigil marketing materials – a number derived from a special supplement to a 2004 Bureau of Labor Statistics (BLS) Current Population Survey. The questions added to this survey to determine hours of the day Americans are working have not been asked since, explained BLS press officer Gary Steinberg. It costs money to add additional questions to the survey, he noted. It’s been 10 years since BLS had funding to ask questions about work hours despite the fact that the labor market has undergone some significant changes in the past decade. It would be possible to compile an estimate from the BLS’s American Time Use Surveys but they look at a slightly different cross-section of the US population than that used by for the BLS employment data used to gauge health of the US labor market. So it turns out there is no officially compiled US Department of Labor figure for how many Americans are currently engaged in “shift work.”
The National Institute for Occupational Health and Safety (NIOSH), however, did have a more recent number to offer, from data gathered in the Centers for Disease Control and Prevention’s (CDC) 2010 National Health Interview Survey (NHIS), a representative sample of the U.S. population. Based on data for 27,157 adults, authors of a 2013 NIOSH study found that 28.7% of these people worked “an alternative shift.” In comparison, data collected in 2004 by BLS indicated that 17.7% of workers worked an alternative shift. The NIOSH study also found that the prevalence rate of alternative shift work for each industry group was higher than what the BLS survey sample found. “Prevalence rate differences may be due in part to the six year time difference between the two surveys and to the increased use of flexible or alternative work schedules in recent years,” explained NIOSH health communications specialist Stephanie Stevens in an email. While we still don’t have an official discrete number for how many Americans work outside daytime hours, we do have a snapshot that suggests that between one-quarter and one-third of US workers may be on the job outside “regular” business hours.
In the NHIS survey, those working “alternative” shifts tended to be younger workers (43% percent were under 29), and black and Hispanic workers together made up a striking approximate 60% of these workers. Those with a bachelor’s degree or higher, made up only about one-fifth of this workforce. In this survey – done when US manufacturing jobs were at a particularly low level, service industries – food service, security, retail and hospitality – reported higher rates of working these alternate hours than others.
Whether it’s nurses, police officers, long-haul truck drivers, manufacturing or retail workers, shift work is associated with a variety of health risks, not just risks of fatigue-related accidents and injuries. Some studies have found associations between night-shift work and increased risk for metabolic and cardiovascular disease and cancer risk. What these studies do not suggest is that working a night shift itself is a health disorder. The Nuvigil literature filed with the FDA does, however, explain that when diagnosed, the symptoms of “shift work disorder” are consistent with the American Psychiatric Association’s DSM-IV-TR criteria for Circadian Rhythm Sleep Disorder: Shift Work Type.
A dangerous drug?
Which brings us back to “shift work disorder” and the drug being marketed to combat it. Nuvigil is the trade name for a substance called armodafinil, which like its slower acting companion drug, modafinil, marketed as Provigil is, as FDA documents explain, “a wakefulness-promoting agent.” The precise biochemical mechanism by which the drugs work to promote wakefulness, writes FDA, “is unknown.” But the drugs appear to affect dopamine, a neurotransmitter and hormone released by the brain that plays a role in sleep, memory, mood and other neurological functions. In addition to promoting wakefulness, modafinil, writes FDA, “produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS [central nervous system] stimulants in humans.”
There are many other possible side-effects, including a serious rash that can include Stevens-Johnson Syndrome and various psychiatric symptoms (among them aggression, mania, anxiety, suicidal thoughts and depression), shortness of breath and abnormal heart beat. Nausea, headache, dizziness and insomnia were the most common. Modafinil, writes the FDA, also “has reinforcing properties, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine.” Nuvigil is a federally controlled substance because it can be abused or lead to dependence, says the drug’s medication guide. In contrast, information about the drug posted on the National Sleep Foundation’s website says, “These medications are not amphetamines and are not habit forming.”
Back in 2010, Cephalon applied to the FDA for approval of Nuvigil to treat jet lag but was turned down. More recently the company’s application for approval of the drug for bipolar disorder treatment was also declined. But the drug has been found effective at treating “shift work disorder” as described in published, peer-reviewed journal articles. Yet a close look at these studies quickly shows that many, including one investigating modafinil published in the New England Journal of Medicine – and their authors – were directly funded by pharmaceutical companies, including Cephalon for whom at least one of these scientists (listed as an author on numerous such studies) served as a consultant and speaker.
What is the real disorder?
At this point, what we don’t have a really good picture of is how many Americans work outside daytime hours and how many of these workers might be working night shifts as second or third jobs, which could contribute to fatigue factors if it prevents them from catching up on sleep. And because this information has not been gathered consistently over time, it’s hard to know how it has changed with other overall employment and economic conditions. This data seems important as part of assessing the health effects of working nights and who among US workers is most impacted. That people who work nights are sleepy and have their sleep cycles thrown out of balance does have serious consequences but urging a potentially habit-forming, psychoactive drug – free samples are available – on an economically stressed, overworked workforce, would seem to be a symptom, at the minimum, of a pharmaceutical industry gone awry. Shouldn’t we instead be figuring out other ways to reduce the occupational health risks of work schedules?
Elizabeth Grossman is the author of Chasing Molecules: Poisonous Products, Human Health, and the Promise of Green Chemistry, High Tech Trash: Digital Devices, Hidden Toxics, and Human Health, and other books. Her work has appeared in a variety of publications including Scientific American, Yale e360, Environmental Health Perspectives, Ensia, The Washington Post, Salon and The Nation.
About one in every 10 U.S. children is living with asthma — that’s closing in on 7 million kids. And while we have a good handle on what triggers asthma attacks and exacerbates respiratory symptoms, exactly what causes asthma in the first place is still somewhat of a mystery. However, new research points to some possible new culprits that are difficult, if not nearly impossible, to avoid.
Those culprits are phthalates, ubiquitous chemicals found in just about everything, from food packaging to shower curtains to vinyl flooring to personal care products such as fragrances and shampoos. (Phthalates are a group of chemicals that make plastics flexible and hard to break and are also used to help cosmetic products cling to the skin.) Just this week, researchers from the Columbia Center for Children’s Environmental Health at the Mailman School of Public Health published findings that children born to mothers who experienced high levels of exposure to two particular phthalates during pregnancy had a significantly higher risk of developing asthma. Specifically, they found that high maternal exposure to butylbenzyl phthalate (BBzP) and di-n-butyl phthalate (DnBP) resulted in a 72 percent and 78 percent increase, respectively, in the risk of a child developing asthma between ages 5 and 11 years old when compared to mothers with lower levels of exposure.
“Everyone from parents to policymakers is concerned by the steep rise in the number of children who develop asthma,” Robin Whyatt, study co-author and co-deputy director of the Columbia Center for Children’s Environmental Health, said in a news release. “Our goal is to try and uncover causes of this epidemic so we can better protect young children from this debilitating condition. Our study presents evidence that these two phthalates are among a range of known risk factors for asthma.”
To conduct the study, which is the first of its kind, Whyatt and her colleagues followed a group of 300 pregnant women and their children in New York City. All of the women were either African American or Dominican. Researchers measured the exposure to four different phthalates via urine samples taken during the woman’s third trimester and when the children were ages 3, 5 and 7. To control for confounding variables, the study excluded women if they used tobacco or illicit drugs or were living with diabetes, hypertension or HIV.
Phthalates were detected in 100 percent of maternal prenatal urine samples. Among the children, 154 had a history of reporting asthma-like symptoms and 94 were diagnosed with asthma. Since pretty much everyone tests positive for phthalates exposure, researchers compared women with the highest levels to those with lower levels. They found a significant association between concentrations of BBzP and DnBP metabolites during the third trimester of pregnancy and an asthma diagnosis among children ages 5 to 11 years old. However, the researchers reported their results with caution. Authors Whyatt, Matthew Perzanowski, Allan Just, Andrew Rundle, Kathleen Donohue, Antonia Calafat, Lori Hoepner, Frederica Perera and Rachel Miller write:
These findings may imply that prenatal exposure to some phthalates has effects on transient wheeze and/or nonspecific airway hyper-responsiveness. It is possible that the respiratory consequences of prenatal exposure to phthalates mimic what has been observed following prenatal exposure to cigarette smoke, where several large cohort studies have essentially established its role in recurrent wheeze in very young children. Alternatively, prenatal phthalates exposure may induce a nonspecific airway hyper-responsiveness, manifested as report of wheeze, use of asthma medication, cough or other breathing problems, that develops into clinical asthma during childhood only in a subset of children. The development of airway hyper-responsiveness is believed to have an environmental component, and develops at a very early age. Further prospective studies are needed to resolve these important clinical questions.
On the preventive side, avoiding phthalates is quite difficult, both because the chemicals are pretty much everywhere and because they’re rarely listed as an ingredient in the products we buy. The news release announcing the study results notes that several phthalates, including BBzP and DnBP, have been banned from many children’s products, but steps haven’t been taken to warn pregnant women about the possible health risks to their fetuses. This newest study builds on the researchers’ previous findings that child and prenatal exposure to certain phthalates is associated with a higher risk of asthma-related airway inflammation and childhood eczema. Like many environmental exposure risks, limiting exposure to phthalates in an effective way will likely take action from policy-makers and regulators.
“While it is incumbent on mothers to do everything they can to protect their child, they are virtually helpless when it comes to phthalates like BBzP and DnBP that are unavoidable,” said study co-author Rachel Miller, co-deputy director of the Columbia Center for Children’s Environmental Health. “If we want to protect children, we have to protect pregnant women.”
According to the American Lung Association, asthma is the third leading cause of hospitalization among children younger than 15 years old. Every year, the chronic respiratory disease results in about $50.1 billion in direct health care costs.
To read the full study, which was published this week in Environmental Health Perspectives, click here.
Kim Krisberg is a freelance public health writer living in Austin, Texas, and has been writing about public health for more than a decade.
Not an “accident”: Ernesto Rodriguez, 41, suffers fatal work-related injuries at southern Oklahoma oil rig site
Ernesto Rodriguez, 41, suffered fatal traumatic injuries on Wednesday, September 10 while working at an oil rig site in southern Oklahoma. Local news reports provide some initial information on the worker’s death:
- The incident occurred at an XTO Energy well near Mannsville, OK (about 2 hours north of Dallas, TX). Rodriguez was employed by Mercer Well Service. The company’s headquarters is in Gainseville, TX, which was also Rodriguez’s hometown.
- Sheriff John Smith reported “that a pipe was somehow forced out of a well hole and struck Rodriguez.”
- “Rodriguez was operating a workover rig drilling out frac plugs” when the blowout occurred. The sheriff reported that “the victim was knocked about 10 feet down a stairway due to the force of the blast.” Two workers, who were in a rig basket situated just above where Rodriguez was working, witnessed the event.
Mercer Well Services has a history of violating worker safety regulations. Since 2009, the company has been the subject of 17 OSHA inspections, primarily in Texas (but none in Oklahoma.) For more than 20 violations, including four repeat and six serious, OSHA proposed $169,200 in penalties. (As a result of settlement agreements, the firm actually paid $83,925 for those infractions.) Following a November 2011 inspection at an oil drilling worksite in the Midland, TX area, Mercer received a citation for five repeat violations. OSHA said in a news release announcing the citations:
“Repeated disregard of employee safety will not be tolerated.”
Despite their illegal behavior, Mercer Well Services did not meet OSHA’s criteria for the designation “severe violator.” Now that Ernesto Rodriguez has been killed on the job, maybe now they will. (As I’ve said before, OSHA’s threshold for the “severe violator” label is too steep.)
Each year, dozens of workers in Oklahoma are fatally injured on-the-job. The Bureau of Labor Statistics reports 86 work-related fatal injuries in Oklahoma during 2013 (preliminary data, most recent available.) Nationwide, at least 4,405 workers suffered fatal traumatic injuries in 2013.
The AFL-CIO’s annual Death on the Job report notes:
- Federal OSHA has 19 inspectors in Oklahoma to cover more than 90,000 workplaces.
- The average penalty for a serious OSHA violation in Oklahoma is $1,872.
Federal OSHA has until mid-March 2015 to issue any citations and penalties related to the incident that stole Ernesto Rodriguez’s life. It’s likely they’ll determine that Rodriguez’s death was preventable. It was no “accident.”
New data from the U.S. Census Bureau finds that the U.S. poverty rate declined slightly between 2012 and 2013, however the numbers of people living at or below the poverty level in 2013 didn’t represent a real statistical change.
Yesterday, the Census Bureau released two annual reports: “Income and Poverty in the United States: 2013” and “Health Insurance Coverage in the United States: 2013.” The agency found that between 2012 and 2013, the nation’s poverty rate declined from 15 percent to 14.5 percent. But the 45.3 million people living in poverty as of 2013 was not a “statistically significant change” from 2012. The 2013 poverty rate was still two points higher than it was in 2007, before the recession. It’s the third year in a row that the actual poverty numbers did not experience a statistically significant change.
Median household income didn’t change in a significant way either, increasing less than $200 from $51,759 in 2012 to $51,939 in 2013. In better news, the Census reported that the poverty rate for children younger than 18 years old declined from the previous year for the first time since 2000, falling from 21.8 percent, or 16.1 million, in 2012 to 19.9 percent, or 14.7 million, in 2013.
The income and poverty report also found that in 2013, real median household income was 8 percent lower than it was in 2007, just before the recession began. And while 2012–2013 changes in real median household income weren’t significant for most populations, it did increase by 3.5 percent among Hispanic households — and that’s the first annual increase in median income that Hispanic households have experienced since 2000. The 2013 male-to-female earning ratio (sometimes referred to as the gender wage gap) was about the same as the previous year at 0.78.
The Census found that income inequality between 2012 and 2013 didn’t change in a significant way; however, it did note that income inequality has increased between 1999 and 2013. The report stated that “incomes at the 50th and 10th percentiles declined by 8.7 percent and 14.3 percent, respectively, while there was no statistically significant decline in income at the 90th percentile between 1999 and 2013.”
In examining the job market, the Census found that the number of men and women working full-time and year-round increased by 1.8 million and 1 million, respectively, between 2012 and 2013, “suggesting a shift from part-year, part-time work status to full-time, year-round work status.”
The new poverty and income numbers attracted the attention of advocates, many of which called on policy-makers to address the issues facing working families. At the Center for American Progress, President Neera Tanden said:
The new Census data reveal that four years into the economic recovery, low- and middle-income families are still feeling the pain of unshared growth, stagnant incomes, and widespread economic insecurity. The economy is off kilter, with households at the top continuing to capture most of the gains from economic growth, while middle-class and struggling families are still waiting for the recovery to reach them.
Congress seems intent on making things worse. In 2013, Congress allowed across-the-board cuts to hit education, job training, and child care services, alongside reductions in nutrition assistance for families who can barely put food on the table. Today’s data should be a clarion call that Congress must change course to invest in job creation, raise the minimum wage, and enact measures to improve the economic security of struggling families.
In an article on MSNBC, writer Ned Resnikoff reported this quote:
“We’ve still got a large, ongoing crisis,” said Stephen Pimpare, a professor in Columbia University’s School of Social Work. “And it’s a crisis not just of economics and the Great Recession, which is the way a lot of people are going to talk about it. Because while it was true that poverty is greater than prior to the Great Recession, poverty is where it was in the early 1990s and early 1980s.”
And in a statement from the Center on Budget and Policy Priorities, President Robert Greenstein said:
In contrast with the 1960s, 1970s, and 1980s — when the benefits of economic recoveries were more broadly shared and poverty and median income improved more quickly when recoveries started — the recoveries of the past two decades have been much slower to generate income gains for middle- and low-income Americans. Part of the problem is the rising inequality of recent decades, which has meant that economic growth has not been widely shared.
Along with poverty and income data, the Census also released new health insurance numbers. The agency reports that in 2013, 42 million people, or 13.4 percent of Americans, didn’t have health insurance for the entire calendar year. That’s a big change from 2012, when the Census reported that 15.4 percent of Americans had no health insurance. Still, children living in poverty were less likely to have health insurance, as were black and Hispanics residents. Liz Borkowski offers additional insights into changing health insurance numbers in a post published yesterday.
Visit the Census Bureau to download the new reports and read highlights.
Kim Krisberg is a freelance public health writer living in Austin, Texas, and has been writing about public health for more than a decade.
New findings from CDC’s National Health Interview Survey show the uninsured rate at its lowest level since the agency started tracking this statistic 17 years ago. In the first quarter of 2014, an estimated 13.1% of the US population did not have health insurance at the time of interview. That figure was 15.4% in 1997, and rose to 16.0% in 2010 before it began falling.
Vox’s Sarah Kliff points out that the percentage of US children without health insurance has dropped more dramatically than that of the US population as a whole, from 13.9% in 1997 to 6.6% in 2014. Much of the credit for that decrease goes to the Children’s Health Insurance Program.
Uninsurance rates have also declined more substantially for the poor and near-poor than for those not living in poverty. In 2009, 30.2% of those with incomes under 100% of the federal poverty level and 29.4% of those with incomes between 100% and 200% FPL were uninsured, compared to 10.7% of those with incomes above 200% FPL. In early 2014, 24.1% of the poor, 26.2% of the near-poor, and 9.0% of the not-poor were uninsured at the time of interview. (For 2014, the federal poverty level is $11,670 for one person and and $23,850 for a four-person household, so even the “not-poor” income of 200% FPL will leave many families struggling.)
CDC’s report on the new NHIS findings highlights the differences between states that accepted the Affordable Care Act’s Medicaid expansion (which the Supreme Court made optional) and those that didn’t. The researchers found that in states that expanded Medicaid, the percentage of uninsured adults ages 18-64 fell from 18.4% in 2013 to 15.7% in the first quarter of 2014. They found no such significant decrease in the states not accepting the Medicaid expansion.
It’s still shameful that 13% of people in one of the world’s wealthiest nations don’t have health insurance coverage. But at least things are moving in the right direction.
“OSHA nunca llego.” [Translation: "OSHA never came."] That was the disappointed phrase I heard from a worker who told me about his on-the-job injury. He was a temp worker hired by a moving company to relocate a small manufacturing company. The worker’s shoe got caught in a faulty industrial dumbwaiter and his toes were smashed. He was patched up at a local urgent care clinic, but developed a serious infection a couple of weeks later. Gangrene set in and his toes had to be amputated. He still suffers pain and walks with a limp.
The fact that “OSHA nunca llego” surprised this worker. Like the public at large, the worker thought OSHA would investigate the incident. Afterall, he lost part of his foot. What he didn’t know is there’s no requirement for employers to report to OSHA a serious injury of this nature.
Under current federal OSHA regulations, there’s a high bar for employers before they are required to report serious incidents to the agency: a fatality or the hospitalization of three or more workers. But that will change on January 1, 2015 in regulations announced last week by OSHA.
In the 29 states covered by federal OSHA, employers will be required to report to the agency all work-related in-patient hospitalizations, amputations and losses of an eye, within 24 hours of the event. In the case of a fatality or hospitalization of three or more workers, they are already required to report those incidents within 8 hours.
The 21 states that run their own OSHA programs have six months to adopt the new OSHA rule or one of their own that is more stringent. Six of these State OSHA agencies already have a rule on the books that is comparable or more robust than the new federal regulation. For example:
- Alaska OSHA: Since 1976, employers have been required to report within 8 hours, occupational accidents that result in the death or overnight hospitalization of one or more employees.
- Utah OSHA: Since 2002, employers have been required to report, within 8 hours, work-related fatalities, disabling, serious, or significant injuries, and occupational disease incidents.
- Washington OSHA: Since 2009, employers have been required to report, within 8 hours, the death, or probable death, of any employee, or the in-patient hospitalization of any employee.
“Last year, OSHA was notified after a worker was struck and killed when he entered a large wire mesh manufacturing machine to retrieve a fallen metal bar. The worker killed was 32 year old Luis Rey Rivera Pavia – he was the sole supporter of his mother, who lives in a small village in Mexico. His death should never have occurred. The light curtain that would have automatically turned the machine off before he entered the danger zone had been disabled. During our inspection, OSHA learned that previously, two other workers at that same factory had been severely injured on this same piece of machinery — one worker suffered an amputation and the second had his right forearm crushed by that same machine. Earlier this year, we issued a fine of almost $700,000 against Wire Mesh Sales, of Jacksonville, Florida. However, I believe that if we had been notified after that amputation, or after his co-worker was hospitalized with a crushed forearm, Mr. Rivera might be alive today.”
OSHA estimates that it will receive annually reports for 6,300 amputations, and for about 112,000 in-patient hospitalizations. The total cost to employers is an estimated $2.6 million per year.
OSHA proposed these changes in June 2011 and took comments from the public for four months on its proposal. The agency submitted its draft final rule for review to the White House’s Office of Information and Regulatory Affairs (OIRA) in February 2014. OIRA’s review, which is supposed to be no longer than 135 days, extended more than six months.
OSHA last revised these reporting requirements in 1994. Prior to that, stemming back to 1971, employers were only required to report hospitalizations if it involved five or more employees. The report had to be made within 48 hours. The 1994 rule changed the threshold to three employees and required the report be made within in eight hours.
These new OSHA requirements do not go as far as what is required of employers in the mining industry. Following the 2006 Sago mine disaster, Congress mandated that mine operators notify MSHA within 15 minutes of the death of an employee or serious injury incident. There are a host of injury and non-injury incidents that must be reported to MSHA within 15 minutes. Failure to comply will result in a penalty of at least $5,000 and up to $60,000. OSHA penalties for failing to report incidents will be a fraction of these MSHA amounts.