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Science Policy Around the Web – March 18, 2017

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By: Joel Adu-Brimpong, BS

By James Tourtellotte, CBP Today [Public domain], via Wikimedia Commons

Public Health Policy

Missing the Brush Strokes while Gazing at the Bigger Picture

Last Wednesday, the House Committee on Education and the Workforce approved a little-advertised bill called HR 1313, or the genetic testing bill, with partisan-line voting (all 22 republicans in favor and all 17 democrats opposed). Overshadowed by the highly publicized, contentious debate over the Affordable Care Act repeal-and-replace efforts, this bill has remained largely undetected by the media as it traverses congress. This genetic testing bill would not only enable employers to require their employees to undergo genetic testing but also allow employers access to the genetic information, according to an article by STAT news. Employees refusing such requests could be at risk for thousands of dollars in penalties.

Current legislation, including the Americans with Disabilities Act (ADA) and the 2008 Genetic Information Nondiscrimination Act (GINA), prohibit such authority by employers, preventing requests by employers for “underwriting purposes”, which include “basing insurance deductibles, rebates, rewards, or other financial incentives on completing a health risk assessment or health screenings.” Additionally, genetic information provided to employers must be de-identified and aggregated to protect individual identities.

The HR 1313 bill would circumvent current legislation by nullifying these protections as long as the genetic test requests are part of “workplace wellness programs.” Employers purport that the ADA and GINA are “not consistent with the well-established and employee protective wellness program regulatory framework under HIPAA.” They argue that the House bill will aid in aligning the ADA and GINA with laws about workplace wellness programs. Conversely, experts including Jennifer Mathis, director of policy and legal advocacy at the Bazelon Center for Mental Health Law, and Nancy Cox, president of the American Society of Human Genetics, have come out against the bill. In an opposition letter to chairwoman Representative Virginia Foxx (R-N.C.), and ranking member, Robert Scott, of the U.S. House Committee on Education and the Workforce, critics of the bill state that “Workplace wellness programs are fully able to encourage healthy behaviors within the current legal framework: they need not collect and retain private genetic and medical information to be effective. Individuals ought not to be subject to steep financial pressures by their health plans or employers to disclose their own or their families’ genetic and medical information.” Nonetheless, with the possibility of such infringement, we remain lost in the bigger debate surrounding Affordable Care Act repeal-and-replace efforts with little regard for subtle components like HR 1313. (Sharon Begley, STAT news)

Infectious Diseases

Here We Go Again? The Re-emergence of Yet Again, Another Arbovirus

The recent resurgence of arboviruses, or ARthropod-BOrne viruses, in the Americas is concerning. While the 1990’s saw the reemergence of Dengue and the West Nile, Chikungunya resurfaced in 2013 and, recently, Zika in 2015. With South and Central America and the Caribbean still reeling from the reemergence of these viruses, another arbovirus appears to be making a comeback. Over the past weeks, a fifth arbovirus has been detected. Per a perspective piece co-authored by Dr. Anthony Fauci, infectious disease expert and director of the National Institute of Allergy and Infectious Diseases, there are on-going outbreaks of yellow fever in Brazil.

As of February 2017, there have been 234 reported cases and 80 confirmed deaths, with many other infections pending investigation. In context, the number of reported cases currently exceeds previously observed rates of infection for this time of the year. Regionally, the reported cases appear localized to rural areas in southeastern Brazil, chiefly Sao Paulo, Espirito Santo and Minas Gerais. According to the article, current cases appear to be “sylvatic” or jungle cases, with transmission occurring primarily between forest mosquitoes and non-human primates. Thus far, there is no evidence to suggest human-to-human transmission via the infamous Aedes aeqypti mosquito. Humans currently serve as “incidental hosts.” However, the propinquity of the affected areas to major urban centers in Brazil, where routine coverage of yellow fever vaccination is low, is alarming.

Experts posit that the likelihood of spread to the continental United States is low. However, they caution, “In an era of frequent international travel, any marked increase in domestic cases in Brazil raises the possibility of travel-related cases [anywhere].” A particularly poignant example in the article is the December 2015 large urban yellow fever outbreak in Angola and subsequent spread to the Congo. This led to an exhaustion of the world’s emergency supply of vaccines for epidemic response, “prompting health authorities to immunize inhabitants in some areas using one fifth of the standard does in order to extend vaccine supply.” Amidst these critical times of global health crises, threatened cuts to U.S. global health support will likely be catastrophic for developing nations. (Madison Park, CNN)

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Written by sciencepolicyforall

March 18, 2017 at 9:31 pm

Incentivized employee wellness programs: Is our genetic privacy at risk?

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By: Monica Markovski, Ph.D.

CC0 Public Domain

In March, new Congressional legislation was introduced that would legally allow companies to request employee and family medical history as part of financially incentivized wellness programs. These types of wellness programs are now common in the workplace. They reward employees who provide health information and participate in health assessment programs and biometrics testing. In theory, these programs have laudable goals. Companies would have healthier, more productive workers and a more stable workforce. Absences would be reduced, and rising healthcare costs and other related expenses would be lowered (1). Employees would also benefit with their own improved overall health, reduced health care premiums and costs, and even monetary rewards. Such financial incentives encourage employee participation. Research has shown that participation in wellness programs nearly doubled when non-incentivized programs offered a monetary reward. When the reward was tied to reductions in health care premium costs or adjustments, participation more than doubled (2).

Two companion bills under the Preserving Employee Wellness Act of 2015 would seek “to clarify rules relating to nondiscriminatory employer wellness programs”. Drafted by John Kline (US Representative, R-MN) and Lamar Alexander (US Senator, R-TN), this Act would allow companies that seek to promote worker health and disease prevention to legally obtain genetic and medical information about employees and their families as an employee participates in an incentivized wellness program (3). This bill is in direct opposition to the Genetic Information Nondiscriminatory Act (GINA) and poses a risk to its privacy protections.

In 2008, GINA, which prohibited workplace discrimination based on genetic information, passed both the House of Representatives and the Senate with overwhelming bipartisan support. Here, genetic information was defined as information obtained from genetic tests from individuals and their family members or the manifestation of a disease or disorder. Thus, a family’s medical history falls under “genetic information” because such information can be directly tied to one’s own or a relative’s own disease predisposition. For example, mutations in the gene BRCA1 have been linked to breast cancer, and these mutations generally run in families. Providing one’s own genetic information inadvertently then also supplies that of one’s relatives. Title II of GINA more specifically prohibits employers “from requesting, requiring or purchasing genetic information, and strictly limits the disclosure of genetic information” to ensure genetic privacy protection for employees (4).

Many health advocacy groups are concerned that the Preserving Wellness Act of 2015 invades the privacy protections afforded by GINA. In a letter to the House of Representatives Committee on Education and Workforce, fifty-three non-profit patient advocacy groups strongly opposed any legislation that legally allows employers to question or inquire about an employee’s private genetic or medical information (through health risk assessments, for example) and penalizes employees who choose not to provide it (5). Under GINA, questionnaires like health risk assessments (HRAs) that ask for such information are prohibited. Moreover, providing incentives or rewards to employees that participate in and complete these HRAs discriminates against those employees who choose not to offer their medical information. If the genetic information provided by the employee shows that he or she is at risk for, or predisposed to a certain disease, then these wellness programs can provide incentives for participating in efforts to manage the disease. However, to comply with both GINA and the Americans with Disabilities Act (ADA), the program then must also provide similar incentives for those employees who choose not to share their genetic information, but who are at risk for developing a particular condition due to their lifestyle or encoded by their genetic information (2).

One specific exception to the privacy protections afforded in GINA allows a company to obtain genetic information from employees as part of health or genetics based services, like wellness programs, that are offered voluntarily by the employer. Here, the employee has the right to choose whether to provide his or her genetic information. While incentivized wellness programs reward participation, they also enforce harsh penalties when employees do not comply with the program. In three lawsuits filed in federal court against three different companies, the Equal Employment Opportunity Commission (EEOC) claims that such incentivized programs that give rewards for those who participate and discriminate against those who opt out are not voluntary due to large and substantial fines imposed on those employees who do not participate (1, 6). These companies (Honeywell International, Orion Energy Systems, and Flambeau) are alleged to simultaneously violate the ADA, which explicitly prohibits employers from requiring a medical examination or asking employees disability-related questions (7, 8). The EEOC claims that Honeywell International requires its employees and covered dependents to undergo biometric testing or face financial losses that can add up to thousands of dollars in lost employer health savings account contributions and surcharges. Under these conditions, the wellness program does not seem to be ‘voluntary’. Orion Energy Systems allegedly required an employee who declined to participate in the company’s wellness program to cover all of his or her own health plan benefit premiums, plus a monthly penalty. Shortly after, the employee was fired (9). Also, in the lawsuit against Flambeau, Inc., a Wisconsin-based plastics manufacturing company, an employee who did not submit to biometric testing and an HRA simply had his medical insurance canceled and was required to pay all premium costs (10). In contrast, employees who participated did not have their insurance canceled and only paid a quarter of premium costs. In all of these cases, companies retaliate against an employee for nonparticipation by subjecting the employee to severe penalties for noncompliance. These conditions, the EEOC argued, render incentivized wellness programs functionally involuntary and violate the ADA (8). This can also be interpreted as being in direct violation of GINA.

Many critics of GINA believe the original legislation was overly broad and did not go far enough to protect those persons whose diseases have manifested, but are not physically disabled. More recently, the Affordable Care Act (ACA) addressed this concern and prohibited health insurers from discriminating against those with preexisting conditions, however the ACA fails to address discrimination in the workplace. To further complicate matters, the ACA also encouraged employers to offer benefits like employee wellness programs, but did not discuss the conflict that arises with GINA when these programs use HRAs and biometric tests.

Safeguarding private genetic information and prohibiting genetic discrimination have become even more important since the enactment of GINA in 2008 as overall health concerns increase and initiatives are taken to provide a customized healthcare experience for each person. GINA was established to both prevent individuals from being genetically discriminated against and to alleviate fears about potential genetic discrimination (11), and the Preserving Wellness Act of 2015 presents a new possibility to counteract these effects. This fear extends to participating in biometric testing and may prevent some individuals from taking part in clinical research studies that look at how genomic information can be used to prevent and treat disease. Current and future privacy protections are necessary to alleviate these fears of genetic discrimination. Legislation such as GINA and the ADA are required so that the research that underlies the translational science of genomic medicine can move forward without compromising individual privacy.

Written by sciencepolicyforall

June 3, 2015 at 9:00 am

Science Policy Around the Web – June 2, 2015

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By: Kaitlyn Morabito, Ph.D.

photo credit: GENE A101 via photopin (license)

Genetic Information Non-discrimination Act (GINA)

Test for ‘devious defecator’ was unlawful, judge rules

The Genetic Information Non-discrimination Act (GINA), which protects people from health care and employment discrimination based on their DNA, is being used in court for an unlikely case. A mysterious person had been leaving feces in a warehouse run by Atlas Logistics Group Retail Services near Atlanta. In an effort to solve the mystery, two employees suspected of being involved were threatened with losing their jobs if they did not take a DNA test. The DNA was then compared to the DNA in the fecal sample. The samples were not a match showing that these employees did not commit the crime. Despite being cleared, the employees sued the company citing humiliation. The employees won the lawsuit with the judge ruling that using a DNA test to identify the employees was a violation of GINA, even though there were no disclosure of medical information. In this case, the judge argued that even though they weren’t using the test to check for genetic disorders, the information they received could have been used for this purpose. This case suggests that GINA can be more far-reaching than originally intended. (Nita Farahany, The Washington Post)

GMO Debate

A proposal to modify plants gives GMO debate new life

A process dubbed “rewilding” where scientists re-introduce genes lost through years of breeding back into plants is sparking a new debate in the labeling of genetically modified organisms (GMO). This technique may be used to bolster fragile organic crops using “precision breeding” where modern molecular biology techniques are used to insert or delete genes. By US law, organic non-GMO foods cannot contain any “foreign” genes which could not have occurred in nature in that organism. Since rewilding is introducing genes, which have previously been in the plant, this may not be considered GMO by US standards. The EU, however, uses a different definition. The EU’s definition revolves around the process of genetic engineering to introduce genes, making rewilding a GMO in the EU. Regardless of whether rewilding would be considered GMO, opponents of GMO would likely not accept precision breeding since it involves genetic engineering. (Gina Kolata, The New York Times)


Anthrax inquiry widens to 24 labs in 11 states, two foreign countries

A military lab at Dugway Proving Ground outside of Salt Lake City accidentally sent live Bacillus anthracis, Anthrax, spores to 24 labs inside and outside the US. The samples were supposed to have been inactivated prior to shipment. The army lab sent samples to laboratories that were testing a new diagnostic for anthrax. The error was discovered when a private lab in Maryland was able to culture the anthrax bacteria. The CDC and other agencies are working to determine how the samples were shipped and whether all the labs received live anthrax samples. 26 people are currently being treated for potential exposure, but no infections have been confirmed.   The public is not at risk for exposure. This recent breach of biosecurity is not an isolated incident. Last year, the CDC’s Bioterror Rapid Response and Advanced Technology laboratory also failed to properly inactivate anthrax before releasing it to another CDC laboratory. (W.J. Hennigan, The LA Times)

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Written by sciencepolicyforall

June 2, 2015 at 9:00 am