Posted by: rongeri | April 1, 2012

WHAT’S IN MY GENES AND JEANS IS MY BUSINESS NOT YOURS

             

G.I.N.A. IN THE WORKPLACE: A CASE SCENARIO –WHAT WOULD YOU TELL CAROL? WHAT WOULD YOU TELL TED?

   While on break at a work water cooler, Carol tells her coworker Bob about the battle her mom is having with Huntington’s Disease, Carol tells Bob that “Huntington’s Ddisease is a progressive, degenerative disease” that causes certain nerve cells in the brain to waste away. As a result,” a person may experience uncontrolled movements, emotional disturbances and mental deterioration.”

Carol tells Bob that she fears she is at risk for this genetic disease and that she  periodically uses in the rest room at work, a Direct To Consumer testing kit she purchased over the Internet. Carol’s supervisor, Ted, walks by and overhears the conversation. Carol becomes concerned that she may be treated differently by Ted or fired due to her risk for developing HD.  Carol starts reading about the disease during her lunch time at work.Carol starts using “sick days” in order to take her mom to the doctor. At her annual performance review, Ted gives Carol numbers that are so low they will preclude her qualifying for the promotion she wanted and would otherwise get.

Carol had always had stellar reviews in the past. When Carol asks Ted about the numbers, Ted tells her “Carol, you are no longer  a team player. Whenever I really need you here working you are out sick.” He also says, “Carol,  you are not as mentally sharp as you used to be.  You seem to be  emotionally disturbed and deteriorating mentally.  What’s wrong with you?”

Furious, Carol leaves the performance review, and goes back to her work cubicle. Saying “He does not know who he is messing with!”, she proceeds to  put up  four posters.  Two deal with not being a team player.  In the first poster, the woman’s thought bubble says “I think I have a better idea about how to tackle that problem” and the man’s thought bubble says “She’ll never be a team player…and she’s taller than me!” In the second poster the man’s though bubble says:”Being a manager is simple…If anybody disagrees with you, just say they’re ‘not a team player’.”

The third poster reads” Power to the People”.  Every time Carol passes it she starts chanting: “United, the people, can never be defeated!” The fourth is A Genetic Bill of Rights poster that reads “All People Have The Right To Be Free From Genetic Discrimination.”

Carol also starts coming to work wearing Jeans for Genes  with a button that reads “How my jeans fit or my genes  behave is none of this company’s business!”

Q1.  

Q2. 

Answers To These Questions are found near the end of this post.

A GROWING CONCERN

There is a growing concern about genetic information, its uses and misuses. Those concerns range from what an employer can or cannot do with that information, whether you have to provide a DNA sample if you are detained by the police( http://apps.americanbar.org/litigation/committees/probono/articles/winter2012-DNA-collection-fourth-amendment.html), and how knowledge about your genes might be used proactively in connection with health care.

If a person believes that he or she has been discriminated against in the workplace on the basis of genetics, that person may choose one of the following responses:

 be passively disappointed but take no action;

be actively angry and make it known verbally in the way Tyler Perry’s character Medea would do; or

 like Pameal Fink, be a combination of disappointed, angry, and file a lawsuit.

Perhaps common concerns about the use and misuse of genetic information were best expressed this way by the late Dr. Bernadette Healy, former head of the National Institute of Heath:

“In a season of political divisiveness, the overwhelming majority of Americans agree on one thing: Your genes are your own business and should not be tapped by employers or health insurers deciding whether you or your family are fit for their company. Genes are not crystal balls. But they can be red flags signaling susceptibility to disease—and early preventive steps can be lifesaving. An example: Patients found to have genes predictive of colon cancer can cut the chances of getting the malignancy by undergoing a yearly colonoscopy that also removes any developing cancer-prone polyps. And information is growing on groups of genes that influence the development of more common conditions like diabetes, hypertension, and asthma. When combined with health histories and environmental exposures, personalized preventive strategies promise major public health benefits and healthcare cost savings. This envisions a personal genetic profile in everyone’s medical record. Your genomic information is powerful but, like all powerful tools, it bears risks. Genetics is fundamentally the science of differences and can be used to categorize people, stigmatize them, or subject them to social or economic discrimination. This concern has been felt for decades.” http://health.usnews.com/health-news/articles/2007/11/16/threats-to-your-genetic-privacy

Dr. Healy’s concerns were in part addressed and answered with the passage of the Genetic Information Nondiscrimination Act (“G.I.N.A.”)

Genetic Testing and Crystal Balls

Everyone should have an understanding of what G.I.N.A. does and does not cover, and prevent situations from occurring that could lead to violations of G.I.N.A.. Similarly, everyone should have an understanding of what the results of genetic testing mean and don’t mean, and should remember these five words from Dr. Healy:”Genes are not crystal balls.”

More recently, reseachers at John Hopkins University provided the following additional insights: “Sequencing a person’s entire genome will foretell many diseases only marginally better than gazing into a crystal ball, according to a report in the April 2 Science Translational Medicine online. Researchers at Johns Hopkins University in Baltimore, Maryland, modeled data from identical twins to determine if a person’s genome can predict disorders such as cancer, Alzheimer’s, and heart disease. The results sound neither a ringing endorsement nor a death knell for whole-genome sequencing. The analysis suggests that the average person’s genome would likely predict one future condition with a reasonable degree of accuracy. But it would also yield a host of negative results that are largely meaningless, because all they indicate is that the person’s risk of those conditions is no higher than the risk to the general population….“our destiny is not in our genes. Rather, many other things that we can influence, such as our lifestyle and doing medical checkups, may be much more important for reducing our risk of prematurely being affected by diseases.”—” http://www.alzforum.org/new/detail.asp?id=3112

What is G.I.N.A.?

Though G.I.N.A. is not a remake of the old television series starring Barbara Eden and Larry Hagman, some would say that DNA  is like the genie in the Thief of Bagdad movie ; it is hard to put the genie back in the bottle (of privacy)  once it is out in public.

G.I.N.A. has two principal titles. Title I prohibits discrimination in health coverage based on genetic information while Title II prohibits discrimination in employment based on genetic information. Specifially, Title II prohibits use of genetic information in the employment context, restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic information, and strictly limits such entities from disclosing genetic information.

The law forbids discrimination on the basis of genetic information when it comes to any aspect of employment, including hiring, firing, pay, job assignments, promotions, layoffs, training, fringe benefits, or any other term or condition of employment. Genetic information includes information about an individual’s genetic tests and the genetic tests of an individual’s family members, as well as, information about any disease, disorder, or condition of an individual’s family members (i.e., an individual’s family medical history).

Who Enforces G.I.N.A. ?

There are four federal enforcers: The Department of Labor, the Department of the Treasury, and the Department of Health and Human Services have specific responsibilities for enforcing the health insurance provisions and the E.E.O.C is responsible for enforcing the employment provisions.

What is Genetic Discrimination?

“Genetic discrimination occurs if people are treated unfairly because of differences in their DNA that increase their chances of getting a certain disease.” But remember, an increased genetic chance is not the same thing as an inevitable genetic certainty.

What Is and What Is Not A Genetic Test?

  • “Genetic test” refers to “analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes.”
  • “Tests to determine whether an individual carries the genetic variant evidencing a predisposition to breast cancer, colorectal cancer are genetic tests.”
  • “Tests for infectious and communicable diseases that may be transmitted through food handling, complete blood counts, cholesterol tests, and liver-function tests are not genetic tests.”

Information about race and ethnicity that is not derived from a genetic test is not “genetic information” for  purposes of G.I.N.A.

Genetic Testing Issues Have Popped Up In A Variety of Contexts, For Example in Sci-Fi Films, Identity Fraud Cases in Major League Baseball, Testing Controversies in the National Basketball Association, and in Difficult Real Life Choices

The uses and misuses of genes and genetic information have popped up in a variety of older sci-fi and film contexts. Perhaps the most memorable of those film contexts are:

in the film The Boys from Brazil starring Gregory Peck as Joseph Mengele and Laurence Olivier as Nazi hunter Ezra Lieberman,  and in the genetically-engineered Khan Noonien Singh (Ricardo Montalbán) in Star Trek’s Eugenic Wars   and in the Wrath of Khan.

More recently the theme has popped up in films such as Gattaaca.

Officially they are called ‘In-valids’…They are the ‘healthy ill’. They don’t actually have anything yet—they may never have. But since few of the pre-conditions can be cured or reversed, it is easier to treat them as if they were already sick.”—Columbia Pictures, Gattaca[1],1997

 

In July, 2009, Major League Baseball is reported to have used DNA testing to determine if Miguel Sano, a prospect from the Dominican Republic, was really 16 years old. MLB said that testing in the Dominican Republic is used“ in very rare instances and only on a consensual basis to deal with the identity fraud problem that the league faces in that country.” The statement added that the results of the tests were not used for any other purpose. Also in July 2009, the New York Yankees are reported to have voided the signing of an amateur from the Dominican Republic after a DNA test conducted by Major League Baseball’s department of investigations showed that the player had misrepresented his identity.

Several years ago, it was widely reported in the sports news and general press that the Chicago Bulls of the NBA traded Eddy Curry  to the New York Knicks after Curry declined to take a DNA test to determine if his irregular heartbeat was just a benign arrhythmia or was hypertrophic cardiomyopathy, a heart condition that caused the on-court death of the Boston Celtic’s guard Reggie Lewis and Loyola Marymount’s Hank Gathers.

Related Ethical and Legal Issues

There are a host of related issues and concerns, such as ethical issues like those present in The Immortal Life of Henrietta Lacks. (“In 1951, an African-American woman named Henrietta Lacks was diagnosed with terminal cervical cancer. She was treated at Johns Hopkins University, where a doctor named George Gey snipped cells from her cervix without telling her. Gey discovered that Lacks’ cells could not only be kept alive, but would also grow indefinitely .For the past 60 years Lacks’ cells have been cultured and used in experiments ranging from determining the long-term effects of radiation to testing the live polio vaccine. Her cells were commercialized and have generated millions of dollars in profit for the medical researchers who patented her tissue. Lacks’ family, however, didn’t know the cell cultures existed until more than 20 years after her death. Lacks died of cancer 60 years ago, but her cells — taken without her knowledge or consent — are still alive today.”) http://www.npr.org/2011/03/18/134622044/tracing-the-immortal-cells-of-henrietta-lacks  and http://www.npr.org/2010/12/13/132030076/henrietta-lacks-immortal-cells-live-on-in-labs

Can Someone Own or Patent Your Genes?

Related issues also include questions such as who owns your genes, whether ownership is possible, and if so, what can be done with such ownership, for example under a patent. According to one report:

“The U.S. Patent and Trademark Office (PTO) has been issuing patents on human genes for over 20 years, giving private corporations, individuals, and universities exclusive rights to those genes and to test, study, or even look at them. Approximately 20 percent of all human genes have been patented, including genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, asthma, and many other illnesses. Federal district court Judge Robert Sweet made history by issuing the first ruling ever that human genes can’t be patented. The judge issued his decision in …a breast cancer gene patents lawsuit, which challenged the government’s granting of and Myriad Genetics’ control of patents on the BRCA1 and BRCA2 human genes, which are associated with breast and ovarian cancer. The judge declared that all 15 patent claims … invalid, based on the fact that they cover products of nature and abstract ideas”. http://www.aclu.org/blog/free-speech-womens-rights/who-owns-your-genes-you-do

“A divided panel of the federal appeals court in Washington that handles patent cases reversed Sweet’s ruling. The appeals court said genes can be patented because the isolated DNA has a “markedly different chemical structure” from DNA within the body. The Supreme Court threw out that decision, and sent the case back to the lower courts for rehearing. The high court said it sent the case back for rehearing because of its decision in another case … saying that the laws of nature are unpatentable. In that case, the Court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn’s disease.” http://www.huffingtonpost.com/2012/03/26/human-genes-patent-supreme-court_n_1380990.html

On March 30, 2012,federal district judge Beryl Howell ” issued what the winning party’s lawyer believes to be the first patent invalidity decision applying the Supreme Court’s recent ruling in Mayo Collaborative Services v. Prometheus Laboratories Inc. invalidating two diagnostic test patents. Judge found the claims in two patents owned by Advanced Biological Laboratories S.A. to be invalid and dismissed the declaratory judgment action, SmartGene Inc. v. Advanced Biological Laboratories S.A. Howell repeatedly cited the Supreme Court’s ruling in Prometheus, in which Justice Stephen Breyer noted that Supreme Court precedent held that nature, natural phenomena and abstract ideas are not patentable. The unanimous ruling also held that a patentable process must contain an “inventive concept,” so the patent is about more than the natural law.”The issue before this Court is whether the patents-in-dispute are abstract such that they do not constitute patentable subject matter,” Howell wrote. “The patents-in-dispute do no more than describe just such an abstract mental process engaged in routinely, either entirely within a physician’s mind, or potentially aided by other resources in the treatment of patients.”http://www.law.com/jsp/cc/PubArticleCC.jsp?id=1333418859471&Quick_on_the_Heels_of_emPrometheusem_a_Patent_Invalidity_Ruling=&et=editorial&bu=Corporate%20Counsel&cn=cc20120405&src=EMC-Email&pt=Corporate%20Counsel%20Daily%20Alerts&kw=Quick%20on%20the%20Heels%20of%20Prometheus%20%2C%20a%20Patent%20Invalidity%20Ruling

Real Life Personal Choices

Genetics is not just the central theme of movies and lawsuits, it is also the central theme of immensely personal decisions, such as those related by Allison Gillette, a Nova Online intern, in the following sections from her At a Personal Genetic Crossroads

“As genetic testing becomes more accessible, more people will not only consider testing, but also have to understand the immense responsibility and ethical decisions surrounding their results. I am currently at that genetic crossroads, and I am not sure which path to take. My family history suggests that I could be at risk for inheriting the BRCA and Lynch syndrome mutations. BRCA 1 and BRCA 2 are tumor suppressor genes; a person who inherits a mutated BRCA gene no longer has that safeguard against tumors. BRCA is an autosomal dominant gene, which means parents with the mutation have a 50 percent chance of passing it on to their children. In an article published by the Journal for Woman’s health, Stanford researchers have estimated that women with a BRCA mutation have a 60-85 percent lifetime risk of getting breast cancer and a 40-50 percent lifetime risk of getting ovarian cancer. Women without these mutations only have a 12 percent lifetime risk of breast cancer and a 2 percent risk of ovarian cancer. Lynch syndrome, on the other hand, is comprised of five different genes that affect the GI tract in a manner similar to the way that BRCA affects the breasts and ovaries. These genes are also autosomal dominant. A positive result for Lynch syndrome means a 60-85 percent lifetime risk of colon cancer and a 40-65 percent lifetime risk of uterine cancer as well as a heightened risk for other GI cancers. In the general population, the lifetime risk of colon cancer is five percent and the lifetime risk of uterine cancer is two percent.”

“As genetic counselors… explained, the first thing I need to consider is my insurance. The Genetic Information Non-discrimination Act (GINA), which went into effect in 2010, made it unlawful for health insurance companies or employers to discriminate against a person because of genetic test results. However, this does not apply to life insurance or disability insurance. Genetic counselors may suggest that patients secure life insurance before they sign up for genetic testing. As a potential patient, I will also need to know whether my insurance company covers genetic testing and counseling. Many companies cover it for people already diagnosed with cancer, but charge (over $5,000 full price) for diagnosing the BRCA and Lynch syndrome mutations in those without a cancer diagnosis.”

“I will also need to consider what health care choices I might make if I test positive for one of these mutations. First, I could elect to get health screens (such as mammograms and colonoscopies) earlier and more often. Getting colonoscopies yearly could reduce the risk of getting colon cancer to almost zero because it is gives doctors a chance to spot growths before they become malignant. I could also choose to go further and have prophylactic surgery–that is, have my ovaries removed–some time before I turn 35. That drastic measure reduces the risk of ovarian cancer to four percent. However, the genetic counselors explained, that intervention cannot start for a young woman until she is 25. “ The … genetic counselors ask their patients, “If you have a genetic mutation with a chance of intervention, what would you do with that information?” Would you completely alter your life? Your family’s lives? Or would you use the information to empower your decision-making?” I know I have asked myself all of these questions and weighed my options, but my genomic future still isn’t clear. As genetic testing becomes more accessible, it’s about time we all ask ourselves: What will we do with that information?”  ( http://www.pbs.org/wgbh/nova/insidenova/2012/03/genetic-choices.html

If your family history suggests you are at risk

As two university professors point out, the future as envisioned in science fiction may already be happening today in clinical settings and a host of legal and ethical concerns remain unaddressed even after the passage of G.I.N.A:“In the not-so-distant future, genetic testing will be a routine part of medical care. Doctors will screen for genes that influence your risk of heart disease, Alzheimer’s, or diabetes. They will perform genetic tests to see how–or whether–you will respond to a particular medicine. (In fact, in some cases they already do.) It’s not hard to imagine a future in which whole genome sequencing–that is, having your entire genome read out, not just a particularly juicy bit–will be routine at birth.”

“Many patients are concerned about the confidentiality of their genetic test results and the potential for discriminatory use. The Genetic Information Nondiscrimination Act (GINA) prohibits employers and health insurers from using genetic information to discriminate, but does not extend to life and disability insurance or to other important molecular test results that do not fall under GINA’s definition of “genetic information.” Surreptitious DNA testing, in which anyone can secretly collect and test your DNA from a drinking cup, straw or licked envelope, also raises privacy concerns, as many states currently have no protections against police or private parties testing others’ DNA.” “Genetic research is not only identifying traits that affect disease risk but also is discovering genetic variants that influence our personalities and intellectual, athletic, and artistic capabilities. How will the expansion of this sensitive new information affect education programs, workplaces, and the criminal justice system, among others? Already such behavioral variants are being presented as mitigating factors in criminal trials, demonstrating that behavioral genetics is no longer science fiction. “

http://www.pbs.org/wgbh/nova/insidenova/2012/03/top-ten-policy-ethical-and-legal-issues-with-genetic-information.html

Genetic Counseling

“Someday soon, a company will offer to decode your genome for as little as $1,000. To make sense of your unique collection of A’s, Cs, Ts and Gs, you may turn to a genetic counselor — DNA guides who have been advising patients since the early 1970s. The profession routinely appears on lists of hot jobs for the 21st century.” http://articles.latimes.com/2008/nov/08/science/sci-geneticqa8

There is a lot of misinformation in the popular press about genetic counselors, what they do and how, if at all, they can assist a person in making decisions involving genetic information. The following useful information about genetic counseling is provided by the National Institute of Mental Health:

“ Genetic counseling provides information and support to people who have, or may be at risk of, inherited disorders. A genetics professional (medical geneticist, genetics counselor, or genetics nurse) discusses your risk with you and may or may not suggest genetic testing. Genetics professionals:

  • Assess your risk by looking at your family’s health history and medical records.
  • Provide support and information to help you decide whether to be tested.
  • Explain what the results of genetic tests mean.
  • Provide counseling or refer you to support services.
  • Explain options for treatment or prevention.
  • Explain how test results could affect decisions about having children.

If your test shows that you do have a genetic variation clearly associated with a specific disease, you may be referred to a doctor or researcher who specializes in that illness. Both your primary care provider and a genetics professional can help you with decisions about testing and can help you interpret your test results. Some genetics professionals specialize in a disease category (such as cancer), age group (such as adolescents), or type of counseling (such as prenatal).” http://www.nimh.nih.gov/health/publications/looking-at-my-genes-what-can-they-tell-me/index.shtml

Genetic Information: In Cloud Computing and In Cyberspace

According to a recent New York Times article “Amazon’s cloud computing unit, Amazon Web Services, will store for public use the entire contents of the National Institutes of Health’s 1000 Genomes Project, a survey of genetic information from 1,700 individuals that is some 200 terabytes in size. Anyone can access the information for free, and there is no requirement to share any research results…The people in the study have consented to have their data made public, and there is no personal information, such as a history of disease, associated with the genetic information. “It’s the only public data set like this,” said Lisa D. Brooks, program director for the Genetic Variation Program of the National Human Genome Research Institute, a part of the National Institutes of Health.” (http://bits.blogs.nytimes.com/2012/03/29/amazon-web-services-big-free-genetic-database/

What is cloud computing? “Cloud computing is a general term for anything that involves delivering hosted services over the Internet.” http://searchcloudcomputing.techtarget.com/definition/cloud-computing .In essence, personal cloud computing means “having every piece of data you need for every aspect of your life at your fingertips and ready for use. Imagine your PC and all of your mobile devices being in sync—all the time. Imagine being able to access all of your personal data at any given moment. Imagine having the ability to organize and mine data from any online source. Imagine being able to share that data—photos, movies, contacts, e-mail, documents, etc.—with your friends, family, and coworkers in an instant. This is what personal cloud computing promises to deliver. Whether you realize it or not, you’re probably already using cloud-based services. Pretty much everyone with a computer has been”.http://www.pcmag.com/article2/0,2817,2372163,00.asp

What is Amazon web services? “In 2006, Amazon Web Services (AWS) began offering IT infrastructure services to businesses in the form of web services — now commonly known as cloud computing. One of the key benefits of cloud computing is the opportunity to replace up-front capital infrastructure expenses with low variable costs that scale with your business. With the Cloud, businesses no longer need to plan for and procure servers and other IT infrastructure weeks or months in advance. Instead, they can instantly spin up hundreds or thousands of servers in minutes and deliver results faster. “http://aws.amazon.com/what-is-aws/

Genetic Testing and State Intervention

Overall, 24 states prohibit or limit so-called direct access testing without a doctor or other medical professional’s involvement”—Forbes

There is increasing state regulation that prohibits or limits so-called direct access testing without a doctor or other medical professional’s involvement. G.I.N.A. sets a floor, not a ceiling. States can go beyond G.I.N.A., and some states are proposing legislation doing just that.

The Growth of Genetic Testing and the Direct to Consumer Market

According to a March 12, 2o12 article in the Los Angeles Times, “spending on genetic tests has reached $5 billion annually and could top $25 billion within a decade, according to an insurance industry study published Monday”. The article goes on to state:”“The growing availability of genetic and molecular diagnostic tests offers the promise of earlier detection of disease and more personalized treatments that could wring substantial savings from the nation’s $2.6 trillion-a-year healthcare tab. But many medical providers and other experts worry that those benefits may be outweighed by indiscriminate use of genetic testing, similar to what has occurred with some spending on popular prescription drugs and expensive imaging tests.”

In 1995, only about 300 genetic tests were available. Most of those tests were for rare diseases and were usually performed in research settings. Today, more genetic tests are available to health care consumers and providers, and in a variety of settings, including churches and direct mail. The Direct-to-consumer (DTC) genetic testing market is rapidly expanding. There are now some 1,500 things you can be genetically tested for – including a genetic susceptibility to cystic fibrosis, muscular dystrophy, hemophilia, Huntington’s chorea, sickle cell disease, multiple sclerosis, Cohn’s disease, breast cancer, diabetes, heart disease and Alzheimer’s.

Under the traditional business model, tests are performed with a physician’s involvement, from ordering the test to communication of its results. But with the confluence of the Internet and completion of the Human Genome Project, the procurement of genetic tests is migrating from health professional-controlled domains to cyberspace, where these tests are available to anyone. Marketing and selling genetic tests directly to consumers not only adds a new business model that can exclude the consumer’s physician but raises scientific, regulatory, and even ethical issues. http://www.insightpharmareports.com/reports_report.aspx?r=640&id=88534

In March 2011, the FDA’s Molecular and Clinical Genetics Advisory Panel recommended that “Certain types of genetic tests that are available for at-home use without a prescription should not be used without the involvement of a physician or genetic specialist. The panel wasn’t clear on whether that would mean a physician would have to order the test, or if a physician would have to interpret the test, or both. That will ultimately be up to the FDA to decide.”[2]

Three Upshots from the Growth in Genetic Testing in the DTC Market

#1.  A lot more information is going to be available to users of the tests.

#2.  The meaning of DTC genetic test results may be misinterpreted. (False Negatives and False Positives).

#3.  Users of the test may tell someone their test results at work. That information could be overheard, and misused.

ANSWERS TO THE SCENARIO QUESTIONS

No, Carol can not be fired or denied a promotion due to her risk of Huntington’s disease.

No, the employer can not use information on a FMLA form to discrimination against  Carol.

“GINA indicates when an employer can legally have genetic information about an employee, two examples: (1) An employer accidentally becomes aware (overhearing a conversation); (2) When an employee provides information for family and medical leave.. When an employer has genetic information, the employer can not use it to discriminate against an employee, and the information must be kept in a separate and confidential file.”[3]

 FINAL REGULATIONS UNDER G.I.N.A.—THE WATER COOLER EXCEPTION

The `water cooler problem’ arises when an employer unwittingly receives otherwise prohibited genetic information in the form of family medical history through casual conversations with an employee” or by overhearing conversations among co-workers. Congress did not want casual conversation among co-workers regarding health to trigger federal litigation whenever someone mentioned something that might constitute protected family medical history. The Commission’s proposed regulation therefore noted that a covered entity inadvertently acquires family medical history where a manager or supervisor overhears a conversation among co-workers that includes information about family medical history (e.g., a conversation in which one employee tells another that her father has Alzheimer’s disease).

 

Six  Important things for Employers To Do/Not Do

1.   Understand what G.I.N.A. requires you to do and not  to do.

2.   Map out a compliance strategy engaging key individuals with leadership skills  to serve on a cross-functional compliance team:  Management, Legal, Human Resources, and  EEO-AA. If you have a corporate Medical Department, engage a leader from that group as well.

3.   Do update your non-discrimination policies and procedures to include  G.I.N.A.

4.   Do incorporate the safe harbor language into the forms you utilize for requesting business related health information (including ADA accommodation,  FMLA or state equivalent).

SAMPLE LANGUAGE: SAFE HARBOR PROVISION

“The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits employers and other entities covered by GINA Title II from requesting or requiring genetic information of employees or their family members. In order to comply with this law, we are asking that you not provide any genetic information when responding to this request for medical information. ‘Genetic information,’ as defined by GINA, includes an individual’s family medical history, the results of an individual’s or family member’s genetic tests, the fact that an individual or an individual’s family member sought or received genetic services, and genetic information of a fetus carried by an individual or an individual’s family member or an embryo lawfully held by an individual or family member receiving assistive reproductive services.’’

5.   Do not discriminate or retaliate against a person on the basis of protected genetic information in any employment context.

6.   Do not  request, require, or purchase genetic information about an individual or their family members, for example, a wellness program with a premium discount or waiver if the participant takes a health risk assessment.

Requesting information has a very broad scope under the EEOC Final Regulations under G.I.N.A. Under those regulations, an employer who does the following would be in violation of GINA: “conducting an Internet search on an individual in a way that is likely to result in a covered entity obtaining genetic information; actively listening to third-party conversations or searching an individual’s personal effects for the purpose of obtaining genetic information; and making requests for information about an individual’s current health status in a way that is likely to result in a covered entity obtaining genetic information.” 

 

What About G.I.N.A. AND Corporate Wellness and Disease Management Programs?

 

 This is a potential minefield.

However, an employer is allowed to collect genetic information for corporate wellness and disease management programs with three provisos.

#1: That employees give “prior, knowing, voluntary, and written consent”.

#2: That the employer only receives the genetic information in aggregate form.

#3: That the employee does not have to fill out a health risk assessment form in order to get a reward.

We end this post by turning to the first lawsuit brought under G.I.N.A. and to two pre-G.I.N.A lawsuits.  Lawsuit happen for a variety of reasons, and most lawsuits are concluded by way of a setttlement.  People going to court when they can not agree on what is right, or fair, legal. One way to reduce possible exposures to G.I.N.A. lawsuits  is for employers to follow the six suggestions made above on things employers should or should not do.

ENDING UP: IN LITIGATION

Fink v MXEnergy Company

This is the first reported case under G.I.N.A.

Fink’s attorney, Gary Phelan, of the Stamford- and New York-based law firm Outten & Golden, said Fink is the first person in Connecticut to file a complaint under GINA. Fink filed complaints with both state employment officials and the Equal Employment Opportunity Commission (EEOC).

In 2004, Pamela Fink and her two sisters had genetic tests  done at the Yale Cancer Center. The tests showed all three carried the BRCA2 gene. That gene predisposed them to developing breast cancer. Both of Fink’s sisters developed breast cancer, but survived with treatment. After several biopsies and frightening false alarms, Fink opted for a preventative double mastectomy. Fink took four weeks off, during which a consultant took over her duties. In the months following her return to work, the consultant became her permanent supervisor.

Fink says she started to receive negative performance reviews, which hadn’t been the case in her previous four years with the company. Finally, after she had taken an additional ten days off for a second procedure, she was fired.

“I’d had great reviews, I had merit increases, I had bonuses. I really felt it was a place where I could be comfortable and confident and be honest with them, and that was a mistake,“ Fink said. Fink said “I was a great employee and I did really great work.” “The only thing that changed from the time that I had a great review to when I didn’t was my two surgeries.”

Fink then sued, saying her termination was illegal because it was brought on by her medical condition — not her on-the-job performance. She claims that her bosses gave her glowing evaluations for years — until her test results were revealed. Company spokesman Todd Miller said MXenergy “emphatically and categorically” denies the allegations, but has a policy not to discuss personnel matters and will not comment further.

THREE VIEWS FROM THREE LAWYERS

1. “The purpose of GINA is to offer protections from companies trying to purge their workforce of people who drive up health insurance costs, or those who could drive up costs based on test results that show they’re susceptible to certain diseases.”

2. “I can see [litigation] happening with more and more people as genetic testing becomes less costly and more available”.

3. The chairwoman of the board of the national Women’s Law Project says: “Unfortunately, I think in today’s day and age people have started sharing a lot more personal information about themselves, whether it’s in social media or in the workplace. I think it may behoove people to keep some of that information closer to the vest”.

The Pre-G.I.N.A. Legal Landscape

EEOC  v, Burlington Northern Santa Fe (2002 Settlement) (Alleged violation of ADA)  and Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998).

The EEOC filed suit against BNSF “for secretly testing its employees for a rare genetic condition that causes carpal tunnel syndrome as one of its symptoms.” BNSF claimed the testing was a way of determining whether the high incidence of repetitive-stress injuries was work related. “Besides testing for this rare problem, company-paid doctors were also instructed to screen for several other medical conditions such as diabetes and alcoholism.” Employees were not told they were being genetically tested and one employee who refused testing was threatened with possible termination. EEOC argued the tests were unlawful under the ADA because they were not job related and any condition of employment based on such tests would be cause for illegal discrimination based on disability.” Thirty six Burlington employees received a total of $2.2 million.

The Bloodsaw case raised the question whether a clerical or administrative worker who undergoes a general employee health examination may, without his or her knowledge, be tested for highly private and sensitive medical and genetic information such as syphilis, sickle cell trait, and pregnancy. Lawrence Berkeley Laboratory is a research institution jointly operated by state and federal agencies. Plaintiffs- appellants, present and former employees of Lawrence, allege that in the course of their mandatory employment entrance examinations and on subsequent occasions, Lawrence, without their knowledge or consent, tested their blood and urine for intimate medical conditions — namely, syphilis, sickle cell trait, and pregnancy. Their complaint asserted that this testing violated Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act (ADA), and their right to privacy as guaranteed by both the United States and State of California Constitutions. The district court granted the defendants-appellees’ motions for dismissal, judgment on the pleadings, and summary judgment on all of plaintiffs- appellants’ claims. The U.S. Court of Appeals, Ninth Circuit, affirmed as to the ADA claims, but reversed as to the Title VII and state and federal privacy claims.


[1] “In the not-too-distant future, a less-than-perfect man wants to travel to the stars. Society has categorized Vincent Freeman as less than suitable given his genetic make-up and he has become one of the underclass of humans that are only useful for menial jobs. To move ahead, he assumes the identity of Jerome Morrow, a perfect genetic specimen who is a paraplegic as a result of a car accident. With professional advice, Vincent learns to deceive DNA and urine sample testing. Just when he is finally scheduled for a space mission, his program director is killed and the police begin an investigation, jeopardizing his secret.” http://www.imdb.com/title/tt0119177/plotsummary  “Gattaca Corp. was an aerospace firm in the future. During this time society analyzes your DNA and determines where you belong in life. A man with a congenital heart condition tries to assume the identity of a former athlete with perfect genes in order to fulfill his dream of traveling in space.The corporate name Gattaca was derived from the four basic chemical building blocks or nucleotides of DNA: Guanine (G), Adenine (A), Thymine (T), and Cytosine (C).”

[2] http://abcnews.go.com March 12, 20110, 2011.

[3] Case and answers from the Genetics and Public Policy Center website


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