Blog Entry

A New Online Interactive Course in Genomics

In 1953, two young scientists published the structure of DNA, a Nobel Prize winning discovery that gave birth to the Interdisciplinary field of genomics. Beginning in 1990, scientists around the world embarked upon the Human Genome Project, with the goal of determining the composition of the entire human genome. The project is now complete, but there is so much more to learn from the genome: how our bodies function, how to prevent diseases, what makes different species unique, and even how life evolved on earth.

To ensure that future scientists, physicians and policy makers are prepared to take full advantage of the genomic revolution, the National Research Council issued a report (BIO2010) calling upon academic institutions to alter the way their students prepare for post-baccalaureate education in the health care professions.

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Thinking Genomically

If ever there were an area of medicine that is appropriate for lifelong learning, it is genomics, the study of the functions and interactions of all the genetic material (DNA) belonging to an organism, including interactions with environmental factors to understand the root causes of disease and to better understand how an organism works. Because it is a young and quickly evolving field, it is difficult to precisely determine either the genomic knowledge or the clinical application of that knowledge that will be required for healthcare providers in the future. 

What is clear is that the practice of "genomic medicine" will require the implementation of educational tools by which the health-care workforce can begin to shrink the gap between genomic knowledge and its application to patient care.  Eric Green, the current Director of the National Human Genome Research Institute at NIH, puts a fine point on the tremendous potential of genome knowledge to affect the future of health care when he writes, "Primary care providers are the front lines in what will have to be an integrated and collaborative model for using genomic advances to enhance patient care."

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Shock treatment administered to autistic at Mass. School

The Boston-area special needs school, which is called the Judge Rotenberg Center, enrolls students ages 3 to adult, all of whom are either autistic children or are struggling with severe emotional, behavioral or psychiatric disorders. Those students who display undesirable behavior, reports ABC News, are subjected to a treatment which the United Nations is calling "torture." All of the Judge Rotenberg students are subject to shock treatment.

Source for this article: Autistic kids subjected to shock treatment at Mass. School by Personal Money Store

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What does GINA mean?

A comment to one of my blog entries on genetic testing asked whether genetic testing would affect life insurance rates. My response pointed out the first GINA challenge to employment discrimination and referenced a personal refusal for long-term care insurance based on family history. 

Note that my answer ddidn't address the question. I've since checked further into the details and learned the following--which I should have remembered:

GINA's provisions prohibiting discrimination in health coverage based on genetic information do not extend to life insurance, disability insurance, or long-term care insurance. For example, GINA does not make it illegal for a life insurance company to discriminate based on genetic information. In addition, GINA's provisions prohibiting discrimination by employers based on genetic information generally do not apply to employers with fewer than 15 employees. For health coverage provided by a health insurer to individuals, GINA does not prohibit the health insurer from determining eligibility or premium rates for an individual based on the manifestation of a disease or disorder in that individual. For employment-based health coverage provided by group health plans, GINA permits the overall premium rate for an employer to be increased because of the manifestation of a disease or disorder of an individual enrolled in the plan, but the manifested disease or disorder of one individual cannot be used as genetic information about other group members to further increase the premium. GINA also does not prohibit health insurers or health plan administrators from obtaining and using genetic test results in making payment determinations. 

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Employee tests nondiscrimination in employment

The following story describes the first known case testing GINA, the Genetic Information Non-discrimination Act:

Will Washington Enforce the Genetic Non-Discrimination Act? (http://www.inthesetimes.com/working/entry/6065/will_washington_enforce_the_genetic_non-discrimination_act/)
Monday, June 7, 1:21 by Lewis Maltby

First-ever case tests 2008 law banning employers from discriminating based on workers' genetic profiles

Pamela Find didn't want to make history; she just didn't want to die of cancer. But when her employer fired her because she carried a gene linked to breast cancer, Fink became the first American worker to file an official federal complaint under the Genetic Information Non-Discrimination Act (GINA), which Congress passed in 2008.

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I just sent for a genetic test--now what?

In the light of recent developments in the genetic testing arena, individuals are wondering what to do if they have ordered a test. Akira! news, in a well-written staff article, asks "Should you test your genes?"

Like anyone else, Dr. Rachel Zahn loves a deal, so when a friend e-mailed her a link to an internet site offering $99 genetic testing — usually it costs $499 — she figured, “Why not?” and sent away for the test.

Now she’s thinking — Why?

Zahn is having, if not buyer’s remorse, at least some very strong doubts about the wisdom of her decision to get genetic testing. “I did it out of curiosity,” she says.

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FDA finally steps up to the plate

I no longer work in the pharmaceutical industry, so I no longer have to fear backlash if I say negative things about the FDA. I also feel that we Americans expect way too much of this government agency. They're understaffed and underfunded. When I did work in the industry, I had chances to review and comment on their work and found most reviewers to be careful and detailed in their review of New Drug Applications. I never worked with medical device approvals. 

Since genetic testing was offered online for consumers, the FDA has been saying that the tests are being offered by individual labs and are thus "home brews", not medical devices, and do not need to enter the FDA approval process. Now, the view has changed and the FDA has sent major players letters telling them they need to justify not getting medical device approval. 

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Beware of Genetic Testing

Here's a piece from the Philadelphia Inquirer, written by Arthur Caplan, May 21, 2010, that you might find interesting:

Type "genetic testing" on an Internet search engine and then hang on. You will be in for quite a ride. There is an endless parade of companies touting genetic tests for everything, including determining whether your kid has the potential to be a star athlete, finding out whether your ancestors were kings or ne'er-do-wells, finding a date, optimizing your diet, or knowing what diet to use if your intake is not optimal. Apparently, there is more self-discovery to be had by spitting your saliva into a cup and sending it off to be genetically analyzed than in a whole month of Dr. Drew.

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what's in the Walgreens genetic test?

Walgreen's decision to temporarily withhold plans to sell a DNA test in its stores is presumably based on interference from the FDA. However, there's no requirement to have DNA tests approved by the FDA. None of the tests sold by other companies are FDA approved, and the FDA has been consistently saying that these "home brew" tests are not regulated by the FDA.

So, what's going on?

Who knows?

Meanwhile, if you want to know what the test does, check out the following link: http://singularityhub.com/2010/05/13/exclusive-i-already-took-the-dna-test-that-hits-walgreens-on-friday-video/  You should find it interesting. 

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Pathway/Walgreens: Collect your DNA--$20 -$30; test your DNA--extra!

Wow--this is fantastic! For only $20 to $30, you can purchase--at Walgreens later this month--a saliva sampling kit (a couple of cotton swabs, aplastic container, label, postage-paid envelope, instructions). Great, now what?

For an additional fee of $79 to $249, you can actually have the DNA tested. 

In part because on-line offers of genetic testing kits have not gleaned much business, Pathway Genomics--a new company--will test the drug store market, hoping to make their money that way. 

Are you interested? Consider that the company is linked with Walgreens, so the data collected can be used to market treatments and drugs for the diseases supposedly being tested for. I say "supposedly" because we now know that nearly all disease tests touted in these direct-to-consumer products are actually determined by many factors, both genetic and environmental. The "answers" you get may or may not affect your future health--but will likely affect your emotional and psychological health, and will definitely affect your pocketbook. 

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