GINA is putting her makeup on and getting ready for the big dance...

AND...we're back! Like Google's Gchat developers we've been away from the GinaWatch blog building something secretive but we thought it was important to alert you to an upcoming meeting.

The U.S. Equal Employment Opportunity Commission (EEOC) will hold a public meeting on the subject of genetic discrimination at10 a.m. (Eastern Time) Wednesday, Feb. 25, at the agency's new headquarters, 131 M Street, N.E., Washington, D.C. In accordance with the Sunshine Act, the meeting is open for public observation of the Commission's deliberations.

IN THIS MARKET EQUAL EMPLOYMENT OPPORTUNITY SOUNDS GOOD. Back soon to launch something exciting!!!

A life insurance amendment to GINA is necessary and citizens should be outraged that its not in the original legislation

Why were Life Insurance companies and their affiliates excluded from GINA?

Recently, my wife and I had our first child, Giselle (7'7oz and full of charm). For the first time in our lives, it seemed prudent to obtain a life insurance policy to protect our new family from any unfortunate, unforeseen or untimely events. So, we contacted a friend who works for one of the major US life insurance companies and she prepared a policy for each of us. We went into the process admittedly naive but open to the guantlet of activities that quickly ensued. The process was probably fairly standard but certain elements seemed somewhat peculiar and invasive to me.

First, each of us were asked to answer at least a hundred rapid-fire questions by phone about our family and medical history, personal financial records and employment history. This would have been fine, except for the fact that I don't have instant recall of the last five-plus years of medical visits, procedures, prescriptions, etc. So the data they got from me was not particularly accurate (and I consider myself fairly adept at answering healthcare questions). In fact, I had to stop the woman interviewing me several times to back-up and re-answer the questions she was working through.

For example, "In the past five years have you seen a physician for gastrointestinal issues?" I originally answered "no". About 3 minutes later, I remembered I was laying on the table at a local hospital about a year ago to have a gastric scope for a possible GERD condition (they didn't find anything). How could I forget that? Maybe it was the way the interviewer was pushing me through the questions, maybe it was because I was laying in bed answering the questions half-asleep, maybe it was because I have a certain apathy re: phone surveys. Any way you slice it - the information they were retrieving from me was partial and not as robust as it could have been. Further, I can't imagine how someone outside the healthcare industry would answer these questions with any degree of accuracy.

Second, a few days later, a mysterious man calling himself Mr. Reid showed up at our apartment in the city to administer our "medical evaluation". We thought he might ask some questions, put a blood pressure cuff on, execute a physical exam, ask me to "turn my head and cough", etc. We were shocked when he showed up with sampling kits asking for blood and urine samples. Blood and urine samples? Taken in our home? When we asked him what tests he would run on the samples he said, "Oh, I don't have a record of the tests that will be run, but it's routine screening and I just pick up the samples"...huh? Sounds like when you take your cell phone into the place you bought it from and they tell you they can't help you with service...

I wasn't born yesterday, what did he mean "routine screening"?

So, I probed further. Who CAN tell me what tests will be run, exactly? He said, "Well you'll have to contact your agent, she should be able to give you a list of the tests they typically perform."

I gave him the samples he requested (I know I shouldn't have but I didn't want the hassle of re-scheduling to delay the inevitable - we need insurance - and this is what you have to do to get it). A few hours later, I was on the phone with our insurance agent (actually my friend's mother). I asked her, "Can we get a list of the tests that you'll be running on our blood and urine samples?" and commented, "we weren't aware that this was part of the process." She said, "Certainly, I can get you the information. However, I don't have the list of all the tests that they'll run right now. But, its likely to be some of the same tests you're asked to take during a physical in your doctor's office. If you still need it, I'll get you the list after the holidays when our team is back in the office"...

Now... ... ... are you kidding me? What did that mean? I had already given my blood and urine samples to a guy who showed up, out of the blue, at our apartment asking for them, stuck a needle in my arm, and left with my body parts...to do "routine testing" that couldn't be readily identified by my friend's mom - our new life insurance agent.

This is a lot of information they've just acquired on my work history, financials, health, etc... What did i just agree to? Its now clear to me that they could run any genetic test they wanted to to confirm disease, assess pre-disposition to disease, etc and then just inform me that they did it? They could deny me coverage, hike my rates to any level, share the information with other Life Insurers or affiliates, etc.

What if this was life insurance through my employer (its not)? GINA doesn't and won't (in its current form) protect me against any discriminatory activity by a life insurer or companies it might share my information or do business with...

The question is, why is LIFE INSURANCE excluded from GINA legislation? Who are the beneficiaries of this policy choice? and when will we WAKE UP and DEMAND an amendment to include it in GINA? Am I missing something?

Is Genentech attempting to stifle competition in personalized medicine?

Genentech (DNA) recently filed a Citizen Petition with the FDA attempting to persuade the agency to use a monocle for ALL diagnostic tests, with particular attention paid to Laboratory Developed Tests which are designed to guide therapeutic decisions.

"According to Genentech, pharmacogenomic information is contained on the label of around 10 percent of all FDA-approved drugs." -- Genomeweb

This is a surprisingly high number if it's true but even if it is not the percentage is sure to grow as we learn more about human genetic variation.

Interestingly, DNA received nearly instantaneous support from Kathy Hudson at the Center for Genetics and Public Policy. She is clearly developing an integral position as an informed player in this and other ongoing debates. However, as a policy group, it seemed odd to provide such quick, unconditional and one-sided support to a single, large, publicly-traded company without a counterbalancing perspective on behalf of all the small and mid-sized laboratories doing innovative work in this nascent field. Particularly because a fair amount of the innovation in the field falls within the LDT silo.

If the current 15 year, heavily-regulated drug development process is any indication of the success and expediency of the FDA's regulatory authority, I think we're in for a bumpy ride and significant delays in diagnosis of genetic diseases. That can't be good for patients. On the flip side, I think we can all appreciate the need for standardization and an "apples to apples" approach to diagnostics in medical practice. So how should we think about this public move by a public company?

Well...what does Genentech stand to gain? OR more importantly, what do Combimatrix, Monogram, Clinical Data, Genomic Health, Response and others practicing non-DNA approved LDT tests stand to lose?

Genentech's soon to be parent, Roche Holding AG, may be providing the motivation. Roche's hostile $3 billion cash offer for Ventana Medical Systems Inc. last year underlines the Swiss health-care company's strategy of acquiring midsized and small companies whose diagnostic products allow it to target drugs to individual patients. Roche also acquired NimbleGen, a maker of high-density DNA microarrays, tools used in pharma research to understand the genetic causes of disease and the identification of potential drug targets. In April of last year, Roche agreed to buy BioVeris Corp., a U.S. diagnostics company, for $600 million and also recently bought 454 Life Sciences Corp. a maker of sequencing products for diagnostic tests.

It appears Roche/Genentech are trying to use this broad public appeal to protect their investment and break the back of small companies with revenues from LDTs. In this pernicious fundraising environment they will likely not survive regulation. Read: the losers may be the cash-starved start-up companies providing high-quality LDTs and surviving/developing new tests via those early testing revenues.


I think its safe to assume that any FDA regulation at this point will slow progress, limit/delay disease diagnosis, stymie small business innovation, etc. Is that a good thing? Is NOW the right time for this legislation to be enabled/enacted? Or should we let things mature a bit more?

If you need evidence that the FDA process will delay new commercial products without taking all the risk out of the end product just think (Vioxx, Celebrex, Fen-Phen, etc) and see the graphic at the right...

Biobanking has long-term consequences and a few, intangible near-term benefits

In today's genomics community few would argue that a million SNP chip analysis yields "hard evidence" of disease or a particularly high-degree of clinically and medically relevant pre-disposition information. SNPs might rather be applied as guideposts of "hints to dig deeper". So why are we broadly consenting patients and biobanking blood samples without access to tools that can more definitively diagnose disease or predisposition to disease?

On December 9 at 2:00 p.m. EST Kathy Hudson and her group at the government backed Genetics and Public Policy Center are putting on a seminar named: "Genetic Biobanks: Deposits, Withdrawals, and Consumer Protection” at the National Press Club in Washington, DC to dig deeper on these issues.

From my view, taking biological samples from broadly consented patients to perform SNP studies does enable much needed research but biobanking also leaves patients open to a quagmire of more sophisticated future analyses (CNV analysis, epigenetics, etc). More advanced interrogation of the old sample could expose things about the patient that we/they haven't anticipated. These patients, not being privvy to advances in diagnostic technologies or disease associations, may not have otherwise consented to the new tests, AND they may learn things no one could have foreseen. Consider: not only their physical health but also their mental health...their social health/fitness...

While now outdated, a 2005 paper by Caitlin Jones from the Rochester Institute of Technology on "Genetic and Environmental Influences on Criminal Behavior" shows the possible link between genetics and sociopathic behavior.

I wonder if the consented and later potentially de-indentified patients would want anyone to know they have a pre-disposition to Attention Deficit Hyperactivity Disorder (ADHD), Conduct Disorder (CD) or Oppositional Defiance Disorder (ODD)?

How do we prospectively write consents to anticipate technological changes? How do we inform patients of these kinds of unanticipated results? It is a physician's duty, no? Or will we distribute the results ONLINE...DTC?

Welcome to our new site covering genetic discrimination issues

If GINA protects Americans from discrimination starting mid-year next year, what about all the people taking genetic tests this year? What happens to the information captured on those people?

ADDITIONAL FOOD FOR THOUGHT:

The NHGRI says: "The law does not cover members of the military. In addition, the law does not cover life insurance, disability insurance and long-term care insurance."

Since GINA is designed only to prevent discrimination by health insurers and employers I'm wondering why did they make the law so narrow from the outset?Why not include Life Insurers, military personnel, etc?