Talk

I’d say that this year’s stories ran the spectrum from “what’s in our genome?” to “what does it say about us?” to “what should we do with that information?” Yes, here’s science to policy in six easy pieces!

Diabetes Risk Genes Are Confirmed. The body of research behind this discovery is impressive, covering populations around the world and all hitting publication in a very short window of time. (I think Denise Grady, a health journalist at the New York Times captured this best with the context of a personal perspective.) With news about Americans’ skyrocketing diabetes rates, our overweight children, and our heaviest nation status, you’d think this genetic news would have made a bigger splash. Stay tuned in 2007 and let’s see what happens once testing becomes available.

The FDA Recommends Relabeling Tamoxifen - In October, the FDA met to review a compelling body of research that shows 7-10% of people may not receive medical benefit of tamoxifen, because of their 2D6 genes. This is an historic first for pharmacogenetics: it’s the first time FDA has recommended relabelling for the effectiveness of a drug, not just toxicity warnings (e.g. atomoxetine/Strattera for ADHD). It’s also notable that certain SSRIs, particularly Paxil, interfere with the metabolism of tamoxifen just like these genes do - so taking both Paxil and tamoxifen effectively cancels out the benefit of the tamoxifen. Please indulge me as I proudly say that my company is on the ball - we began providing this genetic test to consumers and doctors in October, right after the FDA’s recommendation came out.

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Since DNA Direct first began offering CYP2D6 testing for tamoxifen efficacy last month, we’ve had calls from women asking, “how come my doctor didn’t recommend this?” and “why doesn’t my doctor know about this?”

Dr. Kevin Knopf, a respected medical oncologist who specializes in breast cancer, has an explanation in his post this week “Something to Worry About? Tamoxifen Effectiveness.” He wrote this post upon first learning about tamoxifen and 2D6 — from his newspaper. He says:

It is also interesting how oncologists and other doctors find out about news this big – were it not for my newspaper I don’t know when it would first come to my attention (I’ll let you know next month!) When I asked my partner if he had heard about it, it was news to him. There are often no “mass broadcasts” of “breaking news” –e.g. nothing on my email yet. So this can create anxiety for patients who might see something before their oncologist does. I think the best approach would be to let the information get absorbed prior to making any decisions about tamoxifen and to seek guidance from your personal oncologist.

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Ryan (the CEO and founder of DNA Direct) and I just returned from an FDA meeting where members of the Clinical Pharmacology Subcommittee, a group composed of doctors and researchers, made an important decision about the breast cancer drug tamoxifen. As Lisa Lee described last week, the purpose of this meeting was to decide whether to recommend changing the tamoxifen package insert, also known as the drug label, to include information about how the 2D6 gene is a predictor of response to tamoxifen.

Clearly the decision of the Subcommittee is a historic moment, both for the emerging field of pharmacogenetics (or how genes influence a patient’s response to drugs) and, most importantly, for the breast cancer community. After all, hundreds of thousands of women are on the drug tamoxifen, and more women are put on the drug every day. The fact that some of them may not be receiving full benefit from tamoxifen because of their genes — therefore increasing their risk of cancer recurrence — could not be more important for breast cancer patients to know about.

So, what did the Subcommittee recommend? (more…)

Speaking of breast cancer - we’re on a roll this month! - there are very important happenings at the FDA next week. On October 18, the FDA will to evaluate recent research regarding 2D6 gene variants and response to the breast cancer drug, tamoxifen, and whether this research warrants any warnings or changes to the tamoxifen package insert.

Here’s a link to the FDA’s Executive Summary on Tamoxifen and 2D6. (Clicking this link will download a .PDF.)

In concert with the hearing, DNA Direct is launching our first drug metabolism test: 2D6 testing with personalized test results interpretation for tamoxifen. (Testing can be ordered online at the Genes&Drugs website.) Below is DNA Direct’s backgrounder, which explains the test, the research and why we’re offering 2D6 Tamoxifen testing to certain patient populations.

TAMOXIFEN & 2D6 BACKGROUNDER

Recent research on tamoxifen has shown that potentially up to 7-10% of women with breast cancer may not receive the full medical benefit from taking tamoxifen, because of their unique genetic make-up. These women have a special version of a gene (CYP2D6, commonly referred to as 2D6), which may reduce the effectiveness of tamoxifen and increase their chance of breast cancer recurrence. With over 500,000 women currently taking tamoxifen, this research has wide-reaching implications. (more…)

I’ve been looking for something other than breast cancer to talk about since I just posted on hereditary breast and ovarian cancer, because September was Ovarian Cancer Awareness Month…but I can’t avoid it. Everyone’s wearing pink ribbons and news about breast cancer abounds:

• A new breast cancer gene has been found: BRIP1.
• The White House issued an official proclamation by the President that October is National Breast Cancer Awareness Month.
• The FDA is meeting next week to discuss tamoxifen, a drug metabolism gene called CYP2D6, and their relationship in terms of risk for breast cancer recurrence.

Stay tuned for more info on the FDA hearing next week….

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