Why the FDA has denied you vital information

genetic, healthIf you knew you were going to have a heart attack in two years, would you start doing something to prevent it?

My guess is yes, you would.


We live in a society that likes to take a pill to make us better and keep us ticking along. No matter all the statistics and risk factors for disease that are brought to our attention, a lot of us don’t do a heck of a lot when it comes to changing our lifestyle to prevent disease. There’s a safety blanket for us in the form of a pill. Medicine will fix it!

So we keep on smoking, drinking and sitting around all day, forgoing our doctor’s best advice.

Your roadmap to good health

But if we knew that we were heading straight for a heart attack or diabetes or kidney failure, well, we might decide to take notice and do something about it. What if our genetic fingerprint could be read like a roadmap, pointing to conditions that would crop up like construction roadblocks or detours along our life journey? If you had access to such a roadmap, I bet you’d make some changes to your life for a smoother, more enjoyable ride.

No one likes potholes or costly car repairs!

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That’s why I’m in favor of personal DNA tests that can predict illness before it hits, and provide information on how you might respond to certain medications. Wouldn’t you want to know if your prescription would be effective beforehand, instead of having your doctor suggest you should try a certain medication and see how you get on?

Reducing prescription overload

This data is empowering. This is a new technology that you can use to change your life for the better. If the health care system expects patients to take matters into their own hands, stay informed and make the right decisions about their health, this testing can help.

You may have heard about these kits from a California company called 23andMe. You buy the at-home test, take a saliva sample, and send it back to the company for laboratory analysis and receive a report on your health risks based on a range of gene variants.

The company had tested about 500,000 people when the federal Food and Drug Administration (FDA) banned 23andMe in November 2013 from selling the kits in the United States, indicating the company hadn’t provided enough information to support its claims.

Basically, the reliability of the tests had not been proven to FDA satisfaction. The company CEO argued that with any new technology, the system won’t readily embrace it. There will be naysayers. Physicians may shy away, thinking their authority and role in the medical community will be undermined.

Gene data first step toward the right treatment

Adding to the controversy are worries that people will make health care decisions based on genetic risks they don’t fully understand, or opt for unnecessary treatments or even surgeries. In one high-profile case, actress Angelina Jolie tested positive for the BRCA genes for possible breast cancer and underwent a preventative double mastectomy.

Critics have also said that even if the home genetics test shows that someone is at higher risk for a certain illness, that test doesn’t account for a number of outside factors, including biological, social and environmental, that determine if someone will develop a disease.

For a healthy person looking to stay that way and prevent the onset of illness, some argue these genetic tests are useless.

But I say, as with any medical concerns, do your homework and make an appointment with your doctor for further discussion and possible treatment. No one should look at a gene test result and dismiss a doctor’s consult as unnecessary.

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Home kits now selling in United Kingdom

Now the company is selling its kits to customers in the United Kingdom and plans to launch them in Canada. U.K. residents, and soon Canadians, will be able to find out their genetic risks for diseases like Alzheimer’s, breast cancer and dozens of other conditions. Why can’t Americans?

If you read or listen to an interview with the company CEO, Anne Wojcicki, you might be inspired. She did the spit-test herself and learned she was at serious risk for breast cancer. She stopped drinking socially as one measure of prevention and is living healthy and happy. “There’s no reason why you can’t be healthy at 100,” she told CBS. Given medical advances, treatment and prevention therapies, she may be right.

Don’t you want to know your genetic fingerprint?

Genomics research is fascinating. It will lead to major advances in our understanding of the genetic basis of common diseases, although it won’t make them any less complex. The level of predictive value may lead to more personalized medical intervention and alleviating some of the burden of cost to the health care system as our aging population gets sick.

Regulatory officials in the U.K. say they support the use of commercial genomic testing because it will help people be better informed about their health and future medical conditions. Customers in the U.K. will pay 125 pounds or about US$150 for the kit, so this knowledge comes at a cost.

There’s also the question of how genetic mutations could affect your health insurance. Plans may cover the cost of testing when it’s recommended by a doctor. However, state privacy protection laws vary and there is such a thing as genetic discrimination, where people are treated differently by their employer or insurance company because of an identified gene mutation that puts them at higher risk for illness.

A federal law, the Genetic Information Nondiscrimination Act (GINA), was designed to protect people from this type of discrimination, but consider this a word of caution if you decide to pursue testing down the road.


I’m all for prevention and taking steps to do what we can to stay healthy. I feel strongly that insight into the future of our own individual health can only help us make better decisions and develop better habits. I’m all for living to a healthy age 100.

Karen Hawthorne is managing editor at Health eTalk and BelMarraHealth.com. Karen has worked for the National Post, Postmedia News, CBC Radio Vancouver, the Edmonton Journal, the Kitchener-Waterloo Record and the Cobourg Daily Star, reporting on health news and lifestyle trends for over 15 years.