There are about eleventy-two things wrong here.

Please pay close attention.

Empowering patients is the goal of enlightened health care professionals so that skilled clinicians appreciate patients who want to know how to help themselves be healthier. It is true some patients are in the “I don’t want to know” group.  The great majority of patients are eager to prevent diseases they know are common in their families or for which they suspect their personal risk is higher than average.

Enter a company, Pathway. It will sell, starting Friday, genetic tests for consumers in 6,000-plus Walgreen’s drugstores, says this Washington Post story. There is more than one type, with some offering different information than others.

Some of the diseases this test can detect are so serious, the delivery of the news calls for a doctor and a qualified genetic counselor. They help patients absorb the information, understand their personal risks and what they can or cannot do about the disease which they may or may not develop. They can refer them for counseling if it is needed.

The full story quotes the company as saying that it will have the following support for those who buy their kits.

“Officials said that the company has strict procedures to protect confidentiality and that it offers genetic counseling by phone, both before and after getting the test results, to make sure customers interpret them properly. (Emphasis added)

In my opinion, telephone genetic counseling cannot possibly be equal to face-to-face genetic counseling. If a person needs it, the person needs a trained professional to assess how well they are tracking with the information provided.

Pathway has crossed so many clinical boundaries, I lost count way back there.

They did not seek FDA approval, saying the company does not need it.

They claim to have privacy protections in place. If one of their tests discloses an expensive disease and there is a security breach, then what? What, exactly, are those privacy protections? Who, besides the company, checks on these protections. Does HIPPA apply here? They did not say. As much of a hassle as HIPPA seems to be to patients, it is an important safeguard in protecting their personal medical records. What is Pathway doing about that?

Finally, and perhaps, most important, what are the credentials of the personnel who will be the telephone counselors for users of this product?

That’s the most important question of all. Who will be helping the users of these tests should they discover they have a genetic risk that shakes that person to the core?

This is a giant class action suit waiting to happen. Please don’t be someone eligible in the class.  Go slowly, please.

Also, remember, only a few genetic risks equal destiny. Genes, environment and behavior combine to lower or raise risks. Therefore, any genetic test should be chosen with your specific medical needs in mind.

If you are concerned about your risk enough to consider buying this test, please discuss this with your doctor first.

The Washington Post

“Beginning Friday, shoppers in search of toothpaste, deodorant and laxatives at more than 6,000 drugstores across the nation will be able to pick up something new: a test to scan their genes for a propensity for Alzheimer’s disease, breast cancer, diabetes and other ailments.

“The test also claims to offer a window into the chances of becoming obese, developing psoriasis and going blind. For those thinking of starting a family, it could alert them to their risk of having a baby with cystic fibrosis, Tay-Sachs and other genetic disorders. The test also promises users insights into how caffeine, cholesterol-lowering drugs and blood thinners might affect them.

“The over-the-counter test marks the first foray of personalized genomic medicine into the corner drugstore. The move is being welcomed by those who hope that deciphering the genetic code will launch a new era in biomedical science.

“But it’s being feared by those who worry it will open a Pandora’s box of confusion, privacy violations, genetic discrimination and other issues.’

Source: Washington Post, May 11, 2010