Newspaper and internet articles, psychiatry

Sundance Diagnostics, a genetic test pre-suicide

Sundance Diagnostics<- Click on the picture to go to the Sundance website.

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Did you know that there could soon be a test which will enable doctors to establish whether a person will react badly to antidepressants? An American company, Sundance Diagnostics, is in the early stages of developing a Genetic test for Prescription Drug Side Effects. This test, if successful, will establish whether a person is at risk of Suicide and Violence before (not after) being prescribed an antidepressant.

This from their website:

“Sundance Diagnostics is working to develop the world’s first genetic safety tests to predict a patient’s risk of antidepressant-induced suicidal thinking or behavior. There is a strong need to make pharmaceutical drugs safer for patients—especially when those drugs have serious side effects and are being sold to millions of people. Sundance is using the most advanced genetic technologies to develop its safety tests to predict a patient’s risk. The goal is to save lives, improve treatment, increase patient confidence in treatment, and reduce the cost of treatment.”

CEO Kim Bechthold, referring to the fact that over 90% of school shooters were on psychiatric drugs, stated “The importance of genetic tests to curb the risk of suicide and risk of acts of violence has been heightened as governments and communities search for effective ways to halt tragic mass shootings.”

Maria has written a great article on the MIA website about this. Unbelievably, she mentioned that she was offered a blood test to assess any risk for her cat pre-operation but not a test for her 17 year-old son Toran who died by a Fluoxetine/Prozac induced suicide. I could argue forever that a ‘drug-induced suicide’ is not suicide but that’s for another day. In her article Maria debated whether this test would in fact give the impression that antidepressants actually work for some people and she didn’t want to give people false hope. She answers that one perfectly, as usual. My thoughts on that one slightly differ with others. If you or anyone else is on an antidepressant and feel that the drug is helping, whether it’s the placebo/smartie effect or not, why fix what’s not broken? It’s when the drugs don’t work and cause awful adverse-effects such as suicide and homicide, that I do have a big problem. Informed consent, which you don’t get in Ireland, is my problem. If a person is pre-warned of the possible adverse-effects as recommended by the Irish Human Rights Commission, at least that person will have some chance of survival. In Ireland, people do not get that chance. Considering that this test is being developed in America at huge expense and, if successful, will be used worldwide, what will Ireland’s excuse be? That there is no point ordering a test which will solve a problem that doesn’t exist?

What surprised me most was the comments under Maria’s article, where some people opined that this test might actually make things worse. I hadn’t actually thought about that, and while there are some valid and understandably differing opinions, if this test is successful, in my opinion the pros will definitely outweigh the cons. Or in psychiatric language, in this case (unlike with antidepressants), the benefits will definitely outweigh the risks!

Maria’s Article.

Sundance Press Release 3-11-13 A (3)

I, being a natural cynic, had a few questions which I needed to be clarified. I put them to Kim and her scientific advisor, Peter Tolias, Ph.D,…

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I’ve been enquiring about suicide tests and read a lot about the STAR*D trial. What happened to the hints of a Pharmacogenetic marker from the STAR*D study that you initially referred to?

Dear Leonie,

This is Peter: The STAR*D study itself was the largest and most comprehensive study ever performed that studied drug-induced suicide risk, however, the technology that was available to be used at the time to examine markers only allowed them to study a small fraction of the human genome.  In spite of this, several new markers were identified that could ultimately be useful as a component of a broader genetic test.  These STAR*D markers, plus additional markers we hope to be discovered by Sundance, need to be confirmed in an independent study before a test is ready for the clinic.  Sundance intends to initiate a clinical trial for confirmation just as soon as the sequencing study is completed.

Your press release mentioned Whole Genome Screening (WGS) being an advance on Genome Wide Association Screening (GWAS). Will WGS really tell more than GWAS would?

This is Peter; Absolutely, because whole genome sequencing means identifying the complete sequence of a patient’s genome rather than a fraction of a percent identified by GWAS.  (10 million compared to 3 billion base pairs in the haploid genome (or 6 billion nucleotides), roughly 300 times the information)

How soon do you intend to have this genetic testing ready for distribution, months, years, decades?

Leonie, this is Kim again.  The sequencing portion of our work and the confirmatory study can take from 12 months to 18 months.  Sometimes a study actually has to be redone, resulting in more time.   If the sequencing is successful,  and if all else goes well, we could have a laboratory-developed test for physicians in 18 months in the U.S.  If we seek FDA approval, it will require at least another year.  FDA approval is not required in the United States however. For approval in Ireland, we will submit our initial confirmatory study results.  If the authorities require the type of studies that are required for FDA approval, it will take additional time.