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Author Archives: Robert Pollack

Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.

The APA Brings Genetic Testing Under Fire, Genomind and Genesight Respond

On April 25th 2018 the American Psychiatric Association published the following criticism of genomic testing emphasizing their skepticism towards psychiatrists who are using genetic testing to make informed decisions about diagnosis and treatment. An abstract of their statement reads:




Evidence Does Not Support Commercial Rush Of DNA Tests Designed To Inform Decisions Regarding Patients’ Psychiatric Medications, Review Indicates.

STAT (9/28, Robbins) reported that “several dozen companies” are now “probing patients’ DNA in search of insights to help inform decisions about what psychiatry medications patients should take,” and are even “touting applications for depression, bipolar disorder, attention deficit hyperactivity disorder, and post-traumatic stress disorder.” Now, “some top psychiatrists say the evidence doesn’t support the commercial rush.” In fact, in a review published online April 25 in the American Journal of Psychiatry, “a task force of the American Psychiatric Association’s research council concluded that such genetic testing is not ready for prime time in their field.” The members of the task force wrote, “Although some of the preliminary published data sound promising…there is insufficient evidence to support widespread use of combinatorial pharmacogenetic decision support tools at this point in time.”

To read their full statement please visit this link.

Genomind and Genesight – two separate entities that are both equally dedicated to the science behind psychotropic testing put forward responses to the criticisms made by the American Psychiatric Association.

Genesight: An in-depth look at the psychotropic testing process.

They thoroughly answer common questions about genetic testing:

How are molecular diagnostic tests evaluated?

Molecular diagnostic testing and pharmacogenomic testing differ in their objectives and possible testing outcomes. Diagnostic testing detects whether an individual is affected with a specific disease or not, and the testing outcome is generally one of two outcomes: positive or negative. In diagnostic testing, sensitivity is the ability of a test to correctly identify a patient who has a disease as having the disease (true positive). Specificity is the ability of a test to correctly identify a healthy individual as not having the disease (true negative). Both sensitivity and specificity have only two possible outcomes: for sensitivity, consider that a diagnostic test may either result in a true positive or a false negative; for specificity, a diagnostic test may either be a false positive or a true negative.

Why is it necessary to evaluate pharmacogenomic tests differently than diagnostic tests?

Psychiatric pharmacogenomics does not have an individual genetic marker or causative gene like is often typical in molecular diagnostic testing; rather, medication response is multifactorial, relying on the interaction of many genes, as well as environmental factors. For this reason, the GeneSight test’s proprietary CPGx® technology takes into account all relevant genes known to be associated with medication response. Consequently, the potential measurements of sensitivity and specificity shift from the association of a genetic marker with response to the association of the GeneSight algorithm with response. Instead of diagnosing the bimodal presence or absence of a disease state, the GeneSight test predicts patient response to medications using a three category system (green, yellow, red), which correlates with the predicted amount of gene-drug interaction for the patient (none, moderate, and significant, respectively). Unlike a two-category system, a three-category system does not lend itself to sensitivity and specificity measurements.

Additionally, a complexity arises in the fact that many patients taking psychiatric medications are not taking just one. Polypharmacy further complicates the multifactorial nature of medication response, since medications may compete for the same target or induce/inhibit relevant metabolizing enzymes. In the context of the GeneSight test, this means patients may be taking medications from each of their green, yellow, and red categories. Consequently, calculating the sensitivity and specificity for each individual medication loses real world application. In the clinical studies that validate the GeneSight test, patients are entered into analyses based on their total medication regiment. This is accomplished by putting a patient in their “worst” medication category. For example, a patient taking one green and one red category medication is entered into the analysis as a red category patient. This approach empowers a more comprehensive analysis of a patient’s overall medication response, rather than analyzing a patient’s response to each medication individually, since it is nearly impossible to determine which medication correlates to specific aspects of a patient’s response.

To read their description of how genetic tests are evaluated please visit this link.

Genomind: Genetic Testing Can Reduce Healthcare Costs for the End User

Genomind, raised a further interesting point how genetic testing can help decrease costs for the end user. They say:

“Pharmacogenetic testing represents a promising strategy to reduce the amount of medication trial and error and associated complications for patients with mood and anxiety disorders,” said Roy Perlis, M.D., Professor of Psychiatry at Harvard Medical School, a Genomind scientific advisor and one of the paper’s authors.

Genomind’s Genecept Assay®, a pharmacogenetic test, requires only a small sample of saliva, collected by a clinician from swabbing the inside of the patient’s cheek with a cotton swab. The test looks at key genes in a patient’s DNA that can affect the patient’s response to medication. In the study based on claims data, 817 Aetna members with mood and anxiety disorders who underwent testing with the Genecept Assay (cases) were matched with 2,745 similar Aetna members who did not undergo testing (controls) on a variety of dimensions, such as diagnosis, duration of illness, comorbidities, number of prior treatment failures, age, gender and socioeconomic status.

Those who had genetic testing experienced 40 percent fewer emergency room visits and 58 percent fewer inpatient hospitalizations than individuals in the control group who did not receive genetic testing to help guide their treatment (p<0.0001 for both). That is, testing was associated with significantly less utilization of emergency rooms and inpatient visits during the following six-month period. The two groups did not differ significantly in number of psychotropic medications prescribed or mood disorder–related hospitalizations.

PASWFL Uses Genetic Testing

As part of our diagnostic and evaluative processes PASWFL is a firm believer in the science behind DNA. PASWFL finds that using genetic testing can save time and money for the end user and leads to a more direct treatment plan. PASWFL uses genetic testing to provide outstanding psychiatric care using a combination of ketamine treatment, theta burst stimulation and transcranial magnetic stimulation. We believe genetic testing can help us perfect our already customized treatment plans for our patients. Read more about our genetic testing and all our services on our website.

October 2, 2018
Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.

Brexanolone Infusion Rapidly Relieves Postpartum Depression

NEW YORK (Reuters Health) – A 60-hour infusion of brexanolone significantly improves symptoms in women with postpartum depression, according to results from two phase 3 trials.

The results “confirm and extend the previous work showing that brexanolone has a rapid onset of action that is unlike anything else currently available,” said Dr. Samantha Meltzer-Brody from the University of North Carolina at Chapel Hill School of Medicine.

“Further, the robust treatment response to a single 60-hour infusion was maintained through the 30 days of follow-up in this clinical trial,” she told Reuters Health by email.

Brexanolone is a proprietary, intravenous formulation of allopregnanolone, an endogenous progesterone metabolite that appears to modulate gamma-aminobutyric acid (GABA) receptors. Brexanolone showed rapid and durable antidepressant effects during an earlier phase 2 clinical trial.

Dr. Meltzer-Brody and colleagues investigated the efficacy and safety of brexanolone injection in 246 women with moderate to severe postpartum depression in two randomized, placebo-controlled phase 3 trials at 30 U.S. centers.

In study 1, Hamilton Rating Scale for Depression (HAM-D) total scores decreased to a significantly greater extent at the end of the 60-hour infusion in the group receiving brexanolone 60 mcg/kg per hour (mean reduction, 19.5 points) and in the group on brexanolone 90 mcg/kg per hour (17.7 points) than in the placebo group (14.0 points).

Similarly, in study 2, HAM-D scores improved significantly more in the higher-dose group (mean, 14.6 points) than in the placebo group (12.1 points), the team reports in The Lancet, online August 31.

Depression scores had not returned to baseline by day 30 in any of the brexanolone groups and remained significantly lower in both treatment groups than in the placebo group of study 1 at day 30.

Remission (HAM-D total score 7 or less) and response (reduction in HAM-D total score of at least 50%) rates were higher in the brexanolone groups than in the placebo groups.

Brexanolone injection was generally well tolerated in both studies, with dizziness and somnolence occurring more frequently in women receiving brexanolone injection than placebo.

“If approved, brexanolone would be a powerful new tool that would act quickly (within a few days or less) to treat women suffering with postpartum depression (PPD),” Dr. Meltzer-Brody said. “PPD can often be debilitating to women and their families, and a rapidly acting treatment would be a most welcome addition to current options. It is important for symptoms of PPD to be quickly treated, as this can prevent long-term adverse consequences including impairing mother-child bonding and attachment.”

Dr. Michael E. Silverman from Icahn School of Medicine at Mount Sinai, in New York CIty, who has researched various aspects of postpartum depression, told Reuters Health by email, “Probably the most important finding is the reported 60-hr effect of brexanolone infusion treatment. This is a potentially important finding given the time course of currently available psychopharmacologic treatments for depression.”

“The fact that brexanolone must be infused over an extended period of time and cannot be taken orally complicates matters as a first-line treatment option,” he said.

He pointed out a number of issues complicating the interpretation of this report: why did the lower dosage of brexanolone appear to have a larger effect? Why did study 2 not show a significant 30-day effect of brexanolone? The placebo effect in both studies was considerable. These issues, he said, require further study.

“Brexanolone as a treatment for PPD is a potentially exciting avenue; indeed, as clinicians we could use more options in our treatment toolbox,” Dr. Silverman said. “I’m hopeful additional work, including replications of the above study to clarify the reported findings, will continue to be conducted.”

Sage Therapeutics, Inc. funded the studies and employed several of the authors. Dr. Meltzer-Brody reports financial ties to the company.

SOURCE: https://bit.ly/2Mr9xwc

Lancet 2018.

September 17, 2018
Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.

Another FDA clearance for MagVenture: 3 minute depression treatment

August 2018: MagVenture’s Theta Burst solution is now FDA cleared.

For people suffering from severe depression, the road to remission just became a lot shorter: The treatment is known as Transcranial Magnetic Stimulation (TMS), and MagVenture has now, as the only company in the US, received FDA clearance for a newer and much faster treatment protocol which will cut down treatment time to just 3 minutes per session*. Before that, the required treatment time per session was up to 37 minutes.

TMS has been FDA cleared for treatment-resistant major depressive disorder since 2008. Since then, over 1,000 psychiatric clinics have emerged in the US. Most private health insurance companies also cover the treatment. The relatively long treatment sessions have, however, not only limited the treatment capacity for TMS practices but also hindered a more widespread dissemination. Until now, each session has been up to 37 minutes long, with 20-30 sessions needed in total. The new treatment form, which is known as Theta Burst Stimulation (TBS), offers one significant advantage: Time. A TBS treatment session lasts only 3 minutes and thus has the potential to revolutionize the clinical field of TMS.

“We have named it “Express TMS®” because that’s what it is: a treatment which is just as safe and effective for the treatment of depression as conventional TMS, only much, much faster. We are happy and proud to be the first in the US to receive an FDA clearance for this revolutionary treatment which is backed up by substantial scientific evidence. Our current treatment system, MagVenture TMS Therapy, can easily be upgraded with the new Express TMS option. This will enable our many customers to treat far more patients per day without having to invest in another TMS device. For people needing treatment, this will also be a huge benefit, as treatment will now take up less of their time,” says Kerry Rome, Vice President of Sales, MagVenture Inc.

The new FDA cleared treatment protocol, currently only offered by MagVenture, is based on a new clinical study, named the THREE-D trial, and led by a partnership of three leading research hospitals in Canada (CAMH, UHN, and UBC). It is the largest, double-blinded, randomized TMS trial to date, with 414 participants suffering from major depressive disorder. Response/remission rates were 32% for those receiving the TBS protocol, whereas 49% had an improvement in their depressive symptoms. These rates are similar to the standard, longer TMS protocol. The article was published in The Lancet in 2018.

Download press release
Contact MagVenture’s US office in Atlanta

September 5, 2018
Robert Pollack

About Robert Pollack

Board Certified Psychiatrist in practice over 42 years. Currently focused on Genomic Assessments as part of our treatment assessments and Transcranial Magnetic Stimulation (TMS) therapy along with general adult psychiatry. Currently serve on adjunct faculties of UCF, FSU, USF and Uof F. We currently accept most Insurances.