Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Saturday, September 20, 2014

In the Blogs: A Blood Test for Depression May Show the Illness Is Not A Matter Of Will







By Anna Almendrala 

Screening for depression might soon be as easy as a blood test.

A new test that identifies particular molecules in the blood could help doctors diagnose patients with clinical depression, according to a new study published in the journal Translational Psychiatry. The blood test can also predict which therapies would be most successful for patients, and lays the groundwork for one day identifying people who are especially vulnerable to depression -- even before they’ve gone through a depressive episode.

But perhaps just as important, said lead investigator Eva Redei, Ph.D., is the potential the test has for taking some of the stigma out of a depression diagnosis. When depression can be confirmed with a blood test like any other physical ailment, she said, there’s less stigma about having the disease and getting treatment.

“I really believe that having an objective diagnosis will decrease stigma,” Redei, a neuroscientist and professor at the Northwestern University Feinberg School of Medicine, told The Huffington Post. “Once you have numbers in your hand, you can identify that [depression] is an illness -- not a matter of will.”

The most effective way to treat depression is to treat it early, but past studies show that it takes an average of two to 40 months to diagnose depression -- if it gets diagnosed at all. Redei’s depression blood test could lead to faster and more accurate diagnoses, thereby transforming the way depression is treated.

If Redei’s findings are independently replicated and confirmed, then approved by the Food and Drug Administration, laboratories across the U.S. could incorporate the test into their battery of routine exams. This is in contrast to MDDScore, a depression blood test owned by Ridge Diagnostics that was announced in 2012. Because the test is proprietary to Ridge Diagnostics, doctors have to submit samples to the company’s lab in North Carolina, where the company analyzes the blood and sends back results. Redei's test, however, "can be done by any clinical laboratory anywhere, just like a cholesterol test,” Redei explained. “That is, assuming that we can go through the FDA approval [process] fast.”

Redei’s study compared the blood samples of 32 patients who had been diagnosed with depression in the traditional way (a clinical interview) with samples taken from 32 people without depression. She found nine RNA blood markers -- the molecules that carry out DNA's instructions -- that differed significantly between the two groups, which she then used as the basis for the depression diagnosis.

Then, the depressed patients went through 18 weeks of cognitive behavioral therapy, a common treatment for depression. Re-testing their blood, Redei was able to tell which patients had benefitted the most from therapy, just by examining the changes in their RNA markers. In other words, the test was also a biological way to tell if treatment had been effective.

Finally, Redei also noticed that there were three RNA markers that didn’t change in depressed patients, no matter if they had benefitted from cognitive behavioral therapy or not. She suspects they may be markers that show if a person is predisposed to depression.

"Being aware of people who are more susceptible to recurring depression allows us to monitor them more closely,” said David Mohr, Ph.D., co-lead author of the study in a press release. “They can consider a maintenance dose of antidepressants or continued psychotherapy to diminish the severity of a future episode or prolong the intervals between episodes.”

Zachary Kaminsky, Ph.D., of the Mood Disorders Center at Johns Hopkins Medicine, wasn’t involved with the study but is excited about its potential implications for depression treatment. Kaminsky is a pioneer in blood tests to predict suicide risk, and although he and Redei measure very different things in their tests, he sees that both researchers have similar goals when it comes to creating biological tests for mental illnesses.

“It’s an exciting time -- there is potential to find factors that are going to distinguish between various mental illnesses as well as responses to direct clinical treatment,” said Kaminsky to HuffPost. “Any finding that gets us closer to that is very interesting and worth following up.”

But Kaminsky also pointed out that Redei and Mohr’s research still needs to be independently validated by other patient populations to confirm that it works. For instance, Kaminsky pointed out, the study would have been more scientifically rigorous if it had used a different patient group to confirm the blood test, as opposed to using the same participants to both create and then test the predictions.

"I think this is very early stage and this model needs to be investigated in an independent sample,” Kaminsky said. “It will be important to test the predictability of these expression measures in independent cohorts.”

Redei acknowledged that the next step in research would be to run the tests on larger samples in order to validate the models and then submit them for FDA approval.

“The major question here is always funding,” said Redei. “We are really trying to gather as much funding from as many sources as possible so it can move ahead."

Major depressive disorder affects an estimated 6.7 percent of the U.S. population and is the leading cause of disability for Americans ages 15 to 44, according to the Anxiety and Depression Association of America. Despite the research hurdles she still needs to overcome, Redei is confident that her test can make a positive impact on the millions who struggle with depression -- not only by making treatment more precise, but by bringing psychiatry "into the 21st century,” Redei said. “We’ll get to the point where there won’t be any discrimination between physical illness and mental illness.”





Tuesday, September 18, 2012

More Anxiety, Please: BPA Linked With Kids' Obesity, Study Claims

We're doomed! Protect your epigentics!




3-D chemical structure of bisphenol A.
  from the HuffPost Healthy Living Blog
posted: 09/18/2012


Kids and teens with higher levels of the notorious plastics chemical bisphenol A (known simply as BPA) in their urine may also be more likely to be obese, according to a new study in the Journal of the American Medical Association.

The Food and Drug Administration raised questions about the risks of BPA in 2010, even though it was deemed "safe" in 2008, the New York Times reported. The chemical is already banned from kids' sippy cups and baby bottles.

"In experimental studies, BPA exposure has been shown to disrupt multiple metabolic mechanisms, suggesting that it may increase body mass in environmentally relevant doses and therefore contribute to obesity in humans," New York University School of Medicine researchers wrote in the study.

To test this theory, the researchers looked at the body mass indexes and urinary BPA levels of 2,838 kids and teens between the ages of 6 and 19 who were part of the National Health and Nutrition Examination Surveys between 2003 and 2008.

Overall, 17.8 percent of the study participants were obese, while 34.1 percent were overweight. The researchers also divided up their urinary BPA levels into four levels, ranging from the lowest levels to the highest.

A little more than 10 percent of study participants in the level with the lowest urinary BPA levels had a BMI indicative of obesity, compared with more than 22 percent of those with the highest urinary BPA levels.

"We note the recent FDA ban of BPA in baby bottles and sippy cups, yet our findings raise questions about exposure to BPA in consumer products used by older children," the researchers wrote in the study. "Last year, the FDA declined to ban BPA in aluminum cans and other food packaging, announcing 'reasonable steps to reduce human exposure to BPA in the human food supply' and noting that it will continue to consider evidence on the safety of the chemical. Carefully conducted longitudinal studies that assess the associations identified here will yield evidence many years in the future."

A study just last month appearing in the journal PLoS ONE linked higher urinary levels of BPA with a condition called coronary artery stenosis, or narrowed arteries. That research, conducted by scientists at the University of Cambridge and University of Exeter, included 591 people.

That same Cambridge-Exeter team also showed in a circulation study that high BPA may be linked with an increased risk of heart disease, Reuters reported.

What other chemicals are lurking in your household products? A study in the journal Environmental Health Perspectives identified which consumer products contain endocrine-disruptors:

1. Vinyl Shower Curtains The phthalate DEHP has been found in vinyl products, and has been linked to respiratory problems.

2. Air Freshener  Fragrances not only trigger asthma but, the researchers say, have been shown to mimic estrogen, and can make breast cancer cells grow in laboratory tests.

3. Dryer Sheets Like in air fresheners, the fragrances in dryer sheets can trigger asthma and mimics estrogen.

4. Perfumes It goes without saying that perfumes can similarly trigger respiratory issues. Some may also mimic estrogen.

5. Sunscreens Sunscreens have some of the largest concentrations of chemicals, according to the researchers, including cyclosiloxanes, according to WebMD, which produced liver and lung damage in mice in one study.

6. Cleaning Solutions Even "alternative" cleaning solutions, considered by many of us to be greener and safer, tested positive for some of the 55 chemicals the researchers focused on. They suggest cleaning with baking soda and vinegar, when appropriate.

7. Laundry Detergent In detergents and soaps, watch out for alkylphenols, which seem to exhibit estrogen-like properties.

8. Cosmetics Many cosmetics contain parabens as preservatives, but the class of chemical is shown to act similarly to estrogen. However, like many potential endocrine disruptors, parabens have been approved up to a certain amount by the FDA for use in cosmetics, and most are used at levels far below the upper limit.

9. Shampoo And Conditioner Along with cleaning solutions, the researchers tested "alternative" shampoos and conditioners and discovered potentially harmful chemicals. In fact, according to the press release: A consumer who used the tested alternative surface cleaner, tub and tile cleaner, laundry detergent, bar soap, shampoo and conditioner, facial cleanser and lotion and toothpaste would be exposed to 19 of the target compounds. Like cosmetics, many may also contain parabens.

And, from yee Wiki:

Bisphenol A (BPA) is an organic compound with the chemical formula (CH3)2C(C6H4OH)2. It is a colorless solid that is soluble in organic solvents, but poorly soluble in water. Having two phenol functional groups, it is used to make polycarbonate polymers and epoxy resins, along with other materials used to make plastics. Bisphenol A has a vapor pressure of 5*10-6 Pa.

BPA exhibits hormone-like properties that raise concern about its suitability in consumer products and food containers. Since 2008, several governments have questioned its safety, which prompted some retailers to withdraw polycarbonate products. A 2010 report from the United States Food and Drug Administration (FDA) warned of possible hazards to fetuses, infants, and young children. In September 2010, Canada became the first country to declare BPA a toxic substance. The European Union, Canada, and recently the United States have banned BPA use in baby bottles.