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Genetic Testing

Product

Genetic laboratory tests with claims to predict a patient’s response to specific medications, that have not been reviewed by the FDA and may not be supported by clinical evidence. For example, genetic tests with claims to predict whether some medications used to treat depression may be less effective or have an increased chance of side effects.

Purpose

The FDA is alerting patients and health care providers that claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by the FDA, and may not have the scientific or clinical evidence to support this use for most medications. Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient.

Summary of Problem and Scope

The FDA has become aware of genetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication’s effects has not been determined. These genetic tests might be offered through health care providers or advertised directly to consumers and claim to provide information on how a patient will respond to medications used to treat conditions such as, depression, heart conditions, acid reflux, and others. They might claim to predict which medication should be used or that a specific medication may be less effective or have an increased chance of side effects compared to other medications due to genetic variations. Results from these tests may also indicate that the health care provider can or should change a patient’s medication based on results from these tests. The FDA is also aware of software programs that interpret genetic information from a separate source that claim to provide this same type of information. However, clinical evidence is not currently available for these genetic tests or software programs and, therefore, these claims are not supported for most medications.

For example, the FDA is aware of genetic tests that claim results can be used to help physicians identify which antidepressant medication would have increased effectiveness or side effects compared to other antidepressant medications. However, the relationship between DNA variations and the effectiveness of antidepressant medication has never been established. The FDA is aware that health care providers may have made inappropriate changes to a patient’s medication based on the results from genetic tests that claim to provide information on the personalized dosage or treatment regimens for some antidepressants. Patients and health care providers should not make changes to a patient’s medication regimen based on the results from genetic tests that claim to predict a patient’s response to specific medications, but are not supported by scientific or clinical evidence to support this use, because doing so may put the patient at risk for potentially serious health consequences.

There are a limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body, and this is described in the labeling of FDA cleared or approved genetic tests and FDA approved medications. The FDA authorized labels for these medical products may provide general information on how DNA variations may impact the levels of a medication in a person’s body, or they may describe how genetic information can be used in determining therapeutic treatment, depending on the available evidence.

Descriptions for how to use genetic information to manage therapeutic treatment can be found in the following sections of the FDA approved drug labeling: warnings (Boxed Warning, or Warnings and Precautions sections), Indications and Usage, Dosage and Administration, or Use in Specific Populations, as appropriate.

Recommendations for Patients

  • Do not change or stop taking any medicine based on a report from a genetic test you took on your own. Discuss the results of the genetic test with your health care provider, including whether the medication label includes information on how to use genetic information to determine dosage, and whether your health care provider recommends changes to your treatment. Medicine should always be taken as prescribed by your health care provider.
  • Be aware that most genetic tests that make claims about the effects of a specific medicine are not supported by enough scientific information or clinical evidence.

Recommendations for Health Care Providers and Laboratories

  • If you are using, or considering using, a genetic test to predict a patient’s response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication’s effects has not been established. Check the FDA-approved drug label, or the label of the FDA-cleared or approved genetic test for information regarding whether genetic information should be used for determining therapeutic treatment.
  • If a patient brings you a test report from a genetic test offered directly to consumers that claims to predict a person’s response to a specific medication, seek information in the FDA-approved drug label regarding whether genetic information should be used for determining therapeutic treatment.
  • Be aware that there are some FDA-approved drug and genetic test labels, and labels of FDA-cleared genetic tests that provide general information about the impact of DNA variations on drug levels, but do not describe how that genetic information can be used for determining therapeutic treatment. These labels are intended to be informational, but do not indicate that there is evidence to support making treatment decisions based on the information provided by the genetic test.
  • Know that information regarding therapeutic treatment recommendations for patients with certain genetic variations can be found in the warnings (Boxed Warning, or Warnings and Precautions), Indications and usage, Dosage and Administration, or Use in Specific Populations sections of the FDA approved drug labeling, as appropriate.
  • Be aware that most genetic tests that make claims regarding effects of a specific medication have not been evaluated by the FDA.

Recommendations for Genetic Test Manufacturers and Developers

  • If your test claims to predict a patient’s response to specific medications, confirm that the FDA-approved drug labels for medications included in your test labeling describe how genetic information can be used in determining therapeutic treatment. Know that information regarding therapeutic treatment recommendations for patients with certain genetic variations can be found in the warnings (Boxed Warning, or Warnings and Precautions), Indications and usage, Dosage and Administration, or Use in Specific Populations sections of the FDA approved drug labeling, as appropriate.
  • Assure your test report and any labeling support an intended use that is consistent with the FDA-approved use of the medication.
  • Contact the FDA if you have any questions about genetic tests that are intended to be used to direct use of specific medications.

FDA Actions

The FDA is looking into certain developers that may be inappropriately selling genetic tests for the unapproved uses noted above and will take compliance actions when appropriate, such as when the tests pose significant public health concerns.

Following issuance of the safety communication, FDA reached out to several firms marketing pharmacogenetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication’s effects has not been established. Most firms addressed the FDA’s concerns by removing specific medication names from their labeling, including promotional material and patient test reports.

On April 4, 2019, the FDA issued a warning letter to Inova Genomics Laboratory, of Falls Church, VA,  for illegally marketing genetic tests that claim to predict patients’ responses to specific medications, also known as pharmacogenetics tests.

The FDA will continue to monitor this issue and will keep the public informed if significant new information becomes available.

Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with these products. If you suspect or experience a problem with a laboratory test, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirementsshould follow the reporting procedures established by their facilities.

Additional Resources

Contact Information

If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.

Dementia Tied to Trans Fats

— Study links all-cause dementia and Alzheimer’s to higher blood levels of elaidic acid

A photo of french fries cooking in a deep fryer

People with higher blood levels of trans fatty acids were more likely to develop dementia in later years than people with lower levels, a prospective study in Japan showed.

Higher levels of elaidic acid, a major trans fatty acid formed when vegetable oils are partially hydrogenated, were significantly associated with greater risk of developing all-cause dementia and Alzheimer’s disease over a 10-year follow-up period, after accounting for hypertension, diabetes, and other risk factors, according to Toshiharu Ninomiya, MD, PhD, of Kyushu University in Fukuoka, and co-authors.

These relationships remained significant after adjusting for calories consumed and saturated and polyunsaturated fatty acid intake, they reported in Neurology.

“Since serum elaidic acid levels are likely to reflect industrially produced trans fat intake, our findings raise the possibility that avoiding the intake of foods high in trans fat may reduce the risk of future onset of dementia,” Ninomiya told MedPage Today.

“The mechanisms underlying the link between serum elaidic acid levels and dementia are still unknown and residual confounding cannot be fully excluded,” Ninomiya added. “Further investigation is needed to clarify the potential role of elaidic acid in the development of dementia.”

Nutrition may be an important modifiable risk factor in dementia, but “it has been notoriously difficult to identify the culprit components of diet that explain the association between unhealthy diet and dementia,” observed Frank Wolters, PhD, of Erasmus Medical Center in Rotterdam, the Netherlands.

This research provides a step forward, but looking at additional components simultaneously is needed to guide dietary interventions in future clinical trials, said Wolters, who was not involved with the study. Moreover, diet differs greatly among people: “Further study in other populations, both within and outside of Japan, is needed to confirm or refute a role of trans fatty acids in dementia onset,” he told MedPage Today.

In their analysis, Ninomiya and co-authors studied 1,628 men and women from the Hisayama Study cohort in Japan who were were ages 60 and older at baseline and free of dementia. The researchers analyzed blood samples and health information gathered from cohort screening in 2002–2003. Serum elaidic acid levels were measured with gas chromatography/mass spectrometry and categorized into quartiles.

Participants were followed for a median of 10.2 years and were screened for dementia in 2005 and 2012. Researchers used DSM-III-R guidelines to define participants with dementia, NINCDS‐ADRDA criteria to identify Alzheimer’s disease, and NINDS-AIREN criteria to diagnose vascular dementia. During the study, 369 participants died and 237 of them had brain autopsy; in those cases, the researchers used both clinical and neuropathologic information to make a definitive diagnosis.

On average, people with higher elaidic acid levels were younger and less likely to be men, current drinkers, or physically active. Blood pressure, total cholesterol, triglycerides, body mass index, and dietary intake of saturated fat increased with higher elaidic acid levels, but total calorie intake did not. During the follow-up period, 377 participants developed all-cause dementia, 247 developed Alzheimer’s disease, and 102 developed vascular dementia.

Incident dementia was 29.8 per 1,000 person-years for people with the highest elaidic acid levels and 27.6 for the second-highest levels. In contrast, incident dementia was 21.3 per 1,000 person-years among people with the lowest levels.

Alzheimer’s incidence was 18.2 per 1,000 person-years for people with the highest elaidic acid levels, 14.9 for the second highest levels, and 13.1 for the lowest levels. There were no significant associations between elaidic acid levels and vascular dementia.

Compared with the lowest group, the highest elaidic acid group had an incident dementia HR of 1.52 (95% CI 1.10–2.12; P=0.01) and the second-highest group had an HR of 1.74 (95% CI 1.28–2.37; P<0.001), after adjusting for hypertension, diabetes, current exercise levels, smoking, and other variables.

Sweet pastries appeared to be the strongest contributor to elaidic acid levels, followed by margarine, candies and caramels, croissants, non-dairy creamers, and ice cream.

“Because elaidic acid is an exogenous fatty acid, it is essential to check the nutrition facts label for ‘0 g trans fat’ and the ingredients list for no hydrogenated oils on every food product you buy,” said Klodian Dhana, MD, PhD, of Rush University Medical Center in Chicago, who was not part of the study.

“Healthier alternatives to replace trans fats are unsaturated fats, such as monounsaturated and polyunsaturated fats,” Dhana told MedPage Today. “Research has shown that a healthy diet for the brain should emphasize the consumption of vegetables, especially leafy greens, berries, whole grains, fish, poultry, nuts, and olive oil, and should limit red meat, fried food, pastries, and sweets.”

The analysis had several limitations, the researchers noted. Serum elaidic acid was measured only once, at baseline. Residual confounding may have occurred. Outcomes may depend strongly on geographic regions and cannot be applied to other populations, they added.

Last Updated October 24, 2019

Disclaimer

The study was supported in part by the Japanese Ministry of Education, Culture, Sports, Science and Technology, the Japanese Ministry of Health, Labor and Welfare and the Japan Agency for Medical Research and Development.

Researchers reported a relationship with Sysmex Corporation.

Borderline Personality Disorder And Bipolar Disorder: What’s The Difference?

By Ken Duckworth, M.D. | Jun. 12, 2017

Getting the right diagnosis often isn’t easy for psychiatric conditions. In our field, we don’t yet have biologic tests that can easily define one condition from another. If your blood pressure is 140 over 90, you have hypertension or high blood pressure. In mental health, we have to rely on a description of patterns or symptoms to makes diagnoses. This model is fraught with challenges.

Without a clear biological model to work from, and given the complexity of the human brain, the field has settled upon dividing these descriptions of symptoms into syndromes. The Diagnostic and Statistical Manual of Mental Disorders (DSM) holds these symptom descriptions in order to help professionals make reliable and consistent diagnoses. This means a social worker in Detroit should make the same diagnosis as a psychiatrist in Boston and a psychologist in Santa Fe.

However, the diagnostic process is more complex than just reading symptoms in a DSM. Here are a few thoughts on what I have observed in making diagnoses:

  • Diagnosis is best viewed as a movie, not a snapshot. In a snapshot, people with different diagnoses can appear to have similar symptoms. The key is to step back and develop a view of their history and the pattern of symptoms.
  • People may present different symptoms over time, which can change their diagnosis. A person who has a depressive disorder, for example, could have a manic episode a year later. This would change that person’s diagnosis to bipolar disorder. The original diagnosis wasn’t a misdiagnosis—rather the movie changed its storyline and the diagnosis needed to change as well.
  • It’s common to have more than one diagnosis. For many people, there may not be one simple diagnosis. For example, people can have both bipolar disorder and a substance use disorder diagnoses.
  • Medical problems or medications can influence or even mimic symptoms. Hypothyroidism presents with almost all symptoms of depression for example, and steroids can add risk for mood symptoms.
  • Get informed. Patients who know their symptoms can help in the search for a diagnosis. People have brought write-ups to their appointment as they search for answers, and I have referred some people to the DSM-5 so they can evaluate their experience.

Let’s focus on the sometimes-confused conditions of Bipolar Disorder and Borderline Personality Disorder (BPD). In a snapshot, they can look similar—both can present with impulsive behavior, intense emotions and suicidal thinking. But this snapshot is not the best way to tell them apart. It’s really the movie of the symptom presentation over time that can help make the diagnosis distinct.

Classic Bipolar Disorder Type 1 is easier to differentiate from BPD than Bipolar 2. True manic symptoms (often with hallucinations) are the hallmark of Type 1 and these symptoms are not seen in the same way in BPD. Bipolar Type 2 is a more challenging diagnosis to differentiate from BPD, because the classic manic episode is absent. So, on the surface, it can appear more like BPD. Here are a few ways to help tell the difference between bipolar and BPD:

How Often Do Moods Change?

People with Bipolar Type 1 have cycles that switch from a depressive state to a manic state. Manic symptoms sometimes include flashes of deep depression within the manic episode (called rapid cycling). Between cycles, people often have periods of true symptom-free wellness. This period of wellness can last weeks, months or years depending on the person. People diagnosed with BPD typically have more persistent day-to-day emotional symptoms which can impact everyday life. BPD mood changes are more persistent, short-lived and reactive to environmental factors, like stress at work or home.

Is Sleep Normal?

Sleep changes are often an early indicator of a bipolar disorder. During a bipolar episode, a person might be awake for days and not experience fatigue or they may sleep for days. Meanwhile, sleep patterns are less commonly impacted in BPD.

Is There A Family History?

Mood disorders, like bipolar disorder and depression, run in families, but aren’t directly passed on through a single, specific gene. A family history of mood disorders increases the chances of mood disorders appearing in relatives.

Are Relationships Often Unstable?

Intense relationships often fraught with conflict are the hallmark of borderline personality disorder. People with BPD often have intense relationship histories, and many of their experiences with emotional dysregulation (intense reactions and variabilities) are in response to relationship interactions.

Is Self-Harm A Symptom?

Self-harm such as cutting one’s skin is more common in BPD and is thought to be a way to help with emotional regulation. “I’m not suicidal, I was just trying to change my feelings by cutting,” I’ve been told by individuals with BPD. In fact, 75% of individuals with BPD have cut, burned, hit or injured themselves.

Diagnosing a mental illness isn’t like diagnosing some physical illnesses—it takes a lot of observation and understanding to find the right diagnosis. If your diagnosis doesn’t feel right or isn’t clear, it’s best to talk to your clinician. Ask about your diagnosis and treatment plan and be engaged in the diagnostic process. If you and your practitioner aren’t sure, ask for a second opinion. It’s okay not to be sure, and it’s smart to keep learning.

Both BPD and bipolar have good treatment options, but they are very different options, so putting time into getting a correct diagnosis is essential. These are serious health conditions that need individualized support and care in order to optimize recovery.

Ken Duckworth is medical director at NAMI.

https://nami.org/Blogs/NAMI-Blog/June-2017/Borderline-Personality-Disorder-and-Bipolar-Disord

PTSD And Trauma: Not Just For Veterans

By Luna Greenstein | Nov. 08, 2017

When we think about posttraumatic stress disorder (PTSD), it’s typically in the context of active duty service members and veterans—for good reason. Dangerous and potentially traumatic situations are common occurrences in the context of military service. However, it’s important to note that PTSD is not exclusive to this type of trauma.

In the U.S., about eight million people experience PTSD. While any traumatic experience can lead to PTSD, there are a few types of trauma that are the most common. Examples include sexual assault/abuse, natural disasters, accidents/injuries to self or other, or being in a life-threatening situation. When you consider these examples, it’s understandable why people would associate PTSD most frequently with military service members. However, this assumption can be problematic.

If people believe that only service members and veterans can develop PTSD, the recognition of symptoms and treatment can be delayed. The fact is: Anyone can develop PTSD when they experience or witness a traumatic event—adult or child, man or woman. Anyone.

How Do You Know If You Have PTSD?

About 50% of all people will go through at least one traumatic experience in their lifetime. But not everyone will develop PTSD. In fact, the majority won’t. However, it can be difficult to distinguish between the typical symptoms that follow a traumatic event and when it has reached the point that a condition like PTSD has developed.

It’s common for people who experience trauma to have nightmares or flashbacks for a few weeks and then gradually improve. It’s when those symptoms don’t improve and begin to interfere with a person’s life that a mental health evaluation should be considered. A person who experiences the following intense symptoms for more than a month may have PTSD:

  • At least one “re-experiencing” symptom (flashbacks, bad dreams, frightening thoughts)
  • At least one avoidance symptom (avoiding thoughts, feeling, places, objects or events related to the traumatic experience)
  • At least two arousal and reactivity symptoms (easily startled, feeling tense, difficulty sleeping, outbursts of anger)
  • At least two cognition and mood symptoms (difficulty remembering details of the traumatic experience, negative thoughts, distorted feelings, loss of interest)

It’s important to note that PTSD-related symptoms may not occur immediately after the traumatic event; they may not surface until weeks or months afterwards. Another major, key difference between typical reactions and PTSD is that while most will remember the fear they felt during trauma, PTSD can cause a person to actually feel as if they are reliving that fear.

What Should You Do After Trauma?

If a person feels supported by friends and family after a traumatic event, it can reduce the risk of developing symptoms of PTSD. It can also be helpful for a person to join a support group, so they can share their thoughts, fears and questions with other people who have also experienced trauma. Using healthy, positive coping strategies—such as exercise, mediation or playing an instrument—can also be helpful.

If symptoms persist, it’s essential to seek treatment. Those with PTSD typically respond better to structured therapies such as:

  • Cognitive behavioral therapy (CBT) – helps a person replace their negative thoughts and behaviors with positive ones
  • Eye movement desensitization and reprocessing (EDMR) – exposes a person to traumatic memories with varying stimuli, such as eye movements
  • Exposure therapy – helps a person safely face their fears so they can learn to cope with them
  • Imagery rehearsal therapy (IRT) – is a new treatment for reducing the intensity and frequency of nightmares

If you or someone you know is having a difficult time coping with trauma, these interventions can make a huge difference. PTSD is treatable. It’s more effective if treated early, but it’s never too late to get treatment no matter how long ago the trauma occurred.

Trauma is a part of life—it affects most people at some point. But that doesn’t mean it’s a mundane experience that can be ignored or brushed off. The key is to check-in on symptoms and seek care from a mental health professional if they persist.

Whether you’re a military service member, veteran, salesperson or elementary school student, PTSD has the potential to develop in any of us. And if it does, please know that help is available. No one should face PTSD alone.

Laura Greenstein is communications coordinator.

https://nami.org/Blogs/NAMI-Blog/November-2017/PTSD-and-Trauma-Not-Just-for-Veterans

Discontinuing Cannabis Improves the Long-Term Course of Psychosis

Joel Yager, MD reviewing Setién-Suero E et al. Acta Psychiatr Scand 2019 Aug 5

Patients who used cannabis during their first psychotic episodes and never stopped had worse outcomes 10 years later than ex-users and never-users.

(High Potency) Cannabis contributes to the risk for first-episode psychosis in adolescents and young adults. These investigators used data from an interventional program enrolling patients with first-episode psychosis to examine the impact of cannabis cessation versus continuation at 10-year follow-up in patients from a single Spanish geographical area (baseline age range, 15–60).

Patients meeting criteria for substance dependence other than for nicotine were excluded. Of 307 enrolled patients, 209 were examined 10 years later (54% men). Of the follow-up group, 79 (38%) were self-reported cannabis users at baseline (73% men; mean age at cannabis use onset, 17; mean consumption, 26 joints/week). Compared with baseline nonusers, initial users were more likely to be younger, male, and less educated and to have lower IQs, lower neurocognitive processing speeds, and poorer academic performance and adjustment in adolescence.

In a subanalysis of 191 patients (baseline cannabis users, 68) with additional assessments at 3 years, most users who stopped cannabis had done so by 3 years. The 10-year follow-up analysis compared persistent cannabis users (8%), ex-users (28%), and never-users (64%) and adjusted for sex and age. Although some improvement was seen overall, persistent users consistently showed more severe positive symptoms and poorer functioning than ex-users and never-users, who did not differ from one another. The three groups showed no long-term differences in cognitive function.

You Can Be Strong And Still Seek Help

By Chris Hubbard | May. 17, 2019

As a kid, I vividly remember sitting around my grandmother’s house thinking, “I want to be an NFL player and have a big NFL contract one day.” Looking back, I never dreamed that I would be where I am now, having just finished my first season with the Cleveland Browns.

However, it wasn’t an easy road. In addition to all of the physical demands of becoming a professional athlete, I have also battled with depression and anxiety. 

The challenges started when I was a student: dealing with demanding transitions, bullying and balancing my schoolwork with athletics. I could see that others around me were going through similar issues, but I didn’t feel the need to speak to a school counselor. Along the way, I taught myself to brush off my symptoms and I would try to shift my focus to elsewhere.  

During my time at the University of Alabama Birmingham (UAB), balancing my schoolwork and football began to feel like a daily struggle. On top of that, the high expectations of the NFL draft started to take a toll on me. When you make the transition from college to pro-level sports, no one really talks about the pressure that comes with it.

That kind of pressure can wear on your body immensely and cause anxiety to really sink in. The anxiety felt like a constant voice in my head telling me, “I’m not good enough.” Thankfully, I had support from UAB counselors, who were able to help me with the stress and the transition. This is when I learned how important it is to seek out help, and not to be ashamed of it.

These lessons really helped me after I was undrafted in 2013 and went through a very tough time emotionally. I experienced a lot of self-doubt and questioned whether this journey was right for me. And with support from my wife, I realized that it was. She was by my side throughout the whole process—from my lowest points to when I finally got the call from the Pittsburgh Steelers.

This was a time of joy in my life, but I still felt an immense amount of pressure: moving to an unfamiliar  city, needing to perform well on the field, wanting to make my family and hometown proud. And then, four seasons later, when I was picked up by the Cleveland Browns, I went through that whole process and all of the anxiety again. 

Even when you sign the contract of a lifetime, your anxiety doesn’t just fade away. You are still playing a high intensity game that wears on you every day, beating you down physically and emotionally. But there’s always a way to get help. What worked for me was reaching out to someone close to me. It’s not always easy, but finding the courage to express yourself is better than bottling everything in. 

More and more, we see professional athletes using their voice and platform for good, and that is exactly what I am hoping to accomplish. For Mental Health Month, I am hosting the Cars & Coffee Rally for Mental Health Awareness on May 18 at PTAP (839 Veterans Parkway) in Columbus, Georgia. 

Bringing attention to this event and my hometown means the world to me. It is not just one month of the year, but every day that I want to help spread mental health awareness. I want my community to know that their voices are being heard. I want them to know that it’s okay to ask for help.


Chris Hubbard is a NAMI Ambassador and an offensive lineman for the Cleveland Browns of the National Football League (NFL). In 2018, Hubbard started in all 16 games and played every offensive snap as well as contributing on field goal protection. Hubbard was born in Columbus, GA and enjoys spending time with his wife and son.

SOURCE: https://www.nami.org/Blogs/NAMI-Blog/May-2019/You-Can-Be-Strong-and-Still-Seek-Help


War, Peace And Mental Illness

Oct 23 2012

ARLINGTON, Va., Oct. 23, 2012 — During the final presidential debate, in the war of words between President Obama and Governor Romney over U.S. foreign and military policy, there were three brief references to America’s veterans.

Only once was traumatic brain injuries (TBI) and posttraumatic stress disorder (PTSD) specifically mentioned.

“One of the terrible costs of war is mental illness,” said Michael J. Fitzpatrick, executive director of the National Alliance on Mental Illness (NAMI). “It is part of the calculation every voter needs to make about war and peace.”

“Too often, debate over Afghanistan and the Middle East or the defense budget occurs only in abstract terms. But it is also important to think about the human terms.”

Earlier this year, NAMI released a special report Parity for Patriots: The Mental Health Needs of Military Personnel, Veterans and their Families, which outlined some of the human costs:

  • One in five active duty military personnel have experienced symptoms of PTSD, depression or other mental health conditions.
  • One active duty soldier dies by suicide every 36 hours and one veteran every 80 minutes.
  • Suicides have increased within National Guard and Reserve forces, even among those who have never been activated and are not eligible for care through the Department of Veterans Affairs.
  • More than one-third of military spouses live with at least one mental disorder. One-third of children with at least one deployed parent have had psychological problems such as depression, anxiety and acute stress reaction.
  • The presidential debates have not focused on veterans or mental health care to any significant degree—despite the fact that one out of four American adults experience a mental health problem in any given year.

“The debates ignored important dimensions and distinctions about mental health care within broader issues,” Fitzpatrick said. “That is not necessarily a surprise, but it still is a disappointment.”

“The challenge between now and Election Day is for individuals and families affected by mental illness, and their friends, to keep working to raise mental health issues with congressional, state and local candidates and to encourage all voters to consider them in making decisions between candidates.”

NAMI’s non-partisan Mental Health Care Gets My Vote campaign advocates the following priorities:

  • Protect mental health funding.
  • Expand access to mental health coverage.
  • Ensure that effective mental health services are available.
  • Promote integration of mental health, addictions and primary care.
  • Improve the mental health of children, youth and young adults.
  • Meet the mental health needs of service members, veterans and their families.
  • Provide homes and jobs for people living with mental illness.
  • Eliminate disparities in mental health care.
  • End inappropriate jailing of people with mental illness.

About NAMI

NAMI is the nation’s largest grassroots mental health organization dedicated to building better lives for millions of Americans affected by mental illness.

Source: https://www.nami.org/Press-Media/Press-Releases/2012/The-Presidential-Debate-War,-Peace-and-Mental-Illn

Pot and Psychosis

Smoking High-Potency Marijuana Daily May Increase Chances Of Developing Psychosis By Nearly Fivefold, Study Indicates.

The AP (3/19, Cheng) reports, “Smoking high-potency marijuana every day could increase the chances of developing psychosis by nearly five times,” researchers concluded in a study comprised of “about 900 people who were diagnosed with a first episode of the disorder at a mental health clinic, including those with delusions and hallucinations,” who “were compared with more than 1,200 healthy patients.” The findings of the contribution of cannabis use to variation in the incidence of psychotic disorder across Europe were published on March 19 in The Lancet Psychiatry.

 

 

Addictive Personality?

What Are the Traits of an Addictive Personality?

It’s not a surprise then that people who are worried about developing an addiction to drugs or alcohol often try to find out what the traits of an addictive personality might be. They want to know what to watch for, either to absolve themselves of the “addict” label or to give themselves a reason never to start using drugs or alcohol to begin with. However, the simple fact is that this whole idea is based on a mix of truth and fiction.

The Myth of the Generic Addictive Personality

The fiction is the concept of a specific addictive personality. In fact, most researchers in addiction today would caution against the idea of a single, generic personality that is prone to addiction. An article in Scientific American verifies and offers evidence for the fact that there is no one personality type that leads to addiction. In fact, some seemingly disparate traits can lead different people to become addicted to drugs or alcohol, depending on other factors.

While there are several different types of traits that can be recognized in individuals who develop substance use disorders, they are not all present in every person who becomes addicted. Therefore, the image that some people see of the socially outcast criminal is an inaccurate vision of the individual who becomes addicted to drugs or alcohol.

Traits of People with High Risk of Developing Addiction

Nevertheless, there are traits that can be recognized in people who have a higher risk of becoming addicted to psychoactive substances rather than just being able to moderate behavior around these types of substances. People with this higher addiction risk include those who are:

  • Related to others who have developed addiction
  • Experiencing other mental health disorders
  • Adventurous and risk-taking
  • Disconnected and cautious
  • Obsessive and compulsive
  • Apathetic
  • Unable to self-regulate

A more thorough discussion of each of these traits is explored below.

Related to Others with Addiction

There is no question that genetic makeup has at least some effect on a person’s risk of developing addiction. As described by many studies, including one from the journal Psychiatry, having a close family member who is struggling with an addiction can make it more likely that an individual will develop an addiction as well.

In fact, certain portions of the human genome have even been identified as having a direct connection to specific addictions, according to a study in Nature. With this knowledge, it may be possible in the future to more accurately identify just how likely a person is to develop addiction. Still, genetic potential is no guarantee that an individual will develop addiction. Other complex, environmental factors also contribute to the potential that a genetic predisposition will become a true substance use disorder.

Experiencing Other Mental Health Disorders

Along with the genetic connection, another individual health trait that can correspond with a higher risk of addiction is the presence of pre-existing mental health disorders. People who struggle with various mental health conditions can be more likely to abuse and become dependent on substances. These conditions include but are not limited to:

For example, as explained by Brain Facts, multiple studies over the last decades have demonstrated a strong link between schizophrenia and addiction to nicotine. In fact, it has been shown that nicotine can even temporarily lessen some of the symptoms of schizophrenia. The use of cigarettes to manage these symptoms is a phenomenon known as self-medication, which is a common source of substance abuse that later becomes addiction.

The Adventurous, Risk-Taking Trait

Some personality traits have higher risk of addiction than others. Individuals who like to take risks and who have little impulse control around experimenting and playing with new experiences and dangerous activities are more likely to try drugs. A study reported by Reuters indicates that this may have to do with the individual’s levels of dopamine and the brain’s sensitivity to it.

The Adventurous, Risk-Taking Trait

People with high levels of dopamine in the brain may have a lower sensitivity to its effects, meaning that they need to have more intense experiences in order to feel the pleasure that this brain chemical causes. This, in turn, can be bound into the person’s experience using drugs and alcohol, which directly affect the dopamine system. In this way, the adventure-seeking, risk-taking personality can have a higher likelihood of experimenting with and, later, becoming addicted to these substances.

The Disconnected, Cautious Trait

According to the Scientific American article, the bold, risk-taker type who develops addiction is more likely to be male. On the other hand, cautious people who have difficulty with social relationships – and who at the same time may suffer from depression, anxiety, or both – can also develop addiction; these personality types are more often women.

Considering the self-medication idea mentioned above, people with these personality traits may be more likely to try to manage symptoms of anxiety or painful feelings of loneliness, disconnection, and depression by using alcohol or drugs that dull those feelings. This may then lead to the person becoming dependent on the substance to feel good in general, which in turn can lead to tolerance and addiction.

The Obsessive, Compulsive Trait

Addiction sometimes has to do with a lack of impulse control, but this is not exclusively the inability to resist impulses. In fact, people who are too rigid with managing their impulses may also end up using substances as a manifestation of an obsessive-compulsive behavior pattern. In fact, addiction often becomes a compulsion to use the substance based on a habit that has formed over time rather than a single impulse to try something new.

In this way, people with intense focus and habitual behaviors may be as likely to develop addiction as those who are unable to control impulses. The obsession with using psychoactive drugs is a main symptom of the disorder, and it can exist both separate from and in concert with a lack of impulse control that can also be a hallmark of addiction.

Being Unable to Self-regulate

What all of these traits have in common is an inability for the individual to regulate behaviors, thoughts, and feelings that might otherwise enable an ability to moderate use of alcohol or other substances. As explained in an article from the University of Rochester Medical Center, studies are beginning to show that an inability to regulate behavior around the anticipation of receiving a reward is strongly linked to the development of addiction.

However, this is not the end of the issue. Individuals who pursue the idea of reward so strongly often do not experience as much pleasure from having gotten the reward as those who do not have this issue. This diminished sense of pleasure leads the person to push harder to win more in the hope that the reward response might be stronger. This, again, is linked with the person’s levels of, and sensitivity to, dopamine and potentially to other neurochemicals as well.

How to Help a Person with High Addiction Risk

Various forms of behavioral therapies can help individuals struggling with these issues to learn to manage their behaviors and acquire self-regulation skills that can moderate the addictive response. In addition, for those who have already developed substance use problems, treatment programs can incorporate these therapies with other demonstrated treatments. This approach may help the person safely stop using drugs or alcohol and live a sober life as well as gain control over the various traits above.

Seeking out research-based, professional care can provide the individual with tools to understand and manage these various traits, making recovery possible.

Last Updated on November 29, 2018

SOURCE: https://americanaddictioncenters.org/the-addiction-cycle/traits-of-an-addictive-personality

American Addiction Centers

Vitamin D and the Sun

These are dark days for supplements. Although they are a $30-plus billion market in the United States alone, vitamin A, vitamin C, vitamin E, selenium, beta-carotene, glucosamine, chondroitin, and fish oil have now flopped in study after study.

If there was one supplement that seemed sure to survive the rigorous tests, it was vitamin D. People with low levels of vitamin D in their blood have significantly higher rates of virtually every disease and disorder you can think of: cancer, diabetes, obesity, osteoporosis, heart attack, stroke, depression, cognitive impairment, autoimmune conditions, and more. The vitamin is required for calcium absorption and is thus essential for bone health, but as evidence mounted that lower levels of vitamin D were associated with so many diseases, health experts began suspecting that it was involved in many other biological processes as well.

And they believed that most of us weren’t getting enough of it. This made sense. Vitamin D is a hormone manufactured by the skin with the help of sunlight. It’s difficult to obtain in sufficient quantities through diet. When our ancestors lived outdoors in tropical regions and ran around half naked, this wasn’t a problem. We produced all the vitamin D we needed from the sun.

But today most of us have indoor jobs, and when we do go outside, we’ve been taught to protect ourselves from dangerous UV rays, which can cause skin cancer. Sunscreen also blocks our skin from making vitamin D, but that’s OK, says the American Academy of Dermatology, which takes a zero-tolerance stance on sun exposure: “You need to protect your skin from the sun every day, even when it’s cloudy,” it advises on its website. Better to slather on sunblock, we’ve all been told, and compensate with vitamin D pills.

Yet vitamin D supplementation has failed spectacularly in clinical trials. Five years ago, researchers were already warning that it showed zero benefit, and the evidence has only grown stronger. In November, one of the largest and most rigorous trials of the vitamin ever conducted—in which 25,871 participants received high doses for five years—found no impact on cancer, heart disease, or stroke.

How did we get it so wrong? How could people with low vitamin D levels clearly suffer higher rates of so many diseases and yet not be helped by supplementation?

As it turns out, a rogue band of researchers has had an explanation all along. And if they’re right, it means that once again we have been epically misled.

These rebels argue that what made the people with high vitamin D levels so healthy was not the vitamin itself. That was just a marker. Their vitamin D levels were high because they were getting plenty of exposure to the thing that was really responsible for their good health—that big orange ball shining down from above.


One of the leaders of this rebellion is a mild-mannered dermatologist at the University of Edinburgh named Richard Weller. For years, Weller swallowed the party line about the destructive nature of the sun’s rays. “I’m not by nature a rebel,” he insisted when I called him up this fall. “I was always the good boy that toed the line at school. This pathway is one which came from following the data rather than a desire to overturn apple carts.”

Weller’s doubts began around 2010, when he was researching nitric oxide, a molecule produced in the body that dilates blood vessels and lowers blood pressure. He discovered a previously unknown biological pathway by which the skin uses sunlight to make nitric oxide.

It was already well established that rates of high blood pressure, heart disease, stroke, and overall mortality all rise the farther you get from the sunny equator, and they all rise in the darker months. Weller put two and two together and had what he calls his “eureka moment”: Could exposing skin to sunlight lower blood pressure?

Sure enough, when he exposed volunteers to the equivalent of 30 minutes of summer sunlight without sunscreen, their nitric oxide levels went up and their blood pressure went down. Because of its connection to heart disease and strokes, blood pressure is the leading cause of premature death and disease in the world, and the reduction was of a magnitude large enough to prevent millions of deaths on a global level.

Wouldn’t all those rays also raise rates of skin cancer? Yes, but skin cancer kills surprisingly few people: less than 3 per 100,000 in the U.S. each year. For every person who dies of skin cancer, more than 100 die from cardiovascular diseases.

People don’t realize this because several different diseases are lumped together under the term “skin cancer.” The most common by far are basal-cell carcinomas and squamous-cell carcinomas, which are almost never fatal. In fact, says Weller, “When I diagnose a basal-cell skin cancer in a patient, the first thing I say is congratulations, because you’re walking out of my office with a longer life expectancy than when you walked in.” That’s probably because people who get carcinomas, which are strongly linked to sun exposure, tend to be healthy types that are outside getting plenty of exercise and sunlight.

Melanoma, the deadly type of skin cancer, is much rarer, accounting for only 1 to 3 percent of new skin cancers. And perplexingly, outdoor workers have half the melanoma rate of indoor workers. Tanned people have lower rates in general. “The risk factor for melanoma appears to be intermittent sunshine and sunburn, especially when you’re young,” says Weller. “But there’s evidence that long-term sun exposure associates with less melanoma.”

These are pretty radical words in the established dermatological community. “We do know that melanoma is deadly,” says Yale’s David Leffell, one of the leading dermatologists in the country, “and we know that the vast majority of cases are due to sun exposure. So certainly people need to be cautious.”

Still, Weller kept finding evidence that didn’t fit the official story. Some of the best came from Pelle Lindqvist, a senior research fellow in obstetrics and gynecology at Sweden’s Karolinska Institute, home of the Nobel Prize in Physiology or Medicine. Lindqvist tracked the sunbathing habits of nearly 30,000 women in Sweden over 20 years. Originally, he was studying blood clots, which he found occurred less frequently in women who spent more time in the sun—and less frequently during the summer. Lindqvist looked at diabetes next. Sure enough, the sun worshippers had much lower rates. Melanoma? True, the sun worshippers had a higher incidence of it—but they were eight times less likely to die from it.

So Lindqvist decided to look at overall mortality rates, and the results were shocking. Over the 20 years of the study, sun avoiders were twice as likely to die as sun worshippers.

There are not many daily lifestyle choices that double your risk of dying. In a 2016 study published in the Journal of Internal Medicine, Lindqvist’s team put it in perspective: “Avoidance of sun exposure is a risk factor of a similar magnitude as smoking, in terms of life expectancy.”


The idea that slavish application of SPF 50 might be as bad for you as Marlboro 100s generated a flurry of short news items, but the idea was so weird that it didn’t break through the deadly-sun paradigm. Some doctors, in fact, found it quite dangerous.

“I don’t argue with their data,” says David Fisher, chair of the dermatology department at Massachusetts General Hospital. “But I do disagree with the implications.” The risks of skin cancer, he believes, far outweigh the benefits of sun exposure. “Somebody might take these conclusions to mean that the skin-cancer risk is worth it to lower all-cause mortality or to get a benefit in blood pressure,” he says. “I strongly disagree with that.” It is not worth it, he says, unless all other options for lowering blood pressure are exhausted. Instead he recommends vitamin D pills and hypertension drugs as safer approaches.

Weller’s largest study yet is due to be published later in 2019. For three years, his team tracked the blood pressure of 340,000 people in 2,000 spots around the U.S., adjusting for variables such as age and skin type. The results clearly showed that the reason people in sunnier climes have lower blood pressure is as simple as light hitting skin.

When I spoke with Weller, I made the mistake of characterizing this notion as counterintuitive. “It’s entirely intuitive,” he responded. “Homo sapiens have been around for 200,000 years. Until the industrial revolution, we lived outside. How did we get through the Neolithic Era without sunscreen? Actually, perfectly well. What’s counterintuitive is that dermatologists run around saying, ‘Don’t go outside, you might die.’”

When you spend much of your day treating patients with terrible melanomas, it’s natural to focus on preventing them, but you need to keep the big picture in mind. Orthopedic surgeons, after all, don’t advise their patients to avoid exercise in order to reduce the risk of knee injuries.

Meanwhile, that big picture just keeps getting more interesting. Vitamin D now looks like the tip of the solar iceberg. Sunlight triggers the release of a number of other important compounds in the body, not only nitric oxide but also serotonin and endorphins. It reduces the risk of prostate, breast, colorectal, and pancreatic cancers. It improves circadian rhythms. It reduces inflammation and dampens autoimmune responses. It improves virtually every mental condition you can think of. And it’s free.

These seem like benefits everyone should be able to take advantage of. But not all people process sunlight the same way. And the current U.S. sun-exposure guidelines were written for the whitest people on earth.


Every year, Richard Weller spends time working in a skin hospital in Addis Ababa, Ethiopia. Not only is Addis Ababa near the equator, it also sits above 7,500 feet, so it receives massive UV radiation. Despite that, says Weller, “I have not seen a skin cancer. And yet Africans in Britain and America are told to avoid the sun.”

All early humans evolved outdoors beneath a tropical sun. Like air, water, and food, sunlight was one of our key inputs. Humans also evolved a way to protect our skin from receiving too much radiation—melanin, a natural sunscreen. Our dark-skinned African ancestors produced so much melanin that they never had to worry about the sun.

As humans migrated farther from the tropics and faced months of light shortages each winter, they evolved to produce less melanin when the sun was weak, absorbing all the sun they could possibly get. They also began producing much more of a protein that stores vitamin D for later use. In spring, as the sun strengthened, they’d gradually build up a sun-blocking tan. Sunburn was probably a rarity until modern times, when we began spending most of our time indoors. Suddenly, pasty office workers were hitting the beach in summer and getting zapped. That’s a recipe for melanoma.

People of color rarely get melanoma. The rate is 26 per 100,000 in Caucasians, 5 per 100,000 in Hispanics, and 1 per 100,000 in African Americans. On the rare occasion when African Americans do get melanoma, it’s particularly lethal—but it’s mostly a kind that occurs on the palms, soles, or under the nails and is not caused by sun exposure.

At the same time, African Americans suffer high rates of diabetes, heart disease, stroke, internal cancers, and other diseases that seem to improve in the presence of sunlight, of which they may well not be getting enough. Because of their genetically higher levels of melanin, they require more sun exposure to produce compounds like vitamin D,and they are less able to store that vitamin for darker days. They have much to gain from the sun and little to fear.

And yet they are being told a very different story, misled into believing that sunscreen can prevent their melanomas, which Weller finds exasperating. “The cosmetic industry is now trying to push sunscreen at dark-skinned people,” he says. “At dermatology meetings, you get people standing up and saying, ‘We have to adapt products for this market.’ Well, no we don’t. This is a marketing ploy.”

When I asked the American Academy of Dermatology for clarification on its position on dark-skinned people and the sun, it pointed me back to the official line on its website: “The American Academy of Dermatology recommends that all people, regardless of skin color, protect themselves from the sun’s harmful ultraviolet rays by seeking shade, wearing protective clothing, and using a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher.”

This seemed to me a little boilerplate, and I wondered whether the official guidelines hadn’t yet caught up to current thinking. So I asked David Leffell, at Yale. “I think that sun-protection advice,” he told me, “has always been directed at those most at risk”—people with fair skin or a family history of skin cancer. “While it is true that people with olive skin are at less risk, we do see an increasing number of people with that type of skin getting skin cancer. But skin cancer… is very rare in African Americans… and although they represent a spectrum of pigmentation, [they] are not at as much risk.”

Still, David Fisher at Mass General didn’t think that changed the equation. “There’s a pharmacopoeia of drugs that are extremely effective at lowering blood pressure,” he said. “So to draw the conclusion that people should expose themselves to an elevated skin-cancer risk, including potentially fatal cancer, when there are so many alternative treatments for hypertension, is problematic.”


Am I willing to entertain the notion that current guidelines are inadvertently advocating a lifestyle that is killing us?

I am, because it’s happened before.

In the 1970s, as nutritionists began to see signs that people whose diets were high in saturated fat and cholesterol also had high rates of cardiovascular disease, they told us to avoid butter and choose margarine, which is made by bubbling hydrogen gas through vegetable oils to turn them into solid trans fats.

From its inception in the mid-1800s, margarine had always been considered creepers, a freakish substitute for people who couldn’t afford real butter. By the late 1800s, several midwestern dairy states had banned it outright, while others, including Vermont and New Hampshire, passed laws requiring that it be dyed pink so it could never pass itself off as butter. Yet somehow margarine became the thing we spread on toast for decades, a reminder that even the weirdest product can become mainstream with enough industry muscle.

Eventually, better science revealed that the trans fats created by the hydrogenation process were far worse for our arteries than the natural fats in butter. In 1994, Harvard researchers estimated that 30,000 people per year were dying unnecessarily thanks to trans fats. Yet they weren’t banned in the U.S. until 2015.

Might the same dynamic be playing out with sunscreen, which was also remarkably sketchy in its early days? One of the first sunscreens, Red Vet Pet (for Red Veterinary Petrolatum) was a thick red petroleum jellyinvented in 1944 to protect soldiers in the South Pacific;it must have been eerily reminiscent of pink margarine. Only after Coppertone bought the rights and reformulated Red Vet Pet to suit the needs of the new midcentury tanning culture did sunscreen take off.

However, like margarine, early sunscreen formulations were disastrous, shielding users from the UVB rays that cause sunburn but not the UVA rays that cause skin cancer. Even today, SPF ratings refer only to UVB rays, so many users may be absorbing far more UVA radiation than they realize. Meanwhile, many common sunscreen ingredients have been found to be hormone disruptors that can be detected in users’ blood and breast milk. The worst offender, oxybenzone, also mutates the DNA of corals and is believed to be killing coral reefs. Hawaii and the western Pacific nation of Palau have already banned it, to take effect in 2021 and 2020 respectively, and other governments are expected to follow.

The industry is now scrambling to move away from oxybenzone, embracing opaque, even neon, mineral-based formulations, a fashion statement reminiscent of the old Red Vet Pet. But with its long track record of pushing products that later turn out to be unhealthy, I remain skeptical of industry assurances that it finally has everything figured out. We are always being told to replace something natural with some artificial pill or product that is going to improve our health, and it almost always turns out to be a mistake because we didn’t know enough. Multivitamins can’t replace fruits and vegetables, and vitamin D supplements are clearly no substitute for natural sunlight.


Old beliefs don’t die easily, and I can understand if you remain skeptical of old Sol. Why trust one journalist and a handful of rogue researchers against the august opinions of so many professionals?

Here’s why: many experts in the rest of the world have already come around to the benefits of sunlight. Sunny Australia changed its tune back in 2005. Cancer Council Australia’s official-position paper (endorsed by the Australasian College of Dermatologists) states, “Ultraviolet radiation from the sun has both beneficial and harmful effects on human health…. A balance is required between excessive sun exposure which increases the risk of skin cancer and enough sun exposure to maintain adequate vitamin D levels…. It should be noted that the benefits of sun exposure may extend beyond the production of vitamin D. Other possible beneficial effects of sun exposure… include reduction in blood pressure, suppression of autoimmune disease, and improvements in mood.”

Australia’s official advice? When the UV index is below 3 (which is true for most of the continental U.S. in the winter), “Sun protection is not recommended unless near snow or other reflective surfaces. To support vitamin D production, spend some time outdoors in the middle of the day with some skin uncovered.” Even in high summer, Australia recommends a few minutes of sun a day.

New Zealand signed on to similar recommendations, and the British Association of Dermatologists went even further in a statement, directly contradicting the position of its American counterpart: “Enjoying the sun safely, while taking care not to burn, can help to provide the benefits of vitamin D without unduly raising the risk of skin cancer.”

Leffell, the Yale dermatologist, recommends what he calls a “sensible” approach. “I have always advised my patients that they don’t need to crawl under a rock but should use common sense and be conscious of cumulative sun exposure and sunburns in particular,” he told me.

This does not mean breaking out the baby oil or cultivating a burnished tan. All the experts agree that sunburns—especially those suffered during childhood and adolescence—are particularly bad.

Ultimately, it’s your call. Each person’s needs vary so much with season, latitude, skin color, personal history, philosophy, and so much else that it’s impossible to provide a one-size-fits-all recommendation. The Dminder app, which uses factors such as age, weight, and amount of exposed skin to track the amount of sunlight you need for vitamin D production, might be one place to start. Trading your sunscreen for a shirt and a broad-brimmed hat is another. Both have superior safety records.

As for me, I’ve made my choice. A world of healthy outdoor adventure beckons—if not half naked, then reasonably close. Starting today, I’m stepping into the light.

Source: Rowan Jackobson, Jan 10, 2019