Opinion: Time To Lift The Black Box Warning On Antidepressants

Paxil, or paroxetine, an antidepressant that raised early alarms about possible suicidal effects in the United Kingdom. (Wikimedia Commons)

Paxil, or paroxetine, an antidepressant that raised early alarms about possible suicidal effects in the United Kingdom. (Wikimedia Commons)

By Drs. Steve Schlozman and Gene Beresin
Guest contributors

In 2004, the Food and Drug Administration made the difficult decision to apply a “black box” warning to virtually all antidepressant medications.

A few months earlier, British health officials had issued a similar warning for paroxetine, or Paxil, a frequently used antidepressant. Both the United States and the United Kingdom were worried about the possibility of antidepressant use in some people causing an increase in agitated, and even suicidal, behavior. The warnings, still in effect, apply particularly to adolescents.

But recent research suggests that perhaps the black box warning should itself have a black box warning. A new Harvard study suggests the warning has actually led to an increase in suicides because it caused a decrease in the treatment of depression through antidepressant prescriptions. Similar studies published back in 2007 showed a fairly dramatic increase in suicide attempts by adolescents, corresponding to a decrease in prescriptions for antidepressants. The Harvard study is a reiteration of these previous findings.

We believe it is time for the black box warning to be lifted. And we suspect that bias and ignorance may play a role in the fact that it has not been.

First, some background information.

A “black box warning” is a written message that by U.S. law must accompany every prescription for which the warning is indicated. Continue reading

Meditation ‘Overrated’? Not So Fast.

(RelaxingMusic/Flickr via Compfight)

(RelaxingMusic/Flickr via Compfight)

My doctor recently suggested I stop multi-tasking. Focus on one thing at a time, she said: our brains aren’t wired to take on the kind of intense juggling — from chauffeuring to food prep, extracurricular logistics, work strategies, worry over aging parents, anxiety about climate change — that many of us attempt (with varying degrees of success) every day.

For me, meditation and yoga offer a lifeline: a quiet sanctuary where focusing on one thing is the only thing required.

So I was slightly annoyed by the headline of a recent Scientific American story: “Is Meditation Overrated?”

The premise of the piece is this: Many people report that meditation improves their mood and relieves various symptoms of chronic stress and other health problems, BUT the data on this isn’t terribly robust. So, the story continues, “Johns Hopkins University researchers carefully reviewed published clinical trials and found that although meditation seems to provide modest relief for anxiety, depression and pain, more high-quality work is needed before the effect of meditation on other ailments can be judged.”

So shouldn’t the headline be: “Meditation Relieves Some Modern Woes; More Research Needed To Conclusively Prove Further Benefits?”

Or, my own personal headline: “Meditation Helps Me Scream At My Kids Less And Not Attack My Husband When There’s Yet Another Wet Towel On The Bed.” (See also, a new study, entitled: “I Am A Nice Person When I Do Yoga!!!)Continue reading

Mental Health Parity: If Not Now, When?

According to ABC News, the latest alleged Ft. Hood shooter was struggling with a number of mental health problems, “ranging from depression to anxiety to sleep disturbance,” and in the midst of being evaluated for post-traumatic stress disorder.

If true, it’s a familiar story of a stressed-out soldier with mental health issues and easy access to guns: we’ve been here before.

Of course, we don’t know exactly what kind of care or treatment this shooter was receiving — and the VA system is generally better than others. Still, it’s worth reviewing the history of legislation to put mental health services on equal footing with all other medical care.



The latest policy brief published in the journal Health Affairs, documents the convoluted history of mental health parity, the idea that mental health care and treatment be comparable with all other types of “physical” medical care (and why make the distinction, anyway)?

Parity efforts began in earnest in the late 1990s, but still aren’t fully implemented today, despite widespread support, including from notable advocates like former Congressman Patrick Kennedy.

The paper examines some of the obstacles remaining to true mental health parity, including these:

…”Critics have argued that parity legislation alone is not enough to fix other underlying problems in how our health system provides access to treatment of mental health and substance use disorders.

The supply and availability of mental health providers has been the subject of numerous research articles. A 2009 Health Affairs article by Peter Cunningham found that two-thirds of primary care physicians reported that they were unable to get outpatient mental health services for their patients–more than twice the percentage who reported trouble finding specialist referrals, nonemergency hospital admissions, or imaging services. Mental health professionals tend to be concentrated in high-population, high-income areas, and the lack of mental health care providers in rural areas as well as in pediatrics has been well documented. Finally, there is still a stigma associated with receiving mental health or substance use treatment. Eliminating the stigma and increasing the availability of high-quality providers are two keys to increasing access to care.

…Much of the debate in implementing parity is around determining equivalence of services between mental health/substance use benefits and medical/surgical benefits. Some of the treatments for mental health and substance use disorders do not have an equivalent medical/surgical treatment, Continue reading

Study: Meditation Relieves Some Anxiety, Depression Beyond Placebo



We’ve all been there: feeling low, overwhelmed, anxious, or just majorly bummed out about the freezing cold, the dead-end job, the noncompliant spouse, whatever, and we dream of a pill — a quick fix — to put an end to all that negative muck.

Of course, pills have side effects, and don’t always work. But it turns out there’s something that may be more effective with no downside, though it takes a bit of effort: meditation for about 30 minutes a day.

A new analysis by researchers at Johns Hopkins find that just a half-hour of “mindfulness meditation” may improve some of these garden variety, not yet full-blown, symptoms of anxiety and depression. The findings, published online in JAMA Internal Medicine, also found that some pain symptoms can also be relieved through a consistent meditation practice.

This should not come as breaking news. Many studies over many years link meditation to all kinds of health improvements. But I think it’s worth restating, since meditation is still viewed as a crunchy, ineffective practice by so many — including those in the medical mainstream.

Here’s lead study author Dr. Madhav Goyal, assistant professor in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine, quoted in the news release:

“A lot of people use meditation, but it’s not a practice considered part of mainstream medical therapy for anything,” says Goyal, M.D. M.P.H. “But in our study, meditation appeared to provide as much relief from some anxiety and depression symptoms as what other studies have found from antidepressants.” Continue reading

Family Meal Boost: Lower Depression, Eating Disorder Risk In Girls

The concept of “the family meal” remains elusive — more nostalgia than reality — for many modern families. But it’s still worth striving for, according to a recent analysis by public health researchers at Tufts, who found that frequent family meals can reduce the likelihood that teenagers, particularly girls, will develop problems ranging from alcohol and tobacco use to eating disorders and depression.



Despite the benefits, researchers report that less than 60 percent of children eat five or more meals with their parents each week.

I asked the lead researcher, Margie Skeer, an assistant professor of public health and community medicine at Tufts University School of Medicine, a little about her analysis, published in the Journal of Youth and Adolescence. Here, lightly edited, is what she said:

RZ: What happens at family meals that may be protective against risky behavior, like substance abuse, or other mental health problems?

MS: If family meals are frequent and consistent, mealtime can serve as a conduit for open, ongoing communication, where people come together to not only eat, but to talk about their day. In this regard, mealtimes can provide for a baseline level of communication, whereby parents/guardians can learn about the everyday, ongoing aspects of their children’s lives — both important and ordinary. This can create an environment that allows for the development of three crucial features of the parent-child relationship. Continue reading

Tumblr Blocks Some Mental Health Topics, Thwarts Therapy

LibbiAs a member of the Millennial Generation, Libbi Gildea, 20, discovered a new coping mechanism for dealing with an age-old mental health issue – social media.

But just as she started to heal from a personal trauma, she found that a tech giant was starting to dismantle her new, safe space.

In December 2012, Libbi was raped on the campus of a prestigious school in Massachusetts. She was 19 at the time, a college sophomore. After the attack, she developed PTSD and depression and took time off school, trying to heal. She spent time recovering in the hospital, and traditional talk therapy helped. But, she says, she found the most comfort in a more contemporary setting. Libbi joined the microblogging site Tumblr and started browsing posts tagged with topics she was interested in, like depression and PTSD, meeting others that were going through similar experiences. In an interview, she gave me permission to use her name, and explained how she evolved from feeling totally alone after the assault, to much more connected and supported through social media:

I felt really isolated because I didn’t know anyone else that had PTSD. You don’t realize that what you’re experiencing is normal … After I was done with the hospital and I didn’t have group therapy anymore, a friend mentioned that there was a pretty vibrant mental health community on Tumblr.

So I made a blog there. I started randomly one day, posting that I wished I could make a mental health “resume” so I wouldn’t have to go through my experience every time I saw a new doctor. I did another post of more of a personal nature on the night of my birthday because I was angry and feeling that my attacker had taken a lot away from me. I wrote him an open letter that said, “You may have raped me, you may have taken this from me, but I’m still here, and my life is only going to get better, and frankly, I feel sorry for you.” Continue reading

Study: Your Brain Makes Hundreds Of New Neurons A Day

(Digital Shotgun/flickr)

(Digital Shotgun/flickr)

This just in from the journal Cell: Your hippocampus, a key region for memory in your brain, makes a few hundred new neurons every day.

Does this mean you can now drink Tequila shots with impunity because you can more than make up for the brain cells you damage? Nope, no reason to think so. But the findings in Cell could have implications for future research in areas from antidepressants to Alzheimer’s disease.

Mainly, the new study helps cement the long-controversial claim that new neurons keep a-borning in the human brain all through life. And it does so in a creative new way, using carbon-14 left in humans by above-ground nuclear tests in the mid-20th century to measure the ages of brain cells.

I asked Prof. Joshua Sanes, director of Harvard University’s Center for Brain Science, to explain what the study could mean — why it matters whether our hippocampi keep making new neurons or not. His reply, lightly edited:

The basic dogma of neurobiology has been that you’re born with all the neurons you’re ever going to get, and then everything goes downhill from there.

But there was heated debate about this, and eventually, it was found in experimental animals that you do actually get new neurons throughout life — but weirdly, only in a few places. Where would depend on the species, but for mammals like us, it’s your olfactory bulb — what the heck that is about, nobody has any idea — and the other place is the hippocampus.

The hippocampus has proven to be critical to memory, and I’m not sure whether you’d say memories are stored there, but they certainly seem to be made there. You probably know about the famous patient HM: When he lost his hippocampus, he lost his ability to make memories.

So the idea arose that maybe if you’re making new neurons in the hippocampus, that’s to help you make new memories. In mice, there’s some evidence that favors that idea. I think nobody thinks it’s going to be as simple as that — that every time you need a new memory, you make a new neuron — but there are lots of experiments where they prevent the making of new neurons and somehow degrade memory in mice. And it seems that a lot of the things that a mouse does can affect how many new neurons are made, or at least how many of the new neurons that are made wire up.

One of those things is exercise: if you exercise more, you make, or keep, more new neurons. If you suffer a lot of stress, you make fewer neurons. Depression has been implicated; nobody knows how but there’s some idea that antidepressants can help you make new neurons, and if you’re depressed, you make fewer neurons.

So people have been interested in these new neurons, but nobody knew whether they were made in the human hippocampus, and this new study tells you that they are. Continue reading

Swartz On Depression: ‘Unable To Feel The Joy’

I can’t stop thinking about what, exactly, drove 26-year-old Aaron Swartz, the technology whiz kid and free-information crusader facing federal charges for wire and computer fraud, to hang himself last Friday. What was the final straw that broke this brilliant, so-very-promising young man?

His family clearly believed it was government persecution. In a statement they said his suicide “is the product of a criminal justice system rife with intimidation and prosecutorial overreach. Decisions made by officials in the Massachusetts U.S. Attorney’s office and at MIT contributed to his death. The U.S. Attorney’s office pursued an exceptionally harsh array of charges, carrying potentially over 30 years in prison, to punish an alleged crime that had no victims. Meanwhile, unlike JSTOR, MIT refused to stand up for Aaron and its own community’s most cherished principles.”

But Swartz’ own writings suggest that he suffered from depression, which could have been a factor as well.  In 2007 he offered this portrait of his distraught state of mind; the deadened outlook and sense of being trapped in a downward spiral:

Depressed mood: Surely there have been times when you’ve been sad. Perhaps a loved one has abandoned you or a plan has gone horribly awry. Your face falls. Perhaps you cry. You feel worthless. You wonder whether it’s worth going on. Everything you think about seems bleak — the things you’ve done, the things you hope to do, the people around you. You want to lie in bed and keep the lights off. Depressed mood is like that, only it doesn’t come for any reason and it doesn’t go for any either. Go outside and get some fresh air or cuddle with a loved one and you don’t feel any better, only more upset at being unable to feel the joy that everyone else seems to feel. Everything gets colored by the sadness. Continue reading

Help For When Grief Gets ‘Complicated’

Mourner at a funeral for a school shooting victim in Newtown, Conn. (AP Photo/David Goldman)

A mourner leaves a funeral for a school shooting victim in Newtown, Conn. (AP Photo/David Goldman)

Even after all the funerals in Newtown are over, the mourning will long go on. If experience is any guide, the heartbreak there will slowly heal with time. But for some who lost loved ones, the pain of bereavement may remain intense and constant, even years afterward.

Psychiatry calls this ‘complicated grief.’ ‘Complicated’ meaning not complex but that the healing process that normally occurs, after even a sudden and terrible loss, goes somehow awry. It develops a complication, like an infection in a wound. Complicated grief is under consideration to become a new official diagnosis, and psychiatrists have developed specific therapy to help patients who become “stuck” for years in their grief. Carey Goldberg, of WBUR’s CommonHealth blog, explains:

One beautiful July evening, as 62 year-old Gerrit Schuurman was cooking dinner, he told his wife, Cynthia, that he was having some trouble swallowing. Two days later he was dead, killed by an aneurysm his surgeons said was like a ticking time bomb in his brain.

Numb, disbelieving and alone after 37 years of marriage, Cynthia soldiered on. She left Germany, where she and Gerrit had been living, and returned to her native Boston. She found work as a teacher trainer for a non-profit, spent time with her new granddaughter.

Cynthia Leblanc Schuurman found that Complicated Grief therapy helped her. (Carey Goldberg)

Cynthia Leblanc Schuurman found that Complicated Grief therapy helped her. (Carey Goldberg)

On the outside, Cynthia was doing all right. But not inside. Every pleasure was soured by sadness; she obsessed about Gerrit’s death — “Why did this happen? Could I have done something?” — and the parallels with her father’s sudden death when she was just 13. The grief just wasn’t letting up, and it threatened to break her.

“I thought, well, I’m going to feel better in a year. People always say the first year is very difficult,” she recalled. “Other people told me the second year is even worse in the grief process,” she said. “And the second year came and it was worse. So I thought okay, maybe by the third year I’m going to feel better. But I was going through the motions. I was functioning but inside I was a mess. I was very, very upset and crying when nobody was around…About the third year, I was in a class, I was teaching my students and I broke down in the middle of a sentence.”

“The day I had that ‘mini-meltdown,’ I sent up a silent prayer to God and the universe saying, ‘I need help, please help me.’ So on the way home on the train there was a big sign, a big poster, an advertisement poster for ‘complicated grief.’ It said, ‘Are you crying all the time? Are you depressed? Are you stuck in grief?’ And I said, ‘Well, that’s me, it has my name on it.’”

Dr. Naomi Simon, head of the complicated grief program at Massachusetts General Hospital — the program Cynthia noticed in the subway ad — says people can ‘get stuck’ in grief for a wide variety of reasons. Continue reading

Questioning The True Benefits Of Magnets To Treat Depression

Sometimes, when something seems too good to be true, it is.

An example: this story about an expensive (up to $12,000 for the full treatment), newly-approved medical device to treat depression that involves magnets pulsing repetitively that was published in USA Today last week.

The FDA recently approved the NeuroStar Transcranial Magnetic Stimulation system to treat some people with depression when other therapies have failed. (robertmcdonald1989/flickr)

Though the treatment, called transcranial magnetic stimulation, may help some subset of depressed patients and is now covered by Medicare when other therapies have failed, the expert medical news analysts over at explain why the USA Today report paints an overly rosy picture of the treatment’s potential effectiveness.

Gary Schwitzer and colleague Harold DeMonaco write that “the story did not provide any semblance of balance in its reporting of the device.” Here’s a bit more from their far-reaching critique:

The story describes a single patient anecdote and does provide us with some information about the NIMH sponsored clinical trial: “Both Cochran and West cite high patient response rates. A clinical trial funded by the National Institutes of Health revealed a “significant effect of treatment” when patients received TMS treatment. It compared outcomes of patients who actually received the magnetic pulses against patients in a “sham” group, who sat down in the treatment chair for fake sessions.”

Here is what the lead author of the NIMH funded study said about the results performed in 190 patients with depression who failed standard drug therapy::

Thirteen (14 percent) of 92 patients who received the active treatment achieved remission, compared to 5 (about 5 percent) of 98 patients who received the simulation treatment.

“…the overall number of remitters and responders was less than one would like with a treatment that requires daily intervention for three weeks or more, even with a benign side effect profile.”

Hardly the results suggested by the story… Continue reading