Zoloft Depression

U.S. PSYCH: Depression Remission Rates Remain Low, But There’s Hope

April 28, 2007

SAN FRANCISCO, April 25 — Remission rates remain low for major depression even with multiple antidepressant drug classes available, but the recently approved selegiline patch (Emsam) aims to bring the rates up.

“The mission for the condition is remission,” said James W. Jefferson, M.D., of the University of Wisconsin in Madison, but “we are still stuck with this low remission rate.”

Just getting a response with treatment, defined as reducing depression scores by at least half, is not enough, he said in a presentation here at the U.S. Psychiatric and Mental Health Congress regional extension.

The consequences of failing to achieve remission include greater relapse risk, increased risk of resistance to treatment, and worse prognosis for Axis III disorders.

Remission should encompass complete resolution of symptoms and full restoration of psychosocial and work-related functioning, Dr. Jefferson said. But the cutoffs that somewhat arbitrarily define remission on rating scales — such as a score of seven or more on the Hamilton Rating Scale for Depression — allow for residual symptoms.

Several studies, including the National Institutes of Health-funded STAR*D trial (Sequenced Treatment Alternatives to Relieve Depression), have shown complete remission rates as low as 7%, he noted.

While there are few neuropeptide-based agents on the horizon for depression, a new administration route of an old agent may be a new tool in improving remission rates, Dr. Jefferson suggests.

The monoamine oxidase inhibitors were “decent drugs but a little hard to use,” he acknowledged. Adverse events, particularly the risk of acute hypertensive effects with tyramine intake from cheese and other foods and with concomitant use of over-the-counter decongestants, were a major problem.

But the selegiline transdermal patch, FDA approved in February 2006 for treating depression, bypasses the gut to eliminate those problems, Dr. Jefferson said.

One study showed a “large margin of safety” for tyrosine intake and others showed it was well-tolerated compared with placebo, which led the FDA to allow the lowest dose of the drug (6 mg/day) to be used without dietary restriction.

Five placebo-controlled clinical trials have now been done, of which two were positive for efficacy, two showed a trend toward efficacy, and one failed. The one placebo-controlled study of the selegiline patch showed it was effective in preventing relapse.

“Monoamine reuptake is helpful for half of depressed patients, but only a third or fewer reach remission,” Dr. Jefferson concluded. “Other mechanisms of action are needed and are becoming available.”

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In a study of fluoxetine (Prozac) published in the Journal of Clinical Psychiatry in 1999, only 20% of patients who achieved a remission score were fully in remission. Of the rest, 44% had sleep disturbance, 38% had fatigue, and 27% had low interest or pleasure scores.

For a more clinically relevant look at remission rates, the NIH-funded STAR*D trial (Sequenced Treatment Alternatives to Relieve Depression) was undertaken. The results were published in 2006 in the American Journal of Psychiatry and the New England Journal of Medicine.

In the trial, patients progressed from initial treatment with citalopram (Celexa) to bupropion (Wellbutrin), sertraline (Zoloft), venlafaxine (Effexor), or augmented citalopram, then to mirtazapine (Remeron) or nortriptyline (Aventyl, Pamelor) or their previous therapy augmented with lithium or another antidepressant, and finally to tranylcypromine (Parnate) or mirtazapine plus venlafaxine.

Only about 30% of patients achieved remission in the first treatment level. In the second level, remission was about 20% when medication was switched or about 30% when it was augmented, with no significant difference between medications.

In the third level, remission was 12% to 19% when medication was switched and 16% to 25% when it was augmented, with no difference between the medications in remission rates.

By the fourth level, remission rates were “terribly low” at 7% and 14% with no significant difference between treatments.

STAR*D showed how hard it is to achieve remission, Dr. Jefferson said.

Nonetheless, “don’t settle for less than remission,” he admonished psychiatrists. “Don’t give up!

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Nearly One Quarter of Seniors Could Have Avoided Medicare ‘’Doughnut Hole'’

April 26, 2007

ST. LOUIS — Analysis Uncovers Opportunity to Steer Clear of Prescription Coverage Gap and Cut Overall Medicare Part D Costs by 13 Percent Through Increased Use of Generic Drugs Express Scripts (Nasdaq: ESRX), a leading pharmacy benefit manager, today announced results of an analysis examining the 2006 prescription claims history of 220,000 non-low-income seniors with Medicare drug plans that have a standard coverage gap, “doughnut hole,” of $2,250. According to the report, 23 percent of the seniors who fell into the doughnut hole could have avoided doing so if they used available, lower-cost generic drugs instead of brand-name options. A senior in the doughnut hole during 2006 typically paid considerably more of the drug cost from the $2,250 total-cost point until the senior had spent $3,600 of his or her own money. Express Scripts, which supports Medicare Part D and Medicare Advantage plans serving more than 644,000 seniors, presented the analysis today at its annual Outcomes Conference in St. Louis. The analysis also found that greater use of generics, particularly to treat heart conditions, ulcers, depression, diabetes and inflammatory conditions (i.e., arthritis) could have cut total Medicare Part D spending costs by 13 percent. Among the seniors in the analysis, 22 percent hit the doughnut hole and more than half of these (51 percent) had done so just seven months into the year (by August). Despite numbering less than a quarter of the seniors served by the plans in the analysis, “Medicare Doughnut Hole Seniors” accounted for 60 percent of total cost. Seniors who fell into the doughnut hole also lagged in overall generic utilization compared to seniors who did not (53 percent versus 67 percent respectively). “Since the total cost of the drug, including the amount spent by the federal government and the patient’s out-of-pocket expenses is calculated towards the $2,250, using just two branded chronic medications instead of generic alternatives can put a senior in the doughnut hole,” explained Rebecca Rabbitt, Express Scripts senior director for Medicare. “For example, annual average costs for a fully compliant beneficiary taking brand anti-cholesterol and ulcer drugs are $1,046 and $1,390 respectively, putting the patient into the doughnut hole.” Savings were calculated by examining the individual claims histories of each senior in the study to identify where substitution of a generic for a brand drug would have been clinically indicated. While plans distributed the monthly explanation of benefits, there were few additional initiatives to provide seniors with targeted and timely information on savings opportunities. “Generic drugs clearly provide Medicare drug plans and consumers an excellent opportunity to save money which can be critical for seniors who often find themselves unable to afford their medications once they enter the doughnut hole.” adds Rabbitt. “However, it is also very clear that seniors need more information and assistance to help them choose lower-cost options in consultation with their physicians. Education is particularly important for this group as many do not understand the implications of the drug coverage gap until they have entered it.

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” Express Scripts is leveraging its success with consumer engagement in traditional pharmacy benefits to promote greater use of generic drugs. Within commercial pharmacy benefit plans in 2006, Express Scripts saved plan sponsors and patients $126 million just through greater use of generic cholesterol-lowering drugs. By the end of the year, 40 percent of all cholesterol-lowering prescriptions at Express Scripts were for generic simvastatin, lovastatin and pravastatin, up from 8 percent at the beginning of 2006. Contributing significantly to the company’s success in this area is a comprehensive, multi-faceted consumer behavior change program that encourages patients to ask their physician about low-cost generic medication options available to treat high cholesterol. The program includes tailored communications and decision assistance timed for greatest relevance and ease of use. For example, in plans that adopted the program, utilization of generic cholesterol fighting drugs exceeded that of plans without the program by 24 percent. Express Scripts now offers plan sponsors a similar education program for use with Medicare beneficiaries.

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For kids, depression drugs help

April 22, 2007

Authors of a new comprehensive analysis of antidepressants for children and teenagers say the benefits of treatment trump the small risk of increasing some patients’ chances of having suicidal thoughts and behaviors.

The risk they found is lower than the one the Food and Drug Administration identified in 2004, the year the agency warned the public about the drugs’ risks in children. After the warning, U.S. youth suicides increased and some mental health experts said reluctance to try antidepressants might be to blame.

The new analysis includes data from seven studies that were not part of the previous FDA analysis, including information from two large pediatric depression trials that was unavailable three years ago.

Researchers analyzed data on 5,310 children and teenagers from 27 studies. They found that for every 100 kids treated with antidepressants, about one additional child experienced worsening suicidal feelings above what would have happened without drug treatment. In contrast, the FDA analysis found an added risk affecting about two in 100 patients.
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There were no suicides in any of the studies. The antidepressants included Prozac, Paxil, Zoloft, Celexa, Lexapro, Effexor, Serzone and Remeron.

“The medications are safe and effective and should be considered as an important part of treatment,” said study co-author Dr. David Brent of the University of Pittsburgh School of Medicine. “The benefits seem favorable compared to the small risk of suicidal thoughts and behavior.”

The antidepressants worked best when used to treat anxiety, the analysis found. They worked moderately well treating obsessive-compulsive disorders. They worked less well but were still effective in treating depression.

The analysis, supported by grants from the National Institute of Mental Health and the Robert Wood Johnson Foundation, appears in the April 18 issue of the Journal of the American Medical Assn. For a summary of the study, go to

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Study backs drugs for kids’ depression

April 18, 2007

CHICAGO - Authors of a new comprehensive analysis of antidepressants for children and teenagers say the benefits of treatment trump the small risk of increasing some patients’ chances of having suicidal thoughts and behaviors.The risk they found is lower than the one the Food and Drug Administration identified in 2004, the year the agency warned the public about the drugs’ risks in children. After the warning, U.S. youth suicides increased and some mental health experts said reluctance to try antidepressants might be to blame.

The new analysis includes data from seven studies that were not part of the previous FDA analysis, including two large pediatric depression trials that were unavailable three years ago.

Researchers analyzed data on 5,310 children and teenagers from 27 studies. They found that for every 100 kids treated with antidepressants, about one additional child experienced worsening suicidal feelings above what would have happened without drug treatment. In contrast, the FDA analysis found an added risk affecting about two in 100 patients.

There were no suicides in any of the studies. The antidepressants included Prozac, Paxil, Zoloft, Celexa, Lexapro, Effexor, Serzone and Remeron.

“The medications are safe and effective and should be considered as an important part of treatment,” said study co-author Dr. David Brent of the University of Pittsburgh School of Medicine. “The benefits seem favorable compared to the small risk of suicidal thoughts and behavior.”

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Adolescents responded better than children to treatment for depression and anxiety, the researchers found. They also found that only Prozac worked better than dummy pills in depressed children younger than 12.

In the studies involving depression, 61 percent of patients improved while on antidepressants. But 50 percent of depressed patients taking dummy pills also improved.

Among young patients with obsessive-compulsive disorders, 52 percent improved on antidepressants, compared to 32 percent who improved on dummy pills.

And in the studies of anxiety disorders, 69 percent improved on antidepressants and 39 percent improved on dummy pills.

Effectiveness of the drugs was measured in the studies using widely accepted rating scales. The analysis appears in today’s Journal of the American Medical Association.

The study was supported by grants from the National Institute of Mental Health and the Robert Wood Johnson Foundation

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Drug combinations may result in disaster

April 15, 2007

My mother was admitted to the hospital a few weeks ago for dehydration, acute bronchitis and pneumonia. During the admission, they checked her blood level of Coumadin and discovered that it was about 10 times higher than normal.

The doctors in the emergency room were shocked, as were Mom and I! The doctor said that had Mom fallen, she could have bled to death in a couple of minutes. The ambulance would never have arrived in time.

My mother was taking Cymbalta as well as Coumadin. The doctor who prescribed this new antidepressant for my mother didn’t know about this interaction. It is NOT listed in the prescribing information. Please warn others of this drug interaction, as it may save someone’s life.

Taking the wrong combination of medicines can be lethal. Thank you for alerting us to the potential danger of mixing the blood thinner Coumadin (warfarin) with the antidepressant Cymbalta.

Like some of your readers, I get cracked fingers when it’s cold. This year I decided to try something different. I had a place split open at the end of my thumb. I put Super Glue on it, held it together and let it dry. It worked beautifully.

Instant glue seals up the crack so there’s no pain. When it starts washing off, I just put more on it until it’s well. Works great!

Physicians have been using a product similar to instant glue to close cuts. The cyanoacrylate glue they use is called Dermabond. This is now also available to consumers in Band-Aid brand Liquid Bandage. It may be less irritating to the skin than household instant adhesives like Super Glue or Krazy Glue.

My doctor said that I should be taking an aspirin every day, but my pharmacist said that aspirin doesn’t protect women the way it does men. Who’s right, and what’s the best dose?

A new study of almost 80,000 women who were followed for more than 20 years suggests that women do indeed benefit from aspirin (Archives of Internal Medicine, March 26, 2007). The nurses who participated had a lower likelihood of dying of a heart attack if they took aspirin regularly for at least five years. After 10 years, they were also less likely to develop cancer.

Doses ranged anywhere from one to 14 standard aspirin tablets a week. Some experts have suggested that the optimal dose to protect against heart attacks is around 160 mg daily — half a regular tablet. No one should take aspirin daily without medical supervision, because it can damage the digestive tract and interact with other medications.

I was diagnosed with “depression,” and for several years I took a series of different antidepressant drugs. The results were unsatisfactory, and I experienced many unpleasant side effects.

Then one year I was hospitalized for an unrelated medical problem. During the tests I was found to be suffering from severe hypothyroidism. I needed Synthroid, not Zoloft!

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If any of your readers are being treated for depression and have not had a complete physical exam and a thyroid test, they should ask for this immediately.

People with underactive thyroid glands may experience a range of symptoms, including depression, apathy and fatigue, as well as weakness, anemia, high cholesterol or mental slowness. Treating such symptoms with an antidepressant instead of thyroid hormone could be counterproductive. Certain antidepressants (particularly lithium, but drugs such as Paxil or Zoloft in rare cases) have been associated with thyroid imbalances.

I am interested in purchasing flatulence filters. My mom has severe gas problems and is taking charcoal tablets along with other things. The problem is still noticeable. I would like to try the filters. I have checked a couple of drugstores but have had no luck.

Search the Web for the GasBGon flatulence filter seat cushion (www.GasBGon.com). It contains activated charcoal to trap odors from the digestive tract. The same company (Dairiair at 877-427-2466) also makes underwear with activated charcoal woven into the fabric. These carbonized undies reduce the problem of unpleasant smells even when the wearer is not sitting on a flatulence filter seat cushion.

Last summer you ran a letter from a woman who reported that gin-soaked raisins had helped BOTH her arthritis and restless legs syndrome (RLS). Mercifully, I don’t have arthritis, but I do have RLS, so I’ve been trying this remedy after dinner ever since.

I am most happy to report that those silly little raisins have gone a long way toward moderating the problem for me. I can once again watch a few hours of TV in the evening without wanting to crawl out of my skin. It’s usually a lot easier to fall asleep as well. Oh joy!

We have been writing about gin-soaked raisins since 1994. We have no idea why some people find them so helpful for arthritis pain.

Last July we received this letter from a reader: “I read about your home remedy of white raisins soaked in gin to help arthritis pain. I tried this and found only a moderate improvement in arthritis pain. But after two weeks of treatment I noticed a marked improvement in RLS.

“Have others reported this seeming cure? I used to experience RLS two or three times a week, but have not had a recurrence since beginning the gin/white raisin treatment.”

Anyone who would like to know more about the gin-soaked raisin remedy or other approaches to leg cramps and RLS may order our Guides to Home Remedies and Leg Pain. Please send $4 in check or money order with a long (No. 10), stamped (63 cents), self-addressed envelope to: Graedons’ People’s Pharmacy, No. RR-51, P.O. Box 52027, Durham, NC 27717-2027.

I am 70. When I was 13, my mother told me to use rubbing alcohol as a deodorant. It works.

I have tried over-the-counter products but find Mom’s advice works like a gem. All my six children use this cheap remedy, and now their families do, too!

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Supporters Rallying Around ‘Zoloft Killer’

April 12, 2007

COLUMBIA, S.C. — Supporters are rallying around a teenager who killed his grandparents and blamed the antidepressant drug Zoloft. Every week, Janet Sisk rises as early as 5 a.m. and drives nearly 100 miles to spend her Sundays with the boy who was just 12 when he murdered his grandparents in their sleep.She planned to spend part of Easter weekend sitting across a table from Christopher Pittman at his maximum security prison in Columbia. She also made the trek from her home in Charlotte, N.C., to spend Christmas Eve with him.

She’s not alone — a half-dozen people drawn to Pittman’s case visit him weekly. Another woman has flown from Michigan to see him twice in the past year. Hundreds of others rally around him in other ways: promising to pay for college when he gets out of prison, and campaigning for extra safeguards for arrested juveniles in South Carolina.

To Sisk, director of the Juvenile Justice Foundation, Pittman has become more than the youth who attracted worldwide attention when he blamed the 2001 slayings on Zoloft, the antidepressant he was taking. She now thinks of him as her third son.

“He’s shy and he’s quiet and he’s polite,” Sisk said recently. “It’s like we’ve been friends with him forever.”

Pittman used a pump-action shotgun to shoot his grandparents, Joe and Joy Pittman, and then set fire to their Chester County home.

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During his trial, not held until four years later, Pittman’s attorneys unsuccessfully argued he was involuntarily intoxicated by Zoloft and did not know right from wrong. A judge sentenced him to 30 years in prison.

Pfizer Inc., the manufacturer of Zoloft, said in a news release after the verdict that Zoloft “didn’t cause his problems, nor did the medication drive him to commit murder. On these two points, both Pfizer and the jury agree.”

Zoloft is the most widely prescribed antidepressant in the United States, with 32.7 million prescriptions written in 2003. In 2004, the Food and Drug Administration ordered Zoloft and other antidepressants to carry “black box” warnings — the government’s strongest warning short of a ban — about an increased risk of suicidal behavior in children.

Now 6-foot-2, Pittman turns 18 on Monday in an adult prison where he was moved six months ago from a juvenile facility, but the supporters who visit him say that even Pittman doesn’t consider himself to be grown up.

“Chris said, ‘You have to remember, that everyone here is the age that they were when they went in,’” said Teresa Strattard, the Saginaw, Mich., woman who has visited twice. “So, he was basically saying that he was 12.”

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Aspirin benefits both sexes

April 7, 2007

My doctor said that I should be taking an aspirin a day, but my pharmacist said it doesn’t protect women like men. Who’s right? and what’s the best dose?

A March 2007 study of almost 80,000 women followed for more than 20 years suggests that women do benefit from aspirin. The nurses who participated were less likely to die of a heart attack if they took aspirin regularly for at least five years. After 10, cancer rates dropped also.

Doses ranged from one to 14 standard aspirin tablets a week. Some experts have suggested that the optimal dose to protect against heart attacks is around 160 milligrams daily — half a regular tablet. Do not take aspirin daily without medical supervision: It can damage the gut and interact with other medications.

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I was diagnosed with depression, and for years took different antidepressants. The results were unsatisfactory. I experienced unpleasant side effects. Then I was hospitalized for an unrelated medical problem and was found to suffer from severe hypothyroidism. I needed Synthroid, not Zoloft!

People with underactive thyroid glands may experience depression, apathy and fatigue, as well as weakness, anemia, high cholesterol or mental slowness. Treating such symptoms with an antidepressant instead of thyroid hormone could be counterproductive. Certain antidepressants (particularly lithium, but Paxil or Zoloft in rare cases) have been associated with thyroid imbalances.

Joe Graedon, a pharmacologist, and Teresa Graedon, an expert in medical anthropology and nutrition, can be reached at www.peoplespharmacy.com or care of this newspaper.

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Fewer Children and Teens Received Antidepressants Following FDA Warnings

April 5, 2007

CHICAGO, April 2, 2007—The number of children and teenagers prescribed antidepressant medications appears to have decreased following public warnings about suicidal behavior potentially associated with the drugs, according to a report published in the April issue of Archives of General Psychiatry, one of the JAMA/Archives journals. In addition, antidepressants are now more often prescribed to this age group by psychiatrists rather than primary care physicians.

The U.S. Food and Drug Administration (FDA) issued a public health advisory on Oct. 27, 2003, warning of an increased risk of suicidality (suicide attempts or suicide-related behavior) among children and teens taking antidepressants, according to background information in the article. A much-publicized hearing was held on the topic in February 2004. On March 22, 2004, the FDA issued another advisory instructing manufacturers to include a black-box warning on product labels recommending close monitoring of adults and children taking antidepressants. Conflicting information has since been presented regarding whether these warnings had any effects on prescription patterns.

Charles B. Nemeroff, M.D., Ph.D., Emory University School of Medicine, Atlanta, and colleagues analyzed prescription data and information from physician surveys provided by Verispan, a Pennsylvania-based health care information company. The prescription data capture about 55 percent of all U.S. retail pharmacy claims, including private payers, Medicaid and cash transactions—more than 1.4 billion prescriptions per year. The physician survey involved approximately 3,400 office-based physicians across 29 specialties, and is projected out to provide a representative view of diagnoses and prescriptions in the United States.

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Upon analyzing the data from 2000 to 2005, the researchers found that “the growth in total antidepressant prescriptions seemed to begin to slow around the timing of the public health advisories in October 2003 and March 2004 about pediatric suicidality,” they write. “However, by the time the FDA panel met to discuss the data findings in September 2004, the proceedings from the meeting had little effect on the market—behavior had already been altered.” Prescriptions of antidepressants to patients younger than 18 years increased by .79 percent per month from April 2002 to February 2004, decreased by 4.23 percent per month from February 2004 to July 2004 and stabilized from July 2004 to March 2005.

In addition, “there has been a shift in the providers of care of depressed patients younger than 18 years away from primary care and other providers to psychiatrists,” the authors write. From December 2003 through February 2004, psychiatrists accounted for 44 percent of patient care for those younger than 18 years. From December 2004 through February 2005, psychiatrists cared for 63 percent of pediatric and adolescent depressed patients.

The only antidepressant approved by the FDA for use in pediatric patients is fluoxetine, which is a member of a class known as selective serotonin reuptake inhibitors (SSRIs). However, the analyses also showed a trend toward prescribing bupropion, a non-SSRI antidepressant, to young patients. This trend “could stem in large part from physicians attributing the increased risk of suicidality primarily to SSRIs, even though bupropion is also labeled with a black box warning.”

Although the findings do not speak to whether these changes in prescriptions are appropriate, they do indicate that the warnings have had an effect, the authors write. It is also unclear how warnings about suicidality and antidepressants in older patients will change the treatment of depression. “It is evident, however, that there is need for additional exploration into the relationship between FDA action, media reaction and physician behavior change to ensure that dissemination of drug safety information does not interfere with appropriate access to care,” the authors conclude.
(Arch Gen Psychiatry. 2007;64:466-472. Available to the media pre-embargo at www.jamamedia.org).

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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