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Lilly’s Cymbalta cleared for anxiety disorder

February 28, 2007

Cymbalta is already approved to treat major depression and diabetic peripheral neuropathy, a condition associated with diabetes that causes pain or numbness in the limbs.

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The drug belongs to a group of newer psychiatric medications called SNRIs — short for serotonin-norepinephrine reuptake inhibitors — that also includes Effexor from Wyeth

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Merck is on the mend

February 26, 2007

In the dark autumn of 2004, when Merck withdrew its blockbuster heart drug Vioxx over concerns it caused cardiac arrest, the company lost roughly a third of its market value within days. But in 2006, Merck’s shares quietly surged 40%. What’s more, there may be enough upside left to this recovery to make the company a solid long-term investment again.

Merck (Charts) is delivering on new CEO Richard Clark’s recovery plan, making improvements and eking out efficiencies in all aspects of its business. The company garnered more FDA approvals than any of its competitors in 2006, launching five new drugs, including the first-of-its-kind cervical-cancer vaccine, Gardasil. And Merck is improving research productivity. Since 2005, the labs have cut seven months from drug development times. That means the company’s experimental drugs will reach the final stages of research in 30 months, vs. the industry average of 44 months.

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There’s also a sense of order in the court for Merck. The first Vioxx lawsuits went to trial last year, and the results were better than expected. In the 18 cases scheduled during 2006, juries decided in Merck’s favor nine times. The company lost four cases, and another five were withdrawn from trial calendars. Analysts believe that the Vioxx lawsuits no longer weigh on Merck’s shares the way they once did. “They’ve won two-thirds of the cases, and everything seems to be in control,” says Herman Saftlas, an analyst with Standard & Poor’s.

John Boris of Bear Stearns upgraded Merck shares to market overweight on Jan. 3. Boris believes that Merck, which has a nifty 5% yield, will probably outperform the S&P in 2007, with a gain of roughly 22%. His year-end target price: $53

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Stone Age solutions A University of Kansas psychologist has Stone Age solutions to depression

February 20, 2007

To confront the country’s growing depression epidemic, a modern phenomenon, psychologist Steve Ilardi peered backward into human history.

Way back, tens of thousands of years and beyond. His research steered him there, to an examination of the hunter-gatherer way of life, to a time when humans lived in roving, close-knit bands. Back to the Stone Age.

What he learned led Ilardi and his research team at the University of Kansas to propose a program to reclaim six disappearing lifestyle elements. They call it Therapeutic Lifestyle Change, intended to help modern humans deal with depressive illness.

The team identified factors that are antidepressant but are compromised by contemporary culture: Exercise, omega-3 consumption, light exposure, sleep, social connectedness and anti-ruminative behavior.

The latest and sobering statistics predict that one in four Americans will become clinically depressed by age 75, Ilardi said. Americans are 10 times more likely to have depressive illness than they were 60 years ago.

Ilardi is an associate professor of psychology, not a self-help guru. And he knows the hunter-gatherer talk can sound a little wacky. But he said his early results are showing phenomenal success.

About a year ago Becky Foerschler of Lawrence, a mother of three, felt herself drifting, pulling back from social commitments, uncharacteristically sapped of energy.

Foerschler’s situation wasn’t dire. But a series of stressful family matters had preceded her troubling lethargy, and friends hinted that her symptoms looked like depression.

“I thought, ‘This isn’t something that’s going to go away by itself.’ �

She wasn’t keen on taking antidepressant drugs, so when she heard about Ilardi’s research, she called to make an appointment. She met with therapists and was accepted into the program.

Depression treatment often centers on talk therapy and antidepressant drugs. The drugs have been lifesavers for many people. But antidepressants aren’t working as well as advertised, Ilardi said, and their side effects can go from bad to devastating, including suicidal behavior.

In the last two decades, the use of antidepressant drugs has increased 800 percent, yet depressive illness continues to climb. Recently one of the largest studies of an antidepressant drug found a 47 percent favorable response. “Favorable� meant complete recovery or significant reduction in symptoms. But that’s more than half who weren’t helped, Ilardi said.

“Clearly we need to do better,� Ilardi said.

Depressive illness is more frequent in developed countries than in developing ones and worse among city dwellers than among rural folks. The Amish have very low depression rates.

An anthropologist who studied the Kaluli people, a modern-day hunter-gatherer group in Papua New Guinea, found only one case of depression among 2,000 people interviewed. Like hunter-gatherers of old, the Kaluli lack modern comforts and medicine. They deal regularly with infant mortality, disease and violence.

Culturally the contrast with modern Americans is huge. Biologically, however, we’re not so different, not even from the hunter-gatherer clans going back hundreds of thousands of years.

“In many respects we’re walking around with Stone Age brains and Stone Age bodies,� Ilardi said.

Rapid cultural change is relatively recent, starting with farming, then city-building, then the technological explosion. So Ilardi asked: Are there built-in features of that ancient way of life that are antidepressant and that we need to reclaim?

Hunter-gatherers walked for miles. They got lots of light exposure. They slept when the sun was down. And they ate differently. Many obesity experts think our appetites trace back to a time when food was an uncertain commodity.

So far, 47 clinically depressed adults have completed treatment in the program. Ilardi is impressed with the results: 75 percent recovered fully or had a significant reduction in symptoms.

Rick Ingram, KU professor of psychology, was skeptical of Ilardi’s program at first but sees the results as promising. One caveat is that the treatment program requires further testing, done independently from Ilardi’s team.

“This is an innovative program in its initial stages, and, as such, the data are not fully in,� he said.

Ingram said the Therapeutic Lifestyle Change program, rather than competing with traditional therapies, could eventually be used in conjunction with them.

“Areas of biology and psychology converge in this program,� Ingram said. “The innovation is in bringing them all together.�

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In the 12-week program the 90-minute, weekly sessions are led by two clinicians and include five to eight clients. The six elements are introduced one week at a time. Clients talk with therapists by phone between sessions.

Foerschler completed the program last summer and remains free of symptoms.

“By the sixth week I was definitely noticing a difference, and by the end of the 12 sessions I wasn’t having any symptoms,� Foerschler said
The six elements of change

Researchers at KU are studying the effects of a six-part Therapeutic Lifestyle Change program for people with symptoms of depressive illness.

But the techniques could benefit a wide range of people, said Steve Ilardi, associate professor of psychology, including those at risk of depression or with a family history. And many of the elements have been shown to be mood-boosters, he said.

Here are the six elements. Clients in the Therapeutic Lifestyle Change study are under the guidance of therapists and doctors. Always consult with a doctor before starting an exercise program or using dietary supplements.

OMEGA-3 FATTY ACIDS

The brain needs essential fatty acids, omega-6 and omega-3, for healthy function. The typical American diet provides a 16-to-1 ratio of omega-6 to omega-3 fats. The healthiest ratio is 1-to-1. Omega-3 intake has dropped precipitously in the last 100 years, due in part to grain-fed meat and fish, Ilardi said. Some studies associate omega-3 deficiency with increased depression risk.

Treatment : Daily supplement of 1,000 milligrams of omega-3, known as EPA (eicosopentaenoic acid), a concentrated form of fish oil, and a multivitamin. Ilardi said this is a high, therapeutic dose but “there’s still no consensus among researchers on the optimal omega-3 dose.� The multivitamin is to reduce oxidative effects.

EXERCISE

While people in hunter-gatherer societies spend hours a day in physical activity, a majority of American adults get no regular physical exercise. Clinical trials have identified exercise as an effective depression treatment, with just 90 minutes a week being effective.

Treatment: Thirty minutes of aerobic exercise three times a week.

LIGHT EXPOSURE

Hunter-gatherers spend the day outside, exposed to sunlight. The light on a sunny day is at least 10 to 20 times brighter than light indoors. A lack of light exposure has been found to disrupt sleep and alter hormones, contributing to fatigue.

Treatment: Thirty minutes of daily exposure to sunlight. The program also provides clients with a 10,000-lux light box — lux is a measure of illumination — for use in simulating a sunny day.

SLEEP

Americans on average get 6.8 hours of sleep a night. Just 100 years ago, they slept nine hours. Some members of modern-day hunter-gatherer societies complain about getting too much sleep. Lack of sleep is a well-established health risk.

Treatment: The goal is eight hours. Therapists suggest ways to improve sleep, such as dimming lights and lowering the thermostat an hour before bedtime.

SOCIAL CONNECTEDNESS

Hunter-gatherer societies live in groups of 50 to 150, chiefly with close relatives and friends. American adults have grown isolated from other family members and from friends. Social support is a safeguard against the risk of depression. “We’re designed to have lots of face time with those closest to us,� Ilardi said.

Treatment: Therapists and clients discuss ways to improve relationships and to overcome social withdrawal. Clients set goals for social activities, including scheduling conversations with friends and relatives. Ilardi noted that while spiritual practices are not specifically in the program, many find powerful social connections in church communities.

ANTI-RUMINATIVE BEHAVIOR

Rumination is the tendency to dwell on negative thoughts. Episodes of rumination occur most often when alone. With nearly constant social activity, hunter-gatherers have little opportunity for rumination. Many Americans spend a lot of time alone, including sitting in traffic and staring at TV.

Treatment: Therapists explain the toxic effects of rumination and how to combat it by avoiding long periods alone and by interrupting such periods with an activity or by contacting a loved one.

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Sanofi unveils new antidepressant

February 19, 2007

Sanofi-Aventis has announced promising clinical trial data for a new antidepressant drug that works in a different way to others currently available.

Saredutant is designed to block the effects of a G protein coupled receptor (GPCR) called neurokinin 2 (NK2). The drug could prevent neurochemical changes induced by different stressful conditions in brain regions implicated in depression and anxiety disorders.

The clinical results were announced alongside the company’s financial results after what Sanofi themselves described as “not an easy year” with several “major adverse events.”

Established antidepressant treatments work by causing serotonin levels to be increased. However, a report in the Journal of Clinical Psychology claimed that some mutations in the gene 5HT transporter gene could predispose patients to not respond well to these treatments. Therefore, there is a need for antidepressant s based on a different mechanism of action.

Antidepressant drugs also fail because they are often associated with a variety of unpleasant side effects, such as decreased sex drive, gastrointestinal disorders and weight gain, which can lead to patients stopping taking their medication.

Sanofi expects its once-a-day drug to have low incidence of these side effects. The company is conducting several Phase III trials looking at safety, efficacy (both short and long-term) and the effects of sudden withdrawal.

Saredutant is in development to treat major depressive disorder and General Anxiety Disorder. Of four Phase III studies for depression, two showed statistically significant results and two studies were not statistically significant versus placebo. The results from four other Phase III studies are expected this year or in 2008.

In a recent Phase IIb study, 44 per cent of patients responded to treatment with saredutant with 37 per cent classed as being in remission after six weeks of treatment.

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The side effects of saredutant were studied compared to GlaxoSmithKline’s $1.2bn (€926m) antidepressant drug Seroxat/Paxil (paroxetine). Incidence of nausea and diarrhoea was more than halved with Sanofi’s drug and the proportion of patients who felt any side effect was reduced by 10 per cent.

GPCRs are the largest known class of drug targets with proven therapeutic benefits. Drugs that interact with these proteins make up nearly 40 per cent of the top 50 selling drugs worldwide. The proteins are responsible for responding to signals outside the cell and translating this into biological processes inside the cell.

NK2 is one of three tachykinin receptors. It binds to neurokinin A and induces the production of a chemical called inositol triphosphate, which is found in elevated levels in patients suffering from depression.

There are several other drugs in development that also target the GPCR, NK2, although these drugs are not for depression therapy. One example is nepadutant from Menarini, the first Italian pharma company. Currently conducting Phase II trials, the drug is designed to treat irritable bowel syndrome.

AstraZeneca was also developing a NK2 inhibitor drug called M274773, although it no longer appears on the firm’s pipeline listing.

Meanwhile, Sanofi also announced that it has dropped two experimental anticancer drugs from its pipeline. SR31747 was in Phase IIb trials for prostate cancer and tirapazamine was a Phase III drug candidate, designed to treat head and neck cancer.

SR31747 binds to two proteins: sigma 1 receptor and emopamil-binding protein (EBP) and can inhibit tumour growth by preventing cell proliferation.

Tirapazamine (SR 259075) is activated by hypoxia to make cancer cells more sensitive to chemotherapy

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Sanofi unveils new antidepressant

February 14, 2007

Saredutant is designed to block the effects of a G protein coupled receptor (GPCR) called neurokinin 2 (NK2). The drug could prevent neurochemical changes induced by different stressful conditions in brain regions implicated in depression and anxiety disorders.

The clinical results were announced alongside the company’s financial results after what Sanofi themselves described as “not an easy year” with several “major adverse events.”

Established antidepressant treatments work by causing serotonin levels to be increased. However, a report in the Journal of Clinical Psychology claimed that some mutations in the gene 5HT transporter gene could predispose patients to not respond well to these treatments. Therefore, there is a need for antidepressant s based on a different mechanism of action.

Antidepressant drugs also fail because they are often associated with a variety of unpleasant side effects, such as decreased sex drive, gastrointestinal disorders and weight gain, which can lead to patients stopping taking their medication.

Sanofi expects its once-a-day drug to have low incidence of these side effects. The company is conducting several Phase III trials looking at safety, efficacy (both short and long-term) and the effects of sudden withdrawal.

Saredutant is in development to treat major depressive disorder and General Anxiety Disorder. Of four Phase III studies for depression, two showed statistically significant results and two studies were not statistically significant versus placebo. The results from four other Phase III studies are expected this year or in 2008.

In a recent Phase IIb study, 44 per cent of patients responded to treatment with saredutant with 37 per cent classed as being in remission after six weeks of treatment.

The side effects of saredutant were studied compared to GlaxoSmithKline’s $1.2bn (€926m) antidepressant drug Seroxat/Paxil (paroxetine). Incidence of nausea and diarrhoea was more than halved with Sanofi’s drug and the proportion of patients who felt any side effect was reduced by 10 per cent.

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GPCRs are the largest known class of drug targets with proven therapeutic benefits. Drugs that interact with these proteins make up nearly 40 per cent of the top 50 selling drugs worldwide. The proteins are responsible for responding to signals outside the cell and translating this into biological processes inside the cell.

NK2 is one of three tachykinin receptors. It binds to neurokinin A and induces the production of a chemical called inositol triphosphate, which is found in elevated levels in patients suffering from depression.

There are several other drugs in development that also target the GPCR, NK2, although these drugs are not for depression therapy. One example is nepadutant from Menarini, the first Italian pharma company. Currently conducting Phase II trials, the drug is designed to treat irritable bowel syndrome.

AstraZeneca was also developing a NK2 inhibitor drug called M274773, although it no longer appears on the firm’s pipeline listing.

Meanwhile, Sanofi also announced that it has dropped two experimental anticancer drugs from its pipeline. SR31747 was in Phase IIb trials for prostate cancer and tirapazamine was a Phase III drug candidate, designed to treat head and neck cancer.

SR31747 binds to two proteins: sigma 1 receptor and emopamil-binding protein (EBP) and can inhibit tumour growth by preventing cell proliferation.

Tirapazamine (SR 259075) is activated by hypoxia to make cancer cells more sensitive to chemotherapy.

Posted by toshko under Anit Depressant News | Comments (0)

Glaxo distorted Paxil drug test data: BBC

February 13, 2007

GlaxoSmithKline Plc was accused on Monday of distorting clinical trial results of its antidepressant Seroxat, or Paxil, and covering up a link with suicide in teenagers.

The BBC plans to air a Panorama program later saying the drug company attempted to show that Seroxat worked for depressed children despite failed clinical trials and that Glaxo-employed ghostwriters influenced “independent” academics.

“We utterly reject the allegations that are being made in their program,” a Glaxo spokeswoman said.
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She denied the company had improperly withheld any trial information and said results from pediatric studies were documented and submitted to regulators in accordance with requirements, as well as being presented publicly and published.

Regulators in 2003 recommended against using Seroxat in people under 18 due to an increase in the rate of self-harm and potentially suicidal behaviors in this age group when the drug was prescribed.

But Glaxo said the increase in suicidal thinking was only revealed when results of separate clinical studies were pooled at the end of its research program, at which point the company brought the findings to the attention of regulatory authorities.

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Generics’ delays draw scrutiny

February 8, 2007

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February 8, 2007

Generics’ delays draw scrutiny
Congress ponders limiting efforts by brand-name drug makers to stave off cheaper rival offerings

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By Maureen Groppe
Star Washington Bureau
Brand-name and generic drug makers compete over consumers’ drug dollars, but some members of Congress think they’ve been colluding to share profits at the expense of cheaper drugs for the public.

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Lawmakers want to tighten regulations that have allowed brand-name drug makers to pay generic rivals millions of dollars to delay putting a low-cost competitor on the market.
For consumers, getting a generic version can cut their drug bills by more than half.
For drug makers such as Eli Lilly and Co., losing the right to sell a brand-name drug can cost billions.
When Lilly’s blockbuster antidepressant drug, Prozac, lost its patent protection in 2001 after 13 years on the market, the drug’s share of antidepressant prescriptions fell from 22 percent to 8 percent in just three weeks.
By the end of the year, Prozac’s sales had dropped by nearly 70 percent, forcing the company to tighten its belt.
Drug companies are under enormous pressure to protect their blockbuster products, which often account for more than half of their sales.
Best-selling drugs that are currently being challenged by generic firms include Lilly’s Gemzar for cancer, AstraZeneca’s ulcer drug Nexium, and anti-psychotic Seroquel, also made by AstraZeneca.
Eli Lilly isn’t accused of making payoffs to generic companies, and Lilly spokesman Ed Sagebiel said the company has not used “reverse payments” to stave off generic competition.
But in half of the 28 recent settlements on challenges to drug patents, brand-name companies gave some form of compensation to the generic challenger that agreed to delay production, according to the Federal Trade Commission.
“It is critical to eliminate the pay-for-delay settlement tactics employed by the pharmaceutical industry,” FTC Commissioner Jon Leibowitz recently told the Senate Judiciary Committee. “Companies should not be able to play ‘deal or no deal’ at the expense of American consumers.”
The committee could vote as early as today on a bill aimed at preventing such settlements. It would ban generic companies from settling for “anything of value” while agreeing not to develop or market a product for a specific time.
“Congress never intended for brand-name companies to be able to pay off generic companies not to produce generic medicines,” said Sen. Patrick Leahy, the Vermont Democrat who heads the committee.
Sagebiel said Lilly is still reviewing the proposed legislation and hasn’t taken a position on it.
Lilly is currently involved in patent challenges to Zyprexa, which treats schizophrenia and bipolar disorder, the osteoporosis drug Evista and Gemzar.
Generic competition to four major brand-name drugs, including Prozac, saved consumers more than $9 billion, according to the Generic Pharmaceutical Association.
Congress passed a law in 1984 aimed at striking a balance between allowing brand-name companies to benefit from the patents they earned through hundreds of millions of dollars in research, while preventing them from unfairly extending the patents. As part of the law, Congress made it easier for generic companies to challenge invalid or narrow patents.
The FTC has tried to prevent payoffs to settle the patent challenges, but court rulings in 2005 — four years after Prozac lost patent protection — reversed FTC rulings and opened the door to such settlements.
For example, an appeals court said it was OK for Schering-Plough Corp. to pay $75 million to two generic manufacturers who agreed to delay marketing of the generic version of K-Dur 20, used to treat high-blood pressure and congestive heart disease.
The trade groups for the brand-name and generic drug companies argue that rather than prohibiting cash settlements in exchange for delayed competition, all settlements should continue to be reviewed by the FTC and the courts.
Billy Tauzin, the former House member who heads the Pharmaceutical Research and Manufacturers Association, said some settlements are good because they end costly litigation and set a date certain for market entry.
“Don’t shoot the good,” Tauzin said. “Let’s just keep shooting the bad and the ugly.”
But the FTC’s Leibowitz said it’s better for Congress to draw a bright line on what’s allowed because that would be a “swifter, more certain and more comprehensive solution,” than allowing the settlements to be hashed out in the legal system.

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Antidepressants Versus Placebos: Meaningful Advantages Are Lacking

February 5, 2007

This is a preview of the Rumble in Reno II scheduled for Oct. 18. The debate between Kirsch and Thase will focus on the issues highlighted in these point/counterpoint articles. Brochures for this conference are available online at -Ed.)

Antidepressants are widely believed to be exceptionally effective medications. The data, however, tell a different story. Kirsch et al. (2002a) analyzed the data sent to the U.S. Food and Drug Administration by the manufacturers of the six most widely prescribed antidepressants (fluoxetine [Prozac], paroxetine [Paxil], sertraline [Zoloft], venlafaxine [Effexor], nefazodone [Serzone] and citalopram [Celexa]). Their research showed that although the response to antidepressants was substantial, the response to inert placebo was almost as great. The mean difference was about two points on the Hamilton Rating Scale for Depression (HAM-D). Although statistically significant, this difference is not clinically significant (Jacobson et al., 1999). More than half of the clinical trials sponsored by the pharmaceutical companies failed to find significant drug/placebo difference, and there were no advantages to higher doses of antidepressants. The small difference between antidepressant and placebo has been referred to as a “dirty little secret” by clinical trial researchers (Hollon et al., 2002), a secret that was believed by FDA officials to be “of no practical value to either the patient or prescriber” (Leber, 1998, as cited in Kirsch et al., 2002b).

Previous reports of vanishingly small drug/placebo differences (Kirsch and Sapirstein, 1998) were met with skepticism (e.g., Klein, 1998). In contrast, the basic findings from this new meta-analysis have been accepted as accurate (e.g., Thase, 2002). The dispute is no longer about the small size of the average drug/placebo difference, but rather about how to interpret this fact and what to do about it.

Various interpretive possibilities have been raised. One of the most popular theories is that there may be a subset of patients for whom at least some antidepressants are very effective, but that their relative lack of efficacy with other patients masks effect (e.g., Thase, 2002). Specifically, whereas mildly depressed patients respond to both drugs and placebos, more severely depressed patients respond only to active drugs. The FDA data contradict this hypothesis. Although severely depressed patients benefited more from medication than mildly depressed patients due to a phenomenon known as regression toward the mean, they also benefited more from placebo than their more mildly depressed counterparts.

Of course, one can never rule out the possibility of undetected moderator variables. But if there are hidden moderators, the overall mean difference between drug and placebo (two points on the HAM-D) constrains the conclusions that can be drawn from them. If the mean drug/placebo difference is greater than two points for a subset of medications or patients, then it must be less than two points for the others. For example, if the mean difference between drug and placebo is four points for half of the patients (which is still a rather small drug effect), then the mean effect of antidepressants on the other patients must be zero, and if it is more than four points for half the patients, then the medications must be interfering with responsiveness in at least some others who would fare better on placebo.

Another popular hypothesis is that drug effects are more stable than placebo effects, resulting in lower relapse rates. This hypothesis is also contradicted by the data. A meta-analysis of relapse prevention trials published between 1973 and 1990 indicated that 71% of the drug response was duplicated by placebo (Walach and Maidhof, 1999). Kirsch et al.’s meta-analysis also examined response to treatment as a function of the duration of the trial. The data indicated that responses to both drug and placebo decrease over time. Contrary to conventional wisdom, however, the correlation between duration of the trial and response to treatment was higher for active medication (r=-0.84) than for placebo (r=-0.62), suggesting a steeper decline in effectiveness for active drugs than for placebo (Kirsch et al., 2002b).

In light of these data, what should be done in clinical contexts? Some have suggested that antidepressants continue to be prescribed, even if their effects are largely placebo effects. If nothing else, these agents can be used as active placebos. Given the side effects of these medications, we suggest an alternative approach. There are many interventions that seem to be as effective or nearly as effective as antidepressants. These include physical exercise, bibliotherapy and psychotherapy (Kirsch et al., 2002b). Psychotherapy has the further advantage of demonstrated superiority to medications in long-term comparative studies (Antonuccio et al., 2002). Given these data, antidepressant medication might best be considered a last resort, restricted to patients who refuse or fail to respond to other treatments.

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Dr. Kirsch is professor of psychology at University of Connecticut and former president of Division 30 of the American Psychological Association.

Dr. Antonuccio is professor of psychiatry and behavioral sciences at University of Nevada School of Medicine, and director of and staff psychologist for the stop smoking program at the Reno Veterans Affairs Medical Center.

References

Antonuccio DO, Burns DD, Danton WG (2002), Antidepressants: a triumph of marketing over science? Prevention & Treatment 5:Article 25. Available at: journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.

Hollon SD, DeRubeis RJ, Shelton RC, Weiss B (2002), The emperor’s new drugs: effect size and moderation effects. Prevention & Treatment 5:Article 28. Available at: journals.apa.org/ prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.

Jacobson NS, Roberts LJ, Berns SB, McGlinchey JB (1999), Methods for defining and determining the clinical significance of treatment effects: description, application, and alternatives. J Consult Clin Psychol 67(3):300-307.

Kirsch I, Moore TJ, Scoboria A, Nicholls SS (2002a), The emperor’s new drugs: an analysis of antidepressant medication data submitted to the U.S. Food and Drug Administration. Prevention & Treatment 5:Article 23. Available at: journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.

Kirsch I, Sapirstein G (1998), Listening to Prozac but hearing placebo: a meta analysis of antidepressant medication. Prevention & Treatment 1: Article 0002a. Available at: journals.apa.org/prevention/volume-1/toc-jun26-98.html. Accessed Aug. 2, 2002.

Kirsch I, Scoboria A, Moore TJ (2002b), Antidepressants and placebos: secrets, revelations, and unanswered questions. Prevention & Treat-ment 5:Article 33. Available at: www.journals. apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.

Klein DF (1998), Listening to meta-analysis but hearing bias. Prevention & Treatment 1:Article 0006c. Available at: www.journals.apa.org/prevention/volume 1/toc-jun26-98.html. Accessed Aug. 2, 2002.

Thase ME (2002), Antidepressant effects: the suit may be small, but the fabric is real. Prevention & Treatment 5:Article 32. Available at: journals.apa.org/prevention/volume5/toc-jul15-02.html. Accessed Aug. 2.

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Shionogi, Eli Lilly to develop antidepressant

February 2, 2007

Japanese drug maker Shionogi and Co. Ltd. (4507.T: Quote, Profile, Research) said on Friday it has agreed with Eli Lilly and Co.’s (LLY.N: Quote, Profile, Research) local unit to jointly develop and market an antidepressant drug in Japan.

Duloxetine, whose global sales last year totalled $1.32 billion, is already used for the treatment of depression for adults in Europe, Latin America and the United States, the drug companies said in a statement.

The drug can also be used to treat diabetes pain.

Eli Lilly Japan spokeswoman Miyuki Watanabe said her company expects Japan’s antidepressant market to grow 30 percent to 130 billion yen ($1.08 billion) by the time the drug is approved for sales in Japan around 2009.

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Shionogi started developing duloxetine in 1992 after signing a license agreement with Eli Lilly which had created the drug in the United States.

Shionogi said it plans to file a new drug application for duloxetine in Japan sometime this year and would continue to solely develop it for the treatment of depression and then market it with Eli Lilly.

The drug is currently undergoing Phase III clinical trials for antidepressant use.

For the treatment of pain related to diabetic peripheral neuropathy, Shionogi said it and Eli Lilly will work together on the development as well as marketing. For this use, the drug is now going through Phase II clinical trials

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