F.D.A. Panel Rejects Drug for Obesity

A drug once viewed as a possible magic bullet against obesity was rejected yesterday by a federal advisory panel because of worries that it causes neurological and psychiatric problems and increases the risk of suicide.

Although the drug, rimonabant, is already marketed in 37 countries, it is now unlikely that the FDA will approve its sale in the US without additional safety data.

The advisory panel voted unanimously, 14 to 0, against recommending the drug, saying there was inadequate evidence of its safety. The FDA is not required to follow the advice of such panels, but it typically does.

READ MORE @ NY TIMES

Eli Lilly: Drug ads influencing patients

Eli Lilly, which has faced thousands of lawsuits over its anti-psychotic Zyprexa, says lawyers' ads about the drug are prompting some patients to stop taking mental illness medications when they shouldn't.

The advertising blitz "presents yet another barrier for patients who suffer from severe mental illness" and increases the risks that people will not get the care they need, said Carole Puls, a spokeswoman for the Indianapolis-based drug maker.

Lilly released the results of a company-funded survey that asked 402 psychiatrists who treat patients with bipolar disorder or schizophrenia to complete an online questionnaire. More than half of the participating psychiatrists said they believed their patients who stopped medication or reduced the dosage did so after seeing lawyers' advertisements about anti-psychotic drugs.

READ MORE @ AP

Eli Lilly: Lawyers' Ads Are Hurting Patients - Law.com

Gabapentin (Neurontin) Eases Chronic Pain in Fibromyalgia

For treating the chronic pain and other symptoms of fibromyalgia, the anticonvulsant gabapentin (Neurontin) proved safe and effective, researchers here reported.

In a 12-week randomized, double-blind clinical trial, patients taking gabapentin displayed significantly less pain, better sleep, and less fatigue than placebo controls, Lesley M. Arnold, M.D., of the University of Cincinnati, and colleagues reported in the April issue of Arthritis and Rheumatism.

READ MORE @ MEDPAGE TODAY

Drugs industry economics 'not sustainable' - report

The pharmaceutical industry business model is "economically unsustainable", according to a report by accountants PricewaterhouseCoopers. The study suggested drug companies' reliance on heavy marketing of a few drugs in the hope of huge sales meant they were "operationally incapable" of acting quickly enough to produce innovative treatments demanded by global markets.

According to Steve Arlington, the main author, drug companies spend twice as much on research and development than 10 years ago, yet produce half as many drugs: 40 to 45% of medicines in phase 3 clinical trials, the last stage, now failed.

READ MORE @ THE GUARDIAN

Young People, Mental Illness and The Pharmaceutical Industry

"As a practicing child and adolescent psychiatrist, I have been following with great interest the recent media attention being paid to young people, mental illness and the pharmaceutical industry."

"This is a topic that has been of continuing concern to the medical and non-medical communities. It raises a variety of important questions regarding the relationships between patients, physicians and drug companies; there are a variety of factors that have yet to be addressed."

READ MORE @ HUFFINGTON POST

Depression + osteoporosis link still unclear

Older women who take certain antidepressants are at increased risk of fracturing a bone, but it's not clear whether the association is due to the drugs, depression itself, or some other factor, according to a new report in the Harvard Women's Health Watch.

Nevertheless, while women shouldn't stop taking antidepressant drugs for the sole reason of protecting their bones, those who suffer from depression should get their bone mineral density checked out, the report's authors state.

READ MORE @ REUTERS

Big Headache for Big Pharma

For pharmaceutical giant Eli Lilly, death and injury are just a cost of doing business. When Zyprexa, Lilly’s drug to treat schizophrenia and bipolar disorder, hit the marketplace in 1996, it was hailed as an “atypical” – a “safe, gentle psychotropic,” more effective than older drugs like Thorazine and Trilafon, without the dangerous side effects. Sales skyrocketed. The hype soon gave way to reality, as Lilly faced waves of lawsuits by patients suffering from diabetes, massive weight gain, pancreatitis and cardiac problems. Lilly responded with the cozy arrangement that worked with Prozac, another blockbuster plagued with problems: quietly settle suits out of court, with proceedings sealed and secret under a gag order. Anything embarrassing – or illegal – that Lilly is doing behind closed doors would remain hidden from public view.

By - Will Hall co-founder of the Freedom Center, and a member of the Icarus Project.

READ MORE @ Adbusters

Potentially Incompatible Goals at F.D.A.

Safety and speed are the yin and yang of drug regulation. Patients want immediate access to breakthrough medicines but also want to believe the drugs are safe.

These goals can be incompatible. Race a drug to market and much is likely to remain unknown when patients take it. Test a drug thoroughly to assess all possible risks and its release may be delayed by years.

A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.

READ MORE @ NY TIMES

Antidepressant Augmentation Can Be Useful in Treatment Resistant Elderly Patients

While the recovery rates of those receiving augmentation are not as high as in those who responded to first-line therapy, the recovery rates are still high enough to suggest that augmentation should be tried when older adults' depression is not improving

READ MORE @ RxPG NEWS

Swag from APA Conference

Psychiatrists attending the American Psychiatric Association conference in San Diego last month could stop by the exhibit hall, where reps from 160 companies doled out giveaways. The pharmas spent tens of thousands of dollars on booth space to tempt the docs to use their branded tchotchkes.

Above: The next time you reach for a tissue in the middle of a weepy therapy session, don't be surprised to see this reminder that depression is nothing to sneeze at. Effexor, an antidepressant, not only provides the tissue, but warns on the dispenser about rare side effects like life-threatening serotonin syndrome, sustained increases in blood pressure and "discontinuation symptoms" when people stop taking the drug.

READ MORE and see a slide show of more swag @ Wired News

Depression with dysphoria may need two drug types

Findings from a small study suggest that combining an antidepressant with an anticonvulsive drug, a type of drug normally used to treat epilepsy, may be an effective treatment for patients with depression plus dysphoric mood, such as anger or hostility.

READ MORE @ REUTERS

Khat use linked to psychiatric disorders

British researchers are calling for improved research into the stimulant plant khat and its possible association with psychiatric disorders.

Investigating the potential link between the African plant and mental illness is the first systematic review of the topic.

READ MORE @ SCENTA

Genetic variations may predispose some men to suicidal thoughts

Genetic variations may help explain why some men with depression develop suicidal thoughts and behaviors after they begin taking antidepressant medications, while most do not, according to a report in the June issue of Archives of General Psychiatry.

Although most patients with depression respond favorably to antidepressant medications, a very small subgroup may experience worse symptoms after beginning treatment, according to background information in the article.

“Regardless of treatment specificity, nearly all antidepressant medication studies find that some patients experience suicidality after treatment initiation,” the authors write. “Identification of this subpopulation before treatment would have tremendous clinical utility.”

READ MORE @ EUREKALERT

Antipsychotic Medicine Inspires Tuberculosis Drug

The antipsychotic medication chlorpromazine (Thorazine) can be used to treat tuberculosis, but it causes terrible side effects. Scientists at SRI International are using this knowledge as a starting point to develop a new tuberculosis drug. Their challenge is to find a chemical that kills Mycobacterium tuberculosis, the bacteria that causes tuberculosis, without causing restlessness and uncontrollable jitters that are brought on by the antipsychotic medication.

READ MORE @ Wired News

Antipsychotic Drug Use in Older Adults with Dementia

Antipsychotic drugs are widely used to manage behavioral and psychological symptoms in dementia despite concerns about their safety.

READ MORE @ Annals of Internal Medicine
READ MORE @ Science Daily

SSRIs and Birth Defects: More Data Urgently Needed

There is a problem out there for prospective mothers and fathers. The problem is that instead of being able to find good information on the interplay between SSRIs (a group of antidepressants including Zoloft, Paxil and Prozac) and safe pregnancy, there is a big black void.

READ MORE @ LAWYERS & SETTLEMENTS

Depression Risk Is Higher Among Battling Siblings

It could be that closeness with a sibling in childhood helps to develop skills in relating to peers that are taken into adult life or that lack of such closeness is an early sign of vulnerability to depression.

Poor sibling relationships in childhood may be an important and specific predictor of major depression in adulthood.

READ MORE @ Psychiatric News

Sildenafil Effective for SRI Associated Sexual Dysfunction

Depressed women with serotonin reuptake inhibitor (SRI) antidepressant-associated sexual dysfunction are able to continue taking effective antidepressant treatment with sildenafil while avoiding sexual side effects.

READ MORE @ DOCTOR'S GUIDE

Consensus OCD Report Published

Leading international experts in obsessive compulsive disorder have published a new consensus report aimed at providing analysis and guidance to drive improved diagnosis and management of OCD worldwide.

Presented at The European Congress of Psychiatry, Madrid, 17-21 March 2007 and recently published in CNS Spectrums, the report has made a number of important recommendations including the removal of OCD from anxiety disorders to create its own category.

READ MORE @ PRNewswire

Early Response to Antidepressant Treatment Predicts Remission

Patients with depression who have an early response with certain symptoms are more likely to have a sustained remission, investigators reported here at the American Psychiatric Association 2007 Annual Meeting.

"At 2 weeks, the improvement on the Hamilton Depression Rating Scale (HAMD) significantly predicted remission for key symptoms with both duloxetine and escitalopram," said principal investigator Martin Katz, PhD, clinical researcher, University of Texas Health Science Center, San Antonio, Texas, United States.

"Improvements for depressed mood, anxiety, and somatic symptoms significantly predicted remission for both treatments," Dr. Katz said in his presentation on May 21st.

READ MORE @ DOCTOR'S GUIDE