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.

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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.

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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.

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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.

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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.”

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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
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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.

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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.

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Routine Metabolic Screening Is Necessary for Antipsychotic Treatment

Although antipsychotic treatment guidelines recommend routine metabolic screening, glucose and lipid profiles are not routinely being ordered at baseline by prescribing physicians in a patient population already at risk for diabetes and cardiovascular disease.

The purpose of the study was to evaluate the impact of abnormal laboratory test results on the selection of atypical antipsychotic treatment for patients whose lipids and fasting blood glucose (FBG) were being measured.

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Iloperidone Results Show Favorable Akathisia Profile

According to study results presented today at the 2007 American Psychiatric Association annual meeting, iloperidone, an investigational atypical antipsychotic, was shown to have a favorable akathisia profile.

Akathisia is a debilitating sensation of restlessness that manifests as an inability to sit still is a frequent side effect of antipsychotic medications. Iloperidone is being studied by Vanda Pharmaceuticals.

READ MORE @ MEDICAL NEWS TODAY

Poor Understanding Called Biggest Barrier to Antipsychotic Drug Adherence

The most common reasons patients don't adhere to antipsychotic regimens are poor insight into the nature of their illness, forgetfulness, and simply deciding to stop, surveyed physicians said....

"The other thing that can happen is that individuals can be lulled into a false sense of security. When they're doing particularly well, they think that perhaps they don't need to take their medication," he said. "One can stop taking medication in an illness like schizophrenia and not necessarily notice a change immediately."

READ MORE @ PSYCHIATRIC TIMES

Psychiatrists Want More Effective Antipsychotics

Pharmacotherapy for schizophrenia may be better than it's ever been, but it's not nearly good enough.

In a nationwide survey of psychiatrists, 95% said that there is a need for new, highly effective drug options, said Peter Buckley, M.D., of the Medical College of Georgia.

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Insomnia and Psychiatric Illness: Presented at APA

There is a prevalence of insomnia seen in psychiatric illness although insomnia itself can be a risk factor for psychiatric disorders. That's according to research presented here on at the annual meeting of the American Psychiatric Association (APA).

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Abilify helps as add-on depression treatment-study

Bristol-Myers Squibb's Abilify proved effective as an add-on therapy for patients suffering from major depression who were not getting satisfactory relief from their regular medication, according to a clinical study.

The drugmaker is hoping to use data from the study, which were presented on Monday at the American Psychiatric Association annual meeting in San Diego, to broaden the approved uses for Abilify, which is also approved to treat bipolar disorder.

READ MORE @ REUTERS