Monday, August 08, 2005

FDA Responds to Criticism With New Caution August 6 New York Times article - "Stung by a series of drug safety scandals, the Food and Drug Administration has in recent months issued a blizzard of drug-safety warnings and approval times for new drugs are slower. The agency is issuing twice the number of public advisories about drug risks as it did a year ago and adding five times as many black box warnings - its most serious alert - to drug labels. And drugs approved in the first half of this year took almost twice as long to get that approval as drugs approved in the same period last year. This new conservatism, a response to fierce recent criticism from Congress that the F.D.A. has failed to protect the public against drug dangers, has upset some doctors and drug makers..." [Viewing New York Times resources requires registration, which is free].  
  

Data Behind Antidepressant Advisory Don't Give Clear-Cut Answers  Psychiatric News story - "The FDA's most recent public health advisory regarding antidepressants appears to have been based on seemingly contradictory studies published earlier this year. The FDA's June 30 public health advisory concerning antidepressants was prompted, the advisory said, by 'several recent scientific publications' that suggested 'the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications.' FDA spokesperson Christine Parker told Psychiatric News that the advisory was prompted by 'two papers of particular interest.' Both appeared in the February 19 BMJ..." See also abstracts of the BMJ studies.  
  

FDA Alert Covers Cymbalta  Psychiatric News story - "In conjunction with its release of the public health advisory regarding increased risk of suicide in adults taking antidepressants, the FDA issued a separate FDA Alert involving duloxetine (Cymbalta) and suicidality in pediatric and adult patients. The alert largely echoes the language of the advisory, noting that the FDA is 'highlighting that adults being treated with any type of antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.' "  
  

 Sunday, August 07, 2005

Wall Street Journal Examines Eli Lilly's Tactics To Persuade Physicians To Prescribe Antidepressant Cymbalta Item in the Kaiser Daily Health Policy Review - "The Wall Street Journal on Friday examined how pharmaceutical companies' contracts with insurers and medical organizations to sell their drugs sometimes restrict 'unflattering statements about the costs and risks of drugs when they communicate with health practitioners.' For example, Indianapolis-based Eli Lilly offers health facilities a 5% discount for the antidepressant Cymbalta, but the contract states that most of the discount could be revoked if the facility engages in certain actions, including 'negative [drug utilization review] correspondence to physicians.' A drug utilization review is a type of analysis of prescription patterns often used by insurers to identify risky or inappropriate practices and to reduce expenses. Pharmaceutical industry officials have said that insurers or other groups could use DURs to encourage doctors to use lower-cost drugs that might not be as effective. The Cymbalta contract also restricts 'negative educational counterdetailing,' a practice often used by insurers to counterbalance a drug maker's sales pitch to doctors that can focus on recommending generic drugs."  
  

 Tuesday, July 26, 2005

Quetiapine Seen Safe, Well Tolerated for Bipolar Depression Reuters Health story at Medscape - "Monotherapy with the atypical antipsychotic quetiapine is safe and effective for bipolar depression, according to a report in the July issue the American Journal of Psychiatry. ... 'In an unexpected post hoc analysis, quetiapine was found to be twice as effective as placebo in reducing suicidal thinking, and this improvement was evident as early as the first time point, the end of the first week, and at each and every time point thereafter,' Dr. Calabrese told Reuters Health. 'To my knowledge this is the first time any drug has been shown to have an ability to reduce suicidal thinking in a short-term study of bipolar depression.' " [Viewing Medscape resources requires registration, which is free].  
  

 Thursday, July 14, 2005

NIH Inquiry Shows Widespread Ethical Lapses, Lawmaker Says LA Times story - "Results from an ongoing internal review of drug company consulting payments to scientists at the National Institutes of Health show the agency's ethical problems are serious and widespread, a House committee chairman said Wednesday. The review examined whether a sample of 81 NIH scientists had moonlighted for industry without getting required permission from the agency, whether they disclosed company payments on annual forms and whether they performed company services on government time. More than half, 44, were found by NIH officials to have violated the agency's then-existing policies or recommendations. Excerpts from the findings, provided in recent days by NIH Director Elias A. Zerhouni to three members of Congress, were obtained by the Los Angeles Times." [Viewing Los Angeles Times stories requires registration, which is free].  
  

 Wednesday, July 13, 2005

Antipsychotics Suppress Symptoms of Obsessive-Compulsive Disorder Reuters Health story at Medscape - "The antipsychotic agents risperidone and haloperidol reduce manifestations of obsessive-compulsive disorder (OCD) when used as add-on therapy with an antidepressant, results of a small crossover trial suggest. Serotonin reuptake inhibitor (SRI) antidepressants are commonly used to treat OCD, but approximately half of patients do not respond to SRI monotherapy." [Viewing Medscape resources requires registration, which is free].  
  

 Thursday, July 07, 2005

Drug Lobby Second to None: How the pharmaceutical industry gets its way in Washington Report at the Center for Public Integrity web site - "The pharmaceutical and health products industry has spent more than $800 million in federal lobbying and campaign donations at the federal and state levels in the past seven years, a Center for Public Integrity investigation has found. Its lobbying operation, on which it reports spending more than $675 million, is the biggest in the nation. No other industry has spent more money to sway public policy in that period. Its combined political outlays on lobbying and campaign contributions is topped only by the insurance industry. The drug industry's huge investments in Washington—though meager compared to the profits they make—have paid off handsomely, resulting in a series of favorable laws on Capitol Hill and tens of billions of dollars in additional profits..."  
  

 Monday, July 04, 2005

Is There a Delay in the Antidepressant Effect? A Meta-Analysis Journal of Clinical Psychiatry story at Medscape - "It has long been thought that there is a delay of several weeks before a true antidepressant effect occurs, although this theory has increasingly come into question. The goals of this meta-analysis were to determine whether significant drug-placebo separation occurs during the first 2 weeks of treatment and to ascertain whether the timing of response to antidepressant medication and placebo is distinct." [Viewing Medscape resources requires registration, which is free].  
  

FDA warns anew about antidepressants and suicide AP story reprinted at PsycPORT - "The Food and Drug Administration issued a second public warning Friday that adults who use antidepressants should be closely monitored for warning signs of suicide, especially when they first start the pills or change a dose. Much of the concern over suicide and antidepressants has centered on children who use the drugs. The FDA last fall determined there is a real, but small, increase in risk of suicidal behavior for children and ordered the labels of all antidepressants to say so. A year ago, the FDA issued a warning that adults, too, may be at increased risk. The agency began reanalyzing hundreds of studies of the drugs to try to determine if that's the case, and told makers to add or strengthen suicide-related warnings on their labels in the meantime. Since then, several new studies have been published in medical journals about a possible connection. Citing them, FDA issued a new public health advisory reminding doctors and patients to watch closely for suicidal thinking or worsening depression and seek medical care if it happens."  
  

Michigan checks up on doctors Brief Detroit News story - "To improve care for people who are mentally ill, the state Department of Community Health is launching a two-year program to make sure doctors are up-to-date and follow recommendations when they prescribe medicine. The Michigan Pharmacy Quality Improvement Project is aimed at assuring that some of the 450,000-650,000 Michiganians who suffer mental illness or emotional disorders get proper medication. ... Advocates for the mentally ill complain that the mental health system in Michigan does not provide a program for recovery, including a regimen of the latest medications and adequate supervision. The new program, financed by drug manufacturer Eli Lilly and Co., enables the state to analyze prescriptions for Medicaid members to identify patterns inconsistent with industry guidelines."