Thursday, February 24, 2005

Vioxx and Other Painkillers: More Confusion, Less Relief? Although this article at Wharton's Public Policy and Management web site focuses primarily on Vioxx, its treatment of the pharmaceutical industry and FDA regulation may be of interest to many readers - " According to Wharton management professor Lawrence Hrebiniak, author of a new book entitled Making Strategy Work: Leading Effective Execution and Change, flaws in the culture and business model of the pharmaceutical industry are illustrated by Vioxx and the other Cox-2 inhibitors. Drug companies, he argues, have become overly reliant on the blockbuster model in which huge investments in research are targeted to a drug that could reach massive sales volume and drive profits for the entire organization. The model breaks down when a problem arises, he says. If safety concerns crop up, there is little incentive for executives to pursue [these concerns] since the company has invested so much in developing the drug. ... FDA culture and the structure of the regulatory system are bound to create problems with monitoring drug safety after a product goes on the market, Field notes. That is a critical time for drugs because most are only tested on several thousand people before gaining marketing approval -- not enough to pick up side effects that would occur in one out of 10,000 cases or even less frequently, he suggests. 'There's an institutional culture within the FDA that presents an inherent conflict of interest,' says Field."  
  

Substance Use and Need for Treatment Among Youths Who Have Been in Foster Care Page at the OAS web site with links to HTML and Acrobat versions of a report based on SAMHSA's National Survey on Drug Use and Health - "Youths from substance-abusing families frequently have serious emotional and behavioral problems, including a tendency to choose risky behavior, such as alcohol or other drug use. Substance abuse is a factor in at least three quarters of all foster care placements, and recent studies indicate high rates of lifetime substance use and substance use disorders for youths in the foster care system.1,2 The National Survey on Drug Use and Health (NSDUH) asks youths aged 12 to 17 if they ever stayed in foster care.3 This report looks at the need for and receipt of substance abuse treatment among youths who have been in foster care. All estimates are annual averages based on combined 2002 and 2003 NSDUH data..."  
  

Explaining Enrollment Trends and Participant Characteristics of the Medicaid Buy-In Program, 2002-2003 A 206-page report (in Adobe Acrobat format), from Mathematica Policy Research, brought to our attention at the Open Minds web site - "Persons with disabilities who wish to enter or remain in the labor force face multiple challenges, including those originating from the nature of their disabilities, the limited availability of employer-based and individual private health coverage, and the risk that higher earnings could cause them to lose public assistance they might receive. As a result, the unemployment rate among people with disabilities has been high and has increased (Kaye 2002; Taylor 2001). The Medicaid Buy-In program was enacted to encourage work by reducing work disincentives. Specifically, it allows people with disabilities to earn more and still be eligible to obtain Medicaid coverage. Participants “buy in” to the program by paying a premium or co-payment and receive full Medicaid benefits in return. The Buy-In program is one major component of a broad federal and state effort to support the employment of people with disabilities that includes the Americans with Disabilities Act (ADA) of 1990 and the President’s New Freedom Initiative."  
  

U.S. Health Spending Projections For 2004–2014Article in Health Affairs - "National health spending growth is anticipated to remain stable at just over 7.0 percent through 2006, the result of diverging public- and private-sector spending trends. The faster public-sector spending growth is exemplified by the introduction of the new Medicare drug benefit in 2006. While this benefit is anticipated to have only a minor impact on overall health spending, it will result in a significant shift in funding from private payers and Medicaid to Medicare. By 2014, total health spending is projected to constitute 18.7 percent of gross domestic product, from 15.3 percent in 2003." The article is also available in Adobe Acrobat format.  
  

Yale Researchers to Study Soldiers, Stress  AP story at Yahoo - "Soldiers from the U.S. Army's 10th Mountain Division will help Yale University researchers who are studying how prolonged periods of stress affect the brain. The study will help scientists understand the underlying biology of post-traumatic stress disorder, said Maj. Paul Morrissey, chief of the behavioral health department at Fort Drum, located 90 miles north of Syracuse near the U.S.-Canadian border. Researchers will use magnetic resonance imaging to obtain detailed images of the brain as they study soldiers who were in combat and who have developed PTSD, combat veterans who did not develop the disorder and soldiers who have not yet deployed, said Deane Aikins, a professor of psychiatry at Yale School of Medicine. "  
  

Bipolar Disorder More Common Among Urban Poor  Reuters story at Yahoo - "Bipolar disorder may often go undiagnosed and untreated in the urban poor, with one in 10 found to have the mental illness in a study of one New York clinic published on Tuesday. The 13-month study at the clinic serving low-income patients found that few reported being diagnosed or treated for the illness. Bipolar disorder is normally treated with a mood stabilizer such as lithium as well as anti-depressants to counteract the swings from dark moods to mania and associated irritability, racing thoughts, decreased need for sleep, talkativeness, and excessive involvement in risky activities..."  
  

New Treatment Guidelines for Bipolar Children WebMD story - "New guidelines have been issued for treating bipolar disorders in children. 'Clinicians who treat children and adolescents with bipolar disorder desperately need current treatment guidelines,' write the guidelines' authors, who included Robert Kowatch, MD, of the psychiatry department at Cincinnati Children's Hospital. Kowatch and colleagues don't claim to have all the answers. Their report says the guidelines aren't intended as an 'absolute standard,' and they call for more studies on bipolar disorders -- and their treatments -- in children. The guidelines appear in the March edition of the Journal of the American Academy of Child & Adolescent Psychiatry. "  
  

Mental-health outpatient program faces budget cuts Journal-News story - "Ten hospitals in the area that run mental-health outpatient programs stand to lose $8 million in funding under Gov. George Pataki's proposed state budget. Summit Park Hospital and Nursing Care Center in Ramapo and St. Joseph's Hospital in Yonkers are among those that could be affected. Pataki has called for cutting $2 million from a state Medicaid program that reimburses hospitals at a higher rate to operate structured day-treatment programs. The federal government pitches in an additional $6 million in matching funds."  
  

Nation's Leading Mental Health Groups Warn Against Relying Solely on Effectiveness Research NMHA press release - "The American Psychiatric Association, NAMI and the National Mental Health Association welcome the dialogue on 'effectiveness research' and its impact on consumers at AARP's 'Rx Watchdog Forum' today. However, we warn against using only these research reviews, such as those promoted by the Oregon Center for Evidence-based Policy, in developing public policies that drive access to treatments, including medications. Research is an important component of any evidence-based approach to treating chronic illnesses, such as mental disorders. However, true evidence-based approaches marry all available and appropriate scientific research with clinical experience to ensure treatments lead to the best possible outcomes. Implementing public polices based on only one of these elements without the other is not an evidence-based approach. Moreover, using a narrow definition of evidence-base simply to rationalize budgetary objectives not only threatens patient health, but will ultimately cost taxpayers more..."  
  

Mental health authority may still be an option (Michigan) Plymouth Observer story - "The proposal to replace the Detroit-Wayne Community County Mental Health Agency county board with an independent authority is still a possibility, according to the agency's new 'transitional director.' Gov. Jennifer Granholm vetoed legislation in December to replace Wayne County oversight and the agency's 12-member board with an independent authority. Under the legislation, the county executive and the mayor of Detroit would still appoint six members each to an authority board, but funding would go directly through the authority rather than through Wayne County. "  
  

State health chief retiring amid problems (Arizona) Arizona Republic story - "Facing fire over the state's handling of mental health services, Arizona Department of Health Services Director Catherine Eden is stepping down. She is retiring at the end of this legislative session. The Governor's Office plans a national search for her replacement. Eden, 55, lately has faced a double dose of problems with the department's mental health programs, which accounts for the largest portion of the department's budget. A damaging audit showed that despite $230 million in extra funding, parts of the Valley's mental health program are in worse shape than four years ago. Secondly, the state's mental hospital, Arizona State Hospital, has failed two separate federal investigations."