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July 7, 2005
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patients face stigma, globally
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States Resist Medicare Reform Law Drug Provision
Texas is leading the resistance by several states to a provision of the 2003 Medicare reform law that requires states to pay the federal government billions of dollars to help finance the costs of the Medicare prescription drug benefit. In vetoing a bill that would have paid for what Texas owes the federal government, Gov. Rick Perry said he opposes the provision in principle and how it’s being interpreted by the federal government. Under the law, states have to return the funds they save by having Medicare take over medication costs for people who are eligible for both Medicare and Medicaid. States will also have to incur new administrative costs, all of which will mean that states will lose money, Perry and other state officials throughout the country say. (The New York Times, 7/4/05)
FDA Urges Monitoring of Adults Who Take Antidepressants
The FDA issued a warning on its Web site last week that cautions adults who take antidepressant drugs to be monitored for suicidal thoughts and behavior, a message that is already included on some antidepressant labels, according to two pharmaceutical companies. The agency, which is currently conducting a review of research to see if there’s a definite link between antidepressant use and suicidal tendencies, wanted to highlight its concerns about this research, according to Steven Galson, acting director of the agency's drug center. (The Wall Street Journal, 7/1/05)
Frist Calls for Ban of New Drugs’ Consumer Advertising
Senate Majority Leader Bill Frist, R-Tenn., called on the pharmaceutical industry Sunday to ban direct-to-consumer advertising for the first two years that new drugs are on the market. Although the industry, as represented by the Pharmaceutical Researchers and Manufacturers of America (PhRMA), is unlikely to approve of any moratorium, PhRMA members will discuss voluntary guidelines at its annual meeting later this month, PhRMA Vice President Ken Johnson said. Frist, who is a physician, said that the “dramatic” increase in such advertising has lead to “inappropriate prescribing” and increased spending on drugs. (The Wall Street Journal, 7/3/05)
Medicaid Programs Are Paying Too Much for Drugs, Reports Find
The Department of Health and Human Services’ Inspector General’s office released two reports last week that conclude that state Medicaid programs are paying substantially more for medications than they need to. Medicaid programs reimburse pharmacists based on the drugs’ average wholesale price, which is 59 percent higher on average than the average manufacturer’s price, and which is used by the federal government to determine the price drug manufacturers sell medicines to the programs. About $4 billion could be saved from the Medicaid program if states changed how they reimburse pharmacists, said Sen. Charles Grassley, R-Iowa. (The Wall Street Journal, 6/29/05)
CMS Should Do More to Prevent Medicaid Fraud, GAO Urges
Government Accountability Office (GAO) officials told Congress last week that the federal Centers for Medicaid and Medicaid Services (CMS) should do more to help states prevent fraud in the Medicaid program. CMS “essentially moves when the horse is out of the barn, essentially after you've had yet another example of a program getting ripped off," said Sen. Ron Wyden, D-Ore. "What I want to see is a much more strategic approach to rooting out this fraud than such a reactive approach." Agency officials took issue with the GAO officials, saying that their review was too narrow in scope. Reducing waste is one way some people have advocated as a way to cut Medicaid costs. (Dow Jones Newswires, 6/29/05)
Survey Indicates That Medicaid Enjoys Widespread Support
Nearly three-quarters of Americans say that the Medicaid program is a “very important” program, a Kaiser Family Foundation survey released last week indicates. Forty-four percent of respondents said that Medicaid funding levels should remain where they are, while 36 percent said that they support increased funding. Although 74 percent said that Medicaid was the main reason for their state’s budget problems, 24 percent said other programs should be cut to help their states compared with 21 percent who said Medicaid should be cut at least somewhat to help their states. (Dow Jones Newswires, 6/29/05)
California: In response to a lawsuit, a federal judge last week said that he’ll appoint a monitor to provide oversight of California’s adult prison healthcare system, the nation’s largest. The judge noted that “extreme measures” were needed to fix a system that kills one inmate each week on average through medical incompetence or neglect. By placing the system in receivership, essentially all decisions about the system, which includes mental health services, will be made by the court. (Los Angeles Times, 6/30/05)
Missouri: Some critics of the state’s new Medicaid reforms, which were instituted last Friday, say that they are among the most severe in the nation. About 68,000 people will be cut from the program, including 24,000 children. Under the new standards, a single mother of two children who makes more than $350 a month — about one-third of the previous levels — will be dropped from the program. Officials with the state, which spends about $2 billion a year on the program, said that the previous spending levels couldn’t be sustained. (Reuters/Los Angeles Times, 7/2/05)
Mississippi: Starting with the new fiscal year last Friday, Mississippi Medicaid beneficiaries became restricted to just five prescription medications at a time, with no opportunity to appeal. The cap includes a limit of two brand-name drugs with the only exceptions being children, people in nursing homes and people who have HIV/AIDS. Although it is probably the most restrictive prescription drug limit in the country, many states have similar limits but offer appeals processes. Gov. Haley Barbour, who backed even more stringent limits, said that “states are limited in their options” to control Medicaid costs. Of the 768,000 people in the state who are enrolled in Medicaid, 80,000 used more than five prescriptions in 2004. (The New York Times, 7/2/05)
Antidepressants Appear to Help Prevent Second Heart Attacks: People who have survived heart attacks and have clinical depression are less likely to have another heart attack if they are treated with antidepressant drugs than if they are not treated with these drugs, a study published in the Archives of General Psychiatry indicates. A physician in an accompanying commentary notes that depression has at least as much risk to a person’s health after a heart attack as other disorders, but is often not taken into account. Treating depression in heart attack survivors with SSRIs (the type of antidepressants studied) could “save thousands of lives each year,” the physician wrote. (Reuters Health, 7/4/05)
Stigma Affects People With Bipolar Disorder in North American and Europe: Forty-seven percent of people who have bipolar disorder in the United States, Canada and several European countries say that the disorder has had a “highly negative impact” on the quality of their lives, a World Federation for Mental Health survey indicates. The survey also revealed that 35 percent of people who have bipolar disorder say that they have experienced discrimination in their daily social interactions as a result of their disorder, and 26 percent never tell anyone about their disorder due to fear of stigma. (I-Newswire.com, 7/4/05)
Paxil CR Is Back: Skyepharma and its partner company, GlaxoSmithKline, announced the return of the antidepressant Paxil CR to the U.S. market last week. The FDA ordered Glaxo earlier this year to halt production of the drug at the company’s Puerto Rico manufacturing plant for issues related to production of the drug and another drug at the plant. (Dow Jones Newswires, 6/28/05)
FDA Panel Recommends Rewriting ADHD Drugs’ Labels: An FDA advisory panel recommended last week that the agency should move forward with plans to rewrite the labels for several drugs used to treat ADHD to more clearly warn of the possibility of psychiatric episodes, including visual hallucinations and suicidal ideation. Although the labels currently warn of a possible link, panel members recommended that the labels clearly spell out the warning. The recommendations didn’t include Adderall, which was pulled from the Canadian market earlier this year after the sudden deaths of 20 people who took the drug. An agency spokesperson said that if the FDA accepts the recommendations, it would just be a rewriting of the labels and would not require the agency’s most serious warning, a “black box” label. (The Wall Street Journal, 7/1/05)
Newly Published Study Investigates SEROQUEL(R) as Monotherapy Treatment for Bipolar Disorder.
PR Newswire; 7/5/2005
- More Than Half of SEROQUEL-Treated Patients Achieved Remission from Depressive Symptoms -
WILMINGTON, Del., July 1 /PRNewswire-FirstCall/ -- AstraZeneca today announced the publication of results from a large-scale clinical study that examined its psychotropic medication SEROQUEL(R) (quetiapine fumarate) as a treatment for depressive episodes in patients with bipolar I and II disorders. In the study, published in the July issue of the "American Journal of Psychiatry," patients receiving SEROQUEL showed a statistically significant decrease in depression scores(*) at week one and continued to decrease throughout the eight-week study. More than half of the patients receiving SEROQUEL responded(+) and achieved remission. (++,1)
This is the first published large-scale, controlled clinical trial to evaluate SEROQUEL as a monotherapy treatment for depression in outpatients with both bipolar I and bipolar II disorders. SEROQUEL is approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia.(2) It is currently under investigation for use in the treatment of bipolar depression.
Bipolar disorder, which affects more than 7 million American adults every year,(3) consists of recurring episodes of mania and depression. "The standard for treating bipolar disorder has not been optimal, with multiple medications required to manage the depressive and manic states," said Joseph Calabrese, M.D., principal investigator and co-director of the National Institute of Mental Health Bipolar Research Center at University Hospitals of Cleveland and Case Western Reserve University. "These data have prompted further studies that, if successful, should make SEROQUEL the first agent approved for the treatment of patients with both depressive and manic episodes associated with bipolar disorder."
Patients with bipolar disorder are symptomatic almost half of their lives, and approximately two-thirds of that time is spent in the depressed phase of the illness.(5) Prolonged periods of sadness, unexplained loss of energy, persistent lethargy and recurring thoughts of death or suicide characterize depressive episodes.(6) Up to 20 percent of patients with bipolar disorder attempt suicide.(1)
The most common adverse events reported in this study were similar to those seen in clinical trials for acute bipolar mania and included: dry mouth (42%), sedation (31%), somnolence (26%), dizziness (20%), constipation (11%), headache (11%) and fatigue (10%).(2) There were no significant differences in the rates of serious adverse events across treatment groups, and no serious adverse events were considered treatment related.
"The results of this study are an exciting step in the exploration of SEROQUEL and the treatment of depressive episodes associated with bipolar disorder," said Wayne Macfadden M.D., U.S. Medical Director for SEROQUEL. "AstraZeneca is dedicated to improving patient's lives and developing new treatments for mental illness."
ABOUT THE STUDY
The study results are from a double-blind, placebo-controlled trial of 542 outpatients with bipolar I or II disorder who were randomized to receive eight weeks of treatment with fixed doses of SEROQUEL (300 mg or 600 mg) or placebo administered once daily.(1) Results showed:
-- Patients taking SEROQUEL had a statistically significant
ABOUT BIPOLAR DISORDER
Bipolar I disorder consists of recurring episodes of mania with or without depression. Bipolar II disorder consists of recurring episodes of hypomania and depression.(7) In the long term, patients with bipolar I disorder spend three times longer in the depressed state than in mania.(1) Patients with bipolar II disorder have traditionally been difficult to treat as they spend almost forty times longer in the depressed state than in mania. Without appropriate treatment, patients usually suffer for a lifetime with periods of wellness and functioning punctuated by severe episodes of illness.(7) Both men and women are equally at risk for this illness, which most often emerges in adolescence or young adulthood and recurs throughout life.(7)
IMPORTANT SAFETY INFORMATION
SEROQUEL is indicated for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy with lithium or divalproex, and the treatment of schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment. It is recommended SEROQUEL be taken twice daily in divided doses.
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs. 2.6% respectively). SEROQUEL is not approved for the treatment of patients with dementia-related psychosis.
Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including SEROQUEL.
Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including SEROQUEL. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.
Precautions include the risk of seizures, orthostatic hypotension and cataract development.
The most commonly observed adverse events associated with the use of SEROQUEL in clinical trials were somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, SGPT increase, dyspepsia, and weight gain.
For full prescribing information for SEROQUEL, please visit the website http://www.seroquel.com/.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com/
This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2003.
* Depression scores were measured by the Montgomery-Asberg
+ SEROQUEL patients met response criteria (58.2% in the 600 mg
++ 52.9% of SEROQUEL patients met remission criteria versus
(A) Response defined as a decrease of at least 50% in MADRS
** Remission defined as MADRS score of 12 or lower.
CONTACT: Sandra Heinig of AstraZeneca, +1-302-885-1084, firstname.lastname@example.org, or Jim Minnick of AstraZeneca, +1-302-886-5135, email@example.com
Web site: http://www.astrazeneca-us.com/ http://www.seroquel.com/
Company News On-Call: http://www.prnewswire.com/comp/985887.html
COPYRIGHT 2005 PR Newswire Association LLC
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The Warning Signs Of An Impending Bipolar Disorder Manic Episode
Bipolar disorder - as the name implies - involves two distinct set of symptoms. One set throws the individual down into the depths of a massive depression. The other places the individual who suffers with bipolar disorder at the top of a peak manic episode.
Most everyone can eventually recognize the warning signs of an impending depressive episode related to bipolar disorder. More likely than not, individuals with bipolar disorder try very hard to avoid it.
However, for many individuals with bipolar disorder, it's more difficult to recognize the signs of an impending manic episode. After all, a manic episode of bipolar disorder can be mistaken in some cases - especially in the very early formation -- for the lifting of the corresponding mood swing of the depression.
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