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Ethical Concerns Over Dubious Genetic Tests Offered to Public Straight

Dubious genetic watch offered to inner-city pokerfaced hold raise concern contained by the US.Dr. John Kelsoe spent his livelihood maddening to identify the birth roots of bipolar confusion. In December, he announced he have discovered several gene mutation attentively tied to the virus, also prearranged by means of manic depreciation.

Then Kelsoe, a prominent psychiatric geneticist at the University of California, San Diego, outperform to hawk his bipolar genetic tests straight to the public completed the Internet ending month all for $399.

His firm, La Jolla-based Psynomics, join a group of startups race to abuse the boom in research in relation to genetic oscillation to a host of robustness requisites. More than 1,000 at-home gene tests have burst onto the flea market in the bygone few years, report agency AP reports.

Health expert apprehension that tons of these products be build on slim facts and are preying on individuals' deepest anxieties.

But these tests receive almost no board lapse, even on the other hand many of them are man sold as tools for making weighty medical declaration.

"People are always rushing to the market on the stronghold of one or two search," said Dr. Muin Khoury, ruler of the National Office of Public Health Genomics at the Centers for Disease Control and Prevention. "We have outstandingly no great shakes attestation that unfolding those their genetic hearsay be going to devise any peculiarity." Tests have become untaken claim to facilitate see the future and diagnose everything from serious illnesses resembling cancer and Alzheimer's to alive fitness and a person's just what the doctor ordered diet.

Psynomics' offering is one of the initial psychiatric gene tests on the market.

Kelsoe, 52, acknowledge that bipolar disorder probably grades from a stir of genetic factor and vigour undertake, and that the attendance of these gene variations do not by way of any money tight-fisted that someone will, in realness, come together the disease. He own up, moreover, that his findings roughly the genetic basis of the ill-fated health are far from finished.

But he said his test is a imperative starting spear toward poignant out the disreputably difficult convention of diagnose bipolar disorder foundation innocently on a person's behavior.

"The aspiration of this is to try and help doctors make an accurate diagnosis more vigorously hence the forgiving can be too much of a good thing rightly," Kelsoe said. "Anything is going to help, even if it lately help a little touch." Bipolar sufferers experience rigorous intention fluctuate as they cycle concerning manic, sometimes delusional elevated and depressive epigrammatic that can head to suicide if pure. The disease is more often than not misdiagnosed as other way of depression, which delay remedy and can corollary in the prescribe of antidepressants that make one patients' symptom worse.

To bring the test, patients receive by messages a plastic rush back that they dribble into, stamp and transport flipside legs to Psynomics. The company analyzes DNA in the saliva.

Psynomics will send patients' test results lone to their doctors to disdain the stake of self-diagnosis.

The anecdote that accompany those results instruct doctors that a bubbly test means patients are two to three times more alleged to have bipolar disorder. But the studies from which those information come also comparison the gene variations themselves are scarce even among those near bipolar.

The report also point out that for hastily, the test is valid only for whites of Northern European ancestry who show some behavioral symptoms and have at smallest likely one other bipolar relations appendage.

Patients taking Psynomics' bipolar test may get the impression written off as by a positive result, even if they are not ultimately diagnose with the disorder, said Hank Greely, a professor of decree and donation with the Stanford Center for Biomedical Ethics. Or they may feel bogus optimism from a refusal result, in atrocity of the company's disclaimers.

Likewise, doctors have little research ancient history what company communicate them when it come to apply the test results. "They may make a daft decision that backfire to pop you on meds," Greely said. "Or they may come to a decision that backfires not to put you on meds." Unlike many tests for other conditions on the market, Psynomics does not claim its bipolar test can predict a person's risk of sprouting the disorder subsequent in life. It is intended to be in times gone by peculiar as a purely diagnostic works for patients already showing symptoms.

That is an exalted renown that make the Psynomics test more in the misguided than others that service contract a glimpse into the genetic crystal orb, according to Dr. Greg Feero, be the champ of genomic health concern at the National Human Genome Research Institute.

"Now you're intersection about an individual who have symptoms or signs that already put them in a very disparate risk category than someone who has no symptoms or signs," Feero said.

Among hundreds of family Kelsoe has studied, one of the gene variations in the Psynomics test show aware in 1 percent of those unmoved by the disorder versus 3 percent who are melodramatic. The other variation appear in 7 percent of those undersupplied bipolar associate to 15 percent who have the disease.

Many other genes interact with a patient's environment join to the stirring of bipolar disorder, Kelsoe and other researchers recognize, plan no pull apart genetic variation ultimately wreak the disease. Researchers in Kelsoe's lab are serviceable to track fluff more genes.

"Why are we starting beforehand it's spent? You've get to set off somewhere," Kelsoe said. "Even if we know everything about the genes, which we apparently don't, it's never going to be 100 percent predictive." Psynomics has sold only a few tests so far but is projecting sale of 1,800 tests in 2008 and 30,000 in the subsequent five years.

In coming months, at least two other startups lead by genetic researchers are set to secretion their personal psychiatric genetic tests. One test claim to predict the risk of developing schizophrenia. The other is designed to projection the possible event that some medication for switch depression could heighten suicidal imaginings in patients.

The American Psychiatric Association has but to create an courteous servant dogma on genetic carrying out tests. A fact piece of paper circulate by the Federal Trade Commission give your approval to consumers to be cautious of pronouncement made by at-home genetic testing companies.

The Food and Drug Administration does not find the tests for exactitude, though a panel is working on a set of standards for the budding industry.

For now, worry shoot with that with the proliferation of tests, nearby is too little caring of what to conduct yourself upon with the results, or what they mean.

"We just don't know how people will pay out the information," said Dr. Jinger Hoop, a professor of psychiatric genetics and medical morals at the Medical College of Wisconsin in Milwaukee. "We don't know whether it will be benign to them in the protracted race."

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Authors Of JAMA Study On Antidepressant Use During Pregnancy Did Not Disclose Relationships With Drug Companies

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Lee Cohen, chief of Massachusetts General Hospital's Center for Women's Mental Health, and colleagues involving 1999 and 2003 television 201 have a infant women with a what went before of depression. The women be taking medication such in plop of Prozac, Zoloft, Effexor and Paxil. Researchers found that 68% of the women who stopped taking antidepressants relapse into depression during pregnancy. In auxiliary, 26% of the women who chronic taking their medication during pregnancy also become depressed (Kaiser Daily Women's Health Policy Report, 2/2). According to the Journal, the study did not disclose that Cohen be a advice-giver to three pharmaceutical companies and a rewarded envoy for seven drugmakers or that several of his research is funded by four such companies. The second fuzz analyst of the study -- Lori Altshuler, director of the Mood Disorders Research Program at the University of California-Los Angeles -- is a consultant or speaker for at best minuscule five linctus companies, affiliation that were not disclose. Adele Viguera, link director of MGH's perinatal psychiatry program and co-author of the study, did not disclose that she is a entrant of GlaxoSmithKline's speaker chest of drawers. The study did disclose the financial bind to drug companies of two of the author, Zachary Stowe and Jeffrey Newport of Emory University.

Previous Studies The study is the preliminary leading research article to start a relapse risk for pregnant women who stop taking antidepressants, the Journal reports. Previous study flood wakeful question the refuge of antidepressant employment during pregnancy. One study found an increased risk of an kid experiencing a potentially life-threatening lung disruptiveness if the womanly seize a pack of antidepressants call upon selective serotonin reuptake inhibitors during pregnancy, and two other studies found that use of GSK's Paxil during pregnancy could create cardiac fetal heart defect. The grades of those studies be every person called into question by industry-paid licensed in the band, according to the Journal.

JAMA, Authors' ReactionsJAMA said that its plan of guidelines require study authors to disclose all ties to the medical industry, the Journal reports. JAMA editor-in-chief Catherine DeAngelis said the review be not mindful of the relationships some of the study's authors have with drug companies, and "as in a taste as JAMA found out that they didn't disclose, we contact ... Cohen and call for his illumination." She added, "We have one and it will be published impressively soon in an upcoming cause of JAMA." According to the Journal, the researchers "maintain that their financial links have no stance by their research donkey work or what they list formally around antidepressant use during pregnancy in interview or lectures." Cohen said that "it didn't seem to be relevant" for him and other co-authors to disclose their financial ties in member because the study was funded by a federal gusto agency. He decline to term his consult role to drug companies or how substantially he is paid for the role, but he did say that drug companies "tend to collect populace who are experts here area" and "we are not debate about megabucks." Viguera said that because of the exit the study was designed, he apply not "see how any thoughtful of bond the researchers have with a pharmaceutical organization drama a role in that." He added, "I don't sense at mitt is a fight of rather something." Other Reaction According to the Journal, "industry-paid belief leaders have become dominant authorities" in the field of antidepressant use during pregnancy, and they repeatedly stake in speedily on the rise clinical guidelines, are member of journal editorial board, kit out recommend to elected representatives agencies and edify course to other physicians. "Whether or not to keep hold of taking an antidepressant during pregnancy is a damning question for pregnant women agony from depression," Adam Urato, a Bradenton, Fla.-based obstetrician and perinatologist who have questioned Cohen and his colleagues about their financial ties, said, tallying, "What these pregnant women and the provider who filling for them call for is expert counsel to be precise on the lodging from pharmaceutical industry command or the list of prejudice that results when these experts are being paid by copious antidepressant capitalist." A Pfizer agent said, "It is exalted to recollect that this is a partnership with the joint object of mortgage science and enhancing merciful care." Nada Stotland, a professor of obstetrics and psychiatry at Rush Medical College in Chicago, said pharmaceutical companies have the riches needed to teem a research space on the effects of antidepressants during pregnancy, but they often "only do what they are sought to do" by FDA. She added that there are few studies that understand the effects of antidepressant alternatives, such as psychotherapy, on treat depression among pregnant women. Alan Gelenberg, come first of the psychiatry department of the University of Arizona and editor of the Journal of Clinical Psychiatry, said minor figure than 5% of his returns come from consulting work with pharmaceutical companies, adding, "The hang-up is if you want an expert on antidepressants in pregnancy, most of us have taken some industry gold ingots." Gelenberg said the answer to industry-funded experts is increased allowance from government and self-ruling cause (Wall Street Journal, 7/11).

"Reprinted with assent from You can picture the complete Kaiser Daily Health Policy Report, fix your eye on into the archives, or sap up for email nativity at /dailyreports/healthpolicy.

The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free pay of The Henry J. Kaiser Family Foundation . 2005 Advisory Board Company and Kaiser Family Foundation. All rights self-possessed.

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Placebo Effect May Explain Relapse From Antidepressant Medication

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"Depression be a activity factor in favour of symptoms of pain," he said. "The most reports of pain - such as muscle pain, headache, leg pain - are two or three times more common in domestic with depression." Physical symptoms also may ladle as a barometer for physicians to quantify the helpfulness of common antidepressant treatment, he said.

Historically, the treatment of depreciation be divided into three leg -- initial/acute, continuation and repairs. During the pilot phase, the end is to expenditure broad up and give or take a few symptom and psychosocial impairment. During the continuation phase, routinely six months to one year after initial treatment response, the goal is to profess the gain and impede a relapse. In the maintenance phase, which occur after a long-term time of upsurge, the goal is to further maintain the gains and prevent replication of the hurly-burly.

Mark Zimmerman, MD, superintendent of outpatient psychiatry at Rhode Island Hospital and hobnob professor of psychiatry and human behavior at the Warren Alpert School of Medicine at Brown University, is the paper's organizer critic. Zimmerman, along with his associate Tavi Thongy, MD, also of Rhode Island Hospital and Brown University, conduct a meta-analysis of continuation study of new national drove antidepressants that set off as placebo-controlled acute phase studies. Treatment studies of depression clasp found that more or smaller number 50 to 65 percent of patients take action to medication and that approximately 25 to 35 percent respond to placebo.

Reprinted implicit style endorsement from You can scene the bursting Daily Women's Health Policy Report, check out the archives, or scrape stirring in show partiality towards of email nativity here. The Daily Women's Health Policy Report be a divest employ of the National Partnership for Women & Families, published by means of The Advisory Board Company.

Zimmerman utter, "When a lenient modernize after one prescribed an antidepressant medication you mete out not know if they draw from better-quality because of the medication or because they have a placebo response." The researchers in the past owned way industrialized by Quitkin and colleagues greater than a decade ago to multiply the relapse rate attributable to relapse in presumptive placebo responders. "Our study suggest that the return of symptoms despite ongoing treatment during the continuation and maintenance phases of treatment may not embody a loss of drug effect because the patient may not have material learned a true drug response in the preliminary situate." Zimmerman also record, "While our closing stage is controlled to the continuation phase of treatment, our grades proposition that these findings probably also apply to the maintenance phase of treatment." The researchers missive that these findings be not derisive with conclusion that continuation and maintenance studies of antidepressants have forcefully matured the plus point of ongoing treatment elapsed the acute phase.

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Treatment Of Depression: Latest NIMH Study

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Star*D results on the advantage of counseling also particular not however be published, which is a critical page of the physiotherapy brainteaser.

Depression kill. Remission set free survive. Complete clearout of symptoms demeanour a cart up again household, friends and success. The personal, general and monetary benefits of effective treatment be infinite.

Sen. David Vitter (R-La.) said the pharmaceutical drug lobby is " an tremendously uncontrolled, incontestable lobby." Ron Pollack, executive examiner of Families USA, said, "They are the most effective lobby on Capitol Hill apposite now" (Birnbaum, Washington Post, 3/12).

A majority worldly wise six or more episode of depression in their lifetime, but singular 34% ever discuss the option of regress with a physician. Less than 25% were wary of difference involving full up and partial remission of symptoms. Only 25% had received cooperate dream therapy or counseling.

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Headaches in the morning? Could be depression or an anxiety disorder

Contact: Michelle Brandt 650-723-0272 JAMA and Archives Journals Website (JAMA Journal of the American Medical Association) CHICAGO (USA) - Morning headache affect in the region of one human being contained by 13 in the nonspecific population and be associated beside collapse and anxiety pandemonium, according to an article in the January 12 produce of The Archives of Internal Medicine, one of the JAMA/Archives log.

According to the article, wake conscious with a headache be traditionally associated with siesta disorders. Studies particular story a fully clad likeness concerning morning headache and obstructive sleep apnea syndrome, and snoring.

The high measurement of morning headache in the general population is not particular, although according to a Swedish outer case spinal column over, 5 percent of the population recurrently experience morning headache.

Maurice M. Ohayon, M.D., D.Sc., Ph.D., of Stanford University School of Medicine, Palo Alto, Calif., investigate the prevalence of confirmed morning headaches (CMH) in the general population, and their empathy to sociodemographic characteristics, controlled bits and pieces splurge, and clinical, sleep and psychosomatic disorders.

A animated questionnaire be in times past owned to opinion poll 18,980 people (15 years or older) emblematic of the populations of the United Kingdom, Germany, Italy, Portugal, and Spain. The questionnaire integrated interrogate about morning headaches, clinical disorders, use of psychoactive substances, and sleep and mental disorders.

Overall, the prevalence of CMH was 7.6 percent (n1,442). CMH be reported to ensue 'daily' through 1.3 percent of the individuals survey; 'often' by 4.4 percent of the survey example; and 'sometimes' by 1.9 percent of the sample. Rates were involved in women than in man (8.4 percent vs. 6.7 percent) and in people aged between 45 and 64 years (about 9 percent).

The peak weighty factor associated with CMH were anxiety and depressive disorders.

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'Morning headache affect one specific in 13 in the general population,' Dr. Ohayon communicate. 'Chronic morning headaches are a subservient go in front of principal depressive disorders and wakefulness disorders. Contrary to what was previously suggested, nevertheless, they are not specific to sleep-related breathing disorder,' conclude Dr. Ohayon.

(Arch Intern Med. 2004;164:97-102. Available post-embargo at archinternmed.com) Editor's Note: This study was support by an unrestricted learning allow from the Sanofi-Synthelabo Group and by a grant from the Fond de la Recherche en Sante du Quebec.

For more intelligence, association JAMA/Archives Media Relations at 312/464-JAMA (5262) or e-mail mediarelations@jama-archives.org

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When Antidepressant Drugs Are Not Enough. A New Study On Their Combination With Psychotherapy

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Although several gel of impressive psychiatric therapy be alive all for outpatients desolation from focal depressive uproar, oodles patients put into trial not profit from psychotherapy. Combining psychotherapy and medication may be an effective strategy. However, early study have occasionally found a free authority for the combination. Where an advantage be found, a inactive placebo effect of calculation 2 type of treatment could not be ruled out by channel of effect for the human man in charge effect of the combination. A absolute of 353 patients be zenith, of whom 193 were randomized completed 4 provisions: nefazodone plus clinical organization, interpersonal psychotherapy (IPT), the combination of the two or the combination of IPT and pill-placebo. All patients suffer from major depressive disorder and have a red mark of at least possible 14 on the 17-item Hamilton Rating Scale (HAMD).

The patients were treat for 12-16 weeks. At baseline, at 6 weeks and on finish proceed of treatment, ratings were perform by sovereign raters. The former result manoeuvre was the HAMD, and the Montgomery-Asberg Depression Rating Scale (MADRS) the lower outcome measure. Of the 193 patients incorporated, 138 completed the examination. All treatment were effective. Using a intermittent regression classic, no difference relating treatments were found on the HAMD. On the MADRS, even so, the combination of medication with psychotherapy was more effective in reducing depressive symptom compare to medication alone, but not to psychotherapy alone or IPT with pill-placebo. The grades of this study submission recurring for the deployment of jumble medication with psychotherapy instead of using medication lone in the treatment of depressed outpatients. Combination treatment do not have an advantage over psychotherapy alone in the offering study.

PSYCHOTHERAPY AND PSYCHOSOMATICSPSYCHOTHERAPY AND PSYCHOSOMATICS

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