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An updated edition of a mental health bible for doctors may include diagnoses for “disorders” such as toddler tantrums and binge eating, experts say, and could mean that soon no-one will be classed as normal.
Leading mental health experts gave a briefing on Tuesday to warn that a new edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is being revised now for publication in 2013, could devalue the seriousness of mental illness and label almost everyone as having some kind of disorder.
Citing examples of new additions like “mild anxiety depression,” “psychosis risk syndrome,” and “temper dysregulation disorder,” they said many people previously seen as perfectly healthy could in future be told they are ill.
“It’s leaking into normality. It is shrinking the pool of what is normal to a puddle,” said Til Wykes of the Institute of Psychiatry at Kings College London.
The DSM is published by the American Psychiatric Association (APA) and contains descriptions, symptoms, and other criteria for diagnosing mental disorders. It is seen as the global diagnostic bible for the field of mental health medicine.
The criteria are designed to provide clear definitions for professionals who treat patients with mental disorders, and for researchers and pharmaceutical drug companies seeking to develop new ways of treating them.
Wykes and colleagues Felicity Callard, also of Kings’ Institute of Psychiatry, and Nick Craddock of Cardiff University’s department of psychological medicine and neurology, said many in the psychiatric community are worried that the further the guidelines are expanded, the more likely it will become that nobody will be classed as normal any more.
“Technically, with the classification of so many new disorders, we will all have disorders,” they said in a joint statement. “This may lead to the belief that many more of us ‘need’ drugs to treat our ‘conditions’ — (and) many of these drugs will have unpleasant or dangerous side effects.”
The scientists said “psychosis risk syndrome” diagnosis was particularly worrying, since it could falsely label young people who may only have a small risk of developing an illness.
“It’s a bit like telling 10 people with a common cold that they are “at risk for pneumonia syndrome” when only one is likely to get the disorder,” Wykes told the briefing.
The American Psychiatric Association did not immediately respond to a request for comment.
The scientists gave examples from the previous revision to the DSM, which was called DSM 4 and included broader diagnoses and categories for attention deficit hyperactivity disorder (ADHD), autism and childhood bipolar disorders.
This, they said, had “contributed to three false epidemics” of these conditions, particularly in the United States.
“During the last decade, how many doctors were harangued by worried parents into giving drugs like Ritalin to children who didn’t really need it?,” their statement asked.
Millions of people across the world, many of them children, take ADHD drugs including Novartis’ Ritalin, which is known generically as methylphenidate, and similar drugs such as Shire Plc’s Adderall and Vyvanse. In the United States alone, sales of these drugs was about $4.8 billion in 2008.
Wykes and Callard published a comment in The Journal of Mental Health expressing their concern about the upcoming DSM revision and highlighting another 10 or more papers in the same journal from other scientists who were also worried. DSM 5 is due to be published in May 2013.
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Despite what many social observers have described as a generally dark and brooding take on life, a new report suggests that Russians are actually less likely than Americans to be depressed.
In fact, researchers have uncovered indications that the Russian cultural tendency to dwell on the negative may ultimately insulate them from feelings of distress when engaged in self-reflection.
“Among Westerners, focusing on one’s negative feelings tends to impair well-being, but among Russians, that is not the case,” study co-author Igor Grossmann, a doctoral candidate in psychology at the University of Michigan, said in a university news release.
“Russians focus more on their negative feelings than Americans do,” Grossmann explained, “but they spontaneously distance themselves from their emotions to a greater extent than Americans, who tend to immerse themselves in their recalled experiences.”
Grossmann and co-author Ethan Kross, a University of Michigan assistant professor of psychology, published their findings in the August issue of Psychological Science.
Grossmann and Kross reported on two studies, funded by the U.S. National Institute of Mental Health, that explored cultural influences on depressive tendencies.
The first study focused on 168 Russian and American students who underwent testing to measure their degree of brooding and depressive symptoms. While the Russians were found to brood more, they also displayed fewer indicators of depression than their American counterparts.
The second study involved 162 students who were measured for distress after being asked to remember and discuss a not-too-distant unpleasant memory involving themselves and another individual.
The Russians appeared to experience less distress than the Americans after retelling the experience, and placed blame less often on the person involved in the incident. The Russians were also able to immediately distance themselves from their recollections, even while discussing them — a skill linked to less distress and feelings of blame, the study authors noted.
Culture, concluded the authors, has an impact on the emotional and cognitive consequences of bad experiences.
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Some obese adults may be at increased risk of having their breathing difficulties misdiagnosed as asthma, a new study suggests.
Researchers found that among nearly 500 Canadian adults who said a doctor had diagnosed them with asthma, objective lung-function testing ruled out the lung disease in 150, or 30 percent.
When the investigators looked at risk factors for misdiagnosis, obesity in general did not play a clear role. However, among patients who had sought emergency care for breathing problems in the past year, obese men and women were four times as likely as their normal-weight counterparts to be misdiagnosed with asthma.
The study, reported in the journal Chest, could not ascertain the reasons for patients’ misdiagnoses or for the higher risk among obese adults who sought urgent care.
But past research has indicated that spirometry, a standard test of lung function, is not used as often as it should be in diagnosing asthma, said Dr. Smita Pakhale of the Ottawa Hospital in Ontario, Canada, who led the new study.
Asthma should be diagnosed based on both symptoms and lung-function testing, and underuse of the latter could be a factor in some of the incorrect diagnoses in this study, Pakhale told Reuters Health — though, she added, that is just speculation.
Pakhale also pointed out that obese adults are at heightened risk of a number of health problems that could cause asthma-like symptoms such as breathlessness and chest tightness. Those include low fitness levels, acid reflux and heart disease.
Pakhale said that people who are told they have asthma after seeking care at an emergency room or walk-in clinic should be sure to follow up with their primary care doctor. That way, she said, they can get any additional evaluation or testing that may be needed — which may uncover the actual cause of the symptoms, if it is not asthma.
The study included 496 randomly selected adults from eight Canadian cities who said a doctor had diagnosed them with asthma. Roughly half were obese and the rest were normal-weight.
Overall, lung function testing confirmed the asthma diagnosis in 70 percent of study participants. Of these men and women, 14 percent and 15 percent of obese and normal-weight people, respectively, had sought emergency care for breathing problems in the past year.
Of study participants who turned out not to have asthma, 21 percent of obese individuals had sought urgent treatment for respiratory symptoms in the past year. That figure was less than 10 percent among normal-weight men and women.
When Pakhale’s team considered other factors, including socioeconomics, obese study participants who needed emergency care were four times more likely to have been misdiagnosed with asthma as their thinner counterparts.
The researchers also found that the time since diagnosis mattered: study participants who had been diagnosed in the past few years had a higher likelihood of misdiagnosis than those who had been told they had asthma “many” years ago.
It’s possible, Pakhale speculated, that increased asthma awareness among the general public and doctors — possibly via the recent proliferation of asthma-medication ads — could have something to do with that finding.
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A mental disorder whose symptoms include lashing out in aggressively verbal or violent ways has recently been found to be nearly twice as common as previously thought. The research has sparked debate within the psychological community about the diagnosing of a mental illness whose symptoms overlap with normal, if undesirable, human behaviors, as well with as symptoms of other disorders.
Intermittent explosive disorder (IED), which is characterized by flying off the handle and overreacting to stress, was first recognized by the American Psychiatric Association in 1980. Now, as the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is the book psychologists use when making diagnoses, is undergoing evaluation and revision, some are calling for new criteria to be used in identifying IED and other related disorders.
The next edition of the book, the DSM-V, is planned to be released in May 2013, almost 20 years after the last edition, the DSM-IV, was published in 1994.
“IED is a behavioral disorder that is a medical condition in the same way that depression or panic disorder is – it is not simply ‘bad behavior,’” said Emil F. Coccaro, a professor of psychiatry and behavioral neuroscience at the University of Chicago. “Aggressive behavior is under genetic influence and IED runs in families.”
How common?
It’s not clear how many people have IED. The DSM-IV states that “reliable information is lacking, but Intermittent Explosive Disorder is apparently rare.” However, others say IED is much more common than previously thought.
A 2004 study of 253 Baltimore residents estimated that 4 percent of people develop the disorder at some point during their lives. But according to a 2006 study published in the Archives of General Psychiatry, “Depending upon how broadly it is defined, this disorder affects as many as 7.3 percent of adults, or 16 million Americans, in their lifetimes.”
The reason one study found IED to be nearly twice as prevalent as the other, Coccaro said, was in part due to gray areas in the diagnosis guidelines.
“The disorder was under-diagnosed,” Coccaro said. “The proposed changes will lead to it being diagnosed to a more correct degree.”
One problem with the current criteria is that they don’t clearly delineate the severity level or the frequency of aggressive outbursts that define IED, said Coccaro.
“Looking at the criteria as written, having only three aggressive outbursts in one’s life could give you the diagnosis,” Coccaro said. “However, people with only a few aggressive outbursts in their life do not look that different from other people. You really need to see much more frequent outbursts whether they involve very severe aggression or not.”
Coccaro said that the criteria should require that a person has had three episodes involving physical assault against other people or destruction of property within one year, with a degree of aggressiveness “grossly out of proportion” to the situation. Also, the aggressive behavior should not have been committed to achieve a logical goal, such as attaining someone’s money.
The criteria should also be written so that doctors diagnosing IED must rule out that the anger attacks, as they are sometimes called, aren’t related to other mental disorders that also involve problems of impulse control, such as antisocial personality disorder, conduct disorder and schizophrenia, Coccaro said.
Anger attacks
According to the current criteria, a “blow up” occurs when a person with IED becomes enraged and fails to resist their aggressive impulses. They may strike or otherwise hurt another person, threaten to hurt someone, or destroy property, according to the DSM-IV.
“Typically, these people perceive a slight when none was meant and they ‘blow up,’ or they get frustrated by something, or by a rejection, and they ‘blow up,’ “said Coccaro.
During an anger attack, a person with IED expresses a degree of hostility that is grossly out of proportion to any sudden psychosocial stressors. The explosive behavior is often preceded by a sense of tension and is immediately followed by a sense of relief. After the episode, a person with IED may feel upset, remorseful, regretful, or embarrassed about their aggressive behavior, according to the DSM-IV.
Road rage, domestic abuse, and angry outbursts or temper tantrums that involve throwing or breaking objects may be signs of IED, according to the Mayo Clinic. According to Coccaro and other researchers, treatment for IED may involve medication, such as Prozac, and psychotherapy to help control aggressive impulses. People with the disorder have been shown to responds positively to a combination of both.
Improving the criteria, Coccaro said, may further increase the number of people diagnosed with IED.
“The criteria in DSM-III and IV were poorly set up and encouraged clinicians not to make the diagnosis if the patients seemed to be generally impulsive or aggressive,” Coccaro told Life’s Little Mysteries.
Beyond IED
Confusing or inaccurate diagnosing guidelines are not as common as they used to be in the DSM, Coccaro said, but still exist. As more research is done on any disorder, it becomes better understood and defined more accurately. While some aspects of anger-related disorders remain mercurial, ongoing research has helped to bring data and awareness to the problems that exist.
How IED and other disorders will be defined in the upcoming edition of the DSM is still in question, as the DSM Task Force considers the comments and opinions of health professionals, patients, professional societies and researchers regarding the current definition, classification and diagnosing standards.
“There have been discussions about whether IED will change in the DSM-V, but no decisions have been made yet,” Jaime Valora, a spokesperson for the American Psychiatric Association, told Life’s Little Mysteries.
Still, Coccaro is hopeful that those revising the DSM will consider his research’s findings so that the latest edition of the manual can be used to more accurately diagnose people.
“Typically, changes are due to better data about a disorder that makes the writers and editors of the DSM make changes in the criteria,” Coccaro said.
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The Medicare drug benefit may be helping more older Americans with heart failure get the medications recommended for controlling the disease, a new study finds.
The study, of nearly 7,000 older heart failure patients in one large insurance plan, found that the number of filled prescriptions for standard heart failure medications increased after the Medicare drug benefit kicked in in 2006.
The biggest increase was seen among seniors who had previously lacked any form of drug coverage.
Since January 2006, Medicare beneficiaries have been able to purchase the “Part D” prescription-drug benefit subsidized by the program and available through private plans. Drugmakers strongly backed the 2003 law creating the drug program, and one of the criticisms of the landmark policy shift was that the pharmaceutical industry would be the biggest winner.
A 2007 report by IMS Health, a firm that provides sales data to the drug industry, found that the Medicare drug benefit boosted sales of pricey brand-name cholesterol-lowering statins and ulcer drugs by 5 percent to 7 percent, for example.
However, there has also been evidence that the goal of the program — helping seniors, especially those with low incomes, afford needed medications — is being met.
For example, a 2009 study by the research organization RAND found that by 2008, Medicare drug coverage had trimmed seniors’ annual out-of-pocket drug costs by 16 percent, on average, while increasing the number of prescriptions by 7 percent.
The new findings, reported in the American Heart Journal, are the first to show that the program may be helping more beneficiaries with heart failure get the medications that are routinely recommended to help lower their risk of hospitalization and extend their lives.
Heart failure is a chronic condition in which the heart can no longer pump efficiently enough to meet the body’s needs, leading to symptoms like fatigue, breathlessness on exertion and fluid buildup. Guidelines state that people with heart failure should take drugs called beta-blockers in combination with either an ACE inhibitor or similar medications known as angiotensin II receptor blockers (ARBs).
For the current study, researchers led by Dr. Julie M. Donohue of the University of Pittsburgh looked at records for 6,950 heart failure patients age 65 and older who were enrolled in a Pennsylvania Medicare managed care program between 2003 and 2007.
In the year before the Medicare drug benefit kicked in, 534 plan members had no drug coverage, while just over 4,600 had coverage with quarterly caps of $150 or $350. The remaining 1,800 had drug coverage through an employer or union, with no cap on benefits.
After January 2006, the study found, the number of filled prescriptions for heart failure drugs increased among beneficiaries who had previously lacked drug coverage or had limited coverage.
Among those who had lacked coverage, the average number of filled prescriptions per year rose from 13 to roughly 19, according to Donohue’s team.
In line with that, the percentage who filled at least one prescription for a beta-blocker increased from 45 percent in the two years prior to Medicare Part D, to 59 percent in 2006 and 2007. For a beta-blocker plus an ACE inhibitor or ARB, the corresponding figure rose from 21 percent to 32 percent.
Plan members who had previously had drug coverage with quarterly caps showed smaller increases. The percentage filling a prescription for a beta-blocker, for instance, rose from between 55 and 58 percent to about 63 percent.
“These findings,” Donohue and her colleagues write, “are consistent with a major goal of the (Medicare Part D) policy, which was to reduce financial barriers to medication access among the elderly.”
However, Medicare drug coverage did not erase the gaps in prescription drug use seen between seniors who had previously lacked coverage and those who’d had generous benefits through an employer or union.
Before and after Medicare Part D kicked in, about 45 percent of the latter group had filled prescriptions for both a beta-blocker and an ACE inhibitor or ARB. And while that rate rose among seniors who had previously lacked coverage, it stood at 32 percent after Medicare drug coverage came into effect.
Still, Donohue’s team writes, that increase in prescription use could potentially translate into fewer heart-failure hospitalizations — and lower costs — as well as longer lives.
Future research, they say, should investigate whether that is the case.
SOURCE: http://link.reuters.com/pam58m American Heart Journal, July 2010.
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The fate of a GlaxoSmithKline Plc diabetes drug may become clearer on Wednesday when U.S. advisers vote on whether the widely used pill carries too much heart risk to stay on the market.
The high-stakes decision by a panel of outside experts is designed to help the Food and Drug Administration settle a three-year safety dispute over Avandia.
Views on Avandia’s risks are mixed within the FDA. Opinions also could be split within the 33-member panel of scientific experts after hearing hours of sharply conflicting data on Tuesday on whether Avandia causes heart attacks.
Avandia’s U.S. sales were just 1.5 percent of Glaxo’s 2009 revenues, but investors fear the company could face more lawsuits if the drug is pulled from the market.
On Tuesday, Glaxo agreed to pay $460 million to settle thousands of lawsuits over Avandia, Bloomberg reported, citing people familiar with the settlements.
Glaxo will settle about 10,000 suits for an average of $46,000 each, Bloomberg said. A Glaxo spokeswoman declined to comment. Plaintiffs’ lawyers reached by Reuters also could not confirm a settlement.
The advisory panel is due to vote Wednesday afternoon on recommendations ranging from keeping the drug on the market with no warnings, to urging a withdrawal. Restrictions on use or beefing up warnings are among other choices.
Because the FDA asked panelists to select only one of the five options, there may be no clear majority.
The agency will make the final call in the coming months but usually follows the advice of its panels.
The debate on Avandia’s safety has raged since warnings were placed on the drug in 2007 saying some research linked the drug to a higher heart attack risk but the data is “inconclusive.”
DIVIDED FDA
FDA staff are deeply divided over the safety of Avandia, also known as rosiglitazone, and the agency has thrown the issue to the expert panel to untangle.
Dr. David Graham, an FDA reviewer who has pushed for Avandia’s withdrawal for years, said the agency applies different standards when deciding whether to approve a drug versus determining risk after a medicine is on the market.
Graham told the panel on Tuesday the Record study relied on by Glaxo to show no increased heart attack risk from Avandia compared to older diabetes drugs would not pass muster for an approval. “You wouldn’t even hear about it because it’s garbage,” he said.
Dr. Ellis Unger, a deputy director of drug evaluation, said he found Record’s results “pretty reassuring” on heart safety.
But he added it was up to the expert panel to decide if Record was legitimate.
“Can we trust the sponsor (Glaxo) with the results of Record? I think that is something the committee is going to need to think about,” Unger said.
Panelists asked some questions of Tuesday’s presenters but gave little hint on how they were leaning.
On Wednesday morning, ahead of the voting, the panel will hear from a statistical expert and an opinion on TIDE, a trial comparing Avandia to Takeda Pharmaceutical Co’s rival diabetes pill, Actos, which some FDA staff see as safer.
GLAXO DEFENDS
Glaxo officials defended Avandia before the advisers on Tuesday saying diabetes was a serious disease that needed multiple treatment options to control blood sugar and prevent devastating complications including amputations and blindness.
“When used appropriately, (Avandia) has a positive benefit/risk profile and should remain a treatment for type 2 diabetes,” said Dr. Murray Stewart, a Glaxo vice president for drug research and development.
For the FDA, the Avandia case is seen as a test of how the agency will handle major controversies under Democratic President Barack Obama. Officials are facing heavy pressure from consumer groups and some lawmakers who say the FDA fumbled decisions in past administrations and failed to protect the public.
(Reporting by Lisa Richwine; Editing by Tim Dobbyn)
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Federal health scientists have panned a GlaxoSmithKline study that the company used to defend the safety of its embattled diabetes drug Avandia, a once blockbuster-seller that has fallen out of favor because of potential ties to heart attacks.
The Food and Drug Administration posted an exhaustive 700-page review of Avandia on Friday ahead of a meeting next week to decide whether the drug should stay on the market.
The FDA finds itself in a difficult position that’s all too familiar: reviewing a drug approved a decade ago that now appears tied to deadly side effects. Experts say the FDA’s predicament is a result of shifting standards for the agency: increased scrutiny on safety and stepped-up pressure from Capitol Hill.
The FDA reviewed dozens of studies of Avandia, including one Glaxo has pointed to as proof of the drug’s safety. But an FDA reviewer said the study was plagued by “serious flaws” and actually supports the case against Avandia.
The drug works by increasing the body’s sensitivity to insulin, a key protein needed for digestion that diabetics don’t adequately produce.
People with diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or because of resistance to insulin. They are at higher risk for heart attacks, kidney problems, blindness and other serious complications.
Avandia was Glaxo’s third best-selling drug in 2006 with U.S. revenue of $2.2 billion, according to health care statistics firm IMS Health. But safety concerns swirling around the drug have pummeled sales over the last three years, with sales falling 75 percent to $520 million last year.
In 2007 an analysis of dozens of studies first linked the drug to heart attacks. The FDA responded by adding a warning label to the drug later that year.
Glaxo, based in London, has argued for years that Avandia’s safety should be assessed only based on clinical trials, considered the gold standard of medical research.
But the FDA reviewer said Glaxo’s chief trial “was inadequately designed and conducted to provide any reassurance” about the heart safety of Avandia.
The FDA holds a special two-day meeting starting Tuesday to help decide what course of action to take. A panel of outside physicians will consider a range of recommendations including:
• Adding more warning labels.
• Limiting which doctors can prescribe the drug.
• Pulling the drug from the market.
The FDA is not required to follow the advice of its outside panels, though it usually does.
The agency has been down this road before. In 2007 the FDA assembled the same group of experts to vote on the same drug. The group voted 22-1 in favor of keeping Avandia on the market.
New data on Avandia’s risks and pressure from politicians have prompted the agency to re-examine the drug’s safety.
Despite the reams of information posted online, the FDA’s main problem remains one of too little data.
Avandia, like many other drugs of the 1990s, was approved based on relatively small studies in several thousand patients. While those studies were sufficient to show the drug helped control blood sugar levels — the key measure for diabetes drugs — they were not large enough to detect all of the drug’s potential side effects.
“The problem is the drug wasn’t studied in enough patients up front to know whether it causes serious cardiovascular events,” said Dr. David Kessler, former FDA commissioner and now a professor at University of California at San Francisco. “And chasing that question after millions of prescriptions have been written leads to a lot of confusion.”
Since 2009 the FDA has required longer, larger studies of diabetes drugs that include more high-risk patients.
Scientists have tried to get an accurate picture of Avandia’s risks by pooling hundreds of thousands of data points from various sources.
The most recent such analysis was published last month and suggested Avandia is more likely to cause strokes and heart-related death than a rival drug, Actos, made by Japan-based Takeda Pharmaceuticals.
The paper’s chief author, Dr. David Graham, an FDA scientist who wants the pill banned, estimated as many as 100,000 heart-related problems may have been caused by Avandia.
The study analyzed medical records of more than 225,000 elderly Medicare patients.
Graham first came to prominence for his role in publicizing the risks of the Merck painkiller Vioxx, which was pulled in 2004 from the market after showing links to heart attacks and strokes. He argued that lives could have been saved if the FDA had acted more swiftly.
The legacy of Vioxx and the political firestorm that followed will hang over next week’s deliberations.
Lawmakers on Capitol Hill already have painted Avandia as a test of the agency’s competence and courage.
Senate Finance Committee ranking Republican Charles Grassley helped kickstart the review of Avandia with an investigation that concluded GlaxoSmithKline tried to downplay the risks of its drug. Last week Grassley said the drug should be pulled from the market.
But former FDA officials say such political prodding hurts the agency’s mission.
“Public policy decisions don’t get made in a vacuum, and that’s a reality of FDA decision making that everyone has to recognize,” said Mary Pendergast, a former FDA deputy commissioner who now consults for companies. “But when members of Congress who are not scientists tell the FDA what to decide, I think that’s hard for the FDA.”
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