Mental Health Association of Portland

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Prejudices, misconceptions about serious mental illness creep into medical treatment plans

Posted by Jenny on 26th May 2013

By Lauren LeBano, PsychCongress Network, May 23, 2013

Doctor shaking fingerPrejudices about individuals with mental illness play a role in many healthcare providers’ treatment decisions involving physical conditions, a randomized trial suggested.

When providers of all types — even mental health professionals — were presented with hypothetical vignettes of patients with medical conditions such as obesity, the treatment plans differed markedly when the patient also had schizophrenia, said Dinesh Mittal, MD, of the University of Arkansas for Medical Sciences in Little Rock.

Providers tended to assume that schizophrenia patients would be less adherent to instructions, more likely to miss appointments, and less competent at making their own medical decisions — none of which are justified by evidence, Mittal said at the American Psychiatric Association annual meeting here.

The biggest surprise in the study, he said, was that psychiatrists and mental health nurses had most of the same prejudices about schizophrenic patients as their counterparts in primary care.

Previous research had indicated that patients with mental illnesses often receive different treatments for medical conditions than other individuals. For example, Mittal said at a press briefing, a 2000 study indicated coronary angioplasty was performed less than half as often in Medicare patients diagnosed with mental illnesses than in otherwise similar patients without a psychiatric comorbidity.

To examine whether different types of medical providers would regard patients with mental illnesses differently from others when it comes to their medical conditions, he and his colleagues performed a prospective, randomized, survey-based trial among 275 providers at five Veterans Affairs medical centers.

The researchers presented respondents with one of two hypothetical patient scenarios, identical except that one of the patients was described as also having schizophrenia, and asking about the expectations for that patient and the types of treatment they would recommend.

The scenarios described a 34-year-old male patient with rising hypertension, moderate but increasing obesity, insomnia, and chronic back pain. This patient was coming to the clinic for a follow-up visit to seek stronger pain medication for the back pain; he was currently taking lisinopril, naproxen and fluoxetine (Prozac). He was also described as employed, with above-average work performance, and a regular churchgoer with hobbies including fishing and reading magazines.

Respondents included 91 primary care nurses, 55 primary care doctors, 67 mental health nurses, and 62 psychiatrists. Half of each group was given the scenario in which the patient also was described as having clinically stable schizophrenia managed with risperidone (Risperdal).

Overall, in response to questions about how the schizophrenic individual would behave as a patient, the participants had significantly lower expectations in most categories.

Just over 50% of respondents in all categories indicated that this patient would be competent to make his own medical decisions, compared with 84% of respondents asked about the otherwise identical non-schizophrenic patient (P<0.05).

Mean ratings of the schizophrenic patient’s expected social functioning and his ability to read and understand written materials were significantly lower, Mittal said.

Also, nearly 85% of respondents indicated that the patient might try to hurt others or himself; 59% of those asked about the non-schizophrenic patient said the same (P<0.05).

In each case, Mittal said, studies have shown that such beliefs are unfounded, at least as long as schizophrenia remains under control and no psychosis is present.

The preconceptions about the schizophrenic patient translated into differences in how the providers would care for him.

Even though at least one recent study has shown that weight loss programs are effective in obese schizophrenics, Mittal said, the healthcare professionals were significantly less likely to recommend it for the schizophrenic patient in the vignette.

They were also less likely to recommend a sleep study, although the difference in that case was smaller and nonsignificant. There was no difference at all in recommendations that the patient try a pain management program.

In one respect, however, prejudice might work in the schizophrenic patient’s favor — significantly more providers indicated that they would involve his family in his medical management. Mittal said this represents “good medical practice,” but it may also reflect a paternalistic attitude and lack of trust in the patient himself.

He said his expectation going into the study was that mental health providers would be less prone to stereotyping of the schizophrenic patient. Yet, he said, the patterns of responses they gave did not differ markedly from those of the primary care providers.

“There is a need for reducing stigma among all healthcare professionals” toward patients with mental illnesses, he said.

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DSM-5 launch marked by psychiatrists sparring in print, protesters gathering out front

Posted by Jenny on 24th May 2013

OccupyTheAPAPosterBy Jenny Westberg, Portland Mental Health Examiner, May 23, 2013

A rising controversy over the DSM-5, the new edition of the so-called Bible of psychiatry, heated up to a flashpoint last weekend as the book was launched at the 166th annual meeting of the American Psychiatric Association.

Criticism of the new psychiatric manual has issued from sources as diverse as the director of the National Institute of Mental Health and the activists of Occupy Psychiatry.

Occupy Psychiatry mounted a protest outside the Moscone Center in San Francisco, where the APA was meeting. Among the protesters was Portland mental health activist, coach and group facilitator Chaya Grossberg, who said Occupy Psychiatry drew some respectful attention from APA members.

“Some of the psychiatrists stopped and listened, some for almost the whole time!” Grossberg said yesterday.

In recent weeks, however, psychiatrists were likelier to be sniping at each other.

Shrink vs. Shrink

NIMH director Thomas Insel, MD, criticized the manual’s “lack of validity” April 29, calling it “at best, a dictionary” that defines the exact set of labels it creates. “Patients with mental disorders deserve better,” he wrote.

But David Kupfer, MD, chair of the DSM-5 task force, defended the diagnostic manual and struck back at Insel in a May 6 statement, saying the NIMH director’s proposed replacement for the DSM — use of biological and genetic markers for diagnosis and treatment — “cannot serve us in the here and now.”

Though he said he hopes such a system will exist someday, Kupfer called it “disappointingly distant. We’ve been telling patients for several decades that we are waiting for biomarkers. We’re still waiting.”

Word War

Fellow psychiatrists parried in the New York Times letters section after professor of psychiatry Ronald Pies, MD, scoffed at criticism of the DSM. “There is nothing inherently dehumanizing or ‘stigmatizing’ about a psychiatric diagnosis,” he wrote, before apparently contradicting himself with a reference to “society’s animus and prejudice toward those with mental illness.”

Victor Altshul, MD, a psychiatrist in New Haven, pointed out that “responsibility for the stigmatization of large groups of people can partly be laid at our door. Just ask gay people who were around before 1973, when homosexuality was finally removed from the DSM.”

And psychiatrist Leon Hoffman, MD, joined the dissent: “The problem with the DSM is that psychiatry over at least the last four decades has attempted to categorize mental and psychological manifestations as distinct illnesses, similar to the categorization of medical and surgical illnesses, instead of recognizing that the best way to understand psychological health is on a spectrum.”

“All of us are a little depressed, a little obsessional, a little histrionic and a little borderline,” wrote Hoffman. “Some of us have a little more of one of these qualities and less of one of the others. We seek help when one of our traits causes us or those around us too much psychic pain.”

DSM-5 coverOverdiagnosis a Threat

Specific criticisms of the DSM’s fifth edition center around certain diagnostic criteria that threaten to make the categories so broad that overdiagnosis is a looming risk. For example:

  • People with normal grief and sadness after the death of a loved one, previously excluded from a depression diagnosis, might now be diagnosed with major depression.
  • Diagnosing a child’s temper tantrums as “disruptive mood dysregulation disorder” could saddle normal kids with a mental illness label.
  • Older people who sometimes find it more difficult to do everyday tasks or have an occasional “senior moment” might now be diagnosed with “mild neurocognitive disorder.”
  • Excessive thoughts or feelings about pain or other discomfort is now termed “somatic symptom disorder,” which could give cancer patients another, perhaps unwarranted, diagnosis.
  • It will be easier to qualify for a diagnosis of ADHD, a condition many say is already overdiagnosed.

As of today, psychologists had collected 14,888 signatures on an online petition raising questions about the DSM-5 and asking for a collegial reconsideration.

Occupy Psychiatry and O.P.P.

For the 40 or so Occupy Psychiatry protesters outside the Moscone Center, and many of their supporters, the problem is broader — and deeper — than changes from the previous manual, the DSM-IV. The problem is psychiatry itself.

“The issue is not about this edition of the DSM,” said PJ Moynihan, who was not at the protest, busy instead with the Open Paradigm Project, a social media campaign giving voice to people who reject psychiatric labeling. “It is a broader, philosophical issue about how we respond to human emotion, or life challenges.”

WATCH – Video Testimonial by Cicely Spencer (Open Paradigm Project)

Moynihan added, “My experience in listening to countless stories from individuals whose lives have been severely damaged by psychiatric diagnosis, and consequently psychiatric medication, is that the point of intervention by psychiatry, due to whatever the circumstances may be, is more harm than good.”

“Telling someone who is going through a period of overwhelm, or emotional difficulty, as well as their support system of family and friends, that they have a biological brain disease that is most effectively treated with long term medication, is devastating to the individual, informs how their support network responds or views them, and not founded in any real science or proven biological markers.”

“In short,” said Moynihan, “we need a paradigm shift in mental healthcare, not variations on the prevailing model.”

Speaking Out

Chaya Grossberg

Chaya Grossberg

Speakers at the protest, most of whom identified as psychiatric survivors, included:

  • Attorney Ted Chabasinski: “The increased labeling and drugging of children, and the way the new DSM puts everyone at risk for being called ‘mentally ill’ must be stopped. Everyone must realize that they too can be called crazy, not just those who have already been dragged into and trapped by the system.”
  • Licensed therapist and human rights activist Michael Cornwall, Ph.D.: “The profession of psychiatry lives in a collective state of denial. Psychiatrists are true believers with a religious fundamentalist type of fervor that allows them to routinely injure, and frequently hasten the death of those they are sworn to heal. But the reckoning is upon them. Their blatant human rights violations will not stand the light of day.”
  • Attorney James B. (Jim) Gottstein, Esq.: “Hundreds of thousands of people are locked up and drugged or electroshocked against their will every day under the auspices of the American Psychiatric Association. These are human rights abuses on a massive scale in violation of United States and International Law. The American Psychiatric Association must be held accountable for its role in these horrors.”

Chaya Grossberg, the Portland activist, said the protest was effective and important. “Hundreds of people watched on Livestream,” she said. “People came to the protest for community and solidarity, from Alaska, Portland, Los Angeles, and even Alberta, Canada.”

For many, the protest had a personal impact. Said Grossberg, “Some people who came have been isolated, trying to come off of, or recover from, psych drugs for many years. This protest helped them to know they are not alone, and their voice matters and can be heard.”

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APA releases new psychiatric manual, the DSM-5

Posted by Jenny on 20th May 2013

By The Associated Press, in The Oregonian, May 15, 2013

DSM-5 coverIn the new psychiatric manual of mental disorders, grief soon after a loved one’s death can be considered major depression. Extreme childhood temper tantrums get a fancy name. And certain “senior moments” are called “mild neurocognitive disorder.”

Those changes are just some of the reasons prominent critics say the American Psychiatric Association is out of control, turning common human problems into mental illnesses in a trend they say will just make the “pop-a-pill” culture worse.

Says a former leader of the group: “Normal needs to be saved from powerful forces trying to convince us that we are all sick.”

At issue is the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, widely known as the DSM-5. The DSM has long been considered the authoritative source for diagnosing mental problems.

The psychiatric association formally introduces the nearly 1,000-page revised version this weekend in San Francisco. It’s the manual’s first major update in nearly 20 years, and a backlash has taken shape in recent weeks:

  • Two new books by mental health experts, “Saving Normal” and “The Book of Woe,” say the world’s most widely used psychiatric guide has lost credibility.
  • A British psychologists’ group is criticizing the DSM-5, calling for a “paradigm shift” away from viewing mental problems as a disease. An organization of German therapists also attacked the new guide.
  • Even the head of the U.S. National Institute of Mental Health complained that the book lacks scientific validity.

This week, the NIMH director, Dr. Thomas Insel, tried to patch things up as he and the psychiatrists group issued a joint statement saying they have similar goals for improving the diagnosis and treatment of mental illness.

The manual’s release comes at a time of increased scrutiny of health care costs and concern about drug company influence over doctors. Critics point to a landscape in which TV ads describe symptoms for mental disorders and promote certain drugs to treat them.

“Way too much treatment is given to the normal ‘worried well’ who are harmed by it; far too little help is available for those who are really ill and desperately need it,” Dr. Allen Frances writes in “Saving Normal.” He is a retired Duke University professor who headed the psychiatry group’s task force that worked on the previous handbook.

He says the new version adds new diagnoses “that would turn everyday anxiety, eccentricity, forgetting and bad eating habits into mental disorders.”

Previous revisions were also loudly criticized, but the latest one comes at a time of soaring diagnoses of illnesses listed in the manual — including autism, attention deficit disorder and bipolar disorder — and billions of dollars spent each year on psychiatric drugs.

The group’s 34,000 members are psychiatrists — medical doctors who specialize in treating mental illness. Unlike psychologists and other therapists without medical degrees, they can prescribe medication. While there has long been rivalry between the two groups, the DSM-5 revisions have stoked the tensions.

The most contentious changes include:

  • Diagnosing as major depression the extreme sadness, weight loss, fatigue and trouble sleeping some people experience after a loved one’s death. Major depression is typically treated with antidepressants.
  • Calling frequent, extreme temper tantrums “disruptive mood dysregulation disorder,” a new diagnosis. The psychiatric association says the label is meant to apply to youngsters who in the past might have been misdiagnosed as having bipolar disorder. Critics say it turns normal tantrums into mental illness.
  • Diagnosing mental decline that goes a bit beyond normal aging as “mild neurocognitive disorder.” Affected people may find it takes more effort to pay bills or manage their medications. Critics of the term say it will stigmatize “senior moments.”
  • Calling excessive thoughts or feelings about pain or other discomfort “somatic symptom disorder,” something that could affect the healthy as well as cancer patients. Critics say the term turns normal reactions to a disease into mental illness.
  • Adding binge eating as a new category for overeating that occurs at least once a week for at least three months. It could apply to people who sometimes gulp down a pint of ice cream when they’re alone and then feel guilty about it.

Removing Asperger’s syndrome as a separate diagnosis and putting it under the umbrella term “autism spectrum disorder.”

Dr. David Kupfer, chairman of the task force that oversaw the DSM-5, said the changes are based on solid research and will help make sure people get accurate diagnoses and treatment.

Dr. Jeffrey Lieberman, the psychiatry association’s incoming president, said challenging the handbook’s credibility “is completely unwarranted.” The book establishes diagnoses “so patients can receive the best care,” he said, adding that it takes into account the most up-to-date scientific knowledge.

But Insel, the government mental health agency chief, wrote in a recent blog posting that the guidebook is no better than a dictionary-like list of labels and definitions.

He told The Associated Press he favors a very different approach to diagnosis that is based more on biological information, similar to how doctors diagnose heart disease or problems with other organs.

Yet there’s scant hard evidence pinpointing what goes wrong in the brain when someone develops mental illness. Insel’s agency two years ago began a research project to create a new way to diagnose mental illness, using brain imaging, genetics and other evolving scientific evidence. That project will take years.

The revisions in the new guide were suggested by work groups the psychiatric association assigned to evaluate different mental illnesses and recent research advances. The association’s board of trustees decided in December which recommendations to include.

Advocacy groups have threatened Occupy-style protests and boycotts at this week’s meeting.

“The psychiatric industry, allied with Big Pharma, have massively misled the public,” the Occupy Psychiatry group contends. Organizers include Alaska lawyer Jim Gottstein, who has long fought against overuse of psychiatric drugs.

The new manual “will drastically expand psychiatric diagnosis, mislabel millions of people as mentally ill, and cause unnecessary treatment with medication,” says the website for the Committee to Boycott the DSM-5, organized by New York social worker Jack Carney.

Committee member Courtney Fitzpatrick, whose 9-year-old son died seven years ago while hospitalized for a blood vessel disease, said she has joined support groups for grieving parents “and by no means are we mentally ill because we are sad about our kids that have died.”

Gary Greenberg, a Connecticut psychotherapist and author of “The Book of Woe,” says pharmaceutical industry influence in psychiatry has contributed to turning normal conditions into diseases so that drugs can be prescribed to treat them.

Many of the 31 task force members involved in developing the revised guidebook have had financial ties to makers of psychiatric drugs, including consulting fees, research grants or stock.

Group leaders dismiss that criticism and emphasize they agreed not to collect more than $10,000 in industry money in the calendar year preceding publication of the manual.

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Psychiatrists represent half of top earners in ProPublica’s Dollars for Docs database

Posted by Jenny on 16th March 2013

PillsBy Tracy Weber and Charles Ornstein, ProPublica, March 11, 2013

Dr. Jon W. Draud, the medical director of psychiatric and addiction medicine at two Tennessee hospitals, pursues some eclectic passions. He’s bred sleek Basenji hunting dogs for show. And last summer, the Tennessee State Museum featured “African Art: The Collection of Jon Draud.”

But the Nashville psychiatrist is also notable for a professional pursuit: During the last four years, the 47-year-old Draud has earned more than $1 million for delivering promotional talks and consulting for seven drug companies.

By a wide margin, Draud’s earnings make him the best-paid speaker in ProPublica’s Dollars for Docs database, which has been updated to include more than $2 billion in payments from 15 drugmakers for promotional speaking, research, consulting, travel, meals and related expenses from 2009 to 2012.

Payouts to hundreds of thousands physicians are now included.

Draud is not the only high earner: 21 other doctors have made more than $500,000 since 2009 giving talks and consulting for drugmakers, the database shows. And half of the top earners are from a single specialty: psychiatry.

“It boggles my mind,” said Dr. James H. Scully Jr., chief executive of the American Psychiatric Association, referring to the big money paid to some psychiatrists for what are billed as educational talks.

Paid speaking “is perfectly legal, and if people want to work for drug companies, this is America,” said Scully, whose specialty has often been criticized for its over-reliance on medications. “But everybody needs to be clear — this is marketing.”

When Dollars for Docs launched in 2010, it gave the first comprehensive look at the money that drug companies spend to enlist doctors as a sales force. The new data show how payouts to psychiatrists like Draud and other doctors have added up over time. And they underscore the key role physicians play for drugmaker profits even as scrutiny and criticism of such payments grows.

The companies say physician speakers are the best messengers to teach their peers about new and effective treatments. But critics counter that the speakers are little more than highly credentialed pitchmen who typically use the drug companies’ slides and talking points to sell rather than educate.

Attention to the issue has prompted prominent medical schools to tighten rules on faculty acceptance of drug company money for such talks. Questions about undue industry influence also have bedeviled medical journals and professional groups representing physician specialists.

Susan Chimonas, a research scholar at the Center on Medicine as a Profession at Columbia University, said many medical centers that regulate interactions between drug companies and their doctors would be “alarmed” by the high tallies in the updated Dollars for Docs.

“How do these folks have time to do their real jobs if they’re speaking so much?” Chimonas said. Hospital administrators, she predicted, would be “concerned not only about the conflict of interest, but also the conflict of commitment.”

Draud’s $1 million in drug company earnings is probably a minimum figure. Some of the seven companies he represented have reported their payouts for only a short time. And Draud has separately disclosed ties with at least four additional companies that haven’t revealed how much they pay speakers.

Draud has friends among the other highest-paid doctors in the database. He teaches continuing medical education courses with fellow psychiatrists Rakesh Jain and Vladimir Maletic. Jain, of Lake Jackson, Texas, has earned $582,049.  Maletic, of Greer, S.C., made $527,850 , according to Dollars for Docs. Both also speak for other companies that keep their payments private.

Draud did not return several messages seeking comment. But in an interview, Jain said he loves teaching and delivers the same lectures about drugs and medical conditions regardless of whether a drug company is paying him.

“I am not a marketer, I am an educator,” Jain said.

In a later email, Jain said he is proud of his collaboration with Draud. “He’s been fair, balanced and is wickedly smart. And I like smart people who serve community needs.”

In written responses provided after this story published, Maletic said he speaks about treatments for mood disorders, schizophrenia and sleep-wakefulness disorders because he believes that “good quality education about pharmaceutical products may be beneficial to both physicians and their patients.”

Maletic said he uses company-prepared presentations because they are required to ensure compliance with federal rules. Asked how often he speaks, he replied, “The frequency of speaking varies, but based on the numbers that you have quoted, it may possibly be too often.”

Jain, Maletic and many top earners also have active clinical or research practices.

Next year, every drug and medical device maker that pays physicians will have to report such spending to a federal database as part of the Affordable Care Act health reform law. The first disclosure, scheduled for public release in September 2014, will include payments from August to December of this year.

The companies in Dollars for Docs accounted for about 47 percent of U.S. prescription drug sales in 2011. It’s unclear what percentage of total industry spending on doctors they represent, because dozens of companies do not publicize what they pay individual doctors. Most companies in Dollars for Docs are required to report under legal settlements with the federal government.

Even the $2 billion total underrepresents spending by these companies. Some in the database have begun reporting only in the past year, and others report spending in only a few categories. In addition, two companies reported some payments in ranges, so that spending was excluded from the total.

Overall, roughly half the payments were for research. A third went to speakers and the rest was for consulting, educational materials, meals and travel.

For Some Docs, An Earnings Drop

The push for transparency on physician payments started years ago.

Studies began showing that even trinkets doled out by drug sales reps could affect physician attitudes. At the same time, drugmakers were settling federal lawsuits alleging that they paid kickbacks and encouraged doctors to push drugs for unapproved uses. Two U.S. senators began calling out prominent physicians for not properly disclosing financial ties to the companies.

Dollars for Docs took transparency a step further by putting the available payment disclosures in one place and making them easy to search.

In 2010, many universities and teaching hospitals were surprised to find that their faculty members were engaged in promotional speaking. ProPublica compared the faculty lists of institutions with conflict-of-interest policies barring such speaking with the database and found a number of physicians in violation.

Drug firms, too, learned of problems with their chosen speakers. ProPublica found their rosters peppered with some physicians who had serious disciplinary actions against their medical licenses.

Both the drug companies and academia tightened their policies.

Only a handful of doctors who were among the 20 highest-paid in 2010 have maintained their level of income from speaking, the new data show.

Ten of the doctors dropped from making about $100,000 a year to less than $20,000 in 2012. Some doctors whose payments declined spoke about drugs the companies are no longer pushing. Others, like prominent cancer expert David Rizzieri at Duke University School of Medicine, faced new restrictions from their employers.

Rizzieri had been a speaker for Cephalon, GlaxoSmithKline and Novartis in 2010 and 2011. But after Duke restricted participation in speakers’ bureaus, his speaking pay dropped markedly in 2012, the new data show. All told, Rizzieri has received at least $567,300 in speaking and consulting payments since 2009.

Dr. Ross McKinney Jr., director of the Trent Center for Bioethics, Humanities and History of Medicine at Duke, said university officials “had multiple discussions” with Rizzieri, who “is getting more restrained.”

McKinney said Duke physicians can deliver paid talks about diseases, but only if they use their own slides and presentation materials. “The general tone is a little bit more distant and less cozy than it used to be,” he said.

In an email, Rizzieri said he still did some paid speaking that is allowable within Duke’s new guidelines, but has focused his attention on a series of educational talks developed by the Division of Cellular Therapy at Duke.

New Drugs, New Dollars

Drug companies say their spending often reflects market realities — not a changing opinion on the use of physician speakers. Should a top-selling drug lose its patent, allowing cheaper generics to compete, there’s no impetus to push sales. A new drug or a new approved use for an existing drug, conversely, may prompt a burst of speakers.

New York’s Forest Laboratories, for example, is a fraction the size of its Big Pharma brethren Pfizer, AstraZeneca and Merck. But when it comes to paying doctors to promote its products, the drugmaker has recently dwarfed its rivals.

During the first three quarters of 2012, Forest spent $31 million on doctors who touted the virtues of such drugs as Bystolic for high blood pressure, the antidepressant Viibryd, and Daliresp for chronic obstructive pulmonary disease. Nine doctors each made nearly $100,000 from Forest in that time alone, the data show.

Pfizer — whose U.S. sales are five times greater than Forest’s — spent a fifth of Forest’s total, paying out $6.2 million to promotional speakers during the same period. AstraZeneca, second to Pfizer in sales, spent $12.2 million.

Forest spokesman Frank Murdolo said in an email that the company spends more on speakers because it doesn’t use pricey direct-to-consumer TV marketing. It also has more new drugs than its competitors, Murdolo said.

In contrast, GlaxoSmithKline spent $52.8 million on speakers in 2010. That fell to $24.1 million in 2011 and $7.6 million in the first three quarters of last year.

Glaxo spokeswoman Mary Anne Rhyne wrote in an email that the company’s spending tracks with new drugs or new uses for existing products. “That activity has been relatively low in the past year, so spending for speaker programs has been lower, too,” she said.

The top recent speaking programs for Glaxo involved Advair, a drug for asthma and chronic obstructive pulmonary disease, and Jalyn, which treats problems with urination for men with enlarged prostates, Rhyne said.

Glaxo and other top pharmaceutical companies have laid off thousands of workers in the past couple of years as their top drugs have lost patent protections, the pipeline of new drug approvals has slowed and cost pressures arose.

Other companies contacted by ProPublica about their spending would not reveal which products they paid speakers to extol or why.

“We don’t disclose how we allocate our speaker program budget,” Tony Jewell, a spokesman for AstraZeneca, said in an email. AstraZeneca’s spending on promotional speakers decreased from $31.6 million in 2010 to $17.6 million the following year and $12.2 million in the first three quarters of 2012.

“The decrease in spending is based on a variety of factors, including where our medicines are in their life cycles and brand budgets and strategies,” Jewell wrote.

The company’s blockbuster antipsychotic drug Seroquel went off patent last year. Another top drug, Nexium, which treats acid reflux, goes off patent in 2014.

Because each company is in a different stage with its blockbuster drugs, it’s difficult to compare their outlay on speakers and consultants head to head.

It may be too soon to tell whether continued publicity over the spending will cause companies to cut back further, said Chimonas, of the Center on Medicine as a Profession. But transparency might be having some effect.

At a recent conference, Chimonas said she heard that pharmaceutical companies themselves are using the disclosures about payments to “push back on doctors who are greedy.”

“They can say, ‘No. We see you’re taking this amount of money from our competitor. Why should we give you more than that?’” she said.

A Harder Sell For Antipsychotics

Once a reliable profit machine for drug companies, psychiatric drugs are now a challenge. And drugmakers are fighting hard to stanch the losses.

Starting in the 1990s, when the second generation of antipsychotics hit the market, drugmakers enjoyed a period of wild profitability. Doctors embraced these new drugs, such as Risperdal, Seroquel and Zyprexa, as safer and causing fewer of the troubling side effects of older psychiatric drugs. Domestic sales of Seroquel hit $4.7 billion in 2011, the year before it went off patent.

But as the drugs lost their patent protection, their makers have tried to shift the market to newer drugs in their stables. Critics say these new drugs are not appreciably different, but the drug companies claim they are easier to take or have fewer side effects.

Johnson & Johnson, for example, lost its Risperdal patent in 2008 but now markets Risperdal Consta, a long-acting injection, and Invega, another antipsychotic. AstraZeneca lost Seroquel but is now marketing Seroquel XR, which works for an extended period.

The pressure to reclaim sales is great. Overall, the market for antipsychotics dropped from $18.5 billion in 2011 to $13.7 billion last year, according to IMS Health, which closely tracks the industry’s ups and downs.

The newer drugs, like their predecessors, need someone to explain their benefits, several doctors said.

“I actually enjoy the aspect of educating my counterparts about developments in the field,” said Dr. Gustavo Alva, a California psychiatrist.

Alva has received $663,751 speaking and consulting since 2009 for the companies in Dollars for Docs. He separately discloses speaking for other companies as well.

Tighter restrictions on speaking and consulting mean doctors will be less up to date on new treatments, according to several current physician speakers.

Psychiatrists aren’t always among the highest-paid. In 2010, when Dollars for Docs first launched, endocrinologists represented 11 of the 43 top money-making speakers. From year to year, the in-demand specialists are largely a function of the market.

But critics say psychiatrists are a particular concern because of their controversial role when the first waves of new antipsychotics hit the market.

AstraZeneca, Johnson & Johnson and Eli Lilly have paid billions in settlements to the federal government over allegations that they paid doctors to push these drugs for unapproved uses from children to seniors with dementia. One lawsuit alleged that a Florida psychiatrist switched patients from drug to drug based on his relationships with companies.

Texas psychiatrist Jain acknowledges the excesses of the past and said he does not excuse them. But he said he sees real value in the new brands because they give psychiatrists options if their patients are not responding to older drugs.

He said he has recently spoken on behalf of Forest’s antidepressant Viibryd, Merck’s antipsychotic Saphris, Lilly’s ADHD drug Strattera, Pfizer’s antipsychotic Geodon and its antidepressant Pristiq.

Having the financial support of drug companies does not lessen the value of this teaching, he said.

Jain’s tally in Dollars for Docs does not reflect his work with another group that is heavily sponsored by drugmakers.

Jain, top-paid speaker Draud and Maletic all serve on the advisory board and steering committee of the U.S. Psychiatric and Mental Health Congress, which will hold its annual convention in Las Vegas in September and October. Maletic is the 2013 program chairman.

The convention receives financial support from several drug companies, and some of its presentations are sponsored by the firms, according to information on its website. Much like professional medical societies, the congress also collects fees for drug company ads on things attendees see at their conventions, from tote bags to hotel room keys.

The congress is owned by North American Center for Continuing Medical Education, LLC, a for-profit New Jersey company that provides continuing medical education courses. Health professionals must take such classes periodically to retain their licenses. Draud, Jain and Maletic also teach classes for the company.

In response to written questions, Randy P. Robbin, president of the company, said members of the steering committee have “demonstrated experience and expertise in mental health and commitment to providing the highest quality education possible.”

The trio are paid for their work for the congress, but the money does not come from pharmaceutical sponsors, Robbin said. In continuing medical education courses, he said, drug companies don’t have a say in the educational content or speaker selection.

Jain said in an interview that his talks for the company are reviewed for bias before and after he speaks. “I cannot present anything at the Psych Congress that hasn’t been vetted repeatedly,” he said. “Pharma is not able to influence anything that I do at the Psych Congress.”

Scully, of the American Psychiatric Association, said he hopes all the drug company money doesn’t taint relationships between patients and their doctors.

“The public trust,” he said, “is too important.”

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DSM-5 approved, including ‘substantial changes’ to psychiatric diagnosis

Posted by admin2 on 3rd December 2012

By Amanda Gardner, U.S. News & World Report, Dec. 3, 2012

The long-awaited revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM) has been approved, bringing with it a series of revisions, additions and subtractions to the tome that is considered the Bible of psychiatry.

The revision, announced Saturday, has been more than a decade in the making and included input from more than 1,500 experts in all walks of medicine in 39 countries.

The changes to the DSM “will have some impact because there are some substantial changes in diagnostic criteria,” said Dr. Bryan Bruno, acting chair of psychiatry at Lenox Hill Hospital in New York City. “The implications [will relate] not only to insurance coverage but to what we consider psychopathology. That is very much influenced by what the DSM says,” he added.

The fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-4) has been in use since 1994. The new DSM-5 will be available in its entirety in the spring of 2013, according to the American Psychiatric Association (APA), which publishes the volume.

“We have produced a manual that best represents the current science and will be useful to clinicians and the patients they serve,” APA president Dr. Dilip Jeste said in a statement from the association.

READAPA press release (PDF, 155KB)

READ - Message from APA president (PDF, 106KB)

Although the new manual will include roughly the same number of disorders as the one it is replacing, a number of changes in content are significant.

One of the biggest revisions is a change in nomenclature for “autistic disorder,” which will now be known as “autism spectrum disorder.” That means Asperger’s syndrome, a less debilitating form of autism, will be folded into the larger category and no longer have its own designation.

This change was met with some concern.

“Although there is a strong scientific rationale for these changes in the diagnostic criteria, we are concerned about the impact of the new DSM-5 criteria when they are used in real-world settings,” said Geraldine Dawson, chief science officer of Autism Speaks, adding that the trials on the new criteria were based on a relatively small number of children.

“It is crucial that we monitor how the DSM-5 impacts diagnosis and access to services in the real world,” she continued. “We want to make sure that no one is excluded from obtaining a diagnosis and accessing services who needs them.”

Bruno said it was difficult to predict what sort of impact the inclusion of Asperger’s within autism spectrum disorder would have on insurance coverage and access to services. Many clinicians already consider Asperger’s part of the autism spectrum, he noted.

Another expert agreed.

Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at the Steven and Alexandra Cohen Children’s Medical Center of New York in New Hyde Park, said the new DSM is “codifying or formalizing what experts have been doing informally for years.”

This is true not only for the term “autism spectrum disorder,” which is already in wide use, but also for the age cutoff for symptoms of individuals with the inattentive form of attention-deficit/hyperactivity disorder (ADHD). The new DSM extends the age for symptom manifestation to 14, said Adesman.

Also in the new DSM-5, binge-eating disorder has been bumped up to a bona fide medical condition from one that simply needed “further study.” With a formal code in hand, mental-health practitioners may now be able to get insurance reimbursement for treatment efforts.

Children may also now receive a diagnosis of “disruptive mood dysregulation disorder,” a condition new to the DSM-5, which is characterized by “persistent irritability and frequent episodes of behavior outbursts three or more times a week for more than a year.”

Although the new diagnosis is intended to cut down on the number of children labeled with bipolar disorder, some say it simply medicalizes temper tantrums.

Bruno stressed, however, that the new disorder refers only to particularly severe tantrums that occur frequently. “This is much more extreme than a tantrum,” he explained. “There are definitely those kids where the tantrums and irritability are very chronic and very severe. A lot of kids who were captured by a bipolar diagnosis may be captured by this.”

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Off-Label Use Of Risky Antipsychotic Drugs Raises Concerns

Posted by admin2 on 19th March 2012

By Sandra G. Boodman, for Kaiser Health News, March 12, 2012

This story was produced in collaboration with The Washington Post.

Adriane Fugh-Berman was stunned by the question: Two graduate students who had no symptoms of mental illness wondered if she thought they should take a powerful schizophrenia drug each had been prescribed to treat insomnia.

(Illustration by Richard Borge)

(Illustration by Richard Borge)

“It’s a total outrage,” said Fugh-Berman, a physician who is an associate professor of pharmacology at Georgetown University. “These kids needed some basic sleep [advice], like reducing their intake of caffeine and alcohol, not a highly sedating drug.”

Those Georgetown students exemplify a trend that alarms medical experts, policymakers and patient advocates: the skyrocketing increase in the off-label use of an expensive class of drugs called atypical antipsychotics. Until the past decade these 11 drugs, most approved in the 1990s, had been reserved for the approximately 3 percent of Americans with the most disabling mental illnesses, chiefly schizophrenia and bipolar disorder; more recently a few have been approved to treat severe depression.

But these days atypical antipsychotics — the most popular are Seroquel, Zyprexa and Abilify — are being prescribed by psychiatrists and primary-care doctors to treat a panoply of conditions for which they have not been approved, including anxiety, attention-deficit disorder, sleep difficulties, behavioral problems in toddlers and dementia. These new drugs account for more than 90 percent of the market and have eclipsed an older generation of antipsychotics. Two recent reports found that children and adolescents in foster care, some less than a year old, are taking more psychotropic drugs than other children, including those with the severest forms of mental illness.

In 2010 antipsychotic drugs racked up more than $16 billion in sales, according to IMS Health, a firm that tracks drug trends for the health-care industry. For the past three years they have ranked near or at the top of the best-selling classes of drugs, outstripping antidepressants and sometimes cholesterol medicines. A study published last year found that off-label antipsychotic prescriptions doubled between 1995 and 2008, from 4.4 million to 9 million. And a recent report by pharmacy benefits manager Medco estimated that the prevalence of the drugs’ use among adults ballooned more than 169 percent between 2001 and 2010.

Critics say the popularity of atypical antipsychotics reflects a combination of hype that the expensive medicines, which can cost $500 per month, are safer than the earlier generation of drugs; hope that they will work for a variety of ailments when other treatments have not; and aggressive marketing by drug companies to doctors and patients.

“Antipsychotics are overused, overpriced and oversold,” said Allen Frances, former chair of psychiatry at Duke University School of Medicine, who headed the task force that wrote the DSM-IV, psychiatry’s diagnostic bible. While judicious off-label use may be appropriate for those who have not responded to other treatments for, say, severe obsessive-compulsive disorder, Frances said the drugs, which are designed to calm patients and to moderate the hallucinations and delusions of psychosis, are being used “promiscuously, recklessly,” often to control behavior and with little regard for their serious side effects. These include major, rapid weight gain — 40 pounds is not uncommon — Type 2 diabetes, breast development in boys, irreversible facial tics and, among the elderly, an increased risk of death.

The Latest Fad?

Doctors are allowed to prescribe drugs for unapproved uses, but companies are forbidden to promote them for such purposes. In the past few years major drugmakers have paid more than $2 billion to settle lawsuits brought by states and the federal government alleging illegal marketing; some cases are still being litigated, as are thousands of claims by patients. In 2009 Eli Lilly and Co. paid the federal government a record $1.4 billion to settle charges that it illegally marketed Zyprexa through, among other things, a “5 at 5 campaign” that urged nursing homes to administer 5 milligrams of the drug at 5 p.m. to induce sleep.

Wayne Blackmon, a psychiatrist and lawyer who teaches at George Washington University Law School, said he commonly sees patients taking more than one antipsychotic, which raises the risk of side effects. Blackmon regards them as the “drugs du jour,” too often prescribed for “problems of living. Somehow doctors have gotten it into their heads that this is an acceptable use.” Physicians, he said, have a financial incentive to prescribe drugs, widely regarded as a much quicker fix than a time-intensive evaluation and nondrug treatments such as behavior therapy, which might not be covered by insurance.

In a series in the New York Review of Books last year, Marcia Angell, former editor in chief of the New England Journal of Medicine, argued that the apparent “raging epidemic of mental illness” partly reflects diagnosis creep: the expansion of the elastic boundaries that define mental illnesses to include more people, which enlarges the market for psychiatric drugs.

“You can’t push a drug if people don’t think they have a disease,” said Fugh-Berman, who directs PharmedOut, a Georgetown program that educates doctors about drug marketing and promotion. “How do you normalize the use of antipsychotics? By using key opinion leaders to emphasize their use and through CMEs (continuing medical education) and ghost-written articles in medical journals,” which, she said “affect the whole information stream.”

James H. Scully Jr., medical director of the American Psychiatric Association, sees the situation differently. He agrees that misuse of the drugs is a problem and says that off-label prescribing should be based on some evidence of effectiveness. But Scully suggests that a key factor driving use of the drugs, in addition to “intense marketing and some effectiveness,” is the growing number of non-psychiatrists prescribing them. Many lack the expertise and experience necessary to properly diagnose and treat mental health problems, he said.

Among psychiatrists, use of antipsychotics is rooted in a desire to heal, according to Scully. “All of the meds we use have their limits. If you’re trying to help somebody, you think, ‘What else might I be able to do for them?’”

Since 2005, antipsychotics have carried a black-box warning, the strongest possible, cautioning against their use in elderly patients with dementia, because the drugs increase the risk of death. In 2008 the Food and Drug Administration reiterated its earlier warning, noting that “antipsychotics are not indicated for the treatment of dementia-related psychosis.” But experts say such use remains widespread.

In one Northern California nursing home in 2006 and 2007, 22 residents, many suffering from dementia, were given antipsychotics for the convenience of the staff or because the residents refused to go to the dining room. In some cases the drugs were forcibly injected, state officials said. Three residents died.

A 2011 report by the Inspector General of the Department of Health and Human Services found that in a six-month period in 2007, 14 percent of nursing home residents were given antipsychotics. In one case a patient with an undetected urinary-tract infection was given the drugs to control agitation.

“The primary reason is that there’s not enough staff,” said Toby S. Edelman, senior policy attorney for the Center for Medicare Advocacy, a Washington-based nonprofit group, who recently testified about the problem before the Senate Special Committee on Aging. “If you can’t tie people up, you give ‘em a drug” she said, referring to restrictions on the use of physical restraints in nursing homes.

Drugs At 18 Months

Nursing home residents aren’t the only ones gobbling antipsychotics.

Mark E. Helm, a Little Rock pediatrician who was a medical director of Arkansas’s Medicaid evidence-based prescription drug program from 2004 to 2010, said he had seen 18-month-olds being given potent antipsychotic drugs for bipolar disorder, an illness he said rarely develops before adolescence. Antipsychotics, which he characterized as the fastest-growing and most expensive class of drugs covered by the state’s Medicaid program, were typically prescribed to children to control disruptive behavior, which often stemmed from their impoverished, chaotic or dysfunctional families, Helm said. “Sedation is the key reason these meds get used,” he observed.

More than any other factor, experts agree, the explosive growth in the diagnosis of pediatric bipolar disorder has fueled antipsychotic use among children. Between 1994 and 2003, reported diagnoses increased 40-fold, from about 20,000 to approximately 800,000, according to Columbia University researchers.

That diagnosis, popularized by several prominent child psychiatrists in Boston who claimed that extreme irritability, inattention and mood swings were actually pediatric bipolar disorder that can occur before age 2, has undergone a reevaluation in recent years. The reasons include the highly publicized death of a 4-year-old girl in Massachusetts, who along with her two young siblings had been taking a cocktail of powerful drugs for several years to treat bipolar disorder; the revelation of more than $1 million in unreported drug company payments to the leading proponent of the diagnosis; and growing doubts about its validity.

Helm said that antipsychotics, which he believes have become more socially acceptable, serve another purpose: as a gateway to mental health services. “To get a child qualified for SSI disability, it is helpful to have a child on a medicine,” he said, referring to the federal program that assists families of children who are disabled by illness.

Ask Your Doctor

Psychiatrist David J. Muzina, a national practice leader at pharmacy benefits manager Medco, said he believes direct-to-consumer advertising has helped fuel rising use of the drugs. As former director of the mood disorders center at the Cleveland Clinic, he encountered patients who asked for antipsychotics by name, citing a TV commercial or print ad.

Some states are attempting to rein in their use and cut escalating costs. Texas has announced it will not allow a child younger than 3 to receive antipsychotics without authorization from the state. Arkansas now requires parents to give informed consent before a child receives an anti-psychotic drug. The federal Centers for Medicare and Medicaid Services announced it is summoning state officials to a meeting this summer to address the use of antipsychotics in foster care. And Sens. Herb Kohl (D-Wis.) and Charles E. Grassley (R-Iowa) introduced legislation that would require doctors who prescribe antipsychotics off-label to nursing home patients to complete forms certifying that they are appropriate.

Medco is asking doctors to document that they have performed diabetes tests in patients taking the drugs. “Our intention here is to get doctors to reexamine prescriptions,” Muzina said.

“In the short term, I don’t see a change in this trend unless external forces intervene.”


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Doctors on Alert

Posted by admin2 on 23rd June 1994

From the Oregonian, June 23, 1994 – not available elsewhere online.

“A man just came in,” a frightened secretary told Dr. Elmore E. Duncan, “carrying a gun.”

That June morning in 1985, the psychiatrist was in the hall, picking up his mail. “I think we’d better get out of here,” he said as, confused and afraid, he began rounding up patients and staff.

They were heading out the door when they heard the shotgun blasts.

Duncan’s partner, 41-year-old Dr. Michael J. McCulloch, lay dead in his office, shot in the head and body by a longtime patient who had threatened to kill him.

Something else died that day in the Portland psychiatric community: the denial that it could happen to them. The hands of a patient could harm them, as they had McCulloch and, four months earlier, Dr. Brian Buss, who was clubbed to death at Salem Hospital.

Monday’s shootings of a psychiatrist , psychologist and bystanders at Fairchild Air Force Base hospital in Spokane are cold reminders that caregivers and hospitals are as vulnerable to violence as any other person or place in America.

“It used to be that physicians and hospitals were pretty much protected,” said Dr. Michael P. Resnick, a psychiatrist for 20 years and director of psychiatric education at Providence Medical Center. ‘A hospital was like a church. Nobody would expect somebody to go in and shoot up a hospital.”

But Portland hospitals have become wary. They bristle with surveillance cameras. Emergency room nurses at Oregon Health Sciences University work behind bulletproof glass. Security guards carry chemical Mace and handcuffs. At the Portland Veterans Affairs Medical Center, when the most troublesome patients arrive, they are surrounded by a welcoming committee of staff and security guards.

But what can a hospital do to protect itself against someone who is bent on killing?

“Little if anything,” said Russell Colling of Denver, one of the nation’s leading authorities on hospital security.

Colling said hospitals were at a disadvantage in controlling access to people with guns in their hands and killing in their minds. Hospitals have less control over who comes and goes than, say, a manufacturing plant.

“A hospital is more like a library,” he said. “We are inviting the public in — just the same as a department store might.”

More likely, hospital workers will find their violence in the form of patients who are wildly intoxicated with drugs or alcohol. Or from distraught visitors who think not enough is being done for sick or injured relatives. Or from gang members seeking to even a score.

Words, body language

In Portland and elsewhere, hospital officials are learning that words and body language may be the most powerful weapons in defusing violence before it begins.

Barbara L. Glidewell, patient advocate and ombudsman at Oregon Health Sciences University, routinely talks with furious patients and relatives. And she’s been physically threatened more than once.

Just by coincidence, she convened a group of 30 nurses, physicians and security workers at OHSU on Wednesday — just two days after the Fairchild killings — to discuss a coordinated approach to avoiding hospital violence.

“You have people who come to the emergency room who demonstrate malevolent or dangerous behavior,” she said. “How do we identify dangerous behavior before they get through the triage door? Each of us have our own methods. But we want to deal with this in an active manner rather than a reactive manner.”

Glidewell said that while hospitals have fire and earthquake drills there is no widespread training on how to handle threats from people.

“What happens when a person walks into a nursing unit and brandishes a gun?” she asked. “Does everyone know what to do?”

A designated talker

Ideally, staff members should quietly leave the area to reduce the amount of stress for the disturbed person. Someone should be designated to talk to the person while others quietly call for help.

“If you’re prepared for fires you should be prepared for Uzis,” she said.

Glidewell hopes to adopt a system similar to one used by the Portland Veterans Medical Center.

Dr. David J. Drummond, chairman of the center’s committee on violence, said 200 of the hospital’s 30,000 patients have been classified as potentially violent and have electronic flags attached to their records.

Dr. William R. Dubin, former chairman of an American Psychiatric Association task force on violence toward clinicians, cited a 1988 report from the Department of Health and Human Services, which studied 418 hospitals in a one-year period and found they reported 2,118 assaults, 63 rapes, 551 bomb threats and 72 arsons.

Incidents probably on rise

He said studies suggest 40 percent of all psychiatrists have been assaulted by patients sometime in their careers, and almost everyone had been threatened at least once. No one keeps track of such incidents, but his sense is that they are increasing.

“We live in a very violent society and that violence has spilled into medicine,” said Dubin, who now is acting medical director of Belmont Center for Comprehensive Treatment in Philadelphia.

Although psychiatrists are allowed to breach doctor-patient privilege and go to the police if they feel there is any danger of the patient harming himself or others, they tend to delay in hope of treating the patient, Dubin said.

He warned that psychiatrists should take precautions if there are warning signs, such as uneasiness on their own part or a history of violence on the part of the patient.

“We stay in the role of the healer too long,” he said. “And then we tend to get into very dangerous situations.”

Resnick, the Providence psychiatrist, doesn’t hesitate when he has any safety concerns. “There are some people I would see only in an emergency department,” said Resnick, who works in an unmarked office, keeps an unlisted phone number, quizzes patients about their access to weapons — and takes all threats seriously.

“Threats indicate a basic breakdown in what should be a positive relationship,” he said. “They indicate somebody’s impulses and feelings are out of control.”

Seen as an adversary

Another piece — beyond the disturbed emotions or distorted expectations of a minority of mental patients — is psychiatrists ‘ increasing role in assessing patients for legal or insurance reasons or, as in the Spokane situation, to determine fitness for a job. Such patients might see a psychiatrist as an adversary rather than a partner in solving a problem.

A jammed system also plays into the mix. Voluntary hospital beds for seriously mentally ill people are in short supply, says Dr. Joseph D. Bloom, head of psychiatry at Oregon Health Sciences University. “Oregon had 5,800 people in mental hospitals in the mid-’50s, and now we have less than 1,000,” including forensic patients. Bloom expects to see more conflict between patients and doctors if managed care’s economizing squeezes out longer-term therapy.

But, as several doctors noted, they have company when it comes to workplace risks. “A lot of professions dealing with the public are going to have this kind of problem,” said Daniel S. McKitrick, executive director of the Oregon Psychological Association.

“With or without mental illness,” Bloom agreed, “we have a high level of violence in this country.”

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