Wednesday, January 9, 2013

Study Questions Effectiveness of Therapy for Suicidal Teenagers

NEW YORK TIMES
By BENEDICT CAREY
January 8, 2013


Most adolescents who plan or attempt suicide have already received at least some mental health treatment, raising questions about the effectiveness of current approaches to helping troubled youths, according to the largest in-depth analysis to date of suicidal behaviors in American teenagers.

[Matt Nock, a professor of psychology at Harvard and the lead author of a study on the mental health treatment of troubled young people, said his research showed that “we’ve got a long way to go to do this right.” The study found that 55 percent of adolescents who plan or attempt suicide have already received some therapy.]

The study, in the journal JAMA Psychiatry, found that 55 percent of suicidal teenagers had received some therapy before they thought about suicide, planned it or tried to kill themselves, contradicting the widely held belief that suicide is due in part to a lack of access to treatment.

The findings, based on interviews with a nationwide sample of more than 6,000 teenagers and at least one parent of each, linked suicidal behavior to complex combinations of mood disorders like depression and behavior problems like attention-deficit and eating disorders, as well as alcohol and drug abuse.

The study found that about one in eight teenagers had persistent suicidal thoughts at some point, and that about a third of those who had suicidal thoughts had made an attempt, usually within a year of having the idea.

Previous studies have had similar findings, based on smaller, regional samples. But the new study is the first to suggest, in a large nationwide sample, that access to treatment does not make a big difference.

The study suggests that effective treatment for severely suicidal teenagers must address not just mood disorders, but also behavior problems that can lead to impulsive acts, experts said. According to the Centers for Disease Control and Prevention, 1,386 people between the ages of 13 and 18 committed suicide in 2010, the latest year for which numbers are available.

“I think one of the take-aways here is that treatment for depression may be necessary but not sufficient to prevent kids from attempting suicide,” said Dr. David Brent, a professor of psychiatry at the University of Pittsburgh, who was not involved in the study. “We simply do not have empirically validated treatments for recurrent suicidal behavior.”

The report said nothing about whether the therapies given were state of the art or carefully done, said Matt Nock, a professor of psychology at Harvard and the lead author, and it is possible that some of the treatments prevented suicide attempts. “But it’s telling us we’ve got a long way to go to do this right,” Dr. Nock said. His co-authors included Ronald C. Kessler of Harvard and researchers from Boston University and Children’s Hospital Boston.

Margaret McConnell, a consultant in Alexandria, Va., said her daughter Alice, who killed herself in 2006 at the age of 17, was getting treatment at the time. “I think there might have been some carelessness in the way the treatment was done,” Ms. McConnell said, “and I was trusting a 17-year-old to manage her own medication. We found out after we lost her that she wasn’t taking it regularly.”

In the study, researchers surveyed 6,483 adolescents from the ages of 13 to 18 and found that 9 percent of male teenagers and 15 percent of female teenagers experienced some stretch of having persistent suicidal thoughts. Among girls, 5 percent made suicide plans and 6 percent made at least one attempt (some were unplanned).

Among boys, 3 percent made plans and 2 percent carried out attempts, which tended to be more lethal than girls’ attempts.

(Suicidal thinking or behavior was virtually unheard-of before age 10.)

Over all, about one-third of teenagers with persistent suicidal thoughts went on to make an attempt to take their own lives.

Almost all of the suicidal adolescents in the study qualified for some psychiatric diagnosis, whether depression, phobias or generalized anxiety disorder. Those with an added behavior problem — attention-deficit disorder, substance abuse, explosive anger — were more likely to act on thoughts of self-harm, the study found.

Doctors have tested a range of therapies to prevent or reduce recurrent suicidal behaviors, with mixed success. Medications can ease depression, but in some cases they can increase suicidal thinking. Talk therapy can contain some behavior problems, but not all.

One approach, called dialectical behavior therapy, has proved effective in reducing hospitalizations and suicide attempts in, among others, people with borderline personality disorder, who are highly prone to self-harm.

But suicidal teenagers who have a mixture of mood and behavior issues are difficult to reach. In one 2011 study, researchers at George Mason University reduced suicide attempts, hospitalizations, drinking and drug use among suicidal adolescent substance abusers. The study found that a combination of intensive treatments — talk therapy for mood problems, family-based therapy for behavior issues and patient-led reduction in drug use — was more effective than regular therapies.

“But that’s just one study, and it’s small,” said Dr. Brent of the University of Pittsburgh. “We can treat components of the overall problem, but that’s about all.”

Ms. McConnell said that her daughter’s depression had seemed mild and that there was no warning that she would take her life. “I think therapy does help a lot of people, if it’s handled right,” she said.
A version of this article appeared in print on January 9, 2013, on page A11 of the New York edition with the headline: Study Questions Effectiveness of Therapy for Suicidal Teenagers

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Tuesday, June 28, 2011

Beware pf ghost(writer)s of medical research, Well placed journal articles sell more pills than sales staff do

Straight Goods News
by Dr. Marc Andre Gagnon and Dr. Sergio Sismondo
June 28, 2011

The medical research world has been concerned about the problem of ghostwriting for more than a decade. The issue has been repeatedly raised in the mainstream media over the past few years, with most of the commentary focused on the ethics of academics serving as authors on papers they did not write and on some of the most egregious actions by pharmaceutical companies.

Big Pharma firms spend twice as much on promotion as on research and development (R&D).
But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.

Big Pharma firms spend twice as much on promotion as on research and development (R&D). Worse, more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry's external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals. Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck's Vioxx, GlaxoSmithKline's Paxil, Astra-Zeneca's Seroquel, and Wyeth's hormone-replacement drugs.

To promote the now-notorious Vioxx, Merck organized a ghostwriting campaign that involved some 96 scientific articles. Key articles did not mention the death of some patients during clinical trials. Through a class action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck — the Australasian Journal of Joint and Bone Medicine — and perhaps 10 other fake journals for Merck and other Big Pharma companies.
In another example, GlaxoSmithKline organized a ghostwriting program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called "Case Study Publication for Peer-Review", or CASPPER, a playful reference to the "friendly ghost". Such strategies are not exceptions; they are now the norm in the industry.

Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies' capacity to influence medical knowledge and create market share and market niches for their products.
In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were, and two-thirds of those were spun to make them look more positive. Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010, for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo. Compared to placebos, however, SSRI antidepressants can result in serious adverse drug reactions.

There we see one of the problems with the ghost management of medical research and publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in positive lights — and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.

Why do academics serve as authors on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues for how much they publish and for its prominence. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and then make them even more prominent by having their armies of sales reps circulate them and talk them up.
Researchers who serve as authors on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.

What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck's internal e-mails, revealed during the class lawsuit, it was exposed that the company drew up a hit list of "rogue" researchers who needed to be "discredited" or "neutralized" — "seek them out and destroy them where they live," reads one e-mail. Eight Stanford researchers say they received threats from Merck after publishing unfavourable results.

In the ghost management of research and publication by drug companies we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes, and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones — and sometimes through outright fraud. As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

Dr Marc-André Gagnon is assistant professor with the School of Public Policy and Administration at Carleton University. He is also an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan online resource designed to help journalists covering health policy issues in Canada. Dr Sergio Sismondo is professor of Philosophy and Sociology at Queen's University. His current research is on the pharmaceutical industry's relationships with academic medicine and practicing physicians.

This article previously appeared in Troy Media.

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Thursday, March 25, 2010

Top US psychiatrist calls for ethics cleanup

The Boston Globe
By Carla K. Johnson
AP Medical Writer
March 23, 2010


FILE Photo- In this Sept. 13, 2006 file photo, National Institute of Mental Health Director Dr. Thomas Insel, left, testifies on Capitol Hill in Washington. American psychiatrists need to break away from a 'culture of influence' created by their financial dealings with the drug industry, Insel said in Journal of the American Medical Association. FILE - In this Sept. 13, 2006 file photo, National Institute of Mental Health Director Dr. Thomas Insel, left, testifies on Capitol Hill in Washington. American psychiatrists need to break away from a "culture of influence" created by their financial dealings with the drug industry, Insel said in Journal of the American Medical Association. (AP Photo/Dennis Cook, File)



CHICAGO—American psychiatrists need to break away from a "culture of influence" created by their financial dealings with the drug industry, the head of the National Institute of Mental Health said in a leading medical journal.

Dr. Thomas Insel stops short of calling researchers corrupt or asking them to stop taking money from drug companies. But he highlights a "bias in prescribing practices" that favors brand names drugs over cheaper generics and non-drug treatments. And he says the situation must change with new standards for transparency and full disclosure of psychiatry's collaborations with industry.

"We can show the rest of medicine how to clean up our act," Insel told The Associated Press. His commentary appears in Wednesday's Journal of the American Medical Association.

His efforts got a boost Tuesday with the signing of the health care overhaul legislation which requires drugmakers and others to file annual reports to the government on their financial ties to doctors. The law requires reporting of gifts, entertainment, food, research money and other fees and grants. Consumer advocates applaud the "sunshine" provision because it also requires a database the public can search for their own doctors' ties to industry.

"Transparency is the first step toward giving patients and the public the tools they need to evaluate those relationships," said Allan Coukell, director of the Pew Prescription Project, a consumer health project of the nonprofit Pew Charitable Trusts.

Current National Institutes of Health rules on financial disclosure are confusing, Insel said. They allow researchers seeking federal funds to make their own judgments about what constitutes a significant financial interest, which they must report to their academic or research institutions. The rules also exempt disclosures of anything below $10,000 annually or 5 percent equity interest in a company. Insel is helping oversee a revision of the NIH's rules, which date back to 1995.

Industry pays for much of the medical research in the United States and many scientists have financial relationships with drug and device makers. Researchers at many institutions are expected to fully disclose those ties to their universities, to the NIH and to the medical journals that publish their research.

Beginning in 2008, an inquiry by Sen. Chuck Grassley, R-Iowa, uncovered millions of dollars in unreported fees paid by drug industry to prominent researchers. The investigation prompted universities and NIH to reassess their conflict-of-interest policies.

When the Grassley inquiry accused seven psychiatrists of failing to report payments they received from drug companies, Insel, himself a psychiatrist, said he tried to determine whether psychiatrists were being targeted unfairly.

He found, instead, evidence that psychiatry may have more drug ties than other medical specialties. In Vermont, for example, which requires public disclosure of industry payments to doctors, psychiatrists receive more money from drug companies than do other types of doctors.

Psychiatric journals report slightly higher rates of industry funding of published studies than other medical journals. And one study found that 90 percent of the advisers who help write American Psychiatric Association guidelines had undisclosed financial ties to industry, Insel writes in JAMA.

Meanwhile, antidepressants and other drug treatments rack up multibillion-dollar annual sales while non-drug treatments such as therapy are "woefully underused," Insel writes.

Insel said he has no financial ties with the drug industry.

Dr. Alan Schatzberg, president of the American Psychiatric Association, told the AP that future leaders of guidelines work groups "will have zero financial relationships with industry during their terms."

Insel's commentary will be influential, said Dr. Emil Coccaro, psychiatry department chairman at the University of Chicago and a recipient of NIH grants.

"It's important that our potential patients and their family members know we're above reproach in terms of undue influence by Big Pharma," Coccaro said.

That's why he threw away all the coffee mugs and pens given to him by drug companies and is careful to report any payments he receives as a board member of a startup biomedical company, he said.

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On the Net:

JAMA: http://jama.ama-assn.org

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