June 3

USA Today: Conflicts of interest bedevil psychiatric drug research

Ever wondered how toxic psychoactive drugs that have been shown to be clinically insignificant have been catapulted into multi-billion dollar blockbuster sellers despite the fact that these drugs pose serious safety risks?  

Today’s USA Today report by  Marilyn Elias focuses on Dr. Lisa Cosgrove’s illuminating study documenting gross and unabashed conflicts of interest by psychiatrists who formulate psychiatry’s diagnostic and treatment guidelines.

Dr. Cosgrove’s findings flat out contradict the widely reported pledge by the American Psychiatric Association that it has instituted screening procedures for the 27 members of its DSM-V Task Force, to avoid even the appearance of conflicts of interest. The APA called the effort the "most transparent" in the medical industry. In fact, as Dr. Cosgrove documents, the current roster of psychiatrists on the DSM-V Task Force is overwhelmingly compromised by financial ties to drug makers whose drugs are recommended in psychiatry’s treatment guidelines.

Dr. Cosgrove documented 68% of task-force members having economic ties with drug companies—and of those, four out of five are on corporate boards, hold stock or collect money as advisers.  As for psychiatry’s most influential leaders who formulate treatment guidelines for major depression, bipolar disorder and schizophrenia: 90% of them had financial ties to firms that make the drugs they recommend for the disorder.

The stakes are high indeed: sales for drugs prescribed for major depression, bipolar and schizophrenia– according to IMS HEALTH, reached $24.2 billion–$14.6 billion for antipsychotics and $9.6 billion for antidepressants. These mega sales, despite the clinically insignificant effects these drugs produce and the  documented, life-shortening adverse effects they induce.

Dr. Cosgrove’s study has nailed psychiatry as handmaidens of drug manufacturers. The question that has now been hurled into the public arena is:  Does it matter if most of the experts who are creating definitions of mental disorders, and standards for the best way to treat them, receive substantial amounts of money from pharmaceutical companies?

As Marilyn Elias says, “That question cuts to the core of public welfare by making it possible for financial profit to affect decisions about who needs treatment, whether they are prescribed medicine and which ones.”

Psychiatry’s leadership is scrambling and fumbling in its effort to explain why it’s collusion with industry for pay is okay.

Posted by: Vera Hassner Sharav

Conflicts of interest bedevil psychiatric drug research
By Marilyn Elias

Does it matter if most of the experts who are creating definitions of mental disorders, and standards for the best way to treat them, receive money from pharmaceutical companies?

That question is hotly debated in scientific journals, but it isn’t just academic. It also cuts to the core of public welfare by making it possible for financial profit to affect decisions about who needs treatment, whether they are prescribed medicine and which ones, says Lisa Cosgrove, a psychologist at the University of Massachusetts-Boston.

Critics such as Cosgrove say there’s a damaging conflict of interest in the financial ties between drug companies and leaders who are revising the "bible" of psychiatric diagnoses, the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), as well as guidelines on the best treatments.

About 160 experts appointed by the American Psychiatric Association are doing the heavy lifting on the updated manual, expected in 2012. They’re tops in their field, and because industry pays for two-thirds of research, many of them consult for drug companies or do corporate-funded studies, says Darrel Regier, research director for the group. "There’s this assumption that a tie with a company is evidence for bias. But these people can be objective," he says.

This is the first time the psychiatry association has required members of 13 working groups on diagnoses, as well as the leadership task force, to publicly disclose all industry ties.

Sixty-eight percent of task-force members report economic ties with drug companies, Cosgrove says. And of those with links, about four out of five don’t just get research funding, they’re on corporate boards, hold stock or collect money as advisers, she says. She and Harvard Medical School psychiatrist Harold Bursztajn have criticized these ties in The New England Journal of Medicine and Psychiatric Times.

Even small changes in the symptoms for diagnosis of a problem can greatly increase prescriptions for drugs, Cosgrove says, so anyone who could benefit from changes has a potential conflict.

More than half of the members on the 13 working groups also have such ties, according to Cosgrove’s analysis. She says no group should have a majority with drug company links.

But Regier argues: "We want the best people. We don’t want quotas or an artificial litmus test." He says potential conflicts are limited by a rule that panel members can’t receive more than $10,000 from drug companies while at work on the new DSM.

The $10,000 limit "is not a particularly sensible idea," says Daniel Carlat, a Tufts psychiatrist who publishes an independent monthly, The Carlat Psychiatry Report, on trends in the field. "They’ve had lucrative relationships in the past, and they know they’re going right back to them."

Carlat says it’s unrealistic to exclude people with industry-research funding, but he favors limits on those who give promotional talks on drugs, "the real hired guns," and others with a direct financial interest in firms. "Maybe no more than 30%, maybe no more than 50%. These panels shouldn’t be stacked the way they are now," he says.

Another flash point: clinical guidelines. Cosgrove led a study on 20 authors of treatment standards for major depression, bipolar disorder and schizophrenia: 90% of them had financial ties to firms that make drugs recommended for the disorder.

But the psychiatry group casts a net to hundreds of reviewers for every guideline, says John McIntyre, who chairs the guidelines committee. The depression and bipolar standards are being updated, "and we’ve gotten thousands of comments online," Regier says. So any bias gets diluted by diverse voices, McIntyre says; plus, the guidelines are based on evidence.

But there’s the rub, critics say, because drug company-funded studies consistently come out with more positive results for their drug than do independent studies.

"In psychiatry, many diseases are treated equally well with medication or therapy," Carlat says. "But the guidelines tend to be biased toward medication" because it’s costly to make and study drugs.

Much is at stake. Antipsychotics, which had $14.6 billion in sales last year, were the top-selling class of U.S. medicines; antidepressants brought in $9.6 billion, says IMS HEALTH.

The debate over whether economic self-interest may bias the DSM and treatment guidelines leads to a root issue: Drug companies pay for gathering evidence, and there’s no major alternative on the horizon, says Paul Appelbaum, an expert on ethics in psychiatry at Columbia University. He’s concerned about potential conflicts. But other financing suggestions — for example, companies contributing money for studies run independently by the government — have gone nowhere, he says.

"We’re a capitalist society built on competition, and that has led to many successes," Appelbaum says. "But this conflict-of-interest issue shows the side effects of the system we have."

Depression diagnoses fell after FDA antidepressant warning
By Carla K. Johnson, Associated Press

CHICAGO — A persistent decline in the rate of Americans, especially children, newly diagnosed with depression followed the first federal warning on risks connected with antidepressant drugs, a study suggests.

In 2003, the Food and Drug Administration first warned about the risk of suicidal thoughts and behavior in young people taking the drugs. That action may have helped reverse a five-year trend of rising rates of diagnosis for depression, the researchers found.

The findings, published Monday in the Archives of General Psychiatry, are based on an analysis of eight years of data from nearly 100 managed care plans and more than 55 million patients.

It was already known that antidepressant use among young people had fallen since the drugs began carrying a so-called "black box" warning about risks. But the data showing an extended decline in the level of depression diagnoses are new.

In some cases, untreated depression can be more dangerous than suicidal feelings when starting antidepressants and a spike in teenage suicides in 2004 worried some experts that could be another unintended result of the FDA warnings. Then, teen suicides fell slightly the following year, offering hope that the suicide increase was just a blip.

The new research can’t explain why diagnosis rates have declined, said lead author Anne Libby of the University of Colorado Denver. Diagnosis rates for anxiety and bipolar disorder, also sometimes treated with antidepressants, also fell.

"It could be that people who have depression aren’t coming forth and getting diagnosed," Libby said. "It could be that providers are increasingly reluctant to diagnose cases of new mental health problems."

Libby said the FDA "should reopen its discussion about the boxed warning on antidepressants."

Only two antidepressants, Lexapro and Prozac, are approved for treating children and adolescents with depression, but doctors can legally prescribe others to young patients "off label." Prozac, Luvox and Zoloft are approved for pediatric obsessive compulsive disorder, said FDA spokeswoman Sandy Walsh.

Pinning the slumping diagnosis rates on the FDA warning is a leap, said Dr. Peter Lurie of Public Citizen’s Health Research Group, which has warned of antidepressant risks in kids. There could be other explanations.

"It’s possible that the drive toward more diagnosis and treatment had been nearing a point of exhaustion," Lurie said. "The data are interesting but the conclusion seems forced."

Lurie also questioned the authors’ suggestion that the FDA overreacted.

"Is the implication that patients would be better off kept in the dark (about risks)?" he asked.

Dr. Gregory Simon, a psychiatrist and researcher at Group Health Center for Health Studies in Seattle, said the findings are "pretty convincing" evidence that the FDA’s warning had unintended consequences.

"The warning appears to have scared people away from treatment; whether that’s doctors or patients is unclear," Simon said.

Better follow-up care for patients on antidepressants is sorely needed, he said. Health plans consistently do poorly on quality measures of such follow-up visits, important for avoiding problems when people start taking antidepressants.

The study examined health claims data from July 1999 through June 2007.

For children, the rate of new depression diagnoses rose from 3.3 per 1,000 patients in 1999 to 5.2 in 2004. But by 2007, the rate had fallen to 3.5 per 1,000 patients.

A lesser downward shift was seen for adults, which the authors said could be a spillover effect of the FDA warnings.

The researchers obtained a license to use the health claims database through funding from Eli Lilly and Co., maker of Prozac, for an earlier study. Lilly paid for that license so the researchers could analyze use of another Lilly drug for European regulators.

Libby and her co-authors disclosed receiving past unrestricted research grants from other makers of antidepressants. But Libby said drug makers weren’t involved in the design, analysis or conclusions of the current research.

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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