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Professional News
Psychiatry-Related Issues Prominent on AMA Agenda
Psychiatric News
Volume 43 Number 14 page 4-27

What are the health effects of firing 50,000 volts of electricity at someone, as typically happens with the use of a Taser—the "stun gun" increasingly used by law-enforcement officials to subdue suspects?

And what of reports that Tasers have been implicated in hundreds of deaths? Or that they are being used disproportionately on people with mental illness, or that they are sometimes employed in health care facilities?

These are some questions the AMA has vowed to investigate in response to a resolution put forward at last month's House of Delegates meeting by the Section Council on Psychiatry and the American Academy of Pediatrics. (The section council includes representatives of APA, the American Academy of Child and Adolescent Psychiatry [AACAP], and the American Academy of Psychiatry and the Law [AAPL].)

The use of Tasers was just one of several issues relevant to psychiatry that were discussed in the house; others included therapeutic equivalence of generic medications and health and mental health care for military personnel and veterans (see Lazarus, Kraus Elected to Key AMA Positions).

The house also approved the report titled "Access to Psychiatric Beds and Impact on Emergency Medicine" (see AMA Calls for Remedies for Psychiatric-Bed Shortage).

The resolution on Tasers requests that the AMA's Council on Science and Public Health (CSPH) prepare a report summarizing the scientific data on morbidity and mortality associated with the use of the device. It also calls on the AMA to advocate for the development of appropriate guidelines to ensure that Tasers are used only in a manner that minimizes the risk of injury or death and to encourage the Joint Commission and other appropriate accreditation and regulatory agencies to develop standards and guidelines regarding the use of Tasers in hospitals and other health care facilities.

There was considerable support during reference committee hearings prior to the House of Delegates meeting for the study on the health effects of Tasers and their association with death and injury. The resolution was referred for follow-up to the CSPH, representatives of which agreed to undertake the study.

(Taser is a registered trademark of Taser International Inc. The Taser is named after a fictional weapon, the "Thomas A. Swift's Electric Rifle," which made its appearance in early 20th-century adventure comics. More information about the weapon can be found online at<www.taser.com>).

"According to the manufacturer, Tasers fire 50,000 volts of electricity with more 'stopping power' than a .357 magnum," said David Fassler, M.D., during reference committee hearings on the resolution." Although advertised as 'nonlethal' weapons, Tasers have now been implicated in several hundred deaths. As a psychiatrist, I'm particularly concerned that people with mental illness seem to be Tasered with disproportionate frequency. One survey in Houston found that of 1,000 incidents in which Tasers were used, nearly 1 in 8 involved people with psychiatric disorders.

"In my own state of Vermont, several psychiatric patients have recently been Tasered, and one adolescent was Tasered while a patient in a local treatment facility," Fassler continued. "It's clear that these devices are being used with increased frequency and in more diverse settings."

Support was especially strong from pathologists and forensic pathologists.

"We would welcome some science about this subject," said James Caruso, M.D., a representative of the College of American Pathologists." I'm a forensic pathologist, and many of my colleagues have signed out deaths that have been associated with Tasers. They have been attacked by the manufacturer because any allusion that the Taser may have been involved in that death gives [the manufacturer] bad publicity."

The House of Delegates also agreed last month to seek reexamination of the standards and criteria used for approving generic medications by the Food and Drug Administration (FDA) to ensure bio- and therapeutic equivalence.

Though the CSPH has looked at the issue in the past and formulated policy on bioequivalence, testimony at the meeting suggested that clinical reports and some published literature continue to indicate not all generics are therapeutically equivalent to name-brand drugs.

For that reason, the resolution—brought to the house by APA, AACAP, and AAPL—was removed from the "reaffirmation calendar" (which is reserved for resolutions that reaffirm existing policy), and the house agreed to ask the FDA to undertake a good-faith review of the processes used in determining bio- and therapeutic equivalence.

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APA President and alternate delegate Nada Stotland, M.D., tells AMA delegates that serious questions have been raised about the therapeutic equivalency of generics to name-brand medications. 

Credit: Mark Moran

APA President Nada Stotland, M.D., author of the resolution, acknowledged during testimony that at a time when organized medicine is under public scrutiny regarding ties to the pharmaceutical industry, a resolution raising questions about the clinical efficacy of some generics would raise skepticism in some quarters.

"But our responsibility is to our patients, wherever that takes us," she said. "There is a growing literature in the wake of clinical observations raising very serious questions about the therapeutic equivalence between generic and name-brand medications, and between generics."

She cited reports in the lay press that have cited problems with generic formulations of drugs for a wide range of conditions, including mental illness. And a report in Psychiatric News (June 1, 2007) described Stotland's clinical experience—as well as that of others—with generic formulations that seemed to be therapeutically ineffective, along with a broad overview of the FDA's process for testing bioequivalence.

That article, "Physicians Question FDA's Confidence in Generic Drugs' Safety, Efficacy," is posted at<http://pn.psychiatryonline.org/cgi/content/full/42/11/17-a>.

"It's possible that if we looked into this issue more, we would learn about what vehicles or formulations may affect different groups of patients differently, when all we do for generics [presently] is test them on very small groups and generalize to everyone," Stotland said. "yet the FDA has categorically defended its processes. If you have already decided you don't need to look for [a problem], the odds of your finding it are very low."

She urged the AMA to advocate for increased funding for the FDA and for the administration to take a "much more serious look at generic medications."

Carol Berkowitz, M.D., a delegate from the American Academy of Pediatrics, also spoke in support of the APA resolution. "We think this is particularly relevant to children and adolescents with psychiatric and neurological disorders," she said. "Studies have shown that generic medications have not always shown the same therapeutic equivalence with name-brand medications."

Stotland also spoke in support of the AMA Board of Trustees' Report on Healthcare for Veterans and Their Families, written in response to a resolution brought by the psychiatric delegation at the 2007 AMA annual meeting.

The board report urged that the AMA support the recommendations of the President's Commission on Care for America's Wounded Warriors report titled" Serve, Support, Simplify." It also called on the AMA to work with all appropriate medical societies, the AMA National Advisory Council on Violence and Abuse, and government entities to assist with the implementation of all recommendations put forth by the President's Commission on Care for America's Wounded Warriors.

The report also recommends that the AMA advocate for improved access to medical care in the civilian sector for returning military personnel when their needs are not being met by resources locally available through the departments of Defense and Veterans Affairs.

Stotland called attention to the APA and RAND Corp. studies showing the extent to which returning veterans are affected by PTSD and traumatic brain injuries, and referenced the leadership of then-APA President Carolyn Robinowitz, M.D., in urging psychiatrists to contribute time to the care of returning soldiers, veterans, and their families (Psychiatric News, June 6). She noted the profound effect of stigma on military personnel.

"We know that many returning soldiers do not seek the mental health care they need because they are very worried about the effect on their careers," she said.

The AMA also approved reports and resolutions regarding pharmacists' refusal to fill legitimate prescriptions, the health care costs of violence and abuse across the lifespan, same-sex marriage, mandatory drug screening, and drug abuse relapse reduction.

More information about actions taken by the House of Delegates is posted at<www.ama-assn.org/ama/pub/category/18187.html>.

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APA President and alternate delegate Nada Stotland, M.D., tells AMA delegates that serious questions have been raised about the therapeutic equivalency of generics to name-brand medications. 

Credit: Mark Moran

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