Check Up

By Michael C. Cohen, president of the Institute for Safe Medication Practices

The link between violence and prescription drugs has rarely been studied. However, a study published last week in the journal PLoS ONE identified 31 drugs that are disproportionally associated with reported cases of violence.

The study drew on reports of violence and aggression made to the Food and Drug Administration from 2004 through the third quarter of 2009. While far from definitive, these findings signal that more research is needed.

Leading the list in numbers of reports is the smoking cessation drug Chantix (varenicline).

Also associated with violence were psychoactive medications for depression (Prozac and Paxil), attention deficit disorder (Strattera), and sedative/hypnotic drugs.

The authors, Thomas J. Moore, a consulting senior scientist at the Institute for Safe Medication Practices, Joseph Glenmullen of Harvard Medical School, and Curt D. Furberg of Wake Forest University School of Medicine, selected cases from the ISMP QuarterWatch database, which is composed of computer extracts of all adverse drug event reports received by FDA.

A violent event was defined as any case report mentioning homicide, physical assault, physical abuse, homicidal ideation or violence-related symptom.

For the five-year study period, the authors identified 484 drugs that accounted for 780,169 serious adverse event reports of all kinds. This total included 1,937 (0.25 percent) cases that met the violence criteria.

Thirty-one drugs met study criteria for a disproportionate association with violence, accounting for 1,527 (79 percent) of the violence cases.

Included were 387 reports of actual homicide, 404 that were physical assaults, 223 cases with violence-related symptoms, and 896 homicidal ideation reports.

The prominence of Chantix was not a surprise. An association between that drug and serious psychiatric symptoms, including hostile behavior, was also a finding in a 2008 study by our group that looked at FDA adverse event reports in the fourth quarter of 2007. The authors of the present study had earlier linked Chantix to thoughts and acts of aggression/violence. The association also led FDA to require product label changes, including a boxed warning for the drug.

The authors conclude that their data "provide new evidence" that violent acts are "associated with a relatively small group of drugs" and that systematic studies "are needed to establish the incidence, confirm differences among drugs and identify additional common features."

nolead begins

By Robert Field, a law and public health professor at Drexel University

Opponents of health reform are now one for three in federal court decisions. In the first two rulings on the law's validity, judges found the law to be fully constitutional. Last week, U.S. District Judge Henry Hudson ruled in a suit brought by the Virginia attorney general that a key part of the law is not.

This variation in decisions is not surprising. About two dozen suits have been brought against the law in courts around the country. Differing decisions on so complex and polarizing an issue are to be expected.

However, it is disappointing that the rulings so far have hewed so closely to partisan lines. The two judges who upheld the law are both Democrats appointed by President Bill Clinton, and Hudson is a Republican appointed by President George W. Bush. This may be a harbinger of rulings to come, especially when the case reaches the Supreme Court. . . .

In the meantime, Hudson's decision . . . was quite narrow. It struck down the law's individual mandate, which requires that all Americans have health insurance starting in 2014 or pay a penalty. However, it did not invalidate any of the law's numerous other provisions. . . .

Among the most important are those that create the exchanges through which individuals can buy policies starting in 2014 and those that expand Medicaid to cover an additional 16 million people.

Other key provisions untouched by Hudson's decision are consumer protections, including coverage for adult children up to age 26, prohibitions on annual and lifetime caps in policies, and limits on premium hikes. Surviving too are incentives to spur innovations in care, including comparative effectiveness research, accountable care organizations, and medical homes. Many of these elements remain popular in opinion polls.

The judge also declined to stay implementation of the law pending final resolution of the case on appeal. Therefore, the rollout will continue, at least for now. . . .

Of course, other legal rulings await, including a key one by a Republican judge in Florida that is expected next month. The law must also endure a hostile reception in the new Congress and in many state governments. We still have a long way to go before its final fate is known.