A new lawsuit filed against Janssen Pharmaceutica and its parent company Johnson & Johnson again pits state-level judgment about a drug's safety and efficacy against FDA's. The suit, filed by Arkansas Attorney General Dustin McDaniel, seeks to recover money paid by the state to purchase the antipsychotic Risperdal (risperidone) as well as money the state claims it spent to treat people injured by the drug.

 The state's lawsuit documents claim that Janssen marketed Risperdal, an atypical antipsychotic, for "medically unnecessary" uses, including ADHD, depression, bipolar disorder, and aggressive behavior in late-onset dementia.

 The state argues that Janssen didn't adequately test the drug. "[P]rior to marketing Risperdal, defendants should have been concerned about Risperdal causing neurological problems, weight gain, diabetes, pancreatitis, hyperglycemia, cardiovascular complications, and cardiovascular syndrome," the filing reads. "And yet Risperdal's original label, and all label changes since, have not adequately warned of these adverse effects."

The state, in effect, argues that Risperdal should have had a different label—a point that raises the currently contentious issue of FDA preemption, which is working its way toward the Supreme Court on several fronts.

 The state is in better sync with FDA in pointing out that the agency had soundly critiqued some Risperdal advertising for making unproven claims, minimizing risks, and printing warnings in out-of-the-way locations in tiny, pale-colored text.

This suit is similar to the one filed by 

 in September. New York argued that it was owed money for Vioxx prescriptions that were covered by state-funded insurance providers. New York City Mayor Michael Bloomberg, who was listed as a plaintiff in that suit, also cited false or misleading advertising. The suit is still outstanding.

In April 2004, Janssen received a warning letter from FDA noting that a "Dear Doctor" letter sent from the manufacturer to physicians was false or misleading in its risk assessment of Risperdal. The drug is scheduled to go off patent later this month.

"We are prepared to vigorously defend ourselves against these claims. Janssen routinely informs and fully discloses all appropriate information about Risperdal to the medical community, government agencies, and other payers, and this includes clear, FDA-approved information about the product's efficacy and safety profile," Janssen spokeswoman Ambre Morley stated in a release to 

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The State of Arkansas filed suit against Risperdal manufacturer Johnson & Johnson, claiming promotion of the drug for nonmedical uses has led to increased prescriptions being written and bigger payouts by Medicaid.

Arkansas Attorney General Takes J&J to Task

To take advantage of the nearly 18.5 billion text messages being sent every month, the Department of Health and Human Services (HHS) and the Kaiser Family Foundation have established a text messaging service that informs people of the location of the nearest HIV testing center.

The campaign launched on World AIDS Day, December 1. To find a testing location, users simply type their zip code into the phone and send it to the number 566948, or KNOWIT. The number connects to the Center for Disease Control and Prevention's HIV testing database and returns a message with a list of nearby sites.

"In the last couple of years, we have used text messaging because it is one of the fastest-growing media technologies, and it is very popular with young people," Jennifer Kates, VP and director of HIV policy at the Kaiser Family Foundation, told 

 "Texting is also very common for African Americans and is used more than the Internet."

HHS and the CDC approached the Foundation to learn how to use Kaiser's existing text-messaging platform as part of a combined World AIDS Day campaign. The text message information is promoted across all the partners' Web sites, brochures, and posters.

"With HIV prevention, you really need to reach people where they are, in the multiple ways, so that they get information," Kates said. "We also have to be quick, because young people are at the forefront of new technology."


Although text messaging has yet to be adopted as a marketing strategy by most pharma companies, the technology has been implemented in a number of health information and compliance campaigns.

"One of the challenges with pharma is all the regulations around marketing," Mike Jelley, cofounder of electronic-marketing firm Ipsh!, told 

 on Tuesday. "Any time you design a program that is sponsored by a pharma company, there are a lot of pitfalls and a lot of concerns from a legal and compliance standpoint. However, there is a lot of potential in areas of awareness."

Some pharma companies are using text messaging to increase dosing compliance. They are sending patients text messages with reminders to take their medication.

"This not only helps the patient complete a dosage, but it is also good for the pharma companies because they sell more products," Jelley said. "These types of campaigns are less restrictive from a regulatory standpoint because the company isn't pushing a particular drug. However, there are less measurable results."

HHS and Kaiser Family Foundation leverage phone texting technology to help people locate their nearest HIV/AIDS testing facility. Although slow to be adopted by the pharma industry, text marketing is becoming a useful tool to send health information directly to patients.

Pharmaceutical Executive-12-05-2007

Arkansas Attorney General Takes J&J to Task

Text Against AIDS