Clinical Notes: Risperdal Maker Faces Major Fine - MedPage Today PDF Print
By John Gever, Senior Editor, MedPage Today

Published: April 15, 2012

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Risperdal Marketing Proves Costly

An Arkansas jury found that, in marketing the antipsychotic drug risperidone (Risperdal), Johnson & Johnson and its Janssen subsidiary had downplayed the drug's serious side effects.

The judge in the case then hit the companies with a fine of more than $1.1 billion.

The state of Arkansas had sued J&J and Janssen, alleging that the companies' marketing practices constituted fraud against its Medicaid program.

Attorneys for the state presented evidence that the firms' marketing representatives told physicians that risperidone did not cause adverse effects such as weight gain and diabetes that, in fact, had been demonstrated in clinical studies.

The jury took just 3 hours to find in the state's favor.

Bats on a Plane!

Well, actually only one, but it was enough to prompt health authorities in Wisconsin to screen more than 50 passengers and crew members for rabies.

Last August, a bat flew through the cabin of a Delta Airlines plane shortly after takeoff from Madison, Wis., and bound for Atlanta. Crew members eventually trapped the flying mammal in the lavatory and the plane returned to Madison.

No one was reported to have been bitten, but the bat escaped before it could be tested for rabies. But authorities took no chances and had passengers and crew tested for rabies infection, according to an article last week in Morbidity and Mortality Weekly Report.

All had a clean bill of health.

Novel Food-Related Disease Threat

Another item in Morbidity and Mortality Weekly Report described a previously unrecognized health threat related to food -- infection with so-called orf viruses when preparing sheep or goat meat at home.

Orf viruses (also called contagious ecthyma) are common in sheep, goats, and certain other farm animals, and can infect humans as well. Previous reports of zoonotic transmission centered on petting zoos and occupational exposure in the meat industry, but the new report indicated that people can pick up infections at home as well.

The MMWR report described four cases of orf virus infection in people working with sheep or goat carcasses at home. In two of them, the individuals cut themselves on a bone, while a third involved a minor knife wound. No specific mode of entry was given in the fourth case.

Infections manifested as large, tumor-like lesions on the victims' hands. These resolved in all cases without specific treatment, but they took a long time to diagnose because the treating physicians were unfamiliar with orf virus.

The report's authors said physicians should be aware of the possibility in patients with such lesions, especially those from "ethnically diverse communities" where home slaughtering and butchering of sheep and goats may occur.

Amyloid Imaging Agent Meets Trial Endpoints

Industry clearly believes that PET tracers for Alzheimer's disease-related beta-amyloid plaques will be widely used, as last week's approval of florbetapir (Amyvid) is not dissuading them from pursuing their own "me-too" products.

Right after the FDA said it had approved florbetapir, GE Healthcare announced topline results of two, phase III clinical trials with a rival agent, flutemetamol, saying both studies had met their primary endpoints for success.

In one, results of PET imaging with flutemetamol in terminally ill patients agreed strongly with findings on subsequent brain autopsies, the company said. The other study, conducted in young healthy volunteers, found a very low plaque burden with the PET imaging, as would be expected in this population.

GE Healthcare said results of both studies would be reported at future medical meetings. Some data on flutemetamol will be presented at the American Academy of Neurology's annual meeting later this month, an advance program indicated.

Another, similar agent, called florbetaben, is also making its way through clinical trials.

FDA Fast Tracks ESRD Devices

The FDA said it had selected three products for a pilot program aimed at bringing new technologies for end-stage renal disease (ESRD) to market faster.

Chosen for the program were the following:

  • Implantable renal assist device under development at the University of California San Francisco
  • Wearable artificial kidney produced by Blood Purification Technologies of Beverly Hills, Calif.
  • Vascular access system designed by CreatiVasc Medical of Greenville, S.C.

Under the program, the developers will be able to work closely with FDA staff in determining how to demonstrate the products' risk-benefit profiles and map out a customized regulatory pathway, the FDA said.

Stem-Cell Clinics in China Defy Gov't Ban

Although the Chinese government has prohibited clinics from offering unapproved stem-cell therapies, many continue to operate openly, according to a report in Nature.

The government nominally requires that clinics submit applications for stem-cell therapies before they can be used on patients, as well as register their research and clinical activities. Patients participating in research studies should not have to pay, according to rules set in January by China's health ministry.

But a ministry spokesman told Nature that no clinics have registered, even though dozens continue to advertise stem-cell treatments for various ailments and charge tens of thousands of dollars for them.

Part of the problem, the journal suggested, is that the central government has not sought to enforce the regulations itself, instead leaving it up to local authorities.

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