Smallpox vaccine draft guidance issued by FDA
The FDA this month issued draft guidance for companies developing drugs to treat the side effects of vaccination against smallpox with vaccinia virus.
Although it is not believed that smallpox vaccine complications requiring treatment would be widespread in the event of a terrorist attack, the agency said plans for drug development should be designed to make use of all data collected.
The draft guidance summarizes appropriate nonclinical studies recommended during early drug development. It includes sections on chemistry, manufacturing and controls, nonclinical toxicology, microbiology; and clinical pharmacology.
The guidance concludes with sections addressing the acquisition of human efficacy and safety data, issues surrounding the design of clinical trials and sections detailing data-collection requirements and recommendations.
Before Sept. 11, 2001, smallpox essentially was a memory for most people in the U.S. Routine vaccination for the incurable, highly transmittable, often deadly disease ended in the 1970s when it was eradicated. Smallpox has a case-fatality rate of 30% or more and has the ability to spread in any climate or during any season, the Center for Civilian BioDefense Studies at Johns Hopkins University in Baltimore said.
The old vaccine used on children born before the early 1970s was developed decades ago and provides good protection, but causes a vaccinia infection at the inoculation site. Also, people who are immunosuppressed or have eczema or other skin conditions could suffer complications. Healthy people, on rare occasions, also could develop infections.
The draft guidance is available on-line at www.fda.gov/cder/guidance/5518dft.pdf. Comments and suggestions should be submitted within 60 days to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
New technology, lack of consent leads to lawsuit
A recent Tampa, FL, lawsuit involving a patient who died after robotic surgery to remove a cancerous kidney has raised informed consent issues regarding new technology.
"The conventional surgery was basically jettisoned and this robotic surgery was not only suggested but really pushed," said a lawyer for the patient’s family in a lawsuit filed against the hospital.
With new technology, it’s critical to discuss the reason for using the technology, says Steven Schwaitzberg, MD, director of the Minimally Invasive Surgery Center at Tufts-New England Medical Center in Boston.
"When the choices affect the approach to the surgery, significantly, such as robotics, then those issues need to be discussed with the patient," he says.
First, the surgeons must have the reasons for use of the new technology firmly planted in their own minds, "because unless that occurs, it’s hard to have a coherent discussion with the patient," Schwaitzberg explains.
With some technology, such as larparoscopes, the advantage is obvious, even if you just consider cosmetic issues, he adds. "[T]he advantage of using a robot is less obvious for routine procedures such as cholecystectomy but may have a clear role in more complicated procedures," Schwaitzberg says.
The point to make with patients is that you want to provide a procedure that is of equal or greater benefit with new technology, but warn them of the possibility of unforeseen outcomes, advises Mary H. McGrath, MD, MPH, FACS, chair of the Committee on Emergency Surgical Technology and Education at the American College of Surgeons and professor of surgery, Division of Plastic Surgery, at the University of California San Francisco Medical Center.