FDA Fears Fake Flu Fighters

The government is warning health workers and the public to beware of peddlers of illegal flu vaccine trying to take advantage of current shortages.

Meanwhile, some states report the number of cases is already leveling off, and a poll says many Americans skipped getting flu shots this fall.

The Food and Drug Administration is investigating attempts to bring unlicensed vaccine into the country and at least one case of someone not licensed to practice medicine giving shots purported to be flu vaccine.

"Reports we're following up on indicate that the demand is so high that people are apparently willing to obtain the vaccine in any number of ways other than through legitimate channels," said Steven Masiello, who is overseeing FDA's investigations. "Demand like this brings out all kinds of charlatans."

In one case, Washington's state health department has turned over vials of questionable vaccine to FDA, seeking to verify what was in injections reportedly administered by a counselor. Counselors are not licensed to administer injections; investigation of the worker is ongoing.

In a second case, FDA and Florida health officials stopped an attempt to import flu vaccine not approved for sale in this country.

Florida's health department alerted FDA after an unlicensed company offered to sell the state half a million vaccine doses, said department spokeswoman Jackie DiPietre. The investigation is continuing so neither agency would identify the company or say if the vaccine appeared real.

State health officials are cautiously optimistic over preliminary reports from physicians statewide that indicate Virginia's flu epidemic may have peaked or hit a plateau, a spokeswoman said Tuesday.

Fewer new cases of suspected influenza are being reported in Arkansas also, that state's health department said, but agency officials are being cautious about the latest numbers, and aren't yet ready to say the virus has hit its peak.

"Late Friday, we saw reports that flu seemed to be lessening in the southern part of the state, which was the first hit for us," said Ann Wright, spokeswoman for the department. "But it's voluntary for doctors to supply flu data, so we really don't know for sure. We don't want to give people false hope."

Health officials believe the flu outbreak in North Carolina may be nearing a peak, too, despite the confirmation of the sixth death of a child.

"We will probably have another tough couple of weeks, but based on national and international trends we've been monitoring, we believe that the season is close to its peak and the number of cases should start to fall in early 2004," state health director Dr. Leah Devlin said Tuesday.

Autopsy results indicate the 18-month-old boy died from type A influenza. The child had received a flu shot in October.

"The deaths of these six children are personal tragedies for the families involved, and we all experience great sadness for these families," Devlin said.

"But, it is important to remember that flu and its complications are the sixth leading cause of death nationally among children four and younger."

A substantial majority of Americans skipped getting a flu vaccine this year and many say they didn't feel they needed one or feared a flu shot would do more harm than good, an Associated Press poll found.

Now health officials are scrambling to cope with a vaccine shortage during a severe flu season.

Among the two-thirds of the population who did not get the shot were many people who are at risk, including a sizable number of seniors and a majority of young children, according to the poll conducted by Ipsos-Public Affairs for the AP. Vaccine shortages were cited by only 6 percent of those who did not get the shot.

To assure that patients receive vaccine certified safe and effective, the FDA urged health care providers to purchase inoculations from reputable distributors.

Patients can't tell if the shot they receive is legitimate. But FDA urged that they accept vaccination only from a licensed health care provider.

The FDA has licensed three flu vaccines for U.S. use: Shots sold by Aventis Pasteur as Fluzone and Chiron Corp. as Fluvirin, and the nasal spray vaccine FluMist, made by MedImmune Inc.