High demand for flu vaccine spawns suspicious suppliers

Last month, when the evening news was full of reports about childhood flu deaths and vaccine shortages, things went a little crazy. People suddenly were desperate for a flu shot.

The Georgia Division of Public Health, like many public health agencies across the country, placed an order for an additional 100,000 doses to meet the fast-growing demand. Similarly, the Florida Dept. of Health placed an order for 500,000. And many people across the country stood in line and waited for a chance to roll up their sleeves.

But what these public health officials and some patients have since learned is there are always individuals and companies willing to manipulate and profit from this kind of panic.

"It is really unfortunate that in a time where there's a high demand for a product like a vaccine that people can be tempted to take advantage of that demand and engage in some unscrupulous activities," said Centers for Disease Control and Prevention Director Julie Gerberding, MD, MPH.

For instance, the extra doses the state of Georgia purchased never existed. The companies involved are being investigated by various law enforcement agencies, although the state has recovered all of its money.

"We've never had an experience where what we paid for didn't exist," said division spokesman Richard Quartarone. "We had the lot numbers and photographs of vaccine. The manufacturing checked out. Everything looked legitimate."

Meanwhile, the doses offered to the state of Florida did exist but were not licensed for use in the United States.

Elsewhere, a warrant has been issued for the arrest of Shahid Sheikh of Bellevue, Wash. Officials allege he administered the vaccine to hundreds of people through his company, MedSources Inc., without a license.

In addition, Sheikh is being investigated for allegedly providing shots to patients in Arizona, Idaho, Nevada and Oregon. There are also allegations that he may have used outdated or diluted vaccine.

"Our public health system is centered on public trust, and this case involves a huge violation of that trust," said Norm Maleng, the King County (Wash.) prosecutor pursuing the case.

Anticipating the grifters

These situations are among a number now being investigated by the Food and Drug Administration -- although in general such activity is considered uncommon. Still, these incidents have wider implications for public health -- particularly for disaster planning or improving flu vaccine supplies.

"I really need to add those considerations to future discussions and planning sessions," said James J. James, MD, DrPH, MHA, director of the AMA Center for Disaster Preparedness and Emergency Response. "There will always be unscrupulous people that will take advantage of any situation."

For those working to stabilize the vaccine supply, a season like this -- one that hits early and hard and prompts high vaccine demand -- is another reason to do more than just up the number of doses available. What's needed is a system in which it is economically viable for companies to manufacture a lot of vaccine for any given season, even though it may not all be used.

"The simple but not easy solution is to assure adequate supply," said Raymond Strikas, MD, medical epidemiologist at the CDC's National Immunization Program. "If one had adequate supply, a lot of this would go away. And we need surge capacity."

Most seasons are characterized by a demand that dies after Thanksgiving, leaving millions of leftover doses after the flu wanes. Thus, it is not good business for companies to produce more than conventional wisdom suggests will be sold. Similarly, physicians and other vaccine providers are unlikely to order more doses than past patient demand suggests is necessary. But in a year like this one, the result is that there is no way to accommodate circumstances when demand suddenly skyrockets, even though the more than 85 million available doses exceeded the amount historically used in the United States.

"In October we were worried we weren't going to be able to use up all the vaccine and therefore the manufacturers would make even less vaccine for next year," said Arnold S. Monto, MD, professor of epidemiology at the University of Michigan School of Public Health in Ann Arbor. "A lot of this is straight economics. It's not public health."

But with this year's experience, many experts have high hopes for the next time around.

"People will be standing at the door in September asking for vaccines after this year and the threat," said Ronald Bangasser, MD, president of the California Medical Assn. He is also a member of the AMA- and CDC-sponsored National Influenza Vaccine Summit. "Maybe people will forget, but I think it'll be easier to re-educate them after we've had this scare."