Washington Editor

WASHINGTON - With the daily numbers of infections from the 2009 H1N1 swine-origin Influenza A virus on the rise, would-be profiteers are seeking to take advantage of the anxiety and fear also spreading around the globe, federal officials said, warning the public about a proliferation of Internet advertisements about bogus cures.

The FDA and the Federal Trade Commission (FTC) said they were working to identify, investigate and take regulatory or criminal action against anyone promoting or selling phony or unapproved treatments for the H1N1 influenza A virus, also known as the swine flu.

FTC Chairman Jon Leibowitz said his agency would "act swiftly" against any companies or persons that resort to deceptive advertising.

"The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies," Leibowitz said in a statement.

The FDA and the FTC noted that the bogus advertised swine flu treatments come in a variety of forms, including oral drugs, devices and dietary supplements.

The only antivirals approved for treatment or prophylaxis of the 2009 H1N1 flu are Roche AG's and Gilead Sciences Inc.'s Tamiflu (oseltamivir) and GlaxoSmithKline plc's and Biota Holding Ltd.'s Relenza (zanamivir), which were both granted an emergency use authorization last week for expanded indications, drug regulators said. (See BioWorld Today, April 29, 2009.)

The FDA also noted that there currently are no licensed vaccines against the virus.

Officials from the World Health Organization (WHO), which reported Monday that the H1N1 swine-origin Influenza A virus has infected 1,025 people in 20 countries, said they were concerned about the spread of the virus to the Southern Hemisphere - which is entering its winter months, when influenza viruses typically thrive - and countries in Europe and Asia, but is not yet ready to declare a full-blown pandemic.

The Centers for Disease Control and Prevention Monday said the number of laboratory-confirmed cases in the U.S. had risen to 286, now affecting people in 36 states.

"We've been stressing the fact that we should not focus too much on the figures because they are pretty fluid and change pretty often," Keiji Fukuda, WHO's interim assistant director-general for health security and environment, told reporters Monday.

The greatest number of cases reported remains from North America, he said.

While world health officials have continued to see a number of infections in several different countries in Asia, Europe and Latin America, as of Monday, those cases remain travel-related, Fukuda said.

"We do no have any evidence that the virus has taken hold and has led to community-level transmission in any other countries," outside North America, Fukuda said. "We are not quite certain how this is going to evolve. There is always uncertainty about the evolution of a disease as it spreads worldwide," he added.

Fukuda noted that there have been many more cases of diarrhea in patients with the 2009 H1N1 virus than with seasonal influenza.

Researchers also are observing that the incubation period may be longer with the new strain than the typical two to seven days first thought, he added, noting that the investigation into that information is ongoing.

Young, healthy people also are being more disproportionately affected by the 2009 H1N1 virus than with the seasonal flu, Fukuda said. Acting CDC Director Richard Besser told reporters Monday that the median age of those infected with the virus in the U.S. is 16 years, with patients from 3 months to 81 affected.

So far, WHO and CDC officials have not observed any viral resistance to Tamiflu or Relenza with the new influenza strain.

While world health officials have been working with manufacturers on making preparations for a potential vaccine, no hard decisions have been made on large-scale production or immunization, Besser noted.

If a vaccine for the current H1N1 flu strain is produced, it is unclear whether such a product would protect against a more virulent strain that potentially could affect the globe next winter, he said.

"Each year there is a process for selecting what strains are going to be in the next season's flu vaccine," he said, noting that the CDC is part of the world health committee that makes that determination.

While some years, health officials get the selection "right on target," other years they have missed, Besser acknowledged. "A lot of that has to do with the subtle changes that take place in the virus over time," he said.

And, Besser said, there could be a major change in the H1N1 influenza virus that makes a vaccine produced this summer less effective.

Much like the current H1N1 strain, the 1918 influenza virus started out mild. However, that earlier 1918 virus came back in the winter as a more virulent killer disease.

Some scientists have suggested that those affected by the first wave of the virus that created the 1918-19 pandemic had some immunity against the stronger virus.

Besser said it currently is unclear whether exposure now to the 2009 H1N1 strain would provide any protection to a more virulent strain, if one occurs.

"There are a number of unknowns right now; one is will there be later disease, and if so, will it be more severe," he told reporters. "It is very difficult right now to say that you would want somebody to get this infection, given what we know about flu viruses and the fact that each year, there are a lot of people who get very sick and many could die. We don't have a firm answer to that, but it is our belief that protecting people from this infection is the right way to go."

If a vaccine against the H1N1 is developed, Besser said, regulators and health officials will ensure that the product is safe. "That is critically important," he said.