With the sudden announcement that this year’s supply of influenza vaccine would be cut in half, federal and local health officials zoomed into warp drive, apparently willing to do whatever it takes to get the scarce vaccine to those who need it most. Barbara Loe Fisher, co-founder of the National Vaccine Information Center, a Vienna, Va., nonprofit organization dedicated to the prevention of vaccine injuries and deaths through public education, questions whether the CDC has done all it can to ensure that the vaccine they tout as the miracle cure is everything they say is cracked up to be.

“There has been this cavalier attitude toward approving both safety and efficacy in the flu vaccine, which is difficult because every year you have a new strain for the vaccine and they don’t do any substantive clinical trials,” she says. She says she is not surprised that the CDC studies show the vaccine has no efficacy in young children because there isn’t any systematic way to measure efficacy of the flu vaccine in children or adults.

“I continue to be extremely concerned with both the safety and efficacy of this flu vaccine,” she said. “This is the first time that babies will be getting two flu shots and they have not studied this vaccine and it will be given to six-month-olds simultaneously with other vaccines, including DTaP, HIV, Polio, Pneumacoccal, Hepatitis B and the flu shot. That’s eight vaccines in one day. This is a national experiment this year on infants with giving them two doses of the flu vaccine.

Is there a better alternative?

The CDC quietly announced guidelines for antiviral medication on their Web site www.cdc.gov, but only after two weeks of generating panic with scare tactics. According to the CDC’s antiviral medication guidelines, titled Influenza Antiviral Medications 2004-2005 Interim Chemoprophylaxis and Treatment Guidelines, four medications have been approved for use during the flu season. They are: Amantadine (Trade Name Symmetrel) and Rimantadine (trade name Flumadine) were approved by the Food and Drug Administration in 1966 and 1993, respectively, for the prevention and treatment of Influenza A.

In 1999 Sanamivir (Trade Name Relenza) and Oseltamivir (Trade Name Tamiflu) were approved for the treatment of the influenza virus, both A and B. Tamiflu, however, produced by Roche Pharmaceuticals, is the only antiviral medication FDA approved for both the treatment and prevention of both A and B influenza viruses.

Dr. Mark Geier, president of Silver Spring-based Genetic Centers of America and consultant on vaccine issues long has been aware of the benefits of the antiviral medications available for the treatment and prevention of the influenza infections. “There are several drugs to choose from but Tamiflu is better than the others because it prevents influenza strains both A and B and has few side effects,” he said. “The fact is, I would argue that this drug is so effective that if it were widely used there would be no influenza. People don’t have to die from influenza because this drug is and has been available for many years. Tamiflu can be used for treatment or prevention and it is much more effective with an upwards prevention rate of 90 percent. Furthermore, when taken as a treatment, it significantly reduces the symptoms and shortens the days that a person has the infection. The vaccine has never been that effective.”

The problem is that the CDC isn’t making this information widely available, Geier notes. “Rather the (CDC) spends time and money telling people to take the vaccine, which is marginally effective at best. People don’t have to die from the influenza and the CDC knows that this drug is extremely effective both in the prevention and treatment of the influenza virus.”

Despite the CDC’s claim that the agency has made the public aware of alternatives to the vaccine, a presentation delivered at last April’s American Medical Association meeting by Glen Nowak, then the Associate Director for Communications for the National Immunization Program, paints a different picture. Nowak’s presentation includes a “Seven-Step Recipe for Generating Interest in, and Demand for, Flu (Any other) Vaccination.”

Within the “Seven-Step Recipe,” Nowak explains that the recipe that fosters influenza vaccine interest and demand is “medical experts and public health authorities who publicly state concern and alarm and urge influenza vaccination.”

Nowak further states that when health officials ring the alarm, there will be significant media interest and attention at which time officials must frame the flu season in terms that motivate behavior, such as characterizing it as “very severe,” or “more severe than last or past years,” and even “deadly.”

When questioned about the Recipe, Nowak, now the Acting Director of Media Relations for the CDC, said he was asked to find out why there was so much late-season demand for flu vaccine in the 2003-2004 season.

“One of the things that happened in the past is that demand tends to decrease around Thanksgiving,” he said. “What happened last year was that, going into the first weeks of Decembe,r there was a lot of consumer demand and as part of the presentation, I looked at what was different.”

He said several factors led to consumer demand for influenza vaccination that were beyond the control of medical providers. “Last year the influenza arrived early during the time when people could get vaccinated,” he noted. “And last year the initial cases were among people who are not typically associated with severe complications of influenza, and it tended to get more media attention.”

Nowak did not make clear in his presentation just who was responsible for the scare tactics, but given that all but 4 million doses of last year’s ineffective vaccine were sold, the alarm and dire outcomes certainly appeared to have worked.

But why did they keep pushing the alarm button when the CDC knew from its own studies that the 2003-2004 vaccine had no or low effectiveness? Nowak failed to make note of it in his April presentation of the Seven-Step Recipe.  In addition, there is not a single mention of the antiviral medications in the Seven-Step Recipe.

Nowak brushed off the failure to include or conduct any presentation on antiviral medications by insisting that topic was never meant to be part of a public seminar.

While the CDC has no immediate plans to launch a major information campaign about the antiviral medications, Nowak claimed that the CDCs efforts about the antiviral medications have been targeted toward our clinicians, health care providers and healthcare professionals to make them more aware of how antivirals can be used in treating influenza.

The concerns the CDC has about the antivirals is that “they are prescription medications and so patients have to talk with their doctors and the antivirals can be relatively expensive and many health plans don’t cover the cost of antivirals,” he said.

In other words, the CDC decided not to heavily promote antiviral drugs because they deemed them too expensive for the consumer – even though many physicians advocate such drugs are more effective and safer than the influenza vaccine.

Instead, the CDC continues to push the influenza shot upon 4 million children even though its own statistics indicate less than 15 children die from influenza each year. In fact, less than 2,000 people die from the flu each year and most of those are 85 years and older. How many of them might be alive today if they knew about antivirals? If federal health officials are truly guardians of the public health, wouldn’t they be aggressively promoting these drugs or have they become salesmen for vaccine manufacturers.

Kelly O’Meara is a veteran investigative reporter who holds journalistic awards for articles in the medical field.

At a glance...

Monday: Are the CDC estimates of flu deaths this year fact or fiction?

Today: Why hasn’t the CDC pushed safe alternative FDA-approved drugs?

Wednesday: What are the best antivirals and why aren’t they being talked about?