Doctors Question Flu Shot Statistics

By KELLY O'MEARA

Special to The Journal

Americans are scared. From coast to coast, young and old have stood in lines, signed up for lotteries and even crossed national borders with the hope of getting a shot at this year’s limited supply of the influenza vaccine.

The credit for the mass hysteria that has swept the nation in the last two months should be given to federal health officials, who, through ongoing public relations campaigns that easily rival those of corporate America’s top-selling products, have successfully convinced the public that without the vaccine tens of thousands, or worse, might die.

In fact, the Centers for Disease Control and Prevention has told the public that influenza is the most frequent cause of death from vaccine-preventable disease in this country and that from 1990 through 1998, an average of 36,000 flu-related pulmonary and circulatory deaths occurred each season in the United States.

Alan Clark, a family physician in Atlanta, specializing in emergency medicine argues that those “deaths” cannot be confirmed.

“The CDC cannot show anyone in any year where there were 36,000 actual deaths due to influenza,” he said. “I think the vaccine is not working, and even if they do get the right strain of virus the chances of it being helpful is maybe 60 to 80 percent in a healthy adult, less than 50 or 60 with health problems – and I mean maybe. The only thing the vaccine is effective for is making money for the vaccine manufacturers.”

Even CDC officials reluctantly admit the deaths are not “real” numbers, but only estimates. CDC spokesman Von Roebuck said the CDC uses indirect modeling methods to estimate the numbers of deaths associated with influenza, an approach that has been used for 40 years. Using this approach, the CDC estimates that about 36,000 influenza-associated deaths occur annually in the United States, he said.

This estimate is obtained by using the models to analyze the National Center for Health Statistics, NCHS, for underlying respiratory and circulatory deaths. The estimated 36,000 deaths from influenza represents about 3 percent of about 1.1 million underlying respiratory and circulatory deaths that occur during the year.

However, what the CDC fails to tell the public is that it has no idea how many people who died from underlying respiratory and circulatory problems actually had the influenza infection. In other words, the CDC doesn’t know if a person who died of pneumonia also had the flu, because those statistics are not collected. The one fact that CDC can state for certain is this: The greatest number of influenza deaths recorded since 1979 were 3,006 in 1981.

Still, most physicians eagerly will admit that the influenza virus is nothing to, well, sneeze at, and that history well documents the bug’s lethality.

But is the influenza scare justified? To answer that question, The Journal decided to take a hard look at the CDC’s historical data and last year’s flu season as a good place to start.

Recall that public health officials announced that the 2003 flu season not only began earlier than normal but that the strain of influenza circulating in North America did not match the strain formulated in the vaccine. Early in the 2003-2004 flu season, the CDC advised that although a vaccine had been developed with the wrong strain of virus it, nevertheless, “may provide some protection or lessen the symptoms,” and continued to encourage worried Americans to be vaccinated.

However, after analyzing 2003 data this year, the CDC acknowledged that the 2003-2004 influenza vaccine had “no or low effectiveness against ILI (influenza-like illness).” In other words, last year’s shot didn’t work.

Mark Geier, a Silver Spring physician and president of the Genetic Centers of America along with his son, David Geier, a Maryland consultant on vaccine issues, argue that the “no or low effectiveness” statement by the CDC is misleading.

“What the CDC looked at in its study of the 2003-2004 season were people who received the vaccine versus those who did not receive the vaccine and they followed these people for weeks to months,” explained David Geier.

“What was demonstrated was that last year’s vaccine did not prevent any influenza-like illness – it had no statistical efficacy against the influenza infection.” “Anyone can look at the CDC data and see that there is no statistical difference between those who received the vaccine and those who did not,” David Geier said.

The data can be found at the CDC Web site, www.cdc.gov, under the report titled Preliminary Assessment of the Effectiveness of the 2003-2004 Inactivated Influenza Vaccine Colorado, Dec. 2003.

The data shows that vaccine efficacy runs from -0.14 to 0.33. “The zero means that statistically it is not different from zero and has no efficacy,” David Geier said. “In other words last year’s vaccine made no difference in the rate of developing influenza-like illness,” David Geier said. “The CDC says it had “no or low effectiveness,” but that’s just the CDC’s spin that maybe one person was helped but they can’t find them.”

The Geiers also point to additional historical CDC data to further question not only whether the influenza vaccine is effective in any given year, but also raise questions about the reported 36,000 estimated deaths associated with the influenza virus.

“What is most disturbing is that the CDC’s own data posted at the CDC’s National Center for Health Statistics show that the influenza vaccines do not work,” adds Mark Geier. “What we see (from the CDC data) is that in the late 1970s between 10 and 15 million doses of influenza vaccine were given to high-risk people, and by 2001-2002 nearly 80 million doses were distributed.

Despite the enormous increase in the number of people receiving the influenza vaccine and the CDC’s public relations campaign to sell the vaccine, there has not been a decrease in the population rate of influenza deaths or influenza illnesses.” In response to Mark Geier’s claim that the “vaccines do not work,” CDC spokesman Roebuck explained that “the studies looking at trends in mortality over time cannot address the effectiveness of the vaccination program since influenza vaccine information is not linked to death certificates or hospital data.

One explanation for not seeing a decline in influenza-related hospitalizations and deaths is the aging population, particularly persons 85 years and older. In addition, A (H3N2) viruses have predominated in more recent seasons.”

“This response is ridiculous,” countered Mark Geier. “The rules in science and medicine are that the vaccine manufacturers have to demonstrate efficacy – now we have to demonstrate that it isn’t efficacious. What the CDC is saying is ‘well, the data don’t show that it’s efficacious, but the numbers aren’t good enough so we’re going to keep giving it.’ That’s not how this is supposed to work.

They have to prove that the vaccine is working, and the CDC has no proof.” “Furthermore,” explained Mark Geier, “the CDC reports that roughly 100 children die from influenza each year, but the data show that there really are between five and 15 deaths in any given year. The CDC also touts the estimated 36,000 yearly deaths due to the influenza virus. All anyone has to do is look at the CDC’s own data to see that in reality it is maybe 1,000 deaths.”

Mark Geier is referring to the data made available by the CDC’s National Center for Health Statistics which show, for example, the actual number of deaths due to influenza in 1979 were 604. The highest number of deaths recorded occurred in 1981 with a total of 3,006. These data include all age groups.

“The argument by the CDC that the vaccine is stopping these deaths doesn’t hold up because with the increase of the vaccine over the years one would expect to see the number of deaths going down,” Dr. Geier said. “We don’t see a decrease. There is very little, if any, trend in these numbers and the point is there aren’t a whole lot of deaths to be prevented.”

“Given the CDC’s data,” concludes Mark Geier, “no one should be standing in a line thinking ‘Oh God, if I get the vaccine I’m going to live and if I don’t get the vaccine I’m going to die, because it appears that it just doesn’t make much difference whether you get the vaccine or not.”

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

Is the CDC hiding flu shot alternatives?

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.

CDC Pushes Fear over Reassurance

Atlanta-based family physician Alan Clark has heard patients tell him one too many times: “Every time I get a flu shot I get sick. ’That’s not surprising, he said, considering thimerosal (mercury) is used as a preservative in the influenza vaccine, which knocks out the immune system.

“Many people come down with the first virus or bacteria that invades their system,” he said. “There are better ways to prevent and treat the flu, which brings up the idea of prescription medications that the CDC is aware of and, more importantly, why aren’t these known to the public?”

In fact, for years public health officials have been aware of the Food and Drug Administration approved antiviral drugs for the prevention and treatment of the influenza virus, but still it took nearly two weeks into this year’s vaccine shortage hysteria before the antiviral drugs were quietly recommended by officials tasked with protecting the public health.

When The Journal asked why the CDC wasn’t pushing the antiviral medications, CDC spokeswoman Christine Pearson insisted public health officials had made the information available and blamed the media for dropping the ball.

“I believe, Dr. (CDC Director Julie) Gerberding has mentioned (antivirals) in nearly all the press conferences she’s had in the last few weeks,” Pearson said. She further insisted, “I know that it has been talked about by either Dr. Gerberding or Secretary Thompson (Department of Health and Human Services) in many of the press conferences that have happened. I don’t know why the media was just interested in the supply (vaccine) issue. I can’t speculate on why the media does what it does.”

And, in an effort to better clarify the CDC’s position on making the public aware of the use of antiviral medications, CDC spokesman Von Roebuck explained that it is not fair to say something is “pushed” by the CDC.

“The CDC makes recommendations based on scientific research and consultation. Those recommendations often become the standard practice by clinicians and state health departments,” he said.

While it may be true that the media appears to be fixated on this year’s vaccine shortage, the missed opportunities to explore prevention and treatment alternatives surely can be traced to the lack of interest in, and information provided by public health officials about the antiviral drugs.

In fact, none of the information handed out by both Montgomery and Prince George’s County officials to schools and the media contained information about antiviral medications.

Furthermore, a review of press releases and briefings by public health officials clearly demonstrate that information about antiviral drug use for prevention and treatment of influenza has taken a backseat to the vaccine.

For example, on Oct. 5 public health officials announced the contamination of half of the expected influenza vaccine but, it wasn’t until one full week later, on Oct. 12, that Gerberding mentioned in a press briefing that they have a stockpile of Tamiflu, which is one drug used to treat influenza or to prevent it, and she noted, “we are in the process of purchasing a second drug, Rimantadine, to also have in the stockpile. We are hoping to purchase up to five million treatment courses of that drug.”

Then, on Oct. 15, 10 days after first notice of the vaccine shortage, a CDC press release advised that pharmaceutical giant Aventis Pasteur will provide an additional 2 million doses of the vaccine, but Gerberding makes no mention about the antiviral drugs.

Rather than taking the opportunity to aggressively reassure the public that there are antiviral prevention and treatment alternatives available, Gerberding again raises the vaccine shortage fear factor and explains “this shortage is frightening to people and they’re rushing out and standing in long lines thinking they need the vaccine right now before it s all gone. We want them to know that more is coming, so as hard as it may be, please try and be patient and check with your provider ahead of time for availability of vaccine in your area.”

On Oct. 18, two weeks into the vaccine shortage saga, the CDC posted on its web site “Guidelines and Recommendations for Influenza Antiviral Medications”. And the following day, Oct. 19, Health and Human Services Secretary Tommy Thompson in a press release announced the availability of “antiviral medicines to help keep you safe from the flu.”

If CDC spokeswoman Pearson is correct and public health officials have communicated often about the benefits of antiviral drugs for the treatment and prevention of influenza, why does the latest Oct. 22 CDC Public Health Announcement focus on the limited supply of vaccine and omit any mention of antiviral medications?

Gerberding declined requests to be interviewed.

Despite the brief and sporadic mentions by public health officials about the availability of antiviral drugs and, in light of both the shortage of the vaccine and the questions surrounding its efficacy, the benefits of these FDA approved alternatives to the influenza vaccine physicians state cannot be overstated.

There are four antiviral medication alternatives to the influenza vaccine, including one that, unlike the vaccine, will prevent and treat any strain of Influenza virus A or B.

Public knowledge of this medication could have been especially helpful during last year’s flu season when the influenza vaccine did not match the circulating virus and CDC officials admitted that the vaccine actually had “no or low effectiveness.”

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

Doctors Question Flu Shot Statistics

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