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Posts Tagged ‘flu’

WHO & Pharma under fire over swine flu

Posted by medconsumers on April 2, 2010

Before the faux swine flu pandemic fades from memory, consider this: One country—Poland—made the decision not to knuckle under to the pharmaceutical industry and buy H1N1 swine flu vaccines for its citizens. Dr. Ewa Kopacz, who is Poland’s minister of health, decided against a national vaccination campaign for several good reasons. She was not convinced that the vaccines were completely safe. Furthermore, the H1N1 flu appeared to be relatively mild in the countries of the southern hemisphere where the flu season was coming to an end. But it was the “conditions of purchase” that confirmed her decision. She was told by the vaccine companies that only the government could purchase their products—-vaccines would not be sold to clinics or anyone in Poland.

The price of each vaccine would be two to three times the cost of the yearly seasonal vaccine, though Dr. Kopacz knew the H1N1 vaccine is based on exactly the same technology. What’s more, it was not known at the time whether people would need one or two vaccines for full protection. And most outrageous: the Polish government was expected to sign a contract, stating that anyone injured by a vaccine would be the government’s responsibility. (Note: the U.S. government had long ago accepted this one-sided agreement.) Poland had fewer swine flu deaths this season and the virus was less virulent than in other countries. Though only half the vaccines in the U.S. were used, the estimated number of U.S. flu deaths this season was the lowest in years.

For standing up to the vaccine companies’ threats of dire consequences of her decision, Dr. Kopacz was the star of a hearing conducted on Monday by the Council of Europe in Paris, and attended by members of parliament. The gathering aimed its initial ire at the World Health Organization (WHO) for its changing definitions of pandemic and its alarmist warnings that were described as a “monumental mistake.” The result: a huge waste of money, unnecessary fear and anxiety; and a distortion of health services. Several speakers listed other pandemics like SARS, Creutzfeldt-Jakob disease (“mad cow”) and the avian (bird) flu that never lived up to the threat level announced by WHO. “Not a single person died from the avian flu in my country,” said the professor who was the former head of the French Red Cross. It is like the boy who cried ‘wolf,’ warned Paul Flynn, MP from the U.K, “If a truly dangerous virus does emerge some day, few people will take notice of it. The trust in the WHO has been undermined and it must be rebuilt.”

The WHO was the proverbial empty chair at this meeting because it declined the invitation and, the MPs said, had cloaked itself in secrecy at a prior meeting which was the first attempt to get answers to questions like: who decides that something is a ‘phase-6 pandemic’? And based on what evidence? (Another meeting, this time with WHO representatives, is planned for April 15 in Geneva.) Dr. Tom Jefferson of the Cochrane Collaboration spoke of how little reliable scientific evidence there is—not only to support vaccine use but also for understanding influenza itself. “The randomized trials that have been conducted are too small and too short [in duration],” he said, referring to vaccine trials that are usually funded by companies that make the vaccines. “The harms are not even looked for. We can’t answer the question of whether vaccines are safe.” Dr. Jefferson called for a large taxpayer-funded multi-country vaccine trial to fill the serious information gaps about vaccine effectiveness and possible harms.

As the hearing went on, the pharmaceutical industry became the major target. Several speakers called for more scrutiny of the pharmaceutical industry’s influence on health policy. They know that billions of pounds and Euros were spent on vaccines and unproven antiviral drugs like Tamiflu, and now they want to know who profited from WHO decisions. There must be more scrutiny of WHO’s key opinion leaders, especially those who fanned the flames of pandemic fears while taking pharmacuetical industry consulting fees. (Though unmentioned at this hearing, one H1N1 key advisor to WHO has been under investigation for personally profiting from the vaccination. Click here for more.)

Dr. Marek Twardowski, Poland’s undersecretary of state, ministry of health, brought the discussion back to the vaccine companies’ preposterous contract that his country was expected to sign. “Your governments did in fact sign contracts that shifted the responsibility for vaccine-related harm to your governments, and these agreements were made in confidence [i.e., secret],” he told the MPs. “As of March of this year, none of the vaccine companies brought their products into your countries under normal marketing conditions. Can you imagine if car companies like Toyota decided that they will only sell their cars to a government and then when a serious defect shows up like the Toyota’s accelerator problem, the taxpayers are expected to pay for it?” This is an “extremely dangerous precedent,” he said. “And I hope that today’s deliberations result in this never happening again.”

It’s hard to imagine such a conversation taking place in the U.S. Congress, which is bought and paid for by the pharmaceutical industry. And it’s unlikely many Americans know that vaccine companies already made sure the government pays for injuries caused by their products. In the wake of 9/11, Congress passed a federal law that allows vaccine companies to be protected from liability in the event of a vaccine-related injury. Authorities need only declare a public health emergency for the protection to go into effect. And if you think that the vaccine companies need protection from lawsuits to continue making vaccines, see this Bush-era press release from Public Citizen: “Flu Vaccine Shortage: Another Example of How Bush Dis-Torts the Truth About Lawsuits”

Click here to see the Webcast of the March 29 Council of Europe hearing.

Maryann Napoli, Center for Medical Consumers©ISSN 2155-1480

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Posted in Conflict of Interest, influenza, vaccines | Tagged: , , , , , , , , , , | 1 Comment »

Swine flu hysteria

Posted by medconsumers on December 4, 2009

So far the H1N1 virus, or swine flu, has been extremely contagious but mild to moderate in severity. About 9,820 Americans have died from swine flu since it emerged in April, according to the Centers for Disease Control and Prevention. The CDC and the World Health Organization estimate that the swine flu may have already peaked in the U.S. But some experts point out that the flu season usually starts in December, therefore another peak would be expected in early 2010. By these estimates, I figure that the 2009-2010 flu season is still not likely to become the pandemic it was heralded to be. Think of it this way, even if the second peak doubles the number of deaths, the total would be lower than the CDC-estimated number of deaths (36,000) in any given flu season. As observed in our September 2009 article, the H1N1 virus appears to be just another seasonal flu, see “Why the Swine Flu is Not a Major Threat.”

The media kicked off the season with the usual fear-mongering that focused on the deaths or near-deaths of healthy young people. 60 Minutes provided the prime example of flu reporting at its worst. It focused on one healthy teenager who became desperately ill with the swine flu, which landed him in the intensive care unit. A news show of this caliber would be expected to let us know who is most likely to die (this teenager did not) and how many deaths occur in those hospitalized with swine flu. In other words, provide a context for this one case.

It wasn’t like a context was unavailable. A “window” on what was to come appeared in the October 2009 Online First version of The New England Journal of Medicine. In the early phase of the swine flu “pandemic,” a research team reviewed the medical records of 272 people hospitalized in the U.S. between April and June 2009. All had tested positive for swine flu. Here’s the finding that 60 Minutes might have included in its reporting, 7% of the people in this study died and nearly half were children. Almost three-fourths of all who died had at least one underlying medical condition, primarily asthma; diabetes; heart, lung, and neurologic diseases; and pregnancy. 60 Minutes might have compared these findings to what happens in a normal flu season when 90% of the deaths occur in people over the age of 65, mostly in those with serious underlying medical conditions.

To its credit, 60 Minutes started the story this way: “99% of people with H1N1 virus, it’s just the flu…a few miserable days at home.” Funny, I didn’t remember hearing this until I saw the show over again on the 60 Minutes Web site while writing this article. Unfortunately, the camera focus on a young man struggling for his life with terrified parents at his side totally overwhelmed the fact that this might be the fate of 1% of the people who contract the H1N1 virus and a tiny fraction of 1% of the entire U.S. population. The tragic deaths of healthy young people would be rarer yet. As of December 10, the CDC estimates that there were 1,100 deaths in children under the age of 18, two-thirds of them had an underlying medical condtion, mainly asthma, cerebral palsy and muscular dystrophy.

Sometimes I get the feeling that the media is doing the CDC’s bidding by encouraging panic so we’ll all rush off and line up for the swine flu vaccine. After all, the federal government paid for these vaccines and would not want to see them go to waste, nor would the CDC want the public to lose faith in vaccines. Maybe this was all a trial run in the event of a real pandemic. Many who lined up for the vaccine were elderly people, usually the priority group, now told to get to the proverbial back of the line.

As time went on, we learned that everyone born before 1957 has natural immunity so they don’t need the vaccine. This is a startling public health about-face. Haven’t we always been told that vaccines are equal to or better than natural immunity—that is, getting the flu naturally? “It is a false assumption that the vaccine provides similar immunity to the natural infection. We have evidence that the natural infection provides long-term immunity for more than 50 years. We don’t know how long the vaccine-induced immunity lasts, but estimates are two to three years at best,” explained researcher, Jim Wright, MD, in response to an e-mail inquiry.

Dr. Wright, based at the University of British Columbia, co-authored a recent letter to the editor of the British Medical Journal in which he called attention to the need for a randomized trial to determine whether vaccines are actually effective for both the H1N1 virus and the seasonal flu. Some of us in the U.S. would like to know why the seasonal flu death rate has remained unchanged in the last 20 years, despite the fact that there was a steady increase in the number of people vaccinated during that time. Even the CDC is tacitly admitting the lack of progress with its 36,000 annual flu deaths statistic that hasn’t changed in years.

There are plans to form a panel of experts from outside the government to watch for any rare or unexpected side effects in the millions of Americans who were vaccinated in the last three months. But that’s not all I want verified. I’d like to know whether we were getting an honest assessment of the threat level of the swine flu. And was it worth spending the billion dollars that the U.S. government put into the production of these vaccines, or are there better ways to spend the taxpayers’ health dollars? Most of all, I want to know whether the H1N1 vaccines were effective in preventing death and hospitalization, especially in young people. When I directed these concerns to the CDC, a spokesman told me no decision has been made to study these issues.

For more information
Read this about the World Health Organization and the investigation of the gross conflict of interest of its expert on the H1N1 virus. And this on the home front: “Advisers on vaccines often have conflicts, report says.”

Maryann Napoli, Center for Medical Consumers©

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How good is Tamiflu?

Posted by medconsumers on September 28, 2009

The antiviral drugs Tamiflu (generic name: oseltamivir) and Relenza (zanamivir) are getting renewed attention now that the flu season is upon us. Both are in the same drug class called neuraminidase inhibitors. Because Tamiflu dominates the market for antivirals, it is named throughout this article but the findings are generally applicable to both drugs.

The benefit once you get the flu: Roche Laboratories had to conduct two trials to get FDA approval for this indication. The studies showed that Tamiflu, reduced the duration of the seasonal flu by a little more than one day…but only when taken within 40 hours of the onset of flu symptoms. This benefit, however, is limited to those with influenza A or B. The two trials had a combined total of 1,355 people who were randomly assigned to take 75 mg Tamiflu or a placebo, twice daily for five days. At the start of the trials, all participants were proven to be infected with influenza A. In time, more studies were published and all were reviewed for a recent issue of Lancet Infectious Diseases. This review found Tamiflu shortened the duration of influenza by 13 hours for healthy people and by 18 hours for high-risk people. Tamiflu costs between $5 and $10 a pill, depending on where it is purchased.

Problems with the above: When flu symptoms develop, you are not likely to know whether you have influenza A or B; nor will there be much time for laboratory confirmation. (The test is highly inaccurate anyway.) Chances are high that you don’t have influenza A or B because both are relatively rare, representing less than 10% of the 200 or so circulating viruses. What’s more, the symptoms are indistinguishable from the other 90% of circulating viruses that cause what is known as influenza-like illness. H1N1, or swine flu, is an influenza A virus, which is why this drug is allowed to be marketed for seasonal as well as H1N1 influenza. (The yearly seasonal vaccines are also aimed solely at influenza A and B viruses.)

Benefit when trying to prevent the flu: In the Roche-sponsored trials for this purpose, healthy unvaccinated adults, aged 13 to 65 years, took 75 mg Tamiflu once daily for 42 days during an outbreak of influenza in their community. 5% of the people taking a placebo got the flu, compared with 1% of those taking Tamiflu. In healthy children, aged 1 to 12 years, taking 30 mg or 60 mg (depending on the child’s weight) Tamiflu once daily for ten days, 17% of those taking the placebo got the flu, compared with 3% of those taking Tamiflu. As for Tamiflu’s ability to reduce complications, see Postscript below.

Resistance: “Emergence of drug-resistant influenza viruses after treatment has been reported, particularly in children in Japan, where the dosing schedule is different [i.e., more aggressive] from that used throughout the rest of the world,” according to a report in the February 15, 2009 issue of Clinical Infectious Diseases. The authors of this report also found that resistance to Tamiflu is more likely to occur in H1N1 influenza A [swine flu] than in other influenza A or influenza B viruses.

Revised CDC recommendations: On September 22, 2009, the CDC updated its recommendations to physicians, stating that Tamiflu should be reserved for high risk populations like pregnant women and babies. “Most healthy persons who develop an illness consistent with influenza, or persons who appear to be recovering from influenza, do not need antiviral medications for treatment or prophylaxis.” In other words, now that antivirals have shown some resistance, not to mention marginal effectiveness, the CDC says these drugs should be reserved for people at high risk for flu-related complications.

History: Tamiflu was approved by the FDA in 1999 for the treatment of influenza A and B. About four years ago when the avian flu was the threat, several governments, including that of the U.S., started stockpiling Tamiflu. In the U.S. government’s case, the stockpiling was for the military. Just since the emergence of swine flu in Mexico last spring, J.P. Morgan, the investment bank, estimated that governments have placed new orders for antiviral drugs of $3billion, despite the fact that this flu season looks like it will be relatively mild. Initially, Roche was required by the FDA to state in the drug’s label that Tamiflu’s efficacy in the treatment of influenza in people with chronic cardiac disease and/or respiratory disease had not been established. This disclaimer appears again in the updated 2008 FDA-approved label for Tamiflu because Roche still has not tested its drug for this high-risk population that needs it the most. [The drug label is the package insert that comes with medications and reprinted in the Physicians’ Desk Reference. The label is written by the drug company and then negotiated and approved by the FDA.]

Unanswered questions: Why haven’t the government-customers for Tamiflu leaned on Roche to prove its drug is effective in treating people with chronic cardiac disease and/or respiratory disease? What incentive does a company have to develop a better drug when it can make a billion dollars selling a barely effective drug like Tamiflu to the U.S. government each year?

Risks: Years after Tamiflu went on the market, reports surfaced that Tamiflu-treated people with influenza had experienced delirium and abnormal behavior, leading to injury and even death. Most of the cases occurred in children and in Japan where this drug was used excessively. Influenza itself (without Tamiflu) can be associated with a variety of neurologic and behavioral symptoms such as hallucinations, delirium, and abnormal behavior. In 2008, the FDA and Roche revised the label for Tamiflu accordingly. Nausea is a common side effect of Tamiflu.

Other antiviral drugs to avoid: In 2005 the Lancet published a study showing that influenza A viruses had developed resistance to Symmetrel and Flumadine and other antiviral drugs in a class called amantadine. These drugs were widely prescribed before 2005.

Postscript, added December 8, 2009
The British Medical Journal announced the publication of an updated review of all studies related to Tamiflu effectiveness, concluding, “There is no clear evidence that the antiviral drug most commonly used against influenza – oseltamivir (Tamiflu) – prevents complications like pneumonia in healthy people [who who become ill with influenza]. …Yet such claims have been a key factor in decisions to stockpile these drugs as part of global pandemic preparedness plans.” The review is described as part of a joint investigation by the Cochrane Collaboration, the British Medical Journal, and [BBC] Channel 4 News.

Maryann Napoli,Center for Medical Consumers(c)

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Why the swine flu isn’t a major threat

Posted by medconsumers on September 24, 2009

For the last 15 years, physician and epidemiologist Tom Jefferson, MD, has made it his mission to conduct extensive reviews of all studies of seasonal influenza vaccines. With colleagues at the Cochrane Collaboration, Dr. Jefferson has co-authored over 10 Cochrane reviews to answer a wide range of questions such as: do these vaccines reduce the chance of getting influenza or reduce the risk of complications, hospitalizations and deaths in elderly people, children, healthy adults and asthmatics? Based in Rome, Italy, Dr. Jefferson has published extensively and is arguably the world’s leading authority on the quality of the evidence supporting seasonal influenza vaccines. As we head into winter, the U.S. media is reporting a new, more ominous viral threat that may well become a pandemic. It is, of course, the swine flu, now known as the H1N1 virus or the 2009 H1N1 virus. Dr. Jefferson is interviewed by Maryann Napoli.

MN: Thanks for sending me that September 16, 2009 letter from the Health Protection Service of Australia. It made me turn my attention to that part of the world. Now that winter is ending in the southern hemisphere, what has happened in Australia doesn’t appear to be a pandemic. There were 131 H1N1 deaths out of a population of nearly 22 million people. Is it fair to conclude that the H1N1 virus did not turn out to be a pandemic in Australia?

TJ: Yes, you may conclude that the H1N1 virus is not the threat that it has been portrayed to be.

MN: And no H1N1 vaccine was available to Australians in time for their winter season.

TJ: Yes, that’s right. But notice that I did not answer the second part of your initial question about whether Australia experienced a pandemic. That’s because the definition of pandemic has changed on the World Health Organization’s (WHO) website since May 2009. The earlier version defines pandemic as: “An influenza pandemic occurs when a new influenza virus appears against which the human population has no immunity, resulting in epidemics worldwide with enormous numbers of deaths and illness [emphasis in the original document].” In the lookalike document that currently appears on the WHO Web site, the definition of pandemic has changed to: “A disease epidemic occurs when there are more cases of that disease than normal. A pandemic is a worldwide epidemic of a disease. An influenza pandemic may occur when a new influenza virus appears against which the human population has no immunity.”

MN: The phrase “enormous numbers of deaths and illness” is gone. And we now have a lower threshold for calling something a pandemic

TJ: The definition we’re left with makes the difference between seasonal influenza and pandemic influenza a matter of debate.

MN: What do you think is going on?

TJ: I am wondering if this means that the world will always be in a pandemic. The world will always have to be doubly vaccinated and the world will always be spending a huge amount of money for vaccines, and of course, buying anti-viral drugs by the barrel load. Journalists and others have contacted WHO to find out why the change in definition, and they are always told that someone will get back to them, which never happens.

MN: What about funding? The WHO funded the osteoporosis meeting in 1993 where the definition of osteoporosis was expanded. Do you know whether the same thing may have happened here?

TJ: No, I don’t, but when you look at the WHO pandemic preparedness document, which is 62 pages long, you see in the citation count only 2 references for hand washing, 3 for masks, 1 for gloves, 23 for vaccines and 18 for anti-viral drugs. What WHO should be pushing worldwide, especially for poor countries, are these public health interventions; instead, it’s pushing pharmacologic interventions. We now have clear evidence from our reviews that pharmaceutical industry-sponsored influenza vaccine studies have risen in importance and visibility, considerably more than non-pharmaceutical industry-sponsored studies. However, this is not explained either by size or quality of the studies which is the same. The likely, and very unpalatable, explanation for this finding is that the most prestigious scientific journals are more likely to print pharmaceutical industry-sponsored studies probably because of the money they make out of selling reprints of the studies and advertising space.

MN: But Tom, many who read this will say, “Yes, maybe a lot of people are going to make money from our fear, but I’ll still get the vaccine.”

TJ: First of all, it’s not “maybe” a lot of people are going to make money. Here’s a swine and bird flu stocks index, which tells you just how much money vaccine companies made in the last six months. So if you want to know how the pandemic is going, you can consult this Web site. I call it a “pandemiometer,” the barometer of the pandemic. Don’t forget to read the comments at the end of the page and the insights from the contributing pundits.

MN: Don’t you mean that this Web site is a barometer of the fear of the pandemic?

TJ: No, I think it is a reflection of what this pandemic really is: a commercial operation.
Why else would the Australian government plan to immunize millions of people after the epidemic with a partially evaluated vaccine?

MN: The Food and Drug Administration recently announced approval for four new vaccines against the H1N1 virus. They come with the usual warnings for people with allergies to eggs and possible “unexpected or rare serious adverse events.” Do you have any other reservations about these vaccines?

TJ: Yes, I do. I am aware of only one published study. It appeared recently in the online version [September 11, 2009] of the New England Journal of Medicine. I have four problems with this study, which was done in Australia. 1) It was tiny, only 240 adults. The authors made reassuring statements about Guillain–Barré syndrome, which is ridiculous because GBS occurs in one out of 750,000 to 1 million vaccinations, and this study only had 240 participants; 2) one third of these volunteers had side effects that resembled influenza-like illness (headaches, sore throats, etc.), so they were vaccinating to prevent symptoms that they were causing; 3) there was no placebo arm in the study [a group that was injected with an inert vaccine], yet there’s no ethical excuse for not having a placebo arm because these are experimental vaccines; and 4) the description of what additive substances [ingredients that boost the immune response] were in the vaccine was unclear. We know that there is thimerosal [mercury] in this H1N1 vaccine, but its manufacturer did not say whether there are additional substances like aluminum, which can be found in many other vaccines. We just don’t know. And they are advising this vaccine for pregnant women and children over six months of age!

MN: Can you just back up and explain how vaccine studies determine whether a new vaccine should be approved?

TJ: In all our reviews of the studies involving seasonal influenza vaccines, we always looked for real outcomes, i.e., cases of influenza, bronchitis, pneumonia. [In other vaccine studies like this new one from Australia], researchers look at the quantity and quality of antibodies [in the bloodstream] of the volunteers once they are injected with an experimental vaccine. If they produce a pre-set quantity considered to be “protective,” then it is assumed that once vaccinated, people will be protected. So the key question is how these laboratory markers relate to the protection of people. To answer the question we reviewed all influenza vaccines studies from 1948 to 2007. A straight answer is made difficult by the poor quality of these studies, but vaccines have performed very poorly especially in the elderly (for which they are universally recommended). So if this is the track record, why are researchers pursuing the same old tired and fruitless road?

MN: Yes, you made that so clear when I interviewed you in 2006 after you published an extensive report in the British Medical Journal. What about that CDC-generated statistic that the media hauls out each year to scare us into getting vaccinated: 36,000 U.S. deaths each year from influenza? It never changes. And when you think of it, 36,000 out of 300 million Americans is miniscule.

TJ: We know that in the last 20 years in the U.S., the seasonal influenza-related mortality rate is flat, despite the fact that over the years a higher and higher number of people have been getting influenza vaccines.

MN: Re the seasonal influenza vaccine which the CDC usually recommends for certain populations like children under age two and the elderly…

TJ: There is no evidence whatsoever that seasonal influenza vaccines have any effect, especially in the elderly and young children. No evidence of reduced [number of] cases, deaths, complications.

MN: Obviously, there’s no Cochrane review on the horizon for the H1NI virus.

TJ: Of course not, there’s no data yet to review. There is no problem with the H1N1 virus. It’s no different from any other seasonal virus. In fact, it looks—from the Australian experience—like it’s going to be milder and it can be handled with public health measures, such as hand washing, masks.

At the end of this interview Dr. Jefferson was asked if he had any conflicts of interest to report about influenza vaccines. His response: “Yes: I am publicizing my work. But no, I have no financial conflicts.”

More articles written during and after the swine flu “pandemic” of 2009-2010:

“WHO & Pharma draw fire over H1N1 hype”

“Swine flu in the U.S.—final death count”

“Flu risk overrated”

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Posted in Advocacy, Alternative Medicine, Children's Health, Drugs, Women's Health, influenza, vaccines | Tagged: , , , , , , , , , | 19 Comments »

Flu Vaccines Do Not Work For Kids Or The Elderly

Posted by medconsumers on March 1, 2005

Flu vaccines provide virtually no benefit to children. That’s the conclusion of a new review of all relevant studies. Interestingly, the news comes at a time when some health officials have begun to recommend the vaccination of all children in order to prevent them from passing on the flu to their elderly relatives. The review follows on the heels of a study that looked at three decades’ worth of data and found that vaccines for the elderly are not as effective as previously thought. And contrary to conventional medical wisdom, vaccines do not seem to reduce flu-related deaths in elderly people.

To determine the value of flu vaccines to children, Tom Jefferson, MD, and colleagues at the Cochrane Collaboration looked at over a thousand studies. They selected 14 high-quality clinical trials in which vaccinated children had been compared with unvaccinated children. The combined results of these 14 trials were reported in the British journal The Lancet (2/26/05). Here’s the conclusion: “We recorded no convincing evidence that vaccines can reduce mortality, [hospital] admissions, serious complications, and community transmission of influenza.”

The best the Cochrane reviewers could come up was this: “Vaccines were somewhat effective at reducing school absence…” Though the U.S. Centers for Disease Control (CDC) and Prevention advises flu vaccines for babies 6-23 months because they tend to suffer more complications once they get the flu, no evidence supports the recommendation. The Cochrane reviewers found that vaccines had little effect on bronchitis, ear infections, and hospitalizations, compared with the babies given placebo vaccines. In short, the CDC recommendations are irresponsible given the fact that the only two studies that involved babies found no benefit and little is known about adverse effects of these vaccines for babies.

Benefit to Elderly overrated
Now for the importance of flu vaccines to the elderly. A new comprehensive study cast doubt on the widespread belief that flu vaccines save lives (Archives of Internal Medicine, 2/14/05). Though the authors work for a federal government health agency, they produced evidence that failed to support CDC recommendations.

Lone Simonsen, PhD, and colleagues at the National Institute of Allergy and Infectious Diseases conducted a review of 33 consecutive flu seasons, from 1968 to 2001. The authors began their report with an acknowledgement that an accurate assessment of flu-related deaths is virtually impossible because few cases are confirmed with blood tests. And the viral infection is usually cleared from the body before the appearance of complications that cause death. For these reasons, the authors had to use a special statistical method to estimate flu-related deaths and deaths from all causes among elderly Americans over the three-decade-period.

Here is what Dr. Simonsen and colleagues found:

  • The number of flu-related deaths among elderly Americans increased steadily during the 33-year-period, despite the fact that their acceptance of flu vaccinations also steadily increased. For example, only 20% of all elderly Americans had a flu shot in 1980, compared with 65% in 2001.
  • There was a decline in flu-related deaths among people 65-74 years in the decade after the 1968 flu pandemic because people had naturally acquired immunity due to exposure to the emerging viruses of that period. The increasing flu vaccine coverage after 1980, however, did not correlate with a decline in flu-related deaths.
  • The over-all death rate for people over 85 during flu seasons did not change over the 33-year-period. Dr. Simonsen and colleagues cite earlier research that might provide an explanation for why flu vaccines did not reduce the flu-related deaths in “the very elderly” after 1980 when vaccine coverage began to increase, “…antibody responses following influenza vaccination decline sharply after age 65 years and a clinical trial involving subjects 60 years or older…found that the efficacy of influenza vaccine in preventing influenza illness was lower in people older than 70 years.”

Because fewer than 10% of all winter deaths can be attributed to the flu in any year during this study’s three-decade period, the authors conclude that vaccination’s benefit to elderly people has been substantially overestimated.

Maryann Napoli, Center for Medical Consumers ©
March 2005.

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Flu Vaccines Virtually Useless For Healthy Adults

Posted by medconsumers on November 1, 2004

How Effective is the Flu Vaccine?

Thousands of elderly Americans are lining up for hours to receive a flu shot. And the media are filled with stories about the inadequacy of the flu vaccine supply now that one of the only two suppliers had to be shut down due to contamination. Nearly half the nation’s expected supply of influenza vaccine has been wiped out.

In recent years, the federal government has been promoting the flu vaccine for everyone, not just for the elderly and the sick; but now it has had to do a complete about-face. Because the supply is so limited, the public has been told that influenza vaccines should be reserved for the elderly, the chronically ill, health care workers, babies 6-23 months old, pregnant women and women who plan to become pregnant in the next four months. The public trust was shaken soon after this announcement with the news that members of Congress and at least one football team got flu shots.

Understandably, a certain amount of hysteria has erupted because flu vaccines have not reached many of the people in the government’s high-risk category. Now everyone seems to want the flu vaccine. It’s time to step back and look at the big picture. Time to look at the question of how effective vaccines have been in preventing the flu. More importantly, how effective have vaccines been in reducing the deaths and severe complications sometimes associated with influenza?

As is commonly known, the vaccine formulation changes each year. The three different flu strains are usually chosen in the spring, and the choice is based on a combination of guesswork, flu outbreaks in Asia , and the recommendations of the World Health Organization.

What is not commonly known is this: Researchers divide influenza into two types, and the yearly flu vaccine is more likely to be effective against the type that afflicts fewer than 15% of all who appear to have influenza-this is the one caused by influenza A or B. Researchers refer to all other forms of influenza as influenza-like illness . Both types produce exactly the same symptoms-headache, fever, muscle aches, cough and runny nose.

All Influenza Looks Alike
In a telephone interview, vaccine researcher Tom Jefferson, MD, explained, “The flu is not caused by a single ‘bug’-about one-third of all influenza is caused by an unknown agent; about one-third are caused by rhinoviruses, the same viruses that cause the common cold; and the remainder are a mixed bag of other agents including influenza A and B viruses and members of the coronavirus family.”

What makes things complicated, according to Dr. Jefferson, is that they all appear to be the same illness. Moreover, one cannot forecast how much of the influenza viruses in the upcoming flu season will be influenza A or B, he explained, “yet the public is never told this.”

Dr. Jefferson co-authored the first review of all clinical trials in which healthy people under age 60 were randomly assigned to receive a flu vaccination or a placebo vaccine. (More on that later.) And he recently wrote an editorial entitled, “How to deal with Influenza?” for the British medical journal, BMJ. Vaccination successes are largely confined to influenza A and B, the type that accounts for only a small percentage of all influenza cases, he wrote. What’s more, public health officials are not good at predicting how much influenza A and B to expect in the next flu season. Putting these concerns together, Dr. Jefferson expressed reservations about mass vaccination, given the costs and variable benefits. “Before committing scarce resources to deal with influenza we need better proof that what we see is influenza and not an influenza-like illness.”

How good was last year’s vaccine?
The panic over flu shots this season is an even more extreme version of what occurred in November 2003 when influenza broke out earlier than usual in some parts of the country. The public was warned that the flu season was going to be much worse than previous years. Reports of flu-related deaths among previously healthy young children sent thousands of people to stand in line for the flu vaccine.

But we are far enough away from last year’s crisis to learn that the flu vaccine of the 2003-2004 season was a flop. It was the first time the federal government ever looked at the effectiveness of the flu vaccine in the midst of the flu season. The U.S. Centers for Disease Control (CDC) and Prevention funded this study which followed health care workers in Colorado , where the 2003-04 flu season started with a vengeance.

Lab tests were given to the vaccinated as well as the unvaccinated health care workers. Results showed that last year’s vaccine “was not effective or had very low effectiveness against influenza-like illness.” Still, the CDC managed to put a positive spin on these pitiful findings, stating that its study did not prove that last year’s vaccine was totally ineffective.

CDC pushed vaccine known to be ineffective
Here is how the CDC explained the poor performance of the 2003-04 vaccine. “Last year, the U.S. public health officials and the companies that make vaccines miscalculated and failed to predict that a new strain called the Fujian influenza A would be the most common cause of infection and left it out of the mix.” The CDC explanation is more than a bit disingenuous to consumer advocate Barbara Loe Fisher, president of the National Vaccine Information Center in Virginia .

As the consumer voting member of the FDA’s advisory committee on vaccines, Fisher participated in the discussions regarding the Fujian strain and why it was not included in the 2003-04 flu shot. As early as March 18, 2003, Fisher said the advisory committee knew that Fujian strain was the most important virus for the upcoming flu season. “Federal officials were prevented from replacing the A/Panama strain with the Fujian strain emerging out of Asia and being detected in Europe and the U.S. last spring,” according to Fisher, “because scientists in labs around the world were unable to isolate and grow the virus in a way that would allow vaccine production.”

In a telephone interview, Fisher said that the transcripts of these discussions at the FDA are publicly available (see below). “I called for the federal health officials to be honest with the American public about the effectiveness of the [2003-04] flu vaccine,” she continued. (In mid-January 2004, just as the time to be vaccinated had passed, the CDC issued a press release admitting the ineffectiveness of the current flu vaccine.) The National Vaccine Information Center , which Fisher co-founded in 1982, is a national, non-profit advocacy organization that often points to the lack of scientific evidence to support public policy regarding childhood immunizations.

Efficacy of Vaccines Past for People Under 60
It is, of course, too early to see whether the CDC 2004-05 flu predictions are more accurate, but for the first time a systematic assessment has been conducted of all flu vaccine trials worldwide. The review was conducted by the Cochrane Collaboration* and Dr. Jefferson was one of the four authors. The Cochrane reviewers wanted to answer the question of how effective flu vaccines are for healthy people under the age of 60 years. They also wanted to see whether there were any adverse effects.

They found 25 clinical trials in which healthy people between the ages of 14 and 60 years had been randomly assigned to have a flu vaccine or a placebo (inactive) vaccine. All the trials had been published in medical journals between 1969 and 2002. Altogether they involved 59,566 participants. Here is the Cochrane Review conclusion: Influenza vaccines are effective in reducing influenza A and B, but they do not work against the overwhelming majority of influenza-like illnesses.

When the Cochrane reviewers pooled the results of all 25 trials, they found that only 6% fewer vaccinated people got the flu, compared to the unvaccinated people. The vaccine formulations, which differed each year, were based on the recommendations of the World Health Organization or single governments (the 25 trials took place in eight different countries). No adverse reactions to the vaccines were reported.

The Cochrane review, which was published this year, produced these additional findings: The influenza vaccine did not reduce the number of working days lost, nor did it reduce flu-related complications, deaths or hospitalizations. From a public health standpoint, another disappointing finding was the failure of the vaccines to stop the spread of influenza.

Elderly People
Dr. Jefferson and his colleagues are currently conducting a similar Cochrane Review of all vaccine clinical trials involving the elderly (another one about children is in the works). Surprisingly few randomized trials have been conducted for the elderly and chronically ill. In less well-designed studies (20 in all), the influenza vaccine reduced the risk of pneumonia, hospitalization, and death in people over 65.

People with asthma
Another Cochrane Review focused solely on the benefit of the influenza vaccine to people with asthma. It addressed two important questions: Does the vaccine itself trigger asthma attacks? Does it protect against asthma attacks caused by influenza? Combined results of trials involving adults with asthma and children with asthma came to the same conclusion: Asthma attacks did not increase in the two weeks following a flu vaccination.

As for the question of whether the flu vaccine reduces the rate of asthma attacks following influenza infection (as opposed to the vaccination itself), few trials have looked at this crucial issue. The Cochrane Review, which was published in 2003, concluded, “.uncertainty remains in terms of how much difference vaccination makes to people with asthma.”

Children and Babies
A yearly flu shot for healthy babies and children is a relatively new policy in the U.S. As noted, last year’s reports of flu-related deaths among healthy children drove many panicked people to line up for flu shots. But the CDC web site (as of October 22, 2004) acknowledges that there is no way of knowing whether more children than usual died of the flu last winter. “Because the number of influenza deaths in children has not been tracked before, it’s not possible to compare the number of deaths in children this year with previous years.”

As far as the CDC knows, 152 children died of influenza in the 2003-04 season. For this article, the CDC officials were asked how many of these children had been severely ill before they got influenza. Answer: “The CDC will report these statistics at the end of this year.” (The agency would not permit direct access to its scientists for this article, so the answers to all questions came via a press officer.) Since CDC had used these deaths to promote flu shots and has since admitted the vaccine was largely ineffective, it is important to know more about the children who died.

One imperfect study supports policy on babies
The basis of the CDC recommendation for babies between 6 and 23 months rests on one rather imperfect study conducted in Colorado during last year’s flu season. It was a retrospective study of the nearly 30,000 children enrolled in a Kaiser Permanente health plan. The 6-23 month-olds represented only about one-sixth of all the children in the health plan. The study was funded by the CDC and led by Debra P. Ritzwoller, PhD, research scientist in the Research Unit at Kaiser Permanente, Colorado.

In a telephone interview, Dr. Ritzwoller was asked to explain the results, as they were not described clearly on the CDC Web site. Compared to unvaccinated children, the vaccinated children had 49% fewer cases of influenza, according to Dr. Ritzwoller. This finding, she noted, applied only to the children who had influenza A or B. Whereas, there was a smaller benefit to those with the more common influenza-like illness: 25% fewer cases among the vaccinated kids. But the key question is: 49% and 25% of what? Dr. Ritzwoller was not able to provide the answer. Here’s why the question is important: If few children in this study got the flu, then these reductions are less than meets the eye. For example, if 10,000 kids belong to a health plan, and only four of the unvaccinated kids and three of the vaccinated kids got an influenza-like illness, that’s 25% fewer cases.

The children had their illness type determined in laboratory tests that were administered in the emergency room. Unlike the well-designed clinical trials that formed the basis of the Cochrane Reviews, the Colorado Kaiser Permanente study had not randomly assigned the children to receive a flu vaccine or a placebo vaccine. This study appeared online last summer in the MMWR (Morbidity & Mortality Weekly Report), but is yet to be published in a peer-reviewed journal. When asked whether the flu vaccine caused any adverse reactions, Dr. Ritzwoller said there were none, but acknowledged some gaps in her study. “Hospital admissions were not tracked, and the parents were not interviewed,” she explained, attributing this to inadequate CDC funding.

The CDC’s rationale for its relatively new policy regarding yearly flu shots for babies 6-23 months is also based on their purportedly worse incidence of influenza complications. But consumer advocate Barbara Loe Fisher has her doubts. Giving the flu vaccine to babies under age two who are likely to receive other, standard childhood immunizations at the same doctor visit is a “national experiment,” said Fisher.

She faults the CDC for creating hysteria about the dangers of the flu-last year and this year-without warning parents and doctors about the unknowns surrounding the safety of the flu vaccine in combination with other childhood vaccines. The one exception she identified was Prevnar, the pneumonia vaccine which has been studied in combination with the flu vaccine.

Fisher is concerned about public health officials “cavalierly adding yet another vaccine to the childhood regimen without proof of safety or efficacy.” A new Japanese study, published in Pediatrics International, supports her concerns. Japanese babies, aged 6 to 24 months, had been vaccinated against influenza A and then age-matched to unvaccinated babies.

All the babies were followed for three flu seasons. The study found that the vaccine was ineffective in preventing influenza A. What’s more, the research team led by Tao Maeda concluded that influenza vaccination of healthy infants and young children is not justified unless the benefits clearly outweigh the risks. More studies are needed, say the Japanese researchers, before vaccinating children under the age of two becomes public policy.

In conclusion
Most people will not get the flu (only 5-20% come down with it each season, according to the CDC). Influenza does not pose a risk of serious complications to most people who get it. The flu vaccine (which changes formulations each year) does not prevent the type of flu that the overwhelming majority of Americans get each fall/winter season. The flu vaccine will cut the odds of getting influenza A and B by only 25%. This type of influenza, however, represents less than 15% of all cases, and public health officials cannot forecast how much of the influenza viruses expected in the upcoming flu season will be influenza A and B.

Elderly people may benefit from a flu vaccination in terms of reduced risk of pneumonia, hospitalizations and death, but the supporting studies are not very good. There is no good evidence to show that the benefits outweigh the risks of vaccinating babies and young children against the flu. Healthy people under age 60 years do not benefit from the flu vaccine, in terms of reduced odds of getting the flu, days lost from work, or stopping the spread of influenza. No adverse reactions to the flu vaccine have been identified, though long-term consequences are unknown.

For more information:

  • Visit the CDC Web site (www.cdc.gov/flu), or call the hotline at 1(800) 232-2522. This is the vaccine policy-setting government agency, and clearly not an objective source of information. For example, the Web site explains that the current vaccine shortage is due to the fact that the British supplier to the U.S. stopped production at the order of the British version of the FDA, but fails to give the reason (contamination).
  • For an entirely different viewpoint, go to the National Vaccine Information Center ‘s Web site at (www.nvic.org/diseases/influenza.htm), or call 1(703)938-0342. You will get an explanation, for example, about the difference between temporary immunity as delivered by a flu vaccine and natural or permanent immunity as conferred by recovering from the flu. The NVIC offers a free fact sheet and newsletter about influenza. At the Web site, you can read the transcripts of last year’s FDA advisory committee meetings mentioned by Barbara Loe Fisher in this article.
  • At www.bmj.com, go the 9/18/04 issue of the BMJ to read Dr. Jefferson’s editorial, “How to deal with influenza?”
  • If you believe that the flu vaccine shortage is due to lawsuits against pharmaceutical companies, go to the Web site of the Washington, DC-based, advocacy organization, Public Citizen (www.citizen.org/documents/ACF7D6.pdf).

*The Cochrane Collaboration is an international organization that conducts systematic reviews of all relevant studies to determine whether or not medical treatments work. The reviews are maintained in a subscription-only “library” online or in a CD ROM format.

Maryann Napoli ©
November 2004

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Colds & Flu: What Works?

Posted by medconsumers on October 1, 2003

By Maryann Napoli

We took this question to the Cochrane Library and found positive results for high doses of vitamin C, the herbal remedy called Echinacea, and enough evidence to suggest that zinc lozenges merit more research. The Cochrane Collaboration (CC) is an international network of experts from different fields who examine the quality of medical research to help consumers determine which treatments have scientific evidence of efficacy.

Vitamin C
The CC reviewed 30 trials; most of them tested both the preventive effect of maintenance doses (10-30 mg/daily) of vitamin C as well as the therapeutic effect of taking high doses once a cold developed. In all of the trials, adults and children had been randomly assigned to take vitamin C or a placebo. Though the combined results of these trials showed no preventive benefit to vitamin C, the CC reviewers did find an exception. People who were malnourished and/or under heavy physical stress did, in fact, had a lower number of colds taking maintenance daily doses of C.

As for stopping a cold once it appeared, the CC reviewers found a “clear effect on the duration of symptoms” in people who began taking high doses of vitamin C at the first sign of a cold, as well as a reduction in severity. This finding was judged “modest but certainly not trivial.” The study participants began taking incremental doses of vitamin C in the 1-3 gram range, which would not be considered high enough by the late Linus Pauling, the leading proponent of this treatment. In a 1987 interview, Dr. Pauling told this reporter that people should begin taking vitamin C at the first sign of a cold and continue taking it to their level of tolerance. To Dr. Pauling, high doses will eventually reach the realm of 20 grams for adults. (In its powdered form, vitamin C is measured in grams, rather than milligrams.) The level of tolerance differs from person to person, but Dr. Pauling said it is reached once diarrhea begins.
The CC reviewers left the door open for the possibility that the doses were not high enough in these trials, concluding “dose response clearly requires further research…incremental doses as high as 8 grams daily may heighten the therapeutic effect.”

Echinacea
Echinacea is an herb believed to be an immune stimulant. The CC located 16 clinical trials in which people with colds had been given either this herb or a placebo. Half the trials looked at preventing colds, and the other half looked at treatment. The CC found that the majority of the trials reported positive results for both prevention and treatment. There was not enough evidence to recommend a specific Echinacea product, however. Echinacea is sold in a variety of forms, ranging from powdered root to tinctures. Many of the trials assessed by the CC combined Echinacea with vitamin C or other herbs. In Germany alone, the CC found that there are 200 different Echinacea products on the market.

Zinc
Zinc lozenges have been pitted against placebos in seven clinical trials. Though the CC found the results to be inconclusive, zinc showed enough potential to indicate that further research is warranted.

Antibiotics
Many consumers and doctors think that antibiotics are appropriate treatment for a cold because they will prevent the development of a bacterial infection. The CC found nine clinical trials with the combined total of 2,157 participants who range in age from two months to 79 years. All of the participants had been randomly assigned to take antibiotics or a placebo once a cold had been diagnosed. No benefit was found for antibiotics and they were associated with a significant increase in adverse effects, such as rash, vomiting, and diarrhea.

For More Information:
Access to the Cochrane Library is on a subscription-only basis, but the abstracts or summaries of the reviews are freely available at www.cochraneconsumer.com.

Maryann Napoli is the associate director of the Center for Medical Consumers in New York City.
October 2003

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