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Flu death risk overrated

Posted by medconsumers on March 22, 2010

Here’s the final death count on the pandemic that wasn’t. An estimated 12,000 Americans died from the H1N1 swine flu between April 2009 (when it first emerged) and March 12, 2010, according to the U.S. Centers for Disease Control and Prevention. Out of the American population of over 315 million, this number of swine flu deaths is pretty low on the list of things likely to kill us before our time. (The majority of flu-related deaths occur in people over age 65.) Swine flu proved to be much less lethal than the ordinary seasonal flu that accounts for an estimated 36,000 deaths, which is the CDC’s usual yearly estimate. The CDC must resort to estimates because laboratory-confirmed deaths are uncommon. Many people die at home; or they die in the hospital of influenza complications (e.g., pneumonia, congestive heart failure) and the virus has left the body by the time the death occurs. One of the many things we’re not likely to find out is: how many deaths occurred among people who were vaccinated?

The relatively benign nature of this flu season confirms the position taken by international influenza expert Tom Jefferson, MD, who has long maintained that the threat of influenza is greatly overestimated. (See “Why the swine flu is not a major threat.”) As for the crucial question about vaccine effectiveness, he says that there is no proof that vaccines reduce the chance of death or complications in people who need them the most, e.g., people with severe respiratory problems. His judgment is based on the careful assessment of 50 years’ worth of research on this topic for the Cochrane Collaboration.

The amount of money governments spent on influenza vaccines and minimally effective anti-viral drugs like Tamiflu and Relenza has raised questions in several European countries. The Council of Europe will hold a hearing March 29 about how the World Health Organization’s pandemic guidelines were established and how national health authorities interpreted these guidelines. (WHO has at least seven different definitions of pandemic, according to Dr. Jefferson.) Dr. Jefferson will speak at this hearing that will be attended by members of the European Parliament. Polish Health Minister Ewa Kopacz will explain why Poland decided not to order any H1N1 vaccines. Pointed questions from the European media, most notably Der Spiegel, before and after the “pandemic” were the impetus for this meeting. So far there is no equivalent public soul-searching in the U.S. about the money, time, and effort spent on the pandemic that wasn’t.

Read our report of the Council of Europe hearing.

Related postings
Swine flu hysteria
Tamiflu: serious questions remain
WHO accused of losing public confidence over flu pandemic.

Maryann Napoli, Center for Medical Consumers(c)

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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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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”

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

Those Ubiquitous Gardasil Ads

Posted by medconsumers on March 1, 2007

The first thing you notice about the Gardasil TV ads, featuring teen-age girls engaged in various athletic activities, is that there is no mention of the fact that the Gardasil vaccine is for the prevention of a sexually transmitted disease.

The voiceover says, “Every year thousands of women die of cervical cancer. I want to be one less woman who will battle cancer.” The first sentence is entirely true (3,700 in the U.S.); the second is merely a wish.

One version of these ads, which features mothers and daughters, was found to be cleverly manipulative by a New York Times reporter, Claire Dederer. The ad shows cool, self-reliant girls involved in cool, self-reliant physical activities with the repeat message: I want to be one less woman who will battle cancer.

“The mothers appear about halfway through [the ad] and they’ve got the bad news,” writes Dederer. “In loving tones they break it to their daughters: ‘Gardasil may not fully protect everyone,’ they say. Tenderly they list the side effects.This is an ingenious ploy: the cool girls want to be ‘one less’; the moms are the ones putting on the brakes. Having mothers voice the downside of Gardasil reinforces the message that if you get this vaccination, you’re the rebellious, independent thinker: ‘forget the side effects. Forget Mom. I’m getting vaccinated.’”

Maryann Napoli, Center for Medical Consumers© March 2007

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How Vaccine Policy is Made: The Story of Merck and Gardasil

Posted by medconsumers on February 1, 2007

Much has happened since the November HealthFacts took the position that the new cervical cancer vaccine should not be mandated. By now, most of the U.S. is probably aware that donations from Merck, maker of the Gardasil vaccine, influenced Governor Rick Perry’s decision to make Texas the first state to mandate Gardasil vaccinations for all girls entering the sixth grade.

Behind the scenes, Merck was found to be bankrolling similar mandates under consideration in at least 20 other states. In doing so, the company moved from the usual pharmaceutical industry hucksterism (hype the disease, hype the new drug) to blatantly purchasing a public policy that is clearly a windfall for the one and only company that sells a cervical cancer vaccine.

The prolonged nationwide publicity given Merck’s actions frequently overlooked a key element to the question of whether mass cervical cancer vaccinations make sense whether they are mandated or voluntary. Cervical cancer is, by any measure, a rare disease in the U.S., afflicting fewer than 10,000 women and causing about 3,700 deaths each year.

And then there’s the proverbial elephant in the room that no one seems to want to address. It has been known for over three decades who is most likely to get cervical cancer. In fact, it is known by geographical region. So why not save taxpayers’ money, especially at a time when the states are running out of health dollars for children, and provide the vaccine for the girls most in need?

All medical decisions made by and for healthy people boil down to probabilities. What are the odds of dying of the disease that the vaccine protects against? (There are three cervical cancer deaths for every 100,000 women in the U.S.) How protective is the vaccine? (70%, according to Merck) What are the odds of serious harm from the vaccine itself?

The last question is not answerable because the vaccine has only been available for eight months, and several hundred thousand girls must be vaccinated and followed for many years before any rare or even uncommon serious adverse reactions can be documented. The longest follow-up is 4 ½ years, so how long the protection lasts is another unknown.

What makes this vaccine different from virtually all others currently given to babies and young children is the fact that cervical cancer is a sexually transmitted disease. (The hepatitis B vaccine given to newborns since 1991 is the other exception.) There are more than 100 different types of human papilloma virus (HPV), but only 23 are considered high risk. “Rarely can an infection with high-risk HPV develop into precancer or cancer. The majority of HPV infections go away on their own and do not cause any abnormal cell growth,” according to the National Cancer Institute’s Edward L. Trimble, MD. Gardasil protects against two of the cancer-causing strains that account for about 70% of all cases of cervical cancer
Typically, a new vaccine goes into use gradually, and a mandate comes only after several years. The haste with which Gardasil became mandatory in Texas is challenged. “This [cervical cancer] is not a public health emergency, so the government has no right tell parents or kids to have the vaccine or even to opt out,” said Michael Policar, MD, associate clinical professor of Obstetrics, Gynecology and Reproductive Science at the University of California, San Francisco. “You can’t get this disease from someone sitting next to you on a bus. If you have TB, a judge can tell you to take your drugs because you can give the disease to other people and if you don’t take the drugs, the judge can have you confined,” Dr. Policar said in a telephone interview.

Physicians and public health experts quoted in the media were unanimous in their recommendation of the vaccine, though some, like Dr. Policar, do not like the mandate. And all insist that strong evidence supports its safety and efficacy. Physicians seem untroubled by the fact that no published HPV vaccine trial had participants under the age of 15. The CDC recommends the HPV vaccine for 11- and 12-year-old girls, and the American Cancer Society sees the vaccine as appropriate for girls as young as nine years of age. The girls must receive the vaccination before they become sexually active or else it will not be effective.

Why is there so little public discussion among doctors about the wisdom of vaccinating all young girls for a rare disease? “Great question,” responded Dr. Policar. “Certain people are very tied into vaccines—pediatricians, infectious disease doctors, public health doctors—these people have never seen a vaccine they didn’t like. The pressure to vaccinate comes not only from them, but also from industry.”

The rush to make a new vaccine compulsory appears to be all about Merck making as much money as possible before Cervarix, GlaxoSmithKline’s version of the HPV vaccine, comes on the market. “Merck started three to four years ago convincing us that HPV is a dangerous infection,” said Dr. Policar, noting that the company has been overdoing it. “HPV is a marker for sexual activity. The majority of us are infected with it and that doesn’t mean we’ll all get cancer. This is another industry-created disease,” he explained, stressing that all HPV-vaccinated women should have regular Pap tests. (For a critique of the Pap test, see page 4.) Dr. Policar is favorably inclined toward the vaccine, but has reservations about the excessive cost and possible need for booster shots (“it took 30 years to learn that the pertussis vaccine needs a booster”). Dr. Policar said he has been “a paid lecturer on occasion for Merck regarding Gardasil.”

More and more parents worry about the growing number of vaccines now given to babies and young children, according to Barbara Loe Fisher of the National Vaccine Information Center, who notes that 40 vaccine doses are already mandated for babies and young children. Fisher, an advocate for vaccine safety, is concerned that doctors are not giving enough attention to possible harmful effects of Gardasil when combined with other vaccines.

She advises parents to inform themselves. But this is difficult when the trials are funded by the vaccine companies and the last place parents will get an unbiased evaluation of any vaccine are the U.S. Centers for Disease Control and Prevention (federal promoters of vaccines in general) or the American Academy of Pediatrics (represents the specialty that sees all vaccines as a medical triumph). In fact, Fisher’s Web site www.909shot.com is the only evidence-based independent Web site on this topic.

Science seemed to take a back seat in the prolonged media coverage last month. The one trial that proved “sustained efficacy up to 4.5 years” was funded by GlaxoSmithKline, and published last year in The Lancet. This is the longest follow-up. The majority of the participants were over 18. About half of these 776 study participants were randomly assigned to receive the HPV vaccine, thus the longest follow-up involves less than 400 women.

And now for the elephant in the room. Cervical cancer is largely a disease associated with extreme poverty, smoking, lack of education, and less than sanitary living conditions. According to a 2005 National Cancer Institute report, most cervical cancer deaths occur in black women in the rural South, Hispanic women living along the Texas-Mexico border, white women in Appalachia, American Indians in the Northern Plains, Vietnamese-American women and Alaskan Natives. These groups are also more likely than other U.S. women to be diagnosed with other diseases like breast cancer, colorectal cancer and heart disease.

Wouldn’t it make sense to aim the Gardasil vaccine recommendation at these women? Or better yet, given the limited federal health dollars, why not spend some money to improve their health in general? The answer, of course, is that this would not suit Merck, who appears to be setting the national agenda on cervical cancer. Nor does it suit the federal government and the special interests—so aptly represented in Congress—who want to do everything to keep companies from shunning the vaccine business as risky and unprofitable. Merck needs to make as much money as quickly as possible from Gardasil before Cervarix goes on the market. Each year in the U.S., about a million girls turn 11. Mandating a $360* series of three injections means an estimated $360 million-a-year market.

It didn’t take long for Merck to experience a well-deserved backlash. Within three weeks of Governor Perry’s announced mandate at the end of January, Merck revealed that it would stop lobbying state legislatures to mandate Gardasil. (Texas legislators are reportedly at work undoing the mandate.) But Merck is not the only company to provide “unrestricted educational grants” to Women in Government, a Washington, DC based advocacy organization of female state legislators. This group, the conduit for Merck donations, has also received funding from Glaxo, as well as Digene, a company that makes a test that detects HPV.

The funding paid off as female state legislators were highly visible in the media coverage given Gardasil last month. The legislators were presenting themselves as champions of women’s health and spreading the word about the dangers of HPV, often quoting worldwide cervical cancer statistics (500,000 deaths annually!! Second leading cause of cancer deaths!!) as if these numbers pertained to U.S. women. The Merck people probably knew that a vaccine company presenting itself as champions of women’s health wouldn’t fly with the public. Much better to send in the female legislators to shill for them.

*This is the most widely quoted price, but a random survey by the National Vaccine Information Center found the price varies considerably and can be as high as $825 plus office visit charges.

Maryann Napoli, Center for Medical Consumers© March 2007

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New Cervical Cancer Vaccine Should Not Be Mandatory

Posted by medconsumers on December 1, 2006

The new cervical cancer vaccine raises concerns that did not show up in the news coverage about its approval last summer. Usually mass vaccinations are advised for diseases with a high rate of death and/or disability, but cervical cancer doesn’t come close to meeting those criteria. And most important: Is it safe to vaccinate all girls for a disease that afflicts only 9,710 American women yearly and causes 3,700 deaths? The answer might be yes, if the vaccine is risk-free. But the nation’s leading vaccine safety organization raises some serious reservations.

Those reservations were ignored last summer when the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted to recommend that all 11- to 12-year-old girls receive the human papillomavirus (HPV) vaccine called Gardasil. This is a major step toward making the vaccine mandatory—at an age well before girls are likely to become sexually active.

Only one company, Merck, makes the HPV vaccine, which is given in three injections over six months and will cost $360. Merck says its trials proved Gardasil is “100% effective in preventing HPV infection in those who do not already have HPV with strains 16 and 18, which together cause about 70% of all cases of cervical cancer.”

These Merck-sponsored trials were submitted to the FDA, and Gardasil was approved. But Barbara Loe Fisher, an advocate for vaccine-safety studies and the president of the National Vaccine Information Center, questions the need for a cervical cancer vaccine given the availability of the Pap test, which she believes has greatly reduced the incidence of the disease. She also sees methodological flaws and major deficiencies in what has been reported to the public about HPV disease and the vaccine.

“Most people who have sex will have experience with HPV, but the majority will clear it from the body and go on to have healthy lives. Only a tiny percentage will have persistent HPV infection and will experience changes over a long period of time that will lead to cancer. On the list of cancers that kill, this is at the bottom,” she said, referring to U.S. women, as opposed to those in developing countries where cervical cancer deaths are far more common.

As a former member of the FDA Vaccines and Related Biologic Products Advisory Committee, Fisher has considerable experience analyzing the lengthy documents submitted by the vaccine companies to the FDA, as well as the agency’s own review of company-sponsored trials. Fisher’s safety concerns center on the type of placebo Merck used in the Gardasil trials. “A true placebo would be a saline solution—something that is innocuous and has no potential to cause a reaction on its own,” she said, referring to the injection given study participants who were assigned to the control group against which Gardasil was compared.

Instead, Merck used a solution that contained aluminum, Fisher explained, and neither the company nor the FDA has publicly disclosed the amount used in the solution. “Aluminum is used as an adjuvant in many vaccines to boost the potency of the vaccine,” she continued, “and though it has been in vaccines for decades, it has never been tested in clinical trials to see whether it is safe.

“We know from animal and human biological mechanism research that aluminum can cause inflammation and brain cell death. Putting it in the placebo [in a clinical trial] violates the principle of the scientific method when trying to ascertain truth,” said Fisher. “To make matters worse, aluminum is also in the Gardasil vaccine which makes it difficult to tell whether the many adverse events reported in the trials were due to the aluminum-containing placebo or the Gardasil,” she explained, referring to the well-documented fact that adverse events will show up in all clinical trial participants, even those given an inactive placebo.

Why would the FDA overlook this potential for confounding trial results? “The FDA has become partners with the vaccine manufacturers in fast-tracking these vaccines and in the process, the precautionary principle has been thrown out,” Fisher responded, adding that most health problems occurring in vaccine trials are often dismissed. “The companies tend to write them off as unassociated with the vaccine.”

Maryann Napoli, Center for Medical Consumers ©
December 2006

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Getting a Flu Shot? Read This First

Posted by medconsumers on November 1, 2006

Science Does Not Support Flu Shot Recommendations

The benefits of influenza vaccines are exaggerated and little is known about their safety, according to a new report in the British Medical Journal. Drawing from studies conducted over a 30-year period, Tom Jefferson, MD, concludes that the scientific evidence supporting the annual flu vaccine is of poor quality. Yet many governments, particularly those of the U.S. and Canada, have a policy that urges large segments of the population, including babies from 6-23 months, to be vaccinated yearly.

“There is a large gap between policy and evidence,” says Dr. Jefferson who works with the Cochrane Collaboration, an independent, international organization that evaluates clinical trials involving medical interventions, such as vaccines, in order to determine their effectiveness. His new report entitled, “The prevention of seasonal influenza—policy versus evidence,” is based on his assessment of all the evidence that might support claims made for influenza vaccination, including reduction in the number of people who get influenza and the rate of sick days, hospitalizations, and deaths in the elderly.

“At best, the effect of the influenza vaccine is slight,” said Dr. Jefferson in an interview, referring to its benefit to healthy adults and children as well as those with chronic conditions like asthma. He has conducted numerous vaccine-related systematic reviews. Two years ago, for example, Dr. Jefferson co-authored a review of all trials that looked at influenza vaccines given to children under age two and found they were no better than a placebo.

And when he looked for the serious adverse effects of influenza vaccines in the largest company-sponsored trial in this review, Dr. Jefferson found that the data had been withheld and said so in a 2005 letter to the editor of the international medical journal, Lancet. “The [vaccine] company did not take me to court,” he said, citing the most obvious confirmation of his charge.

He explained the motivations of public health officials and others who urge everyone to get vaccinated. “They have mixed influenza and influenza-like illness to make it appear as if each year is an influenza emergency, so they can sell vaccines, get grants for research and new departments, etc.” Both influenza and influenza-like illness have exactly the same symptoms—headache, fever, muscle aches, cough, runny nose—but the vaccines are aimed at only influenza A or B, which researchers call real influenza. “Influenza A or B represents less than 10% of all influenza-like illness,” explained Dr. Jefferson. “The rest are caused by anywhere from 152 to 200 viruses. The common cold, for example, is an influenza-like illness.

“Because there is no way of telling the difference between influenza and influenza-like illness on the spot, vaccine performance can only be realistically judged in formal studies carried out during the [influenza] season and usually published several months or years later. Given all these very complicated permutations, the best way to judge how well inactivated influenza vaccines [the most commonly used vaccines which contain killed viruses] perform is to synthesize all data from known studies into what is called systematic reviews.”

The new report by Dr. Jefferson found that the systematic reviews show a consistent pattern of modest or no effect” of inactivated vaccines. What’s more, the original studies were of poor quality, especially those that have not randomly assigned half of the participants to receive a placebo vaccine.

“Given the huge resources involved in yearly vaccination campaigns, a re-evaluation should be urgently undertaken,” concludes Dr. Jefferson.

Maryann Napoli, Center for Medical Consumers ©
November 2006

For a critique of a new study that supposedly proves influenza vaccines are risk-free for children: www.909shot.com/PressReleases/pr1031flu.com

Related Articles:
Doubts About Safety of Influenza Vaccines in Kids
Influenza Vaccines and Influenza Drugs – Both Losing Effectiveness

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Doubts About Safety of Flu Vaccine in Kids

Posted by medconsumers on October 1, 2005

Last winter, researchers found that influenza vaccines provide no benefit to babies under age two years. In children over the age of two, vaccines showed a modest reduction in cases of influenza. But there is no evidence that vaccines can prevent the serious complications that are the primary justification for vaccinating children. That was the conclusion of a review of all relevant studies published last February in the British journal, Lancet.

The authors of this review, Tom Jefferson, MD, and colleagues at the Cochrane Collaboration, recently wrote a follow-up in a letter to the editor of The Lancet. They reported that the safety of influenza vaccines given to babies and children is unknown. Incredibly, most of the trials they reviewed were not designed to assess serious adverse reactions.

Given the fact that the U.S. and Canada now recommend flu vaccines for all children older than six months, this news is extremely disturbing. The review published last winter focused solely on the question of how well flu vaccines work for children over six months. After the review was published, Dr. Jefferson and colleagues took on the equally important question of vaccine safety.

At issue are two types of vaccines: inactivated and live attenuated (nasal spray). Where it concerned the  inactivated vaccine, the research on safety was pitiful. Only one trial exists; it was small (35 participants) and conducted 30 years ago. All other safety studies of inactivated vaccine were in children three years or older. When the reviewers looked at safety studies of the live attenuated vaccine, Dr. Jefferson explained in an e-mail interview, “We found clear evidence of systematic  suppression (non-reporting) of safety data.” Worse, he said that the authors of the trials did not have access to safety data from their own trials!  “Do U.S. parents know all this?” asked Dr. Jefferson,  “I do not think so.”

One trial in this review stood out from the rest. With 10,000 participants, it included a chart showing a nearly double number of “medical adverse events” among the vaccinated kids, compared with the unvaccinated. When Dr. Jefferson and colleagues noticed that fewer than half of these events had been adequately identified, they wrote to request the missing data, first from the lead author and then from the final authority, the vaccine manufacturer MedImmune. The company’s response: “MedImmune does not provide safety data to outside parties.”

Noting that serious omissions like this are common, Dr. Jefferson and colleagues wrote, “An incomplete or fragmented evidence base could hinder identifications of rare and serious adverse events.”

The U.S. Centers for Disease Control and Prevention, known as the CDC, is the most influential promoter of vaccinations for children (and everyone else). Presently, flu vaccines for babies and children are recommended; they are not mandated, as are other childhood vaccinations. At the CDC Web site, you will find no cautions regarding the missing information about the safety of vaccines for children. Nor will you find any evidence that the agency is aware of the review published last winter by Dr. Jefferson and colleagues. The CDC Web site’s main message: “The single best way to protect against the flu is to get vaccinated each fall.” And babies 6-23 months are listed as one of the priority groups for flu vaccines.

“Their rate of influenza-related hospitalization is similar to that of people 65 and older,” warned Carolyn Buxton Bridges, MD, medical epidemiologist in the CDC’s National Immunization Program. By e-mail, Dr. Bridges was asked for proof that flu vaccines reduce the rate of hospitalization in babies  6-23 months. “I fully acknowledge that the number of randomized studies is very limited and none published to date  have evaluated the benefits of the vaccine in terms of preventing influenza hospitalization. However, ample data exists that the vaccine prevents laboratory confirmed influenza in young children 6-23 months. And, if you prevent the initial infection, you would also prevent the complications that would follow the infection.”

Consumer advocate Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, has a different perspective. “Children these days get so many vaccines that they almost always get them together on the same day. Use of the flu vaccine in combination with other childhood vaccines in babies this young amounts to a national medical experiment on American babies. The science should precede the policy and not the other way around.”

Dr. Bridges was asked whether the CDC will warn parents about the lack of safety data and the fact that some vaccine companies refused to release their data to Dr. Jefferson and colleagues. She partially addressed only the second half of the e-mailed question. “As to why the researchers [sic: vaccine companies] will not share their data with Dr. Jefferson, I cannot comment.”

As for proof of safety Dr. Bridges points to 40 years of vaccine usage and the Vaccine Adverse Event Reporting System, established in 1990, under the joint administration of the CDC and the FDA. (The CDC’s own assesment of VAERS in 2003 found, “multiple limitations” to be associated with this “passive surveillance system [in which] reports of events are voluntarily submitted by those who experience them, their caregivers, or others.” Underreporting and unconfirmed diagnoses are the major problems. )

Dr. Jefferson identified the problem in using the CDC as a credible source of advice, though it is the one used most frequently by the media. “The CDC, which should have a neutral public health role, is in fact a vaccine advocate, with all the good and bad things that that entails.”

Bottom Line

The Lancet review of all relevant trials published last winter by Dr. Jefferson and colleagues found no evidence to support the CDC position. Asked to summarize the findings of this review, which was published as the 2004/05 flu season was just about over, Dr. Jefferson responded,“Our review showed that influenza vaccines below the age of two have the same effects as placebo. Beyond the age of two, they may be effective in preventing cases of influenza, but we found no evidence that they could prevent serious outcomes (death, hospitalization, pneumonia etc).”

The CDC’s Dr. Bridges conceded that there is, as yet, no proof that flu vaccines will reduce the rate of serious complications in young children. Due to incomplete reporting of adverse reactions to influenza vaccines in clinical trials involving children, safety questions remain unanswered.

Maryann Napoli, Center for Medical Consumers ©
October 2005

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Influenza Vaccines, Influenza Drugs – Both Losing Effectiveness

Posted by medconsumers on October 1, 2005

This flu season got off to an unusual start with a well-publicized study that found influenza vaccines are far less effective for the elderly than previously thought. A second study found a worldwide viral resistance to several drugs that are widely prescribed once a person comes down with the flu. Both were published this month in the British journal, The Lancet.

The first study was a systematic review of the evidence for the effectiveness of influenza vaccines in people aged 65 years and older. Studies in this review were conducted in many countries over the course of 37 years. People living in long-term care facilities were more likely to benefit with a 42% reduction in deaths caused by influenza and pneumonia. Whereas elderly people living on their own had a more modest 30% reduction in hospitalizations for pneumonia. The review was conducted by Tom Jefferson, MD, and colleagues at the Cochrane Collaboration, an international organization that evaluates studies to determine the efficacy of medical care.

While the reductions in deaths and hospitalizations described above appear praiseworthy, they are actually more modest than meets the eye—something that will become clear once you learn how flu vaccine studies are conducted. These reductions are also more modest than those quoted by the Centers for Disease Control and Prevention. This federal agency, known as the CDC, is the most influential promoter of flu vaccines.

It is possible that this review by Jefferson and colleagues might initiate a more honest public discussion about the issue. And this, in turn, might lead to improvements in vaccines. Not only is the impact of vaccines oversold to the public but there is also a lot of confusion over the definition of influenza.

Influenza and Influenza-like Illness

Each flu season between 5% and 20% of the population comes down with symptoms of the illness. A vaccine, at best, will only lower the chances of getting influenza. What isn’t explained to the public is this: in any given year, the vaccine has some proven effectiveness only against influenza A or B. This is what researchers call influenza, and it afflicts fewer than 15% of all people who appear to have the flu. All other forms of the flu are called influenza-like illness. Both types cause exactly the same symptoms: headache, fever, muscle aches, cough, and runny nose. Doctors have no way of distinguishing the two types without a blood test or a culture.

Every year, the vaccine formulation changes.  According to the CDC Web site, “three viruses (two subtypes of influenza A viruses and one influenza B virus) are selected to go into the flu vaccines for the following fall and winter. Usually, one or two of the three virus strains in the vaccine are changed each year.” The selection is based on a combination of educated guesswork, flu outbreaks in Asia, and recommendations of the World Health Organization. “This guesswork actually works quite well in healthy adults, [but] not so well in the elderly,” warned Dr. Jefferson, the lead author of the new review in an e-mail interview.

How well a vaccine will protect you against influenza depends on the virus strains selected that year and whether it matches the circulating viruses in your environment. At the section of its Web site for health professionals, the CDC gives a high rate of effectiveness for vaccines. For example, the MMWR (Morbidity and Mortality Weekly Report) 2004, states, “When the vaccine and circulating viruses are antigenically similar [emphasis ours], the influenza vaccine prevents influenza illness among approximately 70%–90% of healthy adults under age 65 years and children one year and older 77%-90%.” Note the carefully worded qualification.

In other words, if influenza A or B viruses are circulating in your part of the world and the vaccine happens to be the right match, then the vaccine might lower your chances of getting influenza by 90%. The vaccine, however, provides no protection if people in your immediate vicinity have influenza-like illness.

Drugs to Treat Influenza A

The second study, published in the same issue of The Lancet, found that influenza A viruses have developed a resistance to drugs that are widely prescribed to people once they have flu-like symptoms. Rick Bright of the CDC and colleagues analyzed 7,000 blood samples of flu viruses collected from people around the world and found a resistance to Symmetrel, Flumadine, and others in a drug class called admantadine. (One of these drugs is given immediately on the presumption that the patient has influenza A because the drug must be taken within the first 48 hours of the onset of symptoms. Until recently, these drugs shortened the duration of influenza A by 30 hours.)

Vaccine Review’s Puzzling Results

The first study—the review by Jefferson and colleagues—had a puzzling finding about the vaccines’ effect on elderly people not living in nursing homes. When the reviewers combined data from 15 studies, they found that inactivated influenza vaccines were ineffective against influenza-like illnesses, influenza, or pneumonia, but prevented up to 30% of hospitalizations for pneumonia. How can vaccines be useless in preventing illness but helpful in preventing hospitalizations for pneumonia? “We are not sure,” answered Dr. Jefferson. “Our  [finding] was based on non-randomized studies, which are well known for producing overestimates of effectiveness. The real effect is likely to be more modest.”

This qualification didn’t make it into the CDC “talking points” memo that went out to the media on the day Dr. Jefferson’s review made headlines across the country. The CDC first acknowledged, “Vaccine effectiveness is not 100%,” but then went on to uncritically assert, “The [review] did demonstrate that influenza vaccine is effective in preventing the complications and death from influenza in older persons, both in the community and in long term care facilities.

But qualifications were present throughout the review by Jefferson and colleagues. Phrases like “with good vaccine match and high viral circulation” preceded findings of vaccine effectiveness. When asked how often the vaccine matches the viruses circulating in any given flu season, Dr. Jefferson said, “Unless there is a known epidemic underway in the surrounding community and someone is doing real time surveillance (i.e., testing of specimen), never. The problem with such studies is that they are logistically very difficult, as we acknowledge in our review.”

As for that honest discussion about vaccines and how well they work, Dr. Jefferson identified a major stumbling block. “Vaccines are a business, like any other. The only difference is that governments are co-sponsors with industry,” he explained. “Overestimation of the threat by the target diseases, suppression of data on possible adverse events, and exaggeration of effectiveness are frequent, as the case of influenza vaccines demonstrates. In the case of population vaccination programs, both government and industry have conflicts of interest. Beware.”

Maryann Napoli, Center for Medical Consumers ©
October 2005

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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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