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Vaccination for H1N1 “swine” flu: Do The Atlantic, Shannon Brownlee, and Jeanne Lenzer matter?

I had meant to address this topic last week, but the whole Suzanne Somers thing bubbled up and overwhelmed my blogging attention. Regular readers of this blog probably realize that I tend to live and die as a blogger by the maxim that if some is good more must be better. So I clobbered the topic with three posts in rapid succession. Now that that’s out of the way, I can address topics that readers have been bugging me about sending to me.

At or near the top of the list has to be a biased and poorly framed article that appeared in The Atlantic this month. I tell ya, I’ve been a subscriber to The Atlantic for at least 25 years, and for the first time ever I’m seriously tempted to let my subscription lapse when it expires early next year. In the 25 years I’ve been a subscriber, I’ve never seen such a credulous, irresponsible piece of “journalism” appear in The Atlantic.

I’m referring to the recent article by Shannon Brownlee and Jeanne Lenzer entitled Does the Vaccine Matter? The article takes doubts about the efficacy of the seasonal flu vaccine, conflates them with an entirely different situation, namely the pandemic of H1N1 (a.k.a. “swine”) flu that we are currently experiencing, mixes them with the cliched trope of the brave maverick doctor and scientist bucking the status quo and being reviled for it, and serves a steaming, stinking mess of confusion that puts the worst possible spin on the evidence. It’s a perfect storm of obfuscation. Indeed, I can picture the pitch for the story to the editors of The Atlantic. “Conventional wisdom” found to be overoptimistic? Check. Brave maverick doctor fighting a lonely battle against scientific and medical dogma? Check. Scientific dogma overturned and a major public health strategy shown to be useless? Check. Well, not exactly. Only seemingly so as framed in the article. My guess, though, is that that last part of the pitch was indeed pitched that way, with the tagline, which I quote directly from the article:

But what if everything we think we know about fighting influenza is wrong? What if flu vaccines do not protect people from dying–particularly the elderly, who account for 90 percent of deaths from seasonal flu? And what if the expensive antiviral drugs that the government has stockpiled over the past few years also have little, if any, power to reduce the number of people who die or are hospitalized? The U.S. government–with the support of leaders in the public-health and medical communities–has put its faith in the power of vaccines and antiviral drugs to limit the spread and lethality of swine flu. Other plans to contain the pandemic seem anemic by comparison. Yet some top flu researchers are deeply skeptical of both flu vaccines and antivirals. Like the engineers who warned for years about the levees of New Orleans, these experts caution that our defenses may be flawed, and quite possibly useless against a truly lethal flu. And that unless we are willing to ask fundamental questions about the science behind flu vaccines and antiviral drugs, we could find ourselves, in a bad epidemic, as helpless as the citizens of New Orleans during Hurricane Katrina.

Journalists do so love that cliché, don’t they? It’s an irresistable hook, cliché or not. People love reading about issues that we thought to be true but–surprise! surprise!–turn out not to be true. It was also sheer genius to compare the issue vaccination for influenza to that of New Orleans before Hurricane Katrina. What a striking visual image of a city being leveled by flooding due to a hurricane because of neglect and the failure to listen to lone voices in the wilderness warning that the levees couldn’t hold against a major storm! I suppose I should be grateful that she didn’t also use images of engineers warning about the O-rings before the Challenger disaster. In any case, just Google the phrase “What if everything we think we know about is wrong?” (I left out the topic in order to pull in pretty much all topics.) As of Sunday afternoon, Google returned 90,700,000 hits on that search. Put the word “vaccine” after the word “about” and do the search, and guess what came up number one in a Google search? Well, at least as of Sunday in my location at the time I did the search, it was Shannon Brownlee’s Atlantic article. I sense serious Google optimizing going on. And, yes, I’m including that phrase in order to see if I can fire up some Google mojo for myself. Whether it works or not, who knows? Probably it won’t. But I think I’ve made my point. Framing an issue as arguing that conventional wisdom is wrong and highlighting a couple of “lone voices in the wilderness” warning, Cassandra-like, of impending disaster represent a time-honored journalistic trope, not to mention a story structure that goes back thousands of years to, well, Cassandra at least. Add a healthy dollop of “skepticism” about big pharma and the government, and you definitely have a winner. I can see why the editors of The Atlantic bit.

Now, it’s time to move on to the meat of the Atlantic article. Before I do, let me just point out that revere addressed many of the factual issues with the article in his analysis, and Mark Crislip did an excellent job reviewing the data for and against the efficacy of flu vaccines, which is largely shades of gray. I encourage you to read those posts, because I’m not going to go into as much detail as they did over that issue. The other thing that I like to point out is that Shannon Brownlee is a senior fellow at the New America Foundation and is best known for her recent book Overtreated: Why Too Much Medicine Is Making Us Sicker And Poorer. Jeanne Lenzer is a freelance journalist who, it would appear, frequently shares bylines with Shannon Brownlee. As revere noted, both appear to have made their names promoting the contention that we are “overtreated” as a society. As Steve Novella once noted, Brownlee rather credulously fell for the alt-med myth that only 15% (or even less than 50%) of current medical treatments are based on valid scientific evidence in an article she published for The Washington Monthly. While it is arguably true that in many areas we are overtreated and it isn’t hard to find examples, vaccination is arguably not one of those areas. Among medical interventions, vaccines arguably have saved more lives and prevented more suffering than every other medical intervention combined. Moreover, choosing the flu vaccine as an example in the middle of a pandemic borders on–hell, is–the height of irresponsibility.

In any case, as Mark Crislip pointed out, vaccines for seasonal flu are suboptimal for a variety of reasons. For one thing, health officials have to make educated guesses every year about which strain(s) of influenza virus will be circulating each year. Sometimes they guess correctly, and in those years the vaccine is very effective. Sometimes, to paraphrase the Knight guarding the Holy Grail in Indiana Jones and the Last Crusade, they choose poorly. In those years, the flu vaccine doesn’t work very well. Also, the elderly, the ones most likely to die of complications after the flu, tend not to develop as robust an immune response to the vaccine. This is not new news, although Brownlee and Lenzer trumpet it like some sort of revelation. Of course, what they fail to emphasize sufficiently is that H1N1 is actually a strain that is more likely to cause serious complications in those who are under 60. Moreover, the strain match for H1N1 is excellent. Consequently, this year for this pandemic, the H1N1 vaccine is likely to be highly effective. Of course, we won’t know this until this flu season is further along, but confusing seasonal flu with pandemic flu is not a productive way of bringing clarity to the issue of whether flu vaccines work, which is, to lay people at least, surprisingly difficult to figure out.

I think the thing that most annoys me about this article is how it uses the cliché of the “Brave Maverick Doctor.” In this case, it’s Tom Jefferson of the Cochrane Collaboration, who, if you believe Brownlee and Lenzer, is the only researcher who knows anything about the flu and the only one who has ever actually examined the literature in detail. Like all Brave Maverick Doctors, he is portrayed as reviled by the medical community:

The most vocal–and undoubtedly most vexing–critic of the gospel of flu vaccine is the Cochrane Collaboration’s Jefferson, who’s also an epidemiologist trained at the famed London School of Tropical Hygiene, and who, in Lisa Jackson’s view, makes other skeptics seem “moderate by comparison.” Among his fellow flu researchers, Jefferson’s outspokenness has made him something of a pariah. At a 2007 meeting on pandemic preparedness at a hotel in Bethesda, Maryland, Jefferson, who’d been invited to speak at the conference, was not greeted by any of the colleagues milling about the lobby. He ate his meals in the hotel restaurant alone, surrounded by scientists chatting amiably at other tables. He shrugs off such treatment. As a medical officer working for the United Nations in 1992, during the siege of Sarajevo, he and other peacekeepers were captured and held for more than a month by militiamen brandishing AK-47s and reeking of alcohol. Professional shunning seems trivial by comparison, he says.

Of course. Not only is he a Brave Maverick Doctor, but he’s a Outcast Brave Maverick Doctor, if you know what I mean. Of course, I’ve gone to meetings where no one greeted me, where I had no one to talk to, and where I had to eat some of my meals alone–even at one where I had had an abstract accepted and was going to speak. Help! I’m being shunned! Well, no, actually. The reason was because these were huge meetings where I didn’t really know any of the attendees. Because I tend to be a bit on the shy side in person, I tend not to introduce myself and insinuate myself into conversations with my colleagues. Of course, it’s quite possible that Dr. Jefferson’s colleagues were shunning him, but one wonders if he may not be a particularly enjoyable dinner companion. Who knows?

But this is a relative quibble compared to what really bugs me about Dr. Jefferson, namely the disconnect between what he says in public to journalists and what he writes in various Cochrane Reviews about influenza for which he is a coauthor. First, a couple of samples straight from Brownlee and Lenzer’s article. Here’s sample 1:

“Tom Jefferson has taken a lot of heat just for saying, ‘Here’s the evidence: it’s not very good,'” says Majumdar. “The reaction has been so dogmatic and even hysterical that you’d think he was advocating stealing babies.” Yet while other flu researchers may not like what Jefferson has to say, they cannot ignore the fact that he knows the flu-vaccine literature better than anyone else on the planet. He leads an international team of researchers who have combed through hundreds of flu-vaccine studies. The vast majority of the studies were deeply flawed, says Jefferson. “Rubbish is not a scientific term, but I think it’s the term that applies.” Only four studies were properly designed to pin down the effectiveness of flu vaccine, he says, and two of those showed that it might be effective in certain groups of patients, such as school-age children with no underlying health issues like asthma. The other two showed equivocal results or no benefit.

Ah, yes, the Brave Maverick Doctor encounters pushback by the “dogmatic” and close-minded medical community that obviously cannot see his brilliance. And here’s sample 2:

In a phone interview, Fauci at first voiced the opinion that a placebo trial in the elderly might be acceptable, but he called back later to retract his comment, saying that such a trial “would be unethical.” Jefferson finds this view almost exactly backward: “What do you do when you have uncertainty? You test,” he says. “We have built huge, population-based policies on the flimsiest of scientific evidence. The most unethical thing to do is to carry on business as usual.”

Wow. “Rubbish” and “the flimsiest of evidence.” Strong stuff. I wonder. Does Dr. Jefferson say the same things in his Cochrane Reviews? Well, no, as revere pointed out. Take a look at the Cochrane Reviews page for flu vaccines. Then take a look at the conclusions he makes in Cochrane Reviews about the flu vaccine. As revere says, they are–shall we say?–considerably weaker than what Dr. Jefferson says in public to journalists, including the extra bonus example I included after stealing revere’s examples:

  • In long-term care facilities, where vaccination is most effective against complications, the aims of the vaccination campaign are fulfilled, at least in part. However, according to reliable evidence the usefulness of vaccines in the community is modest. The apparent high effectiveness of the vaccines in preventing death from all causes may reflect a baseline imbalance in health status and other systematic differences in the two groups of participants. (Rivetti D, Jefferson T, Thomas R, Rudin M, Rivetti A, Di Pietrantonj C, Demicheli V, Vaccines for preventing influenza in the elderly, Cochrane Database Syst Rev. 2006 Jul 19;3:CD004876)
  • We concluded that there is no credible evidence that vaccination of healthy people under the age of 60, who are HCWs [health care workers] caring for the elderly, affects influenza complications in those cared for. However, as vaccinating the elderly in institutions reduces the complications of influenza and vaccinating healthy persons under 60 reduces cases of influenza, those with the responsibility of caring for the elderly in institutions may want to increase vaccine coverage and assess its effects in well-designed studies. (Thomas RE, Jefferson T, Demicheli V, Rivetti D, Influenza vaccination for healthcare workers who work with the elderly, Cochrane Database Syst Rev. 2006 Jul 19;3:CD005187)
  • Influenza vaccines are efficacious in children older than two but little evidence is available for children under two. There was a marked difference between vaccine efficacy and effectiveness. No safety comparisons could be carried out, emphasizing the need for standardisation of methods and presentation of vaccine safety data in future studies. It was surprising to find only one study of inactivated vaccine in children under two years, given current recommendations to vaccinate healthy children from six months old in the USA and Canada. If immunisation in children is to be recommended as a public health policy, large-scale studies assessing important outcomes and directly comparing vaccine types are urgently required. (Jefferson T, Rivetti A, Harnden A, Di Pietrantonj C, Demicheli V. Vaccines for preventing influenza in healthy children. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004879)
  • Inactivated parenteral vaccines were 30% effective (95% CI 17% to 41%) against influenza-like illness, and 80% (95% CI 56% to 91%) efficacious against influenza when the vaccine matched the circulating strain and circulation was high, but decreased to 50% (95% CI 27% to 65%) when it did not. Excluding the studies of the 1968 to 1969 pandemic, effectiveness was 15% (95% CI 9% to 22%) and efficacy was 73% (95% CI 53% to 84%). Vaccination had a modest effect on time off work, but there was insufficient evidence to draw conclusions on hospital admissions or complication rates. Inactivated vaccines caused local tenderness and soreness and erythema. Spray vaccines had more modest performance. Monovalent whole-virion vaccines matching circulating viruses had high efficacy (VE 93%, 95% CI 69% to 98%) and effectiveness (VE 66%, 95% CI 51% to 77%) against the 1968 to 1969 pandemic. Influenza vaccines are effective in reducing cases of influenza, especially when the content predicts accurately circulating types and circulation is high. However, they are less effective in reducing cases of influenza-like illness and have a modest impact on working days lost. There is insufficient evidence to assess their impact on complications. Whole-virion monovalent vaccines may perform best in a pandemic. (Jefferson TO, Rivetti D, Di Pietrantonj C, Rivetti A, Demicheli V., Vaccines for preventing influenza in healthy adults, Cochrane Database Syst Rev. 2004;(3):CD001269.)

Pretty wishy-washy, full of the usual cautious wording that scientists expect and use, wouldn’t you say? I would. I also note that that last quote indicates to me that the flu vaccine is actually pretty darned good, with 80% efficacy when the vaccine matches the circulating strain. The H1N1 vaccine matches the strain quite well; so we should expect that it will be quite efficacious.

In any case, so why does Jefferson go all full mental jacket negative when he’s speaking with journalists? Why does he do what irritates the crap out of me and many other advocates of science-based medicine when it’s done by researchers, be they legitimate scientists or mavens of “alternative medicine” whose statements in press releases and in public are far stronger (and often more inflammatory) than anything one can find in their scientific papers? The answer is obvious. It’s because he can! Dr. Jefferson can’t say stuff like “rubbish” and “the flimsiest of evidence” in scientific papers because peer reviewers will quite properly shoot it down, but he sure can say what he really thinks to reporters. Moreover, Jefferson wouldn’t be the first scientist to fall for the blandishments of fame and a public reputation as bucking the establishment, something the media loves. Being an “iconoclast” or a “maverick” is very seductive. It brings attention and fame. In recent years, Dr. Jefferson has become the go-to vaccine scientist for the “skeptical view” on the flu vaccine whenever a journalist is doing a story, and he appears only too happy to oblige these days with juicy quotes.

He’s also become so attractive as a quote source because journalists tend not to like nuance. With only a limited space to say what they have to say and ubiquitous deadline pressures, explaining nuance is hard. That’s why they tend not like statements like the ones in the Cochrane Reviews co-authored by Dr. Jefferson cited above. They like concrete statements, especially if they are pith, juicy, or controversial, statements like calling the evidence base for flu vaccines “rubbish” and the basis for flu vaccination the “flimsiest of scientific evidence.” There are many reasons to be cautious when discussing the efficacy of flu vaccines and many shortcomings to how scientists make and use flu vaccines. In short, there are many legitimate issues to debate about flu vaccines and our policies for combatting the H1N1 pandemic. Inflammatory statements, such as the ones Jefferson is fond of making, however, shed far more heat than light on the legitimate issues and problems surrounding vaccination against influenza and the murky evidence regarding its efficacy.

I also have to wonder if this celebrity effect was responsible for Dr. Jefferson’s initial acceptance of an invitation to speak at the annual conference of the oldest and largest anti-vaccine organization there is, the National Vaccine Information Center (NVIC), where he was to receive the NVIC Courage in Science Award. (No, I am not saying that Jefferson is anti-vaccine.) True, he did ultimately bow out and refuse to attend after he found out that he would be sharing a stage with Andrew Wakefield, who was slated to receive the NVIC Humanitarian Award. That is to Jefferson’s credit. However, it only partially absolves him. After all, that Jefferson ever accepted the invitation in the first place tells me that he is either clueless about the ramifications of his stance about the flu vaccine and how it is used by anti-vaccine activists as part of their overall war on vaccination programs or he doesn’t mind. That’s not to say that skeptics of current flu vaccination policies shouldn’t speak out, either. What I do argue is that skeptics like Tom Jefferson, who holds a prominent position in the Cochrane Collaboration, has a special responsibility not to make his message too easy for antivaccine advocates to coopt and especially not to lend his name to their message. That is something he has failed at utterly. Yes, Jefferson did ultimately withdraw from the NVIC meeting less than a month before it was scheduled, but he did not, as far as I know, ever make a public statement about why he withdrew, which is why I don’t consider him completely absolved. Maybe he was embarrassed; if so, he should be.

Moreover, I have to wonder if it was more Jefferson’s contempt for Andrew Wakefield that was responsible than anything else and whether he would have minded sharing the stage with the other NVIC award recipients, such as that promoter of quackery and anti-vaccine nonsense Dr. Joe Mercola, who received the NVIC Visionary Award; Peggy O’Meara, founder of that repository of anti-vaccine “mommy instinct,” Mothering Magazine, who received the NVIC Courage in Journalism Award; or Vicky Debold, who sits on the board of NVIC and received the NVIC Parenting Leadership Award. Without Wakefield, it wouldn’t surprise me if the blandishments of Barbara Loe Fisher, stroking Jefferson’s ego with the words “iconoclast”, “maverick,” and “visionary,” would have led him to participate in a pure crank anti-vaccine conference. Jefferson’s agreeing to appear at the NVIC was, from my perspective, still more evidence that Jefferson has drifted too far beyond reasonable skepticism about the boosterism surrounding flu vaccine programs and an “outlier” viewpoint. He’s now flirting dangerously with becoming a crank himself.

This is the hero of Brownlee and Lenzer’s article.

As I said before, I agree that, even more than most Cochrane afficianados, Jefferson does indeed fall prey to the sin of “methodolatry,” which is, as revere puts it, the “profane worship of the randomized clinical trial as the only valid method of investigation.” While it is true that RCTs are the gold standard for many areas of medical investigation, they can’t be done for many areas, either for practical or ethical reasons. I work in just such an area, namely surgery, where it is, with few exceptions, impossible to blind researchers to experimental groups and is often very difficult to randomize to different operations. These are just practical, logistical considerations, too. Does that mean that surgical research is bogus and we can’t know what operations do and do not work? Of course not!

There are also ethical grounds. Brownlee and Lenzer write:

Demonstrating the efficacy (or lack thereof) of vaccine and antivirals during flu season would not be hard to do, given the proper resources. Take a group of people who are at risk of getting the flu, and randomly assign half to get vaccine and the other half a dummy shot. Then count the people in each group who come down with flu, suffer serious illness, or die. (A similarly designed trial would suffice for the antivirals.) It might sound coldhearted, but it is the only way to know for certain whether, and for whom, current remedies actually work.

This statement is the purest rubbish (to paraphrase Tom Jefferson himself). Indeed, such a statement is pure methodolatry. That’s because an RCT is not the “only” way to know if a flu vaccine works. It may be the most rigorous way to determine if a flu vaccine (or any other intervention) works. It may be the methodology that would provide the clearest answer (assuming the RCT is properly done). It may be the methodology that allows researchers to control variables the best. However, it is most definitely not the “only” way to know if an intervention works. There are numerous other strategies, and they are all being used. Moreover, such an RCT would not necessarily be nearly as easy to do as Brownlee naively thinks.

When doing clinical trials, one of the most important principles is clinical equipoise. What that means is that, to the best of the knowledge of the investigators running a trial, there truly must not be known difference between the interventions being tested. In other words, RCTs are only acceptable from an ethical standpoint if we truly do not know whether one treatment is superior to another (in the case of trials of one treatment versus another) or a treatment is better than a placebo (in the case of testing a single treatment). There must be genuine uncertainty, even if the investigators believe strongly in the treatment being tested. After all, that’s why we do the trial, to try to eliminate that uncertaint. If there is good reason to believe that one arm will be receiving inferior care, then an RCT is not considered ethical because it would be randomizing patients to a treatment (or lack of treatment) that is either inferior or potentially harmful. Here’s a hint that neither Jefferson nor Brownlee seems to get: That evidence suggesting superiority of one arm or another does not have to come from RCTs. It can come from observational studies, preclinical studies, and other sources. In the case of the influenza vaccine, there is more than enough convergence of evidence to suggest that leaving a placebo-control group unvaccinated against the flu does not meet the standard of clinical equipoise. As revere points out:

The bottom line is this. There is excellent and credible evidence in the scientific literature that vaccination against influenza reduces infections in people under 60, evidence that even Dr. Jefferson accepts. For those over 60, there are legitimate questions that were raised by others about the extent of the benefit of seasonal flu vaccine, but they were raised before Jefferson got into the act. The argument put forward in this piece is a straw man argument as far as pandemic influenza is concerned (and in which context it was placed).

Given this background evidence, at the very least leaving a control group unvaccinated leaves them more likely to get the flu–a definite potential for harm even if it ends up being true that differences in death rates due to vaccination may be small or nonexistent. Thus, a truly randomized trial would very likely be unethical and violate the Helsinki Declaration. At the very least it would be highly suspect from an ethical perspective.

As a breast cancer surgeon, I found one passage most telling:

The annals of medicine are littered with treatments and tests that became medical doctrine on the slimmest of evidence, and were then declared sacrosanct and beyond scientific investigation. In the 1980s and ’90s, for example, cancer specialists were convinced that high-dose chemotherapy followed by a bone-marrow transplant was the best hope for women with advanced breast cancer, and many refused to enroll their patients in randomized clinical trials that were designed to test transplants against the standard–and far less toxic–therapy. The trials, they said, were unethical, because they knew transplants worked. When the studies were concluded, in 1999 and 2000, it turned out that bone-marrow transplants were killing patients.

Well, yes and no. First off, the evidence was not quite as flimsy as Brownlee and Lenzer paint it, although I can see why it is necessary for her to portray it that way in the context of how she is framing her story. There were a couple of phase II trials showing of a benefit, but they were not large and it was unclear if selection bias was playing a role. Second, comparing the evidence base for bone marrow transplantation (BMT) for breast cancer to the evidence base for the flu vaccine is disingenuous at worst and ignorant at best. There are numerous studies, a confluence of evidence from various sources, that attest that the flu vaccine does, in fact, prevent the flu. The point of contention is for what groups it reduces mortality and by how much. Moreover, having lived through the era of BMT for breast cancer, I get the impression that Brownlee overstates the use of the ethical argument against doing a randomized trial of bone marrow transplant versus standard high dose chemotherapy. Indeed, throughout the 1990s, numerous oncologists argued for and ultimately pushed for just such a study because of a distinct feeling that BMT had become popularized before the evidence base supported it. More than ethical concerns, what stood in the way were more political considerations. No, I’m not saying that some oncologists hadn’t come to believe in BMT passionately enough to make that argument. I’m saying that, more importantly, the public had come to believe that BMT worked and lobbied the government and insurance providers to pay for BMT for breast cancer.

The whole mess is well summarized in this article by Michelle M. Mello and Troyen A. Brennan entitled The Controversy Over High-Dose Chemotherapy With Autologous Bone Marrow Transplant For Breast Cancer. Basically, the controversy over BMT for breast cancer was far more complex than Brownlee and Lenzer portray, with patient advocacy groups demanding insurance coverage for BMT for cancer absent phase III trial evidence and lawsuits against insurers, which were also partially egged on by some researchers and oncologists who should have known better. Indeed, the experience has led at least one patient advocate to adopt a more cautious approach to clinical research. Moreover, flu vaccines are not BMT, which is a risky procedure full of toxicity. A large benefit is required to justify such a risk. In contrast, the risk from a flu vaccine is minimal; hence the benefit does not have to be as great to justify it from an ethical standpoint.

Come to think of it, it’s about as simplistic as the way Brownlee and Lenzer portray the state of evidence for flu vaccination and the use of anti-viral drugs. But, then, a Brave Maverick Doctor story using a heroic martyr as the protagonist does not leave room for nuance, which would put a damper on the drama. Better to have a dogmatic establishment persecuting the heroic visionary whose genius they can’t comprehend and don’t accept. It’s much more interesting. Sadly, there was a germ of a decent story buried within Brownlee and Lenzer’s article. There are real problems with the use of the flu vaccine and its shortcomings, but it is the best vaccine we have at the moment, and other public health interventions that could help have been de-emphasized in favor of vaccination. Unfortunately, Brownlee and Lenzer saw the issue through the simplistic lens of the hoary old story of the prophet of doom whose message is rejected due to dogma.

Does the vaccine matter? Brownlee and Lenzer ask. More like: Does The Atlantic matter any more, to me at least? Unfortunately, Brownlee, Lenzer, and The Atlantic do matter, but in this case they matter in a negative way. Maybe I will just let my subscription lapse without renewal. Clearly, its editorial standards have fallen, and I hate to be reading a magazine whose latest article is being passed around anti-vaccine circles as “vindication” that the flu vaccine doesn’t work. If Brownlee and Lenzer happen to read this, given that they’ve shown up on revere’s blog, I would ask them to consider this: Their article is being touted by one of the most notorious anti-vaccine crank blogs there is, Age of Autism, and at repositories of pure quackery and anti-vaccine insanity that exists on the Internet, namely Mike Adams’ NaturalNews.com, in an article entitled Flu vaccines revealed as the greatest quackery ever pushed in the history of medicine. Yes, I realize that cranks will be cranks, and that cranks can misuse even reasonable denialist objections to science, but Brownlee and Lenzer made it just so incredibly easy for the anti-vaccine movement to hold up their article as “proof” that flu vaccines don’t work.

If I were a journalist, that’s not something I’d be proud of.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

143 replies on “Vaccination for H1N1 “swine” flu: Do The Atlantic, Shannon Brownlee, and Jeanne Lenzer matter?”

Not to nitpick, but the specific search term (“what if everything we know about” “is wrong”) in Google gets under 100 hits for me. It’s a cliche, but evidently like the cold it mutates subtly to evade detection. A more general search, but one hopefully specific enough to avoid false positives (“What if” “know” “is wrong”), gets on the order of ten million.

Whenever someone prefaces a comment with “not to nitpick,” I can be 99.99999999% sure that what that person is about to do next is to nitpick. 🙂

In any case, I would appreciate it if commenters on this thread would avoid the temptation to let the above comment derail the discussion off topic right from comment #1.

@Alex Whiteside — If you type in the phrase “What if everything we think we know about is wrong” without any quotes, you will obtain Orac’s result.

Orac, great post. You noted, quite correctly, that

Moreover, choosing the flu vaccine as an example in the middle of a pandemic borders on–hell is–the height of irresponsibility.

The problem is, the middle of a pandemic is when interest is high. It’s just another case of Big Publishing working for its own interests against the interests of its noble readers.

In the 25 years I’ve been a subscriber, I’ve never seen such a credulous, irresponsible piece of “journalism” appear in The Atlantic.

Well, there was that Betsy Mcaughey piece in the 90s that killed Clinton’s health care reform legislation….

Ahistorical,

I’m pretty sure that was in the New Republic. You’re probably confused because Andrew Sullivan was the editor of TNR who let it get in despite its falsehoods.

Thanks for the commentary on the Brownlee and Lenzer article. Though I’m not in the medical field, certain hyperbolic statements in the article obvious even to a layperson (e.g., that Dr. Jefferson knows the flu vaccine literature better than anyone else on the planet – really, who would be the judge of such a thing?) made me want to read the types of informed critiques you and Revere have now done.

Your comments regarding marrow transplant as a breast cancer treatment reminded me of a time not so long ago when patients and their advocates (including physicians) in favor of marrow transplants were characterized as the brave mavericks fighting against the insurers, and calls for more evidence were viewed in popular media as mere delaying tactics.

This illustrates very well one of the difficulties with the brave maverick trope, which is that many mavericks turn out to be wrong. As Carl Sagan is reputed to have said:

They laughed at Columbus, they laughed at Fulton, they laughed at the Wright Brothers. But they also laughed at Bozo the Clown.

That being said, I don’t view Dr. Jefferson’s passion as necessarily a bad thing, understanding he feels there’s a case that urgently needs to be made. (This is aside from whether his view regarding administration of seasonal flu vaccine to the aged turns out to be correct, for some arbitrary value of “correct.”) We all have issues we’re passionate about. If doctors or scientists always spoke in the qualified language of academia, the public would have a hard time understanding what it wasn’t too bored to listen to. Whether the generalization of his statements by the media occurred with his encouragement (tacit or otherwise), over his objections, or due to naivete is something on which I have no information and can’t comment.

I do view as necessarily bad Brownlee and Lenzer’s failure, given the timing of their article, to include the journalistic equivalent of flashing warning signs cautioning that what they and the subjects of their article were saying applies far less if at all to swine flu vaccine for younger people. Their comment in response to Revere’s post, where they are already taking care to try to disclaim any responsibility for flu deaths in the unvaccinated (and where, sadly, they resort to relatively insulting and content-free terms such as “faith-based science”), does not address this point, in spite of being quite thorough in other respects. Perhaps they’ll comment about this specific point either at Revere’s blog or here.

Re The Atlantic, I’m also a long time subscriber. In spite of the occasional article or part of an article that departs from the usual high standard (e.g., William Langewiesche’s relation in an otherwise fine article of a likely untrue tale regarding NYC firemen stealing blue jeans in the aftermath of 9/11), there are regrettably few other places to find good long form journalism these days – Harper’s, The New Yorker – so on balance I’d counsel continuing your subscription. (Feel free to ignore my sage advice, of course. 😉

Orac – don’t forget to add to the “Brave Maverick Doctor” label the “unappreciated genius” moniker, too.

(Jud points out the hyperbole – maybe the reason other scientists don’t like Jefferson is because he goes around having articles proclaming him to “know the literature better than anyone” – I have to admit, if I were a scientist working in the field, that might make me a little bitter, as well)

“I sense serious Google optimizing going on.”

This isn’t optimizing — the article is being driven to the top of the relevant Google search rankings by people like, oh, YOU!

You’ve linked to the article at least twice and that, coupled with all of the other folk linking to the article and readers clicking the links to see what all the fuss is about — that is driving up its popularity rating which is driving up its listing position.

If you don’t want to aid and abet traffic to the article you mention (or any other content you disapprove of), don’t link to it. Most of your readers are smart enough to find it on their own.

“I’ve been a subscriber to The Atlantic for at least 25 years, and for the first time ever I’m seriously tempted to let my subscription lapse when it expires early next year. In the 25 years I’ve been a subscriber, I’ve never seen such a credulous, irresponsible piece of “journalism” appear in The Atlantic.”

Dr. Orac,

If you are going to do the above, make sure to tell them why you are doing it. Otherwise, they’ll never know and just assume you lost your job or are cutting back in a rough economic time.

Speaking of “methodolatry,” I’ve been browing through journal articles about common herbal supplements like echinacea and ginseng for colds. The studies seem to have very mixed results, but I don’t have the clinical background to properly interpret them. Does anyone know anything about research into that area? I have family members constantly pressuring me into taking that Cold-fX stuff and am pretty skeptical about it.

Sometimes I’m asked, “Gimme an example,” when I express some frustration with the way journalists represent science to the public. So on that count this Brownlee Atlantic article is both timely and useful.

New website idea for ScienceBlogs: LOLhacks.

The premise: Readers submit science-in-the news titbits that seem ripe for translation into LOLcat. Others then translate, edit, or polish these submissions to humorous effect.

Cats, as everyone knows, are rather emotional and prone to drama. Plus they like to text on the webs –pretty amazing considering their difficulties with standard English and typing.

Ideal submissions to LOLhack should exemplify:

1) the “drama turned up to eleven”
2) formulaic or hackneyed (dur!) style
3) empty or overly vague verbiage and/or
4) reduntant repetitions suggesting authorship post-TBI.

@Ariel

Surprisingly, the agency established with the intention of validating herbal and other alternative treatments, NCCAM, reports on an NIH study looking at echinacea and finding no positive effects on the common cold. So, there’s one source for you. Go to the NCCAM web site and visit their index. There are entries for echinacea and a glance, echinacea and adult colds and echinacea and child colds.

Ariel, I’d recommend Dr. Mark Crislip’s podcast Quackcast at quackcast.com. #2 & #18 are all about echinacea, #13 is about many herbs, and #28 is about Vitamin C and the Common Cold.

Thanks everyone, that looks really helpful. Sorry for derailing the conversation a bit.

@ Scientizzle, have you heard of the podcast Skeptoid with Brian Dunning? It sounds similar to your Quackcast, he basically debunks popular culture myths and emphasizes critical thinking.

@lee

The effect of linking to a discredited article or site can be mitigated by using rel=nofollow (I may not be doing that exactly right) in the link code. Looking at the source code for this site, it does not appear that Orac has done that, but I might not be looking properly.

Regardless, it’s a valuable tool for bloggers and news organizations to use when they want to be informative by providing a link but they don’t want the existence of that link to be used by search engines as lending credence to that linked page.

Maybe, just maybe if the pharmaceutical companies weren’t such big business and didn’t have lobby groups running the Government of this Country, people might actually take the “newest” epidemic more seriously. Maybe if the media wouldn’t sensationalize everything like they did with SARS or the AVION flu, people wouldn’t have the “sky is falling” or the “cry wolf” attitude that persists in this Country. I have worked more pharmaceutical conferences where companies like Pfizer and Merck pay for trips, hand out golf clubs and give big rewards to salesmen and doctors alike for pushing their products on patients than I care to admit. There are lawsuits for days against these companies for pushing through drugs that weren’t thoroughly tested. If you are going to say that this is an epidemic, then give give the shots for free. Isn’t that how a Government is supposed to take care of it’s people ? The normal old flu kills over 30,000 people a year in this country and nobody says boo. Have the pharmaceutical companies lost so much money in this bad economy or have had so many lawsuits held against them that this is a new way for them to make money by making the public spend money on yet another fully untested drug ? Sorry, but I will wash my hands, get sleep, eat less sugar and take care of myself before I let this “the sky is falling ” thinking run my life.

Original Shannon Brownlee:

The most vocal–and undoubtedly most vexing–critic of the gospel of flu vaccine is the Cochrane Collaboration’s Jefferson, who’s also an epidemiologist trained at the famed London School of Tropical Hygiene, and who, in Lisa Jackson’s view, makes other skeptics seem “moderate by comparison.” Among his fellow flu researchers, Jefferson’s outspokenness has made him something of a pariah. At a 2007 meeting on pandemic preparedness at a hotel in Bethesda, Maryland, Jefferson, who’d been invited to speak at the conference, was not greeted by any of the colleagues milling about the lobby. He ate his meals in the hotel restaurant alone, surrounded by scientists chatting amiably at other tables. He shrugs off such treatment. As a medical officer working for the United Nations in 1992, during the siege of Sarajevo, he and other peacekeepers were captured and held for more than a month by militiamen brandishing AK-47s and reeking of alcohol. Professional shunning seems trivial by comparison, he says.

LOLhack Shannnon Brownlee:

O hai! I herd u liek needles… WAAAAIT!!!! COME BACK!!! J/K!!!

ok, now I tellz u bout Dr. Tom, a kitteh u liek (but mebbe not moar den cheezburgers, LOL!). Anywai, Dr. Tom wuz on Itteh Bitteh Doctor Kitteh Committeh. But he haz wai moar smart den eben de smartest kittehs. Dis maded udder kittehs jeelus an meens. Der wuz big meetin uf Doctor Committeh an all de kittehs wuz nice an shared noms. But dey chased Dr. Smart Kitteh away. He no can haz noms or rubz or buttsnifs or nethin gud. He by himsef an cries. But smart doctor is smart an only cries wen udder kittehs not lookin his direkshun.

Goggies wuz runnin in de yard makin loud WOOFS an Dr. Tom an udder kittehs wuz leik, “OMG WTF??” Dey hided in de bushes leik eleventy days. When? oh I dunno, long time ago… Wai I brings dis up nao? oh I dunno… Oh wait! I do noes: Goggies wuz scarie wif big drippy teefs an dey wuz huntin fer noms. But dey no finded smart Dr. Tom. So at meeting wen udder kittehs wuz meens to Dr. Tom he finks, “If big goggies no can nomz me, meen kittehs no can noms nether. Hah! A winner iz me!”

Sorry, but I will wash my hands, get sleep, eat less sugar and take care of myself before I let this “the sky is falling ” thinking run my life.

Do you actually think eating less sugar is going to magically protect you from pathogens?

This is like blaming BigPaint for making people paint their houses too many times.

I love America: We drive our 10 MPG V8s 100 miles round trip to work and back every day and have second homes on the lake. But it’s utter INSANITY when GSK wants $10 for a flu shot because that’s not “how a Government is supposed to take care of it’s people”.

Maybe, just maybe if the pharmaceutical companies weren’t such big business and didn’t have lobby groups (You know, just like ANY OTHER business) running the Government of this Country(and competing with every other big business and public interest group). Maybe if the media wouldn’t sensationalize everything like they did with SARS (Oh it only killed a bunch of people. No biggie) or the AVION (I assume you mean Avian, which kills about 50% of people it infects. Again, no biggie) flu, people wouldn’t have the “sky is falling” or the “cry wolf” attitude that persists in this Country (In Canada, about 50% of people aren’t interested in getting a flu shot. Some sky. Some falling.). I have worked more pharmaceutical conferences where companies like Pfizer and Merck pay for trips, hand out golf clubs and give big rewards to salesmen and doctors alike for pushing their products on patients than I care to admit.(Where are these conferences? I am a doctor who has gone to a shitload of conferences, and the best swag I have scored in 35 years is an umbrella. I haven’t got so much as a bus ticket to Saskatoon or a putter, and cash? Bring it on – wherever it is.) There are lawsuits for days against these companies for pushing through drugs that weren’t thoroughly tested (Actually they were tested. The problem arose when the companies tried to hide reports of adverse effects). If you are going to say that this is an epidemic, then give give the shots for free. Isn’t that how a Government is supposed to take care of it’s people ? The normal old flu kills over 30,000 people a year in this country and nobody says boo (Yes they do, they bring out a seasonal flu vaccine every year). Have the pharmaceutical companies lost so much money in this bad economy or have had so many lawsuits held against them that this is a new way for them to make money by making the public spend money on yet another fully untested drug (you really don’t have a clue, do you?) ? Sorry, but I will wash my hands, get sleep, eat less sugar and take care of myself before I let this “the sky is falling ” thinking run my life.

Well, since I assume that you are a healthy young male, you will probably be all right. If you’re a healthy older male like me, you’ll be in even better shape. I wash my hands, get a good sleep and look after myself. But I will still get an H1N1 shot after the high-risk population is taken care of.

I’ve been posting about this, thanks for responding.

I discounted most of the evidence in the article, remembering Mark Crislip’s earlier blog post about the vaccine, roughly “it’s not the best, but it’s the best we’ve got.”

But in the real world, according to them, we saw no drops in deaths in years in which vaccine manufacture didn’t work (wrong stains guessed, or manufacturing problems). That seems pretty strong evidence, although they gave no citations or numbers.

I would really like to see that part addressed. 95% of the article may have been poo, but I’d like to see a science-based response to that specific mention, not ad hominems about how much they suck.

Joseph C. asks:

“Do you actually think eating less sugar is going to magically protect you from pathogens?”

You got it in one! The key to understanding “alternative” therapies (and “alternative ways of knowing” about biology and medicine) is magical thinking. It doesn’t have to make sense if it is “magical”. You just have to “believe” (say it after me: “I do believe in fairies! I do believe in fairies!…”).

Magical thinking also applies to “conspiracy theories” (like “Big Pharma runs the government”) because how else can you explain away the contradictory “facts” of a massive, wide-reaching and ruthless conspiracy and the plethora of living, breathing (and often ‘blogging) “whistle-blowers”?

“I love America: We drive our 10 MPG V8s 100 miles round trip to work and back every day and have second homes on the lake.”

Maybe I’m not actually in America, since my car gets better gas mileage, I drive (when I don’t ride my bicycle) only 6 miles to work and I don’t have a second home anywhere. However, I think I get Joseph’s point – a $10 (or $20) flu vaccination seems expensive until you look at the alternatives.

A colleague just stopped by the lab after being out seven days with the H1N1 influenza. She’s a week behind and still looks dreadful, but she’s doing better than the three adults and six children in the University’s hospital on extra-corporeal membrane oxygenators (“artificial lung”) because of the same virus.

So, for “less than three lattes”, you can be protected against a virus that can knock you into bed for a week or more – if it doesn’t put you in the ICU or in the grave.

Seems like a bargain to me.

Prometheus

Michael says: “The normal old flu kills over 30,000 people a year in this country and nobody says boo.”

Actually there’s considerable attention given every year to risks of the flu in especially susceptible populations and the need to vaccinate people in those groups. Antivaxers and other alties have been railing against this for years. Didn’t you get the memo?

“Have the pharmaceutical companies lost so much money in this bad economy or have had so many lawsuits held against them that this is a new way for them to make money by making the public spend money on yet another fully untested drug?”

The technology involved in making flu vaccine including the H1N1 vaccine is well established and there is nothing “untested” about it. The H1N1 vaccine has been tested in a number of patient groups. One point is well taken though – we probably wouldn’t have a vaccine shortfall right now if there weren’t so many drug companies who got out of the vaccine business because of scaremongering and the claims of antivaxers who call vaccines “untested drugs”. There’s an article in the N.Y. Times today discussing the vaccine shortage, and it mentions that one of our suppliers is an Australian vaccine manufacturer that decided to fill that country’s needs first.
When we become dependent on foreign vaccine makers and limited numbers of suppliers, we become vulnerable to unanticipated manufacturing difficulties and political pressures. Remember the shortfall in seasonal flu vaccine a couple years back, because an English firm ran into production problems? We have antivaxers to thank for much of our limitations when it comes to supply.

“Sorry, but I will wash my hands, get sleep, eat less sugar and take care of myself before I let this “the sky is falling” thinking run my life.”

Getting immunized is “running your life”? It usually takes me about 10 minutes.

“I have worked more pharmaceutical conferences where companies like Pfizer and Merck pay for trips, hand out golf clubs and give big rewards to salesmen and doctors alike for pushing their products on patients than I care to admit.”

Wow, where are they handing out golf clubs to physicians? How come I’m always overlooked when the Big Sinister Forces That Run The World are handing out the freebies? Here I am, entitled to more conspiracy-generated goodies than you could shake a stick at*, and I’m lucky to pick up a cheap ballpoint pen at a tumor conference.

*if that’s your idea of fun.

Maybe I’m not actually in America, since my car gets better gas mileage, I drive (when I don’t ride my bicycle) only 6 miles to work and I don’t have a second home anywhere. However, I think I get Joseph’s point – a $10 (or $20) flu vaccination seems expensive until you look at the alternatives.

Maybe it’s just the state I live in. SUVs, trucks, vans, and the like all seem to still be the norm. Big cars that totally blind me when I’m pulling out of a parking space. It all seems quite excessive when compared to what I’ve seen on the roads in Europe. Then again having to pay European gas prices pretty much rules out V8s for the great majority of people.

And, yeah, my point was that it’s a fairly affluent country and for the majority of us $10 is a great price to potentially avoid being sick for a week. Maybe “Big Pharma” is raping the consumer. Who knows? But the flu shot sure isn’t a good example of gouging.

“Moreover, flu vaccines are not BMT, which is a risky procedure full of toxicity.”

So wait, which one’s which again?

I was actually surprised no credulous individuals started whining at that one. I mean, that’s their whole schtick after all. 😛

@ Michael,

Just to point out, I’m Canadian and ou government DOES pay for the H1N1 vaccination, and is trying just as hard to get it’s population to take it. It doesn’t always have to be a conspiracey, maybe your government really does want to keep it’s people from getting sick. It’s costing my government alot of money to vaccinate everyone, but it’s still more cost effective than a pandemic putting thousands out of work and into hospital beds.

If you are going to say that this is an epidemic, then give give the shots for free.

Michael, the vaccine is being provided free to healthcare providers. They are permitted to charge a “reasonable administration fee.”

If your idea of a reasonable fee does not agree with your provider (for example, our local Doc-in-the-Box has determined that $79 is entirely reasonable), your local health department is vaccinating for free. If you aren’t in a priority group you may have to wait for it, but it won’t cost you anything but your time.

Orac, I am very curious to hear your take on the Desiree Jennings case that is all over youtube. She allegedly got a flu shot and ten days later developed dystonia. Several things seem fishy about the story. First, she claims to have gotten the flu from the flu shot prior to the dystonia. Secondly, she can walk backwards & speak without difficulty while running forward. Any other time she’s a complete mess. Is this just psychogenic or legit dystonia? Is there any way it could be caused by a flu shot?

Our county (very small upstate NY) is providing FREE vaccine to people ages 3-24. Hmmm, guess Big Pharma isn’t doing its job.

Our county (very small upstate NY) is providing FREE vaccine to people ages 3-24. Hmmm, guess Big Pharma isn’t doing its job.
———————–
There is no such thing as free. Your county is just paying for the vaccine with someone else’s money

So, Sid Troll, are all the roads in your county toll roads and do you pay dues to your local fire and police departments? Do your local restaurants have to pay each time the public health department comes by to check for sanitary food prep areas?

What of “public health” did you think was not “public”?

“But what if everything we think we know about fighting influenza is wrong? What if flu vaccines do not protect people from dying–particularly the elderly, who account for 90 percent of deaths from seasonal flu? And what if the expensive antiviral drugs that the government has stockpiled over the past few years also have little, if any, power to reduce the number of people who die or are hospitalized?”

And what if the penguins are going to reveal their technological superiority and exterminate all humans next Saturday, unless we turn our resources from vaccination to shoemaking?

I would like to know where Michael gets his “50% of Canadians aren’t interested in getting the flu shot” from. Especially since the H1N1 wasn’t available prior to yesterday (Monday Oct 26). In Calgary they only had 4 clinics for the H1N1, people were lining up for hours and there is a lot of outrage about the poor planning. Although I qualify as at risk (Asthma), I am going to wait until I can get it from my Dr. in mid November – I figure it is less risky to wait than to stand in line with a bunch of unvaccinated people. I got the regular flu shot last week.

Demonstrating the efficacy (or lack thereof) of vaccine and antivirals during flu season would not be hard to do, given the proper resources. Take a group of people who are at risk of getting the flu, and randomly assign half to get vaccine and the other half a dummy shot. Then count the people in each group who come down with flu, suffer serious illness, or die. (A similarly designed trial would suffice for the antivirals.) It might sound coldhearted, but it is the only way to know for certain whether, and for whom, current remedies actually work.

Well, that made my jaw hit the floor. Especially since anyone pulling that kind of trial would be excoriated in the press (rightly so) for putting people at unnecessary risk of death.

I never get the seasonal flu (I haven’t had flu since I was seven, and I am now almost 40), so I wait to get the vaccine until (and if) everyone at greater risk gets theirs first. But that’s risk assessment; the above is ID10T error level journalism.

What really hurts is that anti-vaxxers will use it as fodder for their (un)LOLconspiracy pages, and people will die. I’ve already lost an acquaintance to H1N1, I’d rather not lose more because of irresponsible scare-mongering disguised as a “good hook for a story”.

@Sid
Yes, there is such a thing like free. Just because *others* pay *indirectly* for vaccination via taxes doesn’t mean it isn’t free to the poor, for instance. Stupid argument is stupid.

>>There are lawsuits for days against these companies for pushing through drugs that weren’t thoroughly tested < < (Actually they were tested. The problem arose when the companies tried to hide reports of adverse effects). >>The H1N1 vaccine has been tested in a number of patient groups.< And this time, in a grand experiment, they are exempt from all liability. Are you implying that this tiny little problem has disappeared? I've asked once, however impolitely. I'm solidly pro-vaccination, but like hundreds of thousands of people across the world, I want answers- not this easy cheap dialectic that so many are able to see through. Please demonstrate how the safety profiles of AS03 and MF59 adjuvanted vs unadjuvanted vaccines in children and young people were determined. I've been haunting blogs trying to find answers about the use of the vaccine for my daughter in a risk category. Loads of people out there don't fit into your blatantly simplistic little categories of pro or anti-vax. Either one of the shining brilliant people or stupid idiots and trolls. You patronize a huge number of people and don't serve the profession you claim to uphold by ignoring real questions from people who have never before considered not vaccinating their children, but who are worried about the latest batch of adjuvanted vaccines in the pipeline and you jeopardize untold people by ignoring their questions. US vs THEM, how complex and nuanced an argument! Show us carefully the long term safety data and the track record of squalene-based adjuvants vs unadjuvanted vaccines in children and adults. Since you concede there is a track record of hiding adverse effects, obscuring safety data isn't a giant leap either. Instead of teaching people to be skeptical, you are converting them to the so-called "lunacy" by obscuring the fact that there is very little data and very unclear risk/benefit of having the vaccine vs. getting the flu. Knowing what I know about the industry, I fear for this womans life- she is an unpaid pediatrician who has spent the last few years helping to create systems for families flu preparedness and is solidly pro-vaccination, however she has grave reservations about adjuvanted vaccines in children. I don't expect this to be printed, since I am "on moderation" for suspicion of being an anti-vax troll, which is actually laughable, but is the tired knee-jerk response to anyone with questions. If you genuinely give one iota about vaccine safety , please explain the following... the links are http://www.newfluwiki2.com/showComment.do?commentId=144521 >> Attempts by the UK government to downplay AEs for the HPV vaccine by simply telling NHS staff to NOT report certain symptoms (more here). The misleading/fraudulent presentation of data in the FDA Gardasil file, to hide an 44.6% increased risk of getting CIN (carcinoma in situ) AFTER vaccination, for the group that was already seropositive and PCR positive (see here). I can go on.
So, I didn’t think I could still get so angry. Last night I started to look through the H1N1 vaccines ‘approved’ by the EMEA. I went through the file for the GSK vaccine. Tonight I started to read the one for the Novartis vaccine. These files are important because these products are proprietary, therefore NO ONE has any safety (or any) data on them except what the companies put out. And, supposedly, these are the kinds of information the EMEA depended on, to license these products to be given to MILLIONS AND MILLIONS of people, pregnant women and their unborn offsprings included.

The EMEA approved the Novartis vaccine based on 4 clinical trials on a grand total of 1018 subjects, of whom – drum rolls please – only 59 were given the nonadjuvanted flu vaccine as control. (see CHMP assessment report for Focetria) All other trials compared MF59 adjuvanted H5N1 vaccine vs MF59 adjuvanted seasonal flu vaccine (or different doses of HA in the H5N1 adjuvanted vaccine). And that included 471 kids. Like, Hello? How on earth are you supposed to evaluate the safety of an ADJUVANTED vaccine, when the ADJUVANT is given to both groups? Do we care to compare the safety difference between H5N1 and seasonal flu? Heck, No!! But obviously, the EMEA scientific committee thinks it’s perfectly proper and acceptable. Hence the vaccine is approved. << I have been instructed that my questions will be answered if I ask politely of the nice people here, whose time is limited in their pursuit of the higher mind and the public good, to protect us all from lunacy. Please answer. How is this considered to be safety data? And where is the long term data on the safety and AE's of children and young adults for these adjuvanted vaccines to justify their use, even in a pandemic.

I don’t expect this to be printed, since I am “on moderation” for suspicion of being an anti-vax troll, which is actually laughable, but is the tired knee-jerk response to anyone with questions.

Not true at all. Various things will automatically put your post into moderation, but you’re not being censored here. I think only about three people or so have actually been banned from commenting here and you’re nowhere that level.

And you most certainly are an anti-vax troll. The best evidence of this is your repeated insistence that you’re not. If you take people’s word for it, nobody is anti-vaccine. Jenny McCarthy, by her own claims, is pro-vax.

@doctrinalfairness

Haven’t read all the comments, here, but in reading your last comment at #40, I feel you would probably be more likely to get answers regarding AS03 and MF59 if you asked on a European-based blog, since neither of those are approved for market in the U.S. and so, are not used here.

As to comparing adjuvanted flu vaccine vs. non-adjuvanted flu vaccine, you could get a reasonable idea if you compare the U.S. vaccine against the European vaccine. The relevant government agencies (CDC and/or FDA in the U.S. and EMEA in Europe) might be able to provide appropriate data to you. While it may take a few days to get a response to an e-mail, my experience has been that they can be quite helpful.

And this time, in a grand experiment, they are exempt from all liability.
Are you implying that this tiny little problem has disappeared?

Can you point to the relevant law that specifically exempts companies from being sued? As I understand it, if a person is not satisfied with the ruling of the vaccine court, they can still go after the company when their case is done. Information on this can be found here: http://tinyurl.com/ylmkglv

Please demonstrate how the safety profiles of AS03 and MF59 adjuvanted vs unadjuvanted vaccines in children and young people were determined.

You do realize, of course, that none of the H1N1 vaccine used in the United States contains adjuvants.

It has been explained to doctrinalfairness over and over and over again why her concerns are baseless. The adjuvant in question has been used in Europe for over ten years, and she has yet to come up with the data to show that autoimmune disease increased in children in Europe, and especially more than the USA which does not use the adjuvant.

See her concern trolling and ignoring patient answers: here.

One other thing on squalene. As I understand it, it has been in use for at least 10 years in Europe. My guess is that there have not been sufficiently bad adverse events to warrant its discontinuation as an adjuvant.

My husband nearly died of bacterial meningitis, I know exactly what pathogens can do if they go unchecked in the body and the categorization of me as anti-vax is too easy for you. Every member of my family is completely up-to-date on every one of their vaccinations, three of us elected to have series of vaccinations for travel which weren’t even required. I have never before, along with countless others, considered not having a vaccination for a serious communicable disease. From my lurking on blogs, there are many thousands of people like me. I understand that these adjuvants are not in the US vaccine, but there are numerous vaccines in the pipeline awaiting the FDA’s permission to include them in future vaccines, including H1N1 vaccine if supplies run short.
I don’t anticipate any time in the future that autoimmune disease will be listed as an adverse effect, it’s a strawman argument as it can take months or years to develop. If you want people to trust experts, insure that they aren’t routinely misled or lied to about safety of something there is very real data on- the population studies have been largely in adults.

One more thing, it bears repeating that an overwhelming majority of people like me have never even heard the name Jenny McCarthy until they show up on blogs like this. Having learned of the concept of “tittytainment” by an astutely political friend, I avoid TV and the calculated distraction from what is actually happening in the world by parading the endless goings on of inane celebrities. This is a science blog, I came here for instruction and learn instead about aging starlets and their questionable beliefs. You create an entirely new kind of skeptic when the bulk of your time is spent giving more attention to people who are best ignored. Unless of course, the pandemic IS political and you are doing your bit in the distraction of what increasing numbers of average people fear- a depopulation agenda aimed at removing the “useless idiot eaters” that are often implied by the commentary here. Your openly unapologetic Darwinian tone, used to describe all of the “stupid followers” of people unimportant to a large majority of us, bringing them far more attention than they deserve, casts more suspicion on the entire enterprise of “skepticism”. I haven’t ever read one word by Jenny Mc Carthy before, but I certainly intend to now- you and she are very strange bedfellows indeed.

I’ll admit that I haven’t been paying too close attention to doctrinalfairness since the “I’m not anti-vax, I just have concerns” attitude became apparent, but even when I was, there was something that confused me. It has to do with the “there isn’t any data to know” claims about the safety. I am merely a chemist, so drug safety is not my specialty, but when I hear things like, “We don’t know if it’s safe” the thing that goes off in my head is, “What would such knowledge look like?”

What do we mean by “evidence that it is safe?” Now, from a clinical standpoint, it seems to me that this would boil down to a combination of

1) There is no evidence it is significantly harmful, and
2) With enough of a dataset to indicate the limit is lower than some threshold we establish.

In a non-clinical setting, I suppose you could also look to ensure that it doesn’t cause any physiological effects that you know are harmful, but in that respect, to know that they aren’t harmful you have to go through the steps I list above. So it seems to me that, as a short answer, “evidence of safety” comes down to “absence of evidence of harm.” I’d gladly hear an alternative view.

But given that, I am somewhat puzzled by the language that is used. Why “there is no evidence it is safe” as opposed to, “there is evidence of too much harm”? As far as I can tell, the only way you can claim something is not safe is to satisfy one of the criteria above. Either there has to be significant harm that has been found to occur, or the limit of how harmful it can be is too high. But if that’s the case, why not say it? Why not say, “The level of harm that it causes is too high?” or “The limits on the harm it could cause are still too high”?

Why couch it in terms of something so undefined and unattainable instead of something actually tangible?

One more thing, it bears repeating that an overwhelming majority of people like me have never even heard the name Jenny McCarthy until they show up on blogs like this.

Perhaps I missed it. Who said you did?

@doctrinalfairness

The reason Jenny McCarthy is brought up a fair bit is because she has a lot of clout in the antivax community, particularly among the autism community. She has an organization, Generation Rescue, and a blog, Age of Autism, dedicated to fighting against vaccines, with a veneer of advocating for autism, though much of that includes shilling for questionable treatments that are dubious, at best, and harmful at worst. She has also led rallies and a march on Washington, DC. She gets a lot of readers and followers, who then go tell their friends about the “science” raised on those sites and in her speeches about vaccines. So, the information spreads to people who may not give a rat’s ass about McCarthy, but they fall for the propaganda. The end result is a lot of people who eschew vaccines because of what they read on McCarthy’s sites or because of what their friends read on those sites. Granted, she’s a pretty easy target, but she has a lot of company: David Kirby, Barbara Loe Fisher, Robert F. Kennedy Jr., Mark and David Geier, Joe Mercola, Mike Adams, Meryl Dorey (a yank in Australia) and even Bob Sears and Jay Gordon (who tend to be more wishy washy than outright anti-vaccine).

Combating the sources of misinformation is almost as important as combating the misinformation itself, particularly where public health is concerned.

doctrinalfairness says: “I’m solidly pro-vaccination, but”

Uh-oh. Antivax detection meter starts vibrating.

“You create an entirely new kind of skeptic when the bulk of your time is spent giving more attention to people who are best ignored. Unless of course, the pandemic IS political and you are doing your bit in the distraction of what increasing numbers of average people fear- a depopulation agenda aimed at removing the “useless idiot eaters” that are often implied by the commentary here…I haven’t ever read one word by Jenny Mc Carthy before, but I certainly intend to now”

Ding ding ding! (concern troll alarm sounds, antivax meter in red zone).

Isn’t it awful when our Secret Plan to depopulate the world of morons through vaccination is exposed? Worse – all our additional efforts to cull the herd (chemtrails, GM foods, CT scans, Olsen Twins publicity) are proving ineffective as resistance rapidly develops, while facts and logic harmlessly bounce off the target population’s mental shields.

We must seek new and ever more powerful diabolatry.

Unless of course, the pandemic IS political and you are doing your bit in the distraction of what increasing numbers of average people fear- a depopulation agenda aimed at removing the “useless idiot eaters” that are often implied by the commentary here.

Now we get to add conspiracy nut in addition to being an anti-vax concern troll. Thanks!

I’m detecting some crank magnetism here. What do you think of the idea that HIV causes AIDS? Was 9/11 an inside job?

doctrinalfairness writes:

trying to find answers about the use of the vaccine for my daughter in a risk category

Very simple answer: The threat of serious illness or death to your daughter from seasonal flu or H1N1 is a far, far greater probability than any occurrence of ill effects that has been observed from the vaccines. Based on data from a number of countries (and available to you with a Google search), compared to seasonal flu, H1N1 appears to have a greater possibility of causing serious illness or death in young people relatively quickly after onset.

To add to what Jud said, I would also recommend speak with a doctor, if it’s medical advice you want. If you want something more specific, visit your local hospital and speak to an infectious disease specialist or epidemiologist on staff.

@Chris

The adjuvant in question has been used in Europe for over ten years, and she has yet to come up with the data to show that autoimmune disease increased in children in Europe
———————————–

I don’t know why you’s expect an increase in autoimmune diseases in Europe when the adjuvanted vaccine, Fluad, is used in the elderly
———————————

What of “public health” did you think was not “public”?

I’m sure the drug companies can sell their vaccine without the public health’s Anne Schuchat appearing on TV in her little Navy uniform warning of the dire consequences of the novel, pandemic H1N1

Any reasonable person who examines the data for how this and the HPV vaccine were tested would raise serious questions as to the quality and rigor of the science behind these studies and the approval of the vaccines. The fact that you are defending this shoddy example of “the peer reviewed clinical trial” on which you all stake your very souls,and defend this as good science within an inch of your lives, yeah, it’s very illuminating.
All of the insults hide the fact that there is utter avoidance of a reasoned defense of the methods used.
Todd, thank you for the link.
I wonder if the reporting system reflects the approval process at all?

I think Docness is telling the truth that she is not anti-vaccination. She is just pursuing her anti-adjuvant agenda in the same style that the anti-vaccinationists do: she reverses the burden of proof and demands proof of a negative, and she assumes that anyone who is not compliant with her wishes and her beliefs must at best be “sheeple”, and at worst be following some dark sinister motive (I’m curious, does anyone have any idea what she means by the suggestion “the pandemic IS political”? Last time I checked, viruses had no political ambitions…)

@Antaeus Feldspar

If we get enough people claiming all sorts of bad things about adjuvants, I might have to write up an antiantiadjuvant site to go with my antiantivax site…though I’d need to do a bit more research for that. 🙂

Sid stated;

“There is no such thing as free. Your county is just paying for the vaccine with someone else’s money.”

Yea Sid, and other people are taking the vaccine which you and I paid for, which will reduce the likelhood of you getting the virus whether you get the vaccine or not. This is the lame angry curse that teachers get when they have a parent yell. “I pay your salary!” Yea and my taxes payed her salary as well (not someone else), so that the population could recieve an education for the improvement of the society as a whole, which also appears to be some sort of a scam to some as well.

As of today there is a shortage of the H1N1 vaccine in southern Cal. People are lining up at the wee hours of the morning at distribution centers to recieve the vaccine.

I have checked and I cannot get the seasonal vaccine from my doctor (all out until next week) and my wife who requires the H1N1 vaccine because of respitory issues cannot get that one yet either.
So I suppose that to some this could be a scam to limit distribution and subsequently increase the spread which would increase the demand. But then you would have to admit that the H1N1 virus is dangerous and is spreading.

As people are beginning to see first hand all those around them dropping from the virus and worst of all having serious complications brought on by this virus, people are beginning to line up.

Yet we still have some with thier “government and big pharma are scamming ya”. I would much rather get scammed for the minimal cost of a vaccine then to spend a week or two sick or expose a loved one to the virus and make funeral arrangements for a respitory compromised loved one.

This argument is merely a smoke screen because I think Sid’s terrified of getting a shot. Ya know the next step is to break down our front doors and have government gools wrestle us down and give us the vaccine by force!!!;)

@Militant Agnostic

I suspect Michael got his information from a national poll conducted for one of the national newspapers (The Globe and Mail). The poll was reported October 23, 2009. Here is the link.

When asked if they want to get an H1N1 vaccination (not if they got it), sadly 49% of Canadians said “yes” and 51% said “no”.

A similar poll in July had 62% saying yes and only 38% saying no.

Unfortunately, I fear more and more of my fellow Canadians are drinking the anti-vax Kool-Aid…

On a somewhat related note, there is some interesting praise and criticism for journalists in the last few posts over at your sister-site SBM. Peter Lipson says “Journalists fail” in his criticism of Shannon Brownlee and Jeanne Lenzer who co-authored the recent Atlantic article about flu vaccine efficacy, and ends his less than scintillating blurb with a rousing, sporting “Go Blue”. He dismisses the Atlantic article as “monumentally horrible” in his six-sentence review. David Kroll praises Amy Wallace’s “wordsmithing” in his lengthy paean, while letting her slide on her factual errors in the recent biography of Paul Offit published in Wired. It it obvious upon reading Ms. Wallace’s article that she does not have a command or even a grasp of some basic facts about vaccines. I was curious to know which of these journalists actually know something about science.

Jeanne Lenzer is a freelance medical investigative journalist and former MIT Knight Science Journalism fellow. She is currently a stringer for the BMJ (formerly British Medical Journal). Her articles, reviews, and commentary have appeared in The New Republic, Discover, Slate, The American Prospect, The Scientist, The (London) Independent, USA Today, Newsweek Japan, and Mother Jones.

Shannon Brownlee’s stories and essays about medicine, health care, and biotechnology have appeared in such publications as the Atlantic Monthly, the New York Times Magazine, the New Republic, and Time. She holds a master’s degree in biology from the University of California. She is a senior fellow at the New America Foundation in Washington, D.C. Her non-fiction book on medicine titled “Overtreated” was praised by the NY Times, JAMA, Jerome Groopman MD, Marcia Angell, and other medical experts (see Amazon.com)

Amy Wallace is an entertainment journalist. She has a slick LA-style website. She has a degree in history from Yale. She covers state politics, higher education, and the entertainment industry. Her work has appeared in the New Yorker, Vanity Fair, Details, Esquire, the Nation, the New York Times Magazine and Elle. Not exactly science-based journalism, and no science training that I can see. This may explain some of the factual errors she made in her Wired article, including the inaccurate prevaccine measles mortality rate and the misinformation about thimerosal in vaccines, among others. Although a good journalist should check all the facts before publishing.

Kroll’s praise of Wallace’s article as “an example of what science journalism can and should be” is quite amusing. Newsflash: One biography of a physician/scientist does not make an entertainment journalist into a science journalist. Amy Wallace is not a science journalist. Lenzer and Brownlee are science journalists.

Shannon Brownlee’s stories and essays about medicine, health care, and biotechnology have appeared in such publications as the Atlantic Monthly, the New York Times Magazine, the New Republic, and Time. She holds a master’s degree in biology from the University of California. She is a senior fellow at the New America Foundation in Washington, D.C. Her non-fiction book on medicine titled “Overtreated” was praised by the NY Times, JAMA, Jerome Groopman MD, Marcia Angell, and other medical experts (see Amazon.com)

So what? In the case of The Atlantic article, Brownlee laid a big turd. Revere and I went into excruciating detail why.

kayliegh and Militant Agnostic:
I was the one who posted the 50% figure for Canadians not interested in the Swine Flu vaccine. I did indeed get it from the recent Globe and Mail poll. My point in posting it was to counter Michael’s claim that everyone has gone into Chicken Little mode about Swine Flu. My point (probably clumsily made) was that the population wasn’t concerned enough, as least to be “arsed” enough to get immunized.
Don’t blame Michael for that number, for one thing, it’s true.

Pablo,
You repeatedly ask me to provide proof that adjuvanted vaccines are unsafe. Unfortunately I don’t know any German cabinet members to ask directly. The German citizens are getting adjuvanted vaccines while their government officials are not.
http://www.spiegel.de/international/germany/0,1518,656028,00
.html

Coincidence? Isn’t that what they like to call serious autoimmune side effects when they do appear during studies?

The AS03 adjuvanted vaccine was tested in 300 kids with 100 controls, who were then followed for 6 months. Two of them developed new onset autoimmune conditions (acute anterior uveitis AAU and autoimmune hepatitis AIH) within 3 weeks of vaccination. I wonder what the statistic probabilty of that is?
By your estimation, we have to now wait until millions upon millions of children are vaccinated with adjuvants so we can then determine that this was or wasn’t a coincidence.

FriedBacon and Pablo,

Some facts bounced back once more:
Pablo asks, Was there testing? Was there not testing?

You tell me. My guess is that the judges of the Peoria High School Science Fair would be quite harsh in assessing the designs of the vaccine manufacturers safety testing and award an F to the very studies that are being touted as adequate evidence that millions of children and pregnant woman should take the adjuvanted vaccine in Europe and Canada.
Once again,
>The EMEA approved the Novartis vaccine based on 4 clinical trials on a grand total of 1018 subjects, only 59 were given the nonadjuvanted flu vaccine as control. (see CHMP assessment report for Focetria) All other trials compared MF59 adjuvanted H5N1 vaccine vs MF59 adjuvanted seasonal flu vaccine (or different doses of HA in the H5N1 adjuvanted vaccine). And that included 471 kids.
The experts here have explained it all to me very patiently how adjuvanted vaccines have been well tested in children. Without adequate controls,or testing one dose against another of the same product doesn’t sound like good science to me, but I’m no expert. Or not testing adjuvants against unadjuvants.
Nothing but the highest standards of safety testing for the children of the world. Thanky Jesus for all those skeptics out there protecting them.

It it obvious upon reading Ms. Wallace’s article that she does not have a command or even a grasp of some basic facts about vaccines.

I am sure that someone whose brain is filled with misinformation about vaccines would certainly read Ms. Wallace’s article and think that she was missing “basic facts” about vaccines. I have a friend of a friend who similarly laments how most of the people out there are unaware of the “basic facts” about astrology and how the influence of the planets affects our daily lives.

Without adequate controls,or testing one dose against another of the same product doesn’t sound like good science to me, but I’m no expert. Or not testing adjuvants against unadjuvants.

You didn’t mention how many were given non-vaccine controls, so it is not possible for me to determine whether they had adequate controls.

Unfortunately I don’t know any German cabinet members to ask directly.

Wow, so it is a conspiracy now!

But you aren’t anti-vax, and just have concerns, right?

Two of them developed new onset autoimmune conditions (acute anterior uveitis AAU and autoimmune hepatitis AIH) within 3 weeks of vaccination. I wonder what the statistic probabilty of that is?

I suspect that is addressed in the original paper, yes? Perhaps you can tell us what the authors of the original study think about it?

@doctinalfairness:

You’re terrible at hiding your blatant contempt for vaccines. The truth will set you free, bring out your inner “common sense”.

@doctinalfairness: OMG! Not the Huns!

No, seriously. I’m a bit drunk and I don’t get it. What are the german cabinet ministers supposed to be teaching us again? Flu vax is bad or what? Aren’t they getting the vaccine, even if it is unadjuvanted? Isn’t the US flu vax unadjuvanted?

Anyway I’m getting the h1n1 vax as soon as I can, here in the socialist paradise, Canada. Even if my language skills and eye contact deteriorate, as a young healthy person I’m still better off.

Kristin,
The German people apparently aren’t too happy because the Cabinet is getting unadjuvanted and the people aren’t.
I guess that makes the German officials anti-vax conspiracy theorists?
Not sure what it makes the people.
The FDA hasn’t opened the floodgate to squalene adjuvants , but it’s just a matter of time, especially if the flu vaccines are in short supply. Adjuvants have a much higher profile of local adverse reactions.

in response to post 69: Ms. Wallace made at least three factual errors in her article: 1) prevaccine measles mortality rate 2) thimerosal in vaccines and 3) attributing pertussis rates solely to unvaccinationed children (when 95% of kindergartners are vaccinated) without addressing the thorny issues of 85% efficacy rate for the vaccine; waning vaccine-induced immunity and extremely low adult vaccination rates. A science journalist she is not. How about addressing the issues instead of making wisecracks about the brain capacity of commentators here? (Are you really a mind reader? Or did your astrologer just tell you that you could discern intelligence levels telepathically?)

This is on the CDC website… According to CDC findings announced recently in Atlanta, one in five U.S. children have already experienced the flu this month, and most of those were likely H1N1 swine flu cases, the CDC says. The H1N1 virus has reached a peak in Oct. and is now declining..

Why are people still going insane for/or against the vaccine? The CDC even says it is declining. Their is so much hype it is sickening, literally. The vaccine will not make a difference. The deaths are tragic, but it is a fallacy to think that a vaccine would have saved them. We all had the virus already. 80% in the schools here, already had it. It made no difference for those of us who did get some of the first vaccines. We all got H1N1 anyway, the symptoms were the same and lasted the same as the rest of the family who couldnt get the shot yet. We were tested, and H1N1 pos. Our hospitals and doctor offices have seen a marked decline in flu cases since the first week of Oct. Not to mention, many of the cases reported from here in Aug and Sept were not actually H1N1, but just ‘flu like’. I believe all hospitals were told, as ours was, to stop testing in Aug. and report all ‘probable flu like’ cases as H1N1. Many of our affluent, left the ER after being dx with H1N1 (it was reported to the CDC as such), paid for their own test at their doctors office which later came back as not H1N1. These are not corrected with the cdc which falsely raises their total count of H1N1. All the stress brought on by the media and false reporting is not going to help anyones immune system. Stay healthy.

I just read the links to the research from Doctrinalfairness. There is definite lack of safety testing in the studies provided. Why does nobody comment on this instead of hurling accusations? Bad science is bad science. I do wonder why it is acceptable to say something is safe for a child when it was only followed for 2 weeks or even 10 years?? What about when they are 30 or 40? or when they have kids? Why is that not considered?

This post by revere at Effect Measure had this scenario, see if you can find a problem with the request for “more studies”:

But if you insisted, picture this. Those long lines of anxious pregnant women and families with small children lining up for blocks to get the flu vaccine arrive at the head of the line and are handed an informed consent form saying that half of them won’t get a real vaccine but only a dummy shot with buffer and they won’t know which ones they got. I’d nominate the authors or Dr. Jefferson to be in charge of getting the consent forms signed, but I’m not sure they could be there. Most of us live on planet earth but only someone living on a planet orbiting slightly past Pluto would think a randomized double blind trial could be done with swine flu vaccination (I know Pluto is no longer a planet; so sue me).

By the way, I second Joseph’s suggestion that you stop reading Prison Planet and get to a psychiatrist.

Ms. Wallace made at least three factual errors in her article: 1) prevaccine measles mortality rate 2) thimerosal in vaccines and 3) attributing pertussis rates solely to unvaccinationed children (when 95% of kindergartners are vaccinated) without addressing the thorny issues of 85% efficacy rate for the vaccine; waning vaccine-induced immunity and extremely low adult vaccination rates.

@diatom: I’m not really interested in spending time verifying what the exact claims were and making sure they were 100% accurate. Explain how these alleged errors are key to the central argument of the article.

@54 You cant make blanket statements like that! My son with excema had a fatal anaphylactic reaction to his flu shot. Do you not think that was a greater threat than some virus? You live with yourself after you chose the vaccine that killed your child. He didnt have the chance to fight off an illness he ‘might’ have been exposed to because I told them to stick it right in his body.

as per 55, Please talk to your doctor first if your child has underlying conditions!

@diatom: I’m not really interested in spending time verifying what the exact claims were and making sure they were 100% accurate. Explain how these alleged errors are key to the central argument of the article.

They weren’t. Anti-vaxers have no real rebuttals to the article, so they focus on minutae and smears.

In fact, the only claim that diatom makes that is even reasonable was the fact that the author didn’t note that thimerosal is in some childhood flu vaccines. That correction has since been made in the article.

But if that is your best argument against the piece, you might as well stop now.

Anon @83

That correction has since been made in the article.

And therein lies the difference between the voices of reason and the antivaxers.

There are lots of differing opinions about those who use ridicule to defeat what they perceive to be an attack on their irrefutable reason. Yours doesn’t even meet Thomas Jefferson’s.

Irrefutable ain’t science. Your repeated harping on the buffoonery of Germany politicians still proves nothing. The idea that a bunch of politicos have some special knowledge about vaccine safety is crazy. Your suggestion about vaccines being part of a depopulation effort is doubly crazy.

You can keep acting like you’re just raising reasonable questions all you like, but you’re not fooling anyone. You’re a paranoid conspiracy nut. Get help.

Chris,
What is fascinating to me is that lock-step, like good little Germans USED TO DO, every one of you defends these adjuvants hands-down. I don’t need to spend hours now producing evidence to prove my point- it was just proven by a body of educated people, governmment officials of a major foreign power, who examined the evidence and made an informed choice. YOU DISPROVE IT.
If I’m so insane to need a psychiatrist, are you diagnosing the German ministers, too? In the face of the evidence, would YOU want a vaccine that the entire cabinet of your government found to be less safe? YOu want to put everyone in a box. YOU ARE THE BOX.
And what of the two-tier problem? And the vast distrust that this will now cause? A HUGE part of the problem is the stonewalling of scientists defending their precious dogma with NO room for dissent. Inert little homeopathic pills harm absolutely no adult person who chooses to take them. Placebos harm no one, vast numbers of pharmaceutical drugs work no better than half of the woo you defend. Keep ridiculing.

And lots of people who are beginning to see how it works will be watching for the predicatable studies that will now rapidly appear, lock step, with much better numbers on those adjuvant AE profiles. By then no one will believe them and why should they?
Boo hoo that so much of science is woo-woo. You are averse to the truth and need victims to scapegoat and diagnose. Physician, heal thyself.

@doctrinalfairness

Inert little homeopathic pills harm absolutely no adult person who chooses to take them. Placebos harm no one, vast numbers of pharmaceutical drugs work no better than half of the woo you defend. Keep ridiculing.

The pills themselves may not cause harm, but using them in lieu of actual medicine/treatment can. Take a look at the case of the little girl from Australia (I believe her last name was Sam) who had eczema. Her parents opted for homeopathy over real medicine. Her eczema got worse to the point where her skin cracked and allowed secondary infections, ultimately leading to her eyeball basically melting. She ultimately died from septicemia. Actual medicine would have prevented that. Homeopathy isn’t as harmless as you might think.

As to adjuvants, you haven’t really shown that they are harmful. Do they have increased rates of local, temporary reactions? Yes. But you’ve yet to show that they cause serious harm that throws the risk:benefit ratio toward not using them.

86, dont waste your time with Chris. Completely one track mind. After following the posts over 6 months, I see a definite issue with guilt for whatever reason. Oh, she will name call and fight over that comment, but that is all she knows. I know science, get my family vaccinated, and still have no problem admitting where more studies need to be done. Makes me truthful, not certifiable.

What is fascinating to me is that lock-step, like good little Germans USED TO DO, every one of you defends these adjuvants hands-down.

Honestly, I’m surprised that it took doctrinalfeyness this long to drop a Godwin.

“In fact, the only claim that diatom makes that is even reasonable was the fact that the author didn’t note that thimerosal is in some childhood flu vaccines. That correction has since been made in the article.”

CDC measles prevaccine mortality rate per the Pink Book: 150. Amy Wallace prevaccine mortality rate: 3,000. Read the DTaP package insert for the 85% efficacy rate. Not interested in the facts? Then I guess you’re not interested in science. I have no “argument” against the Wired “piece” as a biography. Science journalism it is not.

CDC measles prevaccine mortality rate per the Pink Book: 150. Amy Wallace prevaccine mortality rate: 3,000. Read the DTaP package insert for the 85% efficacy rate. Not interested in the facts? Then I guess you’re not interested in science. I have no “argument” against the Wired “piece” as a biography. Science journalism it is not.

@diatom: So in your view, if a science article contains any errors, then it’s no longer science journalism. Nonsense. Those kinds of errors can be corrected, and they have absolutely no bearing on the central argument of the article.

Not all errors are equal. Yes, there can be errors that completely invalidate what is being argued. That’s not the case here.

It’s not like because there were “only” 150 deaths a year from measles, vaccines aren’t useful anymore.

@diatom: I believe your figure is incorrect as well. Since you care so much about science, I’m sure you’ll appreciate this. According to Egelhardt et al. before 1965 the mortality rate from measles was just over 0.2 per 100,000 per year.

The population of the US in 1960 was 179 million. Doing the math, there had to have been about 358 deaths per year.

I suppose 358 might be considered 300, and a typo could make it 3,000.

@diatom:

Glad to see you got your anti-vax talking points in order.

Do you have a real source for your “only 150” claim?

http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/meas.pdf

Before 1963, approximately 500,000 cases and 500 deaths were reported annually, with epidemic cycles every 2–3 years. However, the actual number of cases was estimated at 3–4 million annually.

I am confident that the number of actual measles fatalities during epidemic cycles was a whole lot higher than 500 per year. Not to mention that disease reporting half-a-generation ago wasn’t nearly as good as it is today.

I read this blog for pure entertainment that a bunch of unattractive, fat, balding men shower love upon someone who calls himself Orac.
Any dissent posted here immediately gets discredited. There WOULD NEVER be enough proof for the lovers of Orac or Orac himself that a vaccine is bad. These fellas believe in SCIENCE. Well, keep lining up for the vaccines fellas and as you increase in age and you go limp, go bald, develop allergies, maybe throw in a tumor or cancer – well, all I can say is you get what you deserve.

Very little of the dissent here is credible.

It’s hard to discredit something that never had credit in the first place.

These fellas believe in SCIENCE

You say that as if it were a bad thing. What’s the alternative? Magic? Religion?

@L.Harper:

Well, keep lining up for the vaccines fellas and as you increase in age and you go limp, go bald, develop allergies, maybe throw in a tumor or cancer – well, all I can say is you get what you deserve.

You do realize that one or more of those things can (and probably will) happen to you, whether you get a vaccine or not?

@#82 I’m so sorry. But thank you for mentioning what’s at stake. It’s all hypothetical until it’s your own. We have spoken to our doctor, who is a family friend and he was honest enough to say that it’s a crapshoot- risks in either scenario. Which is how all this started.

Jennifer, I was discussing present day Germans and totalitarianism in the scientific community, I think you need to get back to your exhaustive Skeptic’s library and have another look at the definition of Godwin’s Law.
I’m certain that you are aware that invoking Godwin is often used as a tool in the censorship of valid arguments.

Re: eczema
Tod – if you slog through, you will encounter both the bold faced lie that testing of adjuvants has been done on millions of children (in fact predominantly >65 yr olds)as well as eczema being one of the autoimmune disorders which they are now closely watching out for. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM175998.pdf

I read this blog for pure entertainment that a bunch of unattractive, fat, balding men shower love upon someone who calls himself Orac.

Sorry to burst your bubble, but:

Height: 6’2″
Weight 175 pounds
BMI: 22.5 (and no abdominal fat)
Full head of hair
Attractive enough that before I married, the vast majority of my girlfriends came from women who hit on me first.

As for showering love on the computer who writes this blog, I do have a high degree of respect for a man who is clearly VERY busy with surgery and research yet still spends his valuable time keeping a very active blog with minimal remuneration. Let’s face it: If Orac wanted to, he could ditch his academic post, take on a heavy case load in private practice, and make more cash than most people here could ever dream of making. But he doesn’t do that.

I’m certain that you are aware that invoking Godwin is often used as a tool in the censorship of valid arguments.

Is accusing the medical profession of colluding to engage in the mass murder of “worthless eaters” without any substantial evidence your idea of a “valid argument”?

>>Is accusing the medical profession of colluding to engage in the mass murder of “worthless eaters” without any substantial evidence your idea of a “valid argument”?<<< Kindly show me where I ever accused the medical profession of mass murder. I made a connection between the gloating, Darwinian tone that is taken by so many here toward anyone in disagreement and said it's not a huge stretch to wonder why so many average Americans believe in the Illuminati depopulation plots of David Ickey and Louis Farrakhan. (Links to their websites are to be found on this very blog, I didn't go looking- they were in this months stories) I strung together "useless idiot eaters" because a very favorite expression to be seen on this blog is useful idiot. You just don't even see how YOU make the case for many of the people you cast doubt on here.

103 “You just don’t even see how YOU make the case for many of the people you cast doubt on”

Exactly! I have tried to explain that particular point to no avail. There are some here who just dont get it! It may be entertaining but not beneficial.

I made a connection between the gloating, Darwinian tone that is taken by so many here toward anyone in disagreement and said it’s not a huge stretch to wonder why so many average Americans believe in the Illuminati depopulation plots of David Ickey and Louis Farrakhan. … You just don’t even see how YOU make the case for many of the people you cast doubt on here.

See, that would be a totally convincing story, except the fact is that you didn’t start out treating us like human beings and then resort to calling us Nazis; from the very start, you were attacking us for not having psychically read your mind to determine your concerns and then agreed that they were all perfectly justified.

In short, you showed up acting like a classic crank and now you’re trying to attribute the reception you got to anything but your crank-like behavior.

Kindly show me where I ever accused the medical profession of mass murder.

Sure!

Unless of course, the pandemic IS political and you are doing your bit in the distraction of what increasing numbers of average people fear- a depopulation agenda aimed at removing the “useless idiot eaters” that are often implied by the commentary here.

Wouldn’t the “depopulation agenda” involve those incredibly dangerous squalene-enhanced vaccines? Which presumably would mean that the medical profession is in on it.

I made a connection between the gloating, Darwinian tone that is taken by so many here toward anyone in disagreement and said it’s not a huge stretch to wonder why so many average Americans believe in the Illuminati depopulation plots of David Ickey and Louis Farrakhan.

This is a complete and total non sequitur. Condescending blog comments are not the reason people believe in strange things. Like AF says above, you’ve been a complete horse’s ass here. We’re just giving it right back to you.

Joseph is correct, the prevaccine measles mortality rate was closer to 350 than 150. I was off by 200 deaths per year. I corroborate this by sourcing the US Census Bureau population and mortality data 1959-1962, when the measles death rate was 0.2 per 100,000. Given the US population for the years 1959 through 1962, this calculates to 1959 – 352 deaths; 1960 – 354 deaths; 1961 – 360 deaths and 1962 – 366 deaths.

A-non is incorrect in extrapolating from 500 deaths annually to arrive at 3,000 deaths annually based upon the morbidity figures of 3-4 million. Mortality reporting has always been more accurate then morbidity reporting. Also, the Vaccines textbook edited by Plotkin, Orenstein & Offit states roughly 500 prevaccine era deaths annually while acknowledging the 3-4 million cases per year.

diatom, it is disturbing that you think even 150 deaths from measles is acceptable. Also, the 345 is classic cherry picking — you chose a year with a low, when the numbers usually went up an down. The deaths ranged from a low of 340 to a high of 680 in a year.

Here is the numbers from, http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/G/cases&deaths.pdf (perhaps you should share the census URL you used):
Disease: Measles in the USA
Year__Cases____Deaths
1950__319,124__468
1951__530,118__683
1952__683,077__618
1953__449,146__462
1954__682,720__518
1955__555,156__345
1956__611,936__530
1957__486,799__389
1958__763,094__552
1959__406,162__385
1960__441,703__380
1961__423,919__434
1962__481,530__408
1963__385,156__364
(^^ first vaccine licensed)
1964__458,083__421
1965__261,905__276
1966__204,136__261
1967___62,705___81
1968___22,231___24
1969___25,826___41
1970___47,351___89
1971___75,290___90
(^^^ MMR licensed)

It may be worth noting that the population of the USA is almost double what it was in 1950.

Joseph,
I had already referred once to David Icke, after following the link I found to his website right here- on this discussion on RESPECTFUL INSOLENCE- this blog…
http://respectfulinsolence.com/2009/09/why_you_should_get_vaccinated_against_th.php

which took me here

http://worldofweirdthings.com/2009/08/06/vaccines-the-evil-alien-conspiracy/
Follow that link on that page and then get the sarcasm, ok, Joe? I learned every bit about the Nazi plot, none other than right here. Which is the point I have made repeatedly. It’s your whole little Hegalian Dialectic- NO ONE I KNOW HAS EVER HEARD OF THESE PEOPLE. I know all about them now, when instead I came here wanting to know WILL MY CHILD BE HARMED, like the poster on this thread, only from a cytokine storm from a vaccine for a flu she might not have ever gotten. Because she already has a pre-existing condition that doesn’t really need a whole pile of stimulating if need be. Got that?
Do check out the work of colleague Susan Chu, I have been watching for weeks for comments and there are no takers.
http://www.newfluwiki2.com/showDiary.do?diaryId=4051
But you won’t. Your mind is made up. Hope that you are comfortable with that down the road.
Feldsy, I came here asking why you were talking about celebrities when there is really, truly not enough data for you to tell me unequivocally that adjuvanted vaccines are safe in children and young adults. They’ve only really been used in populations 65 and over for seasonal flu. Science is NOT protecting us and in a word, Andrew Weil is far less of a threat than the big woo-fightin mob on this blog.
So if you want to confess to the evil reptilian plot now, I’m all ears.

HCN, don’t you know? There was just a big improve in the hygeine between 1966 and 1967. Probably due to Woodstock.

Young man, Woodstock was in 1969. Perhaps you were thinking of the Monterey Pop Festival in 1967 (my brother was in Sea Scouts, and some participants of that festival stole their boat and sank it!).

@diatom:

A-non is incorrect in extrapolating from 500 deaths annually to arrive at 3,000 deaths annually based upon the morbidity figures of 3-4 million.

I never extrapolated that at all.

However, it is reasonable to assume that 50 years ago mortality reporting was not perfect. It is also reasonable to assume that not every death that resulted from measles was reported as a measles fatality, especially if there was a secondary complication involved.

For all the idiots who say things like “my doctor said it’s a crapshoot,” “the swine flu has already spiked, what’s all the fuss,” etc. – two weeks ago I was on a conference call of the Texas State Disaster Commission, where the usual discussion is about hurricanes, tornadoes and maybe the occasional fire. They’d had 49 swine flu deaths reported so far, 17 in the prior week.

Now go find me 17 deaths in a single state in a week from squalene or thimerosal or reactions to the unadjuvanted vaccine.

Jud,
Since I’m the idiot you are referring to above, let’s be clear that I’ve NEVER minimized the severity of the risk from this pandemic. If the goal of the scientific community is herd immunity and vaccine compliance- if that is your genuine “CONCERN”, then it would behoove you to listen and heed the “CONCERNS” of pro-vaccination parents who are instead ridiculed for their rational fear of ingredients that have been NOT adequately been tested in children and proven to be safer, even in a pandemic, than the very flu they are vaccinated against.

From the VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
July 23, 2009
Hilton Hotel
620 Perry Parkway
Gaithersburg, Maryland
(Dr. Debold’s credentials are: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm055414.htm )

DR. DEBOLD: I think because we are asking the
public to do something very special, we are asking them to
consume a pharmaceutical product that has not gone through
necessarily the traditional route here. I think this is part
of informed consent and openness and transparency.
To the extent that I think information can be made
available to people so they can take responsibility for the
choices that they make, I think it is going to be better for
everybody, particularly if something happens and we have some sort of a bad outcome. People will be less likely to blame others if they have had full information and been able to make decisions on their own.
DR. DEBOLD: I would say if you could do that, I
think that would go a long way to helping to provide
information for people to make their own personal decisions
with.
I would also like to add, I know in the materials
that we had to review prior to the meeting, and we talked
about this also at the February meeting, about the child who
had autoimmune hepatitis, we need to be thinking about which
people should not be getting vaccines with these adjuvants in
them, order to improve safety; is there a list of people with
certain health conditions that should not get those vaccines.
DR. INNES: Perhaps it would be useful to update
the committee on what happened to that child and maybe some
of the follow-on investigations that have taken place.
It has been subsequently determined that the child
215
in fact had autoimmune hepatitis prior to receiving a dose.
It was asymptomatic and not recognized. That child had a
fluctuating course of liver enzymes, but was never
symptomatic.
In a period of months after the first dose, the
child was removed from the trial, once it was recognized
there were abnormal enzymes, so she never got a second dose.
Enzymes went up, they went down.
We presented the case to outside consultants that
were experts in autoimmune liver disease, and they felt that
what happened to that child was pretty typical for what
happens with autoimmune hepatitis. She was placed on
therapy, had a very, very rapid response to therapy and now
has normal liver enzymes and throughout the entire course
remained well.
In discussing how to handle the issue of whether
children or adults, because the prevalence of autoimmune
liver disease is about one per 10,000 across the entire
spectrum of age, their recommendation to us was that clinical trials should enroll these kinds of subjects. They are at
risk, perhaps at increased risk for complications from
influenza, and there is not really biological plausibility
that adjuvants that are being used — and I think all the
manufacturers have presented data that shows that the effects of the adjuvants are limited in time, limited to the space 216 where it is injected and in the draining lymph nodes. They don’t have widespread activation of the immune response,and isn’t plausibility that they would activate autoimmunity in organs separate from the
muscle where they are injected.
So their recommendation to us was, please, you
should screen and you should follow biochemical parameters of safety, but don’t exclude these kinds of subjects in the
trials. You will end up with labeling that says such people
shouldn’t get the product.
Now, we have had discussions with CBER about what
to do, and we reached agreement that in phase I studies, it
makes sense to screen out persons who have abnormalities of
liver enzymes, who have abnormalities of renal function. But
at some point after a phase I study when you have more
certainty about what the risk-benefit profile of that is,
these are the kinds of patients that then need to go into
pre-licensure trials and be followed with controls.

DR. DEBOLD: I think anything you make publicly
available on the topic you should, because it is not just
autoimmune hepatitis that the parents are worried about.
There are kids with diabetes, kids with asthma, a lot of
immune activated illness out there, and there are a lot of questions about what happens when you bump up someone’s
immune system to the extent that we do.
If you have information also about mechanism that
these adjuvants work by, the biological mechanisms, that
would be helpful, because I would like to see them myself.

>>>I guess Dr. Debold, along with Dr. Chu- whose organization, Ready Moms, has been helping to prepare for pandemics for several years, is an ANTI- VAX idiot too! Since she raised scientific CONCERNS about adjuvants, this makes her a VERY SUSPICIOUS CHARACTER, DO BEWARE of the woo-meister Dr. Debold, blah, blah, blah.

I’m horrified that people are dying. (especially since the Influenza Strain A has been circulating for decades, according to the above report, and we appear to have not gotten very far in understanding it.) But I don’t want to wait two years to find out that fewer of them might have died from something that was not immediately apparent in their taking of a vaccine.

Um, Tod,
we “concerned parents” among the pro-vax community are all going to now hold our breath for two years before learning the answer to Dr. Debold’s question.
IS THERE A LIST OF PEOPLE WITH CERTAIN HEALTH CONDITIONS THAT SHOULD NOT GET THOSE VACCINES?
Jenny McCarthy, whoever you are, if you troll this blog, I hereby apologize for calling you an inane aging celebrity with nothing relevant to say. After just a few days with this crowd, I am 100% convinced of why your following is growing and I don’t doubt that you are onto something. This kind of willed blindness is frightening.

HCN: I chose the 4 years prior to vaccine licensing because those were the closest years to vaccine licensing (“prevaccine”). I believe when the “prevaccine” label is used for infectious disease mortality statistics it should apply to the period immediately preceding the vaccine licensure, as mortality for most of the infectious diseases was decreasing even before vaccine licensure. I have seen many cherry picked comments using disease mortality statistics 20 years prior to vaccine licensure, which distort the facts when the mortality rates were decreasing substantially in that 20 year period. That doesn’t appear to apply here, however as you point out the US population grew considerably between 1950 and 1962, so it’s surprising the measles mortality rate did not increase during that period. It’s also interesting to note in the Pink Book appendices that the measles vaccine coverage rate was only 60% in 1967, and hovered around 60-65% through 1985.

Don’t have a URL, I used the hard copy of the US Census Bureau Historical Statistics of the US, Colonial Times to 1970, which states the measles mortality rate for the period as 0.2 per 100,000.

‘They’d had 49 swine flu deaths reported so far, 17 in the prior week.’

How many of those were confirmed H1N1? Most hospitals are not testing, are yours? Top news story last night: ‘a healthy (very fat in the pix) 48yo woman just died from swine flu. Then they go on to say that she was tested 3 times for H1N1 and it was always negative. But we are still reporting as a death from swine flu.’ What?? I am so sick of seeing that crap on the television. There are dozens of ‘flu like’ pathogens that can cause death. Why is everything swine flu? Now that people will be getting seasonal flu more in the next few months, will that all be called swine flu too? Our hospital continued to test well after the cdc reco to stop. At least 70-80% of all the flu-like illnesses from July until Sept were not H1N1. Even so, the cdc wanted them all reported under that blanket. What kind of crap data is that!? Ridiculous.

btw- doctrinalfairness(df) started the posts with questions… instead of answers- none of the important ones were answered because there is no answer yet- so instead of accepting that shortcoming in the scientific data, several have tried to turn the point away by attacking specific comments instead. It is obvious df wants the protection of a vaccine if the info is there to show it is safe for children with underlying medical issues in particular. That type of safety testing has not even been done.

@doctrinalfairness

Dr. Debold’s statements, as quoted by you above, did not make clear whether the vaccine was responsible for any issues in the child. However, it is generally recommended that individuals with hepatic or renal impairment be included in clinical trials to determine how their condition affects the product under investigation. If they are not included in clinical trials, then the labeling needs to include something along the lines of “This product has not been tested in individuals with renal/hepatic impairment.”

The end result is that those with impairment will not be able to receive the product, which, I think, is Dr. Debold’s primary concern, considering they are at increased risk for complications from the flu. So, it doesn’t appear that he is calling for investigation in special populations because of concerns about safety in general, but rather that they be included in trials so that there will be a better understanding of the product’s effects in the special population specifically, particularly when the product has the potential for protecting the special populations from disease complications.

Out of curiosity, what specific questions do you have about the adjuvants as it relates to you or your family?

Re #s 114 & 115 – First, I’d recommend keeping Caps Lock off if you hope to be taken seriously.

You’ve cited Dr. Debold, whose work is featured on web sites such as that of Safe Minds, which bears the slogan “Stop the Mercury. Start the Cure.” (By the way, the “Dr.” is for a Ph.D., not an M.D. Debold is a registered nurse.) In the passage you quote from her testimony, Debold repeats the all-too-familiar inaccuracy that the swine flu vaccine is relatively untested. Swine flu vaccine is the same as the seasonal flu vaccine. The “seasonal” variety in the case of the swine flu vaccine is H1N1. It is no less tested than the seasonal flu vaccine given to millions annually for decades.

In support of her concerns regarding adjuvants, Debold raises the case of a single child, whose autoimmune problems were found to be preexisting.

Why the failure to find a single autoimmune problem stemming from use of adjuvants should cause any reasonable person even a moment’s hesitation in giving an at-risk child an unadjuvanted vaccine is simply beyond me.

Todd, Thanks for your response to the questions.
There aren’t adequate answers to me- if the adjuvant (which is admittedly dose-sparing and probably a financial decision for strapped govenment finances) has an AE profile of higher local inflammatory response, even uneducated parents like me have been told that these type events can trigger an unseen autoimmune response whose symptoms can take a few years to develop.
If the activity of the adjuvant is indeed local and doesn’t make it into the lymph, how is it then responsible for improving to help get the antigen to where it has to go? One dissipates and the other mysteriously evaporates?, following a high rate of retrogenicity that can trigger a hit and run immune response? The adjuvant doubles the chances of this, is my guess, if it is true that it “boosts” the response of the antibodies, so too does it boost the already high levels of inflammatory cytokines. Or, please show me how it does not.

Also, I have been following for ten years the official story in IBS and Crohn’s undergoing a change, one from where pathogens played no role whatsoever, to a MAP vaccine today. Stories change.
I don’t think Dr. Debold (she) is just referring to the clinical trials, in that she refers to the transparency required in this unprecendented push for untested adjuvants.
Because we DON’T know about the relationship between IL6 and inflammation and cytokine storm, and autoimmunity. It’s an educated guess. And a crapshoot.

>>>There are kids with diabetes, kids with asthma, a lot of
immune activated illness out there, and there are a lot of questions about what happens when you bump up someone’s
immune system to the extent that we do.
If you have information also about mechanism that
these adjuvants work by, the biological mechanisms, that
would be helpful, because I would like to see them myself<<

119 No, it was not an autoimmune problem stemming from use of adjuvants…the question is whether the vaccines would be safe for children, or adults for that matter, who have pre existing auto immune or other disorders. and yes, some of us do not have the choice to get the vaccine without adjuvants, and if the shortage continues, nobody will have the choice of no adjuvants.

Of course, the ‘seasonal’ vaccine seldom works, and it has its own problems. So, am I to assume the H1N1 variety of the seasonal vaccine wont work, and it will have problems too? The last person who died of the swine flu here, already had the swine flu vaccine. It didnt help him. Of course the swine flu diagnosis was given to him by the doctor’s ‘experience’ only, no testing. Since the skeptics here only believe in scientific testing and not experience, I find it curious that you all take the CDC’s numbers of swine flu cases as fact. Our doctors are not testing here in NC as someone posted from Fl. Although, the numbers for swine flu keep increasing all based on ‘experience’. The doctor actually told me my daughter had swine flu “because she had what it looked like”. She was fine 2 days, had to wait an extra day to go back to school, never stopped eating even though she slept alot. I hope it was swine flu and gave her immunity, but it could have been any virus. I agree, that is a terrible way to track a dz. Totally false numbers.

@doctrinalfairness

Are there particular adjuvants about which you have questions? In the U.S., I believe primarily aluminum salts are used. CDC has some information on vaccine ingredients that may be worth a read, including a fact sheet on aluminum. See here for more: http://www.cdc.gov/vaccines/vac-gen/additives.htm. You may also want to read this article from Science-Based Medicine contributor, Dr. Joseph Albietz: http://www.sciencebasedmedicine.org/?p=851

I’m a layperson, so I do not have specific answers for you. Your best bet would be to, as I suggested before, talk to your doctor or send an e-mail to CDC with your questions.

Now who is being disingeneous Tod? I support unadjuvanted alum-based vaccines for this epidemic and some of my family is already vaccinated with same.
But if the pipeline is opened to squalene based adjuvants for the use of this vaccine, it’s an entirely different matter and there IS very little or no data regarding people under 65 and their use.
Fascinating, too, that in the very lengthy and varied list of Dr. Debold’s numerous activities and credentials, you focus on the single one to paint her as a loon.
She’s currently advising the FDA on Vaccines, would you prefer that it be stacked entirely with industry representatives from the pharmaceutical companies?
At least two journal editors of prominent medical journals, one in the UK and one in the USA, have illustrated how that kind of IDIOCY harms us all. But do get busy right away to the task of ridding the FDA of anyone with a CONCERN.

And haven’t studies recently shown that swearing (ie CAPSLOCK) reduces stress? You won’t take me seriously CAPS or no, if no one here can see anything at all but the single work of Dr. Debold’s that isn’t lockstep in agreement with yours.

@doctrinalfairness

Now who is being disingeneous Tod?

Umm…to whom are you responding? Did you mean Jud? There have been a couple posts, now, addressed to a “Tod”, which I assumed was a typo of my name.

And, to be fair, Dr. Debold did suggest that the vaccine was rushed by stating:

we are asking them to
consume a pharmaceutical product that has not gone through
necessarily the traditional route here.

The implication is that it was not adequately tested, although it went through the same process as the regular seasonal flu. It is a pretty common criticism of the H1N1 vaccine, so Jud was not entirely off-base calling her out for that. Another article at SBM, “More Flu Woo for You, Boo Boo” (http://www.sciencebasedmedicine.org/?p=1455#more-1455), by Dr. Mark Crislip, has a section explaining the testing process of the H1N1 vaccine. Scroll about halfway down for that part.

PS HCN: Please point out where I said 150 deaths were acceptable. I did not. You would do well to exercise some caution before attempting to read minds. My original point had nothing to do with the acceptability of the mortality rate. The point was that Wallace’s figure of 3,000, even using the CDC’s number of 500, is a significant error and should have been verified before publication. My larger point was that it and other errors are indicative of the fact that Wallace is not a science journalist and the article is not science journalism.

Todd, mea culpa- I am poorly multi-tasking many things at the moment. And you have been patient with my questions, so its double dose of dumb of me to not be paying attention to who is who.
I read D. Crislip’s article – beginning with this
>>-A NEW AND UNTESTED VACCINE IS BEING TESTED ON THE AMERICAN PUBLIC

It is new, and it is untested. As the flu vaccine is every year. Or, more appropriately, it’s the same old flu with the same old vaccine.<< And I agree completely about unadjuvanted H1N1 vaccine for the majority of people, myself included, as the best route to protect the public from this pandemic. Add the squalene based adjuvants, which I respectfully argue have not NOT been tested extensively on young people, and I disagree. And won't wait til 40 million are vaccinated to find out, just on the basis on the AE's alone, which in her case, to me ARE a red flag. No one can authoritatively say they do no harm, either. Autoimmune diseases are among the top ten killers of young women at a much higher rate than men. So let men innoculate against HPV and see if the rate of cervical cancer goes down if it's sexually transmitted. Otherwise, you are saving her, in particular, from nothing. There ARE other technologies and other adjuvants being developed that look very promising and I am watching closely. It's a fascinating area. I agree wholeheartedly with much of what he is saying- my son who is a healthy horse is in a completely different category as my daughter, for instance. The preliminary data already in from that vaccine makes it scary to me- autoimmune disease is in the top ten causes of death for young women. I want to see the math or educate my own self about the data that shows elevate

oops, i apologize for the editing mess above and am rushing and have no time to elaborate, other than
1. there are real dilemmas with one size fits all
2.although i haven’t ever read Jenny M, if “green adjuvants”, whatever they may be, don’t cause arthritis in rats or cause stillbirths, or worse yet, no births- roll out the trials because there are MANY diseases yet to be eradicated by vaccination.

Chris, I have little or no problem with unadjuvanted seasonal flu or H1N1 vaccine, and listening to this podcast – I agree with very much of what he is saying.

We part company over squalene-based adjuvants, which the data shows add another layer of inflammatory reactogenicity on top of that of the vaccine’s antigen and at that point, no one, not even Dr. Crislip, knows whats going to happen to young immune systems. We are trying them out during a pandemic characterized by ARDS and cytokine storm IN THE YOUNG, whose response has not been adequately studied. Accusing them of narcissism for not wanting to risk triggering something that will put them in a wheelchair is grossly unfair. There is NO preponderance of data. None. The adjuvant has been used in Europe in over 65’s predominantly and the fact that the body manufactures it is a moot one- the body manufactures cytokines too and they storm or go crazy in people with underlying conditions.
Treating us all like anti-vaxers or stupid children that require patronizing insults to chide us into compliance isn’t going to help herd immunity.

Also, by now, many of us have already been exposed and NO ONE has answered the question of what happens to a young person who unknowingly brewing H1N1 virus, gets an ADJUVANTED vaccine and has an underlying autoimmune disorder.

And this is why trust is rapidly going down the drain….

@doctrinalfairness

I poked about on PubMed searching for “MF59 children” and came upon the following article:

http://tinyurl.com/yft6g7q

Although it does not specify whether or not children with underlying autoimmune conditions were included, it found that the “only statistically significant difference between [adjuvanted vs. unadjuvanted] groups was found for injection site pain in the older age cohort”.

There were several other studies, as well, where the lead authors worked for Novartis or Chiron Vaccines. Those of a conspiracy-bent would likely discount those, however, as being propaganda pieces and not good science, simply because of the lead author connection. The study I linked to above has three authors from Novartis, but the lead author and one other are from the University of Tampere Medical School in Finland.

I also found this Phase II trial of an MF59 adjuvanted vaccine:

http://www.who.int/vaccine_research/immunogenicity/82_astractvisicari.pdf

doctrinalfairness wrote: No one can authoritatively say they do no harm, either.

And that, even if possibly true, compares just how to the people who are rignt now being very authoritatively harmed or killed by swine flu?

You keep talking about the potential for autoimmune disorders somewhere down the road – on the basis of exactly zero data regarding the swine flu vaccine currently available in the U.S. – and frankly (this may sound cruel, but believe me it isn’t at all meant that way) I hope your daughter lives through the pandemic so you can continue to worry about that.

Re: post #119: “By the way, the “Dr.” is for a Ph.D., not an M.D. Debold is a registered nurse.”

Nice attempt to discredit Ms. DeBold.

Ms. DeBold’s PhD is from the University of Michigan’s School of Public Health.

Thou doth protest too much. Hasn’t it dawned on you that the H1N1 vaccine is the perfect solution to over-population. Why can’t you convince me otherwise? Someone once said to determine what the future holds, look to the past.

To the beat of the old time elixer salesman

Come close my friends. I keep hearing how those everyday vaccines don’t do the job on the eldrerly and they just keep dying. Well, I’ve got the answer for you, a magical elixer. It does things never dreamed of by Tom Jefferson.

For the only the price of a more painful arm you get – more doses from your virus, better protection against antigen drift and one big kick at the immune system.

Here’s what we do — take only 3.75mcg of dead virus protein and add the magical (but deadly) AS03 elixer. You get more doses per gallon of vaccine. You get better protection against antigen drift and you kick that immune system real….hard.

Look what you get:

http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10119.htm
These results show that 88.0% of the subjects between 61-70 years of age, and 86.7% of those over 70 years of age, demonstrated a response that was above the regulatory threshold of 1:40 seroprotection, which is considered indicative of protection. Results in the age group 18 60 years of age were similar to previously reported studies in thatage group, with 97.5% of subjects reaching the 1:40 seroprotection level in this trial.

Now you might get that with a double dose of your standard vaccine (studies show 4x definitely works safely) but you don’t get extra doses and better protection against drift. See US study on double dose for asthmatics
http://www3.niaid.nih.gov/news/QA/H1N1VacASTHMAqa.htm

And folks it gets better ..

You say you’re worried about the infants and the kiddies under 10 because CDC is saying it takes 1/2 dose plus 21 days plus booster plus 10 days to get great protection… that I can’t help you with…I’m sorry

Up in Canada and in Europe it will probably end up at 1/2 dose plus 21 days is good protection.
http://www.ctvbc.ctv.ca/servlet/an/local/CTVNews/20091023/who_swine_091023?hub=BritishColumbiaHome

http://www.pharmanews.eu/gsk/361-experience-of-gsks-h1n1-adjuvanted-vaccine-pandemrix-and-preliminary-paediatric-results

Next year it should be different. There will be the AS03 results from Canada and Europe and perhaps similar results with MF59. The US has large stockpiles of both adjuvants.

The contents of the 10 dose vaccine vial are injected into the larger vial of adjuvant and shaken. So the US, if it wanted to do so, could have shipped off adjuvant to all the vaccine makers and them add it to the vials of vaccine. I think the US made the right decision.

Canada’s decision was gutsy next door to the US madness. The deaths of two kids seemed to have changed the public mood.

Vanetia Warner Cornwall, Ontario
10-year-old Vanetia Warner passed away on [October 26th]at the Children’s Hospital of Eastern Ontario after being diagnosed with H1N1 influenza. She attended St. Anne’s Catholic School in Cornwall and was in good health before contracting swine flu.
http://tinyurl.com/Vanetia-Warner

Evan Frustaglio,Toronto, Ontario
A 13-year-old Toronto boy, described as “healthy as can be,” has died of the H1N1 virus. Evan Frustaglio, who played in a minor hockey league, died Monday night at St. Joseph’s hospital. Evan went from having minor cold symptoms to dying within 48 hours, his father said.
http://tinyurl.com/Frustaglio

Randy Olson says Skeptics answer emotion with reason. I’ve been commenting, a lot at Huff-Po (sheldon101) and I’ve started answering back the my poor kid lines with a signature that ends with one of 20 or more of these vignettes about kids and adults that have died. I think that’s the way to go.

Finally, I think I’ve got the best slogan.

Flu Vaccination: If not for you, for your cat.

In some of the material above there are quotes like “Inactivated parenteral vaccines were 30% effective (95% CI 17% to 41%) against influenza-like illness, and 80% (95% CI 56% to 91%) efficacious against influenza”

I’d appreciate clarification on the use of the word “effective” versus the word “efficacious,” as these seem to me to be nearly synonyms. Is there some distinction that I’m not getting?

Just for the record Orac, how many deaths does it take to make a flu a pandemic? How many deaths could one normally expect from seasonal flu, in say, California? Michigan?

I understand the Southern Hemisphere went through their winter (flu season) with only 17 deaths instead of the predicted thousands.

Thank God for the vaccine.

Except they didn’t have it. No-one did, until Sept and Oct 2009.

P.S. Are you the same Orac who got his clock rewound in a right-royal smackdown by Steve Harris?

I believe one reason that Tom Jefferson is so hyperbolic when speaking to journalists is his work is painstaking and frustrating. At the rate he dismisses research for weak methodology and insufficient data, he certainly must be a frustrated man. He’s possibly just letting some steam out when he gets a chance. I haven’t heard him really complain about being ostracized.

I am currently building a blog/website (in french) with information about vaccination. My ambition is to make it a place where parents can come and get the information they need to figure things out by themselves. Tom Jefferson is an interesting figure for me because his credibility can appeal to a broad range of people. On the one hand, his own review work has led him to conclude that current evidence does not support a MMR/autism link. On the other hand, his outspokenness against financial interests makes him appealing to all but the most radical fringe of the anti-vaccination movement. His real achievement is the published work. So what if he acts like a real-life Dr. House with journalists.

“This statement is the purest rubbish (to paraphrase Tom Jefferson himself). Indeed, such a statement is pure methodolatry. That’s because an RCT is not the “only” way to know if a flu vaccine works.”

This and your statements on this point is totally wrong. Just think of Vioxx. Without RTC the risk would never be known! Unethical is the actual situation of recommendation without proof of less harm due to the vaccine than due to the illness.

You argue a lot about the behaviour of the “man” Jefferson, but your scientific argumentation is poor, apart your strong belief in the flu vaccine.
See also: http://archinte.ama-assn.org/cgi/reprint/165/3/265.pdf

The influenza vaccine is not Vioxx, which was a useful painkiller for those without certain health issues. What you need to do is explain more carefully the issues about the flu vaccine itself, using the entire body of literature, not one cherry picked paper (especially since the novel H1N1 has been hitting a much younger population than those in that paper):
http://www.sciencebasedmedicine.org/?p=2495

#123 I support unadjuvanted alum-based vaccines for this epidemic and some of my family is already vaccinated with same.

Dude, alum is an adjuvant.

On some less-detailed maps their layout looks similar except they’re inverted relative to one another and there isn’t always a sign telling you you’ve crossed the border from one to the other. I once was using a map to navigate.

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