Effect Measure

There are multiple trials of swine flu vaccine in different countries and involving different subpopulations. Recent news strongly suggests that — surprisingly — a single dose of viral antigen (i.e., one injection) may be sufficient to raise antibody against swine flu to protective levels. There are a lot of uncertainties here, but the data have been fairly consistent. But that’s for adults (over 18 years old). Since children are also had high risk, there is much apprehension whether a single dose will also work for children. Now we’re getting some of the first results and the news is good and not quite so good. Here’s the short version. If you’re over ten years old, one shot might do it. If you’re under ten, it looks like you’ll need two (but if you’re under ten and sitting at computer, you’re probably playing video games and not reading this). Since this news is all over the wires you don’t need to read it here. So instead of talking about flu news, we’re going to discuss meta flu news, i.e., observations about how this news is disseminated. We use the word “observation” because it’s not a scholarly study, but just, well, an observation. We have a small, but significant, sample: stories written by excellent and knowledgeable science journalists.

First the news report that is certainly authoritative, the NIH Press Release upon which all the stories are based. Here’s the lede and a subsequent paragraph:

Early results from a trial testing a 2009 H1N1 influenza vaccine in children look promising, according to the trial sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Preliminary analysis of blood samples from a small group of trial participants shows that a single 15-microgram dose of a non-adjuvanted 2009 H1N1 influenza vaccine – the same dose that is in the seasonal flu vaccine – generates an immune response that is expected to be protective against 2009 H1N1 influenza virus in the majority of 10- to 17- year-olds eight to 10 days following vaccination. These results are similar to those recently reported in clinical trials of healthy adults. Younger children generally had a less robust early response to the vaccine.

“This is very encouraging news,” says NIAID Director Anthony S. Fauci, M.D.” As we had hoped, responses to the 2009 H1N1 influenza vaccine are very similar to what we see with routinely used seasonal influenza vaccines made in the same way. It seems likely that the H1N1 flu vaccine will require just one 15-microgram dose for children 10 to 17 years of age. The 2009 H1N1 influenza virus is causing widespread infections among children, so these are welcome results.” (NIH Press Release)

You have to read a couple of more paragraphs, almost halfway through before getting to this:

The immune responses in children nine years old and younger were not as strong. Among 25 volunteers aged 3 to 9 years old, a strong immune response was seen in 36 percent of those given 15 micrograms of vaccine. In the youngest group, 20 children between 6 months to 35 months old, a single 15-microgram dose of vaccine produced a strong immune response in 25 percent of recipients.

“These results are not unexpected and are both similar to what is seen with seasonal influenza vaccines and consistent with what we and our colleagues at the Food and Drug Administration anticipated,” notes Dr. Fauci.

Now here’s the lede from one of the world’s best flu reporters, the Canadian Press’s Helen Branswell:

The first clinical trial of swine flu vaccine in children suggests that those 10 and over will only need one shot of the vaccine, but children under 10 will need two doses for protection, U.S. officials said Monday as they released interim data from the study.

That dosing regime follows the pattern used for seasonal flu shots, where two doses are recommended for children nine and under if it is the first time they are getting a flu shot. (Helen Branswell, Canadian Press via Toronto Sun)

And Science Magazine’s Science Insider blogger, Jon Cohen:

Early results from clinical trials suggest that healthy children under the age of 9 will likely need two doses of the swine flu vaccine, but those between 10 and 17 can get by with a single shot, U.S. health officials announced today. (Jon Cohen, ScienceInsider)

Here’s Richard Knox, from NPR:

Ten days after the government announced the new pandemic flu vaccine works better than expected in adults, officials say it performs well in kids too.

But kids under 10 are not going to get away with just one shot or just one squirt in the nose, officials say. (NPR Health Blog)

And Maggie Fox (Reuters):

WASHINGTON, Sept 21 (Reuters) – Younger children will need two doses of the vaccine against the new pandemic of H1N1 influenza, U.S. officials said on Monday.

They said tests of Sanofi-Pasteur’s (SASY.PA) swine flu vaccine showed children respond to it just as they do to seasonal flu vaccines, with children over 10 needing only a single dose. (Reuters)

Here’s my point. Each of these experienced science journalists rewrote the NIH lede to emphasize the good news that one shot for the over tens was sufficient but that for their younger sibs it would take two. NIH portrayed that as meaning things are just like seasonal flu (where two shots for those first immunized under ten are also used), and that’s technically correct. But that wasn’t the real news buried halfway through the press release.

I’ve spent a lot of time here complaining how so much science reporting I see everyday is barely massaged press releases regurgitated by reporters acting as stenographers. So I wanted to make sure to say — again, because I’ve said it a lot here — that there are some really good science reporters out there that don’t do that. For the ones I didn’t mention I apologize. It’s one of the hazards of mentioning any. You inevitably leave out more just as deserving. But you know who you are and so do we. And we’re glad some of you are still around.

Addendum, 7 am, 9/22/09: Compare the above with the lede by “staff writers for Agence France Presse”:

US health officials announced “more good news” Monday in the fight against swine flu, saying clinical trials have shown that a single dose of H1N1 vaccine will be enough to immunize healthy older children.

“Preliminary data from our trials indicate that a single 15-microgram dose of vaccine is well tolerated and induces immune responses in most older children that is generally predictive of protection,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (NIH), told a news conference.

“Among healthy children aged 10 – 17 years old, 76 percent had a robust immune response” eight to 10 days after being given a single shot of a vaccine made by French manufacturer Sanofi Pasteur, said Fauci.

The announcement came 10 days after US health officials announced that a single dose of swine flu vaccine could be enough to immunize healthy adults aged 18-64 (“One swine flu shot enough for pre-teens, teens: trials”, AFP)

AFP is a frequently unreliable wire service, but what we see here is all too typical of science and health reporting in general. It’s a rewrite of a press release, following the same emphases and little thought as to what was really news.

Comments

  1. #1 George T
    September 22, 2009

    Hey, these are nothing. Yes, they have problems, but I’m in the computer industry. Any time the press writes about it I’m usually just shaking my head on the errors and misleading information. Like 1 in 50 articles are factual.

  2. #2 Jason Dick
    September 22, 2009

    Man, that AFP report was just bad. I mean, you’d think that reporters would know how to, well, report! That half-assed job either means they really don’t care, or they really didn’t understand a word of the press release.

  3. #3 davincispb
    September 22, 2009

    What do you make of the publicity being given by Newsweek about Laurie Garrett having “swine” flu? In reading the article, Garrett herself comes out and says she hasn’t been diagnosed with swine flu but she’s sure that’s what it is and then she goes on about how devastating a swine flu pandemic would be.

    My point of contention is Garrett is a well known writer, most well known for her book The Coming Plague. She’s also a senior fellow at CFR. I feel she shouldn’t be, basically, fanning the flames of the public’s fear about this misnomered flu since she herself admits that she hasn’t been diagnosed with anything but she just feels bad.

    There are enough things for people to be worried about without a writer in a major news weekly going around intimating that she’s sick. The inference is “If someone like Laurie Garrett can get this flu, how do you think you are going to protect yourself and your family from it?”

  4. #4 revere
    September 22, 2009

    davicnic: Ms. Garrett has been writing about this from a particular point of view for a long time and she is not only knowledgeable but was among the first to call attention to a global lack of awareness and preparation. No one can say for sure if her illness is swine flu, but if it’s flu that’s pretty surely what it is and there is no testing being done now (for reasons we’ve explained here many times). So I am not bothered by it. There are various points of view on this and we all express them differently, but I don’t see anything that crosses the line. We are in unchartered territory and she is as qualified or more so than most people talking about it. We’ll all know soon enough.

  5. #5 miso
    September 23, 2009

    Clearly I’m not looking for articles that lull me into a restful sleep at night, safe in the belief that the Hypocratic Oath is recited at each big pharm board meeting.

    PrisonPlanet.com translated the German source (http://www.merkur-online.de/nachrichten/muenchen/schweinegrippe-impfung-testpatient-packt-meta-451084.html) of more disquieting news.

    “Axel Sch., a 40 year old man with a degree in business, enrolled for the “swine flu” clinical trials at Munich’s Ludwig-Maximilians-University led by Dr Frank von Sonnenburg.

    After receiving an injection on August 10th he became seriously ill.

    “The injection made me sick – the test is irresponsible,” he said.

    He felt the impact just a few hours after the injection, he said.

    “I felt totally shattered. On the third day, I felt pain in my kidneys and head and I got a fever. Then I had a coughing fit – and my washbasin was suddenly red. It was blood.”

    Sonnenburg has denied the patient’s claims, but good clinical practice requires a doctor to include all the side effects, no matter how serious to avoid falsifying data.

    The failure of Sonnenburg to acknowledge the report of Axel Sch. raises serious questions about just how independent and valid the clinical study results on this new and untested vaccine material with adjuvant can be considered.

    It appears that the vaccine material being tested on Axel Sch. was from GSK which has produced a swine flu vaccine using the oil-based adjuvant containing squalene.

    GSK issued a press release on Monday 14th September maintaining that a one dose “swine flu” vaccine with adjuvants had proved successful in its first clinical trials in Germany. Source .

    In other development German anti corruption watchdog criticises key government vaccine body for links to big pharma. ”

    http://www.prisonplanet.com/h1n1-swine-flu-vaccine-makes-german-man-extremely-sick-during-clinical-trials.html

  6. #6 Magpie
    September 23, 2009

    Prison Planet, man. Seriously, what are you even doing in that dank hole of seething crazy?

    …but in any case, this article is talking about the scary adjuvant (Squaline! FLEE!!!), which the tests that Revere discussed wasn’t using. And if Sonnenburg “denied the claims” – whatever that means – then that’s easy to follow up (for people who speak German). How would this bloke know that his data wasn’t included, anyway? If the newspaper (or whatever it is) has the report, wouldn’t they quote from it? So a guy says “that doctor totally rolled his eyes when I told him about my blood cough” – well, maybe he did, but does that mean the doctor didn’t include it in the figures?

    …and finally, some adverse reactions are expected for any medical intervention. If my pill saves a million lives, but makes one person on earth explode in a gout of purple flame, it’s still a good pill.

  7. #7 revere
    September 23, 2009

    miso: Prison Planet? If that’s where you get your info, don’t bother passing it on here. Pass it into the toilet, which is where it belongs. Even reading that site causes brain damage.

  8. #8 Tom
    September 23, 2009

    Just read the original German article. On Sonnenberg, the article states: “Sonnenberg does not want to believe the claims of the patient [that his reaction are due to the vaccination]: ‘Such side-effects cannot be related to the vaccine.’

    This doesn’t mean that the reactions will not be included in the report. As far as I can tell from the article, the study has just finished so there wouldn’t be a report yet.

    Personally, I think the claims that the test is irresponsible are bullshit. The article has the inane sentence: “Has the vaccination substance been included in the study too soon? Fact is, it hasn’t been used on humans in this composition yet.” No, duh. That’s why they are doing the study bozos!

    Regarding the side effects, the German study examined two vacciations, one with and one without adjuvants. From the article it isn’t clear in which group Axel Sch. was placed. Second, there are still clinical trials to follow before the vaccine is approved, all over the world with about 9000 study subjects. If more people get a violent reaction, we will hear about it.

  9. #9 albatross
    September 23, 2009

    Does the same result hold for the live-virus up-the-nose vaccination? That is, kids under ten will need a second dose? Or has this been looked into enough to know yet?

  10. #10 Marilyn Mann
    September 23, 2009

    Revere

    I was wondering if you could address the argument that healthy young people and adults would be better off not receiving the flu vaccine because it will prevent them from acquiring long-lasting natural immunity that would protect them from coming down with the flu when they become elderly.

    Thanks,
    Marilyn

  11. #11 miso
    September 23, 2009

    Tom,
    Careful Roche stooges don’t like my posts, even when I’m bagging GSK. Not fair questioning the ethics of big pharma; GSK might be someones next funding source.

    Big pharma stooges,
    I read Prison Planet for the first time in response to a word search using Google News. I don’t have a boss that tells me what I can read, or what I can post, and since I do the filtering myself, and don’t rely on a PR firm, or a respected blog site to do my thinking for me, I’m far from susceptible to brain damage.

    There was a German link and a credible story.

    The story is that someone was selected to help determine the safety of a medicine based on his and many other peoples observation, and instead of letting statistics do their job and deciding if he was a fruit case, or whether he represented millions like him that would react in the same way so that further testing would be required, his data was passed into the toilet by discerning science men like you and m….well like you. As reasonable as flushing out Prison Planet sources?
    Just so GSK could report what a resounding success their vaccine is.

    It’s nothing new, but at least Gilead didn’t flush Tamiflu resistant influenza results in the first Tamiflu trial, they did the next best thing, they announced that tamiflu resistance,(H274Y)was harmless, instead of proving it was harmless, or was that an inconvenient test that got passed into the toilet?
    Anyway, it’s turned out well, Roche has the money to “prove” that careless victims cause Tamiflu resistance, and the money to cancel funding to anyone who says different.

    revere,
    whether you ignore me or respond to my posts you never fail to live up to my expectation.

  12. #12 glock
    September 23, 2009

    FWIW
    Here in Fl. we hear that SF is rampant in the schools and my significant others’ granddaughter (5 years old) starting coughing with a mild malaise was sent home from school, went to the doctor that said it was probably a cold, did a swab and said she had “swine flu”…Ok, got Tamiflu (not easy BTW) and she basically was never “sick” stayed home from school drove everyone nuts (high energy kid) but that was it.
    Today her sister (8years old) went to the nurses office, sore throat, NO cough, slight malaise, sent home, off to same doctor, swab, SF diagnosis again, (as of now 4hrs later she feels fine- no Tamiflu prescribed)
    Since my SO took her to the doctor as well, she decided to get herself swabbed, while she was there, she too got SF diagnosis, She’s felt a little “funny” but no temp, no cough, slight headache, blah blah blah….

    I guess I’ve got lots of questions…. were diagnoses of SF possible ? could it just as easily have been another ILI or bug that wasn’t the seasonal flu or if not, does any exposure to SF without symptoms also confer immunity?

    These are 3 cases that could almost be excused as NOTHING at all.
    Mild is to strong a word here.

    How many SF cases are really going unnoticed and uncounted?

    I’m getting a headache and post nasal drip just writing about this…….

    But a vaccine? Not from where I sit.

  13. #13 Magpie
    September 24, 2009

    Glock: where do you live? Some (most?) places don’t bother testing for swine flu any more, since it’s pretty much assumed that flu will usually be swine flu (that is, some testing will be done to make sure this is still correct, but general testing is not being done).

    What was the time from swab to diagnosis? Because if the diagnosis was at the time of consult then I very much doubt they had time to test. You need a lab for that.

    Regarding the mildness: 5 out of 6 players of russian roulette suffer no ill effects whatsoever. Doesn’t mean it’s safe to play. Thing about flu, it hits a LOT of people. So even if it only kills one in ten thousand, that’s still a lot of deaths from a national or global level. If your vaccine, given to the general population, saves 2 thousand lives, that’s great, isn’t it? Even if you, personally, probably weren’t saved, someone definitely was. It’s not just stopping you getting it, either – it’s stopping you from passing it on, too. Which means fewer ten-thousands to get infected, and fewer ones to die.

    (*Note that the numbers above are entirely made up for illustrative purposes. I have no idea what the actual death rate is).

    It is generally accepted that most swine flu cases are uncounted.

    Miso: …his data was passed into the toilet by discerning science men

    Here’s a crash course in assessing the reliability of your source: notice that they do not actually SAY what you just said they did. They IMPLIED it. If they could have said it, they would have. All they actually have, all the data, is that a guy said that a doctor said his reaction couldn’t be from the vaccine. That’s it. Third hand, inconclusive eye-rolling. There’s nothing to show that the reaction won’t be included in the report. Nothing. Just speculation.

    Note, too, that there are LOTS of tests of this vaccine, and it’s getting rolled out right now in multiple countries around the world. Do you seriously think that “blood vomit” is going to be missed, if the vaccine causes it? Of course not. So what the hell would be the point of “big pharma” from “covering it up”? This isn’t some hard-to-quantify, easy-to-cover-up effect like depression or cancer, it’s BLOOD VOMIT within a few hours of the injection. I think people will notice.

    I don’t think for a minute that “big pharma” is some shining example of the beauty of the human spirit – I wouldn’t put any evil shit past them to be honest – but they’re not retards. Even if they COULD suppress test results like this, it would be completely pointless and stupid, since it’d all come out in the next couple of weeks, and there would be hell to pay. Even if you believe in this vast conspiracy, surely you can see that it only remains a profitable conspiracy as long as they DON’T stick up a big “haha tricked you” sign.

    If you’re going to be a tin-foil-hat wearer, at least try to be a bit more sophisticated about your gullibility. Some stuff really doesn’t make any sense, from any point of view.

    And FFS, Prison Planet is running a story that US troops are occupying America, which is in a state of martial law. If you believe this is a reliable news source, I’m not sure there’s much point arguing with you.

  14. #14 Tom
    September 24, 2009

    Miso, two things:
    1) I am not defending unethical behavior. I am pointing out running tests first before wide dissemination of the vaccine is ethical behavior. At some point you have to test on a small group of humans, before using the vaccine on the whole population. Sometimes unexpected things happen, this is the reason for testing. If you have a better idea, let me know. Otherwise shut up. The vaccine isn’t released yet, this was the first test of many before the vaccine is released. The German story was sloppy on that point.

    2) The German article stated that the primary investigator did not believe that the complaints of the subject were related to the vaccine. This does not mean that they were not included in the report. For that, you would need to read the report, the article makes no mention of whether it is in the report or not.

  15. #15 Marilyn Mann
    September 24, 2009

    http://www.equipocesca.org/wp-content/uploads/2009/09/swine-flu-vaccines-gervas-and-wright-sep-2009.doc

    The attached link takes you to a document by Juan Gervas and James Wright. Among other things, they advance the argument that by giving people the flu vaccine you could be preventing them from acquiring long-lived natural immunity that could protect them from flu strains that may circulate in the future. In other words, the idea is that immunity acquired from the flu vaccine is short-lived whereas immunity acquired from exposure to the flu virus can last for decades, potentially protecting people in their old age when they are more vulnerable to morbidity and mortality from the flu. I know very little about flu or flu vaccines, so I am wondering if there is any validity to this argument. In the case of the swine flu, it does appear that people born before 1950 are less likely to get sick, perhaps because of exposure to a similar flu strain that circulated when sometime in the 1950s (I don’t remember the exact dates).

    Just to be clear, I am NOT advocating the arguments in the attached document. I am just trying to educate myself on these issues.

    Thanks!

  16. #16 glock
    September 24, 2009

    Magpie
    Glock: where do you live? Some (most?) places don’t bother testing for swine flu any more, since it’s pretty much assumed that flu will usually be swine flu (that is, some testing will be done to make sure this is still correct, but general testing is not being done).

    I live in FL orida, the diagnosis was made in about 15 min. in the office, and the gist of my question how was :

    1.How was THAT diagnosis made? (We ALL KNOW that MOST cases are assumed to be SF at this point- What type of rapid test was most likely used? and what did tell or NOT tell him?) The test would give the doc one bit of information and that would need to added to the observational and patient information (that was minimal or marginal at best) to come to the conclusion. (This is essentially what happened in the 3 cases I have personal 1st hand knowledge of).

    My inferred question is, is SF over diagnosed and/or under reported in the current environment? [probably] and how does it shift the risk assessment for vaccination.

    2. If one has the almost unnoticeable symptoms mentioned and in fact is assumed to have been exposed, does the severity of the bout have any bearing on future immunity? And so is there a LOT more naturally acquired immunity out there? I myself would rather use that, than hastily tested adjuvants.

    I am not advocating non-vaccination, I’m mulling over non-OVERvaccination.

    FWIW, for an upcoming trip my local travel-medicine clinic suggested 5 vaccinations….. my assessment was 2. I’m not motivated monetary compensation because I can make a plausible case for certain levels of protection that don’t REALLY apply…..

  17. #17 Kausik Datta
    September 27, 2009

    @Marilyn at 15: I see that you have posed the same question at the Science Based Medicine blog also. Someone far more knowledgeable than I am would perhaps address this question of yours. Meanwhile, let me share my thoughts on this.

    the strategy they propose requires subjecting oneself to an immediate increased risk in order to reduce a future risk

    This is similar to the ridiculous ‘pox parties’ anti-vaccination parents often subject their children to in this country. You suspect rightly that there is a fallacy in the arguments of messrs. Wright and Gervas. There are, in fact, two.

    First, the 2009 H1N1 strain has been seen to cause disease with lethal outcomes in several countries. In fact, according to CDC,

    2009 H1N1 influenza virus seems to be causing serious health outcomes for:
    1. healthy young people from birth through age 24;
    2. pregnant women; and
    3. adults 25 to 64 who have underlying medical conditions.

    Note that ‘healthy young people’ bit, and in addition, the bit about ‘underlying medical conditions. In such a situation, it is extremely irresponsible to suggest that people should deliberately let themselves be exposed to the virus.

    Secondly, the question of ‘long term immunity’ is a moot one. There is no evidence that exposure to the 2009 H1N1 flu virus provides better immunity than the vaccine. Besides, given the genomic changes that the flu virus undergoes, it is highly unlikely that one time exposure (as also vaccination) will provide immunity against novel flu strains that may occur in future. For example, the 1976 swine flu virus and the 2009 H1N1 virus are different enough that a person vaccinated in 1976 cannot have full protection from the 2009 H1N1, and should be vaccinated for the 2009 strain.

    Vaccination remains the best way to prevent influenza infection and its complications, and is the best public-health tool available. Pretending otherwise, as messrs. Wright and Gervas are doing, is disingenuous, and dishonest at worst, and misinformation such as this seriously impacts public health, since the situation is of great concern; as estimated by the CDC, more than one million people became ill with novel H1N1 flu between April and June 2009 in the United States.

    FDA has just approved four 2009 H1N1 vaccines earlier in September. Based on preliminary data, the approved vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose.

    I don’t know enough about the topic of flu or flu vaccines

    There is an easy remedy to that. Do go and explore the H1N1 pages at CDC. They are very informative for a starter.

  18. #18 Marilyn Mann
    September 27, 2009

    Thanks Kausik. Just to clarify, Drs. Gervas and Wright are not (so far as I know) advocating that people *deliberately* seek to infect themselves with swine flu, as is the case with parents who organize “pox parties.” Rather, they are advocating that people forgo the H1N1 vaccine, which could in the ordinary course result in those people coming down with swine flu. If, as you say, there is no evidence that immunity acquired from exposure to the H1N1 virus provides longer-lasting immunity than the H1N1 vaccine, then of course their argument makes no sense at all. Even if exposure to the virus *did* provide longer-lasting immunity than the vaccine, that would just be one item to consider when weighing risks and benefits, and it would not necessarily mean one should not be vaccinated.

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