flu confusion blog

Flu shots for pregnant women: proof of effectiveness?

Wed, 13 Oct 2010 05:36:26 -0400

News reports last week featured a study that apparently showed that flu vaccine for pregnant women decreases flu by 41% in their babies.

I’ve read this study. There are many serious problems with it:
1. The primary outcome chosen by the authors was Influenza-like-illness (ILI). OK. But if you look at the results, they tell you “No statistically significant associations were found between maternal influenza vaccination status … and ILI occurrence.” For the statistically literate out there, you can look at table 2 and see the confidence interval goes through one. In any case, the authors themselves are saying flu vaccine made no difference for their primary clinical outcome.
2. This is not a randomized clinical trial (RCT), which is the standard and normally the legally required way to show that a medical treatment works. The authors claim they could not do a RCT because “influenza vaccination of all pregnant women is recommended.” Who is it recommended by? The CDC and federal flu experts. Who is funding and doing this study? The CDC and other flu experts. So this is absurd circular reasoning. They recommend it without rigorous testing, but forbid rigorous testing on the basis of the recommendation.
3. This was not a blinded study. In rigorous clinical studies, doctors and patients don’t know who got the treatment.
4. This was not a placebo-controlled study. Based on other studies of flu vaccine, part or all of its impact is as a placebo. A rigorous study would control for this.
5. Instead of doing a blinded placebo-controlled RCT, they do an “observational cohort.” This is a weaker study design than a RCT. For it to have validity, the authors would need to make sure they are controlling for confounding variables, i.e. whatever might be different between women who choose to get flu shots and those who don’t, if that difference could have an impact on infant health. There is a long list of things like this that would be relevant: prenatal care, prenatal vitamins, going to the doctor in general, taking care of oneself in general, alcoholism, illegal drug use, poverty, literacy, family support, nutrition, obesity, diabetes, etc. None of these were controlled for. Without controlling for all these things, it is hard to believe that the only difference between people choosing and not choosing a flu shot is the flu shot. Thus any benefit from flu vaccine found in the study would likely be in reality a benefit of a healthier overall lifestyle.
6. Smoking would be an obvious thing to control for, and they talk about that, but they only measured it by self-report and they didn’t control for smoking in their analysis, because they said it didn’t matter for infant outcomes of respiratory illness in this population. This is fishy. This would be a major discovery by itself, that somehow passive smoking does not affect infant respiratory health. The fishiness of this finding makes the rest of the study suspect. The bizarre finding is not explained.
7. They included in their study only infants who were born healthy and on time. If the point of the study is to determine the safety and effectiveness of flu vaccine in pregnancy, this is crazy in my opinion. One of the concerns about any drug in pregnancy is if it increases miscarriages or has other unknown effects. Their study was unable to look at this because they only enrolled people after delivery of a healthy baby. Babies at highest risk of problems with respiratory illness are those who are born premature or with other problems. Excluding them excludes the group that should presumably benefit the most from the vaccine. I don’t understand that.
8. Much of the paper is devoted to reporting on blood tests of various kinds. These are not clinically relevant outcomes.
9. Flu vaccine status “was based on medical record review or, if missing, by maternal report.” Basing the major variable on self-report is weak.
10. Outcomes were limited to the flu season. This is something commonly done in flu studies, but it is silly. People don’t live just during flu season. The flu vaccine’s biological effects do not stop after flu season. If flu vaccine decreases outcomes during flu season but increases them the rest of the year (as has been found in previous flu vaccine research) then we need to know that.
11. They claim a 41% decrease in hospitalizations for ILI, and if that were real, that would be great, but with all the weaknesses listed above, it is hard to interpret that. Hospitalization and death are “hard” outcomes. Death is not mentioned at all, presumably because there were no deaths. There were 193 ILI hospitalizations total in the 1160 infants. 1 out of 6 people getting hospitalized for flu sounds like an awful lot. This suggests that there is other stuff going on in this population (that should be controlled for). It also indicates that probably not all these hospitalizations were from flu. After all, if the flu vaccine failed to decrease ILI overall (see point 1 above), how would it decrease ILI hospitalizations? They need to look at all-cause hospitalizations to make sure we’re getting an accurate picture of what’s going on. This would be a standard thing to do in any test of any medicine, otherwise you get these problems like with Avandia that was in the news recently because it supposedly cured one problem but was causing increased death and disease from another.
12. The study was done on Navajo and Apache reservations. Nothing against Navajo or Apache people, but these groups may not be representative of the whole U.S. population, so the results may not be generalizable, especially without controlling for numerous environmental variables.
13. The study was partially funded by a vaccine company. A ton of research on medical journal articles indicates that this would bias the reporting of results in the direction of finding a benefit from the vaccine.
14. In the accompanying editorial, the authors disclose no conflict of interest but at least one of them has received funding from flu vaccine companies. (See image above re Dr. Neuzil receiving funding from Sanofi and MedImmune.) Maybe by some technicality it is OK for her not to disclose this here, but if her career is built on support from the flu vaccine companies, then this seems to me like the kind of thing one is supposed to disclose with an editorial that emphatically promotes flu vaccine.

We have spent billions of taxpayer dollars on flu vaccine. If we don’t know whether flu vaccine for pregnant women prevents illness in their infants, then wouldn’t it be good to fund unbiased researchers to do a real clinical trial to answer the question, and then make a recommendation based on scientific evidence???????

Note: the article and editorial mentioned will be in the Feb. 2011 issue of Archives of Pediatrics and Adolescent Medicine.

Disclaimer: This blog is a commentary on news items about flu. It is not intended as individual medical advice. Please consult a well-informed health care professional for your personal medical concerns.

The herd returns

Tue, 28 Sep 2010 09:39:36 -0400

Flu news died down over the summer, but now it’s flu-shot season and the stories have returned. One thing that made national news was that the American Academy of Pediatrics wants to mandate flu shots for medical care workers. I recently debated this in a public forum with another pediatrician, and there were a few new points brought up, so I’ll try to address those.
Before I start, let me clarify that I do think it is very sad when a child dies of flu or anything else, and that I understand the emotional reaction to want to do something about it. However, that emotional desire for a remedy does not constitute proof that the proposed remedy works. Good intentions don’t equal good interventions. The history of medicine includes a long series of deadly disasters caused by well-meaning doctors.

1. The first point made by my detractor was that the research studies and evidence-based reviews I cited didn’t matter because this doctor had his own “personal evidence-based medicine” based on his anecdotal experience. In other words, we should go back in time to the age of quackery when doctors just did whatever they wanted to regardless of what any science showed. Do I even need to argue against this point?
2. What was his personal evidence? He has seen children die of flu. So, he was vaccinated against flu but his patients died anyway. Somehow he sees this as proof that vaccinating doctors prevents patients from dying, when actually this is evidence in the other direction.
3. Acknowledging that studies show no effect from vaccinating healthcare workers (HCWs), he claims the reason they show no effect is because not enough people are immunized and so there is no herd immunity. This appears to be the new talking point from the vaccine industry because it keeps popping up in the media. Herd immunity is the idea that if you vaccinate a high enough percentage of the population, you can stop transmission of an infection so that even people who are not immunized will be protected from the disease. That’s wonderful. The problem with bringing this up as an argument for giving everyone flu shots is that the assumption behind herd immunity is that the vaccine works. If the vaccine doesn’t work, it doesn’t matter how many people you give it to. Giving it to more people won’t make it work better. In the studies I was referring to, the research design was to give shots to all the HCWs AND all the patients in a nursing home. It still didn’t make a difference. If vaccinating HCWs doesn’t work in a highly controlled situation in a small study population, why would it work by scaling up this program to the whole country?
4. One of my points had been that the experts who promote flu vaccine often have financial ties to Big Pharma, so their opinions are biased, but most practicing doctors just accept what they say without looking up the primary research. My opponents’ response was there might be greed somewhere in Big Pharma but that pediatricians don’t profit from vaccinating children. Whether or not this is true, it was completely off topic. The original question was if vaccinating doctors protected children and had nothing to do with the reimbursement to doctors for vaccinating children. His retort was a red herring to dodge the issue of whether he had actually ever looked at the science. Presumably he hasn’t.

When facts don’t fit with the theory, you have to throw out the theory.

Disclaimer: This blog is a commentary on news items about flu. It is not intended as individual medical advice. Please consult a well-informed health care professional for your personal medical concerns.

The verdict on the swine flu vaccine of 2009?

Wed, 7 Jul 2010 06:03:41 -0400

The Associated Press recently ran another article about tens of millions of swine flu shots expiring and being incinerated. The bottom line of the article was that this was somehow normal and to be expected--a necessary part of having enough flu vaccine to protect us just in case.

The official European government investigations into possible malfeasance by the WHO allegedly making a false pandemic declaration to sell vaccine were referred to as “some commentators attacking the WHO.” This seems like something of an understatement. One commentator they quoted was Prof. Ulrich Keil of Muenster, Germany, seen above pointing at meat for some reason, who said that the flu was not as big a priority as other health issues.

This sort of dueling experts controversy is typical for mainstream media reporting and does not really help the cause of creating an informed citizenry. It just confuses things by making it seem that no one understands anything. Reality exists. It is extremely dangerous to act as if it doesn’t.

Many of the statements in the article were verifiably true or false. They could have and should have been truth-checked. For example, did swine flu vaccine prevent death and disease? This is not a matter of personal opinion. I can understand maybe how a year ago, in the hight of the “pandemic” frenzy there was a rush to jump to conclusions, but by now there should be one medical reporter in the world who has caught up on the subject. At what point do we get sober analysis by someone who has actually examined the science of the issue instead of merely parroting talking points?

Disclaimer: This blog is a commentary on news items about flu. It is not intended as individual medical advice. Please consult a well-informed health care professional for your personal medical concerns.

Obama’s one achievement: flu vaccine?

Fri, 2 Jul 2010 06:50:53 -0400

David Axelrod, President Obama’s Senior Advisor was on The Daily Show this past week [yes Comedy Central is my only source of TV news]. When challenged on the competence of the Administration, the one thing Mr. Axelrod pointed to was the H1N1 vaccine program, which he implied had prevented an epidemic. ????????????? In Europe, as reported here the last few weeks, political leaders are investigating the leaders of the “pandemic” vaccine campaign for fraud and incompetence. Not only are we not having similar investigations here, but the president is holding up the Swine flu campaign as a model of effective government. Here or there, somebody is seriously divorced from reality.

Disclaimer: This blog is a commentary on news items about flu. It is not intended as individual medical advice. Please consult a well-informed health care professional for your personal medical concerns.

WHO profits from redefining “pandemic”?

Sun, 13 Jun 2010 16:21:52 -0400

Last week the Council of Europe report on the 2009 pandemic scare was released. I read it. Much of it is stuff that I’ve reported on here before so I won’t go into it in detail, but it is nice to have official vindication, especially for the most unbelievable items, like the WHO changing the definition of “pandemic” (by taking out the part about severity) just before they declared a pandemic.

The author of the report, Paul Flynn, seemed to be particularly outraged by this, especially in the context of “sleeper contracts” that various nations had with the vaccine companies, obligating them to buy vaccine if the WHO declared a pandemic. Billions in profits were made on the special “pandemic” vaccine, which was 3 times more expensive than regular flu shots. There was thus a gigantic financial incentive for someone to declare a pandemic whether there was one or not. It is extremely suspicious that the WHO refuses to say who was on the emergency advisory committee that made the decisions about pandemic levels, etc. Mr. Flynn’s request for transparency in this area seems entirely reasonable.

Flynn also points out that there are far-ranging harms caused by crying wolf over non-existent pandemics, like wasting money, scaring people for nothing and diminishing confidence in warnings when there is a real threat.

The report zooms in on the UK, France and Poland as three examples of what happened in Europe. Poland was particularly interesting because the health minister refused the contracts offered by the drug companies with the very high prices and the transfer of liability for side effects to the Polish government. France and other European countries are doing national-level investigations into the apparent corruption and incompetence in the management of the “pandemic.”

Ironically, while I am not aware of any such investigation here, the leader appointed by the WHO as an outside reviewer of this issue is an American, Dr. Harvey Fineberg, President of the Institute of Medicine, who was mentioned in this blog previously as the author of the report on the 1976 Swine Flu fiasco.
A look over here at home would be relevant because there is direct personnel overlap between the WHO flu leadership and the CDC.

Disclaimer: This blog is a commentary on news items about flu. It is not intended as individual medical advice. Please consult a well-informed health care professional for your personal medical concerns.