Last week I was asked to give a lecture to the Cardiology Department at Emory and since I had been having an online schermish about the topic I offered “Why I Am Not Getting a Flu Shot This Year“. Well, flu shots are mandated for Emory Healthcare employees so I guess that raised some eyebrows, and I got a call at home asking why I wanted to give a talk about that. After some back and forth I said that I would be willing to give up half of my time, and infectious disease expert James Steinberg MD arrived at the lecture. I presented the fact that randomized controlled trials (RCTs) did not show that flu shots reduced time lost at work or mortality, and that the conclusion of the Cochrane Review is that the evidence does not fit with public health policy when it comes to flu shots, as I have written about before. The one group that might benefit from flu shots according to the Cochrane Review is elderly living in nursing homes, although that may due to the ‘frailty bias’ i.e. some are too infirm to get a shot. A recent study in Lancet of the elderly showed that there was a 40% reduction in pneumonia in vaccinated patients that occured during a time when they could not possibly get the flu; it was mostly due to the bias related to functional status. The actual reduction in flu related pneumonia during the peak flu season was only 4%!
He countered with a study showing that they reduced mortality in cardiac patients (he actually presented only one of two, and the combined evidence is negative, as an article in last month’s Lancet shows). He also showed cohort studies, which are prone to bias.
Finally he showed some studies on vaccination of health care workers showing a reduction in mortality of patients when healthcare workers (HCWs) were immunized. I didn’t think we were talking about HCWs, but I guess that is the reason they showed up. We had some discussions about the utility of immunizing all HCWs, even those not around sick patients, so I thought I would research the topic some more.
It turns out that (surprise, surprise) the evidence for the efficacy of flu shots in HCWs is not that great. The only positive studies are in HCWs who are working with the elderly in nursing homes. And even in that group it looks like both HCWs and the patients need to have flu shots. In fact the Cochrane Review concluded that there wasn’t sufficient evidence to conclude that giving flu shots to HCWs was benificial in reducing mortality in their patients.

Today there was the first death in the US from swine flu, a 23 month old in Houston, Texas, and the earliest case found so far was identified in La Gloria, Mexico, a five year old named Edgar Hernandez. Schools are closed throughout Mexico, and the virus continues to spread, with over 150 dead in Mexico (20 confirmed), and 91 CDC confirmed cases in California, New York, Texas, Ohio, Kansas, Indiana. Based on this news we have to consider the possibility of school closings here. Some have already started to close in California, South Carolina, Connecticut and Ohio. Protective masks are flying off the shelves in the US. Oh, and Israel said that the name “swine flu” is offensive to Jews.

Check out this nifty graphic for a world wide map of the spread of the flu and what countries are doing about it.

Swine Flu World-Wide Distribution

The biggest death toll so far is in Egypt, where they are slaughtering all 300,000 of their pigs. That’s a real rational move, considering it is mostly human-to-human transmission anyway. But considering the fact that only the 10% Christian minority have pigs there anyway, they probably figured it was no big deal.

Roche and Glaxo, makers of Tamiflu and Relenza, respectively, are watching their stocks shoot upward with beady little eyes, thrilled that they get to pursue their primary aim of making profits while looking like good guys to boot.

Meanwhile Representative Michelle Bachmann (R-Minn.) suggested that swine flu was a plot of the Democrats to foist national healthcare and increased spending on medical research (hmmm, maybe not such bad ideas after all), taking her cue from yesterday’s rants by talk show host Rush Limbaugh and his unemployed white male fan club. And Republican leader Michael Steele defended the previous Republican opposition to spending in the stimulus bill on preparation for pandemics on the grounds that “it couldn’t have been predicted“. Yeah right, like the breach of the New Orleans levees. Go figure.

As I wrote yesterday, current flu vaccines are not effective against the swine flu, and it will take six months to make an effective vaccine. What is more disturbing is that our wonderful war on terror has not resulted in an ability to manufacture vaccines, with only one site in the US, Sanofi Pasteur, currently able to manufacture vaccines. And those are made from hen’s eggs. Go technology, go war on terror. And with current manufacturing capability we will only be able to make 6 million doses by September, which is 10% of the total needed to vaccinate the population of the US. Which introduces the possibility of rationing. Who should get the vaccine first? Well public officials, of course.

Meanwhile acting CDC Director Richard Besser continues to tell the lie that 36,000 people die every year from influenza and that we need to start thinking about the “conventional flu” vaccine. As I wrote here before (”Flu shots are for idiots“) only half of those really had the flu, those who did were often the elderly who might be immune impaired and unable to benefit from flu shots anyway, and since the flu virus mutates by the time they make a flu shot less than half of the bugs are blocked by the current flu shot. In spite of the fact that experts tell us that flu shots for the conventional flu are a waste of time and money, public officials at the CDC and elsewhere continue to tell us to get them. One thing that is sure, though, is that 34,000 people will die this year from car accidents.

We're sure glad we don't live in Egypt!

Another thing that hasn’t been covered in the media which I wrote about yesterday, and have been harping on since last year, is the fact that some H1N1 strains of flu are resistant to the anti-malarial drug Tamiflu. For instance, as I said yesterday the CDC claims swine flu is susceptible to Tamiflu. But on what evidence? It takes them a week to grow out the virus and see what drugs it is susceptible to. And why didn’t it save that 23 month old in Houston? Is the government continuing its pattern of hyping Tamiflu inappropriately? Maybe the same confluence of commercial interest and misplaced concerns discussed in relation to conventional flu shots described by flu expert Thomas Jefferson a few years ago.

Ominously, vaccine expert David Fedson MD, was quoted today as saying countries are likely to ration their flu shots to their own countries. Since all but one are out of the country, we aren’t looking too good. And we haven’t exactly been nice to France, at least during the Bush years. Can you say “s’il vous plait?”

Dr. Fedson is sitting pretty though, living in France with his second wife and consulting to drug companies. I’m sure he will get his flu shot.

In the news today is an article about the influenza virus which continues to quote the bogus statistics promulgated by the CDC that 36,000 die every year from the flu (half of those are actually “flu-like illness” which is NOT the flu) and panders idiot advice that everyone should get the flu shot. What’s new is that they point out the fact that the number of flu strains resistant to the bird flu drug Tamiflu (oseltamivir) is growing. It’s not just that the makers of Tamiflu, Hoffman LaRoche, are my least favorite drug company, but that I have been predicting for over a year that if and when the bird flu became transmitable to humans, that Tamiflu would no longer be effective because the virus would have mutated (see “Bird Flu Drugs are for Bird Brains” if you don’t believe me). The other anti flu drug in this class is Relenza (zanamivir) which is taken in inhaled form.

The most widely prevalent strain of the flu this year, Type A H1N1, is resistant to Tamiflu. Type A H3N2 and Type B are not. H1N1 can be treated with Relenza if patients can tolerate the inhalation method. If not they can take amantadine or rimantidine, but those drugs don’t work against H3N2 flu or type B flu. Giving two drugs increases the side effects of nausea, nervousness and dizziness.

The actual bird flu, H5N1, was found last year to have been developing resistance to Tamiflu last year, as I had originally predicted, when it was reported that although previously less that 1% of influenza viruses were resistant to Tamiflu, that number increased to as many as 13%. The experts were quoted as saying that they were “surprised” that the virus could mutate to a form that is transmitable to humans and still be viable. However as I had previously pointed out in “Bird Flu Drugs are for Bird Brains” , if bird flu mutated to have human to human transmission, bird flu drugs probably wouldn’t work anymore. But of course that didn’t stop the promotional machine from scaring the living daylights out of people and pumping up sales for Tamiflu.

Our former Chief Weasel in Charge of War Crimes Donald Rumsfeld personally made over a million dollars from the publicity through the stock he owns in the company that developed Tamiflu when the bird flu panic struck, which he promulgated by holding press conferences to tell us that we were all about to die from the bird flu. Remember when, in response to the looting in Iraq a few years back, he said “Henny Penny the sky is falling!” Well he probably said “Don’t worry, Henny, your bird flu drug will protect you.”

Here’s a little virology 101. Bird flu is transmitted from birds to birds, not birds to humans. Actual human infections are pretty rare. And when and if it does mutate into a virus that can be transmitted to humans, the vaccine probably won’t work anymore. What about for the regular flu? Tamiflu (and Zanamivir) are neuraminidase inhibitors; they prevent replication of influenza A and B viruses by interfering with the production and release of virus from cells that line the respiratory tract. They both need to be taken within 48 hours of the onset of flu symptoms to be useful. Although I say “useful” with tongue in cheek; if you get the flu, Tamiflu will reduce the number of days you have symptoms from about seven to about five. Not a very big deal. And in terms of prevention, they cut your risk by about half. I don’t want to take a drug all the time to prevent flu, do you? And if you take it after someone in your house gets sick, it’s too late to prevent the flu.

Not only are drug companies trying get your money, gentle reader, it looks they want to drive you crazy as well. The Japanese drug regulatory agency has reported 64 cases of neuropsychiatric side effects, including “impaired consciousness, abnormal behaviors, hallucinations and other psychological and neurological symptoms” associated with Tamiflu, including two suicides. There have also been reports of seizures. A spokesperson for the manufacturer of Tamiflu, however, denied that there was any association (they always say that—do you ever wonder if they have real people making these comments, or just some virtual online being or avatar or something programmed to say “we see no evidence of an association”)?

In this week’s bmj there is an article by Thomas Jefferson of the Cochrane Vaccine Institute (”Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review“) whom I have often quoted before (”Flu Shots are for Idiots“) regarding the dubious evidence behind policy recommendations regarding flu shots. Now he presents data that studies of flu shots funded by pharmaceutical companies are more likely to be published in prestigious journals than those funded by other sources, in spite of the fact that they have the sample sample size and comparable methodology. He goes on to write:

The study shows that one of the levers for accessing prestige journals is the financial size of your sponsor. Pharmaceutical sponsors order many reprints of studies supporting their products, often with in-house translations into many languages. They will also purchase publicity space on the journal. Many publishers openly advertise these services on their website. It is time journals made a full disclosure of their sources of funding.

A position supported by the staff at Drug Safety and Health News. He goes on to discuss the “impact factor”, a metric related to how many times other authors of journal articles cite you in their articles, which is supposed to be a measure of how good or important your study is. However there is a tendency to cite articles in the big journals like JAMA or New England Journal of Medicine just because we all think that if they got in there they must be really good. What this does is give an advantage to those physicians and researchers who are doing the clinical trials funded by pharma, makes them more cited, enhancing their prestige, and hence even more valuable to their pharma friends. Soon everyone is wining and dining, have a good time, and making more money all around.

Yeah! Let's Have Some Drugs with our Wine!

But you can see how this has a corrupting influence on the practise of medicine. As pointed out in a letter to the editor of Houmatoday.com in Terrabonne Parish, Louisiana, by Dr. Randolph M. Howes (”Death by Peanut Butter or Drugs?”) 50% more people die of prescription drugs every hour than have collectively died from peanut butter.

Hat tip to Dan Abshear.