Finally some clear-headed thinking about flu shots

Just as the media frenzy is reaching a fever pitch about the swine flu (variant H1N1 influenza), the Atlantic has a well-researched and thought-out story about the holes in the data supporting the utility of the flu shots in the first place. Mike Adams has a reasonable, point-by-point summary of the story as well. However, allow me to summarize the fundamentals of the story:
  • While the influenza vaccines have become a ritual in the fall, there is no reasonable evidence that they do any good.
  • The studies that the influenza vaccine supporters use to justify the shots is quite lousy. On one hand it claims a 50% reduction of total death rates (which is patently absurd since it would then have to also prevent heart attacks, traffic accidents and other things that have nothing to do with the flu), and on the other hand they refuse to do any quality studies on the vaccines since they claim it would be unethical. (The 50% reduction is based on cohort studies, so it compares people who voluntarily got the shot to those who didn’t. At the time of the studies, not that many people got the shot and they were mostly people who were trying to stay healthy and avoided doing risky things and thus had a lower mortality rate at baseline.)
  • By examining death rates during times when there was a shortage of flu vaccine (2004) or there was a completely ineffective vaccine (the strains that hit the US weren’t any of the strains that were in the vaccine in 1968 and 1997) we see that the lack of effective vaccination does exactly nothing to the death rate, ergo the vaccine doesn’t affect the death rate.
  • In a best case scenario, the vaccine would only build up antibodies in people with robust immune systems. These are not the people who are at risk from the flu.
  • Evidence for benefit of antiviral medications is about the same quality and timbre as for the influenza vaccine. On average it only knocks 1 day off the time someone’s sick with the flu (at $10/pill taken twice daily), and Gilead (who makes Tamiflu) was required to take back its earlier claim of benefit for the medication by putting this up on their website: “Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza.” (Also note that Donald Rumsfeld, a major stockholder of Gilead’s, was Secretary of Defense when the military got $1.8billion to stock up on Tamiflu and then his president asked congress to approve legislation for another $1billion to stockpile more–all of which led to a greater than 50% jump in the stock’s price.) All this for a 20% incidence of medication side effects that seem to be worse in children. Also, viruses mutate so quickly that using lots of antivirals when not absolutely necessary will only lead to widespread resistance and a loss of whatever benefit they might give.
  • The medical establishment has decided that flu shots are good despite the lack of decent evidence for it and will attack anyone saying otherwise. Mr. Adams labels this as quackery (a fair turnabout of when orthodox medicine accuses others of practicing things not supported by evidence).
There are a few dots that the article fails to connect, however:
  • The writers say that no one knows why there’s more flu in the winter, which is technically true. However, a good deal of evidence points to less sun exposure and lower vitamin D levels as a major component of the increase in incidence. Read point 3 at the end of my last article on swine flu to see some of the evidence or go read more at the vitamin D council’s website.
  • The 1918 “Spanish Flu” that killed 40-100 million people is the pandemic flu that everyone is worried about. It’s thought that if we had another like it we would be in trouble and this is why everyone gets so excited about H1N1. However there are several differences between then and now. 1918 was near the end of WWII, so health care and nutrition were pretty bad across the world. In 1918 there were very few antibiotics, so the secondary pneumonias that would kill people were left unchecked. Finally (as pointed out by Dr. Starko in Clinical Infectious Diseases and discussed in the NYT science section), 1918 was when global marketing for that new “wonder” drug aspirin was in full force (the patent had just expired and Bayer fought to preserve its marketshare by using massive advertising campaigns while other manufacturers pushed to build their markets) and the surgeon general and the US Navy both recommended using aspirin for the flu (we now know that using aspirin in a viral illness can cause Reye’s syndrome and so discourage it’s use during viruses) while the recommended dose was double the maximum dose used today. These massive doses of aspirin can cause the symptoms exhibited by the people who died early in the course of the disease. So, with late deaths looking like bacterial pneumonia and early deaths looking like aspirin overdose, it’s certainly reasonable to think that even if the same 1918 Spanish Flu virus came around again there would be much lower rates of complications and death.
Finally, the article in the Atlantic offers a useful sidebar with answers to questions about H1N1 influenza and immunity. It does a good job of delivering the basic information about the flu, treatment and vaccination, including the tidbit that nearly all the current flu is H1N1 so the current seasonal vaccine is essentially useless even if it did work.

Swine flu over the cuckoo's nest

Nearly every patient is asking me these days if I have any thoughts about the new novel H1N1 flu, also known as the swine flu. Yes, I do have some opinions. Of course, like everything else, this should not be construed as medical advice, talk to your doctor, blah blah blah.
First, let me apologize to Chicago magazine for baldly stealing the title of this article from an article they had back after the 1976 swine flu vaccination fiasco. In case you don’t remember, in 1976 there were 2 strains of a swine flu that hit the US but only resulted in one death (they were fairly limited in how much they spread). Public-health officials got alarmed (remember that the 1918 influenza that killed 10-20% of those infected (over 500,000 Americans died) was thought to be a swine flu) and recommended immunizing the entire population of the country. The vaccinations started in october and the first day three seniors died shortly after receiving the shot (though they were never proven to have died from the vaccine and there didn’t seem to be any further events like this reported) and then there were some cases of Guillain-Barré Syndrome (GBS), a few of which resulted in death. By the time the vaccination program ended, over 48 million people had been vaccinated (over 20% of the population). There were 1098 cases of GBS reported, though only half of those were linked to the vaccination, and 25 people with GBS died. This means that a little more then 1 in 100,000 people got GBS and one in twenty of them died. So, the vaccine wasn’t especially dangerous, but it was more dangerous than the swine flu that year.
Now, the swine flu this year is clearly nowhere near as deadly as the 1918 influenza. Recently, it’s been estimated that 10% of New York City has already had the flu and there no reports of large numbers of empty apartments cleared out by the flu. Also, England recently
downgraded their estimate of the number of people who will die from it to as low as 3,000 (if only 5% are infected) or more likely around 19,000, while the regular flu kills 6-8,000 each year.
So, while this novel flu is clearly more dangerous than the regular flu, it’s not the plague that was being predicted. As for the various conspiracy theories about the virus being man-made because it contains DNA common to other flu viruses, they conveniently manage to neglect the fact that this is how viruses normally adapt and rearrange themselves.
The current swine flu is susceptible to treatment with oseltamivir (Tamiflu) or zanamivir (Relenza)
according to the CDC, but they only trim 1-2 days off the duration of the illness (amantadine seems to be ineffective against it). Neither of these have ever been tested on pregnant women, Tamiflu has been tested on kids down to 1 year of age while Relenza is only approved for children 7 and over, and you may recall the report of some kids in Japan jumping off a building during a Tamiflu-induced delirium during the bird flu craze. Generally, however, the drugs are well-tolerated but will only do their trimming of 1-2 days off the total duration of the flu if the drugs are started in the first 2 days of the flu. Also the drugs should be limited to only those at high risk for complications: the ill and infirm.
The vaccine is supposedly safe and effective (at least, in so much as
any influenza vaccine is safe and effective) despite not being available yet (actually, there are reports of it just starting to become available). I’m not a fan of the regular flu vaccine and not much more of a fan of this one. Of course adding any thimerasol (ethyl mercury) containing vaccine to your body should only be done for sound benefit, realizing that the effects of the mercury may not manifest for years. While there have been some alarms sounded about squalene in the vaccine causing GBS and worse, the only official information I’ve found about squalene in the vaccine suggests that it isn’t being used now and would only be used if the vaccine supply suddenly needed to be expanded massively, however it’s listed under various names so it may be in there and people may not know it.
So, on to the big question: what can you do to prevent yourself from getting swine flu? It’s fairly elementary:
1. Wash your hands. The virus gets into you usually by contact, so keep ‘em clean.
2. Keep your fingers out of your face. It needs to get into your body and your face has the most enticing routes of entry. 2 lines of defense: a moat and a wall.
3. Take some vitamin D. A
recent article shows the clear association between season and latitude (and therefore vitamin D status back when people went outside) and 1918 influenza pandemic survival: more vitamin D led to less death. Reports by 2 physicians who keep their patients’ vitamin D up to good levels shows a profound reduction in influenza among those replete with vitamin D. If you can get your 25-OH vitamin D level checked, take enough to get it up to 50 ng/ml (it generally takes 1,000 iu daily to make it go up 10 points and can take 3 months to level off, so you could double the dose for the first week). If you can’t get your level checked, take 2,000 iu daily (you could double it the first week). Remember all these guides are for normal sized adults and vitamin D does have some toxicity at higher levels (over 150 ng/ml), so don’t go crazy with it.
4. Take some vitamin C every day. White blood cells need vitamin C to do their jobs. Give them what they need, at least 1,000 mg daily, spread it out if you can manage it.
5. Get enough sleep. I can’t say enough about the importance of sleep for the immune system.
6. If you do get sick, IV vitamin C may knock the flu back quite a bit (if not completely eliminate it). Read
dr. Klenner’s papers about his experience with using IV vitamin C for various illnesses. See also dr. Weeks’ article on using vitamin A at the onset of the flu.

What's the deal with the flu shot recommendations?

The flu season is approaching and people are starting to ask about getting the flu shot. The CDC recommendations came out a couple months ago and claimed that there are 36,000 deaths annually from the flu so everyone should get flu shots. I’ve become a bit skeptical of these recommendations.
Do you remember back in 2004 when one of the factories (Chiron) that made flu shots
had a problem and had to junk its entire output for the year? At that point, there was only enough demand to justify 2 companies making the entire amount for the whole country. One factory can't meet its amount for the year and then suddenly there's not enough and all the "health authorities" go into a tizzy about the lack of flu shots. Fewer people got vaccinated and nothing much in reality changed: no bump in flu deaths or anything.
Now, in order to reduce the risk of this happening again, we need to have more places making it, but in order to get that to happen, there has to be more demand. How do you do that? Expand the criteria for who needs one and then stir up the fear about flu so the people are frothing at the mouth to get a shot. So, rather than shot recommendations based on valid health concerns, the recommendation becomes based on economic concerns.
Frankly, the original recommendations for flu vaccine are the only ones that are supportable: for people for whom a flu would be enough to push them over the edge (frail, nursing homes, etc.) and the people who care for them. Everyone else was gravy for the vaccine makers. Expanding the definition of who needs it to "chronic disease" and huge swaths of ages covers a much bigger chunk of the population and ensures enough of a demand to justify more manufacturers.
As far as the recommendation for children and pregnant women, it's unconscionable to inflict further vaccines onto an already overburdened childhood vaccine schedule when the justification is ensuring a demand for flu shots. Even worse is giving thimerasol-containing vaccine to pregnant women: the developing fetal brain is particularly vulnerable to the ethyl mercury in the vaccine.
Even for the targeted population, the shot is of questionable utility. The virus that the flu shot protects against covers only a small proportion of the things people get sick with and call "the flu", and the match between the vaccinations and the strains that go around every year aren't very good: after the season is over they invariably say "well, it was only a partial match for what actually went around." One study demonstrated that the vaccine only reduced the severity of the flu but slightly increased the incidence of it in the people who got the vaccine.
This article summarizes the data on the effectiveness of the vaccine in adults as only 30% effective in preventing flu-like illness and didn’t affect the hospitalization rate overall nor the amount of time off work. In the elderly (65 and over), this article shows that in the community (most people who would be reading this, as opposed to institutionalized in a nursing home or hospital) the flu vaccine is not significantly effective against the flu, flu-like illness, or pneumonia. However, for people who are institutionalized, there does seem to be a clear benefit.
Now, I know people still like to reduce their risks of getting something that may knock them out for a week or so, so for a couple years I tried to get the vaccine, but I wasn't willing to put mercury into people's bodies to do it. To that end I tried to pre-order "preservative-free" vaccine for the upcoming flu season (buying flu vaccine is like getting rock concert tickets: the sales open and everyone rushes to snatch stuff up), but every time all the preservative-free stock was snatched up leaving only the exact same stuff with thimerasol in it left available (and this is before the stuff has even been made: why can't they just change the supply to meet the demand?). The first year I discovered that at the end of the season there was some preservative-free stuff left over, which I got and made available. I haven't been able to get it since, so I gave up.
So if you are determined to get the vaccination, I would try to get the preservative-free stuff (which Kroger claimed to have last winter). Otherwise, being sure you have enough vitamin D (check a 25-OH vitamin D level and get it well into the normal range, I like to get it to 50 ng/dl or more) and take vit C at least daily.
Am I recommending not to get the vaccine? No, I'm just trying to add some perspective so people can make their own decisions. For most people it isn't a matter of life and death and it comes down to if it will make your life easier. Read the fourth paragraph before this one (especially the last sentence) and make your decision.

If you want some perspective of the risk of death from influenza, it's a little obfuscated by combining it with deaths from pneumonia (which is much deadlier in general than influenza) in the data available from the CDC for 2002
here, but let's do the best we can. Incidentally, this report gives the total number of flu/pneumonia deaths for 2002 as 65,681, so I have to say I'm skeptical of the number of influenza deaths given in the CDC/MMWR report (35,000) and, indeed, looking at the references it cites, it appears the authors misread the article and used the number for chronic disease-related deaths rather than the influenza-related deaths which is less than 1/3 of the number: 8,097. This, then, implies that less than 1/4 (actually only 12.3%) of the flu/pneumonia deaths are actually from the flu, so we'll use this number.
So, in the age 1-4 group (for which universal annual flu vaccination is recommended) the combination for flu and pneumonia accounted for 110 deaths in 2004, while the US population aged 1-4 was nearly 16 million. Thus, assuming _all_ the deaths were from flu, there would be ~150,000 children vaccinated to prevent one death (assuming that vaccinations would be 100% effective in preventing death from the flu, which is unlikely considering the matches generally are 50% or less). Far more likely, less than 25% of the kids' deaths were from the flu and it is less than 50% effective in preventing death from the flu, so we're looking at over 1,200,000 1-4 year olds vaccinated to prevent a single death. To break it down to purely economic terms, that's over $20 million to prevent one death, not a good use of funds when there are more cost-effective ways to prevent deaths for children aged 1-4. Then, consider the incidence of side-effects of the vaccinations: is the incidence less than 1 in 1,200,000? The vaccine adverse event reporting system is designed to minimize the reporting of these events as being vaccine related, and with the data available
here we can calculate that with 62 million flu doses distributed and 1400 adverse events, there's about 1 adverse event per 45,000 doses. This means that in order to save that 1 life we have to tolerate 27 adverse events on the way. Yes, most adverse events aren't life threatening, but (overall for all vaccines since the data isn't broken down by vaccine) 15.8% were in 2001, so we're looking at 4 additional hospitalizations or deaths on the way to maybe preventing one death. Even this article demonstrated that there is “little evidence” of benefit of vaccination in children under 2.
For the next recommended universal vaccination group >50, some segments have vanishingly small amounts of flu deaths: it's not in the top 10 causes of death for 55-64 y.o. americans and not in the 45-54s either, so we can safely assume that it's a minor risk (<0.4% of deaths) for the entire 50-64 age range. There's 45 million people who won't significantly impact their risk of death with a flu shot.
FInally, we're getting to the age range who shows some risk: 65 and older. 3.2% of deaths (59,000) are in the flu/pneumonia category, so a drastically smaller amount of over 65s, perhaps 15,000 died of flu in 2002. But remember that when you die, you have to die of something, so in some of these cases, flu was merely the last straw. So, with a population of 35.5 million over 65s in 2002, there's less than 1 in 2000 dying of the flu, and with the vaccine being less than 50% effective that's over 4000 vaccines (>$80,000) to prevent 1 death.
However, 4000 vaccines to prevent 1 death isn't that bad, but realizing that the flu is much more likely to kill someone who is already on the edge (among over 65s, those 85 and older were 16 times more likely to die of influenza, says
JAMA), it would be much easier and more cost effective to target those people and vaccinate them and their caregivers. Which brings us back to the original recommendation for the vaccine: those likely to die from catching the flu and the people who take care of them.
So, why all the recommendations for more vaccinations? 16 million 1-4 year olds and 45 million 50-64s means the they are recommending 60 million vaccinations that aren't remotely supported by the data. It's got to be to ensure an adequate market for the vaccine. Either that or someone's making a good profit off it.