Nov 25, 2008 Filed in:
MedicalThe 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.Tags: Medical Orthodoxy, Flu
Jul 27, 2008 Filed in:
OfficeI'm going on a medical brigade in Honduras the week of August 18: http://www.hondurasmedical.org/
We're going to have to reschedule everyone from that week and I won't be around for the week. Sorry about the short notice, the plans just came together.
Jun 02, 2008 Filed in:
MedicalFireworks tomorrow, 31 days early!
In case you haven't heard, Wyeth, the maker of Premarin and Prempro (Premarin + Provera), has been plotting to maintain their marketshare by restricting women's freedom to choose safer medications for themselves. Ever since the Women's Health Initiative revealed in 2002 that Prempro increased the risk of stroke, breast cancer, heart attacks, and blood clots (a finding that I, in residency at the time, thought was obvious since Provera was well known to increase the risk of clots), Wyeth has been struggling to maintain its sales of these patent medicines.
Wyeth has managed to keep a monopoly on PREgnant MARe urINe (PREMARIN, get it?) products in the US since it was introduced in 1942 by dubious legal and political maneuvers including using at least seven women's advocacy groups it funded to influence congressional hearings in 1995. By maintaining this stranglehold on relief of menopausal symptoms, Wyeth has extended its dominion well past the 20 year patent protection and in 2001 had over 11 million women using its hormone medications and over $2 billion in sales of those medications. Following the revelations of the Women's Health Initiative, sales of Premarin and Prempro drop and by 2006 sales are half of 2001 levels (though they had dipped even lower before Wyeth made lower strength versions and pushed for more prescribing).
As women flock to safer treatments like bioidentical hormone replacement (using hormones identical to the ones originally in the women's body), Wyeth decides to protect its profits at the expense of women seeking relief of menopausal symptoms and preventing other changes related to loss of estrogen like osteoporosis and memory loss. In 2005, Wyeth files a "citizen's petition" with the FDA that pushes the FDA to ban estriol, an estrogen naturally produced by women, as an unapproved new drug. Within 70 days, 11 organizations, mostly funded by Wyeth (in a stunning repeat of their tactics 63 years earlier), submit letters of support for this petition. Again, May 19, 2008, members of congress received a letter (coordinated by Wyeth) from 14 organizations (all with major funding from Wyeth) supporting the FDA's actions.
Besides estriol having a 50 year history of use and listing in the US Pharmacopeia, it was in the precursor to Premarin (that was made from pregnant women's urine- but it proved too difficult to collect), and is used by Wyeth itself in products sold overseas. Recent research has shown estriol may reduce the risk of breast cancer and be beneficial in treating multiple sclerosis.
This year, in response to Wyeth's petition, the FDA bans the use of estriol (though the FDA does not have jurisdiction over compounding pharmacies, so this is also a power grab by the FDA) despite admitting that there have been no reports of adverse events associated with its use ever. Somehow, the FDA has managed to put an import restriction on estriol as well, so even though compounding pharmacies shouldn't be subject to the FDA's decrees they are having trouble getting supplies of estriol. Under the FDA's plan, it would require a physician to file an Investigational New Drug form (with the associated $50,000 fee to the FDA) to order estriol for patients.
In the end, women are losing their options so Wyeth can make more profits.
So, what's with the fireworks? Well, Tuesday, June 3, is the day that hundreds of compounding pharmacists will descend on capitol hill to support H. Con. Res. 342 at the same time the AAHF is delivering independent letters of support, and a full page ad will appear in Roll Call.
Learn more about this issue here, and learn more about estriol specifically here.
Corporations will only be able to get away with this as long as we remain quiet, so speak up for this and get active in politics: corporations pay big money to bend the laws in the direction of increased profits whatever the human cost, so the humans have to speak up. It's time.
Tags: Hormones, Medical Orthodoxy
