How effective is the Shingles vaccine?

These days, the shingles vaccine (for herpes zoster) can be found at just about any pharmacy. However it’s been hard to find real numbers on the benefit of this vaccine and so once again scare tactics come into play to get people to get the vaccine. How effective is it really? (Please note all these studies were done on healthy seniors, whose incidence of shingles is higher than younger populations.)
A
new study came out which adds to a previous study showing that the vaccine reduces the burden of illness by 50% and the incidence of post-herpetic neuralgia (where the pain of shingles never goes away) by 60%. In the new study, it looks like the benefit of the vaccine drops dramatically after the fourth year, so people would need to get a new shot every 5 years or so.
So, the cumulative risk reduction is about 50% for getting shingles and 60% for getting post-herpetic neuralgia, which sounds great, but what does that really mean for the person getting the shot. After all, if you wore a metal helmet around all the time, it might reduce your risk of getting killed by a meteorite by 50%, but the risk of getting hit my a meteorite is so small in the first place (less than 1 in 5 billion/year) that it’s not worth the trouble to wear the helmet.
In the study, the annual risk of getting shingles in seniors was 1.1% without a vaccine and 0.54% with the shot, meaning 0.57% of the people who get the vaccine will avoid shingles because of it. Put another way, if 175 people got the vaccine 1 person wouldn’t get shingles because of it. Usually, shingles is a temporary annoyance (about 1 in 8 seniors getting shingles will get post-herpetic neuralgia), so 175 shots and $38,500 (around $220/shot) seems like a lot to prevent 1 case of shingles. But wait! The shot gives similar protection for about 5 years, so we have to amortize that cost over 5 years: 35 shots and $7,700 to prevent 1 case of shingles.
However, post-herpetic neuralgia can be quite devastating, so what does it cost to prevent that? The risk in seniors is about 0.14% per year and goes down to 0.046% with the shot, so 0.09% of those who get the shot will avoid post-herpetic neuralgia each year. That’s 1087 shots, but spread over 5 years it’s only 217 shots to prevent 1 case of post-herpetic neuralgia at a cost of around $48,000. Compare that to the risk if avoiding a second heart attack by taking a statin: 50 people taking it for 5 years to prevent 1 heart attack at a cost of (say $20/month on the cheap end: $1200/person x50 people) $60,000.
What does all this mean to you? If you are a senior and get a shingles shot (for about $220), you have a 1 in 35 chance it will prevent you from getting shingles over the next 5 years and a 1 in 217 chance it will prevent you from getting post-herpetic neuralgia in the next 5 years. Better odds than wearing a meteor-protecting helmet (everyone on the planet would have to wear one for a few years to prevent 1 death from meteor), but still something to think about.
Also, note that having shingles is at least as effective at preventing future episodes of shingles as the vaccine is, so no need to get the vaccine if you’ve had shingles within the past five years.
Finally, understand that this is only looking at the simplest to measure outcome of the vaccine and monetary costs associated with it. Costs from side effects haven’t been discussed. Whatever immune dysregulation may occur from this vaccine is not only difficult to measure (it isn’t going to happen right away so would be hard to connect with the event of being vaccinated), but actively hidden (any reaction severe enough do trigger a lawsuit and prompt enough to implicate a vaccine bypasses the normal court system and goes to a special vaccine court, where all outcomes are kept secret, so there is no record of how much of a problem there is from any vaccine).

I'm not crazy: aspirin for everyone?

I sometimes start to wonder if I’m crazy when conventional docs continually and persistently do things that I’m sure are a bad idea. Are they all practicing bad medicine or am I crazy? It’s nice when I’m reassured that I was right all along.
This time, it’s about aspirin. Whenever anyone over the age of 35 goes into a doctor’s office, it seems like the doctors routinely put them on an aspirin a day. The dose of aspirin depends on the doctor’s specialty: primary care docs recommend 81mg and cardiologists want people on 325mg or more.
Ostensibly, the aspirin is to reduce the risk of heart attacks. It reduces the stickiness of platelets (which make blood clot), making them less likely to clump and clog up arteries and cause heart attacks and ischemic strokes (caused by a clot).
However, aspirin is (like most drugs) not an entirely benign substance. It can cause bleeds in the stomach and intestine, which can be worsened by the anti-clotting actions of it. In addition, it can increase the risk of any type of bleeding, particularly hemorrhagic strokes (caused by a bleed rather than a clot: less common but worse).
Recent research has demonstrated that while aspirin does reduce the risk of another heart attack in people who have had one, it isn’t so impressive in people who have never had a heart attack. In particular, the only people who haven’t had a heart attack yet who should be candidates for daily aspirin use are people over 45 (men) or 55 (women) who are already at high risk of a heart attack and don’t have risk of bleeding (BP is close to normal and not at risk for falls).
Now the big question: if some should get aspirin, what dose should they get? Once again, the
primary care docs provide better care than specialists: 81mg provides better risk reduction and less increase in risk than 325mg. In fact, it appears that higher doses of aspirin might blunt the anti-platelet effects in addition to increasing the risks of adverse events (however it appears that cardiologists might not be reading their own journals like Chest).
So, how effective is it? Well, 119 high-risk men under 60 would need to take aspirin for 5 years to prevent one heart attack. Over those 5 years, there is a little more than a 1 in 3 chance that someone in that group will have a major intestinal bleed because of the aspirin. Put another way, if we took 1000 men with a 6% 10-year risk of hart attack and gave them aspirin for 10 years, we will have prevented 19 heart attacks (dropping the number from 60 to 41), caused 8 major bleeds and 1 hemorrhagic stroke. Men can
look up their risk/benefit ratio here.
In women, the benefit is less impressive: the chance of preventing a stroke is less and isn’t that different from the chance of causing a bleed. Women can
look up the specific risk/benefit ratios here.
However, if you are
having a heart attack, one of the best things you can do (in addition to calling 9-1-1) is chew up and swallow an aspirin. I’d still make the phone call first, though.

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.

The Fosamax facade is starting to crumble

After years of hints that all the bisphosphonates (medications used for osteoporosis) caused jaw osteonecrosis (destruction of the jaw bone after dental work), a new article shows that the risk of jaw osteonecrosis when the person gets dental surgery who has been on Fosamax is one in 23, or around 4%, 1600 times higher than the 0.0005-0.0025% Merk “estimated” in 2007.
While 4% may not seem like a big number, it seems a lot more problematic when realizing how devastating jaw osteonecrosis can be. The jaw bone near the surgery breaks down, leaving a broken jaw, and it can continue to expand. Any attempt to bridge the gap will cause further destruction, as drilling into the bisphosphonate saturated bone will only trigger more breakdown. With no known way to remove the bisphosphonate from the bone once it’s in there, all the dentist can do is watch helplessly as the jaw falls apart.
Hyperbaric oxygen therapy is the only treatment that has shown any promise in stemming the collapse and even that isn’t stunningly effective.
Understandably, dentists are reluctant to operate on people who may be at risk due to the devastating effects on the patient, and are also reluctant to report it happening due to the devastating effects on their reputation and office. So, the condition is dramatically under-reported. Even with less loaded conditions, 90% are never reported.
Of course, this is on top of the risk of erosions and cancer of the esophagus from these medications.
The companies making the bisphosphonates (Fosamax, Actonel, Boniva, Aredia, Zometa and Reclast) have been attempting to portray these medications as safe and effective for the treatment of osteoporosis as well as attempting to expand the market to include the treatment of osteopenia (milder bone loss). Clearly, if one in 23 of people on the oral form of these medications (the IV form is much worse) will have their jaw disintegrate if they get dental surgery, it’s not safe. Whether it’s effective is open to debate.
When trying to prove that putting their new chemical into people is a good idea, drug companies and the researchers that work for them have a lot of tricks to make the chemical that they’ve dumped a pile of money into producing look good enough to produce the serious return on investment they need. Drug companies like to use intermediate markers rather than outcomes since they are easier and cheaper to measure and easier to game than the real outcomes we care about. With cardiac disease, the outcome we’re concerned about is dying or having a hospitalization, while cholesterol or LDL levels are an intermediate marker that may not translate into the outcomes I mentioned. With bone loss, the real outcome is fractures, while an intermediate marker is bone density. By strapping a lead rod behind your leg, it can look denser to the machine, but it won’t do a thing to reduce fractures. While a medication may increase bone density (remember that density is mass per volume, so heavier bones), it may not actually make them stronger (they can be dense and brittle, or lighter but with just enough give to resist breaking: think glass compared to titanium).
While the drug companies have been doing their typical attempt to brush it all under the rug, they also engaged in their typical pastime of trying to get doctors to prescribe it to people for whom it isn’t indicated. As I
discussed 18 months ago, the evidence doesn’t support the idea that this drug is beneficial for osteopenia. Perhaps the only thing that does support the idea is the money the drug companies spend on lunches for physicians so they can whisper these sweet nothings in their ears.

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.

Why, oh why, Wyeth?

Fireworks 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.

Crohn's costs

I just came across an article about a lottery in Oregon for covering healthcare expenses. The woman mentioned in the story is $15,000 in debt from the year's treatment of her Crohn's disease.
I've learned of a natural therapy for Crohn's disease that achieved remission in 62% of patients and improvement in 76%, much better than conventional medicine. When I initially looked into it, I thought it was expensive, with a standard first course of therapy costing in the neighborhood of $4000, but now I see that is substantially less than then conventional treatment and with much better outcomes. The treatment does seem a
bit odd, but the science makes sense and it seems to work. The duration of remission is longer the younger people are, with the elderly maintaining remissions up to 2 years.
It seems like it may be helpful in other autoimmune disorders as well (asthma, MS, eczema, psoriasis, food allergies). Time will tell.

"Pharmacologic Treatment of Osteopenia Not Usually Indicated"

A recent American Family Physician journal, citing a JAMA article, puts the lie to the idea that people (particularly women) with osteopenia (low bone density) should be on medications. With all the evidence that these medications (like Fosamax or its friends) shouldn't be first-line treatments, why are doctors still prescribing them so quickly? If your doctor pulls out the pad for this, ask them when the last time they saw that drug rep and whether they are pushing the doc to use it as a preventative. This kind of behavior is occurring more and more, so let your doctor know that it's getting so obvious and blatant that even the patients are picking up on it. There are some movement among conventional docs to limit their exposure to drug reps, No Free Lunch for practicing physicians and Pharmfree for medical students. Sadly, the No Free Lunch doesn't turn up any drug-rep free primary care physicians in Ann Arbor (though it does find a pediatrician in Ypsilanti).
Interestingly, the article points out that the
only treatment that has been shown to reduce nonvertebral fracture risk in women with osteopenia is estrogen. Bioidenticals, anyone?

Who woulda thought? Folic acid is effective.

After the incessant drumbeat coming out of the pharma-pumped media disparaging nutrition, a refreshing article came out the other day: "Folic Acid May Lower Stroke Risk." One of the key findings is that there are greater improvements in risk in the people who took it longer. This is, of course, obvious, since you can't expect to starve yourself for months then have a good meal and be right back to normal.
Of course, in order not to lose her professorship, dr. Carlsson (who is quoted in the article) has to say that it is premature to recommend a benign and inexpensive nutrient to prevent strokes in the population that shows the greatest reduction in stroke risk from folic acid supplementation (people who've never had strokes, "primary prevention").
Dr. Wang (one of the researchers) suggests that "people in the U.S. who eat healthy diets probably get enough folic acid in the foods they eat." Any guesses what fraction of the population would fall in to that category?

Challenge to mammography screening before 50.

The American College of Physicians noticed that all those mammograms in younger women may not be a good idea. This article doesn't mention the downsides like compression possibly rupturing tumor capsules or high radiation exposure from mammograms (which increase the risk of breast cancer, particularly in women at high risk). They did also admit that mammograms cannot prevent most breast cancer deaths. So, the final recommendation is that women 40-49 should discuss it with their doctors. If only more doctors knew about alternatives like thermography.

Hormones and cardiovascular risk

Sometimes I'm disappointed by the journals. Circulation recently had an article on reducing women's risk of cardiovascular risk, in which hormone replacement was listed as class III (not useful/effective, may cause harm). A summary of the article in Medscape breaks down the variation in risk:

Researchers found that "route, type, and dose" of hormone therapy matters, in the Estrogen and Thromboembolism and Risk Study (ESTHER), a multicenter study conducted in 8 hospitals in France that included 271 cases and 610 controls. Compared with nonusers, oral estrogen users had an odds ratio of 4.2 (95% confidence interval [CI], 1.5 - 11.6) and 0.09 [this is probably a typo and the risk should be 0.9] (95% CI, 0.4 - 2.3) for transdermal estrogen. Norpregnane derivatives were linked to a 4-fold increase in venous thromboembolism; but there was no risk for venous thromboembolism with micronized progesterone and pregnane derivatives in the study.


So, there is risk in the standard hormone treatment of oral estrogen and progestins (synthetic progesterone-like molecules): each raises the risk of a clot 4-fold. However, it also shows that transdermal estrogen doesn't increase the risk and may lower it and that progesterone similarly doesn't raise the risk. Using bioidentical hormones in a smart manner, then doesn't raise the risk and likely lowers it going from this article.
Sadly, they also list folic acid and antioxidants in the same class that says "may cause harm". Clearly, no one has died from antioxidants or folic acid. There has been a limited number of studies showing some increase in risk with fractionated antioxidants (beta-carotene or alpha-tocopherol alone) in certain circumstances, so it is important to get use full-spectrum antioxidants when using higher doses (mixed carotenoids with selenium or mixed tocopherols).
Sadly, newspapers often pick up these articles without any background and trumpet it as fact. It pays to read in more depth, and be cautious about people who paint all hormone replacement with the same brush: there are clear differences in risk between approaches, and this is why I do not use oral estrogen at all.