Warning: this post has a long, boring prologue. Proceed at your own risk.
I am an expert in the prevention and treatment of adult diseases. That's what I do from well before the sun rises until well after it sets every day of every week. To become an expert and retain this status is not a simple task. After college I completed four years of medical school, three years of residency in my specialty, and chose to become "board-certified". There are doctors who are not board certified in their specialties, and there's nothing nefarious about that---all that is required to practice medicine is a valid license from the state. But my hospital doesn't allow physicians on staff if they are not board certified, recognizing that this status means something. There is no good reason to eschew board certification. To fail the boards repeatedly betrays a lack of basic competency, given that most doctors are actually good test takers, otherwise they'd never have made it so far.
Historically, once one was board certified in internal medicine, the certification was for life. Several years ago this changed, with older doctors being grandfathered into permanent certification, and all new internists being required to re-certify every decade. Since medicine is an ever-changing field, my license required fifty hours of continuing medical education yearly. In addition to that, I'm now two years away from my re-certification, which requires more continuing education. The American Board of Internal Medicine suggests spreading re-certification over a two year period. I've started doing the required learning modules and they are hard. Depending on the field, each question takes me about twenty minutes of research just to make a reasonable guess at the answer. Most of the modules are knowledge-based, but I'm required to do at least one that helps me review my practices. I could, for example, review a few dozen charts of hypertensive patients to see how well I am managing them, and come up with a plan to improve my practices. After all of this, I may sit for my board exam.
All this is simply to serve as a bit of background---when I talk about medicine, I'm not pulling it out of my ass. Some doctors, though...
Which brings us back to the Huffington Post, that web-repository of quackery. The latest abomination is from Dr. Frank Lipman, a self-proclaimed expert in preventative health care. I emphasize self-proclaimed because he doesn't seem to understand much about the subject. Doctors must be able to think independently. They must be able to look at the data, look at the recommendations of others, and apply these to individual patients. While one patient might "by the book" require a particular type of medication, you may know that this particular patient won't do as well for one reason or another. But one cannot ignore evidence.
Lipman starts out with the predictable but clearly false claim that he is not "anti-vaccine" (instead being pro-vaccine safety and freedom of choice, setting up the false dichotomy implying that the rest of us are against safety, freedom, and presumably the American way). He then goes on to forcefully, in bold typeface, declare that most of his patients should not get the swine flu vaccine (I can hear Rebecca Watson's voice in my head doing the voiceover of the capslock---good lulz). A generous person might take this information and think, "Gee, perhaps he has a geriatric practice so that most of his patients don't fall within the current evidence-based recommendations." That would be stretching generosity to the breaking point. He goes on to discuss why he anti-vaccine (in this case). But let's talk a bit about flu and about prevention from, you know, an expert.
Let's start with what swine flu is and is not. Every year, influenza sweeps across the world, affecting the US most strongly in the winter months. It causes at least 35-40 thousand excess deaths every year, and even more hospitalizations and lost days of work and school---and all that is in a "typical" year. In typical years, flu is most brutal on the very old, very young, and chronically ill. Swine flu follows a different pattern. It isn't any less virulent or deadly than seasonal flu, but attacks a much greater number of people, especially those who don't usually suffer much during a typical flu season. It also has refused to confine itself to the normal flu season, having simmered all through the summer. Vaccination helps prevent illness, hospitalization, and death due to influenza, so each year we formulate a vaccine based on the current circulating strains. To what extent vaccination is beneficial is an open area of investigation, but that it helps is clear.
Vaccination is an important tool in prevention of morbidity and mortality. Prevention is generally discussed as being primary or secondary. Primary prevention is the prevention of disease as you might typically think of it. If you can prevent someone from developing diabetes, polio, or heart disease, that is primary prevention. Once someone has a particular disease, preventing further episodes is secondary prevention. If my patient has coronary artery disease (say, having had a heart attack in the past), I can I practice secondary prevention by treating them with certain medications and with good health habits that reduce the risk of further heart attacks. There is another category---tertiary prevention---which usually refers to preventing a disease which complicates another. Diabetics are prone to heart disease, and there are ways to prevent heart disease in diabetics.
So let's see what our "expert" in prevention says about flu shots.
1) At this stage, for the most part the swine flu seems benign.
Over a million people in the US have already come down with swine
flu, many of them without even knowing that they had it. The vast
majority of people who get the swine flu recover after a week or so of
high fever, aches, and respiratory distress. It's not pleasant, but
except in rare circumstances, it is not fatal. Most people who've been
infected by swine flu think so little of it, they believe they just had
a really bad cold or a regular flu. So unless the swine flu evolves to
a much more virulent form, there's no need for mass vaccination.
Given what we know about the flu, this is foolish. Yes, swine flu is about equally as virulent as the usual flu---that is, it causes a great deal of excess significant illness and death. What threshold does Dr. Lipman, as a prevention expert, recommend for preventing a preventable disease? Is there a certain prevalence threshold? A certain virulence threshold? Apparently, his recommendation is based on his "feeling" that it is "rarely fatal" and "relatively mild".
2) We don't know if the vaccine will be effective.
Vaccines are only useful against the specific viral strain that was
available at the time of their manufacture. But influenza viruses
mutate quickly, and as the WHO has already said, the real concern with
H1N1 swine flu is that it will combine with seasonal flu in the Fall,
creating a new strain that will of course be immune to all available
vaccines.
That reasoning is, in a word, stupid. The reason we need a new vaccine every year is that the flu changes. The reason we know which strains to vaccinate against is through careful public health surveillance. We do this fairly successfully most years. This year there is a seasonal flu vaccine based on the current strains, and a separate swine flu vaccine based on the fact that swine flu is still circulating widely. It has been tested as safe and effective, and is developed and produced just as all previous flu vaccines. To take the nihilistic view that because the flu mutates we should ignore decades of evidence and experience and just give up is the height of arrogant ignorance.
3) We don't know if the vaccine is safe.
The FDA has authorized an expedited approval process for the swine flu vaccine but we don't know yet if it is safe. Even GlaxoSmithKline, one of the vaccine manufacturers has said, "The
total population studied in clinical trials will be limited, due to the
need to provide the vaccine to governments as quickly as possible.
Additional studies will therefore be required and conducted after the
vaccine is made available."In other words, the only thing that is safe, is to say that no one
knows. Since it's never been used before and they have not had time to
conduct any sufficient human testing, by getting vaccinated you are
being a human guinea pigs.
That is simply untrue. This vaccine has been developed and produced just as previous vaccines have, and there is no reason to think that it is any more or less safe. To take this particular paranoid view is to ignore the science and the evidence.
His next point is either completely ignorant or sinister: vaccine manufacturers are insulated from liability, therefore they have no incentive not to hurt you. The reason vaccine manufacturers receive immunity is so they will still be able to provide this not-very-profitable service. Anti-vaccine cultists would sue the vaccine makers into oblivion, or clog the courts trying. Instead we have a rational surveillance program. Since significant vaccine-related side effects are vanishingly rare, it is only on mass release that rarer ones may become apparent, therefore we have a system for monitoring vaccine safety. Thankfully, serious side effects of flu vaccine are not distinguishable from the baseline incidence of these problems, and are rarer than serious flu-related illness.
The evidence shows that the most effective primary prevention of influenza is vaccination. Still, it's rather more invasive than, say, dietary changes. Is there any evidence for other primary prevention strategies? The answer is essentially, "no". Lipman gives a heap of worthless advice about "phytonutrients", vitamin D, and exercise, some of which is plausible but not supported by evidence, and some of which is implausible enough to be laughable.
When you read the comments to a post like this, you can see that some will never be persuaded by evidence or science---they hold fixed-false beliefs which people like Lipman feed. His self-declared status as an expert in prevention is irresponsible. He makes no evidence-based recommendations, and many that are downright dangerous. He illustrates one of the fundamental contradictions in the alternative medicine movement: the claim to be pro-prevention but actions that completely belie the claim. It would be sad if it weren't dangerous and irresponsible.
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Love your blog. I tackled Lipman as well for his stupidity in that HuffPo post, but it's nice that there are much more qualified people doing the smackdowns with more precise knowledge.
Any speculation why folks over 50 seem less susceptible to the swine flu?
Yes. It may have significant antigenic overlap with the pandemic of 1957.
Yes vaccination is the best way to control any virus, both for the individual and society. However, do not dismiss vitamin d as quackery or only "plausible without evidence". The evidence that all simians use vitamin d in their innate immune systems is very strong. It is also been shown that in cases of insufficiency the body will reserve vitamin d for the control of calcium and immunity falls. Try http://www.sciencedaily.com/releases/2009/08/090818182053.htm .
Type "vitamin d" into Medline (or your favourite search system) and see what has been published in the last year. Then read each paper critically, identifying errors in methodology and weighing the evidence. That is proper evidence based medicine. Does the evidence mainly seem to be pointing in one direction?
By the way being good at taking tests does not make you a good thinker only at repeating what you were told. And what you were told may be outdated.
Only 50 hours CME a year?
I do more than that and I am a patient. However, I have a vested interest in understanding what attacks me, and I have access to a full medical library. Medical journals are a good read at the end of the working day, although some researchers should learn to get there methodology correct before starting and the referees should stop letting so much flawed work through.
Pete: I'm not even in the medical field and I know that CME involves more than researching on your own in a medical library (if that counted doctors would have no trouble getting all the hours they need). It's class time, lectures, etc. that all involve some sort of quiz or exam to show that you understood the material.
As for vitamin D you are confusing what medical research says about it and what the quacks say. There is no evidence that doses of vitamin D far exceeding the amount that humans need is beneficial. In fact I've seen some of these advocates for it recommend doses that are very close to toxic levels of vitamin D. Vitamin D deficiency is definitely a bad thing but mega-dosing it is useless to potentially dangerous.
Thanks for being a voice of reason; keep up the good work. It might not be a double digit IQ that is the biggest problem, rather it's believable pseudo-experts with bad information and a big megaphone. So glad that the vaccine appears to be in plentiful supply and relieved that the virulence didn't increase. Earlier this past summer I was envisioning a scenario where it would have to be explained to senior citizens and the population at large that college age kids were a more important target group to be vaccinated. Imagine that firestorm if this turned into a Spanish flu sort of outbreak where the healthy young were at biggest risk.
I am afraid you are also confusing the facts here. The CDC 36k deaths from "flu" is an estimate for deaths due to flu-like illness and pneumonia. This is not comparable to the official swine flu death of 593 put out by CDC.
@Pete
If you are suggesting that you "do more than" 50 hours of CME a year by reading articles such as the one you cite from sciencedaily.com, then I would suggest that you don't know what exactly is meant by CME.
Continuing education (at least, in pharmacy profession) is basically education through presentations, lectures or written material with clinical cases and short exams (to be submitted for evaluation). All the education material is developed by experts, reviewed and approved by an accreditation board (made up of other experts). They all involve some of the best and most up to date primary literature (ie: recent trials done in humans and on clinical ouctomes).
CMEs are an important tool - but not the only one - for health professionals to stay on top of all the recent advances in medical sciences. And as you probably know, there is lot of new science that is evolving everyday. The point of CME is to cut through the crappy evidence and get to the good evidence so that we can act on it and update our practice.
BTW, typing "vitamin D" in pubmed reveals 2300 studies in the last year...most of them are useless to physicians and pharmacists since they are only in vitro, preliminary and only look at surrogate outcomes (ie: intricate biochemical pathways slightly affected by vitD) which have little bearing on clinical practice. As far as I know, there are no RCTs that looked at vitamin D in the prevention OR treatment of human influenza. (pubmed search: "Vitamin D"[Mesh] AND "Influenza, Human"[Mesh], no limits)
Perhaps it's because I've been reading here and at Orac's place a lot this past year, so I'm just more aware, but it seems "woo" is getting a lot play recently in mainstream journalism.
You noted the recent one in the NYT and I also read one about acupuncture for knee injuries in Men's Health.
Hospitals and the government support of this kind of stuff has obviously led to it being a sort of legitimacy it doesn't deserve.
I'm not trying to be critical, but isn't HuffPo a soft target compared to NCCAM and "alternative" programs at well-known hospitals?
What's the best way to counteract that much bigger threat?
And the reason the flu viruses are so much more virulent in the winter seasons is because believe it or not, we're exposed to a lot more dry air, especially in the colder parts of the U.S.
Dries out the mucus producing membranes which are pretty much responsible for the first line of defense against a lot of things. That mucus traps things and gives the immune system time to react.
That said, I've not gotten flu shots in almost 20 years. Yet surprisingly no flu.
Instead what do I get? Sinus infections during the winter, and severe allergies in spring/late summer. Yes, the whole trees, grasses and weeds group.
ughhh, this vitamin D thing is such an irritation. how many ways can one explain that correlation is not causation!??!?!ELEVENTY!
people think they're covered by taking megadoses of vitD, and when i explain to them that there is zero evidence that vitamin D prevents anything other than rickets and osteoporosis, they send me this onslaught of correlational studies and no amount of me smacking them down will convince them that vitamin D is not the one preventive measure for any and all illnesses.
someone recently posted on a forum i frequent a claim that hypersupplementation of vitamin D has been "proven" to prevent 77% of all incidence of cancer- it was part of an advertisement for another pseudoconference of quackery. this claim was of course based on a weak correlational study and a highly criticized n=18 clinical trial in which the control group had vastly higher cancer incidence than the general population. COME THE FUCK ON.
Thank you very much for the time and energy you spent crafting your response to fears about swine flu vaccine. I am sincerely appreciative since I found your blog while doing a search sparked by the concerns raised in a family internet network in my neighborhood. one mother said her friend, a hospital worker, had refused the vaccine on the grounds that it contains animal cancer cells. That sounded kind of crazy to me but I don't anything about vaccine production so I started to read different things on the internet and found both the scary articles about the possible danger from the vaccine and eventually I also came upon your response as well. I do give more credence to what you have written than most of what i have read on the other side, but you do leave a few questions unanswered for me and I hope you will have time to address them in the future. Is the swine flu vaccine manufactured in the same way as other flu vaccines? Why are animal cancer cells considered safe (if indeed they are in the vaccine)?
Finally, I wonder if the risks associated with flu warrant taking a vaccine which does not have a track record long enough to weed out the potential, very very rare complications if you happen to be healthy as a horse. i only ever get a mild cold every two or three years and I am confident in my ability to fight off a mild flu without complication so why should someone who fits my profile bother with vaccination? Do the benefits really outweigh the benefits for those who can afford to miss a day or two of work?
Again, my sincere thanks for your blog!
Catalina -
(warning, lengthy response)
I'm not expert myself but will tender my 2c worth. As always, check with a qualified physician (note the above reference to Board Certification).
My understanding of the "animal cancer cells" is the way the vaccine is produced. Remember first of all that a vaccine is a bit more than a random collection of chemicals. With a lot of vaccines the "chemicals" may be as complex as a living cell or hundreds of thousands of molecules connected to form a fragment of a whole cell. Others are based not on shape, but on the ability to bind to a certain sequence of amino acids. To assemble even one copy of the active components of a vaccine by hand would take months (at least). The nano-fabrication capability of cells (the cell is really just a nano-factory) is well known and can be harnessed for our own uses. So where do we get a collection of reliable cells to do the task? Stem cells are in vogue and would seem like the first choice, but they too have problems. For a start, after a certain number of replications they stop working properly. Think of a photocopy - any copy done from the original will be pretty good - but if you start copying the previous copy, rather than the original, each copy gets less accurate and fuzzy until eventually none of the original image can be found in the copy. The equivalent in the cell is death and the cell has some pretty complex means to check that the cell is working (and suicides if it isn't). So where do we find a cell line that doesn't get errors and die? Scientists isolate an "immortal line" - basically cancer cells that seem better at "repair" (that's why cancer is so invasive) and don't naturally age (ie get copy errors) or die. Some of these lines have been cultured for decades. The oldest human cell lines are also based on (human) tumours.
Also, the origin of the cell (animal/human) is really just flak thrown up by the anti-vax crowd. In a vaccine, it is the chemicals (mainly proteins) that are used, not the whole cell. Some of these proteins we coax the cell culture to produce may actually be parts of the invasive agent targeted (eg just the cell wall).
The earliest vaccines came from real animals, not a cluster of cells in a flask. Smallpox vaccines came from blood taken from cows that had cowpox. Until recently all vaccines were produced by injecting human pathogens (sometimes killed) into draught horses or cattle (their size is important but I won't elaborate).
The trick with a vaccine is to teach our own immune systems which part of the invasive agent to attack. Cowpox has a similar shape to smallpox, so antibodies that attach to cowpox will attach to the same part of the smallpox virus and kill it also. A tick vaccine was invented in Australia by grinding up ticks and injecting them into cattle. The cattle then developed antibodies to attach to some part of the ticks' biochemical makeup. After that, if a tick attached to the cow, the cows' immune system would attack the live tick's head buried in the skin (either killing it or forcing it to drop off).
Growing vaccines in a flask allows far better quality control - the growth is easier controlled and the extraction and purification is better than with animals.
But vaccines have come a long way in the past few hundred years. The latest melanoma vaccines work not by antibodies building a physical, 3D shape-based, lock-and-key approach, but instead interrupt a key biochemical pathway. I assume this was because melanomas tend to be caused by UV damage (energy), not a (matter based) invasive organism. My neighbour had this vaccine about 5 years ago (part of the aussie trials) and it works great - every time a melanoma occurs it turns red, swells a little then flakes off as a scab. It's quite unusual to see the effectiveness of a vaccine right in front of your eyes. Its a shame that other vaccines are not so obvious or there wouldn't be so many batshit crazy, uniformed, pusillanimous, sanctimonious, wowser religiots and new age crystal weenies spreading dangerous lies and proven bullshit to an uncritical and gullible populace with their brains pre-softened by 2,000 years of mindless pap being bludgeoned into children and terrified, uneducated peasants.
In answer to the other question - why should you have the vaccine? Because if you don't you become a target for the disease. Unless you are a hermit, if you get the disease, you will (not maybe, will) pass it to at least one other person, probably many people. Very quickly (exponentially) the whole population will be infected. The effect is called "herd immunity". If enough members of a population are vaccinated (ie, immune to the disease) then it is unlikely to infect unvaccinated members (because no-one has it to infect others). If you have no risk factors (eg immuno-compromised) then you being vaccinated reduces the risk of those that cannot be safely immunised from falling sick of the disease. It is the herd effect alone that protects anit-vax nutters. They are just deluded fucks that are freeloading off the rest of the community. Consequently, they don't deserve respect and they should be prevented from setting public policy.
Flu vaccines are one thing. If you want to see the deadly consequences of letting the feeble-minded make these decisions - read up on the measles outbreaks over the last few years. One outbreak in the US could be traced back to a single group of un-immunised people - and there were deaths across the States as a result. Another outbreak (in Australia) was spread by some "spiritual" guru-type (actually someone on their staff, not the guru). This "hugging" guru and her contingent "hugged" the disease around the country!!! This group it should be noted were NOT anti-vaxxers, just someone in the group wasn't immunised and had caught measles.
It should also be noted that enclaves of anti-vax proponents represent a festering, infectious boil on the arse of all communities. Would you invite someone covered in raw sewage and E. coli into your house? Just because anti-vaxxers have shit for brains instead of on their skins means that even mixing with them or having their kids mix with yours at school places us all in mortal danger. In Australia a child will not be permitted to enrol at a school unless they have been immunised against a number of diseases (MMR and a few others). Home schoolers avoid this restriction.
In extreme circumstances (think black death in London) those infected will be isolated and very probably killed to remove the risk to everyone else. Fire kills most disease and is the preferred method. In London they burned the whole city and pity help anyone too sick to flee. Law is better and more effective than torching cities, but the very concept of a "right to refuse vaccination" must be seriously challenged.
Regarding this particular variant (ie swine flu), the most vulnerable are the healthy. Despite a daily and rigorous "preventative health" regime of smoking, drinking, pizza and inactivity I would definitely advocate anyone living in a densely populated area (eg city or urban) be immunised and those in rural areas should regard vaccination as "highly recommended".
Seeing that the cranks are inventing their own "board certifications," I propose we likewise invent our own specialty board, the American Board of Quack Medicine (ABQM).
Rather than a lengthy test and CMEs, certification in quack medicine will be awarded for written or recorded misleading health advice offered in a public forum by a licensed MD or DO. The certification will expire when the certificate holder publicly apologizes for his ignorant ramblings and commits to sound science.
The ABQM should have a web site listing all current board certified quacks in good standing, with a link to the material that qualified each for certification.
I believe this would prove very handy.
Eric:
He didn't claim it was. He was talking about regular flu, not specifically the novel strain of H1N1 that's so big in the news right now. Of course the number of verified influenza deaths associated with novel H1N1 would be much smaller. There are more influenzas than just novel H1N1, and most cases do not get the specific strain diagnosed.
I don't have much use for homeopathy, but there's an increasing amount of epidemiological data linking flu to low levels of vitamin D. This 2006 review proposes low winter levels of vitamin D as the flu's "seasonality factor".
One the review's authors, Dr. John Cannell has written an article explaining his theory that influenza is a symptom of vitamin D deficiency. BTW Cannell is not anti-vaccine. On his website he states that he plans to get the H1N1 vaccine for himself and his family as soon as it's available.
Cannell admits it will take years to prove or disprove the Vit. D/flu connection. But that doesn't stop anyone from optimizing their vitamin D levels now. for more information, there's this article from the Vitamin D Council website:
Am I Vitamin D Deficient?
i was under the impression that the H1N1 vaccine, like the seasonal flu vaccine, was being produced in chicken eggs.
the "animal cancer cells" stuff appears to originate from the website of infamous woomeister Mercola. basically, anything that comes from that fountain of quackery is not trustworthy.
Speaking of H1N1 prevention...my wife has had several flu screens come back positive for H1N1. She's recommended chemoprophylaxis for children 2 and younger to her patients with chidren that showed a positive H1N1 flu screen, but all of the pharmacies in our area are out of children's Tamiflu liquid and capsules. She had to spend several hours last night seeking out the one compounding pharmacy within a 30 mile radius of our town. This after the local hospital (through which she is employed) assured her that adequate supplies would be available (specifically with respect to Tamiflu). Now she has local school principals and daycare workers paging her at all hours of the night. And she's working on her ABIM recert to boot! This is gonna be a rough year.
Pete:
Oh, honey - no!
50 hrs CME does not mean passive reading of journals.
I'm a professionally designated accountant - my regulatory body specifies that I must do around 35-40 hours of PD every year. It's divided into "verifiable" and "non-verifiable". Only a small percentage of "non-verifiable" is allowed - reading journals is "non-verifiable".
So, I must attend about 30 or so hours of PD each year that often involves additional reading, research, writing etc outside of session time. That's "verifiable".
Now, if that's what's required in an accountant, picture to yourself what 50 hours of CME for a specialist actually entails.
hint - it ain't reading journals.
"Warning: this post has a long, boring prologue..." the boring prologue being the only part that has any hard data, if you consider the writer puffing himself up with doctor mystique data. Gotta wonder about a guy who wants to protect me from charlatans but can't manage to use the word "percent" one time in an almost two thousand word article about public health. Just because you're a BOARD CERTIFIED M.D. and you're talking about health, doesn't mean you're not talking out your ass. The red herring parable of some guy (Dr. Lipman?) is not one I intend to follow into the doctor's office to get a vaccine or to take my kids there.
Huh?