Respectful Insolence

America the “overvaccinated”?

Blogging on Peer-Reviewed ResearchHe’s baaack.

Yes, that radio voice of the mercury militia, the shock jock Don Imus, who was so ignominiously booted from his nationwide syndicated radio show last spring is coming back to the airwaves on December 3 on WABC radio in New York, with plans to syndicate him again nationwide. Personally, although I consider Imus a clueless twit, I’m not sure that he should have been fired over that remark after he apologized, but CBS had every right to can him over it if it so desired. In any case, as some may know, I live within AM radio range of New York; the reasons Imus’ impending reappearance annoys the hell out of me are because (1) he’s an hugely overrated, unentertaining, boring, obnoxious has-been hack and (2) he’s taking the place of the radio show that I normally listen to during my morning commute and when I happen to be able to be working in my lab or office in the morning. Oh, and there’s also one more reason as well, of course. Don Imus is a True Believer in the mercury militia’s contention that vaccines somehow cause autism, as I pointed out very early on in the history of this blog, and even offered to host staged “debates” between David Kirby and supporters of real science. His return means that the mercury militia will soon regain one of its most famous voices. (Expect Jenny McCarthy to be an early guest…any bets?) It also means that Deirdre Imus, who’s also drunk the Kool Aid, will be more visible. An example appeared on that purveyor of antivaccination propaganda from its very inception, The Huffington Post, where Deirdre Imus has posted a truly inane column, Over Medicated and Over-Vaccinated: The Unintended Consequences of Medicines Meant to Protect (don’t worry; I’ll get to the peer-reviewed literature soon):

Just a few weeks ago another study called into question long prescribed vaccination recommendations and added more “fuel to the fire” in the on going controversy over our nation’s immunization policies.

Published in the New England Journal of Medicine [Nov. 8, 2007] the study, funded by the U.S. Public Health Service, suggests we may want to reevaluate and adjust our nation’s current vaccination recommendations.

Scientists from the Oregon Health & Science University found many of the vaccines administered to millions of American’s may be providing immunity longer than what was first believed, making the need for some booster shots unnecessary.

“Surprisingly, we found that immunity following vaccination with tetanus and diphtheria was much more long-lived than anyone realized, and that antibody responses following viral infections were essentially maintained for life,” stated lead author Dr. Mark Slifka, a scientist at the Vaccine and Gene Therapy Institute. The study also found similar longer than expected immunity for several other vaccines.

So far, not so bad, and I’ll get to what this journal article actually did say in a minute. But then, Imus goes right off the deep end into serious antivax propaganda:

But our kids are getting a lot of booster shots…shots containing heavy metals and viruses. Shots that a growing number of parents, physicians and researchers believe could be contributing to the rise of chronic illnesses and developmental disorders affecting our children. If the booster shots are unnecessary because immunity is present, why expose our children to these toxins?

If this study found there has been no increase in diseases in countries that discontinued the booster shots, as was noted, why is the current policy of over vaccinating our children continuing? Where are the conflict-free studies that prove giving infants and children 49 immunizations – most of them by age 5, are safe and effective?

Ah, yes, the old antivax scaremongering technique, telling us how those evil vaccines are full of…heavy metal and viruses! (You know, that would make a good name for a band.) Never mind that the mercury-containing thimerosal preservative has not been used in childhood vaccines other than the flu vaccine since 2002, and also never mind that the reason there are killed viruses in the vaccines is to what vaccines are designed to do, you know, provoke a specific immune response to the viruses for which they are designed. And the–gasp!–toxins! I am, however, grateful that Imus controlled what surely must have been her urge to list all these toxins individually, a favorite technique of antivaxers.

Not unexpectedly, as I did a few searches, I found that Deirdre Imus is only the most recent of many antivaxers to jump all over this NEJM article as “proof” that Americans are “overvaccinated” (whatever that means). The usual suspects are there, including Barbara Loe Fisher, Dr. Joel Fuhrman, and Chicago Tribune alt-med true believer Julie Deardorff. Of course, in a way, I almost can’t blame them, though. The press release about the story was entitled OHSU research suggests America may over-vaccinate, and a Science Daily column was entitled America May Over-vaccinate, According To New Research. If I were an antivaxer, I’d jump all over such unfortunate “framing” as well. Fortunately, I’m not and decided to go to the source to see what the study actually said, the actual New England Journal of Medicine article being referenced, whose abstract follows:

Duration of Humoral Immunity to Common Viral and Vaccine Antigens
Ian J. Amanna, Ph.D., Nichole E. Carlson, Ph.D., and Mark K. Slifka, Ph.D.

Background Maintenance of long-term antibody responses is critical for protective immunity against many pathogens. However, the duration of humoral immunity and the role played by memory B cells remain poorly defined.

Methods We performed a longitudinal analysis of antibody titers specific for viral antigens (vaccinia, measles, mumps, rubella, varicella-zoster virus, and Epstein-Barr virus) and nonreplicating antigens (tetanus and diphtheria) in 45 subjects for a period of up to 26 years. In addition, we measured antigen-specific memory B cells by means of limiting-dilution analysis, and we compared memory B-cell frequencies to their corresponding serum antibody levels.

Results Antiviral antibody responses were remarkably stable, with half-lives ranging from an estimated 50 years for varicella-zoster virus to more than 200 years for other viruses such as measles and mumps. Antibody responses against tetanus and diphtheria antigens waned more quickly, with estimated half-lives of 11 years and 19 years, respectively. B-cell memory was long-lived, but there was no significant correlation between peripheral memory B-cell numbers and antibody levels for five of the eight antigens tested.

Conclusions These studies provide quantitative analysis of serologic memory for multiple antigens in subjects followed longitudinally over the course of more than one decade. In cases in which multiple exposures or repeated vaccinations were common, memory B-cell numbers did not correlate with antibody titers. This finding suggests that peripheral memory B cells and antibody-secreting plasma cells may represent independently regulated cell populations and may play different roles in the maintenance of protective immunity.

Basically, subjects were recruited from the Oregon National Primate Research Center as part of a centerwide, comprehensive program to permit serologic testing of people working in close proximity with primates. In the event of an exposure to an animal (e.g., a scratch or bite), an additional serum sample was drawn. Blood samples were also drawn at weekly intervals after smallpox vaccination in a subgroup of eight subjects in order to monitor the acute phase of the immune response.

It’s a bit of a stretch to conclude from this study that Americans are “overvaccinated.” For one thing, it’s a pretty small study, with only 45 subjects. The mean age of the subjects was 52 on enrollment, and many of them had had measles, mumps, or rubella during childhood, leaving only two to five patients as the source of data for some vaccines. Indeed, the authors themselves point out that further studies will be needed before statistically meaningful comparisons can be made. They also pointed out that the subjects examined were all healthy, other than a few cases of hypertension and asthma, neither of which would be likely to affect long lasting antibody responses to vaccination. What we can conclude from this study is that immunity from many common vaccines may last longer than we had previously thought, and that booster vaccines for some diseases may not be required in some populations. As the authors put it:

“We want to emphasize that proper vaccination is vital for protecting people against infectious disease. We also need to mention that over-vaccinating the population poses no health or safety concerns — it may just be unnecessary under certain circumstances. What our study found was that the lifespan of protective immunity for certain vaccines is much longer than previously thought. So what does this mean? Based on this data and other studies, we may want to consider adjusting some of our recommended vaccination schedules. Doing so may reduce the number of required shots that are administered each year in this country while at the same time help extend limited health care resources,” Dr. Slifka explained.

Also, it should be noted that, since we’re talking about humoral immune responses that last decades, we are not discussing that bugaboo of antivaccinationists and the mercury militia, childhood vaccination. This study may suggest that tetanus booster shots may only be necessary every 30 years and that varicella boosters may not be necessary at all; it does not suggest that our children are “overvaccinated.” Unfortunately, the way the study was reported totally feeds into the preferred antivaccinationist terminology, and I really, really wish the word “overvaccinated” hadn’t been used in the press release.

Not that things like facts stop Imus from going off the deep end:

I’m also starting to think that we should follow the lead being set in veterinary medicine. Studies have provided evidence that the over-vaccination of dogs and cats can result in numerous maladies including cancer, skin and ear conditions, arthritis, allergies, diabetes, aggression, behavior problems and other immune system dysfunctions.

There is even a name for the conditions caused by animal over-vaccination, vaccinosis and it is note worthy to read what veterinarians’ say about over-vaccinating our pets.

“Vaccinosis is the reaction from common inoculations (vaccines)…These reactions might take months or years to show up and will cause undue harm to future generations.”

“In a general and frightening context, I see the overall health and longevity of animals deteriorating. The bodies of most animals have a tremendous capacity to detoxify poisons, but they do have a limit.”

I was curious about what vaccinosis was. Not surprisingly, it’s not a concept that you often find in the standard medical literature (otherwise I would have heard of it). Indeed, a PubMed search for “vaccinosis” revealed only 10 hits, two of which came from the journal Homeopathy, seven of which came from non-English-speaking literature, mostly Italian (leading me to think that the term means something different in Italian). If you Google the term “vaccinosis,” what comes up are a whole bunch of alternative medicine and antivaccination sites, at least on the first few pages. While it is true that there are some autoimmune syndromes that can on rare occasions be triggered by vaccination, such as Guillain-Barré syndrome, these are defined diseases, not the vague “chronic diseases” to which Imus refers

But if you thought this article was bad up to this point, you ain’t seen nothin’ yet:

What most people don’t realize is that any liquid waste containing more than 200 parts per billion (ppb) mercury must be deposited at a hazardous waste site and that drinking water cannot exceed 2 ppb mercury. But when the influenza vaccines arrive and are injected into pregnant woman and infants as young as six months, those vaccines contain 50,000 ppb mercury. This is an amount that is 250 times higher than hazardous waste. According to EPA guidelines, this amount of mercury can only be considered safe if a person weighs 550 pounds. Even trace amounts of mercury in vaccines can be anywhere from 600 to 2000 ppb.

The CDC and The Institute for Vaccine Safety claim there are “no biological effects” from trace amounts (.3 micrograms) of mercury. So, where are the evidenced based (conflict free) studies that prove the safety of these “trace” amounts and proof that there are “no biological effects” of any amount of mercury being injected into our children and pregnant moms? Also, where are the evidence based studies proving the safety of vaccines given to pregnant moms and our children that contain other toxins such as aluminum and formaldehyde?

[...]

Thimerosal has been proven to be a carcinogen, immunotoxic, genotoxic, nephrotoxic and neurotoxic. One study found thimerosal’s lethal toxicity to developing human neurons below 1 part per billion (Parran et al., 2005). Another study concluded, “thimerosal…has been found not only to render its primary toxic effect, but also capable of changing the properties of cells. This fact suggests that the use of thimerosal for the preservation of medical biological preparations, especially those intended for children, is inadmissible.” (Kravchenko et al., 1983).

The stupid, it really does burn, and bad. I need to apply some Silvadene cream right now.

Let’s just put it this way, Deirdre. Of the multiple large studies done since 1999 looking at the question of whether thimerosal has anything to do with autism, none have found even a hint of a link. Five years after thimerosal was removed from most childhood vaccines, new autism diagnoses in the 3-5 year old cohort show no signs of falling, despite the fact that the amount of mercury to which children are being exposed from vaccines is at its lowest level since the 1970s. Indeed, a very large study failed to find a link between vaccines or thimerosal and a wide variety of neurodevelopmental disorders. You’re just plain wrong. As for your “conflict-free” studies, no doubt the blatant conflict of interest of plaintiff’s “expert” witnesses like Dr. Mark Geier publishing “scientific” papers to bolster their contention that mercury in vaccines causes autism should be of equal concern to you.

I’m sure it’s not though.

In fact, if you want to see just how wrong Deirdre is, you should take a gander at this study in a recent issue of the Journal of the American Medical Association. In essence, it looked at the data and showed a 92% decline in cases of and a 99% decline in deaths from diseases targeted by vaccines before 1980 (diphtheria, mumps, pertussis, and tetanus) and an 80% decrease in cases and deaths from diseases targeted by newer vaccines introduced after 1980 (hepatitis A, acute hepatitis B, Hib, and varicella). That is the true legacy of vaccines, the claims of antivaccination loons like Deirdre Imus notwithstanding.

Of course, antivaccinationists don’t appreciate this. No, they don’t appreciate it at all. They hate it when such studies are reported in the media, they see it as “bias.”

There are none so blind as those who will not see, as they say, and these particular blind will, if they have their way, bring about a resurgence of vaccine-preventable disease, morbidity, and mortality.

REFERENCES:

  1. Amanna IJ, NE Carlson, and MK Slifka (2007). Duration of humoral immunity to common viral and vaccine antigens. N Engl J Med 357: 1903-1915.
  2. Roush SW and TV Murphy (2007). Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States. JAMA 298: 2155-2163.

Comments

  1. #1 BA
    November 21, 2007

    Orac with a WBAGNFARB comment (would be a good name for a rock band). I thought I had mistakenly navigated to Dave Barry’s blog while reading the article.
    (Try these after reading about antivax loonies, it might cheer you up: http://blogs.herald.com/dave_barrys_blog/productivity_enhancers/index.html)

    By the way, “mercury militia” also WBAGNFARB.

  2. #2 daedalus2u
    November 21, 2007

    Orac, you mean when I don’t finish a can of tuna I am supposed to dispose of the excess as hazardous waste because it has 353 ppb mercury in it?

    http://www.cfsan.fda.gov/~frf/sea-mehg.html

  3. #3 Dangerous Bacon
    November 21, 2007

    “I need to apply some Silvadene cream right now.”

    Surely you meant to say, a nice dose of colloidal silver? It cures _everything_, but Big Pharma doesn’t want us to know.

  4. #4 Warren
    November 21, 2007

    Hmm, sounds like someone’s working extra hard to earn the Imus family a collective Soylie.

  5. #5 DLC
    November 21, 2007

    So, basically, the anti-vax people can’t wrap their brains around some of the basics of the science involved.
    Or perhaps they are being willfully ignorant.
    In the former case, I would say that they fear such things as vaccinations simply because it is human nature to fear the unknown. In the latter case, they’re being disingenuous, and need to be smacked down at all opportunities. Thanks for doing a bit of smackdown, Orac.

  6. #6 Avicenna
    November 21, 2007

    Speaking as an immunologist, I don’t believe we are weighing the pros and cons (other then the financial ones) when considering the use of vaccines. Apart from the preservatives and stabilizers used in vaccines (to which sensitivity is variable across the population), I am more concerned that the way and frequency of the way the antigen is introduced to the immune system is less then ideal. The mechanism by which vaccines induce an immune response is not anywhere close to how the immune system would normally generate humoral immunity (antibodies) – there is no regulation through innate immunity to orchestrate the proper adaptive immune response when we inject things into the bloodstream with adjuvants. Could this lead to an oversensitivity to other inocuous antigens present simultaneously? Could it exacerbate a mild sensitivity by expanding immune cells that could lend themselves to develop into a full-blown autoimmune disorder or systematic allergy? Is that why we are seeing an unparalleled increase in childhood allergies from everything like peanuts to wheat? Don’t blame the doctors – they are indoctrinated into believing that vaccines are equivalent to exercise when it comes to disease prevention – unfortunately, that is just a matter of miseducation and superb marketing. Sometimes, money makes things seem like we know more then we do – and we end up selling antidotes tinged with the disease.

  7. #7 HCN
    November 21, 2007

    DLC, there are members of the anti-vax forces who actually believe that the diseases are not at all harmful. There are those who I’ve debated on this blog who do not believe that HiB caused serious meningitis less than two decades ago, and those who only think those harmed by measles are those who live in third world countries or were somehow ill to begin with (though why that would make them worthy or acceptible targets for death is beyond me). These are the people who think children are made STRONGER by surviving measles, mumps, meningitis, pertussis and influenza. If some die or become permanently disabled, well then that child deserved it.

    Avicenna, can you please tell us how doctors are supposed to prevent measles? If it was all just due to a matter of marketing, then a voluntary reduction of measles vaccines would not cause a problem, right? So why is it that Japan experienced a surge of measles cases after making the MMR voluntary? Was there some kind of other “mideducation”? How would you, as an immunologist, have prevented the numbers of mumps, mealses and rubella increses shown in this table:
    http://www.who.int/vaccines/globalsummary/immunization/timeseries/TSincidenceByCountry.cfm?country=Japan

    By the way, they never used the Merck MMR in Japan, they had their own with a Urabe mumps strain, and even now only have a MR vaccine (measles, rubella).

    Also, the Merck MMR has been in use in the USA since 1971. Is that the year big bad allergies and diagnoses of autism started to increase? What studies link food allergies to vaccines? (I mostly found papers on how to give vaccines to kids with egg allergies)

  8. #8 wfjag
    November 21, 2007

    “It also means that Deirdre Imus, who’s also drunk the Kool Aid, will be more visible.”

    Be careful. Someone will conclude that you listen to O’Reilly.

    On a more serious note, I didn’t see anything in the “study” that noted that there are large differences in the effects of ethylmercury and methylmercury. Any comparison of thimerosal and mercury in leachate from a hazardous waste site should note the difference.

    Maybe you should try to be a guest on Imus’ new show. Maybe you could educate him on basic biochemistry, and explain the evidence at the Vaccine Trial. He probably still thinks Wakefield’s study is considered good science.

  9. #9 HCN
    November 21, 2007

    DLC, here is someone expressing how safe the diseases are, from:
    http://mikestanton.wordpress.com/2007/09/24/jenny-mccarthy-and-autism-quackery/#comment-27474

    She says “I would never do MMR for my kids, I had measles and rubeola as a child and it was really nothing. Also varicella is ongoing here and really no one gives a damn about it. I’m sorry to say it’s mostly advertising from pharmaceutical lobby.. …
    Poeple move your asses like Jenny and at least try it. No one will blame you for it. I know one day my child will thank me for saving his life.”

    Isn’t that sweet?

    There is also this kind of brilliance:
    http://groups.google.com/group/misc.health.alternative/msg/0924aae470871d2e

    Where Yuri says “Stop lying. It was never common for a family to have a child permanently disabled or die from measles. “

  10. #10 ozzy
    November 21, 2007

    Avicenna,

    Actually, vaccines are not injected directly in the blood stream. They are injected intramuscularly and for a very good reason. The intramuscular injection results in localized inflammation due to the injection itself and adjuvants included in the vaccine. This results in an activation of the innate immune response, presentation of viral antigens and appropriate cytokine signaling, leading to a proper helper T cell response, thereby potentiating antibody responses.

    In regards to food allergies, in particular peanut allergies, the average american infant/child isn’t exposed to peanut allergens during the time of heaviest vaccination since most pediatricians recommend waiting until they are 3 before introducing peanuts. There is a hypothesis that is currently being investigated that this avoidance of peanut containing foods is one of the explanations for the increase in food allergies. In countries where pediatricians don’t recommend abstinence from peanuts the incidence of peanut allergies has not increased. For instance, in Israel infants are commonly given a “puff” that is made from peanuts begining at 6 mos of age and the incidence of peanut allergies has remained stable over the last 20 or so years. It could be that it is this avoidance that is not allowing tolerance to peanut allergens to develop in children with peanut allergies. I think the vaccine-food allergy link is a big stretch.

    “Speaking as an immunologist, I don’t believe we are weighing the pros and cons (other then the financial ones) when considering the use of vaccines.”

    Why this fascination with money? Isn’t it enough to review the data regarding the dramatic decreases in morbidity/mortality from vaccine-targeted diseases to realize that the dramatic improvement in human health is what is driving vaccination programs, NOT money.

  11. #11 John C. Welch
    November 22, 2007

    Lord…as if the OMGMMR idiots weren’t enough…can someone with the knowledge and experience take a look at the study about WiFi possbily causing autism? http://www.informationweek.com/blog/main/archives/2007/11/study_links_wif.html talks about it.

    I thought about digging up the study myself, but I’ve not the background to properly interpret it.

    It sounds off, but that’s just a gut feeling, and could very well be caused my my lunchtime curry.

  12. #12 skeptigirl
    November 22, 2007

    Avicenna,

    I am skeptical of your claims of being “an immunologist”. Would that be a title you bestowed upon yourself? A little reading in your spare time perhaps? An incomplete degree?

    Ozzy has already pointed out above your glaring error claiming vaccines are injected into the bloodstream. Routes of vaccine administration are oral, intranasal, intradermal, subcutaneous, and intramuscular. Not a single one is injected into the bloodstream. And lest you claim this was just your hasty description, anyone in immunology would be well aware that the immune response to any killed vaccine which is distributed systemically as an injection into the bloodstream would be diluted to such a degree as to most likely fail to elicit an immune response. Injecting a live vaccine into the bloodstream might also fail to provide the conditions needed for the organism to grow, also resulting in vaccine failure.

    Further, there is no immune response to a vaccine which is qualitatively different than the immune response to a ‘natural’ infection. The immune response may only be to a portion of the organism rather than to the whole such as the hepatitis B vaccine which contains inactive surface antigen and no viral core, but I doubt you can cite any evidence supporting your superstitious belief there is a qualitative difference. And with live vaccines, the immune response is certainly not different as you claim.

    But even if it were, vaccines are not introduced to the public based on a ‘theory’ that they should work. They are approved only after they can be demonstrated to work. And after they are approved for the market, they are further evaluated by many independent researchers for both safety and effectiveness. Not to mention there is overwhelming evidence that vaccines have a eliminated significant disease burden which graphs of the introduction of vaccine and the decline in cases show time and time again. (All of the anti-vaxers claims these declines in disease rates were from improved nutrition and sanitation are ludicrous, BTW. Perhaps those anti-vaxers weren’t around in the 50s before MMR vaccines came on the market but I can assure them we didn’t drink gutter water and we had the same nutritious McDonald’s burgers way back then.)

    You might be able to fool someone not in biology or medicine with your post, but you aren’t fooling anyone here who is truly familiar with human immunology. Your claims are simply unsupportable nonsense.

  13. #13 Freddy the Pig
    November 22, 2007

    Not much Polio or Smallpox these days is there. I don’t think they went away by themselves. Our pseudo immunologist friend is bringing up the “just a theory” canard just like a creationist.

  14. #14 MartinM
    November 22, 2007

    And lest you claim this was just your hasty description, anyone in immunology would be well aware that the immune response to any killed vaccine which is distributed systemically as an injection into the bloodstream would be diluted to such a degree as to most likely fail to elicit an immune response.

    Homeopathic vaccination!

    Although the succussion stage could be rather unpleasant.

  15. #15 has
    November 22, 2007

    Bring back the iron lung. A few years locked in one of those suckers should cure even the most rabid anti-vaxxer.

  16. #16 Back_Sin_Nation
    November 22, 2007

    Bring back the iron lung. A few years locked in one of those suckers should cure even the most rabid anti-vaxxer.

    The iron lung has been replaced with the trache and ventilator. The polio cases have been replaced with guillan barre adverse events after mass vaccinations with adjuvants which produce auto-immune diseases.

    If you believe in polio vaccination, then go ahead and give your self polio with the sabine live polio vaccine, banned because it causes polio .

    Not banned in third world countries, though. We still give polio to lucky Nigerians.

  17. #17 Orac
    November 22, 2007

    Oh, goody. I’ve got a live one here. Too bad it’s Thanksgiving, Maybe tomorrow or Saturday, if I’m in the mood.

  18. #18 Back_Sin_Nation
    November 22, 2007

    Why this fascination with money? Isn’t it enough to review the data regarding the dramatic decreases in morbidity/mortality from vaccine-targeted diseases to realize that the dramatic improvement in human health is what is driving vaccination programs, NOT money.

    This incredible propaganda must becoming directly from a drug company rep.

    FACT: money is the driving force for corporate capitalism.

    FACT : the drug industry is a member of corporate capitalism.

    FACT: There has been no dramatic improvement in human health from any new vaccine in the past 10 years. There has been a decline in health from some of the banned vaccines though.

    FACT: new vaccines and drugs are brought to market TO MAKE MONEY for the corporations. Everything else is secondary.

    Pigs at the Trough, How corporate greed and political corruption are undermining America, by Arianna Huffington
    Three Rivers Press, 2003

    The Nexus and the Pharmaceutical Industry: Money Is the Drug

    … Each year, tens of thousands of people are killed by the giant drug companies, whose wanton disregard for human life is only matched by the tobacco companies and firearms manufacturers.

    With more than 100 deaths linked to its best-selling cholesterol drug, Baycol, Bayer was finally forced to pull it off the market. Though not until Baycol earned Bayer profits $720 million in 2001 alone. Bayer was earning $7.2 million for every death its product caused by leaving it on the shelves. Or, depending on the way you look at it, a few more deaths were just the price of doing business.

    The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers, a new book by Katharine Greider,

    reveals how big pharma maintains a stranglehold on the health and pocketbooks of working families. Greider’s meticulous research explores the industry’s profit-over-research priorities, its complex and unregulated pricing practices, pervasive advertising and marketing strategies, excessive influence on the doctors who write prescriptions and cozy relationships with the nation’s lawmakers.
    A prescription for profiteering ……
    The drug industry’s gargantuan profits result in large part from big pharma’s business practices that industry critics say border on the unethical–practices that have helped boost the number of prescriptions written from 1.9 billion in 1992 to more than 3 billion 10 years later, while jacking up the price of an average name-brand prescription from $27 to $65, according to Greider.

  19. #19 Orac
    November 22, 2007

    As I said, a live one.

    Too bad I plan on chilling this Thanksgiving. I have better things to do than to spar with an anti-vaxer today.

    Actually, it’s not too bad at all.

  20. #20 daedalus2u
    November 22, 2007

    I saw a recent suggestion that the increase in peanut allergies might be due to the use of peanut oil in topical lotions. That absoption of peanut allergens through the skin might be a much more highly allergenic route than through the gut. Which actually makes sense to me.

  21. #21 Dangerous Bacon
    November 22, 2007

    Ah, the vaccination-driven-by-lust-for-obscene-profits rant is back.

    Who is allegedly making all this money off vaccines? Not physicians. And if it was such a profitable industry, why has the number of U.S. firms manufacturing vaccines declined so much in recent decades, to a mere handful now (the lack of domestic production leading to the necessity of importing flu vaccine from England a couple of years ago).

    Pharmaceutical companies are not enthusiastic about making vaccines – government is your biggest customer, it sets onerous rules and regulations as well as controlling prices, and big profits aren’t there.

  22. #22 HCN
    November 22, 2007

    Also, there must be more profits in providing hospital care for a child with pneumonia or encephalitis than giving them about $100 series of shots.

    I know that my son’s week in the hosptital was well over $10000 almost 20 years ago, I am sure it is more now. How much did it cost to keep this baby alive:
    http://www.thesun.co.uk/sol/homepage/woman/health/article491866.ece

    Isn’t preventative medicine cheaper in the long run?

    (something I need to practice right now… my first attempt at making a low-fat pumpkin pie with evaporated milk instead of heavy cream, and egg whites instead of whole eggs)

  23. #23 shirin
    November 22, 2007

    You have got to be kidding! Pharmaceutical companies don’t see a cash cow when they get nations to stock pile Tamiflu (thanks to the endorsement of the White House – Old Rummy has quite a bit of “stock” in Tamiflu/Roche – or at least he had when the bird flu was the new plague – another WMD intelligence primer)? Merck did a wonderous job lobbying the Canadian gov’t to implement the “anti-cervical cancer” mass vaccination of grade 8 girls (without there being any efficacy or clinical trials completed of girls that age – nor without showing that the girls hadn’t already been exposed to HPV and were fully able to defend themselves immunologically – like all healthy people against HPV) – that targets 4 strains of the very many strains. Vaccines – like antibiotics – are very powerful tools that can both do good and harm. I find it unbelievable that so-called “science-minded” people lack critical thinking skills or maturity enough to realize that we know crap. Some poster actually thinks that vaccination mimicks the “natural” host-pathogen interaction that occurs when an “educated” immune system decides what is a harmful antigen vs an inocuous one. Furthermore, I also think that the rabid response to our “immunologist” friend was shrill by some who seem to take personal offense at the questioning of mass and chronic vaccination regimes for conditions (like the flu – which is usually a best guess) may be overkill (pardon the language). Really – being skeptical means that proceding with caution is wise – whereas, making up groups like the “anti-vax idiots” and the “pro-vax demi-gods” defeats the purpose of critical discourse.

  24. #24 HCN
    November 22, 2007

    Uh, since when is TamiFlu a vaccine?

    And how is pushing the MMR vaccine the equivalent of the HPV? Do you seriously think there would be less profit to medical supply and pharmaceutical companies if we went the route of Japan and stopped using the MMR? Do we really want to get the numbers of mumps and measles up to levels high enough to close college campuses (see WHO link above).

    Also, only about 30% of the population gets the flu vaccine. How is that “mass vaccination”? See:
    http://www.cdc.gov/nchs/data/hus/hus06.pdf#083

    Speaking of HPV, have you seen this (I know, rare, but it is interesting):
    http://scienceblogs.com/aetiology/2007/11/it_still_amazes_me_sometimes.php

    Finally you said ” I find it unbelievable that so-called “science-minded” people lack critical thinking skills or maturity enough to realize that we know crap. ”

    Like the use of paragraphs and using links to evidence?

  25. #25 Back_Sin_Nation
    November 22, 2007

    Who is allegedly making all this money off vaccines?

    hard to believe yet true, mandatory vaccination of all 11 year old girls in texas by executive decree was briefly in the books at 300 bucks a pop times three. Want to add up the profits? Also known as mercks plan to pay for vioxx litigation.

  26. #26 meg
    November 22, 2007

    hard to believe yet true, mandatory vaccination of all 11 year old girls in texas by executive decree was briefly in the books at 300 bucks a pop times three.

    A good friend of mine, in her early thirties, just had to have a hysterectomy to remove her cervical cancer, which was missed by several distinguished medical facilities until it had spread significantly. She is considered lucky because her ovaries were saved; she might be able to have biological children via a surrogate.

    As you may guess, I don’t fucking care if Rick Perry was trying to mandate the administration of Gardasil out of a desire for Merck to have a profit or out of a desire to, say, prevent cervical cancer among the many poor immigrant girls who will be lucky to see a doctor a handful of times in their lifetime, and who will probably die if they get cervical cancer, because they sure as hell aren’t getting regular Pap smears. I suspect it was a mix of both. You know what? It was the right thing to do. And I’m putting my money where my mouth is at the moment – it’s been confirmed that I don’t have HPV, and thus I’m paying out of my pocket to receive the set of shots. Yes, it’s more than $800. That’s infinitely cheaper than the cost of treating advanced cervical cancer, plus it leaves me with a fully functioning set of reproductive organs.

    We now have a vaccine that can prevent cancer. This is the stuff of science fiction, and you’re bitching and moaning because someone, somewhere might be making some profit off of it? No offense to the other XY types on the board, but gee, must be nice to be a guy and have HPV be something that doesn’t affect you, huh?

  27. #27 Men in Chartreuse
    November 22, 2007

    Back Sin Nation: Thanks for the comedy. Keep your head down and close the shades. The men in the black van outside are watching you. Oh, and don’t forget to tinfoil your CRT – those same guys are Van Eck Frequing you.

    How do I know this? Because I hacked into their wifi and am watching you pick your nose right now.

  28. #28 Shirin
    November 22, 2007

    This is directed at Meg. I think it is wonderful to be proactive against cancer (ounce of prevention is worth more than the pound of the cure); however, please don’t let getting vaccinated be the way you safeguard against cervical (or any other cancer). The HPV vaccine targets 4 strains – there are over 70 I believe – and it has been stated that they think that the majority of the cervical cancer cases are caused by 3 of the 4 strains the HPV vaccine from Merck targets. This does not mean that one of the other strains not targeted cannot become one that induces cancer (since they will have the opportunity to take over the niche left by the one of the dominant strains targeted). Furthermore, the only real guarantee against cervical cancer is a pap spear. I’m from Canada, where we have access to free medical care – such as pap smears – and we have one of the lowest rates of cervical cancer (partly because it takes being both immuno-incompetent and not being able to clear HPV as well as letting the infection fester for 10 years before cancer usually appears). Catching such a potential growth early and treating it is both successful and the only guarantee you won’t die of cervical cancer. So, for having public funds going into a mass vaccination program – when the results are still to come in as to pros and cons of where we can actually use a billion dollars of our health care dough is a very senstivie issue. I never stated that being vaccinated against things like meningitis and polio is unnecessary. – I do think it should be a choice, and I think we should use the tool wisely so we don’t abuse it – and are fully cognizant of the possible repercussions of abuse (like antibiotics or any other medical intervention). Looking at the fact that guardasil has not come out without its share of negative side effects (even death), I think we really need to pause when mass vaccination programs are implemented as well as have a proper longitudinal study in place so we will actually know if there are real correlations between subsequent disorders that may are more frequently seen in the vaccinated cohort.

  29. #29 has
    November 22, 2007

    >>Bring back the iron lung. A few years locked in one of those suckers should cure even the most rabid anti-vaxxer.

    >The iron lung has been replaced with the trache and ventilator.

    Neat, let’s give all the anti-vaxxers a tracheotomy instead. If nothing else, the rest of us will enjoy the quiet.

  30. #30 DLC
    November 22, 2007

    For HCN : Depressing isn’t it ? The anti-vaxer says: “I had Measles as a child and it wasn’t that bad.” Do they know that this is anecdotal evidence and that it is not supported by the facts ? These facts are readily available to anyone who wishes to look them up, either on the internet or at the public library. (sarcasm) Oh, but wait… these numbers are generated by Them and so are not reliable… Right… (/sarcasm).

  31. #31 Calli Arcale
    November 22, 2007

    What I find amazing is that some folks criticize others for not questioning — by lambasting them for daring to question someone.

    Why is it that for some people, “critical thinking” means “discounting anything the establishment says”? And why is it that when those people are themselves questioned, they immediately assume the questioner must be a lackey of the establishment?

    I’ll answer my own question: it’s because for some people, it’s not about the truth. It’s about fighting the establishment. For them, this is not an honest pursuit of knowledge. It’s war. Thus, you are either with them, or against them. And they have become so entrenched in this that they are largely unaware of it themselves, and are immune to the irony of accusing a person of lacking critical thinking skills when all they did was ask for supporting evidence.

  32. #32 jvv
    November 23, 2007

    Shirin:

    Immunization is a matter of public health, as well as personal health. For an infectious disease, immunizing a random 10% of the population reduces the incidence of the disease by far more than 10%.

    For even the most virulent infectious diseases, only 70-80% of the population needs to be immunized to eradicate the disease.

    And eradication is even possible in cases with many uncommon mutant strains. There is likely a reason that the 4 strains of HPV are responsible for most cervical cancers — either they are the most destructive or they are the most infectious. So even if we simply make HPV less of a killer, is that not worth it? Do you want to bet your daughter’s life on it?

    And most minor strains are a consequence of the scope of major strain infection. For example, I have seen several well-founded models that, with HIV, a vaccine that had only 25% (random) application, and only protected against the top two most common strains, would lead to a virtual elimination of the virus within two generations.

    So when you say you want the choice to immunize yourself or your children against various diseases, what you are really saying is I want other people’s children to have a much higher chance of death from something we could have fixed.

  33. #33 shirin
    November 23, 2007

    JVV,
    First, thank you for not resorting to insults and engaging in discourse. I know that the chances of me being afflicted with HPV and getting cervical cancer are significantly smaller then of my suffering an adverse reaction to Guardasil (which is still under evaluation). In regards to your strain argument – I suggest taking a look at:http://jama.ama-assn.org/cgi/content/full/297/16/1784
    How appropriate a vaccine program would be for a community should be evaluated at both the individual level, the threat of the disease, and the nature of the virus.

  34. #34 wfjag
    November 23, 2007

    “Lord…as if the OMGMMR idiots weren’t enough…can someone with the knowledge and experience take a look at the study about WiFi possbily causing autism?”

    Dear Mr. Welch:

    Take a look at Dr. Novella’s blog NeruoLogicaBlog at http://www.theness.com/neurologicablog/index.php in his recent article “Wireless Technology and Autism”. It may not be the same study, but it’s the same assertion that he dissects.

  35. #35 Back_Sin_Nation
    November 23, 2007

    We now have a vaccine that can prevent cancer.

    Really?

    How many cases of cervical cancer were in the placebo group?

    None.

    How many cases of cervical cancer were in the vaccine group

    …also none.

    This essentially shows that Merck is very good at selling the idea of cervical cancer prevention by vaccines which have not been proven to prevent cervical cancer.

  36. #36 Jesse
    November 23, 2007

    “FACT: There has been no dramatic improvement in human health from any new vaccine in the past 10 years.”

    What do you think the HPV vaccine is going to do? You know what, don’t answer. Have a daughter, refuse to let her get the vaccine and then see how pleasant a death from cervical cancer is.

  37. #37 ozzy
    November 24, 2007

    “This incredible propaganda must becoming directly from a drug company rep.”

    For the record, I am not a drug company rep but instead a post-doc working doing immunology research at an academic institution and anyone who has been a post-doc can attest that it is definitely NOT for the money.

    No back to the science:
    “Some poster actually thinks that vaccination mimicks the “natural” host-pathogen interaction that occurs when an “educated” immune system…”

    What is an educated immune system? Let me answer this question for you. It is an immune system that has been primed for an effective response once it encouters the pathogen that it has been primed against. Guess what does that priming…(Insert drum roll here)…A vaccine!!!

    “…decides what is a harmful antigen vs an inocuous one.”

    Tell me how the immune system can tell what is harmful and what is innocuous. Actually, the immune system recognizes ALL foreign antigens and works to eliminate them. (With the exception being beneficial gut bacteria) However, it takes time for the immune system to mount a proper cell-mediated immune system to some viruses. So by the time the immune system has mounted n T-cell mediated response, the virus has had enough time to mutate thereby making the immune response less effective because it is directed against the original virus but not the mutated virus. Therefore by vaccinating against the common strains that are being passed around the vaccine is giving the immune system a head start.

    So Shirin, now it’s your turn. Tell me about this magical power that “educates” the immune sytem to decide “what is a harmful antigen vs an inocuous one?”

  38. #38 HCN
    November 24, 2007

    ozzy said “So Shirin, now it’s your turn. Tell me about this magical power that “educates” the immune sytem to decide “what is a harmful antigen vs an inocuous one?””

    OOoooh… please tell us! I would really like to know why I break out in rashes when I touch nickel. This is a metal that seems to be everywhere! I have to buy special sewing needles, and I can’t wear my wedding set because nickel is commonly used to harden gold and keep things from rusting.

  39. #39 Jackdog
    November 24, 2007

    For Jesse: No “dramatic improvement in human health”? How dramatic do you need? I am a pediatrician who trained during the era of common varicella, h.flu meningitis, pneumococcal meningitis in young children. I have seen a child in the ICU eaten alive by necrotizing fasciitis after a case of chicken pox while his parents cried at his bedside. I have LP’d numerous children and have seen post meningitis children with hearing loss and seizures. Incidentally, I have hospitalized two different undervaccinated children with whooping cough in the past year. These are anecdotes, but they are certainly supported by statistics. I hope to see the day when the same thing happens for common pediatric scourges such as RSV and influenza.

    On another note: Check out Orac on your new Kindle. How appropriate for a super intelligent computer.

  40. #40 back_sin_nation
    November 24, 2007

    What do you think the HPV vaccine is going to do? You know what, don’t answer. Have a daughter, refuse to let her get the vaccine and then see how pleasant a death from cervical cancer is.

    My daughter has refused the HPV vaccine, and I agree with her. As recommended for all females, she gets annual pap exams. That is true prevention for cervical cancer, not the HPV vacine which has never been shown in a clinical study to prevent cervical cancer. The vaccine can prevent certain strains of HPV which are thought to be associated with increased cancer risk 20-40 years later. This is quite different from showing fewer cases of cervival cancer in a clinical study. This type of study would take 40 years and has never been done. Until then, the HPV vaccine is unproven, and whether or not it prevents cervical cancer is merely speculation.

  41. #41 ozzy
    November 24, 2007

    Jackdog,

    Thanks for sharing your personal experiences, as unfortunate as they may be. The other night I decided to check out some die-hard anti-vaxer propaganda over on the mothering.com discussion boards. Holy sh*t. You would not believe the stuff that that was gleefully fed to often confused questioners. Yes, the tone of the discussion could actually be described as giddy at time. Such as: (disclaimer: these are not actual comments just dramatizations)
    “Polio causing infantile paralysis, you are kidding right…Polio never harmed anybody, but the vaccine did”
    “Measles (insert chickenpox here) is just a mild childhood. They say it kills 1 in 333 but it really kills 1 in 1000. or I had measles when I was a kid and I turned out OK.” I could go on and on. I couldn’t stop myself from reading. But it really troubled me and it really steams me when a few people with an agenda take advantage of the ignorance of new moms who just want to do what’s best for their kid.

  42. #42 ozzy
    November 24, 2007

    Nation:
    “As recommended for all females, she gets annual pap exams. That is true prevention for cervical cancer…”

    This is secondary prevention of cancer, otherwise known as early detection resulting in treatment strategies to stop the progression of cancer. In other words you are catching it once it has started. True prevention, or primary prevention, is eliminating the exposure that results in cancer. That is what the vaccine is doing. It is preventing exposure to 4 strains of HPV that have been estimated to cause ~70% of all cancers. Of course, in order to definitively state that the HPV vaccine truly prevents cervical cancer you will need a 20-30 year study but I think it would be highly unethical to withhold a prevention strategy that eliminates exposure to a carcinogenic pathogen.
    I hope you made sure your daughter knew all the facts:
    1. Pap smears are not true prevention but instead secondary prevention. A positive pap smear doesn’t prevent anything. It leads to biopsies and treatments (surgery with loss of being able have children, chemo or radiation). It does however result in detection of cancer at an earlier stage thereby resulting in an improved prognosis, which is a good thing.
    2. The false negative rate of pap smears have been demonstrated to be 15-25%. Therefore, off all of the women with cervical cancer 15-25% of them will have a negative pap smear and will think they are cancer free.
    3. The strains targeted by the vaccine have been associated with 70% of all cervical cancers. Meaning that 70% of all women with cervical cancer are infected by these strains and women infected with these strains are at much greater risk of developing cervical cancer than women not infected with HPV or infected with other strains.
    4. Condoms are not nearly as efficient at preventing the spread of HPV as they are with HIV. This is because the virus is contained in shed skin from areas that are not covered by the condom.
    5. Most men are asymptomatic while infected with HPV so there is no way of knowing whether they are infected.

    So to end with a play on your above-mentioned quote, the only true prevention of cervical cancer would be to completely abstain from any sexual contact with men since the mode of transmittance beyond intercouse isn’t completely understood. You might want to tell your daughter to abstain from sex until marriage and then only marry a virgin. But, we all know how ineffective those abstinence programs are so it might be best for her to just get the vaccine.

  43. #43 ozzy
    November 24, 2007

    By the way she should get the vaccine and continue to have her annual pap smears.

  44. #44 back_sin_nation
    November 25, 2007

    Of course, in order to definitively state that the HPV vaccine truly prevents cervical cancer you will need a 20-30 year study but I think it would be highly unethical to withhold a prevention strategy that eliminates exposure to a carcinogenic pathogen.

    This is exactly my point. There is no study which shows that the vaccine prevents cervical cancer. It is highly unethical to withhold this information from the advertising materials, and this informatrion should be included in the informed consent form. The patient and/or the family should decide if they wish to participate in this experimnental HPV vaccine, the vaccine should not be mandated by the government.

    What are the dangers and adverse side effects of the HPV vaccine? We dont know. Initial reports fron the Vaccine Adverse Event Reporting System (VAERS)have been disturbing.

    Three deaths were related to the vaccine, including one of a 12-year-old. One physician’s assistant reported that a female patient died of a blood clot three hours after getting the Gardasil vaccine. Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.”

    My question is how many deaths are caused by the vaccine, and how many deaths are prevented by it? In the case of smallpox, live polio and swine flu these were all discontinued because the deaths/adverse effects caused by the vaccine exceeded the lives saved/benefits. This could easily be the case for the HPV vaccine. It may take another year or two to find out.

  45. #45 ozzy
    November 25, 2007

    From the CDC website, (I don’t have home access to the NJEM articles that are refenced in the CDC report):

    Gardasil and Cervarix are highly effective in preventing infection with the types of HPV that they target. FDA-approved Gardasil prevented nearly 100 percent of the precancerous cervical cell changes caused by the types of HPV targeted by the vaccine for up to 4 years after vaccination. Two follow-up studies of Gardasil confirmed these findings. The studies also found the vaccine to be less effective in women who had previously been exposed to HPV types 16 and 18 (5, 6).

    Therefore, Gardasil appears to be highly effective in preventing pre-cancerous cervical lesions, an event highly predictive of prevention of cervical cancer, similar to the removal of precancerous colon polyps and prevention of colorectal cancer.

    You continue to state the 3 deaths figure. But that figure is not relevant unless you state the rate. How many people have received the vaccine? I could state that 3 children have died from severe allergic reactions to organic peanut butter or that 3 infants deaths were linked to co-sleeping with their parents and these would have the same meaning as your 3 vaccine-related deaths. Following your example, I would be forced to conclude that the eating of organic peanut butter and infant co-sleeping should be banned.

    Some facts regarding cervical cancer (from Am. Cancer Society and CDC websites):
    1. 11,150 new diagnoses of invasive cervical cancer a year. So by extrapolation, 7805 HPV-related invasive cervical cancer diagnoses a year. In terms of rates, 8.1 new cases/100,000 women a year or 5.7 HPV-related cases/100,000 women per year.
    2. The overall five-year survival rate is 72%. So of these 7805 HPV-related invasive cervical cancer diagnoses made every year, 2185 will die within five years. The death rate from cervical cancer is 2.5 deaths/100,000 women per year with 1.8 HPV-related deaths/100,000 women per year.
    3. While these are only mortality stats, they say nothing about the morbidity associated with having to go through chemo, radiation or surgery.

    Besides, these deaths you site have been investigated and shown to not be related to the HPV vaccine (CDC website):

    “There also have been four deaths reported among females who received the HPV vaccine: One involving a blood clot in the lungs (pulmonary embolism); one involving inflammation of the heart muscle due to influenza; one from a blood clot; and one from multiorgan system failure due to influenza infection unrelated to vaccination. Preliminary data indicate that the two women who died of blood clots were taking birth control pills, and blood clots are a known risk associated with birth control pills. All four deaths are being fully investigated but none appear to be caused by vaccination.”

    Lets see, birth control and influenza. Another line of evidence demonstrating the importance of flu vaccine.

  46. #46 back_sin_nation
    November 25, 2007

    Therefore, Gardasil appears to be highly effective in preventing pre-cancerous cervical lesions

    Whether or not this translates into fewer cases of cervical cancer is unknown, and at present merely speculation. Pap smear cytology can vary considerably in the same patient over time due to many factors. Pre-cancerous (atypia and dysplasia) cytologies can spontaneously change back to benign cytology due to many factors none of which include the use of the HPV vaccine.

    I could state that 3 children have died from severe allergic reactions to organic peanut butter

    Peanut allergy can cause death. However, if three deaths occurred with no allergy, then any such product would be either banned or seriously controlled.

    1.8 HPV-related deaths/100,000 women per year.

    What is the death rate for the HPV vaccine? 3 deaths in how many vaccinated? We dont know. If the number is close to 1.8 per 100,000 then it it would be the same as the disease and there is no benefit fron the vaccine.

    Of 2 million vaccinations, there have been 136 adverse events deemed serious by the FDA, ranging from seizures to Guillain-Barre Syndrome, a rare life-threatening disorder in which the immune system attacks nerves and induces paralysis. Of the 18 pregnancy complications, 16 have involved miscarriages.
    Get the facts about HPV and GARDASIL vaccine to make an informed decision, provided the following facts: 1. HPV infection is naturally cleared by more than 90% of sexually active women and men but, rarely, HPV infection can become chronic. 2. Among high risk factors for chronic HPV infection are smoking: co-infection with herpes, chlamydia, or HIV; long term birth control use; multiple births. 3. Women chronically infected with HPV, who don’t get pre-cancerous cervical lesions promptly identified and treated, can get cervical cancer and die. 4. After pap screening became routine in the 1950’s, cervical cancer cases in the U.S. dropped 74%. 5. Less than 1% of all diagnosed cancer cases and cancer deaths in the U.S. every year involve cervical cancer. 6. Merck’s GARDASIL vaccine was studied for several years in less than 1200 girls under age 16 and a few hundred girls age 11 or younger. 7. GARDASIL contains only 2 of 15 HPV types associated with cervical cancer and it is unknown if it will prevent cervical cancer long term or if it will increase the risk for those actively infected with HPV types in the vaccine. 8. Reported GARDASIL reactions include sudden collapse, seizures, facial paralysis, Guillian Barre Syndrome, arthritis and other serious health problems. 9. It is unknown if GARDASIL will cause infertility, cancer or damage genes. 10. There is no pre-licensure data proving it is safe to give GARDASIL with most of the other vaccines for children.

  47. #47 HCN
    November 25, 2007

    Actually, the HPV prevents four different strains of human papillomavirus, which are known to cause cancer. This is one of the papers that shows what the effectiveness is of the vaccine to prevent the viral disease (there were several studies done in different countries):
    http://content.nejm.org/cgi/content/abstract/356/19/1915

    They followed more than 12000 test subjects for three years. Some in the placebo group did get the actual HPV disease, and may or may not develop cancer later.

    Here is another full paper. It is a smaller group, but has both boys and girls. There is an interesting paragraph on adverse reactions including one where “A 15-year-old girl experienced an intentional overdose of chlorpheniramine tablets and arsenicum homeopathic tablets 13 days after receiving dose 2 that was judged by the reporting physician to not be vaccine related.”:
    http://pediatrics.aappublications.org/cgi/content/full/118/5/2135

    One quibble: PAP smears do NOT prevent cervical cancer. They hopefully detect it when they are hopefully treatable. Preventing contracting the virus that causes the cancer PREVENTS cervical cancer.

    Another quibble: The HPV vaccine is not the first vaccine to prevent cancer. The HepB vaccine also prevents an infection that causes cancer.

    Speaking of cancer and viruses… Read “Vaccinated”, the biography of Maurice Hilleman. There is an interesting thread on cancers, infections and chickens (apparently there was a disease that would wipe out chickens, and in order to get enough eggs to produce vaccine that had to be conquered).

  48. #48 Jesse
    November 25, 2007

    Jackdog, thanks for your stories. However, I was merely “copying and pasting” what this back_sin_nation cretin posted. I firmly believe in vaccination (My PhD lab is actually in the department of Pathology and Immunology ;)) and I get a flu shot every year.

  49. #49 ozzy
    November 25, 2007

    “HPV infection is naturally cleared by more than 90% of sexually active women and men but, rarely, HPV infection can become chronic.”

    10% persistence is not a rare event.

    “Less than 1% of all diagnosed cancer cases and cancer deaths in the U.S. every year involve cervical cancer.”

    So 7850 HCV-related cervical cancer deaths is a trivial number.

    “it will increase the risk for those actively infected with HPV types in the vaccine” or “It is unknown if GARDASIL will cause infertility, cancer or damage genes.”

    Typical fear-mongering. There is no reason to expect that injecting a pseudoviral particle consisting of only the envelope protein but not any nucleic acids necessary for viral replication would increase the risk of those actively infected. I can say with certainty that:

    Not getting vaccinating will greatly increase your risk of being infected with the strains of HPV known to increase your risk of developing cervical cancer.

    People use to argue that there was no way to predict that decreasing the smoking rate will result in decreased lung cancer incidence. Time and time again studies have shown that when you decrease exposure to cacinogenic agents you decrease carcinogenesis. So your statement “it is unknown if it will prevent cervical cancer long term,” while technically true, is truly disingenuois.

    Once again, no death has ever been conclusively linked to Gardasil. 2 death from blood clots in women who were taking birth control pills. 2 deaths from complications from influenza. So right now the death rate is 0.

  50. #50 HCN
    November 25, 2007

    Jackdog, on the theme of folks denying the dangers of the actual diseases… several months ago a Dr. Flea blog had an article on Hib:
    http://scienceblogs.com/insolence/2006/12/fleas_stepped_in_it_again.php

    Unfortunately, Dr. Flea’s blog is gone, and so is lost the debate from one woman who claimed that the Hib did not really kill toddlers. Even with lots of papers being cited, she still refused to believe that Hib could kill.

    sigh

  51. #51 Diora
    November 26, 2007

    “There is even a name for the conditions caused by animal over-vaccination, vaccinosis and it is note worthy to read what veterinarians’ say about over-vaccinating our pets.”

    There is in fact a case for less vaccinations in cats: vaccine-associated sarcoma (http://www.avma.org/vafstf/) which occurs in between 1 in 10000 and 3/10000 vaccinations; some sources say 1/1000. Of course, it a) has nothing to do with humans since no other animal seems to be affected and b)according to some sources is thought to be caused by local inflammation and may even occur after other injections as well e.g. antibiotics, but as vaccines are done more often, it hasn’t been noticed as much in other cases and c) humans aren’t vaccinated every year. VAS is very aggressive.

    There is also something in dogs (not vaccinosis though), but I don’t know much about dogs.

    It is interesting that instead of a real condition like VAS, Imus choose something unproven.

  52. #52 Common Sense
    November 26, 2007

    This was the best thing that I’ve read here in a while:

    ———————————————————-

    We now have a vaccine that can prevent cancer.

    Really?

    How many cases of cervical cancer were in the placebo group?

    None.

    How many cases of cervical cancer were in the vaccine group

    …also none.

    This essentially shows that Merck is very good at selling the idea of cervical cancer prevention by vaccines which have not been proven to prevent cervical cancer.

    ———————————————————–

    Beautifully said.

  53. #53 I will type very slowly so you will understand
    November 26, 2007

    1) HPV is a known cause of cervical cancer.

    2) … and other nasty things like warts:
    http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/11/12/wtree112.xml

    3) It takes longer than three years for the cancer to occur after HPV infection, sometimes between 5 to 10 to decades after infection, see Lancet. 2007 Sep 8;370(9590):890-907. Human papillomavirus and cervical cancer.

    4) The vaccine trials were looking only at HPV infection, often for three years (on PubMed there are several), here is one:
    http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15863374
    … which concludes “INTERPRETATION: A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types.”

    You are building a strawman that is so dry that you should be careful because “the stupid, it burns”

  54. #54 Robster, FCD
    November 27, 2007

    Will Type,

    It is questionable if cervical cancer ever occurs in the absence of previous HPV infection.

  55. #55 Schwartz
    November 27, 2007

    I will type very slowly so you will understand:

    Is it not customary in science to market only that which is proven? I see a lot of marketing about Gardasil and it’s efficacy in preventing cervical cancer.

    From what I can tell, it’s efficacy in preventing cancer is purely based on a hypothesis, not scientific study.

    The hypothesis and justification of mass application of the vaccine itself has the following assumptions:
    1) The 4 strains of HPV virus cause the cancer in the affected populations and their removal will reduce the rate of cancer
    2) Other strains that may replace the targeted four do not cause as much cancer in the affected populations
    3) The vaccine does not cause any long term damage to the recipient

    There are a lot of if’s there, and this is hardly a proven theory although it is a sound THEORY.

    Scientific study of safety would require a randomized placebo based clinical trial on the age of the population that it is being administered to, with a lengthy followup.
    It is my understanding that this has not been done. Therefore, the true safey data on Gardasil is not known.

    Scientific study of efficacy would require the randomized application of the vaccine and following the two populations through many years life, and only then would we know the true efficacy.

    So let’s review the scientific evidence:

    Scientific evidence of safety on populations being vaccinated: None
    Scientific evidence that the vaccine prevents Cervical Cancer: None
    Scientific evidence that the vaccine prevents 4 strains of HPV: Yes
    Scientific evidence that reducing HPV virus will result in a reduction of Cervical Cancer: Unproven Hypothesus

    So what do you call the people and governments who are saying we have a vaccine that prevents cervical cancer?

    Where is the evidence based medicine that justifies both mandated mass vaccination and significant expense?

  56. #56 MartinM
    November 27, 2007

    Scientific study of safety would require a randomized placebo based clinical trial on the age of the population that it is being administered to, with a lengthy followup.
    It is my understanding that this has not been done. Therefore, the true safey data on parachutes is not known.

  57. #57 daedalus2u
    November 27, 2007

    Pretending that the only way to determine “true safety” (what ever that is) is via a placebo controlled trial with arbitrarily long follow-up is disingenuous.

    What level of “true safety” do you consider acceptable? If you are unable to define what level of “true safety” is acceptable, then you do not understand the term and your rejection of vaccines cannot be based on “true safety”. It is a smoke-screen to hide your ignorance behind.

  58. #58 ozzy
    November 27, 2007

    Schwartz:

    Do smoking cessation programs decrease lung cancer incidence?

  59. #59 Schwartz
    November 27, 2007

    Ozzy,

    “Do smoking cessation programs decrease lung cancer incidence?”

    No idea, never studied the issue myself. How many women have those strains of HPV and never get cervical cancer?

  60. #60 Schwartz
    November 27, 2007

    MartinM,

    Congratulations, you read that study too. Since you’re so well read, why don’t you point out the logical fallacy in your post?

  61. #61 Schwartz
    November 27, 2007

    Daedelus2u,

    Interesting way to avoid presenting scientific evidence. I see you completely avoided commenting on the efficacy argument, so I take it you agree then?

    Since you aren’t offering any concrete criteria for safety acceptance, I’ll be a little more specific:

    There are very good reasons for performing randomized placebo based safety studies (and efficacy for that matter) on the age group you are planning to vaccinate.

    If your only complaint is that I didn’t specify a follow-up period, that is hardly a reason to invalidate the whole point.

    I think that the original follow-up period of 36 months is reasonable, though personally, I would prefer 5 years.

    So let’s review the facts again:

    1) No evidence of safety for populations being vaccinated
    2) Little evidence of short term HPV efficacy in population being vaccinated
    3) No evidence of long term HPV efficacy in population being vaccinated
    4) No evidence of efficacy for preventing Cervical Cancer (for which is being marketed AND cost justified)

    So I ask again, how is the evidence based medicine approach being applied here? Even more disturbing as a taxpayer: Where is the cost justification coming from?

  62. #62 daedalus2u
    November 28, 2007

    Schwartz, what is evidence of safety? The only thing that evidence of safety is, is a lack of evidence of harm. That is, in an exposed population, a sufficiently low adverse event rate that the hypothesis “treatment X will cause harm at rate greater than Y” is shown to be false.

    When you say “no evidence of safety”, what exactly do you mean? That there has been no testing and no follow-up in any population for any length of time? That is clearly false. If you are going to throw around false statments (aka lies), what basis do we have for trying to communicate?

    Your position (there is no evidence of safety) is demonstrably false. One might reasonably argue that only when an adverse event rate is below a certain level is it “safe enough”. But that is not what your arguement is, you are arguing that there is no evidence of safety.

    The only way to determine if a vaccine is “safe”, is to measure it. The only way to measure it is to actually administer it to a relevant population and look at the adverse event rate. If you demand an adverse event rate below 1 in a million before administering it to more than 1,000 people, you will never get there.

  63. #63 Orac
    November 28, 2007

    I’ve addressed this whole topic of how antivaccinationists have no clue about the concept of relative risk before. Suffice it to say vaccines are virtually the only thing in life that antivaccinationists seem to demand “complete safety” about.

  64. #64 MartinM
    November 28, 2007

    Congratulations, you read that study too.

    …what study?

  65. #65 MartinM
    November 28, 2007

    No evidence of efficacy for preventing Cervical Cancer

    And that’s precisely where you’re wrong. Evidence of efficacy in preventing some common causes of cervical cancer is evidence of efficacy in preventing cervical cancer. It is not conclusive proof. We understand the consequences of waiting for a larger, longer-term study; more deaths from cervical cancer while we wait. We have good reason to believe some of those deaths can be prevented. Ergo, we take measures which, based on the best evidence available to date, should be preventative. This isn’t exactly complicated.

  66. #66 ozzy
    November 28, 2007

    Well put MartinM. I think it’s pretty safe to say that eliminating a carcinogenic exposure (HPV infection) will result in a decrease in cancer. Smoking cessation programs have clearly illustrated this. Look at the lung cancer mortality rates in males over the last 50 years and then look at survival rates. The survical rates have not increased at all so it’s not due to better treatments. The drop in mortality is due to decreased incidence of lung cancer.
    Also, to focus on cervical cancer deaths only obscures the total picture. Granted the cervical cancer survival rates are pretty good but the women who are cured have to go through chemo, radiation and surgery which are associated with some serious physical and psychological suffering. So in addition to preventing deaths, the vaccine would prevent alot of women from having to go through these treatments and would be greatly beneficial to women’s health.

  67. #67 Diora
    November 28, 2007

    “One quibble: PAP smears do NOT prevent cervical cancer. They hopefully detect it when they are hopefully treatable. ”
    This statement is wrong. PAP smears detect abnormal leisions which may or may not become cancer, so PAP smears do prevent cancer. Read USPSTF, for example (http://www.ahrq.gov/clinic/uspstf/uspscerv.htm)
    “The USPSTF found good evidence from multiple observational studies that screening with cervical cytology (Pap smears) reduces incidence of and mortality from cervical cancer.” Note “reduces incidence of” in the statement.

    Also if you click on “Clinical consideration” on the same page, you’ll see the following statement: “The majority of cervical cancers in the United States occur in women who have never been screened or who have not been screened within the past 5 years”

    As to Gardasil, while I think its greatest benefit is in preventing abnormal pap smears and resulting colposcopies, biopsies, leision removal that may have effect on fertility (by the way, ozzy, do look up “treatment of abnormal pap smears” before claiming that it is the same as cervical cancer treatment), and if I had a daughter I’d probably seriously consider it. At the same time, I think that the government shall only mandate health care measures that affect public health, not just the individual involved. Since there is no “herd immunity” here, and cervical cancer is not a public health risk, I think this decision should be left to the individual. It seems a slippery slope for government to mandate medical interventions “for the individual own good”, however beneficial these interventions may be.

    I do strongly support other vaccinations by the way, so don’t confuse me with anti-vax crowd. By the way, a number of medical bloggers (medpundit, TBTAM, Musing of the Dinasaur) commented against mandating Gardasil, so it is not only anti-vax crazies who aren’t wildly enthusiastic about it yet.

  68. #68 HCN
    November 28, 2007

    Diora said “This statement is wrong. PAP smears detect abnormal leisions which may or may not become cancer, so PAP smears do prevent cancer.”

    I stand corrected. Also, thank you for pointing out the further benefits of the HPV vaccine.

    Though I do feel that the HPV vaccine DOES contribute to herd immunity, but not as much as it could be until young men are also vaccinated.

  69. #69 Schwartz
    November 28, 2007

    MartinM, Ozzy,

    You don’t seriously expect me to believe you made up the parachute analogy do you?

    http://www.bmj.com/cgi/content/full/327/7429/1459

    So let me understand then, you accept a theory as proof of efficacy that justifies spending millions of taxpayer dollars and you don’t even mandate a long term study to prove efficacy? I have a strong sense double standard here.

    The comparison to smoking is not acurate because this vaccine selectively targets only 4 of over 100 strains of the virus. Additionally, many women naturally clear the virus and it alone is not considered enough to cause the cancer. If you look even closer to the statistics, you’ll find that a very large percentage of smokers (I’ve seen > 50% of men) will die from a smoking related disease. What is the equivalent percentage from women infected with HPV strains 16 and 18 dying from cervical cancer?

    By quitting smoking, we are by no means risking a replacement smoke entering the lungs, but we certainly are risking new strains of HPV becoming more prevalent. We are already seeing unexpected results from a similar approach taken with the Prevnar vaccine, where the originally targeted strains of bateria have been quickly replaced by others, and in come cases by anti-biotic resistant strains.

    What’s even worse, is that the timing of application of such vaccines can be very important, and the ages that the vaccine are being applied weren’t effectively studied for longer term efficacy against HPV at the younger age. There is one long time researcher of HPV (involved in these trials) that has said just that (Diane Harper, the professor and director at the Gynecologic Cancer Prevention Research Group at Dartmouth).

    If you want to present a strawman, you should make sure the comparison is a bit closer.

    Don’t get me wrong. I think that the theory holds significant promise. But there no actual evidence of efficacy against cervical cancer (there are a bunch of IFs in the Theory) or safety in the vaccinated populations to mandate through law the mass medication of all women and certainly not enough evidence of efficacy to bypass a mandated long term study of efficacy. There are too many variables involved.

    To state otherwise flies in the face of glaring lack of evidence to date.

  70. #70 ozzy
    November 28, 2007

    Diora,

    As I stated before, it is secondary prevention because you are catching it once it has started. Some abnormal lesions are pre-cancerous lesions. For some, the only thing that is needed is the removal of the lesion however for others it means the start of a cervical cancer treatment program. By the way, 48% of cervical cancer patients had a pap smear in the last 3 years according to the study that your above linked govt report cited, so it hasn’t really prevented their cancer. The only true way to prevent cancer is to remove the agent/chemical that is causing the cancer.

    On another note, I wasn’t talking about the treatment of abnormal lesions. I was talking about the treatment of cancer. ~ 5600 women a year have to go through cervical cancer treaments NOT just abnormal tissue removal and 2688 of these women had a pap smear in the last three years prior to their cancer diagnosis. All I’m stating is that preventing the morbidity that these cancer treatments are associated with needs to also be included in the discussion and not just preventing cancer deaths.

    On the other hand, I’m undecided if mandating it is the right way to go. I can understand the arguments both ways. However, I would like to see the anti-HPV infection efficacy studies done in boys. Have they been? If it is able to prevent male HPV infections then I would be in favor of mandatory vaccinations for all. By the way, my daughter will get the HPV vaccine.

  71. #71 HCN
    November 28, 2007

    ozzy said “However, I would like to see the anti-HPV infection efficacy studies done in boys. Have they been?”

    http://pediatrics.aappublications.org/cgi/content/full/118/5/2135

  72. #72 daedalus2u
    November 28, 2007

    Schwartz, do you have a link to back up your (false) statement that there is “no actual evidence [...] of safety”?

  73. #73 ozzy
    November 28, 2007

    Schwartz,

    Here’s where your argument begins to break apart. The reason for the increased cancer risk from subtypes 16 and 18 isn’t due to a greater infection rate but instead is that they have the highest likelihood of becoming chronic. That is they are more effective at evading the host immune response so they tend to stay around longer resulting in increased insertion of viral oncogenes increasing the risk of carcinogenesis. The other subtypes are more effectively cleared by the immune system. I don’t think there is much of a niche to be filled.

  74. #74 ozzy
    November 28, 2007
  75. #75 ozzy
    November 29, 2007

    Thanks for the link HCN. I am beginning to think that boys should also be vaccinated to help elicit herd immunity.

  76. #76 Schwartz
    November 29, 2007

    Daedelus2u,

    Since it is incumbant on a drug manufacturer to prove safety, and you are claiming I made an inaccurate statement, I would think that you should be the one providing references to contradict my statement.

    But since you probably can’t find any, here is the background:

    “”Giving it to 11-year-olds is a great big public health experiment,” said Diane M. Harper, who is a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire.

    “It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue.”

    Internationally recognized as a pioneer in the field, Harper has been studying HPV and a possible vaccine for several of the more than 100 strains of HPV for 20 years – most of her adult life.””

    If you read the info from Merck http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

    You’ll see a few interesting things:
    1) Merck did not use a saline placebo, but a much more reactive aluminum containing placebo for the majority of it’s safety trial. This will always help hide reactivity of people to the vaccine. (Wyeth pulled a similar stunt by running using an experimental vaccine in it’s safety control group for Prevnar many years ago)

    2) The number of women in the safety trial for ages 9-17 are very low, and the number of children ages 11 and 12 are unspecified. How many volunteers would offer their pre-teen daughters up for a vaccine against an STD?

    As I (correctly) stated (along with others who have done extensive research in the field), not enough safety data available for the population being madated to get the vaccine.

  77. #77 Schwartz
    November 29, 2007

    Ozzy,

    I’m assuming you’re referring to the replacement by other strains part of my argument? I’m not saying that other strains will prove to be worse, only that we don’t know. It’s an experiment that will only yield results after many years. But I do know that the Prevnar experience has resulted in unexpected results and it’s approach is very similar to this vaccine (target the strains most strongly associated with Mennigitus).

    My infection rate comment was referring to the comparison to smoking where the damage rate amoung those afflicted with the condition of smoking is extremely high.

    I also suspect that herd immunity would require vaccination of both men and women since the virus is so easily transmitted between all people.

    Apparently, those two strains of HPV are also strongly related to neck and head cancers providing a theoretical benefit to men as well.

    Are you planning to lead the way and sign up?

  78. #78 ozzy
    November 29, 2007

    Schwartz,

    My comparison with smoking has to do with the idea that eliminating carcinogenic exposures results in decreased cancer. Yes, the mortality and morbidity stats are not similar but I provided that example to show that decreasing carcinogenic exposures results in decreased cancer incidence. Therefore, expecting cancer incidence to decrease following the implementation of HPV vaccination is not a stretch by any means. Another fine example would be HBV and HBV-related liver cancer.

    By the way, as I am well past the age of effective vaccination and have probably been infected already vaccination would not be effective for me. However, my children will get vaccinated.

  79. #79 Schwartz
    December 1, 2007

    Ozzy,

    I did catch that part, but my point is that in smoking there is a huge percentage of people damaged by smoking (> 50%) in men.

    In order to hypothetically get the same type of benefit from this vaccine, one would have to count the percentage of people that might benefit from the removal of the dangerous strains. I don’t know what that percentage of people who have the strains compared to those that actually contract cervical cancer, but you would have to know. Then a hypothetical cost analysis can be done to justify the millions being spent.

    Additionally, the side effects from quitting smoking are probably less damaging than those from a vaccine, although I suspect one could debate that.

  80. #80 daedalus2u
    December 1, 2007

    To compare the risks of quitting smoking to vaccination against HPV, wouldn’t you have to account for other addictions that someone might pick up after quitting smoking? As you want to account for other strains of HPV? Heroin for example? The major difficulty with a heroin addiction is that it is illegal, so it is expensive and clean drugs and paraphernalia are difficult and costly to obtain. Trading a smoking addiction for heroin addiction and potential exposure to hepatitis C, HIV and other diseases of self-injected drug users isn’t necessarily an improvement. Similarly, a tobacco addiction is relatively cheap. An addiction to cocaine or amphetamine isn’t. If the expense of the new addictions forces one to become a crack whore, the risk of acquiring STDs may outweigh the risk of cancer from smoking. Because other addictive drugs are (mostly) illegal, the risk of incarceration goes up a lot, along with the diseases that go along with incarceration.

    Applying your “logic” on HPV vaccination to smoking cessation, by no means has it been shown that stopping smoking is worth the risks.

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