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Mercola, Gardasil, and Toyota?

Joseph Mercola, D.O. should be well known to readers of SBM for reflexively opposing science-based medicine while providing an endless stream of misinformation on his blog, advocating detoxification, homeopathy, the tapping of meridians chiropractic and more at his clinic, and peddling a treasure trove of vitamin supplements, foods, and Mercola-endorsed devices (on sale at his site for your convenience, no conflict of interest there!).

Nothing seems to personify the evil of modern medicine to Dr Mercola more than the concept of vaccination, and Gardasil, the vaccine against human papillomavirus (HPV), has been drawing a good deal of his ire of late.  Case in point is this train-wreck of a post comparing the recent Toyota recall to Gardasil entitled “Time for the Truth About Gardasil.”  The post is ill-named.

It begins:

Cervical cancer accounts for less than 1 percent of all cancer deaths — so it was somewhat surprising when the U.S. Food and Drug Administration fast-tracked approval of Gardasil, a Merck vaccine targeting the human papilloma virus that causes the disease.

Cervical cancer tallied 11,982 new cases of cervical cancer and 3,976 deaths in 2006, not to mention the non-cervical cancers for which it is also responsible.  Worldwide it has an even greater impact as the second leading cause of cancer in women.  Unless Dr Mercola is trying to tell us that he considers the prevention of several thousand deaths per year in the US alone a waste of effort, the fact that cervical cancer isn’t one of the leading causes of cancer death in the US is irrelevant to the FDA’s approval of Gardasil.

I’m certain the actual point Dr Mercola is trying to make is that in his opinion, Gardasil was inadequately tested prior to release, and that he does not accept the data supporting its efficacy or safety.  The fact is that it was tested on over 20,000 women in stage 3 trials where both its safety and efficacy profiles were excellent while identifying a few rare but legitimate side effects, and that post-licensure studies after over 23 million doses have supported the original licensure data (I covered this topic at some length here, as has Dr David Gorski here).  If Dr Mercola insists on having such exceedingly high standards for the safety and efficacy of a vaccine, surely he holds the myriad concoctions and other products he endorses and sells on his site to the same standard.  Surely.  Right.

He then continues:

As of the end of January 2010, 49 unexplained deaths following Gardasil injections have been reported to the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System.

Mercola implies that the 49 “unexplained” deaths are in fact due to Gardasil (there were 48, not 49 on my check on April 2nd, 2010).  There are two major problems with this statement.  First and foremost, an unexplained death is, by definition, unexplained.

Second, of the deaths associated with Gardasil reported to CDC’s VAERS, the majority of them are explained.  At the time of the post-licensure review published in JAMA in August of 2009, there had been 32 deaths reported following Gardasil injection occurring between 2 to 405 days after the last injection. This is the breakdown of those 32 reported deaths after investigation:

Eight of the reports were second-hand reports that could not be verified. Four were manufacturer reports with no identifying information for confirmation or medical review… Causes of death (of the remaining 20) included 4 unexplained deaths, 2 cases of diabetic ketoacidosis (1 complicated by pulmonary embolism), 1 case related to prescription drug abuse, 1 case of juvenile amyotropic lateral sclerosis, 1 case of meningoencephalitis (Neisseria meningitidis serogroup B), 1 case of influenza B viral sepsis, 3 cases of pulmonary embolism (1 associated with hyperviscosity due to diabetic ketoacidosis), 6 cardiac-related deaths (4 arrhythmias and 2 cases of myocarditis), and 2 cases due to idiopathic seizure disorder.

Keep in mind that over 23 million doses of Gardasil had been administered in the US at this point.  It would be remarkable if none of those millions of women had died within a year or so of receiving the vaccine.  A rate of death similar to that of the control population with a random smattering of causes should be expected, and is exactly what is found.  As always, correlation does not necessarily mean causation, and Dr Mercola is deprived of his greatest source of rhetoric against Gardasil.

Not that it will stop him from jumping another shark:

By contrast, 52 deaths are attributed to unintended acceleration in Toyotas, which triggered a $2 billion recall.

Holy false analogy, Batman!  He’s comparing apples to… I don’t know, mops or something.  Where to begin?  Let’s just accept the number of 52 deaths for now.  These deaths are not simply associated with unintended acceleration in Toyotas, they are attributed to them.

These are two very different things!  If Dr Mercola wants to compare 52 deaths attributed to defective Toyotas, he needs to compare it to zero deaths attributed to Gardasil, not 49.  On the other hand, if he wants his analogy to use the 49 deaths associated with Gardasil, he needs to figure out how many people have died from any cause within a year or so of riding in a Toyota.  Methinks the number will be slightly higher than 52.

Not to mention that he completely ignores the starkly different risk/benefit ratios of using Gardasil and driving a Toyota.  No one risks developing cancer or dying from not driving a Toyota.

He concludes:

There has been no recall for Gardasil, however. In fact, it is required for sixth-grade girls in D.C., Maryland, Virginia, and many other states. Merck denies any of the deaths are related to its vaccine — and of course, it is difficult for the grieving parents to prove they were.

No, Merck doesn’t deny the deaths are related to the vaccine, the data does.  There has been no recall of Gardasil because no recall is warranted, and in the meantime the vaccine is protecting millions from contracting HPV and the cancers it can cause.

My heart goes out to the grieving families to whom Dr Mercola refers; their loss is tragic regardless of its cause.  But their grief is being needlessly compounded, and the memory of those lost insulted, as Dr Mercola insists on misrepresenting the conditions of their deaths and callously exploits their loss to spread misinformation and fear of vaccination.

Posted in: Science and Medicine, Vaccines

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20 thoughts on “Mercola, Gardasil, and Toyota?

  1. Todd W. says:

    Dr. Albietz

    Minor correction. I think “Cervical cancer tallied 11,982 new cases of cervical cancer and 3,976 deaths in 2006, not to mention the non-cervical cancers for which it is also responsible.” should read “Human papillomavirus tallied…”, no?

  2. Watcher says:

    So he’s trying to make the fallacious argument that there’s something “broken” with the Gardasil Vaccine when he compares it to the Toyota problem. It would probably work on the general populace unfortunately.

  3. Jeremy says:

    This is a horrible piece of reporting by Joseph Albietz. A cursory check at the web link provided shows that the original, full-length article was written by Barbara F. Hollingsworth, the local opinion editor of the Washington Examiner. The original article is here:

    http://www.washingtonexaminer.com/opinion/columns/Time-for-the-truth-about-Gardasil-89466882.html

    It is true that Joseph Mercola, or an employee of his company, posted a link to the Washington Examiner article and included the first three paragraphs as an excerpt on his website, but he is not the author of the piece under discussion.

  4. BillyJoe says:

    Todd,

    “Minor correction. I think “Cervical cancer tallied 11,982 new cases of cervical cancer and 3,976 deaths in 2006, not to mention the non-cervical cancers for which it is also responsible.” should read “Human papillomavirus tallied…”, no?

    No.

    The Human Papilloma Virus (HPV) is the infectious agent that leads to cervical cancer. Those statistics ARE for cervical cancer and cervical cancer deaths

    Here are the statisitcs for 2009:

    http://www.cancer.gov/cancertopics/types/cervical

    “Estimated new cases and deaths from cervical cancer in the United States in 2009: New cases: 11,270; Deaths: 4,070″

  5. BillyJoe says:

    Jeremy,

    “This is a horrible piece of reporting by Joseph Albietz. A cursory check at the web link provided shows that the original, full-length article was written by Barbara F. Hollingsworth, the local opinion editor of the Washington Examiner”

    And I suppose you couldn’t be accused of hyperbole? ;)

    You are correct, though. The article was written by Barbara Hollingsworth of “The Washington Examiner”. So, he attributed the piece to the wrong author. I don’t suppose it had anything to do with the fact that it was identified on his website as a post by Dr. Mercola instead of as a direct quote from the linked article?

    In any case, it has to be assumed that Dr. Mercola fully endorses it’s contents because he added no qualifying comments.

  6. KJ says:

    Billy Joe,

    Todd is correct–it doesn’t make any sense whatsoever that cervical cancer would cause non-cervical cancer deaths. HPV, however, does cause multiple cancers, although the vast majority of cases are eliminated by a properly functioning immune system.

    Also, Jeremy is also correct in that the post was attributed and linked to the Examiner at the bottom of the post–’posted by’ does not mean ‘written by’ in the blogosphere; quite illogically, of course, but there it is.

    Although I have as little use for the Examiner as for Dr Mercola, it isn’t quite fair to totally poo-poo the death statistics. Gardasil is far more plausibly linked with neurological and autoimmune damage than with most of the reported deaths, but at least one of the ‘juvenile ALS’ deaths was quite definitely linked with Gardasil by the neurologist overseeing the case. In fact, the neurologist presented the case at a major conference. I believe the FDA is investigating because the autopsy showed an unusual immune response and inflammation.

  7. No one risks developing cancer or dying from not driving a Toyota.

    Aw, c’mon. I betcha plenty of people die within a year of not driving a Toyota.

  8. TsuDhoNimh says:

    I went through the VAERS reports and found a couple on patients who could not have received the vaccine because they were male infants.

  9. BillyJoe says:

    KJ,

    I see your first point.

    What was actually written was:
    “Cervical cancer tallied 11,982 new cases of cervical cancer and 3,976 deaths in 2006…”
    Somehow, I read this as:
    “Cervical cancer tallied 11,982 new cases and 3,976 deaths in 2006…”
    Putting “HPV” in there instead of “cervical cancer” would not have worked. It does work in what was actually written though:
    “HPV tallied 11,982 new cases of cervical cancer and 3,976 deaths in 2006…”

    Apologies to Jeremy and embarassment for me!

    ———————–

    As to your second point:

    “’posted by’ does not mean ‘written by’ in the blogosphere; quite illogically, of course, but there it is.”

    I will need to keep an eye out to see if this is true.
    If it is, it IS illogical and I suppose the only way to change that is to call bloggers on it. It would be quite easy for Mercola to have writen: “Here is a quote from Babara Worthington of the Washington Examiner:”, followed by the quote in actual quotation marks. Then there would be no false attribution. Also posting such a quote without comment qualifies as a complete endorsement of that quote in my opinion.

  10. KJ says:

    I believe it’s just the way blogs work–the blogger doesn’t actually WRITE ‘posted by’; the blog template does. Attribution is often badly managed by bloggers. Also, although in this case Mercola probably does endorse the post, often a blogger will post something that s/he doesn’t necessarily endorse in order to excite discussion and comment.

    More to the point, though, is the content. I think the comparison to Toyotas is ludicrous, but I’m not at all opposed to questioning Gardasil. It’s my opinion that for many of us–but certainly not all–the benefits are simply not there. I’m not against vaccination, but I am against loading kids up with more and more vaccinations without considering each one carefully. Although there are multiple possible causes for the growing epidemic of autoimmune disease, we certainly have to look at the role of vaccinations and adjuvants.

  11. Zoe237 says:

    Can cervical cancer deaths from HPV be prevented if caught early enough from regular pap smears? $385 for a series of shots seems excessive, especially in the U.S. where cervical cancer isn’t a major public health threat to those who have regular checkups.

  12. BillyJoe says:

    Zoe,

    “Can cervical cancer deaths from HPV be prevented if caught early enough from regular pap smears?”

    Yes, that’s the reason to do them. If done regularly (biannually in Australia, triannually in UK), they can detect the early “in situ” or “pre-invasive” form of the dsease which can be treated and cured with minimally invasive surgery. Once it becomes invasive, total hysterectomy is required and cure is less certain.

  13. halincoh says:

    “HPV, however, does cause multiple cancers, although the vast majority of cases are eliminated by a properly functioning immune system.”

    I initially misread your above statement. As a clarification, I shall present the following:

    The vast majority of HPV INFECTIONS are indeed transient, contained by one’s functioning immune system, but IF cancer develops, then the activity of one’s immune system is not sufficient to contain that subsequent disease.

    Most, not all, infections that we vaccinate for are self contained by their own immune systems, so in almost every case, we are vaccinating against the what if it doesn’t self contain scenario. It’s simply easier to prevent encephalitis, pneumonia, sepsis, severe gastroenteritis, etc etc. It also prevents spread of the primary disease, further preventing complications. Since the risk of vaccinating is so low, this is the most effective method we have of combating infectious disease in the population at large. We will never see another plague AS LONG AS the scientists and physicians make the vaccines accurate enough and we act fast enough against that bug. And that is simply an amazing thing we all take for granted.

    I have begun to vaccinate the boys in my practice against HPV as well ( recently approved by the FDA ) to prevent further spread still … whether or not their parents drive a Toyota.

  14. KJ says:

    halincoh;

    Apologies; I did in fact mean that the majority of cases of HPV (I believe up to 95 percent), not cancer, are eliminated by…blah, blah. As far as I know, the immune system doesn’t deal with actual cancer. I wrote that badly.

    I don’t take vaccinations for granted at all. I used to live in Africa–enough said. However, I think parents and, hopefully, doctors, should look at the pros and cons of any treatment or vaccination with clear eyes. I’m sure you’re aware of last year’s article in JAMA that discussed the serious over-selling of Gardasil.

    If Gardasil could unequivocally prevent any strain of HPV from ever taking hold, I might be more enthusiastic. But it can’t. Even its strongest supporters recognize (or at least, they do if they’ve read beyond the Merck ads) that a third of cervical cancers and apparently the majority of cervical abnormalities are caused by strains other than 16 and 18, which is why the results of Merck’s trials come in at 17-45 percent reduction in various types of abnormalities.

    What with the plethora of vaccinations recommended, enforced, and on the horizon, I wonder whether vaccination isn’t starting to suffer the same overload as antibiotics. While antibiotic overuse created superbugs (and actually the potential is there for Gardasil to create super HPV), it’s entirely possible that vaccination overload is one of the causes of the rapid rise in autoimmune disease.

    I am deeply curious as to why responses to my post never addressed this question. Or the point about the ALS cases.

    I have chosen not to vaccinate my own girls with Gardasil. I have instead had long talks with them about the ways that smoking, diet, sleep etc. seriously up the chances that HPV could become persistent, whereas strong immune systems clear the HPV and aparently create a natural immunity. We have also discussed the importance of regular check ups and the fact that pairing Pap smears and HPV tests can leave you with an almost zero chance of developing cervical cancer. Personally, I just don’t see the value in Gardasil.

  15. edgar says:

    I attended an APHA session in November 2007 touching in this very subject.
    Lawrence Gostin, JD, LLD, Director, Center for Law and the Public’s Health, Johns Hopkins Bloomberg School of Public Health, had a novel approach to Guardasil. That it be up to the teens as part of their sexual decision making.

    An interesting approach.

  16. Calli Arcale says:

    KJ: don’t take it personally if nobody responds directly to your point. Happens to all of us; it’s because most people responding tend to be responding to the original post and not to the replies. Furthermore, oftentimes people will read only some of the posts, and will only reply to one near the end; between these two factors, you can wind up with quite a few unrelated responses after yours, and that can end up burying your own comment, reducing the chance anybody ever will reply to it. It’s not personal, and it doesn’t really reflect on the content either; it just happens.

    I’m dubious of the contention that “overvaccination” could cause problems comparable to overuse of antibiotics. Most of the time, people who argue this are arguing that we could breed resistant pathogens; while this is possible, it’s not likely with vaccination, and especially unlikely with universal vaccination. The reason is because while antibiotics attack an established population, vaccination (when successful) prevents them from getting established in the first place. If they don’t have a foothold, then there is no population in which to breed resistance.

    But that wasn’t your argument. Your argument was that it could be causing a rise in autoimmune disorders. I’m dubious of this, because I don’t really see any reason why they *should* cause autoimmune disorders. Especially given how vastly more immunological insult a person receives on a daily basis. (Indeed, while I feel the jury is still out, experimental work seems to suggest the reverse: that autoimmune disorders are more common when people get *fewer* immunological challenges.)

  17. KJ says:

    Edgar:

    That IS an interesting approach. I have to say, though, that if I were going to give Gardasil to my own children, it would be before they were sexually active, probably around 12 or 13. Would they be able to make a rational decision at that point? Doubtful. And I wouldn’t want them to get it after they became sexually active, particularly if an HPV test showed that they were already infected, because there would be very little point and possibly more risk.

    I do feel, however, that we baby our teenagers too much and deem them incapable of making intelligent choices—sometimes with justification, and often not. So I’d definitely support making them part of the conversation and being sure that they understand their physical, emotional and spiritual responsibilities to themselves and their partners. That would certainly include attempting to teach them to weigh the pros and cons of Gardasil.

  18. KJ says:

    Calli Arcale:

    Nah, I don’t take a thing personally; I just get a little frustrated when responses focus on sentence structure rather than substance. Thanks for responding to substance (however dubious).

    I’m not really arguing that over-vaccination would be just like creating antibiotic superbugs, more that sometimes there are unintended consequences to our actions—although we certainly did find with Prevnar that when a vaccine targets only a few strains of a virus, it’s entirely possible to create room for an antibiotic-resistant strain to move in.

    My curiosity lies more along the lines that, a) yes, as you said, autoimmune disease is more common when we have fewer immunological challenges, which is why helminthic therapy appears to be extremely helpful for Crohn’s disease, etc. So if we remove the challenges of childhood diseases in healthy children with good diets, are we setting some of us up for a fall?

    And b) vaccines themselves have already most certainly played a part in autoimmune disease—during the 1976 swine flu vaccination frenzy, the relative risk of acquiring Guillaine-Barre syndrome was ten times higher in the 6 weeks post-vaccination, and it was higher again in 92, 93 and 94 after flu vaccinations. That we know. When you look at Gardasil, the risk of autoimmune disease as reported to VAERS isn’t statistically significant—although few parents and doctors even think to file VAERS reports when an autoimmune disease develops weeks, months, or years later—but it’s anecdotally notable, and the incidence of autoimmune disease “we can expect” in the population just keeps rising.

    Part of the problem is that what we know, scientifically, is extremely limited. For instance we “knew” that we could reduce neural tube defects by putting truckloads of folate into nutritionally depleted diets. Now we know that, oops, unlike folate in whole grains, added folate raises the risk of cancer. What is it we don’t know yet about how vaccines work?

    The fact that one of the Gardasil recipients who died of an unusual type of ALS had spinal inflammation mediated by immune response certainly made me sit up and take notice. Was it the vaccine itself, or the adjuvant? And why isn’t the FDA more curious about two Canadian studies that found that the aluminum adjuvant used in both anthrax and, I believe, Gardasil, caused neurological damage in rats?

    I would seriously doubt that there’s any one smoking gun when it comes to the rapid rise of autoimmune disease. But vaccination certainly bears looking at.

  19. islandgirl2010 says:

    Zoe237- you wrote: “Can cervical cancer deaths from HPV be prevented if caught early enough from regular pap smears? $385 for a series of shots seems excessive, especially in the U.S. where cervical cancer isn’t a major public health threat to those who have regular checkups.”

    As a cervical cancer survivor I can attest to the fact that having regular paps are not enough. I had a pap every year after first becoming sexually active and never had an abnormal result until the one that diagnosed invasive cervical cancer – advanced at stage 2B2.

    It pains me to read that there are governments, etc reccommending paps at longer intervals than one year. I am Canadian and even our Federal dept of Health would have told me with 3 years in a row of clear paps, I could wait 3 more years. At which point, I may have died.

    So, no I don’t think the almost $400 I spent vaccinating my teenaged daughter was excessive. I might be preventing her from the same fate I faced.

    I also think that the cases of cervical cancer are misleading. It does not include all the statistics involving dysplasia and the pre cancerous diagnoses that are treated early before advancing to invasive cervical cancer. If all those cases were lumped in with the cancer it would be a far more powerful fact. If only I had had the opportunity to fight the dysplasia and not the cancer, I would have a much easier life now. If you polled all the women you know and asked whether they have ever had an abnormal pap, you have a much clearer picture of the real number of women affected by HPV.

  20. KJ says:

    Islandgirl: I’m sorry you’ve gone through all that–it must have been devastating.

    However, while I agree that even cervical abnormalities that don’t progress to cancer are pretty awful, unfortunately Gardasil wouldn’t necessarily prevent them–not by a long shot.

    In fact, Gardasil is only marginally effective in preventing them–I think about 17 percent. The statistics are there somewhere. It is actually more effective–though a long way from 100 percent effective–at preventing the highest grades than the lowest grades I believe, although actually I’d have to go back and check the stats, and I don’t have time right now.

    Although Pap smears aren’t 100 percent effective at detecting potential cancers (as you found out), they are close to that when paired with HPV tests. You still have to get regular pap smears even post-Gardasil precisely because it’s so far from 100 percent. That’s one of the reasons that, personally, I think that the risks outweigh the benefits, although of course everyone should get informed about the risks and benefits given their own lifestyle and then make the choice.

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