Like many physicians, I often peruse Medscape. It’s generally been a convenient and quick way to catch up on what’s going on in my field not directly related to my research, for which I tend to rely on pre-configured RSS feeds for PubMed searches to highlight any articles related to my areas of interest. Since these searches routinely flag hundreds of articles a week whose titles and abstracts I end up perusing, sometimes only cursorily to identify the articles I might want to read, it is impractical for me to rely on this approach for areas that are even only a bit out of my field. That’s where, at least so I thought, services like Medscape came in handy. I could look over stories and quickly find out about research and medical of interest to me, only occasionally needing to look up the actual journal articles. Like a fair number of physicians, I rely on it fairly regularly. I should also point out that Medscape sometimes even tries to go against the tide of woo, as it did when it published an article by authored by two of my co-bloggers, along with two others. The article, authored by Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; and Wallace I. Sampson, MD, entitled Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned, was a tour de force deconstruction of why TACT is bad science and unethical to boot.

So how to explain an article published in Medscape last week and authored by Alison Gandey entitled HPV Vaccine Adverse Events Worrisome Says Key Investigator?

The article could have been a fair assessment of whether the risks of Gardasil are higher than reported. “Could have” is the operative phrase. Unfortunately, in among the real scientists quoted (and quoted rather selectively, I might add), Gandey parroted back a whole lot of antivaccination nonsense and a misunderstanding. I expect far better from Medscape. Unfortunately, this time I did not get it. For example, there was this howler from Gandey’s report:

Members of the antivaccine movement point to a number of potential perils, including the presence of aluminum in injections. Like many vaccines, Gardasil contains aluminum salts. Each 0.5-mL dose contains approximately 225 μg of aluminum, 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 μcg of polysorbate 80, 35 μg of sodium borate, and water.

Oh, no! Toxins! We’re poisoning the children! Won’t you help?!

I suppose I should be grateful that Gandey refrained from repeating the formaldehyde, antifreeze, or the ever-dreaded “fetal parts” gambit. On the other hand, although you may not know it, let me assure you that anti-vaccine advocates know the significance of mentioning borate (it’s a “roach killer,” don’t you know?) or polysorbate 80, (it’s been linked to infertility in mice–supposedly). Remember my old “toxins” post, and you’ll see how ridiculous these gambits are. For example, the rat study of the effects of polysorbate 80 injected rats with amounts of the chemical that, by body weight, were incredibly high; nowhere near that amount is found in vaccines on a per weight basis. Similarly, I can’t figure out why L-histidine was included in this list. Histidine is an amino acid that’s found in virtually every protein in the body. It’s also an essential amino acid in growing children. That Gandey would even mention it along with aluminum and other ingredients in the context of antivaccinationists’ complaints about a “number of perils” shows a serious lack of understanding of nutrition and pharmacology. As for aluminum, as I’ve said many times before, now that mercury in vaccines is being increasingly exonerated as a cause or “trigger” for autism by multiple high quality studies and lots of science, aluminum is fast becoming the new mercury among antivaccinationists. This goes in stark contrast to science and clinical experience, where aluminum salts used as adjuvants have an 80 year track record of safety in vaccines. Nor is there any compelling evidence, as claimed by antivaccinationists, that it causes or contributes to Alzheimer’s disease.

Next, Gandey quotes Christiane Northrup, MD. Yes, that Christiane Northrup, Oprah Winfrey’s favorite OB/GYN and a regular guest on her show, the doctor who has discussed with Oprah how women should use qi gong to direct their qi into their vaginas in order to achieve more powerful orgasms. Indeed, my co-blogger Harriet Hall, MD has deconstructed Dr. Northrup’s ideas, which, much like Andrew Weil‘s, are a mix of the sensible and science-based thrown together haphazardly with a whole lot of woo to the point where it’s often hard to tell which is which. For instance, Dr. Nortrhup is an advocate of so-called “bioidentical hormones,” a highly dubious “rejuvenator” advocated by Suzanne Somers that lacks any plausible basis in scientific medicine, as Dr. Hall discussed a while back right here on this very blog in the context of hormone replacement therapy.

Sadly, Dr. Northrup more than lived down to my expectations based on seeing her on Oprah. She exceeded in pseudoscience beyond even the dim view I generally have of her. Indeed, she did even worse than I would have expected, as she regurgitated a standard trope of germ theory denialists. Yes, germ theory denialists. I kid you not:

Dr. Northrup recommended that the money going toward vaccines and related programs be allocated to general health and wellness initiatives and proper nutrition. This harkens back to the age-old debate between Louis Pasteur and Antoine Beauchamp, Dr. Northrup suggests.

For most of his career, Pasteur subscribed to germ theory, while Beauchamp backed the more unpopular theory of biological terrain. The question: Is it the germs themselves that make people sick or a weakened state of immunity that allows germs to take root? “Pasteur was widely supported, but on his death bed conceded that Beauchamp was right,” Dr. Northrup said during an interview. She suggests that this is what experts should be concentrating on now.

Here’s the problem. None of what Dr. Northrup claimed in the quote above is true, other than that there was a debate between Pasteur and Beauchamps in the late 1800s over the role of “seed versus soil” in infectious disease. That debate was settled long ago–and not in Beauchamps’ favor. Indeed, that Pasteur “recanted’ germ theory on his deathbed or admitted that “Beauchamps was right” after all represents nothing more than a myth promulgated by germ theory denialists (shaking my head in disbelief, I still can’t fathom how it is that such people still exist in this day and age, but they do). Northrup simply parroted the same sort of misinformation beloved of “alternative” medicine advocates and especially germ thoery denialists, such as Bill Maher, and Gandey serves up this quote without even bothering to check whether what Dr. Northrup said was, in fact, true.

Worse, Gandey fails to give any sort of context for the reports of 9,700 adverse reactions reported to the Vaccine Adverse Event Reporting System (VAERS). What people don’t understand about VAERS is that it’s not a good epidemiological for establishing strong evidence of causation, and it’s dubious even for correlation. Indeed, such was never its intent when it was designed. VAERS was originally intended as a “canary in the coalmine,” so to speak, in that anyone can report problems that occur in close temporal proximity to vaccines. It’s an early warning system, not a rigorously administered database. “Adverse events” reported don’t even have to be something that looks suspicious as having been caused by vaccines. Indeed, I still remember the infamous story of how Dr. Jim Laidler once reported to VAERS a most unusual complication from vaccination:

The chief problem with the VAERS data is that reports can be entered by anyone and are not routinely verified. To demonstrate this, a few years ago I entered a report that an influenza vaccine had turned me into The Hulk. The report was accepted and entered into the database.

Because the reported adverse event was so… unusual, a representative of VAERS contacted me. After a discussion of the VAERS database and its limitations, they asked for my permission to delete the record, which I granted. If I had not agreed, the record would be there still, showing that any claim can become part of the database, no matter how outrageous or improbable.

In other words, just because a health problem or event is reported to VAERS does not mean that it was related to any vaccine. Moreover, whenever a reporter writes about VAERS, he or she should be aware that VAERS is very susceptible to corruption by publicity, well-meaning advocacy groups, or even litigation in a way that no other vaccine database is. As Dr. Laidler put it:

Since at least 1998 (and possibly earlier), a number of autism advocacy groups have, with all the best intentions, encouraged people to report their autistic children–or autistic children of relatives and friends–to VAERS as injuries from thimerosal-containing vaccines. This has irrevocably tainted the VAERS database with duplicate and spurious reports.

It’s even worse than that, though. As was shown in a study by Michael J. Goodman and James Nordin published in the journal Pediatrics in 2006, vaccine litigation has hopelessly corrupted the VAERS database. In the study, the authors, did something incredibly simple that no one had done before. They took data from the VAERS database from 1990 through 2003 and imported it into SAS data files for analysis. Then they searched the database using key words to look for reports associated with litigation, particularly with regards to autism. They also searched for records containing “thimerosal,” “mercury,” or “autism” in their fields, especially when coupled with terms like “lawyer,” “legal,” “attorney,” or “litigate,” while excluding records containing “legal” coupled with the term “guardian” that did not relate to litigation. They also excluded cases related to well characterized allergic reactions to thimerosal. Finally, they compared records from nonlitigation cases to those from litigation cases regarding symptomatology reported.

Not surprisingly, beginning in 2001, they noted a dramatic increase in the number of non-Lyme disease VAERS reports related to litigation, from only 7 in 2000 to 213 in 2002 and 108 in 2003. (They attributed the decline in 2003 reports to processing delays in creating public use files.) Next, they examined reports related to symptom sets. For autism, they observed a dramatic increase in the percentage of litigation-related reports from 0% of the reports related to litigation in 1999 to over one-third (35%) in 2002. For records mentioning thimerosal that weren’t related to allergic reactions, the rise was even more dramatic, from 0% of these reports related to litigation in 2000 to 87% in 2002.

Given that study from a couple of years ago, I have to wonder whether anti-vaccine advocacy groups, religious groups opposed to Gardasil on the grounds that it will “encourage promiscuity,” or potential litigants might be doing something similar with VAERS reports related to Gardasil. There’s no way of knowing yet because Gardasil is too new and there hasn’t been sufficient time to look at such trends and correlations in VAERS. In any case, the ease with which the VAERS database can be influenced by simple publicity (of which there has been a lot recently over Gardasil), advocacy, or litigation-driven reports is what makes it virtually useless for longitudinal studies or studies of correlation. It’s also why VAERS is so beloved of antivaccine pseudoscientists like Mark and David Geier, who love to go data mining in it for spurious correlations between vaccines and autism. The CDC’s Vaccine Safety Datalink (VSD) is a much better resource for doing epidemiological studies about whether vaccines cause or contribute to specific adverse events or complications, not the least of which because reports are entered only by health care professionals and rigorous documentation is required.

Now, let’s take a closer look at those reported adverse events, shall we? The reason, of course, is that it’s not just Medscape that reports these VAERS numbers without context. CNN has the same thing recently, too, but I expect more of Medscape. Unfortunately, this time, I didn’t get it, and indeed Medscape appears this time to have done even worse a job than CNN. For example, when Medscape reports that 6% of the adverse events reported to VAERS were considered “serious,” as it turns out, this is less than half the 15% of reactions reported as “serious” for other vaccines. Moreover, although there is a perfunctory mention from a spokesperson from Merck that it’s impossible to tell whether these events were related to vaccines or not, the overall impression left by the article is that there’s a strong reason to be concerned. This impression is reinforced by the relatively free rein given to Gardasil critics, even to the point of reporting nonsense spouted by Dr. Northrup, and the relatively little said by those supporting the safety of vaccines, complete with a heart-tugging anecdote of a suspected Gardasil-related complication. It’s also bolstered by the lack of anything resembling a serious discussion of why VAERS reports are very poor evidence for adverse events causation by a vaccine.

Left out for the most part was information to put these reports in context. For example, here’s what the American Cancer Society says about the possible link between Gardasil and Guillain-Barré syndrome or death:

There have been 15 reports of sudden death after vaccination. The CDC says after careful review of the 10 reports that had adequate information for analysis, CDC could not establish the causal relationship between vaccination and death.

In addition, there had been 31 reports of Guillain-Barré Syndrome (GBS) after Gardasil vaccination in the U.S, ten of which had been confirmed as GBS. Of those 10, 5 reported vaccination with Menactra, a vaccine against meningitis, at the same time. Of the remaining 21 reports, 7 did not meet the case definition for GBS, one had symptoms of GBS prior to vaccination, 4 were unconfirmed reports, and 9 were pending additional follow-up. The CDC says the number of GBS cases reported are within the range that could be expected to occur by chance alone after a vaccination. CDC and FDA physicians and scientists continue to review all reports of serious side effects reported to VAERS to identify potential new vaccine safety concerns that may need further study. The American Cancer Society continues to monitor those reviews to ensure the safety of those who receive the vaccine, which has the potential to prevent the majority of the cases and deaths of cervical cancer.

It struck me as odd that none of this was discussed in the Medscape article. Where Gandey went wrong as well was in emphasizing doubts about the vaccine’s effectiveness above all else, whether valid concerns or not. For instance, she reported this quote:

At the 2006 American Society of Clinical Oncology annual meeting, delegates were enthusiastic. One presenter showed a series of cervical cancer photos and told observers that “these types of pictures will soon disappear in clinical oncology.”

Unfortunately, that utopian prediction is unlikely. “Cervical cancer is not a vaccine-preventable disease,” Dr. Lippman said during an interview. And in her recent editorial, she points out that surrogate end points — not cervical cancer — were used to measure the efficacy in the clinical trials.

“No one would want to wait to see cervical cancer develop in participants,” she writes. “But the general failure to mention that the precancerous lesions chosen for study are not only potentially removable, most (those that are CIN 2) would probably have resolved on their own without any intervention, is arguable.”

By this rationale, the MMR vaccine does not prevent subacute sclerosing panencephalitis (SSPE), a rare but late complication of measles, and the influenza vaccine does not prevent flu-associated pneumonia. I realize that some advocates of the HPV vaccine sometimes have a distressing tendency to oversell its benefits or label everyone, not just religious fundamentalists who see Gardasil as the tool of the devil that will take away a penalty for premarital sex, questioning whether the HPV vaccine is ready for widespread use yet as ““anti-woman,” but it’s a mistake to go too far the other way and undersell the vaccine’s potential benefits as well. There’s also a difference between saying that a vaccine against HPV can prevent cervical cancer, which is what is claimed based on the data, and saying it’s a “cervical cancer vaccine,” which strikes me as a bit of a straw man characterization of what advocates of HPV vaccination actually do say about it.

In conclusion, let me just point out that, as one of the main resident vaccine advocates here on Science-Based Medicine, even I am not yet convinced entirely that state-recommended and state-funded mass vaccination programs with Gardasil or any other HPV vaccine are, at this stage, warranted by science and policy considerations. The reason is not so much that I am concerned that the vaccine is not safe or that it is not effective. Indeed, the evidence suggests that it is. Rather my concern emerges in the context of the entire vaccination program taken as a whole. One problem is the expense of Gardasil. Compared to other vaccines that protect against acute deadly diseases, it’s not cheap, and without the funds to pay for mass vaccination a lot of parents won’t be able to afford it if their health insurance won’t cover it. Worse, the poor and uninsured, who would be most likely to benefit from it, would be the most likely not to be able to afford it. Second, my concern lies in whether the evidence is such that the vaccine’s benefits outweigh its expense and risks by a margin comparable to that of other vaccines in the routine childhood vaccination schedule, which is what I consider a necessary burden of proof to be met before the vaccine is added as a routine part of the overall vaccination schedule. Personally, I’m of the belief that HPV vaccination is safe and probably a good idea, but I haven’t yet been convinced that a mass vaccination program is yet justified. I’m close, but I”m not quite there yet, and I don’t claim that some skepticism isn’t warranted. The problem is that skepticism demands accurate information about potential risks and benefits, and this Medscape article provided neither.

That being said, Medscape is supposed to be operating at a higher plane, scientifically speaking, than mainstream news outlets. It failed miserably in its responsibility by publishing this misinformation-laden and biased article that even went so far as to allow the parroting of germ theory denialism by someone as unqualified as Dr. Northrup. The debate over whether the HPV vaccine should become a regular part of the routine health care of girls in this country is an important one, and articles such as this Medscape article serve far more to confuse,rather than enlighten.

I guess I now know that I should be a lot more skeptical of anything published on Medscape. I spotted this because I know a bit about the issues involved. I’m not so sure I could spot a similar level of misinformation in articles regarding topics about which I am not as conversant. I like to think I can, but that’s probably a falsely reassuring self-delusion.

NEXT: Serious woo in a very prestigious medical journal.



Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.