Correcting a Blogger Who Thinks She’s Smarter than the FDA

 

Vaccines are important for everyone, but one of the highest risk groups who greatly benefit from vaccinations is pregnant women. The anti-vaccine community often presents misinformation which encourages pregnant women to forgo the recommended vaccines. One example is a blog by Gretchen Bossio featured on Mom.Me entitled “If You’re Pregnant, Read This Before Listening to the FDA (1).”

Gretchen Bossio is a freelance writer with no medical training, yet she writes this blog post which states right in the title that pregnant women should listen to her before listening to the medical experts at the U.S. Food and Drug Administration (FDA) about the safety of vaccines during pregnancy. It is irresponsible to make poor health care recommendations for a high risk group without any background to do so. This is best evidenced by her statement that “The FDA is recommending intravenous injections during pregnancy…” Vaccines are not given intravenously; they are given through either the intramuscular, subcutaneous or intra-nasal routes, hence why they are often referred to as “shots” and not infusions (2).

Bossio states that “it’s apparent that the FDA has a poor track record of fast-tracking drugs and vaccination[s] that are meant to do good, but in the end, after sending their money-making recommendations into a larger pool, do great harm.” However, Bossio offers no credible links or references when making this claim. The FDA does not fast track just any drug; it must demonstrate superior effectiveness, avoid serious side effects and be effective enough to replace a current drug therapy (3). There have only been two vaccines which have been fast tracked by the FDA. The first was the Gardasil vaccine, which prevents HPV; this vaccine has been found to be safe and effective in trials of over 10,000 women from 13 different countries (4). Secondly, the MenB vaccine, which prevents meningitis, was fast tracked to allow inoculation in high-risk areas where outbreaks were occurring. (5) Further, there have never been any recalls on any of the drugs which were fast tracked for serious issues, as Bossio claims (6). Therefore, Bossio’s statements regarding the FDA and their “poor fast-tracking” record are completely false.

Perhaps the most ridiculous moment in this blog post is when Bossio quotes Barbara Loe Fischer, president of the National Vaccine Information Center (NVIC). Fischer, just like Bossio, has no medical training. The NVIC is one of the largest anti-vaccine organizations which spreads misinformation and promotes unnecessary fear about life-saving vaccines. Considering that there are countless credible resources regarding vaccines including the Centers For Disease Control (CDC), Food and Drug Administration (FDA), and the Advisory Committee on Immunization Practices (ACIP), it’s unacceptable and irresponsible that Bossio chose to quote Fischer, an unlicensed medical professional. Further, it is irresponsible for either of them to make a single recommendation about healthcare decisions for pregnant women since neither of them have a license to do so.

Bossio claims that there isn’t any data to support the recommendations for vaccines during pregnancy yet she provided no references for this statement. If she had “done her research,” as she tells her readers she did, she would know that leading organizations such as the Centers for Disease Control (CDC) and the Mayo Clinic have demonstrated that both the influenza and Tdap vaccines are safe, effective and recommended during pregnancy (7) (8). If Bossio had “done her research,” she might also have shared with readers that the Advisory Committee on Immunization Practices (ACIP) makes public all transcripts of their meetings with top health officials in order to formulate vaccination recommendations (9).

Bossio contradicts her conspiracy theory comments against the FDA and pharmaceutical companies by saying, “That’s right, vaccines during pregnancy. Even though every vaccine insert I have ever read specifically says there are no long-term safety tests or data available for effects on pregnant moms and their unborn children.” It doesn’t make any sense to proclaim in one instance that drug companies and the FDA honor profit over patient safety but then to point to their vaccine package insert as some holy grail in another.

Another example of Bossio supporting the conspiracy theory of the drug companies is when she states, “…if every single pregnant mom received one, two or three more vaccines throughout her pregnancy, that’s big money.” What Bossio fails to discuss is the fact that vaccines must yield some profit for the drug companies so that they can continue to produce them; essential oil peddlers also yield a profit, but anti-vaxxers don’t stand outside of their offices and protest against them. It’s also worth noting that doctors often lose money on vaccinations (10). According to The Economist, “for decades vaccines were a neglected corner of the drugs business, with old technology, little investment and abysmal profit margins” (11). Vaccines only comprise about 1.82% of total drug sales revenue for pharmaceutical companies (12).

Bossio makes the claim that the recent resurgence of pertussis in the U.S. is due to those who have been receiving the pertussis vaccine rather than taking responsibility for the fact that anti-vaxxers have led to these resurgences. In California in 2010, more than 9,000 children became infected with pertussis and a study published in Pediatrics showed that anti-vaxxers contributed to this outbreak by forgoing the recommended vaccine schedule (13).

In conclusion, Bossio presents a poorly written blog post urging readers to choose her cherry-picked misinformation rather than following the plethora of peer-reviewed, scientifically sound data from the FDA when she has no business doing so.

References:
1. http://mom.me/blog/26059-if-youre-pregnant-read-following-fdas-recommendation/

2. http://www.immunize.org/catg.d/p3084.pdf

3. http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

4. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

5. http://blogs.fda.gov/fdavoice/index.php/2014/04/fda-is-working-closely-with-manufacturers-of-meningitis-b-vaccines/

6. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM216527.pdf

7. http://www.cdc.gov/vaccines/adults/rec-vac/pregnant.html

8. http://www.mayoclinic.org/healthy-lifestyle/pregnancy-week-by-week/expert-answers/vaccines-during-pregnancy/faq-20057799

9. http://www.cdc.gov/vaccines/acip/

10. http://pediatrics.aappublications.org/content/pediatrics/124/Supplement_5/S492.full.pdf

11. http://www.economist.com/node/17258858

12. http://www.skepticalraptor.com/skepticalraptorblog.php/big-pharma-supports-antivaccine-movement-conspirac-vaccines-maybe-not/

13. http://healthland.time.com/2013/09/30/parents-not-vaccinating-kids-contributed-to-whooping-cough-outbreaks/

 

By: Angela Quinn, BSN, RN

 

Angela Quinn is a registered nurse on Long Island, NY. She is passionate about nursing and public health. She is an Executive Board Member for Nurses Who Vaccinate and is the founder of Correcting the Misconceptions of Anti-Vaccine Resources.

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