5 Horrifying Facts About FDA-Vaccine-Approval-Process-2019
5 Horrifying Facts About FDA-Vaccine-Approval-Process-2019
5 Horrifying Facts About FDA-Vaccine-Approval-Process-2019
Hammond
All Rights Reserved
3rd Edition
Published by
Worldview Publications
P.O. Box 181
Cross Village, MI 49723
5 Horrifying facts about
tHe fDa Vaccine approVal
process
M
ost people think that the government is watching out
for them, and when they are told that vaccines are safe
and effective, they believe it in part because they know
that these products have been approved by the US Food and Drug
Administration (FDA). However, most people also know little to
nothing about vaccines or how they go through the FDA vaccine
approval process and on to the market. Here are five horrifying
facts about this process that neither public health officials nor the
mainstream media are disclosing to you:
Notes
1. Merck & Co., Inc., “Public Policy”, MSDResponsibility.com,
accessed June 20, 2018, https://www.msdresponsibility.com/
our-approach/public-policy/.
2. Jeremy R. Hammond, “Crony Capitalism: My Review in Bar-
ron’s”, JeremyRHammond.com, November 8, 2013, https://
16
www.jeremyrhammond.com/2013/11/08/crony-capitalism-
my-review-in-barrons/. The quote is from page 167 of Crony
Capitalism.
3. National Institutes of Health, “Licensing Opportunities”,
OTT.NIH.gov, accessed June 20, 2018, https://www.ott.nih.
gov/opportunities.
4. National Institutes of Health, “Non-Profit License Agree-
ment – Summary”, OTT.NIH.gov , accessed June 20, 2018,
https://www.ott.nih.gov/licensing/non-profit-license-agree-
ment-summary.
5. Swathi Padmanabhan, et al., “Intellectual property, technol-
ogy transfer and manufacture of low-cost HPV vaccines in In-
dia”, Nature Biotechnology, July 1, 2010, https://www.nature.
com/articles/nbt0710-671.
6. Food and Drug Administration, “Questions and Answers
on Dietary Supplements”, FDA.gov, updated June 19, 2018;
accessed June 20, 2018, https://www.fda.gov/Food/Di-
etarySupplements/UsingDietarySupplements/ucm480069.
htm#wording.
7. Zach Walsh, et al., “Cannabis for therapeutic purposes: Pa-
tient characteristics, access, and reasons for use”, International
Journal of Drug Policy, November 2013, https://www.ijdp.org/
article/S0955-3959(13)00135-7/abstract. Charles W Webb
and Sandra M Webb, “Therapeutic Benefits of Cannabis: A
Patient Survey”, Hawai’i Journal of Medicine & Public Health,
April 2014, https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC3998228/. Tabitha A. Iseger and Matthijs G. Bossong,
“A systematic review of the antipsychotic properties of canna-
bidiol in humans”, March 2015, https://www.schres-journal.
com/article/S0920-9964(15)00063-8/abstract.
8. Lucija Tomlijenovic and Christopher A. Shaw, “Too Fast or
17
Not Too Fast: The FDA’s Approval of Merck’s HPV Vac-
cine Gardasil”, Journal of Law, Medicine & Ethics, October
12, 2012, https://onlinelibrary.wiley.com/doi/abs/10.1111/
j.1748-720X.2012.00698.x.
9. Frederik Joelving, “What the Gardasil Testing May Have
Missed”, Slate, December 17, 2017, https://slate.com/health-
and-science/2017/12/flaws-in-the-clinical-trials-for-gardasil-
made-it-harder-to-properly-assess-safety.html.
10. Arbyn M, et al., “Prophylactic vaccination against human pap-
illomaviruses to prevent cervical cancer and its precursors (Re-
view)”, Cochrane Database of Systematic Reviews, May 9, 2018,
http://cochranelibrary-wiley.com/doi/10.1002/14651858.
CD009069.pub3/abstract;jsessionid=D9859D63D6110706
C458E70120CCCF29.f01t01.
11. Matthew Herper, “Former NIH Director To Lead Sanofi’s
Labs”, Forbes, December 14, 2010, https://www.forbes.com/
sites/matthewherper/2010/12/14/former-nih-director-to-
lead-sanofis-labs/#9b9fe424ffcc.
12. Sanofi, “Executive Committee: Elias Zerhouni, MD”, Sanofi.
com, accessed June 20, 2018, https://www.sanofi.com/en/
about-us/governance/executive-committee/elias-zerhouni-
md/.
13. Merck & Co., Inc., “Dr. Julie Gerberding Named President of
Merck Vaccines”, Merck.com, December 21, 2009, archived at
https://web.archive.org/web/20091231001726/http:/merck.
com/newsroom/news-release-archive/corporate/2009_1221.
html.
14. Food and Drug Administration, “CDER: The Consumer
Watchdog for Safe and Effective Drugs”, FDA.gov, updated
May 4, 2016, accessed June 20, 2018, https://www.fda.gov/
drugs/resourcesforyou/consumers/ucm143462.htm.
18
15. Food and Drug Administration, “The FDA’s Drug Review
Process: Ensuring Drugs Are Safe and Effective”, FDA.gov,
updated November 24, 2017, accessed June 20, 2018, https://
www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.
htm. Ibid., “Drug Approval Process”, consumer information
infographic, FDA.gov, accessed June 20, 2018, https://www.
fda.gov/downloads/Drugs/ResourcesForYou/Consumers/
UCM284393.pdf. Ibid., “Development & Approval Process
(Drugs)”, FDA.gov, updated June 13, 2018, accessed June
20, 2018, https://www.fda.gov/drugs/developmentapproval-
process/. Ibid., “How Drugs are Developed and Approved”,
FDA.gov, August 18, 2015, https://www.fda.gov/Drugs/De-
velopmentApprovalProcess/HowDrugsareDevelopedandAp-
proved/.
16. Robert M. Jacobson, Inna G. Ovsyannikova, and Gregory A.
Poland, “Testing vaccines in pediatric research subjects”, Vac-
cine, May 26, 2009, https://www.ncbi.nlm.nih.gov/pmc/ar-
ticles/PMC2831649/.
17. Jacobson, et al. “Testing vaccines in pediatric research sub-
jects”.
18. Jacobson, et al. “Testing vaccines in pediatric research sub-
jects”.
19. Jacobson, et al. “Testing vaccines in pediatric research sub-
jects”.
20. Merck & Co., Inc., Gardasil package insert, FDA.gov, accessed
June 20, 2018, https://www.fda.gov/downloads/Biologics-
BloodVaccines/Vaccines/ApprovedProducts/UCM111263.
pdf.
21. University of California — San Diego, “No standard for the
placebo?”, Science Daily, October 19, 2010, https://www.sci-
encedaily.com/releases/2010/10/101018174335.htm.
19
22. Beatrice A. Golomb, et al., “What’s in Placebos: Who Knows?
Analysis of Randomized, Controlled Trials”, Annals of Internal
Medicine, October 19, 2010, http://annals.org/aim/article-
abstract/746290/what-s-placebos-who-knows-analysis-ran-
domized-controlled-trials.
23. Jacobson, et al. “Testing vaccines in pediatric research sub-
jects”.
24. Ben Goldacre, “Pick your pill out of a hat”, The Economist,
September 29, 2012, https://www.economist.com/books-
and-arts/2012/09/29/pick-your-pill-out-of-a-hat.
25. Sidney M Wolfe, “Does $760m a year of industry funding af-
fect the FDA’s drug approval process?”, BMJ, August 5, 2014,
https://www.bmj.com/content/349/bmj.g5012.
26. David Brown, “Maker of Vioxx Is Accused of Deception”, Wash-
ington Post, April 16, 2008, http://www.washingtonpost.com/
wp-dyn/content/article/2008/04/15/AR2008041502086.
html. Julie Steenhuysen, “Vioxx risks could have been detected
earlier: study”, Reuters, November 23, 2009, https://www.re-
uters.com/article/us-vioxx-risks/vioxx-risks-could-have-been-
detected-earlier-study-idUSTRE5AM4MV20091123. Jona-
than D. Rockoff, “Analysis Finds Vioxx’s Heart Attack Risk in
2001”, Wall Street Journal, November 24, 2009, https://www.
wsj.com/articles/SB1000142405274870477970457455407
1807123380.
27. Brown, “Maker of Vioxx Is Accused of Deception”.
28. Steenhuysen, “Vioxx risks could have been detected earlier:
study”.
29. Rockoff, “Analysis Finds Vioxx’s Heart Attack Risk in 2001”.
30. Steenhuysen, “Vioxx risks could have been detected earlier:
study”.
31. Avery Johnson, “Vaccine Makers Enjoy Immunity”, Wall
20
Street Journal, February 23, 2009, https://www.wsj.com/ar-
ticles/SB123535050056344903.
32. Meredith Melnick, “Bruesewitz v. Wyeth: What the Supreme
Court Decision Means for Vaccines”, Time, February 24,
2011, http://healthland.time.com/2011/02/24/bruesewitz-
v-wyeth-what-the-supreme-court-decision-means-for-vac-
cines/.
33. Barbara Loe Fisher, “No Pharma Liability? No Vaccine Man-
dates.” National Vaccine Information Center, March 2, 2011,
https://www.nvic.org/NVIC-Vaccine-News/March-2011/
No-Pharma-Liability--No-Vaccine-Mandates-.aspx.
34. US Department of Health and Human Services, “National
Vaccine Injury Compensation Program” HRSA.gov, page ar-
chive from February 15, 2015, available at https://web.ar-
chive.org/web/20150215065401/http:/www.hrsa.gov/Vac-
cinecompensation/index.html.
35. Ibid.
36. Supreme Court of the United States, Brueswitz et al. v. Wyeth
LLC, FKA Wyeth, Inc., et al., February 22, 2011, https://www.
supremecourt.gov/opinions/10pdf/09-152.pdf.
37. Copper BK, “Notes and comments ‘High and dry?’ The
Public Readiness and Emergency Preparedness Act and li-
ability protection for pharmaceutical manufacturers”, Jour-
nal of Health Law, 2007, https://www.ncbi.nlm.nih.gov/
pubmed/17549932.
38. overnment Accountability Office, “Vaccine Injury Compen-
sation: Most Claims Took Multiple Years and Many Were
Settled through Negotiation”, GAO.gov, November 21, 2014,
https://www.gao.gov/products/GAO-15-142.
39. Department of Health and Human Services, “National Vac-
cine Injury Compensation Program Statistics Report for Feb-
21
ruary 2015”, HRSA.gov, February 2015, archived at https://
web.archive.org/web/20150210045233/http:/www.hrsa.gov/
vaccinecompensation/statisticsreport.pdf.
40. US Department of Health and Human Services, National
Vaccine Injury Compensation Program Monthly Statistics Report,
October 2019, accessed October 23, 2019, https://www.hrsa.
gov/sites/default/files/hrsa/vaccine-compensation/data/data-
statistics-october-2019.pdf. To access the most recent report,
visit https://www.hrsa.gov/vaccine-compensation/data/index.
html.
41. Johnson, “Vaccine Makers Enjoy Immunity”.
22