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An editorial written by Arthur Haines (guest writer)

I was recently directed to a webpage hosted by the Center for Disease Control and Prevention (CDC), which can be viewed here: http://www.cdc.gov/flu/professionals/vaccination/effectivenessqa.htm?mobile=nocontent. 

This particular webpage has some useful information that discusses how flu vaccine efficacy is determined, the differences between kinds of vaccines, and factors that affect the observed results in vaccine research (the research that gets published).  This webpage also discusses vaccine research results and presents very positive information about how well flu vaccines work.  What struck me was how amazingly well the vaccines performed in the discussion by the CDC.  In some research papers and reviews I had examined, the efficacy of the flu vaccination was only slightly better than no vaccination at all (1% of test subjects contracting influenza vs. 4% of control subjects contracting influenza).  But here, in the research highlighted by the CDC, I saw numbers like 93% efficacy for vaccinated persons.  Part of this discrepancy, I came to realize, was how numbers are reported.  For example, in the numbers I provided above (1% vs. 4%), that calculates as a vaccine efficacy of 75% (sounds much stronger than the other numbers). But, I also noted something that caused me considerable concern.

The CDC webpage provided 18 literature citations in their references section. Of those papers, only 13 of the hyperlinks provided actually direct to full papers where funding sources, competing interests, pharmaceutical company involvement, and place of author employment could be identified (though not all provided this information).  Of those 13 papers where this type of information might be listed, 10 have conflicts of interests that I will highlight.  Note that I wrote “might be listed”.  That is because some papers did not report conflicts even when they could be shown to have existed.  Conflicts of interests ranged from an author of a paper working for a pharmaceutical/biotechnology company to complete funding by a pharmaceutical company who (the company) also had total involvement in the research and writing of the results.  Many of the authors had received grants, consulting fees, and lecture fees from one or more pharmaceutical companies.  Some authors were former employees of pharmaceutical companies.  Others even owned equity in pharmaceutical companies (but were still considered “unbiased” researchers).  I’ve presented below the results of what I could find (without digging too deeply).  If you take the time to read it, you may find the research you rely on for efficacy (and safety) of vaccines is not being performed by what I would consider impartial researchers (that is not to say all researchers funded by private companies are liars—I do not believe that to be case).  If you are limited in free time, examine numbers 4 and 12.  I am (again) let down by the CDC and don’t feel the information they provide can be described as completely trustworthy.

Before I end this short article (and leave you to the specifics of each paper), be aware that if a pharmaceutical company pays for the research, that means they own it.  They don’t have to publish any study that contradicts their official stance (of pro-vaccine efficacy and safety).  So we (and our doctors) don’t often see the studies that show negative or inconclusive results.  This phenomenon is known as publication bias (and can be rightly described as a form of research misconduct).  It leaves us wondering who and what to trust.  To help you see this clearly, I’ll ask you a question.  How many industry-funded studies (i.e., studies funded by companies like MedImmune, Merck, and GlaxoSmithKline) can you find that demonstrate relative ineffectiveness of a vaccine or harm caused by vaccines?  Such studies do exist, but please note who usually funds them.   [by Arthur Haines]

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(1) Ashkenazi et al. (2006). This paper was funded by Medimmune and Wyeth Research (both biotechnology companies).

(2) Belshe et al. (1998). Robert Belshe is the lead author and a member of the ACIP (Advisory Committee on Immunization Practices).  Members of this organization are alleged to have financial ties to the vaccine industry (he does, see Number 4).  The study in question was funded (in part) by Aviron, a biotechnology company.

(3) Belshe and Gruber (2000).  Lead author discussed above (in number 2; see also number 4), the second author is employed by Wyeth-Lederle Vaccines, which is a business unit of the Wyeth-Ayerst Laboratories, which is a division of American Home Products Cooperation.  Wyeth-Ayerst Laboratories has been accused of deceptive practices in the publication of their research (http://www.premarin.org/fen-phen.html).

(4) Belshe et al. (2007).   This paper was supported by Medimmune (a biotechnology company).  Near the end of this article, printed in The New England Journal of Medicine, is the following statement:

“Dr. Belshe reports receiving research support from Merck and MedImmune and consulting fees or lecture fees from MedImmune, Merck, Novartis, GlaxoSmithKline, and Sanofi; Dr. Edwards, research support from Sanofi Pasteur, Vaxgen, Merck, and Nabi and consulting fees from MedImmune; Dr. Vesikari, consulting fees or lecture fees from MedImmune, Merck, and GlaxoSmithKline; and Dr. Black, research support from Chiron, GlaxoSmithKline, MedImmune, and Merck and consulting fees or lecture fees from Chiron, MedImmune, and Merck. Drs. Walker, Kemble, and Connor and Ms. Hultquist are employees of MedImmune. No other potential conflict of interest relevant to this article was reported.”

In summary, every author was either an employee of a biotech company or received funding/payments from a biotech company.

(5) Beran et al. (2009).  This paper had an author employed by GlaxoSmithKline Biologicals.

(6) Bridges et al. (2000).  This paper does not appear to have obvious conflicts of interest.  As a result, the conclusion is not so dramatically different from what I have observed in other vaccine research performed by unbiased researchers.  Here are the last words of the concluding statement:  “our results suggest that vaccination of healthy adults younger than 65 years is unlikely to provide societal economic benefit in most years.”

(7) Flemming et al. (2006).  The authors of this paper were, in part, employed by biotechnology companies, including Wyeth-Lederle Vaccines (see Number 3).

(8) Govaert et al. (1994).  CDC link directs to a brief abstract where funding sources and potential conflicts of interest are not listed.

(9) Herrera et al. (2007).  CDC link directs to a brief abstract where funding sources and potential conflicts of interest are not listed.

(10) Hayward et al. (2006).  CDC link directs to full article where no obvious conflicts were identified on basis of disclosed information.

(11) Hoberman et al. (2003).  This paper was funded by Aventis Pasteur, the vaccine division of Sanofi Pasteur, which is a global pharmaceutical company (3rd largest in the world) that provides more than one billion doses of vaccines each year.  They also supplied the vaccines (and the matching placebo) for this study.

(12) Jackson et al. (2010).  For this paper, two of the authors worked for GlaxoSmithKline Biologicals (GSK) and one author worked for Variation Biotechnologies Inc.  More importantly, GlaxoSmithKline Biologicals was noted to be involved in all stages of the study conduct and analysis.  GlaxoSmithKline Biologicals also took in charge all costs associated with the development and the publishing of this manuscript.  The competing interests statement, at the end of the manuscript, is quite interesting:

“LJ has received research funding from manufacturers of influenza vaccines, including GSK, Sanofi Pasteur, and Novartis and has served as a consultant to GSK and Novartis. Dr Harry Keyserling received grant support from GlaxoSmithKline to conduct the study.  JB has no conflict of interest to declare.  NB is a former employee of GlaxoSmithKline Biologicals and reports ownership of equity or stock options.  LFF is a full-time employee of  GlaxoSmithKline.  JT discloses having received laboratory support from GSK and MerciaPharma, as well as clinical trial support from Protein Sciences Corporation, Vaxinnate, Ligocyte, Wyeth, Bavarian Nordic, Sanofi and PaxVax.  JT discloses scientific advisory board activities for Immune Targeting Systems and Toyama Chemical Concern.”

(13) Monto et al. (2001).  CDC link directs to full article where no obvious conflicts were identified on basis of disclosed information.

(14) Monto et al. (2009).  CDC link directs to a brief abstract where funding sources and potential conflicts of interest are not listed.

(15) Neuzil et al. (2001).  CDC link directs to a brief abstract where funding sources and potential conflicts of interest are not listed.

(16) Nichol et al. (1999).  One author of this paper worked for Aviron, a biotechnology company, who also sponsored the research.  Two of the authors were paid consultants of Aviron.  The manuscript was noted to have been prepared by authors listed and approved by Aviron.  The authors were heavily indebted to the vaccine industry, as illustrated by the financial disclosure statement noting that the authors had received funding from Aviron, Pasteur-Merieux Connaught (now Aventis Pasteur), Merck, VaxGen Inc., and Wyeth-Lederle Vaccines and Pediatrics.  Note that six of the eight authors of this paper had received contributions from one or more pharmaceutical companies.

(17) Petrie et al. (2013).  For this article, one author reported receiving consulting fees from GlaxoSmithKline, Novartis, Baxter, and Roche.  The research itself was funded, in part, by Sanofi Pasteur (see Number 11).

(18) Treanor et al. (1999).  CDC link directs to a brief abstract where funding sources and potential conflicts of interest are not listed, although it can be determined that one author worked for Aviron, a biotechnology company.

About: Arthur Haines ~ He is an acclaimed research botanist, Author, Teaches foraging and aboriginal skills, New England Wild Flower Society and curator, Delta Institute of Natural History Herbarium.

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