On 2017 Aug 22, Raphael Stricker commented:

Another LYMErix Whitewash.

Raphael B. Stricker, MD

Union Square Medical Associates, San Francisco, CA, USA. rstricker@usmamed.com

The Aronowitz article presents an unsatisfactory analysis of the LYMErix vaccine debacle. The spin in the article is a classic example of blaming the victims for their misfortune while ignoring the problems leading to that misfortune.

The spin in the article is that the science underlying the LYMErix vaccine was sound and beyond question, that the vaccine was proven to be safe beyond a shadow of a doubt, and that the antiscience lobbying of misguided Lyme activists brought down the vaccine. Considering that the LYMErix vaccine was the object of a class-action lawsuit brought by patients who claimed to have been harmed by the vaccine (1), and in view of the safety concerns described below, the article spin is impossible to defend.

The premise of the article is that the LYMErix vaccine was proven to be safe. This ignores substantial reports of LYMErix-induced patient harm in the peer-reviewed medical literature (2-6), and studies using animal models and in vitro systems support these safety concerns (7,8). The vaccine-induced rheumatological and neurological complications are what alarmed the Lyme community and ultimately led to rejection of the vaccine as unsafe. An intriguing and disturbing scientific aspect of the LYMErix vaccine is that, although it was made from a subunit protein, the vaccine elicited all manner of immune responses in vaccinees, and these remain unexplained (9,10). Thus there was significant clinical and laboratory evidence underlying doubts about the safety of this ill-fated vaccine.

Another curious spin is that the author blames Lyme activists for spreading fear about the vaccine that ultimately diminished its use and prevented an adequate assessment of its clinical value. In reality, the vaccine was pulled off the market to avoid disclosure of Phase IV data that would have shown limited efficacy and significant safety concerns related to LYMErix (11-13).

Aronowitz divides the Lyme universe into "orthodox" and "heterodox" camps. The "orthodox" camp defines Lyme disease in a narrow fashion that excludes various clinical manifestations and chronic forms of the disease despite growing evidence to the contrary (14). Thus a patient who develops fibromyalgia or fatigue symptoms after receiving the Lyme vaccine would not have complications related to the vaccine because fibromyalgia and fatigue are separate entities unrelated to Lyme disease. This narrow definition serves to enhance the benefit of the vaccine (ie, no Lyme symptoms) while dismissing potential complications of the vaccine (ie, fibromyalgia and fatigue are separate and unrelated problems). It is easy to see why the Lyme community would be reluctant to go along with this selective view of the vaccine.

In contrast, Aronowitz defines the "heterodox" camp as having a broad view of Lyme disease that requires prolonged treatment with antibiotics rather than any attempt to prevent the disease. The implication that this patient group is opposed to a Lyme vaccine because its members are invested in being chronically ill and taking prolonged courses of antibiotics strains credibility. The recognition that numerous patients fail the "orthodox" approach to Lyme disease and remain chronically ill is what drives these patients to seek better treatment, and certainly a vaccine that is safe and effective would be welcome (15). Unfortunately as outlined above, LYMErix was not it.

References 1. LDA website: Vaccine lawsuit. Available at: https://www.lymediseaseassociation.org/about-lyme/controversy/vaccine/1157-vaccine-suit-lda-ltr-a-judgement. Accessed July 22, 2017. 2. Rose et al, J Rheumatol. 2001;28:2555-7. 3. Latov et al, Periph Nerv Syst. 2004;9:165-7. 4. Souayah et al, Vaccine 2009;27:7322-5. 5. Nardelli et al, Future Microbiol. 2009;4:457-69. 6. Marks DH, Int J Risk Saf Med. 2011;23:89-96. 7. Croke et al, Infect Immun. 2000;68:658-63. 8. Alaedini & Latov, J Neuroimmunol. 2005;159:192-5. 9. Molloy et al, Clin Infect Dis. 2000;31:42-7. 10. Fawcett et al, Clin Diagn Lab Immunol. 2001;8:79-84. 11. Hanson & Edelman, Expert Rev Vaccines 2003;2:683-703. 11. Nigrovic & Thompson, Epidemiol Infect. 2007;135:1-8. 13. LDA website: LYMERIX Meeting; LDA Meets with FDA. Available at https://www.lymediseaseassociation.org/about-lyme/controversy/vaccine/261-lymerix-meeting. Accessed July 22, 2017. 14. Stricker RB, Fesler MC. Chronic Dis Int 2017;4:1025. 15. Stricker RB, Johnson L. Lancet Infect Dis 2014;14:12.

Disclosure: RBS is a member of the International Lyme and Associated Diseases Society (ILADS) and a director of LymeDisease.org. He has no financial or other conflicts to declare.

On 2017 Jul 23, Raphael Stricker commented:

None

On 2017 Jul 23, Raphael Stricker commented:

None

On 2017 Aug 22, Raphael Stricker commented:

Another LYMErix Whitewash.

Raphael B. Stricker, MD

Union Square Medical Associates, San Francisco, CA, USA. rstricker@usmamed.com

The Aronowitz article presents an unsatisfactory analysis of the LYMErix vaccine debacle. The spin in the article is a classic example of blaming the victims for their misfortune while ignoring the problems leading to that misfortune.

The spin in the article is that the science underlying the LYMErix vaccine was sound and beyond question, that the vaccine was proven to be safe beyond a shadow of a doubt, and that the antiscience lobbying of misguided Lyme activists brought down the vaccine. Considering that the LYMErix vaccine was the object of a class-action lawsuit brought by patients who claimed to have been harmed by the vaccine (1), and in view of the safety concerns described below, the article spin is impossible to defend.

The premise of the article is that the LYMErix vaccine was proven to be safe. This ignores substantial reports of LYMErix-induced patient harm in the peer-reviewed medical literature (2-6), and studies using animal models and in vitro systems support these safety concerns (7,8). The vaccine-induced rheumatological and neurological complications are what alarmed the Lyme community and ultimately led to rejection of the vaccine as unsafe. An intriguing and disturbing scientific aspect of the LYMErix vaccine is that, although it was made from a subunit protein, the vaccine elicited all manner of immune responses in vaccinees, and these remain unexplained (9,10). Thus there was significant clinical and laboratory evidence underlying doubts about the safety of this ill-fated vaccine.

Another curious spin is that the author blames Lyme activists for spreading fear about the vaccine that ultimately diminished its use and prevented an adequate assessment of its clinical value. In reality, the vaccine was pulled off the market to avoid disclosure of Phase IV data that would have shown limited efficacy and significant safety concerns related to LYMErix (11-13).

Aronowitz divides the Lyme universe into "orthodox" and "heterodox" camps. The "orthodox" camp defines Lyme disease in a narrow fashion that excludes various clinical manifestations and chronic forms of the disease despite growing evidence to the contrary (14). Thus a patient who develops fibromyalgia or fatigue symptoms after receiving the Lyme vaccine would not have complications related to the vaccine because fibromyalgia and fatigue are separate entities unrelated to Lyme disease. This narrow definition serves to enhance the benefit of the vaccine (ie, no Lyme symptoms) while dismissing potential complications of the vaccine (ie, fibromyalgia and fatigue are separate and unrelated problems). It is easy to see why the Lyme community would be reluctant to go along with this selective view of the vaccine.

In contrast, Aronowitz defines the "heterodox" camp as having a broad view of Lyme disease that requires prolonged treatment with antibiotics rather than any attempt to prevent the disease. The implication that this patient group is opposed to a Lyme vaccine because its members are invested in being chronically ill and taking prolonged courses of antibiotics strains credibility. The recognition that numerous patients fail the "orthodox" approach to Lyme disease and remain chronically ill is what drives these patients to seek better treatment, and certainly a vaccine that is safe and effective would be welcome (15). Unfortunately as outlined above, LYMErix was not it.

References 1. LDA website: Vaccine lawsuit. Available at: https://www.lymediseaseassociation.org/about-lyme/controversy/vaccine/1157-vaccine-suit-lda-ltr-a-judgement. Accessed July 22, 2017. 2. Rose et al, J Rheumatol. 2001;28:2555-7. 3. Latov et al, Periph Nerv Syst. 2004;9:165-7. 4. Souayah et al, Vaccine 2009;27:7322-5. 5. Nardelli et al, Future Microbiol. 2009;4:457-69. 6. Marks DH, Int J Risk Saf Med. 2011;23:89-96. 7. Croke et al, Infect Immun. 2000;68:658-63. 8. Alaedini & Latov, J Neuroimmunol. 2005;159:192-5. 9. Molloy et al, Clin Infect Dis. 2000;31:42-7. 10. Fawcett et al, Clin Diagn Lab Immunol. 2001;8:79-84. 11. Hanson & Edelman, Expert Rev Vaccines 2003;2:683-703. 11. Nigrovic & Thompson, Epidemiol Infect. 2007;135:1-8. 13. LDA website: LYMERIX Meeting; LDA Meets with FDA. Available at https://www.lymediseaseassociation.org/about-lyme/controversy/vaccine/261-lymerix-meeting. Accessed July 22, 2017. 14. Stricker RB, Fesler MC. Chronic Dis Int 2017;4:1025. 15. Stricker RB, Johnson L. Lancet Infect Dis 2014;14:12.

Disclosure: RBS is a member of the International Lyme and Associated Diseases Society (ILADS) and a director of LymeDisease.org. He has no financial or other conflicts to declare.