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Correspondence Regarding fluticasone furoate nasal spray and the control of ocular symptoms To the Editor: It is a reality of our world that projects sponsored by the pharmaceutical industry constitute a significant portion of our primary research. It is also quite evident that conflicts of interest can provide the potential for results to be presented so as to cast company products in the best light possible. The development of a national registry for drug trials was an important step for the scientific community, but it was only a start. I am disappointed in the article by Kaiser et al. 1 Although flu- ticasone furoate (Veramyst, GlaxoSmithKline, Research Triangle Park, NC) is being marketed as an intranasal steroid with an indi- cation for ocular symptoms, not all the ocular symptom results collected in this study are published. The methods indicate that both recall and instantaneous ocular symptom scores were recorded and used as secondary endpoints. Only the recall total ocular symptom scores are reported, which show statistically sig- nificant benefit over placebo. Instantaneous ocular symptom score results are never mentioned in table form or in the body of the text. It is therefore difficult to ascertain the benefit of fluti- casone furoate in its ability to control ocular symptoms. I am trou- bled that although these results are omitted, two full paragraphs of the discussion are devoted to fluticasone furoate’s benefit with regard to ocular symptoms. I encourage the editors of the Journal to insist that all relevant data are presented in studies such as this. When space requires, extra data should be presented in the Online Repository already used by other authors. This adherence to stringent reporting will only augment the Journal’s reputation as the gold standard journal for allergy and immunology topics. Jason H. C. Friesen, MD From the Allergy and Asthma Center of SW Washington, Vancouver, Wash. E-mail: [email protected]. Disclosure of potential conflict of interest: J. H. C. Friesen is employed by the Allergy and Asthma Center of Southwest Washington. REFERENCE 1. Kaiser HB, Naclerio RM, Given J, Toler TN, Ellsworth A, Philpot EE. Fluticasone furoate nasal spray: a single treatment option for the symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol 2007;119:1430-7. Available online September 20, 2007. doi:10.1016/j.jaci.2007.07.060 Reply To the Editor: Dr Friesen 1 laments that the pharmaceutical industry funds re- search and is disappointed that our article 2 did not contain all the data about ocular efficacy that he felt necessary. He also chides the Editors of the Journal for not presenting all relevant data in the text of articles published. Pharmaceuticals fund research. In a more perfect world, it might be different. But in this imperfect world, good research well done and accurately reported, clinical trial registration, and disclosure of possible author conflict are what we can reasonably expect. If Dr Friesen would like to promote public funding of medical research or contribute personally, many worthy options are open to him. Instantaneous ocular symptom scores were not reported in our article even though efficacy was shown. It was a matter of limited space and the author’s decision on what to leave out of an already lengthy manuscript. In retrospect it should have been included. I understand Dr Friesen’s point and will have to live with the burden of his disappointment. The Editors of the Journal do an excellent job of selecting and editing articles and publish a great journal. I am sure they will appreciate constructive comments and advice such as was offered by Dr Friesen in his letter. Harold B. Kaiser, MD From the Clinical Research Institute, Minneapolis, Minn. E-mail: hbk@allergy- asthma-docs.com. Disclosure of potential conflict of interest: H. B. Kaiser has consulting arrangements with GlaxoSmithKline, Merck, and Sanofi-Aventis; has received grant support from Alcon, Allergy Therapeutics, Altana, AstraZeneca, Boehringer Ingelheim, Cobalis, Centocor, Dynavax, GlaxoSmithKline, Genentech, Novartis, Merck, 3M, Sanofi-Aventis, Schering-Plough, Skye Pharmacy, Medpoint, Ivax, Almirall, and Luspire; and is on the speakers’ bureau for GlaxoSmithKline, Merck, Novartis, and Schering-Plough. REFERENCES 1. Friesen JHC. Regarding fluticasone furoate nasal spray and the control of ocular symptoms. J Allergy Clin Immunol 2008;121:265. 2. Kaiser HB, Naclerio RM, Given J, Toler TN, Ellsworth A, Philpot EE. Fluticasone furoate nasal spray: a single treatment option for the symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol 2007;119:1430-7. Available online October 2, 2007. doi:10.1016/j.jaci.2007.07.058 Exogenous vitamin D might contribute to geo- graphic variations in epinephrine prescriptions To the Editor: Camargo et al 1 introduce a very interesting hypothesis—that vitamin D from sunlight exposure might protect against allergy— and use epinephrine prescription data to show that there is some correlation between higher latitudes (and hence less sun) and in- creased EpiPen (Dey L.P., Napa, Calif) prescriptions. Although the authors correctly point out that population studies have shown vitamin D status to be worse in more northern climates, the ques- tion remains as to whether exogenous vitamin D during infancy might contribute to the risk seen. Several studies, including 2 conducted in cohorts from higher latitudes where infant vitamin D supplementation is quite prevalent, have shown that supplemen- tation in infancy with vitamins is associated with increased inci- dence for allergies, 2-4 whereas other experimental data suggest that vitamin D could contribute to allergy, T H 2 pathology, or both. 5,6 Perhaps some of the geographic differences in allergy incidence could be explained by too much, versus too little, serum vitamin D. Joshua D. Milner, MD From the Laboratory of Immunology, National Institute of Allergy and Infectious Dis- eases, 9000 Rockville Pike, NIH Building 10 11N314, Bethesda, MD 20892. E-mail: [email protected]. Disclosure of potential conflict of interest: The author has declared that he has no conflict of interest. 265

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Correspondence

Regarding fluticasone furoate nasal spray andthe control of ocular symptoms

To the Editor:It is a reality of our world that projects sponsored by the

pharmaceutical industry constitute a significant portion of ourprimary research. It is also quite evident that conflicts of interestcan provide the potential for results to be presented so as to castcompany products in the best light possible. The development of anational registry for drug trials was an important step for thescientific community, but it was only a start.

I am disappointed in the article by Kaiser et al.1 Although flu-ticasone furoate (Veramyst, GlaxoSmithKline, Research TrianglePark, NC) is being marketed as an intranasal steroid with an indi-cation for ocular symptoms, not all the ocular symptom resultscollected in this study are published. The methods indicate thatboth recall and instantaneous ocular symptom scores wererecorded and used as secondary endpoints. Only the recall totalocular symptom scores are reported, which show statistically sig-nificant benefit over placebo. Instantaneous ocular symptomscore results are never mentioned in table form or in the bodyof the text. It is therefore difficult to ascertain the benefit of fluti-casone furoate in its ability to control ocular symptoms. I am trou-bled that although these results are omitted, two full paragraphs ofthe discussion are devoted to fluticasone furoate’s benefit withregard to ocular symptoms.

I encourage the editors of the Journal to insist that all relevantdata are presented in studies such as this. When space requires,extra data should be presented in the Online Repository alreadyused by other authors. This adherence to stringent reporting willonly augment the Journal’s reputation as the gold standard journalfor allergy and immunology topics.

Jason H. C. Friesen, MD

From the Allergy and Asthma Center of SW Washington, Vancouver, Wash. E-mail:

[email protected].

Disclosure of potential conflict of interest: J. H. C. Friesen is employed by the Allergy and

Asthma Center of Southwest Washington.

REFERENCE

1. Kaiser HB, Naclerio RM, Given J, Toler TN, Ellsworth A, Philpot EE. Fluticasone

furoate nasal spray: a single treatment option for the symptoms of seasonal allergic

rhinitis. J Allergy Clin Immunol 2007;119:1430-7.

Available online September 20, 2007.

doi:10.1016/j.jaci.2007.07.060

Exogenous vitamin D might contribute to geo-graphic variations in epinephrine prescriptions

To the Editor:Camargo et al1 introduce a very interesting hypothesis—that

vitamin D from sunlight exposure might protect against allergy—and use epinephrine prescription data to show that there is somecorrelation between higher latitudes (and hence less sun) and in-creased EpiPen (Dey L.P., Napa, Calif) prescriptions. Althoughthe authors correctly point out that population studies have shownvitamin D status to be worse in more northern climates, the ques-tion remains as to whether exogenous vitamin D during infancymight contribute to the risk seen. Several studies, including 2conducted in cohorts from higher latitudes where infant vitaminD supplementation is quite prevalent, have shown that supplemen-tation in infancy with vitamins is associated with increased inci-dence for allergies,2-4 whereas other experimental data suggestthat vitamin D could contribute to allergy, TH2 pathology, orboth.5,6 Perhaps some of the geographic differences in allergyincidence could be explained by too much, versus too little,serum vitamin D.

Joshua D. Milner, MD

From the Laboratory of Immunology, National Institute of Allergy and Infectious Dis-

eases, 9000 Rockville Pike, NIH Building 10 11N314, Bethesda, MD 20892. E-mail:

[email protected].

Disclosure of potential conflict of interest: The author has declared that he has no conflict

of interest.

Reply

To the Editor:Dr Friesen1 laments that the pharmaceutical industry funds re-

search and is disappointed that our article2 did not contain all thedata about ocular efficacy that he felt necessary. He also chidesthe Editors of the Journal for not presenting all relevant data inthe text of articles published.

Pharmaceuticals fund research. In a more perfect world, itmight be different. But in this imperfect world, good research welldone and accurately reported, clinical trial registration, anddisclosure of possible author conflict are what we can reasonablyexpect. If Dr Friesen would like to promote public funding of

medical research or contribute personally, many worthy optionsare open to him.

Instantaneous ocular symptom scores were not reported in ourarticle even though efficacy was shown. It was a matter of limitedspace and the author’s decision on what to leave out of an alreadylengthy manuscript. In retrospect it should have been included. Iunderstand Dr Friesen’s point and will have to live with the burdenof his disappointment.

The Editors of the Journal do an excellent job of selecting andediting articles and publish a great journal. I am sure they willappreciate constructive comments and advice such as was offeredby Dr Friesen in his letter.

Harold B. Kaiser, MD

From the Clinical Research Institute, Minneapolis, Minn. E-mail: hbk@allergy-

asthma-docs.com.

Disclosure of potential conflict of interest: H. B. Kaiser has consulting arrangements with

GlaxoSmithKline, Merck, and Sanofi-Aventis; has received grant support from Alcon,

Allergy Therapeutics, Altana, AstraZeneca, Boehringer Ingelheim, Cobalis, Centocor,

Dynavax, GlaxoSmithKline, Genentech, Novartis, Merck, 3M, Sanofi-Aventis,

Schering-Plough, Skye Pharmacy, Medpoint, Ivax, Almirall, and Luspire; and is on

the speakers’ bureau for GlaxoSmithKline, Merck, Novartis, and Schering-Plough.

REFERENCES

1. Friesen JHC. Regarding fluticasone furoate nasal spray and the control of ocular

symptoms. J Allergy Clin Immunol 2008;121:265.

2. Kaiser HB, Naclerio RM, Given J, Toler TN, Ellsworth A, Philpot EE. Fluticasone

furoate nasal spray: a single treatment option for the symptoms of seasonal allergic

rhinitis. J Allergy Clin Immunol 2007;119:1430-7.

Available online October 2, 2007.

doi:10.1016/j.jaci.2007.07.058

265