article by Avner et al2: ‘‘The quantity of Fel d 1 variedwidely from 1 mg/gm to more than 1770 mg/gm of hair.The mean levels of Fel d 1 extracted by using shampoo,water, or buffered saline solution were not significantlydifferent (245, 191, and 102 mg/gm, respectively, n 5

34).’’ This pretty clearly represents a ‘‘real-world sham-pooing.’’

Perhaps the reader is aware of some as yet unpublisheddata to suggest the superiority of a different shampoo thanthe one used by Avner et al. I have been unable to identifyany evidence-based suggestions to that end. We admit, intheory, that detergents may prove to be superior to waterimmersion in providing a sustained suppression of Fel d 1shedding. We were unable to find scientific evidence thatdemonstrates such a benefit and agree that a well-donestudy using shampoo may be enlightening. However, ouranimal handlers suggest that for many cat-owners, theprocess of frequent shampooing may be challengingin animals that may be less cooperative than the well-behaved Boots and Zoe.

Christian Gallus Nageotte, MD

From the Henry Ford Health System, Department of Allergy and Clinical

Immunology, Detroit, Mich. E-mail: cnageot1@hfhs.org.

Disclosure of potential conflict of interest: C. G. Nageotte has consulting

arrangements with MedPointe; is employed by the Henry Ford Health

System; and is on the speakers’ bureau for GlaxoSmithKline, Novartis,

and Genentech.

REFERENCES

1. Goetz DW. Washing the cat requires shampoo. J Allergy Clin Immunol

2007;119:758.

2. Avner DB, Perzanowski MS, Platts-Mills TAE, Woodfolk JA. Evaluation

of different techniques for washing cats: quantitation of allergen removed

from the cat and the effect on airborne Fel d 1. J Allergy Clin Immunol

1997;100:307-11.

Available online January 25, 2007.doi:10.1016/j.jaci.2006.11.635

Reply

To the Editor:I believe that Dr Menendez1 misinterprets the ‘‘black

box’’ warning. The Food and Drug Administration viewis that the prescription drug label’s (package insert) pri-mary use is to provide essential information that the prac-titioner needs to use this drug safely and effectively.2,3

The Food and Drug Administration has established 5levels of cautionary information of which the black boxis the highest level warning of potentially severe adverseeffects. The ‘‘black box’’ warnings for long-acting b-ago-nists and topical inhibitors make it clear there is sufficientinformation of potential adverse events to raise concernabout safety, but insufficient information to support re-moval from the market. The black box is there, hopefully,to ensure the physician becomes aware of the potential riskand the literature reporting these potential risks. The phy-sician is responsible for informing the patient of the risksand benefits of a drug, but the ultimate decider of whetheror not to take a drug is the patient or their surrogate.

In carrying out this responsibility, the physician needsto assess the significance of evidence suggesting there is oris not a significant risk. The black box is an attention getterto help ensure physicians are aware of the potential riskand pass that information on to the patient. The black boxraises questions. We physicians need to assess thesequestions as best as we can. Patients are entitled to knowwhat we know (or should know) in language they canunderstand.

J ALLERGY CLIN IMMUNOL

VOLUME 119, NUMBER 3

Correspondence 759

‘‘Black box’’ warnings and drug surveillance

To the Editor:A ‘‘black box’’ warning1,2 is not a useful or even

minimally informative document to most practicing phy-sicians. Its only reason to exist is to make it easier forthe tort bar to win malpractice cases. That the academicand scientific community could spend most of an issueof the Journal rationalizing the pseudoscientific nature ofthis bureaucratic exercise is terribly disappointing. Whyare there so few true leaders of clinical pharmacologywilling to expose this unholy alliance between the regula-tory and tort liability extortion industries? How can a‘‘black box’’ warning be a substitute for peer-revieweddrug safety and efficacy data and epidemiologic drugsurveillance?

As pointed out by Dr Nelson in his article,3 the fact thata side effect or an adverse outcome is associated with theuse of a drug does not prove that cause and effect is the na-ture of the association. But the ‘‘black box’’ warning pro-vides automatic guilt-by-association status to the adverse

event in question, which is clearly the intent of both theregulatory bureaucracy as well as the tort bar. This makesit very difficult for practicing physicians to justify to indi-vidual patients as well as to the members of the jury the useof the drug regardless of the actual risk/benefit involved.

The system of ‘‘black box’’ warning is a very poor sub-stitute for a statistically well-designed prospective sys-tem of drug surveillance, which does not yet exist inthis country. Rather than supporting this unscientific anddetrimental system to appropriate prescribing practices,I would have liked to see the Journal stand up forthe development of a nationwide comprehensive drugsurveillance system while calling for a scrapping of the‘‘black box’’ warning system.

Rogelio Menendez, MD

From the Allergy and Asthma Research Center of El Paso, El Paso, Tex.

E-mail: rmaacep@swbell.net.

Disclosure of potential conflict of interest: The author has declared that he has

no conflict of interest.

REFERENCES

1. Murphy S, Roberts R. ‘‘Black box’’ 101: how the Food and Drug Admini-

stration evaluates, communicates, and manages drug benefit/risk. J Allergy

Clin Immunol 2006;117:34-9.

2. Aaronson D. The ‘‘black box’’ warning and allergy drugs. J Allergy Clin

Immunol 2006;117:40-4.

3. Nelson HS. Is there a problem with inhaled long-acting beta-adrenergic

agonists? J Allergy Clin Immunol 2006;117:3-16; quiz 17.

doi:10.1016/j.jaci.2007.01.012