Your Voice

April 1, 2001

LETTERS

 

LETTERS

An apology from the authors

We would like to call attention to a citation error in our article, "Artificial fingernails: Too hot to handle" (November 2000). Unfortunately, the error was discovered well after publication. In the fourth paragraph on page 103, the line starting with "A normal nail plate is markedly permeable to water" and the following three sentences should, with the exception of a few words, be enclosed in quotation marks. These sentences were inadvertently incorporated into our article verbatim from Dr. Paul Kechijian's letter to the editor "Dangers of acrylic fingernails" (JAMA 1990;263[3]:458). Misunderstanding and errors in manuscript preparation contributed to this glaring oversight. We apologize to Dr. Kechijian, to Contemporary Pediatrics and its readers, and to the concerned reader who brought this error to our attention. We had no intention of assuming ownership of Dr. Kechijian's work and feel a responsibility to publicly correct this mistake. We have personally contacted Dr. Kechijian and appreciate his understanding and support on this matter. We are truly sorry.

Ulfat Shaikh, MD, MPH
Las Vegas, Nev.
Anne T. Nucci, MD
Bronx, N.Y.

Dosing chart for Dimetapp contained inconsistencies

In the January 2001 issue of Contemporary Pediatrics, Whitehall-Robins Healthcare ran an advertisement with a dosing chart for reformulated Dimetapp liquid products. It has come to our attention that there were inconsistencies in this chart, which was also distributed to some physicians by our sales representatives.

It is important to note that none of the discrepancies in the chart pose a risk to patients.

In addition to running a corrected Dimetapp dosing chart in the March issue of Contemporary Pediatrics and other publications in which the incorrect chart appeared, Whitehall-Robins Healthcare has taken the following steps:

• We mailed an explanatory letter and corrected chart to more than 150,000 physicians. This letter requested that physicians destroy all Dimetapp dosing charts dated earlier than February 2001. (The date appears in the lower right-hand corner of the chart.)

• We have advised our sales representatives to retrieve and destroy incorrect dosing charts that they distributed.

Whitehall-Robins regrets this error and apologizes for any inconvenience that it may have caused. Readers who want to speak to a product specialist at Whitehall-Robins should call 877-304-2742.

Francis Sullivan
Associate Director, Public Affairs
Whitehall-Robins
Madison, N.J.

Categorizing insulin resistance

In regard to "Is it an endocrine disorder or a 'nondisease'?" (October 2000), the title of the article and the first case presented under the discussion "Adrenal nondisease" are inconsistent and misleading. Clearly, the patient in case 1 has insulin resistance, and this is an endocrine disease. It is an increasingly threatening problem. The author does admit that these patients need care.

Kathaleen C. Perkins, MD
Morgantown, W.Va.

The author replies: I agree that the child presented as an example of non-Cushing syndrome does have a potential endocrine disorder, namely, type 2 diabetes, in view of his obesity and acanthosis nigricans. The opening and closing paragraphs of the two-part article state that although these children do not have Cushing syndrome, their obesity does require treatment, as Dr. Perkins reiterated in her letter. I regret any confusion that may be caused by the implication that no other endocrine disorder—for example, type 2 diabetes, overt or potential—could be present in these children.

Michael S. Kappy, MD, PhD
Denver, Colo.

After rapid strep tests: Get culture backup?

We read with interest Dr. Andrew J. Schuman's review on medical technologies and how they are influencing the practice of medicine in the new millennium ("New products for pediatrics: 2000," December 2000). We are flattered that Thermo-BioStar's patented thin film technology, Optical Immunoassay (OIA), was found worthy of discussion, but we think it is important to clarify a possible misconception about claims we have made in regard to our Strep A OIA MAX product.

The author states that the Group A strep OIA's "high sensitivity and specificity make it possible to perform an office rapid strep assay without doing a backup throat culture for negative tests." Several published studies have shown that the sensitivity of MAX OIA equals or surpasses that which can be obtained from traditional culture methods (Gerber et al: JAMA 1997;277:899; Webb et al: J of Fam Pract 2000:49:34; Webb KH: Pediatrics 1998;101:e2; Needham et al: J Clin Microbiol 1998;36:3468). These studies and outcome analyses have indicated an equal or better level of care (detection of Group A strep infections of the throat; decrease in inappropriate use of antibiotics) when using our OIA product alone, without culture backup. It should be noted, however, that, first, the FDA has not approved the use of the product in such a manner and, second, Thermo-BioStar does not make this claim.

The American Academy of Pediatrics Red Book, a nationally recognized authority on accepted standards of care, states that "when a patient suspected on clinical grounds of having GAS pharyngitis has a negative rapid streptococcal test, a throat culture should be obtained to ensure that the patient does not have GAS infection" (25th ed, p 529). The book also acknowledges studies supporting the author's statement when it says "Published data suggest that these tests may be as sensitive as standard throat cultures on sheep blood agar and more sensitive than other rapid tests for GAS. Some experts believe that the optical immunoassay test is sufficiently sensitive to be used without throat culture backup. Physicians who use this test without culture backup may wish to compare their results with those of culture to validate adequate sensitivity in their practice" (25th ed, p 529). We support the guidance of the Red Book for clinical practice.

Catherine J. Cox, MD
Director, Medical Affairs
Thermo-BioStar, Inc.
Boulder, Colo.

The author replies: Utilization of medical technology in the pediatric office is oftentimes a complicated matter. In regard to the office laboratory, pediatricians must decide which diagnostic tests should be available and, most important, which assays to utilize for the tests that are to be performed.

I was guest editor of Thermo-BioStar's August 1993 Seminar-in- Print, a monograph that introduced OIA technology to the medical community. The symposium considered the findings of a well-designed study that compared the Strep A OIA assay and traditional routine throat culture with a broth-enhanced culture system. In more than 4,000 specimens collected and processed from a mixed population of pediatric and adult patients, OIA demonstrated a sensitivity of 96% and a specificity of 98%, while routine cultures had a sensitivity of 88% and a specificity of 99%, respectively. The data supported the company's assertion at the time that the sensitivity of their new optical immunoassay rapid strep test was comparable to that of enhanced broth culture and, therefore, did not require culture backup when a test is negative.

Few physicians are aware that the bacitracin disk used to identify Group A strep in most office labs inhibits growth of non­ Group A strep about 5% of the time; because office labs do not confirm the identity of the strep with appropriate serotyping, false-positive reporting of Group A strep cultures thus results. Additionally, 5% of Group B strep are susceptible to bacitracin, and 5% of Group A strep are nonhemolytic. The traditional throat culture is therefore an imperfect "gold standard" compared with a broth-enhanced culture system.

While the FDA has apparently cautioned Thermo-BioStar against advising physicians to abandon throat culture backup, I anticipate that the strong statement in the Red Book has convinced physicians to consider not using culture backup when an OIA is negative, based on their own experience with this assay. This underscores the need for pediatricians to set rational and reasonable policies for their office lab, based on the performance of their chosen rapid strep assay in daily practice.

Many factors contribute to the accuracy of rapid strep tests—some independent of the assay used. One important factor is the aggressiveness of the person (medical assistant, nurse, physician) obtaining the specimen from the pharynx, because most rapid antigen tests can only detect the amount of antigen equivalent to 10 colonies of Group A strep. The advantage of the OIA test is that it can detect a lower level of antigen compared with EIA­based rapid strep tests.

I suspect that most pediatricians have performed backup throat cultures on hundreds of rapid strep tests and gotten a good sense of their selected assay's sensitivity compared with the culture standard. In my experience, the incidence of false-negative rapid strep assays is quite low when a throat specimen is obtained aggressively and processed as recommended by the manufacturer.

Andrew J. Schuman, MD
Manchester, N.H.

Clarification

In "Newborn discharge: A time to be especially thoughtful" in the October 2000 issue, the final sentence in Table 4 should read: "Caution parents to avoid introducing solids before 4 months of age and feeding honey before 12 months of age and to avoid bottle propping."

 

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Letters. Contemporary Pediatrics 2001;4:119.