Letters to the Editor - April 15, 2000 - American Academy of Family Physicians

Letters to the Editor

Hiding Consumer Ads in Pharmaceutical Samples

TO THE EDITOR: I was chagrined to recently find an unexpected piece of paper glued to the U.S. Food and Drug Administration (FDA) package insert inside a sample box of metformin (Glucophage). This advertisement and coupon for Choice dm, an over-the-counter "nutritional bar and beverage," offered 25 cents off. It further asked the patient to complete demographic information on the coupon and a questionnaire to be mailed back to Bristol-Myers Squibb.

I'm sure that I have unknowingly given this advertisement to numerous indigent diabetic patients on continuous therapy. I only found the advertisement while initially starting a patient on metformin and giving her the enclosed FDA patient label that discusses lactic acidosis. The outside of the sample box gave no indication of the advertisement's inclusion inside. In this particular case, I certainly don't want to encourage my diabetic patients to consume products that look like candy bars and milkshakes. In the bigger picture, I do not ever want to be the involuntary dispenser of any consumer advertisement hidden inside a product sample box.

When I called my two local pharmaceutical representatives for an explanation of this outrageous hidden marketing, both of them were bewildered. They were embarrassed to admit that they were unaware of the advertisement, stating that Bristol-Myers Squibb had not alerted them to its inclusion in the sample product boxes that they deliver daily to physicians.

Most physicians bemoan the recent direct-to-consumer marketing of prescription drugs. This ugly new twist of hiding consumer ads inside pharmaceutical samples that physicians dispense cannot be tolerated. The patient receiving such an ad may incorrectly assume that the product is endorsed by the physician, who in fact has no knowledge of the advertisement inside. I urge all physicians to check for and refuse to accept such samples and further urge the FDA to disallow the practice.

RONALD D. REYNOLDS, M.D.
New Richmond Family Practice
1050 Old U.S. 52
New Richmond, OH 45157

IN REPLY: Bristol-Myers Squibb is committed to extending and enhancing human life by providing the highest quality health and personal care products. One of the conditions that is of great concern to our company is type 2 diabetes (formerly known as non insulin-dependent diabetes), a serious medical condition that affects approximately 15 million Americans. Our oral antidiabetic agent metformin (Glucophage) has helped more than 5 million Americans with type 2 diabetes to better manage their condition.

Proper management of type 2 diabetes also requires attention to diet and exercise. The Choice dm nutrition bars and beverages manufactured by Mead Johnson Nutritionals, a division of Bristol-Myers Squibb, have been clinically proven to result in a lower blood glucose response compared with other snack bars and standard nutritional beverages tested.¹Our aim in providing information about Choice dm products in our sample box was to make type 2 diabetes patients aware of this option.

Bristol-Myers Squibb is constantly reassessing our materials to develop better packaging for patients and physicians who receive our product sample kits. We will certainly take Dr. Reynold's comment into consideration in the development of future samples.

PAUL H. CHEW, M.D.
Vice President, Medical
Bristol-Myers Squibb Company
Princeton, NJ 08543-4000

REFERENCE

Reader D, Johnson L, Hollender P, Franz, ML. The glycemic and insulinemic response to resistant starch in a food bar vs. two commercially available food bars in persons with type II diabetes mellitus. Diabetes 1997;46(suppl 1):Abstract 975.

Use of Intravenous Colchicine in Patients with Acute Gout

TO THE EDITOR: I read the article¹ on the treatment of gout and hyperuricemia. I would like to comment that, in my experience of using colchicine to treat patients with gout, I have found nothing more effective than giving 2 mg of intravenous colchicine in a single dose. The toxicity from a single dose is very low, and it is now my treatment of choice for a patient with an acute gouty attack. I have quite a bit of experience using intravenous colchicine, and I have encountered some problems with extravasation causing some irritation; however, this is the only problem I have experienced.

I reviewed the article² to which the authors referred to regarding the toxicity associated with the intravenous administration of colchicine. All of the patients described in the article who had toxic effects from intravenous colchicine administration had received large dosages over a short period. In fact, the recommendations at the end of the article indicate that "The IV administration of colchicine is an effective way of using the drug and, with appropriate precautions, should lead to little serious toxicity."²

Guidelines provided in the article² for the intravenous administration of colchicine include the following: (1) Single intravenous dosages should not exceed 2 to 3 mg, and cumulative total dosages for an attack should not be more than 4 to 5 mg; (2) Patients should not receive colchicine by any route of administration for seven days; (3) Colchicine dosages must be reduced in patients who have renal or hepatic disease and in older patients with apparently normal renal function; (4) Intravenous colchicine dosages should be half the size of oral dosages; (5) Absolute contraindications to intravenous colchicine therapy for patients with acute gout include combined renal and hepatic disease, creatinine clearance times below 10 mL per minute and extrahepatic biliary obstruction.

I wrote this letter because I am concerned that, after reading this article, physicians who do not have experience with intravenous colchicine therapy might be frightened away from what I believe is a highly effective treatment for patients with acute gout.

WILLIAM H. STEPHAN, M.D.
4080 Delaware Ave.
Tona, NY 14150

REFERENCES

Harris MD, Siegel LB, Alloway JA. Gout and hyperuricemia. Am Fam Physician 1999;59:925-34.

Wallace SL, Singer JZ. Review: systemic toxicity associated with the intravenous administration of colchicine--guidelines for use. J Rheumatol 1988; 15:495-9.

IN REPLY: We appreciate the comments offered by Dr. Stephan concerning the use of intravenous colchicine, and we agree that it is often highly effective therapy for the treatment of patients with acute gouty arthritis. Colchicine is one of the great veteran drugs in medicine, with a long venerable history in the treatment of patients with gout. However, the potential toxicity of the intravenous route of administration is often under-appreciated, and we argue against its routine use.

Colchicine was available well before the 1969 U.S. Food and Drug Administration act that required phase III toxicity trials. Data on toxicity and adverse reactions are based solely on passive surveillance; therefore, the true incidence of adverse reactions, especially with infrequently used medicine, is unknown. Toxicity includes tissue necrosis, bone marrow suppression, disseminated intravascular coagulation, renal failure, seizure, sepsis and death.

Over the past 50 years, more than 20 deaths have been attributed to the use of intravenous colchicine. In fact, it is no longer licensed for clinical use in Great Britain. We agree with Dr. Stephan that improper dosing and poor patient selection accounts for the vast majority of reported serious toxicity. However, with the availability of published guidelines,¹ accurately detailed by Dr. Stephan, improper use and subsequent toxicity continues to be a problem.² Guidelines on the safe use of intravenous colchicine are not widely disseminated in general medical or rheumatology textbooks.

Although the Wallace¹ criteria are often quoted, several other guidelines are published in the medical literature.³ We agree with previous authors^2,4 that the Wallace criteria should be expanded to preclude colchicine therapy in patients with baseline leukopenia. We are most concerned that patients frequently receive care from multiple physicians, as is the case in most teaching hospitals. In this setting, minimizing the total dose of intravenous colchicine, or avoiding concomitant oral and intravenous administration, have proved to be difficult errors to avoid. In a medical setting where patients receive their care from a single physician who is well versed on the toxicity of and various guidelines for the administration of intravenous colchicine, the drug may safely be used.

Intravenous colchicine continues to have the smallest risk-to-benefit ratio of all drugs used for the treatment of patients with acute gouty arthritis. Given the efficacy and low toxicity of alternative treatments, the lack of any prospective studies evaluating the safety or efficacy of intravenous colchicine therapy, and the lack of readily available and validated administration guidelines, we continue to recommend against the routine use of a potentially lethal medicine for use in patients with a nonfatal illness.

MARK D. HARRIS, M.D.
Wilford Hall USAF Medical Center
Department of Rheumatology
2200 Bergquist Dr.
Lackland AFB, TX 78236-5300

The opinions and assertions contained herein are the private views of the author and are not to be construed as official or as reflecting the views of the Department of Defense or other Departments of the U.S. Government.

REFERENCES

1Wallace SL, Singer JZ. Review: systemic toxicity associated with the intravenous administration of colchicine--guidelines for use. J Rheumatol 1988; 15:495-9.

Evans TI, Wheeler MT, Small RE, Breitbach SA, Sanders KM, Roberts WN. A comprehensive investigation of inpatient intravenous colchicine use shows more education is needed. J Rheumatol 1996;23:143-8.

Roberts WN, Liang MH, Stern SH. Colchicine in acute gout. Reassessment of risks and benefits. JAMA 1987;257:1920-2.

Davis JS. Bartfield H. The effect of intravenous colchicine on acute gout. Am J Med 1954;16:214-9.

Corrections

A letter to the editor entitled "Folic Acid Requirements for Women of Childbearing Age" (December 1999, page 2510) contained an error in the dosage unit for folic acid, which occurred in the publishing process. The author, a representative of the March of Dimes, had originally supplied the correct folic acid dosage and emphasizes that supplementation with 400 µg of folic acid per day in women of childbearing age is an important measure in reducing birth defects.

The article "Update on the Prevention and Treatment of Sexually Transmitted Diseases" (January 15, 2000, page 379) contained two incorrect trade names in the first paragraph of the right-hand column on page 385. The correct trade name for procaine penicillin G is Wycillen; the correct trade name for aqueous crystalline penicillin G is Pfizerpen. (Bicillin L-A is penicillin G benzathine; Bicillin C-R is a combination of penicillin G benzathine and penicillin G procaine.)

The article "Newer Pharmacologic Alternatives for Erectile Dysfunction" (September 15, 1999, page 1159) contained an error in the first sentence of the third paragraph. Penile erection is mainly mediated by the parasympathetic nervous system; it is ejaculation that is controlled by the sympathetic nervous system.

*These corrections have been made to the online version of AFP. The links above will take you to the corrected items, which remain part of the online issues in which they were originally published.

Send letters to Jay Siwek, M.D., Editor, American Family Physician, 11400 Tomahawk Creek Parkway, Leawood, KS 66211-2672; fax:913-906-6080; e-mail: afplet@aafp.org. Please include your complete address, telephone number and fax number. Letters should be double-spaced, fewer than 500 words and limited to one table or figure and six references. Please submit a word count. Letters submitted for publication in AFP must not be submitted to any other publication. Possible conflicts of interest must be disclosed at time of submission. Submission of a letter constitutes transfer of copyright to the American Academy of Family Physicians. The editors may edit letters to meet style and space requirements.

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