Blockade of pancreatic lipase

Beth Israel Deaconess Medical Center, Center for the Study of Nutrition and Medicine, OneDeaconess Road, Boston, MA 02215, E-mail:gblackbu{at}caregroup.harvard.edu

Dear Sir:

Despite the fact that Xenical (orlistat; Hoffmann–La Roche, Nutley, NJ) has been evaluated in >17000 individuals worldwide, and is now being prescribed to >1000000 patients, you (1) question the safety of pancreatic lipase blockade in the treatment of obesity. In doing so, you contradict the findings of the Journal's invited editorial writer (2)—a fellow gastroenterologist who, after careful review of the submitted scientific article and several previously published clinical trials, failed to identify a safety risk secondary to fat malabsorption when orlistat is used as directed. Similarly, your stance runs counter to decisions by the Food and Drug Administration and drug control authorities in many other nations to approve orlistat for prolonged use.

That the safety and efficacy of obesity medications are held to a higher standard of proof than that applied to other drugs used for treating chronic conditions is perplexing. In particular, I question why the Editor-in-Chief has not cited medications with known adverse effects on the gastrointestinal tract, eg, insulin sensitizers for the treatment of diabetes and antiinflammatory drugs for the treatment of arthritis, to name only 2. Clinical trials for drugs such as these typically run for just a few months.

No obesity medication approved for prolonged use has resulted in death or organ failure, even in instances of voluntary recall. For editorializing of this kind to thus be credible, the standard of evidence for doubt must exceed that used to establish safety. It took but a brief review of Moran et al's (3) article to dismiss it as a rationale for questioning orlistat's safety in obesity treatment. Perhaps a more pertinent study would be one that investigates why editors feel compelled to challenge not only the management of obesity but the very existence of the disease itself (4–7).

REFERENCES

1. Halsted CH. Is blockade of pancreatic lipase the answer? Am J Clin Nutr 1999;69:1059–60 (editorial).
2. Klein S. The war against obesity: attacking a new front. Am J Clin Nutr 1999;69:1061–3.
3. Moran CE, Sosa EG, Martinez SM, et al. Bone mineral density in patients with pancreatic insufficiency and steatorrhea. Am J Gastroenterol 1997;92:867–71.
4. Kassirer JP, Angell M. Losing weight—an ill-fated New Year's resolution. N Engl J Med 1998;338:52–4.
5. Blackburn GL, Grand RJ, Licht DI, Richardson BE, Soteriades ES, Willcutts HD. More on the obesity problem. N Engl J Med 1998; 338:1702 (letter).
6. Robertson D. Obesity: a role for drug therapy? Drug Therapy 1993; 23:12.
7. Blackburn GL, Greenberg I, Brotman AW. The role of drug therapy in obesity. Drug Therapy 1993;23:17–18, 23–25, 29.