In his two-page editorial entitled "Lotronex and the FDA: a fatal erosion of integrity", Horton accuses the FDA of being a pawn for the drug industry. He maintains that there were two sides to the negotiations over Lotronex, "one official and transparent, one unofficial and covert".

     Lotronex, the first drug developed specifically for Irritable Bowel Syndrome (IBS), was used for IBS in women whose main symptoms was diarrhea. It was not to be taken by women who were troubled with constipation or other digestive disorders, or who had a history of other digestive disorders.

     The United States Food and Drug Administration approved Lotronex on February 9, 2000. Four cases of ischemic colitis were reported before the drug was approved. The condition reversed when the drug was discontinued, and all four cases were considered to be mild to moderate in severity.

     On August 25, after the drug was linked to 11 reports of serious constipation, the FDA required a warning about possible side effects such as ischemic colitis to be issued with each prescription.

     On October 31, the FDA reviewed the safety of Lotronex amidst reports that five women died after using the medication. At this time, the consumer group Public Citizen called for Lotronex to be banned due to the potential for serious side effects. A representative from Glaxo Wellcome Inc., the company that manufactures the drug, said the deaths may not have been a result of Lotronex. They maintain that two of the women who died were not taking Lotronex at the time of death, and a third woman who died had a history of ischemic intestinal disease.

     On November 28, Glaxo Wellcome made the decision to pull Lotronex from the market. After completing the review started on October 31, the FDA gave Glaxo Wellcome the option of a "restricted drug distribution program". This would include continued clinical research, closer monitoring of patients severely debilitated by IBS who were using Lotronex, and the safe use of Lotronex in informed patients. Glaxo Wellcome elected to pull the drug from the market.

     In the wake of Lotronex being pulled from the market, a public debate has been waged over the possible reintroduction of the drug.

     What's not debatable is that people with diarrhea-predominant IBS who took Lotronex experienced a lessening of symptoms. With the withdrawal of Lotronex from the market, there is no comparable medication that abates the sometimes-debilitating symptoms.

     Members of the IBS Self Help Group and other former Lotronex users formed the Lotronex Action Group (LAG) after Lotronex was pulled from the market. The LAG "seeks permanent access and safe distribution of the medicine to those diagnosed with IBS-Diarrhea".

     The LAG has been working with both the FDA and GlaxoSmithKline (formerly Glaxo Wellcome Inc.) to achieve their objectives. They have organized a petition that was signed by current and former Lotronex users and submitted to the FDA. They have also written open letters to GlaxoSmithKline in support of Lotronex.

     On the other side of the debate is Public Citizen, a watch dog organization founded by Ralph Nader. On August 31, 2000 Public Citizen sent a petition to the FDA asking for Lotronex to be removed from the market. They maintain that because IBS is not life threatening, the possible benefits of Lotronex outweigh the risks of ischemic colitis and severe constipation.

     The FDA and GlaxoSmithKline have met to discuss the plausibility of once again releasing Lotronex in some form. The substance of this meeting has not been disclosed to the public.

     At this time the future of Lotronex is unpredictable. The outspoken players in this controversy, the LAG and Public Citizen, are both lobbying hard to do what they feel is right for people with diarrhea predominant IBS. With statistics and evidence supporting claims on both sides of the issue, the end result is impossible to foretell and the ongoing debate promises to be an interesting one.