GlaxoSmithKline August 6, 2001 Dear Mr. Yamada: As over 8 months have past since the removal of Lotronex from the market, all but a handful of people taking the medicine have run out leaving them with no effective alternative treatment. The fact that no effective alternative treatment exists is undisputable and has been stated publicly by Dr. Palmer: "We greatly regret this outcome and believe that Lotronex is effective, that its side effects are manageable, and that the benefits of the product when treating IBS outweigh the risks," said Dr James Palmer, Senior Vice President and Director Group Medical, Regulatory and Product Strategy, Glaxo Wellcome plc. "Thousands of women who have benefited from Lotronex will have to resort to therapies which did not adequately treat their symptoms in the past." While the Lotronex Action Group understands that discussions for "continued marketing" of the medicine are currently taking place, the simple fact remains that those in need of the medicine do not have access to it, thus, causing undue suffering for those with the most severe form of IBS-D. GSK can blame FDA and FDA can blame GSK for eternity, but both are to blame for the pain and suffering of thousands of people that need the medicine. Moreover, both are to blame for the continued delay to the resolution of this issue. GSK has proven through its actions, that the patients come last in this issue. This cannot be disputed as GSK could release the medicine unders many forms of IND, but chooses not to. GSK could also sell the medicine in Mexico according to an early press story regarding locations where the medicine has been approved for sale: "Lotronex is also approved but not yet marketed in Mexico, Argentina, Brazil and South Korea and there are over 30 regulatory submissions pending around the world." Either providing the medicine under an IND or selling it in Mexico would allow those who suffer the most severe form of the illness opportunity for access. If corporate profits and stock holders are the primary concern of your company, than GSK should get out of the pharmaceutical business. If providing effective treatments to those that suffer from debilitating illnesses, such as severe IBS-D, is of importance to your company, than all we can tell you is that the actions of GSK do not show this. We have asked for your compassion, many have begged and pleaded to you, and it is time for GSK to step up to the plate and help those in need. Your competitors, Solvay and Novartis, have reacted with much more force and cooperation with the FDA on the issues of both Cilansetron and Zelnorm. Why will GSK not do the same? Once again, we ask for your compassion and allow Lotronex to be made available under an IND while continued discussions occur for long-term marketing. Sincerely, Corey Miller, Coordinator Lotronex Action group