I’ve been contacted by a chap who works for Prometheus Labs, the company who now hold the rights to Lotronex. They would like to hear your feedback about a number of Lotronex issues.
This is a great opportunity to air your views to someone who is at the heart of the Lotronex story, and that doesn’t happen often, so please do take this chance. I’ve set out the issues that the Prometheus rep raised below, and given a few responses of my own, but the people we really need to hear from are those of you who are using Lotronex, have used it in the past, or have asked your doctor for it and been refused.
Please leave your message in the comments section, either to comment on any of the issues raised below or to make your own points. You can also share your personal experiences of the drug. Just fill in the comment form at the end of this blog entry.
Just to say before we start – I’m not offering any recommendations or endorsements here, either to the makers of Lotronex or the actions of the FDA. These are very important issues and they need an objective evaluation.
I am however firmly on the side of the IBS sufferer, so tell me what you want!
1. “There are many women on multiple medications but they are still experiencing symptoms and their quality of life and daily activities are still impaired. And yet their physicians will not discuss Lotronex with these women and at least offer the option.”
This presumably is because doctors do not believe that IBS is a serious problem (I’ll come back to this point), because of the history of Lotronex itself, or because the patients do not fit the tight criteria that the FDA have specified for drug’s prescription. For anyone who doesn’t know what happened with Lotronex, here is the backstory.
Lotronex was withdrawn by the US Food and Drug Administration (FDA) in November 2000. This was because the FDA had identified 70 cases of adverse reactions to the drug, including five deaths, relating to intestinal damage caused by either ischemic colitis (restricted blood flow to the intestines) or severe constipation.
In 2002 the drug was reintroduced under a restricted drug distribution program which allowed access to the drug for patients who were classified as having severe diarrhea-predominant IBS, which the FDA estimates as applying to less than 5% of patients.
Doctors need to enrol in this special program before they are allowed to prescribe the drug, and patients must also sign an agreement to show they understand the potential risks and benefits. A lower dosage of Lotronex has also been introduced to reduce the risk of constipation.
2. “Patients with IBS are often told it’s in their heads or that it’s not very serious. How can women with IBS-D become empowered to challenge their doctors and demand therapy?”
This is more about the general ignorance surrounding IBS rather than the potential risks and benefits of any drug. Ah, that all in your head quote just won’t die will it? Maybe these doctors should be keeping up to date with their reading:
“IBS is not caused by stress. It is not a psychological or psychiatric disorder. It is not ‘all in the mind’. Because of the connection between the brain and the gut, symptoms in some individuals can be exacerbated or triggered by stress” says the International Foundation for Functional Gastrointestinal Disorders IFFGD
“It is important to note that IBS is not a psychological disorder” says the Canadian Society of Intestinal Research
“Functional gastrointestinal disorders are not psychiatric disorders” says the UNC Center for Functional GI and Motility Disorders
As to the question of whether IBS is serious or not, well, it’s certainly not fatal or progressive, even if untreated, and that is enough by itself to send some doctors to sleep. But there are plenty of medical conditions that won’t kill us that can still ruin our lives.
One of the best ways to measure the impact of a particular medical condition is through a quality of life study. These studies ask patients about everything from their social lives to their emotional wellbeing to find out exactly how difficult it is to live with the disorder in question.
A quality of life study in the medical journal Gastroenterology showed that IBS patients have a significantly lower health-related quality of life than patients suffering from other chronic disorders. In many areas IBS sufferers had a lower quality of life than patients with diabetes, and you can bet that your local doctor treats his diabetes sufferers with respect.
3. “How do doctors and patients define ‘well’. I know Lomotil and Imodium can provide some relief, but is going from 10 bowel movements a day to five ‘well’?”
The quality of life studies are relevant here, but in many ways this is going to be very subjective. It’s certainly a stretch to consider five bowel movements a day healthy, but if the patient isn’t suffering from any pain or discomfort it may not be a huge problem. Or it could mean that you lose your job because you can’t stay out of the bathroom.
I tend to consider myself well when my IBS isn’t limiting my life to a degree that makes me consistently unhappy. I think it’s reasonable for IBS sufferers to have to live with a certain amount of discomfort and pain on an irregular basis, but I also think it’s reasonable to say that any patient who finds that their symptoms start to take over their lives should be offered help. That sounds pretty vague, and I’m not sure how else to answer this question.
So – what do you think? Has Lotronex changed your life? Do you think the FDA acted correctly? Do you worry about the potential risks of Lotronex or has it transformed your life? Speak up on Lotronex!