A former senior consultant for the US Food and Drug Administration (FDA) charges that the agency may be inappropriately influenced by patient groups and the drug industry in making decisions that affect Americans' health and safety.
The FDA engaged Dr. Paul Stolley in 2000 to look into reports of adverse events associated with GlaxoSmithKline's irritable bowel syndrome drug Lotronex. He claims that the agency appeared to buckle under pressure from patient groups in deciding to return the drug to the market after it had been withdrawn due to safety issues.
Stolley also maintains that the agency took special precautions to avoid antagonizing Glaxo. He believes that the funding the FDA receives from drug firms in the form of user fees compromises its objectivity in reviewing medicines.
Glaxo voluntarily withdrew Lotronex from the US market in November 2000 after the firm and the FDA failed to reach an agreement on an appropriate risk-management plan to address a growing number of reports of serious side effects. The reports included hospitalizations and even some fatalities.
Irritable bowel syndrome is not life threatening, and Lotronex's benefit doesn't justify its risks, Stolley asserted. He noted that the FDA and Glaxo were not able to determine which patients are at greatest risk of serious side effects.
In general, Stolley said he supports the idea of risk-management programs for important drugs that raise safety concerns, but he maintains that Lotronex is a poor candidate for such a program "because the complications are so unpredictable.
The FDA does not deny that its decision to allow the Lotronex reintroduction was influenced by patient groups.
The FDA acknowledged that the Lotronex reintroduction is likely to result in a number of adverse event reports, despite the risk-management program. The FDA will monitor the reports and modify the program as needed. A spokeswoman for Glaxo said that when the company decided to withdraw the drug, it had no intention of bringing it back.
British Medical Journal September 14, 2002
If the FDA had made its decision based on science, it would not have approved the reintroduction even with the risk-management provisions. Yet it capitulates to the demands of patients! Patients are just as clueless as their physicians regarding the cure for the cause of their legitimate abdominal pains.
This drug is used to treat irritable bowel syndrome (IBS). IBS is one of the easiest clinical problems to treat. It has been my experience that people following the eating plan and taking care of any emotional traumas are able to resolve this 95 - 99% of the time.
This drug in no way, shape or form addresses the cause of the problem. Yet people are willing to have their insurance companies pay over $200 a month for a drug that could kill them, when the problem could be solved by changing their diet. If this isn't a classic example of how desperately broken our medical system, I don't know what is.
The bottom line is, if you or someone you know has IBS, warn them to stay away from this drug when it's re-released. Start by following the eating plan. If that doesn't work, consult a knowledgeable health care professional (including EFT).
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