There are about 500 individuals who are in the process of suing drug maker Hoffman-La Roche claiming that the drug Accutane is the cause of of their inflammatory bowel disease. Accutane, or isotretinoin, is considered a huge breakthrough in treatment of acne. Last year about 500,000 prescriptions totaling $250 million were written. The drug has had other problems but nothing like this.
The court cases have the potential to eclipse previous controversies surrounding the drug. That's because of the large number of lawsuits alleging that the drug causes intestinal disease, as well as accusations by plaintiffs' lawyers that internal company documents uncovered during trial discovery show that the company has long downplayed the drug's link to the disease.
Predictably the accusations and denials are flying.
Roche "has done everything they can to hide the fact this is not only a real side effect but possibly the most common side effect," said Mike Papantonio, senior counsel at Levin, Papantonio, Thomas, Mitchell, Echsner & Proctor of Pensacola, Fla., one of five law firms representing the Accutane plaintiffs.
Many doctors say that isn't enough evidence to worry them. Dr. Francis Farraye, clinical director of gastroenterology and a professor at the Boston University School of Medicine, said he was comfortable that the drug was safe when used according to its label.
The interesting note for me was that Roche has acknowledged the IBD is "associated" with Accutane.
Today, the drug's label lists Accutane and its generic equivalents as only "associated" with inflammatory bowel disease. That term is crucial, because it means that a side effect is known to occur only while people are on a drug and is so mild that many doctors discount it when prescribing medications.
You can't help but feel sorry for the people that are affected by this. This story is a familiar one to me even if the initial cause isn't.
Tennessee plaintiff Robbins took the medication for several weeks during his senior year of high school. Within weeks, the mild acne that had shaken his confidence was gone. But soon after, the former football player said he began having occasional but severe intestinal problems that caused him to spend months out of work and lose as much as 20 pounds at a time from his 210-pound frame. He was later diagnosed with chronic ulcerative colitis. Initially, Robbins was able to manage the condition with drugs. But four years ago, his condition grew so bad he quit his construction job and moved in with his parents. He spent the next two months in the hospital, during which time his weight dropped to 140 pounds. His life at risk, doctors eventually said he had to have his colon removed. For the rest of his life, Robbins will live with a colostomy bag, which he cleans several times a day. He said he tries not to be bitter. But "I wonder sometimes what my life would have been like."
Acne drug is target of new suits - Los Angeles Times