Acne drug is target of new suits
Tim Robbins is like millions of Americans, most of them teenagers and young adults, who have taken the powerful drug Accutane and watched their embarrassing acne disappear within weeks.
Robbins is also one of nearly 500 individuals who say they paid a terrible price as a result and are suing drug maker Hoffman-La Roche Inc. The first trial opens today in Illinois.
At issue is whether the company downplayed the risk that the medication could cause serious gastrointestinal diseases. But pharmaceutical giant Roche, which is based in Nutley, N.J., flatly denies it and maintains that there is no reliable evidence that Accutane causes inflammatory bowel disease.
Many of the plaintiffs who contend that the treatment led to their conditions -- ulcerative colitis or Crohn’s disease -- say they can be treated with drugs or suffer only occasional but debilitating flare-ups. The conditions are characterized by abdominal pain, diarrhea and weight loss.
The problem was much more severe for Robbins, 28, a former construction worker in Oak Ridge, Tenn. He had his colon removed and permanently lives with a colostomy bag.
“There are days when I wonder, ‘Why did this have to happen to me?’ ” he said. Robbins’ trial is expected to start this summer.
Accutane, or isotretinoin, is considered the biggest breakthrough in acne treatment in the last 25 years. About 500,000 prescriptions for the drug and its generic equivalents were written last year, with combined sales of about $250 million.
But even in today’s environment -- in which nearly every drug firm is under civil or criminal investigation, accused of marketing drugs beyond their approved use or not accurately disclosing their side effects, or both -- the medication is in a legal and regulatory universe all its own.
It has been the target of dozens of lawsuits over alleged adverse reactions, including depression and birth defects, since it debuted in the U.S. in 1982. In 2002, Accutane was the subject of congressional safety hearings.
As a result, Roche has enhanced the drug’s warning label, which now lists depression, psychosis and birth defects in children of women on the drug as possible side effects. Some believe the drug’s relationship with gastrointestinal disease also deserves a stronger warning.
Depending on how the next several months of trials go, experts say, the company may be forced to expand its warning label on the drug, which would surely hurt sales.
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.
The new cases could add fuel to the fire among critics -- including patient safety groups and some members of Congress -- who claim that drug companies routinely mislead the public about risks.
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.
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.
Papantonio said lawyers would present documents in court that showed that the company long ago knew not only that the drugs could cause gastrointestinal diseases but also that they were more common than any other side effects listed on the drug’s label.
In addition, he said, there are more than half a dozen instances in which internal company documents show that the company describes the drug as a possible cause of the disease.
In a statement, Roche said the company does not comment on pending litigation.
One complicating factor, experts say, is that the cause of Crohn’s disease is unknown and that although anyone can develop the condition, the peak incidence rates are in adolescents and young adults between the ages of 15 and 35, generally the same age range of patients who take Accutane.
The Crohn’s and Colitis Foundation of America estimates that 1.4 million Americans suffer from inflammatory bowel disease, with about 30,000 new cases diagnosed each year.
Another problem is that little research exists on a possible Accutane connection. One study, released last summer in the American Journal of Gastroenterology, reviewed all adverse reports for the drug filed with the Food and Drug Administration between 1997 and 2002. It found that in a subgroup of patients, the medication might serve as a trigger for gastrointestinal disease.
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.
“Given the extensive use of Accutane in clinical practice, it is likely that if this association [to gastrointestinal problems] is indeed real, it is rare,” he said.
Dr. Alexander Miller, a Yorba Linda dermatologist, believes the risks of the drug must be weighed against the benefits. “People think acne is relatively benign because it’s not life-threatening,” he said. “But people with severe acne know all too well the damage this disfiguring disease can cause.”
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.”
