By Maria Vogel-Short
New Jersey Law Journal
February 13, 2008
Plaintiffs in New Jersey and six other states who claim the antibiotic Ketek caused liver disease are getting a booster shot from a congressional inquiry into the clinical trials that led to FDA approval.
On Tuesday, witnesses at a hearing before the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations testified that Ketek’s trials were flawed and that the company had knowledge of flawed data even before FDA approval.
More than pending 100 suits raise product liability and consumer fraud claims against the manufacturer, Sanofi-Aventis Pharmaceuticals of Bridgewater. Ten suits are in Middlesex County and the rest in Illinois, Wisconsin, North Carolina, Alabama, Tennessee and California.
The Food and Drug Administration approved Ketek, or telithromycin, in 2004 for treatment of respiratory ailments but later limited its use because of reported health problems, such as liver failure.
The first death due to liver disease linked to Ketek was reported in February 2005, seven months after the drug was introduced, according to the FDA.
Three cases of severe liver problems from use of Ketek at a medical center led the FDA to issue an advisory on Jan. 20, 2006, instructing health care providers to watch for symptoms of liver problems. By the end of 2006, an FDA committee had received reports of 53 cases of liver failure among Ketek users.
On Feb. 12, 2007, the FDA required “black box warnings” on the drug’s packaging to alert users of serious adverse effects, such as liver damage.
As of last September, the most recent data available, the FDA had received 93 reports of adverse reactions, including 12 deaths.
Scrutiny of Ketek’s clinical-trial process began even before FDA approval. In 2003, Anne Kirkman-Campbell, of Gadsden, Ala., one of 1,800 private physicians running the tests, came under investigation. She later pleaded guilty to mail fraud and was sentenced to four years in prison.
Kirkman-Campbell’s clinical trial had been monitored by Ann Marie Cisneros, then a senior clinical research assistant with Pharmaceutical Product Development Inc. in Wilmington, N.C.
Cisneros testified Tuesday that she noticed some medical consent forms were initialed by Kirkman-Campbell rather than the patients, the doctor’s staff and family were enrolled in the 407-patient study, and medical records had been altered.
Cisneros said that she relayed those concerns to the Copernicus Group IRB in Cary, N.C., which sets the protocols for trials, but that no action was taken. Sharon Hill Price, Copernicus’s CEO, testified in response that she never got the message.
Robert West, special agent with the FDA’s Office of Criminal Investigation, testified that in July 2003, after the Kirkman-Campbell allegations, he recommended to his superiors that the FDA launch an investigation of Sanofi-Aventis’ role in the clinical study, but his request was ignored.
Paul Herbert Chew, president of the U.S. Research and Development Division of Sanofi-Aventis Pharmaceuticals, testified that his company was not able to confirm fraud in the clinical trials. He added that the company has since changed training and procedures.
Sen. Charles Grassley, R-Iowa, who chaired the House committee before he was elected to the Senate, testified Tuesday that the investigation into Ketek has been marked by foot-dragging. He said it took a year for the FDA to respond to his questions about Ketek.
Plaintiffs’ lawyer Ramon Lopez, of Lopez McHugh in Moorestown, who represents 30 Ketek users or their survivors, said the hearing testimony bolsters claims that the manufacturer had to have known of the flawed clinical trials.
He represents Charles Gregg of Ashland, Ohio, who took Ketek for bronchitis for four days and then was hospitalized on Feb. 7, 2006, for blurred vision, nausea, vomiting, fever, jaundice, hepatitis and liver failure.
Sanofi-Aventis’ attorney, David Sheehan, of Troutman Sanders in Newark and New York City, declined to comment.
Lisa Kennedy, a Sanofi-Aventis spokeswoman, did not return a call.