CORPORATE CRIME REPORTER
Aventis
Knew of Fraudulent Ketek Study, Researcher Claims
21 Corporate Crime Reporter 8, February 13, 2007 (corrected
2.17.07)
The antibiotic drug Ketek has been used over the last couple of years by doctors
to treat sinus and lung infections.
Bad idea.
All kinds of red flags have been raised about the drug, most recently yesterday by the Food and Drug Administration (FDA), when it restricted the use of the drug to treat pneumonia and not less serious illnesses.
But by the FDA took action last week only after numerous articles in the national press about its dangers – including a risk of liver failure that may lead to death – Congrssional investigations, and the case of an Alabama medical doctor – Anne Kirkman-Campbell – who was sentenced in March 2004 to 57 months in prison for defrauding the drug’s maker – Sanofli-Aventis – in connection with a human study of the drug.
She was fined $557,251.22 and told to reimburse Aventis $925,774.61.
The company claims it didn’t know at the time the study was fraudulent.
Today, the Paris-based Sanofli-Aventis faced more bad news.
Anne Marie Cisneros was a researcher for PPDI, a contract research organization.
In testimony today before the House Oversight and Investigations Committee of the Energy and Commerce Committee, Cisneros, who was monitoring Dr. Kirkman-Campbell’s study, said that Aventis in fact knew that the Kirkman-Campbell study was a fraud.
“Based upon what I observed and learned in monitoring the Kirkman-Campbell site, Dr. Kirkman-Campbell indeed had engaged in fraud,” Cisneros testified. “But what the court that sentenced her did not know is that Aventis is not a victim of this fraud. On the contrary.”
Cisneros said that even before visiting Dr. Kirkman-Campbell’s site, a number of “red flags” were apparent.
First were the number of patients enrolled in the study – 400 – or one percent of the adult population of Gadsden, Alabama. By contrast, another site in Gadsden had enrolled just 12 patients.
Aventis was paying Kirkman-Campbell $400 per patient enrolled.
No patients had withdrawn from the study and no patients had been lost to follow up – “an unusual occurrence given the number of subjects.”
“She enrolled patients within minutes of each other and upwards of 30 patients per day,” Cisneros testified. “She enrolled patients at times and on days when the office was closed.”
Once she started reviewing patient charts, Cisneros discovered that every informed consent had a discrepancy, most of the informed consents looked like they had been initialed by someone other than the patient, a lot of the consents were dated by someone other than the subject, one consent was blatantly forged, and the doctor enrolled her entire staff in the study.
“All Kirkman-Campbell seemed truly interested in was getting more business from Aventis as an investigator,” Cisneros said.
At one point, Kirkman-Campbell told the Aventis manager at the site that Cisneros could stay only if Aventis got her more business.
The Aventis manager agreed, Cisneros said.
Cisneros said she was so concerned about patient safety that she called an independent review board (IRB) – Copernicus.
An IRB’s job is to protect patients in these situations.
“I spoke to the president of the company (Copernicus) and was told that, while she shared my concerns, she preferred to wait and see what actions Aventis took,” Cisneros said. “I never heard from the IRB again. To my knowledge, Copernicus never did audit or blacklist the site, or report any irregularities to the FDA.”
Through e-mail and teleconferencing, Cisneros alerted Aventis of her findings.
Cisneros said that the Aventis site manager coached Dr. Kirkman-Campbell “with leading questions on how to explain away improper conduct.”
The Aventis manager would say “Is this the reason you enrolled so many patients in one day because that is when your supply of the drug came in?”
Cisneros said a former PPD employee told her of the Aventis prepping.
“In my eight years of clinical research work, this is the only instance I’ve come across of such bad behavior by a drug sponsor,” Cisneros testified. “I feel I can speak for those who agonized over this situation when I say we are pleased that Dr. Kirkman-Campbell is serving prison time for her actions. But what brings me here today is my disbelief at Aventis’ statements that it did not know that fraud was being committed. I knew it. PPD knew it. And Aventis knew it.”
But today, Aventis stuck to its story that it didn’t know of the fraud.
“Aventis was unaware at the time that, at one study site (Kirkman-Campbell) which was referenced today, what appeared to be GCP (Good Clinical Practice) deviations in fact reflected fraud in the conduct of the study,” wrote company spokesperson Lisa Kennedy in an e-mail response to Cisneros’ testimony. “At the time of the January 2003 Advisory Committee meeting, Aventis believed that the deviations had been addressed within the parameters of the monitoring program. At that time, we did not know the extent of the evidence regarding underlying investigator fraud. We believe Aventis acted in good faith in conducting the study. We have cooperated fully in all investigations regarding this matter.”
Ann Begley, a partner at Kirkpatrick & Lockhart in Washington, D.C., represents Copernicus. Begley said the company would have no comment on the allegations because they had not had time to review them.
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