On February 27, 2002, Nadine Grethe, an Aventis manager overseeing the study, got an email from PPD warning that there were possible problems with Campbell including the lack of "proper diagnosis of an appropriate medical condition," medical charts described as "very limited," and lab test results that were "suspiciously similar" for multiple patients. PPD also found that many patients signed up during a lunch break when the office was supposed to be closed.
The suspicions were validated on August 29, 2003, in the case of Maria "Anne" Kirkman, MD, aka Maria "Anne" Kirkman-Campbell, DOH Case No 2004-20974, when Campbell was charged in a 21 count indictment in the US District Court for the Northern District of Alabama with 10 counts of using a scheme or fraud to obtain money and property by means of false pretenses and documentation, and 11 counts of knowingly and willingly making and using, and causing to be made and used false writing and document knowing it to contain a materially false, fictitious and fraudulent statement and entry.
The information alleged that Campbell falsified documentation released to a study to establish the safety and effectiveness of Ketek before it could be a approved by the FDA.
Despite all this, when Aventis submitted the results of Study 3014 to the FDA, they included 407 of Campbell's patients, and "did not alert the Agency to any problems" with Campbell, according to a review of Ketek's history, safety and efficacy by FDA official, Dr David Ross, on the FDA web site.
Campbell was eventually sentenced to 57 months in prison and was given an additional 3 years of supervised release after the prison term is completed. She was also fined $557,251 and ordered to make restitution to Aventis to the tune of $925,774.
An FDA inspector ended up at Campbell's office in late 2002, simply by chance because she had enrolled so many patients. The investigator found patients who said they had not received any medication, even though their records said they had, according to Dr Ross. Others patients were being treated for weight loss and not respiratory infections, and some subjects were friends and members of Campbell's family.
Dr Egisto Salerno was a study investigator in San Diego whose 214 patient recruitment made him the 3rd largest recruiter. Here is part of what was known about Salerno at the time he was conducting the study, according to a report by the Medical Board of California, Department of Consumer Affairs, on March 6, 2006
Petitioner started using cocaine in 1994 on an occasional, recreational basis. His use gradually escalated from occasional use in the mid-1990s to using cocaine every weekend by 2001. He "extended" his weekends to use cocaine by taking time off from his practice on Fridays, and sometimes on Thursdays or Mondays as well. He did not use cocaine before seeing any patients. Petitioner testified his denial of his addictions was so intense he was unaware he was dependent. The use of cocaine became an essential part of petitioner and his wife's lives.
Petitioner admitted ingested cocaine and drank alcohol Monday morning, April 22, 2002, after which he thought four or five people were inside his home. He armed himself with a loaded .45 caliber handgun. He threatened to kill his wife if she called the police. His mother in law found out what was going on and contracted the police, who responded to petitioner's home. Petitioner was armed and other weapons n the home, but most of them were antiques. Petitioner was under the influence of drugs and was arrested.
Dr Jeffrey McLeod was another quack who participated in the study from Virginia. On August 24, 2005, the FDA recommended that he be disqualified as a trial investigator and sent him a letter outlining his fraudulent conduct in the Ketek study and said in part:
The FDA's Center for Drug Evaluation and Research believes that you have repeatedly or deliberately violated regulations governing the proper conduct of clinical studies involving investigational new drugs as published under Title 21, Code of Federal Regulations (CFR, Part 312, and that you submitted false information in a required report to FDA or the sponsor.
The FDA told McLeod: (1) You failed to obtain informed consent from seven subjects; (2) For six subjects you provided consent documents that were signed and dated after they had completed the study; and (3) For 17 subjects you provided documents in which the signatures were backdated to make it appear that informed consents were obtained prior to their enrollment in the study.
The investigation even found that consent forms for 22 of the 23 patients contained a date that preceded the date McLeod received the informed consent templates on March 4, 2002, including 13 documents with his own signature. A member of his staff also told the FDA investigator that McLeod instructed her to backdate the consent signatures.
In addition, the study protocol required clinical lab tests on subjects at visit 1 and 2, but there was no documentation to show that such tests were conducted on 11 subjects.
The protocol required that women of childbearing age have a urine pregnancy test before taking the study medication, but there was no documentation to show that the tests were done on 6 subjects.