!! History Commons Alert, Exciting News
Aventis was a participant or observer in the following events:
The FDA informs Aventis that it will not approve the drug Ketek until the company has provided enough information to determine the drug’s safety profile. [Aventis, 6/4/2001] In April, an FDA advisory board recommended additional clinical studies for the drug because of concerns about potential side effects on the heart and liver (see April 26, 2001).
Aventis contracts Pharmaceutical Product Development, Inc. to do a clinical trial for Ketek, an antibiotic designed to treat respiratory infections. The trial, named “Study 3014,” is being done because of FDA concerns (see Early June 2001) about possible links to heart and liver problems. The company pays doctors $400 for each patient they enroll in the study. Some of the doctors—a bit overzealous in recruiting patients—forge signatures, sign up family members, and invite patients into the study who do not have infections. There are also problems with the way some of the doctors collect and record their data. One doctor, who enrolls 251 patients, does not follow the study’s instructions and fails to report adverse drug reactions. Another physician, Dr. Maria Anne Kirkman-Campbell, who runs a weight-loss clinic, signs up 407 patients—but only 10 percent of them actually take the drug. These problems are discovered by FDA inspectors in fall 2002. [ABC, 1/14/2006; Wall Street Journal, 5/1/2006 ]
Two farmers from Saskatchewan, Larry Hoffman and Dale Beaudoin, file a class action lawsuit against Monsanto and Aventis alleging that the two companies’ genetically modified (GM) canola genes have infested their organic canola crops. The contamination has made it impossible for them to get their products certified as organic and as a result they are not able to sell it on the organic market. Arnold Taylor, president of Saskatchewan Organic Directorate (SOD), tells the Canadian Press that “it is almost impossible to buy uncontaminated seed let alone contend with contamination from pollen drift.” According to Marc Loiselle, a director with the same organization, organic grain and oilseed traders have zero tolerance for GM contamination. Representing the farmers is Terry Zakreski, the same lawyer who represents Percy Schmeiser. The suit is also seeking to stop the introduction of modified wheat, which the two companies are developing and which is expected to hit the market in a few years. “We have lost canola as a crop in our rotations because of genetic contamination, but we obviously cannot afford to lose wheat which is our largest crop and largest market,” Arnold Taylor says. [Star Phoenix (Saskatoon), 10/12/2001; Canadian Press, 1/30/2002]
Aventis announces that the FDA has again declined to approve the company’s antibiotic drug Ketek, citing the need for additional analyses and information pertaining to Study 3014 (see October 2001-Fall 2002). [Aventis, 1/27/2003]
The FDA’s Division of Scientific Investigations says in a memo that Aventis’s clinical study for the drug Ketek, study 3014 (see October 2001-Fall 2002), “uniformly failed to detect data integrity problems when they clearly existed.” The report notes that doctors participating in the study failed to comply with FDA regulations and were found to have engaged in “multiple instances of fraud.” [Wall Street Journal, 5/1/2006 ]
The FDA approves the drug Ketek for treatment of chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia in patients age 18 and older. [Aventis, 4/1/2004] The approval decision is made despite evidence that a 2001-2002 clinical trial for the drug, study 3014, was replete with fraudulent data (see October 2001-Fall 2002). The FDA says the approval is based on data submitted in 2000, other studies, and the drug’s safety record overseas where the drug has been in use for several years. [Wall Street Journal, 5/1/2006 ]
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