Basically, Sanofi knew in October 2001 that one of its main researchers on the drug was probably faking her data. That researcher was indicted for research fraud in April 2003. Yet in April 2004, the FDA approved Ketek for sale even though both it and Sanofi knew the data on which the approval was based was entirely bogus. In 2007, after 53 cases of liver failure including four deaths, the FDA all but withdrew Ketek from the market.
If that hasn't got your blood boiling, the judge's ruling in the case will: He holds that Sanofi can't be sued by health benefit providers for defrauding them of prescription costs because each patient who received the drug was seen by a doctor. The doctor's decision to write a Ketek prescription removes the "proximate cause" necessary to establish that the plaintiffs paid for the drug based on fraud -- even though the only reason the drug was on the market was because of Sanofi's fraud, and individual doctors are in no position to know whether drugs are backed by fraudulent data or not.
Here's the timeline, per the ruling:
- June 2001: FDA declines to approve Ketek for pneumonia, sinusitis and chronic bronchitis, and requests more efficacy and safety data.
- October 2001: Sanofi begins "Study 3014" to address FDA's concerns. The company is alerted by one of its clinical trial vendors to concerns about the integrity of data in Study 3014, specifically with the office of Dr. Marie Anne Kirkman Campbell, which treated the largest number of patients in the study. She claimed to have recruited 407 patients in Gadsden, Ala. -- 1 percent of the entire town.
- October 2002: An FDA inspection of Campbell's office and other sites finds protocol violations.
- January 8, 2003: The FDA's advisory committee of independent experts meets to consider the Study 3014 data on Ketek. Information about Study 3014's integrity is withheld from the committee by both the FDA and Sanofi. The panel votes 11-1 to approve Ketek, even though FDA officials and Sanofi both know the data in Study 3014 is garbage.
- January 2003: The FDA ignores the advisory panel's vote and declines to approve Ketek, presumably because it knows about its own ongoing probe of Sanofi's data.
- April 2003: Dr. Campbell is indicted on multiple counts of fraud. She was ultimately imprisoned for 57 months.
- April 1, 2004: The FDA approves Ketek. The parties dispute whether the FDA relied on the 3014 data or not. Sanofi begins a successful marketing campaign for the drug. Hundreds of thousands of patients receive it for respiratory tract infections:
- July 2004: Sanofi submits a report to the FDA "without any caveats about that study's integrity and stated that 'the study was conducted in accordance with good clinical practice and Aventis' standard operating procedures for clinical investigation and documentation,'" the ruling says.
- 2004-2006: Ketek turns out to be three times more likely to result in serious adverse events than other drugs and is no more effective.
- January 2006: FDA warns about liver failure in Ketek patients.
- February 2007: FDA withdraws Ketek for all indications except pneumonia.
The ruling, by the way, merely recommends against class-action status, so the case will continue.
The strictness of the ruling is similar to recent cases involving drug company kickbacks and false statements. It's virtually impossible to prove wrongdoing against a company -- even when the facts are egregious -- because the business by its nature involves long chains of people doing separate acts.
If Congress wanted to find a cost-free way of reducing government spending on medical bills, then loosening the legal definitions of fraud, kickbacks and false statements to include common sense interpretations of bad behavior would be one way to do it.
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