Unproven claims that Tamiflu could “stop the flu” and “reduce complications” at issue.
An investigator with the Cochrane acute respiratory infections group has filed a whistleblower action against Hoffman La Roche on behalf of the US government and 29 states for Hoffman La Roche’s claims that its drug Tamiflu is effective in stopping the spread of pandemic influenza.
In 2009, the Cochrane group reviewed the efficacy of Tamiflu during a large H1N1 influenza outbreak. During this review, the group found that many of Hoffman La Roche’s claims about Tamiflu were based on unpublished data. When researchers asked to review the study data, Hoffman La Roche refused to release the data without a nondisclosure agreement – to which the researchers would not agree. After approximately four years, the researchers were able to obtain much of the study data, which showed that Tamiflu did have a minimal effect on duration of influenza symptoms, but had no effect on decreasing transmission of influenza or on decreasing lower respiratory tract complications of influenza.
According to the complaint, the FDA directed Roche to stop dissemination of advertisements claiming that Tamiflu could “stop the flu” or that Tamiflu could “reduce secondary complications by 45%” because these and similar claims were not supported by substantial evidence. The lawsuit claims Roche knowingly published misleading articles stating that Tamiflu did reduce complications, hospitalizations, mortality and transmission of influenza and then used those misleading articles to market Tamiflu to governments for pandemic use. As a result, federal and state governments spent $1.5 billion stockpiling Tamiflu to combat influenza pandemics.
In a whistleblower action (also known as a qui tam action), private citizens who are aware of fraudulent acts perpetrated against federal or state governments may file lawsuits on behalf of the government to recover damages. If successful, the “relators” are then eligible for an award of up to 30% of whatever money the government recovers (which may include treble damages or up to $4.5 billion in this case). After a whistleblower complaint is filed, the Department of Justice investigates the claim. If the DOJ decides to “intervene,” it will take control of (and pay for) the prosecution of the case. If the DOJ does not intervene, the plaintiff may continue to pursue the matter on behalf of the government. After five years investigating the claims against Hoffman-La Roche, the DOJ decided not to intervene.
Hoffman La Roche has inferred that the DOJ’s lack of involvement is a reflection on the merits of the allegations and is seeking to have the case dismissed, claiming in court filings that the case “ignores reality” and that the US government performed its own effectiveness studies on Tamiflu and has kept Tamiflu in its stockpiles despite the lawsuit allegations.
The relator, Dr. Thomas Jefferson (yes that’s really his name), and his attorneys are reportedly “looking forward to deposing Roche executives about the alleged scheme.”
The case is USA, ex rel. Thomas Jefferson, et al. v. Roche Holding AG, et al., US District Court, D. Md., Case No. 14-CV-03665 (2014).
Note that this lawsuit doesn’t address the efficacy of Tamiflu in general — only whether Tamiflu is potentially useful in a pandemic. There is still some evidence showing that Tamiflu provides minimal reduction in influenza symptom severity and duration – at the possible expense of GI, renal, and psychiatric complications.
This case also highlights the potential lengths to which some pharmaceutical companies may go to sell their products. Recall how Roche refused to release its study data for four years after inquiries were first made about the findings. Authors, journal editors and readers should keep potential bias in mind when interpreting any biomedical research findings and may wish to consider study design before relying on study conclusions.
As a side note, I can’t help wondering what’s going to happen to the government stockpile of billions of Tamiflu pills long past their expiration dates sitting in storage somewhere. Expired medications are a frequent source of hospital citations by the Joint Commission. Would regulatory agencies allow patients to be given ineffective medications that expired many years ago if a pandemic occurred? Would patients want to take the medications?