Drug Efficacy

On November 15, 2010, Scios, Inc. announced that the investigatory study of NATRECOR (ASCEND-HF trial)  demonstrated no statistically significant difference from placebo in the co-primary endpoints of dyspnea, measured at six and 24 hours, or in the composite of heart failure re-hospitalizations and death during the first 30 days following treatment. The results, presented the previous day at an  American Heart Association meeting showed that there was no significant difference for patients when they were experiencing the severe shortness of breath/drowning feeling (because their lungs were filled with fluid). While the study was favorable for Natrecor regarding safety concerns, the study reaffirms the current lawsuit against Scios in which our client is involved, that the off label marketing of Natrecor caused  a colossal waste of taxpayer funds at best.

In an article, the investigator for the Natrecor trial, Dr. Robert M. Califf, a Duke cardiologist, said that “once again, small studies give us the wrong answers”, referring to previous small studies which suggested that Natrecor was effective. [See article in The International Herald Tribune (November 17, 2010) “The uncertainties of clinical testing; The case of a heart drug shows how small studies can lead to misdirection.”]

The article pointed out that “Cardiologists have similar questions about the effectiveness of Zetia, an eight-year-old cholesterol drug that Dr. Califf is also studying and which has been beset by questions about whether it improves heart health.” Zetia is widely accepted as  modestly reducing bad cholesterol and the significantly reducing L.D.L., but the article asserts, studies so far have failed to demonstrate a cardiac benefit to the drugs. It would be a disservice to patients if this drug were marketed off-label as having a benefit in stroke or heart failure for instance,without FDA-approval. Other pharma companies have promoted cholesterol and blood pressure drugs as having a class effect, without the benefit of the indication.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.