To my friends, colleagues, and partners:
My hope is that the recent news reports have not caused any distraction from your vital patient safety initiatives. If they have, I am truly and very deeply sorry. Your job is tough enough as it is and you don't need the negative energy right now.
I was very surprised by the recent events and have had to take the time to collect documents and facts to respond to what has been reported in the press since I was never a part of the whistleblower lawsuit between DOJ and CareFusion. I was as surprised as all of you when the DOJ press release came out.
I want to reassure you that I am absolutely dedicated to bringing clarity to the issues at hand. In the meantime, I want to thank all of our collaborators and partners on projects for their tremendous outpouring of support and prayers and for their acknowledgment of our core values and body of our work.
In order to provide clarity as quickly as possible, my advisors have prepared the following statement. I will update you as soon as I can. Thank you for your prayers and support.
Charles Denham MD
It has been reported in the press that the settlement between the government and CareFusion involved a lawsuit in which it was alleged that CareFusion paid $11.6 million in improper kickbacks to Dr. Charles Denham, while Dr. Denham was serving as co-chair of the Safe Practices Committee at the National Quality Forum. These are blatantly false reports
The actual whistleblower complaint involved in the settlement between the government and CareFusion makes absolutely no mention of Dr. Denham whatsoever
and does not involve him or any of his companies in any way. The whistleblower action revolved around Carefusion's alleged off-label promotion of one of its products.
The government's own press release announcing the settlement apparently contributed to this confusion. In announcing the settlement, the government indicated that the settlement resolved two different sets of allegations.
The first set of allegations are those raised by the whistleblower complaint the knowing promotion of ChloraPrep for uses not approved by the FDA and the making of unsubstantiated representations about the appropriate uses of ChloraPrep. These are the allegations made by a whistle blower in the lawsuit that was resolved by the settlement that did not involve Dr. Denham in any way.
The second set of allegations mentioned in the government press release involves issues about payments made to Dr. Denham for formally contracted services including software development. These allegations are not the subject of any lawsuit.
It is important to note the following facts regarding the payments mentioned by the government. First, the payments were made pursuant to two different contracts. The two contracts were entered into between Dr. Denhams company, Health Care Concepts, Inc., and Cardinal Health entities. The first was signed on June 28, 2008 with an effective date of January 1, 2008 and pertained to development of performance models, care path development, and software addressing Surgical Site Infections, MRSA infections, Blood Stream Infections, Urinary Tract Infections, Ventilator Acquired Pneumonia, and Clostridium difficile infections. The second contract signed and effective on October 1, 2008 was a research grant agreement to address automated infection identification systems and measures. Neither contract mentions ChloraPrep or its ingredients. Both contracts pre-dated the existence of CareFusion as a company. Both of these contracts pre-dated the announcement of a study that was published in the New England Journal of Medicine that related to ChloraPrep and consideration of that study by the National Quality Forum. The first contract pre-dates the actions of the National Quality Forum by more than one year; the second contract pre-dates the actions of the National Quality Forum by more than ten months.
In seeking to resolve the whistleblower action, CareFusion reached an agreement with the government to resolve both the whistleblower lawsuit as well as an inquiry that has not resulted in the filing of a lawsuit.
Dr. Denham has cooperated in the past with the government's investigation of CareFusion and will continue to do so in the future.