Doctors began speaking out against its frequent use, noting the lack of clinical trials to support outpatient treatment, and the drug's link to kidney problems and death.
Dr Milton Packer, a cardiologist who was chairman of the FDA advisory panel that approved Natrecor in 2001, said the drug was approved for a very limited group of patients. ''We said this is a drug that should be approved for patients who are short of breath at rest, who are hospitalized,'' said Dr Packer. He faulted the drug's FDA-approved label for not specifying that Natrecor was meant for hospital use, according to the May 17, 2005 New York Times.
"The fact that the FDA doesn't have much enforcement capability is a problem," Dr Sackner-Bernstein told Health Day Reporter. "Then again," he said, "where are the ethics? The people involved at Scios and others who knew about this data should be hanging their heads."
"What is wrong with everybody," Dr Sacker-Bernstein continued, "that you've got a drug that increases renal dysfunction and death, and costs 50 times as much as a regular treatment, and yet it's given to hundreds of thousands of people?"
Whether Natrecor has been illegally marketed for off-label use, is the subject of an investigation by the Justice Department. On July 20, 2005, Johnson & Johnson acknowledged receiving a subpoena from the US Attorney’s office in Boston, MA requesting documents related to the sales and marketing of Natrecor.
The entrance of Sullivan on the scene is no doubt unwelcome news for Johnson & Johnson. He earned a reputation as the pharmaceutical industry's adversary last year, when he secured a $430 million penalty against Warner-Lambert, with the help of an employee turned whistleblower, involving the off-label sale of Neurontin, a drug approved for epilepsy, but promoted for various other uses. By the time of the settlement, Pfizer had acquired Warner-Lambert.
As if the death rate with Natrecor listed above is not high enough, as it turns out, Johnson & Johnson did not report 2 patient deaths from the study, according to news reports in early January 2006. In addition, to not telling the FDA, the deaths were not included in the results of the study published in the October 2005 Journal of Emergency Medicine.
The October article reported five deaths of patients within 30 days of using Natrecor in hospital emergency rooms in 2001 and early 2002. Of the 237 patient covered in the study, the two new deaths raises the total number of Natrecor deaths to seven.
According to Matthew Herper, in Forbes.com, Johnson & Johnson hired private detectives from Pinkerton Consulting & Investigations, the famous gumshoe agency and the detectives found the two deaths that were not accounted for in the published study.
There seems to be a changing of the guard for Scois. After all the commotion over the hotline, since July 29, 2005, the new message recorded advises callers about the “lack of clinical data” regarding off-label use and warns that Scios “does not recommend Natrecor for this use.”
"As a result," the message states, "the support line does not maintain or provide information regarding the physician office or hospital infusion clinic use of Natrecor." The recording clearly seeks to discourage the off-label use of the drug.
And last but not least, on December 5, 2005, officials from the Centers for Medicare and Medicaid Services, announced that Medicare will no longer cover outpatient costs of Natrecor.
Injured parties seeking justice can find more information at: Lawyers and Settlements
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