Healthy Skepticism Library item: 3582

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

J&J Says It Missed 2 Deaths in Drug Study
Associated Press 2006 Jan 3
http://biz.yahoo.com/ap/060103/j_j_heart_drug.html?.v=2

Notes:

Ralph Faggotter’s Comments:

The question is-

How did the researchers miss the fact that 2 of their closely monitored clients had died?

Was there no box marked ‘fatality’, to tick on the ADR report form?

Did they have trouble deciding whether the patients were clincially dead and therefore under Adverse Drug Reactions ticked the ‘miscellaneous’ box?

Was there a ‘typo’ or a computer virus?

What was the reason?

Surely it was not intentional fiddling of the figures??

Full text: AP J&J Says It Missed 2 Deaths in Drug Study Tuesday January 3, 6:35 pm ET Johnson & Johnson Says 2 More Patients Died After Taking Natrecor Drug Than Previously Reported

FREMONT, Calif. (AP) — Johnson & Johnson said Tuesday that two more patients died after taking its Natrecor heart drug in a study than the company had reported in October.

The pharmaceutical firm said it will reanalyze the data with this information to see if it makes a statistically significant difference in the therapy’s risk.

A Johnson & Johnson spokesman said the company did not receive reports of the two deaths in the original analysis.

The drug, made by J&J’s Scios unit and used to treat acute heart failure, has been approved since 2001. The Food and Drug Administration told Scios a year ago to further analyze study data for mortality data.

In October, the company published the results of the study and said it did not find a statistically significant difference for mortality between patients on Natrecor and those on a placebo.

Johnson & Johnson plans a final report by the end of March.