corner
Healthy Skepticism
Join us to help reduce harm from misleading health information.
Increase font size   Decrease font size   Print-friendly view   Print
Register Log in

Healthy Skepticism Library item: 14021

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

Richwine L.
FDA staff questions J&J antibiotic studies
Reuters 2008 Jul 14
http://www.reuters.com/article/healthNews/idUSWAT00977520080714?feedType=RSS&feedName=healthNews


Full text:

WASHINGTON (Reuters) – U.S. drug reviewers have “several major concerns” about effectiveness data supplied by Johnson & Johnson in a bid to win approval for expanded use of its Doribax antibiotic, according to documents released on Monday.

The Food and Drug Administration will ask an advisory panel that meets on Wednesday if the company has demonstrated that Doribax is safe and effective for hospital-acquired pneumonia and pneumonia associated with placement of a ventilator.

The injectable drug, known generically as doripenem, was approved in October 2007 for treating complicated urinary tract and abdominal infections.

Concerns include questions about the interpretation of chest X-rays in the pneumonia studies, a summary from the FDA staff said.

The agency’s review of company data from two studies “revealed several major concerns that limit the ability to evaluate the efficacy of doripenem,” the summary said.

The FDA plans to ask the advisory panel if Johnson & Johnsons’s study design is acceptable. The company aimed to show Doribax worked as well as other antibiotics. Some industry critics have questioned if that type of “non-inferiority” study is appropriate for judging antibiotics.

Johnson & Johnson, in a separate summary, said Doribax was effective against a broad range of bacteria and its side effects were similar to other widely used therapies.

(Reporting by Lisa Richwine; editing by Gerald E. McCormick and Dave Zimmerman)

 

  Healthy Skepticism on RSS   Healthy Skepticism on Facebook   Healthy Skepticism on Twitter

Please
Click to Register

(read more)

then
Click to Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts


If there is something you don't like, please tell us. If you like our work, please tell others.

Email a Friend








Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909