News Focus
News Focus
Replies to #82262 on Biotech Values
icon url

exwannabe

08/12/09 7:18 PM

#82267 RE: SimpleTruths #82262

Re: FDA co-authorship

"I think generally it's bad form to co-author with a single party in the midst of a drug review process involving that same single party and others."

If I understand you correctly, your don't object to the FDA working with scientists including some related to active sponsors, just individually doing such.

In that case -

Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System
Takashi Kei Kishimoto, Ph.D., Karthik Viswanathan, Ph.D., Tanmoy Ganguly, Ph.D., Subbiah Elankumaran, Ph.D., Sean Smith, B.S., Kevin Pelzer, Ph.D., Jonathan C. Lansing, Ph.D., Nammalwar Sriranganathan, Ph.D., Ganlin Zhao, M.D., Zoya Galcheva-Gargova, Ph.D., Ali Al-Hakim, Ph.D., Gregory Scott Bailey, B.S., Blair Fraser, Ph.D., Sucharita Roy, Ph.D., Thomas Rogers-Cotrone, M.S., Lucinda Buhse, Ph.D., Mark Whary, Ph.D., James Fox, Ph.D., Moheb Nasr, Ph.D., Gerald J. Dal Pan, M.D., Zachary Shriver, Ph.D., Robert S. Langer, Sc.D., Ganesh Venkataraman, Ph.D., K. Frank Austen, M.D., Janet Woodcock, M.D., and Ram Sasisekharan, Ph.D.

Source Information

From Momenta Pharmaceuticals (T.K.K., T.G., S.S., J.C.L., G.Z., Z.G.-G., G.S.B., S.R., Z.S., G.V.) and the Harvard–Massachusetts Institute of Technology Division of Health Sciences and Technology, Koch Institute for Integrative Cancer Research (K.V., Z.S., R.S.L., G.V., R.S.) — both in Cambridge, MA; Virginia–Maryland Regional College of Veterinary Medicine, Virginia Polytechnic Institute and State University, Blacksburg (S.E., K.P., N.S., T.R.-C.); the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD (A.A.-H., B.F., L.B., M.N., G.J.D.P., J.W.); the Massachusetts Institute of Technology, Cambridge, MA (M.W., J.F.), and Brigham and Women's Hospital and Harvard Medical School, Boston (K.F.A.).
icon url

DewDiligence

08/13/09 6:30 PM

#82339 RE: SimpleTruths #82262

This is a clueless blog on the contaminated heparin issue and the conflict-of-interest allegations by Amphastar directed at the FDA’s Janet Woodcock:

http://hcrenewal.blogspot.com/2009/08/who-investigated-case-of-deadly.html

FWIW