Pharmalot… Pharmalittle… The Weekend Nears
2 CommentsBy Ed Silverman // August 27th, 2010 // 6:59 am
And so another work week will soon draw to a close. Not a moment too soon, yes? After all those meetings and deadlines, a respite is in order. We plan on spending time with two of our short people, catching up on sundry chores and maybe a nice drive somewhere with the radio turned up. What about you? Perhaps a day at the beach or a night at the movies? Whatever you do, go safely. See you soon and please do stay in touch…
FDA Rejects Roche Breast Cancer Drug (Dow Jones)
Genzyme To Increase Shipments Of Rationed Drugs (Boston Globe)
Stallergenes Looks For US Marketing Partner (Bloomberg News)
Montana Governor Has New Plan For Cheaper Drugs (Associated Press)
FDA To Review Boehringer Ingelheim Blood Thinner Next Month (Reuters)
Clinical Trial Patients To Get Routine Care Covered (MSNBC)
Lilly Wins Added Halt Of Generic Strattera Sales (Reuters)
Cocktails Are Next For Cancer Drug Makers (Bloomberg News)
Drugmakers Drag Indian Prime Minister Into Patent Dispute (LiveMint)
Finnish Minister Defends Decision To Order Glaxo Flu Vaccine (Helsingin Sanomat)
Greg Pawelski
An article appearing in the Journal of Internal Medicine reported that until the Microvascular Viability Assay (MVA) test, there have been the lack of a relevant and practical system for testing anti-microvascular drugs against human tumors in which to discover synergistic anti-microvascular drug combinations.
According to Dr. Larry Weisenthal, MD, PhD., developer of the test, it works by measuring drug effects upon endothelial cells which make up blood vessels. The MVA test is both relevant and practical for use in discovering synergistic drug combinations and identifying which patients are most likely to benefit from which drug combinations.
Dr. Weisenthal says he would like to see the test become available to patients worldwide through service agreements with larger laboratory companies or with a biotechnology company which might develop a testing kit for sale to hospitals and laboratories. He also would like to license the test to pharmaceutical companies for use in new drug development.
It has been suggested perhaps Genentech/Roche should use assays like MVA to identify a potential target population of breast cancer patients that it thinks will benefit from the drug Avastin and then conduct a randomized clinical trial among this group. I couldn’t agree more!
Source: J Intern Med 264:275-287, September 2008
pharmavet
“Routine care” may actually be disadvantageous in the context of clinical trials for non-life-threatening illness. For instance, when we run inter-rater reliablility sessions for psychiatrists at investigator meetings for psychopharm trials, we instruct them to adhere strictly to the rating scales, such as oft-used HAM-D, and to specificall not offer any type of psychotherapy or supportive care. While this would be unacceptable in clinical practice, it increases a type of “placebo response” in a clinical trial, which may obscure the difference between active drug and the placebo arm of the trial.