FDA issues warning on fraudulent drug product, purporting to be the injectable cancer treatment

The Wall Street Journal (2/6, Weaver, Subscription Publication) reports that the FDA on Tuesday, issued a warning to healthcare providers that a fraudulent drug product, purporting to be the injectable cancer treatment, Altuzan (bevacizumab), is being distributed in the US. The agency said the Great Neck, New York-based drug wholesaler, Pharmalogical, shipped two batches of Altuzan, the Turkish brand name for Roche Holding's Avastin, to providers in the US; and internal laboratory tests so far, have confirmed that there is no active ingredient in at least one of the batches. The FDA said that although it is not aware of any patients having received the fraudulent product, the agency is still working to identify physicians who may have purchased the product from Pharmalogical, which also does business under the names Medical Device King and Taranis Medical. Meanwhile, the Journal says an attorney representing Pharmalogical is claiming the FDA's warning is inaccurate.

from DIA Daily

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

Subscribe to the DIA Daily.
View archives.
iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044
Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

Cancer Stem Cell Therapy: Real Or Just Hype?

Cancer Stem Cell Therapy: Real Or Just Hype?

from BIOtechNow by biotechnow@bio.org (Biotechnology Industry Organization)

Also known as tumor-initiating cells, cancer stem cells (CSC) have unique capability endemic to stem cells of self-renewal and differentiation, thereby causing tumor relapse and/or metastatis. While traditional cancer treatments focus on tumor shrinkage, it’s a distinct possibility that these agents do not effectively destroy all of the CSCs, causing the tumor to reappear.

The CSC theory is relatively new, so the treatment pipeline is still in its early stages.

Nathan Sadeghi-Nejad, a contributor to Forbes and TheStreet, moderated a panel of scientific experts at the forefront of developing treatments targeting CSCs during the 2012 BIO Investor Forum. In an article for Forbes, he provides his thoughts on how CSCs will affect oncology drug development:
“Bulls believe CSC-based therapies will revolutionize oncology drug development and dramatically improve patient outcomes. Bears argue the data are inconclusive or that expectations are unreasonably high. I think the truth lies somewhere in the middle…”

Study on targeted medicines shows different front of cancer battle - from NPR & NewsWorks

Dr. Yael Mosse at The Children's Hospital of Philadelphia with patient Mya who is being treated for neuroblastoma, and is also one of the patients in the Children's Oncology Group trial. Mya is 2 ½ years old. (Photo courtesy of the Children's Hospital of Philadelphia)

Dr. Yael Mosse at The Children's Hospital of Philadelphia with patient Mya who is being treated for neuroblastoma, and is also one of the patients in the Children's Oncology Group trial. Mya is 2 ½ years old. (Photo courtesy of the Children's Hospital of Philadelphia)

Researchers at the Children's Hospital of Philadelphia are reporting success with a new targeted anti-cancer therapy. Experts say the small study shows the ways doctors are fighting cancer differently.

For some conditions, there are now anti-cancer drugs that zero in on DNA-level miscues that allow cells to grow uncontrollably. A targeted medicine from drug-maker Pfizer Inc.has been successful in fighting a particular kind of adult lung cancer. Researchers thought the drug, called crizotinib, might also work in children against aggressive and uncommon types of lymphoma and neuroblastoma.
The researchers weren't sure what dose of medicine might work best, so as a first step, Children's Hospital oncologist Yael Mosse and the team signed up children in urgent need of another option.
"These are patients that, by the time the physician talks to them about a Phase 1 trial, it means there's no known cure. It means they've had all the best available treatment that we know of in the year 2012," Mosse said.
More »

What is the Value of Hope in Cancer Care? from HealthWorks Collective

We have all heard about cancer treatments that cost $100,000 or more, but only yield an average survival of a couple of months.  Is it worth it, you may have wondered, especially when there are so many other healthcare treatments that produce longer survivals and, perhaps, better quality of life?

The answer, of course, depends on who you are.  If you are the young, healthy Chief Medical Officer of a Health Plan, responsible for making decisions about how precious resources are spent, you may not value a very expensive cancer treatment with a short median survival time as highly as a less expensive treatment for another disease that has more impressive survival statistics.  However, if you are a young mother with metastatic breast cancer, it is likely that the value calculation is quite different.

If you now factor in the difference between the average survival and the spread of survival related to any given treatment, the calculation changes yet again.  As a patient with an advanced cancer, you may not want to spend $100,000 on a treatment if you knew for sure that your survival was only going to be three months, but what if there was a 15% chance that the same treatment could give you an additional twenty months of life?

In an effort to shed light on this issue, Darius Lakdawalla (Director of Research at the Leonard D. Schaeffer Center for Health Policy and Economics, USC) and colleagues designed an interesting study that was published in the April 2012 issue of Health Affairs.  The empirical question was “Do patients near the end of life like or dislike therapies with greater spread in survival outcomes?”  In other words, “would patients value the ‘hope’ of a large survival gain, independent of a therapy’s average gain.”

Darius Lakdawalla, Dir. Research, USC

To answer the question, the researchers presented different scenarios to cancer patients and asked them to choose which treatment they preferred and how much they would be willing to pay for it.  There were two scenarios, one that described options for treatment of metastatic breast cancer and the other treatment for advanced melanoma.  The treatments presented to the patients were “real-world” therapies based on the published clinical trials.

The metastatic breast cancer treatment “hopeful” scenario was based on a recent clinical trial in which combination therapy, ixabepilone (Ixempra) plus capecitabine (Xeloda), produced a median survival of 12.9 months, but a one in ten chance of living past forty-eight months.  It was compared to a hypothetical treatment that they were told would produce, with 100% certainty, an eighteen month survival – a “sure bet.”

for more, http://healthworkscollective.com/psalber/31660/what-value-hope-cancer-care?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+healthworkscollective_allposts+%28Healthworks+Collective%29