|
|
By Elaine Schattner, MD, on November 18th, 2011 Today’s breaking breast cancer news is on Avastin. The FDA has just announced, formally, that it will rescind approval for the drug’s use in people with metastatic breast cancer. Commissioner Dr. Margaret Hamburg writes this her statement:
I know I speak on behalf of the many physicians that have been involved with this issue here at the Food and Drug Administration and elsewhere in saying that we encourage patients, and those who support them, to ask hard questions and demand explanations concerning the drugs that are recommended to treat serious illnesses.
On this much I agree with Dr. Hamburg – that patients and others, including doctors who prescribe treatments to patients with likely incurable illnesses, and all medical conditions, for that matter, should ask hard questions.
Others have already, immediately expressed that the FDA did the right thing. Because they think the FDA’s decision was rational, and it was. Likely
See more Final Word on Avastin, and Why We Need Better Physicians
By Elaine Schattner, MD, on August 8th, 2011 This afternoon Ed Silverman of Pharmalot reports that Roche has proposed a compromise to the FDA over Avastin’s use in women with metastatic breast cancer. The drug would be approved for use only in combination with paclitaxel (Taxol), for which the data are strongest, and with special warnings.
He writes:
The deal includes revised labeling in which Avastin would be recommended only for patients displaying “aggressive disease” and who have the fewest treatment options. Roche also suggests a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide.
This sounds like a reasonable solution. As I have considered elsewhere, the FDA commissioner’s decision is pending.
——
Related Posts:No Room For Emotion or Exceptions to the Rule (on Avastin)Final Word on Avastin, and Why We Need Better PhysiciansFDA Approves New Assay for Her2 in Breast CancerNew Data for Avastin (Bevacizumab)Questions for ASCO – on Tamoxifen, ATLAS and aTTom
By Elaine Schattner, MD, on July 7th, 2011 Yesterday’s post was not really about Avastin, but about medical journalism and how patients’ voices are handled by the media.
L. Husten, writing on a Forbes blog, cried that the press fawned, inappropriately, over patients’ words at the FDA hearing last week, and that led him to wonder why and if journalists should pay attention to what people with illness have to say, even if their words go against the prevailing medical wisdom.
There’s a fair amount of controversy on this. For sake of better discussion in the future, I think it best to break it up into 3 distinct but inter-related issues:
1. About health care journalism and patients’ voices:
A general problem I perceive (and part of why I started blogging) is how traditional medical journalists use patients’ stories to make a point. What some of my journalism professors tried to teach me, and most editors I’ve dealt
See more Patients’ Words, Unfiltered, Medical Journalism and Evidence
By Elaine Schattner, MD, on July 6th, 2011 A journalist who covers medical matters of the heart grabbed my attention on the Fourth of July. In The Voice of the Patient: Time To Bring Out the Muzzle?, Larry Husten at Forbes’ Cardiobrief blog, insinuates that the women who spoke at the FDA’s Avastin hearings are simpletons.
In his short strip, Husten skips the possibility that the testifying patients might understand science. He dismisses their familiarity with Avastin. He ignores their potential informational value as bona fide outliers, and jumps to this killer conclusion:
…When reporters cater to these type of people they not only foster fuzzy thinking, they encourage a mob mentality that tears down any semblance of rationality or any possibility of intelligent discourse.
Medicine, of course, is all about the patient. But that doesn’t mean that every patient is right, or deserves a public voice, or that uncritical journalists should assist them in metastasizing their views.
See more Vicious Verbiage Targets Cancer Patients’ Voices, at Cardiobrief
By Elaine Schattner, MD, on June 30th, 2011 
My cousin testified before the FDA oncology advisory board on Tuesday about her experience taking Avastin. This is a tragedy, to deny the only drug that is keeping a 51 year old woman alive.
image from p.3 of today’s NYTimes business section
You have to wonder, are the advisory panel members so rational in all their behavior and choices? Are they always so razor-like in their oncology decisions?
Unlikely.
These experts have an agenda, here: It’s to be perceived as scientists, even when their knowledge is imperfect and exceptions to the rule stand right in front of their eyes. But clinical medicine calls for flexibility, and tailoring of treatment to each case, and caring about each person, including those who fall at the tail, or in this case better end, of any Kaplan-Meier survival curve.
What would Larry Kramer do about this, I’ve been thinking:
See more No Room For Emotion or Exceptions to the Rule (on Avastin)
By Elaine Schattner, MD, on March 7th, 2011 A new report was published on-line this afternoon by the Journal of Clinical Oncology (JCO). It covers a Phase III (randomized) clinical trial of Avastin (Bevacizumab) in women with metastatic BC. Over 1200 patients were included in the analysis, all with Her2 negative disease.
The design of the randomized study protocol was a bit unusual, in that the treating physicians could choose among a few, standard chemo options to give their patients – the so-called “backbone” for treatment for each cohort in the trial, along with hormonal treatment and the study drug: Avastin or a placebo. Avastin is a monoclonal antibody that binds to the vascular endothelial growth factor (VEGF). It’s manufactured by Roche and is quite costly.
What the investigators report, now, is that women who received Avastin and any of the chemo regimens did better – in terms of what’s called progression free survival – than did those
See more New Data for Avastin (Bevacizumab)
|
|
connections…