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Final Word on Avastin, and Why We Need Better Physicians

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

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Patients’ Words, Unfiltered, Medical Journalism and Evidence

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

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Considering Evidence and a New ITP Drug

I’ve been won­dering, lately, why so many of the medical blogs cover the same topics, like last week’s lung cancer detection trial, which are often the exact same studies as are reported by con­ven­tional news outlets. I’ve been trying, here, to some­times con­sider new pub­lished articles that seem important to me but, for whatever reasons, don’t get so much attention.

Here’s one:

Yesterday’s NEJM includes an article Romi­plostim or Standard of Care in Patients with Immune Throm­bo­cy­topenia.* It’s about a drug, man­u­fac­tured and sold by Amgen as NPlate, that received FDA approval for treatment of chronic immune throm­bo­cy­topenia purpura (ITP) in August, 2008. Some con­sider ITP a rare disease, and

See more Con­sid­ering Evi­dence for a New Drug for Immune Throm­bo­cy­topenia Purpura

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News on Comparative Effectiveness Research

What is com­par­ative effec­tiveness research and why does it matter? The idea, basi­cally, is to inform medical deci­sions with rel­evant data derived from well-​​designed clinical trials. This sort of research will provide the foun­dation for evidence-​​based med­icine (EBM).

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More News, and Considerations, on OncotypeDx

This week I’ve been reading about new devel­op­ments in breast cancer (BC) pathology.

At one level, progress is remarkable. In the 20 years since I began my oncology fel­lowship, BC science has advanced to the point that doctors can dis­tin­guish among cancer sub­types and, in prin­ciple, stratify cases according to pat­terns of genes expressed within tumors. This sort of infor­mation – cancer cell pro­filing – might inform prog­nosis and influence treatment deci­sions that BC patients and their doctors, usually oncol­o­gists, make every day.

What dis­ap­points is the slow pace by which this knowledge infil­trates the clinic. In practice, women and their physi­cians rarely have much more infor­mation on BC pathology than what was available two decades ago — the tumor size in its largest dimension (crudely mea­sured in cen­timeters), whether it’s spread to the lymph nodes (and if so, how many nodes), the type of cancer (based on the cells’

See more More News, and Con­sid­er­a­tions, on OncotypeDx