Breast Cancer Diagnosis And Treatment: Can Women Trust It?
The news wasn’t good this week for women concerned about breast cancer.
First came the story that some women were diagnosed with breast cancer, very early stage, had treatment –- including disfiguring surgery -– and then found out they never had cancer in the first place. The pathologist goofed, maybe even a second pathologist also misread the biopsies.
How does this happen? Not surprisingly it comes back to the clinical experience of the doctor. Properly diagnosing breast cancer, whether through radiology scans or pathology biopsies is not always easy. And in many communities the general radiologists and pathologists just don’t have enough specialized experience. This leads to mistakes, especially when the suggestions of possible cancer are subtle and minute.
I have interviewed many patients who were misdiagnosed. This comes as a shock to most of us. One would think a definitive diagnosis like cancer –- said with certainty by our local doctor would not be uttered unless they were sure. Of course, they were sure. It was just that they based this on bad information, or lack of experience or both. That’s the part they don’t tell you.
So second and THIRD opinions matter, certainly before you go “under the knife.” Seeing a sub-specialist at a major hospital should be part of your plan. Mistakes can still be made but it can lower your risk.
Story #2: The FDA is considering revoking the approval of a breakthrough cancer drug, Avastin, for breast cancer. This would be a turnaround from the accelerated approval given last year. New studies, done by the company (Roche) itself, and at variance with original data, show Avastin does not make much difference for this cancer. Data is stronger in other cancer areas where Avastin has also been approved, and it will still be a multi-billion dollar drug, just not so many billions overall.
I do think Roche should get some credit for not trying to hide or obscure the data. It was last week when GlaxoSmithKline looked terrible when there appeared to be a “smoking gun” internal email where a company doctor said unfavorable study data about the blockbuster diabetes drug Avandia should not see the light of day.
This just goes to show not everyone at a drug company wears a “black hat.” My experience is most people in that industry want to do what’s right for patients. But in the media the Avandia story looked awful. The Avastin story is a reversal of high hopes in breast cancer, but it least it shows a drug company and the FDA working together to do what’s evidence-based and right.
Story #3: There are reports a Duke University cancer researcher, in part investigating breast cancer and with a trial that was enrolling patients, has lied about his credentials. The trial has been stopped. He’s in hot water. And, appropriately, Duke has launched an investigation.
Let’s step back from the facts now to see the impression created from this:
- Some women have been harmed because they were mistakenly diagnosed with breast cancer.
- Some women with breast cancer had false hope that a new drug could help them live longer and live better.
- Some women enrolled in a breast cancer trial where the credibility of the researcher is suspect.
Wow! This looks really bad as I write this. Thank God these are taken from the headlines. As a news reporter I know this totally ignores the reality that most women ARE properly diagnosed, most women DO get effective treatment, and most researchers ARE ethical. It just doesn’t make the paper or the 11 o’clock news.
To set the record straight a bit, I am happy to tell you we’ll be producing an in-depth podcast series soon on advanced breast cancer with the most highly-respected guest experts. It’s our effort to help women have accurate information they can trust. Stay tuned for details.
Wishing you the best of health,
Andrew
*This blog post was originally published at Andrew's Blog*
Thanks Andrew.
You article hits the nail on the head.
As you know we here at CareToLive have been trying to obtain forced transparency from Dr. Richard Pazdur at the FDA. We filed a Freedom of Information Act (FOIA) request that was not timely answered by the CDER division of the FDA. We had to get a Court order to even get a response from CDER. The request sought the correspondence between Dr. Pazdur, Dr. Howard Scher and Dr. Maha Hussain regarding their attempt to sabotage the Provenge Advisory Committee (AC) panel and delay approval of that late stage prostate cancer treatment. They were successful in getting Provenge delayed for three years. Provenge was finally approved in April 2010, no thanks to Dr. Pazdur.
I believe that due to the light shined on Pazdur by CareToLive and others that his power has been somewhat marginalized, a good thing, but he is still there, and he should not be.
The funny thing about those documents we requested. By the time we finally got the response under Court order…..the documents had already been admittedly destroyed by Dr. Pazdur. Whether some recovery attempts can be made to still obtain those documents from Dr. Pazdur’s IP server or determine the timing of the destruction or if some documents can be otherwise recovered, is an issue still pending in the 6th Circuit Court of Appeals in Cincinnati in the case of CareToLive versus FDA. Additional detail on that can be found at http://www.caretolive.com.
Kerry M. Donahue