Alicia Mundy of the Wall Street Journal reports:
“Federal officials Tuesday questioned companies that make six cancer drugs about their failure to complete follow-up studies they promised to conduct in exchange for accelerated approval.”
The story reminds readers why these promised follow-up studies are essential:
“The meeting took place in the shadow of a recent announcement by the FDA that it intends to revoke the accelerated approval of the blockbuster drug Avastin for use in treating breast cancer, a move that has jolted the industry and provoked outrage among many women across the country who have asked Congress to intervene.
The FDA said follow-up studies by Avastin maker Genentech, a unit of Roche Holding AG, failed to show that the drug significantly delays the spread of tumors in breast-cancer patients.”
Opinions on other issues in news, journals, PR, advertising, marketing
Take all the issues enmeshed in any cancer screening story and amplify it with the liquid biopsy issue. @AP's @CarlaKJohnson. did a solid job here. https://apnews.com/article/science-business-health-hodgkin-lymphoma-oregon-ca899bb9c4c7f1859d4e9ce16a1cf78d
Come on, NY Times; you must do better than this. Important research doesn’t need hype and the “breaking news” BS doesn’t help readers or patients. https://www.healthnewsreview.org/2022/03/nyt-proclaims-breaking-news/
Comments (2)
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Gregory D. Pawelski
February 9, 2011 at 2:30 pmAvastin combined with chemotherapy has improved the survival of some lung cancer patients. Avastin plus folfox has improved survival for some colon cancer patients. Avastin plus chemotherapy improves the survival of some breast cancer patients. The problem is that it doesn’t improve the survival of all cancer patients.
Roche has reported that women with ovarian cancer who were treated with Avastin in combination with chemotherapy followed by the continued use of single-agent Avastin demonstrated a significant improvement in progression-free survival. It’s unclear if Avastin can help increase the overall survival rate in this indication. Details of the study aren’t scheduled to be published until later in the year.
I remember a clinical oncologist involved with real-time studies under real-world conditions of drugs like Avastin, telling me when the FDA rules on the clinical utility of a drug, they use a broad-brush approach that looks at the global outcomes of all patients, determining whether these glacial trends reflect a true climate change.
The problem is that while Bethesda, Maryland may not be noticing significant changes in ocean levels, people who live on the Maldives are having a very different experience. As these scientists ponder the significance of Avastin, some cancer patients are missing out on a treatment that could quite possibly save their lives.
One breast cancer patient’s life saving therapy is another’s pulmonary embolism without clinical benefit. Until such time as cancer patients are selected for therapies predicated upon their own unique biology, we will confront one Avastin after another.
The solution to this problem is to investigate the VEGF targeting agents in each individual patient’s tissue culture, alone and in combination with other drugs, to gauge the likelihood that vascular targeting will favorably influence each patient’s outcome.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like