Impose Stricter Standards for FDA Cancer Treatment Approvals
- by: Care2
- recipient: Acting Commissioner of Food and Drugs Andrew C. von Eschenbach
The Food and Drug Administration has been rushing the review process for new cancer treatments - but speed should not come at the expense of patient safety!
For example, a recent New York Times article shows that breast cancer patients have a new radiation treatment option - one that has raised concerns in some medical circles that not enough data about this new treatment has been collected.
The FDA approved the MammoSite radiation treatment after a clinical trial that included only 25 women. The trial, done a mere six years ago, has not yet collected any data on long-term effects.
But even without documented success, the FDA approved MammoSite through an expedited review process. While it's important to embrace new medical discoveries, patients need to know that their treatment is experimental - and the FDA should first and foremost be concerned with patient safety! With a history of risky recalls, the FDA must reconsider their quick review process, and get the evidence first.
Despite the constant push for newer technologies and rush for new medicines, it's important to take the time to be sure they work. Tell the FDA to impose stricter vetting standards for cancer treatments.
Dear Commissioner von Eschenbach,
Please revamp the 510(k) system for regulating medical devices. The enforcement of a quick review for any new product deemed "substantially equivalent" to something already on the market is too lenient. The review process for patient treatments should be stricter, especially when it comes to anything as serious as cancer treatments.
Cancer treatments such as MammoSite have been FDA approved even though they have never been clinically proven to be successful. With a FDA approval, doctors have begun widely using the radiation treatment MammoSite, but adequate data about MammoSite has not been collected.
In the past, the FDA has been forced to recall many drugs and medical machines. Let's work to prevent these problematic treatments before the public uses them. There needs to be stricter regulation on the 510(k) law that regulates medical devices. And there must be sufficient data supporting the success of new or updated treatments.
[Your comment here]
It is your job to make all health treatment options safe and successful. Impose stricter vetting standards for cancer treatments.
