Cancer Vaccine Saves Lives, But FDA Doesn't Get The Message

Many lives have been saved by a personalized vaccine for non-Hodgkin's lymphoma cancer called BioVax ID. But inexcusably, BioVax ID, which has been around since 1994, remains unapproved by the Food and Drug Administration (FDA) and is unavailable to many patients.

The FDA says it denied a request for accelerated approval for this vaccine from the company, Biovest, because the vaccine does not fill an unmet need. But patients and patient advocates I've spoken to across the nation strongly disagree.

Betsy de Parry, a respected author, patient advocate, and non-Hodgkin's lymphoma survivor, recently wrote about the vaccine, pointing out that data from three clinical trials spanning 18 years shows the duration of response to this vaccine increased, on average, by more than a year, although some patients have remained disease free for many years. 

And importantly, she wrote, "not a single patient has experienced a serious, adverse vaccine-related event, which makes the vaccine less toxic than existing treatments."

Sounds to me like a legitimate reason for moving this product forward, and quickly. But the Feds turned down the company's request to apply for approval under the agency's Accelerated Approval Program, which allows for earlier approval of drugs that treat serious disease and fill an unmet need. The FDA told the company to conduct another clinical trial and then come back with another request for approval, which will take years. 

But now patient advocates and patients are speaking out. A petition urging the FDA to accelerate approval of BioVax ID is getting a lot of national attention. I urge readers of this blog to please sign the petition here. It will save lives.

There are many promising new cancer treatments that are delayed, often needlessly, by the FDA. Out of more than 900 new cancer drugs in the pipeline, the FDA did not approve a single new drug for lymphoma this year. The Feds are dropping the ball here and not serving the needs of cancer patients. 

Yes, part of the FDA's mandate is to keep us safe. But the other part of the FDA's charter is getting new, safe and effective drugs to the market. That means you and me. In its fears over the first, the FDA is lagging on the second part of its mission. 

The BioVax ID vaccine has 18 years of trial data and no serious vaccine-related adverse events. Considering its safety, there is absolutely no justifiable reason why the FDA can't grant this vaccine an application for accelerated approval so the company can go out and raise the millions of dollars it needs to do the phase III trial and get this approved. 

It's the right thing to do. And you can help get this moving. Let your voice be heard. Please join me in signing this petition for the benefit of cancer patients nationwide. And stay tuned to this blog for news about this vaccine and other very promising cancer treatments.