For the last three years, Provenge itself has been the source of intense feuding between the FDA on the one side, and Dendreon investors and cancer patients on the other. An FDA advisory committee recommended approval of the vaccine in 2007 after a clinical trial had found that men who received Provenge lived about four months longer, on average, than those who received a placebo. But the agency balked at the recommendation and rejected Provenge, saying more data was needed.
In April 2009, Dendreon released the results of a larger trial, which supported the survival gains demonstrated in the first study. Those results are a positive sign, to be sure, but American Cancer Society Chief Medical Officer Otis W. Brawley told the WebMD news site that closer scrutiny of the trial was still needed. So approval of the drug by or before May 1 is anything but certain.
Roth’s article for the Post-Gazette does not dwell on Provenge, however. After introducing the prostate cancer drug at the top of the story, Roth immediately goes on to write, “Not far behind in the [approval] pipeline is Stimuvax, a vaccine being made by Merck in Germany that targets a cancer marker known as MUC1, which is present in many different tumors.” But it is not until twenty-one paragraphs and much digression later that he gets around to mentioning that, “the current testing has been suspended temporarily because one patient got encephalitis.” And Roth quickly dismisses that not insignificant concern with the declaration that, “the man whose company invented the vaccine is [nonetheless] encouraged by the progress it is has made.”
At any rate, Stimuvax and Provenge aren’t really the point of Roth’s story, and he uses them mainly to segue into local research by Dr. Olivera Finn at the University of Pittsburgh Medical Center (UPMC). Finn has developed a cancer treatment vaccine that also targets the MUC1 marker, but Roth provides almost no additional detail except to say that it has “been in development for several years [and] has shown limited success in advanced pancreatic cancer patients.”
It’s a shame that Roth’s reporting isn’t better, because he seems to be onto a perfectly decent story. In an interesting twist, Finn tells him that she believes her vaccine will work best in people who do not have cancer, so they’re now giving it patients who have precancerous polyps in their colons, to see if it prevents the onset of colorectal cancer. Alas, the only thing else Roth has to contribute is that Finn is “still a couple years away from being able to report results.”
He quickly moves on to another piece of UPMC research into a vaccine to treat gliomas, a type of brain tumor. Roth finally begins to provide some details here, reporting, “The trail will be small to start with, involving 18 patients with new cancers and nine with recurrent tumors.” He also explains how the vaccine is used with an adjuvant called Hiltonol that boosts the body’s immune response. The reader has no idea when the trial will begin, however. More importantly, the very early-stage research does nothing to support the article’s premise that “cancer vaccines may be on the verge of wider use.”
According to the National Cancer Institute’s searchable online database, there are currently sixty-nine Phase 3 clinical trials (the last phase of testing required before applying to the FDA for new drug approval) for cancer treatment vaccines happening in the United States. That doesn’t mean all of them will lead to the filing of an application, let alone new drugs, but if a reporter wants to assess progress in the field, the database is the place to start.