The evidence on evidence-based medicine speaks for itself. The approach is a vast improvement over everything that came before, and over current rival approaches. It’s often enough to give its practitioners a bit of hubris –which is why it’s so important to remember that evidence-based medicine can’t tell us everything we want to know, either. Possible pitfalls and limitations of evidence-based medicine were on stark display at a press conference of the American Society of Hematology last week, where not one, but two studies reported results that were the opposite of what one might suspect from looking at one part...

Teary-eyed mother to Michele Bachmann: Michele, my daughter took the HPV vaccine and spontaneously became mentally retarded. Michele Bachmann to the world: We must stop the use of these dangerous government-mandated vaccines which infringe on our liberties as Americans and cause mental retardation. Those aren’t direct quotes . . . but it was the gist of the exchange. I cringed when I read the news reports. It was more than a misstatement; it’s a potential death sentence for the untold number of girls and women who might be lead astray by this heinous misinformation put forth by GOP presidential hopeful,...

Back in 2008, biotech companies working on cancer vaccines were not exactly shouting it from the rooftops. In fact, most companies working in the space quietly began branding their drug candidates “immunotherapies” when they met with investors in an attempt to avoid connection with the spate of disappointing headlines such as the ones that ran in BioWorld Today – “Cell Genesys Crushed on Latest GVAX Failure,” “Favrille Sinks on Phase III Failure of Lead Cancer Drug” and “Genitope Dropping MyVax Work, Focusing Instead on Antibodies.” Then Dendreon Corp.’s Provenge (sipuleucel-T) hit its Phase III survival endpoints and won FDA approval...

Although they’re the stuff of science, statistics too often lack the power to move us. After all, they’re just numbers. So when companies like Dendreon Corp. and Seattle Genetics Inc. price their cancer treatments at nearly $100,000 or more, we may arch our eyebrows, but we don’t really think about the impact those prices will have on the individual faces and names behind the numbers. Instead, we wonder, as reported in BioWorld Today, why more patients don’t take advantage of promising drugs like Dendreon’s Provenge. Unlike statistics, faces and names have stories that can bring us to tears, that make...

This week’s report of remissions in three advanced leukemia patients after immunotherapy has generated quite a lot of excitement in the media – which, in turn, has led to some backlash amongst the twitterati and in the blogosphere, noting that two complete remissions plus a partial one don’t make a blockbuster. Or anything, really, that will be broadly useful within the next few years. Mainly, when I look at these controversies, I am grateful that I write for such a smart audience. If you are reading this blog, chances are that you work in the biopharmaceutical industry – and if...

This week’s report of remissions in three advanced leukemia patients after immunotherapy has generated quite a lot of excitement in the media – which, in turn, has led to some backlash amongst the twitterati and in the blogosphere, noting that two complete remissions plus a partial one don’t make a blockbuster. Or anything, really, that will be broadly useful within the next few years. Mainly, when I look at these controversies, I am grateful that I write for such a smart audience. If you are reading this blog, chances are that you work in the biopharmaceutical industry – and if...

As a biotech junkie, I’ll admit I was shocked to the core by Dendreon Corp.’s second-quarter admission that prostate cancer vaccine Provenge (Sipuleucel-T) is thus far not succeeding commercially. (See BioWorld’s news bulletin for details.) The most shocking part? Analyst and investor assumptions that Provenge’s poor performance is due not to reimbursement hurdles, as Dendreon claimed, but to an underlying lack of demand. Doctors and patients don’t want to use the product. Come again? Are you serious? Provenge is the first and only therapeutic cancer vaccine ever to gain FDA approval. I don’t have to tell anyone in the biotech...

The American Society of Clinical Oncology (ASCO) Annual Meeting kicked off the month of June as, arguably, the biggest event in the life sciences milieu, with 30,000-plus attendees and an inconsistent mélange of dispiriting and heartening news and data, while the Biotechnology Industry Organization (BIO) concluded the month with half that attendance, but with immeasurably more enthusiasm, excitement and expectations. Don't get me wrong — both events are excellently produced and loaded with germane details; however, when my restless mind sees differences, nothing is above satirizing. It's like Halloween for the health care industry vs. a birthday celebration for biotechnology....

BioWorld Today Contributing Writer   If you do a web search on the term “cancer cure,” you’ll get pages and pages of conspiracy theories, alternative medicine sites, and home-cooked “natural” remedies. Some of them, like baking soda and maple syrup (I kid you not) are probably harmless. Some of them cross the line into deception. But what you won’t find, as you click through pages and pages of snake oil, is a legitimate, mainstream medical site with information on curing cancer. The focus is on “controlling” the disease, “inducing” remission, maintaining “complete response,” increasing “overall survival,” and...

It looked Monday as if two of biotech’s long-suffering names might finally be biting the dust. Genta Inc. threw in the towel on beleaguered antisense drug Genasense (oblimersen sodium), after a final analysis of a Phase III melanoma trial – and a previous Phase III melanoma trial, and a Phase III chronic lymphocytic leukemia trial, and a Phase III multiple myeloma trial, and a melanoma approval bid, and a CLL approval bid, and a second CLL approval bid – failed. Meanwhile La Jolla Pharmaceutical Co., which already abandoned lupus drug Riquent (abetimus sodium) after years of mixed data and failed...