WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).

Since being diagnosed with cancer a few months ago, I have been in an unwanted crash course on the patient perspective of everything I’ve been writing about biopharma for the past several years. It’s an eye-opener. Genetic testing, lack of research, unmet medical need, off-label use, drug shortages, adverse events, informed consent, clinical trial data that don’t represent real-world practice, drug-drug interactions, co-morbidities, labeling precautions, reimbursement, data-sharing vs. privacy issues. ... Up until now, these were all topics I wrote about or discussed with my colleagues during our news meetings. Now, they’re personal. They impact my daily life and could...

This isn’t exactly “funny” – nothing about cancer is – but during the American Society of Clinical Oncology (ASCO) meeting in Chicago I couldn’t help noticing the multitude of hand-sanitizer vending devices posted around McCormick Place. They seemed … odd there. “Scrub some alcohol gel on your hands, so you don’t catch cold! Oh, cancer? Not a lot we can do about that. We’re working on it.” So they are. The number of abstracts submitted and attendees set records this year. I’m not always assigned to cover ASCO, but I’ve done my share, and 2014’s meeting seemed uncommonly active. Of...

As the biggest names in cancer care gather at the American Society of Clinical Oncology's 50th annual meeting in Chicago, talk of the exorbitant cost of new cancer drugs is no doubt echoing in the halls of McCormick Place. Outrage is easy to summon. At nearly $10,000 a month the average cost for a branded oncology drug in the U.S. is double what it was a decade ago and a full fifth of annual median household income. Last year, 10 new oncology drugs joined the fray, helping drive global spending on cancer therapeutics to $91 billion. Newer targeted therapies accounted for nearly half the...

So urgently did I think I wanted to read Ben Goldacre’s Bad Pharma, that I ordered it from Amazon’s UK site last November, unwilling to wait for U.S. publication – which happened just as I reached the end, polishing off the book’s afterword, called “Better Data.” Goldacre, it turns out, is as much bothered by the secrecy of data as by its quality, and he has also set up an activist website, where the public can petition for “all [clinical] trials to be registered, for all summary results to be reported, and for full clinical study reports [CSRs] to be...

This week, researchers are presenting their latest and greatest at the annual meeting of the American Association of Cancer Research. The excitement of all those novel findings, though, received something of an advance puncturing last week by a commentary in Nature that reported a successful replication rate of just over 10 percent for roughly 50 landmark studies in cancer research. From my perspective, the study makes it even more difficult to figure out which of the many research findings that (briefly) come to my attention every day to write about, and which to ignore. Is this study more interesting, or...

Reading last weekend’s Wall Street Journal review of “The Forever Fix: Gene Therapy and the Boy Who Saved It” I was struck by an anecdote. It’s about an interview the reviewer did with a scientist who works in the field of neuroprostheses, and that scientist’s refusal to talk about the possible practical applications of his work, because, he said, “false hope is a sinful thing.” Really? To me, it seems like an inevitable part of hope is that it might be false. To illustrate, I don’t hope that my neighbors will be nice to me, because it’s a sure thing....

There’s a story, sometimes used to illustrate the difference between counseling and research psychology, about a man who pulls out one, then a second, then a third drowning person out of a river. When he sees a fourth, he starts walking upstream, prompting a bystander to ask “Aren’t you going to pull that one out, too?” Our hero answers “No, I’m going upstream to figure out what’s pushing all these people in.” In the Harry Potter books, Hogwarts headmaster Albus Dumbledore reacts the opposite way to a similar conflict as he comes to care for Harry Potter in ways that...

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,...