Gaming the system – why clinical trial results falter in the real world

@LizSzabo tweeted out this abstract from ASCO reporting that adverse events from Keytruda therapy were much higher than expected from clinical trial results. My retweet added a snarky remark about how pharma has gotten pretty good at picking its patients for trials and that this result should be no surprise at all. Let me expand Read More …

Phagoburn trial a phage therapy bust; or, why kinetics matter

A hundred years of phage therapy has produced many claims for its utility. Almost none of these claims are backed up by compelling evidence. By “compelling” I mean randomized controlled trials, rather than anecdotes or case studies. The problem with case studies in infectious diseases is that most patients get well on their own, even Read More …

Do researchers reject effective natural solutions because there is no profit if there is no pill?

Is there no pleasing you people? One of the many institutes comprising the National Institutes of Health is the National Center for Complementary and Integrative Health. Right there on its landing page you will see links for herbal therapies and yoga. There’s even an herb app you can download. The budget for the NCCIH is about Read More …

Getting it right about precision medicine

I’ve certainly ragged on sci journos before for superficial and misleading articles (see here and here), so it’s only fair to give a shout out to one who consistently works to get it it right. Liz Szabo’s article in today’s NYT on the overpromising and underdelivering of precision medicine is well worth a read. Here is Read More …

Another – and more convincing – phage therapy case study

As I’ve mentioned before, PT suffers from a lack of well-designed clinical trials. Part of this lack can be attributed to a mind-set of true-believerism among PT practitioners. Part of it can be attributed to a dearth of funding required to design and execute trials – not just for PT, but for anti-infective therapy in general. Read More …

Is the CLOVERS sepsis trial unethical?

Sepsis is the LaBrea Tar Pit of medicine. Many investigators go in; few come out, and those few are covered in ooze. As one review [1] notes: “More than 100 randomized clinical trials have tested the hypothesis that modulating the septic response to infection can improve survival. With one short-lived exception, none of these has resulted Read More …

The Future of Phage Therapy

Phage therapy has been wandering through the wilderness for many decades. It was intensively studied in the 1920’s but fell out of favor in the 1930’s due to inconsistent results and adverse effects. The introduction of sulfa drugs, and then penicillin, rendered it obsolete. But only for a while. Antibiotics were not the end of Read More …

Do Right to Try Laws allow reimbursement for experimental therapies?

The federal RTT legislation, which you can read here, makes no reference to payments of any kind, except to state that a referring physician can not be compensated directly by the drug manufacturer. Indirect is just fine. I wonder if drug companies could possibly figure out ways to pay doctors indirectly? [1] Payments are not forbidden, Read More …

Phage therapy science – still weak

If you’ve read very much of this blog, you know that my opinion of phage science in general is not very high. I haven’t been especially nice about expressing this opinion either, tossing out epithets like “weak”, “porcine” and “innumerate”. The latter, I suspect, riled up Stephanie Strathdee, one of the co-authors of the paper Read More …