Monday, February 23, 2009

FDA Approves a New Drug for the Annoyingly Cheerful

In one of the best satires I've seen since "That Was the Week That Was," the Women's Bioethics Blog called my attention to the FDA's approval of Pfizer's new drug, Despondex, to cure the Pollyannas among us.

I wonder how sales will compare to Viagra? Stay tuned...


Tuesday, February 17, 2009

Medpedia-A Valuable Health Wiki is Born

Eye on FDA, one of my favorite sources, brought Medpedia's launch to my attention today. Medpedia is a authoritative medical wiki powered by a collaboration between the medical schools of Harvard, Stanford, Michigan, and the University of California Berkely School of Public Health.

As a wiki, Medpedia will likely be fluid, uptodate, and interactive. It promises to provide a wealth of useful information about health and medically related topics. Check it out!


Farewell to Pharmalot...and Ed Silverman's Return

I was delighted to discover that Ed Silverman, of Pharmalot fame, will be blogging again. He can now be found occasionally on the InVivo blog.

It was nice, albeit sad, to see his farewell from Pharmalot.

While I wish I had discovered his blog earlier, I enjoyed reading it very much--his writing was often pointed, provocative, and perceptive...and always thought-provoking.

I wish Ed the best, and hope we'll hear from him regularly from his new home.


Sunday, February 15, 2009

Algeferin Conquers Antibiotic Resistant Bacteria: Too Good to be True?

An intriguing report from Science News touts the discovery of algeferin, a chemical from sponges. Algerferin said to be able to reprogram antibiotic resistant bacteria to make them susceptible to antibiotics again. Preliminary tests against "superbugs" (such as MRSA) and biofilms are said to be very promising.

The potential for treating biofilms, clusters of bacteria that cause serious nosocomial (hospital acquired) infections by adhering to foreign devices, such as IV catheters, is quite intriguing, as such infections are particularly difficult to treat. Especially notable was the statement that biofilms "dissolved when treated with fragments of the algeferin molecule. And new biofilms did not form."

Thus far, algeferin has been tested against a variety of resistant organisms, including MRSA and Pseudomonas. That the chemical can restore bacterial susceptibility to antibiotics would be terrific, if it holds up. We are running out of effective antibiotics, which are often irresponsibly squandered (from bacterial resistance partly due to inappropriate use of these drugs for viral illness and in “animal growth” feed, for example). Resistant bacteria are also spread throughout hospitals and nursing homes by ineffective or sometimes irrational infection control policies, as well as by carelessness and increasingly harried staff.

The promise of algeferin is quite exciting...but based on the history of antibiotic development, misuse, and resistance, I have little doubt the bacteria will outsmart algeferin--or its prescribers-- too.


Thursday, February 12, 2009

Nigerian Suit Against Pfizer Revived in U.S.

There is more to the Nigerian Trovan trial debate than has been mentioned in the Washington Post and similar articles. First, it is important to note that some illnesses are more common in developing countries—e.g., the “meningitis belt” in Africa, and thus studies need to be conducted in these settings, rather than in the U.S.

For example, in the 1996 meningococcal meningitis outbreak in Nigeria, ~12,000 children died over 6 months. (Three or four cases in a U.S. community would be considered an “outbreak.”) Pfizer’s study compared Ceftriaxone, given by intramuscular injections, to Trovafloxacin, given orally. Pfizer has been criticized regarding their informed consent documentation and IRB approval–not without justification, from the second-hand reports I’ve read, but…

What is rarely mentioned is that the survival rate was reportedly 94.4% Trovan vs. 93.8 Ceftriaxone. Nor is it widely known that Trovan was also being studied for meningitis in the US by well-respected pediatric infectious diseases specialists. The outcome in the US was clinical success in 79% of the Trovan patients vs. 81% in the Ceftriaxone group, and the longer-term sequelae showed no difference between the groups. (The Pediatric Infectious Disease Journal:Volume 21(1) January 2002, pp 14-22)

Nor is the value of developing oral treatments for infections generally discussed. Doctors Without Borders was treating other meningitis with intramuscular injections of Chloramphenicol—a wonderful drug that is now rarely used because it kills ~1/30,000 patients who receive it.

Multiple IM injections are painful, require sterile technique and more skilled health care workers than do oral medications. Supplies for injected drugs are more difficult and expensive to handle and administer, particularly in poorer, tropical countries.

Pfizer may not have not conducted this trial perfectly or with adequate informed consent—I don’t know, as I wasn’t there. But I do know the horror of watching young people die from meningococcal disease, and I do understand the rationale and goal of developing an oral drug for a devastating disease that episodically kills thousands of children. While I am often critical of this company, they deserve a fair trial.