"We are in the midst of an emerging crisis of antibiotic resistance for microbial pathogens in the United States and throughout the world." So starts a report entitled "The Epidemic of Antibiotic-Resistant Infections," published in Clinical Infectious Diseases, 2008:46, Jan. 15, page 155.
As of the year 2000, an estimated 70,000 deaths due to nosocomially acquired [hospital acquired] drug-resistant infections occurred per year in hospitals throughout the United States. Methicillin-resistant Staphylococcus aureus seriously sickened more than 94,000 Americans in 2005, and almost 19,000 died—more than the 17,000 Americans who died of AIDS-related causes.
As more bacteria become resistant to the old antibiotics, there are few new antibiotics being developed; most pharmaceutical companies have withdrawn from research for new antibiotics, in part because developing new antibiotics is a slow and costly process.
In Canada, the official body counters tell us that "an estimated 220,000 patients who walk through the doors of hospitals each year suffer the unintended and often devastating consequences of an infection," and they estimate that 8,000 to 12,000 Canadian patients die annually from such infections. That would mean that from Jan. 1, 2000, to April 30, 2008, there will have been 100,000 Canadian victims of superbug infections.
Against so much bad news, it would be logical that the news media would jump on any opportunity to publish any good news. So when the Bacteriophage 2008 meeting in Herefordshire was chosen for the release of initial Phase II clinical trial data of the first fully regulated clinical trial to test whether phage therapy really works as a treatment option for superbug infections, one would have expected a media flurry, especially since the trial reported positive results.
To date, only two such reports can be found when using Google-News with the string "phage therapy." The first report that this author found was entitled "Technology to defeat bacterial infections shows positive results" and was published by Disease/Infection News, 25-Feb.-2008 at http://www.news-medical.net/print_article.asp?id=35541
In this trial, U.K. company Biocontrol Ltd. used bacteriophages against Pseudomonas aeruginosa bacteria, which are often resistant to traditional antibiotics. Over a 17-month period a double-blind Phase II trial took place at a specialist London hospital, involving 24 patients with chronic ear infections that were not responding to antibiotic treatments.
Significant improvements amounting to a mean 50 percent reduction in symptoms were noted as compared to a mean of only 20 percent in the control group, which did not receive phages. "Originally designed for 40 patients, the trial was halted after 24, as patients seemed to be getting better. The company, working with the clinicians in charge, has decided to move on with bringing such a potentially important treatment to the market as quickly as possible. We are also planning to offer phage treatment to the patients who did not receive it during the trial," said Dr. Harper.
Biocontrol’s founder and Chief Scientific Officer, Dr. David Harper, stated: "This is the first fully-regulated double-blind clinical trial of the efficacy of a phage treatment, and is exactly what is needed to find out whether such a treatment really works. The fact that patients seem to have been getting better is the most exciting thing. Obviously a major part of the trial was monitoring to ensure that the treatments were safe—and there were no reportable safety events throughout, another very positive result."
Commenting on the successful outcome, the clinical director of the trials, Professor Tony Wright, consultant ENT surgeon at the Royal National Throat, Nose and Ear Hospital in London, said: "All the patients had long histories of ear problems that had failed to respond to all sorts of treatments including topical and oral antibiotics, and sometimes even surgery. Some had had problems for more than 40 years."
The company now plans to perform Phase III trials for the ear treatment as soon as possible and is looking at the future possibility of treating patients with cystic fibrosis where lung infections with Pseudomonas aeruginosa are common and dangerous.
Dr. Riedel, briedel@magma.ca, has a Ph.D. in Microbiology/Food Science. He has held various positions in research, industrial food science, and consumer product regulatory affairs in Canada.