Editorial

Caviar Among the Ruins

“Caviar among the ruins? Where is he going with that depressing metaphor?” I can palpably hear you wondering. Perhaps it conjures up an image of Nero fiddling while Rome burned. With a Stradivarius. But while that image might speak to the cluelessness and profligacy of government in the face of a collapsing health-care system, it’s not where I’m going. Or maybe it is reminiscent of Marie Antoinette’s notorious “Let them eat cake” remark. To be sure, if we did not eat so much cake, there might not even be a health-care crisis. But that’s not where I’m going either.

Where I am going is to the New England Journal of Medicine, January 21, 2010, where a 12-week double-blind trial was published demonstrating that treatment with monoclonal antibodies against Clostridium difficile toxins significantly reduced the recurrence rate of C. difficile infection. The recurrence rate was 25% in the placebo group as compared with 7% in the active-treatment group, a 72% decrease. One recurrence of C. difficile infection was prevented for every 5.6 patients treated. This study was accompanied by an editorial, which described the results as “impressive.”

C. difficile is a gram-positive bacterium that is a common cause of antibiotic-associated diarrhea and pseudomembranous colitis. It occurs most often in elderly frail hospitalized patients, but has also been seen in previously healthy individuals. It has become a major epidemic in recent years, affecting as many as 750,000 patients per year. C. difficile can be effectively treated with metronidazole or vancomycin, but 20% of patients suffer a recurrence, and many of those suffer multiple recurrences. Therefore, any treatment that can produce a 72% decrease in C. difficile recurrences is indeed impressive.

This is where the caviar analogy comes in, because monoclonal antibodies are massively expensive. For example, infliximab (Remicade), a monoclonal antibody used to treat Crohn’s disease, costs more than $2,200 per dose. Considering that the biological half-life of the anti–C. difficile monoclonal antibodies is only about 25 days and that the study lasted only 12 weeks, patients might need to be treated as frequently as every three months in order to maintain a protective antibody level. If every patient who is a candidate for this new drug actually receives it, the total cost would be many billions of dollars per year.

Superimposed on this all-too-familiar scenario of another unaffordable solution to a common medical problem, brought to you by some branch of the medical establishment (in this case the pharmaceutical industry), is previously published but little known research showing that several inexpensive probiotic agents such as Saccharomyces boulardii, S. cerevisiae (brewer’s or baker’s yeast), Lactobacillus acidophilus, and L. GG can reduce the incidence or the recurrence rate of C. difficile infection, in some studies by as much as 57% to 100%. I summarized this research in the July 2009 issue of the Townsend Letter. Based on the available evidence, probiotics show promise as an affordable solution to the C. difficile problem, and therefore represent a more attractive option than budget-busting monoclonal antibodies. Further studies are warranted to identify the most effective probiotic strains, the optimal dosages, and the types of patients who are most likely to benefit.

Unfortunately, those studies may never be done, because the pharmaceutical industry, which is the main source of research funding, is only interested in developing products that it can sell at monopoly prices. The pharmaceutical industry argues that it has to charge high prices because it is so expensive to develop new drugs. There is some truth to that argument, and the fault lies partly with the Food and Drug Administration, which has created a ridiculously expensive drug approval process. However, the pharmaceutical industry is not really unhappy about the FDA rules, because those rules create a rigged game that essentially shuts out safe, effective, and inexpensive natural remedies while leaving the drug companies as the only players. Merck & Co. did not complain when it paid Medarex (the developer of the C. difficile monoclonal antibodies) $60 million last April for the right to commercialize the drug. And Bristol-Myers Squibb Co. did not complain when it acquired Medarex in September for $2.4 billion. We must stop ceding the drug companies our awe, and stop buying into the notion that they are the only ones capable of finding effective treatments. And let us be clear about why the drug companies rarely develop inexpensive treatments anymore. It is not because they are unable to; it is because they do not want to.

As a corollary to the FDA regulations that make it almost impossible for natural remedies to be “approved,” the agency prohibits the dissemination of truthful scientific information regarding the efficacy of natural substances. Thus, we have a government agency and corporations working together, driving us to bankruptcy while failing to meet our needs. Kind of makes one want to have another Tea Party movement, but this time over green tea, hibiscus tea, licorice tea, and chamomile tea.

Alan R. Gaby, MD