Newpharmablog. Health News

The decisions of microbe hunters about what to look for is not the only thing that could foster the second round of the germ theory. The infrastructure of scientific information gathering could be altered as well. In particular, anecdotal information could be used more effectively than it has in the past.The CDC and the FDA jointly administer a program called VAERS, which stands for Vaccine Adverse Event Reporting System. VAERS accepts reports from physicians, patients, and family members who have observed problems that might be attributable to the administration of vaccines. VAERS is a good idea—it gives the health sciences antennae to sense problems far earlier than if recognition depended on some insightful person somewhere mustering the time and effort to make a case for adverse effects of vaccines. With the current standard of vaccine safety, one physician may never witness enough adverse effects to get a sense of whether they are truly effects of the vaccine or simply coincidences, unimportant anecdotal observations. If the people receiving the flood of anecdotal information are astute and insightful, they will see associations that warrant detailed, carefully controlled studies.But VAERS does not go far enough. A parallel reporting system is needed for detection of positive effects of treatments on chronic diseases. Let’s call it EARS, for Effects of Antimicrobials Reporting System. I have received a great deal of mail from readers describing anecdotal associations between the use of a drug and improvement in a chronic disease. Many of these associations may be spurious, but one cannot tell one way or the other from anecdotal reports, just as one cannot tell whether an adverse event that occurred after a vaccine was an effect of the vaccine or a coincidence. If hundreds of thousands of such reports were accumulated in one database, the real effects of a drug could leave behind telltale statistical associations that could provide the basis for controlled epidemiological and clinical studies to determine whether, in fact, it does have a positive effect. If so, the logical next step would be to investigate whether the positive effect results from an antimicrobial action.If such a system had been put in place in the 1940s, antibiotic cures of ulcers could easily have become part of mainstream medical practice by 1955. Some important treatments of chronic disease have been recognized by just such anecdotal observations. The effectiveness of the antimalarial drug Plaquenil (hydroxy chloroquine sulfate) against the autoimmune disease lupus was revealed anecdotally when a lupus patient improved after taking Plaquenil prophylactically during a visit to a malaria-ridden area. The drug also works against rheumatoid arthritis. Does Plaquenil help ameliorate these conditions by an antimicrobial action? No one seems to know.Sometimes insight may come from the reciprocal association: a drug used for a chronic disease shows effectiveness against a known infectious disease, thus implicating infection in the chronic disease. Lithium treatment of schizophrenia and depression offers an illustration: when patients were treated with lithium, their herpes infections improved. This association is one more piece of evidence implicating viral causation of these mental illnesses.The historical record reveals that many such associations would probably be found. Any one of them might fail to turn up an infectious cause. The beneficial effects of Plaquenil on lupus and rheumatoid arthritis, for example, might result from the suppression of another pathogen that is triggering a malfunction in the immune system; or the beneficial effects may result from direct interference with an overreactive immune system. Even if the benefits uncovered by a surveillance program turn out not to result from an antimicrobial effect, the information on their effectiveness against chronic disease is useful. If they do have an antimicrobial effect, then they may point the way to the causative infectious agent. No one knows how many more bits of valuable anecdotal information are being lost because we do not have such a surveillance system in place. If peptic ulcers are any indication, the consequences might translate into additional decades of ineffective treatment and many thousands of people needlessly suffering and dying from chronic diseases with infectious causes.*46\225\2*

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. This entry was posted on Monday, April 25th, 2011 at 3:47 am and is filed under HIV. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.