In 2004, FDA charged Ritchie Shoemaker, MD with seven violations and ordered him to stop injecting patients with a veterinary drug not licensed for human use.
FDA accused Shoemaker of administering and instructing 78 patients to self-administer the veterinary drug Staphage Lysate, which was not approved for human use. FDA also found:
- Shoemaker did not have a written protocol during the time of the study
- Shoemaker did not get the written informed consent from seven subjects
- Shoemaker failed to obtain IRB approval of the study, and
- Shoemaker failed to maintain records.
Medical board charges
On March 3, 2013, Maryland Board of Physicians found that Shoemaker “failed to meet the standard of care.” Shoemaker opted to stop practicing medicine. Accordingly, the Board ordered that, “should the physician resume the practice of medicine, the physician will be placed on Probation for a minimum of two years with terms and conditions.”
Quackwatch provides further discussion of the disciplinary proceedings against Shoemaker.
Strange beliefs about mold
Ritchie Shoemaker is known for inventing a diagnosis called Chronic Inflammatory Response Syndrome (CIRS). Shoemaker believes that CIRS is caused by “biotoxins,” which are often produced by mold. CIRS and “biotoxin illness” are not recognized by any mainstream medical organization.
The symptoms blamed on “mold illness” typically have nothing to do with mold. Unnecessary mold phobia is causing people to be afraid to enter houses and buildings.
According to Dr. Farah Khan, who wrote about beliefs in unsubstantiated mold diagnoses, “The scientific evidence to back up CIRS is severely lacking, and if you search for more details on specific clinical descriptors, you will end up empty-handed.”
Dr. Khan says not to worry about “toxic mold”:
Mold worries are generally unfounded. There is no evidence that otherwise healthy individuals have any reason to fear falling ill from building mold, mold inhalation, or any other type of exposure to so-called toxic mold (PDF). Even when it comes to water-damaged buildings, any medically proven associations with health issues have come with long-term occupational exposures—not household exposures.
Read more about dubious mold diagnoses on the LymeScience Coinfection page.
- 2004: Ritchie Shoemaker FDA warning letter
- 2013: Ritchie Shoemaker consent order following Medical Board charges
- Dr. Farah Khan: Why is the Internet so obsessed with “Toxic Mold”?
- ICTM: Methodological Errors in Dr. Shoemaker’s Published Paper
- MassTortDefense: State High Court Rejects Mold Expert Opinion