Innovating an Ozone-Based Treatment for Sickle Cell Disease
James Caplan has discovered an alternative to expensive and limited gene therapies to better treat sickle cell disease.
His father, Ben Caplan, was an expert in the use of ozone to preserve trans-continental shipments of perishable fruits and vegetables. This familial understanding and expertise with oxygenation came back full circle years later when James Caplan met the esteemed terminal cancer specialist, Dr. Josef Issels, while living in Rottach-Egern, Bavaria.
Dr. Josef Issels worked with the concept of Nobel laureate (1931) Otto Warburg, whose research discovered that cancer would not travel to tissue that was properly oxygenated. Basically, spreading oxygen to these cancer-prone areas meant the disease would not continue to metastasize. Oxygen, the element needed to breathe, was a key to treating cancer metastasis.
Issels told him that hypoxia, when the body is deprived of oxygen, is the "fundamental cause of all degenerative disease." It was a quote that would resonate with Caplan years later when he would embark on his own journey of medical discovery.
In the 1980s, the course of his life and career would change. Caplan became CEO of his family’s company, Capp Inc., in 1987.
While at Capp Inc., he noticed that a Black woman, D.S.H., one of his dedicated employees, was often besieged by fatigue.
He learned she was living with sickle cell disease, which refers to a range of conditions where malformed, crescent-shaped red blood cells are unable to pass through the blood stream effectively. This causes blockages and interruptions in blood flow and early "deaths" of these cells that can lead to a range of serious health problems. Moreover, the disease disproportionately impacts Black people, often diagnosed at birth or early childhood, leading to a lifetime of poor health and chronic pain. The regular attacks D.S.H was experiencing are called Sickle Cell Crises.
At the time, one would assume there were effective therapies for the condition, or that it was widely researched and studied. The answer was decidedly "no." Misunderstood, the condition did not receive sufficient attention from the medical community at large.
Caplan began brainstorming something that had been in his mind from his father to Issels — the power of oxygen. He referenced Pathology for the Physician by William Boyd (p. 595): "In sickle cell disease sickling will occur at an oxygen partial pressure of 60mmHg., a tension corresponding to that of mixed venous blood. Persons with a lower percentage of hemoglobin S, such as is found in sickle-cell/hemoglobin C and sickle-cell/thalassemia disease, must have a lower oxygen tension of about 40mm before sickling appears."
Applying this understanding, he hypothesized that you could apply the oxygenation techniques Issels pioneered with cancer to treat Sickle Cell Disease.
Sickle cell crises take place when a person’s oxygen partial pressure dips below 44mmHg. For Caplan, the solution was to infuse 10mg of ozone in a mixture of ozone and oxygen that would be distributed by way of a rectal insufflation or by blood transfusion. This would replenish that person’s needed oxygen levels.
Caplan has been advocating for this technique to the American medical establishment for decades.
Caplan was invited to the National Institute of Health (NIH) in Bethesda, MD, where he demonstrated the in-vitro efficacy and safety in blood taken from Sickle Cell patients brought into the emergency rooms of NIH. This work was done in the 9th floor laboratory of building 10, under Dr. Allen Schechter’s supervision.
Initially, he brought his idea to the Children’s Hospital of Philadelphia. He told Philadelphia weekly paper Welcomat in 1995 that he "wanted them to join me and do the scientific research [on ozone therapy] in the United States."
While he sought approvals, his revolutionary approach to combatting a disease that affects around 100,000 Americans has run against a brick wall — a system that’s largely driven by the pharmaceutical industry that doesn’t necessarily view his treatment, which he said would most likely cost $100 to be administered at a doctor’s office, as necessarily lucrative.
At the time Dr. Alan Schechter, sickle cell specialist at the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, told Welcomat that "I reviewed the material Mr. Caplan sent me … I was very impressed, the data looked very nice."
Despite some of this early encouragement, nothing materialized at Children’s Hospital or in the U.S. in general. A presentation at a 1989 ozone conference in New York would prove more helpful. It was there that he saw a presentation by Drs. E. Espinosa, Manuel Gomez and Sylvia Menendez, all based in Cuba.
Caplan contacted Cuba and the Cubans were very interested in his hypothesis.
His work has been embraced there, during and since Fidel Castro’s tenure, the only country so far where the Caplan Method has completed successful human clinical trials. There are 5.5 million Blacks in Cuba where 2 to 3% suffer Sickle Cell issues.
"The National Center for Scientific Research (CNIC), specifically the Ozone Research Center, would like to recognize your contribution to our research in applying medical ozone/oxygen for the treatment of sickle cell anemia disease, and subsequently, to the use of ozone/oxygen for the prophylactic treatment of this disease," wrote Dr. Tomás Moreira Hernández, head of Ozone Research Center in Havana Cuba, following the successful trials.
On March 25th, 1992, Dr. Marlene Haffner, director of the United States FDA’s "Orphan drug development" awarded Caplan orphan drug status, good for $3-7 Million/year to replicate Caplan’s Cuban work in the U.S. When Caplan returned to the U.S. having completed successful human clinical trials to shorten the Sickle Cell crisis and to keep patients from going into crisis, Senator Tom Harkin, Iowa, and Congressman Berkeley Bedell, Iowa, invited Caplan to Harkins’ Senate Office to privately explain to them the Cuban work and ask them to replicate that human work in the USA, given that Caplan now had FDA Orphan Drug Designation. Senior executives of the U.S. National Institute of Health were present. "I feared Black Lives did not matter sufficiently in 1993 to capture the interest of the U.S. medical establishment," said Caplan.
So far, no American institution has accepted the funding and verified Caplan’s work.
"Subsequent clinical research in Cuba established the validity of your hypothesis. It was established that the application of ozone/oxygen during sickle cell crisis solved the crisis in half the time normally associated with such crisis," added Dr. Hernández in a 2005 letter. "Additionally, it was determined that bi-monthly application of ozone/oxygen acted as a prophylactic, assuring that patients so treated did not go into crisis while under treatment."
Essentially, when a patient would feel a crisis coming on, the ozone/oxygen treatment would prevent the crisis from occurring.
Despite this affirmation, he has yet to see this level of acceptance for his scientific work domestically.
Nevertheless, Caplan is open to the process of medically vetting his work in the U.S. In fact, he welcomes the chance to have his technique go through proper clinical trials.
Caplan learned from his London School of Economics (LSE) Professor Karl Popper that "no theory is valid unless it can be refuted,’ for it to be science it has to be able to be invalidated in order to pass the validation test," as he recounted to radio host Nick Taliaferro in a 2014 interview. "So, I have always had a strict sense of scientific method. Whether I applied it in a medical application or some other application it’s part of my thinking."
At the end of the day, it’s about making people’s lives easier. Sickle cell disease affects about 100,000 people in the U.S. alone. This work has value beyond this disease. Taking Issels’ lead, what other conditions could be helped by way of popularizing Caplan’s work?
"This has implications beyond sickle cell," he told Taliaferro.
One condition that he believes could benefit from this kind of oxygen therapy is diabetic gangrene. People with diabetes have a higher risk for developing gangrene, a condition when your body tissue dies. Gangrene mainly hits the extremities such as toes and fingers, occurring when blood flow to a part of the body is disturbed. In the case of "dry gangrene," the affected body part starts to turn a dark green or purplish hue, in some cases almost black. This is a result of oxygen not flowing properly to these areas. Caplan’s oxygen/ozone technique for sickle cell could be applied as an intervention during the early stages of this condition.