A team of U.S. clinicians has launched a first-of-its-kind observational study on how repurposed drugs with expired patents, such as ivermectin, might help in treating cancer.
The study, led by the Frontline COVID-19 Critical Care Alliance (FLCCC), began in February and is examining five-year survival rates for several types of cancers. Five hundred patients nationwide will be part of the study.
While conventional cancer treatments, such as chemotherapy and radiation, have succeeded in preventing more than 4 million deaths from cancer since 1991, FLCCC and its partners say emerging research demonstrates that more can be done using treatment regimens that include well-studied, repurposed drugs previously approved by the U.S. Food and Drug Administration (FDA).
“We hope that our research will bring attention to often overlooked methods for treating cancer as well as managing the symptoms of conventional treatment,” said Paul E. Marik, M.D., lead author of the study and chief scientific officer at the FLCCC, in a press release, on February 2. “Our research is intended to advance a better understanding of how cancer can be treated more efficiently, with fewer side effects, using well-studied approaches that include readily available medications … known to have minimal side effects.”
‘Having Remarkable Results’
Joining FLCCC in the study is Kathleen Ruddy, M.D., founder of the New Jersey-based practice Breast Health and Healing and a retired cancer surgeon.
“For over a year, I have been observing and advising 50 patients using a variety of repurposed treatments in the regimen, with some having remarkable results,” said Ruddy, in the FLCCC press release. “More is to be learned, so I am excited to partner with the FLCCC on this new research.”
Clinicians participating in the study acknowledge that by focusing on off-the-shelf drugs, they will run afoul of a medical establishment wed to traditional, very expensive cancer treatments.
Ruddy told Rescue with Michael Capuzzo on Substack that the study will be performed “methodically, impartially, and according to the highest standards of medical research.”
‘Registry Is a Terrific Idea’
The study could be a game changer says Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons.
“Chemotherapy is enormously expensive and highly toxic,” said Orient. “We really don’t know how much it prolongs life—if a drug [treatment] started early, the patient may live longer than expected, but one can’t be sure it is longer than the natural course.”
“There are many common drugs that seem to discourage cancers, at least in the laboratory (for example, digoxin, cimetidine, and doxycycline), and some impressive case reports with ivermectin,” said Orient. “But there are so many variables! The FLCCC idea of a registry is a terrific idea if a lot of honest data can be collected.”
‘Effective Drugs at Lower Prices’
Finding new uses for established drugs could lower the cost of treating cancer, says Gregg Girvan, a resident fellow at the Foundation for Research on Equal Opportunity.
“I support efforts to repurpose drugs that are proven to be effective in treating other diseases when such drugs are available as generics,” said Girvan. “We spend far too much for prescription drugs in the United States despite the fact that 90 percent of drugs dispensed here are generic, and any way to provide patients effective drugs at lower prices should be encouraged.”
Girvan says he is generally skeptical of observational studies.
“You need randomized controlled trials (RCT) to truly know whether these repurposed drugs are effective for conditions like cancer,” said Girvan. “They may very well be effective, and if so, this would be a huge victory not only because the treatments are effective but because they are inexpensive generics. But without RCTs, pronouncements on the effectiveness of repurposed drugs are simply conjecture.”
‘Patient Zero’
The prospect that affordable, readily available drugs could enable patients to survive even the deadliest of cancers was boosted by an experience Ruddy had with a Missouri man thought to be in the final stages of terminal cancer.
Fifty-five-year-old Paul Mann underwent 10 rounds of radiation and six of chemotherapy; then, he was told by his doctors that his only options were hospice and a minister. What had begun as prostate cancer quickly spread to other parts of his body. But a call from Ruddy in October 2022—four months after the cancer diagnosis—advising Mann to add ivermectin to his regimen, set forces in motion that have so far kept death at bay.
Mann still suffers from stage-4 cancer. But he has lived far longer than his doctors originally thought possible. Whether this is attributable to ivermectin or ivermectin in combination with other treatments is unclear.
Study Protocols
Patients in the FLCCC study will choose which FDA-approved drugs they want to use to treat their cancers, either along with or in place of traditional therapies.
Their progress will be monitored by the five clinics participating in the study, with anonymous patient information shared to see which treatments work. An ethics board will oversee the study to ensure patient safety, scientific rigor, independent statistical analysis, and peer review.
Among the conditions included in the study are breast, prostate, lung, and colorectal cancer.
Bonner Russell Cohen, Ph.D. (bcohen@nationalcenter.org) is a senior fellow at the National Center for Public Policy Research.
