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This Researcher Devised His Own Low-Cost Cancer Treatment and Won

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Posted on Apr 23, 2014

By Jake Bernstein, ProPublica

(Page 5)

Ketorolac, a generic, is considered a relatively nontoxic drug. No single company owns it. The drug can cost as little as $5 a dose and might only be needed once before breast surgery. Retsky says a large-scale clinical trial in India could provide a better patient population for study and be done for as little as a few million dollars. But because it’s so cheap, ketorolac offers little in the way of profit incentive.

Retsky met with Brandy Heckman-Stoddard, program director for the Breast and Gynecologic Cancer Research Group for the National Cancer Institute. She had seen one of his presentations at a scientific conference and had been intrigued. “Retsky’s work is very provocative, but it is difficult to believe that such a short course of NSAIDs during surgery could have such a dramatic effect on recurrence,” she says.

Sloan-Kettering’s Norton is also aware of Forget’s paper on ketorolac, but he cautions that there are too many potential variables to draw definitive conclusions from a single retrospective study. Although it would not be his first choice for investigation, Norton believes the effects of ketorolac and other NSAIDs on breast cancer are worth exploring and are the types of research for which there is no business model. “Is it a meritorious hypothesis to test?” he says. “Yes, I think it is.”

Giving patients ketorolac before surgery is not without risk. In some cases it can lead to bleeding. It’s a legitimate issue, says Vikas Sukhatme, and one that surgeons would have to understand. Forget notes that an American Society of Anesthesiologists report approves of ketorolac use for pain prior to surgery.

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The National Cancer Institute estimates the current annual cost of breast cancer treatment in the United States at approximately $19 billion. If a single injection of a low-cost drug could save lives and put a dent in those costs, Vikas Sukhatme contends it’s worth investing in definitive research about its effectiveness and safety.

“Personally, should I have to choose an analgesic drug [to take before] breast cancer surgery, I would choose ketorolac,” Demicheli says. “But it is still a reasonable choice, not a scientifically based choice. To solve the question, at least one high-quality randomized clinical trial is needed.”

Widespread acceptance won’t come without trials that give doctors confidence. Guari Bhide, a community oncologist in the Boston area who has consulted with Global Cures and believes in its mission, says she would not prescribe ketorolac. “The surgeons would kill me,” she says. “Until someone tells them it is safe to take right before surgery, they are not going to do it.”

Forget is trying. After multiple rejections, he cobbled together enough money for a limited double-blind trial that began last year. One of the donors is a small Belgian-based foundation called The Anticancer Fund. Like Global Cures, the group has a dual mission of providing information on alternative cures and encouraging their study. It was started by a wealthy European real estate mogul, Luc Verelst, born from his experience trying to help his sister, who was suffering from uterine cancer.

Still, Forget’s study is not large enough to be dispositive. “It’s a pilot study,” says Retsky. “It’s not designed to confirm or deny [if the drug works].”

Money for trials won’t come easy. Retsky and his collaborators received a $600,000 multiyear research grant in 2009 from the Susan G. Komen breast cancer foundation. The group turned them down for money for a clinical trial of ketorolac a few years later. Only about 3 percent of Komen’s clinical trial investments go to large, final-phase studies, according to a foundation spokeswoman. Retsky’s group made it past the first round for funding from the Department of Defense, which has poured almost $3 billion into breast cancer research since 1992. Then money for the DOD program was sidelined by the sequestration budget cuts mandated by Congress, Retsky was told.

One of the drugs Global Cures highlights has found backing for a large-scale trial — though it took Pamela Goodwin, a Canadian oncologist, more than a dozen years of grant writing, meetings and clinical breakthroughs from other researchers to cobble together what will eventually be close to a $30 million study.

The widely used Type 2 diabetes drug metformin, a generic that has been associated with reduced breast cancer risk, is now the subject of a 3,500-patient trial involving 300 medical centers that Goodwin characterizes as bare-bones. The NCI is providing about half the funding, primarily for the U.S.-based centers, with contributions also coming from Canadian nonprofits and the British and Swiss governments.

Given recent cutbacks in U.S. government funding, both Goodwin and Dr. Lois Shepherd, senior investigator with the National Cancer Institute of Canada Clinical Trials Group, believe that what they’ve done probably can’t be replicated.

“If this trial had come forward for approval today, I’m not sure it would be approved — and it has nothing to do with the science,” says Shepherd.

The Sukhatmes hope that Global Cures can serve as a matchmaker between researchers who want to conduct trials on promising alternatives and family foundations or other donors that might fund them. The group also plans to use crowdsourcing to raise money from patients and others who may want to donate to trials.

Patient groups have become much more active in the way they approach the funding of trials, says Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, who believes that the research gap identified by Global Cures exists across multiple diseases.

“[Patients] have a vested interest in seeing the product developed,” he says. “Their goal is not to make a lot of money but to get [the drugs] out.”

The Sukhatmes hope to create a way for patients to document online the treatments they undergo. Harnessing the experience of cancer patients is also a goal of the American Society of Clinical Oncology, says Lichter, the group’s CEO. The society wants to compile and analyze patient experiences nationwide to give better guidance to patients and doctors. “There is a lot of knowledge out there, but it is locked up in individual files and records,” Lichter says.

Vikas Sukhatme says Retsky’s experience with his own cancer exemplifies what Global Cures hopes to do. Retsky was a patient who, after careful research, adopted a financial orphan treatment and documented the result. The toxicity of the treatment was not bad. Retsky went into it with eyes open and understood the tradeoffs. Although his case is far from conclusive, if there were 50 people like Retsky whose collective data showed strong results, it would build a foundation for further study, Sukhatme believes.

Although Retsky and his collaborators are frustrated about the lack of progress on ketorolac, they are optimistic that scientific advances under way, including the new targeted therapies, will eventually have a real impact. Still, they worry that these new therapies will only be available for the wealthy.

“It is so expensive it makes me weep,” says Baum, the British oncologist. “I weep for all the poor people in the world who will never have access to such treatment.”


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