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

Posted on Apr 23, 2014

By Jake Bernstein, ProPublica

(Page 2)

The financial orphan problem points to a deeper issue with the way cancer drugs are developed. Pharmaceutical companies exist to make a profit and cannot be expected to cover many important areas of research that go unexplored, according toLarry Norton,deputy physician-in-chief for Breast Cancer Programs at New York’s Memorial Sloan Kettering Cancer Center.It’s a gap in the system.

“The biggest challenge we have today is not necessarily the science,” Norton says, “it’s creating a business model that makes sense.”

In 1993, about a year before Retsky received his colon cancer diagnosis, he attended a breast cancer conference in Europe. An Italian scientist named Romano Demicheli presented data from a decades-long study of breast cancer patients. Demicheli also had been a physicist but had switched to oncology research after his wife died of Hodgkin lymphoma in 1976. Like Retsky, Demicheli doubted the dominant view of how cancerous tumors grow.

In a landmark study from the 1960s, Anna Laird at the Argonne National Laboratory had published research showing that tumor growth was predictable. They started fast, grew at an almost exponential rate and then slowed, she wrote. More than 500 scientific papers cited Laird. Based in part on these studies, chemotherapy was developed to attack tumors aggressively in the early, high-growth stage when they presumably would be most vulnerable.

Retsky’s research into the data had convinced him there was nothing linear about tumor growth. Instead, he found that they developed erratically and sometimes experienced periods of dormancy before reawakening. Demicheli’s presentation offered another insight into the progression of tumors.

Data from the Istituto Nazionale dei Tumori in Milan, where Demicheli is a senior researcher, showed two distinct patterns of relapses in a sample of 1,173 Italian women who had undergone breast cancer surgery but no additional treatment. One grouping of relapses came around 18 months after surgery, and a second smaller one cropped up around 60 months.

At the same conference, Retsky saw a presentation by Michael Baum, a professor of surgery at the University College London who later became president of the British Oncological Association. Baum, looking at British databases, had come to a similar conclusion: There were two distinct waves of post-surgical breast cancer recurrence.

Over the next few years, the men met and began to kick around the obvious questions: What was causing that first wave of recurrence? And what did it mean for cancer treatment?

A third question hovered unspoken over the conversation: Who would pay to find out?

Creating an innovative new drug — including everything from early research to late stage trials — costs on average of $1.3 billion, according to the Tufts Center for the Study of Drug Development. The Food and Drug Administration has taken steps to speed up the process for approving cancer drugs. Nonetheless, drug development in the United States, even when it is funded in part by taxpayer dollars and encouraged by federal bureaucracies, isn’t geared toward inexpensive alternative treatments.

The bulk of funding the U.S. government dedicates to research on diseases like cancer goes to basic science and is funneled through the National Institutes of Health (NIH). It is research that might not be done but for taxpayer investment. Federal dollars helped produce such scientific breakthroughs as the human genome project.

The NIH, particularly through the National Cancer Institute, contributes to about 15 percent of all clinical trials related to cancer, but the amount it gives is in decline. In 2012, the NCI spent about $754 million on clinical trials, or nearly $100 million less than in 2008. To leverage the money, the NCI seldom funds an entire trial by itself. The agency instead partners with pharmaceutical companies or academic institutions, and the trials the NCI does support usually are for new drugs, not for repurposing existing ones. Of the 1,785 trials the agency is backing at the moment, only 134 are for the larger and costlier late-stage human trials known as phase III.

The NIH recognizes that commercial drug development has its limitations. For example, a new NIH program targets what researchers call the “Valley of Death.” This area encompasses the research that comes before key human studies, where treatments often languish for lack of funding or attention. One NIH pilot project encourages drug companies to let researchers study compounds that are under patent but are no longer being explored. In 2013, the NIH gave $12.7 million spread over nine projects. The effort does not focus on inexpensive alternatives that could be made available quickly, according to John McKew, acting scientific director for preclinical innovation at the NIH’s National Center for Advancing Translational Sciences.

Holmes, the Harvard professor, says money sets the agenda for cancer drug development. “What is scientific and sexy is driven by what can be monetized,” she says, “and that becomes the norm.”

In September 2013, the British Health Service launched a randomized aspirin trial, something Holmes has been struggling to do in the United States. The trial, which will run through 2025 and involve thousands of patients, looks at whether aspirin taken after standard curative treatments can improve survival and reduce the recurrence of breast, colorectal, prostate and gastro-esophageal cancers.

A summary of the trial explains that concerns about toxicity, particularly the risk of bleeding, are among the reasons aspirin hasn’t been studied for primary prevention of cancer.For patientswho have already been treated, however, the potential benefitas a follow-up therapymay outweighthe risks. If aspirin is shown to work, “it could be implemented in both resource rich and resource poor countries and would have a huge impact, improving cancer outcomes worldwide,” the summary says.


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