Funding clinical trials to test new technology is always a struggle. The Focused Ultrasound Foundation in Charlottesville, Virginia, however, has a new strategy. It turned to best-selling author of legal thrillers and board member John Grisham to promote focused ultrasound. The result is a short book, The Tumor, that Grisham wrote and made available free to the public. The book has brought new light to the therapy but also criticism that it is more of an advertisement than a story.
Details about the therapy
Focused ultrasound is an “early-stage, non-invasive therapeutic technology with the potential to transform the treatment of many medical disorders by using ultrasonic energy to target tissue deep in the body without incisions or radiation,” the foundation says. “With focused ultrasound, an acoustic lens is used to concentrate multiple intersecting beams of ultrasound on a target deep in the body with extreme precision and accuracy. Depending on the design of the lens and the ultrasound parameters, the target can be as small as 1 x 1.5 mm or as large as 10 x 16 mm in diameter.” At this time, FDA has approved focused ultrasound technology for treating prostate disease, metastatic bone cancer, and uterine fibroids. FDA is considering the use of the therapy to treat essential tremor, as well.1
According to the foundation, focused ultrasound is now being studied or used to treat more than 50 medical conditions, including many cancers, neurological, and cardiovascular conditions. “The number of academic and clinical sites utilizing the technology continues to grow, with 274 research sites and 471 commercial treatment centers operating worldwide. In 2015, there was an increase of 26 clinical research sites (17% growth), 80 commercial sites (20% growth) and 19 technical research sites (25% growth).”2
Establishing a connection
Neal Kassell, professor of neurosurgery at the University of Virginia School of Medicine in Charlottesville, and the Focused Ultrasound Foundation’s founder and chairman, had become acquainted with Grisham through social circles in Charlottesville. Kassell asked Grisham to be on the foundation’s board in hopes that the author could raise awareness for the technology. Grisham has held this position for about 8 years. Grisham, however, was not interested in asking potential donors for cash to help with research and clinical trials. Instead, he decided to rely on his strengths and the loyal fan base established from his novels and write a book about the focused ultrasound technology.
His publishing team was not impressed. They worry about everything,” he told The Washington Post. “That’s their job. They were worried a lot of readers would feel like they were deceived, that it wasn’t good for my brand. They are very protective of me.”3
The resulting book is only 49 pages and includes illustrations, photographs, and brain scans. It can be downloaded through the foundation’s website or through Amazon. In The Tumor, Grisham tells the story of Paul, a 35-year-old banker with a wife and three children. Paul is diagnosed with a tumor in the right frontal lobe of his brain. In the first part of the book, Paul goes through conventional brain surgery, chemotherapy, and radiation. He dies nine months after his first surgery. In the alternative ending, Paul receives focused ultrasound treatment to kill the tumor. He goes through additional treatments twice when the tumor returns. Ultimately, the tumor still claims his life. In the meantime, however, he has lived years passed his diagnosis (7 by the time of his third surgery) and does not have to endure the side effects associated with chemotherapy and radiation. The remainder of The Tumor talks about the details of the focused ultrasound therapy, what it is being used for and its potential, and gives stories of several people who say they were helped by the therapy. STAT reports that the book has been downloaded more than 250,000 times.4
The reaction to The Tumor on Amazon has been mixed. More than 1200 reviewers have given it an average of 4.1 stars out of a scale of 5.5 Some readers laud Grisham for raising awareness for a technology that could save many lives. Other readers say they were very disappointed in the book, that it is an oversized pamphlet for the technology or a promo masquerading as a book. The Tumor is a book “written as a ploy to drive donations to a foundation,” says one reader.
Grisham knows the book was a risk but says that he will never regret writing it. “If it finds people to push our research to get us there, that’s a purposeful book.”6 On his website he says that this is “the most important book I have ever written” and through a letter asks visitors to read about the “new, revolutionary therapy that could one day save countless lives.”7 Grisham even made an appearance on CBS This Morning television show and did a TEDx talk with Kassell to promote the book. “The Tumor is the only book that I have written that has the potential of advancing some technology that will have a profound impact on the lives of millions of people.”6
The power of Grisham
But how much sway does a best-selling novelist have in trying to get more funding and attention for this technology? Quite a bit, some industry insiders say. Company executives and physicians interviewed by Reuters about the book say it could make a case for funding the technology. “Having a world-famous author talk about it can only help raise awareness,” Mark Carol, chief executive of Charlotte, North Carolina-based SonaCare Medical LLC, tells Reuters.8 SonaCare currently has three products in its line of high-intensity focused ultrasound (HIFU) technologies.
The Israeli HIFU company InSightec Ltd. tells Reuters that inquiries from patients about the company’s devices for the brain have increased “by a factor of a hundred” since the book’s release. BrainSonix Corp, based in Sherman Oaks, California, says that the book has led to increased inquiries from scientists and investors. The company is conducting early-stage research on brain mapping using low-intensity focused ultrasound pulsation.
It’s who you know
Grisham, however, is not the only advocate for focused ultrasound who has the potential to make noise about the technology. Kassell performed two brain surgeries on Vice President Joe Biden in the late 1980s. Now Kassell has Biden’s ear about the therapeutic power of focused ultrasound waves. A Biden spokeswoman confirms the Vice President attended a workshop sponsored by the foundation, and now Kassell has been named to a panel advising Biden on the National Cancer Moonshot Initiative.4
This initiative was first mentioned by President Barack Obama in his State of the Union address on January 12, 2016. The initiative was established to accelerate cancer research and to “make more therapies available to more patients, while also improving our ability to prevent cancer and detect it at an early stage.”9 Vice President Biden is leading the initiative. Kassell is one of two dozen cancer researchers and advocates advising Biden and developing recommendations for the National Institutes of Health. The Biden spokeswoman also says that focused ultrasound is one of the cutting-edge therapies being considered through the moonshot.4
A Long Road
Kassell, however, knows that the focused technology is still new and that years of ongoing clinical trials are needed to prove that the therapy is effective.6 Lack of data has already held the technology back as a treatment option. In July 2014, members of the Gastroenterology and Urology Panel of the FDA’s Medical Devices Advisory Committee voted not to recommend approval of a high-focus ultrasound technology to treat low-risk prostate cancer with less erectile dysfunction.10
The technology, Ablatherm Integrated Imaging High Intensity Focused Ultrasound (HIFU), is marketed in Europe by EDAP TMS, a French company operating in the United States as EDAP Technology. According to Medscape, the technology had been used in other countries at that time in 40,000 for 15 years. The committee, however, raised concern about lack of data available from the technology sponsor’s research results that were presented as part of its U.S. premarket approval application.10
Focused ultrasound has been more widely used in other parts of the world that the United States and Canada. Of the 471 commercial treatment sites by region, only 46 were in North America. Europe had 240 and Asia 172.2 China has driven most of the growth in using the treatment for uterine fibroids. In addition, the Korean Ministry of Food and Safety approved a device for the treatment of “movement, pain, and behavioral disorders including depression and obsessive-compulsive disorder.”2 The Focused Ultrasound Foundation says this is the first regulatory approval of a focused ultrasound system for psychiatric disorders.
Still, with this growth, the foundation estimates that only about 25,000 patients worldwide received treatment with focused ultrasound last year. The treatment also can be expensive; The Tumor estimates Paul’s cost for the treatment to be about $75,000. Many insurers consider focused ultrasound to be investigational and do not cover it, although some patients have successfully appealed for insurance payment. The therapy also carries some risk such as potential burns and healthy tissue damage.
Grisham’s book has definitely brought more of a public awareness to the use of focused ultrasound technologies. How much of an impact it will make is still to be determined. Kassell tells STAT that his goal for the foundation is that it will advance the technology so much that the foundation will no longer be needed to raise awareness and fund research. “When you go to these philanthropic meetings, they talk about how to make your organization sustainable,” he says. “We say, ‘Why don’t you talk about how to make it not sustainable?’”
Overview. Focused Ultrasound Foundation. Available at http://www.fusfoundation.org/
Focused Ultrasound: State of the Field 2016. Focused Ultrasound Foundation. Available at http://d3nqfeqdtaoni.
Rosenwald MS. John Grisham thinks his new book is so important he’s giving it away for free. The Washington Post. February 22, 2016. Available at https://www.washingtonpost.
Robbins R. How an obscure medical technology caught the eye of Joe Biden. And John Grisham. STAT April 8, 2016. Available at https://www.statnews.com/2016/
Customer reviews for The Tumor: A non-legal thriller. Amazon.com. Available at http://www.amazon.com/Tumor-
John Grisham seeks to advance disease fight with free book. CBS This Morning. April 20, 2016. Available athttp://www.cbs.com/shows/cbs_
Grisham J. Please read this letter. December 2, 2015. http://www.jgrisham.com/the-
Penumudi A. John Grisham turns spotlight on futuristic cancer treatment. Reuters. March 14, 2016 Available athttp://www.reuters.com/
National Cancer Moonshot Initiative. National Cancer Institute website. Available at http://www.cancer.gov/
Hand L. FDA panel pans HIFU for prostate cancer. Medscape Medical News: Oncology. Available athttp://www.medscape.com/
By Sue Coons, MA
This article was reprinted from Research Practitioner, Volume 17, Number 2, May-June 2016.