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Dubious claim to novelty for “multi-room” proton center in Washington, D.C. — hub for medical arms race

Including a 10-Year System Maintenance Agreement

TOKYO–(BUSINESS WIRE)–Hitachi, Ltd. (TSE:6501, “Hitachi”) today announced that Johns Hopkins Medicine has selected Hitachi to provide its proton beam therapy (PBT) system at Sibley Memorial Hospital located in Washington, D.C. This collaboration, which includes a 10-year maintenance service, marks the first multi-room PBT application in the nation’s capital. This will be Hitachi’s fifth PBT system in North America.

The next-generation system “PROBEAT”, which comes with IMPT (Intensity Modulated Proton Therapy) and cone-beam CT, will have improved spot scanning capability in all 3 gantry-type treatment rooms, along with a fixed irradiation room dedicated to cancer research.

Toshiaki Higashihara, President & COO of Hitachi, Ltd. stated that, “We are greatly honored that Johns Hopkins selected Hitachi as their proton partner. As one of the leaders in cancer research and treatment, the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center’s philosophy of being at the leading edge of cancer treatment through research and development is very similar to our Social Innovation concept which supports a healthy and secure society through innovative technologies, systems, solutions and services. The proton center at Sibley Memorial Hospital will be an impressive demonstration of industry and academic medicine collaborating to bring a new technology and new cancer treatment modality to Washington, D.C. and the surrounding communities. Thus, we foresee an exciting, long term relationship that will benefit cancer patients and cancer research.”

In December 2007, Hitachi was the first company in the U.S. to clear FDA Premarket Notification Special 510(k) for the “PROBEAT” system with its spot scanning irradiation technology. Hitachi has delivered the first hospital based spot scanning system in May 2008 and has treated over 1,500 patients to date. The same spot scanning system has already been installed at Nagoya Proton Therapy Center and Hokkaido University in Japan. In fiscal year 2015 (ending March 2016), one of Hitachi’s new PBT site is planning to start treatment of patients. Hitachi has shown great stability in the proton market through continued investment in research and development, track record for high clinical availability of over 98%, along with a commitment to a long term partnership with all of its clients.

Given the growing demand for technical and clinical advancements in the treatment of cancer, interest in proton therapy is on the rise, with more and more hospitals and cancer treatment facilities venturing into this area. Hitachi will continue to globally expand the healthcare business where proton therapy is its flagship solution, and contribute to cancer treatment around the world.

Overview of Proton Beam Therapy

Proton Beam Therapy (PBT) is an advanced type of cancer radiotherapy. Protons from a hydrogen atom are extracted and accelerated up to 70% the speed of light. Its energy is concentrated directly on the tumor while avoiding radiation dose to the surrounding healthy tissues. PBT improves the quality of life for cancer patients since the patient experiences no pain during treatment and the procedure has very few side effects compared with that of traditional radiotherapy. In most cases, patients can continue with their normal daily activities while undergoing treatment. Because there are fewer side effects, PBT is expected to expand, especially for pediatric treatment.

Overview of Spot Scanning Technology

Unlike conventional scattering technology, spot scanning technology delivers narrow beams to the tumor and the complex tumor shape can be irradiated through repetitive beam delivery with quick position change. Spot scanning technology has been achieved by advancing the uniform quality beam extraction technology from the accelerator and beam control technology with high accuracy. Three primary benefits are: (1) more accurate irradiation which reduces the side effects to healthy tissues surrounding the tumor compared with irradiation from conventional double scattering irradiation; (2) patient-specific collimators and boluses become obsolete, shortening set up times for patients; and (3) high proton beam usage factor reducing unnecessary secondary radiation.

About Hitachi, Ltd.

Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, delivers innovations that answer society’s challenges with our talented team and proven experience in global markets. The company’s consolidated revenues for fiscal 2014 (ended March 31, 2015) totaled 9,761 billion yen ($81.3 billion). Hitachi is focusing more than ever on the Social Innovation Business, which includes power & infrastructure systems, information & telecommunication systems, construction machinery, high functional materials & components, automotive systems, healthcare and others. For more information on Hitachi, please visit the company’s website at http://www.hitachi.com.

Sibley Memorial Hospital Selects Hitachi for Their Proton Beam Therapy System in Washington D.C.

Our Review Summary

washingtonThis news release from Hitachi Ltd. describes the company’s sale of a proton beam therapy (PBT) system to Sibley Memorial Hospital in Washington, DC, a Johns Hopkins affiliate. PBT is a radiation treatment that uses protons instead of x-rays to treat cancer. At high energy, protons can destroy cancer cells. Hitachi’s claim that the sale of a PBT system to Sibley Hospital represents the first such system in the region must be challenged. The lack of information regarding the cost of the new installation, and negligible mention of the evidence and comparative advantages over existing radiation treatments also beg scrutiny.

As noted previously on HealthNewsReview.org, the capital region has become a hub in the “medical arms race,” with Sibley Memorial Hospital, MedStar Georgetown University Hospital, and the University of Maryland all investing hundreds of millions in PBT. So Hitachi’s attempt to distinguish this facility by calling it a “multi-room” center is spin. Each major facility can cost $150 to $200 million to build. Many experts question the necessity of these investments in technology that have not been proven to be better than existing and less expensive cancer therapies for the most common types of cancer, and that well-endowed medical institutions are getting a lop-sided share of high tech medical investment while hospitals that serve poorer patients are fighting to acquire standard technology.

 

Why This Matters

Proton beam therapy is a small but rapidly growing treatment model for some types of cancers. Protons are most commonly used to treat central nervous system (CNS) diseases, mainly because tumors in the brain and spinal cord tend to be situated close to very sensitive otherwise-healthy organs such as the eyes, brain-stem and optic chiasm where the optic nerves cross. Protons are often used for pediatric radiotherapy, since children are more likely to develop CNS tumors than any other kind of cancer. There has been an ongoing debate over recent years that the volume of these types of cancers doesn’t justify the cost of constructing new PBT systems in close proximity to each other. Many critics of the PBT building boom worry that institutions are promoting PBT treatment for cancers that could be treated more cost-effectively with existing therapies. This is especially true concerning prostate cancer, for which the medical community is adopting less aggressive treatment strategies. In addition, many health insurance companies say they won’t cover PBT for prostate cancer.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There is no discussion of costs. PBT typically costs twice as much as traditional radiotherapy so it’s definitely relevant to any announcement of a new facility. Several large insurance companies have ruled out coverage of PBT for prostate cancers. Any reliable reporter covering the business, healthcare or technology beats who writes a story based on this news release would be expected to ask about the costs so why not include at least some ballpark figures in the release?

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

PBT’s advantage over other types of radiation treatment is its ability to focus narrow beams of radiation onto tumors with reduced radiation spillover into other organs. That’s why it’s most beneficial for tumors of the CNS and in pediatric patients where oncologists strive to limit damage to surrounding tissues. Unfortunately, the news release didn’t specify which types of cancers are good targets for PBT. There’s the implication that PBT should be used in a wider number of cancers. However, there’s ongoing disagreement over the evidence that PBT has a significant advantage over other types of radiation treatments in prostate cancer, for which it is coming into wider use.

There are two reasons PBT is becoming a common treatment for prostate cancer. With protons, only two fields (or radiation passes) are needed to cover the prostate compared with 7 to 9 fields using photon intensity-modulated radiation therapy (IMRT) in order to achieve an effective dose. The other reason is that clinics that have an expensive proton facility need to justify having it, and prostate cancer is very common. There is no shortage of available patients.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The news release gives the briefest mention of side effects, but we’ll give it the benefit of the doubt. The statement that PBT brings “very few side effects” is understood to be true since proton beams deposit less radiation outside the tumor area than do photon-based treatments. However, there are few (if any) reports of clinical studies comparing the side effects of protons with those from photon treatments.

In addition, claiming that patients “experience no pain” when undergoing proton therapy is slightly misleading, since the same can be said for photon-based radiation therapy.

It’s important to point out that proton facilities don’t typically use an advanced imaging technique (such as CT or MR) to verify the patient’s position prior to administering radiation; whereas this is standard practice for photon IMRT techniques. That is troublesome, because the consequences of a geometric miss in proton therapy are expected to be greater than they would be for photon IMRT.

Does the news release commit disease-mongering?

Satisfactory

The release does not engage in disease-mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

It’s clear that the release comes from Hitachi, the PBT system manufacturer and marketer.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The news release does not mention the alternatives to PBT. The more widely available alternative to proton therapy is photon radiotherapy. The hardware costs for a proton center are approximately twice that of a photon facility.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Several PBT systems are under construction in Washington, DC, proper and within the region. The release did not establish when the newly announced facility is expected to be ready or when those other facilities will be ready. The availability of proton therapy outside the DC area is not discussed.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The release fails on two fronts here. First, the news release claims, “This collaboration, which includes a 10-year maintenance service, marks the first multi-room PBT application in the nation’s capital.” The fact that this a “multi-room” system is not a meaningful claim when there are other facilities under construction (at least one of which will apparently open before Sibley’s) nearby. Second, the release did not meet our standard for establishing the novelty of the technology. The release states, “The proton center at Sibley Memorial Hospital will be an impressive demonstration of industry and academic medicine collaborating to bring a new technology and new cancer treatment modality to Washington, D.C. and the surrounding communities.” But PBT is not a new cancer treatment modality, nor will it be new to Washington D.C. Proton therapy has been used clinically since the mid-1950s. The first proton accelerator (cyclotron) was developed in 1932 by E. O. Lawrence and S. Livingston, and Nobel physics laureate Robert Wilson proposed using it for radiation therapy in 1946. The “passive scattering” technique noted in the news release was used initially at the outset. The “spot scanning” technique described in the release was developed and first implemented in Switzerland during the 1990s. Most proton centers can accommodate treatment using both techniques.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

While there are several questionable claims made in the release, we think those have been addressed in other areas of the review. We didn’t see any examples of over-the-top language.

Total Score: 4 of 10 Satisfactory

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