Chapter 04: Planning the Proton Therapy Center

Authors

Amy Carpenter Hay, The University of Texas MD Anderson Cancer Center
Tacey A. Rosolowski PhD, The University of Texas MD Anderson Cancer Center

Files

Description

Ms. Hay explains the mission areas that Dr. James Cox [Oral History Interview] assigned her when she joined Radiation Oncology, then focuses on her work developing a Proton Therapy Center.

She tells the story of securing financial backing, eventually involving a boutique investment company, Sanders Morris Harris Group. She explains the advantages of securing local and “patient money” [meaning investors that could patiently wait for returns]. She tells about working with Hitachi o provide equipment.

Ms. Hay then sketches the history of the institution’s interest in proton therapy. She talks about the advantages of the LLC status of the Proton Therapy Center.

She explains why research demonstrating clinical efficiency of proton therapy was lacking. She talks about the use of proton therapy in treating different cancers and the effect on the quality of life.

Identifier

HayAC_01_20150204_C04

Publication Date

2-4-2015

City

Houston, Texas

Interview Session

Amy Carpenter Hay, Oral History Interview, February 04, 2015

Topics Covered

The University of Texas MD Anderson Cancer Center - Building the Institution; MD Anderson History; Devices, Drugs, Procedures; The Business of MD Anderson; Institutional Mission and Values; The Administrator; Patients, Treatment, Survivors; Beyond the Institution; The Institution and Finances; Research, Care, and Education; Technology and R&D

Transcript

Planning the Proton Therapy Center

Amy Carpenter Hay:

So as I started to complete my administrative fellowship in that ’99 timeframe, another large opportunity came up, and it could have been just good timing, and it could have been happenstance. But at the time, I was introduced to two men that both became mentors for me. One was a Mr. Mitch Latinkic, and one was a Dr. James Cox. And at the time, Dr. Cox was pursuing a Proton Therapy Center here and it was 1999, and protons were fairly new. They really only existed at Loma Linda and at Harvard. Loma Linda had opened their center in the ’90s. And so, it was really the next—the next evolution of radiation oncology. Dr. Cox had been discussing this with Dr. Mendelsohn, and really felt that, instructionally, we needed to be on the cutting edge. This has to be part of our Radiation Oncology Department. It has to be part of one of our modalities of care for patients that would benefit from it. So, I got very interested. The whole technology kind of intrigued me. The fact that there weren’t very many centers intrigued me. And so, during the latter days of my fellowship, I started engaging with Dr. Cox and with Mitch and others in the division, almost to the point of I used to tell people I’ve made best friends with the secretaries, and I’m gonna go hang out with them until they can see me and talk about protons. [laughter] And I continued to do that, and as my fellowship came to an end, Dr. Cox invited me to join the Division of Radiation Oncology. And right at the time, he kind of gave me three jobs. The first job was, we have to get a Proton Therapy Center. “Dr. Mendelsohn has told us that he supports us. He’s going to ensure it happens, but we can’t use any MD Anderson capital. So, therein lies the problem. So that’s your dilemma. Go fix it.” And the second dilemma is, “Oh, by the way there is no standard reimbursement rate for protons with CMS [Centers for Medicare & Medicaid Services] yet. We need that in order to go out and raise the debt and equity.” The third challenge he gave me is, “Oh, by the way, there’s this small little clinic in Bellaire that I’ve got my eye on, and that I would really like to see if we can extend radiation oncology to the community. Look into it. See what you think. But I’d really like you to see if this is something that makes sense for us.” So I took that—those roles and started running as fast as I could. We were able, through a lot of people’s support across the United States—we formed a consortium around proton therapy. It’s still in existence today. It’s called the Proton Therapy Consortium. And now it’s—it includes more than a dozen centers and centers up and coming. But at the time, it was very small. It was MD Anderson, Mass. General [Massachusetts General Hospital, MGH], Loma Linda—very small. And we banded together, and ultimately were able to get rates for proton therapy. So that was the first key. That happened, gosh right around—for—in the 2001, ’02 area. At the same time, while we were doing that, I went out with a group of people—Mr. Latinkic, and Dr. Cox, and others—and we started looking for someone that was interested in partnering with us around protons—a general partner who could help us get the funding and, ultimately, contract and do the work. It was a fascinating exercise, and it was something that I had absolutely no exposure to before. So, we found ourselves, you know, in meetings with investment bankers and large banking branches, pitching protons, talking about the science, talking about what we could do for patients, literally trying to raise debt and equity. And this was all starting to happen right around September 11th. And we thought we had it almost done. And September 11th hit. And the markets froze. And we all had to kind of take a deep breath. At the same time, we thought we had already agreed on a vendor for protons. We’d been engaged with Tenet Health Care, and they were gonna bring Ion Beam Applications [IBA] to the table as the provider of the equipment. And right before September 11th, Tenet hit Allegheny in California. And they were told that they had to spend millions and millions of dollars re—retrofitting all of their hospitals in California. So, all of a sudden, they turned around to us and said, “Oh, by the way, all those funds we were gonna do on protons including not you, but everything across the United States—we’ve got to—we’ve got to use that to retrofit all of our hospitals in California. So, we’re out.” So, all of a sudden, we have—we have no Tenet. We have no manufacturer, because IBA was with them. September 11th hit, and all the markets froze. So, we took a deep breath and we reevaluated where we were. And we pulled together the two parties—the Styles Group—Styles Company, as the developer of the project. We realized that we needed help developing the project, someone day-to-day to be responsible for the construction. And we also pulled in at the time, it was a small boutique investment-banking firm called Sanders Morris Harris. They were a small boutique here in Houston, and they had clients that—what I refer to as patient money. They had the firefighter’s union. They had the police officer union. They had local clients with funds available to put up debt and equity, but patient enough to get a return on a project that’s a multi-, multiyear project. And so, instead of, you know, finding ourselves in New York talking to Bank of America or Goldman Sachs, we found ourselves in Houston talking to the firefighters and talking to the police officers. And that message was very different because, for example, with firefighters, we could tell them a message that meant something to them. A lot of firefighters have lung cancer. Protons is an unbelievably important tool in the treatment of lung cancer. So being able to talk to people locally where it would be in their backyard, and people within their pension fund could access it and hopefully gain value from it—that was a very different discussion. So, while the aftermath of September 11th was still occurring in the markets, we were able to lockdown 30 million in equity, and the remainder of the 125 million in debt, and launch our proton-therapy journey. Which has been—definitely been a journey. And it takes, as you may know—protons takes approximately three years to construct and equip and commission. So, this is a long-term investment. This center also sits, I should say, on our South Campus, so it was one of the original tenants there. So that, in additional to the fact that we had to, then, go out and find a new vendor of equipment. At the time, there really were not a lot of options out there. IBA—Ion Beam Applications—they had done the MGH facility, and they were, at the time, a bit tired. You know, MGH had been complicated, and had taken a long time.

Tacey Ann Rosolowski, PhD:

And that stands for?

Amy Carpenter Hay:

I’m sorry—Massachusetts General Hospital.

Tacey Ann Rosolowski, PhD:

Oh, okay.

Amy Carpenter Hay:

And so, we started looking around for other opportunities. It’s always interesting how small the world is, but Dr. Cox’s wife is a Dr. Ritsuko Komaki, a famous lung, radiation oncologist, internationally renowned. And she grew up in Japan. Japan has been involved in proton therapy for much longer than we have in the States. They have facilities over there, and Hitachi is a leader in protons there, but also in their engineering. And so, as we started looking for vendors and started requesting proposals, Dr. Komaki introduced us to Hitachi. And we started getting very interested, and our physics staff involved with Hitachi and what they were doing, and their future evolution of protons. We ultimately decided to go with Hitachi, and I think a lot of that was due to the fact that the strength they brought in just pure engineering was something that is unfound. You know, even today our Proton Therapy Center has ninety-eight percent uptime. That’s unheard of anywhere. Just the technology is so sound in its design and construction, it’s really almost stunning. It’s this perfect well-oiled machine just geared to patients.

Tacey Ann Rosolowski, PhD:

Can I interrupt you just for one sec? I want to just pa— [The recorder is paused]

Tacey Ann Rosolowski, PhD:

—to hear those things. [laughs] All right.

Amy Carpenter Hay:

Okay.

Tacey Ann Rosolowski, PhD:

We’re going again.

Amy Carpenter Hay:

Great, thank you. So, as we started our journey with Hitachi, with the Styles Company, with Sanders Morris Harris and our funding partners, we just had this great opportunity of pulling together leaders across not only MD Anderson, but across the world, to really make this happen.

Tacey Ann Rosolowski, PhD:

Was the decision to create this Proton Therapy Center controversial within the institution?

Amy Carpenter Hay:

It’s interesting, and this is actually a fantastic story from a historical perspective. Before Dr. Cox had decided that he was onboard with proton therapy, about four years before the University of Texas Board of Regents had been talking about protons, and had gone to Dr. Cox and said, “What do you think about this?” And he had provided them a written response. And the mem—it was a memo to the Board of Regents, and it said, “I don’t believe this is going to be the next modality of radiation oncology.” Four years later, with everything that he’d learned and everything he was exposed to, he was a full believer. And we oftentimes kid him about that, because we went to the Board of Regents three times before we had the proton-therapy transaction completed, for various reason. You know, the wheels fell off; Tenet fell away; our partners changed; the markets froze. But that perseverance of making sure that we got protons, I think, was almost contagious. So, while it was a large investment for a single modality of care at MD Anderson, the way that we accomplished it, while at the time it felt a bit difficult and uncomfortable, the business transaction behind it allowed MD Anderson to not put that capital investment into protons. Our investment, quite frankly, is the land that it sits on. That two and a half acres of land over there was our investment. The rest of it was through a triple LP [limited partnership] with the Styles Company and Sanders Morris Harris and MD Anderson. At the time, for our investment, we got a percentage of ownership of the proton triple LC—triple LP, excuse me. And we also retained the professional revenue. So, because it was our doctors and our staff, we got the professional side. I think what that allowed is, it allowed us to have protons but somebody else paid for it through a series of seven contracts, which you can only imagine the complexity of negotiating those. But those seven contracts guide our relationship. There’s a contract that says that MD Anderson will provide all medical direction. So, we have full clinical control. There’s a contract that says MD Anderson will provide all of the staffing, all of the physics. So, the way that we put this transaction together gave MD Anderson 100 percent clinical control including all staffing, but it had somebody else paying for it. And so, I think, for that reason, there wasn’t a lot of controversy on doing protons, because we could say we’re not using institutional resources other than land. We’re leveraging institutional resources. We’re bringing something to MD Anderson that perhaps we wouldn’t have the ability to get alone. A hundred and twenty-five million, at that time, was a significant dedication of capital when Dr. Mendelsohn was—rightly so—building buildings and expanding the research program. So, the way that we formulated the transaction allowed MD Anderson to have protons. And, as a good partner, fully participate and clinically lead, but let someone else handle the business, debt and equity side.

Tacey Ann Rosolowski, PhD:

What was it, just going back a little bit in the story—what was it that convinced Dr. Cox? I mean, you said he told the Board of Regents no, not the future of radiation oncology. What, what turned him around?

Amy Carpenter Hay:

You know, I think it was a couple of things. The gentleman I mentioned earlier, Mitch Latinkic—Dr. Cox had recruited him from Loma Linda. Loma Linda was the first clinically based high-throughput Proton Therapy Center. Mitch had built and run that Proton Therapy Center. So, he came here with a rich understanding of the technology, and also with clinical connections back to Loma Linda that were starting to produce research. And what Dr. Cox was looking for, as with most clinicians, was, “Show me the research behind it. Show me the clinical efficacy. If you can show me that, then I will be a believer if it will help my patients.” And so, until, you know, really in the last two decades, there wasn’t a lot of research—published research on protons. You know, in my opinion, a lot of that is because the field of radiation oncology in the past didn’t really lend itself to that. Now I often remind people of this: the field of radiation oncology has really been dominated by the introduction of new technology and, quite frankly, being able to prove, as we treat patients, its higher efficacy. Not necessarily doing the research trials, publishing, and then widely expanding. And a great example of that is IMRT, or intensity-modulated radiation therapy. IMRT is the highest level of radiation you can do with conventional photons. But when that technology came out, it was very clear we could do a dose histogram. We could write a treatment plan and see it on the computer. We knew it was better by seeing it. So, you won’t find a lot of head-to-head trials of conventional photons versus IMRT. No one ever really saw the need to do that. Therefore, it wasn’t as typical in the nature of radiation, whereas it’s very typical in medical oncology and other disciplines. So, with protons, those that had it—which were very, very few—were treating as many patients as they could—because there were very few centers—and weren’t investing a lot in research. I think that’s one of the things that’s hindered the science. It’s also an area that we, as MD Anderson, are trying to fix. Dr. Steven Frank, who’s the head of the Proton Therapy Center now, and an unbelievable leader in that field—he is dedicated to the research side, to doing head-to-head trials, to doing quality-of-life, efficacy, dose trials on protons, to be able to have that scientific data that underlines it. So, I think that’s the reason. It took some time for the science to catch up, and it still is. We still struggle in certain disease sites with protons. And what’s occurring, and what has occurred over time, is that there are certain diseases with protons—for example, prostate cancer—that, in the infancy of protons, many patients were treated that had prostate cancer with protons. And the reason for that is, there are many quality-of-life indicators that clearly show that protons are better. Things like incontinence and sexual dysfunction, protons really curbs those side effects. That said, there was not a lot of science on whether or not the efficacy was better, meaning did—were you able to give more dose? Are your outcomes better? The quality-of-life side was absolutely better. So, you know, that is one of the disease sites that’s always been a bit in question. And you find, if you kind of read press and so forth, a lot of pushbacks on insurance companies. You know, “Am I paying for efficacy or am I paying for quality of life?” Personally, I think you should be paying for both, but that’s an area that has always been a question mark, versus things like pediatrics, base of skull, even lung tumors. Anything near a critical structure we can prove is better is protons, just by the properties of protons. Proton therapy, or protons as a particle, enters the body at a very low dose, and then escalates, and we can allow it to hit the tumor. And when it hits it, it falls off, so, eliminating all of this healthy tissue on the front and the back. So, you can imagine anything near your heart or your brain or your spine, it’s very important. Whereas conventional therapy, just by its property, enters your skin at a very high rate, and then decelerates. And so, you get a large front dose, but you also get a tail of radiation on the back end. In some circumstances, that’s not a bad thing. And so, one of the things that I’m very proud of the fact—that we’ve done here at Anderson, is that we have constantly said that protons should be one method of care in radiation oncology. It’s not the panacea. It is one modality of care, just like conventional, just like brachytherapy, just like all sorts of things. You know, traditionally speaking, about fifty percent of curative patients should have pro—conventional radiation as part of their standard of care; sixty percent if you include palliative. Of those fifty to sixty percent, only about twenty-five to twenty-eight percent are even appropriate for protons. So you really need to have both in order to have a comprehensive program. Or you need to have access to protons. And I think the way that we developed our center here was always with an eye toward it being a regional resource. Shouldn’t have protons on every corner. There’s no need. But you should have access to it if it makes sense for the patient.

Recommended Citation

Hay, Amy Carpenter and Rosolowski, Tacey A. PhD, "Chapter 04: Planning the Proton Therapy Center" (2015). Interview Chapters. 953.
https://openworks.mdanderson.org/mchv_interviewchapters/953

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