What prompts it is this story from the Midwest, where University Hospital has entered the proton beam machine arms race with plans to spend $30 million. Here's the story from MedCity News.
Excerpts:
Few argue that proton therapy is ineffective, though many would like to see it subjected to rigorous testing. The National Cancer Institute (NCI) in 2009 expressed concern that “enthusiasm for this promising therapy may be getting ahead of the research.” NCI experts worry about a lack of published randomized, controlled trials that show proton therapy works better than standard radiation therapy and increases survival, or improves quality of life for patients.
Cost is also a huge concern associated with proton therapy — and one reason so many hospitals are eager to jump into the proton therapy business. Medicare reimburses proton therapy at about twice the rate of standard radiation therapy, which prompts concerns that patients (or their insurers) could pay twice the price for a treatment that may be no more effective than the cheaper alternative.
This one would be paid for by a "a mix of capital, bonds and philanthropy," according to Cleveland.com. What an obfuscation. No, it will be paid for with money! All of which has an opportunity cost. Dear Ohioans, you can do better with your money than throwing $30 million into this machine.Open letter to Don Berwick at CMS:
Please make them stop. You can dry up this source of funds and improve health care and help control its escalating cost. Use the tools you have at hand.
We are stuck betwixt and between - we have no 'free market' system of competition as the Republicans want, and governmental involvement produces travesties such as you describe. The worst of all worlds.
ReplyDeletenonlocal
Speaking of marketing of, and payment for, unproven and expensive technologies, here is a link regarding a study by Johns Hopkins on hospitals misleadingly advertising robotic surgery:
ReplyDeletehttp://www.sciencedaily.com/releases/2011/05/110518092040.htm
This would seem to refute (refudiate?) those who claim the cost increases in medical care can't be helped due to development of great new technologies. The marketers are winning.
nonlocal
I have often heard academic physicians complain that the rest of the world benefits greatly from medical technologies developed here. We pay for the R&D, they get the benefit. That has long been the attitude, and they have a point. Up to a point.
ReplyDeleteBut the flow of resources is rarely mapped in other ways. Intensive technologies entail external costs in rare natural resource extraction (e.g. uranium, rare metals), pollution, infrastructure demands, and energy that I have never seen evaluated.
More obvious is the opportunity costs of human capital on benefiting the few. Yesterday, I heard about a multi-year successful community program with great evaluation results (cost and health outcomes) for high-risk chronic care management. The recipe is low-cost training and support of local leaders and caregivers already in the social network. They are associated with a large academic hospital, but must pay rent and the 70+ % overhead that subsidizes high-tech medical developments. And, guess what? They barely have funding each year.
This is the sheer hypocrisy of our medical system. It isn't true that we do not know what works. Medical business strategies choose to ignore the investment options that don't result in high self-interested financial payoffs. Period.
Couldn't agree with this more; payment reform is badly needed for these high technologies.
ReplyDeleteI'm a neurosurgery resident and the radiation oncologist in our neuro-onc clinic has this old saying:
"There are three places with proton beams, and one place that knows how to use it."
The utilization statistics between the centers were all over the place in terms of who was offered and scheduled for the radiotherapy. Hard to believe such wasn't driven by the fee schedule.
This should be a highly tertiary offering. The proposals on the table for new beams are probably unnecessary. Hard to believe they aren't driven by the fee schedule.
Paul,
ReplyDeleteIdeally, the economics in the delivery of healthcare should not be different than in any other part of the economy. Investment in technology should drive down price, improve quality and deliver a higher value (think computers, cars, mobile phones etc) There are a variety of reasons this does not exist in healthcare today, but the primary one is that the usual tools of easily accessible price and outcome data available in an efficient market do not exist. I can find out more about a new laptop as it relates to price and quality than I can about fixing my sore knee.
I don't know how to fix this in general, but I do know how to fix it at my company (think globally, act locally!)
At ProCure, an owner of four of these very expensive proton centers, we have every patient who consents (north of 90%) on a study. We also strive to use the advantages of protons to drive down the price of delivering proton therapy. We have studies open right now in our OKC and Chicago centers that drastically reduce the price of treating with protons and makes the price of the treatment the same as the best x-ray technology.
That is what technology should do; create better outcomes at the same or better price resulting in higher value for the patient.
Best regards,
Hadley Ford
CEO
ProCure Treatment Centers
Please explain how a machine that costs tens of millions of dollars can deliver treatment at the same cost as one that has a capital cost an order or two lower in magnitude.
ReplyDeleteOne solution here could be to eliminate payment from CMS for any new facilities and continue paying at premium levels for the exiting few. During this time, enough research can hopefully be completed to prove (or disprove) the clinical and economic efficacy of treatment.
ReplyDeleteHey Paul, there you go again bashing proton therapy. When was the last time you had a conversation with a Medicare patient treated with proton therapy? I suspect never. Do you know that less than 1 percent of the more than one million radiation patients last year were treated with proton therapy. Hardly a dent on Medicare's health care radar screen. Sure, proton machines cost more than standard X-ray machines. If protons cost the same as X-rays, every hospital in the country would have proton therapy. Just ask your buddies in radiation oncology what they would prefer to use. I bet I know the answer.
ReplyDeleteLeonard Arzt
Nat. Asso. for Proton Therapy
I have asked them, and they think the level of investment going on in this technology is unconscionable. I'm not bashing the therapy. I'm just suggesting that we don't need as many expensive machines to handle the small number of patients who benefit from them.
ReplyDeleteDear Paul,
ReplyDeleteI assume your question is how does the price of treatment relate to capital expenditure? Or to put it a different way, how can Toyota spend billions on a new car plant and sell you a car cheaper than you could build one for yourself? Or how can you fly roundtrip from Chicago to San Francisco for less than you can drive when a Boeing 767 cost 3,600x your Ford Taurus? I am certain you must already have that information at your finger tips as it relates to protons. How else could you make such assertions of price differences based on capital differences in an open letter to CMS? However, perhaps you have bad data as rumors tend to run wild in the proton world.
You may call me at 212-584-0941 and I would be happy to talk with you about the factors involved in how this economic model works. Or if you would rather visit one of our centers in Oklahoma or Chicago I would be glad to host you. Our conversation will include:
•Initial capital cost: admittedly today proton equipment costs 4x that of x-ray equipment per room. However, ProCure is able to build a four room proton center 40% less expensively than an institution developing a center on their own because we have done it many times before.
•Operating hours: proton equipment is able to run 16 hours a day vs. many fewer hours for x-ray equipment at a typical clinic.
•Replacement cycle: the Harvard cyclotron treated patients for 40 years. Loma Linda installed their equipment decades ago. I haven’t heard of many x-ray centers that have used their equipment for that length of time. So if one has to replace x-ray equipment every seven years instead of every 40, there is a huge advantage for protons.
•Operating efficiency: using ProCure’s patented work process software to operate at peak efficiency and throughput we can ensure that our high cost equipment is efficiently used. This is just like making sure all your seats are full on a flight from Chicago to San Francisco.
•Treatment protocols: I’m sure you are aware of the many proton clinical studies underway across the US which dramatically reduce the number of fractions needed to kill a tumor. If protons cost 40% more to kill a particular tumor and the number of fractions to kill that tumor are cut in half it’s pretty clear what would happen to the price vs. x-rays.
All these factors can add up to a price for proton treatment that can be competitive with x-rays today. Add in the proven benefits of avoiding the irradiation of healthy tissue and proton therapy is a compelling modality for killing tumors cost effectively, avoiding the costs of complications, side effects and secondary tumors caused by that unwanted radiation deposited by x-rays (up to the equivalent of 500,000 dental x-rays!!) all while maintaining a patient’s quality of life.
Best regards,
Hadley Ford
CEO
ProCure Treatment Centers
Dear Hadley,
ReplyDeleteI am not going to make private calls. This is an open forum, and we both say what we want for the broader audience.
Your financial model seems to me to have lots of holes in it. The analogies to automobiles and airlines are not apt. And to suggest that the proton machine will be amortized for business purposes over 40 years is inconceivable: There is no way an investor will do that.
On clinical effectiveness, I have heard of no demonstration that the proton machines do a better job on ordinary tumors than regular radiation treatments. (I don't dispute their efficacy in certain types of cancer.)
Dear Paul,
ReplyDeleteOK, don’t call me. I was busy that night anyway.
I sure hope my financial model doesn’t have holes in it. I’m the investor! But we don’t have to argue about the nuances of GAAP accounting vs. pulling cold hard cash out of your pocket to buy a new linac every seven years. I’m a real world guy. If the data exists, it exists. And right now I have patients being treated for tumors with protons at rates that are equivalent to IMRT.
You are right that protons don’t do a better job at killing tumors than X-rays – radiation is radiation and protons and X-rays kill tumors equally well. But that is not the right question. Any tumor (or cell) can be killed by radiation: protons, X-rays, gamma rays, whatever. The secret is to not harm the patient at the same time. Or put another way, maximize the dose to the tumor, minimize the dose to healthy tissue.
Protons are much better than X-rays at achieving this trade-off. Even studies that show protons doing a better job killing tumors are the result of protons’ ability to get more radiation to the tumor than is possible with X-rays. It would be too voluminous to send you all the studies that exist on this concept (again, I would think you would have done this work yourself before firing off an open letter to the CMS), but why don’t you get started by looking up PROG 95-09, a Phase 3, dual institution, randomized trial that shows the advantages of dose escalation in killing tumors and the benefits of using protons to minimize damage to healthy tissue.
So, what does this mean in the real world? Imagine that you and I each had a brain tumor and we each went for radiation treatment. I got IMRT (X-rays), you got protons (I’m a nice guy, so I’ll give you the better option.) I’ll even stipulate that each of our modalities kills the tumor with equal ability (we’ll assume each of our tumors is getting the same amount of radiation so that is probably a good assumption). So what is the difference between these two treatments? Unfortunately, I will receive a lot more radiation in the healthy part of my brain. How much? In some parts of my brain I will receive the extra radiation equivalent of 500,000 dental X-rays. Is that a bad thing? Well it sure isn’t a good thing! My dental hygienist puts a lead shield on my body and runs out of the room for just one.
But the real issue here is not if protons do a better job at sparing healthy tissue. That is basic math and science. The real issue is cost. Not the cost of the treatment as you seem to believe, but the cost of fixing the damage done by the extra 500,000 dental X-rays. Insurance companies deal in probabilities. So if the extra 500,000 dental X-rays caused massive damage and cost in only 1% of the cases 10 years from now, too bad for me! No insurance coverage. If the extra 500,000 dental X-rays caused massive damage and costs in 100% of the cases next week, I would be covered. This is where the real battle is joined, on cost, timing and probability.
God forbid the damage done by the extra 500,000 dental X-rays would show up as a secondary tumor past the time you would statistically be off the insurance company’s policy. And good luck getting quality of life into the equation, but that would be pretty important to me. A 10% reduction in my IQ (no jokes please) from receiving the extra 500,000 dental X-rays rather than protons wouldn’t cost the insurance company much, but it would bother me, my family and my employer quite a lot.
Best regards,
Hadley Ford
CEO
ProCure Treatment Centers
Dear Mr. Ford;
ReplyDeleteIt is you who is arguing the wrong question, and in a layman-like manner to boot. There are many, many situations in medicine where what may seem like logical, common-sense reasoning does not survive rigorous testing. Therefore your theoretical expostulations sound good, but have little actual basis in clinical research.
The real question is, is proton treatment safer and more effective in real patients than other modalities of radiation therapy, especially given its cost - outside of the few rare tumors where the answer is known to be yes? Or are profit-mongers taking advantage of gullible patients with prostate cancer (the most commonly projected use of this modality currently) by claiming fewer side effects such as the all important impotence and incontinence issues?
I hope your purported clinical trials can prove the answer, for your sake as well as those of patients. However, you should be very careful how they are conducted, because their sponsorship is already statistically proven to be biased toward a 'positive' answer.
nonlocal MD
Dear Dr. Nonlocal Anonymous,
ReplyDeleteTheoretical? There is nothing theoretical here. That radiation damages cells is well known and proven (ever get a suntan?) That additional radiation damages cells even more is also well known (ever get a sunburn?) Giving a cell 500,000 dental X-rays is worse for the cell than giving it no dental X-rays.
So now let’s take the real issue out of play. If the price of the proton therapy treatment were the same as IMRT (the fancy name for the X-ray treatment) and the only difference between the two treatments was that you would receive an extra 500,000 dental X-rays in your brain by choosing IMRT, which treatment would you choose? This is not a theoretical question. This is a real live choice made every day. However, if you are still uncertain as to what you would do because there is no Phase 3, randomized, multi-institution trial perhaps you can help out here.
I would be glad to open a study. As the only difference in the proton and X-ray treatments in my example is that one patient would receive the equivalent of an additional 500,000 unwanted and unneeded dental X-rays in their brain, setting up the study is pretty straight forward. I would need to find participants who would be randomized into two arms: arm 1 would get no X-rays shot into their brain, and arm 2 would get 500,000 dental X-rays shot into their brain. Then we could study what the differences were between the two arms. We could check on things like IQ loss and the creation of tumors. Let me know what other end points you think we should study.
So all I need are some participants. Hey, I have an idea! Since you are uncertain, why don’t you be one participant and I’ll be the other? It’s a small “n” for a study, but we have to get the ball rolling somewhere. Since I took the more dangerous path last time with Mr. Levy, I will let you receive the 500,000 dental X-rays this time. I’ll wait across the street from my dentist and have a beer while you go see my dental hygienist. She’ll zap your skull with a dental X-ray every 30 seconds until you have the full course of 500,000 zaps. Then we’ll see what the side effects and complications are and if you get a tumor caused by all that radiation. Of course we may have to wait a while to see the initial results because at 30 seconds per zap, it will take you 174 days, 24 hours per day, to complete your arm of the study.
As for your last point on sponsor bias, I’ll even let you pick up the tab for the study. I like Stella Artois
Let me know when you want to get started on the trial and I’ll give my dentist a call.
Best regards,
Hadley Ford
CEO
ProCure Treatment Centers
PS. If you would rather do the study as it relates to prostate cancer, we can fire the dental X-rays into your rectum rather than your brain. Your choice.
Dear Paul,
ReplyDeleteDid you have a chance to look up PROG 95-09? I was wondering what you thought of the results. If you have trouble finding it, let me know. I can send you a copy.
Best regards,
Hadley Ford
CEO
ProCure Treamtment Centers
To repeat, I'm not bashing the therapy. I'm just suggesting that we don't need as many expensive machines to handle the small number of patients who benefit from them.
ReplyDeleteDear Mr. Ford;
ReplyDeleteThanks for your offer, but I don't have a prostate.
nonlocal MD
Paul,
ReplyDeleteHow many patients a year do you estimate would benefit from proton therapy if they had access to it today?
Best regards,
Hadley Ford
CEO
ProCure Treatment Centers
Dear Dr. Nonlocal Anonymous,
ReplyDeleteOk, no prostate. Do you have a brain? If so, let me know and we'll get the study fired up.
Best regards,
Hadley Ford
CEO
ProCure Treatment Centers
Dear Mr. Ford,
ReplyDeleteI have published this comment even though I usually do not publish ad hominem remarks. I do it because it says so much more about you than I could comfortably post here if I were to write it myself.
Dear Paul,
ReplyDeleteI see you took the time to make a clever response as a third party in the mildly amusing back and forth of Dr. Nonlocal Anonymous and me. However, you did not answer my question as it relates to your estimate of the patients who would benefit from proton therapy.
To be specific, I was curious from your comments on “not bashing the therapy” of the following:
•What do you consider “small?” (let us have no ad hominem responses, please);
•What indications are included in your “small number of patients?”; and
•What is the capacity of all the centers in the US today?
Again, I assume you must have these numbers and indications at your fingertips to be making such broad requests of the CMS.
Best regards,
Hadley Ford
CEO
ProCure Treatment Centers
PS. Although my comment of “do you have a brain” was perhaps perceived as insulting, it was meant as a true statement. I must assume Dr. Nonlocal Anonymous is a woman and has a brain and therefore was amusingly side stepping my request to participate in the study (of course, the good doctor could be a male who has had his prostate removed, but I’m betting the former.) My comment was meant not as an insult, but as a challenge. She must have a brain, so how does she answer my question as it relates to a brain tumor study, rather than a prostate cancer study?