The center will focus on providing radiation therapy to cancer patients using high-energy protons, generated by a sophisticated particle accelerator.
The theoretic advantage of such therapy is that it can provide more radiation dose to the tumor, while minimizing the dose to normal tissues, thus possibly improving treatment efficacy while reducing adverse effects. Protons scatter less into normal tissue than do x-ray photons.
On the other hand, according to the Chronicle article, proton therapy has mainly been assessed for treatment of a few relatively rare tumors. The Chronicle did suggest that a recent JAMA article showed that proton-therapy reduced recurrent rates for a more common cancer, that of the prostate. However, review of this article [Zietman AL et al. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA 2005; 294: 1233-1239.] showed that it actually compared two doses (conventional and high) of therapy that combined both standard radation therapy and proton-therapy. Furthermore, although the high-dose treatment lowered patients' PSA levels, assumed to be a measure of local control of disease, compared to conventional-dose treatment, it gave no survival advantage, and high-dose patients had more adverse effects. Thus, this article did not actually make a convincing case that proton-therapy provides better a better benefit/harm ratio than does standard therapy.
The issue in the Chronicle story, however, was not so mainly about whether this therapy should be considered investigational.
Rather, the issue was that the new M. D. Anderson center will actually be a for-profit facility, owned by a group of private investors, that "leases" the M. D. Anderson name. Using the Freedom of Information Act, the Chronicle discovered that the center will be financed and owned by venture capitalists. These include a limited partnership whose largest investor is the Houston Police Officers' Pension System. Another sub-partnership includes Nolan Ryan, a subsidiary of the Landry's Restaurant chain, and Rich Kinder of Kinder Morgan. M. D. Anderson is also a limited parter, having invested $2.5 million out of the $30 million dollar total.
The center will be run by "a company co-owned by Sanders Morris Harris and The Styles Company." A separate article in the Chronicle reported that advisors to the Police retirement system advised "extreme caution" about the investment, particularly because of "the large fees that Sander Morris Harris and developer The Styles Company were getting up front, as well as continuing management fees to them."
"In future years, once the limited partners have recouped their investment plus interest, profits get distributed according to a formula. M. D. Anderson gets 15 percent, but if the center achieves the high return it projects - 58 percent - M. D. Anderson gets up to 25 percent." "It could be a federal anti-kickback violation for a doctor or institution to receive incentive for medical referrals if Medicare and Medicaid is among the insurers, but attorneys said they carefully reviewed the arrangement."
The Chronicle article stated, "M. D. Anderson's center, however, won't be nonprofit. Indeed it will address an institutional problem that is as much about business as health care. Of 12,000 M. D. Anderson patients who will need radiation this year... only 5,000 will complete their multiweek course of treatment at M. D. Anderson." "If patients are sold on proton treatment, not available in their hometown, they have to stay and pay at M. D. Anderson, which means more money for the hospital."
Furthermore, the Chronicle reported that M. D. Anderson promised to "promote" the center as part of the deal. "M. D. Anderson is contractually obligated to its venture partners to 'advertise and promote' the therapy, doing such things as touting its benefits on the Internet. 'They're going to promote this like you'd promote a new model of car at GM,' said Larry Churchill, a professor of medical ethics at Vanderbilt University Medical Center."
M. D. Anderson President Dr. John Mendelsohn replied "We are not promoting this in the hyped-up sense. We're going to be educating." In addition, he noted "I'm convinced that proton therapy is at least as good as standard radiation therapy, and there are preclinical and scientific data that says it's very possible it will be better." Finally, he noted that aggressive treatment is "part of our national culture."
In my humble opinion, this case raises major concerns about institutional conflicts of interest and honesty.
- Will the interest of M. D. Anderson in making money from this venture, and the pressure it will be under from investors conflict with its patient care and academic mission?
- Will a clinical center run by a for-profit management group with no obvious expertise or background in clinical health care or academics put patient welfare and academic integrity ahead of finanacial concerns?
- Will M. D. Anderson's obligation to "promote" this center conflict with its core value "to create a caring environment for everyone?"
- Does leasing its name to a group of private investors fit its core value of "integrity," defined as " We work together to merit the trust of our colleagues and those we serve?"