A cancer advocate friend recently forwarded an e—mail making the rounds that read, “I think you will find clicking on this link about inappropriate accrual incentives very interesting and concerning:”
The link was to the “PSA Rising Blog, and was titled “O Lord Won't You Send Me a Mercedes Benz…” (http://psa—rising.com/blog/index. php/2005/12/31/a—porsche—for—patient—accrual/#more—79). It described a letter to Cancer Investigation (2005;23:741—743) by David Steinberg, MD, a hematologist at Lahey Clinic Medical Center.
The blog quoted Dr. Steinberg's abstract, mixing in a few editorial comments, including, “Kudos to Dr. Steinberg for protesting this sleaze.” The abstract read:
“A $1000 lottery ticket for a Porsche Boxster automobile was offered to the investigator who accrued the most patients to a Southwest Oncology Group [SWOG] prostate cancer protocol. This was done with the admirable intention of increasing patient accrual and improving the outlook for men with high—risk prostate cancer. However, the offer of this prize also makes the statement that it is permissible to reward a doctor with an expensive automobile for putting patients on an oncology research protocol. Awarding an expensive prize for patient accrual risks eroding public confidence by creating the perception that clinical investigators, swayed by the allure of an expensive automobile, were motivated by material self—interest rather than the welfare of their patients and the advancement of medical science. I suspect that if the practice of expensive rewards for patient accrual becomes widespread the cumulative damage would ultimately outweigh the benefits.”
Despite the initial perception, SWOG itself was not offering a prize for patient accrual. A little digging presented a slightly different account, shifting accountability somewhat, and making the cooperative group guiltier of poor oversight. The lottery ticket offered as a recruitment incentive had traditionally been sold to SWOG members as part of its Hope Foundation's Platinum Association campaign.
Dr. Steinberg's letter was actually a short article on bioethics in Cancer Investigation that stated in the very first paragraph: “An investigator in the Southwest Oncology Group offered a prize to the doctor who registered the most patients to protocol S9921 (Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy, Phase III Intergroup), during the time period April 1, 2004 to Sept. 30, 2004. The prize was a $1000 raffle ticket for a lottery sponsored by The Hope Foundation, a charitable organization ‘dedicated to a cancer—free future’ and to the support of the research and programs of the SWOG. The lottery prize was a Porsche Boxster automobile.”
Head of Ethics Program at Lahey Clinic
In a telephone interview, Dr. Steinberg, who has been running the ethics program at Lahey Clinic for 14 years in addition to his hematology/oncology practice, said he first learned about the lottery—ticket incentive from a colleague who had received e—mails promoting the contest in 2004.
His interest in medical ethics prompted his writing the paper, and he admitted surprise at the outcome. “I tell people, when you do ethics you write something and it could be 20 years before something happens. But in this case, SWOG made changes right away.”
SWOG Chair Laurence H. Baker, DO, last April officially succeeded Charles A. Coltman, Jr., MD, who had held the position for 24 years. Although SWOG's operations office remains in San Antonio, TX, the headquarters are now based in Ann Arbor, MI, at the University of Michigan Health System, where Dr. Baker is Professor of Internal Medicine, Associate Chief of the Division of Hematology/Oncology, Deputy Director of the Cancer Center, and Director for Clinical Research at the Comprehensive Cancer Center.
Dr. Baker said in an interview that following the publication and subsequent blog posting of Dr. Steinberg's article, he responded with a Letter to the Editor of Cancer Investigation, which also appeared as a comment on the PSA Rising Blog.
‘Perception of Self—Interest Overshadowing the Welfare of Patients Has No Place in Clinical Trials’
The letter read: “The Southwest Oncology Group and the Hope Foundation agree with the commentary that the perception of self—interest overshadowing the welfare of patients has no place in clinical trials. As the new Chair of SWOG, I reconfirm our commitment to making the well—being of patients and advancement of medical science paramount and as such, have reviewed and modified our policies. Although Dr. Steinberg accurately concludes that this situation is not an example of ‘scandalous unethical behavior,’ nonetheless, steps have been taken to prevent actions that could lead to public misperceptions concerning the motivation of SWOG clinical researchers. Perceptions do matter and the potential damage to the patient/clinical investigator relationship is not worth a single additional accrual to this trial.”
On its Web site (www.thehope foundation.org), the Hope Foundation states that the Platinum Association campaign has entered its seventh year and that to date more than $700,000 has been raised in support of SWOG; and that the campaign encourages SWOG members to contribute $1,000 annually to become a member.
“In turn,” the copy continues, “each Platinum Member receives an annual membership in the Association, eligibility for exclusive distinguished drawings and private events held at each Southwest Oncology Group meeting, and most importantly, the knowledge and reward of supporting the work and efforts of the Southwest Oncology Group.”
This section is headlined, “Who Knows, You Might Find Yourself Driving a New Porsche this Fall!” and says the Foundation is honored to have distinguished corporate partnerships with Porsche Cars North America, AstraZeneca, Hyatt Hotels and Resorts, and Southwest Airlines.
On the site's National Board of Directors page, Dr. Coltman is listed as Chairman, and members include, among others, Dr. Baker, as well as Frederick J. Schwab, President and CEO of Porsche Cars North America Inc., and professional tennis players Lindsay Davenport and Steffi Graf.
During the interview for this article, Dr. Baker said that as far as he knew SWOG has no relationship with Porsche, other than being a customer.
“One of the things that the Group doesn't know that the Board just learned is that SWOG buys the Porsches. We're a customer. A lot of people think the Porsche is donated, and Brian Chavez didn't do anything to dissuade people from thinking that.”
Mr. Chavez had been the Hope Foundation's development director, and had left the Foundation before any information about rewarding investigators for patient accrual had become available, Dr. Baker explained, adding that Mr. Chavez's leaving had nothing to do with this particular incident.
Furthermore, Dr. Baker noted that after he assumed the chairmanship of SWOG, inquiries were made regarding some of the Hope Foundation's board members, and that Porsche's Mr. Schwab replied that he knew nothing about the Hope Foundation, and that the tennis players did not verify their relationship with the Foundation.
Made Changes in Structure & Function of Hope Foundation
“We've since made a number of changes in the structure and function of the Hope Foundation, including changing its bylaws,” Dr. Baker said.
“We in SWOG in general, and particularly our GU committee and its Chair, E. David Crawford, MD, have been openly critical that we haven't done everything we should or could to ensure participation in the clinical trials process.”
Dr. Baker said that Drs. Crawford and Coltman had been able to convince the National Cancer Institute to increase funding for participation in protocol S9921 from $2,000 to $3,000 per patient, and that Dr. Crawford had spearheaded an effort to encourage participation.
Dr. Baker said that the decision to offer Porsche raffle tickets as an incentive for recruitment had not been approved by the Hope Foundation's Board nor Dr. Coltman, but that those who were involved included Mr. Chavez and the trial's study coordinator, L. Michael Glodé, MD, who heads the University of Colorado's Urologic Cancer Center with Dr. Crawford; and that Drs. Glodé and Crawford had agreed with SWOG's decision to send the response letter to Dr. Steinberg and Cancer Investigation.
“SWOG's concern continues to be the appearance that something is improper,” Dr. Baker said, “and Dr. Steinberg's article correctly points out that this by itself is really not an unethical act.
“I'm not an ethicist, but I always try to tell people it's a personal decision they need to make themselves. As Group Chair, I'm also very concerned by the perception that we might be doing something improper.”
And Dr. Baker, from the greater—Detroit area, also made it clear that SWOG will never again raffle a Porsche.