R&D Ethics: The Case of the $20 Knee
February 2010 Issue
|From left: Stanford's JaipurKnee and LeTourneau University's LEGS M1 Knee: How similar are they? Photograph courtesy of LeTourneau University.|
Two university teams working to provide highly functional knee joints to the world's poorest amputees have come to public loggerheads over accusations of ethics violations.
The first party is LeTourneau University, Texas, a small Christian undergraduate institution. Since the fall of 2004, LeTourneau student volunteers have been developing, refining, and fitting the LeTourneau Engineering Global Solutions (LEGS) M1 knee, a four-bar polycentric joint tested to ISO 10328 standards. The M1, which has been fitted on more than 100 amputees in the developing world, is block-shaped for ease of manufacture and is made of Delrin, a low-cost polymer used worldwide for machine bearings. The M1 costs about $15 to make and is being locally manufactured at some of the 20 prosthetics clinics in developing nations that provide it. LeTourneau, with its $7 million endowment and student population of 1,400, has called the M1 to the attention of mostly local media, though the knee research was published in 2006 in the Journal of Biomechanics and is featured prominently on LeTourneau's website.
The second party is Stanford University, Palo Alto, California, the college that U.S. News and World Report recently ranked number four among national universities, and is the beneficiary of a $12 billion endowment. In 2008, it received a request: the Bhagwan Mahaveer Viklang Sahayata Samiti (BMVSS), Jaipur foundation, one of the world's largest humanitarian providers of prosthetic care, asked that Stanford's students create a knee that was suitable for use with its Jaipur Foot and centrally manufacturable at the foundation's Jaipur, India, site. During the following two academic quarters, graduate students in a biomedical device design and evaluation class, advised by Tom Andiacchi, PhD, reviewed the academic literature on the subject, studied top-rated first-world knee prostheses, and designed their solution: the JaipurKnee, a block-shaped, $20, four-bar polycentric joint, made from an oil-filled nylon polymer that is self-lubricating and amenable to manufacture in Jaipur.
After the academic project was complete, two former members of the student team, Joel Sadler and Eric Thorsell, teamed up to form Re:Motion Designs, a group with the mission of scaling up the JaipurKnee's production. In April 2009, they presented the knee at the Stanford Cool Products Expo, and Stanford published a press release about it. The international and tech media jumped on the story, and the JaipurKnee was featured in print, Internet, and television news as a hot new invention for a world needing help.
The Internet also brought the story across the desk of Roger V. Gonzalez, PhD, PE, founder of the LEGS program and director of biomedical engineering at LeTourneau. Noting the fraternal-twin resemblance between the two knees, he contacted Andriacchi. In an e-mail exchange, the two discussed their research and the possibility of a LEGS/Stanford collaboration. The Stanford team sent Gonzalez their class report, which documented the JaipurKnee's design process. In September, Gonzalez and Stephen Ayres, PhD, LEGS director of engineering operations, also spoke with Sadler and Thorsell in a conference call. In the conversation, Sadler and Thorsell mentioned that they had known of the LEGS project while designing the JaipurKnee-they said that a student on the Stanford team had known a student who worked on an unrelated project in Gonzalez's LeTourneau laboratory. According to Gonzalez, Sadler and Thorsell said in a later conversation that it had been "an oversight" not to have acknowledged the LEGS knee in their work. On October 29, Gonzalez traveled to California and initiated a side trip to meet with Sadler, Thorsell, and other Stanford team members. At the meeting, all agreed that it would be valuable to collaborate, and Gonzalez was provided with two JaipurKnees to take back to LeTourneau for testing.
Trouble with TIME
The next day, October 30, Re:Motion Designs made a major announcement on the social-networking site, Twitter: The Re:Motion team had been contacted by TIME Magazine, stating that the JaipurKnee would appear on the magazine's Top 50 Inventions of 2009 list. The list was published two weeks later, and the JaipurKnee was named as number 18.
"At that point," Gonzalez told The O&P EDGE, "they [the Stanford team] had an ethical obligation to let TIME know that it wasn't a 'new invention'-that another research team had been producing the same type of device, for the same purpose and the same price, for five years."
On November 13, Robert Hudson, PhD, LeTourneau vice president of academic affairs, appeared on Texas' KLTV news, saying, "I think if [TIME] would do a little investigation, they would come to conclude...that LeTourneau University has been doing this and recognize the value and the credit that they should give LeTourneau University."
Though TIME did not respond to requests to contribute to this article, the December 4 issue of The Chronicle of Higher Education quotes an e-mail from TIME senior writer Lev Grossman, who managed the 50 Best Inventions article. He wrote to Janet Ragland, LeTourneau director of community relations, "We regret that we didn't turn up LeTourneau University's M1 knee when we checked this item, but with 50 inventions to find and vet, and an increasingly limited staff, there's a finite amount of attention and research we can give each item." According to Gonzalez, TIME also did not publish a letter to the editor from LeTourneau President Dale Lunsford, PhD, correcting the magazine's purported omission.
Plagiarism or Convergent Design?
Several media reports have portrayed LeTourneau as accusing the Stanford team of plagiarism. When asked by The O&P EDGE if there was a question as to whether Stanford students had copied the M1's design, Gonzalez declined to speculate. He emphasized, however, that the Stanford team said it had heard of the M1 during the JaipurKnee design process, that the Journal of Biomechanics article about the M1 was available when the Stanford team conducted its literature review, and that information about the LEGS program has been available on the Internet since 2005.
Neither Sadler nor Thorsell responded to a request for an interview regarding the controversy, but Lisa Lapin, Stanford's senior communications officer, said, "The JaipurKnee concept was developed independently, in a brainstorming session among the team with many witnesses, before anyone knew that the LeTourneau knee existed. The information that there was a low-cost knee developed by LeTourneau came very late in the class and in the process, and there was never any technical knowledge about it." She called LeTourneau's public statements "really serious unfair accusations against a group of students who were doing a great service and have done nothing wrong." She also provided an e-mail from Jaipur Foundation founder D.R. Mehta that states, "As you may be aware, the concept of four-bar linkage polycentric joint was developed about 50 years ago, and...there are perhaps 100 different designs based on this concept."
Lapin also provided a statement from Sadler, listing similarities and differences between the two designs. His list includes the following differences between the two joints:
The joints have different kinematic geometries, and, Sadler says, "if the relative position of the pivots in a four-bar mechanism are altered by even a few millimeters, the performance of the knee joint is altered."
"When fully extended, the JaipurKnee uniquely distributes load directly through the joint through contact with the surfaces of the main upper and lower block.... The LeTourneau joint places load entirely on the linkages when fully extended.
"The JaipurKnee was designed to be centrally manufactured...with use of computer numeric controlled (CNC) machining processes.... The LeTourneau joint is designed to be manufactured with the use of only basic machining tools such as a band saw and drill press, with the use of pre-fabricated high-tolerance jigs.
"The JaipurKnee is designed to interface with the Jaipur Foot's existing prosthetic components, including the socket interface and pylon-foot assembly. The LeTourneau joint has alternative interface mechanisms for their partners' individual prosthetic systems."
Gonzalez dismisses this list. "The joint is functionally identical," he says, and states that the M1 can be manufactured as easily on a CNC setup as with simple tools, and can interface with Jaipur Foot. Lapin countered, "Dr. Gonzalez has not identified any meaningful and unique feature of his design that was plagiarized by the Stanford team. An accusation as serious as plagiarism or ethics violation should be rigorously documented.... Merely working on the same problem is not plagiarism."
Publicity Raises the Stakes
And what of the TIME approbation? Lapin said, "We found out a couple of days ahead of time that we were going to be on their list, but it's not something that Stanford sought, and we never said at any point that our knee was the only, the best, or the first of any kind.... There is somehow an implication...that we should have somehow told TIME Magazine, 'We don't deserve this; LeTourneau deserves it.' Why would it be our responsibility...to do public relations for LeTourneau University?"
The O&P EDGE asked Deborah Poff, PhD, founder and editor in chief of the Journal of Academic Ethics, for her opinion on general issues surrounding the conflict: "Do you have an obligation to share information about alternative developments in your own field that are similar? I'm not sure that you do-it might be a nice thing to do, but I'm not sure that there's an ethical obligation to do so. This is pretty standard philosophy around ethics issues-if you have a duty to inform someone, it means someone else has a right. Did [LeTourneau] have a right to have their information shared about their discovery? I don't think so."
As for the plagiarism question, she adds, "Sometimes people don't know your work, even if you're working in the same field. There's often serendipity in discovery. When Darwin published On The Origin of Species, he had been sitting on his theory and then realized that Wallace was going to publish pretty much the same thing, so he rushed to publication. It wouldn't be that strange if independently people were coming with the same kind of strategy to solve the same kind of problem."
At stake, Poff says, are issues of reputation, status, and perhaps most importantly, research dollars-funds that are most likely to go to creators of a "new" technology, and which are already more available to Stanford.
The situation remains contentious. According to Gonzalez, Sadler and Thorsell had remained in communication with him until November, but have not been in contact with him since that time. More than 500 patients have been fitted with the JaipurKnee, and the device was recently voted number nine in CNN's Top 10 Health Innovations of 2009. Gonzalez is preparing to patent the M1 and present it at the 2010 International Society for Prosthetics & Orthotics (ISPO) meeting. He says that LeTourneau would like Stanford to make a public statement that their design is "not new"-both as a correction to TIME's claim that the JaipurKnee is a "new invention" and because Gonzalez contends that Re:Motion continues to pursue "new invention" awards, making moot Stanford's claims that it has refrained from calling the JaipurKnee a new design.
Steven Ayers, PhD, LEGS program director, wrote to The O&P EDGE in April 2009, saying, "The majority of the LEGS [work] is done by undergraduate students who carry a full workload yet believe in this work so much that they are willing to dedicate 20 to 30 hours per week [to it] on top of their regular course loads.... These young men and women were doing this work years before the Stanford project came on the scene and were doing so with great success.... The quality and thoroughness of their work is worthy of recognition."
Poff concludes, "It would be nice if they [Stanford and LeTourneau] could move forward and collaborate-that would obviously be the best thing for them, and would show their seemingly mutual respect. [But] I haven't seen a lot of happiness come out of these kinds of situations. I've seen a lot of people get more and more rigid in their positioning, not agree to move forward together, and then sort of move forward independently.... Whether collaboration can happen means that people have to be willing to put aside feelings of hurt or competitiveness and get past them."