University of Pittsburgh Seeks PET/CT Rights
The recent lawsuit brought against CTI, Knoxville, Tenn, by the University of Pittsburgh demonstrates how strategic relationships between academia and industry can go awry. According to a story reported on knoxnews.com (accessed February 11, 2004), the University of Pittsburgh is challenging CTI’s claims of ownership of the PET/CT scanner, stating that CTI failed to recognize the pertinent role of the university in the development processa familiar argument in the breakdown of these types of partnerships.
“Academia and industry relationships are fairly common in radiology,” says Ronald L. Arenson, MD, chairman of radiology and president of the medical staff at the University of California, San Francisco. “It’s a very synergistic relationship, where academics offer great brain power and a clinical test bed, and companies provide financial resources to develop a product they can market and sell.”
In some cases, however, the relationship can turn sour. In the current suit, which is filed in federal court, CTI, its subsidiary CTI PET Systems (CPS), an executive, and a former University of Pittsburgh researcher are named for violating agreements with the university. CTI is cited for not recognizing the university’s role in the development of the scanner, not including the university in key patents, not properly licensing the technology, and withholding millions in revenues that should have been shared with the university. The university is requesting the courts to recognize the university’s ownership rights in key parts of the development and require CTI to pay royalties on that technology, as well as on unspecified damages.
The university received two National Institutes of Health grants for the development of a technology that merged traditional CT technology with PET imaging, according to the article. The CTI executive was named as one of the several consultants on the project and entered into a joint agreement with the researcher and the university’s PET research facility to develop the machine, which CTI did not have the funding to do on its own, the university claim states.
The university claims to have been under the viable assumption that they had joint rights to the ownership of the invention. However, patents obtained by the CPS consultants and the researcher did not attribute the university. The University of Pittsburgh is suing for rights to the PET/CT technology, actual and punitive damages, and an injunction barring any of the defendants sharing the technology with a third party.
The case raises questions on how academia can protect their intellectual property, while assisting industry in bringing useful, well-researched products into the market.
“The potential downsides to an academic and industry collaboration are numerous,” says Arenson. “Although there are no foolproof contracts, most disputes can be avoided with a properly structured contract and research agreement. The more details that are spelled out in the beginning, the less likely there will be misunderstandings later on.” Arenson indicates that a recently crafted agreement took 1 year to negotiate.
The PET/CT scanner was introduced by CTI in 2000 and has since surpassed sales of PET-only scanners, the article stated.
Canadian C-Spine Rule Edges Out NLC
To determine the most effective rule for evaluating the need for radiographs in case of a cervical-spine injury, a recent study compared the Canadian C-Spine Rule (CCR) with the National Emergency X-Radiography Utilization Study (NEXUS) Low-Risk Criteria (NLC). According to the study, published in the New England Journal of Medicine, the CCR proved to be a more successful decision rule to determine the need for cervical-spine radiography than the NLC for alert patients with trauma who are in stable condition.
Researchers conducted the study in nine Canadian hospitals, where 394 physicians evaluated 8,283 patients before radiography. Among the total number of patients, 2% had clinically important cervical-spine injuries and 10.2% were excluded as indeterminate cases, in which physicians did not assess range of motion as required by the CCR algorithm. In the results, which excluded the indeterminate cases, the CCR showed more sensitivity than the NLC (99.4% versus 90.7%, P<0.001) and was more specific for injury (45.1% versus 36.8%, P<0.001), demonstrating that it would have lower radiography rates than NLC (55.9% versus 66.6%, P<0.001).
The patients used in the study were 16 years old or older and suffered from acute trauma to the head or neck, but were in stable condition and alert. They all had visible injury above the clavicles, were nonambulatory, and had a dangerous mechanism of injury. All the patients considered in the study were required to have normal vital signs as defined by the Revised Trauma Score, a Glasgow Coma Scale score of 15, and injury within 48 hours.
Resident or attending emergency medicine physicians were trained through a 1-hour lecture session on conducting assessments on patients. After evaluating patients and before radiography, the physicians recorded their findings and interpretations of the two rules on a data form. Some patients were assessed independently by a second physician. Throughout the evaluation, all injuries sustained by the patients were considered clinically important, unless the patient suffered from a transverse process not involving a facet joint, osteophyte avulsion, a spinous process not involving lamina, or a simple vertebral compression of less than 25% of body height; these exceptions were standardized through a formal survey of 129 spine surgeons, neuroradiologists, and emergency physicians.
During the study, physicians were told not to order radiographs according to the CCR and the NLC decision rules so patients underwent standard plain radiography according to a physician’s judgment. Staff radiologists who had only routine clinical information on each patient, not the contents of the study data forms, read the radiographs. The final interpretations of the CCR and NLC rules were made by an adjudication committee, which looked at patients’ medical records and physicians’ responses to the study data forms.
Results of the 3-year study showed that the CCR was highly sensitive for clinically important cervical-spine injuries and more specific than the NLC, proving that the CCR may play a greater role in reducing unnecessary radiographs.
