April 1996 Bulletin

Genzyme supports increasing data

Firm concerned about ads, public's expectations

The Academy conducted an Annual Meeting symposium on Chondrocyte Transplantation because of the publicity and accelerating use of a treatment for defects in the articular cartilage of joints, particularly, the knee joint. There was a growing interest in the orthopaedic community and an uneasiness about the amount of data and lack of controlled clinical trials for Genzyme Tissue Repair's CarticelSM procedure, the marketing techniques promoting the treatment, and the public's demand for the treatment. Because of the significance of the development of biotechnologies, in general, and the great interest by orthopaedic researchers, Greg Phelps, president of Genzyme Tissue Repair, was asked to comment on these issues.

Genzyme Tissue Repair supports the concept of expanding the available data on the treatment, said Greg Phelps, president of the company. "We created a data collection registry and ask that all surgeons (using the treatment) submit data to the registry," he explained. "We are building a long-term database that is available to all surgeons and the FDA (Food and Drug Administration).

"We're not only 100 percent behind continuing to build the knowledge behind this approach, but we're also considering comparative studies (with other treatments). There is relatively little data on alternative treatments and it would be useful to have randomized or cohort studies for comparative studies."

Genzyme made the treatment available to orthopaedic surgeons, based on its evaluation of the data supplied by Lars Peterson, MD, who led the research development of the treatment in Sweden, "and considerable feedback from other surgeons," Phelps said. "We feel there is a reasonable baseline of data to allow the surgeons to make their own decisions on whether it would be beneficial for their patients in light of their own experience and knowledge of alternative treatments.

"We did an evaluation from the safety standpoint of the data on the first 153 patients (of Dr. Peterson). There were few adverse events and no serious adverse events deemed to be related to chondrocyte implant. There were some normal side effects from surgery."

Phelps dismissed the concern that the treatment was not in the usually long research stage-decades in some cases.

Research not new

"The basic research was started 15 or 20 years ago," he said. "Dr. Peterson has seven- and eight-year follow-ups on 15 patients and four- or more year follow-ups on 30 patients."

Dr. Peterson disclosed at the Annual Meeting symposium that 251 patients had received the treatment. Phelps said Dr. Peterson will reevaluate the outcomes of a number of patients this spring, and will be performing more biopsies.

Phelps said Genzyme took a conservative approach even though the company was satisfied with the data.

"Instead of just processing cells and limiting our role the company set up a training program for orthopaedic surgeons, required IRB clearance and established a data collection registry," he said. Genzyme expanded the informal training program used in Sweden with input from Dr. Peterson and from other surgeons."

According to Genzyme's last public disclosure, 253 surgeons had been trained in the Carticel treatment. Half of the surgeons were trained in Sweden; the others in Genzyme's Cambridge. Mass. facility. About three-quarters of the trained surgeons are from the United States. There was a waiting list of about 300 surgeons who want the training.

Expects cost to drop

Genzyme doesn't charge a fee for the training; the only fee is the $10,000 cost of processing the patients' cells. The hospital-physician cost to the patient has been quoted in the media as being from $25,000 to $35,000 (which includes the $10,000 cost of cell processing), Phelps said. He expects that, in time, the cost will be reduced by developing a less invasive technique and by automating the cell processing.

Phelps said the company is concerned about statements made about the marketing of the treatment. "We did not orchestrate the marketing in the way mentioned in the Academy News (the Academy's newspaper published at the Annual Meeting)," Phelps said. (A speaker charged there was a "carefully orchestrated marketing program" in which some orthopaedic surgeons contact the media after they have performed a procedure.) Genzyme did provide background information to physicians to ensure accuracy, but, Phelps said, the company has no control over the advertising by physicians, some of which is on the Internet.

He also is concerned about the unrealistic expectations of the public that the treatment might cure osteoarthritis. "We have no way to say that," he said.

"We would be interested in working with the Academy to develop ways to avoid misleading advertising and misunderstandings by patients."

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