GAITHERSBURG, Md. -- Members of an expert panel convened bythe Food and Drug Administration on Friday said they do notsee convincing evidence of a statistically significantrelationship between injectable collagen products and theonset of autoimmune diseases, particularlypolymyositis/dermatomyositis (PM/DM).

Stock of Collagen Corp. (NASDAQ:CGEN), which has beenbesieged by patient suits and other adverse publicity aboutcollagen products, climbed $3 Friday on the news, closing at$20.75.

The eight panel members said they were unconvinced bypresentations made by investigators from the FDA and theTexas Department of Health.

"There is an absence of evidence on both the statisticalrelationship and a biological basis for believing that there is arelationship" between the treatments and the disorders, saidDr. Noel Rose, chairman of the panel and chairman of theDepartment of Immunology and Infectious Diseases at JohnsHopkins University School of Hygiene and Public Health.

"There is clearly a paucity of data regarding the statisticalassociation," agreed Alan Andersen, director of the Office ofScience and Technology in the FDA's Center for Devices andRadiological Health.

After the meeting, the FDA issued a statement that said:

"The group of eight experts indicated there is insufficientevidence to determine whether collagen injections can causeautoimmune or connective tissue diseases in persons without ahistory of such problems.

"The group of experts stressed that the limitation in theavailable data makes it difficult to be certain about thestatistical association, and these limitations include thedifficulty in diagnosing PM/DM, the possibility that a patientmay not have been followed long enough, and the extremerarity of PM/DM.

"Several of the experts stated that it is not certain that thereis a possible biological mechanism through which collageninjections could lead to PM/DM."

Investigators presented to the panel two epidemiologicalanalyses of the nine PM/DM cases identified so far amongcollagen-treated patients. Dr. Richard Beauchamp,environmental public health physician of the Texas Bureau ofDisease Control and Epidemiology, found that the incidence ofPM/DM was 18 times what would be expected if there were noassociation. Richard Chiacchierini, director of the division ofbiometric sciences in the Center for Devices and RadiologicalHealth, found that the incidence of PM/DM was five times theexpected rate.

The findings were challenged by Dr. Michael Rosenberg ofHealth Decisions Inc., who conducted for Collagen Corp. ananalysis of the Texas and FDA studies. Echoing Rosenberg'sarguments, the FDA said in its statement that "small changesin any of a number of assumptions can significantly change theresults" so that they do not show a significant associationbetween injectable collagen and PM/DM.

Rosenberg said that the injectable collagen controversy hasraised concern about the widespread use of collagen in otherproducts, including sutures, hemostats and dermal implants,and that the Palo Alto, Calif., company is developing collagenapplications for use in urinary sphincter implants, bone voidfillers, embolic agents, burn dressings and periodontalmembranes.

FDA Commissioner David Kessler told the meeting that theadvice of the expert panel "will guide our decisions in whataction to take" in the absence of clear information. After themeeting, FDA spokeswoman Susan Cruzan said the agency "willhave to have further discussion" about the issue.

-- Kris Herbst BioWorld Washington Bureau

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