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Collagen Rejects FDA Finding on Rare Diseases

September 13, 1991

PALO ALTO, Calif. (AP) _ A company that makes injectable collagen on Friday rejected a Food and Drug Administration finding that product users have a statistically higher rate of two rare diseases.

An FDA spokeswoman in Washington also cautioned that more study is needed to determine if the statistical finding is meaningful, and to see if collagen is the cause of the debilitating connective tissue diseases.

″We’re working with very preliminary data so it will take at least a few days to determine whether this merits further study,″ FDA spokeswoman Susan Cruzan said Friday in a telephone interview. ″Statistics can be tricky.″

The FDA had previously rejected the notion that injecting collagen, a natural bovine protein, under the skin to smooth wrinkles and repair acne and scars was linked to the rare diseases. But on Thursday in Washington, FDA officials told a House subcommittee that statistically, collagen users do have a 75 percent higher incidence of two connective tissue diseases.

″We do see a statistically significant association,″ FDA official James Benson told the House subcommittee on oversight and investigations during the hearing on FDA enforcement activities.

That preliminary finding looked at seven cases of polymyositis and dermatomyositis reported among the nearly 400,000 people who have used the injected collagen products, Zyderm or Zyplast. In the general population, the incidence of those diseases is one in 100,000.

Polymyositis is an inflammation of muscles, usually in the shoulders and pelvis, which leads to weakened muscles. When the muscle inflammation is accompanied by swelling of the skin, the disease is known as dermatomyositis.

Frank DeLustro, vice president of scientific affairs for Collagen Corp., said Friday that the company’s popular natural protein products have proven safe, and that collagen has been used to treat allergic reactions for decades.

He said the sampling of seven cases the FDA looked at was too small to make conclusions about any possible links between injectable Collagen - which the FDA approved in 1981 - and the rare connective tissue diseases.

″Our data shows that the incidence of these autoimmune diseases among collagen-treated patients is not significantly different than one would expect in the general population,″ DeLustro said. ″There’s no linkage that can be made. And definitely no cause-and-effect findings.″

DeLustro said Collagen Corp. welcomes further study of its products by a scientific panel and the federal Centers for Disease Control.

If further federal studies conclusively prove the link between Collagen and the diseases, the FDA could ban the sale of collagen products or require more strict labeling.

The biotechnology company, which has been battling the FDA on proper labeling issues for years, set up a daytime toll-free telephone number to respond to concerns over the product.

Last month, FDA officials seized 50,770 collagen-filled syringes worth $5 million from the company’s Fremont plant because Collagen had deleted nine words from product labels that warned it might be harmful to people with connective-tissue diseases. Collagen said the omission was an accident.

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The toll-free number set up to respond to concerns over the Collagen product is 1-800-227-4004.

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