GENE THERAPY:
PARENTS SUE HOSPITAL OVER CANAVAN PATENT

American Health Line
Copyright 2000 The National Journal Group, Inc.
November 20, 2000

Chicago-area parents of two children who died of Canavan disease, a rare neurological disorder, have filed suit against the researchers who discovered and patented the gene responsible for the disease, the Chicago Tribune reports. In what is "the first case of its kind" of parents "suing the researchers they once trusted but whom they now view as trying to profit from their children's illness," Daniel and Debbie Greenberg say the patent and the strictly licensed commercial test for the disorder "ha[ve] impeded further study into the disease," and that the restricted tests "ensur[e] that more children will be born into a life of pain and hopelessness." Defendants in the lawsuit include lead researcher Dr. Reuben Matalon and Miami Children's Hospital, where the gene was discovered and which began a campaign to enforce its gene patent when the American College of Obstetricians and Gynecologists recommended in 1998 that all Ashkenazi Jewish women (those of Eastern European dissent), who are more likely to pass the disorder on to children than other women, receive DNA testing for Canavan carrier status. Although the suit does not challenge the patent, it charges that research participants' rights were violated in pursuit of the institution's financial gain and "alleges that the researchers secretly obtained [the patent] using the genetic information and financial resources that have been donated for the public good and began charging royalties and limiting the availability of testing."

BIG QUESTIONS FOR BIOTECH'S FUTURE

The Greenbergs and other families have joined the Canavan Foundation in the fight to "block Miami Children's Hospital's commercial use of the Canavan gene" and recover more than $75,000 in damages from collected gene test royalties. Canavan disease, affecting one in 6,400 children born to Ashkenazi Jewish parents, destroys the myelin sheaths that protect brain cells. Children afflicted are not able to walk, talk or eat by themselves, and usually die between ages 10 and 15. Miami Children's Hospital officials explain that they limited the number of laboratories that could perform the genetic test and the number of tests conducted each year in an effort to attract one company to do all the testing with an exclusive license and allow the hospital to "recoup the millions it spent to discover the gene." The hospital initially charged a $25 fee for every test, and although it later reduced the fee to $12.50, the Canavan Foundation was forced to stop offering free genetic screening. The lawsuit has attracted "little attention" so far, but the Tribune notes that it may "help establish rules of ownership of human genes at what many believe is the dawn of a biotech revolution"

(Gorner, Chicago Tribune, 11/19).
LANGUAGE: ENGLISH
LOAD-DATE: November 20, 2000