The children of a 62-year-old Indiana woman are trying to pressure a Maryland biotech company into treating their mother's pancreatic cancer with an experimental drug not yet approved by the U.S. Food and Drug Administration.
The three daughters of Connie Loughman held a news conference at their parents' Indianapolis home yesterday, pleading for access to the drug. They have launched a video on YouTube devoted to their mother's plight and set up a Web site asking people to e-mail executives at Gaithersburg's GenVec Inc., which is testing the promising cancer treatment.
Company executives say they cannot help until they get more clinical trial information -- maybe not even then. GenVec's entire drug supply is committed to trial participants.
"We are very sympathetic to this family. We know how devastating this diagnosis is, and we're doing what we can to move the drug forward," GenVec Chief Financial Officer Douglas Swirsky said yesterday. "But as a company, we've elected to defer establishing a compassionate-use program until additional data comes out."
The Loughmans are asking for what is known as "compassionate use" treatments -- allowable under a provision within federal regulations -- of GenVec's TNFerade, which is in late-stage clinical testing.
Over the years, more than 100,000 people in life-threatening situations have been allowed access to developing drugs, according to the FDA, which gets about 660 requests for compassionate-use treatments each year. But the companies that make the drugs are often reluctant to get involved in those programs, worried about increasing already high development costs, doing unnecessary damage to patients or falsely raising people's hopes.
Columbia's Osiris Therapeutics offers one of its developing stem cell treatments to children. But the company no longer offers it to adults because it is too expensive.
Navdeep S. Jaikaria, a biotechnology analyst with Rodman & Renshaw in New York, points out that GenVec's TN Ferade is nearing the end of its testing, and he worries that changing the trials could interfere with the drug's commercialization.
"The thing is, you don't know," he said.
While Loughman's daughters understand the business logistics involved, it does little to mitigate their concerns. They've offered to pay for the drug and release GenVec from all liability, and now they've taken their campaign public.
