Fighting Cancer With Star Power

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You Tube can make anyone famous. That's what three sisters in Indiana are hoping for as they fight to save their mother.

She's no Patrick Swayze, but Connie Loughman is one of thousands of people like the actor who is suffering from pancreatic cancer. Having been denied access to an unapproved drug they're hopeful could help her, the Loughman sisters have now turned to the power of YouTube to cut through red tape.

Online Plea for Help

Armed with an online video and a Web site devoted to their cause, the family is encouraging people to blitz the biotech company conducting the drug's clinical trials to convince them to help cancer patients like their mother.

"Ever since my mom got sick, I've been searching — there's got to be something," said 35-year-old Jackie Loughman. "We told them, 'We'll pay for it, we'll release you from liability, we'll do anything that we can.'"

Like several families in their position, Connie Loughman's family has been trying to get access to the drug undergoing trial through an alternate avenue known as compassionate use.

If a drug company gives its okay, the request can proceed to the Food and Drug Administration (FDA) for approval.

Dangers of Drug Trial Access

According to a 2003 FDA report to Congress, the FDA reviewed 557 of those submissions in 2002 and approved the majority of them.

The FDA can also deny those requests for safety concerns or if it concludes that "available scientific evidence does not provide a reasonable basis for concluding that the drug may be effective and would not expose patients to serious additional risk of illness or injury," the report stated.

In the Loughman's case, GenVec, the company testing the cancer drug, denied the Loughman's request.

Robert Young, chancellor of Fox Chase Cancer Center in Philadelphia, emphasized why companies don't always give the green light. He said there is significant reason to be cautious in allowing patients to have access to drugs in the trial phase.

"I think most of us involved with clinical trials and most people who've cared for cancer patients for a long time are uncomfortable with that strategy," Young said.

Young added that allowing just anyone to test the drug slows the pace by which doctors learn whether or not a drug works. Allowing increased access can also make it more difficult for a drug to get approved, compromising its track record if people opt for it in the very last stage of their illness, he said.

But some people who have fought vigorously for access to these medications contend that the potential rewards far outweigh the risks.

"Only the lucky few who can get into clinical trials get the benefits of these drugs," said Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs. "It's an unnecessary tragedy."

Advocacy Group Fights for Access

Burroughs started his group in 2001 on the day his daughter, Abigail, died of cancer after struggling to get access to clinical trials. Burroughs said that of the 16 drugs his group has subsequently advocated for, every single one of them is now approved by the FDA and remains on the market.

The Abigail Alliance has also lobbied for a bill in Congress on the topic for several years. Though introduced in the House and Senate in the 109th Congress, the legislation has not yet been reintroduced in the current session of Congress.

Burroughs has also sued the FDA in hopes of patients gaining earlier access to promising developing drugs; the Supreme Court decided in January 2008 not to hear the case.

According to the American Cancer Society, it's estimated that more than 34,000 people in the United States will die of pancreatic cancer in 2008. Pancreatic cancer is the most deadly of all cancers, with a patient's chances of living for five years the lowest for any cancer.

"I think it's just awful that they're making people suffer like this when they know there's just something that can improve their chances," Jackie Loughman said.

"The fundamental principle of drugs is that they need to be safe and they need to be effective," Young said. "Unless we know that, we need to be cautious about giving them out to people."

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