Robert Goldman is a geek's geek, a Silicon Valley inventor who likes to know exactly how things work.
He tinkered with interactive television back in the day. More recently he developed and sold the patents to key bits of the technology that makes downloadable music possible. His sharp mind has made him rich, but even Goldman has his limits when it comes to understanding how life works.
Like when his sister was diagnosed with colon cancer in 1998. How could anyone understand how that works? Goldman, who is used to finding answers, was the one left asking, Why?
"You go to the doctor and they say to you, 'You've got a 30 percent chance to live,'" says Goldman, 50. "What is this, a lottery?"
He was inspired by his sister, Amy Cohen, who was a fighter. She'd just given birth to a baby girl when she was diagnosed. She fought to be granted compassionate use of an ImClone drug awaiting federal approval. When her appeals to the company were denied, she called ImClone President Sam Waksal directly and persuaded him to give her the drug.
Her story made "60 Minutes," but her persistence did not save her life. Cohen died in 2003 at age 39.
Meantime, Goldman had started researching cancer treatment. What was the state of the art? What had been tried? He seized on the idea that if chemotherapy could be applied directly to tumors instead of throughout the body, some patients would have a better chance.
What he needed, he figured, was a catheter that would deliver drugs right into the blood vessels supplying cancerous tumors. He pondered and tinkered and read up on medicine and devices.
"I never had any experience with medical devices," he says. "I didn't have a clue."
He started talking to doctors. The first question they'd ask, he says, was: "Where did you get your medical degree?"
"I don't have one of those," he'd reply sheepishly. Sometimes that was the end of the conversation. Then Goldman put calls in to a couple of Stanford University Medical Center doctors. They were in Silicon Valley. Maybe they'd understand that good ideas can come from anywhere. Dr. Huy M. Do, an interventional neuroradiologist at Stanford, still remembers his initial reaction about five years ago.
"Who is this crazy guy?" Do says. But he was moved by the story of Goldman's sister and the more he listened, the more Goldman's conceptual design made sense.
"He's obviously very bright, just a great innovator," says Do, an unpaid Goldman adviser. "He's a very positive guy." Do told Goldman to keep working, concentrate on making the device smaller.
Goldman tweaked and tweaked. He formed a company, Vascular Designs, headquartered at his home. He lined up angel investors and $1.8 million in seed money. He added about $3 million of his own. He submitted his design to the Food and Drug Administration. It was rejected. Three times. Then in May, he got it: FDA approval.
"What did I do when I found out?" Goldman says. "I cried." It was a good cry.
"The fact that he was somehow able to get this through the whole FDA system that everybody complains about," says Stanford's Dr. Michael Dake, another unpaid adviser, "that's an amazing story."
It's still too early to know how widely the catheter, known as the IsoFlow, will be deployed. Every cancer case is different and Goldman's catheter is not right for all cases. Goldman's push now is to persuade doctors to try the catheter.
A Wisconsin neurologist became the first to use it recently with mixed results. The device functioned as designed, but the patient's tumor was situated in such a way that the doctor could not thread the catheter all the way to the blood vessels feeding the tumor, says Goldman, who attended the surgery.
Goldman is undeterred. He is continuing to refine the IsoFlow. There will be other cases, he says.
And if he's learned anything in the years since his sister died, it's that sometimes it takes a setback to inspire success.
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