The Battle Over New Cancer Drugs
This story was reported in partnership with Business Week. To read the magazine's report, "Cancer's Cruel Economics," click here.
Dr. Oleg Loran is excited. Soon he'll have a new treatment to offer his kidney cancer patients - a vaccine designed to stimulate their immune systems to fight the disease.
"Of course it is a breakthrough," Loran said through a translator.
There's just one catch. The only place that cancer patients can get this treatment is in Russia. Why? The reason has to do with the way the FDA approves cancer treatments, CBS News medical correspondent Dr. Jon LaPook reports.
The vaccine was tested in a five year clinical trial, but there was no statistical evidence that it helped patients live longer.
However, Antigenics, the vaccine maker, looked a group of patients in the trial who received the vaccine when their cancer was in its early stages.
This group seemed to benefit. On average, it increased the time before their cancer returned by almost two years.
That was good enough for Russia, which approved it in April, and the company plans to submit it for approval in Europe soon. But for it to be considered in the United States, the FDA would require a whole new trial.
"If you were to do the study the FDA would like you to do, what would it cost you in time and money?" LaPook asked.
"Another seven years, and another $4- or $500 million," Antigenics founder Garo Armen said. "We can't do that and neither would anybody else."
Armen founded Antigenics 14 years ago; one of many small biotech companies with big ideas about treating cancer. He believes the FDA drug approval process is too costly and inflexible.
"We're driven by the fact that the drug works and it's our moral and other obligation to reach patients," Armen said.
But before any new cancer drug reaches patients in the United States, it must pass the review of Dr. Richard Pazdur, one of the most powerful and controversial officials at the FDA.
Pazdur is the director of the FDA's Office of Oncology Drug Products.
"If you took this job to make people happy, this is not a job to make everybody happy," he said.
He has become a lightning rod for criticism by cancer advocates who say the FDA is too slow to approve new therapies.
"It is an irrational accusation that is made, that we're sitting here somehow plotting against the pharmaceutical firms or plotting against a particular drug."
Pazdur says he holds cancer drugs to a simple standard: Do they work?
"We have to be confident that this is a real drug, one that works for the American public," he said.
But is the system working? Although the number of drug approvals has gradually risen over the last 20 years, only 8 percent of experimental drugs were approved from 1990 to 2006. That's a total of just 32 new cancer medications.
And that's not good enough for Kathy Giusti, diagnosed in 1996 with a blood cancer called multiple myeloma. Doctors told her she would not live to see her children grow up.
"I remember calling my sister and saying, 'I will fight. I will fight really hard, but there's nothing to fight with,'" she said.
So she fought back the only way she knew, creating a Myeloma foundation that runs like a business; researchers who are usually competitive now have to share information in order to get funded.
"We've had four new drugs approved in the last four years," she said. "That's unheard of in oncology."
Those very drugs have helped Kathy stay alive.
"I want to be there every moment for them because, I don't know, that may be the last time I see a moment like that," Giusti said.
More information
You can learn more about how the FDA regulates and approves new cancer drugs here. Find out how you can get access to unapproved drugs on the FDA oncology Web site. For a full list of approved oncology drugs, and to learn more about their specific approved uses, click here. Having trouble understanding some of the medical jargon? For a dictionary of certain terms used in the oncology drug review process, check out this site. Also, you can find out more about specific diseases these drugs treat here. Check out the Web site of the National Cancer Institute here and see what cancer trials it is working on here.
