Provenge has not been shown to cure prostate cancer. But the drug will extend your life — by an average of about four months.
All that will cost is $93,000. The drug, now available through a Spokane medical group, has stirred controversy over how health care dollars are spent. It's also sparked hope about opening the door to future cancer treatments that use its unique formula. Provenge, which has lumbered through a rocky and sometimes strange journey from development to approval, uses patients' own cells to build a treatment that is injected back into them.
Critics wonder whether prolonging the life of a terminally ill person with ultra-expensive drugs is the best use of money and whether the development of such drugs is pushed too hard by for-profit pharmaceutical companies.
"I think one could question … the value of this kind of investment, versus screening thousands of people for cervical cancer," says Dr. Steven Clinton, director of the prostate cancer clinic at the James Cancer Hospital at Ohio State University. "It is no doubt controversial for the high costs and the perceived modest benefit."
It's not just an abstract question on how to spend $93,000. Earlier this year, Medicare — the federally run insurance program for the elderly — approved the drug for reimbursement. Every federal dollar spent on Provenge is added to the nation's unfunded Medicare liabilities.
Dendreon, the Seattle-based maker of Provenge, did not respond to emails or phone calls requesting comment.
Dr. Arvind Chaudhry of Spokane's Medical Oncology Associates believes that long-term advances in medicine come with expensive drugs.
"In our minds, every new treatment is expensive," says Chaudhry, who, along with his group, is now prescribing Provenge. "Insulin was expensive when it first came out. Now nobody thinks about it as an expense.
"There's been a lot of discussion about expensive drugs in the last, you know, years of people's lives and how much it really adds," he continues, "but that's how we make progress in cancer: by incremental steps."
Only a small percentage of Chaudhry's patients — a sliver of the 10 percent of people whose prostate cancer has spread to their bones — would be eligible to receive Provenge.
That is a message he wants to emphasize. "It's not for everybody who has prostate cancer," Chaudhry says. Clinton, from Ohio State, says that, in a broader sense, the future of immunotherapy is far from determined.
One reason is because people respond more reliably to conventional treatments like radiation or chemotherapy. With immunotherapy, however, for every 20 people treated, one may have a spectacular response while the rest are duds, he says.
therapy is a little more idiosyncratic," he says. "It only works in a
small number of people. How can we make it work for more people?"
Clinton and Chaudhry both suggest Provenge could be more effective if
used at earlier points in a patient's treatment, like before cancer
spreads to the bones.
In May 2007, the Food and Drug Administration told Dendreon that it would not approve Provenge without further clinical trials. After that, two of the FDA board members on that panel — both prostate cancer specialists — received hate mail and death threats, according to HealthBeatBlog.com.
"It's most likely that the hate mail came from investors who had watched Dendreon's shares climb from $5 in early January to $25.25 in late March — before plunging to $3 and change," the New York-based publication wrote. "One Alabama shareholder expressed his feelings on his MySpace page, where he asked ‘Hey, Hey, FDA, How Many Dads Did You Kill Today?' while images of [the two board members] flash across a backdrop of crooked crosses."
The drug also drew more scrutiny than usual from the Centers for Medicare and Medicaid, which conducted an independent review of Provenge before approving it.
If Provenge succeeds financially, money-conscious drug companies will consider expanding on it, Clinton believes.
"If there is a large profit margin, a pharmaceutical company will see this and say, "Hey, let's see if we can improve on this and make it better,'" says Clinton, who himself prescribes Provenge to certain patients.
That, says Clinton, is one of the problems with market-driven health care. While he thinks Provenge could advance the treatment of cancer in the long run, Clinton says having for-profit companies drive research is not good for the health care system.
"If we had an improved funding picture for the National Institutes of Health, which has basically been unchanged for almost a decade, we would see studies that are being designed that are focusing on better science, and with more focus on health outcomes than on financial issues relating to corporate policies," Clinton says. "[Funding has] been flat-lined for a decade.
"I for one would like to see a health care system based on good science," he adds, "for good benefit, where everyone has equal access."
NIH agency officials have told the Washington Post that, while the agency's budget doubled between 1998 and 2003, it has been steadily shrinking ever since. In February, the proposed 2012 budget for the NIH was predicted to be roughly what it was in 2000, according to those agency officials.
"Thirty years ago, the majority of biomedical research was funded by government," says Adrienne Fugh-Bermanm, director of PharmedOut, a watchdog group based out of Georgetown University Medical Center. "Now it's funded by corporations."
She says drugs like Provenge benefit from an industry fraught with conflicts of interest, with pharmaceutical money spent influencing researchers, doctors and public opinion. A better system would include more federally funded research, more sanctions on articles or journal pieces ghostwritten by the pharmaceutical industry, and fewer ties between physicians and the industry. That includes physicians who are working as industry representatives or speakers on behalf of drugs, Fugh-Berman says. "Physicians should not be drug reps, they should not be on speaker bureaus."
But beneath the disappointments of the American health care system, Fugh-Berman suggests, is an even more acute failing for the victims of cancer and those fighting the disease.
"There's a lot of sort of desperation and romance, if you will, around cancer drugs," Fugh-Berman says. "There are a lot of desperate cancer patients, and we have not gotten as far as we would like in successes for cancer treatment."
A version of this article first appeared in The Inlander's health magazine, InHealthNW.