What is the value of a few months of life?
That question is at the center of one of the most controversial debates in medicine today involving a new generation of hyper-expensive cancer drugs.
On Tuesday, the Food and Drug Administration approved GlaxoSmithKline's Tykerb, a once-a-day pill for late-stage breast cancer patients that costs nearly $35,000 a year. It's the latest of half a dozen new cancer therapies with names such as Avastin and Tarceva that can run as much as $100,000 for an annual supply.
Although the medications work much longer in some patients, they help extend the lives of most for only a few months.
The drugs' sky-high costs compared with their relatively small health benefits have sparked arguments among policymakers and medical professionals about what to do with the growing number of people who are depleting their life savings on the drugs or, worse, who can't get them at all.
More broadly, they ask, is this the best way for society to spend its increasingly limited healthcare dollars?
Harriet and Mort Frank illustrate the ethical and financial dilemmas.
Since December, the retired Mission Viejo couple have been paying as much as $2,000 a month in out-of-pocket costs for Harriet's lymphoma medication, Rituxan, by Genentech Inc. and Biogen Idec Inc.
The Franks get by on $1,432 a month with their combined Social Security checks and a small amount of savings. But with the drug's expense eating into their modest nest egg, they're worried about what might happen next.
"So far this medication is working wonders," Mort said. "But I keep thinking, how are we going to keep affording it?"
Drug companies and many patients insist even incremental gains are worthwhile. Small clinical advances are likely to turn into larger ones over time, and patients who can afford the treatments say they deserve them.
Traditionally, drug companies have said the prices of their drugs are based on the costs to develop them. Now, they say, drugs are priced according to what the market will bear.
"The cost of our product incorporates both the extensive costs incurred during research and development as well as the price determined by the market, " said Walter Moore, vice president of government affairs for Genentech in South San Francisco.
But doctors, patient advocates and healthcare economists warn that the drugs are simply too expensive at a time when medical costs are rising rapidly -- and more patients are picking up a growing share of their medical bills.
The costs aren't borne only by those who are sick. Because insurers pay for almost all federally approved drugs, the costs of covering them would eventually spill into the nation's overall medical bill and therefore would raise everyone's insurance premiums.
This year, cancer drugs are expected to account for nearly 22% of the nation's drug bill, up from 13% in 2002, according to Morgan Stanley.
Several countries, including Britain, refuse to pay for the drugs for all patients. Here, Congress is considering legislation to control the costs of biotech drugs.
The debate also is raging among oncologists, who admit being torn about wanting to give patients marginally effective drugs that could cause serious financial harm.
"These drugs are good, but it's important to remember they aren't a cure," said Peter Eisenberg, an oncologist at California Cancer Center in Greenbrae, Calif. "Drug companies are in another world if they think people can afford these things."
Dr. Edith Perez, co-director of the breast cancer center at the Mayo Clinic, said some patients with insurance were paying thousands of dollars for the therapies.
Because many patients now pay as much as 30% of their medical bills rather than flat co-payments, some physicians have started offering payment plans for patients who rack up bills as high as tens of thousands of dollars, Perez said.
In the current issue of the Journal of the American Medical Assn., a general practitioner from Oklahoma City described his experience with the lack of uniform access to new cancer drugs.
In a one-page commentary, Dr. Perry Klaassen, 66, wrote how he was diagnosed with colon cancer in 2001 and was surviving because of a series of cancer drugs he has taken regularly since then. He pays $450 a month, which he described in an interview this week as manageable.
One of his patients wasn't so lucky. Three years ago, Klaassen diagnosed a 63-year-old woman with late-stage colon cancer. He recommended that she try chemotherapy and other drugs, but she declined, saying she didn't have insurance and didn't want to burden her family with unneeded debt. She died a year later.
"We have to be able to do better than this," Klaassen said.