How DC Is Nixing a Cancer Cure

What if they found a cure for a cancer that afflicts half a million people, but a combination of stupid bureaucrats and greedy doctors kept patients from getting it?

It's the kind of scenario that seems like the province of conspiracy theorists or alternative-medicine wackos—but is actually happening right now with a proven treatment for certain common types of non-Hodgkins lymphoma, the sixth-most frequently occurring cancer in the United States.

I'm a bit biased on this one, though the treatment in question is not yet relevant to the rare subtype of lymphoma (mantle cell lymphoma) that I had in 2004. But even if I weren't in the lymphoma family, I would still be outraged by this situation. You can count the number of truly successful cancer treatments on one hand, and one of them is about to disappear.

If there's any justice, heads will roll at the Centers for Medicare and Medicaid Services (CMS) over it. At a minimum, officials there should be facing some hellacious congressional hearings to force them to reverse a Nov. 1 "final ruling" that could doom this life-saver. Ted Kennedy should schedule hearings now.

The treatment at issue is called radioimmunotherapy (RIT), which uses a radioactive isotope to give standard anticancer agents an extra charge. The brand names for these targeted "radio-labeled" therapies, which have fewer immediate side effects than many conventional chemo drugs and need be administered in only a few doses over a two-week period, are Bexxar and Zevalin, both approved by the FDA for lymphoma.

Several clinical trials have shown that the drugs work for most patients. Some seem to have been cured (we won't know for sure for a few more years), and almost all have seen their lives prolonged, often significantly. According to one clinical trial, patients with follicular lymphoma who received standard treatment achieved remission 36 percent of the time. When Zevalin was added, the figure was 89 percent. Bexxar produced at least some response in 97 percent of patients in one study. Particularly for older patients who cannot handle a stem cell transplant, these are essential treatment options.

"RIT is the most effective, least used treatment in oncology," says Dr. Bruce Cheson of Georgetown University Hospital, who treated Sen. Fred Thompson for lymphoma. (Thompson's mild form of the disease did not require RIT.) Many lymphoma patients, including NEWSWEEK's Jamie Reno, believe they simply would not be alive today had they not received Bexxar or Zevalin several years ago.

Some nonradiological alternatives do exist. But another relatively new drug, fludarabine, described by some doctors as "just as good" as RIT, actually achieved results about 10 percent worse than Bexxar and Zevalin in one study, though it is preferable for some patients who cannot tolerate radioactive treatment.

You would think all of this would mean booming sales for Bexxar and Zevalin and cheering from the government, which has approved precious few drugs in recent years that actually show success in treating cancer.

Wrong. The fathers and mothers and husbands and wives and sisters and brothers who are living longer because of RIT are apparently of no (that's right: no) concern. Maybe these doctors and bureaucrats would feel differently if someone in their family had lymphoma.

The first reason RIT is in trouble has to do with doctors who work in offices or small hospitals that are not equipped for what is known as "nuclear medicine." Administering RIT requires special licensing and special equipment. Because most oncologists not affiliated with major cancer centers don't have that particular board certification or technology, they aren't likely to recommend that their lymphoma patients go for RIT at a big hospital. If they do, the doctors are more likely to lose patients and reimbursements, because once these oncologists send their patients to a doctor certified to administer RIT, as one specialist told me, "they don't come back." Not all of these office-park oncologists are greedy; some have good reasons to prescribe another treatment. It depends, of course, on the individual patient. But generally speaking, Bexxar and Zevalin are being dramatically underutilized, even though they have already saved thousands of lives.

With sluggish sales, the future of these wonder drugs is uncertain, as The New York Times explained in a front-page article last summer. But what the Times and the rest of the press has missed is that Washington is now poised to deliver the coup de grâce to RIT.

CMS, the most powerful federal agency you've never heard of, has total authority over which treatments Medicare and Medicaid will cover. Smelling weakness in the RIT market, it announced in August that it will reimburse hospitals less than 50 percent for Bexxar and Zevalin. Because hospitals can't be expected to pick up the other half (the drugs cost more than $25,000), this will mean the effective end of these life-saving treatments.

Even if a wealthy individual wants to pay out of pocket for RIT, it won't be available, because CMS says it will "terminate the provider agreement of any hospital" that administers the treatment to some patients but not to "Medicare patients who need it."

The absurdity of this defies belief. Here's the government acknowledging that many cancer patients "need" the treatment, but warning that if hospitals offer it, they will "terminate" their indispensable Medicare funding for the hospital!

CMS's excuse is that RIT is partly "diagnostic," which means, under complex funding formulas, that it is due less reimbursement. This is nonsense. As GlaxoSmithKline, maker of Bexxar, explained at length to CMS, the treatment is clearly therapeutic. The 1,500 patients and patient advocates who have contacted CMS to complain about the new policy agree.

Lest you think only drug companies and patients are up in arms about this, listen to Dr. Andrew Schafer, who is president of the American Society of Hematology, the most prestigious professional organization in blood cancer: "It [this ruling] will eliminate one of the few treatment options and perhaps the only treatment option for some patients with non-Hodgkins lymphoma who have failed chemotherapy treatment."

In other words, the patients die.

The American Society of Clinical Oncology (ASCO), the main organization of cancer doctors, agrees.

The response of CMS officials to all of this is puzzling. The spokesman for CMS, Jeff Nelligan, tried to get the bean counters there to answer my questions. But the official response is just a repetition of the claim that RIT is "diagnostic."

For an agency that spends more than a billion dollars a day, this may just be business as usual. Or perhaps public pressure can force powerful bureaucrats to feel ashamed of pulling the plug on their fellow Americans, desperately ill with cancer.