NEWS

Clinical Trials Provision Makes Way Into Patients’ Bill of Rights

F. B. Dunn

For nearly a decade, cancer advocates have been pushing for mandated insurance coverage of the so-called routine costs of care for patients enrolled in trials. Denying usual care to patients because they chose to aid research was not only blatantly unfair, they argued, but inhumane too.

Their calls largely languished until 1999, when a chance meeting between then Arizona Congressman Matt Salmon and noted oncologist Sydney Salmon, M.D., at 30,000 feet prompted a flurry of Congressional activity that culminated in this summer’s Senate passage of a Patients’ Bill of Rights that includes the trials provision.

The cancer community paints the provision as vital to advancing research. Some 400 promising compounds—many of them the product of molecular targeting techniques that produced the groundbreaking Gleevec—sit on the lab shelf, awaiting their turn in the human testing hopper. The culprit: chronically low numbers of patients in clinical trials. Fewer than 5% participate.

"If we don’t somehow increase the level of participation, many of these exciting new drugs will be in limbo for a long time," said Robert Comis, M.D., head of the National Coalition of Cooperative Groups. "It’s clear that clinical testing is the major bottleneck in bringing drugs to market."



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Dr. Robert Comis

 
Opinion varies on the effect the mandated coverage of items like routine office visits, blood work, and imaging scans for study patients will have on trial accrual. (Under the Senate and House bills, research sponsors will continue to pay for costs directly related to their studies—new drugs, extra scans, and the like.) While such coverage is almost universally hailed as important, researchers worry that other significant barriers will continue to stymie advancements.

For instance, funding from the National Cancer Institute is low, say trials experts. In 1996, NCI funded trials at about half the level that its advisory boards recommended, furnishing 4% of its total budget, or $89 million. That percentage has remained stable, but the dollar amount jumped to $144 million in 2000—a 62% increase. "Since Dr. [Richard] Klausner took over [as NCI director in 1995] there have been some badly needed funds infused into clinical trials," said Comis. "But reaching our goals will require more resources from both the public side and the private side."

Patient awareness—or lack of it—presents a less clear-cut obstacle. A recent poll of 6,000 patients, sponsored by several cancer organizations and conducted by Harris Interactive, reported that a full 85% of patients knew nothing about clinical trials.

And though many insurance companies already cover usual care costs for trial patients, and several states have mandated coverage in recent years, word has yet to filter down to patients. According to Harris, 60% of trial nonparticipants believed their insurance company would not pay. But in the end, 79% of trial participants did obtain coverage; of those, just 5% reported tedious wrangling with their insurer.

In a similar vein, even though great hoopla surrounded President Clinton’s decision last summer to add the benefit to Medicare, few patients have taken advantage of it, according to cancer lobbyists. The problem? Physicians do not always inform patients of their options.

The Harris poll backs up the claim. Of patients who enrolled in trials, 77% heard about the option from their physician. Of those who did not enroll, just 35% said their physician mentioned trials.

A Tale of Two Salmons

Though other barriers exist, advocates expect the provision to boost trials awareness and enrollment. Patient groups lobbied Congress starting in 1993, when Hillary Clinton included insurance coverage of trials in her doomed health plan. After that debacle, Congress neglected health care issues for several years.

Then in 1996, cancer advocates won the ear of Sen. Edward Kennedy (D-Mass.). David Nexon, Kennedy’s health adviser, said that they had heard from a multitude of patient groups; complaints of low trial participation from leaders at Dana-Farber Cancer Institute in Boston proved most influential. Insurance companies had traditionally paid for routine trial care, said Nexon, but as HMOs came to dominate the scene, "we weren’t too sure they would continue the tradition. We needed to act to hold on to what we had."

On the House side, things took longer to develop, languishing until a bizarre moniker coincidence in 1999. Arizona Congressman Salmon (R), best known for leading the 1998 revolt against Newt Gingrich, was flying to his home state from Washington. He struck up a conversation with the older gentleman next to him.

Within a minute, they connected: his seatmate was the late Sydney Salmon, M.D., founding director of the Arizona Cancer Center, Tuscon. A staunch advocate of clinical trials, the elder Salmon pitched his case to the youngish Republican. "He said, ‘Matt, the best thing you can do to help cancer patients is get insurance companies to play,’" recalled Salmon.



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Dr. Sydney Salmon

 
Inspired by the doctor’s fervor and compassion, Matt Salmon drafted a stand-alone insurance-provision bill. As House members readied three competing versions of a Patients’ Bill of Rights, Salmon convinced all of them to include his bill’s language. Later in the year, the House and Senate passed vastly different versions of patient rights bills, though both included the clinical trials language. The legislation stalled in conference committee.

Dismayed but not defeated, advocates went back to work, with the American Cancer Society taking the lead. They lobbied hard on a dangling but important issue. The Senate bill provided insurance coverage for government-sponsored trials, but left out the larger set of industry-sponsored trials.

Against a backdrop of badgering from the insurance industry—Health Insurance Association of America spokesman Joseph Luchok said companies were worried about paying for trials "that have no scientific validity"—the ACS hammered away at Kennedy and other senators, saying that access to private trials was vital. Just days before the June 29, 2001, Senate vote, Kennedy relented and included language covering all FDA-approved trials. The House followed suit.

"Dr. Salmon had explained to me that not only was this the compassionate thing to do," said Matt Salmon, "but that beyond that, virtually every treatment we have has been developed through clinical trials. If we don’t have that continued support, advances in the war on cancer are going to be slim."



             
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