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Seniors gain access to new treatments

Tampa Bay area doctors hail President Clinton's order that directs Medicare to cover the cost of clinical trials.


© St. Petersburg Times, published June 8, 2000

The 65-year-old woman with breast cancer who finds hope in a new drug. The 75-year-old man seeking a way to save his sight. An elderly man in the early stages of Alzheimer's, eager to try an experimental drug thought to slow the effects.

Tampa Bay doctors see scores of patients like these who could benefit from experimental treatment. Now they, along with millions of elderly and disabled patients, will have access to cutting-edge medicine under a new rule requiring Medicare to cover medical costs for those in clinical trials.

President Clinton signed the order Wednesday, saying he hoped it would help shrink the large gap between the number of ill seniors and the number enrolled in clinical trials to test new therapies.

Although the elderly account for the majority of cases of chronic conditions such as cancer, heart disease, stroke and Alzheimer's disease, only 1 percent of senior citizens participate in clinical trials, the White House said.

Often that's because Medicare, which covers 39-million people, typically won't pay for experimental treatment.

"This type of thing allows funding to permit us to transfer the breakthroughs that occur in the laboratory to the patient's bedside faster," said Dr. W. Michael Alberts, chief medical officer and associate director of clinical affairs at the H. Lee Moffitt Cancer Center and Research Institute in Tampa.

"Given the realities of modern-day society, these drugs and treatments cost significant amounts of money. It will be easier to provide these treatments to more and more people."

The shortage of seniors in clinical trials makes it hard for doctors to know how new drugs or operations will work in the elderly, and many treatments have never been tested on seniors. Dr. Bruce E. Robinson, chief of geriatrics at Sarasota Memorial Hospital and a fellow of the American Academy of Geriatrics, typically won't even try a drug until it has been on the market for 5 percent of the patient's life.

That's four years for an 80-year-old. Robinson hopes that's enough time for unsavory side effects to surface.

"Those of us who deal with seniors have long recognized the difficulty of understanding what will happen to a senior when a new treatment first comes out," he said.

Local doctors said they expect the change will have the biggest impact on seniors who face the most expensive experimental treatment, such as cancer care. According to a December article in the New England Journal of Medicine, 63 percent of all cancer patients are older than 65, but they make up just 25 percent of people enrolled in cancer studies.

A December report from the national Institute of Medicine recommended the Medicare change, and it affirmed what many doctors who treat the elderly here already knew:

When it comes to choosing a traditional treatment that Medicare covers versus an experimental therapy Medicare might not, many prefer not to risk it.

"If you're not sure your insurance is going to cover it up front, you wouldn't sign up, perhaps, if you knew you might get stuck with a $20,000 medical bill," said Dr. Allan Goldman, professor and chairman of internal medicine at the University of South Florida, which conducts hundreds of trials a year. "This removes that risk."

But doctors also stressed the new rule isn't a miracle cure. A big reason seniors aren't included in more trials is because they often have other medical conditions that can skew or obscure the results.

"There's lots of random noise that is often hard to disassociate from the effects of the treatment or the disease," Robinson said. "Clinical investigators . . . like to deal with the youngest and healthiest patients they can find."

Clinton's edict won kudos from Sen. Connie Mack, R-Florida, who lobbied for it for four years, as well as advocates for the elderly and national medical groups.

The change is to take effect within a week.

The White House did not say how much it will cost, but the Institute of Medicine had predicted it would be small. The rule covers doctor's office visits, lab tests and other care needed by a patient participating in a trial that Medicare normally would cover if it were part of traditional treatment. Medicare already may have paid 50 percent to 90 percent of such costs for elderly people who take part in clinical trials because claims don't normally indicate if a patient is participating in a trial. But Medicare has generally deemed such bills improper when audits have uncovered them.

Officials at USF and Moffitt, which together serve as the region's research hub, are trying to determine how the rule will affect their work and their patients.

But some doctors said they're more excited by the broader implications. Dr. Stephen P. Glasser, head of clinical pharmacology at USF, said it's good for researchers, government regulators and seniors themselves to realize the need for recruiting more elderly.

And private insurers, who typically approve experimental treatments on a case-by-case basis, often follow Medicare's lead. That could make it easier for others to persuade private insurers to cover experimental treatment.

"I think that's the trend," Goldman said. "They're almost looking at it as an investment, that the more you learn from these sorts of things the better the care you end up delivering and, hopefully, the more cost-effective it is."

-- Information from the Associated Press was used in this report.

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