The Women's Health Resource. On the web since 1997.

Clinton Orders Medicare to Cover Clinical Trial Costs for Seniors (dateline June 14, 2000)

President Clinton has issued an executive memorandum that requires Medicare to cover the cost of clinical trials for senior citizens in the United States.  According to a White House press release, too few senior citizens participate in clinical trials, despite the fact that the majority of health conditions occur among the elderly.  The new coverage will encourage clinical trial participation by fully reimbursing seniors for treatment and patient care costs incurred during clinical trials.  Medicare coverage should begin in mid-June 2000. 

“America’s seniors are badly under-represented in clinical trials, yet, they bear the heaviest share of illness,” said President Clinton.  “These trials may prolong lives and they are central to finding cures for deadly diseases.  Simply put, the more seniors we enroll in trials, the faster we’ll be able to use these advances to save American lives.”  Clinical trials often compare a new method of treatment (for example, a new breast cancer drug) to a standard one to determine whether the new treatment is safe and effective.

The White House attributes the low rate of clinical trial participation among the elderly to the fact that Medicare does not routinely cover the cost of clinical trials.  Consequently, “[seniors] assume they’ll be saddled with thousands of dollars” in treatment bills if they enroll in clinical trials, said President Clinton.  

It is estimated that approximately 1% of seniors participate in clinical trials in the United States.  Participation among older breast cancer patients is particularly low despite an abundance of trials.  Senior citizens make up 44% of the total number of breast cancer patients yet only 1.6% of seniors participate in clinical trials.

President Clinton cited a number of reasons why he issued an executive order requiring Medicare to cover the cost of clinical trials for senior citizens:

  • too few seniors participate in clinical trials
  • current Medicare policies discourage many seniors from participating in trials
  • increased senior citizen participation in trials will lead to advances in the treatment of many diseases

Breast cancer organizations are praising President Clinton’s executive order.   Nancy Brinker, founding chair of the Susan G. Komen Breast Cancer Foundation, said that senior citizens will now be able to receive the “gold standard” of care for breast cancer and other diseases.  Patients with cancer, heart disease , diabetes, Parkinson’s disease, Alzheimer’s disease, and other conditions may benefits from the new Medicare coverage. 

Several clinical trials are currently recruiting breast cancer patients or women at high risk for the disease.  In 1998, a six-year clinical trial conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) compared the drug tamoxifen to a placebo to determine whether tamoxifen could effectively prevent breast cancer in high risk women. The trial revealed a 49% decrease in the incidence of invasive breast cancer in women who were given tamoxifen in the study.

A second trial by the NSABP called the STAR trial is currently underway that will compare the effectiveness of tamoxifen with raloxifene, a promising new drug that may help prevent breast cancer in women over age 35 who are at high risk for breast cancer. The STAR trial is still recruiting participants across the United States and Canada.  Click here for more information on eligibility requirements and how to enroll in the STAR clinical trial.  

Additional Resources and References