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Marketing, media, wishful thinking, and conflicts of interest: inflating the value of new medical technology.

In 1991, Nelene Fox, a 38-year-old mother of three, was diagnosed with breast cancer. She underwent bilateral mastectomies and chemotherapy but nonetheless developed bony metastases. Her physicians said her only chance for survival was high-dose chemotherapy and autologous bone marrow transplantation. Her Health Maintenance Organization (HMO) refused to cover the procedure (around $140,000) on the basis that it was experimental.1 
 
Her husband launched a successful fundraising effort, and Mrs Fox received the procedure, but died eight months later. Her brother, an attorney, sued the HMO for the delay in her therapy, and won $89 million in damages. Similar lawsuits played out across the country with similar awards. 
 
For the media, this was an irresistible David and Goliath story: relatively powerless individual patients were bringing insurance companies and HMOs to their knees. Reporting focused on access to the new technology, not questioning whether it was effective. With the media frenzy and lobbying, lawmakers began requiring insurance coverage for the new procedure. Insurers, facing lawsuits, bad publicity, and new legal requirements, began to routinely cover the new procedure.2 
 
Physicians and hospitals were generally enthusiastic, optimistic, and sincere in supporting the new regimen for late-stage breast cancer, and the new approach was a financial windfall for physicians and hospitals. Clinicians became vocal advocates for the procedure, and frequently were witnesses in court. Many joined complaints against insurers. Some hospitals built new wings to accommodate patients having the procedure. 
 
However, as clinical trial results rolled in, the story began to unravel. An early positive report from researchers in South Africa proved to be fraudulent. National Institutes of Health (NIH)-sponsored trials, long delayed, finally showed the new treatment to be no more effective than standard chemotherapy, but more toxic. The trials were delayed because women were convinced the procedure was effective, and few were willing to submit to randomization with a chance of receiving standard therapy. By the time the negative results became available, 42,000 women in the US had been treated at a cost of $3.4 billion.2 
 
The approach was rapidly abandoned, but, in retrospect, medical theories, professional egos, wishful thinking, financial incentives, and the media helped disseminate a new technology that decreased quality of care and increased costs. Clinicians sincerely believed the treatment was effective, but theoretical advantages and financial incentives may have obscured the lack of sound evidence. When access to care is a problem for millions of Americans, one may reasonably ask if there were better ways to deploy $3.4 billion.