The market for potential miracle drugs designed to fight cancer has united consumers and manufacturers of oncology drugs in a way unique to the principals of modern product development. Because the amount of time it takes an oncology drug to reach consumers can be detrimental to both the patient and the manufacturer, both parties often try to find ways around the regulatory actions of the United States Food and Drug Administration (FDA) in order to benefit their very different motivations. However, in doing so, consumers release manufacturers of all liability related to experimental drugs, and this fact has generated serious concerns within the oncology community.
“Most agree that cancer drug development is a lengthy process and everyone would like to see it shortened,” said Richard Lee, MD, assistant professor and medical director at the Integrative Medicine Center, M.D. Anderson Cancer Center, in Houston, TX. “The only balance point is safety. Do we rush approval of drugs that we don’t fully understand and might have some hidden dangers? [Patients with cancer] are a very vulnerable population. They’ll do anything to save their lives.”
A Patient’s Battle
One of these patients with cancer is Patsy Hinson, who, upon word she had stage 3 ovarian cancer, did not hesitate to get the blessing of her oncologist in North Carolina to forgo chemotherapy and enroll in a 22-week, blinded clinical trial of the drug Avastin (bevacizumab). Hinson’s cancer went into remission while she unknowingly received a placebo. When her cancer returned 3 years later, Hinson demanded the clinical trial be unblinded so she could make the right decision about which drug to take to combat the recurrence of disease. After finally receiving Avastin, Hinson’s cancer went back into remission. Although she is thankful, she noted that it was an equal measure of the drug itself and her sole determination to put up a very big fight in order to get a second shot at the drug she thought cured her the first time.
“I had to do all the work in getting the drugs. Clinical trials are so bureaucratic and complex, it’s very difficult for oncologists to have the time to look beyond their own cancer center,” said Ms. Hinson.
Patients with cancer are fighting harder than ever for access to the drugs and treatments that may help cure their cancer, taking their arguments to court if necessary. Drug manufacturers feed on this desire and both parties appear determined to create a legal precedent for institutionalized relief from medical malpractice responsibility when it comes to possibly preventing death as a result of cancer. This puts oncologists in an awkward position—stuck between practicing medicine the way they have been trained, and relinquishing control of patient management to a maze of separate, but far from equal, interests.