Drug Therapies: Quality of Life

by Food and Drug Administration (FDA)

For years Bonnie Clayton rarely made it to the bathroom in time. The 70-year-old Columbus, Ga., resident remembers many a humiliating stop by the side of the road. Then in February 2000, she began taking Lotronex, the only drug to give her instant relief from the urgent attacks of diarrhea that constantly plagued her. But just eight months after her miracle drug was approved, the manufacturer took Lotronex off the market — and with it, Bonnie's quality of life and her one chance to be free from the stranglehold of irritable bowel syndrome (IBS).

For three-time survivor Teddy McMillon, breast cancer set a frenzied pace. When the 66-year-old woman from Weatherford, Okla., wasn't having hot flashes, she was hallucinating. Once her heart was stabilized, her lungs gave out. Then there were the countless drugs, the vials of blood, a mastectomy — all between, during and after the CAT scans, x-rays, and chemo treatments. Add to that excruciating back pain, painful, cracking skin, and numbness in her fingers and toes. While many of the problems have been caused by the drugs that control her cancer, none of it is enough to make McMillon stop using Xeloda — the one drug that controls the cancer that has now spread to her bones.

Bonnie and Teddy suffer from very different diseases, but they face the same problem: maintaining the quality of their lives while battling their disorders. They are among millions of people undergoing medical treatments that in some way affect how they function every day. But since the quality of a person's life is rooted in daily and momentary experiences, the value placed on everyday living in the face of illness or disability varies from person to person.

Bonnie, for example, would gladly risk the known and unknown adverse reactions that come with Lotronex (alosetron) because the drug relieved her symptoms for the first time in 25 years. For her, Lotronex made life livable. Similarly, cancer patients like Teddy are often willing to suffer severe side effects because the therapies preserve their lives.

But for others, like colon cancer patient Sallie Forman, the toxic effects of treatment are so severe that any extension of life "just isn't worth it." She says only someone who has lived through constant side effects, every time they take a certain drug, can know what that's like.

The issue of an individual's perception about his or her quality of life now commands new importance in medical decision-making. It's no longer enough to know how a medical treatment preserves life or holds disease at bay. People have very real ideas about what states of physical well-being are desirable or undesirable. And because the patient's perspective is of great interest to those who make decisions about drug use, pharmaceutical companies want to incorporate findings about a treatment's impact on the quality of life into the labeling and promotion of their products. As manufacturers increasingly seek to make such quality-of-life claims, FDA is working with the companies and medical experts to determine which claims are justified and which are not.

But the agency's job of regulating these claims is not easy because little consistency exists in the way quality of life is measured and interpreted. Moreover, the issue is further complicated by the fact that there is no consensus about the preferred terminology — quality of life; health-related quality of life; health status — nor is there agreement on what standards should be used to allow such a claim. The complexity of these issues has caused FDA to begin reevaluating its approach to regulating how manufacturers communicate these important but difficult-to-define qualities in the information they provide about their products.

The division of drug marketing, advertising and communications (DDMAC) in FDA's Center for Drug Evaluation and Research (CDER) regulates all drugs marketed in the United States. DDMAC is in the process of developing a policy regarding the claims made in labeling and advertising about the impact of drugs on the quality of life, in cooperation with FDA's Center for Biologics Evaluation and Research. The policy will ensure that all relevant information about risks and benefits, including quality-of-life benefits, is supported by substantial evidence.

Pharmaceutical companies want to make direct quality-of-life claims for their products, or use equivalents such as "enhances social life," "expect a bright future," or "lead more active lives," because it helps them expand their markets. A growing number of therapeutics could even be considered lifestyle drugs because some of the disorders they treat are not life-threatening, and, depending on the individual, they can certainly add to life's enjoyment. The manufacturer of the drug Viagra, for example, might want to try to claim that as a result of reversing impotence, the drug enhances one's overall marital satisfaction. The company would need to provide evidence before FDA would allow it to make that kind of claim. Other examples might include estrogen replacement that quells the hot flashes of menopause; Accutane, which helps overcome acne; and Propecia, which may grow hair on a bald pate.

A Case in Point

The television commercial portrays an elderly woman on chemotherapy, planning her daughter's wedding. The woman claims the chemotherapy treatments make her too weak and tired to sew the wedding dress. A brief narrative describes Procrit (epoetin alfa) — a drug used to increase red blood cells lost during chemotherapy, and consequently, to boost energy — and how it provides "strength for living." The camera then pans not only to the completed dress, but to the same elderly woman, energetically dancing at her daughter's wedding.

Epoetin alfa was first introduced in 1989 by Amgen under the name Epogen to treat anemia associated with life-threatening end-stage renal disease (chronic kidney failure that requires regular dialysis or kidney transplantation for survival). Epoetin alfa is also marketed by another company under the name Procrit and used to treat other causes of anemia, such as elective surgery or chemotherapy, as portrayed in the ad. But FDA required additional evidence to support the acceptability of the claims that Procrit could restore energy and reduce fatigue, which are symptoms of anemia, when conveying the benefits to consumers.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.