Generic vs. Brand-Name Drugs, Stress & Breast Cancer Survival

Health Report:

Generic vs. Brand-Name Drugs

Stress & Breast Cancer Survival

"A critical weekly review of important new research findings for health-conscious readers..."

By, Robert A. Wascher, MD, FACS

Last Updated: 12/7/2008

The information in this column is intended for informational purposes only, and does not constitute medical advice or recommendations by the author. Please consult with your physician before making any lifestyle or medication changes, or if you have any other concerns regarding your health.

GENERIC vs. BRAND-NAME DRUGS

The FDA requires that all generic drugs be equivalent to their far more costly brand-name counterparts in terms of dosage, safety, strength, quality and clinical performance. Despite these requirements, some patients, and even some doctors, continue to prefer brand-name drugs over their generic versions. However, because brand-name drugs cost so much more than generics, health insurance plans are increasingly favoring the use of generic drugs, whenever they are available. In view of the ongoing healthcare crisis in our country, a greater reliance on generic versions of drugs could significantly reduce skyrocketing healthcare costs in the United States. A new research study from Harvard University, just published in the Journal of the American Medical Association, has exhaustively reviewed the available research comparing generic drugs prescribed for cardiovascular disease with their more expensive brand-name counterparts.

In this study, the authors comprehensively reviewed all previously published studies comparing generic with brand-name cardiovascular medications between 1984 and 2008. Altogether, 47 published research studies were analyzed, 81 percent of which were prospective randomized clinical trials (the “gold standard” method of performing clinical research).

Virtually 100 percent of the previously published research trials found generic drugs to be clinically equivalent to their brand-name counterparts. However, a simultaneous review of 43 editorials published on this same topic, in peer-reviewed medial journals, found that 53 percent of these editorials disapproved of generic drug substitutions. Therefore, while the clinical evidence overwhelmingly supports equivalent efficacy between generic and brand-name drugs, more than half of all medical journal editorials published on this topic between 1984 and 2008 advised against the use of generic cardiovascular medications! This surprising degree of bias against generic medications on the part of academic physicians who serve as medical journal editors, despite overwhelming research evidence to the contrary, speaks volumes about at least one of the causes of soaring healthcare costs in this country. While this research study did not evaluate the causes for physician bias in favor of brand-name drugs, you can bet that at least part of the explanation lies with the aggressive drug company salesman and saleswomen who, daily, bombard harried physicians with pitches in support of their companies’ expensive brand-name medications. While most physicians claim that their prescribing habits are not affected by the gifts, fees and favors that are commonly bestowed upon them by drug company representatives, multiple clinical research studies have convincingly shown otherwise. It is not surprising, then, that the “Big Pharma” drug industry spends an estimated $7 billion per year on “detailing” physicians in the United States. And they spend this enormous sum of money on their outreach activities to physicians for one simply reason: because it works.

We must find ways to improve upon an increasingly unhealthy healthcare system that has become both dysfunctional and unaffordable (we spend more, per capita, on healthcare in the United States than any other country, and yet we have poorer health outcomes in multiple important public health areas than most other industrialized countries). In my view, companies like Walmart, and several other large pharmacies, are to be congratulated for their recent initiatives in offering heavily discounted generic prescription drugs to the public (in the case of Walmart, most generic prescriptions drugs cost only $10.00 for a 90-day supply!). [Disclaimer: I own no Walmart stock, and have no financial, or other, relationship with this company.]

I, and millions of other Americans, routinely take generic medications, when they are available. If we are going to pare down runaway healthcare costs in this country, one area where all of us, both patients and doctors, can make a difference is to increase our utilization of less expensive generic medications whenever possible.

STRESS & BREAST CANCER SURVIVAL

Recent clinical studies have failed to identify an improvement in breast cancer survival following religious or psychological counseling. However, two new research studies from the Ohio State University, just published in the journal Cancer, suggest that marital distress may adversely affect patients’ recovery from breast cancer, and that psychological intervention may actually improve breast cancer survival.

In the first study, 100 women with newly diagnosed breast cancer were followed for an average of 5 years. All of these patient volunteers were assessed upon joining this clinical study, and then at 4 to 6 month intervals thereafter. Levels of stress and depression were measured using standardized psychological tests. Health behavior and health outcomes were also measured, using validated clinical methods.

Based upon initial evaluations, 28 of the women volunteers were determined to be in stable but chronically distressed marital or cohabiting relationships. The remaining 72 women were considered to be in stable but non-distressed marital or cohabiting relationships.

At the time of breast cancer diagnosis, both groups of women were found to have equivalent levels of high stress. However, after the initial observation period following breast cancer diagnosis, the two groups of women quickly diverged in terms of their ongoing levels of stress. Not surprisingly, the initial high level of stress, following diagnosis, declined much more slowly among the women involved in chronically distressed relationships, and 5 years later, the level of stress in this group remained significantly higher than was observed among the women with stable non-distressed relationships.

Among the women who were involved in chronically distressed relationships, when compared to the other group of women, a much slower recovery in terms of physical activity was observed, as well as more symptoms of illness and breast cancer treatment side effects. Symptoms of depression were also much more common within the group of women who were involved in chronically distressed relationships.

To summarize the findings of this breast cancer study, women who were in stable non-distressed relationships resumed normal levels of physical activity sooner than the women who were involved in chronically distressed relationships, and had fewer symptoms of illness, fewer side effects associated with breast cancer treatment, and fewer signs and symptoms of depression. For those of us who regularly care for cancer patients, the results of this clinical study are not at all surprising. In general, patients who are involved in healthy and supportive cohabiting relationships rebound more rapidly, both psychologically and physically, from cancer diagnosis and treatment than patients who are involved in unstable or conflict-ridden relationships. Stable and positive social support systems are important for all patients who experience severe or chronic illnesses and, certainly, patients with cancer exemplify this important observation, as well.

The second, and related, study prospectively randomized 227 women with recently diagnosed breast cancer into two study groups. All of these patient volunteers underwent psychological and behavioral testing upon entering into this study. In the “treatment” group, psychological and behavioral interventions, using group therapy, were initiated, and included the teaching of strategies for reducing stress and improving mood, as well as health behavior modification and cancer treatment compliance training. The second group of patients was merely observed during the course of this study. Both groups of patients were actively observed for a median duration of 11 years.

By the end of the study period, 29 percent of the 227 patients had developed a recurrence of their breast cancer, and 24 percent had died of their disease. In this study, participation in active group therapy was associated with a 45 percent reduction in the risk of breast cancer recurrence at a median duration of 11 years following diagnosis, and with a 56 percent reduction in the risk of death due to breast cancer over the same interval of time. Participation in group therapy, led by a psychologist, was also associated with a 49 percent reduction in the overall risk of death from any cause, in this study.

In summary, this study found that breast cancer patients who were prospectively randomized to receive psychological and behavioral therapy, in small groups, experienced a significantly decreased risk of breast cancer recurrence and death when compared to breast cancer patients who did not receive any therapy. While other studies have failed to confirm any significant reduction in breast cancer recurrence or survival with active psychological or behavioral interventions, this prospective randomized clinical trial has identified such a relationship. While it is not immediately clear why this study reached these rather striking conclusions when compared to previous similar studies, breast cancer is unique with respect to many other cancers in terms of its ability to recur many years after diagnosis. Because of the very long potential latent time between the initial diagnosis of breast cancer and disease recurrence, a long duration of follow-up is necessary when one is studying breast cancer recurrence and mortality factors. This study’s long duration of follow-up, with half of its patient volunteers having been observed for longer than 11 years, sets this study apart from many other similar studies with shorter durations of follow-up.

Multiple psychological, immunological and oncological factors interact together to determine any individual patient’s risk of cancer recurrence or cancer-associated death, and so it is not possible for studies such as this one to definitively identify the precise mechanisms whereby active psychological and behavioral therapy might potentially decrease cancer recurrence and improve cancer-free survival. However, chronic, severe stress is known to impair immune function, and ongoing immune surveillance is an important mechanism that our bodies rely upon to keep microscopic residual foci of cancer under control. Although this particular study did not specifically evaluate immune system function in the participating patient volunteers, other studies have done so, and have found measurable declines in the cellular immune response to cancer cells in both highly stressed laboratory animals and human patients.

The results of this study appear to show an improvement in cancer-free survival associated with psychological and behavioral group therapy, and suggest that patients with recently diagnosed breast cancer should consider participating in similar group therapy sessions.

Disclaimer: As always, my advice to readers is to seek the advice of your physician
before making any significant changes in medications, diet, or level of physical activity.

Dr. Wascher is an oncologic surgeon, professor of surgery, a widely published author, and the Director of

the Division of Surgical Oncology at Newark Beth Israel Medical Center:

http://www.sbhcs.com/hospitals/newark_beth_israel/mservices/oncology/surgical.html

Send your feedback to Dr. Wascher at rwascher@doctorwascher.net