Part IV: Why Doesn’t Insurance Cover Natural Medicine?
In Part IV of this series, we continue our discussion from Part III regarding political barriers to insurance coverage of CAM (complementary and alternative medicine).
Safety, Efficacy, and Cost-Effectiveness Data
In the first two parts of this series, we examined some of the practical barriers to insurance coverage of CAM (complementary and alternative medicine), identified by the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP). Some of those barriers included a reported lack of adequate information on the overall safety and efficacy of CAM therapies, as well as a lack of information on their cost-effectiveness. This information is critically important because it forms the foundation upon which coverage decisions are made, including everything from defining benefits, to designing health care plans, to making claims payment decisions and maintaining the financial soundness of the industry. Conventional medical coverage is based upon such information, and so coverage of CAM will be denied until it meets the same standards. But what about the quality of the information upon which conventional medical coverage decisions are made? How much of that information is reliable and free from non-scientific influences?
According to an article in the Journal of the American Medical Association (JAMA), recent studies have found that when investigators and medical researchers have relationships with pharmaceutical or product manufacturers, they are less likely to criticize the safety or efficacy of these agents. (1) Furthermore, this same JAMA article cited a study that examined the relationship between the source of funding for clinical trials and their reported outcomes. (1) The authors of the study determined that there was a significant association between positive results in general internal medicine clinical trials and funding from a pharmaceutical manufacturer. (1) These findings are not insignificant. According to the LA Times, in two and a half decades, drug companies’ funding of biomedical research (which has mainly been conducted at universities) has risen from $1.5 billion to $55 billion. (2)
But the concern over financial conflicts of interest is not limited to safety and efficacy data. Over the past decade or so, widespread use of economic analysis of pharmaceuticals and medical devices has become a valuable tool for healthcare decision-makers to assess the costs and benefits of drug therapies. These economic studies are playing an increasingly important role in healthcare decision-making because of the rising costs in the industry. This economic data, otherwise known as pharmacoeconomic studies, are used by managed care organizations and insurance companies, among others, to develop their coverage and payment decisions. As a result, pharmaceutical companies are increasingly conducting such studies to provide evidence that their products are cost-effective. And these drug manufacturers face increasing competition to show that their product offers more value and quality in terms of price than their competitors. But various articles have been written regarding concern over the lack of principles governing such studies. Concern has been raised over the validity, methodological quality, as well as the potential for bias and misuse. (1), (3), (4), (5) Pharmacoeconomics has developed into a complex specialty of its own, and at least one article published in JAMA showed once again that pharmaceutical sponsorship of economic analysis is associated with reduced likelihood of reporting unfavorable results. (1) Compounding this problem is the fact that many of those who need to use this pharmacoeconomic data are still not equipped to critically evaluate their quality or interpret them properly. The FDA was even prompted to issue guidelines enumerating principles it would use to review pharmacoeconomic claims for promotional purposes, in the hopes of addressing the lack of regulatory standards and potential for biased results. (4)
Nowhere is this debate over safety, efficacy, and cost-effectiveness more salient than in the area of cancer treatment. In an article published in 1993 in the Journal of the National Cancer Institute, issues regarding the efficacy and cost-effectiveness of cancer treatments were examined. (6) According to the authors, “many cancer treatments are, unfortunately, ineffective. Cancer mortality rates have not changed substantially in the past decade, despite a ‘War on Cancer.’” (6) The authors pointed out that while oncologists have focused on the question of whether treatment causes a “response,” society is asking whether treatment “increases survival or quality of life enough to justify the dollars spent compared with alternative uses of the same money….” (6) Given that now, in 2008, cancer is still claiming a life every 50 seconds, the same question remains: how effective are our current treatment methods?
In a highly controversial article published in 2004, three oncologists assessed the impact of cancer drugs on survival rates in Australia and the United States. (7) The authors analyzed the results of all randomized, controlled clinical trials performed in Australia and the U.S. that reported a statistically significant increase in 5-year survival due to the use of chemotherapy in adult cancers. Data from 1990-2004 were examined. The authors found that the overall contribution of chemotherapy to the five-year survival rate in adults was about 2%. In other words, as stated by one of the authors, Graeme Morgan, during a radio interview, “if there was no chemotherapy…the survival rate of all patients with cancer would drop from 62% to 60%.” As summarized by the authors, “despite the early claims of chemotherapy as the panacea for curing all cancers, the impact of cytotoxic chemotherapy is limited to small subgroups of patients and mostly occurs in the less common malignancies.” (7)
The authors addressed the issue of why so many patients undergo chemotherapy treatment when the benefits are generally so small. According to the authors, the answer is a game of statistics. The medical profession often presents the benefit of chemotherapy to patients in terms of relative risk instead of giving a straight assessment of the impact of such intervention on the overall survival rate. Ralph W. Moss, Ph.D., explained this difference in his March 5, 2006 newsletter. (8) Dr. Moss explained that while relative risk is technically accurate, it has the effect of making the intervention look more beneficial than it truly is. For example, as explained by Dr. Moss, if receiving a treatment causes a patient’s risk to drop from 4% to 2%, this can be expressed to a patient as a decrease in relative risk of 50%, which sounds very impressive. But another and equally accurate way of explaining this reduction in risk is to say that the treatment offers only a 2% reduction in risk, which most likely would not impress most patients. The presentation of these statistics in relative versus absolute terms has even been shown to influence treatment recommendations of oncologists. (8) Ironically, one of the criticisms of the 2004 chemotherapy study was that it examined absolute instead of relative benefit of chemotherapy to patients. The truth of the matter remains that if a seriously ill cancer patient was presented with a chemotherapy regime that would cause only a 2% reduction in risk while causing numerous and devastating side effects, he or she might opt for another form of treatment.
This argument, of course, is not to say that cancer drugs should not be covered by insurance. Indeed, at Envita, we treat certain patients with chemotherapy (alongside our natural treatments), as it still has a place in helping with particular malignancies. But the limitations and harsh side effects of these drugs must be recognized- and they should not be heralded as the answer to cancer.
Nor are we saying that all clinical trials involving conventional drugs should be dismissed or questioned as tainted by conflicts of interest. But the point is that before CAM coverage is denied on the basis of a purported lack of quality data regarding efficacy and safety, the same standards have to be applied to conventional medical coverage. Presumably, medical coverage decisions should not be based on just any data – the quality and reliability of the data should also be examined. And as discussed in Part I of this series, a threshold of what constitutes an “effective” and “safe” treatment must be established. If the threshold is an absolute benefit of only 2%, one has to wonder why alternative treatments are not already covered by insurance.
Both the political barriers discussed in Part III of this series, as well as the problems associated with the pharmacoeconomic model discussed here present considerable challenges to CAM’s gaining entry into the conventional medical system and accompanying insurance industry. Not surprisingly, these political barriers are not easily overcome, even when the scientific data fails to support the safety and efficacy of Big Pharma’s treatments. Let’s look at the real world example of bio-identical hormones.
An Example of Political Barriers to Entry: The Bio-identical Hormone Debate
Over the past decade, concern began to arise over the risks associated with synthetic hormone replacement therapy (HRT), used for the treatment of menopausal complaints and associated conditions. These synthetic hormones contain hormones that do not match those found in the human body, including estrogens from horses’ urine. In 2002, the U.S. government-sponsored Women’s Health Initiative (WHI) published a study showing a relationship between HRT and an increased risk in breast and uterine cancers, heart attack, stroke, and dementia. (9) The study involved 16,608 healthy postmenopausal women with a uterus, ages 50-79 who were randomized to either a test or placebo group. The test group received a combination of synthetic hormones, and the placebo group received none. The National Institute of Health had to halt the first part of the WHI study, because the results showed: a 26% increase of invasive breast cancer for those women who received the synthetic hormones over the placebo; a 29% increased risk of myocardial infarction or death from coronary heart disease; a 41% increased risk of stroke; a 200% increased risk of blood clots. (9) The sales of synthetic hormone therapies dropped almost 50% immediately, as patients and physicians began utilizing bio-identical hormones instead. Bio-identical hormones, unlike synthetic ones, match the structure and function of hormones naturally produced in the body. While synthetic hormones are produced by drug companies, bio-identical hormones are compounded by individual pharmacists.
Wyeth, the pharmaceutical giant that owns the Premarin synthetic hormone, saw a 68% decline in sales, from over $2 billion in 2002 to $880 million in 2004. Wyeth filed a petition with the Food and Drug Administration (FDA) in 2005 to stop the practice of compounding bio-identical hormones by individual pharmacists. Instead, in May of 2006, the FDA notified Wyeth of quality lapses in its manufacturing plant in Puerto Rico. But then in January of 2008, the FDA announced that there was no evidence that bio-identical hormone therapies are safer than prescription hormones made by drug companies. Still, synthetic hormone replacement therapy is generally covered by insurance while bio-identical usually isn’t. The bio-identical hormone debate is just one example of the barriers facing any CAM treatment that would take away from the sales of the pharmaceutical giants, regardless of the purported requirement of safety and efficacy data.
But barriers to insurance coverage of CAM are not necessarily a bad thing. In the last part of this series, we will weigh the pros and cons of insurance coverage of CAM and examine whether it is even in the best interest of patients and the profession.
References:
(1) Friedberg, M., et al. Evaluation of Conflict of Interest in Economic Analyses of New Drug Used in Oncology. JAMA 1999; 282(15): 1453-1457.
(2) Healy, Melissa. “From funding to findings.” Los Angeles Times. August 6, 2007, in print edition F-3.
(3) Task Force on Principles for Economic Analysis of Health Care Technology. Economic Analysis of Health Care Technology: A Report on Principles. Annals of Internal Medicine. 1995; 123(1): 61-70.
(4) Neumann, P., Zinner, D.E., and Paltiel, D.A. The FDA and Regulation of Cost-Effectiveness Claims. Health Affairs. 1996; 15(3): 54-71.
(5) Ofman, J.J., et al. Examining the Value and Quality of Health Economic Analyses: Implications of Utilizing the QHES. Journal of Managed Care Pharmacy. 2003; 9(1): 53-61.
(6) Smith, T.J., Hillner, B.E., and Desch, C.E. Efficacy and Cost-Effectiveness of Cancer Treatment: Rational Allocation of Resources Based on Decision Analysis. Journal of the National Cancer Institute. 1993; 85(18): 1460-1474.
(7) Morgan, G., Ward, R., and Barton, M. The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies. Clin. Oncol. (R Coll Radiol). 2004 Dec; 16(8): 549-60.
(8) Moss, R.W. Aussie Oncologists Criticize Chemotherapy- Part One. Cancer Decisions Newsletter. March 5, 2006.
(9) Moskowitz, D. A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks. Altern. Med. Rev. 2006; 11(3): 208-223.
