U.S. House of Representatives: Committee on Energy and Commerce, RepublicansPrepared Witness Testimony: Delgado, Jane L.

Ms. Jane L. Delgado PH.D., M.S.
President and CEO
National Alliance for Hispanic Health
1501 16th Street, N.W.
Washington, DC, 20036

Good morning. My name is Dr. Jane L. Delgado and I am President and CEO of the National Alliance for Hispanic Health (the Alliance). I am pleased to be here today to present the Alliance's perspective on pharmaceutical access and direct to consumer advertising. Before presenting these views, however, I'd like to provide you with a short background on who the Alliance is so that you may better understand our perspective and our reasons for being here today.

The Alliance is the oldest and largest network of Hispanic health and human service providers. Alliance members serve over 10 million (one in four) Hispanic health consumers annually. Our members are community-based organizations, provider organizations, government, national organizations, universities, for-profit corporations, and individuals. We have a bi-partisan board and three things make the Alliance unique: (1) belief in community-based solutions, (2) representation of all Hispanic groups, and (3) refusal of funding from alcohol or tobacco companies. We are a principled and strong organization.

To meet the needs of our communities, the Alliance operates state-of-the-art services in four program centers: Consumers, Providers, Technology, and Science. We develop national model community-based initiatives for service delivery in areas currently covering: cancer, environmental health, HIV/AIDS, prenatal care, substance abuse, tobacco control, and women's health. In addition, we directly reach Hispanic health consumers nationwide by connecting them to local services and information (using zip code) through our

As one of the organizations that established the field of cultural proficiency for health providers, the Alliance operates a significant support network for health professionals including training and education programs for cultural proficiency. We maintain and update a national database of 16,000 community health providers, representing the largest network of health providers serving Hispanic communities.

As the organization that established the first Hispanic on-line presence in 1991, the Alliance continues to foster cutting edge initiatives in science and technology. We operate hispanichealth.org and this year will unveil a redesign of the site that will include community health chats, training resources, and a portal to accurate health information that will continue the Alliance's role as the Hispanic community's trusted source for the best in health information.

An innovator in health science, the Alliance operates a national network of university-based researchers working with community-based organizations. Alliance research was the first to show over eight years ago that the Hispanic community was growing at a faster rate than Census predictions and would be the largest racial or ethnic minority group by the year 2000. Our research has challenged long held notions of health and well-being by showing that while Hispanics are more likely to be uninsured and in poverty, we also live longer than non-Hispanic whites. We have demonstrated the positive role of community, culture, family, and faith in a healthy life and the negative impact of some U.S. cultural norms on health and well-being.

Alliance research has also shown, that while Hispanics live longer than non-Hispanic whites, it is a life often marked by chronic illness and disease. Hispanics are more likely to suffer from diabetes, depression, asthma, and other chronic illnesses and diseases yet we live longer than non-Hispanic whites. Our chronic conditions benefit from early identification and a treatment plan that includes the appropriate pharmaceutical regimen. For this reason, full access to available pharmaceuticals and information made available through direct-to-consumer (DTC) advertising is a critical issue for the Hispanic community.

Hispanics are the group least likely to have regular access to health care services. More than one third (37%) of Hispanics are uninsured compared to 14% of non-Hispanic whites.^[1] The impact is that about one-third of the uninsured reported no usual source of health care (38%), skipping a recommended medical test or treatment (39%), or not filling a prescription (30%).^[2] This lack of access to health care, including pharmaceuticals, is a significant barrier for Hispanic communities. The picture for pharmaceutical access is further complicated by formularies and other administrative strategies that limit access to the full range of pharmaceutical products. This is of particular concern to Hispanic consumers as research has shown that a number of pharmaceutical products have a different metabolic pathway for Hispanics. Finding the right product with the least side effects requires access to the full range of pharmaceutical products in a given class. However, many Hispanic consumers find that while a pharmaceutical product that works well for a majority of the population is on their formulary, other products which work better for them may not be accessible. The goal of a responsible pharmaceutical policy should be to make the full range of approved pharmaceuticals available to all so that a medical rather than cost-limiting decision can be made between a doctor and patient. It is disturbing that the discussion on pharmaceutical policy has focused on pharmaceutical spending as a negative for the health care system. Quite the opposite, pharmaceutical products are the most cost effective sector of health care. Increased spending on pharmaceuticals is a sign of our evolving health system, which has less of a focus on hospitalization. With improved products coming to market and a healthy research base there are new alternatives for those currently without adequate treatment options.

The facts of increased pharmaceutical spending argue for a responsible and patient-based policy that will expand rather than limit access to pharmaceutical products.

More than two-thirds (71%) of increased spending on pharmaceuticals is a result of increased utilization. According to IMS Health, in 2000, total prescription drug spending increased 14.7 percent. Of that amount, only 3.9 percent represented price increases, the remaining 10.8 percent reflects the fact that more patients are getting new and better medicines. Also according to IMS Health, the rate of increase in drug spending in 2000 (14.7%) was substantially lower than the rate in both 1999 (18.8%) and 1998 (16%).^[3]

Value of new prescription drugs explains increased utilization. Utilization of pharmaceuticals is increasing because untreated patients are coming in for treatment and patients have access to new and better medicines. In the 1990's, according to the industry trade association PhRMA, over 300 new medicines were made available to patients. These mean new and better options for patients. For example, in a study published in The New England Journal of Medicine, it was reported that in the 16 months following the introduction of antiretroviral therapy for HIV, there was a 43 percent decrease in hospital inpatient care. According to Samuel A. Bozzette, a physician with the Veterans Affairs San Diego Healthcare System, who headed the study, "The drugs are almost a perfect substitute for hospital care. We can afford them because, in fact, we were already spending the money on HIV care" in the form of hospitalization.^[4]

Increased utilization is good news-decreases spending on more expensive treatments and means improved health care for consumers. Since the 1960s, spending on prescription drugs as a percent of total national heath expenditures has remained below 10%; with nearly four times as much spent on hospital care.^[5] Pharmaceuticals remain the most cost effective segment of the health care industry. The real story of increased pharmaceutical spending is that patients are getting treated with improved regimens or untreated patients are getting treated before a more costly acute episode arises, leading to reduced spending on other more expensive health care treatments and improved patient satisfaction. For example, a recent study of patients with severely weakened hearts due to heart failure found that use of a new beta blocker, not only reduced deaths by 35 percent compared with patients given a placebo, it also sharply reduced hospital admissions, hospital stays and the use of tests and procedures in the hospital.^[6] Another study published in The New England Journal of Medicine found that the use of ACE inhibitors for patients with congestive heart failure reduced mortality by 16%, avoiding $9,000 in hospital costs per patient over a three-year period. Considering the number of people with congestive heart failure, additional use of ACE inhibitors could potentially save $2 billion annually.^[7]

Pharmaceutical innovation is critical to improved health care. The aging of the population means that chronic illness and disease in this country will increase. The most cost effective to this evolving health challenge is access to the full range of pharmaceutical products and development of new and improved products to avoid hospitalization and costly (in human and economic terms) impact of not treating chronic illness and disease early. For example, about 70% of seniors (28 million) now suffer from cardiovascular disease. If this trend continues, over 50 million elderly could face this disease by 2050.^[8]

Access to Information. New research is showing that health care disparities among black, Hispanic, and white Americans cannot be explained wholly by disparities in income and health insurance coverage among these groups, but that other factors such as lack of information play a critical role. Indeed, a new study sponsored by the federal Agency for Healthcare Research and Quality (AHRQ) has found that one-half to three-fourths of the disparities observed in 1996 would have remained even if racial and ethnic disparities in income and health insurance were eliminated.^[9] Access to information is a critical piece in the access picture for Hispanic and other underserved communities.

DTC pharmaceutical advertising is a responsible approach of discussing benefits and risks. DTC pharmaceutical advertising is more in the model of public health patient education rather than the Madison Avenue tradition of advertising. Indeed, a survey by the U.S. Food and Drug Administration (FDA) found that as many consumers recalled seeing DTC ads that contained information about "benefits of the drug" (87%) as did seeing "risk or side effects" (82%).^[10] The FDA plays a vital and appropriate role in ensuring the patient's concerns are primary in DTC advertising. Unlike other sectors of the health care market (e.g. dietary supplements, over-the-counter drugs), DTC pharmaceutical advertising is required to use a "fair balance" of potential risks and benefits in consumer-friendly language. In addition, print advertising must include a brief summary of product information and broadcast advertising must make reference to label information sources (toll-free number, print ad, web site) and encourage discussion with a health care professional. Furthermore, all advertising is submitted to the FDA at first use. This responsible approach to advertising is one that should be used as a model for other sectors of the industry whose advertising by focusing on benefits without adequate discussion of risks does little to empower and inform consumers.

DTC advertising helps health consumers recognize untreated disease. The $2.5 billion spent by the pharmaceutical industry of DTC advertising in 2000 is less than 10% of the $26 billion spent in 2000 by the industry on research on development. Furthermore, this spending has dramatically increased patients' awareness of and ability to recognize untreated disease. A survey by Prevention Magazine found that since 1997, DTC advertising has prompted an estimated 54.2 million health consumers in the U.S. to talk to their doctors about a medical condition or illness they had never discussed with their physician before. This is critical to the 50% (6-8 million) people with diabetes who are not being treated as well as individuals with a range of other untreated conditions for which treatments are available. Furthermore, the Prevention Magazine survey of DTC advertising and consumers found that one-third (33%) of patients using a prescription medication were reminded to take their medication by a DTC ad.^[11] This compliance benefit is significant for many chronic illnesses and conditions that require long-term compliance with a treatment regimen.

DTC advertising encourages discussion between patients and health providers. Patient-provider communication is being improved with DTC advertising. A study conducted by Harris Interactive found that 64% of doctors thought DTC ads help educate and inform the public.^[12] Furthermore, a 1999 FDA survey of DTC advertising found that 81% of patient's reported that their doctor welcomed their question about a drug as a result of DTC advertising.^[13] In addition, the FDA study also found that 27% of people who spoke to their physician as a result of DTC advertising, talked to them about a previously undisclosed medical condition.^[14] Also, of consumers who spoke to their physician as a result of DTC advertising, a majority (53%) of physicians discussed non-drug therapy with their patient.^[15]

Health care is in transition from a physician-directed, hospital-based system to a patient driven, at-home system. Responsible DTC advertising is another tool that empowers consumers with information that includes both benefits and risks so that the consumer can make an informed choice. Unfortunately, much information for consumers available through the internet and other venues is not subject to FDA standards nor does it benefit from a balance or benefit and risk information found in responsible DTC advertising.

Our challenge is to maintain the information, rather than image, base of DTC advertising and carry-over the high standards employed in pharmaceutical DTC advertising to other health care product advertising.

^[1] The Kaiser Commission on Medicaid and the Uninsured. Uninsured in America: A Chart Book. May 2000.

^[2] Ibid.

^[3] IMS Health Reports. A 14.9% Growth in U.S. Prescription Sales to $145 billion in 2000. May 31, 2001.

^[4] "Providing Antiretroviral Therapy for HIV Infection," The New England Journal of Medicine, Vol. 344, No. 11, March 15, 2001.

^[5] Health Care Financing Administration, Office of the Actuary, National Health Statistics Group, 2001.

^[6] Ron Winslow, "GlaxoSmithKline's Coreg Benefits Heart Patients in Two Big Studies," The Wall Street Journal, March 21, 2001.

^[7] The SOLVD Investigators, The New England Journal of Medicine, Vol.325, No.5, pp.293-302, 1991; Walsh/America/PDS.

^[8] Scott-Levin, Integrated Share of Voice Services IMSHEALTH/CMR, 2001.

^[9] Weinick, Robin, et. al. "Racial and ethnic differences in access to and use of health care services, 1977 to 1996," Medical Care Research and Review, November 2000, No. 57 (Suppl. 1), pp. 36-54.

^[10] FDA 1999 Survey, question 7.

^[11] Prevntion Magazine. International Survey on Wellness and Consumer Reaction to DTC Advertising of Prescription Drugs: 2001.

^[12] Prevention Magazine. International Wellness and DTC Study. 2001.

^[13] FDA 1999 Survey, question 7.

^[14] FDA 1999 Survey, question 7.

^[15] Prevention Magazine. International Wellness and DTC Study. 2001.

Recent Developments Which May Impact Consumer Access to, and Demand for, Pharmaceuticals