Speech at FDA Science Forum: Consumer protection and privacy in the era of advancing gene therapy

Speech by Linda Golodner, NCL president

Good morning. My name is Linda Golodner and I am the President of the National Consumers League. I would like to thank the FDA for inviting me here to provide the consumers’ perspective on health privacy. NCL is America’s oldest nonprofit consumer advocacy organization, dating back to 1899. We have been working on health-related issues since our inception, including working for passage of the first Pure Food and Drug laws in 1906, the Food, Drug, and Cosmetic Act in 1936, and more recently, on the health privacy provision of the Health Insurance Portability and Accountability Act of 1996. Our goal is to educate and protect consumers so they can make informed decisions in the marketplace and workplace. We do this through public education campaigns and advocacy efforts in the regulatory and legislative arenas.

I was asked today to provide a consumer perspective on privacy issues involving gene therapy. The question, as I see it is this, what do consumers need in order to actively and effectively participate in the healthcare marketplace of the twenty-first century? Recent technological and scientific advances have made it possible for scientists and physicians to delve into a world that once seemed possible only in science fiction stories: gene therapy. The recent mapping of the human genome, a monumental triumph of will and scientific advancement opens the door to a “brave new world,” as Aldus Huxley so eloquently put it, a world free of disease and suffering, where medical conditions can be detected and corrected before they even develop. This new world, while still in the future, is rapidly approaching, and like many technological advancements that have preceded it, the benefits promised can also produce disastrous consequences if we do not harness them properly. Often, we are so focused on whether we can do something, that we lose sight of whether we should. Gene therapy is one of those advances.

With an ever-increasing store of health information being developed and collected, consumers need protection. The advancing science of gene therapy poses new challenges to protect the privacy of confidential health information. If gene therapy is to be beneficial in helping to treat and prevent a host of diseases and health conditions, consumers must be assured that their valuable information is protected so that it cannot be used against them in a discriminatory manner such a denial of health insurance or loss of employment. Further, consumers should be fully informed as to how their confidential medical records are to be used—who will have access to them, how they will be distributed. And more importantly, consumers should knowingly consent—opt in—to allow their medical records, which included sensitive genetic information, to be used by outside entities and researchers. 

Consumers are quite fearful of losing control over their health information or having that information used against them. As a result, many consumers are choosing to withdraw from full participation in their own health care. According to a 1999 survey conducted by Princeton Survey Research Associates for the California Health Care Association, one out of every six people engages in some form of privacy-protective behavior to shield themselves from the misuse of their health information, including withholding information, providing inaccurate information, doctor-hopping to avoid a consolidated medical record, paying out-of-pocket for covered expenses, and even avoiding care entirely. These actions demonstrate how serious consumers feel the lack of privacy is becoming; they are willing to jeopardize their own health to avoid disclosing certain information.

What will consumers need to instill a better sense of trust so they can begin to engage in the health care system more fully? First, consumers need information in a useful and understandable manner. We need to feel confident that the information we provide, sensitive and personal information about our health and well being, is secure and will only be used for our individual and common good, not for marketing, and not to discriminate against us. Finally, consumers need access to the system. Let me expand on these three ideas more fully.

The need for privacy and security is vital if consumers are to accept genetic testing and gene therapy. There are already growing concerns about who has access to sensitive medical and health records, and how they are being used. Despite promises to safeguard sensitive data, many consumers do not trust the technology, nor do they trust those who control much of the data, such as insurance companies, employers, financial institutions, and the government. Too often, breaches have occurred. Identities have been stolen, private records have been accessed and distributed, and individuals have been discriminated against, even fired, or denied insurance coverage, because of breaches in the system. Further, because electronic information and genetic testing are new to many consumers, they pose new fears, whether they are rational or not. Perception is reality, and we have to treat it as such if we want consumers to opt into this new vision. Let me give you a few examples of how people’s trust and confidential information has been violated, and you may begin to see why there is a deep sense of mistrust in the general public.

• The 13-year-old daughter of a hospital employee took a list of patient’s names and phone numbers from the hospital when visiting her mother at work. As a joke, she contacted patients and told them they were diagnosed with HIV. (The Washington Post, 1 March 1995).
• A banker who also served on his county’s health board cross-referenced customer accounts with patient information. He called due the mortgages of anyone suffering from Cancer. (The National Law Journal, 30 May 1994).
• Terri Seargent was fired from her job after her employer learned that she had been diagnosed with a genetic disorder that would require expensive treatment. Terri was a valued employee who received a positive review and a raise just before her discharge from the company. A recent EEOC investigation determined that her employer fired Terri because of her disability.  

These are just a few of the numerous breaches that have occurred recently along various stages of the healthcare information continuum. Thus, we can see why a majority of the public is concerned about protecting their privacy and their confidential medical information. In fact, according to a National Consumers League survey conducted by Lou Harris in 1999, 88 percent of consumers are concerned about threats to the privacy of their personal information today, and 75 percent of consumers believe that privacy is more likely to be threatened by the year 2020 than it is today. The California HealthCare Foundation survey that I cited earlier further concludes that, “one in five American adults believes that a health care provider, insurance plan, government agency, or employer has improperly disclosed personal medical information. Half of these people believe that it resulted in personal embarrassment or harm.” When we talk specifically of genetic privacy, a 1995 Harris poll found that 85 percent of those polled indicated that they were very or somewhat concerned that insurers or employers might have access to and use their genetic information. Even more disturbing, and supporting the position I previously stated that many are willing to withhold or forgo treatment is the 1997 National Center for Genome Resources survey which found that 63 percent of people reported they would not take genetic tests for diseases if insurers or employers could access the tests.

We have to do a better job of assuaging consumer fears and perceptions about the technology and how it will be used. This means more than just smoothing things over via public relations. It means creating real safeguards, in the technology itself, and in the political policies drafted into law and regulation. We must enact strict federal standards that will protect personal health information and penalize those who violate it. It is encouraging to see that the recent federal regulations under the HIPAA Act have been finalized, however, the recent backlash from providers and insurance companies to the rule may serve to weaken what are significant protections for consumers. 

Consumers need useful and understandable information in order to make rational and informed decisions. Unfortunately, there is a dearth of such information available about health care. Further compounding the problem is that the majority of Americans have a literacy problem; they simply don’t understand health and medical information and terminology. Even many educated consumers have a hard time understanding what a doctor or even a news reporter is saying when it comes to health care. When you add complicated messages and advanced concepts such as genetic engineering or testing, most people’s eyes glaze over. And even if they do understand the information, they may not be able to put it into context. This is really the most important part of providing useful information. It is not just giving accurate data; it is about showing why the data is pertinent and how it affects the individual’s life. Without this piece, many consumers will remain either confused or distrustful of many of the new technologies designed to supposedly make their lives better. You cannot simply expect Americans to embrace new breakthroughs such as gene therapy simply by stating the benefits. As we know, many people are fearful of change, and the idea of gene therapy conjures up some scary images. We must enter into a patient, rational, and fully informed dialogue among all the stakeholders, consumers, scientists, doctors, government officials, and employers if we are to reap the rewards of these promising new developments in health care.

Finally, we cannot forget the disparities that exist between the “haves” and the “have-nots.” If technological and electronic access to genetic information that may ultimately save lives is the goal, we cannot forget about the population that currently does not have access to technology or other advantages of the modern economy. A gap already exists in health knowledge, access to health care, and coverage for services, mostly based on socio-economic and racial conditions. This is true at the individual as well as institutional level. While many poor inner city and rural consumers lack access to computers and high-technology medical treatments, including gene therapy, so to do many local governments and health care facilities in these same rural and inner city settings. Many local health care agencies and hospitals are struggling to make ends meet and do have the ability to make the necessary investments to upgrade their information systems, putting both them and their patients at risk for breaches in security and privacy of confidential medical records.

In conclusion, we must keep in mind that technology is not the panacea for our ills, and it can’t be the end-all, be-all. It will be how we use the technology that will be important. We cannot forget that just because we can do something, doesn’t mean we should. With the rapidly growing field of gene therapy and genetic engineering, we must proceed cautiously or risk serious complications. If the average consumer is to accept and embrace scientific advancements, they must be presented in ways that allow the consumer to feel comfortable. They cannot simply be forced down our throats. It is incumbent upon the “learned intermediaries” to help people understand why these new developments are relevant to their lives, and ensure that they will be used responsibly and for the good of society. Privacy concerns are real, and must be taken seriously if advances in gene therapy and other medical treatments are to reach their full potential. Thank you.