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.
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.
The National Consumers League, founded in 1899, is America's pioneer consumer organization. NCL's three-pronged approach of research, education and advocacy has made it an effective representative and source of information for consumers and workers. NCL is a private, nonprofit organization representing the consumer on marketplace and workplace issues.