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JULY 15, 1999, THURSDAY

SECTION: IN THE NEWS

LENGTH: 3325 words

HEADLINE: PREPARED TESTIMONY OF
DR. ELIZABETH ANDREWS
DIRECTOR OF WORLWIDE EPIDEMIOLOGY
GLAXO WELLCOME
SUBJECT - H.R. 2470
BEFORE THE HOUSE COMMERCE COMMITTEE
HEALTH AND THE ENVIRONMENT SUBCOMMITTEE

BODY:

Introduction
Mr. Chairman and Members of the Committee, my name is Elizabeth Andrews, and I am Director of World Wide Epidemiology for Glaxo Wellcome, a leading research-based pharmaceutical company. This year, Glaxo Wellcome will spend nearly $2 billion on research of new medicines for the treatment of cancer, diabetes, obesity, rheumatoid arthritis, osteoporosis and viral diseases. As an industry, the nation's research-based pharmaceutical and biotechnology companies discover and develop the majority of new medicines used in the United States and around the world, investing more than $24 billion this year alone on research and development. The industry brought 39 new prescription drugs and biologics to market last year to treat many deadly and debilitating diseases. Medical Information is Essential for Research
Mr. Chairman, I would like to begin by thanking you for the opportunity to testify this morning on behalf of Glaxo Wellcome on the important issue of federal legislation to protect the confidentiality of medical information. As a scientist whose work is committed to discovering and improving health care interventions, I am pleased that this Committee -- which has responsibility for legislation affecting American health and health care -- will play a leading role in crafting that legislation. I look forward to working with you.
Glaxo Wellcome strongly supports new federal legislation that would protect the confidentiality of individuals' medical records from unauthorized or inappropriate use. At the same time, we know that appropriate use of medical information is critical to the delivery of high quality health care and the development of innovative and more effective treatments for patients. We hope that the committee will pass legislation that will result in enactment of a new federal law that safeguards patients' medical privacy while allowing appropriate uses of medical information for research, treatment, payment for services and health care operations. We feel that legislation introduced by Congressman Jim Greenwood, H.R. 2470, "The Medical Information Protection and Research Enhancement Act of 1999," achieves that balance. Glaxo Wellcome strongly supports H.R. 2470, as well as similar legislation, S. 881, introduced by Senator Robert Bennett. We urge the Congress to take action on these bills to meet the August 21, 1999 deadline established by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to enact a medical data confidentiality law.
The pharmaceutical and biotechnology industry can help patients with unmet medical needs only if researchers have access to medical information that enables them to discover new medicines. Today, medical researchers are poised to make countless new discoveries that will alleviate human suffering and the burden of disease. Revolutionary new treatments and diagnostic tests promise to extend and enrich our lives and the lives of future generations. Realizing this promise depends on research: interventional research involving the collection of information directly from individuals such as clinical trials used to develop new drugs, medical devices and biologics; and observational research which relies on existing databases. Observational research allows us to study of the prevalence of disease, evaluate medical treatments and measure the cost- effectiveness of therapies. Observational research can sometimes be conducted with encoded or encrypted data that has been stripped of individual indentifiers, while preserving the ability to link various databases across treatment settings and over the course of time to capture a comprehensive picture of patient care. Having the complete picture of the patient's health and health care is what is essential for the researcher, not the identity of the patient.
As an epidemiologist, I would like to provide to the Committee some examples of research that will explain how we use medical information to help improve the health of patients and the quality of health care delivered to them. I have been involved in the study of HIV/AIDS and other sexually transmitted diseases, the medicines developed for such conditions, and the risk of medicines when used in pregnancy. In these areas, we have made significant strides, coupling drug development programs with company-sponsored public health monitoring activities.
Through such efforts, we ensure the safe use of products developed to treat many serious diseases. There is increasing public attention given to drug safety monitoring and a need to assess the current mechanisms available to evaluate the safety of medicines. Most health professionals agree we need more, not less, information on the safety of medicines in order to better understand the risks compared to the benefits of drugs as they are used in general, not experimental, circumstances. It is through the use of archival medical records that we are able to understand such risks and benefits in large numbers of patients in the real world setting. Each of the following examples involves research using archived medical information.
* An epidemiologic study in the early 1980s that found a strong association between the potentially fatal Reye's syndrome and children's use of aspirin. Eventually, this new knowledge led to a decline in cases of Reye's syndrome in the United States, improving children's health and reducing mortality.
* A recent study documented both the under-use of beta-blockers following myocardial infarction in the elderly, and the serious consequences of that under-use. This study linked large pharmacy and medical claims databases. Its finding of unnecessary deaths and hospitalizations from cardiovascular episodes is likely to lead to basic changes in medical practice and greatly improve patient health.
* A pharmaceutical company worked with a large managed health-care plan to undertake a study of more than 85,000 children to provide further information on the safety of the chicken pox vaccine in clinical practice. These children received the vaccine, with parental consent, as part of their regular medical care. A computer-based search was performed of the records of the children who received the vaccine and of a historical comparison group of children who had not used the vaccine. The medical records of the children who had not been vaccinated were taken from the plan's historical archives of patient records. It would have been extremely difficult, if not impossible, for the health plan to track them down to gain their consent. The information received by the pharmaceutical company was encrypted, so that the company had no patient-identifiable data. This research has provided valuable reassurance about vaccine safety under conditions of broad use in clinical practice.
* A health plan was able to use medical information about its enrollees to identify women with a deficient gene that is linked to some breast cancers. The health plan contacted these women, many of whom chose to enroll in the federally-regulated and IRB-overseen clinical trial that a pharmaceutical company conducted of a new drug to treat breast cancer. Had the health plan been unable to review these women's records and contact them, there would have been significant delays in finding appropriate participants for the clinical trial.
Because of the focused and controlled nature of clinical trials, much of what we learn about drug safety and effectiveness is learned through the use of observational data after drug approval.

In the area of HIV, for example, we learned from observational experience that differences in HIV disease progression seen by gender, race and intravenous drug use were not due to those patient characteristics, but due to differences in treatment and access to treatment. Observational studies demonstrated the effectiveness of pneumocystis carinii pneumonia (PCP) prophylaxis, and quantified the adverse experience rates with antiretroviral therapies and various treatments for opportunistic infections. All of these findings have contributed to more effective care and better outcomes for patients with HIV.
In addition to ongoing safety surveillance studies, health care payers in our cost-conscious system demand more focused outcomes research and economic analysis to select the most efficacious and cost-effective treatment options. For example, Harvard Medical School researchers found that restrictions on the use of schizophrenia medications in the New Hampshire Medicaid program proved penny-wise but pound-foolish. The restrictions yielded some savings on prescription drugs, but ultimately increased state and federal government Medicaid spending overall by sharply increasing the need for emergency care and hospitalization. The Harvard team produced these findings - which can promote both better health care for patients and more cost-effective use of health care dollars - by linking prescription drug use databases with mental health center and hospital data.
These examples illustrate the useful and important observational research that is being conducted with existing medical records, while using various methods for safeguarding the confidentiality of patients. These methods include replacing individual identifiers with a case code number and safeguarding the key from unauthorized use or disclosure, restricting the subset of persons who have access to research databases, and ensuring that employees are aware of their obligation to treat research data as confidential and to protect it from disclosure and unauthorized use.
Medical Data Confidentiality Legislation
Glaxo Wellcome believes that the Greenwood bill, H.R. 2470, provides a workable framework for protecting patient health information while also recognizing the need to access patient data for legitimate health care-related purposes -- primarily treatment, payment, health care operations and medical research. It establishes very clear boundaries around the permissible uses and disclosures of patient medical data and imposes strong penalties on entities and individuals for its misuse.
We feel that strong federal confidentiality protections must complement existing research regulation without needlessly complicating it. For that reason, we are very concerned that H.R. 1941, introduced by Congressman Gary Condit, as well as H.R. 1057, introduced by Congressman Edward Markey, would extend Institutional Review Board (IRB) and informed consent requirements to all private research that has traditionally not been subject to the federal common rule.
Informed consent, which is a cornerstone of the interventional research that is reviewed by IRBs, does not work in the context of database research. In database research, the validity of the scientific conclusions depends on how comprehensive the database is. The researcher does not affect the treatment of the individuals, rather he or she tries to make inferences based on observed differences in ordinary health care settings. The validity of those inferences is suspect if the researcher is missing information from some individuals. What we know based on the experience in Minnesota, which has a law that requires informed consent for medical records research, is that individuals who decline to give consent are not a random sample. This means that imposing informed consent requirements on research databases has the effect of undermining the generality and validity of the conclusions that can be drawn based on research using that database.
Moreover, a recent General Accounting Office (GAO) report examined the protection of patient medical data used in medical research. We were encouraged that GAO's findings are consistent with the widespread belief in the research community that researchers are doing a thorough job of protecting the confidentiality of patients while using medical information in extremely important research concerning public health and health care delivery. The GAO report makes some important points which accurately reflect the current status of research conducted outside the federal system.
First, the report acknowledges many uses of information and data in research, and provides examples of important research that required some type of access to identifiable information. Not all research can be conducted strictly using anonymized records. Research based on archival records with no medical risk to the patients and rigorous safeguards of personally identifiable data should be encouraged, not impeded.
Second, the report provided examples of a variety of safeguards that are in place in different types of organizations that undertake research outside the federal system. The examples demonstrate clearly that many safeguards already exist to protect the confidentiality of identifiable patient information. Those safeguards are tailored to the local needs and circumstances within each organization. Institutions conducting health research take confidentiality of patient information very seriously. The report aptly notes that the institutions in their study may not represent all organizations, and those not studied may not meet the same high standards of those in the study. However, the Greenwood bill would establish uniform national standards that would be required for all organizations that manage health data. Moreover, it would provide for penalties for organizations that fail to adopt or enforce the safeguards.
Third, the report provided a realistic picture of current IRB operations. IRBs provide a valuable function in protecting patients from unnecessary research risks. Their experience and expertise in reviewing studies only for review of confidentiality practices is insufficient to warrant such an expansion of their roles. Moreover, they do not have the capacity to handle the increased volume that would emerge from a new requirement to review all medical records research. We feel it would be counter-productive to institute such a requirement. Uniform national standards for confidentiality protections would offer a more appropriate, more consistent, and more rigorous controls than available through an expansion of the IRB function.
In Glaxo Wellcome's view, the process established by the Greenwood bill is more protective of patient confidentiality interests than the expansion of IRB review and informed consent requirements that would be put in place under H.R. 1941 and H.R. 1057. For instead of needlessly complicating the important tasks already faced by IRBs, the Greenwood bill would provide federal enforcement of the safeguards and review process established by each research institution. In this regard we note that GAO reports that even where they do review projects, IRBs say they rely on the practices and safeguards in effect at the research institution. This fact is important, because to truly understand and oversee what an institution does to protect the confidentiality of data is far beyond what an IRB can or should be charged with doing in its review of a research project. The Greenwood bill would ensure that what GAO found to be true of the institutions it surveyed -- they have policies and safeguards designed to protect confidentiality -- would be enforceable as a matter of federal law. The bill would provide the further assurance that every institution making medical information available for research would be required to establish such federally enforceable policies and safeguards.
I would like to summarize for the committee the key issues that we have identified in previous legislation that could create impediments to our continuing ability to conduct medical research:
* Definitions. It is critically important that any confidentiality legislation draw clear distinctions between "protected health information" and "non-identifiable" information. Both H.R. 1917 and H.R. 1057 define protected health information so broadly that almost no information could be characterized as "non-identifiable." As a result, many vital activities, including research, that rely on non- identifiable information would be subject to burdensome prior authorization requirements. * IRB oversight of research. Pharmaceutical and biotechnology companies comply with IRB requirements when sponsoring clinical trials in support of new drug or biologic and we believe that IRBs effectively protect the welfare of trial participants. As noted above, we do not believe that IRB oversight should be extended to every analysis of medical information or to research that is not federally regulated, sponsored or funded, or modified to encompass unique confidentiality issues.
* Patient consent. We support current federal requirements concerning the informed consent of participants in interventional research.

We do not believe, however, that research projects using databases or archives of previously collected information and materials should require informed consent. In many cases, it may be impossible to gain consent - patients move, change health plans, die - and given the extremely minimal risk to patients from research of this type, requiring informed consent increases the burden on researchers but does not serve to protect the patient's confidentiality interests.
* Retention of data. Researchers should not be required to destroy data once the original study for which it has been collected has concluded. In some cases, it is necessary to retain the data in order to comply with existing federal regulations. In other cases, the collected data can be extremely valuable and may be reanalyzed for other purposes beyond the original intent and would be beneficial to patients.
* Provide Uniform, National Protection for All Medical Information. The same confidentiality standards for all types of medical information should apply nationwide. Legislative distinctions among types of medical information - genetic, psychological, or physical - would conflict with the patient's expectation that all health care information shared with a provider to obtain appropriate treatment should be maintained in confidence. Further, to ensure that individuals' expectations of confidentiality of medical information are valid in every jurisdiction, federal law should provide a uniform set of national requirements that would preempt state laws.
* Penalties. Finally, Glaxo Wellcome supports strong penalties for violations of patients' confidentiality that have been included in most of the legislative drafts. We do not believe, however, that these penalties could or should include enforcement tools such as exclusion from the Medicare and Medicaid programs. We believe that strong penalties, including civil monetary penalties, are a more effective deterrent to misuse and a more appropriate punishment for violators.
Principles for Protecting Patient Confidentiality
As is the case with other companies, Glaxo Wellcome is an active member of the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Healthcare Leadership Council (HLC). We have been working closely with these organizations and other members of the health care provider community on this important issue. We were particularly involved in PhRMA's efforts to develop a key set of principles that reflect a commitment to strong protections for individuals' medical information while ensuring the availability of medical information for research and for the delivery of quality health care. A copy of these principles is attached.
Conclusion
Mr. Chairman, Members of the Committee, I again wish to express Glaxo Wellcome's appreciation for your efforts and your obvious attention to protecting the public's interest in the fruits of health research. We look forward to working with you as you continue your efforts, and we stand ready to help the committee in any way.
END

LOAD-DATE: July 21, 1999

Document 77 of 124.


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