A PLETHORA OF GENETIC PRIVACY BILLS FLOODS
A PLETHORA OF GENETIC PRIVACY BILLS FLOODS
BioWorld via Individual Inc. : WASHINGTON _ Before cloning grabbed the spotlight, genetic discrimination was the biotech ethics issue capturing the most public attention.
Even though the future potential for cloning a human has played on the public imagination of late, the risk of losing health insurance or employment as a result of "flunking the gene test" _ as National Human Genome Research Institute Director Frances Collins calls it _ remains very much in the here and now.
Both federal and state legislators in 39 states have proposed a variety of legislation ranging from granting people ownership of their genetic information to requiring informed consent for any use of the genetic information. As well- meaning as these provisions appear, many of them could bring medical research to a grinding halt.
"The potential for genetic information to be used to discriminate against people was really the first bioethics issue to show up as a priority for us one and a half years ago," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). "Genetic privacy is essential to our industry, but we need to be very careful how genetic privacy laws are written in order to protect research."
As a result, BIO and the Pharmaceutical Research and Manufacturers of America (PhRMA) joined forces to educate legislators both in Washington and in individual states about the untoward consequences their bills may have on research.
The risk to research was first realized last year, when a bill unanimously passed in the New Jersey state legislature that would have granted ownership rights to genetic information. Intense lobbying by BIO and PhRMA resulted in Governor Christine Todd Whitman vetoing the bill and the provision was eliminated.
Establishing that people own their genetic information may seem a reasonable way to assure that individuals maintain control over that information, but as Ann Oman, vice president for communications at PhRMA, noted, "The provision could inhibit clinical trials and ultimately result in preventing patients from having access to these clinical trials."
The problem with granting ownership of genetic information and the samples from which the information was derived is that it would mandate record-keeping to identify the sample and the donor. Such a provision would not only be extremely expensive, but would conflict with the goal of protecting privacy because all samples would have some sort of potentially accessible "deed" associated with them.
In addition, if property laws were brought to bear on medical samples and genetic information, there could be a torrent of litigation over the rights blood relatives have over medical information obtained from other family members as well as royalty litigation for drugs developed from information obtained in clinical trials.
Nevertheless, this year, New Mexico, Nebraska, Maryland and Florida among others had bills proposed that would have granted property rights.
The vast majority of the 91 state bills (some of which are dead) that addressed issues related to genetic information viewed it as a separate issue from medical information. Both BIO and PhRMA oppose such efforts to dissect genetic information away from general medical information.
Because most diseases have a genetic component, Feldbaum pointed out that genetic information is part of the continuum of medical information. For example, a person's cholesterol level is determined by both eating and exercise habits and by the persons genetic predisposition to high cholesterol. That predisposition can be easily inferred from an accurate family history. As such, Feldbaum noted that any distinction between genetic and non-genetic information is likely to be arbitrary at best.
"Genetic information is extremely difficult to separate from medical information," Oman agreed. "That is why we support privacy protections for all medical records."
Many of the state bills also had provisions that would require the destruction of samples used for genetic tests in order to prevent someone from testing the sample without the person's knowledge. Such a provision flies in the face of current FDA regulations regarding samples collected during clinical trials.
A related provision found in several state bills requires that researchers obtain informed consent for every use of a stored sample. Oman noted that would stymie a great number of epidemiological studies that use anonymized information.
"Any legislation must protect anonymized data bases," Oman said. "It is vital that scientists have access to this type of information."
Feldbaum noted that most legislators are amenable to changes in their bills when they learn that the bills could jeopardize research in their states. Nevertheless, monitoring and contacting every state over problematic bills requires a Herculean effort. Both PhRMA and BIO would like to see federal legislation that protects the privacy of medical information.
"Right now, we have a patchwork of laws that provide inconsistent protections depending upon which state you live in," Feldbaum said. "We need a blanket law that standardizes this across the country."
At the federal level, Sen. Pete Domenici (R-N.M.) proposed bill S. 422 that would prohibit genetic discrimination. Feldbaum noted that expanding the Domenici bill to encompass protections for all medical information remains a high priority at BIO.
"We continue to work with Domenici's staff on this bill," Feldbaum said. "But we have not yet convinced him of the need to include all medical information into his bill." n
[Copyright 1997, American Health Consultants]