Genetics firms seeking wide patient base

As for-profit companies begin soliciting recruits to provide DNA for disease research, patients and physicians first need to consider several issues.

By Vida Foubister, amednews staff. Oct. 9, 2000.

Lured by the promise of the genomics revolution, patients are increasingly willing to participate in research that might lead to cures or treatments for diseases affecting them or their family members.

DNA Sciences Inc., a privately held Mountain View, Calif., genetics company, is hoping to capitalize on this interest. In August, it launched The Gene Trust project to identify links between genes and disease, such as breast cancer, asthma and Parkinson's disease. To do this, it needs medical information and genetic samples from thousands of people.

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Another company, Genomics Collaborative Inc. in Cambridge, Mass., has already recruited 55,000 patients worldwide to donate medical information and genetic samples. In addition to conducting large-scale studies to look for genes associated with common diseases, the company has developed a repository of DNA, serum and tissue samples that other researchers can pay to access.

But before patients start lining up to contribute their samples, there are many things they ought to find out.

"It boils down to a couple of simple questions," said Mark A. Rothstein, director of the Health Law and Policy Institute at the University of Houston. "What do you know about the company, and are you willing to trust it with your highly personal medical information and genetic sample? Everything flows from that."

Other ethicists and physicians contacted by AMNews expanded on the issues that patients should explore:

Do volunteers have control over the type of research in which their DNA sample is used?
Are they notified if they are found to have a genetic predisposition to disease?
Can the information be withdrawn at a later date?
Who stands to profit, either from the research process or commercially viable discoveries?
Is there any legal recourse for breaches of privacy?

Despite the hope this new research brings, ethicists and physicians also caution patients against expecting their DNA sample to lead to a cure.

"Each of these efforts to identify a specific polymorphism or a specific defect or disease is a very long-term process and we should be very cautious about offering a specific benefit to a patient," said R. Rodney Howell, MD, president of the American College of Medical Genetics and chair of pediatrics at the University of Miami School of Medicine.

No track record

Several companies, such as deCODE genetics in Iceland, already collect genetic information on specific populations. Obtaining samples from a heterogeneous population, however, is a new approach.

"We think it's critical that genetic research is conducted not only in isolated populations or on rare disease states," explained Michael Pellini, president and CEO of Genomics Collaborative. "We want to get an understanding of what this whole genomics era will mean to the entire world."

Ultimately, these companies must rely on the altruism of patients to get involved. It also requires a leap of faith on the participant's part.

"You've got a bunch of new companies with no track record of doing things well or not so well asking people to put a lot of trust in them, to give them, for free, information that they hope to use to turn a profit," Rothstein said.

Joseph Lough, PhD, chief ethics and policy adviser for DNA Sciences, is well aware the company is breaking new ground. "Nobody else out there has done any of this," he said. "We're blazing the way here. We're trying to establish the standard."

The company, which hopes to develop early diagnostic tests for several diseases, recruits potential volunteers directly through the Web site (http://www.DNA.com/). On that site, patients can read about the steps it has taken to protect privacy, the way the company plans to make money and the research goals it wants to pursue. The project has been reviewed by the Western Institutional Review Board, a private IRB; also, an internal bioethics advisory board began evaluating the company's practices and procedures at its first meeting in late August.

Patients who want to get involved are asked to send personal health and family information over the Internet, a process the company says uses encryption to secure the data. Those with conditions DNA Sciences is interested in studying will be asked to submit a blood sample for genetic research. In addition to drawing the blood sample, the phlebotomist is responsible for explaining the informed consent form to the volunteer.

Though DNA Sciences has taken steps to ensure anonymity, Hugh Rienhoff Jr., MD, chair and CEO, admitted that participation is not for those who are "paranoid" about providing medical information. Instead, it's for those who are comfortable sharing their personal health information on an ongoing basis. "Patients who enroll in The Gene Trust are patients who want to have a relationship with the company," he explained. So far, the response has "exceeded our expectations," he said. Nearly 4,500 people have signed up since the project launched Aug. 1.

Involving physicians

Though some ethicists are troubled by DNA Sciences' direct recruitment of patients, having physicians ask their patients to participate raises another set of ethical questions. But it's the approach with which Genomics Collaborative's CEO felt most comfortable. "We still feel strongly that there should be a firewall of confidentiality between a company and a patient," Dr. Pellini said. "We don't think an extra step there is hurting us; it's helping us."

GCI works with a network of about 270 physician groups in the United States. It also has established a relationship with doctors in Eastern and Western Europe, North Africa, India and Southeast Asia. Many of the physicians are also collaborators in the research, and they are compensated for their "time and effort," Dr. Pellini said.

A. G. Breitenstein, a lawyer who serves on GCI's bioethics advisory board, doesn't believe that this payment will incentivize doctors to recruit inappropriate patients. "The genotypic data set is really only reliable to the extent they can pick up tight groupings of patients focused on the specific disease they're looking for," she said.

Still, Hank Greely, co-director of the program in genomics, ethics and society at Stanford University, believes payment should be disclosed to patients. "Whatever rules you have in the practice of medicine, you should have them even more strongly when it's an ancillary activity," he said.

Added Herbert Rakatansky, MD, chair of the AMA Council on Ethical and Judicial Affairs: "These doctors better be very careful to make sure that any decision that's made about you and the giving of DNA is in your best interest, not the research company's best interest."

Unlike DNA Sciences, GCI makes no promises to provide patients with any information or free services that result from the research. It does, however, keep their physicians informed through a monthly newsletter.

"That's so fanciful that your particular disease is going to be cured by this company because you send in your DNA," said George J. Annas, professor of health law at Boston University School of Public Health.

Although these are commercial ventures, the final analysis should focus on their potential to do good for society and not their potential for profit.

"On balance, I don't think these are necessarily bad things," Greely admitted. "The worst outcome would be for patients to feel embittered and cheated by the process, which could turn them off not only to participate themselves in medical trials but to medical research in general and could have negative political effects on the support for research."

ADDITIONAL INFORMATION:

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The AMA's Genetics and Molecular Medicine page (http://www.ama-assn.org/ama/pub/physician-resources/medical-science/genetics-molecular-medicine/news.shtml)