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Aurora launches technology-driven biobank

Philip Loftus, the Vice President and CIO of Aurora Health Care, will speak next week in Madison at WTN Media’s Digital Healthcare Conference 2009 on research-driven genetic sampling and the ORBIT project.

MILWAUKEE — A Milwaukee-based health care organization has launched a technology-driven biobank at one of its hospitals that aims to link science, technology and patient care.

Aurora Health Care’s Open-Source Robotic Biorepository and Informatics Technology (or ORBIT) databank could help determine whether patients may benefit from a certain drug, and will enable scientists around the globe to share information for research and medical discovery. Aurora hopes to implement this biorepository program system wide within a year.

Matthew Tector, director of the ORBIT project, said Aurora earlier this year began collecting and storing blood samples from its patients who consent to participate in the project. The pilot, which began at Aurora St. Luke’s Medical Center in Milwaukee, has received about 70 percent participation by patients there.

“If they have a blood sample taken for clinical testing, there’s always blood left over. What we can do is collect those samples of those who consent and store it for future analysis and link it to the medical record of the patient,” Tector explained, noting that samples are only collected when patients give blood for other clinical tests.
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In addition to the blood, other specimens such as saliva or tissue could be collected from the patient. After collection, a robot extracts DNA from the blood, bar codes the specimen and stores it in a freezer that holds up to 76,800 vials. Bar coding links the specimen with an individual’s electronic medical record without identifying information such as a name, ensuring patient privacy and complying with privacy laws, Tector said.

Medical history and other information tied to each specimen is updated as participants return to Aurora for care, keeping information current and adding research value to the databank. Data will be made broadly available to scientists, according to Aurora, which will advance pharmacogenomics, a science which analyzes genetic markers to better predict who may benefit from a drug or have an adverse reaction.

“The field of pharmacogenomics aims to find a way to determine the most effective drug for an individual with the fewest side effects, based on that person’s genetic makeup,” according to Aurora vice president of research and academic relations Randall Lambrecht. “This is the prelude to ‘personalized medicine,’ where a drug or drug combinations are developed specifically for an individual.”

Tector said if patients continue to participate in sample collection at the rate of just above 70 percent they are now, Aurora could assemble enough samples to make data attractive to scientists. Aurora serves 1.9 million patients at 13 hospitals and about 120 outpatient clinics. The ORBIT project is expected to be implemented in all of these facilities in the next year.
For patients, that means quicker answers to researcher’s questions on everything from heart disease to cancer, and improved individual care for participating patients whose data will be linked to their electronic health records at Aurora.

Philip Loftus, Aurora chief information officer, calls ORBIT a key to personalized medicine that could lead to early detection or confirmation of genetic risk factors and information that will help providers determine treatment effectiveness. Loftus will speak next week in Madison at WTN Media’s Digital Healthcare Conference 2009 on research-driven genetic sampling and the ORBIT project.

Tector, who has worked to launch the program for five years with his father, Aurora’s Dr. Alfred Tector, said he sees Aurora’s biobank succeeding in reaching some of the goals now being discussed in the field by making available a diverse sample of data from its participating patients.

According to a new report, “The Future of Biobanks,” published by London consultants at Business Insights, predicts that in the next decade new biobanks will speed development of personalized diagnostics and therapeutics with the first advances expected to result in improved treatment of cancer. “Increased co-operation between biobanks can advance this progression, although many scientific and political barriers must be overcome,” the report states.

Comments

Deborah C. Peel, MD responded 6 months ago: #1

Why on earth would anyone in their right mind donate their DNA and medical records to a private, for-profit corporation? Hospitals sell patients’ sensitive electronic health information. Health information and DNA can be used to harm not only donors, but all their children and grandchildren. DNA and medical records are extremely valuable to corporations and industries that use personal data to discriminate against people seeking jobs, insurance, credit and loans, even admission to schools.

Patients should be fully informed about the extreme risks and downsides of donating DNA to biobanks that can sell and fully disclose their DNA and medical records to the for-profit genetic research industry and other corporations without your specific knowledge and informed consent for each use.

Today because so much research is driven by the search for extremely profitable ‘blockbuster’ and ‘designer’ drugs, your DNA and medical records could be sold and used to develop drugs for conditions you don’t care about: such as designer drugs like botox or drugs for anxiety. You may want to contribute to research on diabetes or cancer or ‘orphan’ diseases—but Aurora decides which ‘research’ projects can buy and use your DNA and medical records, not you.

What if Aurora sells copies of your DNA and medical records to a corporation to develop drugs for abortion? What if certain new drugs will cause you to have side-effects other people won't---will Aurora tell you?

There is no way to give meaningful informed consent to biobanks that will forever control your most sensitive personal information. “Consent” that allows unlimited future uses and disclosures of both your DNA and medical records to an unlimited number of corporations for "research" is unethical and illegal.

Further: it is impossible to de-identify DNA---its uniquely your DNA. Taking your name off the sample does not protect your genetic privacy (and in turn puts the genetic privacy of your children at risk too). DNA can be easily be re-identified because Aurora and corporations that buy data from Aurora can link your DNA back to the rest of your electronic health records or cross-match your sample with any other DNA sample from your blood or tissue.

Risks:
1) Security. How easily can the biobank be hacked? Most health data has abysmal security protections. Do you know what security measures and processes Aurora uses?
2) Privacy. Since you do not control any sales or disclosures of your DNA or electronic records that will be used along with your DNA, you have no way to keep your data private. Aurora controls your DNA and medical records. Will you have audit trails of all sales, uses, and disclosures, so you know exactly how many places across the world have copies of your sensitive DNA and medical records and what they are using it for?
3) Aurora can sell your DNA and electronic records to an unlimited number of corporations engaged in for-profit research. How those corporations protect your data from hackers? Will they also sell your data?
4) Will Aurora disclose the revenue made from selling biobank data? If you know how valuable this personal data is, then you can make a more informed decision about donating such a sensitive personal asset to Aurora.

Deborah C. Peel, MD
Founder and Chair, Patient Privacy Rights
www.patientprivacyrights.org

Randall Lambrecht responded 6 months ago: #2

I would like to clarify Aurora Health Care’s mission behind the biorepository project.

Aurora is a not-for-profit health care provider, and the creation of the Open-Source Robotic Biorepository & Informatics Technology (ORBIT) is consistent with our values. We believe that every patient deserves the best care, in responsibly managing resources and in accountability, teamwork and respect.

Both the National Institutes of Health (NIH) and the President’s Council of Advisors in Science and Technology (PCAST) have advocated for the development of biorepositories as a strategy to improve the quality of health care and enhance safety by better understanding how genetic information can impact health outcomes.

Aurora’s leaders have taken every measure they can to ensure the safety and security of participants’ information. All the medical data is stripped of identifying information and no insurer, school, employer, company or researcher will be able to gain access to participants’ identities. The process for participation and consent is clearly explained to all patients, and they can completely withdraw from the biorepository at any time. Linking DNA back to the source would be extremely difficult to do, and Aurora has protocols in place to prevent this from happening.

Aurora’s biorepository is certified by NIH for confidentiality. The Health Insurance Portability and Accountability Act (HIPAA), known as the federal privacy rule, contains national standards for the safety and privacy of electronic health data, information and transactions. Incorporated into HIPAA provisions are federal privacy protections for individually identifiable health information. Also, the Genetic Information Nondiscrimination Act of 2008 protects against discrimination based on genetic information, allowing people to eventually take full advantage of the promise of personalized medicine without fear of the abuse of genetic information. In addition, an Institutional Review Board oversees this project, and its standards for Aurora’s biorepository exceed federal guidelines for research involving human beings. If there is a breach in privacy, the IRB has the authority to close the program.

We anticipate Aurora will be able to support a range of studies through the biorepository. There is an approval process in place, which includes the IRB, for screening requests. However, research in ethically challenging areas, such as abortion or the use of embryonic stem cells, will not be considered.

The Aurora patients who willingly consent to participate in the biorepository are helping advance responsible research that will move us toward safer, more effective personalized medical care. Better understanding how DNA impacts health is a critical part of discovering how to improve disease prevention so that we can offer patients better care in the future.

Sincerely,
Randall Lambrecht, Ph.D.
Vice President for Research
Aurora Health Care

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