“The New Tuskegee”

Can you be forced to participate in research without your informed consent or without even being notified? The most incredible story, first found buried in an international publication, revealed that Perlegen Sciences, Inc. has made a deal with an unidentified electronic medical records company to give it exclusive rights to the clinical information on 4 million U.S. patients, to develop genetic markers to predict how the patients will respond to medical treatments.

Unbeknownst to the patients, their records will be turned over to this private company and mined, and for those who are then identified for DNA testing, samples of their genetic material will be obtained by Perlegen by going through patients’ doctors, via HIPAA, not the patients. All of this will all be done without the knowledge or permission of patients.

Afterwards, says Perlegen, “patients and physicians will receive compensation for providing samples for further analysis.” Patients will never know their private health information had been gone through or their genetic material was used until they get paid, and even then, they might not know why they got a check. Having access to this “rich clinical information” of patient records “integrated from multiple sources and mapped into a standardized, fully-searchable data structure,” will enable Perlegen to quickly and easily identify patients for DNA sampling. It's all to sell genetic-based, “personalized” medicine. This is the ultimate data dredge looking for zillions of tiny genetic markers that can be correlated to conditions and behaviors that its business interests can use to target people for their pills and interventions.

Under the terms of the agreement, according to Perlegen’s news release, in return for the exclusive access to the electronic medical record company’s patient database:

The EMR provider will earn subscription and program fees, as well as significant participation in milestone payments tied to the successful launch of new diagnostic tests resulting from the collaboration. Perlegen will receive an ownership position in the EMR provider tied to the achievement of certain revenue levels.

In other words, the private health records of millions of people have been sold by the electronic medical record provider to this for-profit company without the people's consent.

There is also no way to know how secure the data is in Perlegen’s data banks and no way to know who Perlegen will sell the patient data and results to (employers, insurers, the government...). More critically, the potential abuses, to deny or compel treatment when its genetic profiling suggests links to potential future health problems, are frightening.

As Deborah Peel, M.D., founder and chairman of Patient Privacy Rights, said: “This is the new Tuskegee — forced research participation without informed consent or even notice.”

In today’s HealthCare IT News, Dr. Peel said:

The right of consent is the international ethical standard for researcher subjects and must not be eliminated in federal law or regulations. There must be no more research, whether it's [quality assurance], patient safety, or public health research, without real consent... We need to preserve our fundamental rights to privacy and build an ethical, legal HIT system now. Congress must act to ensure our rights to privacy....

Data theft by EHR [electronic health record] vendors that contract with corporations like Perlegen MUST be stopped. This massive violation of Americans' health privacy deserves Congressional investigation ASAP.

What is Perlegen and who are its business partners seeking to profit off of this?

Perlegen is a biotech firm created to accelerate the development of whole-genome scanning, to target treatments that will supposedly be according to a patient’s genetic profile. The private company is headquartered in Mountain View, California, and was incorporated in 2000, as a spin-off of Affymetrix Inc. of Santa Clara, which maintains 25% ownership.

It has garnered high-dollar partners, calling themselves the Genetic Association Information Network (GAIN). GAIN includes the National Institutes of Health (NIH), Pfizer, Affymetrix, Abbott, the Foundation for the National Institutes of Health, and the Eli and Edythe Broad Institute (of MIT and Harvard University). The National Institute on Drug Abuse, of the NIH, for example, gave Perlegen Sciences $2.1 million to look for DNA variations and candidate genes associated with nicotine addiction.

Pfizer, Inc. made a $50 million equity investment in Perlegen on December 27, 2005, which gave it a 12% interest in the company. Pfizer joins Affymetrix, Maverick Capital, CSK Ventures, Eli Lilly and other corporate and private investors taking significant ownership in Perlegen. Perlegen’s IPO investors include Altus Pharmaceuticals ($105 million in January 2006). Another $115 million was raised in public offerings in April, 2006.

Perlegen holds patents, such as the European Patent (EP1825002) on genetic markers associated with obesity, “metabolic syndrome,” weight gain and insulin resistance, filed on December 8, 2005. A significant portion of its targeted commercial customers are clearly those looking to profit off the obesity hype.

This past October, Perlegen announced its genotyping had mapped more than 3.1 million genetic variations it made available for public use through the International HapMap Consortium. But it made additional reference data for 4.3 million unique genetic identifiers (Single Nucleotide Polymorphism) available to its business partners in GAIN.

How did this for-profit company get the genetic material on all of these people? It would appear other secret deals have taken place to buy the private health information from other databases. This is just one example of why medical professionals, such as Dr. Peel, object to nationalized electronic medical records, and certainly until the violations of our health privacy are stopped.