Profiting on Your Patient Data
Updated: Jul 2, 2019
Privacy in all matters related to patients has been the watchword of healthcare. Laws to protect this information and your rights as a patient are not something that has come to the fore only in the past few years; they've been around for a long time.
But how would you feel if your patient data, including diagnostic images and pathology slides, blood analysis, etc., were being used without your "informed consent" for clinical studies? Do you still have a right if your name or other identifying information is removed? It's still material obtained from you, right? Clinical trials always require that the patient sign an informed consent form, even though these forms are offered as a formality more than something you should read carefully.
How many times have you been told to sign the form without being given time to read it thoroughly or to question whether or not you can strike out portions of the form? Don't want them to use video of your procedure? Have you noticed that in the reams of verbiage in the lengthy form? Have you thought about putting a line through it, initialing and dating that? I would suspect you never gave it a thought. You may have been told it's just a formality so they can bill your insurance.
Ethics are now coming into focus once more as we read about how technology is forging new ways of making money from patient data. Of course, those implicated in these allegations of unethical behavior are offering lengthy explanations regarding why this isn't an ethical problem.
One case in point pertains to the world-renowned cancer center, Memorial Sloan-Kettering, in New York City. A series of agreements between the hospital, prominent researchers, another hospital system and a collaboration with IBM is at issue. Certainly, using sophisticated software and the tens of thousands of bits of data in these databases may result in important medical breakthroughs. But, where is the patient's rights in this mix? For me, it harks back to the Henrietta Lacks ethical violations.
Specimens taken from Lacks (who died from cervical cancer), without her knowledge or permission that it be used for research purposes, were used to formulate an extremely lucrative test from which the researcher profited. Neither Lacks nor her family, including her children, were told of this business arrangement and they did not benefit, initially, from it. The test was given a patent and other researchers paid fees to use it.
A similar situation arose in California where specimens were taken from a man, used by a researcher who then received a patent, and a new era of patient protection was seen as mandated. Aware of this burgeoning area of profit, California began to rewrite protections for patients and universities as well as researchers.
One problem area was the definition of what a patent should be in that it must be an intellectual property which gives the inventor absolute rights over it. If you, in effect, create your own cells and the fluids in your body by your unique DNA code, do you not have an absolute right over it? Can someone else refute your claim and say that they created something from your biological materials and benefit from it without you also benefitting? Such was the case in Moore v. Regents of the University of California.
A researcher took samples from Moore and developed a cell line with valuable commercial properties. Informed consent had been obtained for the procedure but was there a specific mention of commercialization of any samples? No, there wasn't any mention of money. Continued treatment of Moore for a number of years brought him back to the facility, but one day he was asked to sign a different consent form.
The new form indicated, "I (do, do not) voluntarily grant to the University of California all rights I, or my heirs, may have in any cell line or any other potential product which might be developed from the blood and/or bone marrow obtained from me." In effect, there was something here that Moore never perceived, although the researcher had agreed to pay for travel expenses to and from the facility for years.
Wasn't this a bell-ringer? Obviously not. But not for long as Moore became suspicious and rescinded his agreement, giving a copy of the original to his attorney. The attorney, upon researching the patent records, discovered that in 1984 the university had obtained a patient for "Mo."
Moore's spleen has been removed, the samples were kept and then used to develop a commercial product. The Supreme Court of California held that Moore's discarded biological samples are treated much the same as garbage; once discarded it's not your property. They also held that family members could not sue.
As technology advances and databases burgeon ever larger, where will your biological samples or records go, to whom and for what financial benefit to others? Your records are probably, even today, being tossed around the world and analyzed by AI to make more research breakthroughs. Should you be compensated? What is the ethical practice needed in today's world to protect the interests of the patient in all regards?
The courts and the attorneys will have a great deal of untangling of information as they go forth into this ever-expanding landscape in medical research.