Henrietta Lacks and the Great Healthdata Giveaway

Part Seven of Seven-Part Blog Series by Guest Blogger Patrick Taylor

A suggestion runs through the debate on the NPRM to amend the Common Rule that the proposed changes are a tribute to Henrietta Lacks, a necessity so her story is not repeated.

That story was told in a the national bestseller  The Immortal Life of Henrietta Lacks, a moving biography of the young woman whose  aggressive tumor was the source of the ubiquitous HeLa cells (probably without her consent, certainly without her awareness of what followed); her family;  the  cells’  (and her) dehumanization into a research tool to be exploited unthinkingly; and the poverty, disconnection, racism,  lack of health care and lack of concern for her family. Society and scientists received a bonanza, and did nothing for her family in return.  The book criticizes phony consent, and advocates sharing  cell line proceeds with donors and their families. It rekindled discussion of consent and racist legacies, while urging that injustice required social change.

Critically, the NPRM would  not prevent a repeat of Henrietta Lacks’ situation; instead, if implemented as NIH policy regarding genomic datasharing suggests, it reenacts it, and multiplies it across the patient population. It demands that patients accept a one-time grab at all data, for any purpose, in order to provide broad access to others with no promised informational or other return and no mechanism to reciprocate patients’ altruism.  It does not protect patients’ privacy, it compromises it and asks patients in general terms to accept the compromise.  It is the search for knowledge, set amidst vague promises of possibilities that historically benefit some not all; the rough parallel with HeLa cells is obvious, except here the patients may remain very much alive and it is not death that bars continued conversation. Scientists will, through  a single uniformed consent, deliberately avoid what otherwise would be a lifetime of consent opportunities and dialogue with patients that would have valued them  as if they had something to say. The NIH appeared to be arguing that protecting privacy through autonomy requires the new Genomic Data Sharing policy (GDS), but neither privacy nor extolling autonomy explain curtailing choice to all-or-nothing, nor making the “all” be maximum permeability to privacy loss, nor the uninterest in a continuing consent conversation.

If Henrietta Lacks’ story were simply the story of a woman whose extracted tumor cells were retained after her death without her consent, it would be a sad story but not the same one.  What makes it remarkable is the extraordinary value of her tumor cells, the poor return to her family, and the treatment of them as scientific objects not people.  Focused on the cells, scientists were blind to the human context and the poverty, disconnection, and lack of health care access the family experienced. Nothing in the GDS touches on such issues.  Nothing prevents their repetition. Indeed, if oral consent were after all obtained from Henrietta Lacks, as some have maintained, it must have resembled nothing more than the consent the NPRM makes likely, and the GDS now makes mandatory.

The one certainty about the NPRM is that it intends to bring about the consent of every tissue donor and data donor to any research done by anyone (who is thereby by definition a researcher) and  the ability of government, as recipient of data under federal research grants, to use and distribute to anyone that data for anything it can call a research project.  It may be mere coincidence this is all occurring at a time in which every lawsuit to enforce a consent seems “successful” in leading to the outright destruction of whole databases or strict judicial limits on use, whether to halt states’ repurposing of neonatal screening blood spots for research or to prohibit “related” research uses that are stigmatic and taboo.  It may also be mere coincidence that the NIH has partnered with many big drug companies in the belief that translating the Human Genome Project demands open sharing of patient records, and has obligated itself to openly share the genomes and medical records of 150,000 patients.   Short of a new law prohibiting lawsuits, nothing could be more useful than for the patients involved to sign on the dotted line that they agreed to sharing with anyone, for any purpose.

If so, its not public trust generally that is sought.  It is public trust in the Human Genome Project, for which the public will be made to pay  by loss of privacy, and any real choice about how their medical information will be used or by whom.  It is a great giveaway of our health data, so the government can use it, or bargain with it and trade it to others as it wishes.

Read Parts One, Two,Three, Four, Five and Six of the Seven-Part Series.