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The Uneasy Legacy of Henrietta Lacks
Recently, Rebecca Skloot, author of the major best-seller The Immortal Life of Henrietta Lacks, wrote an impassioned plea in the New York Times, urging people to support sweeping revisions to the Federal Policy for the Protection of Human Subjects, which is now under active review in the Department of Health and Human Services. These revisions are directed to the rules that now govern the collection and use of “clinical biospecimens,” which include all the organic substances that are routinely removed from the human body as a consequence of surgery, childbirth, or even normal testing. At first appearance, these materials look like waste products best disposed of in a safe and sanitary manner. But, in fact, they are invaluable in medical research to treat cancer and a host of other genetic and life-threatening diseases.
Without question, the most dramatic illustration of this process involves the so-called HeLa cell line derived from the cancer cells of Henrietta Lacks, an African American tobacco farmer who died of cancer in 1951 at the age of 31. When she was treated at Johns Hopkins Medical Center, her cancer cells were given to the pathologist Dr. George Gey. Gey found to his amazement that, unlike other cancer cells, Lack’s cells were immortal in that they could be cultured and reproduced indefinitely. Within three years of her death, her cell line helped develop the Salk polio vaccine. In the 65 years since Lacks died, about 20 tons of her cell line have been reproduced and distributed worldwide for medical research.
But just what did Lacks and her family get out of the arrangement? At the time, nothing. In accordance with the then standard practice, the Johns Hopkins researchers collected and used her cells without her knowledge or consent. In more recent years, she has received countless public honors for her contributions to medical research. But, at the same time, the many researchers who worked with her cell line collected substantial royalties from the patented cells and the devices developed with their assistance.
So should Lacks and her family have received some fraction of that wealth? The issue was addressed in Moore v. The Regents of California (1990), in which the California Supreme Court held that John Moore did not have property rights to his distinctive cell line. Moore had hairy-cell leukemia, and that resulted in the removal of his “grossly enlarged” and diseased spleen, which proved to be a veritable treasure trove for medical research. Moore’s case did not involve the mere use of cells drawn from his body after his death. Instead, following his initial surgery, the doctors consistently lied to Moore about the supposedly medical purposes for which they collected his various body cells and fluids, which they then used to create a patented cell line of immense value.
Faced with these novel facts, the California Supreme Court issued a split decision. It held that the doctors who took various bodily materials from Moore had not converted his body to their own use, on the odd ground that he did not own the cells after they left his body. Why they could not assert ownership of them before surgery was left unexplained. But, as a way to offset that decision, the Court held that the doctors did breach their duty of informed consent to him. However, this did not allow Moore to recover any royalties from the doctors or any other downstream parties who benefited from using his cell line.
As Skloot and others insist, there is something deeply odd about letting doctors and hospitals profit from cell lines without paying a single dime to the patient from whose body they were obtained, and without obtaining the patient’s permission.
But what’s the best way to correct this odd state of affairs? To people like Skloot, the answer is that all medical researchers should be required to obtain “informed consent” for any research done with a biospecimen, “even if,” as the government proposal puts it, “the investigator is not being given information that would enable him or her to identify whose biospecimen it is.” Such consent would not need to be obtained for each specific research use of the biospecimen, but rather could be obtained using a “broad” consent form in which a person would give permission for future unspecified research uses. Skloot claims optimistically that these people will “probably” say yes, so that research could go on largely as before—but she thinks, as a matter of fundamental fairness, that they should be asked.
There are, however, some powerful objections against the use of the informed consent standard. The consent requirement will result in a vast increase in administrative costs. At a minimum, the new standard will usher in a huge expansion in the number of forms that have to first be explained and then filled out by every patient whose bodily materials are needed for medical research. This means obtaining consent from many thousands of patients as large-scale genomic research is so common. Informed consent would severely slow down such research.
We already have extensive experience with the nightmarish consent requirements under HIPAA (the Health Insurance Portability and Accountability Act of 1996), which created a massive government apparatus for deciding whose consent is needed and when for the myriad uses of routine medical records. The privacy interest with respect to bodily fluids and liquids, especially after death, is far weaker. Why impose an apparatus that costs billions to implement, when there is no real evidence that the current system is broken? After all, the use of the waste products does not affect the patient’s health, well-being, or treatment, even as it facilitates its groundbreaking research.
A larger issue arises if an individual chooses not to sign a blanket consent form for the use of his or her biospecimens. Can the patient decide to not sign the broad form, and limit the use of his or her biospecimens only to some but not to all purposes? If consent is originally given, can it thereafter be revoked, perhaps on the ground that background disclosures were not sufficiently precise? Can family members intervene and claim that, with minors and unconscious people, the patient is not competent to give consent? Is a hospital or physician entitled to refuse to treat a patient who does not acquiesce? May they impose extra charges on them to offset their research losses from not being able to use their biospecimens?
This complex game is not worth playing. The simple answer to all of these endless complications in the routine cases is this: each patient coming into the hospital gets the benefit of the accumulated knowledge acquired from previous patients whose biospecimens have been put to good medical use. It is not too much to insist that patients in routine cases be required to continue to participate in the virtuous circle. There may not be consent, but just compensation is supplied in-kind to all patients who benefit from the medical advances made possible by the research conducted using biospecimens.
At the same time, this generalized form of compensation does not work well with the unique cases like Lacks or Moore. The magnitude of their individual contributions should be compensated somehow. But nonetheless, it does not follow, as Skloot insists, that individual consent for using these biospecimens should be required. With transactions this large, it seems highly unlikely that most patients who have been informed of the benefits that can be derived from their biospecimens would happily sign them over to a research hospital free of charge. Rather, they or their guardians would be well advised to hold out for remuneration as a condition of allowing any of their biospecimens to be used in medical research. Those patients could receive large windfalls without bearing any of the economic and development-related risks that the research hospitals bear.
Outside the medical area, the law has long been reluctant to allow any party to exert this form of monopoly power without legal constraint. Starting with the writings of the British jurist Sir Matthew Hale in the late seventeenth century, the common law has held that common carriers with a monopoly business were “affected with the public interest,” and thus not free to charge whatever they choose for their services. Rather, they must restrict themselves to reasonable and nondiscriminatory rates, commonly called RAND. The system did not require public utilities to supply their services for free, but allowed them a risk-adjusted competitive return on their initial investments, while denying them a monopoly profit.
In modern intellectual property law, RAND rules have been carried over to standard-essential patents, which allow competing companies to share information over an integrated network system. Choosing the right measure of compensation for these patents is never easy, but it is not impossible—and this inquiry may well be easier for biospecimens, which should be made available for medical research for a reasonable royalty interest on the basic research patents, perhaps fixed as a matter of law at a fraction of, say, five percent. Others may prefer to use compulsory arbitration to resolve disagreements over royalty rates. But, critically, both these proposals explicitly reject Skloot’s consent model, which poses a threat to the entire medical research enterprise.
The problem becomes even more acute when, as with Moore but not Lacks, a live patient is asked to contribute further biospecimens to medical research. Usually, the requested intrusions in this case are no greater than those in which the specimens are collected for normal diagnostic purposes, so it is a close question as to whether these transactions should be done solely on a voluntary basis, given the hold-out risk. Alternatively, it is possible to invoke the same compulsory purchase regime that works best for normal waste products.
For the moment, it’s best to keep in place whatever regime is now used. My fear, however, is that any movement toward demanding consent for using biospecimens will undermine the willingness of ordinary patients to participate in medical research. Of course everyone should be uneasy with forced exchanges, and no one should think that individual consent is not needed for ordinary medical treatment. But when transaction costs get high, and monopoly power becomes a serious risk, the model of just compensation in forced exchanges should prevail. It may seem odd to apply standard industrial organization models to biomedical research. But the parallel is precise. The many doctors and hospitals that have vehemently resisted the new proposals that Skloot endorses may not understand the finer points of monopoly power and rate regulation. But they are right to reject unwise proposals to demand broad consent for the use of biospecimens in medical research.
© 2016 by the Board of Trustees of Leland Stanford Junior University
Published in Law, Science & Technology
Am I the only one who, on reading the good professor’s posts, hears it in his voice and at the non-stop manner in which he speaks on the Law Talk podcast?
No.
Seawriter
I can’t see why it would cost an inordinate amount of money to add the use of medical specimens derived from a patient to the ‘informed consent’ process. All they would have to do is add a paragraph to the reams of privacy, red-flag, patient responsibility, patient rights paperwork that we all sign, at every encounter that we have with a health care provider. (It should be noted that the “inordinate” argument was used when these regulations came into effect also, and while they were bothersome and somewhat costly to implement, it got done.)
Just as many people don’t have a clue as to some of the things they’re ‘consenting’ to now, I can’t see that it would make much difference if another thing were added. (Personally, I favor the ‘uninformed consent’ approach, myself. I’d rather just not know).
I don’t know what the proportion of ‘known’ donors versus unknown, to this kind of research. But it’s been standard practice for years to use medical information (data) for research. Usually, it is blinded, and all identifying information (other than some basic demographics) is stripped out. People agree to the use of that sort of information in the existing ‘informed consent’ process all the time (I am not sure if tissue or biospecimens are even excluded*), and it’s highly unusual to have someone kick up a fuss. I’m sure that some of these studied (maybe even some using my information, who knows?) have led to medical advancements. I’ll never know.
I agree that the Henrietta Lacks case is unusual (most obviously in that we know her name), and that the rare instances of individuals having special, and useful, characteristics should perhaps be handled differently. I doubt, for any number of reasons, that it will happen all that often.
*A quick Google search reveals this language in an existing California hospital ‘informed consent’ form:
And then there are a couple of lines where the patient can write in conditions or exceptions.
So it seems to me that many institutions already have their feet set on this path, and that many, if not most, patients are already signing their rights away on this matter already. Which is sort of the first point that I tried to make.
A fascinating and literally ‘bleeding edge’ debate on individual vs. communal rights/obligations. No one better than Prof. Epstein to incise, retract and cauterize! The debate, like HeLa cells will likely prove immortal.
It occurs to me that the donation of cells to a research facility should not entitle one to financial remuneration if those cells are then used in successful research. It is not the cells themselves which earn the monies, but the months and years of hard work by researchers using those materials. We all benefit from the success of great and successful research. I see no reason why the scientist who did it should not profit, nor that those who invested financially in that research without guarantee of return should not also profit.
If the hospital’s tissue committee determines that the surgery was justified and appropriate, whatever is removed was done so justifiably and presented a danger to the patient. What happens to it after it removal no longer involves the patient.
A few points of clarification from the researcher perspective:
– There’s a big difference between using thousands of generic specimens to develop a new product, and finding the one rare patient like Lacks or Moore whose single specimen leads to millions of dollars in commercial exploitation. In the latter cases, it is truly the individual patient who is the limiting factor, while in the former case each individual donor is replaceable.
– In most hospitals, it is already prohibited to collect patient specimens without prior patient consent. As She points out, this means that any patients donating specimens are already filling out consent forms, so adding a clause about commercial exploitation shouldn’t be too difficult (if it isn’t already on the form).
Nobody is saying the researchers shouldn’t profit, only questioning whether the patient should also share in those profits.
The situation is akin to a rancher whose land sits on an oil reserve. Typically, the rancher doesn’t actually do anything to bring that oil to market – the oil company comes and does all of the actual work – yet we would still insist that the landowner be allowed to charge the oil company for using his land because, after all, it’s his property.
Similarly, if I take my car to a shop to upgrade it’s sound system, the old sound system doesn’t automatically become the property of the shop. Why should body parts be any different?
Mendel: The situation is akin to a rancher whose land sits on an oil reserve. Typically, the rancher doesn’t actually do anything to bring that oil to market – the oil company comes and does all of the actual work – yet we would still insist that the landowner be allowed to charge the oil company for using his land because, after all, it’s his property.
The difference is that a landowner (in America at least) owns the mineral rights along with the property unless they have been sold previously.
This leads to a fabulously dynamic energy extraction industry compared to other countries where mineral rights are owned by the state.
What might be interesting is a concept of “tissue ownership rights” that would encourage patients to donate tissue toward research.
I don’t find it particularly odd. Cancer surgery can be seen as analogous to waste removal.
If I hire someone to remove all the crap from my apartment and take it to the landfill, I have relinquished my property rights over the material. If they should happen to find a priceless work of art in the pile I should have little right to complain, since I paid them to take it away!
The patient contracts the surgeons to remove an unwanted bit of their body and chuck it in the trash. If the doctors discover a use for the specimen why should the patient retain any rights to it?
Your trash is no longer yours once it’s on the curb. Why should it be any different for a spleen?
The real problem, perhaps, is that surgery is not widely seen as a commercial service being contracted, but rather as a public service being consented to. If it was widely seen as a contracted service then people might insist on looking at the contract a little more closely.
The difference is that oil/minerals are not considered waste material in the same way that a cancer tumour is.
If the rancher paid someone to get rid of some awful minerals because they were getting in the way of his ranching operation, and then only discovered that the minerals were valuable after the fact, then the situation might be analogous.
If a tumor was only waste material we wouldn’t be having this discussion in the first place.
Also, the example of excised cancerous tissue is only one way (albeit a large one) in which patients’ biological material can be used for commercial exploitation. “Healthy” blood samples drawn for routine testing – which are not necessarily “waste” – are also a huge treasure trove of research material.
I agree. We could stipulate that all biological material is the property of the patient unless contractually relinquished. In that case, every hospital would simply add a clause to their bills saying that all patient material becomes their property, including any future commercial exploitation (these clauses already exist in every clinical trial contract).
If a patient really feels their tissues are worth something, they’re free to shop around. 99.99% of the time, nobody will be willing to pay them anything for their samples. But for the rare patients with unique genetic backgrounds or rare diseases, it could be a boon.
And yet, I don’t sign a form relinquishing my property rights when I chuck my garbage out on the curb.
Mis, when I worked for city government, if a sanitation worker went scrounging through the garbage he collected, we’d have fired him on the spot for snooping in the resident’s houses. And afterwards, the resident would have hanged him for the same reason. Your example isn’t getting you as far as you seem to think.
It is true that at the landfill they will do things like try to pull out scrap metal, and they could, conceivably, pull out letters and so forth (which is why you should shred important documents before throwing them away). If that fact were widely known, I don’t know how people would take it.
And that’s really what we’re dealing with here. Richard says “look at all the great stuff science has produced!” and people respond “you mean the scientists have been exploiting their patients, ripping them off, culturing their cells, and lying to us for decades?! Get a rope!”
I don’t think trash is the apt analogy here.
More analogous would be taking a car to a repair shop. In that situation, it’s not obvious that anything the mechanic removes from the car automatically belongs to the mechanic, especially if that component might have some remaining value. Instead, the ownership of that part is assumed to remain with the owner of the car unless specified otherwise in advance.
And yet, I have to pay them to dispose of my used oil.
It seems simple that researchers be required to provide IC if they ask for additional samples. I agree that the basic issue regarding IC and privacy is administratively burdensome- but it should be noted that when institutions and companies pass samples back and forth for research purposes, they are already promising to keep trakc of commercializable discoveries and promising to agree on fair sharing of the proceeds. All that happens now is to let the sample giver of very unique materials share in the booty.
BTW, I don’t find that HIPAA Privacy rules are that miserably burdensome. There is also a broad research exception. Once you set the process and procedures, you just automatically follow. I can’t imagine ethical research without Institutional Review Boards, given the incentives in front of researchers.
Nope. I hear it too. I thought that while I was reading this, and have thought it before in other posts. I read with his verbal cadence clicking through my brain.
The weird thing is that, in my head, I’m reading it about 25% faster than normal so that I can barely keep up – just like when he’s talking!
I can even hear where he might breath, or change the tone to end a phrase. It is kind of like listening to a favorite band, you know them when you hear them.
I wonder if we could identify a Richard Epstein post if it was anonymous? :)
I don’t entirely recall why it was an issue, but when I had a prostate cancer biopsy I ended up going to a different surgeon for treatment than the one who took the biopsy samples. The biopsy slides got lost in the process, and then found again. Like I say, I don’t quite remember why, but my surgeon encouraged me to think of those as my slides, and that I could insist that they be in my possession, and that my medical records could be in my possession. It may have been that the lab that analyzed the biopsy slides would not release them directly to me, and my surgeon didn’t think they had the right to say that.
That was in late 2001. (The word “cancer” was first thrown at me on my birthday, while the twin towers were on fire but not yet fallen. It was a big day. I got a little teary late in the day as I drove to pick my son up from school, because I knew there would now be an assault on our civil liberties. Which there was – worse than I expected – thanks to major character defects in GWB.)
Another way to look at this would be like patents or copyrights. Government provides these as to protect intellectual property that is easily copied and thereby to encourage the development of intellectual property. But copyrights and patents are for limited terms because government has an interest in the people getting goods as cheaply and widely as possible.
If this is the analogy, then there need be no tissue rights. This is because there is no activity that needs to be encouraged. That is, people have these cells removed for other reasons. Good cells can be valuable, but having them is more like winning a lottery than production of a good.
Further if you consider tissue a raw material for research. IF you make the raw material more expensive, THEN you will discourage the creative work that the government should be trying to promote by making the research more expensive.
Lastly, even if you grant property rights to the tissue “owners” then the rights should be of a very limited duration (maybe 20 years or maybe the life of the donor at most). The idea that a donor’s children should benefit (beyond what they get from the parent) when they have done no good is a mistaken one. You could even argue it makes the descendants less productive than they otherwise would be. Copyrights in general are way too long and should be shortened considerably.
Epstein is a national treasure!
I can imagine Epstein’s voice when I read his work, but I generally don’t, unless I specifically try to do so. Then it is easy.
The only other author in this category, for me, is Andrew Klavan, though in Klavan’s case my brain’s default rule is to imagine hearing his voice when reading his work.