Michelle Mello: Patient privacy and the law are on a collision course
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Michelle Mello: Patient privacy and the law are on a collision course

(piano chiming) – Today on the Future of Everything, the future of health and law. The first thing many people think about when they think about how
law and health intersect, is malpractice. Physicians getting sued
because patients feel that they suffered, because
the physicians did not provide appropriate care or did not deliver it in an appropriate way. Indeed this is an important
area of the intersection between legal world and healthcare world. But there’s much more,
what are the best ways to regulate health insurance? What should we expect
of our health insurers? How can we ensure that drugs
and medical devices are safe and effective and get to
patients in a timely manner? How can we create rules
to guide the advertising about these drugs and devices
so that people are aware of them but we don’t
unduly influence their use? How do we guide biomedical
research so that it is performed ethically and with full
consent of patients? How do we define the rules
for sharing patient data so that we can benefit
the healthcare system while also respecting the privacy of the participants and
how do these relationships all change in the era of the
internet, digital devices and social media. These issues all demand kind
of a balancing act between the needs of individuals, the patients, the needs of the business concerns and the industrial players
and of course the needs of society at large,
particularly the government which serves as a major
payer through government healthcare systems and
also as a regulator. Professor Michelle Mello
is a professor of Law and Medicine at Stanford University. Michelle you have addressed
many of the issues at the intersection of law and
health and one recent issue that you’ve published
about is the attitudes of clinical trial
participants towards sharing their personal data, how
did this issue come to your attention and what did you
find out about data sharing? – Well there has been a
real movement within science to make sure that we
get every possible bang for the buck that we spend
on biomedical research. So there’s been a push by
funders of biomedical research, by the journals, and many
other forces to make sure that scientists are sharing their data with other scientists. There’s been a sort of a backlash within some quarters though about
the implications of that move for patient privacy and
a lot of that opposition has been voiced by the
pharmaceutical companies that sponsor a lot of clinical trials. They typically couch
their objections in terms of wanting to protect the participants in their clinical trials,
but it wasn’t clear to me what those participants actually want. Because no one had ever asked them. – I see and so what did you
do about that gnawing feeling that you had that this might
not be the whole story? – We surveyed 771 current or recent clinical trial participants
in three academic sites across the country we
wanted to know how they felt about expanded access to
their participant level clinical trial data
and what they perceived as the risks and benefits
and overall were they willing to engage in that practice,
having already volunteered for the clinical trial. – And what did they say? – What surprised me was how
overwhelming the support for this practice actually is among people who have volunteered for clinical trials. – So specifically the
practice of sharing the data? – Of sharing the data and
what we’re talking about here is not sharing results
of course everybody wants results to be made available. We’re talking about sharing
the participant level data after their name and
certain other identifiers have been removed, and we
asked them about a variety of people that might receive this data from other drug companies
to academic scientists to members of the public who
might be able to download it and a variety of ways in
which it would be used and 82% of the sample
felt that the positives associated with all these
types of data sharing outweighed the negatives. Only an 8% had a negative view. 93% were willing to share their own data with scientists in academic settings, and 82% with scientists in drug companies. – Now of course when a drug
company or anybody does a trial there’s a consent procedure and many times I hear people
referring to the consent as one of the barriers. So when you looked back at the consents that they had signed,
were they in retrospect perhaps overly restrictive
compared to what the patients would have agreed to? – So we didn’t actually
look at the consents that these patients had signed
but having served on institutional review
boards for clinical trials. I know that the practice has long been to assure participants that
their data will only be viewed by members of the clinical trial team and certain people who
are entitled to have disclosures made to them
like government regulators. That clearly needs to change and is already beginning
to change to contemplate sharing of the data much more broadly. In part because I think for
scientists the main reason has been because the journals require that as a condition of publication. – Right so just to step back a minute. Let’s go over why you would
wanna share this data. So presuming that, let’s
say the drug companies although I know this is
also an issue for academic clinical trials as well,
presuming that they disclose their findings and that
we don’t believe there is fraudulent data going on,
is this checking to be sure that their calculations are correct? Or are there other
unanticipated potential uses of this data, how should
we think of the opportunity associated with the data
if they were to be shared? – So I think there are
two main opportunities, one is along the lines of
checking to make sure it’s right. Interest in this area really
began after the scandals about 10 years ago over Vioxx
and a couple of other drugs. Where upon a second look at
the data it became apparent that the drug was
actually a lot less safe, than the pharmaceutical sponsor had let on and in some cases there
were some pretty glaring statistical deficiencies in the work and the feeling was, if other
scientists had had access to those data we could have prevented harm to patients much earlier. Since then there’s a
feeling that those practices have probably improved a bit. But there’s a broader
concern within science about the ability to replicate studies. The so-called replication
crisis in science. Where more and more it
is being revealed that even good quality work
by honest scientists often can’t be replicated when others try for one reason or another,
and so this leads to a– – And you don’t mean
replicate as in reanalyze the data you mean try to do the same type of trial with a new set of patients? – Certainly that but also
just reanalyzing the data sometimes we fail to
reproduce the results. So again there’s a
feeling that if these data were more broadly available it might lead to greater confidence in
the results that the public is relying on and maybe better practices in terms of statistical
analysis and reporting. So that’s one group of
uses, but the second and maybe more exciting
group of uses for patients, has to do with exploring new questions. Pooling data across
clinical trials for example to do more analysis of sub
groups that were too small in any one trial to really
learn anything about them. Or pooling data across trials to learn about rare conditions that aren’t possible to explore in a deep way in any one trial. So it’s the prospect of
accelerating scientific discovery by making use of what we already have. – Now when you talk to these folks, and I think you said 92%
were pretty okay with it, 82% and even more were generally okay. Did they understand how
restrictive the data agreements that they participated in were? And were they surprised
that these things were not happening or did they
not find that surprising? Or did you even address that issue? – We didn’t ask that
directly but interestingly we did give them an
opportunity to just write in comments at the end of the survey and over and over we heard things like. Of course they should be shared. If you don’t like that you
shouldn’t be participating in clinical trials in the first place. That’s what I’m here for. So that reminds us that in
some sense this is maybe a select group, these are
already research volunteers and if you’re a person whose really, wants to keep your data close to the chest you probably don’t volunteer
for a trial in the first place. But given that you are
a research participant, I don’t think it came as
much of a surprise to them that scientists would
want to make maximal use of their data and indeed
one of the most important functions of data sharing
for them was making sure that their own sacrifice as
a research participant, lead to some good. – This is the Future of Everything, I’m Russ Altman, I’m speaking
with Professor Michelle Mello about data sharing of clinical trials and patient attitudes towards it. So what abut let’s go down to
the nuts and bolts of sharing. So you can just put it on the web and let people download it
but there must be other levels of security and I’m wondering
particularly the different entities and if they should
all be treated the same, and let me just be specific. So you said a pharmaceutical
company runs a trial and they have some data,
they could share it with academic researchers and
there’s, patients might have some response to that idea. They could also share
it with other companies either in the health space,
but increasingly we know that these big tech companies that are not traditionally associated
with being in the tech space. Also may have interest
in health as a new market for them, so what is the
landscape of how sharing does work and perhaps how should it work. – Well here we’re beginning again I think to step out of the specific context of clinical trials because
the issue you raise affects every single
one of us as patients. Our data has long been
shared with a variety of companies without really
our express permission, but they’re being shared in new ways and specifically more
often with identifiers attached to them and more
often in de-identified form with companies that are making radically new use of them particularly
for the development of artificial intelligence in medicine. – Right so, now help me
I just want to make sure that we don’t get confused. The first part of our
conversation was about companies saying we don’t
wanna share the data, we have all these agreements
that we won’t share it. But now you’re also pointing
out that there’s often for healthcare in general, broad sharing. So what are the differences
and why do those two seemingly opposite
situations, why are they both happening at the same time? – Good question, well
in the first context, the situation is a drug company is trying to develop something new that it can sell and make a great deal of money on. So of course it wants
to preclude competitors from figuring out what it’s doing. They are racing to get to
the patent office first and its interest is in not sharing data, with competitors at least until it has obtained patents around the world. In the second instance the data suppliers that we’re talking about are
mostly not drug companies. It’s mostly hospitals,
universities like Stanford and others around the world
that have the one thing that tech companies can never beat them at which is access to patients. So they, tech companies
may be better than you and I at data analysis and analytics. Although probably not
better than you Russ– – Oh they’re very good. – But they will never
have access to patients and so they need hospitals
and healthcare organizations and the question is what’s in it for the healthcare organizations. The answer may be money, but
it may also be the development of new technologies
that can help patients. – So somebody listening to
this might be very surprised to know that their data
from a recent hospital visit may have been sold,
should people assume that that is the case or are there protections? You know every year we get
piles and piles of mails. About all the different
companies that are so worried about our privacy that
they are sending us email and hard copy mail you know
outlining all the processes they undergo, so what do you tell somebody about the inherent privacy
of their medical data at a hospital or at a clinic. – It may well not have been
sold, but it very likely has been shared and again
that has always been the case. Because hospitals have
always needed the help of third party companies to do business. Billing companies, process patient bills. Supplier companies and
so forth and so the law. Our federal privacy statute called HIPAA allows those relationships
to form pursuant to contracts called business associate agreements and once you have one of
those contracts in place you can transfer patient data with names and all kinds of other data attached and the idea this is how we make, how healthcare organizations run. – And so this is definitely
facilitating care in a way that is
reasonable and defensible. – That’s right, and
what’s novel is two things that kind of maybe sit outside the intent of that federal privacy statute. One is the sharing of de-identified data, so as long as you strip
out a bunch of information about us as patients that
data set’s no longer covered by anything and you can do
with it whatever you like. We know however that
it’s increasingly easy to re-identify patients now
with the computing capabilities that we have and HIPAA
simply didn’t anticipate that problem, the second
thing that’s novel is the use of these business
associate agreements. For all kinds of new
partnerships aimed not at just processing bills or
studying efficiency within the hospital, but at developing
new kinds of products and algorithms that might improve care. – And so there’s a gray area
there where we’re slipping out of routine business
use to new opportunities, and this might be with
novel companies that are not traditionally in the healthcare business and may have a different
sensibility about patients and what the business opportunities are? – Yeah I think that’s
one way of looking at it. You know healthcare organizations may view things differently and
say look we have always been in the quality improvement
business and this is just a 21st century form of that. – This is the Future of
Everything I’m Russ Altman I’m speaking with
professor Michelle Mello. We’re getting a little
bit into privacy rules and you mentioned the
HIPAA Act which is an act in the U.S. governing this
and I’m not sure we want to go into the details of that, although I’m sure it’s
fascinating but what has also come to a lot of people’s
attention is that Europe has introduced similar but I
think more strong legislation, and there’s mumblings about
similar things coming out at the state level including California so what, how rapidly
changing is the regulatory and governmental approach
towards patient privacy and really individual privacy? It goes beyond health records. – I think it’s beginning to change. You know the Europeans as in
most things are ahead of us in terms of anticipating social needs and responding to them with regulation. But here in California
too we’ve begun to evolve our law a new statute
called the CCPA was passed in 2018 and it gives consumers the right to own their data and to
opt out of various uses of their data by other companies and to know the uses to which their consumer data are put. It only applies to large companies, and companies that make a
lot of use of patient data. But it still is kind of a paradigm shift from the old world in
which if you as a business collect data, that data
those are yours to do with as you wish, what we haven’t
seen a lot of movement in, is at the federal level,
changing HIPAA for example. There have been some kind of
tweaks and clarifications. But I think the momentum for
a federal privacy statute is just sort of beginning to bud. – So what do you tell, you
mentioned something about a increasing move towards
patient ownership. I’m sure people are still
confused about this. Do I own my medical records? Can I request a copy of them? Is that the same as ownership, and how clear is the law
about those types of issues? ‘Cause I think that especially
in independent America we like to think this is our data, and we can control it. To what degree is that true? – Well HIPAA’s very clear about that and what happens when a
state comes in with a law that says something
different can be tricky. But you know in general
your healthcare providers are the owners of your data
but you have an absolute right to access them,
again you might have to pay five bucks for your copies
but you’re meant to be able to get them without any interference. Now in practice we know
that healthcare providers, all the time throw up the
word HIPAA as a reason not to provide patients with
information or to make them jump through all hoops and
it’s mostly out if ignorance in low level people
within those organizations that are responding to these requests. – So there’s a certain
institutional perhaps inertia, or obstruction whether on purpose or not that makes it difficult
sometimes to get this data, but you should be able to get it. – You should be able to.
– So, I want to go next to this idea of and I know you’ve published about this. The advertising by the
pharmaceutical industry. It’s a little bit of a
switch but let’s say they do get clinical trials they
either share their data, or they don’t share their
data, and then there’s an issue of their role in advertising drugs and as I’m sure many people
know for many years this was not allowed at all but now every morning, on the morning news you can
see lots of commercials. What is the situation with
that, and how fluid is it? – So we and New Zealand are the only industrialized countries in the world that allow direct to consumer
advertising of drugs. Of course everybody allows
advertising to physicians and that’s still the most important form of advertising that drug companies do. But as we all know because
we watch television, there’s a lot of direct
to consumer advertising. It’s about a $6 billion a year industry, and it works, there’s a–
– It drives me crazy. As a physician I must say every morning I’m shouting at the TV because they say, ask your doctor if you have
and then they list these incredibly technical things
which it is precisely, no they say, tell your doctor and it’s like this is
the doctor’s job to know and so it just irritates me but I’m, excuse me for that outburst.
– A lot of physicians feel that way as they’re
already dealing with the constraints of a
15 minute office visit and now some of that has
to be devoted to explaining to the patient why they
shouldn’t have expensive advertised drug X instead of
an older generic alternative. – This is the Future of
Everything, I’m Russ Altman more with professor
Michelle Mello about direct to consumer advertising and other health and legal interactions next on SiriusXM. Welcome back to the Future of Everything, I’m Russ Altman I’m speaking
with professor Michelle Mello from Stanford university
and we were just starting to talk about this odd at least it’s odd, except for New Zealand and
the United States idea, of directly advertising medications and medical devices to patients. So why did that change happen? And is there any data
suggesting it was a good idea, bad idea or that everybody just ignores it and goes to their physician and talks about whatever
they want to talk about. – Well drug companies were really pressing on the FDA and Congress
to allow this because of two things that were going on. One is really a feeling
that they needed another way to get information out there, and the second was in my
view increasing signals from the court that
so-called commercial speech. Speech about products and
services that someone would like to sell you enjoys first
amendment protection and that restrictions
on it would be unlikely to survive legal challenge. I think those two forces
together lead to reconsideration of the traditional ban. – And I guess it’s been 15, 20 years.
– It’s been awhile now yeah. – Do we know if it has,
they continue to do it so I’m going to assume
that it has worked out financially for them and
I’m sure they pay attention to this. – Yeah we know it works
and they know it works. It has both beneficial
and deleterious effects. The benefits are that it alerts patients to symptoms that they may not be aware have a treatment available now, in my view that’s a benefit
that had more importance in the pre-internet era
than when we can all type in our symptoms and get
a range of medical information and treatment opportunities
pushed right out to us. The deleterious effects
have to do with encouraging patients to get on to expensive branded, meaning on-patent drugs. Where there are other
alternatives available that have been in use longer
and are much cheaper and probably as effective. – And although this began as
a radio and television thing. Because that’s what we had available, I think we all see these
now direct to consumer includes internet and social media. Are there special considerations
because then you could imagine that the search
algorithms will target patients who are doing certain kinds of searches, it could be very precise the marketing. This could be a good
thing because it could get the news to precisely
the people who need it, what’s your sense of that? – Yeah it’s an interesting
question, I mean legally there’s nothing particularly
special about it but yes we’re moving into a world
where when you post on Facebook about your gout acting
up you are going to get advertisements for gout
related products and services and that, like many other
forms of targeted adverting just has a creepy factor
for a lot of people. – So this leads to the,
and right before the break you actually mentioned that people are now coming in saying hey why aren’t
I on this drug Mr. Doctor? Or Mrs. Doctor, and then the question is is there any evidence that
this is causing problems in the patient physician relationship? I think you mentioned that the physicians have a very short time
they wanna address the real problems of the patient they
are usually perfectly aware of all of the medical
choices that they have. So and I know you’ve
written about patient trust in physicians has that
come into the dynamic or is it mostly about other things? – My sense is and you probably know better as a clinical physician
is it’s mostly about time pressure and how the
physician would choose to allocate the scarce minutes
available in an office visit versus what’s on the
patient’s priority list. When you’re already rushed
through a visit to have to explain why the newest and
greatest drug is not better than what the patient has
been taking at a fraction of the price that’s probably
not great for the physician. – Yeah and there is an insidious, in some types of medical care
there’s a terrible tradition that the interaction is not
over until the physician writes on a little piece of
paper or types on the computer I’m gonna give you this medication and that’s like a sign
that the visit is over and that’s not very good
because that’s not a good way to have to end the interaction, in fact it would be even
better to say the good news is I don’t need to write you a prescription and we’re not gonna add
any pills to your mornings and evenings, but that’s not the case. So this issue of advertising and really I think plays
right into a very hot topic. Which is the affordability of medications and I know you’ve also written about that. From a legal perspective as
you approach these issues what are these issues about affordability and has there been any progress in trying to think about new ways to price drugs. We all know that we’re not allowed, I think we’re not allowed to go to Canada to get our drugs so where are we? – There’s been a huge
amount of thinking about what to do about this issue. It was as of two years ago
maybe one of the only issues where there was broad
bipartisan agreement. I mean we’re talking about
a congress that can’t agree on whether the planet’s warming right? But they agreed that
something had to be done about this issue and so there
really has been a very intense amount of work both within the congress, within agencies and
outside in universities and other places and lots of
great and interesting ideas on the table now, not much progress yet. – So can you tell me what
are the fundamental tensions? I think a simple minded would
be well the drug companies want to make as much money as possible, and other people wanna
pay as little as possible but there are issues I know
of incentivizing innovation for new drugs, there have
been in the last few years, the introduction of truly amazing drugs. Two examples would be we
now have for many people with hepatitis C we have a
perfectly good curative agent, which is priced in the hundreds
of thousands of dollars. That’s on one end of the extreme, for a pretty common disease hepatitis C. At another extreme there are these very rare childhood
diseases that are fatal. Where we now have million
dollar treatments, I’ve heard people say that
society will go bankrupt if the drug companies
continue being this creative and successful in creating treatments. So what is the set of more
sophisticated considerations to create an ecosystem that really works. – So the central trade off or tension that you’re raising here is between innovation and affordability or between affordability and availability, so there’s no doubt that at some level this has to be right. That if you eliminate
financial incentives to develop new drugs for profit companies and the investors that
back them are not gonna be interested in pouring
as much money into it. The problem is we don’t
really know how to quantify that trade off. When a drug company says oh
you know you can’t possibly reduce my margins, all
innovation will cease! That doesn’t seem plausible
but I can’t give you a beta coefficient if you reduce profits by this much we’ll see
this much less innovation, and then the other
problem is even if I could you and I might not agree
about what we’d be willing to trade off so I’d say
I’d give up three new drugs a year if it meant that
every American can access the ones you have and you might disagree. So we’ve got both an empirical problem and a normative problem. – This is the future of
everything I’m Russ Altman I’m speaking with
professor Michelle Mello, now about drug prices and
so this is a hard problem. Does anybody take it as
their problem to solve, so you pointed at Congress
is it basically an act of congress or are there
other more subtle ways that I don’t know the FDA,
or other federal agencies underneath the congress
could make progress in this area. – I think everybody could
make progress in this area, if we want very large changes to the way our federal programs pay
for and acquire drugs. It will take an act of congress usually, but there is a lot that can
be done through administrative regulation in the FDA
changing the way drugs get approved, how much
that costs and so forth within the centers for
Medicare and Medicaid services, what types of experiments
they allow and so forth. I think it’s also important
to note that there is a lot that can be done without
law, you know for example, one of the most important
problems in my view is that at the point of
prescribing physicians have very little information
about the relative cost of the different drug choices
that they have available. – Yes and particularly how
much it’s going to cost that specific patient because
of if their insurance– – Because as you know there’s
not one price per drug everybody pays a different
price depending on who their ensurer is and what
kind of plan they have from that ensurer, so one
thing that the market has begun to supply is products within
the electronic health record that can tell a physician. Here’s the choice set, here’s
what it’ll cost your patient today and here’s what it’ll
cost their health plan today, and that could become part of
the prescribing conversation. – And as a physician I would be happy to have that information, and I am positive it
would increase the quality of my relationships with my patients. If they were on board with
the idea that I was making these decisions not only
to optimize their care but also to minimize the
impact on their wallet. – You know physicians I
think are often reluctant to bring cost into the
conversation in part feeling the sting of the managed
care backlash from the 1990s where they felt like they
were under attack personally for not having their
patients interest at heart. Patients want cost to be
part of the conversation, they want physicians to acknowledge that, that is a real barrier for
them accessing medication. – Thank you for listening
to the Future of Everything, I’m Russ Altman if you
missed any of this episode, listen any time on demand
with the SiriusXM app.

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