In a recent (January 29, 2015) New York Times Op-Ed, Mayo Clinic anesthesiologist Michael Joyner writes
that “’Moonshot’
medicine will let us down”. What Dr. Joyner is referring to is what is now
most commonly called, particularly in the large academic medical centers that
have bought into it in a big way, “precision medicine” or occasionally “personalized
medicine”. This is the concept that, by knowing your individual genetics,
medicine can devise targeted treatments for diseases (most of the emphasis is
on cancer) that will work for you, but
maybe not for other people. Maybe the treatment most commonly used for the
disease isn’t right for you; this would find it out.
It is a very attractive concept, and one that has clearly
gained traction since the first complete sequencing of the human genome in
2003, moving from a science fiction idea to a mainstream investment by many
institutions. As Dr. Joyner notes, “President
Obama’s new budget is expected to include hundreds of millions of dollars for
so-called precision medicine. The initiative, which he introduced last week in
his State of the Union address, has bipartisan support and is a bright spot in
the otherwise tight funding environment for medical research.” That is the “moonshot”
part – hundreds of millions of dollars. When other funding for research is
stagnant or being cut. Because it sounds cool, exciting, really like something
cutting edge, a step toward the day when disease will no longer bedevil the
human race. However, Dr. Joyner adds: “Unfortunately,
precision medicine is unlikely to make most of us healthier.” Bummer.
Maybe he is wrong. Maybe the medical centers investing
heavily in precision medicine, and the federal government which will fund it
(of course, the “investing heavily” is not unrelated to the “hundreds of
millions in federal funding) are right. “Star Trek” here we come! But let us
look at the evidence that Dr. Joyner presents. He notes that most common
diseases that affect people, even those with clear association with families
and thus likely genetics, such as Type II diabetes, are not the result of a
single or even a few genes that could be targeted if they could be fixed. There
are multiple genetic characteristics that impact whether someone has a tendency
to get DM2. Moreover, whether it actually occurs is a result of a complex
interplay between those genetic risks and actual behaviors such as diet and
exercise. He argues that it is obesity, caused by behaviors but certainly
abetted by social changes in our lives, jobs, and easily availability of cheap
high-calorie food leading to obesity, that has been the major culprit, given
that DM2 (and obesity) is an epidemic of the last half-century, therefore not a
result of any genetic change. In addition, even when there are genetic factors
for differences between people in their response to treatment, it turns out that
these do not explain most of the difference (“missing heritability”), such as
in response to the anticoagulant warfarin (a so-far failed effort to use
precision medicine to choose treatment). Treatment of chronic diseases like
cystic fibrosis by genetic intervention has been unsuccessful, and cancer (like
microbes) mutates a lot faster than genetically normal cells.
Joyner also raises the very real concern that people’s
behaviors will change in ways that work against their health when they learn
their genetic risk. Some people will use the information that they are at lower
genetic risk to adopt risky behaviors. This has been described in many areas, everything
from people with negative cardiac tests continuing to smoke and overeat to men who
have had negative HIV tests and circumcision to decrease their risk of spreading
HIV increasing their unsafe sex practices. He also notes that the opposite test
result, finding yourself to be at greater genetic risk, can also lead to unsafe
practices because you figure you’re doomed anyway. In addition, he notes that there
are some people (“worriers”), “…who might embark on a course of excessive
tests and biopsies ‘just in case.’ In a medical system already marked by the
overuse of diagnostic tests and procedures, this could lead to even more
wasteful spending.”
The main message
here is only in part that “precision medicine” is something whose time has not
yet come and may or may not ever come. More important thing is that, despite
this, the government is planning to invest hundreds of millions of dollars in
it. Most important is that money is not being spent on implementing treatments
for conditions that we do know how to treat. People who are poor or uninsured
cannot access many already available – and often incredibly expensive –
treatments for diseases like cancer (see my piece “Squeezing
the needy: a truly flawed financing system for healthcare”, March 2, 2013) or hepatitis C or many
neurologic diseases. “Precision medicine” treatments are certainly going to be
even more costly. In addition, we do not spend the necessary money to address
the social determinants of health--housing and food and warmth and education--that
make more of a difference in health than all of health care.
Indeed, we invest
large amounts of money, public as well as private, in programs that effectively
make our health worse. Sometimes this is in subsidies to major environmental
polluters (BP, anyone? How about fracking and the Keystone XL pipeline?), and
sometimes it is more direct, when we actually invest government funds in making
treatments more expensive and less accessible to people, albeit to the benefit
of the drug companies? Noted economist Joseph Stiglitz takes this on in another
recent Times Op-Ed, “Don’t
trade away our health” (January 30, 2015). He describes how the US Trade
Representative, who negotiates trade agreements “supposedly on behalf of the American people”, is in fact
consistently working on behalf of big corporations. In the case of the
Trans-Pacific Partnership, this will mean increased obstacles to lower-cost
generic drugs by making competition more difficult. “Just the availability
of generics drives prices down: In generics-friendly India, for example, Gilead
Sciences, which makes an effective hepatitis-C drug, recently announced that it
would sell the drug for a little more than 1 percent of the $84,000 it charges
here.” This competition should be
encouraged; it is the essence of capitalism. But our trade representative is
representing big business, not people.
Of course, high drug costs are already a reality. On January
28, 2015, the Times’ Business Section
previewed a study coming out in the New
England Journal of Medicine from Harvard. “Study
finds HIV drugs priced out of reach”. Much of the great advance made
against HIV in the last few decades come from effective and more tolerable drug
regimens. Atripla, for example, is a once-daily combination of 3 drugs (2 made
by Gilead, one by Merck), that is extremely effective. But this study shows
that the “flexibility” available to insurers under ACA will mean that folks
with worse insurance (usually poorer people) will have to pay $3,000 a year more for Atripla than those with better
policies. Again, the poor pay more.
Precision medicine may sound good, and certainly cool, and
sexy. It may even benefit some people, if at very high cost, in the future. But
right now, today, there are lots of conditions we know how to treat and lots of
people who are not getting that treatment because they don’t have the money,
are not desirable, have diseases not in the most preferred “product lines”. And
we are spending federal money on making some of the drugs that we have that we
know are effective less available.
Despite publicity about or funding for precision medicine or
any other “new idea”, the fatal flaw is that our health system is not about
improving our health, it is about profit. This is intolerable.
