вход по аккаунту


Living in a different world.

код для вставкиСкачать
Vol. 52, No. 2, February 2005, pp 395–401
DOI 10.1002/art.20865
© 2005, American College of Rheumatology
Living in a Different World
David Wofsy
There are moments in a lifetime that would once
have seemed so unimaginable that they don’t seem real
when they arrive. I am having one of those moments
today. It seems fitting, therefore, to begin with a brief
personal story directed at those of you who are just
starting out in your careers. In 1980, in my first year as
an instructor, my division chief called me in to discuss
my future. The tone of the meeting was friendly, but the
message was not pleasant. He began by saying: “I think
you know that you do not have a future at UCSF.” I
suppose that there are many reasons to recall such a
story at a time like this, but I mention it to you today
primarily to point out that most of us do not know
exactly where we are going when we start our professional journey. So don’t look at those of us who happen
at the moment to be in positions of prominence and
think that it will not someday be you. We are you,
displaced only very slightly in the grand scheme of time.
An interesting career—an interesting life—can be
frighteningly like a roller coaster. Just keep in mind that
the low points are an integral part of the ride. Without
them, the exhilaration of the entire experience would be
In preparing for this talk, I reviewed the addresses of my presidential predecessors. Not surprisingly, the themes of these addresses are quite diverse
and some have recurred over time, but one topic has
escaped attention. Through 70 years of presidential
addresses, there has been almost complete silence on the
topic of our delicate relationship with the pharmaceutical industry. A few brief references exist, but they
typically are couched in self-congratulatory comments
about our high ethical standards. It is past time to
address this subject in greater depth. The topic is simply
too important, and the relationships too pervasive, to
Let me begin by emphasizing that it is not my
intent to critique the pharmaceutical industry. Pharmaceutical and biotechnology companies have a welldefined and important role in society, and they have
many critics. Rather, I want to focus on what it means
for a society of health professionals to depend so heavily
upon their largesse. First, some facts are in order—
about the ACR, about the pharmaceutical industry, and
about me. Like many of you in the audience, I have a
conflict of interest when it comes to this topic or, shall I
say, several conflicts of interest. Perhaps that is one of
the reasons we remain silent. So I should not discuss this
topic without providing some personal disclosures. I
spend most of my time these days conducting clinical
trials. Much of this work is supported by industry. In the
course of developing these trials, I have consulted with
numerous pharmaceutical and biotech companies, including, in recent years, Bristol-Myers Squibb, Amgen,
Genentech, IDEC/Biogen, Serono, Protein Design Labs,
Scios, DNAX, TolerRx, and Vasogen. At the University
of California, San Francisco (UCSF), I direct the rheumatology fellowship training program, which has, at
times, received partial support for a fellow’s salary from
Amgen. I also co-chair the UCSF rheumatology board
review course that is supported largely through industry
sponsorship. This year, the principal sponsors were
Abbott, Centocor, and Wyeth/Amgen. I am providing
these disclosures in detail because I want to make it
absolutely clear that I need look no further than myself
to see a problem, and because I think that my own
relationships are illustrative of the kinds of choices we
all face in trying to determine how to function effectively
and ethically in a complex world.
And it is not just a complex world in which we
rheumatologists function; it is a very different world
than existed even 6 years ago (Figure 1). In 1998, the
unchallenged standard of care for rheumatoid arthritis
Presented at the 68th Annual Scientific Meeting of the
American College of Rheumatology, October 20, 2004.
David Wofsy, MD: University of California, San Francisco
and VA Medical Center, San Francisco, California: President, American College of Rheumatology, 2003–2004.
Address correspondence and reprint requests to David
Wofsy, MD, Arthritis/Immunology Unit (111R), VA Medical Center,
4150 Clement Street, San Francisco, CA 94121. E-mail:
[email protected]
Submitted for publication October 29, 2004; accepted November 4, 2004.
Figure 1. Gross annual sales of antirheumatic prescription drugs in billions of dollars (data from http:// MTX ⫽ methotrexate.
was methotrexate, with gross annual sales, across all
indications, of $141 million. The highest selling NSAID
was naproxen, with $490 million in prescription sales.
Since then, there have emerged five billion-dollar drugs
in rheumatology that have been the focus of the most
aggressive advertising campaigns this side of Cialis. If
anyone ever doubted the magnitude of the stakes involved in this area, we now can put a number on it.
During the 24 hours following the withdrawal of Vioxx,
the value of Merck stock declined by $26 billion. These
drugs not only have changed the stakes for the companies that work in our field but, not coincidentally, they
have drastically changed the opportunities and hazards
for the ACR. I will only briefly mention the opportunities, which we discuss often and which are well known to
all of you, and then I will focus on how we are confronting the hazards.
Increased support from industry has enabled us
to substantially expand programs and services for members without a substantial increase in dues. Since 1998,
our annual budget has increased by 75%, while dues
have increased only 6%. The expanded programs include, for example, enhanced educational offerings at
the annual meeting and elsewhere, practice management seminars, scholarships for trainees to attend our
meetings, and major new initiatives to provide assistance
to rheumatologists at the local level. We were also able
to establish the Industry Roundtable (IRT) as a means
of substantially fortifying the Research and Education
Foundation (REF). The IRT is, in effect, a new kind of
business relationship between the ACR and industry. In
exchange for a fee of several hundred thousand dollars
per year that goes directly to the REF, companies
receive several benefits, including the opportunity to
present a symposium during one of the evenings of the
ACR meeting, preferred locations in the exhibit hall,
and a yearly meeting with ACR leadership.
I will not take time today to discuss the pros and
cons of the decision in 1998 to establish the IRT, but I do
want you to know one of the important outcomes.
Throughout the decade of the 1990s, the number of
trainees in rheumatology had fallen far short of the
number required just to replace the current workforce.
The first goal of the REF, therefore, was to reverse this
trend and increase the number of trainees from approximately 115 per year to over 160 per year. This ambitious
goal—an increase of almost 40%—was achieved in 2002,
exceeded in 2003, and has been exceeded again this year.
As a result, for the first time in a decade, the number of
people entering rheumatology is more than sufficient to
replace the anticipated loss from retirement in the years
immediately ahead. This good news serves our members
in practice, some of whom seek partners and some of
whom seek successors in their practices. It serves our
members in academic life by enriching their environment and assuring the viability of their programs. And,
of course, it serves people with rheumatic diseases. In
citing this achievement, it is important to acknowledge
Figure 2. Major sources of income for the American College of Rheumatology. In A, the Journals
segment includes income from advertising and the Meetings segment includes fees from exhibitors.
If these sources of income are shifted to the Pharmaceutical segment as depicted in B, this category
becomes the single greatest source of support for the ACR.
that many factors have contributed to this change in our
field, but it would be a mistake not to recognize the
important role of the REF and to sincerely thank those
who have made this happen: the members of the IRT
and the leaders of the REF, including, in particular, Dan
Wallace, Stan Cohen, Joe Golbus, Mike Weisman, and
Connie Herndon.
So what is the extent of the financial dependence
on industry that has enabled us to do these things, and
what are the consequences? The ACR derives support
from 5 major sources (Figure 2A). The least of these
sources is membership dues, which comprise 10% of our
income. Interest on our investments comes to 13%, and
17% comes from our journals. The lion’s share, roughly
40%, comes from income generated through our educational programs—in particular, the annual meeting. And
the remainder, 20%, comes from industry, primarily in
the form of sponsorships for our meetings. This number
is actually deceptively low, however, because there are
additional industry contributions in the other categories.
For example, the annual meeting income includes exhibit hall fees, and the journal income includes advertising. If these numbers are shifted from the other categories to the industry category, industry support actually
becomes our single greatest source of income at 34%
(Figure 2B), and this number does not include the REF,
which currently derives over 80% of its income from
With this much money on the table, we have an
obligation to be clear about what is for sale and what is
not for sale (Table 1). We sell advertising space in our
journals. We sell sponsorships and exhibit space at our
meetings. We sell the right to conduct an evening
symposium during the annual meeting. And we accept
donations to the REF from anyone who chooses to
support its programs. But there are things that we
cannot sell. We cannot sell our leadership, our young,
our political principles, or our silence. I would like to
Table 1. What is for sale and what is not for sale
For sale
Not for sale
Advertising space in journals
Meeting sponsorships
Exhibit space at meetings
Symposium at the annual meeting
Political principles
comment briefly on each of these, because they are not
hypothetical concerns. All of them have been issues
during my year as President.
Expressions of concern about potential conflicts
of interest for ACR leaders are not new, but they have
certainly increased as the opportunities and temptations
have increased. All of us who have been involved in
ACR leadership in recent years are aware that rheumatology in general, and our leaders in particular, are on
the radar screen in a way that just wasn’t true previously.
From the time involvement with ACR begins, potential
leaders are the subject of steadily increasing interest
from industry based on the flattering, but somewhat
circular, notion that we are thought leaders. Did we rise
in the ACR because we were already thought leaders?
Did we suddenly become thought leaders by virtue of
our positions in ACR? Or have we been anointed by
those who might profit from a connection to thought
leaders? We each face similar questions in our own
communities, and we each have a responsibility to think
carefully about our answers. But there is no denying that
the high visibility of ACR officers makes this a particularly important issue for them. To safeguard against
potential problems in this area, this year the ACR
adopted a formal conflict of interest policy for the
President and President-Elect, distinct from, and much
more restrictive than, the ethics guidelines that apply to
all members. I want to acknowledge the extraordinary
work of Paul Romain, Chair of the Ethics Committee,
who worked tirelessly on this and other important
matters during the past year. The Board subsequently
established additional safeguards that extend beyond the
President and President-Elect and apply to members of
the ACR and REF Boards, the editors of our journals,
and selected committee chairs.
We cannot allow our trainees to be for sale. As
the ACR President and as director of a rheumatology
fellowship program, let me tell you in no uncertain terms
that the pharmaceutical industry is quite openly more
interested in our trainees than in our leaders. These are
the prescribers of the future, and the people whose
habits are not yet set, either in their practice patterns or
in their relations with industry. I am not suggesting that
trainees are not capable of making their own decisions
about these relationships, just as the rest of us do.
However, we should not make that decision for them by
engaging in programs that obligate them in any way.
Without an open discussion of the merits, we have
gradually moved into an era where everything a trainee
does may be attached to a pharmaceutical company—
from salary support for their fellowship position, to
sponsored lectures at fancy restaurants, to travel to ACR
meetings, to support for their research. In some instances, this practice has gone so far that, in exchange
for salary support, pharmaceutical companies design
curricula, assign mentors, and provide the databases and
the goals for research projects. We, the program directors, derive the financial benefit; the fellows assume the
inherent obligation.
We must not allow the next generation of rheumatologists to become the medical equivalent of stock
cars, with corporate labels for everything they do. The
ACR can and should play a role in changing this
dynamic. Accordingly, a task force headed by pastPresident Michael Weinblatt recommended that the
ACR not enter into sole-supporter initiatives with industry for programs designed for trainees. To achieve this
goal, the task force recommended soliciting support
from multiple companies to contribute to a new “ACR
Fellows Education Fund” that would support all of the
major fellowship-related programs of the ACR. The task
force also recommended that, to further demonstrate its
sense of the importance of this issue, the ACR and REF
should become substantial contributors to the fund. I
support this initiative, but I do not think that it goes far
enough. We should also ask the training programs
themselves to demonstrate their commitment to this
concept, in an effort to make the program completely
independent of industry support.
What exactly do I mean by suggesting that the
training programs should contribute? It is often pointed
out to me that some programs have the resources to
send fellows to meetings but others do not, and that the
financially fortunate programs should be careful about
preaching from a position of privilege. That is a point
well-taken, so today I am prepared to put my money
where my mouth is. On behalf of UCSF, I pledge to
contribute to the concept of the ACR Fellows Education
Fund by foregoing this resource and by using our own
existing funds to support our fellows’ participation. I call
on other programs with training grants or other resources to do the same so that, together, we leave
absolutely no doubt about the sincerity of our commitment to the independence of our trainees.
The next topic has been at the heart of much
activity this year and requires some explanation. When
the stakes are high for our supporters in industry, there
may be adverse consequences when we choose an independent path. Let me be specific. We all know that the
advent of the era of biologic therapies has changed the
landscape with respect to reimbursement. There have
been new opportunities for compensation, and new
threats to compensation. In this environment, the ACR
had to make judgments about what we stood for, what
we would fight for, and how we could win. Our political
position was based on three fundamental principles that
we thought were winnable: 1) that rheumatologists
should be compensated appropriately for their cognitive
skills and for their time, 2) that rheumatologists should
receive equal pay for equal work, particularly in reference to oncologists and infusion therapies, and 3) that
rheumatologists should be compensated for the work
they do and not for the drugs they choose. I need not tell
this audience that these were controversial positions. In
particular, they were not shared by some of our members and by some of the companies who stood to profit
from maintaining the status quo. When it became clear
that the ACR position did not align with their corporate
interests, some in industry made a concerted effort to
discredit us by proclaiming, among other things, that the
ACR is dominated by researchers who don’t care if our
members in practice make money. These attempts to
split us politically involved support for the development
of a separate national organization of rheumatologists to
advocate its own political agenda.
I do not question the right of pharmaceutical
companies to advocate for their interests or the rights of
some ACR members to disagree with the ACR position
and pursue a different course. However, I do feel
strongly that these activities undermine our ability to
advocate effectively on behalf of our members. As one
of the smallest subspecialties, we depend heavily for our
political clout on the unity that we have been able to
maintain—among clinicians and researchers, physicians
and allied health professionals, internists and pediatricians. Threats to this unity strike at the core of our
strength. The outcome of this story is important. Last
month, the Centers for Medicare and Medicaid Services
adopted one of the key principles for which we have
been fighting—equal compensation for complex infusion therapy. This is an extraordinary victory against
substantial odds, and it is a credit to the vision, hard
work, and political savvy of Mark Andrejeski, Teresa
Fitzgerald Ogden, and Chris Welch of the ACR staff and
especially ACR members Robert Lloyd, David Boren-
stein, Cody Wasner, and Betsy Tindall. In recent
months, as it became possible to read the tea leaves,
others have abandoned their conflicting political strategies and have sought credit for this achievement. I
should be clear—this achievement involved hard work
and intensive lobbying from many sources, outside the
ACR as well as inside the ACR, but it would not have
happened without us and without our commitment to
keep our political positions independent of our financial
support. There remains much to be done in this area to
ensure that this important victory translates into tangible
benefits for rheumatologists, which makes our unity and
credibility more important now than ever.
In an environment of big money and strong
competing interests, the ACR has asked itself what
measures can be taken to protect our independence.
With this in mind, the Industry Task Force recommended, and the Board approved, a precedent-setting
policy that will officially cap contributions from industry.
The policy limits the amount of support the ACR shall
receive from pharmaceutical and medical device companies to no more than 49% of the ACR’s overall income.
In addition, the Board endorsed new policies designed
to protect against disproportionate dependence on support from any single company. In citing these measures,
I should assure you that we are operating well within
these limits. They can, and probably should, be tighter.
But for now it is the establishment of this principle that
is important—that there are limits—and that we will not
allow ourselves to become too dependent on any single
supporter or on industry in general. To my knowledge,
this is an unprecedented step for a subspecialty society
to take, but one that I expect will serve us well and will
be copied by others.
Finally, a few words about silence. One of the
things that we have sold over the years, without ever
deciding to do so, has been our silence on a whole host
of issues. For example, within the past year, the most
important health care legislation in a generation was
passed. The politics of this legislation were complex, and
there are differing opinions within our own organization
about its merits. The ACR supported this legislation,
because there was much in it that benefited rheumatologists and for which the College had fought. But there was
also no mistaking that the big winner was the pharmaceutical industry, which was granted protection against
any attempt by government to negotiate prices. We were
silent on this issue. Subsequently, a national debate
arose regarding access to low-cost drugs from Canada.
Again, silence. And we have been silent about a small
but conspicuous handful of rheumatologists who have
Figure 3. Annual percent increase in US total health expenditures and expenditures for hospital care, physician
services, and outpatient prescription drugs (from
allowed unconstrained profits from drugs to influence
their clinical judgment.
The pharmaceutical industry has an understandable interest in maximizing profits for shareholders. It is,
in fact, a corporate obligation that is achieved in part
through the high price of drugs. That’s their business,
but why are we silent on this issue? It is extraordinary to
me that we can engage repeatedly in discussions of
access to care as if the problem resides solely in the
greedy and heartless managed care industry. The principal obstacle to access to appropriate medication is
cost. And make no mistake, the high cost of medications
does not just hurt patients, it hurts us. Figure 3 shows the
annual percent increase in US health expenditures since
rising health care costs came under sharp attack roughly
a decade ago. During that decade, there has been a
substantial reduction in the rate of increase of total
health care expenses, hospital costs, and notably reimbursement to physicians. Alone, bucking this trend, is
the cost of prescription drugs. This disparity has consequences for us. In 1999, for example, prescription drugs
accounted for 44% of the rise in health care costs; during
the same year, the net income of internists fell 10% (1).
These are not unrelated phenomena. We have a very
personal interest in controlling the cost of drugs, and we
should speak out. We should speak out, first and foremost, because it is in the interest of our patients, but we
should be aware that if we allow our silence to be
bought, we are also hurting ourselves.
Save for speaking our minds, the measures I have
described today constitute small steps in the context of
the current landscape. The pharmaceutical industry
spends over 21 billion dollars in the US each year to
influence what we think, what we teach, and what we do
(2). That is more than they spend on research and
development, more than is spent in this country on
medical school and residency training combined (Association of American Medical Colleges: personal communication), and over $25,000 per physician. Just as the
ACR is trying to determine how best to maintain its
values in this environment, each of us individually has an
obligation to consider whom we really serve and where
we draw the line.
There is a broad range of opinion within the
ACR on all of the topics that I have addressed, and no
doubt many who disagree strongly with me on one or
more of them. I should emphasize, therefore, that I have
spoken for myself this morning and not for the ACR.
There is room within ACR for differences of opinion,
but there should be no room for silence.
I now ask your indulgence while I thank some
people, beginning with my extraordinary colleagues at
UCSF. Their range of talents represents the fabric of our
profession. In thanking them, I seek also to illustrate the
importance of the diversity and the unity within our
organization. Thank you to Wally Epstein, whose influence during my residency played such an important role
in my decision to enter this field and who allowed me to
move so easily from student to colleague and friend.
Thank you to Eph Engleman, former ACR President
and an ACR Gold Medalist, whose commitment to this
profession, to this organization, and to generations of
rheumatologists at UCSF quite literally knows no
bounds. Thank you to Bill Seaman. The best decision I
made in my career was the decision during my fellowship
to work with Bill. Without his intellect and generosity,
there is no way I would be here. Thank you to my
partners in leadership at UCSF, Art Weiss and John
Imboden. They are both outstanding scientists, but their
success as leaders comes from the respect they have for
the talents that others bring to the division. Thank you to
the two superb clinicians and teachers whom all of us at
UCSF try to emulate, Ken Fye and Ken Sack. It is in the
nature of things that people like me who write grants
and publish papers get the glory, but when our careers
are over and we measure the good we have done in our
lives, I will not hold a candle to the good that these two
have done for their patients and their students. Thank
you to Ed Yelin and Patti Katz, who contribute to UCSF
what the ARHP contributes to the ACR by expanding
the breadth of our activities, broadening our perspective,
and reinforcing our social conscience. A special thank
you to some former trainees who are responsible for
virtually all of the important research that I have ever
done: in particular, Nancy Carteron, Caroline Gordon,
Kari Connolly, Barbara Finck, and David Daikh. Thank
you to those who have borne the brunt of my absences
this year without a single lapse into complaint—at least
not in my presence: Mary Nakamura, John Davis, Maria
Dall’Era, Joann Gillis, and Laura Julian. I am so grateful
for your support and understanding.
I must also thank my extraordinary Board of
Directors, and all the other ACR volunteers who have
made this job so rewarding and enjoyable. I will sorely
miss working with them and learning from them. And
thank you to the entire ACR staff. Only the ACR
President ever gets to really know how well we all are
served by these remarkable people.
I will save my thanks to family and to close
friends outside UCSF for more private moments. Suffice
it to say here how much I value my close friends in
rheumatology. You know who you are and how much
you mean to me.
It has been an honor and a great privilege to
represent the American College of Rheumatology this
year. Thank you all very much.
1. Davidoff F. The heartbreak of drug pricing. Ann Intern Med
2. US promotional spending on prescription drugs, 2002. CMAJ
Без категории
Размер файла
216 Кб
living, different, world
Пожаловаться на содержимое документа