Like most of the folks
reading this commentary, I'm a taxpayer. Although I sometimes
become impatient with the strategic games on Capitol Hill, I
basically appreciate that government helps many things to work, and
some of them even work well.
However, there
are aspects of government function that do trouble me. I
was more than a little perturbed when I had to deal with the
extraordinary time-wasting nonsense that followed the encyclical
from the U.S. Preventive Services Task Force (USPSTF) a couple of
years ago, in which they unilaterally announced a change in
recommendations on screening for breast cancer.
It wasn't that I was
personally opposed to the specific recommendations, as I don't
specialize in the care of early breast cancer and didn't know the
data. But I was troubled that their constituency did not seem to
include an expert specifically in breast cancer care, and more
troubled that they felt it appropriate to issue their bulletin and
press releases apparently without consulting the various specialist
bodies and societies, and without alerting the people who take care
of cancer patients (ie, us) that they were about to create chaos in
the patient and nonpatient populations. As it turned out, some of
their interpretations of data probably had merit, but their
recommendations were widely condemned, several government leaders
disowned them, and the whole episode ended up in confusion and
uncertainty-a questionable use of my tax dollars.
USPSTF
Strikes Again….Twice
Now the USPSTF has done
it again…twice! First, its members decided to assess the
utility of screening for testicular cancer. In a new guideline
published by Annals of Internal Medicine,1 the
Task Force announced that they still do not recommend screening for
testicular cancer, as there are no new data, and gave this
recommendation a D grading (defined as: "The USPSTF recommends
against routinely providing [the service] to asymptomatic patients.
The USPSTF found at least fair evidence that [the service] is
ineffective or that harms outweigh benefits"). They went on to
note that the disease has a low incidence and that it is associated
with favorable treatment outcomes, thus vitiating the need for any
screening approach or further attention to the issue.
Had there been real
experts involved, after noting the lack of level 1 data on
screening, they might have commented on the many papers that have
given useful information on the topic-for example George Bosl's
time-honored observation that delay in diagnosis correlates
directly with stage and inversely with outcome.2 They
might have spoken about the importance of primary tumor stage and
size with regard to outcome of local treatment,3 and the
fact that uneducated populations present usually later than those
with good health education. They might have quoted the NCI
statement4 noting that patients with a history of
testicular cancer are at increased risk of developing a second
testicular cancer, and that this requires lifelong follow-up.
Responsibility for Context
I'm not attempting to
endorse screening for testicular cancer, because I think that the
Task Force is probably correct that there are no level 1 or
level 2 data to support its routine use. However, I do think
that if you grab the bully pulpit (and expend taxpayer dollars),
you have a responsibility to tell the complete story, applying the
pulpit in a useful fashion that helps educate patients and their
medical attendants.
Young men should be made
aware that testicular cancer exists and is curable, and that
achieving cure of testicular cancer by chemotherapy for an advanced
presentation (while an excellent advance in the past 25 years) is
harder and associated with more morbidity than achieving cure by an
uncomplicated inguinal orchiectomy for stage I disease.
Whether screening and testicular self-examination are effective or
not, it is clear that educated men who know about testicular cancer
will have a better chance of cure, and with less morbid treatment.
When a learned body makes a statement on the topic, if there are no
level 1 data, one could at least expect a modicum of common
sense in providing the big picture.
USPSTF Takes
on PSA
Not content with the
above non-event, they now have reconsidered the data that have been
published on randomized screening trials for prostate cancer. This
has been-and will be-covered ad nauseam in the medical
and lay press, and I won't delve into the details. It was
appropriate for an independent body to review this issue for the
government, although disappointing that none of the Task Force
committee members apparently has specific expertise in this domain.
They concluded that there is no role for the use of
prostate-specific antigen (PSA) tests in routine screening for
prostate cancer in the community.5
Based on the published
trials, they are probably correct, as it is hard to endorse a
screening test that does not produce an overall survival benefit.
The reduction of deaths from prostate cancer per se in
some of the trials is potentially very important, but is negated by
the fact that the overall death rates are apparently the
same in screened and unscreened patients. Some members of the
urology community have dealt with this observation by questioning
the constitution and execution of the trials-but it actually
doesn't work that way! You can't just dismiss major randomized
trials because you don't like the results. If screening is to
be used routinely in a community struggling to pay its medical
bills, there needs to be published level 1 data that show an
overall survival benefit at some time point. In fact, that
may eventually be demonstrated, just by following the published
trials for a longer period, as the natural history of prostate
cancer from early detection is long.
So why am I
concerned? Once again, it is the pathway that is the problem.
A group of non-experts have done a re-analysis of well published
data, and have chosen to release draft guidelines,
apparently with no consultation with any serious expert
body-American College of Physicians, American Urological
Association, perhaps even the ASCO Prostate Cancer Panel. The
Task Force has repeatedly argued that such expert groups have
conflicts of interest, and they don't wish their pristine thoughts
to be compromised by venal self-interest. Fair enough-so why could
they not send their draft review and recommendations for a
response from professional societies, consider those responses,
identify any possible flaws in their own arguments, and take advice
on framing the information for public distribution? Instead they
have, again, acted unilaterally, causing chaos among the medical
profession, and more importantly, in the patient community.
Of particular importance,
potentially the most at-risk groups-African-Americans and men with
family histories-are now even more confused about their appropriate
management, and whether screening should have an ongoing role.
These populations were not analyzed by our friends in the U.S.
Preventive Services Task Force, but the blanket statements in the
draft report seem to cover these patients nonetheless.
Dubious
Benefit
The U.S. Preventive
Services Task Force seems, again, to have shown a capacity for
ineptitude that has led to another waste of the money that we pay
the government each year, without obvious benefit to the community
at large. We are moving into a time of budgetary restraint by
government. I wonder if congressional budgetary planners might
consider an investigation of the function and composition of the
USPSTF, and whether this panel really needs to exist. Moreover, the
editors of Annals of Internal Medicine might consider
whether government committees should have a free ride to
publication. ■
Disclosure: Dr. Raghavan reported no
potential conflicts of interest.
References
1. U.S. Preventive
Services Task Force: Screening for testicular cancer: U.S.
Preventive Services Task Force reaffirmation recommendation
statement. Ann Intern
Med 154:483-485, 2011.
2. Bosl GJ, Vogelzang
NJ, Goldman A, et al: Impact of delay in diagnosis on clinical
stage of testicular cancer.
Lancet 2(8253):970-973, 1981.
3. Raghavan D,
Vogelzang NJ, Bosl GJ, et al: Tumor classification and size in
germ-cell testicular cancer: Influence on the occurrence of
metastases. Cancer 50:1591-1595, 1982.
4. National Cancer
Institute: Testicular cancer screening (PDQ®). Available at
www.cancer.gov/cancertopics/pdq/screening/testicular/patient/page3.
5. Chou R, Croswell JM, Dana T, et al: Screening for prostate
cancer: A review of the evidence for the U.S. Preventive Services
Task Force.
Ann Intern Med. October 7, 2011 (early release online).