By Eric Vandenbroeck
In fact drug and
device makers sometimes suppress research results that are unfavorable to their
products. Sometimes they publish favorable data from the same patients several
times, creating redundant research reports that make it hard to know just how
many studies were really done and how many patients were studied.
Companies provide
some research results to the regulatory agencies in order to gain approval for
new products, but they aren't required to publish these results where other
scientists and doctors can evaluate them. For example, a recent systematic
review on nonsteroidal anti-inflammatory drugs ibuprofen, naproxen, Celebrex,
Vioxx, and others-found that only one of thirty-seven studies reported in FDA
reviews had been published. (See MacLean CH, Morton SC, Of man, Roth EA, Shekelle PG. How useful are unpublished data from the Food
and Drug Administration in meta-analysis? Clin Epidemiol 2003; 56: 44-5l.)
And the problem with
unpublished research goes even farther. Many randomized trials get started but
are never finished, for a variety of reasons. These rarely get reported, but
they may offer important insights to doctors and patients. (See Psaty BM, Rennie D. Stopping medical research to save
money: A broken pact with researchers and patients.]AMA, 289, 2003: 2128-213l.)
Even when
trials are completed, the ones that turn out negative-that is, showing no
advantage for a new treatment-are less likely to get published than the ones
that are positive. (See Krzyzanowska MK, Pintilie M, Tannock IF. Factors
associated with failure to publish large randomized trials presented at an
oncology meeting. ]AMA 2003; 290: 495-50l.)
Some clinical trials
get reported only verbally at research meetings or in meeting abstracts; some
never get published at all. (Dickersin K, Rennie D.
Registering clinical trials. ]AMA 2003; 290: 516-523.)
The reasons are complex,
but it appears likely that when the results of their research are negative,
researchers often lose their enthusiasm and fail to write up the results and
submit them for publication. Less often, journal editors or reviewers may be
biased against publishing negative studies.. Even if all the trials on a topic
do get published, the ones with positive results tend to get published faster
than the ones with negative results. (See Stern ]M, Simes
R]. Publication bias: Evidence of delayed publication in a cohort study of
clinical research projects. Br Med] 1997; 315: 640-645.)
Therefore, the good
news about a treatment often appears well before the bad news. The media
coverage, in turn, tends to be unrealistically favorable. The greater
likelihood for favorable studies than for negative studies to get published has
been labeled publication bias. The bias it creates in adopting medical advances
may actually harm patients. As an example, one study of drugs for suppressing
abnormal heart rhythms was completed in 1980, but was not published until 1993.
(Cowley A], Skene A Stainer K, Hampton]R. The effect of lorcainide on
arrhythmias and survival in patients with acute myocardial infarction: An
example of publication bias. Int] Cardiol1993; 40: 161-166.) The study showed
higher mortality in the group with the active drug than with placebo,
consistent with the later studies of encainide and
flecainide. Had these negative results been widely known, some experts believe
that the use of dangerous drugs might have decreased sooner, saving many lives.
Besides distorting the evidence for what works, failure to publish leads to
waste and duplication in research efforts.
Consequently, many
scientists, journal editors, expert panels, and even presidential committees
have argued for a system that would register all clinical trials.15 The NIH and
some other groups have made steps in this direction, but they've been only
partly successful. Even though the FDA has mandated registration of clinical
trials evaluating new drugs for serious or life-threatening diseases, it has no
mechanism for enforcement, and compliance appears to be poor. The barriers have
been reluctance of the drug industry to participate, lack of funding, lack of
any enforcement authority, and lack of publicity or awareness.
Once patients
understand how little is known about most medical problems and treatments,
perhaps their interest in being participants in medical research will increase.
Some experts believe that patients who are enrolled in clinical trials get
better medical care than those outside clinical trials, regardless of whether
they are receiving an experimental treatment or standard care. (See Braunholtz DA, Edwards S]L, Lilford
R]. Are randomized clinical trials good for us (in the short term)? Evidence
for a "trial effect." J. Clin Epidemiol 2001; 54: 217-224.) And
participating in research is the best way to get better answers about what
really works.
One aspect of
informed consent that should be assured is that patients understand the
researchers' conflicts of interest. If the researchers hold stock in the
company that makes the products they're testing, patients should know that. If
the researchers have a grant from the manufacturer to do the research, patients
should know that. If the researchers receive a special reimbursement for every
subject they enroll, patients should know that. And if the researchers simply
get consulting fees from the corporate sponsor of the research, patients should
know that, too.
Surprisingly, this
information, and even the identity of the research sponsor, isn't currently a
required part of the informed consent process at many institutions. We think
that such disclosures should be a routine aspect of the ethical review process
and a part of every research consent form.
So for example in
2002, James Quinn died in a Philadelphia intensive care unit. He had lived nine
months with a new AbioCor artificial heart. For seven
of those months, he had been in the hospital, where he suffered two strokes and
was on a ventilator much of the time. Before he died, Quinn said, "This is
nothing like I thought it would be. If I had to do it over again, I wouldn't do
it. 1
In 2001, Bayer
removed its cholesterol-lowering drug Baycol from the
market. Between 1997 and 2001, manufacturers pulled fourteen drugs off the
market because of unexpected toxicity and related deaths. The makers had
marketed these drugs aggressively; they were taken by millions of patients and
collectively are suspected in over a thousand deaths.2
In 2002, researchers
reported that hormone replacement therapy for postmenopausal women may often
cause more harm than benefit, although it's been used for decades.3 The same
week, we learned that a popular arthroscopic operation for knee arthritis
doesn't work.4
In 2001, twenty-five-year-old
Jennifer Rufer of Seattle discovered that she didn't
have cancer after all. Blood tests had repeatedly suggested a rare form of
uterine cancer, and she had endured an unnecessary hysterectomy, removal of
part of a lung, and months of chemotherapy.5 Rufer
had wanted a big family, but the false positive tests destroyed that dream.
In 2000, the New
England Journal of Medicine reported that an aggressive new treatment for
breast cancer was no better than standard care, although it was more toxic and
cost twice as much.6 Over 42,000 women had received the new treatment, at a
total cost of $3.4 billion.7
In 2002, researchers
reported the largest clinical trial ever conducted for high blood pressure,
involving 33,000 patients. An old fashioned diuretic drug proved more effective
than newer drugs in preventing the complications of high blood pressure.8 But
the use of diuretics had fallen steadily for years before the trial, thanks to
aggressive marketing of newer and higher-priced medicines.9
As doctors and
manufacturers introduce medical advances, good money too often trumps good
science. Vested interests, marketing, politics, and media hype often have more
influence on how new medical advances get used than the best scientific
evidence.
New tests, devices,
or drugs are routinely introduced as "breakthroughs"-when, in
reality, many are marginally effective, useless, or even harmful.
The best scientific
evidence may get pushed to the background, suppressed, manipulated, or ignored.
Good science sometimes wins in the end, but often only after avoidable illness,
discomfort, costs, and delays.
Doctors sometimes
make use of medical advances, at some risk and substantial cost, for the
flimsiest of reasons.
A treatment for
patients who had been referred for cardiac catheterization once involved
threading a long tube through the aorta to the heart and injecting dye into the
arteries that supply the heart. It's usually safe, but serious complications
(like a heart attack) sometimes occured.
With the availability
of balloon angioplasty, which opens narrowed arteries by inflating a tiny
balloon inside the narrowed area, cardiac catheterization has become not just a
diagnostic test, but also a treatment opportunity. And with the addition of
coronary stents small wire tubes that prop open narrowed arteries), the
treatment opportunities and costs have expanded further.
Unfortunately, these
treatments are increasingly being used for patients who don't even have chest
pain or other symptoms-a situation in which the risks are clear, but the
benefits are speculative.
In some cases, the
medical needs are more compelling, but using the latest treatments can still be
hard to justify because the benefits are minuscule or nonexistent. An example
would be aggressive treatment of an elderly patient who is near death from an
incurable chronic disease. Most treatments have smaller benefits in this
situation than in others, and the risks are usually greater.
The pressure from the
public and from industry to develop and disseminate new treatments is intense.
In some cases, patients have no effective treatments for their diseases and are
willing to pay-or at least have their insurance pay-for anything new that comes
along. But most innovations aren't treatments for fatal diseases. Instead,
they're aimed at discomforts and inconveniences, many of which already have
effective treatments. And some new technologies ultimately prove ineffective or
harmful, although this may become clear only after many patients have received them.
Also, in most cases, "new" seems to be synonymous with outrageously
expensive.
When Do New Treatments Stop Being Experimental?
It may be surprising to
learn that there are no standard definitions of experimental and standard care.
There’s no “Good Housekeeping Seal of Approval” that new operations, devices,
tests, or drugs must receive before they become standard care. There’s not even
agreement about what evidence of effectiveness should be required if there
were to be such a seal.
Many people imagine
in the USA that FDA (at times stricter then European authorities) approval
constitutes such a seal. It’s true that for drugs there must be a reasonable
demonstration of safety and efficacy, but the FDA makes no claims concerning
value for money The FDA doesn’t require comparative studies to determine which
of several competing drugs is most effective. As a result, products with
trivial benefits often receive regulatory approval, regardless of their cost.
An expensive new drug may offer no advantages over a cheap old one, but if it
works at all, the FDA generally must approve it. For medical devices, the FDAs
approval process is less rigorous than it is for drugs, and for new surgical
procedures, there’s no approval process at all. The FDA also gives little
scrutiny to nutritional supplements-a multibillion-dollar industry.
There’s no standard
for judging when new medical advances are worth the cost, or when insurance
should cover them. Attempts by researchers to establish such limits have never
reached consensus. Every insurance plan or health-care organization makes this
determination on its own, with wide variability in the process. Insurers often
cover new treatments because others do, because effective marketing creates
demand, or because lawsuits are threatened-not because of convincing evidence
that the new treatments work.
In fact the evolution
of clinical practices seem to share a great deal with the evolution of public
policy-it’s the result of competing interests, rather than a linear translation
of scientific knowledge into practical application. Students of human behavior,
economics, and political science may think it naïve to expect the development
and diffusion of medical treatments to follow a rational process. Doctors are
sometimes surprised when they see marketing or media hype triumph over
scientific knowledge. But no outrage materializes because most of the time,
neither patients nor doctors even recognize them.
The Backlash Against Evidence-Based Medicine
Evidence-based
medicine is a hot topic right now among doctors, insurance companies, planners,
and the public. There are frequent workshops on how to practice and teach it,
as well as workshops on its role in insurance coverage and policy making.
Medical schools and residency programs are figuring out whether and how to
incorporate it into their curricula. New centers and new medical journals have
been launched with this as a central theme.1/2
But there's also been
a backlash against the idea. Many doctors argue that we've always practiced
evidence-based medicine, that medicine has always been based on science. But
"science" has often meant inferences drawn from what we know of human
physiology and disease behavior, information from studies of animals, or expert
opinions. It's sometimes based on the observation that "I tried treatment
X and my patients got better." Even lawyers recognize the fallacy in this
line of thinking, embodied in the phrase "post hoc, ergo propter
hoc." Just because patients get better, doesn't mean that they are getting
better because of the treatment applied. As we saw earlier, they may have
improved because of natural healing, regression of symptoms to their mean, or
placebo effects. It's easy for both doctors and patients to be fooled about the
real benefits of treatment just because someone gets better after the
treatment is given.
The new model argues
that these older methods are often a good basis for designing and testing a
treatment, but they aren't enough. They're necessary, but not sufficient. The
biological inferences, animal models, opinions, and clinical impressions must
generally be subjected to the purifying heat of randomized trials to reveal the
true benefits and risks of a new treatment.
Any hope that doctors
are already consistent about practicing evidence based medicine is dashed by
the repeated observation of huge variations in practice from doctor to doctor,
hospital to hospital, and place to place. Unless all treatments and clinical
strategies are equally effective, the different approaches can't all be right.
If we were all practicing evidence-based medicine, the litany of ineffective
treatments that began this chapter wouldn't have been used for years or
decades. And even with the best of intentions, it's almost impossible for any
doctor to keep up with all the latest scientific advances in any specialty.
Other doctors
complain that evidence-based medicine amounts to "cookbook" medicine.
Some complain that it's "a dangerous innovation, perpetrated by the
arrogant to serve cost cutters and suppress clinical freedom. They argue
that it denies the value of clinical judgment, specialized expertise, and
patients' unique personal preferences.
But advocates of
evidence-based medicine argue just the opposite. They argue that clinical
judgment is critical in deciding how to apply evidence that comes from other
people to each individual patient. Without that ability to generalize, we'd be
lost. Advocates also argue that doctors must always consider patients'
preferences in making clinical decisions. Rather than slavish adherence to
top-down dictates, evidence-based practice integrates the best evidence,
clinical judgment, and patient preferences in every clinical situation. The
hard part for most doctors is finding, evaluating, and interpreting the best
evidence.
As for costs,
evidence-based practice may in some cases decrease costs, but in other cases it
can increase costs. Eliminating useless operations or choosing less expensive
and more effective drugs will decrease costs. On the other hand, we know that
many types of effective screening and treatment are underused. If we start
doing all the screening for colon cancer that's recommended, or treating every
diabetic with the full cocktail of drugs and monitoring that are recommended,
costs are likely to increase. The approach isn't inherently cost saving, though
in some situations it may be.
Requiring evidence of
the sort advocated here places a burden of proof on the advocates of a new
treatment. In areas of medicine where there isn't a long history of rigorous
research design or where research funding is scarce, these criteria are often
unwelcome and are seen as an obstacle to innovation. Some opponents of
evidence-based principles argue that new treatments should be adopted and paid
for unless they're proven ineffective, reversing the burden of proof. As
seen already, both safety and cost considerations make this position untenable.
Too many people have been hurt by blind faith that new treatments have to be
better.
Leave it to the
Aussies to recognize pomposity and pretense, which are sometimes associated
with the resistance to evidence-based medicine. With tongue in cheek, two
Australian doctors summarized some of the alternatives to evidence-based
medicine,3 all of which still operate widely:
Eminence-based
medicine: Grey hair and years of experience are the basis for recommendations.
The faith of such physicians in their clinical experience has been defined as
"making the same mistakes with increasing confidence over an impressive
number of years."
Vehemence-based
medicine: The louder and more strident the advice, the easier it may be to
browbeat colleagues.
Eloquence-based
medicine: Here, a fine suit and verbal eloquence supercede
evidence.
Providence-based
medicine: When the doctor has no idea what to do, decisions can be left in the
hands of the Almighty.
Diffidence-based
medicine: Doing nothing from a sense of despair. Of course, just standing there
may often be better than just doing something, but it's unsatisfying.
Nervousness-based
medicine: Fear of lawsuits drives excessive testing and overtreatment.
"The only bad test is the one you didn't think of ordering."
Confidence-based
medicine: Especially common among surgeons, of whom it's sometimes said,
"they're often wrong, but never in doubt."
What Is the Evidence?
Even for doctors,
hospitals, and insurance carriers who buy the idea, evidence-based medicine is
surprisingly hard to practice. Simply knowing the evidence is hard, because of
the enormous size of the medical literature and the rapid pace of its change.
Busy doctors don’t have the time to do even electronic searches of all the
relevant literature, identify the most useful articles, read them, evaluate the
quality of the results, and integrate the pieces into a coherent whole every
time they see a patient. They’d be lucky if they were able to do this once a
month.
Fortunately, doctors
can get help with this. A growing number of medical journals focus on
high-quality, clinically relevant articles and provide quick summaries. There
also are a growing number of clinical guidelines, which at their best provide a
doctor with summaries of the literature that have been extensively researched
and evaluated, to help guide the doctor’s decisions, but not dictate them.
One hazard is that
guidelines are sometimes promulgated by organizations with a self-interest in
the recommendations or with commercial influences lurking in the near
background. For this reason, doctors can’t accept guidelines uncritically. The
other major hazard is that guidelines can be cumbersome and time-consuming to
construct, so they risk being outdated before they’re released or shortly
thereafter. Nonetheless, they’re generally far more current than what doctors
learned in medical school, and they’re often both more rigorous and more
current than medical textbooks.
Having found the
relevant medical research or guidelines, evaluating their quality is the next challenge
most doctors face. This requires a strong knowledge of research design and
statistical methods, which are rarely taught well in medical schools. If they’re
included at all, they usually are treated as side dishes to the main courses of
biochemistry, pathology, microbiology, and the like. Although the latter remain
integral to training effective doctors, the principles of evidence-based
medicine need to be taught with equal rigor, enthusiasm, and high expectations.
As Dr. Drummond
Rennie, deputy editor of the Journal of the American Medical Association,
remarked, “If you are not trained to think statistically, if you are not
trained to think epidemiologically, it’s extremely difficult to grasp `risk’
and a whole lot of other things like that. You have to have years of training
before you really get into the habit of thinking of risks rationally.”
In other words,
doctors need somewhat different training if they are to distinguish high-quality
from low-quality evidence for clinical interventions. Incorporating principles
of evidence-based medicine into the medical school curriculum may help the next
generation of physicians to become more critical consumers of medical research.
It needs a higher priority than it often receives.
Rennie also notes
that the practice of evidence-based medicine will require constant updating and
questioning throughout a doctor’s career. He has prepared journal articles, a
book, a CD, and a web version of guides for doctors, because he believes “it’s
the only way ahead.”
The Cochrane
Collaboration database is another underutilized resource for doctors, patients,
and insurance companies. Its organizers named the effort for Archie Cochrane, a
British physician and researcher who died in 1988, who argued that society
could afford to pay for all effective treatments, if we would just stop paying
for the ineffective ones. The Cochrane Collaboration is an international effort
to systematically review the medical literature on all treatments, evaluate the
quality of individual studies, summarize the results, and pool data from the
best randomized trials. The program leaders also intend to update the reviews
on a regular basis. All the results are available online, and the number of
topics reviewed (already in the thousands) is rapidly growing.4/5 One advocate
has argued that the Cochrane Collaboration will prove to be as pivotal in
modern medicine as the human genome project.6
Outside the United
States, the Cochrane Collaboration has acquired enormous influence among
doctors, scientists, and those who pay for medical care. This is true in
Canada, Europe, Australia, and most developed countries. In the United States,
though, it’s still only modestly familiar and modestly used, perhaps because
commercial, political, and media influences often outweigh scientific ones. If
we decide that science should play a bigger role, there are resources to help.
Computers in Medicine
Another source of
help in practicing evidence-based medicine, one that's increasingly available
to doctors and hospitals, is computer technology. Medical informatics is the
term that is applied not only to the use of electronic medical records, but
also to so-called decision support programs that can be integrated with
electronic medical records. Many doctors recognize the difficulty they have
keeping up with the literature, and would welcome authoritative, evidence-based
information just at the moment they're making decisions. The computer makes this
increasingly possible.
Suppose the doctor
has just admitted an elderly patient from a nursing home into the hospital and
has diagnosed pneumonia. She doesn't yet know exactly which bacteria (or other
microbes) are causing the pneumonia, and in many cases it never becomes clear.
But she has to choose an antibiotic and a dose based on what infections are
commonly acquired in nursing homes, what the local patterns of antibiotic
resistance may be, how well the patient's kidneys are functioning, what drugs
the patient is allergic to, how each antibiotic may interact with the other six
medicines the patient is taking, the patient's age and weight, what spectrum of
bacteria each drug will kill, the common side effects of each antibiotic, and
the particular clinical pattern of this patient's illness.
In most cases today,
she has neither the time nor the knowledge to look up each of these factors and
somehow integrate them into a precise solution. Instead, she'll choose an
antibiotic based mostly on habit, local convention, or what she recently heard
from a drug rep she likes. She'll prescribe a standard dose that she uses for
most adults. Because there's a good margin for error in many medical judgments,
the patient will usually do just fine-but not always.
Wouldn't it be nice
if this doctor could simply enter her interview and examination findings into
the computer and have the computer automatically look up the most common kinds
of pneumonia among patients recently admitted to this hospital from nursing
homes; consider the antibiotic resistance patterns of bacteria tested by the
lab in this hospital over the last six months; check the lab results for the
patient's kidney function; check the nursing notes for the patient's height and
weight; check the pharmacy records to identify the patient's other drugs; run
an automated check for serious interactions with any of those drugs; check the
pharmacy, previous hospital records, nursing notes, and doctors' notes for any
record of drug allergies; and make a recommendation for an antibiotic and a
dosage based on all these factors plus the best research evidence, embodied in
a current clinical guideline. The computer might even list two or three
alternatives, with the pluses and minuses of each. The doctor is then free to choose
one of the recommendations or to ignore them, perhaps because of other factors
that were not considered by the computer.
Even with this
scenario, there are no guarantees the patient will improve, but the chances are
probably better. The doctor's and patient's autonomy haven't been usurped. The
doctor isn't practicing cookbook medicine; she's had to gather the patient's
symptoms and exam findings, make the right diagnosis, decide on
hospitalization, and make dozens of other decisions. But she's grateful for the
more complete assessment of antibiotic choices she's gotten. It's saved her
time, and she's been able to use that time to talk with the family and reassure
the patient. The recommendations aren't based on commercial interests, personal
biases, or local habits.
This scenario isn't
quite reality today, but it may be in the near future. A few hospital systems
have decision support programs with several of these elements already. Early
indications are that these systems reduce errors in the hospital and can save
money at the same time; their potential in other aspects of medicine is
enormous.
So the computer is
one technology that we think has been underused in medicine. Given the huge
amount of information that we now gather on every patient, the complexity of
decision making, and the volume and volatility of medical knowledge, it may be
our only hope for effectively using the technological progress available to us.
We think that the investment in information technology by American medicine
should increase substantially, and the Bush administration is moving to support
such initiatives.
As with the
construction of guidelines, one caution is that these decision aids must be
developed in an evidence-based fashion by someone who doesn't have a financial interest
in the clinical recommendations. Also, the decision aids will have to be
continuously updated. These tasks, like the hardware, will be expensive, but
they may prove to pay for themselves. Ultimately, the real benefits and risks
of information technology will need to be evaluated as carefully as those of
other medical technology.
Then there are
the commercial pressures of various types that have become a major obstacle to
practicing evidence-based medicine.
Dr. Rennie believes
that practicing evidence-based medicine is against human nature:
It's against human
nature to make decisions based on evidence, and I really believe that-even
though no one could be more wedded than I am to the idea. Doctors form cozy
relationships with nice people who respect them, or seem to respect them, and
give them presents. It's why those doctors so willingly prescribe the latest
brand name drug without ever looking into the evidence whatsoever ... because
it makes them happy, it makes the patient happy, it makes the drug rep happy.
He goes on to
describe the pressures created by advertising aimed directly at patients:
I think a doctor in a
sense would be foolhardy or reckless with his own time and energy to spend time
trying to go against the directo-consumer advertising.
“ I will lose this patient if I don't prescribe what she or he is demanding
right now."
Can doctors and hospitals resist?
Medicine is one of
the three traditional "learned professions": law, religion, and
medicine. These professions acquired this stature because they worked with
ubiquitous, profound human needs. Professionals in these fields had to be
trusted with the intimate details of a client's mind, body, and personal life.
A professional had to be trusted to use such intimate knowledge for the benefit
of the client, not for exploitation. Self-governance, service, quality,
autonomy, altruism, self-sacrifice, and a high level of learning are seen as
defining characteristics of learned professions. These traits are the basis for
the trust most patients still have in their own doctors.7
On the other hand, of
course, medicine is a business. It's the way doctors, nurses, administrators,
technicians, maintenance experts, manufacturers, and salespeople make a living.
Without income, doctors and hospitals couldn't stay in business, nor could the
drug and device makers. Business standards are different from professional
standards, and they mainly focus on return on investment. Medical practice is
always a balancing act between the professional and the business sides of
practice.
Many leaders of
American medicine, including prominent journal editors and leaders of
professional societies, have become concerned that the balance between business
and professional values has recently tilted dangerously toward the business
side. As we have discussed, both doctors and hospitals today often seem to make
choices based on a corporate mentality that focuses on financial return rather
than on good evidence of benefit to patients. When the choices involve new
treatments, the assumption is almost always that more and newer can only be
letter. Conveniently, this stance almost always coincides with financial
self-interest.
Several professional
organizations, including the American College of Physicians and the American
Board of Internal Medicine Foundation, have issued recent calls for
strengthening professional values among physicians 8/9 Though the
initiatives are short on specifics or sanctions, they may serve to refocus
attention on this problem and to enhance the inculcation of professional values
in medical school and specialty training. In some cases, it seems, we've become
so preoccupied with technical training that we've forgotten to convey the
ethical and social values on which the profession is built. Perhaps a combination
of better training in evidence based medicine and reinvigorated attention to
true professionalism will help to counter the commercial pull against
evidence-based practice.
Finally, more support
for primary care medical practice may help deflect some of the pressures to use
unproven treatments. Unlike the cardiologist or the orthopedist, primary
physicians have little to gain from using new procedures or gadgets (although
they may be susceptible to blandishments from the drug companies). They can
therefore afford to be more dispassionate about them. The primary care
doctor-typically a family doctor, general internist, or pediatrician-can serve
the role of providing unbiased information and assisting patients with many
difficult medical decisions.
1. Stolberg SG. On
Medicine's frontier: The last journey of James Quinn. The New York Times,
October 8, 2002, p. Dl.
2. How a new policy
led to seven deadly drugs; Medicine: Once a wary watchdog, the U.S. Food and
Drug Administration set out to become a "partner" of the
pharmaceutical industry; today, the American public has more remedies, but some
are proving lethal. Los Angeles Times, December 20, 2000, p. Al.
3. Writing Group for
the Women's Health Initiative Investigators. Risks and benefits of estrogen
plus progestin in healthy postmenopausal women. JAMA 2002; 288: 321-333.
4. Moseley JB,
O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, et al. A controlled
trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002; 347: 81-88.
5. Bartley N. Cancer
mistake ravages a life. Seattle Times, April 25, 2001, p. B1.
6. Stadtmauer EA, O'Neill A, Goldstein LJ, Crilley
PA, Mangan KF, Ingle JN, et al. Conventional-dose chemotherapy compared with
high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation
for metastatic breast cancer. Philadelphia Bone Marrow Transplant Group. N Engl J Med 2000; 342: 1069-1076.
7. Mello MM, Brennan
TA. The controversy over high-dose chemotherapy with autologous bone marrow
transplant for breast cancer. Health Affairs 2001; 20(5):101-117.
8. The ALLHAT
Officers and Coordinators for the ALLHAT Collaborative Research Group. Major
outcomes in high-risk hypertensive patients randomized to
angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic:
The Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial
(ALLHAT). JAMA 2002; 288: 2981-2997.
9. Petersen M.
Diuretics' value drowned out by trumpeting of newer drugs. The New York Times,
December 18, 2002, p. A32.
See also: Kleinke JD. Oxymorons: The Myth of a U.S. Health Care
System. San Francisco: Jossey-Bass, 2001, p. 79.
Callahan D. False
Hopes: Why America's Quest for Perfect Health Is a Recipe for Failure. New
York: Simon and Schuster, 1998. Kolata G. New heart
studies question the value of opening arteries. The New York Times, March 21,
2004, sec. 1, p. 1. Steinberg EP, Tunis S, Shapiro D. Insurance coverage for
experimental technologies. Health Affairs 1995; 14: 143-158.
The Backlash Against
Evidence-Based Medicine
1. Brown D. First, do
the trials. Then, do no harm. The Washington Post, August 4, 2002, p. B1.
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