Reforming U.S. healthcare will be difficult,  in part because our current system is riddled with conflict of interest. Virtually any health care reformer will tell you that if we are going to have a high quality, sustainable health care system, we will need an independent health care agency that oversees quality by making sure that decision are based on the best medical science available. “Independent” means that this agency must somehow be insulated from both special interests and politics.

If this sounds Utopian, it isn’t. In my first post, I suggested that we might find a model for just such an agency in the U.K.’s National Institute for Health and Clinical Excellence (NICE). To be sure, we would not want to emulate NICE in all respects. Operating on a very tight budget, NICE puts a major emphasis on the cost-effectiveness of the treatments it approves. In the U.S., we could  vastly improve the quality of our care—and save billions—if we just looked at the “comparative-effectiveness” of services and products, without worrying about how many additional years of life $100,000 would buy.

What is remarkable about NICE is its independence. And this is what we should take as a pattern for what is possible.  Founded in 1999, the institute operates with almost no interference from either private sector lobbyists or government.

Sitting at the very center of the U.K.’s health care system, NICE is charged with watching over the quality of care in the U.K. by drawing up “best practice guidelines” for physicians, while also reviewing new and existing medicines, technologies and treatments. The National Health Service of England is legally obliged to provide funding for drugs and procedures recommended by NICE’s independent technology appraisal board. So implicitly, NICE also is deciding what the national health system will cover.

The system works, explains Dr. Gillian Leng, the Institute’s Director
of Implementation Services, in part because NICE consults widely with
interested parties before making its decisions. When reviewing drugs,
devices and treatments, it looks not just at randomized clinical trials
and side effects data, but also at what Leng calls “colloquial
evidence” from health care providers, by engaging physicians outside
NICE in the review process.

“This is important,” Leng explained, speaking at the World Health Care
Congress Europe earlier this month. “If we want them to implement the
guidance, we need a realistic check on the feasibility of
implementation, and we need to increase their ownership of the
evidence.” Out in the field, NICE has six consultants who both help
doctors implement recommendations and bring information back to NICE,
telling Leng what physicians are saying.

A NICE review embraces all available information. During the appraisal
process, an independent academic centre draws together and analyzes all
of the published information on the technology under review and
prepares an assessment report. NICE then consults with patient groups
and organizations representing health care professionals, as well as
the manufacturer of the product undergoing appraisal. (NICE recently
has made it very clear that manufacturers must reveal all of the
information that they have about a product—including side effects and
failed trials.)

These “consultees” submit evidence and comment on the report, which
will be revised, taking their comments into account. During the
appraisal process, medical products are compared to similar products
made by rival manufacturers, and those competitors also provide input.

“We get hundreds and hundreds of comments and yet the process is quite
transparent,” says Leng. “In fact, beginning this summer the
independent advisory committee meetings will be open to the public.”
NICE bases its final decisions on medical evidence of clinical
effectiveness—combined with an awareness of cost-effectiveness. If a
new procedure is only slightly more effective for most people—but costs
twice as much as the alternative—NICE is not likely to cover it. Though
if a product or treatment offers significant benefits for a small group
of patients, NICE will recommend it for that group.  NICE understands
that “one size fits all” does not apply to medicine.

Leng stresses NICE’s “arm’s length” relationship with the government.
Although NICE is funded by the Department of Health, it does not have
to go back to either the Department or to Parliament to seek approval
for its recommendations. “We get the funding; we do the evaluations.
And then we send our recommendations directly to hospitals and
doctors,” Gillian explained. 

Yet while NICE can issues guidelines without parliament’s stamp of
approval, it is crucial to realize that doctors and hospitals are not
obliged to follow NICE’s recommendations for best practice. These are
guidelines, not “rules.” In medicine, hard and fast rules are not
practical.  Every human body is unique; there will always be times when
the treatment that would be best for most people would not be
appropriate for some individuals.

Nevertheless, NICE wants to know whether its non-binding suggestions
are having an impact, and so it monitors whether providers are
following its recommendations.  And, when it can, NICE helps physicians
implement the guidelines.

“When NICE was established in 1999, we had no implementation program,”
Leng recalls with a wry smile. “We just thought we would issue
guidelines, and—a Miracle!, everyone would use them.” This, she
realizes, was naive. Like most people, health care providers tend to
resist change. “Now,” Leng says, NICE has an implementation program
that strives to “motivate and inspire, provide practical support, and
evaluate the impact and uptake of its recommendations.”

The program has been remarkably successful. Today, when NICE checks on
whether its suggestions are being implemented, it finds “89 percent
compliance” reports Leng, “up from 84.5 percent just two years ago.”

“NICE has survived in a very hostile world,” observes Professor Julian
Le Grand, Richard Titmuss Professor of Social Policy at the London
School of Economics. “Doctors tend to be wedded to the way they do
things,” says Le Grand.  Yet NICE often asks them to change the way
they practice medicine.

Often, following NICE’s counsel means that already busy physicians must
take on new responsibilities. Last year, for example, NICE issued
guidelines warning GPs and Midwives that they need to do more to
identify depression in new and expectant mothers.  NICE’s review of the
research suggested that one in seven mothers suffer some form of mental
illness either during or following pregnancy, but very few are
officially diagnosed.

Fiona Shaw, a patient who helped draft the guidelines, and who has
herself suffered mental health problems, remarked: “Many women are
concerned they will not be listened to if they come forward, or that
they will be judged, or that their condition is not serious enough to
warrant help from a healthcare professional.” Fiona, who stopped eating
and was self-harming following the birth of her child, was told by her
doctor to “either start taking anti-depressants and stop
breast-feeding,” or to just “grin and bear it like a good girl.”

This dismissive, patronizing attitude is something that NICE is hoping to change, British newspapers reported last year. Under the new guidelines GPs are urged
to be alert to signs of depression, and are expected to send patients
for counseling within a month of initial diagnosis—and again after
another three months.

In the U.S., such recommendations often come without funding. Family
doctors are told that they “should be alert” to X or Y, and that it is
their job to co-ordinate care with other physicians, but no one pays
them for their time. Meanwhile, many insurance policies will not cover
psychiatric counseling either for pregnant women or for new mothers.

By contrast, in the U.K., once NICE makes a recommendation, Britain’s
national health insurance ultimately must pay for it. Funds are not
always immediately available in all parts of the country, but in the
end, medical research determines what insurance must cover.

This is not to suggest that NICE’s decisions are never controversial.
Last year, when NICE ruled that four drugs for patients suffering from
early-stage Alzheimer’s disease (Aricept, Reminyl, Exelon and Ebixa )
were not “cost-effective” because they had “only a small clinical
effect” on patients suffering with  mild symptoms of early stage
Alzheimer’s, drug-makers decided to push back. Eisai, which
manufactures Aricept, and Pfizer, which distributes the drug in the U.K.,
took NICE to the U.K’s High Court.

“This was the first time that NICE’s procedures have been tested by
judicial review,” points out Le Grand, who has served as an advisor to
the U.K. government and now advises the European Commission. “The
court’s task is to check out the method by which decisions are made.
And NICE came out victorious. The court ruled that NICE had arrived at
its decision fairly, and that the drugs should be covered only for
patients in the later stages of the disease.”

The Alzheimer’s Society, which is partially funded by industry, was
disappointed with the decision. But Professor Richard Gray, the
director of Birmingham University’s clinical trials unit, told The
Guardian: "The benefits from these drugs for Alzheimer’s disease are so
small that the only way you can tell if a patient is taking the drug or
taking a dummy tablet is if they get side-effects such as nausea or
diarrhea. These drugs are simply not a good use of the NHS’s limited
budget, and the court made the right decision."

In another case, NICE decided to approve Herceptin, a new drug for the
treatment of breast cancer, but recommended it only for late-stage
patients. Research showed it also could help patients in the early
stages of breast cancer, but the Herceptin website warned that
"administration can result in the development of certain heart
problems, including congestive heart failure. Severe allergic
reactions, infusion reactions, and lung problems have been observed."

Meanwhile, cost loomed as an issue. Last year, The Guardian warned that
“increasing the availability of Herceptin, which costs around £22,000
for a year’s treatment, could put the NHS budget under great financial
pressure and lead to services for less high-profile diseases and
conditions being cut, according to the medical journal Annals of
Oncology.  The journal calculated that the annual bill for providing
Herceptin to the 5,000 women diagnosed each year with early-stage
breast cancer would come to £109m.”

When resources are finite, choices must be made. “Doctors at the
Norfolk and Norwich University hospital NHS trust said it would cost
£1.9m a year to pay for Herceptin for the 75 patients with the type of
breast cancer for which it is recommended,” The Guardian reported.
“That is four times the cost of the drugs used to treat a range of
other cancers, including lung, colon and post-menopausal breast cancer.
The doctors calculate that the trust could only pay for Herceptin if
they did not give treatment to 355 patients with other cancers, 16 of
whom would be cured.”

At the same time, research showed that Herceptin definitely can improve
the survival rate of breast cancer patients—though it also causes heart
damage in some women.

Emotions were running high in 2005, when the U.K.’s Secretary of State
for Health, Patricia Hewitt, stepped in. NICE had not yet made a final
assessment, yet Hewitt declared that Herceptin should be available for
all breast cancer patients.  “She said that the drug could save 1,000
lives a year,” Le Grand recalls. “Although her action was
understandable, this was a dangerous thing to do. These politically
sensitive decisions must be taken out of politics. Those who are
committed to science support NICE.”
In the end, after reviewing all of the evidence, NICE agreed with
Hewitt. In 2006, the institute issued an announcement saying that
Herceptin should be given to women suffering from early stage breast
cancer, unless they had “heart problems or suffered from high blood
pressure that is not well controlled with drugs or other treatment.”

Meanwhile, the Health Minister came in for widespread criticism. “Government is attacked for interference over Herceptin,” read a headline in BMJ. And in The Guardian,
Karol Sikora, medical director of CancerPartnersUK, chief of the WHO
Cancer Program, and editor of Treatment of Cancer, the standard British
textbook for doctors, wrote:

“This year, our health minister stepped in without waiting for our drug
regulators’ assessment and decided that [Herceptin] should be available
for all suitable breast cancer patients. In a system of finite
resources, this is surprising. We now have the bizarre situation that
people are waiting longer for chemotherapy for other cancers as there
simply isn’t the capacity in the system…We need to improve cancer care
dramatically in Britain, but let’s not attach a value to different
cancers based on their romantic or political profile.” 

One might have expected that the public would applaud Hewitt’s
intervention on behalf of women with breast cancer. And no doubt some
people did. But the fact that many objected to her interference
demonstrates that, in the U.K. many people perceive NICE as generally
fair—and they do not want to see politics or politicians undermining
NICE’s authority.

“There was a real concern that when Hewitt stepped in, this was the
beginning of a slippery slope—and that we would see more political
interference. But that was more than two years ago, and we haven’t seen
another case where the government tried to intrude on NICE’s
decision-making process,” says Le Grand.

Nevertheless, NICE’s judgments as to what is “cost-effective” will
always be controversial. In the U.K. a treatment is considered worth
the price if it will give the patient an extra year of high quality
life for  no more than 30,000 pounds—the unofficial value NICE has put
on a “quality-adjusted life-year”(QUALY), a measure of the longevity
and wellbeing a drug can bring. (Cataract treatment and hip
replacements score highly on this scale—they may not extend life, but
they dramatically improve its quality.)

Some object to the very idea of putting a price on life. Others argue
that NICE is “too nice” in the words of an editorial published in BMJ
(formerly the British Medical Journal) last August. There, lead author
John Appleby, chief economist of the King’s Fund wrote: “an analysis of
NICE’s decisions suggests that its threshold is in practice even more
generous than NICE admits, being closer to £45,000.”

But here in the U.S., I don’t think we need to worry about what a year
of life is “worth.” As I noted above, while there is much that the U.S.
might learn from NICE, it is not at all likely that using
“quality-adjusted life years” to measure cost-effectiveness will become
part of health care reform in the U.S.

For one, we spend more than twice as much as the U.K. per capita on
health care; we are working with a much more generous budget. The U.K.
health system is strapped for cash, and so is forced to make some very
hard decisions that we don’t face—at least not yet.  (Though if we
don’t get a handle on run-away health care inflation, before long we
will have to make some very similar choices.)

Secondly, at present there is so much low-hanging waste in our system
that, if we just weeded out treatments that are ineffective (whatever
their cost), we could save billions. Frequently, the problem is that
expensive drugs, such as statins, are overprescribed, and given to
everyone, exposing patients who won’t benefit from the drug to
unnecessary side effects. In other cases, research shows that too many
Americans are subjected to the risks of procedures like by-passes and
angioplasties when less aggressive treatments would be just as
effective—and safer.

At some point, we will need to think about
“cost-effectiveness”—especially when deciding whether to cover an
extremely expensive procedure that promises only a few extra months of
life.  But right now, if we just focused on “comparative
effectiveness,”  we would be making great strides toward creating an
efficient, effective and affordable health care system.

After listening to Leng’s speech, it was clear to me how NICE has won
the support of many physicians and patients. By enlisting their
comments while making decisions, NICE makes them part of the process.
“But just how is it that NICE is able to keep industry at bay?” I asked
Le Grand.

“NICE has enough power that it can divide and rule,” he replied. “There
are drug companies that like NICE’s decisions. When it rules in their
favor, it creates a market. All in all, the drug companies are quite
ambivalent about NICE.”

In the U.S., the Centers for Medicare and Medicaid Services (CMS) could
be as powerful as NICE. CMS pays 33 percent of the nation’s health care
bill. Its coverage decisions also create markets. But CMS doesn’t use
that leverage. It doesn’t insist that sponsors of a new product share
information on failed trials.  It doesn’t require head- to- head
comparisons showing the benefits of a new treatment. Why not?

Often, people answer such questions by saying, “the U.S. is different.”
In our political system, the lobbyists are too powerful: they simply
wouldn’t let CMS exert that amount of muscle.

Moreover, in this country, many conservatives don’t want to see
government challenging for-profit corporations by asking them to prove
the value of their products—even if government is paying for those
products.  The lobbyists, they argue, have a right to represent
corporate interests, whether by making hefty campaign contributions to
seemingly endless (and endlessly expensive) campaigns, or by lobbying
government agencies.

And because the lobbyists have so much clout, Ezra Klein recently reported
that even health care reformers like Alan Enthoven say that we can’t
ever hope to bargain for discounts on over-priced drugs and
devices—even though we would only be following the model of every other
nation in the developed world.

According to Enthoven, if the Medicare law that now prevents Medicare
from negotiating for lower prices were changed, it still “ would be
pretty hard to actually use the bargaining power, given how individual
Congressfolks would protect the devices, treatments, [and drugmakers]
that are powerful in their districts/states. ”

But what does it really mean to say we can’t borrow ideas that work in
other nations because, in our political system, lobbyists possess so
much power—i.e., the U.S. is “different”?  Here, “difference” becomes a
justification for not doing the right thing. We seem to be saying
“We’re different in that our political process is more corrupt.  Our
legislators are owned by special interests. And we can’t do anything
about it.”

Granted, our Congressmen need a much bigger war chest than politicians
in other countries to pay for our never-ending campaigns.  So perhaps
this means that if we want health care reform, we also need campaign
finance reform. Maybe we need to re-think the campaigns themselves. Is
there any reason why our political contests have to drag on until none
of us wants to hear another stump speech? And is there any real need
for those pricey television “spots”?  At best, they offer a slur or
two—and precious little information. Wouldn’t televised debates—with
the time contributed by the network—suffice to introduce us to the
candidates?

Most importantly, isn’t it time to say that the notion that “the U.S.
is different” just isn’t an adequate excuse for failing to make ours
the best health care system in the world?