Health care very important

[Snufi]

Hi to all, I just heard a senator from arizona on Fox News. His pet project is to keep an eye on the provision in the stimulus pack that allows the gov to tell your doctor what treatment to give you. He cited another country that has the same provision in their health care and then went on to give an example of a disease that gets scrutinized for cost effectiveness for treatment. Can you guess what disease he cited? Thats right guys, BREAST CANCER. Whether we believe in National Health care or not, I'm sure none of you want the government telling your doctor what treatment to give you, for your breast cancer.

I'll leave you with this thought, once the gov sees how much Herceptin costs, do you think they will consider it cost effective, especially for the older ladies or guys?

I worked for the gov for 20 years and was a union officer. I know how the gov works.

I dont want to say too much as to get this message board in trouble, so if any of you want to know more, please privately e-mail me.

Snufi

[alicem]

This provision could possibly be just the first step in cost effective studies. What will be the next steps down the line? Here is a passage from Robert Bazell's book "Her2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer", Chapter 4, published in 1998:

"Based on simple business principles, he (John Curd) believed that Her-2/neu's potential would never justify the crushing cost -- ultimately more than $150 million -- of getting the drug to market. Because a minority of breast-cancer patients -- 25-30% -- suffer from the type of disease positively affected by the treatment, 'today if Her-2 came forward, you couldn't get it into development', he (Curd) says."

John Curd was a medical director who joined Genentech management in 1991. The book goes on to say . . .

"If the decision had been his, Genentech would never have taken Her-2/neu to advanced development. But when he arrived, the company was already committed to developing Her-2/neu."

As more is learned about breast cancer, scientists are finding many more sub-groups of the disease - meaning even lower percentages of women affected by certain aspects of the disease. Go back and re-read that line . . . the one that claims that OUR disease, Her2 +++ is a MINORITY, and because it is a minority, it should not have been explored.

My question is, once the line has been crossed to doing cost effective studies of health care, where will it end? The scary thing for me is the EASE that this was put into place in the stimulus package, a vehicle that is supposed to be about creating jobs? What does health care have to do with job creation and mortgage relief? I challenge you to ask all of your friends if they have even heard about this. More than likely they have no clue.

As in most cases, it is the squeaky wheel that gets greased so we must stay proactive in our Breast Cancer cause, and maybe now, more urgent than ever.

[gdpawel]

Conservatives have been misinforming the public about the health IT provisions of the stimulus package by falsely claiming that it would lead to the government telling the doctors what they can and cannot treat, and on whom they can and cannot treat. The Hudson Institute fellow, Betsy McCaughey, claimed that the legislation will have the government monitor treatments in order to guide your doctor's decisions.

The new language in the bill tasks the (already existing) National Coordinator of Health Information Technology (NCHIT) with providing appropriate information so that doctors can make better informed decisions. The NCHIT provides counsel to the Secretary of HHS and Departmental leadership for the development and nationwide implementation of health information technology.

Contrary to Ms. McCaughey's statements, the language in the House bill does not establish authority to monitor treatments or restrict what your doctor is doing with regard to patient care. It addresses establishing an electronic records system so that doctors can have complete, accurate information about their patients.

The funding for health information technology in the recovery package is projected to create over 200,000 jobs and a down-payment on broader health care reform. Converting an antiquated paper system to a computer system by making the health care system more efficient.

The Congressional Budget Office has estimated that one-third of $2 trillion spent annually on health care in America may be unnecessary due to inefficiencies in the old system such as exessive paperwork. Investing in infrastructure like health IT would help improve the quality of America's health care.

Currently, fewer than 25% of hospitals and fewer than 20% of doctor's offices employ health information technology systems. Researchers have found that implementing health IT would result in a mean annual savings of $40 billion over a 15-year period by improving health outcomes through care management, increasing efficiency and reducing medical errors.

Investing in health would also help primary care physicians who often bear the brunt of tech implementation without seeing immediate benefits, affording the infrastructure for expanison.

[ElaineM]

I have read several posts on this site regarding the new national health care proposals. I am as concerned as everyone else.
Joe reminded us that we should be careful about political issues in another thread, because we are a 501C non profit organization.
So, if we are really worried about these issues we might want to consider contacting our legislators and/or getting involved in a health care advocacy group.
There might be a group in your hometown.
One or more of us might want to start a blog or some other kind of website that can be used for discussion and/or action on this topic.
There are also various groups on the internet. One group can be reached at:
http://www.stopbreastcancer.org/

[StephN]

First of all, I want to say that every hospital in our metro region ALREADY HAS ELECTRONIC MEDICAL RECORDS.
My records are accessable by any one of several hospitals and my cancer center just by entering my medical number!

My husband's records and labs at a different medical center are accessable by US online. That is HOW we have usually communicated with his doctors and nurses for years. For example, we get an email when his lab draws are processed - usually the same day! WITH a comment from his doctor if a value is improved or a med needs adjusting!

Just when all this is working well, I hope they don't take "stimulus" money to try to "upgrade" these systems, only to have them NOT working for some unknown amount of time. Talk about unnecessary "make work!"

AliceM's quotes from the book by R. Bazell are THE REASON I give Dr. Slamon a big hug each time I see him at a cancer conference. I KNOW that his persistence and hard-headedness in doggedly persuing his research is not the norm with researchers. He had the luxury of some independence due to the Revlon-raised money.

People who work in labs usually have a goal they are working on - something to "prove" so that a next step can either go forward or not.

Our business in downtown Seattle is surrounded by biotech and information systems companies. We hear from the employees when they are feeling good about a new success as well as when their research is turned down by such as the FDA. There is a lot of big money going into studies of all kinds in our metro area. Many highly intelligent people are working in these fields, from the best universities and medical centers in the world!

My feeling is that we need private enterprise to have some leeway in making strides against diseases and developing new treatments. I would hate to see them over-regulated by people who have no idea what they are regulating!

[ElaineM]

I totally agree with your last paragraph Steph. Medical professionals in each field of medicine need to be involved in the decision making process.
Wow !! You can get your medical records on line?
That's convenient.
We are just creeping along getting that started in Hawaii. So far only the docs have online access.
I get copies of all my lab tests, scans, pathology reports etc. etc. from the doctor's offices. I have learned alot of medical jargon by just reading that stuff.
However, I can e-mail and IM with some of my docs.
Just had an exchange with one of my docs who is now in Asia the other day.

[fullofbeans]

I do not live in the US so I am not directly involved but I do just want to say that cost effectiveness is a terrible concept. What price do you put on hope ?

In my opinion we should scrutenise the profit from pharmaceutical co and hospital charges before telling people that they are not worth such and such treatment.. The article says that the European use the cost effectiveness thingy, well this is simply wrong since in France for example cancer treatment have been ring-fenced which means cost is never a issue, but because the governement is buying they negociate cheaper prices..

If this is what is happening (hiding this bill inside the stimulus package) maybe I do not understand it well then I have to say that I am very disappointed with the way this law is being pushed through.. I hope that we are all missinformed about this, man I am so annoyed for you.. but I hope that I have completly missed the boat and not understood it because the contrary would be awful..

[gdpawel]

The venue at a recent Institute of Medicine forum on assessing and improving value in cancer care, was the pharmaceutical and biotechnology industry's efforts to beat back efforts at cost control in cancer care, which is increasingly seen as the next big income generator for Big Pharma. No wonder the "industry" is worried.

They put together a coalition, the so-called Partnership to Improve Patient Care, which includes the lobbying arms of the drug, device and biotechnology industries as well as patient-advocacy groups, most of which accept pharmaceutical industry donations, and medical-professional societies, to lobbying Congress to give the "industry" a major say over how it will be run.

The drug and medical device industries are mobilizing to gut a provision in the stimulus bill that would spend money on research comparing medical treatments. The research funding would be doled out to the National Institutes of Health and other government bodies to focus on producing the best unbiased science possible.

Comparative research has the potential to tell us which drugs and treatments are safe, and which ones work. This is not information that the private sector will generate on its own, or that the "industry" wants to share. Companies want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it. Just about the way they are controlling data now.

Do publicly traded companies have a seat on the governing board of the Securities and Exchange Commission? Should Boeing and Airbus be given the right to determine the scope of the National Transportation Safety Board's inquiry into airplane crashes? It is simply bad governance to give "industry" a seat at the table when officials decide what comparative effectiveness studies will get done.

[Yorkiegirl]

Elaine wrote:I have read several posts on this site regarding the new national health care proposals. I am as concerned as everyone else.
Joe reminded us that we should be careful about political issues in another thread, because we are a 501C non profit organization.

Thank you for repeating this again Elaine.

[gdpawel]

The $1.1 billion earmarked for comparative effectiveness research remained in the bill that President Obama will sign. The House conferees also insisted on keeping the phrase "comparative effectiveness" throughout the authorizing language, removing the Senate's insertion of the word "clinical." The report language did note its removal was "without prejudice."

However, the conferees do not intend for the comparative effectiveness research funding included in the conference agreement to be used to mandate coverage, reimbursement, or other policies for any public or private payer. The funding in the conference agreement shall be used to conduct or support research to evaluate and compare the clinical outcomes, effectiveness, risk, and benefits of two or more medical treatments and services that address a particular medical condition.

We saw a perfect example last week of how comparative cost-effectiveness analysis can be coupled with comparative clinical-effectiveness analysis to provide useful guidance to health practitioners, patients and payers faced with a confusing array of alternatives in one particularly crowded area of health care: colon cancer screening. CMS made a preliminary decision not to pay for virtual colonoscopy.

http://www.nytimes.com/2009/02/13/he...noscopy&st=cse

CMS concluded, based on a comparative cost- and clinical-effectiveness analysis conducted by AHRQ, that taking its costs into account, virtually colonoscopy made no sense either medically or economically. Not all comparisons merit a cost-effectiveness analysis. When one drug, device, surgery or other medical technology is clearly superior to another, then the U.S. health care system, which operates without cost controls, pays for it. This legislation reinforces that approach.

Yet as anyone with even a passing familiarity with the medical science and medical economics literature understands, comparisons are rarely black and white. Most medical technologies only help a fraction of patients. Most medical technologies have some risks associated with their use. Comparative cost-effectiveness analysis is an important tool for accurately evaluating those benefits and risks.

Source: GoozNews

[MJo]

I plan to be very cautious and make sure I am not giving credence to a fear and misinformation campaign. Extremists at either end of the political spectrum are dangerous.

[gdpawel]

Competitive effectiveness research is not something to be afraid of. It will help doctors and patients, through research, studies and comparisons, understand which drugs, therapies and treatments work and which don’t and which one could save your life.

There is nothing in the competitive effectiveness research provision that says what treatments, tests and therapies you can and cannot have, or what your doctor can prescribe for you. Contrary to the extremists’ claims, you will not be, and cannot be, denied end-of-life care or medicines.

Health IT does not give the government access to your medical records. They remain confidential between you and your doctor. The government cannot monitor your care and then penalize you or your doctor for so-called unapproved treatments, as the rumor mongers are hollering.

Big Brother will not be in the examination room and will not be designing your treatment according to a government health care menu. You and your doctor decide what’s best. Armed a little with the truth, and some good old-fashioned common sense, you can understand.

[Debbie L.]

From today's New York Times:

U.S. to Compare Medical Treatments

By ROBERT PEAR

WASHINGTON * The $787 billion economic stimulus
bill approved by Congress will, for the first
time, provide substantial amounts of money for
the federal government to compare the
effectiveness of different treatments for the same illness.

Under the legislation, researchers will receive
$1.1 billion to compare drugs, medical devices,
surgery and other ways of treating specific
conditions. The bill creates a council of up to
15 federal employees to coordinate the research
and to advise President Obama and Congress on how to spend the money.

The program responds to a growing concern that
doctors have little or no solid evidence of the
value of many treatments. Supporters of the
research hope it will eventually save money by
discouraging the use of costly, ineffective treatments.

The soaring cost of health care is widely seen as
a problem for the economy. Spending on health
care totaled $2.2 trillion, or 16 percent of the
nation’s gross domestic product, in 2007, and the
Congressional Budget Office estimates that,
without any changes in federal law, it will rise
to 25 percent of the G.D.P. in 2025.

Dr. Elliott S. Fisher of Dartmouth Medical School
said the federal effort would help researchers
try to answer questions like these:

Is it better to treat severe neck pain with
surgery or a combination of physical therapy,
exercise and medications? What is the best
combination of “talk therapy” and prescription drugs to treat mild depression?

How do drugs and “watchful waiting” compare with
surgery as a treatment for leg pain that results
from blockage of the arteries in the lower legs?
Is it better to treat chronic heart failure by
medications alone or by drugs and home monitoring
of a patient’s blood pressure and weight?

For nearly a decade, economists and health policy
experts have been debating the merits of research
that directly tackles such questions. Britain,
France and other countries have bodies that
assess health technologies and compare the
effectiveness, and sometimes the cost, of different treatments.

Hillary Rodham Clinton, as a senator, was an
early champion of “comparative effectiveness
research.” Mr. Obama, who is expected to sign the
stimulus bill Tuesday, endorsed the idea in his campaign for the White House.

As Congress translated the idea into legislation,
it became a lightning rod for pharmaceutical and
medical-device lobbyists, who fear the findings
will be used by insurers or the government to
deny coverage for more expensive treatments and, thus, to ration care.

In addition, Republican lawmakers and
conservative commentators complained that the
legislation would allow the federal government to
intrude in a person’s health care by enforcing
clinical guidelines and treatment protocols.

The money will be immediately available to the
Health and Human Services Department but can be
spent over several years. Some money will be used
for systematic reviews of published scientific
studies, and some will be used for clinical
trials making head-to-head comparisons of different treatments.

For many years, the government has regulated
drugs and devices and supported biomedical
research, but the goal was usually to establish
if a particular treatment was safe and effective,
not if it was better than the alternatives.

Consumer groups, labor unions, large employers
and pharmacy benefit managers supported the new
initiative, saying it would fill gaps in the
evidence available to doctors and patients.

“The new research will eventually save money and
lives,” said Representative Pete Stark, Democrat of California.

The United States spends more than $2 trillion a
year on health care, but “we have little
information about which treatments work best for
which patients,” said Mr. Stark, who is the
chairman of the Ways and Means Subcommittee on Health.

In the absence of information on what works, Mr.
Stark said, patients are put at risk, and
billions of dollars are spent each year on
ineffective or unnecessary treatments.

Steven D. Findlay, a health policy analyst at
Consumers Union, said the action by Congress was
“a terrific step on the road to improving the
quality of care and making it more efficient.”

But critics say the legislation could put the
government in the middle of the doctor-patient relationship.

Bureaucrats “will monitor treatments to make sure
your doctor is doing what the federal government
deems appropriate and cost-effective,” Betsy
McCaughey, a former lieutenant governor of New
York, wrote on Bloomberg.com. Rush Limbaugh
broadcast the charges to millions who listen to his radio talk show.

Lawmakers and lobbyists agree that researchers
should compare the clinical merits of different
treatments. Whether they should also consider cost is hotly debated.

Representative Charles Boustany Jr., a Louisiana
Republican who is a heart surgeon, said he
worried that “federal bureaucrats will misuse
this research to ration care, to deny life-saving
treatments to seniors and disabled people.”

The House Appropriations Committee inadvertently
stoked such concerns in a report accompanying its
version of the economic recovery bill. It said
that research comparing different treatments
could “yield significant payoffs” because less
effective, more expensive treatments “will no longer be prescribed.”

A similar proposal was included in a recent book
by Tom Daschle, who had been Mr. Obama’s nominee
for health secretary, and Jeanne M. Lambrew, who
is the deputy director of the Office of Health Reform in the Obama White House.

Women and members of minority groups expressed
concern about that approach. Drugs and other
treatments can affect different patients in
different ways, they said, but researchers often
overlook the differences because their studies do
not include enough women, blacks or Hispanics.

“Some drugs appear to be more effective in women
than in men, while other medicines are more
likely to cause serious complications in women,”
said Phyllis E. Greenberger, the president of the
Society for Women’s Health Research. “It’s
important to look for these sex-based differences.”

In a letter to House leaders, the Congressional
Black Caucus said, “We are concerned that
comparative effectiveness research will be based
on broad population averages that ignore the differences between patients.”

House and Senate negotiators tried to address
these concerns. The final bill says that the
research financed by the federal government shall
include women and members of minority groups.

Moreover, in a report filed with the bill, the
negotiators said they did not intend for the
research money to be used to “mandate coverage,
reimbursement or other policies for any public or private payer.”

Congress did not say exactly how the findings
should be used. Private insurers can use the data
in deciding whether to cover new drugs and
medical procedures, but it is unclear how Medicare will use the information.

Under existing law, Medicare generally covers any
treatment that is “reasonable and necessary for
the diagnosis or treatment of illness or injury,”
and the agency does not have clear legal
authority to take costs into account when
deciding whether to cover a particular treatment.

Andrew Witty, the chief executive of the
pharmaceutical company GlaxoSmithKline, said
European officials often considered the costs as
well as the clinical benefits of new drugs * with mixed results.

“Comparative effectiveness is a useful tool in
the tool kit, but it’s not the answer to
anything,” Mr. Witty said in an interview. “Other
countries have fallen in love with the concept,
then spent years figuring out how on earth to make it work.”

[gdpawel]

$21 billion to provide a 60% subsidy of health care insurance premiums for the unemployed under the COBRA program; $87 billion to help states with Medicaid; $19 billion to modernize health information technology systems; $10 billion for health research and construction of National Institutes of Health facilities.

One aspect of the monies was to fund a comparative-effectiveness program to assess whether or not treatments (mostly the newer targeted regimens) are really better than older treatments. Decisions are being made about what cancer treatments patients can actually afford.
Comparative research is not rationing health care. The research funding doled out in the recent Stimulus Package would go to the National Institute of Health, the Agency for Healthcare Quality and Research and the Centers for Medicare and Medicaid Services to focus on producing the best unbiased science possible.

Comparative research has the potential to tell us which drugs and treatments are safe, and which ones work. This is not information that the private sector will generate on its own, or that the "industry" wants to share. Companies want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it. Just about the way they are controlling data now.

Comparative-effectiveness research is not something for patients to be afraid of. It can help doctors and patients, through research, studies and comparisons, undertand which drugs, therapies and treatments work and which don't. Nothing in the legislation will have the government monitoring treatments in order to guide your doctor's decisions. Doctors will still have the ultimate decision, along with the patient.

Yet as anyone with even a passing familiarity with the medical science and medical economics literature understands, comparisons are rarely black and white. Most medical technologies only help a fraction of patients. Most medical technologies have some risks associated with their use. Comparative cost-effectiveness analysis is an important tool for accurately evaluating those benefits and risks.

Another aspect of the monies is the funding for health information technology in the recovery package is projected to create over 200,000 jobs and a down-payment on broader health care reform. Converting an antiquated paper system to a computer system by making the health care system more efficient.

The Congressional Budget Office has estimated that one-third of $2 trillion spent annually on health care in America may be unnecessary due to inefficiencies in the old system such as exessive paperwork. Investing in infrastructure like Health IT would help improve the quality of America's health care.

Currently, fewer than 25% of hospitals and fewer than 20% of doctor's offices employ health information technology systems. Researchers have found that implementing Health IT would result in a mean annual savings of $40 billion over a 15-year period by improving health outcomes through care management, increasing efficiency and reducing medical errors.

Investing in Health IT would also help primary care physicians who often bear the brunt of tech implementation without seeing immediate benefits, affording the infrastructure for expanison. Some PCPs are ahead of the IT curve but cannot afford the richness of its expansion. They need this important infrastructure.

[hutchibk]

In the interest of fairness, here are Ms. McCaughey's words as written. Come to your own conclusions, but I find her conclusions very interesting and not to be taken with a grain of salt.

Ruin Your Health With the Obama Stimulus Plan

Commentary by Betsy McCaughey

Feb. 9 (Bloomberg) -- Republican Senators are questioning whether President Barack Obama’s stimulus bill contains the right mix of tax breaks and cash infusions to jump-start the economy.

Tragically, no one from either party is objecting to the health provisions slipped in without discussion. These provisions reflect the handiwork of Tom Daschle, until recently the nominee to head the Health and Human Services Department.

Senators should read these provisions and vote against them because they are dangerous to your health. (Page numbers refer to H.R. 1 EH, pdf version).

The bill’s health rules will affect “every individual in the United States” (445, 454, 479). Your medical treatments will be tracked electronically by a federal system. Having electronic medical records at your fingertips, easily transferred to a hospital, is beneficial. It will help avoid duplicate tests and errors.
But the bill goes further. One new bureaucracy, the National Coordinator of Health Information Technology, will monitor treatments to make sure your doctor is doing what the federal government deems appropriate and cost effective. The goal is to reduce costs and “guide” your doctor’s decisions (442, 446). These provisions in the stimulus bill are virtually identical to what Daschle prescribed in his 2008 book, “Critical: What We Can Do About the Health-Care Crisis.” According to Daschle, doctors have to give up autonomy and “learn to operate less like solo practitioners.”

Keeping doctors informed of the newest medical findings is important, but enforcing uniformity goes too far.

New Penalties

Hospitals and doctors that are not “meaningful users” of the new system will face penalties. “Meaningful user” isn’t defined in the bill. That will be left to the HHS secretary, who will be empowered to impose “more stringent measures of meaningful use over time” (511, 518, 540-541)

What penalties will deter your doctor from going beyond the electronically delivered protocols when your condition is atypical or you need an experimental treatment? The vagueness is intentional. In his book, Daschle proposed an appointed body with vast powers to make the “tough” decisions elected politicians won’t make.

The stimulus bill does that, and calls it the Federal Coordinating Council for Comparative Effectiveness Research (190-192). The goal, Daschle’s book explained, is to slow the development and use of new medications and technologies because they are driving up costs. He praises Europeans for being more willing to accept “hopeless diagnoses” and “forgo experimental treatments,” and he chastises Americans for expecting too much from the health-care system.

Elderly Hardest Hit

Daschle says health-care reform “will not be pain free.” Seniors should be more accepting of the conditions that come with age instead of treating them. That means the elderly will bear the brunt.

Medicare now pays for treatments deemed safe and effective. The stimulus bill would change that and apply a cost- effectiveness standard set by the Federal Council (464).

The Federal Council is modeled after a U.K. board discussed in Daschle’s book. This board approves or rejects treatments using a formula that divides the cost of the treatment by the number of years the patient is likely to benefit. Treatments for younger patients are more often approved than treatments for diseases that affect the elderly, such as osteoporosis.

In 2006, a U.K. health board decreed that elderly patients with macular degeneration had to wait until they went blind in one eye before they could get a costly new drug to save the other eye. It took almost three years of public protests before the board reversed its decision.

Hidden Provisions

If the Obama administration’s economic stimulus bill passes the Senate in its current form, seniors in the U.S. will face similar rationing. Defenders of the system say that individuals benefit in younger years and sacrifice later.

The stimulus bill will affect every part of health care, from medical and nursing education, to how patients are treated and how much hospitals get paid. The bill allocates more funding for this bureaucracy than for the Army, Navy, Marines, and Air Force combined (90-92, 174-177, 181).

Hiding health legislation in a stimulus bill is intentional. Daschle supported the Clinton administration’s health-care overhaul in 1994, and attributed its failure to debate and delay. A year ago, Daschle wrote that the next president should act quickly before critics mount an opposition. “If that means attaching a health-care plan to the federal budget, so be it,” he said. “The issue is too important to be stalled by Senate protocol.”

More Scrutiny Needed

On Friday, President Obama called it “inexcusable and irresponsible” for senators to delay passing the stimulus bill. In truth, this bill needs more scrutiny.

The health-care industry is the largest employer in the U.S. It produces almost 17 percent of the nation’s gross domestic product. Yet the bill treats health care the way European governments do: as a cost problem instead of a growth industry. Imagine limiting growth and innovation in the electronics or auto industry during this downturn. This stimulus is dangerous to your health and the economy.

(Betsy McCaughey is former lieutenant governor of New York and is an adjunct senior fellow at the Hudson Institute. The opinions expressed are her own.)

To contact the writer of this column: Betsy McCaughey at Betsymross@aol.com

[hutchibk]

http://takingnote.tcf.org/2008/06/comparative-vs.html
June 24, 2008
Comparative vs. Cost-Effectiveness
by Maggie Mahar

The idea of “comparative-effectiveness” research has become a hot topic in health care circles. Conservatives are adamantly opposed to it—as are drug-makers, device-makers and even some physicians who have become involved in designing and profiting from new tests and procedures. They don’t want to see their products and services subjected to head-to-head comparisons with the less expensive rivals that they hope to replace. After all, they know that they might lose. As medical research shows, often, what is “newest" isn’t best. And with billions of dollars at stake, who wants to be a loser?

But if you think that any mention of comparative-effectiveness research pushes buttons, try talking about appraising the “cost-effectiveness” of medical products and procedures—i.e. asking whether the benefit justifies the price tag. For example, is it really worth paying $100,000 for a drug that will give the patient an extra six months of life?

Often, the two ideas are confused. Indeed, those who oppose health care reform argue that any attempt to set up a Comparative-Effectiveness Institute (as presidential candidate Barack Obama, among others, has suggested) inevitably puts us on a slippery slope headed straight toward making medical decisions based on “cost-effectiveness.” Before long, the conservatives say, Medicare will be denying treatments simply because they are too pricey.

Yet, is it such a terrible idea to take cost into consideration? In a recent issue of the Annals of Internal Medicine, the American College of Physicians (ACP) argues that the United States needs to invest in a national entity that would generate information on both clinical comparative-effectiveness and cost-effectiveness. According to ACP, by failing to make such information available, we undermine efforts by payers, physicians, and patients to make effective, informed choices that optimize the value they receive for their health care dollars.

In the same issue of the Annals, health care economist Gail R. Wilensky, a senior fellow at Project Hope, disagrees, arguing that it is “vitally important to keep comparative clinical effectiveness analysis and cost-effectiveness analysis separate from each other.” If you talk about “comparative-effectiveness” and “cost-effectiveness” in one sentence, you could doom both ideas.

Measuring “Clinical Effectiveness”—the U.K. Model

Before choosing sides, let’s clarify what measuring “comparative-effectiveness” means –and how it is different from what we do today. One might think that we already test treatments to make sure that they are more effective than existing products before welcoming them into the marketplace. One would be wrong.

The FDA requires only that new nostrums are tested against placebos—proving that they are better than nothing. The FDA also asks that the sponsor shows that the benefit of the “new, new thing” appear greater than the short-term risks. (Trials rarely last long enough to measure long-term risks.)

Manufacturers are happy with the present system. “We’ll never have comparative-effectiveness Research in the U.S.” a staffer on the Senate Finance Committee recently told a friend. “The drug-makers and device-makers don’t want it.”

Yet other countries do feel able to stand up to the lobbyists, and these governments insist on head-to-head comparisons to help health care providers determine which treatments are best. In the United Kingdom, for instance, the National Institute for Clinical Excellence (NICE) reviews new and existing medicines, technologies and treatments.

As I explained a few months ago: “A NICE appraisal embraces all available information. During the review 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. As part of the process, medical products are compared to similar products made by rival manufacturers, and those competitors also provide input.

In the end, NICE makes the decision, and the National Health Service of England is legally obliged to provide funding for drugs and procedures recommended by NICE. NICE also sends out guidelines to hospitals and doctors, recommending which products and procedures are likely to be most effective for patients who fit certainly profiles. These are not “rules”; health providers are not required to follow the guidelines. NICE recognizes that every human body is unique; guidelines will never cover all cases. Nevertheless, doctors and hospitals comply with NICE’s recommendations 89 percent of the time.

Cost-Effectiveness

But NICE doesn’t just compare the benefits of two treatments; it goes a step further and considers just how cost-effective they are. Do the benefits of a given treatment justify the price tag?

NICE’s decisions can be controversial. For instance, 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—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.

Are Americans ready to let a U.S. version of NICE tell Medicare which Alzheimer drugs it should and shouldn’t cover based on price? Probably not.

Unlike comparative-effectiveness research, which just picks the better of two treatments, regardless of how much they cost, cost-effectiveness is all about money. Here the decision is based on whether the treatment is just too expensive to justify its use. The implicit premise here, of course, is that we should do a cost-benefit analysis and establish a threshold beyond which health care consumption and spending is unreasonable and counter-productive.

This means that the sky is no longer the limit. Quality must justify cost. Here, it’s important to realize that it’s not just drug-makers, device makers and some highly-paid specialists who object to this idea. Many Americans are not yet willing to set limits. Doing so means answering questions like “how much is a year of life worth?” Are we willing to spend more for that extra year if the patient is 12, and less if he is 80?

The UK has set such limits. But the UK’s healthcare budget is much smaller than ours. This means that they must make some very difficult decisions. Because we have so much more money sloshing around in our bloated health care system, we can save billions just by concentrating on effectiveness.

This is not to say that we aren’t paying too much for many treatments. Today, decisions about what will be covered are made, implicitly, by the FDA—and the FDA is not allowed to consider prices. Meanwhile, once the FDA approves something, Medicare usually agrees to cover it. And since Medicare gives a product its imprimatur, most private insurers follow—and pass on the cost in the form of higher premiums.

The problem, as noted, is that the FDA’s standards for approval do not require that the sponsor show comparative benefit. As a result, not long ago, the FDA approved a cutting-edge expensive cancer drug that would give the average patient an extra 10 days of life. How many patients will be told that the benefit is so small? The high price will make many assume that this must be a “breakthrough” product.
Yet, even if the FDA is approving pricey products that are only marginally more effective, than an older generation of drugs, this does not mean that the public is ready to let Medicare ration treatments based on cost.

Emphasis on “Cost-Effectiveness” Could Torpedo Research that Compares Benefits

What is certain is that even if we’re not ready to talk about “cost-effectiveness,” the U.S. does need to institutionalize comparative-effectiveness research so that programs like Medicare can get 'smarter' and focus reimbursements on the most beneficial, proven treatments. Doing so would let us pare our health care spending by as much as $358 billion over ten years, according to Merrill Goozner, who cites a Commonwealth Fund study released in December.

In other words, even without worrying about the cost of a product or procedure, we could be saving “anywhere from one-third to two-thirds the cost of covering uninsured,” simply by letting head-to-head trials winnow out the less effective products and services. There is that much low-hanging waste in the system.

And strategically, it would be a mistake to follow the NICE model and couple comparative-effectiveness research with cost-effectiveness research within the same institute, Wilensky argues, because trying to do both at once may well turn comparative-effectiveness research into a huge political target.

While there is widespread interest in a comparative-effectiveness program, “don’t confuse that with widespread acceptance or support,” she warns. Wilensky, who has served as an advisor to President George W. Bush knows that “Until this idea becomes law, it remains just a beautiful but fragile and vulnerable concept.” And even if the idea does becomes law, “the sustainability of such a center will only become clear after it survives the first comparative clinical effectiveness information that contradicts conventional wisdom or endangers the latest therapy du jour.”

“The use of cost-effectiveness information is more politically contentious and its modeling more technically controversial than comparative clinical effectiveness,” Wilensky adds. “For these reasons, I believe that payers should do cost-effectiveness analyses, not a national entity devoted to the development of comparative clinical effectiveness data. Because clinical effectiveness is the most basic and costly step in learning how to spend smarter, it should proceed first and in as politically protected a manner as possible."

This is not to say that Wilenksy doesn’t want information comparing cost and benefit to be available: “Like the ACP, I support the use of cost-effectiveness information as an element in decision making by physicians, patients, and payers for developing smarter strategies of reimbursement.” But unlike the ACP, Wilensky does not want a national comparative-effectiveness institute charged with ruling on cost-effectiveness.

This is a job Wilensky would leave to the payers: “Cost-effectiveness information should be an important consideration in setting reimbursement rates by public and private payers. If an intervention doesn't do more, why should a payer pay more for it? If it does do more, asking how much more and for what additional price becomes relevant. Payers will have to make difficult decisions, and different payers may make different decisions."

“Whether Medicare will be granted the right to use cost-effectiveness information in setting reimbursement rates is unclear, although the history in this regard is not promising,” Wilensky acknowledges. “The first attempt happened when I was the administrator of the Health Care Financing Administration (now the Centers for Medicare & Medicaid Services). The proposed rule was never released from the Office of the Secretary of Health and Human Services because of concern about potential future ‘misuse’ of this authority.”

The Battle Ahead

Wilensky is right. Even though the prestigious Institute of Medicine issued a report in January calling for a “single entity” to produce “credible, unbiased information about what is known and not known about clinical effectiveness,” this is hardly a done deal.

As Merrill Goozner observed in April: “Powerful forces are mobilizing to make certain any comparative effective agency established by Congress remains a toothless tiger.” Already, he noted, “the Advanced Medical Technology Association, which represents device makers, insists that “governance of any public-private entity should include representation of all stakeholders.”

Meanwhile, “a recent article in the Journal of the American Medical Association—which likened a potential [Comparative-effectiveness] Agency to a Federal Reserve Board for medicine—also called for putting ‘stakeholders’ on the board and having input into its studies,” Goozner observes.

But “no banks sit on the Fed’s board,” Goozner noted. “And its studies are conducted by researchers who are scrupulously clean of financial ties to the banks they regulate.

“It’s one thing to give stakeholders a chance to advise the process – just as they have input through comment and testimony into any regulatory proceeding.” This is what NICE does. “But,” Goozner argues, “to allow industry representatives to sit on the board, and ask clinicians with conflicts of interest to conduct its studies, would undermine the new agency’s credibility at the start – and doom it to being just another babbling voice in the health care wilderness.”

Goozner is right. We need to make sure that any agency that oversees comparative-effectiveness is insulated from the lobbyists. They should consult and provide as much information as they have. But they shouldn’t vote.

In the end, we have to pick our fights. Insist on the head-to-head studies and insist that they are overseen by someone other than the product’s sponsors. There we must be firm. But leave questions about cost-effectiveness for other payers—insurers and employers can begin that investigation.

As Wilensky observes, we shouldn’t jeopardize a comparative-effectiveness program simply to please private insures: “Payers—especially private payers—would dearly love for [a comparative-effectiveness] center to do cost-effectiveness analysis because they could then share the onus of implementing the results of difficult, contentious, unpopular studies with a reputable national entity. Their desire is understandable; however, from a long-range perspective, the wiser course is to leave cost-effectiveness analysis out of the scope of work of a national comparative clinical effectiveness program.”

Wilensky has been in Washington for quite a while. She speaks with the voice of experience.

[Marlys]

I guess not very many of us are concerned about Joe reminding us that we should be careful about political issues because we are a 501C non profit organization. I for one do not care to jeopardize this forum by addressing these isuues here instead of directly with our representatives in Washington.

[hutchibk]

I personally view this as a healthcare issue. At some point, politics will always get wrapped in and around issues such as these. For me, it is about not espousing political preferences and not having political arguments, but about sharing the plethora of information that is out there.

There are a few posters who have offered their personal political predilections here, which is best to be avoided, I agree. But posting links and articles which offer different positions on the subject are typically quite valuable.

[gdpawel]

The stimulus package is very much a healthcare issue. $21 billion is providing a 60% subsidy of health care insurance premiums for the unemployed under the COBRA program; $87 billion to help states with Medicaid; $19 billion to modernize health information technology systems; and $10 billion for health research and construction of National Institutes of Health facilities.

I agree with Maggie Mahar's comment about drug-makers, device-makers and physicians involved in designing and profiting from new tests and procedures not wanting to see their products and services subjected to head-to-head comparisons.

It's been difficult for the Medicare program to contol the substantial costs of cancer drugs. In a recent issue of the New England Journal of Medicine, an article by Dr. Peter Bach stated that the costs to Medicare of injectable cancer drugs given in doctors' offices increased from $3 billion in 1997 to $11 billion in 2004, an increase of 267% at a time when the costs for the entire Medicare program increased 47%.

It also states that there was a huge reduction in Medicare expenses that occurred when the off-label use of ESAs (drugs for anemia-related issues) was found to actually cause harm to patients. The drugs were proven to be over-used and the net result of the expose was that use of these drugs quickly dropped and the costs to Medicare dropped from over $1 billion a year to just $200 million.

In 2003, in the political payback deal of the century, Congress guaranteed premium pricing for pharmaceuticals, by prohibiting Medicare from negotiating drug prices, and it provided hundreds of billions of dollars in U.S. taxpayer subsidies to pay for these premium drug costs. Now the specter of "rationing" is raised.

Dr. Bach stated ways that the Medicare program could control costs. One of those ways was to fund a comparative-effectiveness program to assess whether or not treatments (mostly the newer targeted regimens) are really better than older treatments. Decisions are being made about what cancer treatments patients can actually afford.

Comparative research is not rationing health care. The research funding doled out in the recent Stimulus Package would go to the National Institute of Health, the Agency for Healthcare Quality and Research and the Centers for Medicare and Medicaid Services to focus on producing the best unbiased science possible.

Comparative research has the potential to tell us which drugs and treatments are safe, and which ones work. This is not information that the private sector will generate on its own, or that the "industry" wants to share. Companies want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it. Just about the way they are controlling data now.

Comparative-effectiveness research is not something for patients to be afraid of. It can help doctors and patients, through research, studies and comparisons, undertand which drugs, therapies and treatments work and which don't. Nothing in the legislation will have the government monitoring treatments in order to guide your doctor's decisions. Doctors will still have the ultimate decision, along with the patient.

[alicem]

Here are Joe's comments from a similar thread titled "National Health Care", which is what Marlys is referring to:

I do encourage discussions on this subject but please:

1. Try not to offend other country's healthcare systems and
2. DO NOT mention any political parties.
We have 501(c)(3) status and must refrain from any political discussions.

Regards
Joe

In the other thread, both the above mentioned had occurred, thus his reminder to us all. So far in this thread I think it has been a "healthy" open discussion on "healthcare"!