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A new take on "Evidence Based Medicine" - What your doctor can and cannot recommend as directed by your Government

New York Times 2/16/09


U.S. to Compare Medical Treatments
By ROBERT PEAR
Published: February 15, 2009

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.”

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>A new take on "Evidence Based Medicine" - What your doctor can
>and cannot recommend as directed by your Government

The article you posted does not support the claim you have made above. The article describes a federal program to do research to compare effectiveness of various treatments.

Do you have any evidence that there is a federal program that will prevent doctors from using certain treatments?

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>A new take on "Evidence Based Medicine" - What your doctor can
>and cannot recommend as directed by your Government

The article you posted does not support the claim you have made above. The article describes a federal program to do research to compare effectiveness of various treatments.

Do you have any evidence that there is a federal program that will prevent doctors from using certain treatments?



Tell me.

What is the next step to this federal program?

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>Tell me. What is the next step to this federal program?

Publishing the results, I imagine.

You do practice evidence-based medicine, don't you?



There are already NON-government directed studies that publish results of evidence based medicine.

I would prefer to get my data from the green journal, the gray journal and BMJ clinical evidence handbook .... among others.

I would expect a little less bias, lobbying and politics in those results.

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Having politicians run medicine is like having a porti-potty cleaning crew fix your plumbing.

The best medical care in the world is about to be as efficient as the f*cking post office.




I only wish it was that efficient... have you had to deal with your medical insurance company recently???

I have.. and at this point I think at leat 90% of them need to be shut down for defrauding the people of this country.

You will NOT get what you have paid for.

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>There are already NON-government directed studies that publish results
>of evidence based medicine.

I agree! They are excellent sources.

>I would prefer to get my data from the green journal, the gray journal
>and BMJ clinical evidence handbook .... among others.

That's great. I would prefer my doctor to have more, rather than fewer, choices when it comes to evidence.

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>There are already NON-government directed studies that publish results
>of evidence based medicine.

I agree! They are excellent sources.

>I would prefer to get my data from the green journal, the gray journal
>and BMJ clinical evidence handbook .... among others.

That's great. I would prefer my doctor to have more, rather than fewer, choices when it comes to evidence.




So you honestly believe that the government will add non-biased and objective results to those already in existence. No interference by lobbies or politicians with a desired spin. No manipulation of results or misrepresentation....

There are MANY current thoughts against drug company interference with research. With good reason! Disclosure of conflicts of interest and financial bias is a big thing in research. Science should be science. Data should stand on its own. Health care should be evidence based but individualized to specific patients needs.... not reflect a political agenda.

I would be very suspicious of any doctor that just uses the results of this kind of study. The motives behind it are NOT science based.

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>So you honestly believe that the government will add non-biased and
>objective results to those already in existence. No interference by lobbies
>or politicians with a desired spin. No manipulation of results or
>misrepresentation....

Oh, I think the possibility is there - just as the possibility of bias is present when drug companies fund their own research and publish their own results. In such cases, more research is better than less.

>Science should be science. Data should stand on its own. Health care
>should be evidence based but individualized to specific patients needs....
>not reflect a political agenda.

Absolutely. And the more data available, the more likely you are to get an unbiased result. Heck, you yourself might participate in one of said studies, and you would then have the opportunity to help ensure the results are unbiased.

As you know, many areas of medicine receive little to no funding for research because drug companies cannot see a profit in it. This may help fill that void.

>I would be very suspicious of any doctor that just uses the results of this
>kind of study.

I would be even more suspicious of a doctor who uses only study results from the drug company who is trying to get them to use their drug. Ideally I would hope they use the drug company study, AND a NEJM epidemiological study, AND a government study to base their decisions on.

The FCC does studies all the time on spectrum efficiency. Doesn't mean they're going to steal your cellphone and force you to use a government walkie-talkie.

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What is absolutely insane is how the slipped it in there before enough people noticed.
>:(

Maybe because the bill was rammed thru congress w/ nobody having time to read it except Lobbyists Inc.? :S
I hold it true, whate'er befall;
I feel it, when I sorrow most;
'Tis better to have loved and lost
Than never to have loved at all.

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RIGHT - MDs should retain the right to prescribe ineffective treatments for their patients.

Who needs evidence of effectiveness anyway?



Right.

cuz right now all doctors want to do is do ineffective things that just spend money for the sake of pulling the last lonely dollar out of the poor patients hand.

It's not like I've never given a prescription for someone CONVINCED that she NEEDS antibiotics for the viral illness that she has. It's not like I've ever taken the time to try to explain how evidence shows that the antibiotics won't help her and might lead to more problems with drug resistance. It's not like the PATIENTS demand ineffective things DESPITE being told what evidence based medicine would recommend. And trust me, patients NEVER threaten the physician.

Lets just blame the doctors that want to provide "ineffective" treatment.

So, lets go to the next step... what are the penalties going to be to the physicians that do cave to the pressures of what the patient wants? Especially if what the patient wants is contrary to what the government decrees?
How will the government go about "influencing" change to follow recommendations?

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>A new take on "Evidence Based Medicine" - What your doctor can
>and cannot recommend as directed by your Government

The article you posted does not support the claim you have made above. The article describes a federal program to do research to compare effectiveness of various treatments.

Do you have any evidence that there is a federal program that will prevent doctors from using certain treatments?

That is round 2. In secret again of course. ;)
I hold it true, whate'er befall;
I feel it, when I sorrow most;
'Tis better to have loved and lost
Than never to have loved at all.

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>It's not like I've never given a prescription for someone CONVINCED that
>she NEEDS antibiotics for the viral illness that she has.

As you know, many doctors do just that. I prefer they have even better evidence that such practices pose a serious threat to public health.

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Having politicians run medicine is like having a porti-potty cleaning crew fix your plumbing.

The best medical care in the world is about to be as efficient as the f*cking post office.




I only wish it was that efficient... have you had to deal with your medical insurance company recently???

I have.. and at this point I think at leat 90% of them need to be shut down for defrauding the people of this country.

You will NOT get what you have paid for.


I must be lucky. I've never had a problem with my provider. One thing's for sure, though. Having a government agency run medical care is a baaaaaaaaaaaaaaaaaaad idea.

The government f*cks up everything it touches, fortunately including our enemies.;)
Chuck Akers
D-10855
Houston, TX

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Something similar happened in Spain and the authorities found out that there was no real advantage using brand medicines against generic drugs.

Si if the active component of "clamoxil Tm" is amoxiciline the government in the socielized medicine will prescript directly amoxiciline wich is much cheaper and does the same than the branded version. You can still buy clamoxil if you want to, but the government will not pay for it.

It has saved the taxpayers millions of Euros. I don´t see anything bad about it.

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Another twist of government involvement is that they are now training Veterinarians to treat human patients in cases where the human health care system becomes overloaded or breaks down. Right now it is mainly centered around national disasters.
I spent last weekend in a conference put on by Homeland Security outlining the new role Veterinarians will play. It will be interesting to see where this goes.

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Another twist of government involvement is that they are now training Veterinarians to treat human patients in cases where the human health care system becomes overloaded or breaks down. Right now it is mainly centered around national disasters.
I spent last weekend in a conference put on by Homeland Security outlining the new role Veterinarians will play. It will be interesting to see where this goes.




Sit....



Stay



Good boy.

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Something similar happened in Spain and the authorities found out that there was no real advantage using brand medicines against generic drugs.

Si if the active component of "clamoxil Tm" is amoxiciline the government in the socielized medicine will prescript directly amoxiciline wich is much cheaper and does the same than the branded version. You can still buy clamoxil if you want to, but the government will not pay for it.

It has saved the taxpayers millions of Euros. I don´t see anything bad about it.



You might want to look at that study closer. What drugs did they look at (specifically - antibiotics? hormones? anticoagulation? psychiatry?), what were the outcomes (knowing what they used as a bench mark for the "no real advantage" is important) , what was the cost savings? (truly... not just "millions of Euros.")

There are only TWO medicines that I would not write generic for - those are Coumadin and Synthroid. I generally don't write for coumadin because it's contraindicated in pregnancy (I use heparin in those cases).

The reason that I prefer trade in those cases is that generic allows a broader variance of the actual dosage administered. Most of the time that variance isn't truly that big of a deal, but if I'm worried about hypothyroidism in pregnancy or blood clots in high risk patients post surgery... the cost of the trade FAR outweighs the issues of complications.

BUT the bottom line is ... is it truly for the govenment to tell you "ahhhh... it's ok if you get a pulmonary embolus... we saved so much with warfarin." (like a Geico commercial)

(oh. and ... some neurologist write for trade on their anti-epileptics because serum levels are important with that too)

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I only wish it was that efficient... have you had to deal with your medical insurance company recently???



I'm not aware of any private insurance companies with administration costs as low as Medicare's.

Medicare's admin costs are about 5.2% (some estimates are as low as 2%), while private insurance admin costs, including commissions, profit, etc., average 16.7% (some estimates are as high as 20-25%).

While some people might be okay paying that extra 11.5%, I would prefer a more efficient system.
Math tutoring available. Only $6! per hour! First lesson: Factorials!

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I think this whole discussion stems from the thought that every patient should get the best possible care and treatment. The problem today is that the possibilities are endless. We have come to point where one must weigh in the cost efficiency of a procedure.

I don't think that you can seriously tell me that the cost efficiency of American health care is good. The notion that there must be politicians on a board that does Meta-analysis with regard to cost efficiency is, to me, just silly.

Then again if the absolute freedom to chose without loss of compensation is more important then the general health of the population then this proposal might be a bad thing.

Just be clear on that you choose freedom over health. It's an opinion that is OK to have but don't try to make this an issue about the public getting worse health care.

/Martin

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I only wish it was that efficient... have you had to deal with your medical insurance company recently???



I'm not aware of any private insurance companies with administration costs as low as Medicare's.

Medicare's admin costs are about 5.2% (some estimates are as low as 2%), while private insurance admin costs, including commissions, profit, etc., average 16.7% (some estimates are as high as 20-25%).

While some people might be okay paying that extra 11.5%, I would prefer a more efficient system.



Varies widely by state too. Where the mandate is to be not for profit, admin rates are much lower. (Most commercial companies won't even do business in some of those states). Also, some states have legislated loss-ratios (must pay out X% of revenues in form of claims payment). MN is 10% for fully insured.

Also, Medicare isn't doing any underwriting, little actuarial, has a very small set of highly standardized benefits, much cheaper to provide collateral, set-up, service, etc because of standardized benefit sets.

Maybe that makes a case for how the system should be? Just remember, product specialization, flexibility in benefits, cost containment programs, etc all cost money to employ.

One last thing; little known secret - Most, if not all Medicare plans are administered via a bid process by commercial and not for profits. The difference is not who is doing the work, it's the work that needs to be done.
" . . . the lust for power can be just as completely satisfied by suggesting people into loving their servitude as by flogging them and kicking them into obedience." -- Aldous Huxley

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