February 15

$1.1 Billion in Stimulus Package for Comparing Medical Treatments

The New York Times reports that under the economic stimulus package, $1.1 billion has been earmarked for research comparing the effectiveness of different drugs and medical devices for the same illness.  The research will be coordinated by a council of 15 federal employees.

This has the potential for restoring integrity to medicine by providing doctors and the public with impartial risk / benefit information about existing treatments devoid of commercial bias. 

But that goal will be realized only IF:
The council will be entirely transparent. Not only must the and the results be posted on the internet, but before the trials commence,  the design of the comparison trials, including indication of the primary and secondary end points, the inclusion / exclusion criteria for subject selection, must be posted on the internet for independent scrutiny.  

The reality is: "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."

In this economic crisis, continuing to pay for worthless–and even dangerous–treatments, when safer alternatives–or no treatment–are in the best interest of patients, will no longer be an option.

Furthermore, trust alone is no longer an option in medicine, inasmuch as treatment options have been shown to be commercially driven, rather than evidence-based. We must be able to verify the efficacy and safety of treatments. To borrow the mantra from Ronald Reagan: "trust but verify."

Of course there are the usual nay sayers–manufacturers of ineffective, but lucrative drugs; device makers who don't want an honest evaluation of the risk / benefit, cost/ benefit analysis of the scientific evidence; and conservative lawmakers and commentators who raise the specter of "government dictating medical decisions."

Republican lawmakers and conservative commentators such as Betsy McCaughey, a former lieutenant governor of New York, and Rush Limbaugh claim that "the legislation would allow the federal government to intrude in a person's health care by enforcing clinical guidelines and treatment protocols" and "will monitor treatments to make sure your doctor is doing what the federal government deems appropriate and cost-effective."

As a stream of exposes in the national media have revealed, current U.S. medical practice guidelines are not backed up by scientific evidence or governed by the patient's best interest: practice guidelines are crafted under the influence of industry, by doctors with substantial financial interests in the medical products they recommend.

For example, practice guidelines for the treatment of sepsis  recommend using Eli Lilly's Recombinant Human Activated protein C (rhAPC, trade name, Xigris)–which costs close to $7,000 for a course of treatment (4 days)–despite evidence of increased bleeding: 

Another example of practice guidelines crafted under the influence of drug manufacturers is the TMAP and CMAP psychotropic drug formulary :

The push for reforming US healthcare did not originate with government: a groundswell has emerged from consumer groups and a growing number of conscientious doctors:

See: Los Angeles Times, Series by Melissa Healy .

Contact: Vera Hassner Sharav

February 16, 2009
U.S. to Compare Medical Treatments

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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