U.S. to Compare Medical Treatments

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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.”

They are allocating $200B impossibly fast, and the key Congressional people are not experts. Lobbyists with “access” have slipped in some errors. The worst - the $1B earmark for Verizon even if they didn’t build a single additional line - may have been blocked after the NY Times picked up the story. These are still open.

1) Recognize that some broadband spends creates U.S. jobs and other spending does not. Far too much of the latter seems to be in the bill. Building networks needs labor, domestic steel and concrete, and U.S. engineers. Pretty good job creator. Adding equipment to existing networks is a poor job creator, because most telecom equipment is produced abroad.

2) Don’t subsidize what would be built without subsidy if at all possible.

3) Figure out why the cost of Jay Rockefeller’s credits is $128 million according to the official estimate and possibly $billions according to top analysts

4) Problem: The Rural Utilities Service has a 30-40% default rate on their existing broadband loans,

5) Problem:  There’s $200-$400M that people think is mapping but actually is some ill-defined community technology project or worse. Mapping can be done in three months for less than 5% of the money allocated.

6) Auditing must be much expanded.

Saul Hansell was interested in how much Verizon, etc. would collect on the stimulus.  He asked me how I estimated the $1B to Verizon. Looking closely since you ask, my best guess is Verizon collects just over $1B, of which about $750M comes from the additional tax credits in the Rockefeller bill. If they decided to go hard for rural grants, that could double. 

The key thing is that they will get 20% on FIOS in "underserved" areas, which includes most of the Bronx, Brooklyn, parts of Manhattan and Queens, and many others they will build -- especially since they've already done most of the affluent suburbs. "Underserved" as I read it includes most census tracts with a substantial number of poor, no matter what their broadband coverage. More than 20% of the Bronx and Brooklyn are below the poverty line, the cutoff in this bill.

FIOS 20% in underserved areas $700M
FIOS  grants additional in unserved areas $90M
Depends on where Verizon builds in 2009-2010 and the details of what's included.

Non-FIOS in unserved areas, $30M They have been doing some extension of DSL in their 16% uncovered. The bells have more than half of the "rural" lines by geography.

Wireless, $200M
Really tough to estimate this one. There's $2B mostly for rural wireless in the NTIA part and a 10% tax credit for unserved in the finance part. Given that Verizon is one-third of the U.S. wireless business (and actively wants to participate, I believe), I'm assuming

Total, $1,020,000,000
Unscientific likely range $600M to $2B, with the key variables being how much of Verizon's build gets 20% and whether the allowed cost is closer to $700 (Verizon home passed) or twice that (probably including in-home, network, and overhead.)

Disclosure of Industry Payments to Physicians

Specifications of the Physician Payments Sunshine Act (S. 2029).*

Annual electronic reporting, beginning March 31, 2011, by drug, device, and medical-supply companies of payments or other transfers of value to any physician or medical practice. Physician ownership or investment interests in manufacturers, group purchasing organizations, or distributors also reported.

 

The term "physician" includes doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors.

 

Disclosure of name of recipient, city and state, value, and date of payment or other transfer of value and the form (e.g., cash, stock, or stock option) and reason (such as consulting fee, education, research, royalty or license, honorarium, gift, entertainment, food, travel, or charitable contribution).

 

Public availability no later than September 30, 2011, and on June 30 of each subsequent year, of information for the previous calendar year on a searchable, "clear and understandable" government Web site. Background information and overall context can be provided. Appeal and correction process established.

 

Reporting required if aggregate amount paid or transferred exceeds $500 in a calendar year. Exclusions include anything below $25 in value, product samples intended for patients, certain educational materials and direct training, and items used for providing charity care.

 

State reporting requirements preempted. Delayed reporting of payments made pursuant to product-development agreements or clinical investigations for 2 years or until approval of a product by the Food and Drug Administration, whichever is first.

 

Penalties of $1,000 to $5,000 for each failure to report, with an annual cap of $50,000, and $5,000 to $50,000 for every instance of knowledge of failure to report, with an annual cap of $250,000.

 

Payments to physicians who are full-time employees of manufacturers excluded.

 

*Information is from the Senate Finance Committee as of July 2008. A bill similar to the Senate bill has been introduced in the House (H.R. 5605).

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Most physicians in the United States have financial relationships with industry, ranging from the acceptance of meals to the receipt of large sums of money for consulting, speaking, or conducting research.^1,2 Within the next several years, the manufacturers of drugs, medical devices, and medical supplies that are paid for by Medicare, Medicaid, or the State Children's Health Insurance Program may be required to report publicly many of these gifts and payments; the information would be made available in a "clear and understandable" format on a searchable government Web site. Public reporting would be mandated by the Physician Payments Sunshine Act sponsored by Senators Charles Grassley (R-IA), the ranking member of the Committee on Finance, and Herb Kohl (D-WI), chair of the Special Committee on Aging, which is pending in Congress (see Specifications of the Physician Payments Sunshine Act). Sunshine laws are so called because they "let the sun shine in," revealing otherwise private information.

Physician–industry relationships have always been a mixed blessing. Although for-profit companies' primary responsibility is to their shareholders, and physicians' primary responsibility is to their patients, doctors can collaborate with industry to improve patient care. Industry can provide researchers with funds that might not otherwise be available, particularly for drug and device development and pivotal clinical trials. These relationships, however, can influence prescribing behavior and the use of medical devices and supplies, increase the cost of care, create a mind-set of entitlement among doctors, and undermine the independence and integrity of the profession.

New revelations about these relationships are not uncommon. In June 2008, for example, Grassley criticized three prominent psychiatrists at Harvard University and Massachusetts General Hospital for failing to report to their institutions a considerable amount of their income from consulting fees — which apparently totaled at least $1 million apiece between 2000 and 2007. Grassley expressed concern about possible violations of federal and university conflict-of-interest rules by physicians conducting research while receiving more than the allowable amount of money from the company whose product was being studied.³ The institutions, the National Institutes of Health (NIH), and the Senate Finance Committee are all investigating the matter.

Currently, as is the case with educational programs and journal articles, disclosures of payments typically reveal the payer of the funds but not the amount paid. Most commonly, physicians' relationships with industry consist of receiving food in the workplace, receiving drug samples, or being reimbursed for costs associated with professional meetings or continuing medical education (CME) programs.¹ Larger payments are made to researchers, speakers, and consultants and for licenses and patent-related royalties. An analysis of publicly disclosed payments of $100 or more over a 2-year period in Vermont and a 3-year period in Minnesota — two states that have enacted disclosure laws — found that the median payments were $177 and $1,000, respectively.⁴ In fiscal year 2007 in Vermont, psychiatrists were the largest beneficiaries among the top 100 recipients. When it comes to gifts, both the American Medical Association (AMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical trade association, consider it permissible to give doctors textbooks and other items that are primarily of benefit to patients (such as an anatomical model for use in an examination room) and are not of substantial value (defined as $100 or less). A large number of payments, particularly for food, are for more than $100.⁴

Congressional support for a national reporting system reflects exasperation with health care costs and, as Grassley puts it, the "hodge-podge" of state systems and voluntary systems at medical schools and teaching hospitals that rely on doctors to tell the truth about their income from industry. According to Grassley, "The stakes are high for both public safety and the public purse. Making information about financial relationships open to scrutiny is the right thing to do." Some companies, such as Eli Lilly and Pfizer, have released some payment information or are planning to do so, but the specifics vary widely among manufacturers. The five largest manufacturers of prosthetic hip and knee joints disclose physician payments on their Web sites, in compliance with a settlement agreement reached in September 2007 with the Department of Justice about alleged kickbacks paid to orthopedic surgeons for implanting their devices. An analysis of the statements by the Philadelphia Inquirer found that 51 doctors received more than $1 million each in 2007 alone. However, the disclosures are difficult, if not impossible, to understand, because they do not state the reasons the physicians received the money.

The Physician Payments Sunshine Act applies to industry payments to a physician or medical practice or to persons or entities that accept money on their behalf. It otherwise does not cover payments to professional societies, medical schools, hospitals, or intermediaries, such as charitable foundations, that fund research or education, or to medical education and communication companies that provide CME programs or prepare advertising and marketing campaigns. Nor does it apply to businesses outside the drug, medical-device, or medical-supply industries that may fund biomedical research or retain physicians as consultants — such as food and nutrition companies, online health data companies, or tobacco companies.

Moreover, the act has been scaled back since its introduction in September 2007, prompting criticism that industry has received too many concessions — but also resulting in notable endorsements. Supporters now include the Association of American Medical Colleges (AAMC), the AMA, and many other medical organizations, as well as PhRMA, the Advanced Medical Technology Association (a trade association of the medical-device industry and related companies), and individual drug and device companies. Unlike the original bill, the revised legislation would preempt state reporting requirements and delay reporting for some payments. It would raise the threshold for disclosure from $25 for a payment or gift to a total payment or other "transfer of value" per company of $500 in a calendar year. Thus, many payments and gifts, including some gifts not in compliance with AMA and PhRMA guidelines, would not be reported. Penalties for failures to report payments have been reduced.

Massachusetts is considering banning gifts to physicians from drug and device manufacturers and requiring public reporting of other payments. The state senate approved the provision, but the state house of representatives did not. Although the revised federal legislation is not as strict, it is still in many respects more comprehensive than the reporting laws that have been enacted in the District of Columbia, Maine, and West Virginia, in addition to Minnesota and Vermont. These laws apply only to the pharmaceutical industry, and only in Minnesota are disclosures explicitly required to be public records. The Vermont law has a broad exemption for payments that are designated "trade secrets." Reporting criteria are not standardized, and the data may be difficult to obtain and of poor quality⁴; West Virginia has no penalties for lack of reporting.

Some remarkable women have come to power in D.C. during the change. Gigi Sohn is agenda-setting, Kathy Brown has become Verizon's public face, Jessica Rosenworcel is the key staffer, Jennifer Schneider is with Boucher as he takes over the House sub-committer, and Susan Crawford was quietly the sould of the transition with her insistance they start from the data, not the rhetoric.

Gigi Sohn, tireless public advocate,