Alicia Ault

Experts serving on the Food and Drug Administration's advisory committees are now subject to new rules aimed at ensuring that they do not have conflicts of interest that could bias their decisions.

In early August, the FDA issued four final guidance documents and a draft guidance outlining how it plans to handle conflicts of interest among members of advisory committees, which review the safety and efficacy of drugs, medical devices, diagnostic tests, and other products and ingredients that the agency regulates.

In a separate move, the agency said that it plans to make it easier to find documents before and after advisory committee meetings by improving how it posts meeting information on its Web site.

Guidance documents represent the agency's current thinking on a topic, but carry less weight than does a regulation. The FDA has no power to enforce guidance documents, which manufacturers and the agency generally use as rules of thumb.

The newest guidance documents will help ensure that the FDA “is getting the highest quality scientific advice, while at the same time preserving public trust in our decisions,” Randall Lutter, Ph.D., the FDA's deputy commissioner for policy, said in a teleconference briefing with reporters.

In the past, the agency has asked advisers to disclose potential conflicts of interest, but there was no monetary limit. Each potential conflict was weighed individually, and waivers were granted based on whether the adviser's expertise was considered necessary for a particular meeting.

With the new guidance, the agency sets a dollar limit on advisers' financial interests. If an adviser—or his or her spouse or minor child—has interests of at least $50,000 in an entity that would be directly or indirectly affected by the outcome of a particular meeting, the adviser would be barred from participating. Advisers with interests less than $50,000 will be allowed to participate and vote, unless they are found to have a significant conflict of interest.

An advocate who has been critical of the FDA's conflict of interest policy for advisers said that the $50,000 cap is too high.

“The FDA wants us to believe that an advisory committee member can receive $49,999 from a company and still make an unbiased decision. I don't buy it and the research doesn't support it,” said Diana Zuckerman, Ph.D., president of the National Research Center for Women and Families, an advocacy group in Washington.

She and another agency critic, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, both expressed concern that the new guidance would still allow advisers with conflicts to vote. Those advisers will be granted waivers if they are determined to provide essential expertise. This is not much of a change from current policy, according to Dr. Wolfe and Dr. Zuckerman.

“The FDA has consistently used a very low standard for granting waivers, and there is no evidence that this will change,” Dr. Zuckerman said.

But the FDA said that the Food and Drug Administration Amendments Act of 2007, which was signed into law last year, limits the number of waivers it is allowed to grant. The agency also has vowed to make the circumstances of the waivers public.

In another guidance, the agency said that it will require simultaneous voting by all committee members. Advisers at some meetings have begun using an electronic voting system to ensure that panel members don't influence the votes of those who succeed them in voting; the votes are conducted privately, and then broadcast immediately afterwards on a screen.

Dr. Wolfe said that when he has seen the voting system in action, “it worked well and served the stated purpose.”

He also praised the agency's proposed guidance to set out a more definitive policy on when a product should be referred to an advisory committee for review. The basis for referral “has been less than clear,” Dr. Wolfe said.

The FDA also is changing the administrative process for advisory committee meetings. The agency will formally notify a sponsoring company 55 days in advance that a meeting has been scheduled. Also, the FDA will post materials relating to the meeting on its Web site no later than 2 full days in advance of the meeting.

Experts serving on the Food and Drug Administration's advisory committees are now subject to new rules aimed at ensuring that they do not have conflicts of interest that could bias their decisions.

In early August, the FDA issued four final guidance documents and a draft guidance outlining how it plans to handle conflicts of interest among members of advisory committees, which review the safety and efficacy of drugs, medical devices, diagnostic tests, and other products and ingredients that the agency regulates.

In a separate move, the agency said that it plans to make it easier to find documents before and after advisory committee meetings by improving how it posts meeting information on its Web site.

Guidance documents represent the agency's current thinking on a topic, but carry less weight than does a regulation. The FDA has no power to enforce guidance documents, which manufacturers and the agency generally use as rules of thumb.

The newest guidance documents will help ensure that the FDA “is getting the highest quality scientific advice, while at the same time preserving public trust in our decisions,” Randall Lutter, Ph.D., the FDA's deputy commissioner for policy, said in a teleconference briefing with reporters.

In the past, the agency has asked advisers to disclose potential conflicts of interest, but there was no monetary limit. Each potential conflict was weighed individually, and waivers were granted based on whether the adviser's expertise was considered necessary for a particular meeting.

With the new guidance, the agency sets a dollar limit on advisers' financial interests. If an adviser—or his or her spouse or minor child—has interests of at least $50,000 in an entity that would be directly or indirectly affected by the outcome of a particular meeting, the adviser would be barred from participating. Advisers with interests less than $50,000 will be allowed to participate and vote, unless they are found to have a significant conflict of interest.

An advocate who has been critical of the FDA's conflict of interest policy for advisers said that the $50,000 cap is too high.

“The FDA wants us to believe that an advisory committee member can receive $49,999 from a company and still make an unbiased decision. I don't buy it and the research doesn't support it,” said Diana Zuckerman, Ph.D., president of the National Research Center for Women and Families, an advocacy group in Washington.

She and another agency critic, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, both expressed concern that the new guidance would still allow advisers with conflicts to vote. Those advisers will be granted waivers if they are determined to provide essential expertise. This is not much of a change from current policy, according to Dr. Wolfe and Dr. Zuckerman.

“The FDA has consistently used a very low standard for granting waivers, and there is no evidence that this will change,” Dr. Zuckerman said.

But the FDA said that the Food and Drug Administration Amendments Act of 2007, which was signed into law last year, limits the number of waivers it is allowed to grant. The agency also has vowed to make the circumstances of the waivers public.

In another guidance, the agency said that it will require simultaneous voting by all committee members. Advisers at some meetings have begun using an electronic voting system to ensure that panel members don't influence the votes of those who succeed them in voting; the votes are conducted privately, and then broadcast immediately afterwards on a screen.

Dr. Wolfe said that when he has seen the voting system in action, “it worked well and served the stated purpose.”

He also praised the agency's proposed guidance to set out a more definitive policy on when a product should be referred to an advisory committee for review. The basis for referral “has been less than clear,” Dr. Wolfe said.

The FDA also is changing the administrative process for advisory committee meetings. The agency will formally notify a sponsoring company 55 days in advance that a meeting has been scheduled. Also, the FDA will post materials relating to the meeting on its Web site no later than 2 full days in advance of the meeting.

Experts serving on the Food and Drug Administration's advisory committees are now subject to new rules aimed at ensuring that they do not have conflicts of interest that could bias their decisions.

In early August, the FDA issued four final guidance documents and a draft guidance outlining how it plans to handle conflicts of interest among members of advisory committees, which review the safety and efficacy of drugs, medical devices, diagnostic tests, and other products and ingredients that the agency regulates.

In a separate move, the agency said that it plans to make it easier to find documents before and after advisory committee meetings by improving how it posts meeting information on its Web site.

Guidance documents represent the agency's current thinking on a topic, but carry less weight than does a regulation. The FDA has no power to enforce guidance documents, which manufacturers and the agency generally use as rules of thumb.

The newest guidance documents will help ensure that the FDA “is getting the highest quality scientific advice, while at the same time preserving public trust in our decisions,” Randall Lutter, Ph.D., the FDA's deputy commissioner for policy, said in a teleconference briefing with reporters.

In the past, the agency has asked advisers to disclose potential conflicts of interest, but there was no monetary limit. Each potential conflict was weighed individually, and waivers were granted based on whether the adviser's expertise was considered necessary for a particular meeting.

With the new guidance, the agency sets a dollar limit on advisers' financial interests. If an adviser—or his or her spouse or minor child—has interests of at least $50,000 in an entity that would be directly or indirectly affected by the outcome of a particular meeting, the adviser would be barred from participating. Advisers with interests less than $50,000 will be allowed to participate and vote, unless they are found to have a significant conflict of interest.

An advocate who has been critical of the FDA's conflict of interest policy for advisers said that the $50,000 cap is too high.

“The FDA wants us to believe that an advisory committee member can receive $49,999 from a company and still make an unbiased decision. I don't buy it and the research doesn't support it,” said Diana Zuckerman, Ph.D., president of the National Research Center for Women and Families, an advocacy group in Washington.

She and another agency critic, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, both expressed concern that the new guidance would still allow advisers with conflicts to vote. Those advisers will be granted waivers if they are determined to provide essential expertise. This is not much of a change from current policy, according to Dr. Wolfe and Dr. Zuckerman.

“The FDA has consistently used a very low standard for granting waivers, and there is no evidence that this will change,” Dr. Zuckerman said.

But the FDA said that the Food and Drug Administration Amendments Act of 2007, which was signed into law last year, limits the number of waivers it is allowed to grant. The agency also has vowed to make the circumstances of the waivers public.

In another guidance, the agency said that it will require simultaneous voting by all committee members. Advisers at some meetings have begun using an electronic voting system to ensure that panel members don't influence the votes of those who succeed them in voting; the votes are conducted privately, and then broadcast immediately afterwards on a screen.

Dr. Wolfe said that when he has seen the voting system in action, “it worked well and served the stated purpose.”

He also praised the agency's proposed guidance to set out a more definitive policy on when a product should be referred to an advisory committee for review. The basis for referral “has been less than clear,” Dr. Wolfe said.

The FDA also is changing the administrative process for advisory committee meetings. The agency will formally notify a sponsoring company 55 days in advance that a meeting has been scheduled. Also, the FDA will post materials relating to the meeting on its Web site no later than 2 full days in advance of the meeting.

Democrats and Republicans are so confident about the chances of some type of health reform in the next administration that staff meetings and hearings geared toward crafting legislation have been going on in earnest in both the House and the Senate, with the goal of being ready to go in January, according to advocates and policy watchers.

Many health policy analysts have compared and contrasted this election cycle with that of 1992, which sent Bill Clinton to the White House and launched the Clintons' health care reform efforts.

Both elections—1992 and 2008—feature a high level of public concern about access to health care and its costs, said Len Nichols, an analyst at the New America Foundation, a nonpartisan public policy institute.

For instance, a Harris Interactive survey conducted for the Commonwealth Fund in May found that 82% of Americans think the health care system should be fundamentally changed or completely rebuilt.

But the differences between the two elections are striking in a positive way, said Mr. Nichols, in an interview.

First, the two major candidates themselves have acknowledged that cost is an overriding concern, he said. Also, a common theme is the use of private markets, which he called “evidence, I would say, of moderation” and, perhaps, the proposals' better legislative traction.

Both candidates—Sen. Barack Obama (D-Ill.) and Sen. John McCain (R-Ariz.)—have also learned that “no president is going to send [to Congress] a 1,400-page health bill written in a hotel room by 300 wonks,” Mr. Nichols said.

Instead, “Congress is going to own this [effort] far earlier and deeper than before,” he said, adding, “It's still going to require a lot of presidential leadership. But the Congress has to be an equal, more than it has before.”

Several proposals are likely starting points for congressional negotiations with the new administration, he said. First is the Healthy Americans Act, introduced in January 2007 by Sen. Ron Wyden (D-Ore.) and Sen. Bob Bennett (R-Utah). It has 16 cosponsors from both parties, including Sen. Chuck Grassley (R-Iowa), the Finance Committee's ranking minority member.

The bill is being championed in the House by Rep. Debbie Wasserman Schultz (D-Fla.) and Rep. Jo Ann Emerson (R-Mo.). Rep. Wasserman Schultz is important “because she's a rising star and has impeccable liberal credentials,” said Mr. Nichols.

In a paper published in the May/June 2008 issue of the policy journal Health Affairs, Sen. Wyden and Sen. Bennett said they saw “signs of an ideological truce” on the Hill, with agreement that there is a need for the Democratic-backed universal coverage and the Republican-supported desire for market forces to promote competition and innovation.

“The Healthy Americans Act strikes a balance between these ideals,” they wrote (Health Affairs 2008;27:689–92).

The bill would require individuals to purchase insurance for themselves and their dependent children, and would require insurers to offer a prescribed package of benefits.

It would subsidize coverage for Americans with incomes up to 400% of the federal poverty level. Employers would convert benefit dollars into salary; such compensation would be tax free, with the goal that the money would be used to purchase coverage.

Sen. Wyden is likely to be front and center in crafting a bill, as he is a member of two of the committees of jurisdiction: finance and budget, said Mr. Nichols, adding that those committees, along with the Health, Education, Labor and Pensions (HELP) Committee “will play very important roles.”

Ron Pollack, executive director of the advocacy group Families USA, said that although Sen. Wyden may play a part, “I have little doubt that Sen. Baucus is going to be as instrumental in the process as anyone.”

Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, held a health care summit in mid-June.

Staff from the Finance Committee and the HELP Committee, led by Sen. Edward M. Kennedy (D-Mass.), have been coordinating meetings with those two panels and the Budget Committee, Mr. Pollack said in an interview.

Committee chairs have the greatest influence on the legislative process, he said. Both Mr. Pollack and Mr. Nichols also expect Sen. Kennedy to play a very significant part in creating the legislation, as much as his cancer will allow.

Even so, “to pass anything of significance will require bipartisanship,” said Mr. Pollack, noting that Sen. Baucus and Sen. Grassley have worked closely on many bills.

The House is not as far along in preparing for health reform, but staffers on the four relevant committees with jurisdiction over health care have been meeting, said Mr. Pollack.

“I think there's significant movement underway in anticipation of health care reform being a top domestic priority,” he commented.

But, “I don't think any of the proposals that have come out so far are going to be the proposals,” added Mr. Pollack.

Instead, the expectation is that a health reform bill will be developed during the transition period between November and January, “and that's what we should look at most seriously,” he said.

Democrats and Republicans are so confident about the chances of some type of health reform in the next administration that staff meetings and hearings geared toward crafting legislation have been going on in earnest in both the House and the Senate, with the goal of being ready to go in January, according to advocates and policy watchers.

Many health policy analysts have compared and contrasted this election cycle with that of 1992, which sent Bill Clinton to the White House and launched the Clintons' health care reform efforts.

Both elections—1992 and 2008—feature a high level of public concern about access to health care and its costs, said Len Nichols, an analyst at the New America Foundation, a nonpartisan public policy institute.

For instance, a Harris Interactive survey conducted for the Commonwealth Fund in May found that 82% of Americans think the health care system should be fundamentally changed or completely rebuilt.

But the differences between the two elections are striking in a positive way, said Mr. Nichols, in an interview.

First, the two major candidates themselves have acknowledged that cost is an overriding concern, he said. Also, a common theme is the use of private markets, which he called “evidence, I would say, of moderation” and, perhaps, the proposals' better legislative traction.

Both candidates—Sen. Barack Obama (D-Ill.) and Sen. John McCain (R-Ariz.)—have also learned that “no president is going to send [to Congress] a 1,400-page health bill written in a hotel room by 300 wonks,” Mr. Nichols said.

Instead, “Congress is going to own this [effort] far earlier and deeper than before,” he said, adding, “It's still going to require a lot of presidential leadership. But the Congress has to be an equal, more than it has before.”

Several proposals are likely starting points for congressional negotiations with the new administration, he said. First is the Healthy Americans Act, introduced in January 2007 by Sen. Ron Wyden (D-Ore.) and Sen. Bob Bennett (R-Utah). It has 16 cosponsors from both parties, including Sen. Chuck Grassley (R-Iowa), the Finance Committee's ranking minority member.

The bill is being championed in the House by Rep. Debbie Wasserman Schultz (D-Fla.) and Rep. Jo Ann Emerson (R-Mo.). Rep. Wasserman Schultz is important “because she's a rising star and has impeccable liberal credentials,” said Mr. Nichols.

In a paper published in the May/June 2008 issue of the policy journal Health Affairs, Sen. Wyden and Sen. Bennett said they saw “signs of an ideological truce” on the Hill, with agreement that there is a need for the Democratic-backed universal coverage and the Republican-supported desire for market forces to promote competition and innovation.

“The Healthy Americans Act strikes a balance between these ideals,” they wrote (Health Affairs 2008;27:689–92).

The bill would require individuals to purchase insurance for themselves and their dependent children, and would require insurers to offer a prescribed package of benefits.

It would subsidize coverage for Americans with incomes up to 400% of the federal poverty level. Employers would convert benefit dollars into salary; such compensation would be tax free, with the goal that the money would be used to purchase coverage.

Sen. Wyden is likely to be front and center in crafting a bill, as he is a member of two of the committees of jurisdiction: finance and budget, said Mr. Nichols, adding that those committees, along with the Health, Education, Labor and Pensions (HELP) Committee “will play very important roles.”

Ron Pollack, executive director of the advocacy group Families USA, said that although Sen. Wyden may play a part, “I have little doubt that Sen. Baucus is going to be as instrumental in the process as anyone.”

Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, held a health care summit in mid-June.

Staff from the Finance Committee and the HELP Committee, led by Sen. Edward M. Kennedy (D-Mass.), have been coordinating meetings with those two panels and the Budget Committee, Mr. Pollack said in an interview.

Committee chairs have the greatest influence on the legislative process, he said. Both Mr. Pollack and Mr. Nichols also expect Sen. Kennedy to play a very significant part in creating the legislation, as much as his cancer will allow.

Even so, “to pass anything of significance will require bipartisanship,” said Mr. Pollack, noting that Sen. Baucus and Sen. Grassley have worked closely on many bills.

The House is not as far along in preparing for health reform, but staffers on the four relevant committees with jurisdiction over health care have been meeting, said Mr. Pollack.

“I think there's significant movement underway in anticipation of health care reform being a top domestic priority,” he commented.

But, “I don't think any of the proposals that have come out so far are going to be the proposals,” added Mr. Pollack.

Instead, the expectation is that a health reform bill will be developed during the transition period between November and January, “and that's what we should look at most seriously,” he said.

Democrats and Republicans are so confident about the chances of some type of health reform in the next administration that staff meetings and hearings geared toward crafting legislation have been going on in earnest in both the House and the Senate, with the goal of being ready to go in January, according to advocates and policy watchers.

Many health policy analysts have compared and contrasted this election cycle with that of 1992, which sent Bill Clinton to the White House and launched the Clintons' health care reform efforts.

Both elections—1992 and 2008—feature a high level of public concern about access to health care and its costs, said Len Nichols, an analyst at the New America Foundation, a nonpartisan public policy institute.

For instance, a Harris Interactive survey conducted for the Commonwealth Fund in May found that 82% of Americans think the health care system should be fundamentally changed or completely rebuilt.

But the differences between the two elections are striking in a positive way, said Mr. Nichols, in an interview.

First, the two major candidates themselves have acknowledged that cost is an overriding concern, he said. Also, a common theme is the use of private markets, which he called “evidence, I would say, of moderation” and, perhaps, the proposals' better legislative traction.

Both candidates—Sen. Barack Obama (D-Ill.) and Sen. John McCain (R-Ariz.)—have also learned that “no president is going to send [to Congress] a 1,400-page health bill written in a hotel room by 300 wonks,” Mr. Nichols said.

Instead, “Congress is going to own this [effort] far earlier and deeper than before,” he said, adding, “It's still going to require a lot of presidential leadership. But the Congress has to be an equal, more than it has before.”

Several proposals are likely starting points for congressional negotiations with the new administration, he said. First is the Healthy Americans Act, introduced in January 2007 by Sen. Ron Wyden (D-Ore.) and Sen. Bob Bennett (R-Utah). It has 16 cosponsors from both parties, including Sen. Chuck Grassley (R-Iowa), the Finance Committee's ranking minority member.

The bill is being championed in the House by Rep. Debbie Wasserman Schultz (D-Fla.) and Rep. Jo Ann Emerson (R-Mo.). Rep. Wasserman Schultz is important “because she's a rising star and has impeccable liberal credentials,” said Mr. Nichols.

In a paper published in the May/June 2008 issue of the policy journal Health Affairs, Sen. Wyden and Sen. Bennett said they saw “signs of an ideological truce” on the Hill, with agreement that there is a need for the Democratic-backed universal coverage and the Republican-supported desire for market forces to promote competition and innovation.

“The Healthy Americans Act strikes a balance between these ideals,” they wrote (Health Affairs 2008;27:689–92).

The bill would require individuals to purchase insurance for themselves and their dependent children, and would require insurers to offer a prescribed package of benefits.

It would subsidize coverage for Americans with incomes up to 400% of the federal poverty level. Employers would convert benefit dollars into salary; such compensation would be tax free, with the goal that the money would be used to purchase coverage.

Sen. Wyden is likely to be front and center in crafting a bill, as he is a member of two of the committees of jurisdiction: finance and budget, said Mr. Nichols, adding that those committees, along with the Health, Education, Labor and Pensions (HELP) Committee “will play very important roles.”

Ron Pollack, executive director of the advocacy group Families USA, said that although Sen. Wyden may play a part, “I have little doubt that Sen. Baucus is going to be as instrumental in the process as anyone.”

Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, held a health care summit in mid-June.

Staff from the Finance Committee and the HELP Committee, led by Sen. Edward M. Kennedy (D-Mass.), have been coordinating meetings with those two panels and the Budget Committee, Mr. Pollack said in an interview.

Committee chairs have the greatest influence on the legislative process, he said. Both Mr. Pollack and Mr. Nichols also expect Sen. Kennedy to play a very significant part in creating the legislation, as much as his cancer will allow.

Even so, “to pass anything of significance will require bipartisanship,” said Mr. Pollack, noting that Sen. Baucus and Sen. Grassley have worked closely on many bills.

The House is not as far along in preparing for health reform, but staffers on the four relevant committees with jurisdiction over health care have been meeting, said Mr. Pollack.

“I think there's significant movement underway in anticipation of health care reform being a top domestic priority,” he commented.

But, “I don't think any of the proposals that have come out so far are going to be the proposals,” added Mr. Pollack.

Instead, the expectation is that a health reform bill will be developed during the transition period between November and January, “and that's what we should look at most seriously,” he said.

Statin Use Soars

Americans spent $20 billion on statin medications in 2005. This was a massive rise from just 5 years earlier, when that tally was about $8 billion, according to the Agency for Healthcare Research and Quality. The 156% increase in spending went toward well-known drugs such as Lipitor, Lescol, Pravachol, and Zocor, the agency reported. In 2000, a total of 16 million people said they had purchased at least one statin. By 2005, almost twice as many people (30 million) had purchased a statin. Outpatient prescriptions of statins zoomed from 90 million to 174 million Each of the individuals who took a statin saw expenditures increase in this period from $484 per year to $661 annually. The AHRQ did not determine in its analysis how much of that expenditure was covered by insurers and how much of it was out-of-pocket cost to the individual patients. The AHRQ data are drawn from the Medical Expenditure Panel Survey, which details the health services that are used by civilian, noninstitutionalized Americans.

Speedier Device Reviews

The Food and Drug Administration reports that it is reviewing medical devices more quickly than it has in the past, but it is not by much. And they reported that the number of submissions directed to the agency has declined both for breakthrough devices—called premarket approval (PMA) applications—and for those devices that are substantially equivalent to those already on the market—known as 510(k) applications. The agency's Office of Device Evaluation received a total of 31 PMAs in fiscal 2007, compared with 66 submissions in fiscal 1997. In fiscal 2007 there were a total of 3,192 510(k) submissions, compared with 5,049 in fiscal 1997. Of the 2007 submissions, 2,640 were approved. The number of supplemental PMA applications, however, has been increasing. A supplemental PMA usually seeks an additional indication or use for the same device. The average time it took to review original and supplemental PMA applications by the FDA has declined somewhat since the agency began charging the device companies a fee for review in 2002—dropping from 292 days in that fiscal year to 283 days in fiscal 2006. The FDA has not reported fiscal 2007 data yet because many of those products were still under review at the time the report was being compiled.

Dems Seek to Restore Device Suits

Democrats in the House of Representatives were not happy when the U.S. Supreme Court ruled in February that device makers are immune from state lawsuits brought by patients who allege that they were harmed by a product that was approved by the FDA under the pre-market approval process. House Democrats have introduced a bill, the Medical Device Safety Act of 2008 (H.R. 6381), in order to reverse that decision. The charge is being led by Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.), and the bill now has 64 cosponsors. A companion bill is expected to come from Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.), but had not been introduced at press time. The Supreme Court ruling in Reigel v. Medtronic Inc. “ignores both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers from device risks,” according to a joint statement from Reps. Pallone and Waxman. The device industry trade group AdvaMed criticized the “patchwork approach” that has been in existence thanks to the allowance for state suits and said that H.R. 6381 “will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits, and ultimately higher health care costs.”

Feds Scrutinize Generic Maker

India's Ranbaxy Inc., which is one of the top 10 generic drug makers in the world, is now being investigated by various arms of the U.S. federal government for allegedly introducing “adulterated or misbranded products” into the United States market. In addition, the company's auditor, Parexel Consulting, has come under federal scrutiny for violations. According to a subpoena for documents that was filed in the U.S. District Court for the District of Maryland by the Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy Inc. allegedly submitted false information to the U.S. Food and Drug Administration regarding sterility and bioequivalence, covered up good manufacturing practice violations, and defrauded Medicare. Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) said that they would formally investigate the Ranbaxy situation. “If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago,” said Rep. Dingell. “I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”

Medicare Issues PQRI Payments

Physicians who successfully reported their quality measures to Medicare in 2007 as part of the Physician Quality Reporting Initiative should have received their bonus payments last month. Officials at the Centers for Medicare and Medicaid Services recently announced that they had already paid out more than $36 million in bonuses to physicians and other health professionals as part of the PQRI. Of the approximately 109,000 health care professionals who reported data on Medicare services provided during July-December 2007, more than 56,700 met the reporting requirements and would be receiving bonus checks, according to the CMS. The average bonus paid to an individual provider was more than $600, and the average bonus for a physician group practice was more than $4,700. The largest payment to a physician group practice was more than $205,700, the CMS.reported. “These payments to physicians for participating in the PQRI are a first step toward improving how Medicare pays for health care services,” Kerry Weems, acting administrator, said in a statement. Under the PQRI, physicians could earn bonus payments of up to 1.5% of their total allowed Medicare charges by successfully reporting quality data for Medicare services provided from July to December 2007. In addition to the bonus payments, physicians and other health professionals can also start accessing confidential feedback reports on their performance. To access the feedback reports, providers must register with the Individuals Authorized Access to CMS Computer Services-Provider Community (IACS-PC). More information on the program is available at

www.cms.hhs.gov/pqri

Statin Use Soars

Americans spent $20 billion on statin medications in 2005. This was a massive rise from just 5 years earlier, when that tally was about $8 billion, according to the Agency for Healthcare Research and Quality. The 156% increase in spending went toward well-known drugs such as Lipitor, Lescol, Pravachol, and Zocor, the agency reported. In 2000, a total of 16 million people said they had purchased at least one statin. By 2005, almost twice as many people (30 million) had purchased a statin. Outpatient prescriptions of statins zoomed from 90 million to 174 million Each of the individuals who took a statin saw expenditures increase in this period from $484 per year to $661 annually. The AHRQ did not determine in its analysis how much of that expenditure was covered by insurers and how much of it was out-of-pocket cost to the individual patients. The AHRQ data are drawn from the Medical Expenditure Panel Survey, which details the health services that are used by civilian, noninstitutionalized Americans.

Speedier Device Reviews

The Food and Drug Administration reports that it is reviewing medical devices more quickly than it has in the past, but it is not by much. And they reported that the number of submissions directed to the agency has declined both for breakthrough devices—called premarket approval (PMA) applications—and for those devices that are substantially equivalent to those already on the market—known as 510(k) applications. The agency's Office of Device Evaluation received a total of 31 PMAs in fiscal 2007, compared with 66 submissions in fiscal 1997. In fiscal 2007 there were a total of 3,192 510(k) submissions, compared with 5,049 in fiscal 1997. Of the 2007 submissions, 2,640 were approved. The number of supplemental PMA applications, however, has been increasing. A supplemental PMA usually seeks an additional indication or use for the same device. The average time it took to review original and supplemental PMA applications by the FDA has declined somewhat since the agency began charging the device companies a fee for review in 2002—dropping from 292 days in that fiscal year to 283 days in fiscal 2006. The FDA has not reported fiscal 2007 data yet because many of those products were still under review at the time the report was being compiled.

Dems Seek to Restore Device Suits

Democrats in the House of Representatives were not happy when the U.S. Supreme Court ruled in February that device makers are immune from state lawsuits brought by patients who allege that they were harmed by a product that was approved by the FDA under the pre-market approval process. House Democrats have introduced a bill, the Medical Device Safety Act of 2008 (H.R. 6381), in order to reverse that decision. The charge is being led by Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.), and the bill now has 64 cosponsors. A companion bill is expected to come from Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.), but had not been introduced at press time. The Supreme Court ruling in Reigel v. Medtronic Inc. “ignores both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers from device risks,” according to a joint statement from Reps. Pallone and Waxman. The device industry trade group AdvaMed criticized the “patchwork approach” that has been in existence thanks to the allowance for state suits and said that H.R. 6381 “will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits, and ultimately higher health care costs.”

Feds Scrutinize Generic Maker

India's Ranbaxy Inc., which is one of the top 10 generic drug makers in the world, is now being investigated by various arms of the U.S. federal government for allegedly introducing “adulterated or misbranded products” into the United States market. In addition, the company's auditor, Parexel Consulting, has come under federal scrutiny for violations. According to a subpoena for documents that was filed in the U.S. District Court for the District of Maryland by the Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy Inc. allegedly submitted false information to the U.S. Food and Drug Administration regarding sterility and bioequivalence, covered up good manufacturing practice violations, and defrauded Medicare. Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) said that they would formally investigate the Ranbaxy situation. “If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago,” said Rep. Dingell. “I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”

Medicare Issues PQRI Payments

Physicians who successfully reported their quality measures to Medicare in 2007 as part of the Physician Quality Reporting Initiative should have received their bonus payments last month. Officials at the Centers for Medicare and Medicaid Services recently announced that they had already paid out more than $36 million in bonuses to physicians and other health professionals as part of the PQRI. Of the approximately 109,000 health care professionals who reported data on Medicare services provided during July-December 2007, more than 56,700 met the reporting requirements and would be receiving bonus checks, according to the CMS. The average bonus paid to an individual provider was more than $600, and the average bonus for a physician group practice was more than $4,700. The largest payment to a physician group practice was more than $205,700, the CMS.reported. “These payments to physicians for participating in the PQRI are a first step toward improving how Medicare pays for health care services,” Kerry Weems, acting administrator, said in a statement. Under the PQRI, physicians could earn bonus payments of up to 1.5% of their total allowed Medicare charges by successfully reporting quality data for Medicare services provided from July to December 2007. In addition to the bonus payments, physicians and other health professionals can also start accessing confidential feedback reports on their performance. To access the feedback reports, providers must register with the Individuals Authorized Access to CMS Computer Services-Provider Community (IACS-PC). More information on the program is available at

www.cms.hhs.gov/pqri

Statin Use Soars

Americans spent $20 billion on statin medications in 2005. This was a massive rise from just 5 years earlier, when that tally was about $8 billion, according to the Agency for Healthcare Research and Quality. The 156% increase in spending went toward well-known drugs such as Lipitor, Lescol, Pravachol, and Zocor, the agency reported. In 2000, a total of 16 million people said they had purchased at least one statin. By 2005, almost twice as many people (30 million) had purchased a statin. Outpatient prescriptions of statins zoomed from 90 million to 174 million Each of the individuals who took a statin saw expenditures increase in this period from $484 per year to $661 annually. The AHRQ did not determine in its analysis how much of that expenditure was covered by insurers and how much of it was out-of-pocket cost to the individual patients. The AHRQ data are drawn from the Medical Expenditure Panel Survey, which details the health services that are used by civilian, noninstitutionalized Americans.

Speedier Device Reviews

The Food and Drug Administration reports that it is reviewing medical devices more quickly than it has in the past, but it is not by much. And they reported that the number of submissions directed to the agency has declined both for breakthrough devices—called premarket approval (PMA) applications—and for those devices that are substantially equivalent to those already on the market—known as 510(k) applications. The agency's Office of Device Evaluation received a total of 31 PMAs in fiscal 2007, compared with 66 submissions in fiscal 1997. In fiscal 2007 there were a total of 3,192 510(k) submissions, compared with 5,049 in fiscal 1997. Of the 2007 submissions, 2,640 were approved. The number of supplemental PMA applications, however, has been increasing. A supplemental PMA usually seeks an additional indication or use for the same device. The average time it took to review original and supplemental PMA applications by the FDA has declined somewhat since the agency began charging the device companies a fee for review in 2002—dropping from 292 days in that fiscal year to 283 days in fiscal 2006. The FDA has not reported fiscal 2007 data yet because many of those products were still under review at the time the report was being compiled.

Dems Seek to Restore Device Suits

Democrats in the House of Representatives were not happy when the U.S. Supreme Court ruled in February that device makers are immune from state lawsuits brought by patients who allege that they were harmed by a product that was approved by the FDA under the pre-market approval process. House Democrats have introduced a bill, the Medical Device Safety Act of 2008 (H.R. 6381), in order to reverse that decision. The charge is being led by Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.), and the bill now has 64 cosponsors. A companion bill is expected to come from Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.), but had not been introduced at press time. The Supreme Court ruling in Reigel v. Medtronic Inc. “ignores both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers from device risks,” according to a joint statement from Reps. Pallone and Waxman. The device industry trade group AdvaMed criticized the “patchwork approach” that has been in existence thanks to the allowance for state suits and said that H.R. 6381 “will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits, and ultimately higher health care costs.”

Feds Scrutinize Generic Maker

India's Ranbaxy Inc., which is one of the top 10 generic drug makers in the world, is now being investigated by various arms of the U.S. federal government for allegedly introducing “adulterated or misbranded products” into the United States market. In addition, the company's auditor, Parexel Consulting, has come under federal scrutiny for violations. According to a subpoena for documents that was filed in the U.S. District Court for the District of Maryland by the Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy Inc. allegedly submitted false information to the U.S. Food and Drug Administration regarding sterility and bioequivalence, covered up good manufacturing practice violations, and defrauded Medicare. Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) said that they would formally investigate the Ranbaxy situation. “If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago,” said Rep. Dingell. “I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”

Medicare Issues PQRI Payments

Physicians who successfully reported their quality measures to Medicare in 2007 as part of the Physician Quality Reporting Initiative should have received their bonus payments last month. Officials at the Centers for Medicare and Medicaid Services recently announced that they had already paid out more than $36 million in bonuses to physicians and other health professionals as part of the PQRI. Of the approximately 109,000 health care professionals who reported data on Medicare services provided during July-December 2007, more than 56,700 met the reporting requirements and would be receiving bonus checks, according to the CMS. The average bonus paid to an individual provider was more than $600, and the average bonus for a physician group practice was more than $4,700. The largest payment to a physician group practice was more than $205,700, the CMS.reported. “These payments to physicians for participating in the PQRI are a first step toward improving how Medicare pays for health care services,” Kerry Weems, acting administrator, said in a statement. Under the PQRI, physicians could earn bonus payments of up to 1.5% of their total allowed Medicare charges by successfully reporting quality data for Medicare services provided from July to December 2007. In addition to the bonus payments, physicians and other health professionals can also start accessing confidential feedback reports on their performance. To access the feedback reports, providers must register with the Individuals Authorized Access to CMS Computer Services-Provider Community (IACS-PC). More information on the program is available at

www.cms.hhs.gov/pqri

Dental care is “the most prevalent unmet health need among children,” according to a report by the Kaiser Commission on Medicaid and the Uninsured.

Kaiser estimates that 20 million children do not have dental insurance coverage, compared with 9 million who lack health insurance coverage. Even children who have dental coverage—through Medicaid or the State Children's Health Insurance Program (SCHIP)—don't always have access to a dentist, according to the Kaiser report.

The report, “Dental Coverage and Care for Low-Income Children: The Role of Medicaid and SCHIP,” found that a third of children living at or just above the federal poverty level in 2006 had untreated dental caries and an equal number had no dental visit in the past year.

The federal poverty level was $20,000 for a family of four in 2006.

When compared with children from higher-income families, low-income children had 12 times as many days in which they could not participate in their normal daily activities because of dental problems.

Black and Hispanic low-income children had slightly higher rates of untreated tooth decay than did white low-income children. They were also more likely to not have seen a dentist in the past year.

Medicaid and SCHIP offer some dental coverage to eligible children. Under Medicaid, states are required to offer comprehensive dental care through the Early and Periodic Screening, Diagnostic, and Treatment benefit. In states where the SCHIP program is essentially an expansion of Medicaid, SCHIP offers the same dental benefits as Medicaid. But states that created separate SCHIP programs often have different dental benefits, and those benefits can be dropped if it's a tight budget year.

That happened in Texas, for instance, which did not offer dental benefits for several years, William Prentice, senior vice president of government and public affairs for the American Dental Association, said in an interview. At this time, all 50 states offer dental coverage of some sort, he said.

But, in states with separate programs, the benefits can vary. Seven states cap annual dental expenditures or limit services, according to the Kaiser report. In Montana, for instance, benefits are capped at $350 a year.

The separate SCHIP programs are also not required to offer dental benefits. A mandate for benefits was included in SCHIP expansion legislation that was vetoed earlier this year.

Even if benefits are added, that will not get to the crux of the problem: low reimbursement rates for dentists who accept Medicaid or SCHIP, said Mr. Prentice.

“The government loves to promise care and it hates to pay for it,” he said, adding that the ADA has been lobbying for increased pay for dentists. In most states, dentists lose money if they accept Medicaid or SCHIP payment, he said.

A few states have increased pay, and taken other steps to make participation easier, including streamlining billing and allowing electronic submission of claims, according to Kaiser. In those states—Michigan, Alabama, and Illinois—the number of children visiting a dentist in the last year increased after the changes. In Illinois, only 23% of children on public health programs had seen a dentist in the year before payment reform was initiated; once reforms were in place, that number rose to 40%.

More low-income children would likely see a dentist if their parent or guardian had access to a dentist, said Mr. Prentice. According to another Kaiser study, “Access to Affordable Dental Care: Gaps for Low-Income Adults,” 58% of low-income adults had no dental coverage in 2006; furthermore, 67% of low-income adults went without a dental visit in the past year, compared with 35% of higher-income adults.

The ADA has lobbied for Medicaid to offer adults a dental benefit, and will continue to do so in the next Congress, Mr. Prentice said.

Dental care is “the most prevalent unmet health need among children,” according to a report by the Kaiser Commission on Medicaid and the Uninsured.

Kaiser estimates that 20 million children do not have dental insurance coverage, compared with 9 million who lack health insurance coverage. Even children who have dental coverage—through Medicaid or the State Children's Health Insurance Program (SCHIP)—don't always have access to a dentist, according to the Kaiser report.

The report, “Dental Coverage and Care for Low-Income Children: The Role of Medicaid and SCHIP,” found that a third of children living at or just above the federal poverty level in 2006 had untreated dental caries and an equal number had no dental visit in the past year.

The federal poverty level was $20,000 for a family of four in 2006.

When compared with children from higher-income families, low-income children had 12 times as many days in which they could not participate in their normal daily activities because of dental problems.

Black and Hispanic low-income children had slightly higher rates of untreated tooth decay than did white low-income children. They were also more likely to not have seen a dentist in the past year.

Medicaid and SCHIP offer some dental coverage to eligible children. Under Medicaid, states are required to offer comprehensive dental care through the Early and Periodic Screening, Diagnostic, and Treatment benefit. In states where the SCHIP program is essentially an expansion of Medicaid, SCHIP offers the same dental benefits as Medicaid. But states that created separate SCHIP programs often have different dental benefits, and those benefits can be dropped if it's a tight budget year.

That happened in Texas, for instance, which did not offer dental benefits for several years, William Prentice, senior vice president of government and public affairs for the American Dental Association, said in an interview. At this time, all 50 states offer dental coverage of some sort, he said.

But, in states with separate programs, the benefits can vary. Seven states cap annual dental expenditures or limit services, according to the Kaiser report. In Montana, for instance, benefits are capped at $350 a year.

The separate SCHIP programs are also not required to offer dental benefits. A mandate for benefits was included in SCHIP expansion legislation that was vetoed earlier this year.

Even if benefits are added, that will not get to the crux of the problem: low reimbursement rates for dentists who accept Medicaid or SCHIP, said Mr. Prentice.

“The government loves to promise care and it hates to pay for it,” he said, adding that the ADA has been lobbying for increased pay for dentists. In most states, dentists lose money if they accept Medicaid or SCHIP payment, he said.

A few states have increased pay, and taken other steps to make participation easier, including streamlining billing and allowing electronic submission of claims, according to Kaiser. In those states—Michigan, Alabama, and Illinois—the number of children visiting a dentist in the last year increased after the changes. In Illinois, only 23% of children on public health programs had seen a dentist in the year before payment reform was initiated; once reforms were in place, that number rose to 40%.

More low-income children would likely see a dentist if their parent or guardian had access to a dentist, said Mr. Prentice. According to another Kaiser study, “Access to Affordable Dental Care: Gaps for Low-Income Adults,” 58% of low-income adults had no dental coverage in 2006; furthermore, 67% of low-income adults went without a dental visit in the past year, compared with 35% of higher-income adults.

The ADA has lobbied for Medicaid to offer adults a dental benefit, and will continue to do so in the next Congress, Mr. Prentice said.

Dental care is “the most prevalent unmet health need among children,” according to a report by the Kaiser Commission on Medicaid and the Uninsured.

Kaiser estimates that 20 million children do not have dental insurance coverage, compared with 9 million who lack health insurance coverage. Even children who have dental coverage—through Medicaid or the State Children's Health Insurance Program (SCHIP)—don't always have access to a dentist, according to the Kaiser report.

The report, “Dental Coverage and Care for Low-Income Children: The Role of Medicaid and SCHIP,” found that a third of children living at or just above the federal poverty level in 2006 had untreated dental caries and an equal number had no dental visit in the past year.

The federal poverty level was $20,000 for a family of four in 2006.

When compared with children from higher-income families, low-income children had 12 times as many days in which they could not participate in their normal daily activities because of dental problems.

Black and Hispanic low-income children had slightly higher rates of untreated tooth decay than did white low-income children. They were also more likely to not have seen a dentist in the past year.

Medicaid and SCHIP offer some dental coverage to eligible children. Under Medicaid, states are required to offer comprehensive dental care through the Early and Periodic Screening, Diagnostic, and Treatment benefit. In states where the SCHIP program is essentially an expansion of Medicaid, SCHIP offers the same dental benefits as Medicaid. But states that created separate SCHIP programs often have different dental benefits, and those benefits can be dropped if it's a tight budget year.

That happened in Texas, for instance, which did not offer dental benefits for several years, William Prentice, senior vice president of government and public affairs for the American Dental Association, said in an interview. At this time, all 50 states offer dental coverage of some sort, he said.

But, in states with separate programs, the benefits can vary. Seven states cap annual dental expenditures or limit services, according to the Kaiser report. In Montana, for instance, benefits are capped at $350 a year.

The separate SCHIP programs are also not required to offer dental benefits. A mandate for benefits was included in SCHIP expansion legislation that was vetoed earlier this year.

Even if benefits are added, that will not get to the crux of the problem: low reimbursement rates for dentists who accept Medicaid or SCHIP, said Mr. Prentice.

“The government loves to promise care and it hates to pay for it,” he said, adding that the ADA has been lobbying for increased pay for dentists. In most states, dentists lose money if they accept Medicaid or SCHIP payment, he said.

A few states have increased pay, and taken other steps to make participation easier, including streamlining billing and allowing electronic submission of claims, according to Kaiser. In those states—Michigan, Alabama, and Illinois—the number of children visiting a dentist in the last year increased after the changes. In Illinois, only 23% of children on public health programs had seen a dentist in the year before payment reform was initiated; once reforms were in place, that number rose to 40%.

More low-income children would likely see a dentist if their parent or guardian had access to a dentist, said Mr. Prentice. According to another Kaiser study, “Access to Affordable Dental Care: Gaps for Low-Income Adults,” 58% of low-income adults had no dental coverage in 2006; furthermore, 67% of low-income adults went without a dental visit in the past year, compared with 35% of higher-income adults.

The ADA has lobbied for Medicaid to offer adults a dental benefit, and will continue to do so in the next Congress, Mr. Prentice said.

Democrats and Republicans are so confident about the chances of some type of health reform in the next administration that staff meetings and hearings geared toward crafting legislation have been going on in earnest in both the House and the Senate, with the goal of being ready to go in January, according to advocates and policy watchers.

Many health policy analysts have compared and contrasted this election cycle with that of 1992, which sent Bill Clinton to the White House and launched the Clintons' health care reform efforts.

Both elections—1992 and 2008—feature a high level of public concern about access to health care and its costs, said Len Nichols, an analyst at the New America Foundation, a nonpartisan public policy institute.

For instance, a Harris Interactive survey conducted for the Commonwealth Fund in May found that 82% of Americans think the health care system should be fundamentally changed or completely rebuilt.

But the differences between the two elections are striking in a positive way, said Mr. Nichols, in an interview.

First, the two major candidates themselves have acknowledged that cost is an overriding concern, he said. Also, a common theme is the use of private markets, which he called “evidence, I would say, of moderation” and, perhaps, the proposals' better legislative traction.

Both candidates—Sen. Barack Obama (D-Ill.) and Sen. John McCain (R-Ariz.)—have also learned that “no president is going to send [to Congress] a 1,400-page health bill written in a hotel room by 300 wonks,” Mr. Nichols said.

Instead, “Congress is going to own this [effort] far earlier and deeper than before,” he said, adding, “It's still going to require a lot of presidential leadership. But the Congress has to be an equal, more than it has before.”

Several proposals are likely starting points for congressional negotiations with the new administration, he said. First is the Healthy Americans Act, introduced in January 2007 by Sen. Ron Wyden (D-Ore.) and Sen. Bob Bennett (R-Utah). It has 16 cosponsors from both parties, including Sen. Chuck Grassley (R-Iowa), the Finance Committee's ranking minority member.

The bill is being championed in the House by Rep. Debbie Wasserman Schultz (D-Fla.) and Rep. Jo Ann Emerson (R-Mo.).

Rep. Wasserman Schultz is important “because she's a rising star and has impeccable liberal credentials,” said Mr. Nichols.

In a paper published in the May/June 2008 issue of the policy journal Health Affairs, Sen. Wyden and Sen. Bennett said they saw “signs of an ideological truce” on the Hill, with agreement that there is a need for the Democratic-backed universal coverage and the Republican-supported desire for market forces to promote competition and innovation. “The Healthy Americans Act strikes a balance between these ideals,” they wrote (Health Affairs 2008;27:689-92).

The bill would require individuals to purchase insurance for themselves and their dependent children, and would require insurers to offer a prescribed package of benefits. It would subsidize coverage for Americans with incomes up to 400% of the federal poverty level. Employers would convert benefit dollars into salary; such compensation would be tax free, with the goal that the money would be used to purchase coverage.

Sen. Wyden is likely to be front and center in crafting a bill, as he is a member of two of the committees of jurisdiction: finance and budget, said Mr. Nichols, adding that those committees, along with the Health, Education, Labor and Pensions (HELP) Committee “will play very important roles.”

Ron Pollack, executive director of the advocacy group Families USA, said that although Sen. Wyden may play a part, “I have little doubt that Sen. Baucus is going to be as instrumental in the process as anyone.”

Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, held a health care summit in mid-June. Staff from the Finance Committee and the HELP Committee, led by Sen. Edward M. Kennedy (D-Mass.), have been coordinating meetings with those two panels and the Budget Committee, Mr. Pollack said in an interview.

Committee chairs have the greatest influence on the legislative process, he said. Both Mr. Pollack and Mr. Nichols also expect Sen. Kennedy to play a very significant part in creating the legislation, as much as his cancer will allow.

The latest ad emphasizes the need for health care reform. Health Care First

They'rrrre Baaaaack! Harry and Louise Redux

Harry and Louise, who became infamous in a 1993–1994 television ad lambasting the Clinton administration's health care reform plan, were dragged briefly out of mothballs to appear in a new commercial that urged Congress and the next president to make such reform the top domestic policy priority.

The effort was being bankrolled by five groups that by their own admission have “historically divergent views about health care reform”: the American Cancer Society's Cancer Action Network, the American Hospital Association (AHA), the Catholic Health Association (CHA), Families USA, and the National Federation of Independent Business (NFIB).

“We intend to transcend ideology and partisan politics,” said Families USA Executive Director Ron Pollack at a press conference. The multimillion dollar campaign aired nationally for 2 weeks during the Republican and Democratic conventions.

The ad featured Harry and Louise, back at their kitchen table. The characters were portrayed by the same two actors, now 14 years older. Harry noted that health care costs are going up again and that small businesses are being forced to drop their plans. Louise said that a friend just found out he has cancer and can't afford a plan. Harry remarked that “too many people are falling through the cracks.” Finally, Louise said that “whoever the next president is,” health care should be “at the top of his agenda,” and that he should bring everyone to the table and “make it happen.”

Democrats and Republicans are so confident about the chances of some type of health reform in the next administration that staff meetings and hearings geared toward crafting legislation have been going on in earnest in both the House and the Senate, with the goal of being ready to go in January, according to advocates and policy watchers.

Many health policy analysts have compared and contrasted this election cycle with that of 1992, which sent Bill Clinton to the White House and launched the Clintons' health care reform efforts.

Both elections—1992 and 2008—feature a high level of public concern about access to health care and its costs, said Len Nichols, an analyst at the New America Foundation, a nonpartisan public policy institute.

For instance, a Harris Interactive survey conducted for the Commonwealth Fund in May found that 82% of Americans think the health care system should be fundamentally changed or completely rebuilt.

But the differences between the two elections are striking in a positive way, said Mr. Nichols, in an interview.

First, the two major candidates themselves have acknowledged that cost is an overriding concern, he said. Also, a common theme is the use of private markets, which he called “evidence, I would say, of moderation” and, perhaps, the proposals' better legislative traction.

Both candidates—Sen. Barack Obama (D-Ill.) and Sen. John McCain (R-Ariz.)—have also learned that “no president is going to send [to Congress] a 1,400-page health bill written in a hotel room by 300 wonks,” Mr. Nichols said.

Instead, “Congress is going to own this [effort] far earlier and deeper than before,” he said, adding, “It's still going to require a lot of presidential leadership. But the Congress has to be an equal, more than it has before.”

Several proposals are likely starting points for congressional negotiations with the new administration, he said. First is the Healthy Americans Act, introduced in January 2007 by Sen. Ron Wyden (D-Ore.) and Sen. Bob Bennett (R-Utah). It has 16 cosponsors from both parties, including Sen. Chuck Grassley (R-Iowa), the Finance Committee's ranking minority member.

The bill is being championed in the House by Rep. Debbie Wasserman Schultz (D-Fla.) and Rep. Jo Ann Emerson (R-Mo.).

Rep. Wasserman Schultz is important “because she's a rising star and has impeccable liberal credentials,” said Mr. Nichols.

In a paper published in the May/June 2008 issue of the policy journal Health Affairs, Sen. Wyden and Sen. Bennett said they saw “signs of an ideological truce” on the Hill, with agreement that there is a need for the Democratic-backed universal coverage and the Republican-supported desire for market forces to promote competition and innovation. “The Healthy Americans Act strikes a balance between these ideals,” they wrote (Health Affairs 2008;27:689-92).

The bill would require individuals to purchase insurance for themselves and their dependent children, and would require insurers to offer a prescribed package of benefits. It would subsidize coverage for Americans with incomes up to 400% of the federal poverty level. Employers would convert benefit dollars into salary; such compensation would be tax free, with the goal that the money would be used to purchase coverage.

Sen. Wyden is likely to be front and center in crafting a bill, as he is a member of two of the committees of jurisdiction: finance and budget, said Mr. Nichols, adding that those committees, along with the Health, Education, Labor and Pensions (HELP) Committee “will play very important roles.”

Ron Pollack, executive director of the advocacy group Families USA, said that although Sen. Wyden may play a part, “I have little doubt that Sen. Baucus is going to be as instrumental in the process as anyone.”

Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, held a health care summit in mid-June. Staff from the Finance Committee and the HELP Committee, led by Sen. Edward M. Kennedy (D-Mass.), have been coordinating meetings with those two panels and the Budget Committee, Mr. Pollack said in an interview.

Committee chairs have the greatest influence on the legislative process, he said. Both Mr. Pollack and Mr. Nichols also expect Sen. Kennedy to play a very significant part in creating the legislation, as much as his cancer will allow.

The latest ad emphasizes the need for health care reform. Health Care First

They'rrrre Baaaaack! Harry and Louise Redux

Harry and Louise, who became infamous in a 1993–1994 television ad lambasting the Clinton administration's health care reform plan, were dragged briefly out of mothballs to appear in a new commercial that urged Congress and the next president to make such reform the top domestic policy priority.

The effort was being bankrolled by five groups that by their own admission have “historically divergent views about health care reform”: the American Cancer Society's Cancer Action Network, the American Hospital Association (AHA), the Catholic Health Association (CHA), Families USA, and the National Federation of Independent Business (NFIB).

“We intend to transcend ideology and partisan politics,” said Families USA Executive Director Ron Pollack at a press conference. The multimillion dollar campaign aired nationally for 2 weeks during the Republican and Democratic conventions.

The ad featured Harry and Louise, back at their kitchen table. The characters were portrayed by the same two actors, now 14 years older. Harry noted that health care costs are going up again and that small businesses are being forced to drop their plans. Louise said that a friend just found out he has cancer and can't afford a plan. Harry remarked that “too many people are falling through the cracks.” Finally, Louise said that “whoever the next president is,” health care should be “at the top of his agenda,” and that he should bring everyone to the table and “make it happen.”

Democrats and Republicans are so confident about the chances of some type of health reform in the next administration that staff meetings and hearings geared toward crafting legislation have been going on in earnest in both the House and the Senate, with the goal of being ready to go in January, according to advocates and policy watchers.

Many health policy analysts have compared and contrasted this election cycle with that of 1992, which sent Bill Clinton to the White House and launched the Clintons' health care reform efforts.

Both elections—1992 and 2008—feature a high level of public concern about access to health care and its costs, said Len Nichols, an analyst at the New America Foundation, a nonpartisan public policy institute.

For instance, a Harris Interactive survey conducted for the Commonwealth Fund in May found that 82% of Americans think the health care system should be fundamentally changed or completely rebuilt.

But the differences between the two elections are striking in a positive way, said Mr. Nichols, in an interview.

First, the two major candidates themselves have acknowledged that cost is an overriding concern, he said. Also, a common theme is the use of private markets, which he called “evidence, I would say, of moderation” and, perhaps, the proposals' better legislative traction.

Both candidates—Sen. Barack Obama (D-Ill.) and Sen. John McCain (R-Ariz.)—have also learned that “no president is going to send [to Congress] a 1,400-page health bill written in a hotel room by 300 wonks,” Mr. Nichols said.

Instead, “Congress is going to own this [effort] far earlier and deeper than before,” he said, adding, “It's still going to require a lot of presidential leadership. But the Congress has to be an equal, more than it has before.”

Several proposals are likely starting points for congressional negotiations with the new administration, he said. First is the Healthy Americans Act, introduced in January 2007 by Sen. Ron Wyden (D-Ore.) and Sen. Bob Bennett (R-Utah). It has 16 cosponsors from both parties, including Sen. Chuck Grassley (R-Iowa), the Finance Committee's ranking minority member.

The bill is being championed in the House by Rep. Debbie Wasserman Schultz (D-Fla.) and Rep. Jo Ann Emerson (R-Mo.).

Rep. Wasserman Schultz is important “because she's a rising star and has impeccable liberal credentials,” said Mr. Nichols.

In a paper published in the May/June 2008 issue of the policy journal Health Affairs, Sen. Wyden and Sen. Bennett said they saw “signs of an ideological truce” on the Hill, with agreement that there is a need for the Democratic-backed universal coverage and the Republican-supported desire for market forces to promote competition and innovation. “The Healthy Americans Act strikes a balance between these ideals,” they wrote (Health Affairs 2008;27:689-92).

The bill would require individuals to purchase insurance for themselves and their dependent children, and would require insurers to offer a prescribed package of benefits. It would subsidize coverage for Americans with incomes up to 400% of the federal poverty level. Employers would convert benefit dollars into salary; such compensation would be tax free, with the goal that the money would be used to purchase coverage.

Sen. Wyden is likely to be front and center in crafting a bill, as he is a member of two of the committees of jurisdiction: finance and budget, said Mr. Nichols, adding that those committees, along with the Health, Education, Labor and Pensions (HELP) Committee “will play very important roles.”

Ron Pollack, executive director of the advocacy group Families USA, said that although Sen. Wyden may play a part, “I have little doubt that Sen. Baucus is going to be as instrumental in the process as anyone.”

Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, held a health care summit in mid-June. Staff from the Finance Committee and the HELP Committee, led by Sen. Edward M. Kennedy (D-Mass.), have been coordinating meetings with those two panels and the Budget Committee, Mr. Pollack said in an interview.

Committee chairs have the greatest influence on the legislative process, he said. Both Mr. Pollack and Mr. Nichols also expect Sen. Kennedy to play a very significant part in creating the legislation, as much as his cancer will allow.

The latest ad emphasizes the need for health care reform. Health Care First

They'rrrre Baaaaack! Harry and Louise Redux

Harry and Louise, who became infamous in a 1993–1994 television ad lambasting the Clinton administration's health care reform plan, were dragged briefly out of mothballs to appear in a new commercial that urged Congress and the next president to make such reform the top domestic policy priority.

The effort was being bankrolled by five groups that by their own admission have “historically divergent views about health care reform”: the American Cancer Society's Cancer Action Network, the American Hospital Association (AHA), the Catholic Health Association (CHA), Families USA, and the National Federation of Independent Business (NFIB).

“We intend to transcend ideology and partisan politics,” said Families USA Executive Director Ron Pollack at a press conference. The multimillion dollar campaign aired nationally for 2 weeks during the Republican and Democratic conventions.

The ad featured Harry and Louise, back at their kitchen table. The characters were portrayed by the same two actors, now 14 years older. Harry noted that health care costs are going up again and that small businesses are being forced to drop their plans. Louise said that a friend just found out he has cancer and can't afford a plan. Harry remarked that “too many people are falling through the cracks.” Finally, Louise said that “whoever the next president is,” health care should be “at the top of his agenda,” and that he should bring everyone to the table and “make it happen.”

SAN DIEGO — Antibiotic prophylaxis seems to prevent spontaneous bacterial peritonitis in advanced liver disease and also reduces mortality, especially in the short term, according to a report at the annual Digestive Disease Week.

Spontaneous bacterial peritonitis (SBP) develops in 10%–30% of patients with cirrhosis, and the mortality rate is 30%–50%, said Dr. Sammy Saab of the University of California, Los Angeles. The risk of recurrence is as high as 70% in 1 year, he said.

Studies of the effect of antibiotic prophylaxis on prevention and mortality have been inconclusive, Dr. Saab and his colleagues noted. Their aim was to take a broader look at the studies to better assess the effect of prophylaxis.

The researchers conducted a literature search, reviewing the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials, and Medline. They also reviewed citations in the relevant articles and abstracts from 2 decades of national meetings.

They included randomized, controlled clinical trials that compared prophylaxis with placebo or no therapy in patients with cirrhosis and ascites. In all, 65 studies were identified, but only 8 matched the inclusion criteria. The studies included 324 patients who received prophylaxis and 323 patients who were given a placebo or no intervention. In most of the studies, quinolones were used.

Prophylactic therapy reduced the risk of SBP (odds ratio, 0.61). Mortality was also reduced (OR, 0.55).

More specifically, mortality was decreased by 72% during the first 3 months. The mortality rate was 6.2% at 3 months in patients who received treatment, compared with 22% in the placebo arm. At 12 months, mortality was about 20% for those who received treatment, compared with 29% for those receiving placebo.

The overall incidence of infections was also reduced, with a relative risk of 0.32 for treated patients. Only 6.2% of patients in the treated group had infections of any type, compared with 22% of those in the placebo group.

Dr. Saab noted that the study had many limitations. A lack of complete data means that there could be undetected biases. The studies all focused on outpatients, so the authors can't draw any conclusions about inpatients and intravenous antibiotic therapy. Because most of the studies involved quinolones, the preferred antibiotic agent was not revealed. Also, bacterial resistance could be an issue with long-term therapy, but this was not addressed in the studies reviewed.

However, the data do show that oral antibiotics improve outcomes in patients with cirrhosis and ascites, Dr. Saab noted.

SAN DIEGO — Antibiotic prophylaxis seems to prevent spontaneous bacterial peritonitis in advanced liver disease and also reduces mortality, especially in the short term, according to a report at the annual Digestive Disease Week.

Spontaneous bacterial peritonitis (SBP) develops in 10%–30% of patients with cirrhosis, and the mortality rate is 30%–50%, said Dr. Sammy Saab of the University of California, Los Angeles. The risk of recurrence is as high as 70% in 1 year, he said.

Studies of the effect of antibiotic prophylaxis on prevention and mortality have been inconclusive, Dr. Saab and his colleagues noted. Their aim was to take a broader look at the studies to better assess the effect of prophylaxis.

The researchers conducted a literature search, reviewing the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials, and Medline. They also reviewed citations in the relevant articles and abstracts from 2 decades of national meetings.

They included randomized, controlled clinical trials that compared prophylaxis with placebo or no therapy in patients with cirrhosis and ascites. In all, 65 studies were identified, but only 8 matched the inclusion criteria. The studies included 324 patients who received prophylaxis and 323 patients who were given a placebo or no intervention. In most of the studies, quinolones were used.

Prophylactic therapy reduced the risk of SBP (odds ratio, 0.61). Mortality was also reduced (OR, 0.55).

More specifically, mortality was decreased by 72% during the first 3 months. The mortality rate was 6.2% at 3 months in patients who received treatment, compared with 22% in the placebo arm. At 12 months, mortality was about 20% for those who received treatment, compared with 29% for those receiving placebo.

The overall incidence of infections was also reduced, with a relative risk of 0.32 for treated patients. Only 6.2% of patients in the treated group had infections of any type, compared with 22% of those in the placebo group.

Dr. Saab noted that the study had many limitations. A lack of complete data means that there could be undetected biases. The studies all focused on outpatients, so the authors can't draw any conclusions about inpatients and intravenous antibiotic therapy. Because most of the studies involved quinolones, the preferred antibiotic agent was not revealed. Also, bacterial resistance could be an issue with long-term therapy, but this was not addressed in the studies reviewed.

However, the data do show that oral antibiotics improve outcomes in patients with cirrhosis and ascites, Dr. Saab noted.

SAN DIEGO — Antibiotic prophylaxis seems to prevent spontaneous bacterial peritonitis in advanced liver disease and also reduces mortality, especially in the short term, according to a report at the annual Digestive Disease Week.

Spontaneous bacterial peritonitis (SBP) develops in 10%–30% of patients with cirrhosis, and the mortality rate is 30%–50%, said Dr. Sammy Saab of the University of California, Los Angeles. The risk of recurrence is as high as 70% in 1 year, he said.

Studies of the effect of antibiotic prophylaxis on prevention and mortality have been inconclusive, Dr. Saab and his colleagues noted. Their aim was to take a broader look at the studies to better assess the effect of prophylaxis.

The researchers conducted a literature search, reviewing the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials, and Medline. They also reviewed citations in the relevant articles and abstracts from 2 decades of national meetings.

They included randomized, controlled clinical trials that compared prophylaxis with placebo or no therapy in patients with cirrhosis and ascites. In all, 65 studies were identified, but only 8 matched the inclusion criteria. The studies included 324 patients who received prophylaxis and 323 patients who were given a placebo or no intervention. In most of the studies, quinolones were used.

Prophylactic therapy reduced the risk of SBP (odds ratio, 0.61). Mortality was also reduced (OR, 0.55).

More specifically, mortality was decreased by 72% during the first 3 months. The mortality rate was 6.2% at 3 months in patients who received treatment, compared with 22% in the placebo arm. At 12 months, mortality was about 20% for those who received treatment, compared with 29% for those receiving placebo.

The overall incidence of infections was also reduced, with a relative risk of 0.32 for treated patients. Only 6.2% of patients in the treated group had infections of any type, compared with 22% of those in the placebo group.

Dr. Saab noted that the study had many limitations. A lack of complete data means that there could be undetected biases. The studies all focused on outpatients, so the authors can't draw any conclusions about inpatients and intravenous antibiotic therapy. Because most of the studies involved quinolones, the preferred antibiotic agent was not revealed. Also, bacterial resistance could be an issue with long-term therapy, but this was not addressed in the studies reviewed.

However, the data do show that oral antibiotics improve outcomes in patients with cirrhosis and ascites, Dr. Saab noted.

SILVER SPRING, MD. — Tocilizumab's many side effects prompted much discussion during a meeting of the Food and Drug Administration's Arthritis Advisory Committee but did not prevent the drug from winning its recommendation for approval.

The FDA advisory panel voted 10-1 to recommend approval of tocilizumab (Actemra), a humanized anti-IL-6 receptor monoclonal antibody that purports to offer a new line of attack against rheumatoid arthritis (RA). The lone dissenting vote was cast by Diane Aronson, the consumer representative to the Arthritis Advisory Committee, who said she was concerned about tocilizumab's long-term safety issues.

Neither the committee members nor the FDA reviewers took issue with tocilizumab's efficacy. The drug's developers, Chugai Pharmaceutical Co. and Hoffmann-La Roche, said they had already agreed to a postmarketing study that would follow patients for 5 years, and also presented a detailed plan for reducing the risks associated with tocilizumab.

Dr. Gary Hoffman, a panel member from the Cleveland Clinic, said that while safety was a concern, “I don't see a signal here that goes beyond what we've seen with anti-[tumor necrosis factor] agents.”

The FDA usually follows its advisory panels' advice.

The Arthritis Advisory Committee considered data from five pivotal phase III studies and several ongoing open-label extension studies.

Roche was seeking approval for an 8-mg/kg dose, given every 4 weeks, to treat moderately to severely active RA. In several of the pivotal studies, a 4-mg/kg dose was effective, which led some panelists to question whether patients should be started on the higher dose.

Tocilizumab was studied as a monotherapy at 8 mg/kg, and in three studies in combination with methotrexate in patients who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs); another study looked at tocilizumab's efficacy in patients who had an inadequate response to anti-TNF therapy. The primary end point in all five studies was the ACR 20 at 6 months.

Roche pooled the data for the three combination studies and in an analysis of the intent-to-treat population, found that among those who completed the study, 829 (59%) of those taking the 8-mg/kg dose had an ACR 20 response. Only 26% of those taking placebo had an ACR 20.

The patients taking DMARDs had an average 20–30 swollen joints, a mean C-reactive protein of 2.5 mg/dL, and a mean Health Assessment Questionnaire score of 1.5. They had RA for a mean of 9 years.

In patients who were inadequate responders to anti-TNF therapies, 85 (50%) of the 170 patients taking the 8-mg/kg dose had an ACR 20 response at 24 weeks. In the monotherapy study, 200 (70%) of patients taking 8 mg/kg had an ACR 20 at 6 months.

Roche presented safety data from the five pivotal trials and from open-label extension studies. Overall, there were 3,778 patients with exposure to tocilizumab, with the majority—3,242—exposed to 8 mg/kg. Across all the studies, 72% of treated patients had an adverse event. One or more serious adverse events occurred in 152 (6%). The FDA adjusted the incidence rates to account for the differences in exposure. The overall death rate was 0.4 per 100 patient-years on tocilizumab, compared with 0.9 for a DMARD and 0.8 for methotrexate, according to that exposure-adjusted analysis.

Five patients taking tocilizumab died of cardiac etiologies and four from infectious etiologies, said Dr. Sarah Okada, a reviewer from the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products.

There were several adverse events that appeared to signal a possible association with tocilizumab: infections, decreased neutrophil count, gastrointestinal perforations, demyelination, malignancies, stroke and acute myocardial infarction, decreased platelet count, liver enzyme changes, and infusion reactions.

Roche proposed a variety of recommendations to minimize risk of these adverse events, including TB screening and close laboratory monitoring for neutrophils, platelets, cholesterol, and liver enzymes.

The panelists agreed with the need for close patient follow-up, particularly on lab values.

SILVER SPRING, MD. — Tocilizumab's many side effects prompted much discussion during a meeting of the Food and Drug Administration's Arthritis Advisory Committee but did not prevent the drug from winning its recommendation for approval.

The FDA advisory panel voted 10-1 to recommend approval of tocilizumab (Actemra), a humanized anti-IL-6 receptor monoclonal antibody that purports to offer a new line of attack against rheumatoid arthritis (RA). The lone dissenting vote was cast by Diane Aronson, the consumer representative to the Arthritis Advisory Committee, who said she was concerned about tocilizumab's long-term safety issues.

Neither the committee members nor the FDA reviewers took issue with tocilizumab's efficacy. The drug's developers, Chugai Pharmaceutical Co. and Hoffmann-La Roche, said they had already agreed to a postmarketing study that would follow patients for 5 years, and also presented a detailed plan for reducing the risks associated with tocilizumab.

Dr. Gary Hoffman, a panel member from the Cleveland Clinic, said that while safety was a concern, “I don't see a signal here that goes beyond what we've seen with anti-[tumor necrosis factor] agents.”

The FDA usually follows its advisory panels' advice.

The Arthritis Advisory Committee considered data from five pivotal phase III studies and several ongoing open-label extension studies.

Roche was seeking approval for an 8-mg/kg dose, given every 4 weeks, to treat moderately to severely active RA. In several of the pivotal studies, a 4-mg/kg dose was effective, which led some panelists to question whether patients should be started on the higher dose.

Tocilizumab was studied as a monotherapy at 8 mg/kg, and in three studies in combination with methotrexate in patients who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs); another study looked at tocilizumab's efficacy in patients who had an inadequate response to anti-TNF therapy. The primary end point in all five studies was the ACR 20 at 6 months.

Roche pooled the data for the three combination studies and in an analysis of the intent-to-treat population, found that among those who completed the study, 829 (59%) of those taking the 8-mg/kg dose had an ACR 20 response. Only 26% of those taking placebo had an ACR 20.

The patients taking DMARDs had an average 20–30 swollen joints, a mean C-reactive protein of 2.5 mg/dL, and a mean Health Assessment Questionnaire score of 1.5. They had RA for a mean of 9 years.

In patients who were inadequate responders to anti-TNF therapies, 85 (50%) of the 170 patients taking the 8-mg/kg dose had an ACR 20 response at 24 weeks. In the monotherapy study, 200 (70%) of patients taking 8 mg/kg had an ACR 20 at 6 months.

Roche presented safety data from the five pivotal trials and from open-label extension studies. Overall, there were 3,778 patients with exposure to tocilizumab, with the majority—3,242—exposed to 8 mg/kg. Across all the studies, 72% of treated patients had an adverse event. One or more serious adverse events occurred in 152 (6%). The FDA adjusted the incidence rates to account for the differences in exposure. The overall death rate was 0.4 per 100 patient-years on tocilizumab, compared with 0.9 for a DMARD and 0.8 for methotrexate, according to that exposure-adjusted analysis.

Five patients taking tocilizumab died of cardiac etiologies and four from infectious etiologies, said Dr. Sarah Okada, a reviewer from the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products.

There were several adverse events that appeared to signal a possible association with tocilizumab: infections, decreased neutrophil count, gastrointestinal perforations, demyelination, malignancies, stroke and acute myocardial infarction, decreased platelet count, liver enzyme changes, and infusion reactions.

Roche proposed a variety of recommendations to minimize risk of these adverse events, including TB screening and close laboratory monitoring for neutrophils, platelets, cholesterol, and liver enzymes.

The panelists agreed with the need for close patient follow-up, particularly on lab values.

SILVER SPRING, MD. — Tocilizumab's many side effects prompted much discussion during a meeting of the Food and Drug Administration's Arthritis Advisory Committee but did not prevent the drug from winning its recommendation for approval.

The FDA advisory panel voted 10-1 to recommend approval of tocilizumab (Actemra), a humanized anti-IL-6 receptor monoclonal antibody that purports to offer a new line of attack against rheumatoid arthritis (RA). The lone dissenting vote was cast by Diane Aronson, the consumer representative to the Arthritis Advisory Committee, who said she was concerned about tocilizumab's long-term safety issues.

Neither the committee members nor the FDA reviewers took issue with tocilizumab's efficacy. The drug's developers, Chugai Pharmaceutical Co. and Hoffmann-La Roche, said they had already agreed to a postmarketing study that would follow patients for 5 years, and also presented a detailed plan for reducing the risks associated with tocilizumab.

Dr. Gary Hoffman, a panel member from the Cleveland Clinic, said that while safety was a concern, “I don't see a signal here that goes beyond what we've seen with anti-[tumor necrosis factor] agents.”

The FDA usually follows its advisory panels' advice.

The Arthritis Advisory Committee considered data from five pivotal phase III studies and several ongoing open-label extension studies.

Roche was seeking approval for an 8-mg/kg dose, given every 4 weeks, to treat moderately to severely active RA. In several of the pivotal studies, a 4-mg/kg dose was effective, which led some panelists to question whether patients should be started on the higher dose.

Tocilizumab was studied as a monotherapy at 8 mg/kg, and in three studies in combination with methotrexate in patients who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs); another study looked at tocilizumab's efficacy in patients who had an inadequate response to anti-TNF therapy. The primary end point in all five studies was the ACR 20 at 6 months.

Roche pooled the data for the three combination studies and in an analysis of the intent-to-treat population, found that among those who completed the study, 829 (59%) of those taking the 8-mg/kg dose had an ACR 20 response. Only 26% of those taking placebo had an ACR 20.

The patients taking DMARDs had an average 20–30 swollen joints, a mean C-reactive protein of 2.5 mg/dL, and a mean Health Assessment Questionnaire score of 1.5. They had RA for a mean of 9 years.

In patients who were inadequate responders to anti-TNF therapies, 85 (50%) of the 170 patients taking the 8-mg/kg dose had an ACR 20 response at 24 weeks. In the monotherapy study, 200 (70%) of patients taking 8 mg/kg had an ACR 20 at 6 months.

Roche presented safety data from the five pivotal trials and from open-label extension studies. Overall, there were 3,778 patients with exposure to tocilizumab, with the majority—3,242—exposed to 8 mg/kg. Across all the studies, 72% of treated patients had an adverse event. One or more serious adverse events occurred in 152 (6%). The FDA adjusted the incidence rates to account for the differences in exposure. The overall death rate was 0.4 per 100 patient-years on tocilizumab, compared with 0.9 for a DMARD and 0.8 for methotrexate, according to that exposure-adjusted analysis.

Five patients taking tocilizumab died of cardiac etiologies and four from infectious etiologies, said Dr. Sarah Okada, a reviewer from the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products.

There were several adverse events that appeared to signal a possible association with tocilizumab: infections, decreased neutrophil count, gastrointestinal perforations, demyelination, malignancies, stroke and acute myocardial infarction, decreased platelet count, liver enzyme changes, and infusion reactions.

Roche proposed a variety of recommendations to minimize risk of these adverse events, including TB screening and close laboratory monitoring for neutrophils, platelets, cholesterol, and liver enzymes.

The panelists agreed with the need for close patient follow-up, particularly on lab values.

WASHINGTON – Hispanics may place significant stress on the health care system in the future, as they are projected to be the largest segment of the population by 2050, but are less likely to have a usual source of care and have less knowledge about chronic disease, according to new data from the Pew Hispanic Center and the U.S. Census Bureau.

The Hispanic population will triple from 2008 to 2050, rising from 47 million today to 133 million in 4 decades. By 2050, Hispanics will make up 30% of the nation's total population, according to the Census Bureau.

Currently, there are 30 million Hispanic adults in the United States, according a new report from the Pew Hispanic Center, “Hispanics and Health Care in the United States: Access, Information and Knowledge.” The Pew Hispanic Center, in conjunction with the Robert Wood Johnson Foundation, conducted a national telephone survey in 2007; about 4,000 Hispanic individuals completed the survey.

The data showed that Hispanics generally tend to be young and healthy, but have a high prevalence of obesity and a predisposition to diabetes, indicating a potential future crisis, said Susan Minushkin, deputy director of the Pew Hispanic Center, in a briefing with reporters. The Centers for Disease Control and Prevention has estimated that 10% of Hispanics have diabetes, 20% have hypertension, 40% are overweight, and 27% are obese, she said.

Therefore, it is worrisome that 27% of Hispanics–about 8 million adults–lacked a usual health care provider, said Ms. Minushkin. Only 62% of Hispanics without a usual provider had a blood pressure check in the last 2 years, compared with 86% of those who have a provider, the Pew Center found. Only 67% of those lacking a usual provider had a blood sugar test in the last 2 years, compared with 90% of those who have a provider.

Diabetes knowledge was inconsistent, even among those diagnosed with the disease, the Pew Center found. Twenty-seven percent of diagnosed diabetics answered at least three of eight questions about the disease incorrectly. Overall, Hispanic women were more likely to give correct answers, as were middle-aged Hispanics of both sexes. Immigrants had the least amount of knowledge.

Those who did not have a usual health care provider were more likely to be young (aged 18–29 years), to lack a high school diploma, and to be uninsured. They also were more likely to be predominantly Spanish-speaking and to be foreign-born but not yet legal permanent residents. Mexicans and Central Americans were most likely to lack a usual provider.

But 45% of those who did not have a usual provider had health insurance.

The primary reason–given by 41% of respondents–for not having a usual health care provider was that they were seldom or never sick. Another 13% said they treat themselves or don't use a physician. Eleven percent said the cost of care was prohibitive, 2% said they didn't know where to go for care, and 1% said they couldn't find a provider who spoke their language.

Though the vast majority–78%–rated the quality of their care as good or excellent, about 25% said the care they received was poor, which they blamed on their ethnicity or their English-speaking skills or accent.

More than two-thirds of respondents (71%) said they received information about health from a physician or other medical professional, but 83% said they received it from the media. “I can't comment on whether the information they are getting is good or bad,” said Ms. Minushkin, adding that the Pew Center did not ask what types of media were being cited. But, she added, “those who do get information from the media make changes in their behavior.”

At the press briefing, William A. Vega, Ph.D., professor of medicine at the University of California, Los Angeles, noted that the Hispanic population is going through “an intense process of assimilation, including learning how to use the health care system.”

He added, “This study really points out where the jagged edges are.” For instance, the nation has undergone a significant shift toward specialty care, but “populations such as Latinos require greater access to primary care.”

WASHINGTON – Hispanics may place significant stress on the health care system in the future, as they are projected to be the largest segment of the population by 2050, but are less likely to have a usual source of care and have less knowledge about chronic disease, according to new data from the Pew Hispanic Center and the U.S. Census Bureau.

The Hispanic population will triple from 2008 to 2050, rising from 47 million today to 133 million in 4 decades. By 2050, Hispanics will make up 30% of the nation's total population, according to the Census Bureau.

Currently, there are 30 million Hispanic adults in the United States, according a new report from the Pew Hispanic Center, “Hispanics and Health Care in the United States: Access, Information and Knowledge.” The Pew Hispanic Center, in conjunction with the Robert Wood Johnson Foundation, conducted a national telephone survey in 2007; about 4,000 Hispanic individuals completed the survey.

The data showed that Hispanics generally tend to be young and healthy, but have a high prevalence of obesity and a predisposition to diabetes, indicating a potential future crisis, said Susan Minushkin, deputy director of the Pew Hispanic Center, in a briefing with reporters. The Centers for Disease Control and Prevention has estimated that 10% of Hispanics have diabetes, 20% have hypertension, 40% are overweight, and 27% are obese, she said.

Therefore, it is worrisome that 27% of Hispanics–about 8 million adults–lacked a usual health care provider, said Ms. Minushkin. Only 62% of Hispanics without a usual provider had a blood pressure check in the last 2 years, compared with 86% of those who have a provider, the Pew Center found. Only 67% of those lacking a usual provider had a blood sugar test in the last 2 years, compared with 90% of those who have a provider.

Diabetes knowledge was inconsistent, even among those diagnosed with the disease, the Pew Center found. Twenty-seven percent of diagnosed diabetics answered at least three of eight questions about the disease incorrectly. Overall, Hispanic women were more likely to give correct answers, as were middle-aged Hispanics of both sexes. Immigrants had the least amount of knowledge.

Those who did not have a usual health care provider were more likely to be young (aged 18–29 years), to lack a high school diploma, and to be uninsured. They also were more likely to be predominantly Spanish-speaking and to be foreign-born but not yet legal permanent residents. Mexicans and Central Americans were most likely to lack a usual provider.

But 45% of those who did not have a usual provider had health insurance.

The primary reason–given by 41% of respondents–for not having a usual health care provider was that they were seldom or never sick. Another 13% said they treat themselves or don't use a physician. Eleven percent said the cost of care was prohibitive, 2% said they didn't know where to go for care, and 1% said they couldn't find a provider who spoke their language.

Though the vast majority–78%–rated the quality of their care as good or excellent, about 25% said the care they received was poor, which they blamed on their ethnicity or their English-speaking skills or accent.

More than two-thirds of respondents (71%) said they received information about health from a physician or other medical professional, but 83% said they received it from the media. “I can't comment on whether the information they are getting is good or bad,” said Ms. Minushkin, adding that the Pew Center did not ask what types of media were being cited. But, she added, “those who do get information from the media make changes in their behavior.”

At the press briefing, William A. Vega, Ph.D., professor of medicine at the University of California, Los Angeles, noted that the Hispanic population is going through “an intense process of assimilation, including learning how to use the health care system.”

He added, “This study really points out where the jagged edges are.” For instance, the nation has undergone a significant shift toward specialty care, but “populations such as Latinos require greater access to primary care.”

WASHINGTON – Hispanics may place significant stress on the health care system in the future, as they are projected to be the largest segment of the population by 2050, but are less likely to have a usual source of care and have less knowledge about chronic disease, according to new data from the Pew Hispanic Center and the U.S. Census Bureau.

The Hispanic population will triple from 2008 to 2050, rising from 47 million today to 133 million in 4 decades. By 2050, Hispanics will make up 30% of the nation's total population, according to the Census Bureau.

Currently, there are 30 million Hispanic adults in the United States, according a new report from the Pew Hispanic Center, “Hispanics and Health Care in the United States: Access, Information and Knowledge.” The Pew Hispanic Center, in conjunction with the Robert Wood Johnson Foundation, conducted a national telephone survey in 2007; about 4,000 Hispanic individuals completed the survey.

The data showed that Hispanics generally tend to be young and healthy, but have a high prevalence of obesity and a predisposition to diabetes, indicating a potential future crisis, said Susan Minushkin, deputy director of the Pew Hispanic Center, in a briefing with reporters. The Centers for Disease Control and Prevention has estimated that 10% of Hispanics have diabetes, 20% have hypertension, 40% are overweight, and 27% are obese, she said.

Therefore, it is worrisome that 27% of Hispanics–about 8 million adults–lacked a usual health care provider, said Ms. Minushkin. Only 62% of Hispanics without a usual provider had a blood pressure check in the last 2 years, compared with 86% of those who have a provider, the Pew Center found. Only 67% of those lacking a usual provider had a blood sugar test in the last 2 years, compared with 90% of those who have a provider.

Diabetes knowledge was inconsistent, even among those diagnosed with the disease, the Pew Center found. Twenty-seven percent of diagnosed diabetics answered at least three of eight questions about the disease incorrectly. Overall, Hispanic women were more likely to give correct answers, as were middle-aged Hispanics of both sexes. Immigrants had the least amount of knowledge.

Those who did not have a usual health care provider were more likely to be young (aged 18–29 years), to lack a high school diploma, and to be uninsured. They also were more likely to be predominantly Spanish-speaking and to be foreign-born but not yet legal permanent residents. Mexicans and Central Americans were most likely to lack a usual provider.

But 45% of those who did not have a usual provider had health insurance.

The primary reason–given by 41% of respondents–for not having a usual health care provider was that they were seldom or never sick. Another 13% said they treat themselves or don't use a physician. Eleven percent said the cost of care was prohibitive, 2% said they didn't know where to go for care, and 1% said they couldn't find a provider who spoke their language.

Though the vast majority–78%–rated the quality of their care as good or excellent, about 25% said the care they received was poor, which they blamed on their ethnicity or their English-speaking skills or accent.

More than two-thirds of respondents (71%) said they received information about health from a physician or other medical professional, but 83% said they received it from the media. “I can't comment on whether the information they are getting is good or bad,” said Ms. Minushkin, adding that the Pew Center did not ask what types of media were being cited. But, she added, “those who do get information from the media make changes in their behavior.”

At the press briefing, William A. Vega, Ph.D., professor of medicine at the University of California, Los Angeles, noted that the Hispanic population is going through “an intense process of assimilation, including learning how to use the health care system.”

He added, “This study really points out where the jagged edges are.” For instance, the nation has undergone a significant shift toward specialty care, but “populations such as Latinos require greater access to primary care.”

APA Examining Industry Funding

The American Psychiatric Association is considering phasing out all pharmaceutical industry funding. But the move is not a reaction to a recent request from Sen. Chuck Grassley (R-Iowa) for an accounting of how much drug industry money the APA receives, according to Rhondalee Dean-Royce, a spokeswoman for the association. The APA set up an Ad Hoc Workgroup on Adapting to Changes in Pharmaceutical Revenue in March; the work group's goal is to consider the impact if the APA decides to eliminate its industry support. In 2006, the latest year statistics are available, the APA received $18.3 million of its $62.5 million budget from drug companies, Ms. Dean-Royce said. She added that expenses related to those revenues totaled $14.6 million, leaving a “net gain of $3.7 million.” The work group will report to the APA board of trustees in the fall or early next year.

Teens' Easy Access to Rx Drugs

Nineteen percent of teens in a recent survey said it was easy to buy prescription drugs, while only 15% said it was easy to buy beer, according to the National Center on Addiction and Substance Abuse (CASA) at Columbia University. This year's survey was CASA's 13th. Twenty-four percent said they had friends or classmates who abused prescription drugs; that number has held steady since 2003. A third of the teens said they got the prescriptions from friends or classmates and a third from home, parents, or the medicine cabinet. Half said that painkillers were the most commonly abused prescription drugs. Twenty-three percent said it was easier to buy marijuana than beer, with 42% of 12- to 17-year-olds reporting that they could buy pot in a day or less, and 23% in an hour or less. Drugs are the top concern for teens; 28% said it was the biggest problem they face. There was also a strong correlation between drug and alcohol use and staying out past 10 p.m.

SAMHSA Offers Methadone Help

The Substance Abuse and Mental Health Services Administration (SAMHSA) is developing a national network to provide clinical updates, evidence-based outcomes, and education to opioid addiction treatment centers, physicians, and other providers in the appropriate use of methadone. The agency is granting $1.5 million to the American Society of Addiction Medicine for training under a 3-year cooperative agreement. In a statement, SAMHSA Administrator Terry Cline, Ph.D., said the most recent statistics indicate that methadone poisoning deaths have increased nearly fourfold from 786 deaths in 1999 to 3,849 deaths in 2004, and that they were on track to increase in 2005.

Home Drug Errors Rise

A shift in the number of medications being taken outside of the hospital has correlated with a sharp increase in the number of fatal medication errors in the home, researchers reported in the Archives of Internal Medicine. Sociologists at the University of California, San Diego, found a 3,196% increase in fatal domestic medication errors involving alcohol and/or street drugs, and a 564% increase in domestic medication fatalities not involving alcohol and/or street drugs. The study examined nearly 50 million U.S. death certificates from 1983 to 2004, and focused on the 200,000 deaths involving medication errors. “The decades-long shift in the location of medication consumption from clinical to domestic settings is linked to a dramatic increase in fatal medication errors,” the authors said. They noted that it may be possible to reduce fatal medication errors by focusing education efforts on domestic settings in addition to clinical settings.

Health Searches Level Off

The number of adults going online for health information has plateaued or declined, according to a Harris Interactive poll. A total of 150 million people–66% of all adults and 81% of those who have online access–said they obtained health information from the Internet in 2008. That represents a slight drop from 2007, when the poll found that 160 million people reported obtaining health information online. The researchers noted that the slight differences from 2007 to 2008 are within the possible sampling error. But they pointed out that, as opposed to other years, it appears that there has been no increase in the total number of people with Internet access or in the number of people searching for health information–those the poll calls “cybercondriacs”–indicating that a plateau or even a slight decline was underway. Just under half of cybercondriacs said that they had discussed the information they obtained online with their doctors, and 49% had gone online to look for information as a result of discussions with their doctors, the survey found.

Genomics Collaboration

Pharmacy benefit manager Medco Health Solutions and the Food and Drug Administration have partnered to study genetic testing and the impact of genetics prescription drug efficacy, according to Medco. The agreement extends to Aug. 31, 2010. Over the next 2 years, Medco will deliver a series of reports to the FDA that will address the safety of prescription drugs, physician participation in pharmacogenomics testing, the usefulness of the tests in prescribing, and quantifying prescription information that contains genetic information. Medco said its reports will be derived from clinical settings, including one that will examine whether physicians are willing to change the dose of a prescription based on a genetic test result. “Studying this field can advance pharmacy care to remove some of the trial and error in how medications are prescribed,” Medco chief medical officer Dr. Robert Epstein, said in a statement.

APA Examining Industry Funding

The American Psychiatric Association is considering phasing out all pharmaceutical industry funding. But the move is not a reaction to a recent request from Sen. Chuck Grassley (R-Iowa) for an accounting of how much drug industry money the APA receives, according to Rhondalee Dean-Royce, a spokeswoman for the association. The APA set up an Ad Hoc Workgroup on Adapting to Changes in Pharmaceutical Revenue in March; the work group's goal is to consider the impact if the APA decides to eliminate its industry support. In 2006, the latest year statistics are available, the APA received $18.3 million of its $62.5 million budget from drug companies, Ms. Dean-Royce said. She added that expenses related to those revenues totaled $14.6 million, leaving a “net gain of $3.7 million.” The work group will report to the APA board of trustees in the fall or early next year.

Teens' Easy Access to Rx Drugs

Nineteen percent of teens in a recent survey said it was easy to buy prescription drugs, while only 15% said it was easy to buy beer, according to the National Center on Addiction and Substance Abuse (CASA) at Columbia University. This year's survey was CASA's 13th. Twenty-four percent said they had friends or classmates who abused prescription drugs; that number has held steady since 2003. A third of the teens said they got the prescriptions from friends or classmates and a third from home, parents, or the medicine cabinet. Half said that painkillers were the most commonly abused prescription drugs. Twenty-three percent said it was easier to buy marijuana than beer, with 42% of 12- to 17-year-olds reporting that they could buy pot in a day or less, and 23% in an hour or less. Drugs are the top concern for teens; 28% said it was the biggest problem they face. There was also a strong correlation between drug and alcohol use and staying out past 10 p.m.

SAMHSA Offers Methadone Help

The Substance Abuse and Mental Health Services Administration (SAMHSA) is developing a national network to provide clinical updates, evidence-based outcomes, and education to opioid addiction treatment centers, physicians, and other providers in the appropriate use of methadone. The agency is granting $1.5 million to the American Society of Addiction Medicine for training under a 3-year cooperative agreement. In a statement, SAMHSA Administrator Terry Cline, Ph.D., said the most recent statistics indicate that methadone poisoning deaths have increased nearly fourfold from 786 deaths in 1999 to 3,849 deaths in 2004, and that they were on track to increase in 2005.

Home Drug Errors Rise

A shift in the number of medications being taken outside of the hospital has correlated with a sharp increase in the number of fatal medication errors in the home, researchers reported in the Archives of Internal Medicine. Sociologists at the University of California, San Diego, found a 3,196% increase in fatal domestic medication errors involving alcohol and/or street drugs, and a 564% increase in domestic medication fatalities not involving alcohol and/or street drugs. The study examined nearly 50 million U.S. death certificates from 1983 to 2004, and focused on the 200,000 deaths involving medication errors. “The decades-long shift in the location of medication consumption from clinical to domestic settings is linked to a dramatic increase in fatal medication errors,” the authors said. They noted that it may be possible to reduce fatal medication errors by focusing education efforts on domestic settings in addition to clinical settings.

Health Searches Level Off

The number of adults going online for health information has plateaued or declined, according to a Harris Interactive poll. A total of 150 million people–66% of all adults and 81% of those who have online access–said they obtained health information from the Internet in 2008. That represents a slight drop from 2007, when the poll found that 160 million people reported obtaining health information online. The researchers noted that the slight differences from 2007 to 2008 are within the possible sampling error. But they pointed out that, as opposed to other years, it appears that there has been no increase in the total number of people with Internet access or in the number of people searching for health information–those the poll calls “cybercondriacs”–indicating that a plateau or even a slight decline was underway. Just under half of cybercondriacs said that they had discussed the information they obtained online with their doctors, and 49% had gone online to look for information as a result of discussions with their doctors, the survey found.

Genomics Collaboration

Pharmacy benefit manager Medco Health Solutions and the Food and Drug Administration have partnered to study genetic testing and the impact of genetics prescription drug efficacy, according to Medco. The agreement extends to Aug. 31, 2010. Over the next 2 years, Medco will deliver a series of reports to the FDA that will address the safety of prescription drugs, physician participation in pharmacogenomics testing, the usefulness of the tests in prescribing, and quantifying prescription information that contains genetic information. Medco said its reports will be derived from clinical settings, including one that will examine whether physicians are willing to change the dose of a prescription based on a genetic test result. “Studying this field can advance pharmacy care to remove some of the trial and error in how medications are prescribed,” Medco chief medical officer Dr. Robert Epstein, said in a statement.

APA Examining Industry Funding

The American Psychiatric Association is considering phasing out all pharmaceutical industry funding. But the move is not a reaction to a recent request from Sen. Chuck Grassley (R-Iowa) for an accounting of how much drug industry money the APA receives, according to Rhondalee Dean-Royce, a spokeswoman for the association. The APA set up an Ad Hoc Workgroup on Adapting to Changes in Pharmaceutical Revenue in March; the work group's goal is to consider the impact if the APA decides to eliminate its industry support. In 2006, the latest year statistics are available, the APA received $18.3 million of its $62.5 million budget from drug companies, Ms. Dean-Royce said. She added that expenses related to those revenues totaled $14.6 million, leaving a “net gain of $3.7 million.” The work group will report to the APA board of trustees in the fall or early next year.

Teens' Easy Access to Rx Drugs

Nineteen percent of teens in a recent survey said it was easy to buy prescription drugs, while only 15% said it was easy to buy beer, according to the National Center on Addiction and Substance Abuse (CASA) at Columbia University. This year's survey was CASA's 13th. Twenty-four percent said they had friends or classmates who abused prescription drugs; that number has held steady since 2003. A third of the teens said they got the prescriptions from friends or classmates and a third from home, parents, or the medicine cabinet. Half said that painkillers were the most commonly abused prescription drugs. Twenty-three percent said it was easier to buy marijuana than beer, with 42% of 12- to 17-year-olds reporting that they could buy pot in a day or less, and 23% in an hour or less. Drugs are the top concern for teens; 28% said it was the biggest problem they face. There was also a strong correlation between drug and alcohol use and staying out past 10 p.m.

SAMHSA Offers Methadone Help

The Substance Abuse and Mental Health Services Administration (SAMHSA) is developing a national network to provide clinical updates, evidence-based outcomes, and education to opioid addiction treatment centers, physicians, and other providers in the appropriate use of methadone. The agency is granting $1.5 million to the American Society of Addiction Medicine for training under a 3-year cooperative agreement. In a statement, SAMHSA Administrator Terry Cline, Ph.D., said the most recent statistics indicate that methadone poisoning deaths have increased nearly fourfold from 786 deaths in 1999 to 3,849 deaths in 2004, and that they were on track to increase in 2005.

Home Drug Errors Rise

A shift in the number of medications being taken outside of the hospital has correlated with a sharp increase in the number of fatal medication errors in the home, researchers reported in the Archives of Internal Medicine. Sociologists at the University of California, San Diego, found a 3,196% increase in fatal domestic medication errors involving alcohol and/or street drugs, and a 564% increase in domestic medication fatalities not involving alcohol and/or street drugs. The study examined nearly 50 million U.S. death certificates from 1983 to 2004, and focused on the 200,000 deaths involving medication errors. “The decades-long shift in the location of medication consumption from clinical to domestic settings is linked to a dramatic increase in fatal medication errors,” the authors said. They noted that it may be possible to reduce fatal medication errors by focusing education efforts on domestic settings in addition to clinical settings.

Health Searches Level Off

The number of adults going online for health information has plateaued or declined, according to a Harris Interactive poll. A total of 150 million people–66% of all adults and 81% of those who have online access–said they obtained health information from the Internet in 2008. That represents a slight drop from 2007, when the poll found that 160 million people reported obtaining health information online. The researchers noted that the slight differences from 2007 to 2008 are within the possible sampling error. But they pointed out that, as opposed to other years, it appears that there has been no increase in the total number of people with Internet access or in the number of people searching for health information–those the poll calls “cybercondriacs”–indicating that a plateau or even a slight decline was underway. Just under half of cybercondriacs said that they had discussed the information they obtained online with their doctors, and 49% had gone online to look for information as a result of discussions with their doctors, the survey found.

Genomics Collaboration

Pharmacy benefit manager Medco Health Solutions and the Food and Drug Administration have partnered to study genetic testing and the impact of genetics prescription drug efficacy, according to Medco. The agreement extends to Aug. 31, 2010. Over the next 2 years, Medco will deliver a series of reports to the FDA that will address the safety of prescription drugs, physician participation in pharmacogenomics testing, the usefulness of the tests in prescribing, and quantifying prescription information that contains genetic information. Medco said its reports will be derived from clinical settings, including one that will examine whether physicians are willing to change the dose of a prescription based on a genetic test result. “Studying this field can advance pharmacy care to remove some of the trial and error in how medications are prescribed,” Medco chief medical officer Dr. Robert Epstein, said in a statement.

Medicare is making good on a promise to reduce what it sees as runaway costs for certain imaging services in its final rule on hospital outpatient payments for 2009.

The Centers for Medicare and Medicaid Services (CMS) also said that it will continue to hold outpatient departments accountable for quality of care by reducing payment when there has been a failure to meet reporting requirements.

In July, the CMS had proposed to increase outpatient pay by 3% in 2009; that has been increased to 3.6% in the final rule. Hospitals (and other entities that receive payments under the outpatient system) that do not report on the 11 quality measures required for 2009 will receive an increase of 1.6% in payments in 2010.

Quality is a big centerpiece of the new rule. The CMS put hospital outpatient departments on notice that, in the near future, it expects to propose the withholding of payment for care related to illnesses or injuries acquired during the outpatient encounter. Hospitals are already being held accountable for acquired conditions on the inpatient side.

The final rule, published in the Nov. 18 Federal Register, applies to 4,000 outpatient departments, according to the CMS. The agency expects to pay $30 billion in 2009 for outpatient services, up from an estimated $28 billion in 2008.

Imaging services received a special focus. As proposed earlier in the year, the CMS said that it will now make only a single payment for multiple images made in a single outpatient session.

The agency created five imaging-payment groups: ultrasound; computed tomography and computed tomographic angiography without contrast; CT and CTA with contrast; magnetic resonance imaging and magnetic resonance angiography without contrast; and MRI and MRA with contrast.

This new scheme may result in underpayment, according to Madeleine Smith, senior vice president of payment and health care delivery policy at the Advanced Medical Technology Association (AdvaMed), a medical device trade group. AdvaMed expressed concern about the policy when it was proposed because it may provide insufficient payments for multiple procedures when contrast is used with every procedure. AdvaMed also objected to the CMS's proposal that outpatient departments report on four imaging-quality measures in 2009.

Those measures include MRI of the lumbar spine for lower back pain; mammography follow-up rates; certain abdominal CT scans with contrast; and thorax CT with contrast.

The measures were reviewed by the National Quality Forum, but two of the four, certain CT scans and mammography follow-up rates, were rejected, Ms. Smith said in an interview.

Most device-related procedures in cardiology, neurology, and gynecology will receive minimal increases in payment. But some will see fairly large cuts, including implantation of left ventricular pacing leads (45% reduction) and placement of neurostimulator electrodes (49% reduction).

The agency also followed through on its proposal to institute four new payment groups for visits to “Type B” emergency departments (those that are not open around the clock). Type B reimbursement will be lower than reimbursement for full-service emergency departments.

In addition, over the objections of industry groups, the CMS is dropping the additional fee it was paying outpatient departments for the administration of intravenous immune globulin therapy.

Medicare also is updating conditions for coverage that ambulatory surgery centers must meet, including requirements that centers be more transparent about physicians' financial interests, and that appropriate postsurgical care be ensured.

Medicare is making good on a promise to reduce what it sees as runaway costs for certain imaging services in its final rule on hospital outpatient payments for 2009.

The Centers for Medicare and Medicaid Services (CMS) also said that it will continue to hold outpatient departments accountable for quality of care by reducing payment when there has been a failure to meet reporting requirements.

In July, the CMS had proposed to increase outpatient pay by 3% in 2009; that has been increased to 3.6% in the final rule. Hospitals (and other entities that receive payments under the outpatient system) that do not report on the 11 quality measures required for 2009 will receive an increase of 1.6% in payments in 2010.

Quality is a big centerpiece of the new rule. The CMS put hospital outpatient departments on notice that, in the near future, it expects to propose the withholding of payment for care related to illnesses or injuries acquired during the outpatient encounter. Hospitals are already being held accountable for acquired conditions on the inpatient side.

The final rule, published in the Nov. 18 Federal Register, applies to 4,000 outpatient departments, according to the CMS. The agency expects to pay $30 billion in 2009 for outpatient services, up from an estimated $28 billion in 2008.

Imaging services received a special focus. As proposed earlier in the year, the CMS said that it will now make only a single payment for multiple images made in a single outpatient session.

The agency created five imaging-payment groups: ultrasound; computed tomography and computed tomographic angiography without contrast; CT and CTA with contrast; magnetic resonance imaging and magnetic resonance angiography without contrast; and MRI and MRA with contrast.

This new scheme may result in underpayment, according to Madeleine Smith, senior vice president of payment and health care delivery policy at the Advanced Medical Technology Association (AdvaMed), a medical device trade group. AdvaMed expressed concern about the policy when it was proposed because it may provide insufficient payments for multiple procedures when contrast is used with every procedure. AdvaMed also objected to the CMS's proposal that outpatient departments report on four imaging-quality measures in 2009.

Those measures include MRI of the lumbar spine for lower back pain; mammography follow-up rates; certain abdominal CT scans with contrast; and thorax CT with contrast.

The measures were reviewed by the National Quality Forum, but two of the four, certain CT scans and mammography follow-up rates, were rejected, Ms. Smith said in an interview.

Most device-related procedures in cardiology, neurology, and gynecology will receive minimal increases in payment. But some will see fairly large cuts, including implantation of left ventricular pacing leads (45% reduction) and placement of neurostimulator electrodes (49% reduction).

The agency also followed through on its proposal to institute four new payment groups for visits to “Type B” emergency departments (those that are not open around the clock). Type B reimbursement will be lower than reimbursement for full-service emergency departments.

In addition, over the objections of industry groups, the CMS is dropping the additional fee it was paying outpatient departments for the administration of intravenous immune globulin therapy.

Medicare also is updating conditions for coverage that ambulatory surgery centers must meet, including requirements that centers be more transparent about physicians' financial interests, and that appropriate postsurgical care be ensured.

Medicare is making good on a promise to reduce what it sees as runaway costs for certain imaging services in its final rule on hospital outpatient payments for 2009.

The Centers for Medicare and Medicaid Services (CMS) also said that it will continue to hold outpatient departments accountable for quality of care by reducing payment when there has been a failure to meet reporting requirements.

In July, the CMS had proposed to increase outpatient pay by 3% in 2009; that has been increased to 3.6% in the final rule. Hospitals (and other entities that receive payments under the outpatient system) that do not report on the 11 quality measures required for 2009 will receive an increase of 1.6% in payments in 2010.

Quality is a big centerpiece of the new rule. The CMS put hospital outpatient departments on notice that, in the near future, it expects to propose the withholding of payment for care related to illnesses or injuries acquired during the outpatient encounter. Hospitals are already being held accountable for acquired conditions on the inpatient side.

The final rule, published in the Nov. 18 Federal Register, applies to 4,000 outpatient departments, according to the CMS. The agency expects to pay $30 billion in 2009 for outpatient services, up from an estimated $28 billion in 2008.

Imaging services received a special focus. As proposed earlier in the year, the CMS said that it will now make only a single payment for multiple images made in a single outpatient session.

The agency created five imaging-payment groups: ultrasound; computed tomography and computed tomographic angiography without contrast; CT and CTA with contrast; magnetic resonance imaging and magnetic resonance angiography without contrast; and MRI and MRA with contrast.

This new scheme may result in underpayment, according to Madeleine Smith, senior vice president of payment and health care delivery policy at the Advanced Medical Technology Association (AdvaMed), a medical device trade group. AdvaMed expressed concern about the policy when it was proposed because it may provide insufficient payments for multiple procedures when contrast is used with every procedure. AdvaMed also objected to the CMS's proposal that outpatient departments report on four imaging-quality measures in 2009.

Those measures include MRI of the lumbar spine for lower back pain; mammography follow-up rates; certain abdominal CT scans with contrast; and thorax CT with contrast.

The measures were reviewed by the National Quality Forum, but two of the four, certain CT scans and mammography follow-up rates, were rejected, Ms. Smith said in an interview.

Most device-related procedures in cardiology, neurology, and gynecology will receive minimal increases in payment. But some will see fairly large cuts, including implantation of left ventricular pacing leads (45% reduction) and placement of neurostimulator electrodes (49% reduction).

The agency also followed through on its proposal to institute four new payment groups for visits to “Type B” emergency departments (those that are not open around the clock). Type B reimbursement will be lower than reimbursement for full-service emergency departments.

In addition, over the objections of industry groups, the CMS is dropping the additional fee it was paying outpatient departments for the administration of intravenous immune globulin therapy.

Medicare also is updating conditions for coverage that ambulatory surgery centers must meet, including requirements that centers be more transparent about physicians' financial interests, and that appropriate postsurgical care be ensured.