Joyce Frieden

President Barack Obama's executive order reversing the Bush administration's restrictions on government-funded stem cell research drew cheers from some medical groups and jeers from others.

Under the previous policy, government funding for embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence in August 2001, when then-President George W. Bush announced the policy. President Obama's executive order, which he signed in March, lifts those restrictions and allows funded research to include embryonic stem cell lines created after that date. However, the order does not lift a current ban on using federal funds to create stem cell lines if the creation involves destruction of human embryos. Federal policy does not affect privately funded stem cell research.

President Obama noted at the signing ceremony that “many thoughtful and decent people are conflicted about, or strongly oppose, [embryonic stem cell] research. I understand their concerns, and we must respect their point of view.”

But he added that “in recent years, when it comes to stem cell research, rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values. In this case, I believe the two are not inconsistent.

“After much discussion, debate and reflection, the proper course has become clear,” he said. “The majority of Americans—from across the political spectrum, and of all backgrounds and beliefs—have come to a consensus that we should pursue this research. … That is a conclusion with which I agree. That is why I am signing this executive order and why I hope Congress will act on a bipartisan basis to provide further support for this research.”

The president said that the government “will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society.”

Lawrence Tabak, Ph.D., acting deputy director of the National Institutes of Health, expressed support for the decision. “Researchers will now be able to pursue new knowledge about human development, regenerative medicine, and the origins of many of our most devastating diseases,” he said in a teleconference. “This research promises to revolutionize how we predict, treat, and prevent many diseases, and will contribute to the development of lifesaving therapies. NIH will do its part to implement new policy and develop guidelines as expeditiously as possible to make sure the best science is funded and the research is conducted in a responsible manner.”

The American Medical Association also applauded the change. “Stem cell research holds great promise to treat diseases that science has so far been unable to cure, and this change in policy will allow researchers to accelerate their efforts by applying for federal research funds,” Dr. Joseph Heyman, chair of the AMA's board of directors, said in a statement. “The AMA supports biomedical research on stem cells and has encouraged strong public support of federal funding for this research. [This] action by President Obama will help scientists realize the potential of stem cell research to benefit the many Americans living with diseases such as diabetes, Parkinson's and Alzheimer's.”

But Dr. David Stevens, CEO of the Christian Medical Association, in Bristol, Tenn., cited problems with embryonic stem cell research. First, there is a moral issue: “Embryos are human beings,” he said. “When you destroy an embryo, you destroy a distinct human being.” Also, the prospects for embryonic stem cell research have been overblown, he continued. “Even people in this field say that if treatment is going to come out of this, it's probably 20 years away.”

Instead of spending money on embryonic stem cell research, “we should put our money where we can get real cures real fast”—with adult stem cells, which already have shown promising preliminary results, Dr. Stevens said.

President Barack Obama's executive order reversing the Bush administration's restrictions on government-funded stem cell research drew cheers from some medical groups and jeers from others.

Under the previous policy, government funding for embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence in August 2001, when then-President George W. Bush announced the policy. President Obama's executive order, which he signed in March, lifts those restrictions and allows funded research to include embryonic stem cell lines created after that date. However, the order does not lift a current ban on using federal funds to create stem cell lines if the creation involves destruction of human embryos. Federal policy does not affect privately funded stem cell research.

President Obama noted at the signing ceremony that “many thoughtful and decent people are conflicted about, or strongly oppose, [embryonic stem cell] research. I understand their concerns, and we must respect their point of view.”

But he added that “in recent years, when it comes to stem cell research, rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values. In this case, I believe the two are not inconsistent.

“After much discussion, debate and reflection, the proper course has become clear,” he said. “The majority of Americans—from across the political spectrum, and of all backgrounds and beliefs—have come to a consensus that we should pursue this research. … That is a conclusion with which I agree. That is why I am signing this executive order and why I hope Congress will act on a bipartisan basis to provide further support for this research.”

The president said that the government “will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society.”

Lawrence Tabak, Ph.D., acting deputy director of the National Institutes of Health, expressed support for the decision. “Researchers will now be able to pursue new knowledge about human development, regenerative medicine, and the origins of many of our most devastating diseases,” he said in a teleconference. “This research promises to revolutionize how we predict, treat, and prevent many diseases, and will contribute to the development of lifesaving therapies. NIH will do its part to implement new policy and develop guidelines as expeditiously as possible to make sure the best science is funded and the research is conducted in a responsible manner.”

The American Medical Association also applauded the change. “Stem cell research holds great promise to treat diseases that science has so far been unable to cure, and this change in policy will allow researchers to accelerate their efforts by applying for federal research funds,” Dr. Joseph Heyman, chair of the AMA's board of directors, said in a statement. “The AMA supports biomedical research on stem cells and has encouraged strong public support of federal funding for this research. [This] action by President Obama will help scientists realize the potential of stem cell research to benefit the many Americans living with diseases such as diabetes, Parkinson's and Alzheimer's.”

But Dr. David Stevens, CEO of the Christian Medical Association, in Bristol, Tenn., cited problems with embryonic stem cell research. First, there is a moral issue: “Embryos are human beings,” he said. “When you destroy an embryo, you destroy a distinct human being.” Also, the prospects for embryonic stem cell research have been overblown, he continued. “Even people in this field say that if treatment is going to come out of this, it's probably 20 years away.”

Instead of spending money on embryonic stem cell research, “we should put our money where we can get real cures real fast”—with adult stem cells, which already have shown promising preliminary results, Dr. Stevens said.

President Barack Obama's executive order reversing the Bush administration's restrictions on government-funded stem cell research drew cheers from some medical groups and jeers from others.

Under the previous policy, government funding for embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence in August 2001, when then-President George W. Bush announced the policy. President Obama's executive order, which he signed in March, lifts those restrictions and allows funded research to include embryonic stem cell lines created after that date. However, the order does not lift a current ban on using federal funds to create stem cell lines if the creation involves destruction of human embryos. Federal policy does not affect privately funded stem cell research.

President Obama noted at the signing ceremony that “many thoughtful and decent people are conflicted about, or strongly oppose, [embryonic stem cell] research. I understand their concerns, and we must respect their point of view.”

But he added that “in recent years, when it comes to stem cell research, rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values. In this case, I believe the two are not inconsistent.

“After much discussion, debate and reflection, the proper course has become clear,” he said. “The majority of Americans—from across the political spectrum, and of all backgrounds and beliefs—have come to a consensus that we should pursue this research. … That is a conclusion with which I agree. That is why I am signing this executive order and why I hope Congress will act on a bipartisan basis to provide further support for this research.”

The president said that the government “will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society.”

Lawrence Tabak, Ph.D., acting deputy director of the National Institutes of Health, expressed support for the decision. “Researchers will now be able to pursue new knowledge about human development, regenerative medicine, and the origins of many of our most devastating diseases,” he said in a teleconference. “This research promises to revolutionize how we predict, treat, and prevent many diseases, and will contribute to the development of lifesaving therapies. NIH will do its part to implement new policy and develop guidelines as expeditiously as possible to make sure the best science is funded and the research is conducted in a responsible manner.”

The American Medical Association also applauded the change. “Stem cell research holds great promise to treat diseases that science has so far been unable to cure, and this change in policy will allow researchers to accelerate their efforts by applying for federal research funds,” Dr. Joseph Heyman, chair of the AMA's board of directors, said in a statement. “The AMA supports biomedical research on stem cells and has encouraged strong public support of federal funding for this research. [This] action by President Obama will help scientists realize the potential of stem cell research to benefit the many Americans living with diseases such as diabetes, Parkinson's and Alzheimer's.”

But Dr. David Stevens, CEO of the Christian Medical Association, in Bristol, Tenn., cited problems with embryonic stem cell research. First, there is a moral issue: “Embryos are human beings,” he said. “When you destroy an embryo, you destroy a distinct human being.” Also, the prospects for embryonic stem cell research have been overblown, he continued. “Even people in this field say that if treatment is going to come out of this, it's probably 20 years away.”

Instead of spending money on embryonic stem cell research, “we should put our money where we can get real cures real fast”—with adult stem cells, which already have shown promising preliminary results, Dr. Stevens said.

When it comes to public disclosure of drug company payments to doctors, how much your patients know depends on where you live—at least for now.

Although no federal law has yet been passed, “six states and the District of Columbia have already passed disclosure legislation,” Jennifer Colapietro, director of pharmaceutical and life sciences advisory services at PricewaterhouseCoopers, said during an audioconference sponsored by Harvard Health Policy Review and Rx Compliance Report.

Currently, California, Maine, Minnesota, Nevada, Vermont, and West Virginia all have disclosure laws in effect; Massachusetts recently passed a law that does not take effect until next year, she said.

State disclosure laws vary greatly, said Chris Armstrong, investigative counsel for the Senate Finance Committee, where Sen. Chuck Grassley (R-Iowa) is the ranking member. For example, only two states capture device payments, and only a few make the information collected available to the public, he said.

In addition to the laws already in effect, “there are 12 pieces of legislation filed so far, including 3 in Texas. This issue is gaining traction: Over the next few years, there will be a lot of growth in this area which will result in wide variety of rules.”

Maine state Rep. Sharon Anglin Treat (D-Hallowell) agreed that state disclosure laws vary, with only Minnesota's law disaggregating the data so the public can see how much individual physicians are paid.

“States such as Maine and West Virginia also require reporting on [pharmaceutical] advertising and marketing, including direct-to-consumer television ads, whereas Vermont doesn't collect that information,” said Ms. Treat, who is also executive director of the National Association on Prescription Drug Prices, a nonprofit organization formed by state legislators who were concerned about the cost of prescription drugs.

The answer to this problem, according to Mr. Armstrong, “is to have a single, clear, robust, and reasonable federal rule.” On that point, the Physician Payments Sunshine Act (S. 301) was introduced first in 2008 by Sen. Grassley and reintroduced this year. That measure would require drug companies to submit a report to the U.S. Health and Human Services secretary detailing any payments made to physicians, as well as any food, gifts, trips, rebates, admission to medical conferences, or any other compensation deemed appropriate. The reports would be available online.

Mr. Armstrong said that the federal legislation is not intended as a “floor” for state laws. “One person had the idea that if Iowa passed a law saying that companies had to disclose their payments twice a year—rather than once a year [as in] in our bill—that's okay. But that's not our intent. Any requirements that [necessitate] a duplication of that reporting on the state level are preempted.”

On the other hand, “that's not to say Iowa couldn't require reporting of payments to organizations or other prescribers,” Mr. Armstrong continued. “Because those are types of payments not in [the scope] of our bill, those aren't preempted at all.”

Increased disclosure is not expected to discourage physicians from participating in medical education sponsored by drug companies, according to Mr. Armstrong. “I certainly wouldn't want a helpful activity like that to be lessened,” he said. “I have talked to a lot of physician groups, including the American Medical Association and others, and I haven't heard a whole lot [of them suggesting that] that would happen.” In anticipation of a federal law, three pharmaceutical manufacturers—Pfizer Inc., Merck & Co., and Eli Lilly & Co.—have already announced plans to develop payment databases.

On another federal front, John T. Bentivoglio, a partner in the D.C. law firm King & Spalding LLP, noted that the HHS inspector general's office has taken an increasing interest in making pharmaceutical companies disclose their physician payments, with Cephalon Inc. becoming the first company (in September 2008) to sign a corporate integrity agreement with the department that required disclosure of physician payments.

When it comes to public disclosure of drug company payments to doctors, how much your patients know depends on where you live—at least for now.

Although no federal law has yet been passed, “six states and the District of Columbia have already passed disclosure legislation,” Jennifer Colapietro, director of pharmaceutical and life sciences advisory services at PricewaterhouseCoopers, said during an audioconference sponsored by Harvard Health Policy Review and Rx Compliance Report.

Currently, California, Maine, Minnesota, Nevada, Vermont, and West Virginia all have disclosure laws in effect; Massachusetts recently passed a law that does not take effect until next year, she said.

State disclosure laws vary greatly, said Chris Armstrong, investigative counsel for the Senate Finance Committee, where Sen. Chuck Grassley (R-Iowa) is the ranking member. For example, only two states capture device payments, and only a few make the information collected available to the public, he said.

In addition to the laws already in effect, “there are 12 pieces of legislation filed so far, including 3 in Texas. This issue is gaining traction: Over the next few years, there will be a lot of growth in this area which will result in wide variety of rules.”

Maine state Rep. Sharon Anglin Treat (D-Hallowell) agreed that state disclosure laws vary, with only Minnesota's law disaggregating the data so the public can see how much individual physicians are paid.

“States such as Maine and West Virginia also require reporting on [pharmaceutical] advertising and marketing, including direct-to-consumer television ads, whereas Vermont doesn't collect that information,” said Ms. Treat, who is also executive director of the National Association on Prescription Drug Prices, a nonprofit organization formed by state legislators who were concerned about the cost of prescription drugs.

The answer to this problem, according to Mr. Armstrong, “is to have a single, clear, robust, and reasonable federal rule.” On that point, the Physician Payments Sunshine Act (S. 301) was introduced first in 2008 by Sen. Grassley and reintroduced this year. That measure would require drug companies to submit a report to the U.S. Health and Human Services secretary detailing any payments made to physicians, as well as any food, gifts, trips, rebates, admission to medical conferences, or any other compensation deemed appropriate. The reports would be available online.

Mr. Armstrong said that the federal legislation is not intended as a “floor” for state laws. “One person had the idea that if Iowa passed a law saying that companies had to disclose their payments twice a year—rather than once a year [as in] in our bill—that's okay. But that's not our intent. Any requirements that [necessitate] a duplication of that reporting on the state level are preempted.”

On the other hand, “that's not to say Iowa couldn't require reporting of payments to organizations or other prescribers,” Mr. Armstrong continued. “Because those are types of payments not in [the scope] of our bill, those aren't preempted at all.”

Increased disclosure is not expected to discourage physicians from participating in medical education sponsored by drug companies, according to Mr. Armstrong. “I certainly wouldn't want a helpful activity like that to be lessened,” he said. “I have talked to a lot of physician groups, including the American Medical Association and others, and I haven't heard a whole lot [of them suggesting that] that would happen.” In anticipation of a federal law, three pharmaceutical manufacturers—Pfizer Inc., Merck & Co., and Eli Lilly & Co.—have already announced plans to develop payment databases.

On another federal front, John T. Bentivoglio, a partner in the D.C. law firm King & Spalding LLP, noted that the HHS inspector general's office has taken an increasing interest in making pharmaceutical companies disclose their physician payments, with Cephalon Inc. becoming the first company (in September 2008) to sign a corporate integrity agreement with the department that required disclosure of physician payments.

When it comes to public disclosure of drug company payments to doctors, how much your patients know depends on where you live—at least for now.

Although no federal law has yet been passed, “six states and the District of Columbia have already passed disclosure legislation,” Jennifer Colapietro, director of pharmaceutical and life sciences advisory services at PricewaterhouseCoopers, said during an audioconference sponsored by Harvard Health Policy Review and Rx Compliance Report.

Currently, California, Maine, Minnesota, Nevada, Vermont, and West Virginia all have disclosure laws in effect; Massachusetts recently passed a law that does not take effect until next year, she said.

State disclosure laws vary greatly, said Chris Armstrong, investigative counsel for the Senate Finance Committee, where Sen. Chuck Grassley (R-Iowa) is the ranking member. For example, only two states capture device payments, and only a few make the information collected available to the public, he said.

In addition to the laws already in effect, “there are 12 pieces of legislation filed so far, including 3 in Texas. This issue is gaining traction: Over the next few years, there will be a lot of growth in this area which will result in wide variety of rules.”

Maine state Rep. Sharon Anglin Treat (D-Hallowell) agreed that state disclosure laws vary, with only Minnesota's law disaggregating the data so the public can see how much individual physicians are paid.

“States such as Maine and West Virginia also require reporting on [pharmaceutical] advertising and marketing, including direct-to-consumer television ads, whereas Vermont doesn't collect that information,” said Ms. Treat, who is also executive director of the National Association on Prescription Drug Prices, a nonprofit organization formed by state legislators who were concerned about the cost of prescription drugs.

The answer to this problem, according to Mr. Armstrong, “is to have a single, clear, robust, and reasonable federal rule.” On that point, the Physician Payments Sunshine Act (S. 301) was introduced first in 2008 by Sen. Grassley and reintroduced this year. That measure would require drug companies to submit a report to the U.S. Health and Human Services secretary detailing any payments made to physicians, as well as any food, gifts, trips, rebates, admission to medical conferences, or any other compensation deemed appropriate. The reports would be available online.

Mr. Armstrong said that the federal legislation is not intended as a “floor” for state laws. “One person had the idea that if Iowa passed a law saying that companies had to disclose their payments twice a year—rather than once a year [as in] in our bill—that's okay. But that's not our intent. Any requirements that [necessitate] a duplication of that reporting on the state level are preempted.”

On the other hand, “that's not to say Iowa couldn't require reporting of payments to organizations or other prescribers,” Mr. Armstrong continued. “Because those are types of payments not in [the scope] of our bill, those aren't preempted at all.”

Increased disclosure is not expected to discourage physicians from participating in medical education sponsored by drug companies, according to Mr. Armstrong. “I certainly wouldn't want a helpful activity like that to be lessened,” he said. “I have talked to a lot of physician groups, including the American Medical Association and others, and I haven't heard a whole lot [of them suggesting that] that would happen.” In anticipation of a federal law, three pharmaceutical manufacturers—Pfizer Inc., Merck & Co., and Eli Lilly & Co.—have already announced plans to develop payment databases.

On another federal front, John T. Bentivoglio, a partner in the D.C. law firm King & Spalding LLP, noted that the HHS inspector general's office has taken an increasing interest in making pharmaceutical companies disclose their physician payments, with Cephalon Inc. becoming the first company (in September 2008) to sign a corporate integrity agreement with the department that required disclosure of physician payments.

President Barack Obama's executive order reversing the Bush administration's restrictions on government-funded stem cell research drew praise from some medical groups and criticism from others.

Under the previous policy, government funding for embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence in August 2001, when then-President George W. Bush announced the policy. President Obama's executive order, which he signed in March, lifts those restrictions and allows funded research to include embryonic stem cell lines created after that date. However, the order does not lift a current ban on using federal funds to create stem cell lines if the creation involves destruction of human embryos. Federal policy does not affect privately funded stem cell research.

President Obama noted at the signing ceremony that "many thoughtful and decent people are conflicted about, or strongly oppose, [embryonic stem cell] research. I understand their concerns, and we must respect their point of view."

But he added that "in recent years, when it comes to stem cell research, rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values. In this case, I believe the two are not inconsistent.

"After much discussion, debate and reflection, the proper course has become clear," he said. "The majority of Americans—from across the political spectrum, and of all backgrounds and beliefs—have come to a consensus that we should pursue this research. … That is a conclusion with which I agree. That is why I am signing this executive order and why I hope Congress will act on a bipartisan basis to provide further support for this research."

The president said that the government "will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society."

Lawrence Tabak, Ph.D., acting deputy director of the National Institutes of Health, expressed support for the decision. "Researchers will now be able to pursue new knowledge about human development, regenerative medicine, and the origins of many of our most devastating diseases," he said in a teleconference. "This research promises to revolutionize how we predict, treat, and prevent many diseases, and will contribute to the development of lifesaving therapies. NIH will do its part to implement new policy and develop guidelines as expeditiously as possible to make sure the best science is funded and the research is conducted in a responsible manner."

The American Medical Association also applauded the change. "Stem cell research holds great promise to treat diseases that science has so far been unable to cure, and this change in policy will allow researchers to accelerate their efforts by applying for federal research funds," Dr. Joseph Heyman, chair of the AMA's board of directors, said in a statement. "The AMA supports biomedical research on stem cells and has encouraged strong public support of federal funding for this research."

But Dr. David Stevens, CEO of the Christian Medical Association, in Bristol, Tenn., cited problems with embryonic stem cell research. First, there is a moral issue: "We understand that embryos are human beings. Every one of us was an embryo," he said. "When you destroy an embryo, you destroy a distinct human being." Also, the prospects for embryonic stem cell research have been overblown, he continued. "We know that embryonic stem cells are difficult to culture and to control. … Even people in this field say that if treatment is going to come out of this, it's probably 20 years away."

Instead of spending money on embryonic stem cell research, "we should put our money where we can get real cures real fast"—with adult stem cells, which already have shown promising preliminary results, Dr. Stevens said. "If we have one path we can go down which is cheaper, less complicated, and gets us to cures quickly, why would we go down another path?"

President Barack Obama's executive order reversing the Bush administration's restrictions on government-funded stem cell research drew praise from some medical groups and criticism from others.

Under the previous policy, government funding for embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence in August 2001, when then-President George W. Bush announced the policy. President Obama's executive order, which he signed in March, lifts those restrictions and allows funded research to include embryonic stem cell lines created after that date. However, the order does not lift a current ban on using federal funds to create stem cell lines if the creation involves destruction of human embryos. Federal policy does not affect privately funded stem cell research.

President Obama noted at the signing ceremony that "many thoughtful and decent people are conflicted about, or strongly oppose, [embryonic stem cell] research. I understand their concerns, and we must respect their point of view."

But he added that "in recent years, when it comes to stem cell research, rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values. In this case, I believe the two are not inconsistent.

"After much discussion, debate and reflection, the proper course has become clear," he said. "The majority of Americans—from across the political spectrum, and of all backgrounds and beliefs—have come to a consensus that we should pursue this research. … That is a conclusion with which I agree. That is why I am signing this executive order and why I hope Congress will act on a bipartisan basis to provide further support for this research."

The president said that the government "will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society."

Lawrence Tabak, Ph.D., acting deputy director of the National Institutes of Health, expressed support for the decision. "Researchers will now be able to pursue new knowledge about human development, regenerative medicine, and the origins of many of our most devastating diseases," he said in a teleconference. "This research promises to revolutionize how we predict, treat, and prevent many diseases, and will contribute to the development of lifesaving therapies. NIH will do its part to implement new policy and develop guidelines as expeditiously as possible to make sure the best science is funded and the research is conducted in a responsible manner."

The American Medical Association also applauded the change. "Stem cell research holds great promise to treat diseases that science has so far been unable to cure, and this change in policy will allow researchers to accelerate their efforts by applying for federal research funds," Dr. Joseph Heyman, chair of the AMA's board of directors, said in a statement. "The AMA supports biomedical research on stem cells and has encouraged strong public support of federal funding for this research."

But Dr. David Stevens, CEO of the Christian Medical Association, in Bristol, Tenn., cited problems with embryonic stem cell research. First, there is a moral issue: "We understand that embryos are human beings. Every one of us was an embryo," he said. "When you destroy an embryo, you destroy a distinct human being." Also, the prospects for embryonic stem cell research have been overblown, he continued. "We know that embryonic stem cells are difficult to culture and to control. … Even people in this field say that if treatment is going to come out of this, it's probably 20 years away."

Instead of spending money on embryonic stem cell research, "we should put our money where we can get real cures real fast"—with adult stem cells, which already have shown promising preliminary results, Dr. Stevens said. "If we have one path we can go down which is cheaper, less complicated, and gets us to cures quickly, why would we go down another path?"

President Barack Obama's executive order reversing the Bush administration's restrictions on government-funded stem cell research drew praise from some medical groups and criticism from others.

Under the previous policy, government funding for embryonic stem cell research was limited to studies using only the few stem cell lines that were in existence in August 2001, when then-President George W. Bush announced the policy. President Obama's executive order, which he signed in March, lifts those restrictions and allows funded research to include embryonic stem cell lines created after that date. However, the order does not lift a current ban on using federal funds to create stem cell lines if the creation involves destruction of human embryos. Federal policy does not affect privately funded stem cell research.

President Obama noted at the signing ceremony that "many thoughtful and decent people are conflicted about, or strongly oppose, [embryonic stem cell] research. I understand their concerns, and we must respect their point of view."

But he added that "in recent years, when it comes to stem cell research, rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values. In this case, I believe the two are not inconsistent.

"After much discussion, debate and reflection, the proper course has become clear," he said. "The majority of Americans—from across the political spectrum, and of all backgrounds and beliefs—have come to a consensus that we should pursue this research. … That is a conclusion with which I agree. That is why I am signing this executive order and why I hope Congress will act on a bipartisan basis to provide further support for this research."

The president said that the government "will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society."

Lawrence Tabak, Ph.D., acting deputy director of the National Institutes of Health, expressed support for the decision. "Researchers will now be able to pursue new knowledge about human development, regenerative medicine, and the origins of many of our most devastating diseases," he said in a teleconference. "This research promises to revolutionize how we predict, treat, and prevent many diseases, and will contribute to the development of lifesaving therapies. NIH will do its part to implement new policy and develop guidelines as expeditiously as possible to make sure the best science is funded and the research is conducted in a responsible manner."

The American Medical Association also applauded the change. "Stem cell research holds great promise to treat diseases that science has so far been unable to cure, and this change in policy will allow researchers to accelerate their efforts by applying for federal research funds," Dr. Joseph Heyman, chair of the AMA's board of directors, said in a statement. "The AMA supports biomedical research on stem cells and has encouraged strong public support of federal funding for this research."

But Dr. David Stevens, CEO of the Christian Medical Association, in Bristol, Tenn., cited problems with embryonic stem cell research. First, there is a moral issue: "We understand that embryos are human beings. Every one of us was an embryo," he said. "When you destroy an embryo, you destroy a distinct human being." Also, the prospects for embryonic stem cell research have been overblown, he continued. "We know that embryonic stem cells are difficult to culture and to control. … Even people in this field say that if treatment is going to come out of this, it's probably 20 years away."

Instead of spending money on embryonic stem cell research, "we should put our money where we can get real cures real fast"—with adult stem cells, which already have shown promising preliminary results, Dr. Stevens said. "If we have one path we can go down which is cheaper, less complicated, and gets us to cures quickly, why would we go down another path?"

AMA Sues Aetna, Cigna

The American Medical Association and several state medical associations have filed separate class-action lawsuits against insurers Aetna Health Inc. and CIGNA, each suit claiming that the company used faulty data to undercompensate physicians. Filed last month in New Jersey federal court, the two lawsuits are similar to an earlier AMA suit against the owner of the Ingenix billing database used by Aetna and CIGNA, UnitedHealth, to determine fees for patients' visits to out-of-network physicians. As a result of the UnitedHealth lawsuit and an investigation by New York Attorney General Andrew Cuomo, UnitedHealth agreed to shut down the database and pay $50 million to establish a new database run by a nonprofit organization. Among other things, the suits against Aetna and CIGNA seek a declaration that the insurers violated federal antitrust law and that they're liable to the plaintiffs for three times their damages, costs, and attorney fees. The medical associations also want the insurers to calculate and issue unpaid benefits to physicians. “We can no longer ignore the improper business practices of health insurers who decide to play by their own rules without regard to patients or the legitimate costs required to care for them,” said Dr. Nancy H. Nielsen, AMA president.

Many People Go Without Drugs

More children and working-age adults are failing to take needed prescription medications because of cost concerns, according to a national study by the Center for Studying Health System Change. In 2007, 1 in 7 Americans younger than age 65 years reported not filling a prescription in the previous year because they couldn't afford the medication, up from 1 in 10 in 2003. Rising prescription drug costs and less-generous drug coverage probably contributed to the change, the report said. Uninsured, working-age Americans saw the biggest jump in unmet prescription needs during 2003-2007, with the proportion going without medications rising from 26% to almost 35%, the report said. But a growing proportion of working-age Americans with employer-sponsored health insurance also reported going without prescription medications.

FDA on High-Risk List

The Food and Drug Administration faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said in adding the FDA to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address mismanagement within them. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

Report Finds HIPAA Inadequate

The government's main health privacy rule does not adequately protect people's health information, yet it hinders important health research, a report from the Institute of Medicine concluded. The privacy rule, stemming from the Health Insurance Portability and Accountability Act, is difficult to reconcile with other federal regulations governing research and personal information, the IOM report said. In addition, organizations that collect and use health data vary greatly in how they interpret and follow HIPAA, leading to potential privacy problems, the report said. Congress should create an entirely new approach to protecting personal health information in research, separate from the HIPAA rule, an IOM panel recommended.

Poll: Affordability Is Tops

Making health insurance more affordable trumps improving quality and expanding coverage among the public's priorities for health care reform, says a new poll. The survey from the Kaiser Family Foundation and the Harvard School of Public Health found that most people believe that action on health care is important to help the nation out of recession. But when asked to choose between coverage expansion, cost reduction, and delivery-system change, 4 in 10 named affordability as most important, followed by 3 in 10 who said that expanding coverage is the top priority. Roughly 2 in 10 picked improving the quality and cost-effectiveness of the health care delivery system. Two-thirds of those surveyed favored requiring all individuals to have health insurance, but when told that some may then have to buy health insurance they consider too expensive or don't want, support for the mandate dropped to 19%.

AMA Sues Aetna, Cigna

The American Medical Association and several state medical associations have filed separate class-action lawsuits against insurers Aetna Health Inc. and CIGNA, each suit claiming that the company used faulty data to undercompensate physicians. Filed last month in New Jersey federal court, the two lawsuits are similar to an earlier AMA suit against the owner of the Ingenix billing database used by Aetna and CIGNA, UnitedHealth, to determine fees for patients' visits to out-of-network physicians. As a result of the UnitedHealth lawsuit and an investigation by New York Attorney General Andrew Cuomo, UnitedHealth agreed to shut down the database and pay $50 million to establish a new database run by a nonprofit organization. Among other things, the suits against Aetna and CIGNA seek a declaration that the insurers violated federal antitrust law and that they're liable to the plaintiffs for three times their damages, costs, and attorney fees. The medical associations also want the insurers to calculate and issue unpaid benefits to physicians. “We can no longer ignore the improper business practices of health insurers who decide to play by their own rules without regard to patients or the legitimate costs required to care for them,” said Dr. Nancy H. Nielsen, AMA president.

Many People Go Without Drugs

More children and working-age adults are failing to take needed prescription medications because of cost concerns, according to a national study by the Center for Studying Health System Change. In 2007, 1 in 7 Americans younger than age 65 years reported not filling a prescription in the previous year because they couldn't afford the medication, up from 1 in 10 in 2003. Rising prescription drug costs and less-generous drug coverage probably contributed to the change, the report said. Uninsured, working-age Americans saw the biggest jump in unmet prescription needs during 2003-2007, with the proportion going without medications rising from 26% to almost 35%, the report said. But a growing proportion of working-age Americans with employer-sponsored health insurance also reported going without prescription medications.

FDA on High-Risk List

The Food and Drug Administration faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said in adding the FDA to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address mismanagement within them. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

Report Finds HIPAA Inadequate

The government's main health privacy rule does not adequately protect people's health information, yet it hinders important health research, a report from the Institute of Medicine concluded. The privacy rule, stemming from the Health Insurance Portability and Accountability Act, is difficult to reconcile with other federal regulations governing research and personal information, the IOM report said. In addition, organizations that collect and use health data vary greatly in how they interpret and follow HIPAA, leading to potential privacy problems, the report said. Congress should create an entirely new approach to protecting personal health information in research, separate from the HIPAA rule, an IOM panel recommended.

Poll: Affordability Is Tops

Making health insurance more affordable trumps improving quality and expanding coverage among the public's priorities for health care reform, says a new poll. The survey from the Kaiser Family Foundation and the Harvard School of Public Health found that most people believe that action on health care is important to help the nation out of recession. But when asked to choose between coverage expansion, cost reduction, and delivery-system change, 4 in 10 named affordability as most important, followed by 3 in 10 who said that expanding coverage is the top priority. Roughly 2 in 10 picked improving the quality and cost-effectiveness of the health care delivery system. Two-thirds of those surveyed favored requiring all individuals to have health insurance, but when told that some may then have to buy health insurance they consider too expensive or don't want, support for the mandate dropped to 19%.

AMA Sues Aetna, Cigna

The American Medical Association and several state medical associations have filed separate class-action lawsuits against insurers Aetna Health Inc. and CIGNA, each suit claiming that the company used faulty data to undercompensate physicians. Filed last month in New Jersey federal court, the two lawsuits are similar to an earlier AMA suit against the owner of the Ingenix billing database used by Aetna and CIGNA, UnitedHealth, to determine fees for patients' visits to out-of-network physicians. As a result of the UnitedHealth lawsuit and an investigation by New York Attorney General Andrew Cuomo, UnitedHealth agreed to shut down the database and pay $50 million to establish a new database run by a nonprofit organization. Among other things, the suits against Aetna and CIGNA seek a declaration that the insurers violated federal antitrust law and that they're liable to the plaintiffs for three times their damages, costs, and attorney fees. The medical associations also want the insurers to calculate and issue unpaid benefits to physicians. “We can no longer ignore the improper business practices of health insurers who decide to play by their own rules without regard to patients or the legitimate costs required to care for them,” said Dr. Nancy H. Nielsen, AMA president.

Many People Go Without Drugs

More children and working-age adults are failing to take needed prescription medications because of cost concerns, according to a national study by the Center for Studying Health System Change. In 2007, 1 in 7 Americans younger than age 65 years reported not filling a prescription in the previous year because they couldn't afford the medication, up from 1 in 10 in 2003. Rising prescription drug costs and less-generous drug coverage probably contributed to the change, the report said. Uninsured, working-age Americans saw the biggest jump in unmet prescription needs during 2003-2007, with the proportion going without medications rising from 26% to almost 35%, the report said. But a growing proportion of working-age Americans with employer-sponsored health insurance also reported going without prescription medications.

FDA on High-Risk List

The Food and Drug Administration faces significant challenges that compromise its ability to protect Americans from unsafe and ineffective products, the Government Accountability Office said in adding the FDA to its biennial “high-risk” list. The GAO gives that label to government programs or agencies that need to address mismanagement within them. In its 2009 report, the GAO said the FDA needs to beef up its foreign-drug inspection program, better manage its reviews of companies' promotional materials, and ensure that drug makers properly present clinical data.

Report Finds HIPAA Inadequate

The government's main health privacy rule does not adequately protect people's health information, yet it hinders important health research, a report from the Institute of Medicine concluded. The privacy rule, stemming from the Health Insurance Portability and Accountability Act, is difficult to reconcile with other federal regulations governing research and personal information, the IOM report said. In addition, organizations that collect and use health data vary greatly in how they interpret and follow HIPAA, leading to potential privacy problems, the report said. Congress should create an entirely new approach to protecting personal health information in research, separate from the HIPAA rule, an IOM panel recommended.

Poll: Affordability Is Tops

Making health insurance more affordable trumps improving quality and expanding coverage among the public's priorities for health care reform, says a new poll. The survey from the Kaiser Family Foundation and the Harvard School of Public Health found that most people believe that action on health care is important to help the nation out of recession. But when asked to choose between coverage expansion, cost reduction, and delivery-system change, 4 in 10 named affordability as most important, followed by 3 in 10 who said that expanding coverage is the top priority. Roughly 2 in 10 picked improving the quality and cost-effectiveness of the health care delivery system. Two-thirds of those surveyed favored requiring all individuals to have health insurance, but when told that some may then have to buy health insurance they consider too expensive or don't want, support for the mandate dropped to 19%.

The Centers for Medicare and Medicaid Services has made it official: Medicare beneficiaries with type 2 diabetes and a body mass index less than 35 kg/m

The announcement finalizes a proposed decision memo issued by CMS last November. “While recent medical reports claimed that bariatric surgery may be helpful for these patients, CMS did not find convincing medical evidence that bariatric surgery improved health outcomes for these non-morbidly obese individuals,” the agency said in a statement.

In the statement, Dr. Barry Straube, the agency's chief medical officer and director of its Office of Clinical Standards and Quality, said, “Limiting coverage of bariatric surgery in type 2 diabetic patients who are not considered clinically obese is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.”

In its 2006 national coverage decision for bariatric surgery in morbid obesity, CMS said that Medicare would cover three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries who have a BMI over 35, have at least one comorbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.

Also at that time, the agency asked for comments on whether Medicare should cover various gastric and intestinal bypass procedures. The decision is an outcome of that query, and it clarifies that diabetes is one of the comorbidities included in the criteria.

The Centers for Medicare and Medicaid Services has made it official: Medicare beneficiaries with type 2 diabetes and a body mass index less than 35 kg/m

The announcement finalizes a proposed decision memo issued by CMS last November. “While recent medical reports claimed that bariatric surgery may be helpful for these patients, CMS did not find convincing medical evidence that bariatric surgery improved health outcomes for these non-morbidly obese individuals,” the agency said in a statement.

In the statement, Dr. Barry Straube, the agency's chief medical officer and director of its Office of Clinical Standards and Quality, said, “Limiting coverage of bariatric surgery in type 2 diabetic patients who are not considered clinically obese is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.”

In its 2006 national coverage decision for bariatric surgery in morbid obesity, CMS said that Medicare would cover three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries who have a BMI over 35, have at least one comorbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.

Also at that time, the agency asked for comments on whether Medicare should cover various gastric and intestinal bypass procedures. The decision is an outcome of that query, and it clarifies that diabetes is one of the comorbidities included in the criteria.

The Centers for Medicare and Medicaid Services has made it official: Medicare beneficiaries with type 2 diabetes and a body mass index less than 35 kg/m

The announcement finalizes a proposed decision memo issued by CMS last November. “While recent medical reports claimed that bariatric surgery may be helpful for these patients, CMS did not find convincing medical evidence that bariatric surgery improved health outcomes for these non-morbidly obese individuals,” the agency said in a statement.

In the statement, Dr. Barry Straube, the agency's chief medical officer and director of its Office of Clinical Standards and Quality, said, “Limiting coverage of bariatric surgery in type 2 diabetic patients who are not considered clinically obese is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.”

In its 2006 national coverage decision for bariatric surgery in morbid obesity, CMS said that Medicare would cover three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries who have a BMI over 35, have at least one comorbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.

Also at that time, the agency asked for comments on whether Medicare should cover various gastric and intestinal bypass procedures. The decision is an outcome of that query, and it clarifies that diabetes is one of the comorbidities included in the criteria.

The Centers for Medicare and Medicaid Services has made it official: Medicare beneficiaries with type 2 diabetes and a body mass index less than 35 kg/m

The announcement finalizes a CMS proposal issued last November. “While recent medical reports claimed that bariatric surgery may be helpful for these patients, CMS did not find convincing medical evidence that bariatric surgery improved health outcomes for these nonmorbidly obese individuals,” the agency said in a statement at that time.

In the statement, Dr. Barry Straube, the agency's chief medical officer and director of its Office of Clinical Standards and Quality, said “limiting coverage of bariatric surgery in type 2 diabetic patients who are not considered clinically obese is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.”

In 2006, CMS said that Medicare would cover three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries who have a BMI greater than 35, have at least one comorbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. The new decision clarifies that diabetes is one of the comorbidities included in the criteria.

The Centers for Medicare and Medicaid Services has made it official: Medicare beneficiaries with type 2 diabetes and a body mass index less than 35 kg/m

The announcement finalizes a CMS proposal issued last November. “While recent medical reports claimed that bariatric surgery may be helpful for these patients, CMS did not find convincing medical evidence that bariatric surgery improved health outcomes for these nonmorbidly obese individuals,” the agency said in a statement at that time.

In the statement, Dr. Barry Straube, the agency's chief medical officer and director of its Office of Clinical Standards and Quality, said “limiting coverage of bariatric surgery in type 2 diabetic patients who are not considered clinically obese is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.”

In 2006, CMS said that Medicare would cover three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries who have a BMI greater than 35, have at least one comorbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. The new decision clarifies that diabetes is one of the comorbidities included in the criteria.

The Centers for Medicare and Medicaid Services has made it official: Medicare beneficiaries with type 2 diabetes and a body mass index less than 35 kg/m

The announcement finalizes a CMS proposal issued last November. “While recent medical reports claimed that bariatric surgery may be helpful for these patients, CMS did not find convincing medical evidence that bariatric surgery improved health outcomes for these nonmorbidly obese individuals,” the agency said in a statement at that time.

In the statement, Dr. Barry Straube, the agency's chief medical officer and director of its Office of Clinical Standards and Quality, said “limiting coverage of bariatric surgery in type 2 diabetic patients who are not considered clinically obese is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.”

In 2006, CMS said that Medicare would cover three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries who have a BMI greater than 35, have at least one comorbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. The new decision clarifies that diabetes is one of the comorbidities included in the criteria.

Expansion of the primary care workforce is necessary to improve the "poor" state of the nation's health care, according to Dr. Jeffrey P. Harris, president of the American College of Physicians.

"We have too many uninsured. We have too few primary care physicians. We spend more for health care and get less in return than most other industrialized countries," Dr. Harris said during the ACP's annual "State of the Nation's Health Care" briefing, which was held in Washington. He noted that "at this same event in 2006, the American College of Physicians warned that primary care was nearing collapse in the United States. Regrettably, primary care is in even more critical condition today than it was just 3 years ago."

Dr. Harris cited a recent report from the Institute of Medicine, which showed that 16,000 additional primary care physicians are needed to meet the current demand in underserved areas. "The primary care shortage is occurring at a time when the need for primary care is greater than ever," he said. "An aging population, with growing incidences of chronic illness, will increase the demand for general internists and other primary care doctors."

The college has found that nations in which primary care physicians make up 50% of the total physician workforce have better outcomes and lower health care costs, according to Dr. Harris. Therefore, "we are calling for the federal government to convene an expert advisory group to recommend specific targets and the numbers and proportion of primary care physicians appropriate for the United States," which has only 30% primary care physicians in its workforce.

Robert B. Doherty, the ACP's senior vice-president of governmental affairs and public policy, outlined steps the college would like to see the government take to increase the number of primary care physicians:

▸ Make primary care compensation competitive with other specialties. "Specifically, a market and price sensitivity analysis should be conducted to set specific benchmarks for improving primary care compensation so that it is competitive with other career and specialty choices," Mr. Doherty said.

For instance, Dr. Harris said that Medicare payment increases of 7.5%-8% per year over 5 years would be needed to bring primary care compensation to 80% of that of all other specialties. Right now, the average compensation of primary care doctors is about 55% that of their non-primary care colleagues. Commercial payers would need to implement comparable increases.

▸ Expand the patient-centered medical home model to more states, more practices, and more patients. "This innovative model of primary care delivery offers enormous potential to improve quality and lower the costs of care, especially for patients with chronic illnesses," Mr. Doherty said.

▸ Conduct a systematic review of the paperwork burdens on primary care doctors that detract from the time they can spend with patients, and that add to physician dissatisfaction.

▸ Increase funding for primary care training programs and create new programs to eliminate medical education debt for internists, family physicians, and pediatricians who agree to provide primary care in a critical shortage area or clinic.

▸ Implement reforms to improve quality and efficiency of care for all patients, including those seen by specialists. This would include revising the Sustainable Growth Rate formula that governs Medicare payments, improving the Physician Quality Reporting Initiative, funding independent research on the comparative effectiveness of different treatments, and helping physicians acquire health information systems, Mr. Doherty said.

The ACP is making one additional request, Mr. Doherty added: President Barack Obama should consider issuing an executive order to "ensure that all federal agencies are working together seamlessly to design, implement, measure, and evaluate programs to increase primary care workforce capacity."

'Regrettably, primary care is in even more critical condition today than it was just 3 years ago.' DR. HARRIS

Expansion of the primary care workforce is necessary to improve the "poor" state of the nation's health care, according to Dr. Jeffrey P. Harris, president of the American College of Physicians.

"We have too many uninsured. We have too few primary care physicians. We spend more for health care and get less in return than most other industrialized countries," Dr. Harris said during the ACP's annual "State of the Nation's Health Care" briefing, which was held in Washington. He noted that "at this same event in 2006, the American College of Physicians warned that primary care was nearing collapse in the United States. Regrettably, primary care is in even more critical condition today than it was just 3 years ago."

Dr. Harris cited a recent report from the Institute of Medicine, which showed that 16,000 additional primary care physicians are needed to meet the current demand in underserved areas. "The primary care shortage is occurring at a time when the need for primary care is greater than ever," he said. "An aging population, with growing incidences of chronic illness, will increase the demand for general internists and other primary care doctors."

The college has found that nations in which primary care physicians make up 50% of the total physician workforce have better outcomes and lower health care costs, according to Dr. Harris. Therefore, "we are calling for the federal government to convene an expert advisory group to recommend specific targets and the numbers and proportion of primary care physicians appropriate for the United States," which has only 30% primary care physicians in its workforce.

Robert B. Doherty, the ACP's senior vice-president of governmental affairs and public policy, outlined steps the college would like to see the government take to increase the number of primary care physicians:

▸ Make primary care compensation competitive with other specialties. "Specifically, a market and price sensitivity analysis should be conducted to set specific benchmarks for improving primary care compensation so that it is competitive with other career and specialty choices," Mr. Doherty said.

For instance, Dr. Harris said that Medicare payment increases of 7.5%-8% per year over 5 years would be needed to bring primary care compensation to 80% of that of all other specialties. Right now, the average compensation of primary care doctors is about 55% that of their non-primary care colleagues. Commercial payers would need to implement comparable increases.

▸ Expand the patient-centered medical home model to more states, more practices, and more patients. "This innovative model of primary care delivery offers enormous potential to improve quality and lower the costs of care, especially for patients with chronic illnesses," Mr. Doherty said.

▸ Conduct a systematic review of the paperwork burdens on primary care doctors that detract from the time they can spend with patients, and that add to physician dissatisfaction.

▸ Increase funding for primary care training programs and create new programs to eliminate medical education debt for internists, family physicians, and pediatricians who agree to provide primary care in a critical shortage area or clinic.

▸ Implement reforms to improve quality and efficiency of care for all patients, including those seen by specialists. This would include revising the Sustainable Growth Rate formula that governs Medicare payments, improving the Physician Quality Reporting Initiative, funding independent research on the comparative effectiveness of different treatments, and helping physicians acquire health information systems, Mr. Doherty said.

The ACP is making one additional request, Mr. Doherty added: President Barack Obama should consider issuing an executive order to "ensure that all federal agencies are working together seamlessly to design, implement, measure, and evaluate programs to increase primary care workforce capacity."

'Regrettably, primary care is in even more critical condition today than it was just 3 years ago.' DR. HARRIS

Expansion of the primary care workforce is necessary to improve the "poor" state of the nation's health care, according to Dr. Jeffrey P. Harris, president of the American College of Physicians.

"We have too many uninsured. We have too few primary care physicians. We spend more for health care and get less in return than most other industrialized countries," Dr. Harris said during the ACP's annual "State of the Nation's Health Care" briefing, which was held in Washington. He noted that "at this same event in 2006, the American College of Physicians warned that primary care was nearing collapse in the United States. Regrettably, primary care is in even more critical condition today than it was just 3 years ago."

Dr. Harris cited a recent report from the Institute of Medicine, which showed that 16,000 additional primary care physicians are needed to meet the current demand in underserved areas. "The primary care shortage is occurring at a time when the need for primary care is greater than ever," he said. "An aging population, with growing incidences of chronic illness, will increase the demand for general internists and other primary care doctors."

The college has found that nations in which primary care physicians make up 50% of the total physician workforce have better outcomes and lower health care costs, according to Dr. Harris. Therefore, "we are calling for the federal government to convene an expert advisory group to recommend specific targets and the numbers and proportion of primary care physicians appropriate for the United States," which has only 30% primary care physicians in its workforce.

Robert B. Doherty, the ACP's senior vice-president of governmental affairs and public policy, outlined steps the college would like to see the government take to increase the number of primary care physicians:

▸ Make primary care compensation competitive with other specialties. "Specifically, a market and price sensitivity analysis should be conducted to set specific benchmarks for improving primary care compensation so that it is competitive with other career and specialty choices," Mr. Doherty said.

For instance, Dr. Harris said that Medicare payment increases of 7.5%-8% per year over 5 years would be needed to bring primary care compensation to 80% of that of all other specialties. Right now, the average compensation of primary care doctors is about 55% that of their non-primary care colleagues. Commercial payers would need to implement comparable increases.

▸ Expand the patient-centered medical home model to more states, more practices, and more patients. "This innovative model of primary care delivery offers enormous potential to improve quality and lower the costs of care, especially for patients with chronic illnesses," Mr. Doherty said.

▸ Conduct a systematic review of the paperwork burdens on primary care doctors that detract from the time they can spend with patients, and that add to physician dissatisfaction.

▸ Increase funding for primary care training programs and create new programs to eliminate medical education debt for internists, family physicians, and pediatricians who agree to provide primary care in a critical shortage area or clinic.

▸ Implement reforms to improve quality and efficiency of care for all patients, including those seen by specialists. This would include revising the Sustainable Growth Rate formula that governs Medicare payments, improving the Physician Quality Reporting Initiative, funding independent research on the comparative effectiveness of different treatments, and helping physicians acquire health information systems, Mr. Doherty said.

The ACP is making one additional request, Mr. Doherty added: President Barack Obama should consider issuing an executive order to "ensure that all federal agencies are working together seamlessly to design, implement, measure, and evaluate programs to increase primary care workforce capacity."

'Regrettably, primary care is in even more critical condition today than it was just 3 years ago.' DR. HARRIS

Blacks Unaware of Kidney Trouble

The higher rate of kidney failure in African Americans is due in part to less awareness in that population of early stages of the disease, according to a study in the February American Journal of Kidney Diseases. Contributing to the problem may be that some physicians aren't adequately testing for chronic kidney disease, lead author Dr. Michael F. Flessner said in a statement. “Most physicians were trained in an era in which serum creatinine was used as an absolute indicator of kidney disease,” while proteinuria or reduced glomerular filtration rate is now considered a better test, said Dr. Flessner, director of nephrology at the University of Mississippi Medical Center in Jackson. The researchers interviewed and examined more than 3,400 African Americans who were part of the Jackson Heart Study. Overall, 20% of study participants were found to have chronic kidney disease, but fewer than 15% of those affected were aware they had it.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said William F. Jessee, MGMA president. For example, since most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process prone to error. Many health insurance cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

VA Accepts POWs' Osteoporosis

Officials at the Department of Veterans Affairs are proposing to extend benefits to former prisoners of war who suffer from disabling osteoporosis. In a proposed rule issued last month, the VA seeks to establish a presumption of service connection for osteoporosis that's at least 10% disabling in veterans held at least 30 days as POWs. Several studies have shown that POWs suffered serious bone loss following captivity because of dietary deficiencies during their imprisonment. Osteoporosis has not been a major health issue among former POWs until recently, according to the VA, because the condition doesn't typically emerge until late in life. Most former POWs are now in their 80s, according to the VA.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. The agency attributed many of the delays to resource constraint. There have been 800 new people hired by the FDA to review drug and biologic applications, which should help reduce delays, according to analyst Ira Loss at the firm Washington Analysis. But delays may persist for new diabetes therapies and opioids, he said, noting that the potential for cardiac toxicity and abuse hangs over those products.

E-Rx Systems Boost Savings

Electronic prescribing systems that allow doctors to select lower cost or generic medications can save $845,000 per 100,000 patients per year and possibly more, according to a study funded by the Agency for Healthcare Research and Quality. The researchers examined the change in prescriptions written in community practices before and after two Massachusetts insurers launched e-prescribing systems. Although they found that the doctors prescribed electronically only 20% of the time—generally relying on traditional prescription pads—those who used e-prescribing with formulary support increased generic prescriptions by 3.3%. “Our results likely represent a conservative estimate of the potential savings,” said lead author Dr. Michael Fischer of Brigham and Women's Hospital in Boston. Physicians who wrote electronic prescriptions were slightly younger and more likely to be female than those who did not.

PhRMA Revises Ad Guidelines

The Pharmaceutical Research and Manufacturers of America recently advised drugmakers to state when actors portray medical professionals in direct-to-consumer drug advertisements and to acknowledge any compensation given to real medical professionals in ads. In addition, the new, nonbinding guidelines support the inclusion of “black box” warnings in the ads, and reinforce that companies shouldn't promote off-label uses. Rep. John Dingell (D-Mich.) commended PhRMA for the new guidelines but noted that the organization hasn't endorsed a 2-year prohibition on such ads for newly approved drugs, as recommended by the Institute of Medicine.

Blacks Unaware of Kidney Trouble

The higher rate of kidney failure in African Americans is due in part to less awareness in that population of early stages of the disease, according to a study in the February American Journal of Kidney Diseases. Contributing to the problem may be that some physicians aren't adequately testing for chronic kidney disease, lead author Dr. Michael F. Flessner said in a statement. “Most physicians were trained in an era in which serum creatinine was used as an absolute indicator of kidney disease,” while proteinuria or reduced glomerular filtration rate is now considered a better test, said Dr. Flessner, director of nephrology at the University of Mississippi Medical Center in Jackson. The researchers interviewed and examined more than 3,400 African Americans who were part of the Jackson Heart Study. Overall, 20% of study participants were found to have chronic kidney disease, but fewer than 15% of those affected were aware they had it.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said William F. Jessee, MGMA president. For example, since most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process prone to error. Many health insurance cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

VA Accepts POWs' Osteoporosis

Officials at the Department of Veterans Affairs are proposing to extend benefits to former prisoners of war who suffer from disabling osteoporosis. In a proposed rule issued last month, the VA seeks to establish a presumption of service connection for osteoporosis that's at least 10% disabling in veterans held at least 30 days as POWs. Several studies have shown that POWs suffered serious bone loss following captivity because of dietary deficiencies during their imprisonment. Osteoporosis has not been a major health issue among former POWs until recently, according to the VA, because the condition doesn't typically emerge until late in life. Most former POWs are now in their 80s, according to the VA.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. The agency attributed many of the delays to resource constraint. There have been 800 new people hired by the FDA to review drug and biologic applications, which should help reduce delays, according to analyst Ira Loss at the firm Washington Analysis. But delays may persist for new diabetes therapies and opioids, he said, noting that the potential for cardiac toxicity and abuse hangs over those products.

E-Rx Systems Boost Savings

Electronic prescribing systems that allow doctors to select lower cost or generic medications can save $845,000 per 100,000 patients per year and possibly more, according to a study funded by the Agency for Healthcare Research and Quality. The researchers examined the change in prescriptions written in community practices before and after two Massachusetts insurers launched e-prescribing systems. Although they found that the doctors prescribed electronically only 20% of the time—generally relying on traditional prescription pads—those who used e-prescribing with formulary support increased generic prescriptions by 3.3%. “Our results likely represent a conservative estimate of the potential savings,” said lead author Dr. Michael Fischer of Brigham and Women's Hospital in Boston. Physicians who wrote electronic prescriptions were slightly younger and more likely to be female than those who did not.

PhRMA Revises Ad Guidelines

The Pharmaceutical Research and Manufacturers of America recently advised drugmakers to state when actors portray medical professionals in direct-to-consumer drug advertisements and to acknowledge any compensation given to real medical professionals in ads. In addition, the new, nonbinding guidelines support the inclusion of “black box” warnings in the ads, and reinforce that companies shouldn't promote off-label uses. Rep. John Dingell (D-Mich.) commended PhRMA for the new guidelines but noted that the organization hasn't endorsed a 2-year prohibition on such ads for newly approved drugs, as recommended by the Institute of Medicine.

Blacks Unaware of Kidney Trouble

The higher rate of kidney failure in African Americans is due in part to less awareness in that population of early stages of the disease, according to a study in the February American Journal of Kidney Diseases. Contributing to the problem may be that some physicians aren't adequately testing for chronic kidney disease, lead author Dr. Michael F. Flessner said in a statement. “Most physicians were trained in an era in which serum creatinine was used as an absolute indicator of kidney disease,” while proteinuria or reduced glomerular filtration rate is now considered a better test, said Dr. Flessner, director of nephrology at the University of Mississippi Medical Center in Jackson. The researchers interviewed and examined more than 3,400 African Americans who were part of the Jackson Heart Study. Overall, 20% of study participants were found to have chronic kidney disease, but fewer than 15% of those affected were aware they had it.

Group Pushes Swipable Cards

The Medical Group Management Association has launched an effort to persuade providers and health insurers to adopt standardized, machine-readable insurance cards by next January. The initiative, dubbed Project SwipeIT, would save an estimated $1 billion annually that is currently spent on “wasteful, redundant administrative tasks,” said William F. Jessee, MGMA president. For example, since most people's health insurance cards have no machine-readable elements, providers usually photocopy the cards and then manually enter the information into their computers, a process prone to error. Many health insurance cards also feature photos, illustrations, and shading that make legible photocopying difficult. Machine-readable cards would automatically enter patient information correctly and cost-effectively, according to MGMA. The organization has developed a Web site to promote the initiative at

www.SwipeIT.org

VA Accepts POWs' Osteoporosis

Officials at the Department of Veterans Affairs are proposing to extend benefits to former prisoners of war who suffer from disabling osteoporosis. In a proposed rule issued last month, the VA seeks to establish a presumption of service connection for osteoporosis that's at least 10% disabling in veterans held at least 30 days as POWs. Several studies have shown that POWs suffered serious bone loss following captivity because of dietary deficiencies during their imprisonment. Osteoporosis has not been a major health issue among former POWs until recently, according to the VA, because the condition doesn't typically emerge until late in life. Most former POWs are now in their 80s, according to the VA.

FDA Approvals Increase

The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. The agency attributed many of the delays to resource constraint. There have been 800 new people hired by the FDA to review drug and biologic applications, which should help reduce delays, according to analyst Ira Loss at the firm Washington Analysis. But delays may persist for new diabetes therapies and opioids, he said, noting that the potential for cardiac toxicity and abuse hangs over those products.

E-Rx Systems Boost Savings

Electronic prescribing systems that allow doctors to select lower cost or generic medications can save $845,000 per 100,000 patients per year and possibly more, according to a study funded by the Agency for Healthcare Research and Quality. The researchers examined the change in prescriptions written in community practices before and after two Massachusetts insurers launched e-prescribing systems. Although they found that the doctors prescribed electronically only 20% of the time—generally relying on traditional prescription pads—those who used e-prescribing with formulary support increased generic prescriptions by 3.3%. “Our results likely represent a conservative estimate of the potential savings,” said lead author Dr. Michael Fischer of Brigham and Women's Hospital in Boston. Physicians who wrote electronic prescriptions were slightly younger and more likely to be female than those who did not.

PhRMA Revises Ad Guidelines

The Pharmaceutical Research and Manufacturers of America recently advised drugmakers to state when actors portray medical professionals in direct-to-consumer drug advertisements and to acknowledge any compensation given to real medical professionals in ads. In addition, the new, nonbinding guidelines support the inclusion of “black box” warnings in the ads, and reinforce that companies shouldn't promote off-label uses. Rep. John Dingell (D-Mich.) commended PhRMA for the new guidelines but noted that the organization hasn't endorsed a 2-year prohibition on such ads for newly approved drugs, as recommended by the Institute of Medicine.

Medicare will not cover bariatric surgery for beneficiaries who have type 2 diabetes but do not have a body mass index greater than 35 kg/m

Recent medical reports have claimed that bariatric surgery may be helpful for such patients, but the Centers for Medicare and Medicaid Services “did not find convincing medical evidence that bariatric surgery improved health outcomes for non-morbidly obese individuals,” it said in a statement.

Dr. Barry Straube, the agency's director of its Office of Clinical Standards and Quality, said, “Limiting coverage of bariatric surgery in type 2 diabetic patients whose BMI is less than 35 is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.”

The proposal also clarifies that type 2 diabetes is one of the comorbidities that would be acceptable criteria for surgery.

In 2006, the CMS issued a national coverage decision for bariatric surgery in morbid obesity. It said Medicare would cover three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries with a BMI greater than 35, at least one comorbidity related to obesity, and who had been previously unsuccessful with medical treatment for obesity.

At that time, the agency asked for comments on whether Medicare should cover various gastric and intestinal bypass procedures to improve diabetes status in obese, overweight, and nonoverweight diabetes patients.

The proposed decision memo is an outcome of that query; the CMS accepted comments on the memo until mid-December. The agency had up to 30 days to issue a final decision memo, which is available online at www.cms.hhs.gov/mcd/index_list.asp?list_type=nca

Dr. Jeffrey Mechanick, who cochaired a bariatric surgery guidelines committee for the American Association of Clinical Endocrinologists, said that the CMS was responding to a trend in the medical literature and meeting presentations suggesting that bariatric surgery might be helpful for even those diabetes patients who are not overweight. “A lot of surgeons began noticing that after bariatric surgery, patients with diabetes had amelioration of their hyperglycemia. … But they found that a lot of the improvement was independent of weight loss; there was something else,” he said.

There were two hypotheses: proximal changes, such as factors in the proximal small bowel, and distal changes, such as glucagonlike protein-1 and other factors made by the small bowel in the distal ileum, said Dr. Mechanick, who is also director of metabolic support in the division of endocrinology, diabetes, and bone disease at the Mount Sinai School of Medicine, in New York.

He noted that although the CMS does not currently cover the surgery for patients with a BMI under 35 that could change if long-term follow-up data on the procedure became available.

Dr. Schauer said he was pleased that the agency reaffirmed its support for surgery for diabetes patients with the standard BMI threshold of 35 kg/m

Medicare will not cover bariatric surgery for beneficiaries who have type 2 diabetes but do not have a body mass index greater than 35 kg/m

Recent medical reports have claimed that bariatric surgery may be helpful for such patients, but the Centers for Medicare and Medicaid Services “did not find convincing medical evidence that bariatric surgery improved health outcomes for non-morbidly obese individuals,” it said in a statement.

Dr. Barry Straube, the agency's director of its Office of Clinical Standards and Quality, said, “Limiting coverage of bariatric surgery in type 2 diabetic patients whose BMI is less than 35 is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.”

The proposal also clarifies that type 2 diabetes is one of the comorbidities that would be acceptable criteria for surgery.

In 2006, the CMS issued a national coverage decision for bariatric surgery in morbid obesity. It said Medicare would cover three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries with a BMI greater than 35, at least one comorbidity related to obesity, and who had been previously unsuccessful with medical treatment for obesity.

At that time, the agency asked for comments on whether Medicare should cover various gastric and intestinal bypass procedures to improve diabetes status in obese, overweight, and nonoverweight diabetes patients.

The proposed decision memo is an outcome of that query; the CMS accepted comments on the memo until mid-December. The agency had up to 30 days to issue a final decision memo, which is available online at www.cms.hhs.gov/mcd/index_list.asp?list_type=nca

Dr. Jeffrey Mechanick, who cochaired a bariatric surgery guidelines committee for the American Association of Clinical Endocrinologists, said that the CMS was responding to a trend in the medical literature and meeting presentations suggesting that bariatric surgery might be helpful for even those diabetes patients who are not overweight. “A lot of surgeons began noticing that after bariatric surgery, patients with diabetes had amelioration of their hyperglycemia. … But they found that a lot of the improvement was independent of weight loss; there was something else,” he said.

There were two hypotheses: proximal changes, such as factors in the proximal small bowel, and distal changes, such as glucagonlike protein-1 and other factors made by the small bowel in the distal ileum, said Dr. Mechanick, who is also director of metabolic support in the division of endocrinology, diabetes, and bone disease at the Mount Sinai School of Medicine, in New York.

He noted that although the CMS does not currently cover the surgery for patients with a BMI under 35 that could change if long-term follow-up data on the procedure became available.

Dr. Schauer said he was pleased that the agency reaffirmed its support for surgery for diabetes patients with the standard BMI threshold of 35 kg/m

Medicare will not cover bariatric surgery for beneficiaries who have type 2 diabetes but do not have a body mass index greater than 35 kg/m

Recent medical reports have claimed that bariatric surgery may be helpful for such patients, but the Centers for Medicare and Medicaid Services “did not find convincing medical evidence that bariatric surgery improved health outcomes for non-morbidly obese individuals,” it said in a statement.

Dr. Barry Straube, the agency's director of its Office of Clinical Standards and Quality, said, “Limiting coverage of bariatric surgery in type 2 diabetic patients whose BMI is less than 35 is part of Medicare's ongoing commitment to ensure access to the most effective treatment alternatives with good evidence of benefit, while limiting coverage where the current evidence suggests the risks outweigh the benefits.”

The proposal also clarifies that type 2 diabetes is one of the comorbidities that would be acceptable criteria for surgery.

In 2006, the CMS issued a national coverage decision for bariatric surgery in morbid obesity. It said Medicare would cover three procedures—open and laparoscopic Roux-en-Y gastric bypass surgery, open and laparoscopic biliopancreatic diversion with duodenal switch, and laparoscopic adjustable gastric banding—for beneficiaries with a BMI greater than 35, at least one comorbidity related to obesity, and who had been previously unsuccessful with medical treatment for obesity.

At that time, the agency asked for comments on whether Medicare should cover various gastric and intestinal bypass procedures to improve diabetes status in obese, overweight, and nonoverweight diabetes patients.

The proposed decision memo is an outcome of that query; the CMS accepted comments on the memo until mid-December. The agency had up to 30 days to issue a final decision memo, which is available online at www.cms.hhs.gov/mcd/index_list.asp?list_type=nca

Dr. Jeffrey Mechanick, who cochaired a bariatric surgery guidelines committee for the American Association of Clinical Endocrinologists, said that the CMS was responding to a trend in the medical literature and meeting presentations suggesting that bariatric surgery might be helpful for even those diabetes patients who are not overweight. “A lot of surgeons began noticing that after bariatric surgery, patients with diabetes had amelioration of their hyperglycemia. … But they found that a lot of the improvement was independent of weight loss; there was something else,” he said.

There were two hypotheses: proximal changes, such as factors in the proximal small bowel, and distal changes, such as glucagonlike protein-1 and other factors made by the small bowel in the distal ileum, said Dr. Mechanick, who is also director of metabolic support in the division of endocrinology, diabetes, and bone disease at the Mount Sinai School of Medicine, in New York.

He noted that although the CMS does not currently cover the surgery for patients with a BMI under 35 that could change if long-term follow-up data on the procedure became available.

Dr. Schauer said he was pleased that the agency reaffirmed its support for surgery for diabetes patients with the standard BMI threshold of 35 kg/m

Reporters and editors from the Elsevier publication “The Pink Sheet” contributed to this column.

Dapagliflozin Goes to Japan

Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, will be developed and commercialized in Japan, AstraZeneca and Bristol-Myers Squibb announced last month. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in phase III clinical trials in several countries, including the United States, to assess its efficacy and safety as a once-daily treatment for type 2 diabetes. The two companies will jointly market the product in Japan, where the drug is currently in phase II trials, sharing all expenses and splitting profits or losses equally. “Bristol-Myers Squibb and AstraZeneca have been working together to develop dapagliflozin for type 2 diabetes for nearly 2 years, [and] this inclusion of Japan was a natural progression of our collaboration and an important strategic step in our relationship,” said Lamberto Andreotti, executive vice president and chief operating officer of Bristol-Myers Squibb. “Our companies have a shared vision for these diabetes treatments, and this agreement will help ensure we can successfully launch and maximize the potential of dapagliflozin for the more than 6 million people in Japan living with type 2 diabetes.”

Wyeth Buys Thiakis

Madison, N.J.-based Wyeth has agreed to pay $30 million for Thiakis, a privately held London biotech company, the two firms announced last month. Additional milestone-driven payments of up to approximately $120 million are also available to Thiakis' investors. Thiakis' portfolio includes several synthetic gastrointestinal peptides. The company launched a phase I trial of the lead candidate for appetite control, TKS1225, in March. TKS1225 is a potent, long-acting analogue of oxyntomodulin, a naturally occurring peptide hormone involved in regulating food intake. It is thought to work through the GLP-1 receptor and does not cross the blood-brain barrier, an important consideration given the suicidality risks associated with the CB-1 antagonists, another class of obesity treatments.

Bristol-Myers Signs for XL184

Exelixis has signed a deal with long-term partner Bristol-Myers Squibb for its phase III cancer drug XL184, plus an earlier-stage molecule, that will bring in $240 million in assured payments plus a major codevelopment and marketing role. XL184 is a small-molecule inhibitor of MET, VEGFR2, and RET that just entered phase III clinical trials for use in medullary thyroid cancer, for which there is no currently approved treatment. The compound is also in midstage studies for glioblastoma and is being tested for a variety of other tumor types. The second compound, XL281, is a small-molecule RAF kinase inhibitor in phase I development for advanced solid-tumor cancers. In October, GlaxoSmithKline declined to license XL184, probably because it had already licensed a similar compound, XL880, from Exelixis. Under the terms of the licensing agreement with Bristol-Myers, that company will pay Exelixis $240 million in cash upfront, $45 million of it in two installments during the first half of 2009. Exelixis plans to begin “substantial” R&D for both XL184 and XL281 in 2009 and 2010.

Novo Nordisk, VLST Sign Pact

Novo Nordisk has inked a deal with VLST Corp., a Seattle-based biotechnology company, to develop treatments for autoimmune disorders, including diabetes. Under the terms of the agreement, Novo Nordisk and VLST will jointly undertake a research program to identify collaboration targets and develop product candidates. VLST will receive an upfront payment and equity investment totaling about $12 million; the company also is eligible for payments dependent on achieving clinical and regulatory milestones across multiple disease indications, Novo Nordisk said in a statement. Novo Nordisk also will fund the salaries of VLST researchers for the next 3 years, and will provide resources to move product candidates through preclinical development, clinical development, and commercialization. The research collaboration will run for 3 years, with an option to extend the agreement. “VLST's platform technology provides a promising avenue for Novo Nordisk to continue expanding and enhancing its research and development in the field of autoimmune and inflammatory disorders,” said Terje Kalland, senior vice president and head of the biopharmaceuticals research unit at Novo Nordisk. “As Novo Nordisk continues to build its presence in Seattle, the collaboration with VLST marks an important step in our overall strategy to develop therapeutics for autoimmune and inflammatory disorders.”

DexCom CGM Gets European OK

DexCom has received the CE mark in the European Union for SEVEN, the company's 7-day continuous glucose monitoring system, allowing it to market the system in Europe as well as in Asian and Latin American countries that recognize the mark. “We are pleased to have CE mark approval for the SEVEN, and we look forward to working with physicians, nurses, and diabetes educators to bring this important technology to patients around the world,” Terrance H. Gregg, DexCom's president and CEO, said in a statement.

Reporters and editors from the Elsevier publication “The Pink Sheet” contributed to this column.

Dapagliflozin Goes to Japan

Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, will be developed and commercialized in Japan, AstraZeneca and Bristol-Myers Squibb announced last month. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in phase III clinical trials in several countries, including the United States, to assess its efficacy and safety as a once-daily treatment for type 2 diabetes. The two companies will jointly market the product in Japan, where the drug is currently in phase II trials, sharing all expenses and splitting profits or losses equally. “Bristol-Myers Squibb and AstraZeneca have been working together to develop dapagliflozin for type 2 diabetes for nearly 2 years, [and] this inclusion of Japan was a natural progression of our collaboration and an important strategic step in our relationship,” said Lamberto Andreotti, executive vice president and chief operating officer of Bristol-Myers Squibb. “Our companies have a shared vision for these diabetes treatments, and this agreement will help ensure we can successfully launch and maximize the potential of dapagliflozin for the more than 6 million people in Japan living with type 2 diabetes.”

Wyeth Buys Thiakis

Madison, N.J.-based Wyeth has agreed to pay $30 million for Thiakis, a privately held London biotech company, the two firms announced last month. Additional milestone-driven payments of up to approximately $120 million are also available to Thiakis' investors. Thiakis' portfolio includes several synthetic gastrointestinal peptides. The company launched a phase I trial of the lead candidate for appetite control, TKS1225, in March. TKS1225 is a potent, long-acting analogue of oxyntomodulin, a naturally occurring peptide hormone involved in regulating food intake. It is thought to work through the GLP-1 receptor and does not cross the blood-brain barrier, an important consideration given the suicidality risks associated with the CB-1 antagonists, another class of obesity treatments.

Bristol-Myers Signs for XL184

Exelixis has signed a deal with long-term partner Bristol-Myers Squibb for its phase III cancer drug XL184, plus an earlier-stage molecule, that will bring in $240 million in assured payments plus a major codevelopment and marketing role. XL184 is a small-molecule inhibitor of MET, VEGFR2, and RET that just entered phase III clinical trials for use in medullary thyroid cancer, for which there is no currently approved treatment. The compound is also in midstage studies for glioblastoma and is being tested for a variety of other tumor types. The second compound, XL281, is a small-molecule RAF kinase inhibitor in phase I development for advanced solid-tumor cancers. In October, GlaxoSmithKline declined to license XL184, probably because it had already licensed a similar compound, XL880, from Exelixis. Under the terms of the licensing agreement with Bristol-Myers, that company will pay Exelixis $240 million in cash upfront, $45 million of it in two installments during the first half of 2009. Exelixis plans to begin “substantial” R&D for both XL184 and XL281 in 2009 and 2010.

Novo Nordisk, VLST Sign Pact

Novo Nordisk has inked a deal with VLST Corp., a Seattle-based biotechnology company, to develop treatments for autoimmune disorders, including diabetes. Under the terms of the agreement, Novo Nordisk and VLST will jointly undertake a research program to identify collaboration targets and develop product candidates. VLST will receive an upfront payment and equity investment totaling about $12 million; the company also is eligible for payments dependent on achieving clinical and regulatory milestones across multiple disease indications, Novo Nordisk said in a statement. Novo Nordisk also will fund the salaries of VLST researchers for the next 3 years, and will provide resources to move product candidates through preclinical development, clinical development, and commercialization. The research collaboration will run for 3 years, with an option to extend the agreement. “VLST's platform technology provides a promising avenue for Novo Nordisk to continue expanding and enhancing its research and development in the field of autoimmune and inflammatory disorders,” said Terje Kalland, senior vice president and head of the biopharmaceuticals research unit at Novo Nordisk. “As Novo Nordisk continues to build its presence in Seattle, the collaboration with VLST marks an important step in our overall strategy to develop therapeutics for autoimmune and inflammatory disorders.”

DexCom CGM Gets European OK

DexCom has received the CE mark in the European Union for SEVEN, the company's 7-day continuous glucose monitoring system, allowing it to market the system in Europe as well as in Asian and Latin American countries that recognize the mark. “We are pleased to have CE mark approval for the SEVEN, and we look forward to working with physicians, nurses, and diabetes educators to bring this important technology to patients around the world,” Terrance H. Gregg, DexCom's president and CEO, said in a statement.

Reporters and editors from the Elsevier publication “The Pink Sheet” contributed to this column.

Dapagliflozin Goes to Japan

Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, will be developed and commercialized in Japan, AstraZeneca and Bristol-Myers Squibb announced last month. Dapagliflozin, one of two investigational drugs under joint development by the companies, is currently being studied in phase III clinical trials in several countries, including the United States, to assess its efficacy and safety as a once-daily treatment for type 2 diabetes. The two companies will jointly market the product in Japan, where the drug is currently in phase II trials, sharing all expenses and splitting profits or losses equally. “Bristol-Myers Squibb and AstraZeneca have been working together to develop dapagliflozin for type 2 diabetes for nearly 2 years, [and] this inclusion of Japan was a natural progression of our collaboration and an important strategic step in our relationship,” said Lamberto Andreotti, executive vice president and chief operating officer of Bristol-Myers Squibb. “Our companies have a shared vision for these diabetes treatments, and this agreement will help ensure we can successfully launch and maximize the potential of dapagliflozin for the more than 6 million people in Japan living with type 2 diabetes.”

Wyeth Buys Thiakis

Madison, N.J.-based Wyeth has agreed to pay $30 million for Thiakis, a privately held London biotech company, the two firms announced last month. Additional milestone-driven payments of up to approximately $120 million are also available to Thiakis' investors. Thiakis' portfolio includes several synthetic gastrointestinal peptides. The company launched a phase I trial of the lead candidate for appetite control, TKS1225, in March. TKS1225 is a potent, long-acting analogue of oxyntomodulin, a naturally occurring peptide hormone involved in regulating food intake. It is thought to work through the GLP-1 receptor and does not cross the blood-brain barrier, an important consideration given the suicidality risks associated with the CB-1 antagonists, another class of obesity treatments.

Bristol-Myers Signs for XL184

Exelixis has signed a deal with long-term partner Bristol-Myers Squibb for its phase III cancer drug XL184, plus an earlier-stage molecule, that will bring in $240 million in assured payments plus a major codevelopment and marketing role. XL184 is a small-molecule inhibitor of MET, VEGFR2, and RET that just entered phase III clinical trials for use in medullary thyroid cancer, for which there is no currently approved treatment. The compound is also in midstage studies for glioblastoma and is being tested for a variety of other tumor types. The second compound, XL281, is a small-molecule RAF kinase inhibitor in phase I development for advanced solid-tumor cancers. In October, GlaxoSmithKline declined to license XL184, probably because it had already licensed a similar compound, XL880, from Exelixis. Under the terms of the licensing agreement with Bristol-Myers, that company will pay Exelixis $240 million in cash upfront, $45 million of it in two installments during the first half of 2009. Exelixis plans to begin “substantial” R&D for both XL184 and XL281 in 2009 and 2010.

Novo Nordisk, VLST Sign Pact

Novo Nordisk has inked a deal with VLST Corp., a Seattle-based biotechnology company, to develop treatments for autoimmune disorders, including diabetes. Under the terms of the agreement, Novo Nordisk and VLST will jointly undertake a research program to identify collaboration targets and develop product candidates. VLST will receive an upfront payment and equity investment totaling about $12 million; the company also is eligible for payments dependent on achieving clinical and regulatory milestones across multiple disease indications, Novo Nordisk said in a statement. Novo Nordisk also will fund the salaries of VLST researchers for the next 3 years, and will provide resources to move product candidates through preclinical development, clinical development, and commercialization. The research collaboration will run for 3 years, with an option to extend the agreement. “VLST's platform technology provides a promising avenue for Novo Nordisk to continue expanding and enhancing its research and development in the field of autoimmune and inflammatory disorders,” said Terje Kalland, senior vice president and head of the biopharmaceuticals research unit at Novo Nordisk. “As Novo Nordisk continues to build its presence in Seattle, the collaboration with VLST marks an important step in our overall strategy to develop therapeutics for autoimmune and inflammatory disorders.”

DexCom CGM Gets European OK

DexCom has received the CE mark in the European Union for SEVEN, the company's 7-day continuous glucose monitoring system, allowing it to market the system in Europe as well as in Asian and Latin American countries that recognize the mark. “We are pleased to have CE mark approval for the SEVEN, and we look forward to working with physicians, nurses, and diabetes educators to bring this important technology to patients around the world,” Terrance H. Gregg, DexCom's president and CEO, said in a statement.